I|||||lllllllllll||||||||||||li||||||llllllllllllllllllllllllllllllllllllll
`USOO5584671A
`
`United States Patent
`
`[19]
`
`[11] Patent Number:
`
`5,584,671
`
`Schweitzer, Jr. et al.
`
`‘
`
`[45] Date of Patent:
`
`Dec. 17, 1996
`
`[54] APPARATUS FOR DELIVERING FLUID TO A
`PATIENT
`
`10/1991 Sunderland
`5,057,081
`5,156,186 10/1992 Manska_,....
`5,219,327
`6/1993
`
`.... .. 417/63
`137/556
`604/34
`
`Inventors: Frederick F. Schweitzer, Jr., Glencoe;
`Clarence L. Walker, Webster Groves;
`.
`Ra“da"J' Kmhn’ Banwm’ an °f M°'
`
`Assignee: Sherwood Medical Company, St.
`L '
`.
`mm’ M0
`
`APPL N0‘: 345086
`Filed:
`N0“ 28, 1994
`
`Int. CL6 ............................
`
`U.S. Cl.
`
`F16K 25/00; A61M 1/00
`............... .. 417/298; 137/454.4; 251/129.11;
`417/305; 417/505; 604/151
`Field of Search ............................ .. 417/63, 290, 298,
`417/305, 505; 137/454.2, 454.4; 251/129.11;
`604/151’ 152’ 153’ 154’ 155
`References Cited
`U.S. PATENT DOCUMENTS
`
`3,091,239
`3,097,585
`3,831,625
`3,353,501
`3,957,082
`3,985,133
`4,219,021
`47460353
`43557725
`,
`,
`4,604,093
`4,689,043
`4,334,013
`5,005,604
`5,017,192
`
`5/1963 Moelle ................................... 128/214
`7/1963
`I
`_______’_ 95/89
`8,1974 Roediger _____
`_____ 137,377
`1/1975 Ensinger _ _ _ __
`__ ___ 137/374
`5/1976 Fuson et al.
`137/625.41
`..
`10/1976 Jenkins et al.
`128/214 F
`8/1980 Fink ...................... ..
`. 128/214 13
`7/1984 S°m5‘Vi11e 9‘ 31-
`- - --
`--- -- 504/250
`12/1985 Hey“? 6‘ 31- """"""
`:11/1986 Bow ct 31‘
`/1986 Marines .. . .... . . . .
`8/1986 Brown et a1_
`8/1987 Bisha . . ... ... . . . . ..
`11/1939 Jackson et a1_
`_
`4/1991 Aslanian .........
`5/1991 Dodge et al.
`......................... .. 604/250
`
`604/245
`. .... 604/250
`604/248
`. .... 604/250
`
`7
`
`45
`
`' »
`
`HUSH HUSH
`TOTAL
`DDSK
`THU WED
`TOTAL
`DOSE
`
`V cflfi
`-1:xc|:1=v an
`cuaxazk’
`
`5’242=407
`
`9/1993 Stmble 3‘ 31-
`.
`COI'dl'lC1', J1". Cl
`604/151
`5,364,364 11/1994 Kasvikis et al.
`12/1994 Smith ...................................... 604/151
`5,374,251
`
`604/151
`
`, OTHER PUBLICATIONS
`.
`.
`..
`Ross Laboratories, “F1exiflo® Quantumll“ Enteral Pump”
`Operating Manual, 1992, pp. 1-19.
`Ross Laboratories, “F1exiflo® Quantum"‘M Enteral Pump”
`Instructions for Use, Mar. 1992, two pages.
`EntraCare Corp.,
`“UltraFlo"'M” information page, date
`unlmown’ one page.
`Sherwood Medical Company, “Ross Quantum Pump” Bul-
`letin, Nov. 11, 1992, pp. 14.
`‘Ross Clinical Study BD28 Enteral Nutrition Pump Perfor-
`mance and Eflicacy Study” Operating Manual, Jun. 1991,
`pp. 1-12.
`Primary Examiner———Charles G. Freay
`Attorney, Agent, or Firm—Gene B. Kartchner; Montgomery
`W. Srrutlf
`
`[57]
`
`ABSTRACT
`.
`.
`.
`.
`.
`.
