WORLD INTELLECTUAL PROPERTY ORGANIZATION
`lntemauonal Bureau
`
`<~ei,l'-};<~
`I
`I
`I.-
`\'.*_3'-«I-<5
`
`INTERNAT'IONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(51) International Patent Classification 5 =
`F16K 7/04
`
`(11) International Publication Number:
`
`WO 96/30679
`
`(43) International Publication Date:
`
`3 October 1996 (03.10.96)
`
`(21) International Application Number:
`
`PCI‘/US96/04096
`
`(22) International Filing Date:
`
`26 March 1996 (2603.96)
`
`(30) Priority Data:
`08/410,912
`
`27 March 1995 (2703.95)
`
`US
`
`(71) Applicant: ZEVEX, INC. [US/US]; 5175 Greenpine Drive, Salt
`Lake City, UT 84123 (US).
`
`(81) Designated States: AL, AM, AT, AU, AZ, BB, BG, BR, BY,
`CA, CH, CN, CZ, DE, DK, EE, ES, FI, GB, GE, HU, IS,
`JP, KE, KG, KP, KR, KZ, LK, LR, LS, LT, LU, LV, MD,
`MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD,
`SE, SG, SI, SK, TJ, TM, TR, TT, UA, UG, UZ, VN, ARIPO
`patent (KE, LS, MW, SD, SZ, UG), Eurasian patent (AM,
`AZ, BY, KG, KZ, MD, RU, TJ, TM), European patent (AT,
`BE, CH, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC,
`NL, PT, SE), OAPI patent (BF, Bl, CF, CG, CI, CM, GA,
`GN, ML, MR, NE, SN, TD, TG).
`
`(72) Inventors: WINTERER, Sean; 202 East 7800 South, Midvale, Published
`UT 84047 (US). DUMAS, Chris; 1288 Brisbane Drive,
`With international search report.
`Sandy, UT 84094 (US). CHILD, Michael; 5748 Honey-
`Before the expiration of the time limit for amending the
`suckle Way, Keams, UT 84118 (US). McNALLY, David,
`claims and to be republished in the event of the receipt of
`1.; 3671 E. Willow Canyon Drive, Sandy, UT 84093 (US).
`amendments.
`
`(74) Agents: THORPE, Calvin, E. et al.; Thorpe North & Western,
`L.L.P., Suite 200, 9035 South 700 East, Sandy, UT 84070
`(US).
`
`(54) Title: PINCH CLIP OCCLUDER FOR INFUSION SETS
`
`(57) Abstract
`
`A pinch clip occluder for infusion sets is disclosed including a housing and a clamp movably disposed within the housing to selectively
`occlude an infusion set. In one embodiment the clamp has at least one arm (16) which moves between first and second positions to pinch
`closed a silicone tube (86) of the infusion set unless the pinch clip occluder is held in an open position by the user, or placed in a receptable
`which will hold the pinch clip occluder in an open position. In another embodiment a plunger (230) is disposed so as to intersect a passage
`passing through the housing. As the plunger is selectively moved between first and second positions, the flow through a tube in the passage
`is selectively controlled. Such an anangement prevents a free-flow condition from occurring through the infusion set.
`
`ACTA EX. 1017-001
`
`ACTA Ex. 1017-001
`
`

`
`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 PCT.
`
`AM
`AT
`AU
`BB
`BE
`BF
`BG
`31
`BR
`BY
`CA
`CF
`CG
`CH
`CI
`CM
`CN
`CS
`CZ
`DE
`DK
`EE
`ES
`Fl
`FR
`GA
`
`Armenia
`Austria
`Australia
`Barbados
`Belgium
`Burltina Faso
`Bulgaria
`Benin
`Brazil
`Belanrs
`Canada
`Central African Republic
`Congo
`Swinerland
`Cote d'lvoire
`Cameroon
`China
`Cuchoslovakia
`Cnech Republic
`Gennany
`Denmark
`Estonia
`Spain
`Finland
`France
`Gabon
`
`United Kingdom
`Georgia
`Guinea
`Greece
`Hungary
`Ireland
`Italy
`Japan
`Kenya
`Kyrgystan
`Democraric People's Republic
`of Korea
`Republic of Korea
`Kaulrhstan
`Liechtenstein
`Sri Lanka
`Liberia
`Lithuania
`Luxembourg
`Livia
`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. 1017-002
`
`ACTA Ex. 1017-002
`
`

