CA2207824A1

CA2207824A1 - Peristaltic pump with occlusive inlet

Info

Publication number: CA2207824A1
Application number: CA002207824A
Authority: CA
Inventors: Jean P. Montoya
Original assignee: Individual
Current assignee: Michigan Critical Care Consultants Inc
Priority date: 1994-12-14
Filing date: 1995-12-13
Publication date: 1996-06-20
Also published as: WO1996018819A1; EP0797734B1; DE69525650D1; DE69525650T2; EP0797734A4; US5486099A; JPH10511161A; EP0797734A1

Abstract

A peristaltic pump having a pump conduit (12) with an occlusive inlet segment.
The pump includes a frame (14) with rollers (22) carried by a rotor (16) and rotated by a motor (19). A flexible conduit having an inlet end (26) and an outlet end (28) is positioned around the rollers and includes an occlusive segment (38) and a non-occlusive segment (40). In its free condition, the occlusive segment is collapsed and the passageway through it substantially completely occluded when the pressure within the occlusive segment is equal to or less than the pressure acting on the outside of the occlusive segment. The non-occlusive segment is mildly biased to exhibit an inflated condition with an open passage when in its free condition with the pressure within the non-occlusive segment equal to pressure acting on the outside of the non-occlusive segment.

Description

W O96/18819 PCTrUS95/16138 I~t~l~ I ALTIC PUMP WITH OCÇ! IJSIVE INLET

BACKGROUND OF THE INVENTION
1. Field ofthe Invention The present invention genel ''y relates to pe,islallic pumps. More particularly, this invention relates to a pe,i~ldllic pump in which the pumping conduit is i, .leg( 11y formed with two pGI lions. The first portion is an occlusive portion that completely ocn~udes when the pressure within this portion is equal to or less than pressure acting on it. The second portion is a non-occlusive portion which is slightly biased so that this portion will be inflated, defining an open p:l55age~vay, when pressure within it is not sub~tarllially less than pressure acting on its outside.

2. Descli,.lion of the PriorArt Perisldllic pumps have been used with siyl liri~anl success in a wide range of extracor,~.or~al drculation procedures. Generally, during eAIIdcGl ~oreal circulation, blood or other bodily fluids are transferred between a patient and one or more extracorporeal devices which prt,cess the fluid before it is returned to the patient. Medical procedures which commonly employ such pumps include, without 1 nitaLion, the fcl'D~!d,lg: open heart surgery, dialysis procedures and long term continuous care situations. During open heart surgery, blood is l,~r,sre, led by the pump betv/ccn a patient and multiple blood processing devices such as a defoamer, oxygenator and a heater.
During dialysis procedures, the pump passes the blood through a dialyzer which removes impurities. In a long term continuous care situation, intravenous solutions are slowly infused by the pump through a venous cdlheter into the patient, for either general distribution or loc~ ed lreall nenl.
Peristaltic pumps can be described as volumetric pumps which include a movable or rotating ~I~erllber having rollers that will c~nl~,,ess a flexible pump conduit at spaced apart intervals.
The successive of cGmpression of the conduit and the relative movement of this compression point along the length of the conduit, forces the fluid through the conduit. Its simplicity of operation and the absence of direct contact between the pumped fluid and the various pump components are two of the principal advantages of a peristallic pump.
While used with consider ~le success, some peristaltic pump designs exhibit certain il,he,~nl limitations. Obviously, these l;mitdlions must be taken into consideration during the use of the pump. For exa",Fle, some peristaltic pumps use non-occlusive conduits that are progressively compressed by the rollers against a raceway or stator and are driven by conslanl speed motors. A non-occlusive conduit has a normally open passageway defined through its center. These pumps draw blood at a substantially constant rate. If the fluid circuit becomes occluded downstream of such a pump, the pump can overpressurize the conduit resulting in rupture. Addilionally, if the upsl,e:ar,l supply of fluid to the pump stops because of an occlusion, the pump will genendle negative pressures do~,lsll~alll of the occlusion. When low enough, the-pressure will damage or hemolyze the blood and/or result in the emptying of the fluid supply vessel.

