JP2007532234A - Fluid transfer system, pressure isolation mechanism, injector control mechanism, and method using the same - Google Patents

Abstract

The injector system includes a source of infusion fluid, a pump device, a channel set disposed between the source of infusion fluid and the pump device, and a fluid control device operably linked to the channel set. The fluid control device enables removal of air from the flow path set at a pressure and flow rate approximately equal to the pressure and flow rate generated by a pump that delivers a sharp bolus of infusion fluid to the patient, and the infusion fluid to the patient Suitable for stopping the flow of The fluid control device is preferably part of a channel set between the source of infusion fluid and the pump device. In another aspect, the injector system includes a powered injector, a pressure chamber operably connected to the powered injector, a flow path connected to the pressure chamber for fluid flow, and a flow path connected to the flow path for fluid flow. Manual controller included. The manual controller includes at least one actuator that controls the injector when a force is applied by an operator. The actuator provides tactile feedback of the pressure in the flow path to the operator by connecting the flow path and the fluid so that the fluid can flow therethrough. A pressure isolation mechanism used in a medical procedure includes a lumen, an isolation port that is fluidly connected to the lumen, and a valve that has a first state and a second state. The first condition occurs when the lumen and the isolation port are connected. The second condition occurs when the lumen and the isolation port are separated. The lumen remains open to fluid flow through the first state and the second state. The valve is normally in the first state and can be switched to the second state when the fluid pressure in the lumen reaches a predetermined pressure level. The pressure transducer may be communicatively connected to an isolation port of the pressure isolation mechanism. The fluid delivery system includes a manually operated syringe and the pressure isolation mechanism described above.
[Selection] Figure 7G

Description

The present invention relates to a fluid delivery system, pressure isolation mechanism, injector control mechanism and methods of use thereof in medical infusion or fluid delivery procedures.
In many medical diagnostic and therapeutic procedures, a doctor or other worker injects fluid into a patient. In recent years, many injector-actuated syringes and powered syringes that inject fluids such as contrast agents have been developed for use in procedures such as angiography, computed tomography, ultrasound, and NMR / MRI. It was. In general, these powered syringes are designed to carry a preset amount of contrast agent at a preset flow rate.
Angiography is commonly used to detect and treat abnormalities or stenosis in blood vessels.
In an angiographic procedure, an x-ray image of the vasculature is obtained with the help of a radiographic contrast agent (sometimes called simply contrast agent) injected through a catheter.
A blood vessel structure in which fluid is connected to a vein or artery into which a contrast medium is injected is circulated. X-rays that pass through the region of interest are absorbed by the contrast agent, resulting in an x-ray picture outline or image of the blood vessel containing the contrast agent. The resulting image can be displayed and recorded, for example, on a monitor.

In a typical angiographic procedure, a physician places a cardiac catheter into a vein or artery.
The catheter is connected to either a manual contrast agent injection mechanism or an automatic contrast agent injection mechanism. A typical manual contrast injection mechanism includes a syringe that is fluidly connected to a catheter, for example, as illustrated in FIG.
The flow path further includes, for example, a source of contrast agent, a source of saline, and a pressure transducer P that measures the blood pressure of the patient. In a typical system, the source of contrast agent is connected to the flow path via a valve V ¹ (eg, a three-way cock). A source of saline and a pressure transducer P can also be connected to the flow path via valves V ² and V ³ , respectively.
The operator of the manual system of FIG. 1 manually operates the syringe and each valve V ¹ and V ² to draw saline or contrast agent into the syringe through the catheter connection, and the saline or contrast agent. Inject into the patient. The pressure transducer used in such a procedure is very sensitive to moderately averaging the high pressures that occur during the operation of the syringe, and the operator applies pressure to the transducer P when the syringe is operated. to prevent the damage by closing the valve V ^3, no separate pressure transducer P from the flow path. While the syringe is not operating, the valve V ³ is normally open, monitor the patient's blood pressure.
The syringe operator of FIG. 1 can adjust the flow rate and flow rate of the injection by varying the force applied to the syringe plunger. Manual sources of fluid pressure and flow used in medical applications such as syringes and manifolds require the worker's efforts to provide feedback of the fluid pressure / flow generated. Although feedback is desirable, worker efforts often lead to fatigue. Thus, fluid pressure and flow will vary depending on the worker's physical strength and skill.

Automatic contrast agent injection mechanisms typically include a syringe connected to a powered injector having, for example, a linear actuator. In general, the operator inputs settings to the electronic control system of the powered injector for a fixed amount of contrast agent and a constant rate of injection. In many systems, there is no interactive control between the operator and the powered injector syringe other than starting or stopping the injection.
In such a system, the flow rate changes when the machine is stopped and the parameters are reset. Automation of angiographic procedures using powered injectors is described, for example, in US Pat. Nos. 5,460,609, 5,573,515, and 5,800,397.
US Pat. No. 5,800,397 discloses an angiographic injector system having both high and low pressure systems. The high pressure system includes a motor driven injector pump that delivers radiographic contrast media to the catheter under high pressure. The low pressure system specifically includes a pressure transducer that measures blood pressure and a pump that delivers saline to the patient as well as aspirating waste fluid. The manifold is connected to a syringe pump, a low pressure system and a patient catheter. The flow valve associated with the manifold is typically maintained in a first state that connects the low pressure system to the catheter through the manifold (and disconnects the high pressure system from the catheter and low pressure system).
When the pressure from the syringe pump reaches a predetermined and set level, the valve connects the high pressure system / syringe to the catheter, while switching to a second level that disconnects the low pressure system from the catheter (and the high pressure system). . In this way, the pressure transducer is protected from high pressure. See column 3, lines 20-37.
However, when using such a multi-faceted system and adapting system elements (e.g. expanding syringes, tubes and other elements under pressure), the injection will be less than the optimal injection bolus. There is. Further, when a low pressure (saline) system is used, the configuration of the system elements of US Pat. No. 5,800,397 wastes relatively large amounts of contrast agent and / or injects excessive amounts of contrast agent. It is not preferable.

The injector system of US Pat. No. 5,800,397 further discloses a portable remote control connected to a console. Remote control includes a saline push button switch and a flow rate control lever or trigger. By gradually squeezing the control trigger, the user provides a command signal to the console to provide a continuously varying injection rate depending on the degree of pressure on the control trigger.
Similarly, US Pat. No. 5,916,165 shows a portable air controller that generates variable control signals that control fluid velocity to a patient within an angiographic system. US Pat. No. 5,515,851 discloses an angiography system with a finger-operated control pad to regulate fluid injection.
However, unlike a manual injection system, in the system described above, any feedback pressure on the system operator is small. Benefits are expected from such feedback. For example, in the use of a manual syringe, excessive back pressure on the syringe plunger will cause the flow path to become an indication of blockage.
US Pat. No. 5,840,026 discloses an injection system in which an electronic control system is connected in particular to a contrast agent delivery system and a haptic feedback control unit. In one embodiment, the haptic feedback control unit includes a disposable syringe located in a durable and reusable cradle and connected to fluid to be delivered to the patient. The cradle is electrically connected to the electronic control system and physically connected to a sliding potentiometer driven by the plunger of the disposable syringe.
During use of the infusion system of US Pat. No. 5,840,026, the operator holds the cradle and syringe, and when the operator presses the sliding potentiometer / syringe piston assembly, the plunger moves forward, moving the fluid to the patient and into the syringe. Generate pressure. A sliding potentiometer tracks the position of the syringe plunger.

The electronic control system controls the delivery system to inject a volume of fluid into the patient based on changes in the position of the plunger. When fluid is injected, the pressure felt by the physician is proportional to the actual pressure generated by the contrast delivery system. The force required to move the piston provides tactile feedback to the operator of the pressure in the system. The physician uses this feedback to ensure the safety of the infusion procedure.
Unlike the case of a manual infusion system, the infusion system of US Pat. No. 5,840,026 does not require a physician to generate the system pressure and flow rate. The physician generates a small manually applied pressure that corresponds to or is proportional to the pressure of the system. The required manual output (ie, pressure x flow rate) is reduced compared to a manual system, but the haptic feedback associated therewith is maintained.
While progress has been made in the field of angiographic injection systems, it remains desirable to develop injectors, injection systems and methods that facilitate such procedures.

