CA2849486C

Continuous multi-fluid pump device, drive and actuating system, and method

Abstract

A fluid pump device is operable by a drive and actuating system. The fluid pump device includes a pump manifold, a plurality of pump cylinders, a plunger reciprocally operable in each of the pump cylinders, and at least one inlet selector valve. The pump cylinders may extend proximally from the pump manifold and are in selective fluid communication with the pump manifold via, for example, respective inlet and outlet check valves. The plungers are reciprocally operable within the pump cylinders and are independently and reciprocally operable by respective piston linear actuators provided in the drive and actuating system. The inlet selector valve is used to establish selective fluid communication between one or more fluid source containers and the pump manifold to control fluid flow into the pump manifold. The inlet selector valve may be located laterally outboard of the pump cylinders and extend generally parallel to the pump cylinders.

CA2849486C, drawing sheet 1 — Sheet 1 of 71

Term

Projected expiry 20 September 2032.

17 claims: 2 independent, 15 dependent

1
CA 2,849,486 Blakes Ref:67554/00012 CLAIMS: 1. A selector valve tor a medical fluid delivery device comprising: a valve bore in fluid communication with an outlet channel;a first outlet port;a second outlet port;and a selector valve body comprising a valve stem located within the valve bore and having a flow passage, wherein the selector valve body is adapted to place the flow passage in fluid communication with one of the first outlet port, the second outlet port, and a shut-off position, wherein the flow passage comprises a sealing arrangement selected from the group consisting of a lip seal arrangement, an elastomeric core disposed within a thin-walled valve stem, a plurality of O-ring seals in grooves molded in a rigid valve stem, a segmented valve stem having a plurality of finger elements disposed between radial ridges of a cooperating sleeve, a composite valve stem having a lower portion of a compliant material and an upper portion of a stiff material, and an inner liner of a compliant sealing material seated within the valve bore between an outer valve cylinder wall and the valve stem, and wherein an actuator interface head is adapted to interface with a valve actuator associated with a drive and actuating system, wherein the valve actuator controls operation of the selector valve body, and further wherein the actuator interface head and the valve actuator are capable of engagement in only one particular angular orientation.
14
A fluid delivery system comprising:a fluid delivery device;and an outlet selector valve comprising: a valve bore in fluid communication with the fluid delivery device;a first outlet port;a second outlet port;and a selector valve body comprising a valve stem located within the valve bore and having a flow passage, wherein the selector valve body is adapted to place the flow passage in fluid communication with one of the first outlet port, the second outlet port, and a shut-off position, wherein the flow passage comprises a sealing arrangement selected from the group consisting of a lip seal arrangement, an elastomeric core disposed within a thinwalled valve stem, a plurality of O-ring seals in grooves molded in a rigid valve stem, a 22575691.5 CA 2849486 2017-08-08 CA 2,849,486 Blakes Ref: 67554/00012 segmented valve stem having a plurality of finger elements disposed between radial ridges of a cooperating sleeve, a composite valve stem having a lower portion of a compliant material and an upper portion of a stiff material, and an inner liner of a compliant sealing material seated within the valve bore between an outer valve cylinder wall and the valve stem, and wherein an actuator interface head is adapted to interface with a valve actuator associated with a drive and actuating system, wherein the valve actuator controls operation of the selector valve body, and further wherein the actuator interface head and the valve actuator are capable of engagement in only one particular angular orientation.

Independent claims2

404 paragraphs in 140 sections, as filed

CA 02849486 2016-03-14

CA 2,849,486

Blakes Ref: 67554/00012

CONTINUOUS MULTI-FLUID PUMP DEVICE, DRIVE AND ACTUATING SYSTEM, AND METHOD

BACKGROUND OF THE INVENTION

Field of the Invention

[0001] The invention described herein is directed to a fluid delivery system comprising a fluid pump device and an associated drive and actuating system for continuous multi-fluid delivery applications in medical diagnostic and therapeutic procedures wherein one or more fluids are infused/injected into a patient.

Description of Related Art

[0002] In the medical field, fluid delivery devices used to provide fluids to patients are generally well-known and exist in many different forms. A system commonly used for this purpose is a gravity-feed system wherein a fluid containing bag is supported above the level of the patient’s body and wherein the flow rate to the patient is controlled by the gross pressure of a clamp upon the flexible tube extending between the bag and the patient. It will be readily understood that the flow rate of fluid through the tube is a function of the amount of constriction of the tube. Manually operated devices are known in the medical field for delivery of fluid under pressure to a patient. Examples of such manually-operated pumping devices are known from United States Patent Nos. 3,464,359 to King et al.; 2,062,285 to Bergman; and 1,748,810 to Wandel, as examples.

[0003] Syringe-based infusion pumps and peristaltic pumps have also been used in the medical field for delivering fluids to patients under pressure and provide more precise control over the flow rate and volumetric delivery of fluids to patients. An example of a syringe pump adapted to deliver fluid to a patient is described in United States Patent No. 5,529,463 to Layer et al., which discloses a multi-syringe pump for this purpose. A peristaltic pump system suitable for delivering a constant flow of fluid under pressure to a patient is described in United States Patent Nos. 6,558,125 and 6,488,660, both to Futterknecht.

[0004] There are a number of medical procedures which require the delivery of fluids to a patient in a precisely controlled manner. One such application involves the delivery of contrast media fluid to a patient during a diagnostic computed tomography (CT) scan to provide enhanced x-ray images. Traditionally, such contrast media fluid has been delivered to the patient using a syringe-based injection system. Such injection systems require the contrast media fluid to be transferred from its original container to a disposable syringe. The injection

22576015.3

CA 02849486 2016-03-14

CA 2,849,486

Blakes Ref: 67554/00012 the inlet selector valve cylinder or a representation thereof. The valve stem may comprise a plurality of radial inlet ports disposed at different angular orientations around the valve stem. Alternatively, the valve stem may comprise a plurality of radial inlet ports disposed at different angular orientations around the valve stem and at different axial locations along the valve stem. The inlet selector valve cylinder may be oriented generally parallel to the pump cylinders. The inlet selector valve cylinder may comprise multiple inlet ports for connection to multiple fluid sources.

[0014] The identifying information may comprise at least one of a pump configuration/type number, a manufacturing batch number, a pump type identifier, a pump sequential identification number, or any combination thereof.

[0015] In yet another embodiment, the fluid pump device comprises a plurality of pump cylinders, a plunger reciprocally operable within each of the pump cylinders, each plunger comprising a piston interface member extending proximally therefrom that is split into at least two parts that are compressible towards one another, and an inlet selector valve to establish selective fluid communication between at least one fluid source and the pump cylinders. The inlet selector valve located may be laterally outboard of the pump cylinders.

[0016] The plungers may each comprise a distal end disc and a proximal end disc. The plungers may be reciprocally operable in the respective pump cylinders such that the distal end disc of each plunger is operable within a pumping zone of the pump cylinders and the proximal end disc is operable within an isolation zone of the pump cylinders. A seal may be provided at least circumferentially about each of the distal end disc and the proximal end disc.

[0017] A radial lip may be provided on each of the at least two parts of the piston interface member to interface with a drive piston. A support member may be coaxially disposed in the piston interface member. The radial lip on each of the at least two parts of the piston interface member may interface with a receiving groove defined in a socket in a drive piston. The piston interface member may be generally cylindrical shaped and the at least two parts may define at least two arcuate segments.

[0018] In another embodiment, a fluid delivery system is provided including a fluid pump device comprising a plurality of pump cylinders, a plunger reciprocally operable within each of the pump cylinders, and an inlet selector valve to establish selective fluid communication between at least one fluid source container and the pump cylinders, the inlet selector valve located laterally outboard of the pump cylinders. A drive and actuating system independently and reciprocally operates the plungers in the pump cylinders.

22576015.3

CA 02849486 2016-03-14

CA 2,849,486 Blakes Ref: 67554/00012

[0019] The inlet selector valve may be oriented generally parallel to the pump cylinders.

