TW201716100A - Systems and methods for flow stagnation control - Google Patents

Abstract

The present disclosure describes flow stagnation control components that allow improved flow control in systems including injection members, while also limiting the creation of regions of little to no flow in the vasculature, resulting in low flow zones or dead zones. The flow stagnation control components can be formed as an imposed minimum conductance component or a controlled flow partitioning system.

Description

System and method for flow blockage control

In the design of intravascular catheters, occlusion devices are commonly used to control or block flow in an artery or vein. However, in some cases, occlusion of an artery or vein produces a region of a stagnant or no-flow zone in which blood does not move (i.e., also referred to as a "dead zone"). In some cases, long-term production of one of the dead zones in the bloodstream may increase the risk of developing a thrombus or blood clot that may be associated with an increased risk of embolization in the patient.

The present invention provides exemplary systems, devices, devices, and methods that allow control of blood flow in a portion of an artery or vein to control the occurrence and duration of low or no flow regions (including dead regions) in a portion of the vessel. In particular, the illustrative systems, methods, devices, and devices allow for the control of flow tampering through the use of an additional minimum conducting component or a controlled shunt system.

In one example, the systems, devices, devices, and methods use one of a catheter, an injector member, or other instrument coupled to a minimally conductive member to control the flow rate of blood flow in an artery or vein to control low The occurrence and duration of a flow or no flow zone (including dead zones).

In one example, the systems, devices, devices, and methods are structurally designed to calculate the catheter, injector based on sensor measurements coupled to at least two pressure sensors of the catheter, injector member, or other instrument. The vascular portion around a component or part of another instrument The value of the conduction, and the occurrence and duration of the low or no flow zone (including the dead zone) is controlled based on the calculated conduction values.

The illustrative systems, devices, and devices can include an extracorporeal circuit and an externally-accurate component. The extracorporeal circuit includes: a first-class helium for returning blood from the extracorporeal circuit to a vessel in one of the body regions; and at least one injector member engineered to cause blood to be injected into the vessel Flow at the point. The at least one injector member includes a lumen and a distal tip. The additional minimum conductive component is disposed at a proximal end of the distal tip of the at least one injector member.

The illustrative systems, devices, and devices can be structurally designed to implement a method using an applied minimum conductive member. The method includes coupling an extracorporeal circuit to a portion of a body. The extracorporeal circuit includes: a first-class helium for returning blood from the extracorporeal circuit to a vessel in one of the body regions; and at least one injector member engineered to cause blood to be injected into the vessel Flow at the point. The at least one injector member includes a lumen and a distal tip. An additional minimum conductive component is disposed at a proximal end of the distal tip of the at least one injector member. The method further includes causing the injected flow from the at least one injector member to be at a rate such that a net or average countercurrent or downstream flow is maintained above the at least one injector member at a predetermined minimum flow rate in.

Exemplary systems, devices, and devices can include an extracorporeal loop and a controlled shunt system. The extracorporeal circuit includes: a first-class helium for returning blood from the extracorporeal circuit to a vessel in one of the body regions; and an injector member that is structurally designed to cause blood to be injected at a vessel Flowing. The at least one injector member includes a lumen and a distal tip. The control shunt system includes: a first pressure sensor for measuring a first parameter indicative of a flow at a proximal end of one of the distal ends of the injector member; a second pressure sensor a second parameter for measuring the indicator flow, the second sensor being disposed at a proximal end of the injector member at a predefined distance from the proximal end of the distal tip; and an injection flow rate source Coupled to the extracorporeal circuit to cause the injection flow to be at a pre-injection point at the vessel Constant flow rate mode.

The illustrative systems, devices, and devices can be structurally designed to implement a method using a controlled shunt system. The method includes coupling an extracorporeal circuit to a portion of a body. The extracorporeal circuit includes: a primary sputum for returning blood from the extracorporeal circuit to a vessel at a region of a body; and an injector member coupled to the sputum. The injector member includes a distal tip and a shaft member having a lumen. The control shunt system includes: at least one first pressure sensor disposed at a proximal end of the distal tip; at least one second pressure sensor disposed on an outer surface of one of the shaft members of the injector member And an injection flow rate source coupled to the injection member to control fluid flow from one of the distal tips of the injector member. The method includes controlling, at a time interval T, a fluid flow injected at a distal tip end of the injector member to a predetermined flow rate mode using the injection flow rate source; during the time interval T, using the first a pressure sensor and the second pressure sensor recording a pressure measurement; and calculating a proximal external conduction of the distal end of the injector member using data indicative of the pressure measurement and the predetermined flow rate pattern Or a remote external conduction value.

The illustrative systems, devices, and devices can include an extracorporeal circuit, a control shunt system, and a console. The extracorporeal circuit can include: a primary sputum for returning blood from the extracorporeal circuit to one of the vessels at a region of the body; and an injector member including a distal tip. The control shunt system includes a first pressure sensor disposed at a proximal end of the distal tip of the at least one injector member, and a second pressure sensor spaced apart from a proximal end of the distal tip A predetermined spacing is disposed at an outer surface of the at least one injector member; and an injection flow rate source coupled to the injection member to control a flow rate of fluid from the distal tip to a predetermined flow rate mode. The console includes at least one processing unit, the at least one processing unit being programmed to: in a time interval T, receive indication that the blood flow is injected at the distal tip according to the predetermined flow rate pattern Data for pressure measurement by the first pressure sensor and the second pressure sensor; and calculating the distance of the at least one injector member using data indicative of the pressure measurement and the predetermined flow rate pattern At least one of a proximal external conduction or a distal external conduction at the tip end.

The illustrative systems, devices, and devices can be structurally designed to implement a method that includes an extracorporeal circuit. The extracorporeal circuit includes: a primary sputum for returning blood from the extracorporeal circuit to a vessel at a region of a body; an injector member coupled to the sputum, the injector member including a a distal tip and a shaft having a lumen; at least a first pressure sensor disposed at a proximal end of the distal tip; at least a second pressure sensor disposed on the axis of the injector member On one of the outer surfaces; and an injection flow rate source coupled to the injector member to control fluid flow from one of the distal tips of the injector member. The method includes coupling the extracorporeal circuit to a portion of a body; using the source of the injection flow rate to control fluid flow injected at a distal tip end of the injector member to a predetermined flow during a first time interval T1 Rate mode; during the first time interval T1, the first pressure sensor and the second pressure sensor are used to record the pressure measurement; and the data indicating the pressure measurement and the predetermined flow rate mode are used to calculate One of the proximal ends of the distal end of the injector member conducts a value; the first and second pressure measurements and the calculated proximal external conduction are used to calculate an external flow rate, and the external flow rate is used Calculating the ratio of the injected flow rate to the external flow rate in the distal mixed fluid; and controlling the amount of the drug or medicament added to the injected fluid, and using the calculated ratio of the injected flow rate to the external flow rate This amount is such that a specified concentration of one of the drug or agent is achieved in the mixed distal fluid.

It will be understood that all combinations of the foregoing concepts and additional concepts discussed in more detail below, which are not mutually exclusive, are considered to be part of the subject matter disclosed herein. In particular, all combinations of claimed subject matter appearing at the end of the invention are considered as part of the subject matter of the invention disclosed herein. It is also to be understood that the terminology that is explicitly employed in the context of any of the disclosures that are incorporated by reference is to be accorded the meaning of one of the specific concepts disclosed herein.

100‧‧‧ catheter system

101‧‧‧Axis/Shaft Member Holder/Shaft Device

102‧‧‧ plane

103‧‧‧Occlusion components

200‧‧‧External loop

203‧‧‧Occlusion components

205‧‧‧dead area

206‧‧‧ pump system

208‧‧‧ heat exchanger

210‧‧‧Injector components

212‧‧‧Vascular injection point

214‧‧‧ blood

216‧‧‧Injection fluid

320‧‧‧ lumen

321‧‧‧Components/soft airbags

324‧‧‧ Forward new flushing flow

326‧‧‧Backwash flow

328‧‧‧ blood flow

421‧‧‧ components

424‧‧‧Backwash flow

426‧‧‧ Forward flushing flow

428‧‧‧ blood flow

430‧‧ ‧ holes / orifices

431‧‧‧ hole/aperture

440‧‧‧Spring driven film

442‧‧‧ fluid flow

450‧‧‧Multi-leaf soft airbag

455‧‧‧Double leaf soft airbag

460‧‧‧ gap

465‧‧‧Three-leaf soft airbag

470‧‧‧ gap

510‧‧‧ bias valve

521‧‧‧Components/soft airbags

532‧‧‧Offset valve

534‧‧‧ flow

538‧‧‧ blood flow

540‧‧‧Offset valve

542‧‧‧ bypass lumen

548‧‧‧ blood flow

610‧‧‧First pressure sensor

610'‧‧‧ Pressure Sensor

612‧‧‧Second pressure sensor

612'‧‧‧ Pressure Sensor

614‧‧‧Injector member/insert member/inner shaft member

615‧‧‧ blood flow

616‧‧‧Flow rate source

617‧‧‧ blood flow

618‧‧‧Outer shaft parts

620‧‧‧catheter members/catheters

622‧‧‧ Near-end 埠

700‧‧‧Extracorporeal system

700'‧‧‧Extracorporeal system

700"‧‧‧Extracorporeal system

710‧‧‧Main vein-arterial (VA) extracorporeal circuit

711‧‧‧ first

712‧‧‧ pump

713‧‧‧Oxygenator

714‧‧‧Main loop oxygenator/heat exchanger

715‧‧‧Second

716‧‧‧Displacement or volume driven pump

718‧‧‧Regional injector branch

720‧‧‧ heat exchanger

721‧‧‧third

722‧‧‧ distal injector member

724‧‧‧Area

726‧‧‧ plus minimum conductive components

728‧‧‧Coupling pressure sensor pair

800‧‧‧External loop system

802‧‧‧ console

810‧‧‧Main vein-arterial (VA) extracorporeal circuit

811‧‧‧ first

812‧‧‧ pump

813‧‧‧Oxygenator

814‧‧‧ heat exchanger

815‧‧‧Second

816‧‧‧Displacement or volume driven pump

818‧‧‧ branch

820‧‧‧ heat exchanger

821‧‧‧ third

822‧‧‧ distal injector member

826‧‧‧ plus minimum conductive components

828‧‧‧ Pressure sensor pair

850‧‧‧ system

852‧‧‧ console

860‧‧‧Flow rate control source

862‧‧‧Liquid

872‧‧‧ distal injector member

876‧‧‧plus minimum conductive components

878‧‧‧ Pressure sensor pair

905‧‧‧ console

907‧‧‧Processing unit

909‧‧‧ memory

911‧‧‧ display unit

1002‧‧‧Steps

1004‧‧‧Steps

1006‧‧‧Steps

1052‧‧‧Steps

1054‧‧‧Steps

1056‧‧‧Steps

1058‧‧‧Steps

1060‧‧‧Steps

1110‧‧‧ Computing Devices

1112'‧‧‧ processor

1114‧‧‧ core

1114'‧‧‧ core

1118‧‧‧Multi-touch interface

1120‧‧‧ pointing device

1124‧‧‧Virtual Machine

1126‧‧‧ operating system

1132‧‧‧Network devices

1134‧‧‧Storage device

1140‧‧‧Software application

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 average person will understand that the drawings are primarily for illustration purposes and are not intended to be limiting The scope of the subject matter of the invention described herein. The figures are not necessarily to scale; in some instances, various aspects of the subject matter of the invention disclosed herein may be shown in the drawings as enlarged or enlarged to facilitate understanding of one of the different features. In the drawings, like reference characters generally refer to similar features (e.g., functionally similar and/or structurally similar elements).