The present invention relates to a powered injector, a pressure chamber operatively connected to the powered injector, a channel connected to the pressure chamber so that fluid can flow, and a manual controller connected to the channel so that fluid can flow An injector system including the above is provided. The manual controller has at least one actuator that controls the injector by an operator applying force. Actuators provide tactile feedback of the pressure in the flow path to the operator, either directly or indirectly by being operatively or fluidly connected to the flow path (i.e., the pressure in the flow path is Communicates a corresponding or proportional force). In one embodiment, the actuator is configured to stop the infusion procedure when no force is applied to the actuator. The manual controller includes, for example, a chamber that is fluidly connected to the flow path. The actuator can be a button or plunger operatively connected to a piston deployed in the chamber. The actuator can be biased to the off position.
In another aspect, the manual controller has a first actuator that controls the injector in a low pressure mode by the operator applying force. As described above, the first actuator feedbacks the pressure in the flow channel to the operator through the connection through which fluid can flow with the flow channel. The first actuator also controls the flow rate by changing the force applied on it. The manual controller also has a second actuator having an on state and an off state. The second actuator enters a programmed high pressure injection mode when the injector is set to the on state. The manual controller also has a third actuator that controls the flow of saline in the flow path.

In another aspect of the invention, the actuator is operatively connected to an auditory feedback unit that provides tactile feedback of fluid pressure and aural feedback of fluid pressure and / or fluid flow to the operator. The manual controller of the present invention can expel air prior to injection, for example by a purge valve.
The present invention also provides a system for injecting fluid into a patient, the system having multiple patient reusable parts and disposable parts for each patient. The multiple patient reusable parts and the disposable parts for each patient can be removably connected by a connector (eg, via a high voltage connector). The multiple patient reusable portion has a powered injector that is fluidly connected to a first source of infusion fluid and a first flow path that connects the injector to the high pressure connector. The disposable portion for each patient has a second flow path configured to connect the high pressure connector and the patient in fluid communication. The disposable portion for each patient further includes a manual controller, as described above, which includes a connector installed to connect the manual controller to the second flow path in fluid communication. The multiple patient reusable part further includes a valve mechanism connecting the injector, the first fluid source, and the first flow path.
In one embodiment, the multiple patient reusable portion further includes a second source of infusion fluid and a fluid in fluid communication with the second fluid source to apply pressure to the second fluid. Has an ejection mechanism. The ejection mechanism is preferably connected to the valve mechanism so that fluid can flow.

In one aspect, the manual controller includes a first actuator and a second actuator, and controls the flow rate of the first fluid by changing the force on the first actuator, the second actuator being When set to the on state, the injector is placed into a programmed high pressure injection mode. The system further includes a pressure sensor in fluid communication with the second flow path by a pressure driven isolation device that isolates the pressure sensor from pressure in the second flow path that exceeds a set pressure. To do. In one embodiment, the per-patient disposable part is a check valve in the second flow path that separates the elements of the per-patient disposable part from the reusable parts for multiple patients. And reduces or eliminates the flow of contaminated fluid to reusable parts of multiple patients.
The present invention further provides a method of injecting fluid into a patient, the method comprising the following steps. Removably connecting a number of patient reusable parts to a disposable part for each patient with a high pressure connector, wherein the number of patient reusable parts is a source of the first infusion fluid And a first flow path for connecting the injector and the high-pressure connector, and a disposable part for each patient connects the high-pressure connector and the patient so that the fluid can flow. The second flow path configured as described above and a manual controller having a connector are connected to the second flow path, and the manual controller is connected to the second flow path so that fluid can flow therethrough. The manual controller comprises at least one actuator for controlling the powered injector by an operator applying force, the actuator being connected to the second flow path. Body through can flow connection, and a step of the pressure of the second flow path configured to tactile feedback to the operator, the step of injecting a fluid into a patient.
The method further includes the step of fluidly connecting a pressure sensor to the second flow path via a pressure driven isolation device, wherein the isolation device causes the second flow to exceed the set pressure. Isolating from the pressure in the channel.

In addition, the present invention provides a disposable set for each patient used in the infusion procedure, the set including a flow path configured to form a fluid-flowable connection between the high pressure connector and the patient; And a manual controller for fluidly connecting the flow path and the fluid. The manual controller has at least one actuator that controls the powered injector by an operator applying force. The actuator provides tactile feedback of the pressure in the flow path to the operator through a connection through which fluid can flow with the flow path. The disposable set for each patient further includes a pressure sensor that fluidly connects to the flow path through a pressure driven isolation device, the isolation device being a flow path that exceeds the set pressure. It is configured to be isolated from the internal pressure.
The manual (eg, hand-held) controller of the present invention has a number of advantages: It is possible to tactilely feed back the pressure of the actual flow path by connecting the flow path with the fluid, small size and small filling amount, deadman switch is possible, and control both the contrast agent and saline Ergonomic design, injection pressure feedback and auditory feedback linked to variable flow, construction from rigid material, actuator that is pushed within its operating range, ie, the flow rate gradually increases when pressed Control, and high pressure injection at a pressure higher than the pressure that can be generated and accepted by the hand of the operator, but is not limited thereto.

In another aspect, the present invention provides an injection system for use in angiography, the system being powered via a powered injector and a pressure-driven isolation device that fluidly connects to a source of infusion fluid. The isolator is configured to isolate the pressure sensor from the pressure in the flow path that exceeds the set pressure. The height of the pressure sensor can be varied independently of, i.e. independent of, the position of the powered injector, i.e. the position of the rest of the injection system including the height.
In a further aspect, the present invention provides an angiographic injection system for injecting an infusion fluid into a patient, the system connected to a pressure device for supplying the infusion fluid under pressure, a low pressure fluid delivery system, and a pressure device. A pressure isolation mechanism having a first port connected to the patient, a second port connected to the patient, and a third port connected to the low pressure fluid delivery system. The pressure isolation mechanism includes a valve having a first state and a second state different from the first state. It is preferable that the first state and the second state are incompatible with each other. The first state occurs when the second port and the third port are connected and the first port and the third port are connected. The second state occurs when the first port and the second port are connected and the first port and the third port are disconnected. The valve is normally biased to the first state (eg, by a spring) and can be switched to the second state when the fluid pressure from the syringe pump reaches a predetermined pressure level. The first port and the second port remain connected to the first state and the second state.
The system preferably has a valve that is aligned between the pressure device and the first port of the pressure isolation mechanism to control the flow of infusion fluid. The valve is preferably an automated valve. The valve preferably operates to minimize or eliminate the effects of pressure device and associated tube integrity.

The low-pressure fluid delivery system senses the source of saline or other suitable flush medium, an infusion chamber in fluid communication with the source of saline, and the amount of saline in the source of saline. Including detectors. The system further includes an air detector aligned between the saline control valve, the saline drip chamber, and the pressure isolation mechanism.
The pressure device may be communicatively connected to a source of infusion fluid via an infusion fluid drip chamber. The system further includes a detector that senses the amount of infusion fluid within the source of infusion fluid. Similarly, the system also includes an infusion fluid control valve and an air detector aligned between the infusion chamber and the pressure isolation mechanism.
In one embodiment, the system further comprises a handheld controller that controls the infusion fluid injection and saline injection. The handheld controller has a first controller that has a first mode that controls the injection of infusion fluid in a low pressure mode, the rate of injection corresponding to the distance that the first controller is pressed. (Eg, proportional). The low pressure injection is preferably discontinued when the first controller is released during the first mode. The first controller has, for example, a second mode that controls injecting the infusion fluid in a high pressure mode. The high pressure mode injection is preferably stopped when the first controller is released during the second mode. The handheld controller further includes a second controller that controls at least saline infusion. Saline infusion is preferably stopped when the second controller is released during the saline infusion.
The system further includes a pressure transducer that is fluidly connected to the third port of the pressure isolation mechanism.
In a further aspect, the present invention provides an infusion system for use in angiography, the system being a source of saline and a pump that pressurizes the saline by fluidly connecting to the source of saline. A physiological saline valve fluidly connected to the outlet of the pump through the first port, a first connector fluidly connected to the second port of the physiological saline valve, A contrast medium source, a contrast medium valve connected to the contrast medium source through a first port so that fluid can flow therethrough, and a power supply through which fluid can be connected to the second port of the contrast medium valve An injector, a second connector communicatively connected to a third port of the contrast valve, and a pressure isolation mechanism.

