lllllllllllllllllIlllllllllllllllllllIllll||l||||1||||||l|l||||llllllllllll
`US005300044A
`_
`’
`[11] Patent Number:
`5,300,044
`United States Patent
`[45] Date of Patent:
`Apr. 5, 1994
`Classey et al.
`___________________________________________________________
`
`[19]
`
`7/1984 Soinerville et a1.
`4.460.358
`.
`4,524,802 6/1985 Lawrence et a1..
`4,533,347
`3/1955 Decker! ............................... 504/250
`4,585,441
`4/1935 Archibald .
`4,525,591
`5/1935 Kozlow .
`4,689,043
`8/1987 Bisha .
`4,818,190 4/1989 Pelmulder et al.
`4,857,050 8/1989 Lentz et a1.
`.
`4,925,152 5/1990 Huber .................................... 604/67
`4,978,335 12/I990 Arthur’ In ‘
`4,993,455 2/1991 Sulis ........................................ 251/7
`5,017,192
`5/1991 Dodge et a1..
`5,039,279
`8/1991 Natwick et al..
`5,219,327 5/1993 Okada ................................. 504/250
`5,221,268
`5/1993 Barton et a1.
`....................... 504/250
`
`.
`
`Primary Examiner—-Paul J. Hirsch
`Atmmey, Agent’ -0,. F,-,,,,__.\v0od, phmips, vansanten’
`Hoffman & End
`
`[54]
`1751
`
`INTRAVENOUS TUBE SAFETY APPARATUS
`I‘“’°‘“°“‘ D°"‘“ 5- C"9‘°Yv w““k‘8‘“‘9
`1'55"“ 911101 ROW1 Lake 1368011:
`Kenneth Lynn. Mcfienry; John
`McVey, Lake Zurich; Eric Myren,
`Barrington; Gabriel Vehovsky,
`Mcflenfy, all of I]1_
`,
`BIXtCl' IIItCI'flItIOnIl IlIC.,
`111-
`.
`21 A _N _, 45
`1291
`[
`1
`pp]
`0
`[22] Filed:
`Apr. 12. 1993
`Related U.S. Application Data
`
`.
`ASSIEHCCI
`
`[60]
`
`[55]
`
`Division of Ser. No. 884,498, May 15, 1992, which is a
`continuation-in-part of Ser. No. 826,273, Jan. 17, 1992,
`which is a continuation of Ser. No. 765,755, Sep. 26,
`ABSTRACT
`[57]
`1991, abandoned.
`The present invention provides an apparatus for use in
`Int. Cl.5 ............................................... A6lM 5/00
`[51]
`a peristaltic pump 20 which prevents an inadvertent free
`[52] U.S. C1. .................................... 604/250; 25 1/7;
`flow condition prior to loading or after removal of an
`604/256
`I.V. tube 26 in the peristaltic pump 20 and which also
`[58] Field of Search ................... 604/250, 256, 65, 67;
`prevents the inadvertent occlusion of a loaded I.V. tube
`251/7; 128/DIG. 12, DIG. 13
`1216 in tit: pei'1stalt11<:£umcp %0.dAthstandar%1.V. tubet26
`References Cited
`a
`1
`c
`r
`e
`.
`at
`s
`,
`inacfludses £1 I.a\I’I.l1t3ube ggooyrle 2:9 int:r\s?l11ich tlfeallig/'. tziillale
`U'S- PATENT DOCUMENTS
`26 is positioned, a slide clamp receiving area 62 into
`13,200,729 3/1955 coanda _
`which the slide clamp 109 is inserted, and a biased slid-
`D. 230,729
`3/1974 Zeddies .
`ing member 81 which the inserted slide clamp 109 en-
`D- 233.312 10/1974 Lock -
`gages such that the I.V. tube 26 cannot be loaded into
`l1:1_11l1§1‘
`-
`‘
`'
`‘
`,
`,
`18
`S .
`i"{’»‘,‘Il?§‘é"1‘1‘.}’s1°~'1.‘.§"",‘i‘,§§f 1‘§‘3f,f1'3?§1,‘o°3,§,°.f,“,i?‘iL‘EJ,"§
`W905 W55 029-
`d’
`1
`p
`{bl
`.th th
`t
`hp .
`2,775,240 12/1956 Morrissey, Jr. et al.
`si ec amp
`,conipa 1 e.w1
`e appar-a us .av1n_ga
`2,889,848
`6/1959 Redmer _
`surface pad 125 for facilitating automated identification
`3,167,299
`1/1965 Ling _
`of the slide clamp _109, in cooperation with a nonob-
`3,316,935
`5/1957 Kaiser gt ,1],
`structive sensor 85 in the safety apparatus. The present
`3,357,674 7/1963 Coanda et al,
`invention further contemplates a slide clamp 109'. hav-
`3,374,509 3/1968 Logan et al.
`ing an I.V. tube receiving aperture l10’with an inner
`3,612,475 10/1971 Dinser -
`3,?§;,gig
`gnuteé:................................ 250 diameter profile
`rninixnizes friction between I_V_
`,
`,
`aisan ier .
`-
`6
`I
`4-W62 5/1979 Jess -
`13° §,‘?,'L“‘$‘é‘?f,?§I1’fZi?.‘,3i',,e°‘{J3?,122$‘$13125,2‘;
`4,248,401 2/1981 Mittleman .
`'
`'
`,
`.
`.
`.
`4 307 869 12/198] Mimeman
`aperture 110 and which has a surface pad 125 for facili-
`4,367,-,36
`1/1983 Gupta" _
`tatrng automated identification of the slide clamp.
`4,434,963
`3/1984 Russell .
`
`.
`
`.
`
`_
`
`.
`
`4,439,179
`
`3/1984 Lueders et al.
`
`.
`
`15 Claims, 13 Drawing Sheets
`
`ACTA EX. 1015-001
`
`ACTA Ex. 1015-001
`
`