[0020] A pump manifold may control fluid communication to the pump cylinders, and the inlet selector valve may control fluid communication with the at least one fluid source to control fluid flow into the pump manifold. The pump manifold may comprise an inlet manifold channel and an outlet manifold channel, and the pump cylinders may each comprise at least one inlet opening for fluid communication with the inlet manifold channel and at least one outlet opening for fluid communication with the outlet manifold channel. The pump cylinders may be in selective fluid communication with the inlet manifold channel and the outlet manifold channel via respective inlet check valves and outlet check valves. The at least one outlet opening may be positioned at a high point in each of the pump cylinders for air bubble egress.

CA 2,849,486

Blakes Ref: 67554/00012 proximal end disc is operable within an isolation zone of the pump cylinders. A seal may be provided at least circumferentially about each of the distal end disc and the proximal end disc. A radial lip may be provided on each of the at least two parts of the respective piston interface members to interface with a receiving groove in a socket in the respective drive pistons of the drive and actuating system. A support member may be coaxially disposed in the piston interface member. In an alternative configuration, a radial lip may be provided on each of the at least two parts of the piston interface members, and the respective drive pistons may each comprise a distal end socket defining a receiving groove, such that the step of interfacing the plungers with the respective drive pistons comprises receiving the piston interface members into the distal end socket in the respective drive pistons and engaging the radial lip on the at least two parts with the receiving groove in the distal end socket in each of the respective drive pistons.

[0035] Another embodiment is directed to a method of assembling a fluid pump device, comprising providing a pump body having a plurality of pump cylinders and at least one inlet selector valve cylinder located laterally outboard of the pump cylinders, inserting an inlet selector valve body comprising a valve stem into the inlet selector valve cylinder such that the valve stem is in a predetermined angular orientation in the inlet selector valve cylinder, and inserting respective plungers into the pump cylinders.

[0036] The pump body may further comprise a saline manifold extending across the pump cylinders and defining at least one saline channel, and the method may further comprise installing a saline manifold cap onto the pump body to enclose the at least one saline channel. [0037] The pump body may comprise a front plate and the pump cylinders may extend proximally from the front plate, and the method may further comprise installing a pump manifold plate onto the front plate to form a pump manifold. At least one check valve may be captured between the manifold plate and the front plate during the step of installing the manifold plate onto the front plate to form the pump manifold. The front plate may comprise at least one inlet manifold channel defined by at least one channel member, and the method may further comprise installing an inlet manifold cap on the at least one channel member to enclose the at least one inlet manifold channel. The manifold plate may comprise an outlet selector valve cylinder, and the method may further comprise inserting an outlet selector valve body comprising a valve stem into the outlet selector valve cylinder. The outlet selector valve cylinder may comprise a patient outlet port and a waste outlet port and the valve stem of the outlet selector valve body defines a flow passage, and the step of inserting the outlet selector valve body into the outlet selector valve cylinder may comprise aligning the flow passage to be in fluid

22576015.3

CA 02849486 2016-03-14

CA 2,849,486 Blakes Ref: 67554/00012 communication with the waste outlet port. The step of inserting the outlet selector valve body into the outlet selector valve cylinder may be preceded by spraying lubricant onto the interior wall surface of the outlet selector valve cylinder.

[0038] The method may further comprise spraying lubricant onto the interior wall surface of the pump cylinders and onto the interior surface of the at least one inlet selector valve cylinders prior to the steps of inserting the inlet selector valve body into the inlet selector valve cylinder and inserting the respective plungers into the pump cylinders.

[0039] The steps of inserting the inlet selector valve body into the inlet selector valve cylinder and inserting the respective plungers into the pump cylinders can occur concurrently.

[0040] The predetermined angular orientation of the valve stem of the inlet selector valve body may be encoded in identifying indicia provided on the pump body, and the identifying indicia may be a bar code.

[0041] The method may further comprise generating an inlet selector valve position number and encoding the inlet selector valve position number as identifying indicia provided on the pump body. The inlet selector valve position number may correspond to the predetermined angular orientation of the valve stem of the inlet selector valve body in the inlet selector valve cylinder. The method may further comprise etching the identifying indicia on one of the pump cylinders.

[0042] Thus, in one aspect, there is provided a selector valve for a medical fluid delivery device comprising:

a valve bore in fluid communication with an outlet channel; a first outlet port; a second outlet port; and a selector valve body comprising a valve stem located within the valve bore and having a flow passage, wherein the selector valve body is adapted to place the flow passage in fluid communication with one of the first outlet port, the second outlet port, and a shut-off position, wherein the flow passage comprises a sealing arrangement selected from the group consisting of a lip seal arrangement, an elastomeric core disposed within a thin-walled valve stem, a plurality of O-ring seals, a segmented valve stem having a plurality of finger elements disposed between radial ridges of a cooperating sleeve, a valve stem having a lower portion of a compliant material and a an upper portion of a stiff material, an inner liner of a compliant sealing material seated within the valve bore between an outer valve cylinder wall and the valve stem, and combinations thereof.

22576015.3

CA 02849486 2016-03-14

CA 2,849,486 Blakes Ref: 67554/00012

[0043] In another aspect, there is provided a fluid delivery system comprising: a fluid delivery device; and an outlet selector valve comprising:

a valve bore in fluid communication with the fluid delivery device; a first outlet port; a second outlet port; and a selector valve body comprising a valve stem located within the valve bore and having a flow passage, wherein the selector valve body is adapted to place the flow passage in fluid communication with one of the first outlet port, the second outlet port, and a shut-off position, wherein the flow passage comprises a sealing arrangement selected from the group consisting of a lip seal arrangement, an elastomeric core disposed within a thin-walled valve stem, a plurality of O-ring seals, a segmented valve stem having a plurality of finger elements disposed between radial ridges of a cooperating sleeve, a valve stem having a lower portion of a compliant material and a an upper portion of a stiff material, an inner liner of a compliant sealing material seated within the valve bore between an outer valve cylinder wall and the valve stem, and combinations thereof.

[0044] In another aspect, there is provided a selector valve for a medical fluid delivery device comprising:

a valve bore in fluid communication with an outlet channel; a first outlet port; a second outlet port; and a selector valve body comprising a valve stem located within the valve bore and having a flow passage, wherein the selector valve body is adapted to place the flow passage in fluid communication with one of the first outlet port, the second outlet port, and a shut-off position, wherein the flow passage comprises a sealing arrangement selected from the group consisting of a lip seal arrangement, an elastomeric core disposed within a thin-walled valve stem, a plurality of O-ring seals, a segmented valve stem having a plurality of finger elements disposed between radial ridges of a cooperating sleeve, a valve stem having a lower portion of a compliant material and an upper portion of a stiff material, an inner liner of a compliant sealing material seated within the valve bore between an outer valve cylinder wall and the valve stem, and,

22576015.3

CA 02849486 2016-03-14

CA 2,849,486 Blakes Ref: 67554/00012 wherein an actuator interface head is adapted to interface with a valve actuator associated with a drive and actuating system, wherein the valve actuator controls operation of the selector valve body, and further wherein the actuator interface head and the valve actuator are capable of engagement in only one particular orientation.

[0045] In another aspect, there is provided a fluid delivery system comprising: a fluid delivery device; and an outlet selector valve comprising:

a valve bore in fluid communication with the fluid delivery device; a first outlet port; a second outlet port; and a selector valve body comprising a valve stem located within the valve bore and having a flow passage, wherein the selector valve body is adapted to place the flow passage in fluid communication with one of the first outlet port, the second outlet port, and a shut-off position, wherein the flow passage comprises a sealing arrangement selected from the group consisting of a lip seal arrangement, an elastomeric core disposed within a thin-walled valve stem, a plurality of O-ring seals, a segmented valve stem having a plurality of finger elements disposed between radial ridges of a cooperating sleeve, a valve stem having a lower portion of a compliant material and an upper portion of a stiff material, an inner liner of a compliant sealing material seated within the valve bore between an outer valve cylinder wall and the valve stem, and wherein an actuator interface head is adapted to interface with a valve actuator associated with a drive and actuating system, wherein the valve actuator controls operation of the selector valve body, and further wherein the actuator interface head and the valve actuator are capable of engagement in only one particular orientation.

[0046] Further details and advantages of the various embodiments described in detail herein will become clear upon reviewing the following detailed description of the various embodiments in conjunction with the accompanying drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0047] FIG. 1 is a schematic view of a fluid delivery system for continuous multi-fluid delivery applications.

