Patent Grant
12023464
The present disclosure is related generally to features associated with a cassette for retaining and managing fluid path components for a fluid injector system. The cassette allows easy and compact storage of the various fluid path components which can, in turn, be readily accessed and engaged to the fluid injector for utilization in a fluid injection procedure.
Syringe injection systems are among the medical devices used in medical imaging procedures. Many such syringes are operated manually by advancing a plunger extension in operative connection with an internal plunger to pressurize the fluid within the syringe. In numerous medical injection procedures, however, accurate control and/or high pressures may be required that cannot be achieved via manual syringe operation. A number of syringes and powered injectors for use therewith have, therefore, been developed for use in contrast enhanced medical imaging procedures such as angiography, computed tomography (CT), and nuclear magnetic resonance (NMR)/magnetic resonance imaging (MRI). For example, U.S. Pat. No. 5,383,858 discloses a front-loading syringe and powered injector in pressure jacket and jacketless configurations, the disclosure of which is incorporated herein by reference.
To load syringes with contrast fluid, a user typically connects a fill tube and/or spike to a front nozzle or discharge outlet of the syringe and places the other end of the tube/spike in a bottle or bag of contrast medium (hereinafter “contrast”) or other fluid, such as saline or other flushing fluid. The plunger of the syringe is retracted (usually by means of the injector piston) to aspirate the contrast into the syringe until the desired amount is loaded into the syringe. After the syringe is filled, the syringe may be primed to remove air from the syringe and fluid path. The various fluid path components may then be connected to a patient catheter for the fluid injection protocol.
Conventional fluid injector systems may utilize multiple components in the fluid path during the filling and delivery procedures. These fluid path components include tubing and spikes and/or connectors for filling the syringe from the bulk fluid sources for contrast and saline and for delivery of fluid from the syringe to the patient, air management components, valves, and stopcocks for managing fluid flow through the fluid path components, sterility maintaining components, and the like. For example, in certain cases, significant lengths of tubing are used and can become tangled during shipping and set-up. Apparatuses for managing the various fluid path components which allow for rapid access and set up are needed. The loose tubing may also be installed correctly due to the excessive length of the tubing that may be loose relative to the fluid injector.
In one embodiment, a cassette for holding fluid path components for a fluid injector, the cassette may include a body defining at least one feature for holding at least one fluid path component for the fluid injector; and a connecting member for removably connecting the body of the cassette to a receiving surface of the fluid injector, the connecting member operatively connected to the body, wherein the connecting member comprises at least one pivotable connecting feature protruding from the body, and wherein each of the at least one pivotable connecting feature is configured for removably connecting to a corresponding connecting feature receiver on the fluid injector such that the body is pivotally movable relative to the fluid injector between a first, unlatched position and a second, latched position in which the at least one fluid path component on the body of the cassette is positioned for operative connection to a corresponding feature of the fluid injector.
