Patent Application
20230146744
The present disclosure relates generally to fluid injector systems and associated fluid path assemblies for high pressure injection of medical fluids. More specifically, the present disclosure describes a fluid delivery system and fluid path assembly having a downstream automated shutoff valve and an upstream air detector to minimize the chance of air being delivered to a patient during an injection procedure.
In many medical diagnostic and therapeutic procedures, a medical practitioner, such as a physician, injects a patient with one or more medical fluids. In recent years, a number of injector-actuated syringes and powered fluid injectors for pressurized injection of medical fluids, such as a contrast solution (often referred to simply as “contrast”), a flushing agent (such as saline or Ringer's lactate), and other medical fluids, have been developed for use in procedures such as cardiovascular angiography (CV), computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), and other imaging procedures. In general, these fluid injectors are designed to deliver a preset amount of fluid at a preset pressure and/or flow rate. In certain applications, such as angiography, the medical fluids may be injected directly into the cardiac system at fluid pressures up to 1200 psi.
During certain injection procedures at these high fluid pressures with fluid being administered directly to the cardiac system, it is imperative that no air or other gas bubble be co-injected with the medical fluid as patient harm may result. For angiography, injection of even small volumes of air during an injection procedure may be harmful and must be avoided. The danger associated with air injection during angiography procedures is enhanced since the fluids are injected directly into the cardiac system. Further, at pressures of up to 1200 psi, the speed at which the fluid (and inadvertent air bubbles) flow through the fluid path and the compressibility of gas relative to liquids compresses the volume of air bubbles in the fluid line compared to the same molar amount of air at lower pressures make stopping of an air bubble after detection and before injection into the patient a challenge. For example, once the highly compressed air leaves the injector system and enters the patient vasculature system which is at significantly lower pressures (e.g., approximately 1 atm), the volume of the air bubble may increase significantly due to the reduced pressure. Thus, injection of even small volumes of air at the high pressures used for CV procedures must be strenuously avoided. Additionally, because of the high pressures used, the speed of the fluid flowing through the fluid path, the air compressibility, and/or the volume compliance of the system and its components, air may potentially still be injected into the patient even if actuation of the syringe piston is halted.
In view of the foregoing, there exists a need for devices, systems, and methods for preventing air from being delivered to a patient during an injection procedure. Embodiments of the present disclosure are directed to a fluid injector system including at least one syringe configured for injecting medical fluid and a fluid path assembly in fluid communication with the at least one syringe, the fluid path assembly including at least one air detection region. The fluid injector system further includes an air detector configured to detect one or more air bubbles in a fluid path associated with the air detection region, at least one shutoff valve at a distal end of the fluid path assembly, and at least one processor programmed or configured to actuate the at least one shutoff valve in response to the air detector detecting the one or more air bubbles in the fluid path associated with the air detection region to prevent fluid flow out of the fluid path assembly. The fluid path assembly has a length greater than a distance that an air bubble can travel or expand during an actuation time of the at least one shutoff valve.
In some embodiments, the actuation time of the at least one shutoff valve is a time interval between a time at which the air bubble is detected in the air detection region and a time at which the at least one shutoff valve reaches a stop position.
In some embodiments, the fluid path assembly includes a fluid path length having a path length of between approximately 1000 millimeters and approximately 1400 millimeters.
In some embodiments, the fluid injector system further includes a fluid path tubing element including a plurality of tubes arranged in a zig-zag configuration and connected to one another in series. In some embodiments, the plurality of tubes are parallel to one another.
In some embodiments, the plurality of tubes are connected to one another by a plurality of associated u-turn elements. In some embodiments, each of the plurality of associated u-turn elements defines a 180° turn to divert fluid flow from one of the plurality of tubes to another of the plurality of tubes. In some embodiments, the plurality of u-turn elements are formed in a pair of end caps, and the pair of end caps are joined to open ends of the plurality of tubes to form a fluid path between an inlet port and an outlet port
In some embodiments, the air detection region is associated with the inlet port of the fluid path tubing element.
In some embodiments, a total fluid path length of the fluid path tubing element is between approximately 1000 millimeters and approximately 1400 millimeters.
In some embodiments, the fluid injector system further includes a fluid path tubing element including a tortuous path.
In some embodiments, the fluid path tubing element includes a housing having a plurality of baffles to disrupt laminar flow of fluid though the housing.
In some embodiments, the housing includes a widened portion having an increased cross-sectional are configured to create a fluid pressure drop within the widened portion.
In some embodiments, the plurality of baffles extend across a centerline of the housing such that fluid is forced to flow around the plurality of baffles.
In some embodiments, the plurality of baffles includes at least one baffle extending from a first inner surface into a fluid path of the housing, and at least one baffle extending from a second inner surface into the fluid path of the housing and opposite of the first inner surface. The at least one baffle extending from the second inner surface of the housing is offset in a longitudinal direction from the at least one baffle extending from the first inner surface of the housing. In some embodiments, the plurality of baffles are angled to include a plurality of corners.
In some embodiments, the fluid path tubing element is movable between a priming position and an injection position. In the priming position, an outlet of the fluid path tubing element is oriented substantially upward such that air bubbles within the fluid path flow towards the outlet due, at least in part, to buoyancy. In the injection position, the outlet of the fluid path tubing element is oriented downward such that air bubbles within the fluid path flow away from the outlet due, at least in part, to buoyancy.