[0048] FIG. 2 is a front perspective view of a fluid pump device for use in the fluid delivery system shown in FIG. 1.

[0049] FIG. 3 is a rear perspective view of the fluid pump device shown in FIG. 2.

22576015.3

CA 02849486 2016-03-14

CA 2,849,486 Blakes Ref: 67554/00012

[0050] [0051] [0052] [0053] [0054] FIG. 2.

FIG. 4 is a bottom perspective view of the fluid pump device shown in FIG. 2.

FIG. 5A is a bottom view of the fluid pump device shown in FIG. 2.

FIG. 5B is a detail view of detail 5B in FIG. 5A.

FIG. 6 is an exploded perspective view of the fluid pump device shown in FIG. 2.

FIG. 7 is a front perspective view of a pump body of the fluid pump device shown in

[0055] FIG. 8 is a rear perspective view of the pump body shown in FIG. 7.

[0056] FIG. 9 is a rear view of a pump cylinder of the pump body shown in FIG. 7.

[0057] FIG. 10 is a cross-sectional view of the fluid pump device taken along line 10-10 in FIG. 2 and with a plunger of the fluid pump device removed for clarity.

[0058] FIG. 11 is a rear perspective view of a plunger for the fluid pump device shown in FIG. 2.

[0059] FIG. 12 is a cross-sectional view taken along line 12-12 in FIG. 11.

[0060] FIG. 13 is a cross-sectional perspective view of a distal portion of a drive piston adapted to capture and actuate the plunger shown in FIG. 11.

[0061] FIG. 14 is a cross-sectional perspective view showing engagement of the drive piston shown in FIG. 13 with the plunger shown in FIG. 11.

[0062] FIG. 15 is a perspective view of the fluid pump device showing inlet manifold caps exploded from the fluid pump device.

[0063] FIG. 16 is a perspective view of a right front portion of a pump manifold plate adapted for association with the pump body shown in FIG. 7.

[0064] FIG. 17 is a rear perspective view of the pump manifold plate supporting inlet and outlet check valves of the fluid pump device.

[0065] FIG. 18 is a rear perspective view of a right portion of a pump manifold plate adapted for association with the pump body shown in FIG. 7.

[0066] FIG. 19 is a longitudinal cross-sectional and perspective view of a portion of the pump manifold plate adapted for association with the pump body shown in FIG. 7.

[0067] FIG. 20 is a cross-sectional perspective view of a portion of the fluid pump device shown in FIG. 2 showing operation of an inlet check valve of the fluid pump device.

[0068] FIG. 21 is a cross-sectional perspective view of a portion of the fluid pump device shown in FIG. 2 showing operation of an outlet check valve of the fluid pump device.

[0069] FIG. 22 is a cross-sectional perspective view taken along line 22-22 in FIG. 17.

[0070] FIG. 23 is a cross-sectional perspective view taken along line 23-23 in FIG. 3.

22576015.3

CA 02849486 2016-03-14

CA 2,849,486 Blakes Ref: 67554/00012

[0071] FIG. 24A is an isometric perspective view of an outlet selector valve body used in the fluid pump device shown in FIG. 2.

[0072] FIG. 24B is a cross-sectional perspective view taken along line 24B-24B in FIG. 24A. [0073] FIGS. 25A-25Q illustrate additional embodiments of the outlet selector valve wherein the outlet selector valve body is embodiment with different sealing arrangements.

[0074] FIG. 26 is an isometric perspective view of a swabable valve for use in association with the outlet selector valve shown in FIG. 24.

[0075] FIG. 27 is a cross-sectional perspective view taken along line 27-27 in FIG. 3.

[0076] FIG. 28A is an isometric front perspective view of an inlet selector valve stem used in the fluid pump device shown in FIG. 2.

[0077] FIG. 28B is an isometric rear perspective view of the inlet selector valve stem used in the fluid pump device shown in FIG. 2.

[0078] FIGS. 28C-28D are isometric perspective view of the inlet selector valve stem shown in FIGS. 28A-28B and further comprising a first exemplary sealing arrangement.

[0079] FIGS. 28E-28F are isometric perspective view of the inlet selector valve stem shown in FIGS. 28A-28B and further comprising a second exemplary sealing arrangement.

[0080] FIG. 29A-29H are schematic cross-sectional views of the inlet selector valve showing exemplary operation thereof.

[0081] FIG. 30 is a cross-sectional perspective view taken along line 30-30 in FIG. 3.

[0082] FIG. 31 is a cross-sectional perspective view of one of the pump cylinders of the fluid pump device of FIG. 2 showing a forward-most position of the plunger disposed in the right inboard pump cylinder.

[0083] FIG. 32 is a horizontal cross-sectional and perspective view of a right side portion of the fluid pump device shown in FIG. 2 to show inflow from a first fluid source container associated with the fluid pump device.

[0084] FIG. 33 is a horizontal cross-sectional and perspective view of a right side portion of the fluid pump device shown in FIG. 2 to show inflow from a second fluid source container associated with the fluid pump device.

[0085] FIG. 34 is a horizontal cross-sectional and perspective view of a right side portion of the fluid pump device shown in FIG. 2 to show inflow from a right side saline source associated with the fluid pump device.

22576015.3

CA 02849486 2016-03-14

CA 2,849,486 Blakes Ref: 67554/00012

[0086] FIG. 35 is a horizontal cross-sectional and perspective view of a right side portion of the fluid pump device shown in FIG. 2 to show inflow from a left side saline source associated with the fluid pump device.

[0087] FIG. 36 is an enlarged view of the cross-sectional perspective view shown in FIG. 35. [0088] FIG. 37 is a cross-sectional perspective view taken through a pump cylinder of the fluid pump device shown in FIG. 2, and showing an inlet check valve and an outlet check valve of the fluid pump device.

[0089] FIG. 38 is a cross-sectional and perspective view that is an enlargement of a portion of the view shown in FIG. 37.

[0090] FIG. 39 is a cross-sectional perspective view taken through the same pump cylinder shown in FIG. 37, and showing fluid flow in an outlet manifold channel of the fluid pump device. [0091] FIG. 40 is a schematic view showing the fluid pump device of FIG. 2 with a first or basic embodiment of a fluid supply set associated with the fluid pump device.

[0092] FIG. 41 is a schematic view showing the fluid pump device of FIG. 2 with a second or high-use embodiment of the fluid supply set associated with the fluid pump device.

[0093] FIG. 42 is a schematic view showing the fluid pump device of FIG. 2 with a third or limited-use embodiment of the fluid supply set associated with the fluid pump device.

[0094] FIG. 43 is a schematic view showing the fluid pump device of FIG. 2 with a fourth and additional limited-use embodiment of the fluid supply set associated with the fluid pump device that may be used with single-patient fluid source containers.

[0095] FIG. 44 is a perspective view of an exemplary patient supply set for use with the fluid pump device shown in FIG. 2.

[0096] FIG. 45 is a schematic view showing the fluid pump device with the second or highuse embodiment of the fluid supply set as shown in FIG. 41, and further showing a waste collection system associated with the fluid pump device.

[0097] FIG. 46A is a perspective view of the fluid delivery system for continuous multi-fluid delivery applications embodied as a mobile system.

[0098] FIG. 46B is a schematic view of the fluid delivery system of FIG. 46A shown interfacing with external devices including a remotely located display, computed tomography scanner, and a computer network as examples.

[0099] FIG. 47 is a schematic representation of a drive and actuating system for the fluid delivery system shown in FIG. 46A, and further showing features of a control system for the fluid delivery system.

22576015.3

CA 02849486 2016-03-14

CA 2,849,486 Blakes Ref: 67554/00012

[00100] FIG. 48 is a top perspective of the drive and actuating system for the fluid delivery system shown in FIG. 46A, with a pump drawer in a closed position.

[00101] FIG. 49 is a top perspective view of the drive and actuating system for the fluid delivery system shown in FIG. 46A, with the pump drawer in an open position.

[00102] FIG. 50 is a side perspective view of the drive and actuating system for the fluid delivery system shown in FIG. 46A, with the pump drawer in the open position.