1A shows a schematic diagram of an exemplary catheter system in accordance with the principles of the present invention.

1B-1C show an illustrative graph of fluid conduction in a vascular space across a boundary.

2A shows an exemplary extracorporeal circuit in accordance with the principles of the present invention.

2B-2C show schematic views of another catheter system in accordance with the principles of the present invention.

3A-3B show an example of another catheter system in accordance with the principles of the present invention.

4A-4B show an example of another catheter system in accordance with the principles of the present invention.

4C shows an example of another catheter system in accordance with the principles of the present invention.

Figures 4D(i) and 4D(ii) show an example of another catheter system in accordance with the principles of the present invention.

5A(i) and 5A(ii) show an example of one of the biasing valves on one of the apertures in an exemplary catheter system in accordance with the principles of the present invention.

Figure 5B shows an example of one of the biasing valves on one of the apertures in an exemplary catheter system in accordance with the principles of the present invention.

Figure 5C shows an example of one of the biasing valves on one of the apertures in an exemplary catheter system in accordance with the principles of the present invention.

6A shows an exemplary injector member coupled to a pressure sensor in an exemplary catheter system in accordance with the principles of the present invention.

6B shows another exemplary injector member coupled to a pressure sensor in an exemplary catheter system in accordance with the principles of the present invention.

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

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

7A shows an exemplary extracorporeal loop system in accordance with the principles of the present invention.

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

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

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

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

9 is a block diagram showing an exemplary computing device in accordance with the principles of the present invention.

10A-10B are flow diagrams illustrating exemplary methods in accordance with the principles of the present invention.

11 is a block diagram of an exemplary computing device in accordance with the principles of the present invention.

The following are various concepts of systems, devices, devices, and methods for allowing control of blood flow in one portion of an artery or vein to control the occurrence and duration of low or no flow regions (including dead regions) in a portion of the vessel. A more detailed description of its embodiments. Exemplary systems, methods, devices, and devices that allow for control of at least two regions of selective thermal therapy are also described. It will be appreciated that the various concepts described above and discussed in greater detail below may be implemented in any of numerous ways, as the disclosed concepts are not limited to any particular implementation. Examples of specific embodiments and applications are provided primarily for illustrative purposes.

As used herein, the term "include" is intended to include, without limitation, the term "including" is intended to include, without limitation. The term "based on" means at least in part based on.

With respect to the surfaces described herein in connection with the examples of the principles herein, any reference to the "top" surface and the "bottom" surface is primarily used to indicate various components/components. The relative position, alignment, and/or orientation of the plates and each other, and such terms do not necessarily indicate any particular frame of reference (eg, a gravitational reference frame). Thus, reference to a "bottom" of a surface or layer does not necessarily require that the indicated surface or layer be facing the ground. Similarly, terms such as "above", "below", "above", "below" and the like do not necessarily indicate any particular reference frame (such as a gravitational reference frame), but rather are primarily used to indicate various components/components relative to the surface. And relative position, alignment and/or orientation of each other.

The terms "placed on" and "placed above" cover the meaning of "embedded in" (including "partially embedded in"). In addition, references to feature A "placed on feature B", "placed between feature B" or "placed over feature B" encompass instances in which 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" refers to the direction in which one of a catheter, an injector member, or other instrument, such as, but not limited to, a handle or other handle, will be operated toward a user. As used herein, the term "distal" refers to the direction of one of the grips or other handles that are remote from 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.

During certain procedures using a catheter, blood flow to a vein or an artery can be occluded. No flow or low flow zones (including dead zones) may occur in portions of the vessel whenever the blood flow is at least partially blocked. For example, an intravascular catheter or other similar device can include an occluding 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 result in a region of markedly reduced blood flow or a no-flow zone 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 zone (including dead zones) continues for a long period of time, the tissue may be deficient in blood flow and may be damaged. In some cases, long-term production of one of the dead zones in the bloodstream may increase the risk of developing a thrombus or blood clot associated with an increased risk of embolism in one of the patients. Generate questions about how to minimize these risks caused by blocking.

In some systems, the risk of truncation to the blood flow from an artery to the tissue is addressed by the addition of a bypass or perfusion lumen as described in U.S. Patent Nos. 5,046,503 and 5,176,638.

The present invention describes various exemplary systems, methods and apparatus for controlling blood flow in a portion of an artery or vein to control the occurrence and duration of low or no flow regions in a portion of the vessel. As a non-limiting example, the systems, devices, devices, and methods can be used to control the occurrence and duration of dead zone regions in a portion of a vessel.

In some examples, systems, methods, and devices are described for controlling (including reducing) flow fouling during use of an intravascular catheter or other similar device. Exemplary systems, devices, and methods for controlling or reducing the occurrence of no-flow or low-flow regions in a vessel based on data indicative of conduction of a vascular region are described. Control of the flow blockage can be achieved using at least one additional minimum conduction component or using a control flow distribution system. An exemplary additional minimal conduction component can be used to apply a desired known conduction value to the vascular region. If the conductance outside the injector member is known, the fluid injection level at the injection member can be controlled such that there is a certain amount in a region that would normally form a no-flow or low-flow region (including a dead region) The fluid stream is used for rinsing. An exemplary control shunt system can use sensor measurements to calculate conduction in a vascular region, thereby providing a known conduction value. That is, any of these methodologies can be used to provide a known value for conduction outside of the catheter member. Using such known conductance values, the fluid flow can be controlled to ensure that no flow or low flow regions are present in the vessel, or that the duration of the absence of flow or low flow regions does not result in tissue damage or other damage.

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

According to some exemplary embodiments, flow blockage control can be achieved using a controlled split 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 region of the proximal end of the injector member by modifying the flow injected at an injection member. Exemplary devices, systems, and The method can be passively operated to measure fluid flow, or can be actively used to measure fluid flow by introducing or extracting a quantity of fluid.

The present invention describes devices, systems, and methods that can be actively operated to prevent or reduce the occurrence of a dead zone (including flushing) in one of the vessels 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 controlling the decrease in flow rate in a vessel segment while ensuring that the flow rate is not below one of the minimum values based on an applied minimum conduction level. In this paper, conduction is the reciprocal of the resistance. In various examples, the minimum conduction level can be used to control the flow to a fixed flow rate value within a time period t of less than a program time length T (ie, t << T ) (referred to herein as " Fixed constant ") or an average flow rate value (referred to herein as "fixed average"). For example, the time period t can be a heartbeat or minute level, and the time period T can be one of one or more hours of operation or other program.

According to some exemplary embodiments, flow blockage control may be accomplished by the use of structurally designed to allow improved flow control in extracorporeal blood return plus minimal conduction components and systems. The present invention also provides various exemplary additional minimally conductive components that limit or prevent the formation of dead zones in one of the arteries or veins proximal to the minimally conductive component, and also provide specific dead zone rinsing 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 part of an independent catheter system or as an exemplary extracorporeal loop system for injecting blood into a vessel at a particular body location. One of the components.

As used herein, the term "vascular injection point" refers to the most distal location in a vessel away from a catheter inlet or vascular puncture site where blood is injected into the body.

As used herein, the term "peripheral placement loop" refers to having a place to be placed with One part of the body's vasculature is exposed without the need for a detailed guide to the blood output (from the body to the loop) and blood input (from the loop to the fluoroscopy or any other equivalent system that is normally used to guide the device through the arterial or venous branches) One of the catheters (or other input flow and/or output flow components) is an exemplary extracorporeal circuit. This is a subset of all possible placements, some placement through the peripheral loop and some placement through the central loop.

The term "periphery" is used herein in connection with the use of a peripheral circulation system. For example, a catheter (or other input flow and/or output flow 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 seen as part of the central system rather than the peripheral circulation system.

As used herein, the term "systemic perfusion system" refers to a system of blood coupled into the heart via an injector member that is directly coupled to the main vein feeder to the heart, such as the vena cava (inferior vena cava) Or superior vena cava) or iliac vein.

As used herein, the term "local perfusion system" refers to an injector that has been placed such that a major portion of the injected blood flow (greater than about 50%) is fed to an organ system prior to returning to the heart through a general circulation. One of the components of the 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 infusion 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 proximal external conduction or the distal external conduction, and then use the measurements to modify an injection. The injection flow rate at the component prevents one of the dead flow regions in the region of the proximal end of the injector member. As used herein, such a system is directly controlled by at least two pressure sensors and through the injector member on the extracorporeal loop side of the injector member The flow rate is one of the displacement or flow rate control pump components. In any of the examples herein, the control shunt system can include a distributed pressure sensor array.

As used herein, the term "flow rate mode" refers to a form of function that is one of the flow rates over a set period of time. For example, the fluid flow can be set at a source of fluid flow rate such that the fluid flow follows a value set by the flow rate mode. In various examples, the flow rate pattern can be a specified functional form such as, but not limited to, a sinusoidal function form, a sawtooth function form, a functional function of a step function, or another periodic function form of the art ( Contains more complex function forms). In other examples in which the flow rate pattern has an irregular function form, the flow rate value can be measured at regular time intervals over a specified time period to provide an approximation of one of the irregular function forms.

In a non-limiting example herein, an additional minimum conductive component can be structurally designed to set a known specified proximal conduction around a distal region of one of the implant members. This proximal conduction prevents the formation of any no-flow or dead-flow regions. As another example, in controlling a shunt system according to one of the principles herein, measuring the conduction present in the proximal outer portion of an injection member (rather than generating the conduction) and using the measurement to control the relevant region (including Flow rate and flushing of any no-flow or dead-flow zone).

In one example herein, a "bias valve" refers to one of the components of a wall of a conduit section between an internal lumen and the exterior of the shaft member that is exposed to the vessel. In one example, the "bias valve" can be structurally designed such that if the pressure within the lumen is greater than the pressure outside the shaft, there is a value of conduction G _forward established across the valve. In another example, the "bias valve" can be structurally designed such that if the pressure within the lumen is less than the pressure outside the shaft, there is a value of the conduction G _backward established across the valve. In one example, a reasonable pressure difference between the lumen and the vessel can be expressed as G _forward >>G _backward , or G _{backward is} very small or near zero.