In some embodiments, the at least one processor is programmed or configured to move the fluid path tubing element between the priming position and the injection position.
Other embodiments of the present disclosure are directed to a fluid path tubing element for a fluid injector system. The fluid path tubing element includes an inlet port configured for fluid communication with at least one syringe, an outlet port configured for fluid communication with a valve, a tubing portion having a plurality of individual parallel tubes, and a plurality of u-turn elements connecting the plurality of individual parallel tubes in series in a zig-zag configuration. In some embodiments, each of the plurality of associated u-turn elements defines a 180° turn to divert fluid flow from one of the plurality of tubes to another of the plurality of tubes.
In some embodiments, the plurality of u-turn elements are formed in a pair of end caps, and the pair of end caps are joined to open ends of the plurality of individual parallel tubes of the tubing portion to form a fluid path between the inlet port and the outlet port.
In some embodiments, the total length of the fluid path tubing element is greater than a distance that an air bubble can travel or expand during an actuation time of the valve.
In some embodiments, the inlet port includes an air detection region configured for operative communication with an air detector configured to detect one or more air bubbles in the air detection region.
In some embodiments, a total fluid path length of the fluid path tubing element is between approximately 1000 millimeters and approximately 1400 millimeters.
Other embodiments of the present disclosure are directed to a fluid path tubing element for a fluid injector system. The fluid path tubing element includes a housing having an inlet port configured for fluid communication with at least one fluid injector and an outlet port configured for fluid communication with a valve, and a plurality of baffles to disrupt laminar flow of fluid though the housing. The plurality of baffles extend across a centerline of the housing such that fluid is forced to flow around the plurality of baffles.
In some embodiments, the housing includes a widened portion having an increased cross-sectional area configured to create a fluid pressure drop within the widened portion.
In some embodiments, the plurality of baffles includes at least one baffle extending from a first inner surface into a fluid path of the housing, and at least one baffle extending from a second inner surface into the housing of the housing and opposite the first inner surface. The at least one baffle extending from the second inner surface of the housing is offset in a longitudinal direction from the at least one baffle extending from the first inner surface of the housing. In some embodiments, the plurality of baffles are angled to include a plurality of corners. In some embodiments, the plurality of baffles are directional.
In some embodiments, the inlet port includes an air detection region configured for operative communication with an air detector configured to detect one or more air bubbles in the air detection region.
In some embodiments, a total fluid path length of the fluid path tubing element is between approximately 1000 millimeters and approximately 1400 millimeters.
Further aspects or examples of the present disclosure are described in the following numbered clauses:
Clause 1. A fluid injector system comprising: at least one syringe configured for injecting medical fluid; a fluid path assembly in fluid communication with the at least one syringe, the fluid path assembly comprising at least one air detection region; an air detector configured to detect one or more air bubbles in a fluid path associated with the air detection region; at least one shutoff valve at a distal end of the fluid path assembly; and at least one processor programmed or configured to actuate the at least one shutoff valve in response to the air detector detecting the one or more air bubbles in the fluid path associated with the air detection region to prevent fluid flow out of the fluid path assembly, wherein the fluid path assembly has a length greater than a distance that an air bubble can travel or expand during an actuation time of the at least one shutoff valve.
Clause 2. The fluid injector system of clause 1, wherein the actuation time of the at least one shutoff valve is a time interval between a time at which the air bubble is detected in the air detection region and a time at which the at least one shutoff valve reaches a stop position.
Clause 3. The fluid injector system of clause 1 or 2, wherein the fluid path assembly comprises a fluid path length having a path length of between approximately 1000 millimeters and approximately 1400 millimeters.
Clause 4. The fluid injector system of any of clauses 1 to 3, further comprising a fluid path tubing element comprising a plurality of tubes arranged in a zig-zag configuration and connected to one another in series.
Clause 5. The fluid injector system of any of clauses 1 to 4, wherein the plurality of tubes are parallel to one another.
Clause 6. The fluid injector system of any of clauses 1 to 5, wherein the plurality of tubes are connected to one another by a plurality of associated u-turn elements.
Clause 7. The fluid injector system of any of clauses 1 to 6, wherein each of the plurality of associated u-turn elements defines a 180° turn to divert fluid flow from one of the plurality of tubes to another of the plurality of tubes.
Clause 8. The fluid injector system of any of clauses 1 to 7, wherein the plurality of u-turn elements are formed in a pair of end caps, and wherein the pair of end caps are joined to open ends of the plurality of tubes to form a fluid path between an inlet port and an outlet port
Clause 9. The fluid injector system of any of clauses 1 to 8, wherein the air detection region is associated with the inlet port of the fluid path tubing element.
Clause 10. The fluid injector system of any of clauses 1 to 9, wherein a total fluid path length of the fluid path tubing element is between approximately 1000 millimeters and approximately 1400 millimeters.
Clause 11. The fluid injector system of any of clauses 1 to 10, further comprising a fluid path tubing element comprising a tortuous path.
Clause 12. The fluid injector system of any of clauses 1 to 11, wherein the fluid path tubing element comprises a housing having a plurality of baffles to disrupt laminar flow of fluid though the housing.