`
`WO 96130679
`
`PCT/US96/04096
`
`PINCH CLIP OCCLUDER FOR INFUSION SETS
`
`BACKGROUND OF THE INVENTION
`
`The present
`
`invention relates to an occluder device
`
`for
`
`the
`
`administration of
`
`enteral
`
`and/or parenteral
`
`solutions, and in particular to a pinch clip occluder for
`
`infusion sets.
`
`The use of
`
`infusion sets to administer solutions to
`
`patients is well known in the medical arts.
`
`Infusion sets
`
`are used for both enteral
`
`and parenteral applications.
`
`Enteral
`
`feeding pumps are used to provide patients with
`
`nutrition and medication when
`
`they are unable,
`
`for
`
`a
`
`variety of
`
`reasons,
`
`to
`
`eat
`
`normally.
`
`Parenteral
`
`(intravenous) solutions are provided to patients to ensure
`
`adequate hydration and
`
`to provide
`
`needed nutrients,
`
`minerals and medication. Often,
`
`the infusion set is placed
`
`in a free standing arrangement
`
`in which gravity forces the
`
`solution into the patient.
`
`The rate at which the solution
`
`enters the patient can be roughly controlled by various
`
`clamps,
`
`such
`
`as
`
`roller
`
`clamps, which
`
`are
`
`currently
`
`available on the market.
`
`In many applications,
`
`it is necessary to precisely
`
`control
`
`the amount of solution which enters the patient.
`
`When this is the case,
`
`a regulating device,
`
`such as an
`
`enteral feeding pump,
`
`is placed along the infusion set to
`
`control
`
`the rate at which the solution is fed to the
`
`patient.
`
`In applications where a pump, etc.,
`
`is used,
`
`the
`
`clamps used to regulate flow are typically manually opened,
`
`when employed,
`
`as
`
`they may
`
`interfere with the proper
`
`functioning of the pump. when used,
`
`the roller clamp may
`
`ACTA EX. 1017-003
`
`ACTA Ex. 1017-003
`
`

`
`WO 96130679
`
`PCT/US96I04096
`
`2
`
`be closed to stop flow through the infusion set with the
`
`intention that
`
`the medical personnel will momentarily
`
`connect
`
`the pump or other
`
`regulating device to the
`
`infusion
`
`set.
`
`However,
`
`emergencies
`
`or
`
`other
`
`distractions may prevent
`
`the medical personnel
`
`from
`
`properly attaching the pump or other regulating device
`
`or properly operating the clamp.
`when the infusion set is not properly positioned in
`
`free-flow often
`a situation known as
`the pump, etc ,
`develops.
`The force of gravity causes the solution to
`
`flow freely into the patient unchecked by the pump or
`
`other regulating device. Under a free-flow condition,
`
`an amount of solution many times the desired dose can be
`
`time
`supplied to the patient within a relatively short
`the
`period.
`This
`can be particularly dangerous
`if
`solution contains potent medicines and the patient’s
`
`body is not physically strong enough to adjust
`
`to the
`
`large inflow of solution.
`
`Thus,
`
`there is a need for a device that prevents a
`
`free-flow condition if the infusion set is not properly
`
`mounted in the pump or other regulating means.
`
`SUMMARY OF THE INVENTION
`
`It is an object of the present invention to provide
`
`a safety occluder for infusion sets which prevents an
`
`accidental free-flow condition.
`
`It
`
`is another object of
`
`the present
`
`invention to
`
`provide an occluder which is simple to make and use.
`It
`is another object of
`the present
`invention to
`
`provide such an occluder which is inexpensive and thus
`
`disposable.
`
`The above and other objects of
`
`the invention are
`
`realized in a pinch clip occluder biased in an occluding
`
`free-flow conditions.
`position to prevent
`embodiment of
`a pinch clip,
`the occluder‘
`
`one
`In
`includes a
`
`housing with a passage therethrough and a pinch clamp
`nestable in the housing.
`The pinch clamp includes arms
`
`which are typically biased in a closed position when no
`
`ACTA EX. 1017-004
`
`ACTA Ex. 1017-004
`
`

`
`WO 96/30679
`
`PCT/US96/04096
`
`3
`
`external force is acting thereon, but may be moved into
`
`an open/nonoccluding position by movement of
`
`the clamp
`
`relative to the housing.
`
`In another
`
`illustrated embodiment,
`
`the occluder
`
`includes
`
`a housing with a passage therethrough for
`
`receiving a delivery set.
`
`A plunger disposed along the
`
`housing is movable between two positions, one of which
`
`occludes flow through the delivery set and the other of
`
`which allows flow through the delivery set.
`
`To overcome
`
`the
`
`risk of
`
`a
`
`free—flow
`
`condition,
`
`the plunger
`
`is
`
`typically biased in an occluding position.
`
`In accordance with one aspect of the invention,
`
`a
`
`biasing member,
`
`such as a spring,
`
`is disposed between
`
`the housing and part of the plunger or pinch clamp to
`
`bias the plunger or pinch clamp in a closed position
`
`until
`
`the infusion set
`
`is properly mounted in a
`
`flow
`
`regulating device, such as an enteral feeding pump.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The
`
`above
`
`and
`
`other
`
`objects,
`
`features
`
`and
`
`advantages of the invention will become apparent from a
`
`consideration of
`
`the
`
`following detailed description
`
`presented in connection with the accompanying drawings
`
`in which:
`
`FIG.
`
`1
`
`shows a perspective/exploded view of
`
`the
`
`pinch
`
`clip
`
`occluder made
`
`in
`
`accordance with
`
`the
`
`principles of the present
`
`invention;
`
`FIG.
`
`2 shows a perspective view of the pinch clip
`
`of FIG.
`
`1 mounted in a receptacle for maintaining the
`
`pinch clip in an open position, and a fragmented view of
`
`an infusion set passing through the pinch clip;
`
`FIG.
`
`3A shows a side cross-sectional view of
`
`a
`
`pinch
`
`clip
`
`occluder made
`
`in accordance with
`
`the
`
`principles of the present invention, and disposed in an
`
`occluding mode;
`
`FIG.
`
`3B shows a side cross-sectional view of
`
`a
`
`pinch
`
`clip
`
`occluder made
`
`in accordance with
`
`the
`
`ACTA EX. 1017-005
`
`ACTA Ex. 1017-005
`
`