W O96/18819 PCT~US95/16138 lf ~he fluid supply is e",plied, the possibility exists for the supply tissue vessel of the patient to ~o--~Fse resulting in damage to the tissue at the drainage catheter tip.
Another type of pe(i~WIic pump includes a non-occlusive double walled conduit in which the innerconduit is constructed of thin wall (es 'i~nl ",alerial that can col'~se when the pressure 5 acting inside is equal or below the pressure acting outside the conduit. This type of pe(i~ldllic pump is described in U.S. Patent No. 4,515,589. While this pump cannot generate significant negative pressures at their inlets upon u~.alrea", ocl-~ucicn, if the outlet is ocrluded, ove(~,ressurization can result ber~use the conduit is forcefully compressed by the rollers against a raceway or stator.
Another type of peristaltic pump includes an occlusive conduit. These types of pumps are constructed so that when pressure inside of the conduit is equal to or lower than the pressure acting on the outside of the conduit, the conduit will be subaldnlially occluded over its length. One such pump is ~~;s~losed in U.S. Patent No. 5 222 880. While a pump of this variety is inca,~-~le of gene,dti"g negative pressures when the supply of fluid to the pump is stopped in order to operate and overcome the inherent tension of the tubing the pump requires inlet fluid pressures and flow rates which at times may be greater than that which is desired or available.
In view of the above disadvantages and limitations it can be seen that there is still a need in the art to provide an improved peristaltic pump which avoids producing negative pressures upstream of the pump inlet which cannot overpressurize dow"~l,ean, from the pump outlet and which is c~rahle of filling and pumping a greater amount of blood at a lower inlet pressures cGn"~a,t:d to pumps that are no""-"y oc~luded along their length.
It is therefore a ~, in !~ object of the present invention to provide a peristaltic pump which requires lower inlet pressures in order to fill and pump a sigr,iricanl quantity of blood.
It is another object of the present invention to provide a peristaltic pump which will cease to pump blood when the blood supply filling pressure is equal to or falls below the pressure acting on the outside of the pump inlet.
A further object of the present invention is to provide a perislallic pump which is unable to generate subatmospheric pressures ~"csl,ear" from the pump inlet.
Still another object of this invention is to provide a pers 'tic pump which will cease to pump a fluid when the fluid supply filling pressure is equal to or falls below the pressure acting on the outside of the pump's inlet.
It is also an object of this invention to provide a peri:,ldllic pump which can generate a slight suL,~l",ospl~e!ic pressure downstream from its inlet when the fluid supply filling pressure is equal to or less than the pressure acting on the outside of the pump chamber.
It is yet another object of this invention to provide a peristaltic pump which is in~pr - e of ove",,~ssurizing when the outlet is occluded.
The present invention acl. ~ves the above and other objects by providing a peristaltic pump W O96/18819 PCT~US95/16138 without a raceway or stator that uses a pump conduit wrapped under tension around rollers mounted on a ro -'-le rotor. The pump conduit is made of a resilient material and norrnally exhibits a slightly biased condition along its length except for a small segment of its length located acJjacenl to the inlet of the pump. This inlet sey",e"l of the pump conduit is formed so that it is completely ocrluded when the pressure inside the pump conduit is equal to or less than the pressure acting on the outside of the pump conduit. The inlet segment or occlusive portion of the pump conduit begins ~-~,sl,ea", from the looalion where the rotating rollers first engage the pump conduit and may or may not extend slightly into the region engaged by the rotating rollers.