Clause 13. The fluid injector system of any of clauses 1 to 12, wherein the housing comprises a widened portion having an increased cross-sectional are configured to create a fluid pressure drop within the widened portion.
Clause 14. The fluid injector system of any of clauses 1 to 13, wherein the plurality of baffles extend across a centerline of the housing such that fluid is forced to flow around the plurality of baffles.
Clause 15. The fluid injector system of any of clauses 1 to 14, wherein the plurality of baffles comprises: at least one baffle extending from a first inner surface into a fluid path of the housing; and at least one baffle extending from a second inner surface into the fluid path of the housing and opposite of the first inner surface, wherein the at least one baffle extending from the second inner surface of the housing is offset in a longitudinal direction from the at least one baffle extending from the first inner surface of the housing.
Clause 16. The fluid injector system of any of clauses 1 to 15, wherein the plurality of baffles are angled to include a plurality of corners.
Clause 17. The fluid injector system of any of clauses 1 to 16, wherein the fluid path tubing element is movable between a priming position and an injection position, wherein, in the priming position, an outlet of the fluid path tubing element is oriented substantially upward such that air bubbles within the fluid path flow towards the outlet due, at least in part, to buoyancy, and wherein, in the injection position, the outlet of the fluid path tubing element is oriented downward such that air bubbles within the fluid path flow away from the outlet due, at least in part, to buoyancy.
Clause 18. The fluid injector system of any of clauses 1 to 17, wherein the at least one processor is programmed or configured to move the fluid path tubing element between the priming position and the injection position.
Clause 19. A fluid path tubing element for a fluid injector system, the fluid path tubing element comprising: an inlet port configured for fluid communication with at least one syringe; an outlet port configured for fluid communication with a valve; a tubing portion having a plurality of individual parallel tubes; and a plurality of u-turn elements connecting the plurality of individual parallel tubes in series in a zig-zag configuration.
Clause 20. The fluid injector system of clause 19, wherein each of the plurality of associated u-turn elements defines a 180° turn to divert fluid flow from one of the plurality of tubes to another of the plurality of tubes.
Clause 21. The fluid path tubing element of clause 19 or 20, wherein the plurality of u-turn elements are formed in a pair of end caps, and wherein the pair of end caps are joined to open ends of the plurality of individual parallel tubes of the tubing portion to form a fluid path between the inlet port and the outlet port.
Clause 22. The fluid path tubing element of any of clauses 19 to 21, wherein the total length of the fluid path tubing element is greater than a distance that an air bubble can travel or expand during an actuation time of the valve.
Clause 23. The fluid path tubing element of any of clauses 19 to 22, wherein the inlet port comprises an air detection region configured for operative communication with an air detector configured to detect one or more air bubbles in the air detection region.
Clause 24. The fluid path tubing element of any of clauses 19 to 23, wherein a total fluid path length of the fluid path tubing element is between approximately 1000 millimeters and approximately 1400 millimeters.
Clause 25. A fluid path tubing element for a fluid injector system, the fluid path tubing element comprising: a housing having an inlet port configured for fluid communication with at least one fluid injector and an outlet port configured for fluid communication with a valve; and a plurality of baffles to disrupt laminar flow of fluid though the housing, wherein the plurality of baffles extend across a centerline of the housing such that fluid is forced to flow around the plurality of baffles.
Clause 26. The fluid path tubing element of clause 25, wherein the housing comprises a widened portion having an increased cross-sectional area configured to create a fluid pressure drop within the widened portion.
Clause 27. The fluid path tubing element of clause 25 or 26, wherein the plurality of baffles comprises: at least one baffle extending from a first inner surface into a fluid path of the housing; and at least one baffle extending from the a second inner surface into the housing of the housing and opposite the first inner surface, wherein the at least one baffle extending from the second inner surface of the housing is offset in a longitudinal direction from the at least one baffle extending from the first inner surface of the housing.
Clause 28. The fluid path tubing element of any of clauses 25 to 27, wherein the plurality of baffles are angled to include a plurality of corners.
Clause 29. The fluid path element tubing element of any of clauses 25 to 28, wherein the plurality of baffles are directional.
Clause 30. The fluid path tubing element of any of clauses 25 to 29, wherein the inlet port comprises an air detection region configured for operative communication with an air detector configured to detect one or more air bubbles in the air detection region.
Clause 31. The fluid path tubing element of any of clauses 25 to 30, wherein a total fluid path length of the fluid path tubing element is between approximately 1000 millimeters and approximately 1400 millimeters.
Further details and advantages of the various examples described in detail herein will become clear upon reviewing the following detailed description of the various examples in conjunction with the accompanying drawing figures.
Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof, the present disclosure is generally directed to an in-line air bubble suspension apparatus for use with an angiography injector system.
For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the disclosure as it is oriented in the drawing figures. Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, are not to be considered as limiting as the invention can assume various alternative orientations.
As used herein, the singular form of “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.
All numbers used in the specification and claims are to be understood as being modified in all instances by the term “about”. The terms “approximately”, “about”, and “substantially” mean a range of plus or minus ten percent of the stated value.