1A shows a schematic diagram of an exemplary catheter system 100 including one of the shaft members 101 disposed in one of the portions of the vessel. Figure 1A also shows a plane 102 that occludes the assembly 103 through one of the portions of the device that is mounted to the shaft member 101. Shaft retaining device 101 A lumen can be included through one of the devices. In an exemplary catheter system 100, the occlusion assembly 103 can include an inflation balloon that is inflated with saline or other solution. Another exemplary occlusion assembly 103 can include an expansion to squeeze a membrane of an artery wall using a force applied by a spring or other mechanical actuation. In one example, the occlusion assembly 103 can be structurally designed to extend from the shaft member 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 FIG. 1A, the exemplary plane 102 is perpendicular to the arterial segment. The exemplary occlusion assembly 103 is used to modify fluid flow across the plane 102 in accordance with the principles herein. The fluid flow is related to the flow outside the base of the retaining shaft member. The degree of flow is driven by a pressure differential between the zone (Pb) in front of the occlusion assembly 103 and the zone (Pa) behind the occlusion assembly 103.

1B and 1C shows the fluid-conducting (G ₀₎ versus time graph illustrative of a space in the vessel occlusion assembly 103 through the cross-plane 102 of the. Figure 1B shows the use of occlusive assembly 103 to achieve complete occlusion of one of the conducting fluid (G ₀₎ versus time. 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 IB shows that fluid conduction becomes zero when the occlusion assembly 103 is activated for complete occlusion. This definition is independent of the 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, the conduction does not change to zero but instead becomes one of the smallest conduction levels having a magnitude greater than zero.

A catheter can be deployed in various target locations in the vessel. However, it is extremely difficult to precisely control the diameter of the vessel at the target position. If there are no occluding elements or no occluding elements are deployed, the bleed may be large and the bleed may then prevent optimal control of the cis (distal zone) fluid flow. This is constrained by the fact that the fluid is larger in larger diameter arteries and less fluid in the case of smaller arteries. On the other hand, a complete occlusion can result in the formation of a dead zone. In accordance with the principles herein, a small controlled bleed structure can be used in conjunction with the occlusion assembly such that the dead zone is flushed but the leakage is limited such that it does not have a valuable control error for the remote flow due to the use of the device. For a flow rate similar to blood flow in the carotid or femoral artery, a 200 to 500 The forward flow rate of ml/min will be extremely useful, but a flush flow rate of 20 to 50 ml/min or even less may be suitable for flushing the dead zone.

As described herein, the minimum conduction level can be a fixed constant or a fixed average. For a fixed constant, the fluid conductance G ₀ remains constant over time. For a fixed average, the minimum conduction can be time-varying at a time scale t that is less than one of the total device startup times. In an example, a biasing valve can be structurally designed to effect occlusion of the controlled portion such that conduction varies with a heartbeat. In this example, "fixed average" refers to a change in value during a time cycle of a heartbeat but with one of the non-zero averages of the heartbeat as the heartbeat. This results in a non-zero average fluid conduction over a longer period of time.

In an example, the applied minimum conduction is implemented as a fixed constant form. One of the distal conductive tips positioned at the distal tip of an extracorporeal injection member is structurally designed to maintain a minimum conduction that provides a fluid flow to flush a dead zone that would otherwise result from any complete occlusion. The minimum conductive flow resistance is sized such that the flushing flow is no greater than about 50%, or preferably no greater than about 10%, of the flow that the device directs through the injector member.

In one example, the applied minimum conduction is implemented in a passive form. An exemplary occlusive element is structurally designed to include an alternate fluid bypass path to allow a bypass flow to flush a dead zone that would otherwise result from occlusion. The flow resistance of the bypass is sized such that the bypass flow is no greater than about 50%, or preferably no greater than about 10%, of the flow that the device directs through the injector member.

In some examples, the occlusion assembly can include a balloon that is to be used for occlusion. In one example, the flexible bladder can be partially inflated to cause some leakage conduction. This can be useful because the vascular tube is uneven and the amount of leakage conduction under a portion of the inflation is invisible to the user and/or controllable.

2A shows a schematic diagram of an exemplary extracorporeal circuit 200 coupled to one of the persons. The exemplary extracorporeal circuit 200 includes a pump system 206, a heat exchanger 208, and an injector member 210. An exemplary extracorporeal circuit can include two connections to the vessel of a patient. This exemplary extracorporeal circuit can be implemented to pump blood from a vessel using one connector and return blood to the vessel using another connector. An exemplary extracorporeal circuit can be used where the heart does not function or does not supply sufficient blood flow, or can be used to modify blood and return blood to the systemic bloodstream or a localized area. Other modifications may include oxidation, dialysis, heating, removal of bacterial contaminants, removal of cancer-causing cells, and the like. 2A shows the vessel member coupled to a person's body at a vessel injection point 212 to return blood 214 to the body's injector member 210 based on a flow rate that is modulated using pump system 206. The most distal position in the vessel (where blood is injected into the body at this location) is referred to herein as the "vascular injection site."

In one example, the injector member 210 can include an occlusion assembly for separating blood flow on one side from fluid injected on the other side by an extracorporeal circuit through the device shaft. This creates a flow-free or restricted flow region, i.e., a dead zone, in one portion of the vessel. If an occlusion system is located at an exact location relative to the nearest vessel branch, the dead zone can be avoided, but in practice, this exact placement cannot be guaranteed in a real patient. Therefore, a dead zone is often formed in a branch containing an injection point and blood not flowing. This can potentially lead to the formation of a thrombus or blood clot if the occlusion remains in place for a prolonged period of time. The extracorporeal blood supply circuit can be used for a prolonged period of time (such as, but not limited to, a time of the hour to the day), which can be sufficient to increase the risk of thrombosis or blood clot formation.

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

2C shows an exemplary injector member 210 that is an assembly of the exemplary extracorporeal circuit system of FIG. 2A and returns blood (injection fluid 216) to a particular location in the body. The injector member 210 is coupled to one of the occlusion assemblies 203 that is shown to partially occlude one of the vessels. As shown in FIG. 2C, the injector member 210 is permeable to the occlusion device 203. A dead zone 205 can be formed at the proximal end of the occlusion assembly 203 when blood is injected at the tube injection point.

3A-3B show an exemplary external minimum conduction system in accordance with the principles herein. The additional conduction system of Figure 3A includes a lumen 320 having a discrete length l disposed along a shaft of the device and under a component 321 such as, but not limited to, a flexible balloon 321 such that it is The flow used to flush the dead zone provides a minimum conduction. This lumen 320, which is controlled by the design length and diameter, allows the fluid to exhibit a constant flow rate and thus allows for a small bypass flow. FIG. 3A shows a positive new flush flow 324 through lumen 320. FIG. 3B shows a reverse flush flow 326 (backwash flow) through lumen 320. The dashed lines in Figures 3A-3B are used to show the direction of blood flow 328. In both Figures 3A and 3B, fluid flowing through minimal conduction can be used to flush the dead zone at the proximal end of assembly 321 thereby preventing or minimizing unnecessary thrombosis.

4A-4B show another exemplary applied minimum conduction system in accordance with the principles herein. 4A-4B show an exemplary applied minimum conduction system included in one or more of the proximal ends of the assembly 421 (such as but not limited to an air bag), rather than one or more holes or apertures 430 in the shaft of the device, rather than Additional lumens underneath the minimal conductive assembly (as shown in Figures 3A-3B). In such exemplary systems, a portion of the flow 424 of the device directed toward its distal tip leaks through one or more apertures (or apertures) 430 prior to reaching occlusion. Figure 4A also shows the direction of blood flow 428. 4A illustrates an example where the value of pressure Pb is less than pressure Pa, which results in a backwash flow (shown as stream 424). 4B shows an exemplary externally-accepted minimum conduction system in which Pb is sufficiently large relative to Pa to form a positive flushing flow 426.

4C shows another exemplary applied minimum conduction system in accordance with the principles herein. The exemplary external minimum conduction system includes one of one or more apertures (or apertures) 431 plus a minimum conductive 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 applied minimum conduction system of Figure 4C, a cross section of film 440 is depicted. However, film 440 includes symmetric deployment around the device shaft (similar One or more substantially solid film portions in the deployment of an umbrella. 4C also shows the direction of portions of blood flow 428 and fluid stream 442 that escape through one or more of the smallest conductive components (or apertures) 431.

Figures 4D(i) and 4D(ii) show other exemplary applied minimum conduction systems in accordance with the principles herein. The exemplary system of Figure 4D(i) includes a multi-leaf flexible balloon (or other structured balloon) 450 that includes a gap that seals the vessel between the balloon blades to provide minimal conduction. In various examples, a multi-leaf flexible balloon (or other structured balloon) 450 can be formed with two, three or more balloons. Figure 4D(ii) shows a cross-sectional view of a different example of a multi-leaf flexible balloon (or other structured balloon) 450 (through line A-A' shown in Figure 4D(i)). As a non-limiting example, the additional minimal conduction system can include a bilobed soft balloon (or other bilobed structured balloon) 455 that includes a gap 460 or a trilobal soft balloon (or other trilobal structured balloon) that includes a gap 470. .

Figures 5A(i) through 5C show other exemplary extrapolated minimum conduction systems in accordance with the principles herein. In the exemplary system of Figure 5A, a biasing valve 550 is used to add control of the direction of the flush flow to the minimum conduction. Therefore, the directivity can produce a constant constant flow in the direction supported by the pressure difference across the members. As an example, the pressure differential in the vessel may cause a blood pressure shift at the injection point due to each heartbeat change symbol, i.e., a change from a positive pressure value to a negative value based on the systolic/diastolic pressure fluctuation. The exemplary externally-accepted minimum conduction system can be structurally designed such that based on the sign of the pressure differential (ie, direction), the flushing flow can "act" during only a portion of the heartbeat cycle, thereby achieving a "fixed average" minimum conduction rather than a The "fixed constant" is the smallest conduction.

5A(i) shows an exemplary externally-accepted minimum conduction system including a biasing valve 510 on one of the lumens of a catheter lumen including a component 521, such as but not limited to a flexible balloon. The parameters P _in and P _out are the pressures in the lumen and the pressure values outside the proximal end of the airbag 521. In this example, the distal region is the region in which the flow rate and pressure are governed by the flow through the lumen and through the distal tip injection. In general, if P _out is driven by the heart, the value of P _out has a cycle similar to that of the heartbeat, thereby achieving a local maximum and minimum in each cycle. Figure 5A(ii) shows an exemplary biasing valve that can be implemented in the exemplary system of Figure 5A(i). Figure 5A(ii) shows an exemplary biasing valve 510 of a portion of a shaft mounted to a catheter having a lumen that couples the shaft to one of the outer apertures and larger than the aperture and anchored to at least one side A flexible plastic flap covering one of the holes. The exemplary biasing valve is structurally designed such that a positive pressure differential (pressure in the shaft member is greater than pressure outside the shaft member) can cause the flexible plastic flap to open, allowing fluid to flow outwardly and with a negative pressure differential ( The pressure in the shaft member is lower than the pressure outside the shaft member) which causes the flexible plastic flap to close and seal the edge of the hole to block fluid flow inward.