In another embodiment, the at least one fluid path component is selected from at least one of at least one stopcock, at least one air bubble suspension apparatus, one or more fluid line components, at least one fluid path components comprising an air detection region, and at least one removable end cap for a fluid line. The at least one feature of the body is at least one extension member that protrudes from the body, wherein the at least one extension member is configured to hold a fluid path component of the fluid injector. The at least one extension member includes a retaining tab for holding the fluid path component on the at least one extension member. The at least one extension member comprises a plurality of extension members, each extension member configured to hold at least one fluid path component of the fluid injector. The at least one fluid component comprises at least one stopcock, wherein the stopcock comprises a first fluid filling position providing fluid communication between a bulk fluid container and a syringe engaged to the fluid injector, a second fluid delivery position providing fluid communication between the syringe and a patient tubing set, and a third stopped position blocking fluid communication between the syringe, the bulk fluid container, and the patient tubing set, and wherein the at least one extension member retains the at least one stopcock in a position configured to engage at least one stopcock actuator of the fluid injector when the cassette is in the second latched position. The stopcock actuator actuates the stopcock between the first fluid filling position, the second fluid delivery position, and the third stopped position is response to a signal from a controller of the fluid injector. The body further comprises a shield member that prevents a user from accessing at least one stopcock held in the body of the cassette. The at least one fluid component comprises at least one air bubble suspension apparatus fluidly located between the at least one fluid path components comprising the air detection region and the at least one stopcock, wherein at least one retention element retains the at least one air bubble suspension apparatus in a position to be movable between a first priming position and a second injection position with movement of a head of the fluid injector between an upright priming position and a downward angled injection position. The at least one air bubble suspension apparatus is configured to prime substantially all air bubbles out of the at least one air bubble suspension apparatus when primed in the upright priming position; and configured to at least temporarily suspend any air bubble detected in an injection fluid during a fluid injection procedure when in the downward angled injection position. The at least one fluid component comprises at least one fluid path components comprising an air detection region, wherein at least one retention element retains the at least one fluid path components comprising an air detection region in a position to operatively engage an air detector on the receiving surface of the fluid detector. The air detector is configured to detect an air bubble in an injection fluid during a fluid injection procedure, and in response to detecting an air bubble in the injection fluid, send a signal to the controller of the fluid injector to cause the at least one stopcock actuator to move the at least one stopcock from the second fluid delivery position, and the third stopped position. The at least one fluid component comprises at least one removable end cap for the fluid line, wherein the at least one removable end cap covers and prevents inadvertent contamination of a connector element of the fluid line. The cassette comprises two stopcocks, two air bubble suspension apparatuses, a plurality of fluid line components, two fluid path components each comprising an air detection region, and a plurality of removable end caps from the fluid line. The connecting member comprises a locking tab that is configured to be received in a corresponding locking groove on the fluid injector for removably attaching the receiving surface to the fluid injector. The connecting member comprises a latch member configured to removably connect with a locking arm on the fluid injector. An identifier may be positioned on the body, the identifier configured to provide information regarding the cassette including at least one of date of assembly, number of uses of the cassette, and location of the cassette. The identifier may comprise a barcode.
In another embodiment, a fluid injector may include a housing; at least one syringe removably held in the housing; and a cassette for holding fluid path components for a fluid injector, the cassette comprising: a body defining at least one feature for holding at least one fluid path component for the fluid injector; and a connecting member for removably connecting the body of the cassette to the fluid injector, the connecting member operatively connected to the body, wherein the connecting member comprises at least one pivotable connecting feature protruding from the body, and wherein each of the at least one pivotable connecting feature is configured for removably connecting to a corresponding connecting feature receiver on the fluid injector such that the body is pivotally movable relative to the fluid injector between a first, unlatched position and a second, latched position in which the at least one fluid path component on the body of the cassette is positioned for operative connection to a corresponding feature of the fluid injector.