The pressure isolation mechanism includes a lumen having a first port that fluidly connects to the second connector and a second port that fluidly connects to the patient's catheter. The pressure isolation mechanism further includes a third port that is fluidly connected to the first connector and the lumen. The pressure isolation mechanism further comprises a valve having a second state that is preferably mutually exclusive of the first state and the first state that occurs when the lumen and the third port are connected; The second condition occurs when the lumen and the third port are removed. The valve is normally biased to the first state and is preferably switchable to the second state when the fluid pressure from the powered injector reaches a predetermined pressure level. The first and second ports of the lumen are preferably maintained connected, whether in the first state or the second state. The system further includes a pressure transducer that is fluidly connected to the third port of the pressure isolation mechanism.
The system also includes a first air detector, ie, an air column detector, fluidly connected between the saline valve and the first connector, and a fluid between the contrast agent valve and the second connector. Includes a second air detector connected in a flowable manner.
The system also includes a first drip chamber that is fluidly connected between the saline source and the pump, and a saline in the saline source that is operatively connected to the first drip chamber. It has a detector that senses the quantity. Similarly, the system includes a second drip chamber in which fluid is communicatively connected between a contrast agent source and a contrast agent valve, and an infusion in the infusion fluid source operatively connected to the second drip chamber. It has a detector that senses the amount of fluid. One advantage of an infusion chamber is that once the system is initially discharged or filled, there is less chance of air being introduced into the system.

In another aspect, the present invention provides a pressure isolation mechanism for use in medical procedures. A pressure isolation mechanism, or pressure isolation device, includes a lumen, an isolation port connected to the lumen for fluid flow, and a valve having a first state and a second state. The first condition occurs when the lumen and the isolation port are connected. The second condition occurs when the lumen and the isolation port are removed. The lumen remains open for fluid to flow in the first state and the second state. The valve is normally in the first state and can be switched to the second state when the fluid pressure in the lumen reaches a predetermined pressure level. The valve is, for example, biased to a first state (eg, by a spring or other mechanism suitable for applying a biasing force as is known in the art). The pressure sensor, or transducer, can be connected to the isolation port of the pressure isolation mechanism to allow fluid to flow as described above.
The valve can be switched between a first state and a second state by the force of fluid pressure. Alternatively, an electromechanical actuator operatively connected to the pressure sensor controls the state of the valve as a function of fluid pressure. The pressure sensor is, for example, a pressure transducer connected to the isolation port so that fluid can flow as described above.

In general, pressure isolation mechanisms are useful in any medical procedure in which it is desirable to isolate the flow path or flow path element from the fluid flow above a certain fluid pressure. The flow path or the flow path element is connected to the isolation port of the pressure isolation mechanism so that fluid can flow therethrough. For example, the pressure transducer is installed in fluid communication with the isolation port to protect the pressure transducer from damage as a result of exposure to excessive fluid pressure.
In a further aspect, the present invention provides a fluid delivery mechanism having a manually operated syringe and a pressure isolation mechanism as described above.
The present invention, in another aspect, provides a method for delivering fluid to a patient by adding a patient pressure transducer to a flow path used in a medical procedure. The method includes placing the lumen of the pressure isolation mechanism in the flow path, for example, via the first port and the second port of the lumen, as described above. The method also includes connecting a pressure transducer to the third or isolation port of the pressure isolation mechanism. The method is useful, for example, for adding a patient pressure transducer to an angiographic fluid delivery system including a manual syringe.
Other objects and advantages of the present invention will be apparent from the following drawings and detailed description of the invention and preferred embodiments thereof.

DETAILED DESCRIPTION OF THE INVENTION In one aspect, the present invention provides an energy / signal source that generates fluid pressure / flow while providing tactile and / or audible feedback of the generated fluid pressure to the user. This allows the user to adjust the fluid pressure / flow. The powered infusion system of the present invention can provide, for example, slow flow / low pressure flow fluid delivery for powered coronary artery injection and fast flow / high pressure flow fluid delivery for ventricular injection.
FIG. 2 shows one embodiment of the present invention, and the injection system 10 is preferably divided into the following two parts. A) Multiple patient parts or sets. B) A disposable part or set for each patient. Part, or set A and part, or set B are separated by a high pressure connector, ie, a high pressure “sterile” connector (20) such as the diaphragm connector disclosed in US Pat. No. 6,096,011 assigned to the assignee of the present invention. Preferably, fluid is removably coupled to the connection in a flowable manner, and the contents of US Pat. No. 6,096,011 are incorporated herein by reference. The sterile coupler, ie the connector of US Pat. No. 6,096,011, is suitable for repeated use at relatively high pressure (coupled and uncoupled). The sterile connector (20) has a surface that can be sterilized (e.g., between patients) by maintaining a leak-proof seal at high pressure after many such uses, e.g., by wiping with a suitable disinfectant. Is preferred. Another high pressure sterile connector suitable for use in the present invention is disclosed in US Pat. No. 6,471,674 assigned to the assignee of the present invention, the contents of which are incorporated herein by reference.

The multiple patient parts A preferably include a powered injector (30), which is typically fluid pressure / flow through a pressure chamber, such as a syringe (40) as known in the art. Is an electromechanical drive system. Powered injectors and syringes suitable for use in the present invention are disclosed, for example, in International Publication No. WO 97/07841 and US Pat. No. 4,677,980, assigned to the assignee of the present invention, the disclosures of which are incorporated herein by reference. With the description of this application.
In general, an injector drive is an electromechanical drive that produces linear motion on a syringe plunger (not shown in FIG. 2) and generates fluid pressure / flow. The source of the injection medium (60) (e.g., contrast agent bottle) is connected in fluid communication with the syringe, for example by an electromechanical valve actuator assembly (50), preferably a disposable valve (52) (54). To control and direct the fluid flow. The valves (52) and (54) are preferably multi-position valves that get wet with fluid. The valves (52) (54) can alternatively and / or manually be operated. The contrast agent bottle or container (60) is pre-loaded with contrast agent and is often dispensed into a glass or plastic container with a rubber septum and can be connected by IV spikes. A temporary container (70), or reservoir (70), is deployed between the contrast agent bottle (60) and the electromechanical valve assembly (50) to expel air from the system and to provide a source of contrast agent ( It is preferable to create a gap in the flow path that can detect a level of 60), which helps to prevent re-entry of air once discharged.
The temporary container (70) may operate in conjunction with a contrast agent level detection system, as described in detail below. For example, the contrast agent level detector (80) includes one or more electrical, optical, ultrasonic or mechanical sensors that detect the presence of a certain level of fluid in the temporary container (70). .

  Furthermore, injecting air into the patient is protected by various mechanisms that sense the air in the flow path, or flow. For example, ultrasonic bubble detection is used to detect the presence of air in the flow path. Similarly, backlighting facilitates air bubble detection by the operator. In the backlit method of bubble detection, the injector side of the channel is illuminated to make it easier to see the channel, the presence of fluid, and the presence of air. A source (90) of at least one other fluid (generally saline or other suitable medium) may be provided. Additional fluid sources such as therapeutic fluids may also be deployed. A further fluid source, such as a saline supply source (90), is also preferably operatively or fluidly connected to a pressure mechanism, such as a powered injector or peristaltic pump (100). In FIG. 2, a peristaltic pump (100) operatively connected to a saline source (90) allows fluid to flow through the flow path of the injector (30) via an electromechanical valve actuator assembly (50). It is connected to the.