[00103] FIG. 51 is a side view of the drive and actuating system for the fluid delivery system shown in FIG. 46A, with the pump drawer in the closed position.

[00104] FIG. 52 is a top view of the drive and actuating system for the fluid delivery system shown in FIG. 46A, with the pump drawer in the closed position.

[00105] FIG. 53 is a cross-sectional view of the drive and actuating system for the fluid delivery system shown in FIG. 46A, taken along line 53-53 in FIG. 52.

[00106] FIG. 54 is a cross-sectional view of the drive and actuating system for the fluid delivery system shown in FIG. 46A, taken along line 54-54 in FIG. 52.

[00107] FIG. 55 is a top perspective view of a rear portion of the drive and actuating system for the fluid delivery system shown in FIG. 46A.

[00108] FIG. 56 is a front perspective view of the drive and actuating system for the fluid delivery system shown in FIG. 46A, with the pump drawer in the closed position.

[00109] FIG. 57 is a top perspective view of a front portion of the drive and actuating system for the fluid delivery system shown in FIG. 46A.

[00110] FIG. 58 is a cross-sectional view of the drive and actuating system for the fluid delivery system shown in FIG. 46A, taken along line 58-58 in FIG. 52.

[00111] FIG. 59 is a top view of a pressure measurement mechanism for the fluid delivery system shown in FIG. 46A.

[00112] FIG. 60 is a perspective view of a fluid handling compartment provided in the mobile fluid delivery system shown in FIG. 46A.

DESCRIPTION OF THE PREFERRED EMBODIMENTS [00113] For purposes of the description hereinafter, spatial orientation terms, as used, shall relate to the referenced embodiment as it is oriented in the accompanying drawing figures or otherwise described in the following detailed description. However, it is to be understood that the embodiments described hereinafter may assume many alternative variations and configurations. It is also to be understood that the specific components, devices, features, and

22576015.3

CA 02849486 2016-03-14

CA 2,849,486 Blakes Ref: 67554/00012 operational sequences illustrated in the accompanying drawing figures and described herein are simply exemplary and should not be considered as limiting.

[00114] Referring initially to FIGS. 1-6, a fluid pump device 10, generally provided in the form of a disposable pump cassette, is shown. While fluid pump device or pump cassette 10 (hereinafter referred to as “pump 10”) is intended as a disposable component, the pump 10 is intended for multiple uses prior to disposal. Such multiple uses may be for multiple patients or for a multiple and discrete number of uses in medical diagnostic and therapeutic procedures which may involve a single or multiple patients. The pump 10 is adapted to interface with a drive and actuating system 400 that accepts, drives, and actuates various components on the pump 10. The drive and actuating system 400 is described herein in connection with FIGS. 46-60. A control system 800 is also provided to control operation of the various components of the drive and actuating system 800, as described herein in connection with FIGS. 46-60.

[00115] The pump 10 may be considered to have a front or distal side 12, a rear or proximal side 14, a right side 16 as viewed looking from the front or distal side 12 toward the rear or proximal side 14, and a left side 18 as viewed looking from the front or distal side 12 toward the rear or proximal side 14. Generally, as shown schematically in FIG. 1, the pump 10 may be part of a fluid delivery system 2 which includes the drive and actuating system 400, discussed herein. The pump 10 generally comprises a fluid supply section 20, a pump metering and pressurizing section 22, and a pump outlet section 24. The fluid supply section 20 includes one or more fluid source containers 30 containing various fluids to be supplied to the pump 10, and a fluid supply set 32 (see FIGS. 40-43 discussed herein) that conducts the one or more fluids to the pump 10. Various versions and embodiments of the fluid supply set 32 may be associated with the pump 10 to meet different patient and/or procedural needs. Each of the various versions and embodiments of the fluid supply set 32 comprises one or more fluid supply tubes 34 each having one end connected to the pump 10 and the opposing end connected to a spike 36 used to access a fluid source container 30.

[00116] The pump outlet section 24 includes a disposable single-use or single-patient supply set 40 (hereinafter “patient supply set 40; see FIG. 44 discussed herein) comprising medical tubing having opposed free ends each having a fluid connector 42 used to make a fluid connection, such as to a catheter inserted into a patient to convey a desired fluid or mixture of fluids to a desired location within a patient’s body. At least one of the fluid connectors 42 may include a check valve (not shown) to prevent reverse flow from the patient. Additionally, the pump outlet section 24 comprises a waste collection system 44 that is associated with the pump

22576015.3

CA 02849486 2016-03-14

CA 2,849,486 Blakes Ref: 67554/00012 to collect and store waste fluids. The waste collection system 44 generally comprises a waste collection tube set 46 connected to a waste collection container 48, as shown in FIG. 45 discussed further herein. The waste collection tube set 46 is adapted to make a fluid connection with the pump 10.

Blakes Ref: 67554/00012

222 are typically formed during the over-molding process used to form the front lip seal 218 and the rear bead seal 220 on the front and rear end discs 206, 208, respectively. The “flat” front of the front end disc 206 is desirable for minimizing residual fluid volume in the pump chamber 106 of the pump cylinder 104, helps to eject air bubbles from the pump chamber 106 during fluid priming of the pump 10 and, further, helps clean the pump chamber 106 during flushing procedures.

[00134] It is noted that the retaining force of the snap-fit connection between the drive piston 50 and the plunger 200 is significantly greater than the expected retraction force to be applied to the plunger 200. The expected retraction force is the sum of the vacuum/suction force on the plunger 200 during filling of the pump cylinder 104 and the friction between the foregoing plunger seals 218, 220 and the interior wall 108 of the pump cylinder 104. If snap-fit retention force is too low, the plunger 200 could disconnect prematurely from the drive piston 50 during use.

[00135] Referring additionally to FIGS. 15-19, the pump 10, as noted previously, comprises a pump manifold 80 that is formed by the connection or joining of the pump manifold plate 230 with the pump body 100. The pump manifold 80 is generally formed by assembling the pump manifold plate 230 to front plate 102 of the pump body 100. The pump manifold plate 230 (hereinafter “manifold plate 230”) comprises a front or distal side 232 and a rear or proximal side 234. The manifold plate 230 is generally shaped to correspond to the shape of the front plate 102 of the pump body 100 and is joined with the front plate 102 so that the rear side 234 of the manifold plate 230 is in engagement with the front side 140 of the front plate 102. The front side 232 of the manifold plate 230 includes right and left inlet manifold channels 236 provided on lateral right and left halves of the manifold plate 230. The inlet manifold channels 236 generally extend longitudinally along the front side 232 of the manifold plate 230. The two inlet manifold channels 236 correspond, respectively, to the two (2) right side pump cylinders 104 and the two (2) left side pump cylinders 104 of the pump body 100. As noted previously, in the illustrated embodiment, a total of four (4) pump cylinders 104 is provided in pump 10, with the two (2) “right” side pump cylinders 104 providing one fluid circuit and the two (2) “left” side pump cylinders 104 providing a second fluid circuit. The “right” inlet manifold channel 236 corresponds to the two (2) “right” side pump cylinders 104, and the “left” inlet manifold channel 236 corresponds to the two (2) “left” side pump cylinders 104. Alignment slots or holes 237 may be provided in the manifold plate 230 to facilitate loading of the pump 10 in association with the drive and actuating system 400, which is described herein.

22576015.3

CA 02849486 2016-03-14

CA 2,849,486 Blakes Ref: 67554/00012 any air that is initially trapped in the outlet manifold channel 244 to rise up into the connecting passage 268 and valve bore 266 during the fluid priming process.

[00145] The outlet selector valve 280 controls fluid delivery or output from the pump 10. The valve bore 266 is in fluid communication with the outlet manifold channel 244 via the connecting passage 268. The outlet selector valve cylinder 264 further defines a pair of outlet ports 270, 272, including a patient outlet port 270 that accepts a swabable valve 274 and a waste outlet port 272. The swabable valve 274 may be secured within the patient outlet port 270 via medical grade adhesive, solvent bonding, laser and ultrasonic welding, and like joining techniques. As an alternative, the patient port 270 may be overmolded around the stem of the swabable valve 274, which eliminates the need for adhesive, solvents, or welding. The swabable valve 274 is generally used to connect the patient supply set 40 to the patient outlet port 270. Because the valve is swabable, multiple connections may be made without compromising the connection. A self-sealing silicone stem (not shown) in the swabable valve 274 also prevents fluid drips when the patient supply set 40 is removed.