In another embodiment, the at least one fluid path component is selected from at least one of at least one stopcock, at least one air bubble suspension apparatus, one or more fluid line components, at least one fluid path components comprising an air detection region, and at least one removable end cap for a fluid line. The at least one feature of the body is at least one extension member that protrudes from the body, wherein the at least one extension member is configured to hold a fluid path component of the fluid injector. The at least one extension member includes a retaining tab for holding the fluid path component on the at least one extension member. The body of the cassette may comprise a plurality of retention elements, each retention element configured to hold at least one fluid path component of the fluid injector. The at least one fluid component comprises at least one stopcock, wherein the stopcock comprises a first fluid filling position providing fluid communication between a bulk fluid container and a syringe engaged to the fluid injector, a second fluid delivery position providing fluid communication between the syringe and a patient tubing set, and a third stopped position blocking fluid communication between the syringe, the bulk fluid container, and the patient tubing set, and wherein the at least one retention element retains the at least one stopcock in a position configured to engage at least one stopcock actuator of the fluid injector when the cassette is in the second latched position. The stopcock actuator actuates the stopcock between the first fluid filling position, the second fluid delivery position, and the third stopped position is response to a signal from a controller of the fluid injector. The body further comprises a shield member that prevents a user from accessing at least one stopcock held in the body of the cassette. The at least one fluid component comprises at least one air bubble suspension apparatus fluidly located between the at least one fluid path components comprising the air detection region and the at least one stopcock, wherein the at least one retention element retains the at least one air bubble suspension apparatus in a position to be movable between a first priming position and a second injection position with movement of a head of the fluid injector between an upright priming position and a downward angled injection position. The at least one air bubble suspension apparatus is configured to prime substantially all air bubbles out of the at least one air bubble suspension apparatus when primed in the upright priming position; and configured to at least temporarily suspend any air bubble detected in an injection fluid during a fluid injection procedure when in the downward angled injection position. The at least one fluid component comprises at least one fluid path components comprising an air detection region, wherein the at least one retention element retains the at least one fluid path components comprising an air detection region in a position to operatively engage an air detector on a cassette receiving surface of the fluid detector. The air detector is configured to detect an air bubble in an injection fluid during a fluid injection procedure, and in response to detecting an air bubble in the injection fluid, send a signal to the controller of the fluid injector to cause the at least one stopcock actuator to move the at least one stopcock from the second fluid delivery position, and the third stopped position. The at least one fluid component comprises at least one removable end cap for the fluid line, wherein the at least one removable end cap covers and prevents inadvertent contamination of a connector element of the fluid line. The cassette comprises two stopcocks, two air bubble suspension apparatuses, a plurality of fluid line components, two fluid path components each comprising an air detection region, and a plurality of removable end caps from the fluid line. The connecting member comprises a locking tab that is configured to be received in a corresponding locking groove on the fluid injector for removably attaching the body to the fluid injector. The connecting member comprises a latch member configured to removably connect with a locking arm on the fluid injector. An identifier may be positioned on the body, the identifier configured to provide information regarding the cassette including at least one of date of assembly, number of uses of the cassette, and location of the cassette. The identifier may comprise a barcode.
In another embodiment, a method of attaching at least one component to a fluid injector may include attaching the at least one component to a cassette, the cassette comprising a body defining at least one aperture for holding the at least one component, and a connecting member operatively connected to the body; and connecting the cassette to a housing of the fluid injector by operatively connecting the connecting member of the cassette to a corresponding connecting member on the fluid injector, wherein the connection of the cassette to the housing of the fluid injector is configured to position the at least one component at a predetermined location on the housing of the fluid injector.
In another embodiment, the at least one component is at least one of a stopcock, an air bubble suspension apparatus, a fluid line, and a dust cap for a fluid line. The method may include evaluating an identifier attached to the cassette to determine whether the cassette has already been used.
In another embodiment, a connection interface between a cassette and fluid injector, the cassette configured to hold at least one component of the fluid injector, the connection interface may include a first connecting member provided on the cassette that engages the fluid injector; and a second connecting member provided on the fluid injector that receives the first connecting member, wherein a connection of the first connecting member to the second connecting member is configured to position the at least one component at a predetermined location on the fluid injector.
Embodiments of the present invention is also disclosed in the following clauses:
The various features described herein are set forth with particularity in the appended claims. Such features, however, both as to organization and methods of operation may be better understood by reference to the following description, taken in conjunction with the accompanying drawings.
In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. The illustrative features shown and described in the detailed description, drawings, and claims are not meant to be limiting. Other features may be utilized, and other changes may be made, without departing from the scope of the subject matter presented here.
Before describing the various aspects of the cassette, the interaction with injector components, and various features thereof in detail, it should be noted that the various aspects disclosed herein are not limited in their application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. Rather, the disclosed devices may be positioned or incorporated in other devices, variations, and modifications thereof, and may be practiced or carried out in various ways. Accordingly, aspects of the cassette and fluid injector features disclosed herein are illustrative in nature and are not meant to limit the scope or application thereof. Furthermore, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the various aspects of the cassette and fluid injector features for the convenience of the reader and are not to limit the scope thereof. In addition, it should be understood that any one or more of the components of the cassette and fluid injector features, expressions thereof, and/or examples thereof, can be combined with any one or more of the other components, expressions thereof, and/or examples thereof, without limitation.