The controller unit (200) supplies power to the injector (30) and the peristaltic pump (100) in a controlled manner. The controller unit (200) communicates between the various system elements. The graphical user interface display (210) is preferably connected to the controller unit (200) to display information to the user and allow the user to set and adjust device parameters. For example, an audible feedback source (220) is provided to feed back the flow rate supplied by the injector (30) to the user. For example, as the flow rate increases, the sound increases in pitch, volume, and / or frequency.
The per-patient disposable set B includes fluid wetted elements of the fluid delivery path. The per-patient disposable set B includes a waste port (310) (eg, through which blood is drawn), a pressure measurement port (320), and an interface (330) to the catheter (340) (eg, A connector like a standard lure connector). The waste port (310) includes, for example, a manually actuated or automatic valve to allow drainage of unwanted fluids and connection of eg manually operated syringes. In addition, a powered suction mechanism (e.g., a peristaltic pump (314) connected by a tube to a waste bag (316)) is connected to a waste port (310), e.g., via a standard connector (312). And aspirates fluid from the system as well as withdrawing blood from the patient. Drawing fluid from the system and drawing blood from the patient into the waste bag (316) helps remove air from the fluid delivery system.

  The pressure port (320) preferably includes a pressure driven isolation device (350) that isolates the pressure transducer, for example as shown in FIG. The pressure driven isolation device (350) is a fluid driven assembly located along the injection flow. In the embodiment of FIG. 3, the valve (352) in the assembly isolates the pressure transducer (360) by shutting off during high pressure injection. A biasing member or mechanism, such as a spring (354), returns the valve (352) to its original open position when the injection system is not injected at high pressure, thus providing a flow path to the pressure transducer (360). open. In the embodiment of FIGS. 2 and 3, the pressure driven isolation device (350) moves to the closed position and isolates only the pressure transducer (360), except by the pressure driven isolation device (350). Are not connected to a source of contrast medium (60) or a source of physiological saline (90) so that fluid can flow therethrough. The pressure transducer (360), for example, is located near the patient and substantially reduces or eliminates the blunting of pressure signals resulting from interference tubes, fluids and system elements, thereby allowing others currently used in angiographic procedures. Improves accuracy compared to other pressure measurement systems. The pressure transducer (360) is preferably separated from the patient / catheter connector by a minimal tube (eg, less than about 3 feet). Due to the multi-patient nature of set A, the pressure transducer assembly and other per-patient disposable set B are preferably located downstream of the double check valve (370) and continuously measured. As such, the pressure isolation mechanism described above is required to isolate the pressure transducer (360) from the high pressure when powered by power.

The system also includes a manual controller (400), e.g., held by hand or operated by hand, e.g., electrically, mechanical, pneumatic, optical, radio frequency, audible or a combination thereof. Preferably, certain control signals are generated or processed to control the injector (30) and also the peristaltic pump (100). The manual controller (400) also preferably feeds back the injected fluid pressure and flow to the operator (eg, tactile, visual, audible, etc.). The manual controller (400) preferably includes at least one type of feedback (eg, tactile feedback). In the embodiment of FIGS. 2, 4 and 5, a hand held controller or handpiece is operatively connected to the fluid flow so that the user can feel the pressure in the flow path line. The electrical switch preferably allows the user to turn on / off and adjust the fluid / flow pressure of the system only for low pressure / slow flow coronary infusion. The high pressure injection is activated, for example, using either the display (210) on the handheld controller or another (second) controller. In this way, the handheld controller provides pressure feedback to the user while controlling low pressure / slow flow coronary infusion.
The hand-held controller of the present invention has, for example, a flow path sealing chamber, and an element movable in the chamber can move by a predetermined distance. The movable element is preferably in direct contact with the flow path and is affected by fluid flow and flow pressure. The movable element incorporates a mechanism for processing the signal, which can be used to remotely control the source of fluid pressure / flow. The handheld controller can be used with a signal processor for movement of movable elements, as is known in the art.

In one embodiment of the present invention, as shown in FIG. 4, the hand-held control device 500 is movable in a chamber 520 slidably arranged in a direction substantially perpendicular to the direction of fluid flow. The right piston (510). The chamber (520) and the piston (510) can be directly in the flow path or can be separated from the flow path by the length of the tube (see, eg, FIG. 5).
The handheld control device (500) allows the movable piston (510) to be positioned under the finger while the device (500) is held in the hand. The piston (510) preferably incorporates a switch (530) that, when pushed, controls the fluid flow generated by an external fluid pressure / flow source (eg, injector (30)). As pressure is generated, the piston (510) is moved by the increased pressure detectable by the operator.
As the operator pushes the piston (510) further, it is preferable to increase the signal to the fluid flow / pressure, resulting in an increase in the signal in the pressure / flow and increase the pressure on the piston (510). Back pressure or tube occlusion causes pressure buildup in the system, upward movement of the piston (510), tactile feedback to the operator, thereby creating a potential problem for the operator in the infusion procedure. Warning. The system also provides audio and / or visual feedback of the flow rate via a user display (210), preferably controlled by the position of the piston (510), for example.
As shown in FIG. 5, the hand-held controller (500 ′) is connected in a T shape away from the main line to be more flexible. The purge valve (540) is located at the end of the handheld controller (500 ') and removes air during system purge. Air can also be expelled from the handheld controller (500 ′) before the handheld controller (500 ′) is connected to the flow path. FIG. 5 also shows a second switch (560 ′) for initiating high pressure injection. Additional switches can be deployed to control saline delivery.

6A and 6B show a handheld controller that is ergonomic by another person. The handheld controller (600) of FIG. 6A includes a chamber (620) that can be fluidly connected to the infusion system flow path described above. A low pressure control switch (610) operating similarly to the piston (510) is slidably disposed within the chamber (620) to control low pressure injection of contrast agent. The chamber (620) is formed to fit the user's hand, for example. A switch (630) that initiates high pressure injection via the injector (30) is provided on the handheld controller (600). In addition, a switch (640) for controlling the transportation of physiological saline is provided on the handheld controller (600).
FIG. 6B shows an embodiment of a handheld controller (700) that can be worn on a finger. In this regard, the finger of the user's hand passes through the controller (700) via the passage (710) while the handheld controller (700) is held in the user's hand. A rotary switch (720) controls the low pressure injection. A high pressure infusion switch (730) and a saline switch (740) are also provided.

The system 10 (FIG. 2) also includes a foot-operated foot controller (420), which includes one or more actuators (430) connected to the controller (200). The foot controller (420) is connected to the handheld controller (400) or used to control the flow via the system (10) independent of the handheld controller, for example.
Another embodiment of an injection system (800) is shown in FIGS. 7A-7H. In this embodiment (first referring to FIGS. 7A and 7G), the fluid control module (810) is operatively connected to a powered injector (830) to which the syringe (840) is connected as described above. . The syringe (840) is connected to the automated valve (852) of the fluid control module (810) so that fluid can flow, and the automated valve (852) is also contrasted via the intermediate drip chamber (870) (see FIG. 7A). A fluid is connected to the agent source (860) in a flowable manner. The drip chamber (870) preferably includes a fluid level sensing mechanism (880). As is known in the art, an automated valve / stopper (852) is also preferably connected to the first input port of the lumen (954) of the pressure isolation valve (950) (eg, FIGS. 7D-7F). reference). The valve (852) prevents saline and / or dirty fluid from entering the syringe (840) and allows the flow of infused fluid (e.g., contrast agent) from the syringe (840) quickly at any pressure or flow rate. Can be stopped. This ability to stop the flow of infused fluid almost quickly at any pressure or flow rate eliminates the effects of system alignment and allows for “rapid” bolus delivery. An air column detector (856) may be installed in the line between the plug (852) and the pressure isolation valve (950).