[00146] The outlet selector valve 280 comprises a unitary outlet selector valve body 282 with an actuator interface head 284 and a depending valve stem 286 that terminates in a rounded or tapered bottom edge or end 288. Suitable material choices for the outlet selector valve body 282 include, but are not limited to: polyethylene (plain and fiber reinforced), polypropylene, nylon (including fiber reinforced), Ultem® PEI (polyetherimide), polycarbonate (plain and with silicone or siloxane), and like materials. The valve stem 286 defines a 90° flow passage 290 which tapers smoothly to the bottom edge or end 288 of the valve stem 286. The “bell” shape of the flow passage 290 which tapers to the rounded bottom end 288 of the valve stem 286 minimizes the potential for air bubbles to become trapped below the valve stem 286. The flow passage terminates 290 at one side of the valve stem 286 to define an outlet port 291 for fluid communication with the patient outlet port 270 and the waste outlet port 272. The actuator interface head 284 of the outlet selector valve body 282 is adapted to interface with a valve actuator, described herein, associated with the drive and actuating system 400 which operates the pump 10. The valve actuator controls operation of the outlet selector valve 280 to place the valve stem 286 in orientations at least to: (1) place the flow passage 290 in fluid communication with the patient outlet port 270 and, thus, in fluid communication with the connecting passage 268 leading to the outlet manifold channel 244; (2) place the flow passage 290 in fluid communication with the waste outlet port 272 and, thus, in fluid communication with the connecting passage 268 leading to the outlet manifold channel 244; and (3) place the flow

22576015.3

CA 02849486 2016-03-14

CA 2,849,486 Blakes Ref: 67554/00012 passage 290 in a shut-off position or “off’ position where the flow passage 290 is not aligned with either the patient outlet port 270 or the waste outlet port 272, thereby preventing fluid flow from the outlet manifold channel 244 to either outlet port 270,272.

[00147] The actuator interface head 284 is generally T-shaped and comprises, for example, two (2) outwardly extending tabs 292 and a recessed area 294 for engagement with the valve actuator associated with the drive and actuating system 400. The T-shape of the actuator interface head 284 allows the outlet selector valve body 282 to slide into engagement with the valve actuator and also “keys” the outlet selector valve body 282 so that it may be engaged by the valve actuator in only one particular orientation. This interface between the actuator interface head 284 and the valve actuator of the drive and actuating system 400 also prevents the outlet selector valve body 282 from being ejected upward from the outlet selector valve cylinder 264 on the manifold plate 230 under high operating pressure.

[00148] Additionally, the outlet selector valve 280 comprises a rear or proximal pressure sensing port 296 defined in the outlet selector valve cylinder 264 supporting the outlet selector valve body 282 that supports a pressure sensing diaphragm 298, which interfaces with the drive and actuating system 400 so that fluid pressure in the valve bore 266 may be measured. The pressure sensing diaphragm 298 is a thin polyurethane (and like polymeric materials) diaphragm that is used to measure the fluid pressure in the outlet manifold channel 244. The pressure sensing diaphragm 298 is desirably overmolded into the pressure sensing port 296 and seals the port 296 while transferring the fluid pressure within the pressure sensing port 296 to its exterior surface. The pressure sensing diaphragm 298 allows the pressure in the outlet manifold channel 244, which is connected to the valve bore 266 via the connecting passage 268, to be measured at any time, not just when injecting fluid into a patient. As one example, during fluid priming or flushing operations, the control system 800 can monitor the pressure in the outlet manifold channel 244 and determine if the waste collection tube set 46 is blocked or kinked. A load cell or like device, provided as part of the drive and actuating system 400, interfaces with the diaphragm 298 to measure the fluid pressure through the diaphragm 298, as described herein in connection with the drive and actuating system 400.

[00149] As noted previously, the waste collection system 44 is connected to the waste outlet port 272 on the outlet selector valve cylinder 264 on the manifold plate 230 and is used to collect and store waste fluids. In particular, the waste collection tube set 46 is connected to the waste outlet port 272 to conduct waste fluids to the waste collection container 48 when the

22576015.3

CA 02849486 2016-03-14

CA 2,849,486

Blakes Ref: 67554/00012 low fluid pressures, the spring action of the finger elements 1236 presses the sleeve element 1240 radially outward until it is sealed against the wall of the valve bore 266. The radial ridges 1242 that are trapped in the spaces 1238 in-between the finger elements 1236 may also help to force the finger elements 1236 circumferentially apart, increasing the sealing force. In use with high fluid pressures, fluid pressure inside of the flow passage 290 in the valve stem 286 also helps to generate a radial-outward force on the finger elements 1236 and the sleeve element 1240, increasing the sealing force against the wall of the valve bore 266.

[00160] In another sealing arrangement 1250 as shown in FIGS. 25M-25N, the valve body 282 is of composite form, namely having an upper portion 1252 formed of a stiff polycarbonate material or like material, and a compliant lower portion 1254 formed of TPU or other suitable elastomeric materials. The lower portion 1254 generally forms the valve stem 286 while the upper portion 1252 defines the features described previously for interfacing with the drive and actuating system 400. The lower portion 1254 generally forming the valve stem 286 has integral upper and lower sealing beads 1256, 1258 to seal against the wall of the valve bore 266 and another sealing bead 1260 to form a seal about the outlet port 291 of the flow passage 290 to create sufficient sealing force around this port. The material used for the lower portion 1254 generally forming the valve stem 286 may have a higher durometer (and higher stiffness) than the material used for the various fluid seals in the preceding sealing arrangements described in connection with FIGS. 25A-25L.

[00161] In yet another sealing arrangement 1270 as shown in FIGS. 25O-25Q, a sleeve or liner 1272 formed of compliant sealing material is seated within the valve bore 266 of the outlet selector valve cylinder 264 instead of on the valve stem 286. The valve body 282 has the same general configuration as described previously in connection with FIGS. 24A-24B, with the addition of an upper ridge or ledge or sealing bead 1274 formed below the actuator interface head 284 and an exterior raised bead 1276 around the outlet port 291 of the flow passage 290 in the valve stem 286 to ensure suitable sealing characteristics in the valve bore 266. The valve body 282 may be made of a rigid material such as polycarbonate. The elastomeric sleeve or liner 1272 may be made of TPU or a similar elastomer. The liner 1272 defines an upper recessed area 1278 to receive the ridge or ledge and/or sealing bead 1274 provided on the valve stem 286, and defines respective side apertures 1280 to provide fluid communication with the outlet port 291 of the flow passage 290 in the valve stem 286, and the patient outlet port 270 and the waste outlet port 272. The liner 1272 may include one or more axial recessed areas 1282 to prevent contact with the exterior raised bead 1276 around the outlet port 291 of the flow

22576015.3

CA 02849486 2016-03-14

CA 2,849,486

Blakes Ref: 67554/00012 passage 290, and this axial recessed area 1282 is a suitable location to orient the raised bead 1276 during shipment or storage of the pump device 10. By placing the raised bead 1276 in the recessed area 1282 during shipping and storage, the liner 1272 is less likely to experience compression set or creep which could cause a reduction in sealing characteristics. It may also be desirable to integrate the pressure sensing diaphragm 298 as part of the liner 1272 to consolidate components.