`A fluid delivery system is disclosed which includes a pump
`and a fluid delivery set. The fluid delivery set includes a stop
`cock valve, and the pump includes a valve actuation unit into
`which the stop cock valve is positioned for operation of the
`system. The valve actuation unit includes a valve receiving
`mechanism
`requires the Valve [0 be closed in order to
`be inserted into or removed from the valve actuation unit,
`thereby preventing accidental free flow of fluid at all times.
`The fluid delivery set may also include an auxiliary fluid
`.
`.
`.
`.
`.
`.
`source to allow periodic flushing of the fluid delivery line,
`and the Va1Y6 aCt“_a‘_1‘_’n ““1l°_a"_be Programmed b3’_ the PPUIP
`to automatically initiate periodic flushing cycles if desired.
`
`24 Claims, 7 Drawing Sheets
`
`ACTA EX. 1011-001
`
`ACTA Ex. 1011-001
`
`

`
`U.S. Patent
`
`Dec. 17, 1996
`
`Sheet 1 of 7
`
`5,584,671
`
`.
`
`FLUSH FLUSH FLUSH
`TOTAL
`DOSE
`INTVL
`
`FEED
`FEED
`l
`TOTAL
`nos:
`ll ww
`
`FIGURE 7
`
`ACTA EX. 1011-002
`
`ACTA Ex. 1011-002
`
`

`
`aw;-n_“\%%mn...__InINil»::1_mam!’
`
`IIIIIJfrfignfll.5‘..firVIII
`IzlllblI,.@u_-ii;In-55%.”,
`lull!;...
`
`.F’‘’‘‘‘’'‘‘’’,,,
`
`V.
`
`.IE...,..m.Mmu_1
`.=__.
`iihiiigv
`E‘:
`
`...
`
`_
`
`._
`rd.
`
`
`
`\}//ooofllifflflflfliifllflf
`
`r.r
`
`.”_.
`
`FIGURE 2A
`
`FIGURE 25’
`
`FIGURE 20
`
`
`
`d.m.5:2::8.E.$3$53Nam4m.m%_.ad
`
`ACTA Ex. 1011-003
`
`

`
`U.S. Patent
`
`Dec. 17, 1996
`
`Sheet 3 of 7
`
`5,584,671
`
`FIGURE 3
`
`ACTA EX. 1011-004
`
`ACTA Ex. 1011-004
`
`

`
`U.S. Patent
`
`Dec. 17, 1996
`
`Sheet 4 of 7
`
`5,584,671
`
`45
`
`FIGURE 4
`
`ACTA EX. 1011-005
`
`ACTA Ex. 1011-005
`
`

`
`Dec. 17, 1996
`
`Sheet 5 of 7
`
`5,584,1571
`
`FIGURE 5
`
`ACTA EX. 1011-006
`
`ACTA Ex. 1011-006
`
`

`
`FIGURE 6
`
`ACTA Ex. 1011-007
`
`

`
`U.S. Patent
`
`Dec. 17, 1996
`
`Sheet 7 of 7
`
`5,584,671
`
`FOR WARD RO TA TION
`
`FIG URE 7/1
`
`RETURN ROTATION
`
`FIGURE 75’
`
`ACTA EX. 1011-008
`
`ACTA Ex. 1011-008
`
`

`
`5,584,671
`
`1
`APPARATUS FOR DELIVERING FLUID TO A
`PATIENT
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`
`This invention relates to a system for delivering medical
`fluids to a patient. More particularly, the present invention
`relates to an apparatus including an infusion set and a
`peristaltic pump for delivering enteral nutrition fluids to a
`patient.
`2. Prior Art
`
`Accurately controlled volumetric delivery rates of enteral
`nutrition fluids to a patient have been accomplished in the
`past by means of a delivery system which includes a
`motorized pump and a disposable fluid delivery set. In these
`systems, delivery of enteral fluids is controlled by regulating
`the speed of the pump motor in accordance with the desired
`volumetric flow rate. An example of this type of fluid
`delivery system is shown in U.S. Pat. No. 4,884,013 issued
`to Jackson et al.