As used herein, the term “at least one of” is synonymous with “one or more of”. For example, the phrase “at least one of A, B, and C” means any one of A, B, and C, or any combination of any two or more of A, B, and C. For example, “at least one of A, B, and C” includes one or more of A alone; or one or more B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C. Similarly, as used herein, the term “at least two of” is synonymous with “two or more of”. For example, the phrase “at least two of D, E, and F” means any combination of any two or more of D, E, and F. For example, “at least two of D, E, and F” includes one or more of D and one or more of E; or one or more of D and one or more of F; or one or more of E and one or more of F; or one or more of all of D, E, and F.
It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary examples of the disclosure. Hence, specific dimensions and other physical characteristics related to the examples disclosed herein are not to be considered as limiting.
When used in relation to a component of a fluid delivery system such as a fluid reservoir, a syringe, or a fluid line, the term “distal” refers to a portion of said component nearest to a patient. When used in relation to a component of a injector system such as a fluid reservoir, a syringe, or a fluid line, the term “proximal” refers to a portion of said component nearest to the injector of the injector system (i.e. the portion of said component farthest from the patient). When used in relation to a component of a fluid delivery system such as a fluid reservoir, a syringe, or a fluid line, the term “upstream” refers to a direction away from the patient and towards the injector of the injector system. For example, if a first component is referred to as being “upstream” of a second component, the first component is located nearer to the injector than the second component is to the injector. When used in relation to a component of a fluid delivery system such as a fluid reservoir, a syringe, or a fluid line, the term “downstream” refers to a direction towards the patient and away from the injector of the fluid delivery system. For example, if a first component is referred to as being “downstream” of a second component, the first component is located nearer to the patient than the second component is to the patient.
As used herein, the terms “capacitance” and “impedance” are used interchangeably to refer to a volumetric expansion of injector components, such as fluid reservoirs, syringes, fluid lines, and/or other components of a fluid delivery system as a result of pressurized fluids with such components and/or uptake of mechanical slack by force applied to components. Capacitance and impedance may be due to high injection pressures, which may be on the order of 1200 psi in some angiographic procedures, and may result in a volume of fluid held within a portion of a component in excess of the desired quantity selected for the injection procedure or the resting volume of the component. Additionally, capacitance of various components can, if not properly accounted for, adversely affect the accuracy of pressure sensors of the injector system because the volumetric expansion of components can cause an artificial drop in measured pressure of those components.
The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.
All documents referred to herein are “incorporated by reference” in their entirety.
The term “at least” is synonymous with “greater than or equal to.” The term “not greater than” is synonymous with “less than or equal to.”
It is to be understood that the disclosure may assume alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the disclosure. Hence, specific dimensions and other physical characteristics related to the examples disclosed herein are not to be considered as limiting.
While the systems and apparatuses described herein are with reference to an angiography (CV) injection system, other pressurized injection protocols, such as computed tomography (CT) and magnetic resonance imaging (MRI) may also incorporate the various embodiments described herein for preventing injection of air.
Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof, the present disclosure is generally directed to fluid injector systems and fluid path assemblies for detecting and preventing the delivery of one or more air bubbles that may inadvertently occur during an injection procedure. Injection of air to the patient's cardiovascular system is prevented by closing the fluid path assembly and ensuring that the air has insufficient time to reach the closure point in the time required to close the fluid path assembly. The length and/or volume of the fluid path assembly, including various fluid path tubing elements thereof, may be selected based on injection and apparatus parameters to prevent fluid communication between syringes of the fluid injector and a patient tube set downstream of an automated remote shutoff valve, such injection and apparatus parameters including, for example: flow rate, fluid viscosity, ID of tubing, response time of a processor upon detection of one or more air bubbles, and time necessary for the processor to communicate to and actuate a downstream automated remote shutoff valve to a stop position.
Referring first to
The injector housing 12 may further include at least one graphical user interface (GUI) 11 through which an operator can view and control the status of an injection procedure. The GUI 11 may be in operative communication with a controller 900 (see
The dual syringe angiography injector system 1000 may further include at least one upstream air detector 200 for detecting one or more air bubbles within an air detection tubing region 150 of the first fluid path 110A and the second fluid path 110B. The air detection tubing region 150 may for example, be associated with a proximal portion of the first fluid path 110A and the second fluid path 110B. In some embodiments, the at least one air detector 200 may be a single module having at least one sensor operatively associated with each of the first fluid path 110A and the second fluid path 110B. In some embodiments, the at least one air detector 200 may include at least two distinct modules, each module operatively associated with one of the first fluid path 110A and the second fluid path 110B. The at least one air detector 200 may be in operative communication with the controller 900 (see
Referring now to
The angiography injector system 2000 may further include bulk fluid containers 19A and 19B for filling and refilling the respective syringes 10A, 10B with imaging contrast media and flushing fluid, respectively, through bulk fluid paths 216A and 216B and bulk fluid valves 215A and 215B, respectively, during multiple patient fluid injection procedures.