FIG. 5B shows an exemplary external minimum conduction system including a biasing valve 532 coupled to a component 521. The biasing valve 532 includes a flap that is structurally designed to open and allow fluid to flow out of the central lumen of the infusion member but does not allow 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 flow 534 through the flap valve 532 and the direction of blood flow 538. In this example, only a small portion of the blood injected into the body from the extracorporeal circuit is used to flush the dead zone (i.e., flow 534 through the bias valve).

5C shows an exemplary externally-accepted minimum conduction system including one of the flaps acting as a biasing valve 540 on one end of a bypass lumen 542. Similar to the minimal conduction system shown in FIG. 3A or FIG. 3B, the lumen 542 has a discrete length l and is disposed along the shaft of the injector member and below the assembly 521. The coupling action of the biasing valve 540 and the bypass lumen 542 provides a minimum conduction to flush the dead zone (or low flow zone). Figure 5C shows the portion of the flow 544 through the flap valve 540 and the direction of blood flow 548. The flap of the biasing valve 540 can be mounted on the proximal or distal end of the bypass lumen 542, thereby allowing the direction of flushing flow to be selected by design. That is, if the structure is designed to allow only one flap of outward fluid conduction to be mounted at the proximal end of the lumen 542 (as shown in Figure 5C), the distally injected blood is recirculated for irrigation. If the flap is mounted at the distal end of the lumen 542, normal blood flow from the branch is flushed forward and mixed with the injected blood flow at the vessel injection point. The detailed operational portion is determined by the applied pressure difference between P _b (pressure in front of lumen 542) and P _a (pressure behind lumen 542), since the biasing valve can be structurally designed to allow only one direction Flowing on. If the values of the pressures P _a and P _{b are} sufficiently close that the change in P _b caused by the change in contraction/diastolic pressure of the heartbeat causes the bias valve to open during certain time intervals in each cardiac cycle, this exemplary implementation will advantageous.

In accordance with the principles herein, an exemplary external minimal conduction component or an exemplary system comprising an additional minimal conduction component can be used to provide selective thermal therapy. The exemplary external minimal conduction component can be coupled to any system that is structurally designed to apply a selective thermal therapy. In any exemplary implementation, a conventional conductive element can be replaced with a minimum conductive component in accordance with the principles herein. The additional minimally conductive component can be disposed at a proximal end of a distal tip of at least one injector member for use in one of the system's injector members for applying the selective thermal therapy. As a non-limiting example, the addition of a minimally conductive component in accordance with one of the principles herein may be coupled to any system of the art that utilizes selective thermal therapy, such as U.S. Patent No. 7,789,846 B2 or International (PCT) Application No. PCT/ The system disclosed in US 2015/033529.

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 disposed at a proximal end of the tip of the injector member 614 of the catheter, and the second pressure sensor 612 can be spaced from the proximal end of an operator such as from the tip (or from pressure sensing) The 610) measures one of the predefined spacings ([Delta]) disposed on the injector member 614. As a non-limiting example, the predefined spacing ([Delta]) can 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 a sputum-based sensor (with electronic (wired) readout) embedded in the wall of the catheter or in the wall of the conduit The fiber in the lumen is provided to provide a 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 having a distal opening at a location as depicted in Figure 6A And filled with an incompressible fluid; and an external pressure sensor mounted on one of the fluid connectors at the proximal end of the conduit to measure 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 (P _b ) at the proximal end of the injector member 614 . 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 in vitro system. In an exemplary embodiment, the fluid may be volumetric driven rather than pressure driven. When the fluid (F _tip) is injected through the tip into the vessel, it is mixed with the fluid (F _b) and the flow from the upstream of downstream G _tip via conduction. 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 one or predicted conductivity value G _b. Even under a pressure sensor 610 and 612 disposed to measure the case of P _b and P _tip, if the unknown lines G _b, it may still be difficult to directly measure F _b. According to an exemplary embodiment of the principles of the systems and methods described herein may be used to determine the value of one of G _b.

In one example, the flow rate source can be used to control a volumetric 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 such that fluid injected at the distal tip flows with a series of volumetric impulses. In this example, the series of volumetric impulses can be modeled according to a step function. The flow rate source can be one of a pump that executes an instruction from one of the control units of a console to deliver an impulse in the series of impulses, or based on a first signal from the console to initiate and continuously deliver a step function The impulse until the second signal from one of the consoles causes the pump to stop operating one of the pumps.

In other examples, the flow rate source can be used to control the flow rate such that the fluid is based on other A functional form of a type such as, but not limited to, a sinusoidal form, a sawtooth form, or other form of a loop function flows.

In any of the examples herein, the flow rate source can be used to control the flow rate to establish a flow rate mode. As described above, the flow rate pattern can be based on an arbitrary waveform or other type of functional form such as, but not limited to, a sinusoidal function form, a sawtooth function form, or other cyclic function form.

In one non-limiting example in accordance with the principles 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 for measurement or calculation of proximal external conduction. And the value of the external conduction of the distal end. The exemplary system enables the flow around the injector member of the catheter to be inferred from the data indicative of the pressure measurement.

A control shunt system for determining one of the two conductances is provided, including the system depicted in Figure 6A. A first conductive (referred to as a proximal conductive (G _b)) by the space between the two vessels conducting pressure sensor 610 and the plane 612 defined in the exterior of the catheter. The second conduction (called G _tip ) is the conduction of blood from the tip to the core system (or grounded in the sense of flow). In the absence of measurement, these two conducts are usually not inferred, because the calculation will use data indicating the size and shape of the vessel in the region. In the case of G _tip , the calculation will use information indicating the status of the vascular bed and/or the extent of the damage. Knowledge of these two values of conduction can provide clinical benefit because it measures one of the local states of vasodilation/vascular contraction of the patient. Pressure sensors 610 and 612 measure P _b and P _tip, conduction between the other if it is added as one of those previously described minimum conduction control conductivity may be used flow F _b = G _b (P _b -P _tip ) Estimate the stream. Wherein G _b calculated in the vein or contains information indicating one exemplary embodiment of the information surface of the artery, and may not prejudge G _b. In general, it is not possible to determine _Gtip before an operation involving an implanted component or other medical procedure.

Provided herein, exemplary systems and methods of both of the body G _b and G _tip in operation for calculating during a medical procedure or other of a patient. Using a linear approximation, two equations can be used to balance the flow around the distal tip of the infusion 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, flow rate source 616. FIG 6A illustrates an exemplary system used to the amount of the measured values of pressure P _b and the pressure P _tip. Using this value, the equation can be reduced to: (3)....G _tip =F _tip /P _tip +Gb(P _b -P _tip )/P _tip where G _tip and G _b are unknowns. In use the injection member during the returning blood to the body one operation or other medical procedure, at time T ₀ of the injection flow may be used as the initial F _'tip (as a non-limiting example, about 250ml / 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). These non-limiting examples of the flow at times T ₀ and T ₁ value may be selected to fall within the range of clinical and one specific bone-specific clinical applications at the point of injection desired. exemplary system of FIG. 6A of can be used to measure the value of the time point T pressure ₀ of P _b and a pressure P _tip of the (P' _b and P' _tip ) and the values of pressure P _b and pressure P _tip at time T ₁ (P" _b and P" _tip ). Four different pressure values and two in equation (3) are used. 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 will be readily apparent to the average skilled person that equations (1), (2), and (3) are non-limiting examples of equations for flow, conduction, and pressure in a vascular region. Other equations (including more complex versions of the equation) may apply. For example, an equation in which conduction is not independent of pressure but is itself a function of pressure can also be treated by using repeated pressure measurements at different values of the applied flow _Ftip to establish more equations and allowing the pair to be linear Or even the form of conduction (G) of the secondary or higher order pressure function.

As described herein, a flow rate source can be used to control the flow rate such that the fluid injected at the distal tip is in the form of a step function or other type of function (such as, but not limited to, a sinusoidal form, a sawtooth function, or other cyclic function). Form) flow. In other instances The flow rate can be modeled based on the measurement of one of the fluid flow response functions and solved for an applicable function form.

Provided herein, exemplary systems and methods of the two bodies in G _b and G _tip for calculating during a lengthy operation or other medical procedure of a patient. As a non-limiting example, this lengthy operation (or other medical procedure) can last for hours or days. An exemplary method in accordance with the rules may be included during operation or other medical procedure repeated cycles of a step change is applied to the F _tip (i.e., a reference from one discrete value changes) for a short time interval (t _1). As a non-limiting time, the step change can be applied to F _tip within 5 minutes before the hour of operation or other medical procedure (ie, t ₁ = 5 minutes). At the end of t _1, F _tip of the return value to the reference value at a time interval. This exemplary method for modifying the value of F. The _tip of the _B and G may be used for the amount G of the method described herein the _tip measured hourly during lengthy operation or other medical procedure. These exemplary systems and methods are clinically used to monitor vascular status (vasodilation/vascular contraction) or to detect thrombotic processes or thrombolytic times.

Another exemplary clinical application of the exemplary systems and methods is as follows. During an operation or other medical procedure, the use of the value for the calculation of the _tip and G _b G, may determine the amount of space in the flush of the tip of the proximal end of the ilk F _b from the measured pressure P _b and by P _tip. If the flow F _b falls outside a desired range, F _tip can be adjusted to adjust F _b .

Another clinical application of the systems and methods is the determination of the heat capacity of the blood applied to the tissue. During operation or other medical procedure, F _b and F _tip may be mixed in a region of 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 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 procedure for controlling the rewarming can be accomplished by adjusting the flow ratio F _b :F _tip and its equal temperature difference. During an operation or other medical procedure can be applied for the measurement described herein, and G _b G _tip of the exemplary example of the method one or more times. The method can be generalized to use more than one step change of F _tip , in which case the operator can measure the values of G _b and G _tip to determine how the equations (1 to 3) can vary in addition to the linear approximation of equations (1 to 3). . An operator can implement an exemplary method in accordance with the principles herein by, for example, the following steps: directly setting F _tip ; recording sensor records; and performing calculations using a computing device. In another exemplary embodiment, one of the computing devices or systems herein can include at least one processing unit that is programmed to execute processor-executable instructions to cause one of the exemplary system controllers automatic embodiments as described herein for the routine measurement of measured values of G _b and G _tip of. The exemplary system can be structurally designed to allow a user to set a nominal value of F _tip and execute processor-executable instructions at desired time intervals (such as, but not limited to, every 30 or 45 or 60 minutes or other time intervals) ) Perform an automatic measurement of one of G _b and G _tip . In any of the examples herein, the computing device can be a console.

6B shows an exemplary control of a shunt system in accordance with one of the principles herein. The exemplary system includes two pressure sensors that are used in conjunction with a concentric cylindrical two-way catheter to support a separate partial extracorporeal circuit. As shown in Figure 6B, the two pressure sensors 610' and 612' are coupled to one of the components of the outer loop access conduit of one of the concentric shaft types. In this example, the outer shaft member 618 supplies blood to the extracorporeal circuit 618 and the inner shaft member 614 acts as an insertion member for returning blood to one of the positions in the body. Figure 6B also shows the dashed line 615 of the blood flow to the extracorporeal circuit and the dashed line 617 of the blood flow (Fb) around a catheter. By way of non-limiting example, US 7,704,220 and U.S. Patent No. 7,789,846 disclose examples of concentric external access catheters that can be implemented in one or more exemplary systems in accordance with the principles herein.