`
`U.S. Patent
`
`Apr. 5, 1994
`
`Sheet 1 of 13
`
`5,300,044
`
`ACTA EX. 1015-002
`
`ACTA Ex. 1015-002
`
`

`
`4...Hef.3P.
`
`.
`
`«MU
`
`Sheet 2 of 13
`
`5,300,044
`
`3
`
`Iin
`
`ACTA EX. 1015-003
`
`ACTA Ex. 1015-003
`
`

`
`U.S. Patent
`
`Apr. 5, 1994
`
`Sheet 3 of 13
`
`5,300,044
`
`ACTA EX. 1015-004
`
`ACTA Ex. 1015-004
`
`

`
`
`
`Ch.was:mus..aEm.u8.e.3
`
`ACTA Ex. 1015-005
`
`

`
`>2.u.69.mus.uanSm.u8.et
`
`ACTA Ex. 1015-006
`
`

`
`cm.waaa>2.m.GE.mu»:m3.5m.u8.ot
`
`ACTA Ex. 1015-007
`
`

`
`
`
`vast‘sadv1:19:33'5'[1
`
`MH
`
`‘
`.8;
`~l
`
`O-
`
`5H0
`
`3
`
`ACTA Ex. 1015-008
`
`

`
`
`
`#661‘sudv1II818J‘ST;
`
`U)
`B"
`8«-9
`
`Q 9
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`O)
`
`vvo‘oo£‘s
`
`V
`
` &.\\\\\".& :\4+ ,5I \-/
`
`ACTA Ex. 1015-009
`
`

`
`cm.wuss.>2.u.332.8.uan3m.u8.o.R
`
`ACTA Ex. 1015-010
`
`

`
`Sheet 10 of 13
`
`§||
`
`4
`'
`171
`VIIIIJVIIIIIIIIIII
`
`E?‘
`- l‘“‘~
`
`.
`
`ACTA EX. 1015-011
`
`ACTA Ex. 1015-011
`
`

`
`U.S. Patent
`
`Sheet 11 of 13
`
`5,300,044
`
`F | 5. ed
`
`§||;\\\\\.\\V
`
`94
`
`92
`
`II
`§||§
`
`Aucé
`
`77//17//I//IIIIIIIIIIII/IIIAH
`
`§||s\\\.\\\\“
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`Z///17////I/[III/171/I//Iizl
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`V
`
`
`
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`
`87
`
`81 am
`1
`
`/.Z4 IIln:vIIla-
`
`165
`
`ACTA EX. 1015-012
`
`ACTA Ex. 1015-012
`
`

`
`Sheet 12 of 13
`
`5,300,044
`
`1
`
`I
`
`ACTA EX. 1015-013
`
`ACTA Ex. 1015-013
`
`

`
`U.S. Patent
`
`Apr. 5, 1994
`
`Sheet 13 of 13
`
`5,300,044
`
`ACTA EX. 1015-014
`
`ACTA Ex. 1015-014
`
`