The fluid control module (810) further includes a saline source (890) that is fluidly connected to the peristaltic pump (900) via the interference drip chamber (910). The drip chamber (910) preferably includes a fluid level sensing mechanism (920). The peristaltic pump (900) is preferably connected to an automated valve / stopper (854) so that fluid can flow, and the automated valve / plug is connected to a pressure isolation valve (950) so that fluid can flow. In addition to controlling saline flow, valve (854) prevents dirty fluid from reaching peristaltic pump (900) and saline source (890). An air column detector (858) may be installed in the line between the plug (854) and the pressure isolation valve (950).
Controller 970 and display 974 (see FIG. 7A) are also operatively connected to injector 830 as described above. Further, the handheld controller (1000) is operatively connected to the injector (830) and thereby to the fluid control module (810). In the embodiment shown in FIGS. 7A-7C and 7G, the handheld controller 1000 does not provide tactile feedback of system pressure to the operator. However, a hand-held controller (eg, hand-held controller (600)) that provides such tactile feedback is readily used for system (800). In addition, the above foot controller is also deployed.

In general, a set of disposable parts per patient, i.e., system 800, is shown in dotted lines in FIGS. 7A, 7B and 7C. Two connectors (990a) and (990b) (preferably aseptic connectors as described above) are used to connect multiple patient channel sets to the patient-specific channel sets. Using two separate / parallel fluid lines to connect multiple patient sets to a patient-by-patient set provides significant benefits to the current angiographic injection system and is in vain Reducing the amount of contrast medium and avoiding the risk of injecting a dangerous amount of contrast medium into the patient during saline expulsion. In addition, the system (800) facilitates placing the pressure transducer (980) close to the patient and improves measurement accuracy compared to current commercial systems. The handheld controller (1000) in the embodiment of FIGS. 7A-7H is not directly connected to the flow path, but it is preferably disposable because it can be contaminated with body fluids when the operator handles the controller. Because it happens in general.
The lumen (954) of the pressure isolation valve (950) (via the second outlet port) is preferably connected in fluid communication with an automated or manual valve / stopper (994). Preferably has a waste port (996) as described above. The catheter (1100) is preferably connected via a rotating router connection (998).
FIG. 7B shows a portion of the channel set used in the system (800) of FIG. 7A with the pressure transducer (980) connected directly to the saline channel. 7C shows the flow path used in the system (800) of FIG. 7A in which the pressure transducer (980) is separated from the saline flow path by the length of the tube (984) by the T-connector (982). Indicates a set. In the embodiment of FIGS. 7B and 7C, spikes (976a) and (976b) are used to connect the contrast source (860) and the saline source (890), respectively. In general, standard luer connections are used to connect most elements of the system (800). 7B and 7C, some of these luer connections are shown in isolation. Alternatively, one or more of the connections shown are non-luer, i.e. coupled connections.

One embodiment of the pressure isolation valve (950) is shown in FIGS. 7D-7F. The pressure isolation valve (950) has a housing (952) with a high pressure lumen (954) through which fluid passes through the housing. The pressure isolation valve (950) also has a port (956) to which the pressure transducer (980) and the saline source (890) are connected. Once the predetermined pressure reaches the lumen (954) of the pressure isolation valve (950), the piston (958) operates to isolate the pressure transducer (980). As shown in FIG. 7D, in the “open” or standby state, the lumen (954) (including the catheter (1100) and injector (840) connected thereto) and the isolation port (956) (connected thereto) Between the pressure transducer (980) and the saline flow path).
The gaps and openings in the pressure isolation valve (950) are preferably large enough to convey pressure changes that occur quickly during normal cardiac function and to drop or not attenuate the signal. The effect on the piston (958) of the flow of infusion fluid from the syringe (840) through the lumen (954) is shown by the dotted arrows in FIG. 7D, and the saline flow through the pressure isolation mechanism (950) is indicated by the solid arrows. Indicated by When the pressure in the lumen (954) increases during injection, the piston (958) moves to the right in FIG. 7D and FIG. 7E and responds, and the seal (962) at the left end of the piston (958) is shown. The spring (960) is pushed until it contacts the seal sheet (964) shown in 7E. In this regard, the lumen or port (956) is isolated from the lumen (954) and any increase in pressure acts to increase or increase the effectiveness of the seal (962). When the pressure in lumen (954) returns to normal, spring (960) reopens pressure isolation valve (950) by pushing piston (958) to the left. In one embodiment, fluid does not flow through port (956). In this embodiment, the pressure isolation valve (950) only isolates the device from the tip of the tube and port (956) from high pressure and does not control the flow.

The pressure isolation valve (950) of the present invention is suitable for use in any medical flow path, in which pressure sensing flow path elements (e.g., pressure transducers), or other flow path elements, or It is desirable to automatically isolate the fluid path from pressure above a certain predetermined pressure. The pressure where the pressure isolation valve (950) isolates the port (956) from the lumen (954) can be easily adjusted by varying various variables known to those skilled in the art, such as various valve dimensions and Includes the characteristics of the spring (960) (eg, a constant spring force). It is quite easy to connect the pressure isolation valve (950) to any flow path. In this respect, the lumen (954) is simply placed through the connection port (954a) (954b) towards the unconnected end of the flow path, i.e., the open end, and connected to the flow path or pressure isolation valve (950). There are no other changes. As is known in the medical art, standard connections such as luer connections can be used to connect the lumen (954) to the flow path. The valve (950) is incorporated or incorporated within other devices such as manifolds, pressure transducers, or connectors.
In other mechanical operations of the valve piston (958) described above, the valve piston (958) can be controlled by an electromechanical mechanism. For example, a pressure sensor (e.g., FIG. 7B) such as a pressure sensor or transducer (980) may send a signal to an actuator (e.g., spring 960 in operation position and function, as is known in the control field). In a similar manner) to control the position of the valve piston (958), thereby controlling the fluid flow through the port (956).

8A and 8B illustrate the use of a pressure isolation valve (950) that automatically isolates the pressure transducer P from increased pressure in a manual injection system such as that shown in FIG. Valve V ³ (used to manually isolate the pressure transducer, as described above) is removed from or held in the flow path. As shown in FIG. 8A, when force F is applied to the syringe plunger extension, the fluid that has received pressure flows from the syringe to the flow path. Due to the increased pressure, the pressure in the lumen (954) increases. As described above with reference to FIGS. 7D and 7E, the piston (958) moves to the right in FIGS. 8A and 8B and responds until the seal (962) contacts the seal sheet (964) shown in FIG. 8A. Press 960). In this respect, the port (956) and pressure transducer P are isolated from the lumen (954) and other flow paths. As shown in FIG. 8B, when the syringe does not operate, the pressure in the lumen (954) returns to normal, and the spring (960) pushes the piston (958) to the left to re-open the pressure isolation valve (950). open.
By incorporating a pressure isolation valve (950) into the flow path of FIGS. 8A and 8B, a substantial improvement over the injection system of FIG. For example, using the system of FIG. 1 to operate each valve V ¹ , V ^2, and V ³ is cumbersome and difficult for a physician or other operator. When the operator is often injected, forget to close the valve V ^3, thereby causing damage to the pressure transducer, or forgot to open the next injection valve again prevents proper words timely patient monitoring. In the system of FIGS. 8A and 8B, by automatically isolating the pressure transducer P at high pressure, the infusion procedure is much easier.

