throbber
WORLD INTELLECI'UAL_ PROPERTY ORGANIZATION
`International Bureau
`
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(51)1n¢¢rnati°nn|Patent Clnssification 6 =
`
`(11) International Publication Number:
`
`WO 97/10862
`
`A6lM 5/142
`
`A1
`
`_
`_
`(43) International Publication Date:
`
`27 March 1997 (27.03.97)
`
`N
`-
`H
`I
`-
`2
`Pcr/U596/14741
`( 1) I"t°""'"°m App cam" umber
`(22) International Filing Date:
`17 September 1996 (l7.09.96)
`
`:
`
`(74) Agents: WOODWORTH, Brian, R. et al.; Abbott Laboratories,
`CHAD 0377/AP6D-2, 100 Abbott Park Road, Abbott Park,
`H‘ 600643500 ms)‘
`
`(30) Priority Data:
`531,874
`
`21 September 1995 (21.09.95)
`
`US
`
`(81) Designated States: AU, BR, CA, JP, MX, NZ, European patent
`(AT, BE, CH, DE, DK, ES, FI, FR, B, GR, IE, 1'1‘, LU,
`MC, NL, PT, SE).
`
`(71) Applicant: ABBOTT LABORATORIES [US/US]; CHAD
`0377/AP6D-2, 100 Abbott Park Road. Abbott Park,
`IL Published
`60064-3500 (US).
`With international search report.
`Before the expiration of the time limit for amending the
`claims and to be republished in the event of the receipt of
`amendments.
`
`(72) Inventors: OSBORNE, Robert, S.; 227 Brookhill Drive,
`Gahanna, OH 43220 (US). PIONTEK, Carl, J.; 118 Beech
`Ridge Drive, Powell, OH 43065 (US). CLEGG, Robert,
`D.; 8790 Chateau Drive, Pickerington, OH 43137 (US).
`BUCK, Bradford, L.; 3710 Peak Ridge Drive, Gahanna,
`OH 43220 (US). FLEMING, Matthew, S.; 3970 Mountview
`Road. Columbus, OH 43220 (US). JURATOVAC, Joseph,
`A.; 470 Canyon Drive, N.E., Columbus, OH 43214 (US).
`HOFFMAN, Dennis, J.; 3124 Telham Drive, Columbus,
`OH 43204 (US). WILSON, Grant, R.; 308 West Second
`Avenue, Columbus, OH 43201 (US). PATFON, William,
`E.; 6767 Atlin Court, Dublin, OH 43017 (US).
`
`(54) Title: ROTARY PERISTALTIC PUMP
`
`(57) Abstract
`
`A rotary peristaltic pump has a pump housing with a front wall. The front wall of the pump housing has a lower part and an upper
`part which protrudes forwardly over the lower part. A drive shaft for a motor extends through an aperture in the lower part of the front
`body wall and has a peristaltic rotor mounted thereon. There are two retentive receptacles in the body wall for receiving a fluid delivery
`set, and one of the retentive receptacles communicates with a guideway, for a feeding set, which extends horizontally towards a lateral side
`of the pump housing.
`
`ACTA EX. 1016-001
`
`ACTA Ex. 1016-001
`
`

`
`FOR THE PURPOSES OF INFORMATION ONLY
`
`Codes used to identify States party to the PCT on the front pages of pamphlets publishing international
`applications under the PCI‘.
`
`AM
`AT
`AU
`BB
`BE
`BF
`BG
`BJ
`BR
`BY
`CA
`CF
`CG
`CH
`CI
`CM
`CN
`CS
`
`Annenia
`Austria
`Australia
`Barbados
`Belgium
`Burkina Faso
`Bulgaria
`Benin
`Brazil
`Belarus
`Canada
`Central African Republic
`Congo
`Switzerland
`Cote d'lvoire
`Cameroon
`China
`Czechoslovakia
`Czech Republic
`Germany
`Denmark
`Estonia
`Spain
`Finland
`France
`Gabon
`
`United Kingdom
`Georgia
`Guinea
`Greece
`Hungary
`Ireland
`Italy
`Japan
`Kenya
`Kyrgyatan
`Democratic People's Republic
`of Korea
`Republic of Korea
`Kazakhstan
`Liechtenstein
`Sri Lanka
`Liberia
`Lithuania
`Luxembourg
`Latvia
`Monaco
`Republic of Moldova
`Madagascar
`Mali
`Mongolia
`Mauritania
`
`Malawi
`Mexico
`Niger
`Netherlands
`Norway
`New Zealand
`Poland
`Portugal
`Romania
`Russian Federation
`Sudan
`Sweden
`Singapore
`Slovenia
`Slovakia
`Senegal
`Swaziland
`Chad
`Togo
`Tajikistan
`Trinidad and Tobago
`Ukraine
`Uganda
`United States of America
`Uzbekistan
`Viet Nam
`
`ACTA EX. 1016-002
`
`ACTA Ex. 1016-002
`
`