6C and 6D show an exemplary system that can be used to calculate the value of conduction in a region of a vessel proximal to the heart in accordance with the principles herein. In the example of Figures 6C and 6D, the exemplary system is shown positioned in a region of the aortic arch. As shown in FIG. 6C, the illustrative 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, pressure measurement, calculation can be used for in vivo transduction G _b and the two exemplary methods of G _tip according to the above. In the example of FIG. 6C, fluid flow can be introduced from a distal tip end of one of the catheter members 620. 6D shows another exemplary system that is similar to FIG. 6C, but with conduit 620 containing a proximal end 622 that allows one of the fluid streams from one of the conduit members 622 to be more centered.

In any of the illustrative systems, methods, devices, and devices herein, fluid injected through the injector member can be mixed with a fluid (external fluid) passing through the conduit or external space surrounding the device. If the fluid streams are mixed, they 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 agent of a known concentration (in mg/ml or other mass/volume unit) is added to the injected fluid, the concentration of the drug or agent in the distal mixed fluid is unknown, Unless the ratio of external fluid flow rate to injected fluid flow rate is known. The exemplary systems described herein can be used to set external conduction (plus minimal conduction components) or quantitative external conduction (control shunt systems). Based on the conductivity 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 agent added to the injected fluid can be adjusted to the distal fluid The desired drug concentration is achieved in the mixture.

In any of the examples herein, the drug or agent can be any substance used to diagnose, cure, treat, or prevent a disease. For example, the drug or agent can comprise an electrolyte solution, nanoparticles, biologics, small molecules, macromolecules, polymeric materials, biopharmaceuticals, or any other drug or agent useful for blood flow.

An exemplary system can be used to provide at least two regions of selective thermal therapy in accordance with the principles herein. The illustrative system includes an extracorporeal circuit. The exemplary extracorporeal circuit includes an injector member including one of the distal tips disposed at a vascular location and one of the proximal ends disposed at the distal tip plus a minimally conductive component. The exemplary system can also include: a first fistula for drawing blood from the body; a second fistula for returning blood to the body; a first pump disposed on the first fistula and the first Between the two cockroaches to get blood from the first Pumping to the second weir; a branch section positioned between the first pump and the second weir; a third weir coupled to the branch section, the third weir being positioned at the implant On one of the outer sides of the body member; and a second pump positioned between the branch portion and the third turn. The second pump is structurally designed to control a flow rate through the third weir to the injector member outside of the branch section. The exemplary system can also include a first heat exchanger disposed between the first weir and the second weir and a second heat exchanger disposed between the second pump and the injector member. The first heat exchanger can be configured to set a temperature of one of the blood injected into the second crucible to a first temperature level. The second heat exchanger can be configured to set the temperature of the blood injected into the injector member to a second temperature level that is different from the first temperature level. The first heat exchanger may be disposed between the branch section and the first turn or between the branch section and the second turn.

An exemplary system for providing at least two regions of selective thermal therapy can include a proximal occlusion assembly or an external minimal conduction assembly disposed at a distal tip of the injector member.

Another exemplary system for providing at least two regions of selective thermal therapy in accordance with the principles herein can comprise an extracorporeal circuit comprising a distal tip disposed at one of the vessel locations An injector member. The illustrative system can further include controlling the shunt system at one of the proximal ends of the distal tip. The control shunt system can include: a first sensor for measuring a flow at a proximal end of one of the distal tips of at least one injector member; and a second pressure sensor for measuring A second pressure, the second pressure sensor being disposed at a distance from the proximal end of the distal tip that is greater than or approximately equal to one-half the diameter of one of the vessels. In other examples, the spacing may be greater than or approximately equal to three, five, or ten times the diameter of the vessel. In another example, the proximal end of the distal tip is spaced apart by more than about 1.0 cm. The exemplary system can also include: a first fistula for drawing blood from the body; a second fistula for returning blood to the body; a first pump disposed on the first fistula and the first Pumping blood from the first crucible to the second crucible; a branching section positioned between the first pump and the second weir; a third weir coupled to the branching section, the third weir being positioned on an outer side of one of the injector members; a second pump positioned between the branch section and the third turn. The second pump is structurally designed to control a flow rate through the third weir to the injector member outside the branch section. The exemplary system can also include a first heat exchanger disposed between the first weir and the second weir and a second heat exchanger disposed between the second pump and the injector member. The first heat exchanger can be configured to set a temperature of one of the blood injected into the second crucible to a first temperature level. The second heat exchanger can be configured to set the temperature of the blood injected into the injector member to a second temperature level that is different from the first temperature level. The first heat exchanger may be disposed between the branch section and the first turn or between the branch section and the second turn.

An exemplary system for providing at least two regions of selective thermal therapy can include a proximal occlusion assembly or an external minimal conduction assembly disposed at a distal tip of the injector member.

7A shows a schematic diagram of an exemplary three-puppet extracorporeal circuit for providing at least two regions of selective thermal therapy in accordance with the principles herein. As a non-limiting example, the extracorporeal circuit can be implemented to control blood flow to the core and to the local branch under independent flow rate and temperature control. In the non-limiting example of FIG. 7A, the extracorporeal system 700 is a three-way, two-region extracorporeal circuit in which a main vein-arterial (VA) extracorporeal circuit 710 extracts blood from the body via a first fistula 711 and uses one Pump 712 and oxygenator/heat exchanger 714 return to the blood via a second weir 715. The exemplary system can include a displacement or volumetric drive pump 716 positioned on one of the main circuit branches 718 and pulling a controlled volumetric flow rate of blood out of the main loop and through a A separate heat exchanger 720, a third port 721, and a distal injector member 722 inject blood into a body region 724. In a non-limiting example, branch 718 can be a partial perfusion cryogenic branch. The non-limiting exemplary system of Figure 7A allows for the establishment of two independent controls in the body when a suitable zone temperature sensor is deployed Temperature zone. In other examples, branch 718 can be coupled to the main circuit in front of or behind main loop oxygenator 714 depending on whether the user requires oxygenation of the injector member blood. In such instances, if the system is used to apply a local low temperature as disclosed in International (PCT) Application No. PCT/US2015/033529, the concentric cylinder outflow on the injector member. The lack of one can result in an increase in conduction cooling of the component catheter to the artery in which the component catheter is placed. This effect may require some additional warming on the main loop circuit to achieve an equivalent thermal target in the area of the body that needs to be controlled.

7B shows another exemplary extracorporeal circuit for providing at least two regions of selective thermal therapy in accordance with the principles herein. Similar to FIG. 7A, the extracorporeal system 700' of FIG. 7B includes a primary VA extracorporeal circuit 710 that extracts blood from the body via a first fistula 711 and uses a pump 712, an oxygenator 713, and a heat. The exchanger 714 returns blood via a second fistula 715. In one non-limiting example, oxygenator 713 and heat exchanger 714 can be a combined unit. The exemplary system 700' also includes a displacement or volume driven pump 716 positioned on a branch 718 for pulling a controlled volumetric flow rate of blood out of the main loop and through an independent Heat exchanger 720, a third port 721, and a distal injector member 722 inject blood into a localized area of a body. In an example of the extracorporeal system 700', the injector member can also include: an occluding member; an additional minimal conducting component (including any of Figures 3A-5C according to any of the examples herein); or a pair of pressure sensors coupled to the injector member (including any of the examples herein, including FIG. 6A or FIG. 6B); or a pair of pressure sensors and an occluding member or an additional minimum conducting component Both. In the non-limiting exemplary system of FIG. 7B, the injector member 722 includes an additional minimum conductive component 726 and a coupled pressure sensor pair 728. In the example of FIG. 7B, the oxygenator 714 on the primary circuit is positioned in front of the zone injector branch 718 and thus the locally injected blood flow is oxygenated.

7C shows another exemplary extracorporeal circuit for providing at least two regions of selective thermal therapy according to principles herein, comprising components similar to those described in connection with FIG. 7B The components. However, in the extracorporeal system 700" of Figure 7C, the oxygenator 713 on the primary circuit is positioned along the circuit behind the partial injector branch, and thus the locally injected blood is not directly oxygenated. In a non-limiting example, Oxygenator 713 and heat exchanger 714 can be a combined unit.

A non-limiting exemplary system of any of Figures 7A-7C can include a temperature sensor coupled to a region of the body to allow for temperature measurement at two independently controlled temperature zones in the body. For example, at least one temperature sensor can be disposed at or otherwise coupled to the region of the second helium infusion, and the at least one temperature sensor can be disposed in a localized region of the body that is infused by the distal injector member Or otherwise coupled to the local area. At least one temperature sensor disposed at or otherwise coupled to the zone of infusion by the second weir may be structurally designed to measure an average core body temperature and/or an average system temperature of one of the body parts. At least one temperature sensor disposed at or otherwise coupled to a localized region of the body infused by the distal injector member is structurally designed to measure the temperature of the localized region.

A non-limiting exemplary system of any of Figures 7A-7C can include a temperature sensor coupled to at least one of the heat exchangers.

Other non-limiting exemplary systems in accordance with the principles of Figures 7A-7C can be structurally designed to perform other procedures on blood in the extracorporeal circuit, such as, but not limited to, dialysis, oxidation, purification, pharmacological manipulation, photolysis, or use of blood. Other programs. Any one or more of such procedures may be performed on the primary loop or branch or both (where one or more of the different quantities or quantities of such procedures are performed on the loop or branch).

In the non-limiting illustrative example of Figures 7A-7C, the primary loop is depicted as a VA loop. However, in other exemplary embodiments, the primary circuit can be a venous-venous (VV) circuit rather than 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 back into the vena cava, usually above or near the heart. In another example, a single puncture can be used to perform a VV in the femoral vein, and A single dual lumen catheter can be used to place the VV circuit blood output and each lumen return using one of the catheters.

An exemplary system in accordance with one of the principles herein may include one or more consoles. An exemplary console can include one or more user interfaces that are structurally designed to receive pumps, heat exchangers, and/or oxygenation that represent an exemplary extracorporeal system primary and/or partial branch The input to be set by one or more of the devices. An exemplary console can include one or more processing units for executing processor-executable instructions to cause one or more of a pump, heat exchanger, and/or oxygenator for a period of time Change to a different operational setting and/or maintain a specific operational setting. In any example, the input can be received directly from a user or from another computing device at the one or more user interfaces. An exemplary console can include at least one memory for storing processor-executable instructions that can be implemented using the one or more processing units. The illustrative console can be structured to store and/or transmit information indicative of system settings and/or to perform any measurement data derived using one or more programs using an exemplary system coupled to the console.