`
`1
`
`5,300,044
`
`INTRAVENOUS TUBE SAFETY APPARATUS
`
`5
`
`’ CROSS-REFERENCE
`
`This application is a divisional application of Ser. No.
`884,498 filed May 15, 1992; which application is a con-
`tinuation-in-part of Ser. No. 826,273 filed Jan. 17, 1992;
`which application is a continuation of Ser. No. 765,755
`filed Sept. 26, 1991, now abandoned.
`
`FIELD OF THE INVENTION
`
`The present invention relates in general to clamps
`used to control the flow of medical fluid to an I.V.
`tubing and, in particular, to a safety apparatus utilized in
`a peristaltic intravenous infusion pump.
`BACKGROUND OF THE INVENTION
`
`Administration of intravenous fluids to a patient is
`well known in the art. Typically, a solution such as
`saline, glucose or electrolyte in a glass or flexible con-
`tainer is fed to a patient’s venous access site via a length
`of flexible plastic ‘I.V. tubing such as polyvinyl chloride
`(PVC) tubing. The rate of flow of the fluid is controlled
`by a roller clamp which is adjusted to restrict the flow
`lumen of the I.V. tubing until the desired flow rate is
`obtained.
`
`25
`
`Flow from the container to the patient may also be
`regulated by means other than a roller clamp. It is be-
`coming more and more common to use an electroni-
`cally controlled pump. One type of pump that is used
`for intravenous fluid administration is a peristaltic-type
`Pump-
`
`Use of peristaltic pumping action is particularly well
`suited for the medical field. This is because peristaltic
`pumping action can be applied externally of the I.V.
`tubing carrying the intravenous fluid. This maintains
`the sterile condition of the intravenous fluid within the
`I.V.
`tubing while imparting fluid propulsion on the
`fluid. The peristaltic pumping action can also be applied
`on any point on the I.V. tubing.
`In a common type of peristaltic pump used in the
`medical field, a driving motor is connected to an array
`of cams which are angularly spaced from each other.
`The cams in turn drive cam followers which are con-
`nected to corresponding pressure fingers. These ele-
`ments cooperate to impart a linear wave motion on the
`pressure fingers. A pressure plate is secured juxtaposed
`to and spaced from the pressure fingers. The pressure
`plate holds the I.V. tubing against the reciprocating
`pressure fingers to impart the wave motion on the I.V.
`tubing to propel the fluid.
`In another common type of peristaltic pump used in
`the medical field, a driving motor is connected via an
`armature to at least one roller member. The driving
`motor imparts a circular rotation on the armature which
`actuates the roller member. A semicircular pressure
`platehaving the same center point as the armature is
`provided with the I.V. tubing located between the rol-
`ler member and the pressure plate. The pressure plate
`holds the I.V. tubing against the roller member which
`imparts a circular motion on the I.V. tubing to propel
`the fluid.
`
`One drawback of the use of peristaltic pumps is that,
`because when loaded into the pump the peristaltic ac-
`tion drives the propulsion of the fluid, prior to loading
`into the pump, the I.V. tubing is often left in an open
`condition. While a straightforward solution to this
`problem is to simply provide a roller or other flow
`
`2
`clamp on the I.V. tubing to occlude the I.V. tubing
`prior to loading and after removal, this creates the pos-
`sibility that the health care professional loading the I.V.
`tubing into the peristaltic pump will forget to open the
`I.V. tubing after loading has been completed. While a
`solution which includes a dedicated flow clamp and
`housing which is loaded into the peristaltic pump has
`been provided,
`this solution has several drawbacks,
`including the dedicated use of such a flow clamp assem-
`bly for a select peristaltic pump and the ease in which
`the locking mechanism can be bypassed manually by a
`health care professional. Moreover, because this solu-
`tion employs a dedicated slide clamp, health care pro-
`fessionals must take care to remove the slide clamp
`before disposal of the I.V. tubing.
`Prior art slide clamps generally include a regulating
`aperture defining an occluding slot and a non-occluding
`passage. An I.V. tube inserted through the regulating
`aperture in an operative position is slidable transverse to
`the length of the tube between the non-occluding pas-
`sage and the occluding slot to control the flow of fluid
`through the lumen of the I.V. tube. With the I.V. tube
`in an operative position in the non-occluding passage,
`prior art slide clamps tend to slide longitudinally of the
`I.V. tube under the effect of gravity. Often, this sliding
`makes it difficult and cumbersome for medical person-
`nel to quickly locate the slide clamp to occlude flow at
`a desired position along the length of the I.V. tube. In
`addition, the tube contacting surface of the flow regu-
`lating aperture typically extends over the entire depth
`of the slide clamp. As a result, prior art slide clamps
`leave a relatively wide surface contacting an I.V. tube
`in an operative position, providing a significant fric-
`tional force opposing sliding of an I.V. tube relative to '
`the slide clamp between the non-occluding passage and
`the occluding slot. Both of these features make it rela-
`tively difficult to use prior art slide clamps with a safety
`mechanism for use in a peristaltic pump. First, it can be
`difficult for a health care professional to locate the slide
`clamp for insertion into a slide clamp receiving slot in
`the peristaltic pump and second, once inserted, prior art
`slide clamps may offer too much frictional resistance for
`the safety apparatus to drive the slide clamp between
`the occluded slot and the non-occluding passage.
`What would thus be advantageous would be a safety
`mechanism for use in a peristaltic pump which utilizes a
`disposable I.V. slide clamp carried by I.V. tubing which
`can be located longitudinally of the tube and not dis-
`placed solely by force of gravity and which can be slid
`between a non-occluding passage and an occluded slot
`with minimal force. The safety mechanism would pref-
`erably prevent both an inadvertent free flow condition
`prior to loading or after removal of an I.V. tube in a
`peristaltic pump and prevent inadvertent occlusion of a
`loaded I.V. tube.
`
`’
`
`SUMMARY OF THE INVENTION
`
`The present invention provides an apparatus for use
`in a peristaltic pump which prevents an inadvertent free
`flow condition prior to loading or after removal of an
`I.V. tube in a peristaltic pump and which also prevents
`the inadvertent occlusion of a loaded I.V. tube in a‘
`peristaltic pump. The present invention includes a stan-
`dard I.V. tube having a slide clamp provided thereon.
`The apparatus includes an I.V. tube groove into which
`the I.V. tubing is positioned, a slide clamp receiving
`area into which the slide clamp is inserted, and a biased
`
`ACTA EX. 1015-015
`
`ACTA Ex. 1015-015
`
`