The injector housing 12 may further include at least one graphical user interface (GUI) 11 through which an operator can view and control the status of an injection procedure. The GUI 11 may be in operative communication with a controller 900 (see
The dual syringe angiography injector system 1000 may further include at least one air detector 200 for detecting one or air bubbles within an air detection tubing region 150 of the first fluid path 210A and the second fluid path 210B. The air detection tubing region 150 may for example, be associated with a proximal portion of the first fluid path 210A and the second fluid path 210B. In some embodiments, the at least one air detector 200 may be a single module having at least one sensor operatively associated with each of the first fluid path 210A and the second fluid path 210B. In some embodiments, the at least one air detector 200 may include at least two distinct modules, each module operatively associated with one of the first fluid path 210A and the second fluid path 210B. The at least one air detector 200 may be in operative communication with the controller 900 (
Referring to
The controller 900 may be programmed or configured to execute a filling operation during which the piston 13 associated with each syringe 10 A, 10B is withdrawn toward a proximal end of the syringe 10 A, 10B to draw medical fluid F (e.g. imaging contrast media and flushing fluid) into the syringe 10A, 10B from the bulk fluid containers 19A, 19B. During such filling operation, the controller 900 may be programmed or configured to selectively actuate the bulk fluid valves 215A and 215B to establish fluid communication between the respective syringes 10A, 10B and the bulk fluid container 19A, 19B via the bulk fluid paths 216A and 216B to control filling of the syringe with the appropriate medical fluid. Upon completion of the filing operation, and optionally a priming operation to remove any air from the syringe (for example by priming any such air back into the bulk fluid container or through a priming tube), the controller 900 may be programmed or configured to selectively actuate the bulk fluid valves 215A and 215B to block fluid communication between the respective syringes 10A, 10B and the bulk fluid container 19A, 19B via the bulk fluid paths 216A and 216B.
After the filling operation and priming operation, the controller 900 may be programmed or configured to execute a delivery operation during which the piston 13 associated with one or both of the syringes 10A, 10B is moved toward a distal end of the syringe to inject medical fluid F into the first fluid path 110A, 210A and the second fluid path 110B, 210B. The controller 900 may be programmed or configured to selectively actuate the bulk fluid valves 215A and 215B to establish fluid communication between the syringes 10A, 10B and the patient, via the fluid paths 110A, 110B, 210A, 210B. The first fluid path 110A, 210A and the second fluid path 110B, 210B ultimately merge into a patient fluid line 395, 495 in fluid communication with the vasculature of the patient. According to various embodiments, the first fluid path 110A, 210A and the second fluid path 110B, 210B may merge at a fluid mixing connector that provides turbulent mixing of the first fluid and the second fluid, such as a fluid mixing connector described in International PCT Application Nos. PCT/US2021/019507 and PCT/US2014/026324, the disclosures of which are incorporated herein by reference.
The controller 900 may be in operative communication with the at least one air detector 200 such that the controller 900 may stop actuation of the pistons 13 in response to the air detector 200 detecting the presence of one or more air bubbles in at least one of the first fluid path 110A, 210A and/or the second fluid path 110B, 210B. The controller 900 may further be in operative communication with at least one downstream automated remote shutoff valve 390, 490, such that the controller 900 may actuate the at least one remote shutoff valve 390, 490 to stop fluid flow and flow of the one or more air bubbles through the at least one remote shutoff valve 390, 490 and into the patient vascular system. The at least one remote shutoff valve 390, 490 may be actuated by the controller 900 between various positions such a delivery position in which medical fluid may flow to the patient, a stop position in which fluid flow to the patient is prevented, and a hemodynamic monitoring position in which the patient's vasculature is in fluid communication with a pressure transducer and isolated from syringes 10A, 10B.
During a normal delivery operation, the controller 900 may be programmed or configured to move the remote shutoff valve 390, 490, 590 to a delivery position to establish fluid communication between the patient and the fluid paths 110A, 110B, 210A, 210B. The controller 900 may be programmed or configured to transition the remote shutoff valve 390, 490 to a stop position in response to air being detected by the at least one air detector 200. In the stop position, the remote shutoff valve 390, 490 fluidly isolates the patient from the fluid paths 110A, 110B, 210A, 210B, thereby preventing air from being injected into the patient. Further details of the remote shutoff valve 390, 490 will be described in greater detail herein, for example with reference to
With continued reference to
In the embodiments of the fluid injector systems 1000, 2000 described herein, the at least one syringe 10A, 10B may be oriented in any manner such as upright, downright, or positioned at any degree angle. In certain embodiments the fluid injector system 1000, 2000 may be pivotable between one or more positions, for example, the fluid injector system 1000, 2000 may be positioned in an upright position during a filling operation and pivoted to a downward angled position during a delivery operation The injector system 1000, 2000 may be a multi-syringe injector, as shown, wherein several syringes 10A, 10B may be oriented side-by-side or in another spatial relationship and are separately actuated by respective pistons associated with the injector system 1000, 2000. However, it should be appreciated that the various embodiments described herein for preventing air injection to a patient are equally applicable to a single-syringe injector system.
Further details and examples of suitable nonlimiting powered injector systems, including syringes, controllers, and air detectors, are described in U.S. Pat. Nos. 5,383,858; 7,553,294; 7,666,169; 8,945,051; 10,022,493; and 10,507,319, the disclosures of which are hereby incorporated by reference in their entireties. While the fluid path elements described herein are illustrated in combination with a fluid injector system including syringes, other fluid delivery mechanisms, such as a pump, for example one or more peristaltic pumps, may be substituted for one or both of the syringes of the fluid delivery systems.