`
`WO 96/30679
`
`PCT/U596/04096
`
`4
`
`principles of the present
`
`invention, and disposed in a
`
`nonoccluding mode;
`
`FIG.
`
`4
`
`shows
`
`a cross-sectional view of another
`
`embodiment of the present
`
`invention.
`
`FIG.
`
`5
`
`shows
`
`a perspective View of yet another
`
`embodiment of the present
`
`invention;
`
`FIG.
`
`5A shows a side cross—sectional view of
`
`the
`
`embodiment shown in FIG. 5; and
`
`FIG.
`
`6 shows perspective view of the embodiment of
`
`the
`
`invention discussed regarding FIGs.
`
`5
`
`and
`
`SA
`
`positioned in the housing of an enteral feeding pump.
`DETAILED DESCRIPTION
`
`Reference will now be made to the drawings in which
`
`the various elements of
`
`the present
`
`invention will be
`
`given numeral designations and in which the invention
`
`will be discussed so as to enable one skilled in the art
`
`to make and use the invention. Referring to FIG.
`
`I,
`
`there is shown an exploded View of a pinch clip occluder
`
`for infusion sets, generally indicated at 2.
`
`The pinch
`
`clip 2 includes a clamp 8 having a base 12 with a flange
`
`14 around the bottom of
`
`the base.
`
`A pair of pincher
`
`arms 16 extend from the base 12 opposite the flange 14.
`
`A passage 20
`
`in the base 12 enables
`
`a
`
`tube of
`
`an
`
`infusion set, not shown,
`
`to pass through the base, and
`
`between the arms 16. The arms 16 are biased in a closed
`
`position so that a pair of heads 24
`
`(one on each arm)
`
`are sufficiently close together to occlude a tube of an
`
`infusion set passing between the heads,
`
`i.e. pinching
`
`sides of
`
`the tube of the infusion set
`
`together between
`
`the heads
`
`so that solution cannot
`
`flow through that
`
`portion of the tube.
`
`The pinch clip 2 also includes an adjustment means
`
`in the form of
`
`a housing 30
`
`formed by a generally
`
`The housing 30 is designed so that
`cylindrical wall 32.
`the clamp 8 will fit
`inside a hollow 34 extending
`
`through the housing.
`
`The hollow 34 begins at an open
`
`first end 36 of the housing 30 and terminates at an open
`
`ACTA EX. 1017-006
`
`ACTA Ex. 1017-006
`
`

`
`WO 96/30679
`
`PCT/US96/04096
`
`5
`
`second end 38 of the housing 30 in a passage 42. When
`
`the clamp 8 is nested in the housing 30,
`
`the passage 42
`
`in the
`
`second end 38 of
`
`the housing is
`
`in axial
`
`alignment with the passage 20 in the clamp.
`
`The axial
`
`alignment of
`
`the two passages
`
`20
`
`and 42 allows
`
`the
`
`tubing of
`
`an infusion set, not
`
`shown,
`
`to be passed
`
`through the pinch clip 2.
`
`The housing 30 has a pair of channels 48 formed in
`
`at least one position along the wall 32.
`
`The channels
`
`48 are designed to receive projections 52 extending
`
`outwardly from each head 24
`
`on
`
`the arms
`
`16.
`
`The
`
`channels 48 are sloped so that
`
`lower ends
`
`56 of
`
`the
`
`channels are separated from each other by about the same
`
`distance as the heads
`
`24 of
`
`the arms
`
`16 when in the
`
`biased, closed position. Thus, when the projections 52
`
`are disposed at the lower end 56 of the channels 48,
`
`the
`
`arms 16 remain in their biased state and preclude fluid
`
`from passing
`
`through
`
`an
`
`infusion
`
`set
`
`passing
`
`therethrough.
`
`The upper ends 60 of
`
`the channels 48 are disposed
`
`further apart
`
`than the lower ends 56.
`
`Thus,
`
`if the
`
`clamp 8
`
`is pushed upwardly into the housing 30 so that
`
`the projections 52 move from the lower ends 56 of
`
`the
`
`channels 48 to the upper ends 60,
`
`the projections 52,
`
`the heads 24 and thus the arms
`
`16 are forced apart,
`
`overcoming
`
`the biasing of
`
`the
`
`arms.
`
`when
`
`the
`
`projections 52 are disposed at
`
`the upper end 60 of the
`
`channels 48,
`
`the heads 24 of the clamp 8 are held apart
`
`sufficiently that
`
`fluid can flow freely through the
`
`infusion set.
`
`Also shown in FIG.
`
`1 is a spring 70.
`
`The spring 70
`
`is positioned adjacent
`
`the base 12 of
`
`the clamp 8
`
`so
`
`that
`
`the bottom of the spring rests on the base. when
`
`the clamp 8 is nested in the housing 30,
`
`the top of the
`
`spring 70 rests against a lip 76 below the channels 48.
`
`The natural bias of the spring 70 is to push the clamp
`
`8 out of the housing 30.
`
`The clamp 8, however, cannot
`
`ACTA EX. 1017-007
`
`ACTA Ex. 1017-007
`
`