As noted above, saline is sometimes used during normal catheter procedures. For example, the controller (1020a) or (1020b) on the handheld controller (1000) transmits a signal that controls the flow of saline. From the viewpoint of patient safety, physiological saline is introduced close to the proximal end of the catheter (1000), and the amount of contrast medium expelled from the top of the physiological saline during injection of the physiological saline is minimized. As before, the parallel line configuration of the contrast agent transport path and the saline transport path of the present invention helps to prevent such undesired injections.
Since the required saline flow rate is slow and the viscosity of the saline is much lower than the viscosity of the contrast agent, the pressure required to push the saline through the catheter (1100) Much smaller than the force required to push. By protecting the saline line from the high pressure required for contrast injection, further system alignment is avoided and the saline line need not be made from the same high pressure line as for the contrast agent. To protect the saline line from high pressure, connect the saline line to the port (956) of the pressure isolation valve (950) and introduce the saline flow as shown by the solid arrows in FIG. 7D. Is achieved. In this embodiment, the port (956) is normally open, allowing saline flow therethrough as required, as well as monitoring the patient's blood pressure. During high pressure injection, the pressure isolation valve (950) functions as described above to protect the pressure transducer (980) and low pressure saline line from the high pressure of contrast agent injection.

The height of the catheter (1100) often changes as the infusion procedure progresses, for example as the patient rises or falls. Such a change in the height of the catheter (1100) leads to erroneous blood pressure readings by the pressure transducer (980). Thus, the pressure transducer (980) preferably varies in height with the catheter (1100) and is positioned independent of the position of the infusion system, including the position of the injector (830).
In one embodiment shown in FIGS. 7G and 7H, the handheld controller 1000 has a plunger or stem controller 1010 that is pushed by the operator in the first / low pressure mode. Control the flow of contrast agent from the syringe (840). Furthermore, when the plunger (1010) is pushed, the flow rate increases (eg, by a potentiometer such as a linear potentiometer in the housing (1020) of the controller (1000)). In this embodiment, the operator uses the graphical user interface display (974) to change the mode of the plunger (1010) to the second mode, and the injector (830) is the operator in the second mode. Start high pressure injection as programmed by. In this second / high pressure mode, the operator keeps the plunger (1010) pressed and continues the injection. When the plunger (1010) is released, the high pressure injection is preferably terminated almost quickly, for example by controlling the valve (852).
The handheld controller (1000) also includes at least one switch that controls the flow of saline within the system (800). In the embodiment of FIG. 7H, the handheld controller 1000 includes two saline switches 1030a and 1030b on both sides of the plunger 1010 for easy access by the operator. In this embodiment, the switches (1030a) and (1030b) have cantilevered elastic members (1032a) and (1032b), respectively, and are pushed by an operator to convey physiological saline through the system (800). One of the switches (1030a) and (1030b) is preferably kept pressed by the operator and continues to carry the saline.
When the pressed switch is released, the saline flow is preferably stopped almost quickly, for example, by control of valve (854).

As shown in FIG. 7G, many elements of the system (800) may be supported on a movable stand (805). The injector (830) is preferably rotatable around the stand (805) as shown by the arrow in FIG. 7G. In the embodiment of the system (800) of FIGS. 7G and 7H, the stopper is purchased from a medical associate network, the dispenser is Elcam Plastic serial number 565302, and the spike is serial number 23202 purchased from Cosonia. 23207, the tubes are serial numbers DCT-100 and DCT-148 purchased from Merritt Medical, the connector is serial number 102101003 purchased from Merritt Medical, the rotating hub is purchased from the Medical Associate Network, and the distributor Is a manufacturing number 565310 of Elcum Plastic, a peristaltic pump of Watson Marlow has a manufacturing number of 133.4451 THF, and a fluid level sensor was purchased from Omron under the manufacturing number EESPX613.
The following describes the general general use of the injection system of the present invention, where all flow path elements are combined / connected and deployed in place, including a contrast container and a saline container. .

In general, the first step in the infusion procedure is to replace the air in the flow path with a fluid. With the operator's initiation and mechanical control, the powered injector moves the syringe plunger backwards (towards the powered injector), thereby bringing it to a connection point with a control valve in the vicinity of the temporary container of contrast agent. Generate negative pressure. The control valve is positioned to allow fluid to flow from the contrast container into the temporary container and syringe. When drawing a predetermined amount of contrast agent into the syringe, the injector drive reverses direction to create a positive pressure, moving fluid in the direction of the contrast agent container, i.e. the catheter (not connected to the patient), The entrained air is carried from outside the flow path into an “air gap” formed in the temporary container, ie through the catheter. The air is further preferably initially expelled from the system at the beginning by distributing a fluid, such as saline, through the flow path (often referred to as “priming”). The system is preferably kept free of air during the infusion procedure and is preferably used for many patients. Priming is preferably performed once for each patient or once for many patients based on a disposable flow path configuration.
The system has, for example, a “low contrast” level (refill required) and a “stop filling” limit sensor on the temporary container, as described above, so that no air is drawn into the contrast syringe during the fill cycle Help to ensure that. An ultrasonic air column sensor and / or other type of sensor is also deployed downstream of the injector to detect an air gap in the line as a second safety sensor.
A second fluid pump, typically a pre-filled bag, connected to a source of bulk saline by the initiation and mechanical control of another operator, is fluid in the direction of the patient's catheter. Shed. A sufficient amount of saline is preferably jetted through the disposable set to remove any visible air during priming. A hand-held controller (providing tactile feedback as described above), which is configured to prime the saline with fluid flow through the flow path, for example, by opening an essential blood valve, Can be driven out. When priming is complete, the blood valve closes.

Once the system is adjusted and filled, it is connected to the patient via the catheter. The system preferably has a range of parameters for flow, pressure, variable flow, alarms and performance limits, as is known in the art.
When the first button is pressed to deliver contrast agent, for example to the coronary artery, at low and low pressure flows, a piston or other controller on the handheld controller initiates contrast agent flow, in some embodiments In which feedback (eg tactile and / or auditory feedback) is applied. Furthermore, it is preferable that the flow rate of the contrast medium increases when a button on the handheld controller is pressed. At any time the button is released, the fluid flow is preferably stopped and any feedback is terminated. This “deadman” motion is applied, for example, by urging the first controller, ie, the actuator, to the off position (eg, spring drive). The minimum and maximum flows are preferably achieved by setting parameters using a graphical user interface on the display.
For example, a separate switch on the handheld controller, i.e., a second actuator / controller, is preferably pressed to carry the contrast agent to the left ventricle with high flow and high pressure. Alternatively, the second mode of the first actuator / controller is entered to control the high pressure flow. In embodiments where the handheld controller provides tactile feedback during low pressure injection, it is preferred that such tactile feedback not be applied during high pressure flow. However, other feedback such as auditory high and low feedback different from the auditory high and low feedback in the low pressure mode may be provided. The high pressure / fast flow function is preferably first input selected from input / setting parameters using a graphical user interface on the display. The high velocity flow and high pressure injection are preferably programmed so that the flow does not change. As noted above, if the pressure is 1000 psi or more, there is preferably no direct tactile feedback. The injection is preferably stopped whenever the second button is released.

Preferably, the second or third switch, controller or actuator on the hand-held controller is selected to carry the saline and the saline flow occurs at a preselected flow rate. Alternatively, one controller or actuator with three different control modes can be used. As with other actuators or actuator modes on the handheld controller, the saline flow preferably stops once the third button is released.
As noted above, the pressure sensor is preferably connected to the pressure isolation valve. Patient pressure monitoring can be determined at any time except when the fluid infusion exceeds the pressure set by the pressure isolation valve.
Multiple patient sets are designed so that at least some of them can be safely reused for multiple patients. In such designs, for example, interfaces to syringes and contrast / saline elements, disposable valves and associated tubes, and multiple use high pressure, sterile connectors can be reused for multiple patients. Is preferred.