Also, in the following description, it is to be understood that terms such as front, back, inside, outside, top, bottom and the like are words of convenience and are not to be construed as limiting terms. Terminology used herein is not meant to be limiting insofar as devices described herein, or portions thereof, may be attached or utilized in other orientations. The various aspects of the cassette and fluid injector features will be described in more detail with reference to the drawings.
With references to
The cassette and fluid path component assembly may be configured for ready installation onto a receiving surface on a head of a fluid injector, as described herein. Thus, the cassette assembly may be designed to minimize time between injection procedures, allowing more injection procedures to be performed over a period of time. In addition, the cassette may reduce or eliminate user set-up error, since all fluid path components are assembled in the correct position and alignment, and the cassette may engage the receiving surface of the fluid injector in only a single possible orientation.
According to one embodiment of the present disclosure, the disposable cassette 2 simplifies installation of the disposable fluid path components on a fluid injector, such as, but not limited to, CV injector 4 (
According to one embodiment the present disclosure, the cassette 2 may include a body 6 configured to hold the various fluid path components in a position for operative connection with corresponding features of the fluid injector 4, disposable components, such as a syringe, attached thereto, and/or components attachable to the cassette fluid path components, such as a patient fluid line, a bulk fluid source, etc. The body 6 may define various apertures, compartments, and multiple retention elements for holding the various fluid path components. In one example, the cassette 2 is configured to hold at least one fluid line 8 that is used to deliver a medical fluid from the fluid injector 4 (i.e., a syringe on the fluid injector 4) to the patient. In one example, the cassette 2 may be configured to hold two separate fluid lines 8, in which each fluid line 8 is configured to deliver a different medical fluid to the patient. For example, one fluid line 8 may deliver a saline solution to the patient, while the other fluid line 8 may deliver a contrast media or other liquid medication formulation to the patient.
According to some embodiments of the present disclosure, the cassette 2 may include multiple features for mounting different tubing types thereon. According to various embodiments, cassette 2 may operatively hold fluid path components, such as fluid lines 8 which may include fill tubing, patient line tubing, and other fluid path components (see for example U.S. Provisional Application Nos. 63/212,055, filed 17 Jun. 2021; and 63/222,605, filed 16 Jul. 2021, and PCT International Application Nos. PCT/US2021/018523, filed 18 Feb. 2021; PCT/US2021/022421, filed 15 Mar. 2021; PCT/US2021/022321, filed 15 Mar. 2021; PCT/US2021/029963, filed 29 Apr. 2021; and PCT/US2021/01507, filed 25 Feb. 2021), in-line air bubble suspension components (PCT/US2021/037623, filed 16 Jun. 2021) and priming/purging tubing (PCT/US2021/045689, filed 13 Aug. 2021), the disclosure of each of which are incorporated in their entirety by this reference. In various embodiments, the cassette 2 may be designed for a single syringe set-up (e.g., where only contrast media is injected) or as a dual syringe set-up (e.g., including a first syringe containing contrast media and a second syringe containing a flushing fluid, such as saline or Ringer's lactate). According to embodiments, a single set of features could be used for all of these, or separate features for each fluid line 8.
In specific embodiments for example as illustrated in
According to non-limiting embodiments and illustrated in
According to non-limiting embodiments, one or more pocket or well could be molded into the cassette 2 and the fluid lines 8 may be coiled into the cassette 2 prior to setup. The fluid lines 8 could be placed in this pocket in such a way that the fluid lines 8 can be pulled straight out and uncoil itself prior to use with the fluid injector 4. The cassette 2 could also have additional connectors mounted rigidly, such that other fluid line connections are more easily accessed.