`
`W0 97/1 0862
`
`PCT/US96/14741
`
`ROTARY PERI STALTIC PUMP
`
`EIELD_QE;IHE_INENIIQN_
`
`The present invention relates to a rotary peristaltic pump
`
`used for introducing an enteral fluid or a parenteral fluid
`
`into the body of a patient.
`
`EACK§BQHND_QE_IHE_INMENIIQN
`
`The present invention is a rotary peristaltic pump that may
`
`be assembled with a fluid delivery set for use on nearly any
`
`occasion wherein enteral or parenteral fluids are to be
`
`delivered to a patient through a flexible tubing. Parenteral
`
`fluids are delivered into the circulatory system of a patient.
`
`Enteral fluids are delivered into the gastrointestinal tract
`
`of the patient.
`
`Rotary peristaltic pumps are well known and are described
`
`in a number of U.S. patents, such as, 5,250,027; 5,057,081;
`
`4,913,703; 4,884,013; 4,832,584; 4,722,734; 4,720,636;
`
`4,708,604; 4,690,673; 4,688,595; 4,545,783; and 4,513,796.
`
`Rotary peristaltic pumps commonly include a motor driven
`
`peristaltic rotor mounted on a shaft extending out
`
`through the
`
`front wall of the pump housing. The peristaltic rotor carries
`
`an array of two or more circumferentially, i.e., angularly,
`
`spaced apart rollers. The peristaltic rotor is designed to
`
`have a portion of the flexible tubing of the feeding set
`
`ACTA EX. 1016-003
`
`ACTA Ex. 1016-003
`
`

`
`W0 97/10862
`
`PCT/US96/l4‘l4l
`
`wrapped part way around the roller array under tension
`
`thereagainst or confined between the rollers and an opposing
`
`arcuate surface. As the motor within the pump housing rotates
`
`the shaft on which the peristaltic rotor is mounted,
`
`the
`
`spaced apart rollers are sequentially brought into contact
`
`with the flexible tubing with each revolution of the motor
`
`shaft and each roller in turn compresses a portion of the
`
`tubing to form an occlusion. The occlusion is advanced along
`
`the tubing as the peristaltic rotor turns and the roller
`
`advances along the tubing,
`
`the occlusion disappearing where
`
`the tubing diverges tangentially from the rotor. A
`
`predetermined amount of fluid is contained between successive
`
`occlusions so that a predetermined volume of fluid is advanced
`
`in a peristaltic manner through the tubing with each
`
`revolution of the rotor. Accordingly,
`
`the amount of fluid to
`
`be delivered to the patient may be regulated by controlling
`
`the rate of rotation of the peristaltic rotor and the time
`
`duration of the fluid delivery procedure.
`
`Fluid delivery sets, also referred to herein as feeding
`
`sets,
`
`typically comprise a drip chamber having the outlet end
`
`connected to an elastically flexible tubing, such as a
`
`silicone rubber tube, or interconnected lengths thereof,
`
`that
`
`in turn connect, directly or through an adapter,
`
`to the
`
`requisite device, such as a needle or tube,
`
`for parenteral or
`
`enteral administration of fluid to the patient. The inlet of
`
`the drip chamber is adapted to receive, directly or through a
`
`connecting piece of flexible tubing, enteral or parenteral
`
`ACTA EX. 1016-004
`
`ACTA Ex. 1016-004
`
`

`
`W0 97/10862
`
`PCT/US96/14741
`
`fluid from a supply container thereof, usually a hanging
`
`container. A portion of the flexible tubing is appropriately
`
`associated with a pump if the same is to be employed.
`
`For
`
`example,
`
`if the pump is a rotary peristaltic pump,
`
`the
`
`flexible tubing is usually wrapped partially, i.e.,
`
`less than
`
`one complete turn, around the rotor as described above.
`
`The fluid delivery set is typically changed every day. It
`
`is important that the fluid delivery set is manufactured
`
`according to fairly rigid manufacturing specifications so that
`
`delivery volumes are accurately predetermined and controlled
`
`and consistently produced from set to set. The portion of the
`
`flexible tubing, which together with the drip chamber makes up
`
`the fluid delivery set, i.e.,
`
`feeding set,
`
`for mounting on the
`
`pump,
`
`for example, should be cut to a consistent length for
`
`each set and have a lumen of constant and consistent internal
`
`diameter and a consistent flexibility and elasticity as
`
`determined by urometer tests so that the internal diameter of
`
`the lumen will be consistent for each fluid delivery set when
`
`placed in tension around the rotor of the peristaltic pump.
`
`The drip chamber dimensions should also be consistent,
`
`especially in length, so that the drip chamber may be properly
`
`aligned with an adjacent drop sensor on the pump housing,
`
`if
`
`such a sensor is used.
`
`The portion of each fluid delivery set that is typically
`
`assembled with a rotary peristaltic pump housing is placed
`
`into an operative position by inserting the drip chamber into
`
`a complementary retention recess or pocket
`
`formed in the
`
`ACTA EX. 1016-005
`
`ACTA Ex. 1016-005
`
`