When constructed in the above ",anner the pe,islallic pump will pump blood or another 10 fluid as long as the fluid supply filling pressure is above the pressure acting on the outside of the pump chamber. The fluid will cease to be pumped when the fluid supply or filling pressure is equal to or falls below the pressure acting on the outside of the pump chamber. This occurs even if the rotor of the pump continues to operate and rotate. As a result negative relative pressures cannot be gene,dled IJ~sll~dlll from the or~luded inlet segment of the pump conduit. When the occlusive 15 segment is con,~ etely occluded however the pump can generate slight sul,al",ospheric pressures downstream from the occlusive segment if the rotor continues to rotate. These slight sul,dl" ,ospheric pressure, however are insufficient to cause damage to the blood cells.
Another advantage of this pump conduit design is that the pump is cap ~tle of filling and pumping more fluid at lower filling pressures in co" ,pa, ison to pumps having pump conduits which 20 are occlusive along their entire length.
Another advantage is that when used with a reservoir located upstream from the peristaltic pump the present invention would prevent the reservoir emptying and potentially pumping air into a patient.
Addilional benefits and advantages of the present invention will become apparenl to those 25 skilled in the art to which the present invention relates from the suhsequent des~ ,lion of the preferred embodiment and the appended claims taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a diag,dr"(nalic illu~l,dlion of a peristaltic pump embodying the princi, es of the present invention when the fluid filling pressure is greater than the pressure acting on the outside of the occlusive inlet segment of the pump conduit;
FIG. 2 is a diagra",rnalic illu~l,alion of a perislallic pump embodying the principles of the present invention and illustrating the occlusive inlet segment of the pump conduit when the supply 35 fluid pressure is equal to the pressure acting on the outside of the pump conduit;
FIG. 3 is a diag,~m",dlic illu~l,alion of a peri:,lallic pump embodying the principles of the present invention when the fluid filling pressure is equal or below the pressure on the outside of the W O96/18819 PCT~US95/16138 pump conduit and after the dcvelopn ,enl of slight negative pressures in the non-occlusive segment of the pump conduit;
FIGS. 4a and 4b are plan and lateral views of one embodiment of a pump conduit as utilized in a pe-ialdllic pump embodying the p,i.. , !es of the present invention;
FIG. 5 is a cross-seclional view taken subalanlially along line 5-5 in FIG. 4b of the non-occlusive segment of the pump conduit;
FIG. 6 is a cross-seclional view taken substantially along the line 6-6 in FIG. 4b illustrating the occlusive inlet segment of the pump conduit in an occluded con.lilion; and FIG. 7 is a cross-sectional view through the occlusive inlet segment of FIG. 6 in a non-occluded state.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring now to the drawings in greater detail, a peristaltic pump 10 embodying the principles of the present invention is illustrated in FIG. 1 and generally desiy.,aled at 10. It is anticipated that the pump 10 of the present invention will have a broad range of utility in a wide variety of pumping a~F' - ~'ion, in particular eAl, acorf~ort al applicalions including, but not limited to, cardiopulmonary bypass, blood oxygenation, carbon dioxide removal, hemodialysis and blood filtration as well as long temm continuous care situations such as those requ ing r"~~ l infusion.
Prindpally, the pump 10 is co,oprised of a pump conduit ortube 12, a frame 14 and a wheel or rotor 16. The rotor 16 is mounted to the frame 14 for rotation about an axis defined by a shaft 18 cenl, ~iy posilioned in the rotor 16. Driving the shaft 18 is an electric motor 19 or other suitable driving means which causes the rotor 16 to rotate in a clockwise ~ir~clion which is in~ d by arrow 20.
Cxten " ,9 from the rotor 16, generally parallel with the shaft 18, are a plurality of rollers 22.
The rollers 22 are radially positioned around the rotor 16 at equal .lialances and, as the rotor 16 is rotated, the rollers 22 move in a generally drcular path. In the illustrated e" lbodi" ,er,l, three rollers 22 are shown as being spaced app,uAi",ately 120~ apart. The rollers 22 themselves are mounted for rotation about their own axes. Thus, as the rollers 22 move along the pump conduit 12, the rollers 22 will not produce a significant amount of r,i..lional pull or tension on the conduit 12 thereby 30 increasing its useful life.
