CA2970214A1

CA2970214A1 - System for pumping a biological fluid

Info

Publication number: CA2970214A1
Application number: CA2970214A
Authority: CA
Inventors: Dean Kamen; Jason A. Demers; David E. Altobelli; Larry B. Gray; N. Christopher Perry; Brian Tracey; James D. Dale; Dirk A. Van Der Merwe; Kingston Owens; Michael J. Wilt; Scott A. Leonard
Original assignee: Deka Products LP
Current assignee: Deka Products LP
Priority date: 2006-04-14
Filing date: 2007-04-13
Publication date: 2007-10-25
Anticipated expiration: 2027-04-13
Also published as: CA2648803C; MX2008013266A; US20220355006A1; CA2648803A1; US11754064B2; US20210285435A1; JP2022059061A; US20150050166A1; MX2023005766A; US20080058697A1; US20190323492A1; CA3099207C; JP7028851B2; CA3099207A1; EP4074353A1; JP2017006696A; CA2970214C; CA3123166A1; US8870549B2; JP7299364B2

Abstract

Various types and configurations of pump pods, heat-exchanger systems, and thermal/conductivity sensors are described above. Pump pods can be used in a wide variety of applications including but not limited to heat-exchanger systems and for pumping of bodily fluids or medical fluids. Thermal/conductivity sensors can be used in a wide variety of applications including but not limited to thermal/conductivity measurements of fluids and thermal/conductivity measurements in the context of heat-exchanger systems. Heat-exchanger systems may be used in a wide variety of applications to heat or cool fluids and are not limited to use with pump pods and thermal/conductivity sensors.

Description

IQ

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--""""41---------_____- --- IN
..._,_ ..... - .1.)) griii/>........- -4----------- ___------ =
t11:- 410w-'----1:4 -I l ---1.-- itillo- 12 .--460.-i:4).:ir _________________________________________________________ 16 kik4 1114..4 i 41 g ----___ :
'-i if-0,11.. tH11:1 It FIG. 1

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iiiL
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cu =o=
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cv =
=

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c,)``) 7-) cno \
,\

4 .,=o 0 0 V"on ,00 (300 61) -C,7 LCC1I co C.) o o o o o Fluid side V

Pneumatic side 33 32 r--44 Pod I Pressure _____________________________________________________________________ ' Sensor r"--45 r-46 Tank Tank pressure Positive 48 Vacuqm pressure sensor supply 47 supply sensor 1-r valve valve =
Positive Pressure 7-51 Vacuum Pressure Reservior Reservoir Controller FIG. 4 8r-/ry " = 4t,µ =
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c., <
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AP ro FIG. 5B

.
, .
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.
.
, 721 tE ----- .
, 66¨'\
-, , HEAT
co( 1-1.13 1.13-1 ii..0 . HEAT HEAT u) to EXCHANGER BAG 4 Ill A> i5 Z.5 ,--, (----, m RI m m z z z z r- , A 'a 'c 1' lit la', I7.i 0 (I) (43 OgK M
1 ilg- ,ris, -o 13 Z 6 F4 )i CI)q r= FILTER m ......, 0 I ______________ z AIR PURGE/
PATIENT TEMPERATURE
SENS-OR61 62ENSO TRAP R --If--2019 PROBES