`
`5,300,044
`
`5
`
`15
`
`4
`sn I.V. tube. The clamp includes a body and means on
`the body for captively receiving an outer surface of an
`I.V. tube in an operative position. A clamp is provided
`on the body for collapsing an outer surface of an I.V.
`tube in an operative position to thereby selectively oc-
`clude and not occlude a flow lumen of the I.V. tube. A
`structure is provided on the body for facilitating auto-
`mated identification of the clamp.
`The automated identification structure may be a sur-
`faeepadwhichreflectsaselectedportionofabeamof
`lightshinedontothepad.Anopticalsensorisableto
`identify the slide clamp based upon the reflected por-
`tionofthebeamoflight.Theclampcanbeincombina-
`tion with an optical identifying structure including a
`lamp omitting a selected beam oflight, the beam oflight
`beingdirectedontot.hesurfscepad.Thesurfacepad
`absorbsaportionofthebeamoflightsndreflectsa
`portion of the beam of light. An optical sensor receives
`the reflected portion of the beam of light, the optical
`sensorbeinginafirststateinresponsetoreceivingthe
`selected portion of the beam of light and a second state
`in response to not receiving the selected portion of the
`beam of light. An indicator operatively associated with
`the optical sensor indicates whether the optical sensor is
`in the first or second state.
`
`3
`sliding member which the inserted slide clamp engages
`such that the I.V. tubing cannot be loaded into the
`apparatus without the slide clamp occluding the I.V.
`tubing.
`The sliding member includes a cam portion which
`interacts with a cam follower on a pair of retainer arms
`which causes the retainer arms to pivot into an open
`position. Upon completing the loading of the slide
`clamp and I.V. tubing, the peristaltic pumping door is
`closed which (1) secures the I.V. tubing in the I.V. tube
`groove, 2) disengages the loaded sliding mber which
`forces the slide clamp into a free flow or non-occluding
`state with respect to the I.V. tube, 3) engages the retain-
`ing arms which secures the now open slide clamp in the
`apparatus, and 4) positions a safety clamp in a ready but
`open state.
`To unload the I.V. tube from the apparatus, the door
`is opened which causes the safety clamp to occlude the
`LV tube. Prior to removal of the I.V. tube, the slide
`clamp must again be engaged into an occluded state
`with respect to the I.V. tube, thereby l) reloading the
`slide member, 2) pivoting via the cam and cam follow-
`ers the retainer arms into the open position and 3) free-
`ing the safety clamp so that it can be positioned in the
`latched open position. It is only after these steps have
`been completed with the slide clamp occluding the I.V.
`tube that the I.V. tube and the slide clamp can be re-
`moved.
`
`The present invention also provides a safety appara-
`tus for preventing free flow of fluids through a flow
`lumen of an I.V. tube mounted to a pump, the safety
`apparatus including a clamp receiving the I.V. tube in
`an operative position, the clamp being selectively mov-
`able between a flow lumen occluding position wherein
`the clamp collapses a wall of the I.V. tube in the opera-
`tive position, and a non-occluding position wherein the
`clamp does not collapse a wall of an I.V. tube in the
`operative position. A clamp receiving area is provided
`for receiving the clamp. A structure within the clamp
`receiving chamber selectively moves the clamp be-
`tween the flow lumen occluding position and the non-
`occluding position. A non-obstructive sensor within the
`clamp receiving area is in a first state in response to the
`presence of the clamp in a selected position in the slide
`clamp receiving area and a second state in response to
`the absence of the slide clamp from the selected posi-
`tion. A device operatively associated with the non-
`obstructive sensor disables the pump in response to the
`nonobstructive sensor being in the second state.
`The clamp can comprise a slide clamp slidable be-
`tween an occluded position and a non-occluding posi-
`tion in response to the structure for selectively moving
`the clamp. The non-obstructive sensor can include a
`reflective pad on the clamp and a light source in the
`clamp receiving area directing a beam of light onto the
`pad. An optical sensor receives light reflected off the
`pad, the optical sensor being in a first state in response
`to receiving the selected portion of a beam of light and
`a second state in response to not receiving the selected
`portion of a beam of light. The non-obstructive sensor
`may further include a device for determining compati-
`bility of the slide clamp with the sensor,
`the non-
`obstructive sensor being in a first state when the clamp
`is compatible with the safety apparatus and a second
`state when the clamp is not compatible with the safety 65
`apparatus.
`
`The present invention further contemplates a clamp
`for controlling the flow of fluid through a flow lumen of
`
`The present invention also provides a slide clamp for
`selectively occluding and not occluding a flow lumen of
`an I.V. tube. The slide clamp has a body having oppo-
`sitely facing top and bottom surfaces. A regulating
`aperture defined by an internal peripheral wall in the
`body extends transversely between the top and bottom
`surfaces. The regulating aperture has an occluding slot
`and a non-occluding passage. An I.V. tube in an opera-
`tive position extending through the regulating aperture
`is slidable transverse to its length between the occluding
`slot and the non-occluding passage so that a lumen of an
`I.V. tube in the operative position may be selectively
`occluded or not occluded by sliding the I.V. tube be-
`tween the occluded slot and the non-occluding passage.
`The peripheral wall of the aperture, when viewed in
`cross section, has a substantially flat I.V. tube contact-
`ing surface of a length less than the distance between
`the top and the bottom surfaces for minimizing friction
`between the I.V. tube contacting surface and an I.V.
`tube in the operative position as the I.V. tube is slid
`between the occluding slot and the non-occluding pas-
`sage.
`The slide clamp can further include a structure for
`preventing sliding of the slide clamp lengthwise of an
`I.V. tube in an operative position extending through the
`non-occluding passage solely by the force of gravity.
`The sliding prevention structure permits movement of
`the slide clamp lengthwise of the I.V. tube under appli-
`cation of a predetermined force greater than the force
`of gravity. The engaging structure may be at least two
`contact points, an I.V. tube extending through the non-
`occluding passage having an outer diameter that spans
`the distance between the contact points.
`The slide clamp may further include indicia for facili-
`tating automated identification of the clamp. The indi-
`cia for facilitating automated identification of the clamp
`may be a surface portion of the clamp, the surface por-
`tion reflecting a selected portion of a beam of light
`shined thereon, whereby an optical sensor receiving the
`reflected portion of the beam can identify the slide
`clamp. The slide clamp may also include oppositely
`facing leading and trailing edges, each having a selected
`width. The width of the leading edge is less than the
`
`ACTA EX. 1015-016
`
`ACTA Ex. 1015-016
`
`