As the skilled artisan will apprt:cidle, the actual number of rollers utilized will depend on the spedfic apF': "-n and could be varied without departing from the nature of the present invention.
Altematively, the rotor 16 could be designed to carry the rollers 22 in a non-circular path. For the sake of clarity, the rollers 22 are also illustrated as extencl"~g from a single plate 24. However, the 35 rollers 22 can extend between a pair of plates (an interior plate and an exterior plate) which would cooperate to prevent the conduit 12 from inadvertently coming off of the rollers 22.
The conduit 12 is constructed of a flexible ~"alerial, such as surgical grade polyurethane or W O96/18819 PCTrUS95/1613g other suitable material and is poaitioned so as to extend around the rollers 22 with its inlet end 26 and outlet end 28 respectively secured to an inlet cou, ' ~9 30 and an outlet coupling 32. The couplings 30 and 32 are in tum mounted to the frame 14 of the pump 10 and connecl the conduit 12 to an inlet supply conduit 34 which delivers the desired fluid to the pump 10 and an outlet 5 suppiy conduit 36 which directs the fluid back to the patient or to another ext, ..co"~o, eal device.
While not shown, a housing may be mounted to the frame 14 to pr~lecli~/ely enclose the conduit 12 and rotor 16. If desired the housing can be hinged with respect to the frame 14 to readily permit access to the various ~;r"poner,ls of the pump 10.
~ ert "i"~ nowto FIGS. 4a 4b 5, 6 and 7 it is seen that the conduit 12 is generally unitarily 10 fommed with two integral portions herein ~fe"ed to as an occlusive or first seg",enl 38 and a non-occlusive or second segment 40. The occlusive segment 38 occupies a lesser of the conduit's length than the non-occlusive portion 40 for reasons more fully discussed below.The principal clirrerence between the two seg,nenls is that the occlusive segment 38 is naturally flat and the pacsa9e~lvay 42 ll ,er~tl " uugh is fully ou~uded when no blood is being s~ ~F p '.- e d 15 to the pump 10 through the inlet supply conduit 34. Stated another way when the exte",al pressure acting on the outside of the occlusive segment 38 is at least equal to the pressure on the inside of the occlusive segment 38, the occlusive portion will c~ se into a fully occluded state.
This is herein referred to as the "free" condition of the occlusive segment 38. When fully ocrl~!ded the occlusive se~men~ 38 makes it impossible for negative pressures to be generated within the 20 occlusive segment 38 or upsl,~:a", of the segment 38. If the rotor 16 continues to rotate after occlucion of the occlusive segment 38 the present invention prevents emptying of the ~,psl,e~", conduit 34 ~- -" ,9 of the supply tissue (with its potenlial for damage) and the pumping of air into the patient.
To ensure that the occlusive portion 38 is fully oc- luded when in its free condition or that 25 negative pressures can not be generated within the occlusive segment 38 the conduit 12 in the area of the occlusive se~u,,,enl 38 exhibits an inner radius of curvature 44 which is or approaches zero at its side edges 46. Methods of constructing such a conduit 12 are known in the industry.
In one method of construction a thin walled tubing of flexible malerial such as polyu,t:ll,ane or vinyl is heat treated and pe""anently deformed into this free condilion shape. Another method of 30 constnucting the occlusive sey" ,enl 38 involves adl ,e, ing two films or sheets of flat flexible " ,alerial log~ll ,er along their longitudinal edges 46. The edges 46 may be adhered by heat sealing or by the use of adhesives.
When mounted overthe rollers 22 the occlusive segment 38 of the conduit 12 is oriented so that the side edges of the occlusive segment 38 are longitudinally spaced along the lul~lional 35 axes of the rollers 22 such that a flat side 48 of the occlusive segment 38 is in surface-to-surface contact with the circumferential surfaces of the rollers 22.