-\ _________ RT BLOOD OUT
RETURN CATHETER
,-29 66 - .5: : ' 35 36 2022 __ M

mg =IT
_____________________ BLOOD IN
INLET CATHETER

IS shiemill, 35 STERILE FIELD =
=
_______________________________________________________________ 25b 2020 1111111v POD 1 w-0 POD 2 -o DATA
PRIME
x 2:1 m m KEY
25a m cnco co\.....-- 2021 C ) C c c7 `---2018' m ,,, 38 ----\ -C3 ''v.---"011 9, 0 n.) 1 , f t Disposable Module Connection Diagram FIG. 6 . \--.-- 16 Pressure Pulses for low command (approx 15) .....Pod_l_Pressure (PSI) Podl desPos Cmd End of stroke period -= - =- = -2_0 _initial 1 , pumpinqil 1 1 , 1 1 k IMilkil Pod1 PosValve 1.8 -Period i'l 5 il II F, A, ii rl 11 t., il q A 1,, II
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- = T.:1 . .0 li ,' , t! g µ1 :.= : 1: v 1 1 i 1 1 1 .11 ril ' i 1 ! i=-;
1.2 - i ; ...1, L.¨ ____________________________________________________ Command 1.0- 1 - , , =I 1 ti , .-0.8 - .
k. = . ; i-=,____t-- in Valve , 0.6 - -.== - i co Open = = cn 0.4 - l 8 . .
, 0.2- , , . = .., = . = co 0 ---- _______________________________________ .___J 0 6.4 6.45 6.5 6.55 Time in seconds x10' FIG. 7 Command \ Pressure Pulse for a large command ______________________________________________________________ =
_y_odl_Pressure (PSI) i=-= \- -- = =
;
8 -1 Pod1 desPos Cmd --=-=-;
7 - i ______________________________________________ Pod1 PosValve Pressure __ 6 - -____ . _____________ i /v.-- - VVVAAJNA../VVNI-1 2 I
i 1 4 - = I
!Initial Pumpin End of stroke i --1 Period period 3 E
3 - i=
, ____________________________________________________ Valve 2 - I li to Open f ilg- O:
1 rl: milli 8.43 8A4 8.45 8.46 8.47 8.48 .
Time (cycles) x101 FIG. 8 =

Bandpass filters 0 , , .....,,, , I 11114/1!..!...... i .,..
.,....: I 0 6 7.-1 -,......1.., I I = IT - = I I I T 1 I
.....' .
. 16Hz..
.--*".=

.
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0) -50 - .
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45 - _ ..
CD 2Hz¨N___.."-, .
cu=

.
2:--I o- ,.. 16Hz _ co ..
co .
co .
.c a_ -45 - _ .........
--....._._.
-30 . . , , ¨.1 . , , ,,õ,, I I I I I I
III _l_ I I 771.1.rf."=.-- --,-,..r, Frequency (Hz)101 FIG. 9 =
________________________________ ..........._.õ
0 - ....._..._ 6.15Hz ....,õ............ .
...-.. -a:. -.,..
........
CDN.
0.55Hz--.,),.. --, -0 -20 - =
....., _E
rn -...
co .=..=..
.
-.., ---..-.
-----..
-80 , . . . 1_1111 1 1 J I 11111 1 1 1 111111 0 ....
=
--------..._ 6.15 Hz --__,, - *---... 6.15-----,Fiz 0.55Hz _ -di T
- 0.55Hz--=\_>õ..
a) -1, ....
\ NNNN<
co .c ....
CL N.
-135 - N...., .....õ.....
---____ -180 ---,---- ' ' ' ' ' ' ' r 1 1 1 1 1 --1-11.------Frequency (Hz) , FIG. 10 , , _______________________________________ - Pod1 Pressure 700 - il P../. S Pod2 Pressure 600 - isr !-.
lir¨ Pod1 Filtered :4'-'; ------- Pod2 Ripple Filter2 500 -l I !,, I :II _ __ _.Podl Ripple Filter2 -II _________________________________________ Pod1 300 k 1s lv p aMCID NJ.
200 41 ; \I 4 1 i :I i Pod2 Filtered 100-. ,µ ,...--., c.-:.: f 1::___ =-z.\ ,) ,t " i1 !
-- -..,----- - -- - - -0 A5-Pod2 Filtered :.