Referring now to
Referring still to
In the delivery position, the remote shutoff valve 390 provides fluid communication between the input port 391 and the patient port 392. As such, fluid communication between the at least one syringe 10A, 10B and the patient through the fluid path assembly 300, including the length of tubing 360 and the patient delivery tubing 395, permits fluid flow from the at least one syringe 10A, 10B, through the fluid path assembly 300, through the automated remote shutoff valve 390, and into the patient delivery tubing 395. The fluid path assembly 300 may remain in the fluid delivery position until the total desired volume of medical fluid is delivered to the patient, at which time the controller 900 may cease actuation of the plungers 13 to halt fluid flow and also actuate the remote shutoff valve 390 to the closed position to prevent unwanted fluid flow from the system to the patient by loss of capacitance volume (e.g., relaxation of the expanded volume of fluid path components) of the fluid path assembly 300 in the absence of a pressurizing force. Further, the fluid path assembly 300 may remain in the fluid delivery position until at least one air bubble is detected in the air bubble sensing region 350, at which time the controller 900 may move the remote shutoff valve 390 to the stop position as described herein. In some embodiments, controller 900 may additionally close one or more of the three-way valves 315A and/or 315B once the desired volume of fluid has been delivered to the patient in order to prevent over-delivery due to capacitance and mechanical slack in the injector system 1000, 2000.
In the hemodynamic monitoring position, the remote shutoff valve 390 provides fluid communication between the hemodynamic sensor port 393 and the patient port 392. In the stop position, the remote shutoff valve 390 isolates the input port 391 from the patient port 392, such that there no fluid communication between the input port 391 and the patient port 392. In some embodiments, the hemodynamic monitoring position may also act as the stop position because there is no fluid communication between the input port 391 and the patient port 392 in the hemodynamic monitoring position.
As described herein, a typical angiographic injection procedure may experience fluid pressures of up to, for example, 1200 psi during delivery of fluid to the patient. As pressure sensors suitable for use as the hemodynamic monitor 380 may be damaged by such high pressures, the hemodynamic sensor port 393 may be isolated from the inlet port 391 and the patient port 392 in the hemodynamic monitoring position of the remote shutoff valve 390. In some embodiments, the hemodynamic position of the remote shutoff valve 390 may be used during a low-pressure injection phase or a monitoring phase of an injection protocol, such as described in PCT International Publication No. WO 2018/218132, the disclosure of which is hereby incorporated by reference in their entireties.
Suitable structures for the automated remote shutoff valve 390 include, for example stopcocks, pinch valves, high crack pressure valves, check valves, solenoid valves, spool valves, gate valves, knife valves, and the like, including combinations of one or more of these valves. In some embodiments, the automated remote shutoff valve 390 may be a three-way high-pressure stopcock including a rotatable inner valve member.
In some embodiments, an intermediate stop position of the fluid path assembly 300 may be used, for example by moving one of the three-way valves 315A or 315B to a closed position to prevent pressurized backflow of fluid from a pressurized second syringe 10B into the fluid path assembly 300, a bulk fluid source 19A, 19B, and/or a first syringe 10A. In certain embodiments, the intermediate stop position may allow pre-pressurization of a medical fluid in one or more of syringes 10A, 10B prior to delivery of fluid from the fluid path assembly 300 during an injection procedure. This may have the advantage of taking up capacitance in the syringe and other upstream fluid path components and/or taking up mechanical slack in the injector system to provide a more accurate fluid delivery volume. In other embodiments, pre-pressurization of a medical fluid in syringe 10 may provide smoother pressure/flow transitions when switching between injection of a more viscous medical fluid and a less viscous medical fluid, such as contrast and saline, respectively. Examples of injection protocols using pre-pressurization to prevent fluid flow spikes during fluid transitions are described in International PCT Publication Nos. WO 2019/046260 and WO 2019/046259, the disclosures of which are incorporated herein by this reference. In other embodiments, the intermediate stop position may allow for detection of air within the syringe system by pressurization of the syringe contents prior to the injection protocol, as described in International PCT Publication No. WO 2019/204605, the disclosure of which is incorporated herein by this reference. In other embodiments, the intermediate stop position may allow for vacuum coalescences and purging of air bubbles from the syringe system prior to the injection protocol, as described in International PCT Publication No. WO 2019/204617, the disclosure of which is incorporated herein by this reference.
Referring now to
Referring still to
In the delivery position, the remote shutoff valve 490 provides fluid communication between the input port 491 and the patient port 492. As such, fluid communication between the at least one syringe 10A, 10B and the patient through the fluid path assembly 400, including the length of tubing 460 and the patient delivery tubing 495, permits fluid flow from the interior volume of the at least one syringe 10A, 10B, through the fluid path assembly 400, through the automated remote shutoff valve 490, and into the patient delivery tubing 495. The fluid path assembly 400 may remain in the fluid delivery position until the total desired volume of medical fluid is delivered to the patient, at which time the controller 900 may cease actuation of the plungers 13 to halt fluid flow and also actuate the remote shutoff valve 390 to the closed position to prevent unwanted fluid flow from the system to the patient by loss of capacitance volume (e.g., relaxation of the expanded volume of fluid path components) of the fluid path assembly 400 in the absence of a pressurizing force. Further, the fluid path assembly 400 may remain in the fluid delivery position until at least one air bubble is detected in the air bubble sensing region 450, at which time the controller 900 may move the remote shutoff valve 490 to the stop position as described herein. In some embodiments, controller 900 may additionally close one or more of the three-way valves 415A and/or 415B once the desired volume of fluid has been delivered to the patient in order to prevent over-delivery due to capacitance and mechanical slack in the injector system 1000, 2000.