`
`such as
`fluid delivery systems
`Although prior art
`described above are very useful
`in accurately delivering
`fluid to a patient, a disadvantage of such systems is their
`inability to ensure that free—flow through the fluid delivery
`set is prevented when the fluid delivery set is being attached
`or detached from the pump. Another disadvantage is their
`inability to easily pass flushing fluid through the fluid
`delivery set on command, or automatically at predetermined
`intervals, in order to keep blockage from occurring in the
`flow lines of the fluid delivery set.
`
`OBJECTS AND SUMMARY OF THE
`INVENTION
`
`A primary object of the present invention is to provide a
`fluid delivery system which incorporates anti-free flow
`features into the pump and fluid delivery set thereof to
`prevent inadvertent free—flow of fluid through the flow lines
`of the fluid delivery set during attachment and detachment
`thereof from the pump.
`A further object of the present invention is to provide a
`fluid delivery system which includes a fail-safe system
`which will prevent
`free—flow of fluid through the fluid
`delivery set in the event of mechanical malfunction or power
`loss of the pump.
`Another object of the present invention is to provide a
`fluid delivery system which allows for automatic or on
`demand flushing of the delivery set to keep blockages from
`occurring in the flow lines thereof.
`It is further an object of the present invention to provide
`a fluid delivery system in which the pump is automatically
`activated for operation when the fluid delivery set is prop-
`erly attached thereto.
`A further object of the present invention is to provide a
`fluid delivery system in which the fluid delivery set thereof
`is completely primed for use by the pump, without the need
`of operator intervention.
`—
`Another object of the present invention is to provide a
`pump having a fluid delivery set interface which is easy to
`clean between uses.
`
`These and other objects and advantages of the present
`invention are realized in a preferred embodiment of a fluid
`delivery system which comprises a fluid delivery set and a
`pump, which includes a pumping unit and a Valve actuation
`unit which is preferably attachable to the housing of the
`pumping unit. The fluid delivery set includes a stop cock
`type valve which has a handle which can be rotated by the
`
`2
`
`valve actuation unit to a series of predetennined positions
`for fluid flow connection of a desired inlet fluid flow line
`with the outlet fluid flow line of the delivery set. The handle
`of the valve must be oriented in its fully closed position in
`order to be inserted into a similarly shaped opening in the
`fluid delivery set interface of the valve actuation unit and be
`accepted by the valve receiving mechanism thereof for
`operation. Because the delivery set interface will only allow
`attachment of the valve to the actuation unit when the valve
`is in its completely closed position, inadvertent fluid flow
`through the delivery set during attachment is prevented.
`Proper positioning of the valve into the delivery set
`interface of the actuation unit positions the valve handle into
`the valve handle receiving mechanism where it can be
`rotated by the rotating chuck of the receiving mechanism
`during operation.
`The valve actuation unit and the pumping unit are pref-
`erably controlled by a single central processing unit which
`is automatically activated by the proper attachment of the
`valve to the actuation unit. The initial action of the pump
`when activated is to lock the handle in place within the valve
`receiving mechanism for use by initiating a slight rotation of
`the valve handle receiving chuck. The valve is locked in
`position within the valve receiving mechanism and cannot
`be detached therefrom at any time in which the valve handle
`is in a rotational position which can allow fluid to flow
`through the valve. When it is desired to remove the valve
`from the pump, the valve receiving mechanism of the pump
`rotates the stop cock valve handle to its fully closed position
`and automatically ejects the valve from the receiving mecha-
`nrsm
`
`The stop cock valve preferably is designed to allow the
`fluid delivery set of which it is a part to include more than
`one input fluid flow line for alternative access to the outlet
`fluid flow line thereof if desired. In this manner, a secondary
`fluid container can be included as part of the fluid delivery
`set which preferably contains flushing fluid which can be
`pumped through the outlet fluid flow line to flush the
`primary enteral nutrition fluid therefrom on a periodic basis
`to prevent the outlet fluid flow line from becoming clogged
`by enteral nutrition fluid.
`The pump further is preferably programmed with a prim-
`ing operation which is initiated upon proper attachment of
`the fluid delivery set including the stop cock valve thereto,
`and which completely primes the outlet fluid flow lines as
`part of an initial setup operation.