CA 2,849,486

Blakes Ref: 67554/00012 communication between a first source of therapeutic or diagnostic (e.g., pharmaceutical) fluid A1, B1 contained in a connected fluid source container 30 and the corresponding inlet manifold channel 236, while the second inlet port 124 and both of the saline channels 132, 134 of the saline manifold 130 are blocked to fluid flow by the valve stem 306; (2) connect the second inlet port 324 with the second inlet port 124 to provide fluid communication between a second source of therapeutic or diagnostic (e.g., pharmaceutical) fluid A2, B2 contained in a connected fluid source container 30 and the corresponding inlet manifold channel 236, while the first inlet port 122 and both of the saline channels 132,134 of the saline manifold 130 are blocked to fluid flow by the valve stem 306; (3) connect the third inlet port 326 with the first or forward saline channel 132 of the saline manifold 130 to connect the third inlet port 326 with the first or forward saline channel 132 of the saline manifold 130 via saline port 332 (FIG. 5B) to provide fluid communication between a second source of saline S2 contained in a connected fluid source container 30 and the corresponding inlet manifold channel 236, while the first and second inlet ports 122,124 and the second or rear saline channel 134 of the saline manifold 130 are blocked to fluid flow by the valve stem 306; (4) connect the fourth inlet port 328 with the second or rearmost saline channel 134 of the saline manifold 130 via saline port 334 (FIG. 5B) to provide fluid communication between a first source of saline S1 contained in a connected fluid source container 30 and the corresponding inlet manifold channel 236, while the first and second inlet ports 122,124 and the first or forward saline channel 132 of the saline manifold 130 are blocked to fluid flow by the valve stem 306; and (5) an “OFF” position wherein the valve stem 306 is in a position to block each of the first and second inlet ports 122,124 and the first and second saline channels 132, 134, thereby preventing fluid flow from the various external fluid sources contained in the fluid source containers 30 to the corresponding inlet manifold channel 236. Thus, at least a total of five (5) different operational states are present for each of these inlet selector valves 300 in the embodiment of the pump 10 found in the accompanying figures. However, this embodiment should not be considered limiting as additional inlet ports (not shown) may be provided on the respective inlet selector valve cylinders 114, with corresponding inlet ports (not shown) being provided in the valve stem 306 of the respective inlet selector valves 300 to accommodate additional connected fluid sources as desired.

[00168] Referring specifically to FIGS. 5A and 5B, it will be understood that the saline manifold 130 is formed to extend across the pump cylinders 104 and has opposing ends that connect to the respective inlet selector valve cylinders 114. With this construction, the saline channels 132,134 extend the length between the two (2) outboard inlet selector valve cylinders

22576015.3

CA 02849486 2016-03-14

CA 2,849,486

Blakes Ref: 67554/00012

114. Saline ports 332, 334 are defined in the bottom of each of the inlet selector valve cylinders 114 to connect the inlet selector valve cylinders 114 to the saline channels 132, 134. The first or forward saline ports 332 connect the inlet selector valve cylinders 114 to the first or forward saline channel 132 and the second or rear saline ports 334 connect the inlet selector valve cylinders 114 to the second or rear saline channel 134. Accordingly, when the valve stem 306 of the actuated inlet selector valve 300 is rotated to connect the third inlet or “saline” port 326 with the first or forward saline channel 132 of the saline manifold 130, the third inlet “saline” port 326 is actually aligned with the first or forward saline port 332 in the inlet selector valve cylinder 114. Additionally, when the valve stem 306 of the actuated inlet selector valve 300 is rotated to connect the fourth inlet “saline” port 328 with the second or rear saline channel 134 of the saline manifold 130, the fourth inlet or “saline port 328 is actually aligned with the second or rear saline port 334 in the inlet selector valve cylinder 114.

[00169] In the exemplary configuration of the pump 10 depicted in the accompanying figures, the left side inlet ports 122,124 may be connected, respectively, to two (2) different sources of therapeutic or diagnostic (e.g., pharmaceutical) fluids, A1, A2, to be received in the two (2) left pump cylinders 104, and the left side saline port 126 may be connected to a first source of saline, designated as “S1”. Fluid “A1” provided in one of the fluid source containers 30 may be connected to first inlet port 122 and fluid “A2 provided in one of the fluid source containers 30 may be connected to the second inlet port 124, or vice versa, on the left side 18 of the pump 10. Likewise, the right side inlet ports 122,124 may be connected, respectively, to two (2) different sources of therapeutic or diagnostic (e.g., pharmaceutical) fluid, B1, B2 to be received in the two (2) right pump cylinders 104, and the right side saline port 126 may be connected to the second source of saline, designated as “S2”. The two (2)-channel saline manifold 130 permits saline from either saline source S1, S2 to be pulled into either of the inlet selector valves 300 during operation of the pump 10. Fluid “B1” provided in one of the fluid source containers 30 may be connected to first inlet port 122 and fluid “B2” provided in one of the fluid source containers 30 may be connected to the second inlet port 124, or vice versa, on the right side 16 of the pump 10. Further, fluids A1, A2 may be connected to the right side inlet ports 122,124 in any desired pairing, and the fluids B1, B2 may be connected to the left side inlet ports 122,124 in any desired pairing as an alternative configuration for the pump 10. Accordingly, for exemplary purposes only in this disclosure, fluid flow of the fluids A1, A2 contained in the fluid source containers 30 is controlled by the left side inlet selector valve 300 and fluid flow of the fluids B1, B2 contained in the fluid source containers 30 is controlled by the right side inlet

22576015.3

CA 02849486 2016-03-14

CA 2,849,486

Blakes Ref: 67554/00012 selector valve 300. As noted previously, the respective inlet selector valves 300 may draw saline from either of the saline channels 132, 134 of the saline manifold 130. Hence, the respective inlet selector valves 300 may draw from either saline source S1, S2. Accordingly, each half’ of the pump 10 has a single inlet selector valve 300 that allows selection from several fluid sources that are to be fed into the two (2) associated pump cylinders 104. Thus, control of fluids to the two (2) left side pump cylinders 104 is provided by the left side inlet selector valve 300 and control of fluids to the two (2) right side pump cylinders 104 is provided by the right side inlet selector valve 300.

[00170] The initial angular orientation of the valve stem 306 of the inlet selector valves 300 may be preset by the manufacturer and this orientation may be encoded into the pump indicator plate 170 and/or into identifying indicia 172 on the pump body 100, described previously. The control system 800 can thereby determine the initial or preset angular orientation of the valve stem 306 and operate the drive and actuating system 400 accordingly. If the angular orientation of the valve stem 306 is not needed for control by the control system 800 (such as if a readwrite RFID tag is used for the identifying indicia 172) the valve stem 306 of the inlet selector valves 300 may have any suitable initial angular orientation such as the “OFF” position outlined previously. Once associated with the drive and actuating system 400, the respective plungers 200 may be driven forward into the pumping zone 164 of the pump chambers 106 until the distal end of the plunger 200 contacts the distal end wall 110 of the pump cylinder 104. Priming of the various fluid pathways in the pump 10 may be then be conducted.

CA 2,849,486

Blakes Ref: 67554/00012 respect to inlet 122, 124 and saline port 332. Crossing over an unprimed port can undesirably introduce air into the axial passage 310 in the valve stem 306 of the selector valve 300. Accordingly, the rearmost saline channel 134 of the saline manifold 130 is supplied by the saline source S1 connected to the saline port 126 located on the left side 18 of the pump 10 and delivers saline to rearmost inlet port 328 on both the left and right inlet selector valves 300. Next, the forward saline channel 132 is supplied by the saline source S2 connected to the saline port 126 located on the right side 16 of the pump 10 and delivers fluid to the next-to-rearmost inlet port 326 on both the left and right inlet selector valves 300. The inlet ports 322-328 are located so that the valve stem 306 may be moved from a position permitting fluid communication between the rearmost inlet port 328 and the saline port 334 to the saline channel 134 connected to the left side saline fluid source containers 30 containing saline “S1” and the “OFF” position of the valve stem 306, without any of the remaining inlet ports 322-326 crossing over any of the inlet ports 122, 124 of the inlet selector valve cylinder 114 or the forward saline port 332 leading to the saline channel 132 of the saline manifold 130. Accordingly, the valve stem 306 may be rotated from any inlet port 122,124 with an installed or connected fluid source and any saline port 332, 334 with an installed or connected saline source S1, S2 to any other such port with an installed or connected fluid source without crossing over an unprimed inlet port. FIGS. 29A-29H show several exemplary scenarios showing how the angular positioning of the inlet ports 322-328 prevents “cross-over” of unprimed fluid ports. [00180] In FIG. 29A, the valve stem 306 of the inlet selector valve 300 is shown at an “OFF” position and a saline fluid source container 30 containing saline S1 has been installed, primed, and is ready for use as the first “saline” port S1. As shown in FIG. 29B, the valve stem 306 may be rotated between the OFF position and the first saline port S1 without having to pass over any unprimed ports, such as ports A1, A2, or S2, as discussed herein. If the valve stem 306 passes over an unprimed port, it is possible for air to be introduced into the axial passage 310 in the valve stem 306 of the inlet selector valve 300. This air could eventually be delivered to the patient outlet port 270 and to the patient unless the fluid injection is aborted by the control system 800. As shown by FIGS. 29A-29B, the first saline port S1 is always desired to be the first primed port because if the second saline port S2 was primed before the first saline port S1, the valve stem 306 would be forced to pass over the unprimed first saline port S1.