FIG. 8A shows an exemplary extracorporeal loop system 800 coupled to a console 802 in accordance with the principles herein. Similar to FIG. 7B, the extracorporeal system 800 of FIG. 8A includes a primary VA extracorporeal circuit 810 that extracts blood from the body via a first fistula 811 and uses a pump 812, an oxygenator 813, and a heat exchange. The 814 returns to the blood via a second fistula 815. In one non-limiting example, oxygenator 813 and heat exchanger 814 can be a combined unit. The exemplary system 800 also includes a displacement or volumetric drive pump 816 positioned on a branch 818 for pulling a controlled volumetric flow rate of blood out of the main loop and through an independent heat exchange. The 820, a third 821, and a distal injector member 822 inject blood into a localized area of a body. Also similar to the non-limiting exemplary system of FIG. 7B, the injector member includes an additional minimum conductive component 826 and a pressure sensor pair 828. In the example of FIG. 8A, console 802 is coupled to a row positioned on a branch 818. The pump or pump 816 and pressure sensor pair 828 are driven by volume or volume. In other examples, console 802 can be coupled to different components of the system, including any one or more of the pumps, heat exchangers, and/or oxygenators of the exemplary system.

The non-limiting exemplary system of Figure 8A can include a temperature sensor coupled to a region of the body to allow for temperature measurements at two independently controlled temperature zones in the body. For example, at least one temperature sensor can be disposed at or otherwise coupled to the region of the second helium infusion, and the at least one temperature sensor can be disposed in a portion of the body that is infused by the distal injector member The zone is or otherwise coupled to the local zone. At least one temperature sensor disposed at or otherwise coupled to the zone of infusion by the second weir may be structurally designed to measure an average core body temperature and/or an average system temperature of one of the body parts. At least one temperature sensor disposed at or otherwise coupled to a localized region of the body infused by the distal injector member can be structurally designed to measure the temperature of the localized region.

In an example, console 802 can be structurally designed as an operational console. In this example, the operational console can include a graphical user interface for driving one of the heat exchanger water heaters/heaters and user instructions that are structurally designed to display operational steps for implementing an operational sequence . The graphical user interface of console 802 can be structurally designed to implement the sequence of operations to cause an extracorporeal loop to control the temperature of the blood perfused by the second helium to adjust a temperature measurement reported by at least one temperature sensor to remain Within a core body target range, and causing the extracorporeal loop to control the temperature of the blood injected into the localized region such that at least one temperature sensor reports a temperature measurement within a target zone temperature range.

The illustrative console 802 can be structurally designed to automate the performance of Gb and Gtip measurements using the methods described herein for controlling the shunt system. Based on the received input, the console can cause a processor to execute instructions for recording information indicative of the flow in the injector member and the value of the pressure on the injector member, while also controlling the amount of injected flow rate, The automated performance of the method of measuring the proximal and distal conduction at the injector member is assisted or implemented in accordance with the principles of any of the examples described herein. This exemplary console 802 can The control is configured to automate the control split system, wherein the control split system is applied to an injector coupled to an entire outer loop or another conduit system having an external volumetric flow rate source such as, but not limited to, the example of Figure 6A member.

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

An exemplary system in accordance with the principles herein may include one or more controllers for controlling a fluid stream. For example, the one or more controllers can be coupled to an injection member to control fluid flow outside the distal tip of the injector member.

An exemplary system can include a console in accordance with one of the principles herein. FIG. 9 shows an exemplary console 905 that includes at least one processing unit 907 and a memory 909. An exemplary console can include, for example, a desktop computer, a laptop computer, a tablet computer, a smart phone, a server, a computing cloud, a combination thereof, or a Any other suitable device for electronic communication by a controller or other system. The exemplary processing unit 907 can include, but is not limited to, a microchip, a processor, and a micro A processor, a special purpose processor, a specific application integrated circuit, a microcontroller, a programmable gate array, any other suitable processor, or a combination thereof. Exemplary memory 909 can 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 can include a display unit 911. The exemplary display unit 911 can 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 ( A screen or display such as, but not limited to, a smart phone, a tablet or an e-book, and/or any other display unit.

10A-10B illustrate an 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. One or more of the steps of Figures 10A through 10B can be implemented using a controller based on commands or other signals from one of the processing units executing instructions stored to a memory.

10A shows an exemplary method comprising the steps of: (step 1002) controlling fluid flow injected at a distal tip end of the injector member to a predetermined flow rate pattern during a time interval T ; (step 1004) The first pressure sensor and the second pressure sensor record pressure measurement during time interval T; and (step 1006) calculate the distal tip using data indicative of the pressure measurement and the predetermined flow rate pattern At least one of a proximal external conduction or a distal external conduction. The distal tip can be an injector member or a portion of a conduit member of an extracorporeal circuit. In an example, the flow rate mode can be controlled using an injection flow rate source. In an example, the source of the injection flow rate can be a pump.

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. In step 1052, blood flow injected at the distal tip of an injector member (or a catheter member) is controlled to a first constant flow rate during a first time interval (T _A ). In step 1054, each of the first pressure sensor and the second pressure sensor is used to record at least one first pressure measurement (P _1A and P _1B ) during the first time interval (T _A ). In step 1056, blood flow injected at the distal tip of the injector member is controlled to a second constant flow rate different from the first constant flow rate during a second time interval (T _B ). In step 1058, each of the first pressure sensor and the second pressure sensor is used to record at least one second pressure measurement (P _2A and P _2B ) during the second time interval (T _B ). In step 1060, the at least one processor of the processing unit is used to calculate the injector using data indicative of 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 a distal tip of the member (or catheter member).

In an example, the illustrative console can cause the display unit to display the proximal external conduction or the distal external conduction or one of the indications based on the calculation.

In one example, can lead to the external processing unit calculates a proximal end within one of a conductive or later than the first time interval (T _A) and the second time interval (T _B) the third time interval (T _C) Projection of at least one of the distal external conduction.

11 is a block diagram of an exemplary computing device 1110 that can be used to implement an operation in accordance with the principles herein. In any of the examples herein, computing device 1110 can be structurally designed as a console. For the sake of clarity, FIG. 11 is also revisited and provides more detailed details regarding the various components of the illustrative system of FIG. Computing device 1110 can 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 can include, but is not limited to, one or more of the following types of hardware memory, non-transitory tangible media (eg, one or more storage disks, one or more optical disks, one or more fast) Flash drive device, etc. For example, memory 909 included in computing device 1110 can store computer readable and computer executable instructions or software for performing the operations disclosed herein. For example, the memory 909 can be stored in a structural design to perform each A software application 1140 of the disclosed operations (eg, causing a controller to control flow, recording a pressure sensor measurement or performing a calculation). The computing device 1110 can also include a configurable and/or programmable processor 907 and an associated core 1114, and can be used to execute computer readable and computer executable instructions or software stored in the memory 909, as needed One or more additional structural design and/or programmable processing devices of the control system hardware, such as processor 1112' and associated core 1114' (eg, having multiple processors/cores) In the case of a computing device). Processor 907 and processor 1112' may each be a single core processor or a multi-core (1114 and 1114') processor.

Virtualization can be used in computing device 1110 to dynamically share the infrastructure and resources in the console. A virtual machine 1124 can be provided to handle the execution of one of the programs on the plurality of processors such that the program appears to use only one computing resource rather than multiple computing resources. Multiple virtual machines can also be used in combination with one processor.

Memory 909 can include a computing device memory or random access memory such as DRAM, SRAM, EDO RAM, and the like. Memory 909 can also include other types of memory or a combination thereof.

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

The computing device 1110 can also include one or more storage devices 1134, such as a hard disk drive, CD-ROM, or other computer readable medium for storing information and computer readable instructions and/or software for performing the operations disclosed herein. media. The exemplary storage device 1134 can also store one or more databases for storing any suitable information desired to implement the illustrative systems and methods. The database can be manually or automatically updated at any suitable time to add, delete and/or update assets. One or more items in the library.

Computing device 1110 can include structural design to interface through various connections (including but not limited to standard telephone lines, regional network (LAN), or wide area network (WAN) links (eg, 802.11, T1) via one or more network devices 1132 , T3, 56 kb, X.25), broadband connection (eg, ISDN, frame repeater, ATM), wireless connection, controller area network (CAN), or any combination of any of the above ) Interfacing with one or more networks (eg, LAN, WAN, or the Internet). The network interface 1122 can 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 data machine, or a computing device 1110 Any other device connected to any type of network capable of communicating and performing the operations described herein. Moreover, computing device 1110 can be any computing device, such as a workstation, desktop, server, laptop, handheld, tablet, or capable of communicating and having the operations described herein. Other forms of computing or telecommunications devices with sufficient processor power and memory capacity.

Computing device 1110 can run any operating system 1126, such as any of the versions of the Microsoft® Windows® operating system, different versions of Unix and Linux operating systems, any version of MacOS® for Macintosh computers, any embedded operating system, any instant job System, any open source operating system, any proprietary operating system, or any other operating system capable of running on a console and performing the operations described herein. In some examples, operating system 1126 can operate in either a native mode or an analog mode. In an example, operating system 1126 can run on one or more cloud machine instances.

In a non-limiting example, a computing device in accordance with the principles herein may comprise any one or more of the following: a smart phone (such as but not limited to an iPhone®, an ^AndroidTM phone, or a Blackberry®), Tablet, a laptop, a tablet touch computer, an electronic gaming system (such as but not limited to an XBOX®, a Playstation® or a Wii®), an e-reader and/or other An electronic reader or handheld computing device.

In any of the examples herein, at least one of the methods herein can be implemented using a computer program. The computer program (also known as a program, software, software application, script, application or code) can be written in any form of programming language (including compiling or interpreting languages, announcements or programming languages) and Any form (including as a stand-alone program or a module, component, sub-routine, 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 may be stored in a separate file or a plurality of coordinating files (eg, files storing one or more modules, subprograms or code portions) for storing other programs or materials (eg, stored in One of the markup files in one of the files or one of the scripts) is in one of the files. A computer program can be deployed to be executed on a computer located at a location or on multiple computers distributed across multiple locations and interconnected by a communication network.

An exemplary computing device can include an application ("App") for performing functions such as analyzing temperature sensor data, pressure sensor data, and calculating conduction, as described herein. As a non-limiting example, the structured App may be designed to download one of a one Android compatible ^TM * .apk file system or a system compatible iOS® * .app file.

An exemplary console may be implemented in accordance with one of the operational sequences described in the International (PCT) Application No. PCT/US2015/033529, the disclosure of which is incorporated herein by reference. For example, the console can include a display including a user interface and a chiller/heater for driving the heat exchanger. The exemplary console can be coupled to: at least one first temperature sensor positioned to measure an average core body temperature and/or an average system temperature of one of the body portions of the body infused with the second volume; and at least one second A temperature sensor is positioned to measure the temperature of a localized region of the injector member. The user interface is structurally designed to display user instructions for performing the operational steps of an operational sequence. A non-limiting exemplary console can include as defined herein A user interface and computing device for implementing a half automatic control program such that a temperature band can be set in the device during all phases of operation and if the sensor temperature deviates from the target during each phase The range informs the operator to adjust the chiller temperature. A non-limiting exemplary console can include a user interface and computing device as defined herein, the user interface and computing device for implementing a fully automated control program such that in all stages of an operation, A temperature zone is set in the device and the system can be structurally designed to automatically adjust the chiller temperature if the sensor temperature deviates from the target range during each phase.