According to one embodiment of the present disclosure and illustrated in
According to various embodiments, the upper and/or lower surfaces of cassette 2 may include a plurality of retention elements to retain various fluid path components in the appropriate position and configuration on the cassette 2, for example, in the correct position and/or orientation for engagement with a corresponding component on the fluid injector or in the proper orientation for a step in an injection procedure. For example, in various embodiments, the retention elements may include one or more catch members to engage a corresponding feature on the fluid path component. The at least one retention element may be configured so that the fluid path component is removably retained by the at least one retention element or the at least one retention element may be configured so that the fluid path component is non-removably retained by the at least one retention element.
With reference to
With reference to
In one embodiment illustrated in
In various embodiments, the cassette 2 may define at least one holder 28 configured to receive and retain an air bubble suspension apparatus 30. In one example, the air bubble suspension apparatus 30 may be in fluid connection with a fluid line 8 downstream of the air detection region 29 in order to suspend and delay any air bubbles that may be detected within the fluid passing through the upstream air detection region 29 of the fluid line 8 at least temporarily. For example, the at least one air bubble suspension apparatus 30 may be configured to, at least temporarily, suspend and delay the flow of the one or more detected air bubbles within a bubble suspension region for at least a time sufficient to allow the air detector 129 to signal the controller of the fluid injector 4 that air has been detected and to shut down the fluid injection procedure and stop fluid flow into the patient, for example by moving a shutoff valve, such as a pinch valve or stopcock as described herein, to a closed position. In this manner, even small volumes of air may be detected and the injection procedure shut down before the high fluid flow and system capacitance carries the air bubble into the patient. In one example, the cassette 2 may define two holders 28 each configured to receive and retain a separate air bubble suspension apparatus 30, each of which are in fluid communication with a single fluid line 8 (e.g., the contrast fluid line and the saline fluid line). In one embodiment, the air bubble suspension apparatus 30 may be the in-line air bubble suspension apparatus disclosed in PCT International Patent Application No. PCT/US2021/037623. The air bubble suspension apparatus 30 may be retained in the cassette 2 using latches or snap-fit connectors, among other connection arrangements that permit the air bubble suspension apparatus 30 to be removably attached to the cassette 2. With reference to
As illustrated in
In accordance with one embodiment of the present disclosure, as shown in
According to one embodiment, the fluid control valve 34 may be one or more pinch valves on the fluid injector 4 which may be operatively positioned to interact with one or more fluid lines 8, such as a bulk fluid line and/or a patient fluid line, that is retained in the cassette. In certain embodiments, the pinch valve may be a dual pinch valve designed to control flow through two separate fluid lines, for example between the bulk fluid line and/or a patient fluid line. Suitable pinch valves for incorporation into the fluid injector 4 are described in PCT International Application No. PCT/US2021/029963, such as dual pinch valves described therein. For example, in certain embodiments the dual pinch valve may include a first pinch valve for controlling fluid flow between the bulk fluid source and the syringe and a second pinch valve for controlling fluid flow between the syringe and the patient fluid line. According to specific embodiments, the cassette 2 may be configured to align the various fluid lines 8 with the pinch valve. In specific embodiments, the cassette 2 may be configured to apply a force on the fluid line 8 to bias the fluid line 8 into an engaging interaction (i.e., inserting the fluid line tubing into the pinching region of the pinch valve) when the cassette is operatively engaged with the fluid injector 4.
According to one embodiment, the body 6 of the cassette 2 may include a guard member 35 that covers the at least one fluid control valve 34. The guard member 35 is configured to protect and/or prevent a handle of the at least one fluid control valve 34 from being dislodged during shipping or handling by an operator. In one embodiment, a notch 37 may be provided on the guard member 35 to allow visibility of the handle of the fluid control valve 34 to determine the position of the handle.