`
`W0 97/1 0862
`
`PCT/US96/1474]
`
`housing,
`
`tangentially upward from a circumferential edge of
`
`the rotor. The flexible tubing which extends from the bottom
`
`of the drip chamber is stretched sufficiently around the
`
`roller array of the peristaltic rotor to provide for the
`
`peristaltic action of the rollers and back up along another
`
`channel or groove formed in the pump housing and leading
`
`tangentially upwardly from a circumferential edge of the rotor
`
`to supporting means such as a retention recess or pocket
`
`formed in the pump housing. Usually the flexible tubing will
`
`have formed thereon, or attached there around, a collar or
`
`flange that engages with an upper surface of the portion of
`
`the pump housing which defines the retention recess or pocket.
`
`The collar or flange is located along the flexible tubing at a
`
`linear position that will necessitate the flexible tubing
`
`being in tension in order to place the collar in the retention
`
`recess.
`
`In most known devices of the type generally described
`
`above,
`
`the flexible tubing more usually is positioned to
`
`extend out above the pump housing in a nearly vertical
`
`direction and arch over and away from the pump housing towards
`
`the patient being fed or treated, or,
`
`the flexible tubing is
`
`positioned in an arcuate groove formed in the pump housing
`
`leading upwardly as well as laterally away from the retention
`
`recess to the edge of the housing,
`
`from which point the
`
`flexible tubing arches on over and away from the pump housing
`
`towards the patient. The arcuate groove is of great enough
`
`radius, such as an inch,
`
`to not wrinkle or crimp the flexible
`
`tubing and reduce the cross—section of the lumen of the
`
`ACTA EX. 1016-006
`
`ACTA Ex. 1016-006
`
`

`
`WO 97/10862
`
`PCT/US96/14’/4]
`
`5
`
`flexible tubing so as to significantly limit flow of liquid
`
`therethrough. Examples of the arrangement with the path of
`
`delivery of the fluid extending up above the pump housing are
`
`shown in U.S. Patents 5,380,173; 5,250,027; 5,147,312;
`
`5,133,650; 5,057,081; 4,913,703; 4,836,752; 4,832,584;
`
`4,688,595; 4,552,516; 4,515,535; 4,513,796; and 4,231,725. An
`
`example of the arrangement with the delivery of the fluid
`
`through the tubing extending up from the peristaltic rotor and
`
`out laterally along an arcuate groove in the housing is shown
`
`in U.S.Patent 4,884,013.
`
`In still other arrangements the flexible tubing receiving
`
`fluid from the outlet of the drip chamber describes about a
`
`180 degree arcuate bend mating the curvature of the
`
`peristaltic rotor and extends horizontally to and from the
`
`rotor about which it is to a large degree wrapped and held
`
`under tension by retaining means on the pump housing or by
`
`rotor compression as illustrated in U.S. Patents 5,082,429;
`
`4,886,431; 4,813,855; 4,722,734 and 4,545,783.
`
`In yet another
`
`arrangement the flexible tubing leading from the drip chamber
`
`or other supply means is brought upwardly from below the
`
`peristaltic rotor of the peristaltic pump and over the rotor
`
`and back downwardly to then extend laterally towards the
`
`patient. This configuration is illustrated in U.S. Patents
`
`5,266,013; 5,110,270; 4,720,636; 4,708,604; 4,256,442; and
`
`3,963,023.
`
`With some of these designs or configurations it is possible
`
`for movement of a pole supporting a hanging container or other
`
`ACTA EX. 1016-007
`
`ACTA Ex. 1016-007
`
`