`
`wo 95/30579
`
`PCTlUS96/04096
`
`6
`
`be totally pushed out of
`
`the housing 30, because the
`
`projections
`
`52
`
`catch at
`
`the lower
`
`ends
`
`56 of
`
`the
`
`channels 48.
`
`Thus,
`
`the spring 70 biases the clamp 8
`
`into a position in which the heads 24 on the arms 16
`
`will occlude an infusion set passing therethrough. When
`
`the clamp 8
`
`is pushed into the housing 30, overcoming
`
`the force of
`
`the spring 70,
`
`the arms
`
`16 will spread
`
`further apart as the projections 52 follow the channels
`
`48 to the upper ends 60.
`
`Referring now to FIG.
`
`2,
`
`there
`
`is
`
`shown
`
`a
`
`perspective view of
`
`the pinch clip 2 disposed in a
`
`receptacle 80 formed as a half cylinder.
`
`In order to
`
`place the pinch clip 2 into the receptacle 80,
`
`the clamp
`
`(disposed within the housing) must be pushed into the
`
`housing 30 sufficient for the bottom of
`
`the housing to
`
`touch the
`
`flange
`
`14,
`
`or
`
`be positioned very close
`
`thereto.
`
`When the clamp is in such a position,
`
`the
`
`projections 52 are forced to the upper ends 60 of
`
`the
`
`channels 48 so that the heads (not shown) do not occlude
`
`the
`
`infusion set
`
`86.
`
`Such
`
`a
`
`receptacle
`
`80 will
`
`typically be formed in devices such as enteral feeding
`
`pumps
`
`(not shown) which receive an infusion set, rather
`
`than being formed separately.
`
`No solution can flow
`
`through the infusion set 86 unless the pinch clip 2
`
`is
`
`properly placed in the receptacle 80.
`
`Thus, medical
`
`personnel cannot accidently create a free-flow state by
`
`forgetting to thread the infusion set
`
`86
`
`through an
`
`enteral
`
`feeding pump, because the pinch clip 2 Mull
`
`occlude flow unless properly mounted in the receptacle
`
`of
`
`the
`
`feeding
`
`pump.
`
`If
`
`the
`
`infusion
`
`set
`
`is
`
`accidentally pulled out of
`
`the pump,
`
`the pinch clip 2
`
`will automatically spring into an occluding position,
`
`thereby preventing free-flow of the solution.
`
`Those skilled in the art will recognize that each
`
`component of
`
`the pinch clip 2 and the receptacle 80
`
`could be made of numerous different materials. However,
`
`it is anticipated that the all of the structures, except
`
`ACTA EX. 1017-008
`
`ACTA Ex. 1017-008
`
`