In the hemodynamic monitoring position, the remote shutoff valve 490 provides fluid communication between the hemodynamic sensor port 493 and the patient port 492. In the stop position, the remote shutoff valve 490 isolates the input port 491 from the patient port 492, such that there no fluid communication between the input port 491 and the patient port 492. In some embodiments, the hemodynamic monitoring position may also act as the stop position because there is no fluid communication between the input port 491 and the patient port 492 in the hemodynamic monitoring position.
As described herein, a typical angiographic injection procedure may experience fluid pressures of up to, for example, 1200 psi during delivery of fluid to the patient. As pressure sensors suitable for use as the hemodynamic monitor 480 may be damaged by such high pressures, the hemodynamic sensor port 493 may be isolated from the inlet port 491 and the patient port 492 in the hemodynamic monitoring position of the remote shutoff valve 490. In some embodiments, the hemodynamic position of the remote shutoff valve 490 may be used during a low-pressure injection phase or a monitoring phase of an injection protocol, such as described in PCT International Publication No. WO 2018/218132.
Suitable structures for the automated remote shutoff valve 490 include, for example stopcocks, pinch valves, high crack pressure valves, check valves, solenoid valves, spool valves, gate valves, knife valves, and the like, including combinations or one or more of these valves. In some embodiments, the automated remote shutoff valve 490 may be a three-way high-pressure stopcock including a rotatable inner valve member.
In some embodiments, an intermediate stop position of the fluid path assembly 400 may be used, for example by moving one of the three-way valves 415A or 415B to a closed position to prevent pressurized backflow of fluid from a pressurized second syringe 10b into the fluid path assembly 400, a bulk fluid source 19A, 19B, and/or a first syringe 10A. In certain embodiments, the intermediate stop position may allow pre-pressurization of a medical fluid in one or more of syringes 10A, 10B prior to delivery of fluid from the fluid path assembly 400 during an injection procedure. This may have the advantage of taking up capacitance in the syringe and other upstream fluid path components and/or taking up mechanical slack in the injector system to provide a more accurate fluid delivery volume. In other embodiments, pre-pressurization of a medical fluid in syringe 10 may provide smoother pressure/flow transitions when switching between injection of a more viscous medical fluid and a less viscous medical fluid, such as contrast and saline, respectively. Examples of injection protocols using pre-pressurization to prevent fluid flow spikes during fluid transitions are described in International PCT Publication Nos. WO 2019/046260 and WO 2019/046259. In other embodiments, the intermediate stop position may allow for detection of air within the syringe system by pressurization of the syringe contents prior to the injection protocol, as described in International PCT Publication No. WO 2019/204605. In other embodiments, the intermediate stop position may allow for vacuum coalescences and purging of air bubbles from the syringe system prior to an injection protocol, as described in International PCT Publication No. WO 2019/204617.
Referring again to
According to various embodiments, the length of tubing 360, 460 may provide a sufficient overall length and/or volume between the air bubble detection region 350, 450 and the automated remote shutoff valve 390, 490 to ensure that an air bubble detected in the air detection region 350, 450 cannot inadvertently be injected into the patient. That is, the internal volume of the length of tubing 360, 460 is such that an air bubble detected in the air detection region 350, 450 has insufficient time to flow past the automated remote shutoff valve 390, 490 in the actuation time required for the fluid path assembly 300, 400 to reach the stop position. In some embodiments, the overall length and volume of the length of tubing 360, 460 between the air bubble detection region 350, 450 and the inlet port 391, 491 may be a length calculated to prevent the air bubble from moving into the patient tubing 395, 495 before the remote shutoff valve 390, 490 can reach the stop position. The air bubble will thus become trapped in the length of tubing 360, 460 by moving the remote shutoff valve 390, 490 to the stop position and the injection procedure is halted. In certain embodiments, the fluid path assembly 300, 400 between the air bubble detection region 350, 450 and the automated remote shutoff valve 390, 490 may have a length of between approximately 1000 millimeters and approximately 1400 millimeters, and in some embodiments may be approximately 1200 millimeters (or from approximately 3.5 feet to approximately 4.5 feet, and in specific embodiments may be approximately 4 feet) in length to ensure that air bubbles cannot flow into the patient delivery tubing 395, 495. The approximately 1000 millimeter to approximately 1400 millimeter length of tubing may be arranged in any manner between the air bubble detection region 350, 450 and the automated remote shutoff valve 390, 490, for example, may be stretched lengthwise, draped, wrapped, looped, or coiled to reduce the footprint of the tubing length.