:
"\--_,--Pod1 Filtered Ix>
c) _ to -300 - ca . , 7.66 7.68 7.7 7.72 7.74 7.76 Time (cycles) . FIG. 11 .

o o o o Pod Pressure Is Averaged Between the 5th and 10th Pressure Pulse 11 _________________________________________________________________ Pod1 Pulse Cnt.
_____________________________________________________________________ Pod1 Pressure (mmHG) Pulse Count _....pod1 Avg Pressure (mmHG) 9 __________________________________________________________________ ______________________________________________________________________________ t=J

______________________________________________________________________________ ______________________________________________________________________________ o_ ________________________________________________________________ Pressure C=4

5 r-4 ¨
4,) /.%je\ /4 I
,/ µ\ / \I µ
1=
3 ¨_1-51 .1 =
;
(c) , Average P'essure---N
, 2 ;
II
;

= t ;
:
t 5.46 5.47 5.48 5.49 5.5 5.51 5.52 Time (cycles) x1 o4 FIG. 12 Cover A 18 Door Afairallillpftrimmoongw_ \

N ''''- ebk lib& vik.Lc.o.iing I11111111311111.
111.14%.-12111" Numma111116 .iii '', i\. F na .
Pneumatic Sealing -1"-klitka µ1~111011111allIMIKinalak lb 4 ,.õ.õ, ____ 12 Tracks 11011hft112111\1111111.111k111111Mik \ 1 NIII.b,..7111101110111116.111111m1.1.111wli. \
Heat Exchanger Disposable 21 yArb..
Heating 141""=^^ftimilimilae---",------------ _ _ k .14 JLV.
27 AIN%

23a-231b--FIG. 13A

o o o o o 13.4 23a 23b 138b =
Men-=wrfir " a 7;
400., ln 133a 139b 133b 139a FIG. 13B

FIG. 13C

A
141}

142 ll94 = 4 ' Ailk P11 141'41'4%. 143 FIG. 14 lie 121 FIG. 15 FIG. 16 Mal =

FIG. 17 =

,-182 1837--- 184 ' I
I I
t -I-7:LN1 I ' =
=

FIG. 18 =

Measure temperature at first and second points.
Compare temperature readings from first and second points. and __________________________ First alarm if readings are deterrnine if readings are inconsistent.
consistent.
Determine if temperature, Second alarm if readings fall readings fall within safe range. outside of safe range.
FIG. 19 . 20/107 in co cs) css ci oi 0 co CNI
CO

/ CV
/
/
/
/
/
/ \ 4\
=43 t.,,,.. \ \ (r) c) / ..,-.= ' i/'%. I-=
9.
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l.. .
1 C) .1µ4&. ..*.M 04 = A a) c) ........ .
c7i . 0 v.
...;
, . \
/...,:
s's=-.-..
0.1 .s. .x.
. /
/f /
r--------------"--i t.'N's': 03 CO

CV
CD Z71)-Cs1 pr., --) "
. 0 CNI "
a) .

CNI

zif¨ 2098 2090 2096- ______________________________ 2091 m iIIINiaiftj 411.11 4\
/111111111115116, _____________________________________________________________ 2092 2088 _______________________________________________ 2095 FIG. 21 2015 .
. __ 2005 I
._,..,, -2008 === \
.._, _.,--'- 0 -`-,-____,,\.
4 __tHi\
(5(6-0,,,,):
.,\
,,.... .
/
OD 2025b 2025a 0 6 _ )2011 .:

. , - di FIG. 22A .

_ 2096a I _______________ 2000b //I III
2000a --=--wit 2096b - /
0 rya,-

6-;
,=

I le - ,, (0,, =
c , 2025a 2106a ,e) --t \_. to 411111111 2106b 2025b Ire #, 1;ro -, -'11\ if 2096c 2000d W 2000c 2096d _ 2006 FIG. 22B

? j-20432 2045---Tht 0 D
......,,,,,...:
, P rr-----A-, =
"
Ali Am /

r.-I I I 1 I III = 2041 2047-I=2016 FIG. 23 LL
14.

l*k _________________________________ 1 4 = gra ____________________________ 1 411141WMWm %NO
= 0 0 '11)I
-.. d ,ii<....___ ...."11.11...
-.-----....- -----,.---7-- -- 1 - - ....==---"--- ok ' 11--- c---..,._.
10-__õ,1 g,,,w, ,_____ 2500 MOP III
_-----------l, FIG. 25 u, , .Fr:
.
,-.
, o ,I, u, 2539b ----\\
-IIIIP = ' 61 m AV
c ) A
lir 00 0 2539a I
-=::....
%IIill,. c .