According to various embodiments, the cassette 2 includes features that allow for proper locating of the cassette 2 vis-à-vis the receiving surface 11 on the head of the fluid injector 4 and a connection arrangement 36 for ready installation of the cassette 2 on the fluid injector 4 and alignment of the various fluid path components on the cassette 2 with associated features on the fluid injector 4. According to various embodiments, as shown in
Various methods for locating, engaging, and latching the cassette 2 to the fluid injector 4 and are shown in
With reference to
As shown in
Once installed, the cassette 2 may provide a rigid attachment point to the fluid injector 4 to allow for single-handed connection of patient fluid lines 8. Features may also be added to the cassette 2 for storage of the removable end caps 20, as described above. According to certain embodiments, these features could include a removable end cap 20 molded directly into the cassette 2. Additional embodiments may include additional sterile removable end caps for maintaining sterility of the connector end, for example the connector end that attaches to the patient fluid line, after priming of the multi-patient fluid lines 8 and between patient injection procedures. In an alternative embodiment, the cassette 2 may include a sterilizing element, such as an alcohol swabbing feature or feature for accessing a UV light on the fluid injector 4 that allows sterilization of the distal connector end of the fluid line 8 of the cassette 2 between patient injection procedures. The cassette 2 may also serve as a storage location for used removable end caps 20 from setup, which would help maintain a neat workspace and ensure disposal of the removable end caps 20 with the disposable cassette 2. The removable end caps 20 may also be retained on the cassette 2 after removal from the fluid lines 8 to ensure the removable end caps 20 do not fall from the cassette 2.
Removal of the cassette 2 from the fluid injector 4 is simplified, as the cassette 2 provides a one-step, one-handed removal of one or more, for example, all, of multiple fluid path components associated with the cassette 2 when one or a series of multi-patient fluid injections are completed. The cassette 2 can remain attached to the fluid injector and the syringes during this process, for example with the fluid control valve 34 in the third stopped position, minimizing fluid drips between injection procedures in a multi-patient injection set-up or during disassembly steps. The combined syringe and cassette assembly may then be disposed of as a unit. In certain embodiments, the used syringe and cassette assembly may be recycled. Further, maintaining the fluid control valves 34 in the third stopped position, and maintaining the upstream components, such as the syringes and other upstream fluid path components, in the pressurized position may allow for reduction of fluid volume delivery error due to release and uptake of system capacitance (i.e., swelling of system components under injection pressure, uptake of system slack) in between patient injection procedures in a multi-patient injection set-up.
According to some non-limiting embodiments, the cassette 2 may have one or more components that break off once the cassette 2 is removed and renders the cassette 2 and associated fluid path components no longer usable. For example, in certain embodiments, the flexible locking tab 46 or connection arrangement 36 may be configured to break off or deform when disengaged from the fluid injector 4. This avoids accidental reuse of the cassette 2 and associated fluid path components, thus preventing potential cross-contamination and other safety issues associated with multiple uses, beyond those recommended and approved, of the cassette 2 and the fluid path components.
According to some non-limiting embodiments, one or more deformable pieces or shields (not shown) on the cassette 2 could be used to locate components during shipping and installation of the cassette 2 and prevent inadvertent movement of the fluid path components, such as the stopcock handles or engagement feature. For example, during shipment or installation a stopcock engagement feature may be inadvertently moved such that it is no longer in the predetermined position for engagement with the associated stopcock actuator and the shield could prevent access to the engagement feature and minimize the chance of inadvertent movement. These deformable sections could be designed to deflect out of the way when the cassette 2 is installed so that the fluid injector 4 feature, such as an actuator, can interface with the fluid path component, such as the stopcock actuator being able to engage and manipulate the stopcock handle while allowing the controller to identify the specific rotational location of the stopcock so that the controller may accurately move the stopcock between the first, second, and third positions, as described herein.