The non-occlusive segment 40 exhibits a mild bias so that the passageway 42 through it W O96/18819 PCTrUS95/16138 is open when the non-occiusive segn,er,l 40 is in its free co~cJition. I loJ/~vcr, to ensure that the non-occlusive portion 40 is fully oc~ ~uded when in its e e" ~r S ed condilion, and that finite negative pressures can only be generdled within the non-occlusive seg",enl 40, the conduit 12 in the area of the non-occlusive se~",enl 40 prefer~bly exhibits an inner radius of curvature 44 which is or 5 appr~acl ,~s zero at its side edges 46, similar to the occlusive segment 38. A~n ' ~gly, when the pressure v~lithin the passag~ 42 in the non-ocdusive seg" ,e, it 40 is equal to the pressure acting on the outside of the non-occlusive sey",enl 40, the passage~,vay 42 will be open as seen in FIG.
5. This allows slight, but finite, negative pressures to be generdled in the conduit 12 even as the rotor 16 continués to rotate. Also, by not being occlusive along its entire length, the conduit 12 10 requires decltsased inlet pressures and flow rates thereby allowing a greater amount of fluid to be initially pumped with less effort and priming.
With the conduit 12 located about the rollers 22 of the pump 10, it can be seen (in FIG. 1) that the occlusive sey",enl 38 begins upsl,eam from the position where the rollers 22 first engage the conduit 12 during rotation and may, but need not, extend slightly into the region engaged by the 15 rollers 22 and the conduit 12. The area of first engagement between the rollers 22 and the conduit 12 is generally illustrated in FIG. 1 at 49.
When the fluid inlet supply pressure is greater than the pressure acting on the exterior of the conduit 12, the occlusive sag~ ut 38 will inflate and fill with fluid 50 and the pump 10 will force the fluid 50 through the outlet supply conduit 36 as a result. In its inflated state, the occlusive 20 sey" ,e"l 38 assumes a general lemon shape as seen in FIG. 7. One situation where the inlet fluid pressure is greater than the exterior pressure on the conduit 12 is when the fluid 50 is contained within and received into a reservoir 52 whose level 54 of the fluid 50 is above the level defining the inlet end 26 of the conduit 12 and pump 10. This is seen in FIG. 1. Recause the occlusive segment 38 only occupies a relatively small length of the conduit 12, the present invention is 25 capable of filling and pumping more fluid at lower filling pressures than pumps having conduits which are occlusive along their entire lengths.
When the fluid pressure at the inlet end 26 of the conduit is equal to the pressure acting on the outside of the occlusive segment 38, the occlusive segment 38 will assume its free condilion thereby cor,lpl~tely closing the passageway 42 of the occlusive segment 38 designaled at 56 in 30 FIG. 2. One situation where this would occur is when the level 58 of the fluid 50 in the reservoir 52 first corresponds with the height of the inlet end 26 of the pump 10.
As seen in FIG. 3, as the rotor 16 continues to rotate and move the rollers 22 along the length of the conduit 12, all of the fluid filling the passageway 42 of the non-occlusive segment 40 will be progressively forced out of the pump 10 without any addilional fluid 50 being drawn into it 35 through the occlusive sey",enl 38. Resultingly, the non-occlusive segment 40 initially experiences a l~31 , ee as relative pressures are generated within the non-occlusive segment 40 of the conduit 12. Rec~use of the occlusive seyllle"l 38, the present invention is incapable of generating negative W O96/18819 PCTrUS95/16138 pressures at the inlet end 26 or upstream therefrom. A pump which inco,,uorales a non-occlusive or no,.. 'Iy inflated conduit about its entire length would be csF-'le of gener~ling these u~ a", negative pressures and potentially collapsing the supply conduit and damaging tissue of the patient as a result of the caU .eter tip being located in the supply tissue vessel.
While the above des~ i~tion con ~ - s the p, ~re" t:d e" ~bo nent of the present invention, it will be appredated that the invention is susceptible to " ,odiricdlion, va, idlion and change without depa.li.,g from the proper scope and fair ".ean ~9 of the acco,..panying claims.