-AL. ONO

II qt.
410 . 2500 k.) -.1 6"
..1 SP, 1.
FIG. 26 o o Model #
Status Temp Graphs Flow Graphs Logs \ Therapy Controls PATIENT BODY TEMPERATURES
44 C ___________________________________________________________________ 44 C
SYSTEM IDLE

= 40 C

mom PRIME

32 C '¨'1 ______________________________________________________________ 32 C
WARM-UP
0 5 10 15 20 25 30 minutes Core (Bladder) on= Reference Probe #1 c=
oe Monitor (Nasophng) =no Reference Probe #2 =
PLATEAU
Target Temperature ezszz 44 C = BLOOD CIRCUIT TEMPERATURES
COOL-DOWN

END-THERAPY
36 C Enl- 36 C
Phase Progress:

0 min 302gutes I I U 1[W]
Entrance MN Exit =a DATE TIME ENTER COMMENT LOG OUT
FIG. 27 Pressure PR+
-End of stroke Pc, Time Pc_ __________________________________________________________ End of PR- stroke FIG. 28 OUTLET INLET
= AS.
FIG. 29 Gill beg/ill/W.0d FIG. 30A

3006 eifigswillrar/W4 Allikejr=Arri t r 3020 3018 "NW 3018 Amu 3020 -.01101111.

FIG. 30B 3004 3100 ---,\

BB
st:\
mum MINI 41=
j-- 111111111111111.1.
3114 ____________________________________________________________ 3114 1\-4211Mit0 CI" 3112 FIG. 31A

"7////11/Dio1r/11//W....._ _ tor -/Aimeavoimmon

7 kiek-w------hia #11 3106 \4, 3100y 3108 3112 =
FIG. 31B

---0)111111111(0/11 ji .16 B
MI .140111,1111 0 ___________________________________ 0 FIG. 32A

001!nrillellIMPAILTA

111111111eawrArri p 3108 , Alhasu FIG. 32B

______________________________________________ 3302 A /MI
Alai\
= ________________________________________ Za1111111111 _____ D t õ .71111P> _______ FIG. 33A

Adimh=-7, 3302 -1,11111AIMEL = .
odiar MI IF

FIG. 33B

Bt t ________________________________________________________ I

FIG. 34A

3408 ____________________________ - ____________________ -7111 3410 ____________________________ FIG. 34B

3500¨ 3518 ------ .".=
111 =

--.______ __i `l , A t/ ill .1V---1-1-1111-1411 s ''--- .T--------------- --__N.õ......,_______________..õ,.._ _ :-- '--- -=

\.._/,'' 401110.=,....._...s' ' 3520 - ---- e- .- *- ' 3524 9 ,(000+0======....-_% ' --, ':iIMIIIIIMMI11.101 1 NowyrMOP
-,-,-:.=
. 3508 FIG. 35A

3408 ____________________________________________________________ 3408 tt)-, % 4Pc) ocPc i 0-00o00 / 00 _O 0000000 0 0 ¨00s"
¨ _______________________________________________________ FIG. 35B FIG. 35C

r_ ___________________________________________________________ 3408 FIG. 35D FIG. 35E

o o llIL
o 3, 500 Ir3502k õmg -_ 11111.
3610 11110r 4 oo -Immr jikli 3606 FIG. 36A 3504 FIG. 36B
41ifiNkx 3608 Silt_ 3602 ilk _ FIG. 36C

=
=s, \

\.,., d, =--N
. ., 3712 N\
Aiiimor = k AIR ., -\ 19 '(-44*
........................) .' 'S----------------7--=_-_--,----- _LL.L17-: .
----7 6--7-_-- -?fl \II'lft......... 3706 - ---:----- ---I

4111'.1. -----------_______--5"-- =

....
FIG. 37 =

-mei\B3814 dalitt'amtv -.mom _ Of I a it *amt.." Mr gaff" 'µ,4111. 1.11111.1.