[00181] FIGS. 29C and 29D show the inlet selector valve 300 after the first saline port S1 and a first “contrast” port A1 have been installed, primed, and are ready for use. Again, in this situation, the valve stem 306 may be freely rotated from the first saline port S1, past the OFF

22576015.3

CA 02849486 2016-03-14

CA 2,849,486

Blakes Ref: 67554/00012 position, and to the first contrast port A1 without having to pass over any unprimed ports, such as ports A2 or S2. Again, if the second “contrast” port A2 had been primed with fluid before the first contrast port A1, the valve stem 306 of the inlet selector valve 300 would have to pass over the unprimed first contrast port A1. For this reason, the fluid source containers 30 should be loaded in a specific order as outlined herein. In brief, the first saline source S1 should be installed before the second saline source S2, the first “medical” fluid source A1 should be installed before the second such source A2, etc.

[00182] FIGS. 29E and 29F show the inlet selector valve 300 after the fluid source container 30 containing the first contrast source A1 has run empty and the fluid source container 30 containing the second contrast source A2 has been installed. When the fluid source container 30 containing the first contrast source A1 runs empty, an air detector associated with the connected fluid supply tube 34 alerts the control system 800, which actuates the drive and actuating system 400 to stop using the fluid source container 30 before any air can be drawn into the inlet selector valve 300. Thus, the fluid supply tube 34 connected to the fluid source container 30 containing the first contrast source A1 remains primed even though the fluid source container 30 is now empty. The valve stem 306 may be moved from the first saline port

51, past the OFF position, past the still-primed first contrast port A1, and to the second, primed contrast port A2 without having to pass over an unprimed port, such as the second saline port

52. Even though the fluid supply container 30 connected to the first contrast port A1 is now empty, the valve stem 306 can still pass over this port because the connected fluid supply tube 34 remains primed with fluid.

[00183] FIGS. 29G and 29H show the inlet selector valve 300 after the fluid source containers 30 containing the first saline source S1 and the first contrast port A1 have run empty and the fluid source container 30 containing the second saline source S2 has been installed. Again, in a similar manner to the foregoing, the first saline port S1 and the first contrast port A1 remain primed even though their respective fluid source containers 30 have run empty. If the valve stem 306 is initially located at the second saline port S2, it may be safely moved past the first saline port S1, the OFF position, and the first contrast port A1 ports to access the second contrast port A2.

[00184] As will be clear from all the foregoing, fluid as selected by the inlet selector valve 300 enters the associated inlet manifold channel 236 via the corresponding or registering openings 118, 240 in the front plate 102 of the pump body 100 and in the manifold plate 230. The left and right inlet manifold channels 236 are located low across the manifold plate 230 below the outlet

22576015.3

CA 02849486 2016-03-14

CA 2,849,486

Blakes Ref: 67554/00012 manifold channel 244 to allow trapped air to rise upward and into the pump chambers 106 of the respective pump cylinders 104 during saline priming. The inlet manifold channels 236 are also formed with smooth interior surfaces and curvatures to avoid “dead ends” to minimize the potential for trapped air bubbles and to allow fluids to be easily flushed from the pump 10. Moreover, the width and height of the inlet manifold channels 236 are sized and shaped to minimize the pressure drop (e.g., flow restriction) while keeping the total enclosed volume to a minimum to minimize the volume of fluid required to prime the pump 10. Fluid from the inlet selector valve 300 is available to either or both of the pump cylinders 104 on the same side of the pump 10.

[00185] Referring further to FIGS. 37-39, during the forward or distal movement of the plunger 200 in the pump chamber 106 of the pump cylinder 104, pressure within the pump chamber 106 of the pump cylinder 104 is greater than the pressure in the outlet manifold channel 244, and the outlet check valve 196 associated with the pump cylinder 104 deforms to allow fluid flow from the pump cylinder 104. Accordingly, in the example described previously, the pump chamber 106 of the right outboard pump cylinder 104 contains a fluid mixture comprising diagnostic or therapeutic (e.g., pharmaceutical) fluids B1, B2 and saline S1, S2. As the plunger 200 in the right outboard pump cylinder 104 is moved forward or distally in the pump cylinder 104, pressure within the pump chamber 106 is greater than the pressure in the outlet manifold channel 244 and the outlet check valve 196 associated with the right outboard pump cylinder 104 deforms to allow a fluid flow of the fluid mixture comprising fluids B1, B2 and saline S1, S2 to exit the right outboard pump cylinder 104 via the air egress opening 160 and outlet openings 162 present in the distal end wall 110 of the pump cylinders 104, and enter the outlet manifold channel 244. The fluid flow of the fluid mixture comprising fluids B1, B2 and saline S1, S2 from the pump chamber 106 to the outlet manifold channel 244 is identified by arrow As in FIGS. 38-39. The outlet manifold channel 244 collects the fluid ejected from each of the four (4) pump cylinders 104 and directs the combined fluid flow via the connecting passage 268 leading to the outlet selector valve 280 and the flow passage 290 therein. Accordingly, in the foregoing example, the fluid flow of the fluid mixture comprising fluids B1, B2 and saline S1, S2 is delivered under pressure into the outlet manifold channel 244 and enters the connecting passage 268 leading to the flow passage 290 in the outlet selector valve 280. The outlet selector valve 280 may selectively direct the fluid mixture to the patient outlet port 270 having the patient supply set 40 connected thereto, or to the waste outlet port 272 having the waste collection system 44 connected thereto.

22576015.3

CA 02849486 2016-03-14

CA 2,849,486

Blakes Ref: 67554/00012

[00186] Conversely, when the pressure in the outlet manifold channel 244 is greater, such as when the plunger 200 is retracted in the pump cylinder 104, the outlet check valve 196 associated with the pump cylinder 104 is pressed into the recessed area 158 defined in the elongated recess 154 on the front side 140 of the front plate 102 to seal the outlet openings 162 and top opening 160 in the front plate 102 leading to the pump chamber 106 of the pump cylinder 104 and prevents fluid flow from the outlet manifold channel 244 into the pump cylinder 104. This result occurs for each of the outlet check valves 196 to prevent fluid flow from the respective pump cylinders 104 when the corresponding plunger 200 is retracted in the pump chamber 106 of the pump cylinder 104.

[00187] The outlet check valves 196 regulate the fluid flow from each pump cylinder 104. Because pressure restrictions are not a significant concern on the outlet side of the pump 10, the one or more outlet openings 162 and the top opening 160 to each of the pump cylinders 104 may be small in comparison to the inlet openings 142 to the pump cylinders 104 to reduce the pressure stresses on the corresponding outlet check valves 196. Additionally, the preload pins 250 in the outlet check valve receiving recesses 246 located in outlet manifold channel 244 apply a relatively high force to the outlet check valves 196, which causes the valves 196 to have a relatively high cracking pressure and help prevent free-flow due to gravity from the fluid source containers 30 to the outlet selector valve 280. The compression of the preload pins 250 and the thickness of the polymeric discs comprising the outlet check valves 196 may be optimized to prevent free-flow due to gravity from the fluid source containers 30 to the outlet selector valve 280. The preload pins 250 apply a biasing or preload force to the polymeric discs comprising the outlet check valves 196 so that a certain minimum fluid pressure, often termed “cracking pressure”, is required to cause the polymeric disc to initially open. Generally, the fluid source containers 30 as associated with the pump 10 are located at a higher elevation than the location where the patient supply set 40 connects to the pump 10, namely, the patient outlet port 270. Accordingly, there is a possibility that fluid could flow under gravity alone from the fluid source container(s) 30 to the patient when the pump 10 is not operating. To prevent this situation, the preload on the outlet check valves 196 may be made high enough that their cracking pressure is greater than this head pressure.