`The chuck of the valve receiving mechanism is spring
`mounted for axial movement along a spindle of an electric
`motor. Proper insertion of the handle of the stop cock valve
`into the receiving mechanism forces -the chuck against the
`spring and moves it to a compressed position over the
`spindle. In its compressed position, the chuck activates a
`switch which signals the central processing unit of the pump
`to commence the automatic locking and initial set up opera-
`tion.
`
`The above and other objects and advantages of the present
`invention will become apparent from the following more
`detailed description, when taken in conjunction with the
`accompanying drawings in which like elements are identi-
`fied with like numerals throughout.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a plan elevation View of a preferred embodiment
`fluid delivery system made in accordance with the principles
`of the present invention;
`FIGS. 2a—c are partial cross-sectional views of the valve
`of the fluid delivery set and the valve actuation unit of the
`pump of the fluid delivery system of the present invention;
`
`ACTA EX. 1011-009
`
`ACTA Ex. 1011-009
`
`

`
`5,584,671
`
`3
`FIG. 3 is a rear view of the valve receiving mechanism
`motor and sensor monitoring plate made in accordance with
`the principals of the present invention;
`FIG. 4 is a front view of the disc-shaped valve interface
`member of the preferred embodiment of the present inven-
`tion detached from the valve actuation unit of the pump;
`FIG. 5 is a side view of the disc-shaped valve interface
`member shown in FIG. 4;
`FIG. 6 is a cross—sectional view of the disc-shaped valve
`interface member taken along line V--V of FIG. 4; and
`FIGS. 7a and b are schematic views of the operating
`positions of the valve receiving mechanism of the pump.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENT
`
`As shown in the exemplary drawings for the purposes of
`illustration, an embodiment of a fluid delivery system made
`in accordance with the principles of the present invention,
`referred to generally by the reference numeral 10, is pro-
`vided for anti-free flow attachment and detachment of a fluid
`
`delivery set with a pump which includes the capability for
`automatic priming, and automatic or on demand flushing of
`the outlet fluid flow line of the fluid delivery set.
`More specifically, FIG. 1 is an illustration of a fluid
`delivery system 10 formed in accordance with the present
`invention which includes a pump 12 and a disposable fluid
`delivery set 11 attached thereto for operation. The pump 12
`includes a pumping unit 13 and a valve actuation unit 14.
`The pumping unit 13 includes a housing 15 through which
`protrudes a pump rotor 16. The rotor 16 is driven by a
`conventional DC motor and controlled by a central process-
`ing unit (not shown) in a well known manner, such as is
`described in U.S. Pat. No. 4,884,013 issued to Jackson et al.,
`which is incorporated herein by reference.
`The fluid delivery set 11 preferably includes a pair of inlet
`fluid flow lines comprised of inlet tubes 17 and 18 which are
`connected to fluid containers (not shown) which contain
`fluids to be delivered through the fluid delivery set 11 to the
`patient. The fluids are preferably enteral feeding fluid and
`flushing fluid. The inlet tubes 17 and 18 are connected at
`their ends opposite the fluid reservoir containers to a stop
`cock valve 19 which controls the passage of fluid from the
`inlet tubes 17 and 18 to an outlet fluid flow line.
`
`The stop cock valve 19 of the fluid delivery set 11
`comprises a handle 22 and body 66 which are shaped to
`allow attachment of the valve 19 to the valve actuation unit
`14 in a single unique orientation, corresponding to the closed
`position of the valve 19 in which fluid flow therethrough is
`prevented.
`The outlet fluid flow line of the fluid delivery set includes
`an outlet tube 21, a drip chamber 23, a pump tube 20, and
`a patient connector tube 25. The pump tube 20 surrounds the
`pump rotor 16 in use, and is preferably formed of an elastic
`material such as silicone. Rotation of the rotor 16 in the
`direction indicated by the arrow in FIG.
`1 causes the
`pumping tube 20 to pump fluid into the patient connector
`tube 25 at a rate which is determined by the rate of rotation
`of the rotor 16.
`’
`
`The outlet tube 21 is connected to drip chamber 23 which
`is mounted in a recess in the housing 15 of the pumping unit
`13 and secured to the inlet end of the pump tube 20. The
`outlet end of the pump tube 20 is provided with a mounting
`member 24 which is received in another recess in the
`pumping unit housing 15 to thereby secure the outlet end of
`
`4
`
`the pump tube 20 to the pump 12, and to maintain the pump
`tube 20 properly stretched over the rotor 16 for operation.