FIG. 38A
r¨ 3800 frikT. t- ;1%6 3816 "'*111kir A N 38183816 , ji" NMI _ FIG. 38B

390O--. \ 3904 3902\A.. ' - ' --\ --,'"--/--::---t--- .- 1-4p, 3904 411.11W-\
it \\,.....
CO
eMIK--- 3914 ________________________________________________ 3908 ..----(C4104,/

FIG. 39 ,u) .Fr:
,1?.
tl I
,0 4111110.-' 3916 ....___ B
---------46 s, 0.16' /0321rAT
, s'N..."--.....' 3906 = --I

µ..N....

ilk FIG. 40A 4006 I
A

ir 41140, er#

OP' 01.11 FIG. 40B

u, , .
,-.
.D.
IV

I-I
.-.1 GI
I

' ' ' = ' `..
, _______________________________________________________________________________ ____________ 4100 3916 ........, _-_---...õ,, , s B
\
MAO, 'IN
;a..
,,,,i1/47.\........

,--ji\tlk*411111111111111 =>

W
4104 ____________________________________ I
il .i. lift Sµ
FIG. 41A .4-47 P livieb, Ikk bie404110101 FIG. 41B

)11L
I
( I
a , , I

I co CN
=:r.
i i r lip \,,ii LW

sz . 45/107 1.1..
(If-o .
CV @)) vs-' a CV
µ3.
411) 0 =

cµi C
C
(.6 .11.41.1 A4320 _ 4334 fish -%.'== =
¨ '<_,111/01., 4330 =

=

1-11-11¨"---"-!.

FIG. 43A

o o o o o fr ;Firail-17-11111-1' ?IN \
\ 4h ilk 8 ) 04' -A !.j.irs.
1A.04.-1?-411110e =
4342 4- ,==r510.

1111111WiriV

FIG. 43E3 cp I() st t\i, c=I
4=111/ 'fft4 in c=I
Alf / All .
=
r,..., A.
.6,...
,...., , .. ...%_, L, ..,t.
d -.........õ,,,/
il i v, '-o t;
,21 de:,...7....
=
0.-44 rik i \ 11---7 I-0) µ

L
is=
wram ......=

FIG. 44A
, 11701 . c:41 if _Is 1 :44 .4-ii-0 .
.,,*
*-10) =
_,-..,..
,r i o o o o 2625a 2625b !It C.4 Irifiramm_41.111.7 ____________________________________________________________ O, 4, .0 2601 ___________________________________________ FIG. 45 54/11)7 _____________________________________________ 39 - 'AIL.- aro 0,õ. ....;r'...=-=-: , . , 0 C) CD lib f __ 33 " ' ' ' =
, a 0 0 0 0 416 0 =-,.
/ C., I,-, 0 , f06 0 0000 \
Cr ' 0 0 0 o 0 0 0 1 0 0 0 o o , , . , .. ., , - - /
..
FIG. 46A

---- cp¨,c3o--- f."
_ ON\
-A- ___________________________________________________________ 33 FIG. 46B

=
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i:.1%=;"--- _........,---.. = -,'"
ii....y.- ..õ,,,-...-1.-- =-:-=',2Liirõ.........

IL

-14õ,, = ..,=-s--r" -00%4(4 T
--.--7iic- il !clop _ il _r..........,..õ-,..==. rg=
1!i_l______---,-*.
2701 I -- -..,,,:;),,,,. ...;
ip .., I .J
-rCri o-Or,-..Ai L. 10 . NO 1 roPI . 1/10:kr .1 It \ iWu Kfral04 . 40 .44:!... .
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FIG. 47A

_ µ111 ¨
\6) 0Ø01-11007.,0-411101611 _Liquerra finik:. = I
--4004¨ =

4)' .!
kl)) FIG. 47B

.LQ

o o o 2027 = /
(41*

t 41, .-tA16,-147c71.
)17/1\iiii 2028a 2028b WOW 2026b 29 .47;rp 37b fi=
2026a g 25b 37a 34a 34b 25a FIG. 48 o o o o 23a .13S) 23b - \
AtIP,__µ114111111/..-11111% ¨466-jet 1.11.