[00188] The outlet manifold channel 244 collects the fluid ejected from each of the four (4) pump cylinders 104 and directs the combined fluid flow to the outlet selector valve 280. The outlet selector valve 280 allows the fluid output to be directed to either patient outlet port 270 having the patient supply set 40 connected thereto, or to the waste outlet port 272 having the

22576015.3

CA 02849486 2016-03-14

CA 2,849,486

Blakes Ref: 67554/00012 waste collection system 44 connected thereto. As noted previously, the valve stem 286 may be rotated to one of three (3) possible positions, including: (1) placing the flow passage 290 in fluid communication with the patient outlet port 270; (2) placing the flow passage 290 in fluid communication with the waste outlet port 272; and (3) placing the flow passage 290 in a shut-off position wherein flow to either the patient outlet port 270 or the waste outlet port 272 is prevented.

[00197] As noted in the foregoing, the fluid delivery system 2 comprises a drive and actuating system 400 that interfaces with the pump 10 to provide the motive forces for operating the various components of the pump 10. Referring next to FIGS. 46-60, details of the drive and actuating system 400 will be described. The drive and actuating system 400 is supported by a mobile support or superstructure 700 that also supports a fluid management system 720 for supporting, maintaining, and monitoring the various diagnostic or therapeutic (e.g., pharmaceutical) fluids to be associated with the pump 10. Particularly, the fluid management system 720 provides air management functions for the fluid delivery system 2, as described herein in connection with FIG. 60. The mobile support or superstructure 700 permits the fluid delivery system 2 to be a mobile system for applications in various medical environments, such as medical imaging suites that utilize a computed tomography (CT) scanner, as an example. As a result, the fluid delivery system 2 may be positioned in close proximity to the patient during a fluid injection and scanning procedure and a “short patient supply set 40 may be used. Additionally, depending upon the type of procedure being performed, it may be desirable to place the fluid delivery system 2 either in front of the CT scanner gantry or behind the gantry. This placement is typically determined by whether the scan is being performed with the patient’s hands/arms above their head for chest and abdominal scans, or at their sides for head and neck scans. Further, the system 2 may easily be moved out of the way to permit the patient to be placed on or removed from the bed of the CT scanner. Furthermore, the fluid delivery system 2 includes a control system 800, as noted previously, for coordinating and controlling operation of the various components and functions of the drive and actuating system 400 and fluid management system 720, each supported on the mobile support 700.

[00198] FIG. 47 is a block schematic representation of the drive and actuating system 400 of the fluid delivery system 2. Generally, the drive and actuating system 400 comprises a movable pump drawer section 402 that is extendable and retractable on the mobile support 700 to allow loading/unloading of the pump 10 into/from the pump drawer 402. The drive and actuating system 400 also comprises a drive section 440 that generates the motive forces for reciprocal operation of the pistons 50 operating the respective plungers 200 and rotational operation of the inlet selector valves 300. Additionally, the drive and actuating system 400 comprises a drive interface section 460 that translates and/or transmits the motive forces from the drive section

22576015.3

CA 02849486 2016-03-14

CA 2,849,486

Blakes Ref: 67554/00012

CA 2,849,486

Blakes Ref: 67554/00012

604 is mounted on the drive shaft 602 below the support platform 582 and an actuator pulley 606 is mounted to the lower or bottom end 590 of the actuator element 586. A timing belt 608 is reeved about the drive pulley 604 on the drive shaft 602 and the actuator pulley 604 mounted to the lower or bottom end 590 of the actuator element 586 to rotationally interface the drive shaft 602 and the actuator element 586 so that rotation of the drive shaft 602 imparts corresponding rotary motion to the actuator element 586. The outlet selector valve drive motor 600 may be a servomotor or stepper motor that is electronically linked to the sensor control board 804 via an electronic link or connection 610 so that the control system 800 may control operation of the drive motor 600 and, hence, control operation of the outlet selector valve actuator 584. The sensor control board 804 provides power to the drive motor 600 via the electronic link or connection 610. Accordingly, by controlled operation of the outlet selector valve drive motor 600, the outlet selector valve 280 may be angularly positioned to one of the desired operating positions discussed previously, or any desired angular position, and the angular position of the valve stem 286 of the outlet selector valve 280 is monitored by the angular position sensor 596 coupled to the top end 588 of the actuator element 586 and linked to the control system 800 via the sensor control board 804.

[00225] The lower or bottom end 590 of the actuator element 586 is formed with an actuator head 612 that defines a U-shaped pocket 614 for receiving the actuator interface head 284 at the top end of the valve stem 286 of the outlet selector valve body 282 of the outlet selector valve 280. As noted previously, the actuator interface head 284 is generally T-shaped and comprises two (2) outwardly extending tabs 292. The U-shaped pocket 614 accommodates the T-shaped interface head 284 with the outward extending tabs 292 seating against the face of the actuator head 612. The T-shape of the actuator interface head 284 allows the outlet selector valve body 282 to slide into engagement with the pocket 614 in the actuator head 612 and “keys the outlet selector valve body 282 so that it may be engaged by the actuator head 612 in only one particular orientation. The interface between the actuator interface head 284 and the actuator head 612 also prevents the outlet selector valve body 282 from being ejected upward from the outlet selector valve cylinder 264 on the manifold plate 230 under high pressure as the actuator element 586 is limited in the vertical direction by the rotation support bearings 592 in the actuator enclosure 594. The actuator element 586 is desirably vertically positioned above the clamping block 522 and the pressure measurement mechanism 552 so that when the pump 10 is loaded into the pump cradle 412 in the pump drawer 402, the actuator interface head 284 at the top end of the valve stem 286 of the outlet selector valve body 282 of the outlet selector

22576015.3

30 members in 11 offices

This recordMember, by publication datePriority claim1 more office is in the list below

Priority claims3

Priority claims
Document	Office	Kind	Date
61537371	United States of America	–	2011-09-21
201161537371	United States of America	P	2011-09-21
2012056355	United States of America	W	2012-09-20

Members30

Family members, oldest first
Document	Office	Kind
CA2849486A1	Canada	A1	2013-03-28
CA2987358A1	Canada	A1	2013-03-28
WO2013043868A1	World Intellectual Property Organization (WIPO)	A1	2013-03-28
WO2013043881A1	World Intellectual Property Organization (WIPO)	A1	2013-03-28
WO2013043889A1	World Intellectual Property Organization (WIPO)	A1	2013-03-28
AU2012312312A1	Australia	A1	2014-04-10
KR20140067139A	Republic of Korea	A	2014-06-03
EP2758096A1	European Patent Office (EPO)	A1	2014-07-30
EP2758097A1	European Patent Office (EPO)	A1	2014-07-30
US2014224829A1	United States of America	A1	2014-08-14
US2014228762A1	United States of America	A1	2014-08-14
CN103998075A	China	A	2014-08-20
JP2014527881A	Japan	A	2014-10-23
US2015157789A1	United States of America	A1	2015-06-11
EP2758096A4	European Patent Office (EPO)	A4	2015-07-01
EP2758097A4	European Patent Office (EPO)	A4	2015-07-01
HK1199851A	Hong Kong, China	A	2015-07-24
HK1199851A1	Hong Kong, China	A1	2015-07-24
RU2014115613A	Russian Federation	A	2015-10-27
CN103998075B	China	B	2016-11-02
BR112014006869A2	Brazil	A2	2017-04-04
US9649436B2	United States of America	B2	2017-05-16
RU2624327C2	Russian Federation	C2	2017-07-03
US9700672B2	United States of America	B2	2017-07-11
AU2012312312B2	Australia	B2	2017-07-13
CN106975117A	China	A	2017-07-25
JP2017185293A	Japan	A	2017-10-12
US2017296744A1	United States of America	A1	2017-10-19
AU2017245413A1	Australia	A1	2017-11-02
CA2849486CThis record	Canada	C	2017-12-12

2 legal events, as the office reported them to INPADOC

Over the term

Point at a mark for the event

Events

Legal events, newest first
	Event	Code
2019-11-04	LapsedLapsedMKLA	MKLA
2014-07-17	Examination requestEEER	EEER