Any of the exemplary systems and methods herein can be used to establish and control at least a portion of a different temperature region of a body for at least a portion of a treatment procedure for a patient suffering from a local or global damaging ischemia or circulatory damage , as described in International (PCT) Application No. PCT/US2015/033529. An exemplary method can include coupling a systemic perfusion extracorporeal circuit (SPEC) to the body using a peripheral placement loop and coupling a local perfusion extracorporeal loop (LPEC) to a local target zone within the vessel to the body ( Blood such as, but not limited to, the brain. The SPEC can include one SPEC input flow and one SPEC output flow, one SPEC pump, and one SPEC heat exchanger in contact with blood flowing within the vessel. The LPEC can include an LPEC input flow and an LPEC output flow, an LPEC pump, and an LPEC heat exchanger in contact with blood flowing within the vessel. The LPEC input stream is positioned to infuse a local target area of the body. The method includes positioning at least one SPEC sensor to measure an average core body temperature and/or an average system temperature of a body perfused by the SPEC; positioning at least one LPEC sensor to measure a local target zone perfused by the LPEC Temperature; performing an operation step of at least one minimum sequence of operations; and implementing a control program to record the measurement of the at least one LPEC sensor and the at least one SPEC sensor and independently control the SPEC and one of the LPEC blood independently Flow rate and heat exchanger temperature. The LPEC can include an injector member including a distal tip disposed in contact with blood flowing within the vessel, wherein the LPEC injector member is positioned to infuse the body Local target area. The LPEC can include an addition of a minimum conduction component or a control shunt system or both in accordance with one of the principles described herein. In an example where the LPEC includes a control split system, the LPEC pump can be used as one of the control flow splitting systems to inject a flow rate source.

The LPEC input flow can be placed in contact with the left common carotid artery, the right common carotid artery, or one of the arteries downstream of one of the locations.

In one example, the control program can 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 remain within a target core body temperature range, and cause the LPEC control The temperature of the blood injected into the target zone causes one or more LPEC temperature sensors to report a temperature measurement based on a specified mode of the target zone temperature value. The SPEC temperature sensor can be one or more of a bladder temperature sensor or a constant intestinal temperature sensor.

In another example, the control program can cause the SPEC to adjust the body temperature of the body such that one or more SPEC temperature sensors indicate an average temperature in a range from about 32 ° C to about 37 ° C, and cause the The LPEC controls the temperature of the blood to the target zone such that one or more LPEC temperature sensors indicate a temperature below one of about 30 °C. This control program can cause the SPEC to increase blood temperature to prevent the average temperature from dropping below about 32 °C. The control program can cause the LPEC to cool the blood temperature to a value in the range of from about 10 °C to about 30 °C.

Any of the illustrative systems herein can include a control system that is programmed to perform 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 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 from about 10 °C to about 30 °C.

in conclusion

Although various embodiments of the invention have been described and illustrated herein, one of ordinary skill in the art will readily contemplate the use of the functions described herein and/or obtain the results described herein and/or one of the advantages described herein. Each of the various other components and/or structures of the present invention, and such variations and/or modifications, are considered to be within the scope of the embodiments of the invention described herein. More generally, it will be readily apparent to those skilled in the art that all parameters, dimensions, materials, and structural designs described herein are meant to be illustrative and actual parameters, dimensions, materials, and/or structural designs will depend on the teachings of the present invention. Specific application. Those skilled in the art will recognize, or be able to ascertain the equivalents of the specific embodiments of the invention described herein. Therefore, the present invention is to be construed as being limited by the specific scope of the invention and the scope of the invention. Embodiments of the invention may be related to the various features, systems, articles, materials, kits and/or methods described herein. In addition, if such features, systems, articles, materials, kits and/or methods are not mutually exclusive, any combination of two or more such features, systems, articles, materials, kits and/or methods comprises Within the scope of the invention of the invention.

The above-described 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 provided in a single computer or distributed among multiple computers.

In this regard, aspects of the present invention can be embodied, at least in part, as one of a computer readable storage medium (or a plurality of computer readable storage media) encoding one or more programs (eg, a computer memory, one or more soft) One or more programs in a disc, optical disc, optical disc, magnetic tape, flash memory, loop structure design in a field programmable gate array or other semiconductor device, or other tangible computer storage medium or non-transitory medium) The method of implementing various embodiments of the techniques discussed above is performed when executed on one or more computers or other processors. The computer readable medium can be portable such that the program stored thereon can be loaded into one or Various aspects of the inventive technology as discussed above are implemented on a plurality of different computers or other processors.

In the general term, 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 inventive technology 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 techniques of the present invention when executed are not required to reside on a single computer or processor, but may be distributed in a modular manner. Various aspects of the techniques of the present invention are implemented in a number of different computers or processors.

Computer-executable instructions can take many forms, such as a program module executed by one or more computers or other devices. Typically, program modules contain routines, programs, objects, components, data structures, etc. that perform specific tasks or implement specific abstract data types. In general, the functionality of the program modules can be combined or distributed as desired in various embodiments.

Furthermore, the techniques described herein may be embodied as one of the at least one of the examples provided. The actions performed as part of the method can be ordered in any suitable manner. Accordingly, embodiments may be constructed in which the order is performed in a different order than the ones illustrated, which may include performing some actions at the same time, even if shown as a sequential action in an illustrative embodiment.

All definitions as defined and used herein are to be understood as a control of the definition of the dictionary, the definition of the document incorporated by reference, and/or the ordinary meaning of the defined terms.

The indefinite articles "a" and "an" are used to mean "the"

The phrase "and/or" as used herein in the specification and claims is to be understood to mean "any or both" of the elements so joined, that is, in some cases coexistent and Components that exist separately in other cases. The use of "and/or" recited elements, that is, "one or more" of the elements so combined, should be interpreted in the same manner. Vision Where necessary, there may be other elements than those specifically identified by the "and/or" clause, whether or not the other elements are associated with the specifically identified elements. Thus, as a non-limiting example, when used in conjunction with an open language (such as "include"), reference to "A and/or B" may refer to only A in one embodiment (including B except as needed) In another embodiment, only B is included (including elements other than A as needed); in yet another embodiment, both A and B (including other elements as needed) and the like.

&quot;or&quot; as used herein, and the meaning of "and/or" as defined above. For example, when separating items in a list, "or" or "and/or" should be construed as inclusive, that is, including at least one of the plurality of elements or the list of elements, but also includes more than one, and Include additional items not listed as needed. Only the terms that are expressly indicated to be opposite (such as "only one of") or "the only one of" or when used in the scope of patent application "consisting of" will refer to The only one of several components or a list of components. In general, the term "or" as used herein shall be construed as merely indicating an exclusive term (such as "any", "one of", "only one of"," The exclusive alternative to the previous one (ie, "one or the other but not both"). "Consisting essentially of" shall have its ordinary meaning as used in the field of patent law when used in the scope of patent application.

As used herein in the context of the specification and claims, the phrase "at least one" is understood to mean any one of the elements selected from the list of elements. At least one element of one or more of the elements, but does not necessarily include at least one of the elements listed in the list of elements and does not exclude any combination of elements in the list of elements. This definition also allows for the presence of elements other than those specifically identified in the list of elements referred to in the phrase "at least one", whether or not the elements are associated with the particular identifying elements. Thus, 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 is meant to include at least one of A and not at least B. One (and optionally includes elements other than B); in another embodiment, it is meant to include at least one of B and optionally no A (and optionally include elements other than A); In the embodiment, it is intended to include at least one of more than one A and at least one of more than one B (and other components as necessary) as needed.

In the scope of the patent application and the above description, all transitional phrases (such as "including", "including", "carrying", "having", "containing", "involving", "holding", "consisting of" Etc.) should be understood as open, ie, meant to include but not limited to. Only the transitional phrase "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, as set forth in Section 2111.03 of the Patent Prosecution Procedures of the US Patent Office Manual. .

200‧‧‧External loop

206‧‧‧ pump system

208‧‧‧ heat exchanger

210‧‧‧Injector components

212‧‧‧Vascular injection point

214‧‧‧ blood

Claims (54)