`The patient connector tube 25 is connected to the outlet end
`of the pump tube 20 and delivers fluid from the fluid delivery
`system 10 to the patient, either directly, or through connec-
`tion to a tube previously prepared for the patient such as a
`nasogastric, gastrostomy, or jejunostomy tube.
`The pumping unit 13 includes an interactive control pad
`26 mounted in the housing 15 thereof which allows an
`operator to set various functions of the system 10, such as
`flow rate and dose (total volume) of feeding fluid to be
`delivered to the patient, interrupt operations of the pump unit
`13, and an increase or decrease in the designated feed dose
`volume or feeding fluid flow rate. Similarly, the control pad
`26 allows the operator to set the flushing fluid dose and time
`period between each flushing cycle, or to initiate an imme-
`diate flush cycle at any time. However, the flushing fluid
`flow rate is preferably preset and therefore not intended to be
`controlled by the operator. The operation and internal work-
`ings of the pumping unit 13 of the present invention are
`thoroughly described in the above-mentioned U.S. Pat. No.
`4,884,013.
`The valve actuation unit 14 of the pump 12 is enclosed
`within an actuation unit housing 28. The valve recess 29
`which is shaped to receive the stop cock valve 19, the inlet
`tubes 17 and 18, and the outlet tube 21 in a single unique
`orientation (as shown in FIG. 1) is included in a valve
`interface 45 which is detachable from the housing 28 for
`cleaning when necessary. The interface 45 forms a handle
`opening 30 which passes through the bottom of the valve
`recess 29 thereof. The handle opening 30 passes completely
`through the interface 45 to allow access of the valve handle
`22 to the valve receiving mechanism 32 within the housing
`28. The handle opening 30 is nearly identical in shape to the
`valve handle 22, so that, only proper alignment of the handle
`22 with the handle opening 30 will allow the handle 22 to
`pass into or out of the housing 28. As will be explained in
`more detail below, the valve recess 29 and handle opening
`30 force a single unique orientation of the valve handle 22
`with respect to the valve body 66 before the inlet tubes 17
`and 18 and the outlet tube 21 can be received within the
`valve recess 29 and the handle 22 can pass through the
`handle opening 30 for purposes of attachment. This single
`unique orientation of the valve handle 22 with respect to the
`remainder of the valve 19 corresponds to the fully closed
`position of the valve 19. In this manner, as is clearly evident,
`the valve 19 cannot be loaded into the actuation unit 13 of
`the pump 12 for use, nor more importantly, removed from
`the actuation unit 13 at any time, unless the handle 22
`thereof is in its fully closed position. This of course prevents
`accidental fluid flow through the fluid delivery set 11 during
`loading thereof for use, and prevents ejection of the valve 19
`from the actuation unit at any time without first closing the
`valve 19 against fluid flow.
`As shown in FIGS. 2a-2c, when the valve handle 22 is
`passed through handle opening 30, it immediately contacts
`the chuck 33 of the valve receiving mechanism 32. The
`chuck 33.is mounted to a spline 34 which is in turn mounted
`to the rotating shaft 35 of a stepper motor 36. The chuck 33
`is limited to translational movement over the spline 34 by
`the spline ridges 52, and corresponding chuck grooves 53.
`The chuck 33 is biased by the spring 37 to an extended
`position in which the chuck face 38 thereof rests against the
`interior surface 46 of the interface member 45,
`located
`around the valve opening 30 thereof.
`Continued movement of the valve 19 into the valve recess
`
`29 causes the valve handle 22 to force the chuck 33 against
`
`ACTA EX. 1011-010
`
`ACTA Ex. 1011-010
`
`

`
`5
`
`6
`
`5,584,671
`
`the spring 37 and along the spline 34. The chuck 33 will
`slide over the spline 34 a suflicient distance to ensure that the
`valve handle 22 can pass entirely through the handle open-
`ing 30 into the cylindrical recess 64.