According to some non-limiting embodiments, portions of the cassette 2 may be illuminated via one or more lights 50 on the fluid injector 4. These lights 50 may include area lighting where the light is cast onto at least a specific portion of or all of the cassette 2. This may also be a directed lighting such as “light piping”, where the cassette 2 is designed to transmit light internally through one or more portions of the fluid path or cassette skeletal feature. For certain embodiments, the cassette 2 may be made of transparent or translucent plastic, and the light 50 is close coupled into the cassette 2 on the fluid injector 4. Lighting may be used to indicate to the user that the cassette 2 is properly installed on the injector 4 and/or that the fluid path components are primed and/or that the fluid path components are ready for a fluid injection procedure, and/or which fluid-type (e.g., contrast or saline) is associated with a specific fluid path. Lighting features may also be used to indicate whether the fluid control valves 34 are in the first filling position, the second fluid delivery position, and the third stopped position by use of different colors of light for each position. The cassette 2 may be made of a light transmitting material such that, when the cassette 2 is fully loaded, the light from an emitter is conducted to the transmitter to indicate the cassette 2 is fully loaded.
According to some non-limiting embodiments, the cassette 2 may include one or more identification label 52, such as an RFID, a barcode QR code, or other machine readable identification label, and the identification label 52 may be scanned by the fluid injector 4 or other component of the fluid injector system, such as a controller, a hand-held identification label reader, or computer associated with the fluid injector 4. The identification label 52 may be on one or both of the cassette 2 and the cassette packaging. According to various embodiments, the identification label 52 may be used for a variety of purposes. The identification label 52 may be utilized when setting up the fluid injector 4 to work with the various components and properties of the disposable set (workflow, prime volumes, compliance information, patient count, etc.). According to these embodiments, the cassette 2 may be configured to include different fluid path components depending on the specifics of the injection protocol. An identification label 52 may allow the fluid injector 4 to recognize the features, properties, and components of the specific cassette 2 and associated fluid path components, determine if the cassette 2 is the appropriate cassette 2 for the selected fluid injection procedure, and configure the fluid injection procedure according to the properties and components of the cassette 2. The identification label 52 may further be used prevent reuse of a cassette or use of a cassette beyond an approved life-time and/or may include information of the manufacture of the cassette, such as date of manufacture, usable life-time, etc.
The identification label 52 may also be provided to ensure a compatible, non-counterfeit disposable set is used on the fluid injector 4. The fluid injector 4 may notify the user that the cassette 2 is not a compatible or is not an approved disposable set or is not from an approved manufacturer with appropriate quality control protocols; and may result in one or more errors during a fluid injection procedure, if the fluid path components included on the cassette 2 is used. Upon reading of the identification label 52 the controller may indicate to a user that the cassette 2 is not suitable or approved for the associated injection procedure and may further prevent use of the cassette and associated fluid path components during an injection procedure.
The identification label 52 may also be used for logging usage of the cassette 2 and/or fluid injector 4 for a patient/multiple-patients in a hospital records system. In the event the cassette 2 includes a multi-patient fluid path configuration, the identification label 52 may allow communication and data transfer with a hospital records system or other tracking system to ensure that the cassette 2 and associated components are used according to specifications. The identification label 52 may also be used for alerting a user when the multi-patient disposable set nearing or has reached the maximum usage (maximum number of injections or maximum total use time) or has reached end of shelf-life or expiration and instructing the user on the need for replacement and/or proper disposal of the cassette 2. In another embodiment, an indicator may be provided on the fluid injector 4 to notify an operator when fluid control valves 34 are fully engaged to indicate when the fluid injector 4 is ready for operation.
With reference to
With reference to
According to one embodiment of the present disclosure, a method of attaching at least one component to the fluid injector 4 is described. The method may include attaching the at least one component to the cassette 2, the cassette 2 including the body 6 defining at least one aperture for holding the at least one component, and a connecting arrangement or member 36 operatively connected to the body 6. The method may include connecting the cassette 2 to a housing of the fluid injector 4 by operatively connecting the connecting arrangement or member 36 of the cassette 2 to a corresponding connecting arrangement or member 36 on the fluid injector 4. The connection of the cassette 2 to the housing of the fluid injector 4 is configured to position the at least one component at a predetermined location on the housing of the fluid injector 4. The at least one component may be at least one of a stopcock 34, an air bubble suspension apparatus 30, a fluid line 8, and a removable end cap 20 for a fluid line 8. The method may also include evaluating an identifier 52 attached to the cassette 2 to determine whether the cassette 2 has already been used.