`
`wo 95/30579
`
`PCTIUS96/04096
`
`'7
`
`the spring 70 (FIG. 1) will be made of polyvinylchloride
`
`(PVC), or polycarbonate materials which are inexpensive
`
`and easy to fabricate into the structures described.
`
`Such materials would also Amake
`
`the pinch clips
`
`2
`
`disposable.
`
`If greater durability is desired, materials
`
`such as advanced engineering plastics or metal can also
`be used.
`
`Referring now to FIG. 3A,
`
`there is shown a cross-
`
`sectional view of
`
`the pinch clip 2
`
`ljl
`
`an occluding
`
`(closed) mode in that the heads 24 of the arms 16 are in
`
`a first position in the lower ends 56 of the channels 48
`
`in the housing 30.
`
`The heads
`
`24 are close enough
`
`together so that they pinch the sidewall of the tubing
`
`86 together and prevent fluid flow therethrough.
`
`The
`
`clamp 8 is held in this position by the spring 70 which
`
`is fully extended.
`
`Also shown in FIG. 3A is an adapter 90 which has a
`
`first connector 94 for fitting within the tubing 86, and
`
`a second connector 98 to fit around the tubing 102.
`
`The
`
`adapter 90 nests within the base 12 of the clamp 8.
`
`Typically, an infusion set, such as that used with
`
`enteral feeding pumps, will have a pair of long sections
`
`of
`
`tubing formed from a material
`
`such as PVC,
`
`and an
`
`interspaced section of tubing made of silicone.
`
`In the
`
`present
`
`discussion,
`
`the
`
`tubing
`
`86
`
`represents
`
`the
`
`silicone tubing and the tubing 102 typically represents
`
`the proximal
`
`PVC tubing positioned upstream from an
`
`enteral feeding pump.
`
`The silicone tubing 86 is used to
`
`pass
`
`through
`
`an
`
`enteral
`
`feeding pump
`
`because
`
`it
`
`withstands the flexing and pulling of
`
`the pump rotor
`
`better than does the PVC tubing 102.
`
`An adapter,
`
`such
`
`as adapter 90,
`
`is used to connect the silicone tubing 86
`
`to each segment of PVC tubing 102.
`
`Referring now to FIG.
`
`3B there is shown a side
`
`cross-sectional View of
`
`the pinch clip 2
`
`in which the
`
`clamp 8 is forced into the housing 30.
`
`As the clamp 8
`
`moves into the housing 30,
`
`the heads 24 of the arms 16
`
`ACTA EX. 1017-009
`
`ACTA Ex. 1017-009
`
`

`
`WO 96/30679
`
`PCT/US96/04096
`
`8
`
`are forced apart by the channels 48,
`
`so that
`
`the arms
`
`are held in a second, open position.
`
`This leaves the
`
`silicone tube 86 unrestricted by the heads 24,
`
`thereby
`
`allowing solution to flow freely through the tube.
`when the clamp 8
`is held in the housing 30,
`
`in FIG.
`shown
`is
`compressed as
`is
`spring 70
`However,
`to maintain the position shown in FIG. 3B,
`
`the
`
`3B.
`the
`
`pinch clip 2 would be placed into a receptacle as shown
`in FIG. 2, or some other force must be applied to keep
`
`the
`clamp
`8 positioned so
`that
`the housing 30
`is
`adjacent
`the flange 14 of
`the base 12.
`Thus,
`if the
`pinch clip 2 accidently comes out of the receptacle,
`the
`spring 70 will force the clamp 8 away from the housing
`30 and into the position shown in FIG. 3A.
`The silicone
`
`tube
`
`86 will
`
`thereby be occluded,
`
`and a
`
`free—flow
`
`situation cannot develop.
`
`As was discussed regarding FIG. 3A,
`
`the adapter 90
`
`nests in the base 12 of
`
`the clamp 8 and connects the
`
`silicone tube 86 with the PVC tube 102. While this is
`
`a convenient place to make the transition between the
`
`silicone tube 86 and the PVC tube 102,
`
`the change could
`
`be made at any other place along the infusion set.
`
`Referring now to FIG.
`
`4,
`
`there
`
`is
`
`shown
`
`an
`
`alternate embodiment of
`
`the present
`
`invention.
`
`The
`
`pinch clip 120 includes a housing 130 with a single
`channel 134
`formed therein.
`As with the embodiment
`
`shown in FIGS. 1-3B,
`
`the housing 130 has an open first
`
`end 138
`
`for containing a
`
`silicone tube
`
`142.
`
`The
`
`opposing second end 146 is likewise open for receiving
`the clamp 150.
`The clamp 150 has a base 154 with a
`flange 158 and a passage 162 therethrough, similar to
`the embodiment discussed with respect
`to FIGS.
`1—3B.
`
`However,
`
`instead of
`
`a pair of
`
`arms
`
`(such as
`
`those
`
`indicated at 16 in FIGs. 1,
`
`3A and 3B)
`
`the embodiment
`
`shown in FIG.
`
`4 has a single resilient arm 170 which
`
`extends from the base 154.
`
`A head 174 of the arm 170 is
`
`moveable between a first, closed position in which the
`
`ACTA EX. 1017-010
`
`ACTA Ex. 1017-010
`
`