Claims

1. A peristaltic pump for pumping fluids comprising:
a frame having a plurality of rollers and carrier means for carrying said rollers in spaced apart relation along a predetermined path;
drive means for causing movement of said carrier means thereby inducing said rollers to move along said predetermined path;
a flexible conduit having integrally formed first and second segments located between an inlet end and an outlet end, said first segment located upstream from said second segment and said first segment being collapsed and a passageway therethrough being substantially completely occluded in a free condition when pressure withinsaid first segment is equal to pressure acting on the outside of said first segment thereby preventing the transmission of fluids therethrough, said first segment assuming an inflated condition having an unobstructed passageway when pressure within said first segment is greater than the pressure acting on the outside of said first segment thereby permitting the transmission of fluids therethrough, said second segment being biased to exhibit an inflated condition with an open passage therethrough in a free condition when pressure within said second segment is equal to pressure acting on the outside of said first segment thereby permitting the transmission of fluid therethrough; and mounting means for engaging said inlet and outlet ends and for mounting said conduit about said rollers whereby said conduit cooperates along part of its length with said rollers without use of a stator to thereby transmit fluid through said conduit by peristaltic movement.

2. A peristaltic pump according to Claim 1 wherein said first segment exhibits an inflated state having an unoccluded passageway therethrough when pressure within and upstream of said first segment is greater than the pressure acting on the outside of said first segment.

3. A peristaltic pump according to Claim 1 wherein said first segment is shorter in length than said second segment.

4. A peristaltic pump according to Claim 1 wherein said first segment is located such that said first segment is not engaged by said rollers as said rollers are rotated said second segment cooperating along at least part of its length so as to be engaged with said rollers whereby said rollers at least partially collapse said second segment so as to transmit fluids through said conduit by peristaltic movement.

5. A peristaltic pump according to Claim 1 wherein said first and second segments are unitarily formed with each other.

6. A peristaltic pump according to Claim 1 wherein only said second segment is engagable with said rollers.

7. A peristaltic pump according to Claim 6 wherein said second segment is located such that said rollers engage said second segment substantially adjacent to said first segment.

8. A peristaltic pump according to Claim 1 wherein said rotor rotates and said predeterminated path is circular.

9. A peristaltic pump according to Claim 1 wherein said peristaltic pump does not utilize a stator to collapse said second segment.

10. A peristaltic pump according to Claim 1 wherein said conduit is located about rollers such that said first segment is engagable with said rollers.

11. A peristaltic pump for pumping fluids comprising a frame having a plurality of rollers and carrier means for carrying said rollers in spaced apart relation along a predeterminated path, drive means for causing movement of said carrier means thereby inducing said rollers to move along said predeterminated path, a flexible conduit having unifarilly formed first and second segments located between an inlet end and an outlet end said first segment located upstream from said second segment said first segment being collapsed and said passageway therethrought being substantially completely occluded in a free condilion when pressure within said first segment is equal to pressure acting on the outside of said first segment thereby preventing the transmission of fluids ll,ere:~l"uugh, said first s egment assuming an inflated condilion having an unobstructed passageway when pressure within and upstream of said first segment is greater than the pressure acting on the outside of said first segment thereby permitting the transmission of fluids therethrough, said second segment being longer in length than said first segment and being biased to exhibit an inflated condition with an open passage therethrough in a free condition when pressure within said second segment is equal to pressure acting on the outside of said first segment thereby permiting the transmission of fluid therethrough, said second segment cooperating along at least part of its length so as to be engaged with said rollers whereby said rollers at least partially collapse said second segment without the use of a stator so as to transmission fluids through said conduit by peristaltic movement said first segment being located such that said first segment is not engaged by said rollers as said rollers are rotated and such that said rollers engage said second segment substantially ajacent to said first segment and mounting means for mounting said conduit about said rollers and engaging said inlet and outlet ends thereof.

12. A pump conduit for a peristaltic pump including a frame having a plurality of rollers and carrier means for carrying said rollers in spaced apart relation along a predetermined path, drive means for causing movement of said carrier means thereby inducing said rollers to move along said predeterminated path, said conduit being flexible and composing unitarilly formed first and second segments located between an inlet end and an outlet end, said first segment being collapsed and a passageway therethough being substantially completely occluded in a free condition when pressure within said first segment is equal to pressure acting on the outside of said first segment thereby preventing the transmission of fluids therethrough, said first segment assuming an inflated condition having an unobstructed passageway when pressure within said first segment is greater than the pressure acting on the outside of said first segment thereby permitting the transmission of fluids therethrough said second segment being biased to exhibit an inflated contion with an open passage in a free condition when pressure within said second segment is equal to pressure acting on the outside of said first segment thereby permitting the transmission of fluid therethrough.

13. A conduit as set forth in Claim 12 wherein said second segment is longer in length than said first segment.

14. A conduit as set forth in Claim 12 wherein said first segment exhibits in its free condition a radius of curvature approaching zero at its side edges.

15. A conduit as set forth in Claim 12 wherein said first segment is substantially flat in its free condition.

16. A conduit as set forth in Claim 12 wherein said second segment including portions generally defining edges said second segment exhibiting an intemal radius of curvature approaching zero at said edges when in its free condition.

17. A conduit as set forth in Claim 12 wherein said first segment is located upstream from said second segment.