er'4FI ¨ III

133a = 1 139b 39a 133b 053 FIG. 49A

, .'il .
_ l-, 0, (1, 23a 138a 23b 138b ...._.=
.¨....... ,__,.0 ..=...
......=.
o, I
riiirwaiii... idinat .., 133a 1111111111111 11111111111.EIR
139b 133b 139a FIG. 49B

/

FIG. 50A

Y
5i I

FIG. 50B

5108 ____________________________ eN
S

/ .#: .isf4741, FIG. 51A

Aiegf ,-5100 .. .'%

FIG. 51B

_ eN
/

FIG. 52A
5108 ____________________________ I'1 , SO' zez .2 - =N- A

FIG. 52B

54O2 y/
5404 5100 -{
5406 { 4111111111111111 FIG_ 53 s , C
Altir 0., IMP
I
I, , = ire AiTrATKAI, B
FIG. 54 /

5406< e;/ ____________________________ FIG. 55A

1.1 g ;-FIG. 55B

4sN
} 5404 NI%
\
Agee tow- 5406 tZ.% 441' =

FIG. 56A FIG. 56B

5702 \
A s.
%
Ar-- . 5406 r. zza 0, 4 = 5702 5108 FIG. 56C FIG. 56D

il = %

% % = r/-A tk fr, }
} 5406 Arllr r 5406 A

FIG. 56E FIG. 56F

srµ
St 5702 k 5702 \
% N
} 5406 AAIX% 1=.A.11 FIG. 56G FIG. 56H

.=`µ $-N, k T/
// 1)>.5406 4.60k 10 A ZI219Nti FIG. 561 FIG. 56J

eN 5712 k =1 k,:, : fir zi i }54o6 A:.=

FIG. 56K FIG. 56L

.iNk vsk At. g }54o6 Att kr6 str" .4kp FIG. 56M FIG. 56N
\ e . . . .= µ= 5100 =,õ ..\=Nµ

,.\.\ = = \/ =,;.....A iii... õii, \,. k, , ,=,/
\
"NW 5702 " k= ..,. ,.-µ%=\ \ "
''N.10.=== 5702 =
FIG. 560 FIG. 56P

0.>

FIG. 56Q 5704 5100 === 5404 \\KiHs 1:17' FIG. 56R

===\7-FIG. 56S

4eir N

N

tr) N
N'N
s s SS:
s ;
,11 s *ti CO , t s ik4 1"--S s LO
=sr "
co s 0 S S
S U-S
s s 411i II
-=14 #mi,4%
, Sikfr N
co co lt) tf) 110 f:C3) 11) co CO

.7*
oz, u, CO CO
to ,44\
co CO
lf) CO
cD
cD
cD
CI
CO
ir) =
co 1() / V. =

/4/Aap, ZAMIMMir._ FIG. 59 =

=="`,, #oi "9 )=`=
6014 $10:1 6010 .
114 ri FIG. 60A
=
6000¨... 6002 6006 \
hoolor =10';eol 6012 ced;

FIG. 60B

CO

CD
CO
\11411111) (t) LI-1111111 =
<NI
co co V
=-/
C=4 CO

\
6002 =
6000 hi 6016 ,,,4111101111111 5108 FIG. 62A

µ.\
&

I r ."
6000 =Ill 6016 41111I1IrP

. 5108 = FIG. 62B

$4 A

6402 sAY _/ 5406 Nµ4, eo =
d I:

FIG. 63A

e; ,." = -'11% - - Ns 5402 St 4 1 5404 . 1 t 6402 e = -,:s 5406 \N
e0 '0 r 0 1 g i i #
0.
4 , g ill 1 i i FIG. 63B

} 5404 \

6014 4 ;
N!
;
6018 = = 6016 FIG. 64 í

FIG. 65

8¨) w "4. =N

movinemme FIG. 66 6808 visL

A v jo-el*
.3!
II, A 7 FIG. 67 =

r \1/4 =
cifr FIG. 68 r I Mir, / A

7006 -Yr FIG. 69 __________________________________________________ 5108 7¨'5104 7102¨Z-Conductivity Sensor FIG. 70 7001,µ
A\ lk FIG. 71 , .
, .
, , , 0, , Ari...- .