`
`WO 97/10862
`
`PCT/US96/14741
`
`6
`
`supply support, or indeed, movement of the supply container,
`
`per se,
`
`to cause the flexible tubing to become loosened or
`
`disengaged from the peristaltic rotor, or a restless patient
`
`may tug on and accidentally displace the flexible tubing from
`
`the retention recess or pocket on the downstream side of the
`
`peristaltic rotor, resulting in disengagement of the tubing
`
`from compression by the peristaltic rotor.
`
`In these
`
`situations, it is possible to have an uncontrolled rate of
`
`gravity—induced flow of the enteral or parenteral fluid to the
`
`patient because the rollers of the rotor are not properly
`
`compressing, i.e., occluding,
`
`the flexible tubing to restrict
`
`the flow of fluid through the feeding set to a pre-selected
`
`rate.
`
`SHMMAEX_QE_IHE_lNENEIQN_
`
`There is provided in accordance with the present
`
`invention
`
`a rotary peristaltic pump comprising a housing having: a front
`
`body wall with an upper part and a lower part and the upper
`
`part protruding forwardly over the lower part; an aperture in
`
`the lower part of the front body wall for receiving a motor
`
`shaft therethrough below the protruding upper part of the
`
`front body wall; first and second retentive receptacles for
`
`receiving retention elements of a cooperative feeding set
`
`formed in the upper part of the front body wall above the said
`
`aperture; and a horizontal guideway formed in the upper part
`
`of the front body wall connecting to and extending from the
`
`second retentive receptacle toward a lateral side of the pump
`
`ACTA EX. 1016-008
`
`ACTA Ex. 1016-008
`
`

`
`WO 97/10862
`
`PCT/US96/14741
`
`housing.
`
`The special features of the pump housing inhibit unintended
`
`detachment of a fluid delivery set from the pump housing
`
`without sacrificing convenience in mounting and dismounting
`
`the fluid delivery set.
`
`EEIEE_DEE£BIEIIQN_QE_IHE_DBAflINQS
`
`Fig.
`
`1 is a view in front elevation of a peristaltic pump
`
`and fluid delivery set assembly according to the invention
`
`connected at the inlet end of the fluid delivery set to a
`
`supply container of liquid enteral nutritional product, here
`
`suspended from a support on a pole, and, connected at the
`
`discharge end of the fluid delivery set to a feeding tube
`
`extending into the stomach of a patient whose abdomen is shown
`
`in fragmentary view, partly broken away and in section;
`
`Fig.
`
`2 is a perspective view of a peristaltic pump and
`
`fluid delivery set assembly according to the invention;
`
`Fig.
`
`3 is a perspective view of the peristaltic pump of
`
`Fig. 2, without
`
`the complementary fluid delivery set assembled
`
`therewith;
`
`Fig. 3A is a greatly enlarged view of the encircled portion
`
`of Fig. 3;
`
`Fig.
`
`4 is a view in front elevation of the peristaltic pump
`
`and fluid delivery set assembly of Fig. 2;
`
`Fig.
`
`4A is a fragmentary view in section taken along the
`
`line 4A-4A of Pig. 4;
`
`Fig.
`
`5 is a side View of the peristaltic pump and fluid
`
`ACTA EX. 1016-009
`
`ACTA Ex. 1016-009
`
`

`
`W0 97/10862
`
`PCT/US96/14741
`
`delivery set assembly of Fig.4;
`
`Fig.
`
`6 is a top view of the peristaltic pump and fluid
`
`delivery set assembly of Fig. 4, while within the encircled
`
`portion the cap—like or collar—like first retention element is
`
`partly broken away for purposes of illustration of the
`
`relationship of the retention element and one of the bosses on
`
`the floor of the first retentive recess;
`
`Fig.
`
`6A is an enlarged View of the encircled portion of
`
`Fig.
`
`6 with the retention element shown only in dotted outline
`
`for purposes of illustration so that the nature of the floor
`
`of the first retentive recess and the connecting downwardly
`
`extending guideway will be better understood;
`
`Fig.
`
`7 is an enlarged fragmentary view in vertical section
`
`of the peristaltic pump and fluid delivery set assembly of
`
`Fig.
`
`4 taken along the line 7-7 of Fig. 4;
`
`Fig.
`
`8 is a fragmentary view in horizontal section of the
`
`peristaltic pump and fluid delivery set assembly of Fig.
`
`4
`
`taken along the line 8-8 of Fig. 4;
`
`Fig.
`
`8A is a further enlarged fragmentary view in vertical
`
`section of the peristaltic pump and fluid delivery set
`
`assembly of Fig.
`
`4
`
`taken along the line 8A-8A of Fig. 8:
`
`Fig.
`
`9 is a perspective View of a fluid delivery set
`
`according to the invention with the first and third flexible
`
`tubing portions truncated and foreshortened;
`
`Fig. 10 is a front view of the fluid delivery set of Fig.
`
`9;
`
`Fig. 10A is a view in section taken along the line 1OA—l0A
`
`ACTA EX. 1016-010
`
`ACTA Ex. 1016-010
`
`