`
`WO 96/30679
`
`PCT/US96/04096
`
`9
`
`head occludes flow through the tube 142 and a second,
`
`open position (shown in FIG.
`
`4)
`
`in which the head is
`
`moved
`
`away
`
`from the
`
`tube
`
`so
`
`as
`
`to
`
`allow flow
`
`therethrough.
`
`A spring 180 is provided to move the base
`
`150 away from the housing 120 and to force the head 174
`
`into the first, closed position.
`
`When force is applied to the clamp 150 so as to
`
`move the clamp into the housing 130,
`
`the head 174 is
`
`pushed away from the tube so as to allow fluid flow
`
`therethrough. Thus,
`
`the embodiment disclosed in FIG.
`
`4
`
`prevents solution flow through the tube 142 by pinching
`
`the tube between the arm 170 and a sidewall 186 the side
`
`of
`
`the housing 130,
`
`as opposed to a pair of arms as
`
`discussed above.
`
`As with the previous embodiment,
`
`the base 154 of
`
`the clamp 150 will
`
`typically have a hollow 190
`
`for
`
`receiving an adapter 196.
`
`The adapter 196 enables the
`
`silicone tube 142 to be connected to a PVC tube 200.
`
`Each of
`
`the components shown in FIG. 4, with the
`
`exception of
`
`the spring 180,
`
`the silicone tube 142 and
`
`the PVC tube 200 will
`
`typically be made of a thermo-
`
`setting plastic material which is semi-resilient.
`
`Such
`
`materials are inexpensive and inherently disposable.
`
`Referring now to FIG. 5,
`
`there is shown another
`
`embodiment of
`
`the present
`
`invention.
`
`The pinch clip
`
`occluder, generally indicated at 200,
`
`includes a housing
`
`204 having a first end 208 and a second end 212.
`
`A
`
`passage 218 extends along a long axis of the housing 204
`
`from an opening 222 in the first end 208 to an opening
`
`(not
`
`shown)
`
`in the second end so as
`
`to enable the
`
`placement of
`
`a
`
`tube front a delivery set within the
`
`passage 218.
`
`The pinch clip occluder 200
`
`further
`
`includes
`
`a
`
`plunger 230 disposed so as to intersect the passage 218.
`
`Preferably,
`
`a
`
`long axis of
`
`the plunger 230 will be
`
`perpendicular to the long axis of
`
`the housing 204 and
`
`the passage 218.
`
`The plunger 230 includes a plunger
`
`ACTA EX. 1017-011
`
`ACTA Ex. 1017-011
`
`

`
`WO 96/30679
`
`PCT/US96l04096
`
`10
`
`passage 234 disposed therein. when the plunger passage
`234 and the housing passage 218 are in alignment, fluid
`flow is allowed through.
`a delivery set
`(not
`shown)
`extending through the housing 204.
`When the plunger
`passage 234
`and the housing passage 218 are not
`in
`alignment,
`as
`shown in exaggeration in FIG.
`5,
`flow
`through the delivery set is prevented as the tubing of
`the delivery set becomes pinched between the plunger 230
`and an inner wall 240 of
`the housing 204 and a wall
`defining the opening (not shown) at the second end 212.
`Referring now to FIG. 5A,
`there is shown a cross-
`sectional View of the pinch clip occluder 200 discussed
`regarding FIG. 5, as well as a fragmented tube 250 of a
`delivery set. The tube 250 is positioned in the passage
`218 to extend along the passage 218. The plunger 230 is
`positioned in the housing 204 adjacent
`the second end
`212 so that the plunger passage 234 is in alignment with
`the housing passage 218.
`Thus,
`flow through the tube
`250 of the delivery set is not occluded.
`
`the tube 250 has a silicone
`5A,
`shown in FIG.
`As
`section
`a
`250a
`section
`and
`250b
`made
`of
`polyvinylchloride (PVC) or some other suitable material.
`An adapter 252 nests in the opening 222 and connects the
`two sections 250a and 250b together.
`Those familiar
`with delivery sets for use with enteral
`feeding pumps
`and the like will be familiar with such tubes.
`For
`the plunger 230 to be in such a position in
`normal usage,
`some external
`force would need to force
`the plunger downwardly,
`as
`a
`spring 260 biases the
`plunger passage 234 into a position not
`in alignment
`with the housing passage 218.
`Thus, when no external
`pressure is applied to the plunger 230,
`the spring 260
`forces a bottom wall 238 defining the plunger passage
`234 upward so as to pinch closed the tube against an
`upper wall 270 defining an orifice or opening 274 in the
`second end 212,
`and an upper wall
`278 defining an
`orifice or opening 280
`in the inner wall 240.
`The
`
`ACTA EX. 1017-012
`
`ACTA Ex. 1017-012
`
`