The hand-held controller (whether or not fluid is connected to the flow path) and associated tubes and check valves are preferably exchanged for each patient. Similarly, any waste port, pressure port, and interface to the catheter are preferably exchanged for each patient. Multiple patient set aseptic connectors can be wiped clean, for example, before each disposable set is connected to each new patient. Preferably, reusable or multiple patient sets are limited in number of reuses and are not used longer than a set time (eg, 8 hours).
Although the present invention has been described herein with reference to the above embodiments and / or examples, such detailed description is for purposes of illustration only and various modifications can be made by those skilled in the art without departing from the invention. obtain. The scope of the invention is indicated by the following claims rather than the foregoing description. All changes and modifications that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

1 is a diagram illustrating an example of a manual injection system currently used in angiographic procedures. FIG. It is a figure which shows one Example of the injection | pouring system of this invention. FIG. 2 is a diagram illustrating an embodiment of a pressure driven isolation device of the present invention. It is a figure which shows one Example of the hand-held controller of the present invention, ie, a hand-held piece. FIG. 4 is a diagram showing another embodiment of the hand-held controller of the present invention, which is connected to the flow path by a “T” connection. FIG. 6A is a diagram showing another embodiment of the hand-held controller of the present invention. The controller includes a control switch for feeding back pressure in low-pressure injection, a switch for high-pressure injection, and a switch for physiological saline. Have. FIG. 6B is a diagram showing another embodiment of the hand-held controller of the present invention, which can be worn on the user's finger. FIG. 7A shows another embodiment of the injection system of the present invention. FIG. 7B is a side view of some embodiments of the infusion system of FIG. 7A, with the pressure transducer in the flow path. FIG. 7C is a side view of some embodiments of the infusion system of FIG. 7A, where the pressure transducer is separated from the flow path by a T connection and the length of the tube. FIG. 7D is a side cross-sectional view of an embodiment of the pressure isolation valve of the present invention, wherein the valve is in a first state, an “open” state. 7E is a side cross-sectional view of the embodiment of the pressure isolation valve of FIG. 7D, wherein the valve is in a second state, the “closed” state. FIG. 7F is a perspective view of the pressure isolation valve of FIGS. 7D and 7E. FIG. 7G is a front view of the injection system of FIG. 7A. FIG. 7H is a front view of the handheld controller of the infusion system of FIG. 7A. FIG. 8A is a diagram of the angiographic injection system of the present invention, including a manual syringe and a pressure isolation mechanism or valve, which is closed to isolate the pressure transducer from the flow path. FIG. 8B shows the angiographic injection system of FIG. 8A with the pressure isolation mechanism open and the pressure transducer set to flow through the flow path.

Claims (69)