`As the chuck 33 approaches its fully compressed position,
`the outer surface of the chuck 33 contacts the microswitch
`40 to automatically activate the microprocessor of the pump
`12. Continued compression of the chuck 33 causes a control
`flange 39, which extends rearwardly from the chuck 33, to
`operationally engage with photoelectric switches 41, 48 and
`49. This initiates rotation of the stepper motor 36 to rotate
`the chuck 33 a predetermined rotational distance. Since the
`valve 19 is held in a fixed unique orientation with respect to
`the valve interface 45 by the valve recess 29, and the valve
`handle 22 is fixed in the chuck face 38 by the handle
`positioning stubs 65, the handle 22 is forced to rotate in
`response to rotation of the chuck 33 by the stepper motor 36.
`The predetermined automatic initial rotation of the chuck 33
`therefore causes the valve handle 22 to become trapped
`against the interior surface 46 of the interface member 45.
`As best shown in FIG. 3, the control flange 39 is posi-
`tioned on the chuck 33 so as to pass through the series of
`photo-electric switches 41, 48 and 49 as the chuck 33 is
`rotated by the stepper motor 36. The photo-electric switches
`41, 48 and 49 are mounted on a control plate 42 around an
`areuate path followed by the control flange 39. The photo-
`electric switches 41, 48 and 49 send electrical signals to the
`central processing unit of the pump 12, signalling the
`presence or absence of the control flange 39 therein in an
`operational manner which identifies the rotational position
`of the chuck 33, and thus the valve handle 22, to the central
`processing unit. In this manner, electrical commands sent to
`the stepper motor 36 to rotate the chuck 33 (and thusly the
`handle 22 of the valve 19) are controlled by the actual
`rotational position (orientation) of the flange 29 of the chuck
`33 as monitored by the central processing unit using the
`photo-electric switches 41, 48 and 49 as the monitoring
`devices, creating a closed loop electrical system for operat-
`ing the valve receiving mechanism 32.
`If desired,
`the microswitch 40 can also be utilized in
`providing feedback information to the central processing
`unit of the pump 12 relating to the position of the chuck 33
`during pump operation. This can be accomplished by the
`positioning of one or more notches 43 at predetermined
`radial positions around the cylindrical surface of the chuck
`33 to trigger the microswitch 40 each time a notch 43 is
`rotated therepast during operation. When a notch 43 passes
`the microswitch 40, it leaves sufficient space to allow the
`microswitch to release thereinto, and then re-trigger when
`the notch 43 passes. Each release or retriggering of the
`microswitch 40 sends a signal to the central processing unit
`of the pump in the manner well known to those skilled in the
`art of microswitch operation. Each notch 43 can be formed
`to entail as much of a radial arc around the chuck 33 as
`
`desired for the proper positional operation of the chuck
`during use. As is evident therefor, the microswitch 40, or a
`series of similar rnicroswitches, could be used to replace one
`or more photoelectric switches if properly positioned to
`maintain the same signal logic sequence for the replaced
`photoelectric switches, as will be described below. Simi-
`larly, the microswitch 40 could be replaced with an equiva-
`lent switch such as a photoswitch, magneto resistive switch,
`etc.
`
`The total angle of rotation through which the valve handle
`22 can be rotated in the valve body by the receiving
`mechanism 32 is limited by the governor tab 44 on the spline
`34. The governor tab 44 interferes with the stop surfaces 54
`
`and 55 on the motor/sensor monitoring plate 42 at each end
`of its predetermined maximum rotational arc to prevent
`accidental over rotation of the valve handle 22, and to assist
`in resetting the chuck in its starting position if positional
`errors occur during operation. The preferred predetermined
`maximum valve rotation allowed by the governor tab 44 and
`stop surfaces 54 and 55 is approximately l20degrees.
`As is best shown in FIGS. 1 and 4-5, the disc-shaped
`valve interface member 45 may be detachable from the
`actuation unit housing 28 by means of screws or the like
`(which may pass through the back of the housing 28 and are
`not shown)
`to allow cleaning thereof when necessary.
`Removal of the interface member 45 from the housing 28
`also exposes the chuck face 38 for cleaning if desired. When
`the interface member 45 is removed from the housing 28 for
`cleaning, the chuck 33 remains held in position within the
`cylindrical housing extension 64 by the stop tab 61 which
`extends to contact the housing stop surface 62 to stop
`outward movement of the chuck 33 (see FIG. 2). In this
`manner, the sealing engagement between the chuck cup-type
`seal 63 and the cylindrical housing extension 64 is main-
`tained so that fluid which may be present at the chuck face
`38 cannot pass into the housing 28.