It is worthy to note that any reference to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout the specification are not necessarily all referring to the same embodiment. The particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
One skilled in the art will recognize that the herein described components (e.g., operations), devices, objects, and the discussion accompanying them are used as examples for the sake of conceptual clarity and that various configuration modifications are contemplated. Consequently, as used herein, the specific exemplars set forth and the accompanying discussion are intended to be representative of their more general classes. In general, use of any specific exemplar is intended to be representative of its class, and the non-inclusion of specific components (e.g., operations), devices, and objects should not be taken as limiting.
With respect to the use of any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as appropriate to the context and/or application. Various singular/plural permutations are not expressly set forth herein for sake of clarity.
The herein described subject matter sometimes illustrates different components contained within, or connected with, other different components. It is to be understood that such depicted architectures are merely exemplary, and that, in fact, many other architectures may be implemented which achieve the same functionality. In a conceptual sense, any arrangement of components to achieve the same functionality is effectively “associated” such that the desired functionality is achieved. Hence, any two components herein combined to achieve a particular functionality can be seen as “associated with” each other such that the desired functionality is achieved, irrespective of architectures or intermediate components. Likewise, any two components so associated may be viewed as being “operably connected,” and any two components capable of being so associated can also be viewed as being “operably connectable,” to each other to achieve the desired functionality. Specific examples of operably connectable include, but are not limited to, physically mateable and/or physically interacting components, and/or wirelessly interactable, and/or wirelessly interacting components, and/or logically interacting, and/or logically interactable components.
Some aspects may be described using the expression “coupled” and “connected” along with their derivatives. It should be understood that these terms are not intended as synonyms for each other. For example, some aspects may be described using the term “connected” to indicate that two or more elements are in direct physical or electrical contact with each other. In another example, some aspects may be described using the term “coupled” to indicate that two or more elements are in direct physical or electrical contact. The term “coupled,” however, also may mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other.
In some instances, one or more components may be referred to herein as “configured to,” “operative,” “adapted,” etc. Those skilled in the art will recognize that “configured to” can generally encompass active-state components, and/or inactive-state components, and/or standby-state components, unless context requires otherwise.
While particular aspects of the subject matter described herein have been shown and described, it will be apparent to those skilled in the art that, based upon the teachings herein, changes and modifications may be made without departing from the subject matter described herein and its broader aspects and, therefore, the appended claims are to encompass within their scope all such changes and modifications as are within the scope of the subject matter described herein. It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particular claim containing such recitation to claims containing only one such recitation, even if the same claim includes introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and/or “an” should typically be interpreted to mean “at least one” or “one or more”); this holds true for the use of definite articles used to introduce claim recitations.
In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of “two recitations,” without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be understood by those within the art that typically a disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms unless context dictates otherwise. For example, the phrase “A or B” will be typically understood to include the possibilities of “A” or “B” or “A and B.”
In summary, numerous benefits have been described which result from employing the concepts described herein. The foregoing disclosure has been presented for purposes of illustration and description. It is not intended to be exhaustive or limiting to the precise form disclosed. Modifications or variations are possible in light of the above teachings. It is intended that the claims submitted herewith define the overall scope of the present disclosure.
This application is a U.S. national phase application under 35 U.S.C. § 371 of PCT International Application No. PCT/US2021/061201, filed 30 Nov. 2021, and claims the benefit of U.S. Provisional Patent Application No. 63/199,010, filed on 1 Dec. 2020, the disclosures of which are incorporated in their entirety by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/061201 | 11/30/2021 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2022/119837 | 6/9/2022 | WO | A |
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| Number | Date | Country | |
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| 20240017003 A1 | Jan 2024 | US |
| Number | Date | Country | |
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| 63199010 | Dec 2020 | US |