A pressure isolation mechanism used in medical procedures,
Lumen,
An isolation port connected to the lumen for fluid flow;
A first state occurs when the lumen and the isolation port are connected; a second state occurs when the lumen is disconnected from the isolation port; With
The lumen is open in the first state and the second state so that fluid flows through the lumen;
A pressure isolation mechanism in which the valve is normally in a first state and is switchable to a second state when the fluid pressure in the lumen reaches a predetermined pressure level. The pressure isolation mechanism of claim 1, wherein the valve is biased to a first state. The pressure isolation mechanism according to claim 1, further comprising a pressure transducer connected fluidly to an isolation port of the pressure isolation mechanism. The pressure isolation mechanism according to claim 2, wherein the pressure transducer is connected to an actuator to control a state of the valve. A fluid delivery system comprising:
A syringe,
It has a pressure isolation mechanism that allows fluid to flow through the syringe,
The pressure isolation mechanism has a lumen, an isolation port connected to the lumen so that fluid can flow, and a first state and a second state, wherein the first state is when the lumen and the isolation port are connected. And the second condition includes a valve that occurs when the lumen and the isolation port are disconnected, the lumen being open in the first condition and the second condition, and fluid flowing through the lumen. The fluid delivery system, wherein the valve is normally in the first state and is switchable to the second state when the fluid pressure in the lumen reaches a predetermined pressure level. The fluid delivery system of claim 5, wherein the valve is biased to the first state. 6. The fluid delivery system of claim 5, further comprising a pressure transducer connected in fluid communication with the isolation port of the pressure isolation mechanism. A method of delivering a fluid to a patient by adding a patient pressure transducer to a flow path used in a medical procedure comprising:
A process for installing a lumen of a pressure isolation mechanism in a flow path, wherein the lumen includes a first port and a second port connected to the flow path, and the pressure isolation mechanism is further connected to allow fluid to flow through the lumen. A third port, and a valve having a first state and a second state,
The first condition occurs when the lumen and the isolation port are connected, the second condition occurs when the lumen and the isolation port are removed, and the first port and the second port of the lumen are the first The valve is normally in the first state and is switchable to the second state when the fluid pressure in the lumen reaches a predetermined pressure level; and
Connecting the pressure transducer to a third port of the pressure isolation mechanism. 9. The method of claim 8, wherein the flow path is part of an angiographic fluid delivery system that includes a manual syringe. The fluid delivery system of claim 5, wherein the syringe is a manual syringe. An injector system,
A powered injector,
A pressure chamber operatively connected to the powered injector;
A flow path connected to the pressure chamber so that a fluid can flow therethrough,
A manual controller connected to the flow path so that fluid can flow,
The manual controller includes at least one actuator that controls the injector by an operator applying force, and the actuator is tactilely connected to the flow path so that fluid can flow through the flow path to the operator. An injector system configured to stop the injection procedure if no force is applied to the actuator. The manual controller includes a chamber in which fluid is connected to the flow path, the actuator includes a button operatively connected to a piston disposed in the chamber, and the button is biased to an off position. 11. The injector system according to 11. The injector system of claim 11, wherein the at least one actuator controls the injector in a low pressure mode. The injector system of claim 13, wherein the at least one actuator controls the flow rate by changing a force on the actuator. The manual controller further comprises a second actuator having an on state and an off state, wherein when the second actuator is set to the on state, the injector is placed in a programmed high pressure injection mode. Injector system. The injector system of claim 13, wherein the manual controller further comprises a third actuator for controlling the flow of saline in the flow path. The injector system of claim 11, further comprising a haptic feedback unit operatively coupled to the at least one actuator, the haptic feedback unit operable to provide haptic feedback to the operator. . The injector system of claim 11, wherein the manual controller is configured to discharge air prior to injection. The injector system of claim 18, wherein the manual controller comprises a discharge valve. An injection system used for angiography,
A powered injector that is fluidly connected to a source of injected fluid;
Comprising a powered injector and a pressure sensor connected in fluid communication through a pressure driven isolation device;
The isolation device is configured to isolate the pressure sensor when the pressure in the flow path is greater than or equal to a set pressure, the pressure sensor being adapted to a change in the height of a patient's catheter connected to a powered injector so that fluid can flow therethrough. Infusion system not affected. An angiographic injection system for injecting an infusion fluid into a patient,
A pressure device for supplying an infusion fluid under pressure;
A low-pressure fluid transfer system;
A pressure isolation mechanism having a first port connected to the pressure device, a second port connected to the patient, and a third port connected to the low pressure fluid delivery system;
The pressure isolation mechanism has a first state and a second state mutually exclusive with the first state, wherein the second state is connected to the second port and the third port, and Occurs when one port and the third port are connected, the second state occurs when the first port and the second port are connected, and when the first port and the third port are disconnected Arise,
An angiographic injection system in which the valve is normally energized to a first state and is switchable to a second state when fluid pressure from the syringe pump reaches a predetermined pressure level. 24. The system of claim 21, further comprising a valve that is linear between the pressure device and the first port of the pressure isolation mechanism. 23. The system of claim 22, wherein the valve that is linear between the pressure device and the first port of the pressure isolation mechanism is an automated valve. The low pressure fluid delivery system comprises a source of flush fluid, an infusion chamber communicatively connected to the source of flush fluid, a detector for sensing the amount of flush fluid in the source of saline. Item 22. The system according to Item 21. 25. The system of claim 24, further comprising a flush fluid control valve and a foam detector in a straight line between the flush fluid drip chamber and the pressure isolation mechanism. 26. The pressure device is communicatively connected to a source of infusion fluid via an infusion fluid drip chamber, and the system further comprises a detector that senses the amount of infusion fluid in the source of infusion fluid. System. 27. The system of claim 26, further comprising an infusion fluid control valve and an air detector that are linear between the infusion fluid drip chamber and the pressure isolation mechanism. 28. The system of claim 27, further comprising a handheld controller that controls infusion fluid infusion and flush fluid infusion. 29. The handheld controller comprises a first controller having a first mode that controls infusion of infusion fluid in a low pressure mode, wherein the infusion flow rate is directly proportional to the distance that the first controller is pressed. The system described in. 30. The system of claim 29, wherein the low pressure injection is stopped when the first controller is released during the first mode. 31. The first controller has a second mode for controlling the injection of infusion fluid in a high pressure mode, and the high pressure injection is stopped if the first controller is released during the second mode. The system described in. 32. The system of claim 31, wherein the handheld controller further comprises at least a second controller that controls infusion of flush fluid. 34. The system of claim 32, wherein the saline infusion stops if the second controller is released during the flush fluid infusion. 24. The system of claim 21, further comprising a pressure transducer operatively connected to the third port of the pressure isolation mechanism. An injection system used for angiography,
A source of fluid for flushing;
A pump operatively connected to a source of flushing fluid to pressurize the flushing fluid;
A flush fluid valve operatively connected to the pump outlet via a first port;
A first connector connected to a second port of the flush fluid valve so that fluid can flow therethrough;
A source of contrast agent;
A contrast agent valve operatively connected to a source of contrast agent via a first port;
A powered injector operatively connected to the second port of the contrast valve;
A second connector operatively connected to a third port of the contrast agent valve;
A first port that is fluidly connected to the second connector and a pressure isolation mechanism that includes a lumen having a second port that is fluidly connected to the patient's catheter;
The pressure isolation mechanism also includes a third port that is fluidly connected to the lumen and the first connector, the pressure isolation mechanism including a valve having a first state and a second state, The state occurs when the lumen and the third port are connected, the second state occurs when the lumen and the third port are disconnected,
The first port and the second port of the lumen are connected in a first state and a second state, the valve is normally biased to the first state, and the fluid pressure in the lumen from the powered injector. Can be switched to the second state when the pressure reaches a predetermined pressure level;
An infusion system comprising a pressure transducer connected fluidly to a third port of the pressure isolation mechanism. Furthermore, the first air detector is connected between the flush fluid valve and the first connector so that the fluid can flow, and the fluid is connected between the contrast medium valve and the second connector so that the fluid can flow. 36. The system of claim 35, comprising a second air detector configured. In addition, a first drip chamber in which fluid is communicatively connected between the source of flush fluid and the pump, and the flush fluid in the source of flush fluid operatively connected to the first drip chamber. 36. The system of claim 35, comprising a detector that senses the amount. In addition, a second drip chamber that is fluidly connected to the contrast agent source and the contrast agent valve, and operatively connected to the second drip chamber, the infusion fluid in the infusion fluid source 38. The system of claim 37, comprising a detector for sensing the amount. 38. The system of claim 37, further comprising a handheld controller that controls infusion fluid injection and flush fluid injection. 40. The system of claim 39, further comprising a foot controller that controls infusion of at least one of infusion fluid and flush fluid. An injector system,
A source of infusion fluid;
A pump device;
A flow path set disposed between the source of infusion fluid and the pump device;
A fluid control device operably connected to the flow path set;
An injector system wherein the fluid control device is configured to stop the fluid infusion flow to the patient at a pressure or flow rate substantially equal to that produced by a pump device that delivers a short bolus of infusion fluid to the patient. 42. The injector system of claim 41, wherein the fluid control device comprises an automated multi-position valve configured to fluidly communicate with the pump device and the source of infusion fluid through the flow channel set. 43. The injector system of claim 42, wherein the automated multiposition valve comprises an automated stop. 43. The injector system of claim 42, further comprising an air column detector operably connected to the flow path set. 42. The injector system according to claim 41, wherein the fluid control device is part of a flow path set and constitutes a multi-position valve disposed between the source of infusion fluid and the pump device. 42. The injector system of claim 41, further comprising a handheld controller that controls the flow rate of the infused fluid from the pump device. 47. The injector system of claim 46, wherein the handheld controller comprises a piston slidably disposed in the chamber and configured to engage a switch that controls a flow rate of infusion fluid from the pump device. 48. The injector system according to claim 47, wherein the piston and the switch are further configured such that the flow rate of the injected fluid is faster when the piston is pressed into the chamber. 48. The injector system of claim 47, wherein when the spring is deployed in the room and connected to the piston and the piston is pressed into the room, the user of the handheld controller experiences greater tactile resistance when the handheld controller is activated. . 49. The injector of claim 46, wherein the handheld controller is configured to provide at least one of audio and visual feedback to a user of the handheld controller to indicate the flow rate of infusion fluid from the pump device. system. 48. The method of claim 46, further comprising a user display configured to provide at least one of audio and visual feedback to a handheld controller user to indicate the flow rate of infusion fluid from the pump device. The injector system described. 42. The injector system of claim 41, wherein the flow path set comprises a drip chamber and a fluid level sensing mechanism operatively connected to the drip chamber to sense the level of infused fluid in the drip chamber. And a source of medical fluid;
42. The injector system of claim 41, comprising a pump operatively connected to the source of medical fluid and supplying medical fluid to the patient via the flow channel set. 54. The injector system of claim 53, wherein the flow path set comprises a drip chamber and a fluid level sensing mechanism operatively connected to the drip chamber to sense the level of medical fluid in the drip chamber. 54. The injector system of claim 53, further comprising an air column detector operatively connected to the flow path set. In addition, a second fluid control device comprises an automated multi-position valve configured to fluidly connect to a pump and a source of medical fluid via a flow path set. 54. The injector system according to claim 53, comprising: 57. The injector system of claim 56, wherein the automated multiposition valve comprises an automated stopcock. 42. The injector system according to claim 41, wherein the pump device comprises a syringe. 54. The injector system of claim 53, wherein the pump comprises a peristaltic pump. A method of discharging air from a fluid delivery system comprising a source of infusion fluid, a pump device, and a channel set, the channel set comprising a fluid control device disposed between the source of infusion fluid and the pump device. ,
Driving the fluid control device to permit fluid communication between the pump device and the source of infusion fluid;
Driving the pump device to draw infusion fluid from the source of infusion fluid into the pump device;
A method comprising driving a pump device in different modes to discharge air from a flow channel set to a source of injected fluid. 61. The method of claim 60, further comprising driving the pump device using a handheld controller. 61. The method of claim 60, wherein the pump device comprises a syringe. 64. The method of claim 62, wherein the first step, i.e., driving the pump device, includes moving the syringe plunger proximally within the syringe to draw the infusion fluid from the source of infusion fluid into the syringe. 64. The method of claim 63, wherein the second step, i.e., driving the pump device, includes moving the syringe plunger in the reverse direction within the syringe to eject air from the flow path set. 61. The method of claim 60, wherein the fluid control device comprises an automated multi-position valve. A method of delivering a short bolus injection to a patient using a fluid delivery system, the fluid delivery system comprising a source of infusion fluid, a pump device, and a fluid control device disposed between the source of infusion fluid and the pump device. Comprising a set of flow paths,
Driving the fluid control device to prevent fluid from being circulated between the pump device and the source of infusion fluid and permitting fluid to circulate between the pump device and the patient;
Driving the pump device to deliver the pressurized infusion fluid to the patient;
Stopping the fluid connection between the pump device and the patient at a pressure or flow rate substantially equal to that generated by the pump device. 68. The method of claim 66, wherein the pump device comprises a syringe or a peristaltic pump. 68. The method of claim 66, wherein the fluid control device comprises an automated multi-position valve. 68. The method of claim 67, wherein driving the pump device comprises moving a syringe plunger distally within the syringe to push fluid from the syringe to the patient through the flow channel set.

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