/

, = ..õ..0( / õ/õ,/ / / ,/,-ialt.10140, = t oo 130 ,--=
..

- 10 hil..1111111 2026b nqi, 4), i 2026a To Patientl / ) 25a 25b .
(441\L'*-------- 2024 =
FIG. 72 /
From Patient o o o o Pressure Ripple Change During an Occlusion It ' (9 250 ( a) ci 150 ,/

=
(.) Time [sec]
FIG. 73A

o o o 108 Change in Integrated End of Stroke Filtered Value For An Occlusion o x 16 _________________________________________ 14 _________________________________________ -c) 12 _____________________________________ 111 = 10 ___________________________________ (I) = 8 ____________________________________ IL

Q) '42 4 ______________________________________ o LLJ

-2 _______________ 9 75 BO = 85 90 95 100 time [sec]
FIG. 73B

, .
, ,--, Zero Degree Phase Relationship , , 0, , VolumeFlow õ 1 - ¨ Pod 1 1 i ---Pod 2 5i ............... 1 (n 1 i ¨.. l i -5 q ...... ... ....... -=:( -10 __________________________________ _i .................................
¨ =-:i ............... ______,_ _ _ i 0 5 0 0 5 0 _____________ 0 secons Pod Volumes ...............................................................................
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EPatient) __________________________________ Drain Reservoir Valve FIG. 87

Claims

We claim:

1. A reciprocating positive-displacement pump comprising:
a hemispherical rigid chamber wall;
a flexible membrane attached to the rigid chamber wall, so that the flexible membrane and rigid chamber wall define a pumping chamber;
an inlet for directing flow through the rigid chamber wall into the pumping chamber in a direction that is substantially tangential to the rigid chamber wall; and an outlet for directing flow through the rigid chamber wall out of the pumping chamber in a direction that is substantially tangential to the rigid chamber wall.

2. A reciprocating positive-displacement pump comprising:
a hemispherical rigid chamber wall;
a flexible membrane attached to the rigid chamber wall, so that the flexible membrane and rigid chamber wall define a pumping chamber;
an inlet for directing flow through the rigid chamber wall into the pumping chamber in a direction that provides low-shear flow into the pumping chamber;
and an outlet for directing flow through the rigid chamber wall out of the pumping chamber in a direction that provides low-shear flow out of the pumping chamber.

3. A reciprocating positive-displacement pump comprising:
a hemispheroid rigid chamber wall; the wall having a perimeter;
a flexible membrane attached to the wall's perimeter, so that the flexible membrane and rigid chamber wall define a pumping chamber;
an inlet for directing flow through the rigid chamber wall into the pumping chamber; and an outlet for directing flow through the rigid chamber wall out of the pumping chamber, the outlet being spaced away from the wall's perimeter;
wherein the membrane is made from silicone.

4. A reciprocating positive-displacement pump comprising:
a hemispheroid rigid chamber wall; the wall having a perimeter;
a flexible membrane attached to the wall's perimeter, so that the flexible membrane and rigid chamber wall define a pumping chamber;

an inlet for directing flow through the rigid chamber wall into the pumping chamber; and an outlet for directing flow through the rigid chamber wall out of the pumping chamber, the outlet being spaced away from the wall's perimeter;
wherein the membrane includes bumps that space a central portion of the membrane away from the rigid chamber wall when the membrane is in a minimum-pumping-chamber-volume position.

5. A reciprocating positive-displacement pump according to any of claims 1 or 2, wherein the rigid chamber wall has a perimeter, and wherein the flexible membrane is attached to the wall's perimeter.

6. A reciprocating positive-displacement pump according to any of claims 1 or 2, wherein the rigid chamber wall has a perimeter, and wherein the outlet is spaced away from the perimeter.

7. A reciprocating positive-displacement pump according to any of claims 1, 2, or 4, wherein the membrane is made from silicone.