`
`5
`
`5,300,044 I
`
`6
`
`width of the trailing edge for facilitating a selected
`orientation of the slide clamp prior to insertion of the
`slide clamp into a slide clamp receiving area. The clamp
`may further include first and second oppositely facing
`lengthwise sides, each of the sides having a notch for
`receiving a structure for preventing lengthwise move-
`ment of the slide clamp.
`The slide clamp may be employed in combination
`with a safety apparatus for a pump, the safety apparatus
`comprising a clamp receiving area and means within the 10
`clamp receiving area for selectively sliding the slide
`clamp relative to an I.V. tube in the operative position
`between the occluding slot and the non-occluding pas-
`sage.
`-
`
`5
`
`The safety apparatus of the present invention pro-
`vides a device for assuring that the flow lumen of an
`I.V. tube is occluded before insertion of the I.V. tube
`into a flow pump. Furthermore, the safety apparatus
`assures that the slide clamp is held in a non-occluding
`position during operation of the pump. Finally, the
`safety apparatus assures that the I.V. tube is in an oc-
`cluded state prior to removal of the I.V. tube from the
`pump. In this manner, free flow of fluids through the
`I.V. tube before, during and after loading of the I.V.
`tube into the pump is prevented, thus minimizing the
`risk of a harmful bolus dose of medical fluids being
`inadvertently injected into a patient. Moreover, the
`safety apparatus assures that the slide clamp will be in a
`non-occluding position relative to the I.V. tube during
`operation of the pump.
`The safety apparatus of the present invention further
`contemplates a slide clamp_that is slidable relative to the
`I.V. tube under minimal frictional resistance. In this
`manner, smooth operation of the safety apparatus is
`assured. Moreover, the safety apparatus of the present
`invention provides a non-obstructive sensor for pre-
`venting operation of the pump if the slide clamp is not
`in a proper position or if a slide clamp is used with the
`safety apparatus which is not compatible with the safety
`-apparatus. Thus, inadvertent use of an incompatible
`slide clamp with potential catastrophic results to a pa-
`tient is prevented. Moreover, the non-obstructive sen-
`sor has no mechanical linkages, assuring that it will not
`inadvertently jam in a position indicating proper loca-
`tion of the slide clamp. Furthermore, the present inven-
`tion provides a slide clamp having a non-occluding
`passage defining an I.V.'tube receiving area for receiv-
`ing an I.V. tube having an outer diameter slightly larger
`than the I.V. tube receiving area. In this manner, a slide
`clamp in a non-occluding position on an I.V. tube may
`be slid longitudinally of the I.V. tube under a force
`slightly greater than the force of gravity, but held in
`place under the force of gravity. Lastly, the present
`invention provides a slide clamp with a surface pad that
`facilitates automated identification of the slide clamp to
`verify that the slide clamp is compatible with a pump
`safety apparatus.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective view of an intravenous pump
`set utilizing the safety. apparatus of the present inven-
`tion;
`FIG. 2 is a perspective view of the peristaltic pump of
`FIG. 1 with a door in a open position;
`FIG. 3 is a detailed side elevational view of the safety