`
`WO 96/30679
`
`PCT/US96I04096
`
`ll
`
`tubing 250 through the plunger passage 234 prevents the
`
`spring 260 from displacing the plunger 230 out of
`
`the
`
`housing 204, and an upper stop 294 prevents the plunger
`
`passage 234 from passing beyond an alignment position
`
`with the housing passage 218.
`
`The upper knob 296
`
`disposed above the stop 294 and the lower knob 298 are
`
`of similar dimensions so that the housing may be placed
`
`in an enteral feeding pump upside down from the position
`
`shown
`
`in
`
`FIGs.
`
`5
`
`and
`
`SA,
`
`without
`
`affecting
`
`functionality.
`
`Referring now to FIG. 6,
`
`there is shown a pinch
`
`clip occluder 200 disposed in the housing 300 for an
`
`enteral feeding pump.
`
`The enteral feeding pump housing
`
`300 includes a pair of channels 310 and 314 for holding
`
`a delivery set tube, such as tube 250 discussed in FIG.
`
`5A.
`
`In use,
`
`the tube is placed in one channel 310,
`
`wrapped about a motor unit
`
`(not shown) which is placed
`
`in the opening 320, and then positioned in the second
`
`channel 314.
`
`If the tube is not properly wrapped about
`
`the motor unit and placed in the channels 310 and 314 a
`
`free—flow condition may develop. However,
`
`the present
`
`invention prevents such a situation from developing.
`
`As shown in FIG. 6,
`
`the pinch clip occluder 200 is
`
`positioned along the channel 310.
`
`The plunger 230 is
`
`positioned so as to occlude flow through a tube disposed
`
`in the channel 310.
`
`To overcome
`
`the biased. closed
`
`position of the plunger 230, an external force must be
`
`applied. This is typically done by closing a cover 330
`
`which is connected to the housing 300. When closed,
`
`the
`
`cover 330 applies downward force on the plunger 230 so
`
`that the plunger passage 234 and the housing passage are
`
`in alignment. However,
`
`if the tube of the delivery set
`
`is not properly loaded in the channels 310 and 314,
`
`the
`
`cover
`
`is unable to close and the plunger 230 is not
`
`forced downwardly.
`
`Thus,
`
`the pinch clip occluder 200
`
`prevents flow through the enteral
`
`feeding pump unless
`
`the delivery set is properly loaded. Once the cover 330
`
`ACTA EX. 1017-013
`
`ACTA Ex. 1017-013
`
`

`
`WO 96130679
`
`PCTIUS96/04096
`
`l2
`
`is
`
`closed,
`
`the enteral
`
`feeding pump may
`
`function
`
`normally.
`
`In the manner described, a pinch clip occluder for
`
`delivery sets is provided.
`In one embodiment,
`the pinch
`clip occluder utilizes a clamping mechanisnl with at
`least one arm nested at least partially within a housing
`
`which serves as an adjustment mechanism by moving the
`
`arm between a position in which the arm occludes flow
`
`and a position in which it
`through and infusion set,
`allows free-flow through the infusion set.
`In another
`
`embodiment,
`
`a moveable plunger which has
`
`a plunger
`
`passage alignable with a housing passage occludes flow
`through the housing unless
`an external pressure is
`
`applied.
`It
`
`is to be understood that
`
`the above-described
`
`arrangements are only illustrative of the application of
`
`the principles of
`modifications
`and
`
`the present
`alternative
`
`Numerous
`invention.
`arrangements may
`be
`
`devised by those skilled in the art without departing
`
`from the spirit and scope of the present invention.
`
`The
`
`appended claims are intended to cover such modifications
`
`and arrangements.
`
`ACTA EX. 1017-014
`
`ACTA Ex. 1017-014
`
`

`
`WO 96/30679
`
`PCT/US96/04096
`
`13
`
`CLAIMS
`
`What is claimed is:
`
`1.
`
`Apparatus
`
`for selectively controlling flow
`
`through one or more tubes of an infusion delivery set,
`
`the apparatus comprising:
`
`a pump housing having:
`
`at
`
`least one channel disposed therein for
`
`receiving a tube of the delivery set,
`
`a cover means
`
`for holding the tube of
`
`the
`
`delivery set within the housing,
`
`the cover means
`
`having an open position wherein the delivery set
`
`can be removed from the at
`
`least one channel, and
`
`a closed position, wherein the delivery set cannot
`
`be removed from the at least one channel, and
`
`a
`
`void
`
`formed
`
`therein for
`
`receiving an
`
`occluder means;
`
`an occluder means nestable within the void in the
`
`housing,
`
`the occluder means comprising:
`
`an occluder housing having an open first end
`
`and an open second end and a passage therethrough
`
`extending from the open first
`
`end to the open
`
`second end for receiving the tube of the delivery
`
`set;
`
`flow restriction means disposed at least partially
`
`within the housing and moveable between a first position
`
`in which the
`
`flow restriction means occludes
`
`flow
`
`through the tube of
`
`the delivery set
`
`and a
`
`second
`
`position in which the flow restriction means does not
`
`occlude flow through the tube; and
`
`biasing means disposed adjacent the housing and the
`
`flow restriction means for biasing the flow restricting
`
`means into the first position; and
`
`wherein the cover means is disposed to contact and
`
`move the flow restriction means into the second position
`
`when the cover means is moved into the closed position.
`
`ACTA EX. 1017-015
`
`ACTA Ex. 1017-015
`
`