`When the interface member 45 is replaced on the housing
`28, the interior surface 46 thereof pushes the chuck 33 a
`small distance away from the housing 28 to disengage the
`chuck stop tab 61 from the housing stop surface 62. In this
`manner, the valve handle 22, when in position in the chuck
`33, rotates only against
`the interior surface 46 of the
`interface member 45 and is not interfaced with by the
`housing 28. The chuck 33 includes a cup-type seal gasket 63
`which forms a seal between the chuck and the cylindrical
`housing extension 64 and prevents the passage of fluid past
`the chuck 33 into the interior of the valve actuation unit 14.
`
`OPERATION OF THE PREFERRED
`EMB ODIIVIENT
`
`To operate the fluid delivery system 10 of the present
`invention, the operator attaches a fluid delivery set 11 to the
`pump 12 as shown in FIG. 1. This can be accomplished by
`inserting the drip chamber 23 into the proper recess in the
`pump unit housing 15 and stretching the pump tubing 20
`around the pump rotor 16. The mounting member 24 is then
`inserted in its own recess in the pump unit housing 15 where
`its presence is sensed by a sensor (not shown) which signals
`the pump 12 that the outlet flow line has been properly
`positioned thereon. The fluid containers in fluid flow attach-
`ment with the inlet tubes 17 and 18 are preferably suspended
`above the pump 12 in a well known manner.
`The operator then ensures that the handle 22 of the stop
`cock valve 19 is in its fully closed position, and inserts the
`valve 19 into me valve recess 29 of the interface member 45
`
`until the handle 22 thereof passes through the handle open-
`ing 30 and engages the face 38 of the chuck 33. If desired,
`the valve 19 of the fluid delivery set may be manufactured
`and supplied to the operator in its closed position to prevent
`free flow through the valve 19 at all times prior to use. The
`valve 19 may also include a safety tape positioned there-
`around to discourage rotation of the valve handle 22 from its
`closed position, which must be removed by the operator
`prior to attachment of the valve 19 to the valve actuation unit
`14.
`
`The operator continues to force the valve 19 inwardly
`against the bias of the spring 37 until the chuck 33 actuates
`the microswitch 40 (which activates the microprocessor) and
`
`ACTA EX. 1011-011
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`ACTA Ex. 1011-011
`
`

`
`5,584,671
`
`7
`
`the control flange 39 thereof is positioned within the pho-
`toelectric switches 41, 48 and/or 49 for operation. In this
`position, referred to hereinafter as the “starting position” the
`valve handle 22 has moved completely within the housing
`28. After actuation of the microswitch 40 and operational
`engagement of the control flange 39 in the photoelectric
`switches 41, 48 and 49, the stepper motor automatically
`rotates an initial approximately 30 degrees from its starting
`position, which causes the valve handle 22 to be trapped
`against the interior surface 46 of the interface member 45.
`This new position is the “initial locking position” of the
`valve handle 22 within the actuation unit housing 28. The
`initial locking position of the valve 19 does not open any
`fluid flow path therethrough.
`If desired,
`the operator may manually actuate the on
`button 68 before loading the fluid delivery set 11 into the
`pump 12, however, no pump action will occur until the fluid
`delivery set is actually loaded.
`Once the microswitch 40 has been triggered to activate
`the microprocessor,
`the microprocessor in turn initiates
`activation of the upper and lower displays 57 and 27
`respectively. The upper display 57 is preferably smaller than
`the lower display 27 and is used primarily to display a
`running total of fluid delivered, either flushing fluid or
`feeding fluid, so that progress towards the programmed total
`feeding fluid dose or total flushing fluid dose can be moni-
`tored by the operator. The adjacently positioned flushing
`light 58 and feeding light 59 illuminate in turn to correspond
`to the particular accumulated fluid volume showing in the
`display 57 as will be explained in more detail below. The
`lower display 27 is used for displaying more general infor-
`mation and to assist
`the operator in programming and
`operating the system 10. The lower display 27 will display
`any preprograrnrned parameters which have been entered
`from the key pad 26 and also scroll
`through messages
`relating to the immediate operation being performed by the
`pump 12. Operation of the lower display 27 will also be
`explained in more detail below.