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`
`of Fig. 10;
`
`Fig. 11 is a perspective view of a length of the flexible
`
`tubing of a fluid delivery set of the invention, such as the
`
`second length 49, with a novel pinch valve element telescoped
`
`thereon kinking the tubing in valving action when the tubing
`
`is not under tension;
`
`Fig. 12 is an enlarged perspective view of the pinch valve
`
`element of Fig. 11 before being telescopically mounted on the
`
`flexible tubing to provide valving action;
`
`Fig.
`
`13 is a side elevation view of the components of a
`
`pinch valve;
`
`Fig. 14 is a side view of a section of flexible tubing that
`
`has been kinked by the novel pinch valve element of Fig. 12;
`
`Fig. 15 is a perspective view of a fluid delivery set like
`
`that shown in Fig.
`
`9 but having a pinch valve element
`
`telescoped on the flexible tubing near the second retention
`
`element;
`
`Fig. 16 is a front view of the fluid delivery set of Fig.
`
`15;
`
`Fig. 17 is a view, partly in front elevation and partly
`
`fragmentary and in section, of the peristaltic pump—fluid
`
`delivery set assembly of the invention connectable at the
`
`inlet end to the screw cap opening of a hanging supply
`
`container of a liquid enteral nutritional product, and at the
`
`outlet end being connected to a nasogastric feeding tube
`
`extending into the stomach of a patient;
`
`Fig. 18 is a view, partly in front elevation and partly
`
`ACTA EX. 1016-011
`
`ACTA Ex. 1016-011
`
`

`
`W0 97/1039
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`PCT/US96/14741
`
`10
`
`fragmentary and in section, of the peristaltic pump-fluid
`
`delivery set assembly of the invention connectable at the
`
`inlet end to the pierceable cap of a hanging supply container
`
`of a liquid enteral nutritional product, and at the outlet end
`
`being connected to a feeding tube leading into the jejunum of
`
`a patient;
`
`Fig. 19 is a view, partly in front elevation and partly
`
`fragmentary and in section, similar to Fig. 18 but with the
`
`outlet end of the fluid delivery set connected to a feeding
`
`tube extending through a stoma in the abdominal wall and into
`
`the stomach of the patient;
`
`Fig. 20 is a view, partly in front elevation and partly
`
`fragmentary, of a peristaltic pump—fluid delivery set assembly
`
`of the invention with the inlet end of the first length of
`
`flexible tubing connected to a hanging supply container of a
`
`parenteral fluid and the outlet of the third length of
`
`flexible tubing connected to a needle extending into a vein in
`
`the arm of a patient;
`
`Fig. 21 is a perspective view of a peristaltic pump
`
`according to the prior art;
`
`Fig. 22 is a partly fragmentary perspective view of a
`
`hanging supply container of an enteral or parenteral fluid
`
`shown connected to the inlet end of a fluid delivery
`
`set—peristaltic pump assembly according to the prior art,
`
`the
`
`fluid delivery set assembled with the prior art peristaltic
`
`pump of Fig. 21;
`
`Fig. 23 is a perspective view of a preferred form of right
`
`ACTA EX. 1016-012
`
`ACTA Ex. 1016-012
`
`

`
`WO 97/10862
`
`PCT/US96/14741
`
`ll
`
`angle retention/connector element suitable for connecting the
`
`second and third lengths of the flexible tubing of the fluid
`
`delivery set of the invention;
`
`Fig 24 is a top view of the retention/connector element of
`
`Fig. 23;
`
`Fig. 25 is a view in vertical section of the
`
`retention/connector element of Fig. 23 taken along the line
`
`25-25 of Fig. 24;
`
`Fig. 26 is a side view of the retention/connector element
`
`Fig. 23;
`
`Fig. 27 is a front view of the retention/connector element
`
`Fig. 23;
`
`Fig. 28 is a bottom view of the retention/connector element
`
`Fig. 23 looking in the direction indicated by the arrow 28
`
`Fig. 27;
`
`Figs. 29 to 34 show alternative embodiments of right angle
`
`retention/connector elements with various forms of tabs for
`
`grasping, except for the retention-connector element of Fig.
`
`29 which has only a retention tab;
`
`Figs. 35 to 38 are perspective views of more alternative
`
`embodiments of retention/connector elements with various
`
`shaped retention tabs and not having a right angle formed in
`
`the channel within the retention/connector element;
`
`Fig. 39 is a perspective view of yet another alternative
`
`embodiment of the retention/connector element which provides a
`
`right angled passageway therethrough but supports the third
`
`length of flexible tubing forwardly of the pump housing;
`
`ACTA EX. 1016-013
`
`ACTA Ex. 1016-013
`
`