Referring now to
The remote valve assembly 500 further includes an actuator element 510, such as an electromechanical motor, in operative communication with the controller 900 (see
Referring now to
With reference to
With continued reference to
As described herein, the fluid injector system 1000, 2000 according to various embodiments of the present disclosure may take from 60 milliseconds to 90 milliseconds, for example in one embodiment approximately 80 milliseconds, to stop a high pressure (e.g. 1200 psi) injection procedure via actuation of the remote shutoff valve 390, 490. Total actuation time to stop such an injection procedure may include time detecting an air bubble by the air detector 200; time communicating to the controller 900 that an air bubble has been detected; time for the controller 900 actuating the remote shutoff valve 390, 490 to the stop position; and time until the patient delivery tubing 395, 495 is fully isolated from the length of tubing 360, 460 to prevent fluid continued fluid flow from one or more of rapid flow rate, compliance release, and/or bubble expansion from continuing into the patient. At the high injection pressures typical of CV injection procedures, an air bubble may move from 2.8 mL to 3.6 mL of the volume of the fluid path over the 70 milliseconds to 100 milliseconds between detection of the air bubble and valve closing/injection halting. For example, at approximately 1200 psi, an air bubble may travel a distance corresponding to 3.2 mL over 80 milliseconds at a flow rate of 30 mL/sec in a tubing with a 0.072 inch ID. The distance equivalence of 3.2 mL volume for such an embodiment may be approximately 1200 millimeters (or approximately 4 feet) of tubing length travelled during 80 milliseconds. Thus, even with a rapid response time, an air bubble may travel or expand a significant distance after air detection and before system shutdown.
Based on parameters such as tubing ID, the actuation time of the remote shutoff valve 390, 490, and other factors described herein, the total length of the individual tubes 622 may be selected to ensure that air bubbles have insufficient time to travel the entire length of tubing in the tubing portion 620 upon detection of the bubbles and actuation of the remote shutoff valve 390, 490. In some embodiments, the total fluid path length of the individual tubes 622 may be between approximately 1000 millimeters and approximately 1400 millimeters, and in some embodiments may be approximately 1200 millimeters (or between approximately 3.5 feet and approximately 4.5 feet, and in some embodiments may be approximately 4 feet) to ensure that air bubbles detected in the air detection region 650 are not injected into the patient.
With continued reference to
Referring particularly to
In some embodiments, the inlet port 633 of the fluid path tubing element 610 may be configured to serve as the air bubble detecting region 450. In such embodiments, the inlet port 633 may include engagement features for directly interfacing with corresponding engagement features of the air detector 200, thereby holding the fluid path tubing element 610 in place relative to the injector housing 12 (see
Referring now to
With continued reference to
The plurality of baffles 528 may be configured to delay air bubble flow and/or trap certain air bubbles, such as small air bubbles, by adherence to corners 529 of the torturous path sections 527. In particular, the plurality of baffles 528 may be oriented to direct air bubbles into the corners 529 defined where the plurality of baffles 528 meet with the first inner surface 595 and/or the second inner surface 598 of the housing 594. Air bubbles of certain sizes may exhibit surface adhesion properties that cause such air bubbles to adhere to the housing 594 and/or the plurality of baffles 528 rather than be carried along the fluid path 520A with the medical fluid. As a result, the time that an air bubble travels through the torturous path sections 527 is increased, thereby providing additional actuation time for the controller and processor to actuate the remote shutoff valve 390, 490 and prevent flow of the air bubble through the valve to the patient.
In some embodiments, the fluid path 520A may include a widened portion 525 having an increased cross-sectional area relative to a preceding portion of the fluid path 520A. In some embodiments, the widened portion 525 may be located immediately downstream of one of the tortious path sections 527, which may have a diameter less than the diameter of the wide fluid channel 525. The increased diameter of the widened portion 525 may create a fluid pressure drop within the widened portion 525 as fluid flows into the widened portion 525. The fluid pressure drop may slow and/or stop flow of air bubbles through the widened portion 525 and promote surface adhesion of the air bubbles to an interior surface of the housing 594.
Referring now to
In some embodiments, the fluid path tubing element 700 may be movable, such as by an actuator in operative communication with the controller 900 (see
During a delivery operation, in which fluid is injected from the syringes 10 to the patient, the fluid path tubing element 700 may be moved to an injection position. In the injection position, the fluid inlets 533A, 533B may be oriented spatially higher than the fluid outlets 534A, 534B (i.e. a rotation of approximately 180° from the position shown in
Referring now to
Conversely, in the injection position of the fluid path tubing element 700, the angle of the baffles 528 directs air bubbles into corners 529 such that the air bubbles do not flow out of the housing 594. In the injection position of the fluid path tubing element 700 (i.e. approximately a 180° rotation from the priming position shown in
Based on parameters such as tubing ID, the actuation time of the remote shutoff valve 390, 490, and other factors described herein, the total length and/or volume of the fluid path tubing elements 500 and 700 of
While various examples of the present disclosure were provided in the foregoing description, those skilled in the art may make modifications and alterations to these examples without departing from the scope and spirit of the disclosure. For example, it is to be understood that features of various embodiments described herein may be adapted to other embodiments described herein. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The disclosure described hereinabove is defined by the appended claims, and all changes to the disclosure that fall within the meaning and the range of equivalency of the claims are to be embraced within their scope.
This application claims the benefit of U.S. Provisional Patent Application No. 62/990,141 filed on Mar. 16, 2020 and U.S. Provisional Patent Application No. 62/990,179 filed on Mar. 16, 2020, the disclosures of which are hereby incorporated by reference in their entireties.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/022321 | 3/15/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62990141 | Mar 2020 | US | |
| 62990179 | Mar 2020 | US |