`apparatus in accordance with the principles of the pres-
`ent invention;
`
`FIGS. 4a-4f are cutaway views of the apparatus of
`FIG. 3 taken along the line 4-4 of FIG. 3;
`FIGS. 5a-5f are cutaway views of the apparatus of
`FIG. 3 taken along the line 5-5 of FIG. 3;
`FIGS. 6a-6f are cutaway views of the apparatus of
`FIG. 4 taken along the lines 6-6 of FIG. 4;
`FIG. 7 is a plan view of a preferred embodiment of a
`slide clamp for use with the safety apparatus of the
`present invention;
`FIG. 8 is a cutaway view of the slide clamp of FIG.
`7 taken along line 8—.8 of FIG. 7;
`FIG. 8a is an enlargement of the cutaway view of the
`slide clamp of FIG. 8 as indicated in FIG. 8;
`FIG. 9 is a cutaway view of the slide clamp of FIG.
`7 taken along the line 8-8 of FIG. 7 illustrating an I.V.
`tube disposed within the occluding slot of the slide
`clamp;
`FIG. 10 is a cross-sectional view of a prior art slide
`clamp taken transverse to its occluding slot showing an
`I.V. tube disposed therein;
`FIG. 11 is a cross-sectional view of another embodi-
`ment of a prior art slide clamp taken transverse to its
`occluding slot showing an I.V. tube inserted therein;
`FIG. 12 is a block diagram of the optical sensor of the
`present invention;
`FIG. 13 is a slide clamp according to FIG. 7 with an
`occluding slot which is too short; and
`FIG. 14 is a slide clamp according to FIG. 7 with an
`occluding slot which is too long.
`
`DETAILED DESCRIPTION OF A PREFERRED
`EMBODIMENT
`FIG. 1 is an illustration of an intravenous administra-
`tion setup using a pump and a source of intravenous
`fluid such as a flexible container. The pump includes
`pump housing 20 which includes pump operating me-
`chanics and operating electronics (not shown). The
`pump is mounted on an I.V. stand 22 which also serves
`a support for the intravenous fluid container 24. The
`container 24, which typically contains a fluid 26 such as
`saline that is administered to a patient, is also suspended
`from the I.V. stand 22.
`
`An administration set 10 provides a flow path from
`the container 24 to the patient via the pump. The set 10
`includes a segment of flexible plastic I.V. tubing 26 such
`as polyvinyl chloride (PVC) tubing.
`The I.V. tubing 26 at its proximal end is attached to a
`drip chamber 28 that is in turn attached via a spike (not
`shown) to an outlet port 30 of the container 24. I.V.
`tubing 26 has connected at its distal end means for con-
`necting the set 10 to a vein access device, such as a
`catheter or a needle (not shown).
`The pump includes a hinged door 36 which covers
`the peristaltic pumping apparatus hardware To set up
`the pump, the door 36 is opened, the I.V. tubing 26 is
`inserted into the peristaltic pump apparatus as described
`in detail below, the door is closed, and the pump is
`activated The pump also defines apertures at the upper
`38 and lower 42 peripheries of the pump housing 20
`through which the I.V. tubing 26 extends when the
`door 36 is closed. Additionally, the door 36 includes a
`latch 32 which can be pivoted from a released position
`in which the door 36 is not locked and a latching posi-
`tion in which the door 36 is locked in the closed posi-
`tion.
`
`While the embodiment depicted in FIG. 1 includes a
`dual drive peristaltic pump, the present invention con-
`
`ACTA EX. 1015-017
`
`ACTA Ex. 1015-017
`
`