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`
`12
`
`Fig. 40 is a fragmentary view mostly in vertical section
`
`taken through the front wall of the pump housing adjacent the
`
`pump rotor showing the retention/connector element of Fig. 39
`
`assembled with a peristaltic pump of the invention;
`
`Fig. 41 is a fragmentary portion of Fig. 40 further
`
`enlarged to more clearly show the flanges of the recess as
`
`well as of the retention/connector element;
`
`Figs. 42 and 43 are perspective views similar to Figs. 11
`
`and 12, respectively, of an alternative pinch valve element
`
`assembled with a length of flexible tubing and of the pinch
`
`valve element by itself;
`
`Figs. 44 and 45 are perspective views similar to Figs. 11
`
`and 12, respectively, of an alternative pinch valve element
`
`assembled with a length of flexible tubing and of the pinch
`
`valve element by itself;
`
`Figs. 46 and 47 are perspective views similar to Figs. 11
`
`and 12, respectively, of an alternative pinch valve element
`
`assembled with a length of flexible tubing and of the pinch
`
`valve element by itself;
`
`Fig. 47A is a rear View of the pinch valve element of Fig.
`
`47;
`
`Figs. 48 and 49 are perspective views similar to Figs. 11
`
`and 12, respectively, of an alternative pinch valve element
`
`assembled with a length of flexible tubing and of the pinch
`
`valve element by itself;
`
`Fig. 50 is a perspective view of a length of flexible
`
`tubing partly assembled with an alternative pinch valve
`
`ACTA EX. 1016-014
`
`ACTA Ex. 1016-014
`
`

`
`W0 97/10862
`
`PCT/US96/14741
`
`element;
`
`Fig. 51 is a perspective view of the pinch valve of Fig. 50
`
`fully assembled,
`
`the flexible tubing not being under tension;
`
`Fig. 52 is a perspective view of the flexible tubing and
`
`pinch valve of Fig. 51 with the tubing under sufficient
`
`tension to open the pinch valve;
`
`Fig. 53 is a view in front elevation of yet another
`
`alternative pinch valve element;
`
`Fig. 54 is a view in side elevation of an assembly of the
`
`pinch valve element of Fig. 53 and a length of flexible
`
`tubing,
`
`the tubing being in a relaxed state;
`
`Fig. 55 is a View in side elevation of the assembly of Fig.
`
`54 with the flexible tubing under sufficient tension to open
`
`the pinch valve;
`
`Figs. 56 and 57 are longitudinal and transverse
`
`cross—sectional views, respectively, of another form of
`
`tension responsive pinch valve in which a bent spring wire is
`
`embedded in the wall of a section of flexible tubing;
`
`Fig. 57A is a transverse cross—sectional view of another
`
`form of tension responsive pinch valve similar in mode of
`
`action to that of the pinch valve of Figs. 56 and 57, but in
`
`which the bent spring wire is bonded or adhesively attached
`
`longitudinally to the exterior of the wall of a section of
`
`flexible tubing;
`
`Fig. 58 is a fragmentary side view of an assembly of yet
`
`another form of pinch valve element with a length of flexible
`
`tubing which assembly is a tension-responsive valve;
`
`ACTA EX. 1016-015
`
`ACTA Ex. 1016-015
`
`

`
`W0 97/10862
`
`PCTIUS96/1474]
`
`14
`
`Fig. 59 is a perspective view of the front and side of an
`
`assembly apparatus which has been used to assemble a pinch
`
`valve element with a length of tubing;
`
`Fig. 60 is a perspective view of the back and side of the
`
`assembly apparatus of Fig. 59;
`
`Fig. 61 is a front elevation view of the assembly apparatus
`
`of Fig. 59;
`
`Fig. 62 is very greatly enlarged fragmentary view of the
`
`portion of Fig. 61 encircled by a dashed line;
`
`Fig.
`
`63 is a view in vertical section of the assembly
`
`apparatus taken along the line 63-63 of Fig 61;
`
`Fig. 64 is an exploded perspective view of the components
`
`of the assembly apparatus with a corner of the base plate cut
`
`away for purposes of illustration;
`
`Fig. 65 is a greatly enlarged perspective view of an
`
`ejector block which may be used as a part of a sub—assembly
`
`identified by reference character 330 in Fig. 64;
`
`Fig. 66 is a greatly enlarged perspective view of another
`
`ejector block which may be used in a modification of the
`
`sub—assembly identified by reference character 330 in Fig. 64;
`
`Fig. 67 is an enlarged exploded perspective view of some of
`
`the components of the subassembly identified by reference
`
`character 330 in Fig. 64,
`
`including the ejector block of Fig.
`
`65;
`
`Fig. 68 is an enlarged exploded perspective view of all the
`
`components of the subassembly identified by reference
`
`character 330 in Fig. 64 with the components shown in Fig. 67
`
`ACTA EX. 1016-016
`
`ACTA Ex. 1016-016
`
`