`Once the valve handle 22 has been rotated to the initial
`
`the microprocessor immediately illun1i—
`locking position,
`nates the flushing light 58 and causes the upper display 57
`to display the accumulative volume delivered of flushing
`fluid (starting with zero, since no fluid has yet been delivered
`by the pump 12). The lower display 27 will initially provide
`no information to the operator since the operator has input
`no programming information at this point through the key
`pad 26.
`However, it is a preferred embodiment of the present
`invention that the pump 12 also include memory capabilities
`which allow it to store operational parameters which were
`previously input by an operator, and automatically retrieve
`to the preprogrammed operational parameters upon initial
`attachment of a fluid delivery set 11 to the pump 12. Also if
`desired, the automatic retrieval of preprogrammed param-
`eters may be time limited so that only preprogrammed
`information received by the pump 12 within a predetermined
`time period will be retrieved to and any time period greater
`than the time limited period will clear those values and force
`the operator to re-input the desired parameters. A preferred
`time period for automatic retrieval
`to preprograrnmed
`parameters is approximately 16 hours.
`If non-zero preprograrnmed parameters are retrieved to by
`the pump 12 at the initiation of a new operation cycle, the
`parameters are presented in the lower display 27. Otherwise,
`the operator inputs the desired parameters through the key
`pad 26 at a later time as will be explained.
`
`8
`the pump 12 initiates rotation of the stop cock
`Next,
`handle 22 an additional approximately 30 degrees to the
`“flushing position”, which is approximately 60 degrees from
`the starting position, after an additional actuation of the
`run/hold key 47, and makes fluid flow connection between
`the inlet tube 18 and the outlet tube 21. The pump rotor 16
`then draws flushing fluid from the flushing fluid container,
`through the inlet tube 18, and into the drip chamber 23 where
`the pump detects the presence of drops ensuring proper fluid
`flow through the fluid delivery set 11.
`Once the drop detection is complete, the valve handle 22
`automatically rotates an additional 60 degrees to the “feed-
`ing position” which is approximately l20 degrees from the
`starting position.
`This opens fluid flow communication between the inlet
`tube 17 and the outlet tube 21. Priming is then commenced
`by the pumping unit 13 pumping enteral fluid from the
`enteral fluid container through the inlet tube 17 and the
`outlet tube 21 into the drip chamber 23 where it is sensed by
`the drip sensor (not shown). After completion of the enteral
`fluid priming, a leak test is then performed by initiating
`rotation of the rotor 16 by the pump 12 back 30 degrees to
`the “temporary olf position”, which is 90 degrees from the
`starting position. If drops continue through the drip chamber
`23 and are detected by the drip sensors of the pump 12 when
`the handle 22 is in the temporary ofl position, it is assumed
`by the microprocessor that the valve 19 is defective. The
`handle 22 therefor automatically rotates back to the starting
`position which allows the spring 37 of the valve receiving
`mechanism 32 to eject the valve 22 from the handle opening
`30. The lower display 27 then automatically displays the
`phrase “bad set”.
`To recommence operation of the fluid delivery system 10,
`the operator thereafter must remove the defective fluid
`delivery set 11 and replace it with a new fluid delivery set 11
`and re-initiate pump operation by inserting the fluid delivery
`set stop cock valve 19 into the pump’s valve receiving
`mechanism 32.
`
`However, if the leak test is successful, the pump 12 rotates
`once more to the feeding position and continues to pump
`enteral fluid through the fluid delivery set 11 until the entire
`outlet fluid flow line of the set is filled with feeding fluid. It
`is preferred that the priming operation to fill the outlet fluid
`flow line with feeding fluid be performed at the flushing flow
`rate in order to speed up the priming process. While priming,
`the lower display 27 indicates that the priming operation is
`in progress by displaying the phrase “filling set” for all
`phases of priming.
`Once the outlet fluid flow line of the fluid delivery set 11
`is completely primed, the priming operation automatically
`stops by stopping the rotor 16 and the pump 12 rotating the
`valve handle 22 in the reverse direction a distance of 30
`
`degrees to the t