A system comprising: an extracorporeal circuit comprising: a primary sputum for returning blood from the extracorporeal circuit to a vessel in a region of a body; and at least one injector member comprising a tube a lumen, the at least one injector member is structurally configured to cause blood to flow at a vessel injection point; and an additional minimally conductive component disposed at a proximal end of the distal tip of one of the at least one injector member. The system of claim 1, wherein the extracorporeal circuit is structurally designed such that fluid is injected at the at least one injector member at a rate that causes fluid flow through the additional minimally conductive component to continually or periodically flush the fluid Proximal vessel. The system of claim 1 wherein the additional minimum conducting component comprises an air bag. The system of claim 1, wherein the additional minimal conductive component comprises at least one of a non-invasive surface, a hydrophilic coating, or a drug coating. The system of claim 1, wherein the additional minimum conducting component comprises a biasing valve, a discrete lumen or a spring driven membrane, the spring driven membrane having at least one opening formed therethrough. The system of claim 1 wherein the additional minimum conducting component comprises one or more biasing valves coupled to one of the lumens. The system of claim 6 wherein the one or more biasing valves are structurally designed to maintain blood flow at a fixed or average value equal to one of a predetermined minimum flow rate such that blood is flushed over the one or more biasing valves One of the vessels in the proximal end. The system of claim 1, further comprising: at least one pressure sensor disposed at a distal end of the additional minimum conducting component; And at least one pressure sensor disposed at a proximal end of the additional minimum conductive component. The system of claim 8, wherein the extracorporeal circuit is structurally designed to add at least one of a quantity of one of the drugs or agents to the fluid injected through the at least one injector member. A method comprising: coupling an extracorporeal circuit to a portion of a body, the extracorporeal circuit comprising: a primary sputum for returning blood from the extracorporeal circuit to a vessel in a region of a body; At least one injector member including a lumen, the at least one injector member being structurally configured to cause blood to flow at a vessel injection point; and an additional minimally conductive component disposed in the at least one injector member a proximal end of the distal tip; and causing the injected flow from the at least one injector member to be at a rate such that a net or average countercurrent or downstream flow is maintained at the at least one injector member above a predetermined minimum flow rate External to this vessel. The method of claim 10, wherein the additional minimum conduction component sets a conduction such that a flow rate within a blood pressure cycle of one heartbeat is higher than a minimum flow rate during at least a portion of one of the heartbeats, and In each cycle of the heartbeat, blood is used to flush the region of the vessel outside of the at least one injector member. The method of claim 10, wherein the additional minimum conduction component comprises an air bag. The method of claim 10, wherein the additional minimally conductive component comprises at least one of an atraumatic surface, a hydrophilic coating, or a drug coating. The method of claim 10, wherein the additional minimum conducting component comprises a biasing valve, a discrete lumen or a spring driven membrane, the spring driven membrane having at least one opening formed therethrough. The method of claim 10, wherein the additional minimum conducting component comprises one or more biasing valves coupled to one of the lumens. The method of claim 10, further comprising: a first pressure sensor disposed at a distal end of the additional minimum conducting component; and a second pressure sensor disposed adjacent to the additional minimum conducting component end. The method of claim 16, further comprising adding at least one of a quantity of one of the drugs or agents to the fluid injected through the at least one injector member. The method of claim 17, further comprising adjusting the concentration of the at least one of the drug or the agent using a pressure measurement and applying a minimum conduction to produce one of the at least one of the drug or the agent in a mixed distal flow. The desired concentration is performed using the first pressure sensor and the second pressure sensor. A method comprising: coupling an extracorporeal circuit to a portion of a body, the extracorporeal circuit comprising: a primary sputum for returning blood from the extracorporeal circuit to a vessel at a region of a body; An injector member coupled to the flow, the injector member including a distal tip and a shaft having a lumen; a control shunt system comprising: at least one first pressure sensor disposed thereon a proximal end of the distal tip; at least one second pressure sensor disposed on an outer surface of the shaft member of the injector member; and an injection flow rate source coupled to the injector member for control from a fluid flow of the distal tip of the injector member; at a time interval T , the fluid flow injected at the distal tip of the injector member is controlled to a predetermined flow rate using the injection flow rate source Mode; during the time interval T , using the first pressure sensor and the second pressure sensor to record a pressure measurement; and calculating the injection using data indicating the pressure measurement and the predetermined flow rate pattern The distal tip of the member One of a distal or proximal outer conductive of at least one external conducting. The method of claim 19, wherein the predetermined flow rate pattern comprises 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 < T is different from the one of the first constant flow rate of the second constant flow rate. The method of the requested item 20, wherein the controlling the flow of fluid comprising: t _1, using the injection flow rate of the source will be injected into the fluid stream at the distal tip of the injector means to control the first time interval the first constant flow rate; and t _2, using the injection flow rate of the source will be injected into the fluid stream at the distal tip of the injector means to control the flow rate of the second constant second time interval. The method according to item 21 of the request, wherein the recording those pressure measurements comprising: at the first time interval t _1, using the first pressure sensor and the second pressure sensor recording a first pressure measurement; And during the second time interval t ₂ , the second pressure sensor is recorded using the first pressure sensor and the second pressure sensor. The method of claim 22, wherein calculating the distance of the injector member using data indicative of the first pressure measurement, the second pressure measurement, the first constant flow rate, and the second constant flow rate The at least one of the proximal outer conduction or the distal outer conduction at the tip end. The method of claim 19, wherein the second pressure sensor is disposed at the injector member at a distance greater than or approximately equal to about one-half the diameter of one of the distal ends of the distal tip On the outer surface of the shaft member. The method of claim 19, further comprising controlling the far of the injector member The fluid stream injected at the tip end maintains the flow rate at a value such that blood flow is used to flush a region of the vessel at the proximal end of the additional minimum conductive component. The method of claim 19, further comprising controlling the flow such that fluid injected at the distal tip flows according to a step function. The method of claim 19, wherein the second pressure sensor is disposed at a distance from the proximal end of the distal tip that is greater than about 1.0 cm. The method of claim 19, further comprising adding at least one of a quantity of one of the drugs or agents to the fluid injected through the at least one injector member. The method of claim 28, further comprising using the pressure measurements and the measured proximal external conduction to adjust the concentration of the at least one of the drugs or agents to produce a drug in a mixed distal flow or The desired concentration of one of the at least one of the medicaments is performed using the first pressure sensor and the second pressure sensor. A system comprising: an extracorporeal circuit comprising: a primary sputum for returning blood from the extracorporeal circuit to a vessel in a region of a body; and an injector member including a lumen The at least one injector member is structurally designed to cause blood to flow at a vessel injection point; a control shunt system comprising: a first pressure sensor for measuring indications at the injector member a first parameter of a flow of a proximal end of the distal tip; a second pressure sensor for measuring a second parameter indicative of the flow, the second sensor being proximal to the distal tip The ends are disposed at a proximal end of the injector member at a predefined spacing; and an injection flow rate source coupled to the extracorporeal circuit for injection at the vessel The injection flow results in a predetermined flow rate mode. The system of claim 30, wherein the source of the injection flow rate is a syringe pump or a rotary pump. The system of claim 30, further comprising a first-class control module, the flow control module being programmed to: respond to the injection flow according to the predetermined flow rate pattern at the vessel injection point, based on indicating the first The measured data of the pressure sensor and the second pressure sensor calculates an indication of a proximal external conduction. The system of claim 30, wherein the flow control module is further programmed to: generate a signal indicative of a first-class parameter to adjust blood flow or maintain blood flow in the vessel at a predetermined flow rate value. The system of claim 30, wherein the predetermined spacing is a distance from the proximal end of the distal tip that is greater than or approximately equal to about one-half the diameter of one of the vessels. The system of claim 30, wherein the controlled shunt system is structurally designed to add at least one of a quantity of one of the drugs or agents to the fluid injected through the injector member. A system comprising: an extracorporeal circuit comprising: a primary sputum for returning blood from the extracorporeal circuit to a vessel at a region of a body; and an injector member comprising a distal a tip end; a control shunt system comprising: a first pressure sensor disposed at a proximal end of the distal tip of the at least one injector member; a second pressure sensor that is compliant with the distal end A proximal end of the tip end is disposed at an outer surface of the at least one injector member at a predetermined spacing; an injection flow rate source coupled to the injector member to control the flow rate of the fluid from the distal tip And a predetermined flow rate mode; and a console comprising at least one processing unit, the at least one processing unit being programmed to: within a time interval T , receiving an indication that the blood flow is in the predetermined flow rate mode Information on the pressure measurement performed by the first pressure sensor and the second pressure sensor in the case of injection at the distal tip; and using information indicating the pressure measurement and the predetermined flow rate pattern, Calculate the at least One of said proximal outer conductive at a distal tip of the injection member or a distal end of at least one external conducting. The system of claim 36, wherein the predetermined flow rate pattern comprises a first constant flow rate within a first time interval t ₁ < T and a second time interval t ₂ subsequent to the first time interval < T is different from the one of the first constant flow rate of the second constant flow rate. The system 37 of the requested item, wherein the at least one programmable processing unit is further to cause the injection flow rate of the source: In the first time interval t _1, will be injected into the distal end of the injector tip of the member a first fluid flow control to the constant flow rate; and the second time interval t _2, the fluid will be injected into the distal tip of the injector to control the second member of a constant flow rate. The system of claim 38, wherein the at least one processing unit is further programmed to: record the first amount of pressure using the first pressure sensor and the second pressure sensor during the first time interval t ₁ And measuring the second pressure measurement using the first pressure sensor and the second pressure sensor during the second time interval t ₂ . The system of claim 39, wherein the use of the first pressure measurement, the first The second pressure measurement, the first constant flow rate, and the second constant flow rate data are calculated for the at least one of the proximal external conduction or the distal external conduction at the distal tip of the injector member. The system of claim 36, wherein the console further comprises a display unit for displaying an indication of at least one of the proximal external conduction or the distal external conduction. The system of claim 36, wherein the at least one processing unit is further programmed to calculate the proximal external conduction or the distal end within a third time interval that is later than the first time interval and the second time interval Projection of at least one of the external conduction. The system of claim 36, wherein the source of the injection flow rate is a volumetric flow controller configured to control the flow such that fluid injected at the distal tip flows according to a step function. The system of claim 36, wherein the second pressure sensor is disposed at a distance from the proximal end of the distal tip that is greater than about 1.0 cm. The system of claim 36, wherein the at least one processing unit is further programmed to conduct an amount based on at least one of a drug or a medicament added to one of the fluids injected through the injector member and the proximal external conduction or A value of at least one of the distal external conduction calculates a concentration of one of the at least one of a drug or agent in the mixed distal flow. A method comprising: coupling an extracorporeal circuit to a portion of a body, the extracorporeal circuit comprising: a primary sputum for returning blood from the extracorporeal circuit to a vessel at a region of a body; An injector member coupled to the flow, the injector member including a distal tip and a shaft having a lumen; at least a first pressure sensor disposed at a proximal end of the distal tip; At least a second pressure sensor disposed on an outer surface of the shaft member of the injector member; and an injection flow rate source coupled to the injection member to control the distal end from the injector member one tip fluid flow; a first time interval T _1, the injection flow rate of the source will be injected into the fluid stream at the distal tip of the injector means to control the flow rate of a predetermined pattern; the second a time interval T _1, using the first pressure sensor and the second pressure sensor recording the pressure measurement; data indicating use of such a pressure measurement and flow rate of the predetermined pattern, the member of the injector is calculated One of the distal ends of the distal tip Deriving a value; calculating the external flow rate using the first and second pressure measurements and the calculated proximal external conduction, and using the external flow rate to calculate an injected flow rate pair in the distal mixed fluid a ratio of external flow rate; and controlling the amount of drug or medicament added to the injected fluid, and adjusting the amount using the calculated ratio of the injected flow rate to the external flow rate to effect the drug in the mixed distal fluid Or one of the agents specifies the concentration. The method of claim 46, wherein the predetermined flow rate pattern comprises 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 < T is different from the one of the first constant flow rate of the second constant flow rate. The method of the requested item 47, wherein the controlling the flow of fluid comprising: t _1, using the injection flow rate of the source will be injected into the fluid stream at the distal tip of the injector means to control the first time interval the first constant flow rate; and t _2, using the injection flow rate of the source will be injected into the fluid stream at the distal tip of the injector means to control the flow rate of the second constant second time interval. The method of claim 46, wherein the recording the pressure measurement comprises: recording the first pressure measurement using the first pressure sensor and the second pressure sensor during the first time interval t ₁ ; And during the second time interval t ₂ , the second pressure sensor is recorded using the first pressure sensor and the second pressure sensor. The method of claim 49, wherein calculating the distance of the injector member using data indicative of the first pressure measurement, the second pressure measurement, the first constant flow rate, and the second constant flow rate The at least one of the proximal outer conduction or the distal outer conduction at the tip end. The method of claim 46, wherein the second pressure sensor is disposed at the injector member at a distance greater than or approximately equal to about one-half the diameter of one of the distal ends of the distal tip On the outer surface of the shaft member. The method of claim 46, further comprising controlling the flow of fluid injected at the distal tip of the injector member to maintain the flow rate at a value such that blood flow is applied to the proximal end of the additional minimum conductive component. One of the areas of the vessel. The method of claim 46, further comprising controlling the flow such that fluid injected at the distal tip flows according to a step function. The method of claim 46, wherein the second pressure sensor is disposed at a distance from the proximal end of the distal tip that is greater than about 1.0 cm.