`
`W0 97/l 0862
`
`PCT/US96/1474]
`
`already assembled together;
`
`Fig. 69 is a greatly enlarged perspective view of an
`
`'L"—shaped spreader finger element showing the guide pin
`
`extending laterally from the leg portion;
`
`Fig. 70 is a very greatly enlarged partly exploded
`
`perspective view of the sub-assembly identified by reference
`
`character 330 in Fig. 64 in the process of being assembled;
`
`Fig. 71 is a very greatly enlarged perspective view of the
`
`sub-assembly identified by reference character 330 in Fig. 64;
`
`Fig. 72 is a perspective view of the reverse or inside face
`
`of the cover plate;
`
`Fig. 73 is a perspective view of the assembly apparatus
`
`with the components of a pinch valve shown in exploded view
`
`relationship about
`
`to be assembled using the assembly
`
`apparatus;
`
`Fig. 74 is a fragmentary perspective view of the assembly
`
`apparatus shown with a first tubular segment end portion of
`
`the pinch valve element oriented for placing over, i.e.,
`
`around,
`
`the fingers of the spreader finger elements;
`
`Fig. 75 is a view similar to Fig. 74 with the first tubular
`
`segment end portion of the pinch valve element slid onto the
`
`cluster of spreader fingers to commence the assembly process;
`
`Fig. 76 is a view in vertical section of the assembly
`
`apparatus like that shown in Fig. 63, but with a first tubular
`
`segment, namely a tubular end portion of the pinch valve
`
`element, emplaced over the spreader fingers as in Fig. 75;
`
`Fig. 77 is a perspective fragmentary view similar to Fig.
`
`ACTA EX. 1016-017
`
`ACTA Ex. 1016-017
`
`

`
`W0 97/10862
`
`PCT/US96/14741
`
`16
`
`75 showing the first tubular segment end portion of the pinch
`
`valve element shown in Fig. 75 stretched open radially to
`
`receive therethrough the length of tubing upon which the pinch
`
`valve element is to be telescopically assembled;
`
`Fig. 78 is a fragmentary view in section of the assembly
`
`apparatus and stretched first tubular segment end portion of
`
`the pinch valve element shown in Fig. 77, and with the length
`
`of tubing inserted into the apparatus over the central guide
`
`rod and through the cluster of spreader fingers;
`
`Fig. 79 is a front elevation of the portion of the assembly
`
`apparatus encompassed by the cover plate at the point of the
`
`assembly process illustrated in Figs. 77 and 78;
`
`Fig. 80 is a fragmentary view in section of the assembly
`
`apparatus with the tubular segment end portion of the pinch
`
`valve relaxed upon the length of tubing and with the ejector
`
`piston moved forward;
`
`Fig. 81 is a front elevation of the portion of the assembly
`
`apparatus encompassed by the cover plate at the point of the
`
`assembly process illustrated in Fig. 80;
`
`Fig. 82 is a fragmentary perspective view of assembly
`
`apparatus closely similar to that of Fig. 74 but adapted with
`
`a longer ejector block for the next stage of assembling a
`
`pinch valve assembly with the second tubular end portion of
`
`the pinch valve element oriented for placing over, i.e.,
`
`around,
`
`the spreader fingers and with the leading end of the
`
`length of tubing bent aside:
`
`Fig. 83 is a View similar to Fig. 82 showing a further step
`
`ACTA EX. 1016-018
`
`ACTA Ex. 1016-018
`
`

`
`W0 97/10862
`
`PCT/US96/14741
`
`17
`
`in the next stage of manufacturing a pinch valve assembly
`
`wherein the second tubular end portion is being emplaced on
`
`the length of tubing;
`
`Fig. 84 is a fragmentary view in section of the assembly
`
`apparatus and stretched second tubular segment end portion of
`
`the pinch valve element shown in Fig. 83, and with the length
`
`of tubing inserted into the apparatus over the central guide
`
`rod and through the cluster of spreader fingers; and
`
`Fig. 85 is a fragmentary view in section of the assembly
`
`apparatus with the second tubular segment end portion of the
`
`pinch valve relaxed upon the length of tubing and the ejector
`
`piston moved forward.
`
`DEIAILED_DESQEIEIlQN_QE_IHE_lNMENIIQN
`
`As used herein and in the claims, descriptive terms such as
`
`top, bottom, upper,
`
`lower, above, below and the like are
`
`understood to refer to a rotary peristaltic pump when the
`
`shaft upon which the pump's peristaltic rotor is mounted is
`
`oriented in a substantially horizontal position.
`
`Referring now to the drawings in which like parts are
`
`referred to by like reference numerals, and in particular to
`
`Fig.
`
`1 there is shown a rotary peristaltic pump of the present
`
`invention,
`
`indicated generally by the numeral 40, assembled
`
`with a fluid delivery set,
`
`indicated generally by the numeral
`
`42.
`
`The rotary peristaltic pump 40 is shown conveniently
`
`mounted on a conventional support pole 90, as is a supply
`
`ACTA EX. 1016-019
`
`ACTA Ex. 1016-019
`
`