`
`5,300,044
`
`7
`templates use of any number of pump drives in a single
`peristaltic pump.
`Referring now to FIG. 2, the peristaltic pumping
`hardware is seen. An inlet groove 29 is provided leading
`from the access aperture 38 to a peristaltic pumping ’
`mber in a form of a plurality of receptacle fingers 31.
`An outlet groove 33 is provided from the fingers 31 to
`the lower aperture 42.
`An upstream occlusion sensor 35 is provided on the
`inlet groove 29 while a downstream occlusion sensor 37
`is provided on the outlet groove 33. An air bubble de-
`tector 39 is also provided on the outlet groove 33. The
`door 36 of the pump includes a spring-loaded backplate
`43 of conventional construction as well as the cooperat-
`ing members for the upstream occlusion detector 35,
`downstream occlusion detector 37, and bubble detector
`39. A fixed latch member 55 is provided that acts in
`cooperating relationship with the latch member 32 to
`securely latch or lock the door 36 in a closed position.
`The I.V. tube 26 can be loaded into the inlet groove
`29 extending straight across the reciprocal fingers 31 as
`guided by a plurality of I.V. tube guides 41 and into the
`outlet groove 33. When the door 36 is closed a catch 45
`of the latch 32 mates with the fixed latch member 55 to
`latch or lock the door in a closed position.
`Referring now to FIG. 3, the safety apparatus of the
`present invention is seen in detail fixed in the lower
`periphery of the outlet groove 33. The safety apparatus
`includes an upper safety clamp housing 50 and a lower
`slide clamp housing, chamber 52. The safety apparatus
`defines as an extension of the outlet groove 33, an l.V.
`tube groove 54 into which the I.V. tube fits. Extending
`perpendicularly from the I.V. tube groove 54 is a re-
`tainer arm aperture 56 defined in the lower slide clamp
`housing 52. Contained in the retainer arm aperture 56
`are a right cooperating retainer arm 58 and left cooper-
`ating retainer arm 61 which pivot from an open or
`loaded position to a retaining or unloaded position in
`which the distance between the two retainer arms 58,61
`is smaller relative to the position of the retainer arms
`58,61 in the open or loaded position. The central por-
`tion of the retainer arm aperture 56 between the cooper-
`ating retainer arms 58,61 defines the receiving area 62
`for a slide clamp.
`Contained on the upper safety clamp housing 50 is a
`release pin 63 which extends outwardly from and is
`capable of reciprocating into and out of the upper safety
`clamp housing 50. The release pin 63 activates a sliding
`mechanism which orients the slide clamp from an oc-
`cluded to an open position.
`Also contained in the safety apparatus is a safety
`clamp 65. The safety clamp 65 is capable of extending
`into the I.V. tube groove 54 to occlude the I.V. tube.
`The further functioning of the safety clamp 65 and
`release pin 63 will be described in detail below in con-
`junction with FIGS. 4, 5 and 6.
`Referring now to FIG. 4, a cross sectional upper
`view of the lower slide clamp housing 52 of the safety
`apparatus is seen. In FIG. 4a, the slide clamp housing 52
`is seen in an
`or preactivated condition.
`The lower slide clamp housing 52 contains the right
`retainer arm 58 and the left retainer arm 61. Contained
`on each retainer arm 58,61 is a pivot point 67 which
`allows the rotational pivoting of each of the retainer
`arms 58,61. Further contained on the end opposite the
`pivot point 67 of each retainer arm 58,61 is an inwardly
`extending retainer finger 69 which, in cooperation with