`
`W0 96/30679
`
`PCT/US96/04096
`
`14
`
`2.
`
`The apparatus of claim 1, wherein the flow
`
`restriction means comprises at
`
`least one arm slidably
`
`movable between a first position in which the at least
`
`one
`
`arm pinches
`
`the
`
`tube
`
`so
`
`as
`
`to prevent
`
`flow
`
`therethrough,
`
`and a
`
`second position in which the at
`
`least one arm no longer pinches the tube.
`
`3.
`
`The apparatus of claim 1, wherein the flow
`
`restriction means comprises a plunger having a plunger
`
`the plunger being movable between
`passage therethrough,
`a first position in which the plunger passage is not
`in
`
`to
`the housing so as
`alignment with the passage of
`occlude
`flow through the
`tube passing through the
`
`passage of the housing, and a second position in which
`the plunger passage is in alignment with the passage of
`the housing so as to allow flow though said tube passing
`
`through the passage of the housing.
`
`4.
`
`The
`
`apparatus
`
`of
`
`claim 1, wherein
`
`the
`
`occlusion means further comprises an adapter disposed
`
`the occluder housing for connecting two tube
`adjacent
`sections of
`a delivery set,
`one of
`said two
`tube
`
`sections being at
`
`least partially disposed in the
`
`occluder housing.
`
`5.
`
`The apparatus of claim 1, wherein the at least
`
`one channel
`
`in the pump housing defines a passage, and
`
`wherein the passage
`of
`the occluder means
`is
`in
`alignment with the passage of the pump housing when the
`occluder means is nested in the pump housing.
`
`6.
`The
`apparatus
`of
`claim 5, wherein
`the
`apparatus comprises means for precluding flow through
`the delivery set when the passage of the occluder means
`is not
`in alignment with the passage of
`the pump
`
`housing.
`
`ACTA EX. 1017-016
`
`ACTA Ex. 1017-016
`
`

`
`WO 96/30679
`
`PCTIUS96l04096
`
`l5
`
`7.
`
`The apparatus of claim 1, wherein the flow
`
`restriction. means comprises
`
`a plunger having a
`
`long
`
`axis, and wherein the occluder housing has a long axis
`
`disposed perpendicular to the long axis of the plunger.
`
`8.
`
`The apparatus of claim 7, wherein the passage
`
`in the occluder means has a long axis which is disposed
`
`generally perpendicular to the plunger.
`
`9.
`
`The apparatus of claim 1, wherein the pump
`
`housing has
`
`a pair of channels disposed therein for
`
`holding the delivery set.
`
`10.
`
`An apparatus for preventing free flow in a
`
`tube of
`
`a delivery set when used with a pump,
`
`the
`
`apparatus comprising:
`
`a pump housing means
`
`for holding a
`
`tube of
`
`the
`
`delivery set,
`
`the pump housing means having at least one
`
`channel disposed therein for receiving the tube, and a
`
`cover means for selectively holding the tube within the
`
`at
`
`least one channel,
`
`the cover means having an open
`
`position wherein the tube can be removed from the at
`
`least channel, and a closed position, wherein the tube
`
`is held within the at least one channel;
`
`occluder means
`
`for
`
`selectively preventing flow
`
`through the tube,
`
`the occluder means comprising:
`
`an occluder housing having an open first end,
`
`an open second end and a passage extending from the
`
`open first end to the open second end for holding
`
`a tube of an infusion set; and
`
`plunger means disposed generally transverse to
`
`the passage of the occluder housing for selectively
`
`occluding flow through the tube,
`
`the plunger means
`
`comprising a plunger passage movable between a
`
`first position wherein the plunger passage is not
`
`in alignment with the passage through the occluder
`
`housing so as to occlude flow through the tube, and
`
`ACTA EX. 1017-017
`
`ACTA Ex. 1017-017
`
`

`
`WO 96130679
`
`PCT/US96I04096
`
`16
`
`a second position wherein the plunger passage is in
`alignment with the passage through the occluder
`housing so as to allow flow through the tube; and
`wherein the cover means
`is disposed so that when
`
`the cover means is moved into the closed position,
`
`the
`
`cover means contacts and moves
`
`the plunger means
`
`from
`
`the first position, wherein the plunger passage is not
`in alignment with the passage through the occluder
`housing,
`to the second position, wherein the plunger
`passage is in alignment with the passage through the
`
`occluder housing.
`
`11.
`
`The
`
`apparatus
`
`of
`
`claim 10, wherein
`
`occluder‘ means
`
`further comprising biasing means
`
`biasing the plunger means into the first position.
`
`the
`
`for
`
`12.
`
`The
`
`apparatus
`
`of
`
`claim 10, wherein
`
`the
`
`occluder housing comprises at least one wall defining an
`
`the passage adjacent the plunger
`orifice disposed about
`means
`such that when the plunger means
`is disposed
`
`within the first position,
`
`the tube extending through
`
`the occluder housing and the plunger
`the passage of
`passage is pinched between the plunger and the at least
`one wall so as to prevent flow through the tube.
`
`the
`claim 10, wherein