`
`W0 97/1 0862
`
`PCT/US96/14741
`
`18
`
`container 91 of an enteral nutritional product.
`
`A suitable
`
`pole clamp 92 affixed to the back of pump housing 41 is best
`
`seen in top view in Fig. 6.
`
`The assembly of the peristaltic pump and fluid delivery set
`
`is shown enlarged in Figs. 2, 4, 4A, 5, 6, and 6A. The
`
`peristaltic pump is shown separately in Figs.
`
`3 and 3A.
`
`The
`
`fluid delivery set is shown separately in Figs. 9-10, and
`
`15-16.
`
`The fluid delivery set 42 provides a continuous fluid
`
`pathway from the supply container 91 of enteral or parenteral
`
`fluid to the tube or needle or other device directing the
`
`fluid into the body of the patient.
`
`while in this first
`
`embodiment a first end of the fluid delivery set is integral
`
`with a supply container,
`
`in alternative embodiments which are
`
`described herein a first end of the fluid delivery set is
`
`connectable to a supply container, and it is understood that
`
`either alternative may be employed in the practice of the
`
`invention described and claimed herein.
`
`For example, as shown
`
`in Fig. 17 a first end of the fluid delivery set may be
`
`connected to a supply container 101 using a threaded closure
`
`95, or as shown in Figs. 18 and 19 a first end of the fluid
`
`delivery set may be connected to a supply container 104, 105
`
`by penetrating a membrance in the container or its closure
`
`with a spike or cannula 103.
`
`The fluid delivery set 42 is made up of a drip chamber 43
`
`which is shown in Figs.
`
`1 and 4 partially hidden in a first
`
`retentive recess 44 formed in the *
`
`:ture of the front wall
`
`ACTA EX. 1016-020
`
`ACTA Ex. 1016-020
`
`

`
`W0 97/10862
`
`PCT/US96/14741
`
`19
`
`45 and top wall 46 of the pump housing 41. The drip chamber 43
`
`is connected at the inlet thereof to a first length 39 of
`
`flexible tubing,
`
`shown foreshortened. Preferably,
`
`the first
`
`and third lengths of flexible tubing 39, 64 are made of
`
`polyvinyl chloride (PVC) and the second length of tubing 49 is
`
`made of an elastically flexible silicone rubber. The first
`
`length 39 of flexible tubing is connectable to or integral
`
`with the outlet of a supply container and may optionally have
`
`a second drip chamber
`
`(not shown) and/or a conventional slide
`
`clamp 97 assembled therewith. The outlet of the drip chamber
`
`43 is connected to the first end 48 of a second length 49 of
`
`flexible tubing.
`
`The drip chamber 43 is also provided with a collar—like or
`
`flange—like first retention element 47 press fit or adhesively
`
`attached thereto, preferably at the upper end 43a thereof as
`
`best seen in Fig. 4A. The first length 39 of flexible tubing
`
`is attached to the retention element 47 in a telescoping
`
`interference fit relationship.
`
`The first retention element
`
`47, also referred to herein as a drip chamber retention
`
`element,
`
`shown here is rectangular and nearly square in outer
`
`shape and fits complementarily into the first retentive recess
`
`44 of the pump housing.
`
`If desired,
`
`the drip chamber
`
`retention element 47 may be made with a different geometric
`
`shape, such as a triangular or oval or trapezoidal shape, so
`
`long as the retentive recess in the pump housing is shaped
`
`complementarily to receive and retain the drip chamber
`
`retention element.
`
`ACTA EX. 1016-021
`
`ACTA Ex. 1016-021
`
`

`
`W0 97/10362
`
`PCT/US96/14741
`
`20
`
`The pump housing 41 is preferably molded from an impact
`
`resistant polymer or polymer blend such as an ABS
`
`(acrylate-butadiene-styrene) blend or ABS-polycarbonate blend.
`
`Extending from the bottom or floor 44a of the first retentive
`
`recess 44 of the pump housing is a substantially vertical
`
`guideway 50 formed

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