`the retaining finger 69 of the cooperating retainer arm,
`
`65
`
`8
`acts to retain the slide clamp as described below. Each
`retainer arm 58,61 includes biasing means which, in a
`preferred embodiment, can be a spring 74 which pivot-
`ally biases each retainer arm 58.61 towards the cooper-
`ating retainer arm in the retained position. However, in
`the preactivated or loaded position, the retainer arms
`58,61areheldagainstt.hebiasintheopenposition.
`The left retainer arm 61 further includes an upwardly
`protruding stepped portion 76 which extends upwardly
`into the upper safety clamp housing 50. This stepped
`portion76actsasaretainingmemberaswillbede-
`scribed in detail with reference to FIG. 5.
`
`tube
`Also contained in the lower housing is I.V.
`groove housing 78 which defines the l.V. tube groove
`54. The l.V. tube groove 54 is an extension of the outlet
`groove 33 of the pump 20. The I.V. tube groove 54
`enables the l.V. tube to be retained in the appropriate
`position in both the pump 1) and the safety apparatus.
`The l.V. tube groove 54 is located centrally between
`the cooperating retainer arms 58,61. This acts to center
`the slide clamp contained on the I.V. tube between the
`retainer arms 58,61.
`Contained distally from the I.V. tube groove 54 is a
`slide member 81 which is contained on a pair of cooper-
`ating slide rails 83 which allow for inward and outward
`reciprocal movement of the slide member 81. The slide
`member 81 includes an outwardly extending biasing
`means which biases the slide member 81 towards the
`I.V. tube groove 54. In the preferred embodiment, the
`outwardly extending biasing means is a spring 87. The
`slide member 81 includes cam surfaces 89 extending
`outwardly on each side. The cam surfaces 89 act in
`cooperation with the cam followers 72 of the retainer
`arms 58,61 to pivot the retainer arms 58,61.
`Contained between the slide rails 83 is a non-obstruc-
`tive sensor 85 such as an electronic eye which can be
`used to sense the presence of a slide clamp. Electronic
`eye 85 is positioned to sense when the slide clamp has
`been inserted into the slide clamp receiving area. The
`electronic eye 85 is in electronic communication with
`the pump operating electronics. In the presently pre-
`ferred embodiment, the electronic eye 85 senses the
`fully inserted slide clamp; if a fully inserted slide clamp
`is not sensed, the operating electronics prevents the
`pump from operating. The non-obstructive sensor 85
`will be described in further detail below in conjunction
`with FIG. 12. Use of alternative embodiments such as a
`warning or an informational message will also be appre-
`ciated as within the scope of the present invention.
`Contained extending inwardly from the slide member
`81 is a slide shah 92. The slide shaft 92 is housed in a
`
`slide shaft aperture 94 defined in the lower slide clamp
`housing 52 and extending inwardly from the l.V. tube
`groove 54. The slide shaft 92 includes a notched portion
`96 defined therein. A slide latch 98 is also provided
`housed in a slide latch aperture 101 defined in the lower"
`slide clamp housing 52 and extending perpendicularly
`to the slide shaft aperture 94. The slide latch 98 includes
`a cam follower 103. The slide latch 98 is biased towards
`the slide shafi 92 by biasing means such as a spring 105.
`The slide latch 98 thus acts in conjunction with the
`notched portion 96 of the slide shaft 92 to retain the
`slide shaft 92 and thus the sliding member 81 against the
`outward bias of the spring 87. In the retained position,
`the sliding member 81 is in a loaded position while in the
`unretained