8. A reciprocating positive-displacement pump according to any of claims 1, 2, 3, or 4, wherein the membrane is made from high-elongation silicone.

9. A reciprocating positive-displacement pump according to any of claims 1, 2, or 3, wherein the membrane includes bumps that space a central portion of the membrane away from the rigid chamber wall when the membrane is in a minimum-pumping-chamber-volume position.

10. A reciprocating positive-displacement pump according to any of claims 1, 2, 3, or 4, wherein the inlet is oriented to produce a circulatory fluid flow within the pumping chamber toward the outlet and the outlet is oriented so that flow directed out of the pumping chamber peels off of the circulatory flow in a laminar fashion.

11. A reciprocating positive-displacement pump according to any of claims 1, 2, 3, or 4, further including a rigid limit structure for limiting movement of the membrane and limiting the maximum volume of the pumping chamber, the flexible membrane and the rigid limit structure defining an actuation chamber.

12. A reciprocating positive-displacement pump according to claim 11, wherein the actuation chamber is adapted for actuation by pressurized control fluid, and wherein the rigid limit structure includes an integral actuation port.

13. A reciprocating positive-displacement pump according to claim 11, wherein the rigid chamber wall and the rigid limit structure are interconnected.

14. A reciprocating positive-displacement pump according to claim 13, wherein the rigid chamber wall and the rigid limit structure are interconnected by ultrasonic welding.

15. A reciprocating positive-displacement pump according to claim 13, wherein the membrane is held in place between the rigid chamber wall and the rigid limit structure.

16. A reciprocating positive-displacement pump according to claim 11, wherein the rigid limit structure limits movement of the flexible membrane such that the rigid chamber and the flexible membrane urged against the rigid limit structure define the pumping chamber as a spherical volume when the pumping chamber is at maximum volume.

17. A reciprocating positive-displacement pump according to claim 16, wherein the rigid limit structure is a hemispherical limit wall that, together with the flexible membrane, defines a spherical actuation chamber when the pumping chamber is at minimum volume.

18. A reciprocating positive-displacement pump according to claim 11, further including an actuation system that intermittently provides either a positive or a negative pressure to the actuation chamber.

19. A reciprocating positive-displacement pump according to claim 18, wherein the actuation system includes:
a reservoir containing a control fluid at either a positive or a negative pressure, and a valving mechanism for controlling the flow of control fluid between the actuation chamber and the reservoir.

20. A reciprocating positive-displacement pump according to claim 19, wherein the valving mechanism includes one of:
a binary on-off valve; and a variable-restriction valve.

21. A reciprocating positive-displacement pump according to claim 19, further including:
an actuation-chamber pressure transducer for measuring the pressure of the actuation chamber; and a controller that receives pressure information from the actuation-chamber pressure transducer and controls the valving mechanism.

22. A reciprocating positive-displacement pump according to claim 21, wherein the controller causes dithering of the valving mechanism and determines when a stroke ends from pressure information from the actuation-chamber pressure transducer.

23. A reciprocating positive-displacement pump according to claim 22, wherein the controller controls the valving mechanism to cause the flexible membrane to reach either the rigid chamber wall or the rigid limit structure at each of a stroke's -beginning and end, wherein the controller determines the amount of flow through the pump based on a number of strokes.

24. A reciprocating positive-displacement pump according to claim 21, wherein the controller integrates pressure information from the actuation-chamber pressure transducer over time during a stroke to detect an aberrant flow condition.

25. A reciprocating positive-displacement pump according to claim 21, further including:
a reservoir pressure transducer for measuring the pressure of the pressure of gas in the reservoir, wherein the controller receives pressure information from the reservoir pressure transducer.

26. A reciprocating positive-displacement pump according to claim 25, wherein the controller compares the pressure information from the actuation-chamber and reservoir pressure transducers to determine whether either of the pressure transducers are malfunctioning.

27. A reciprocating positive-displacement pump according to claim I I, further including an actuation system that alternately provides positive and negative pressure to the actuation chamber.

28. A reciprocating positive-displacement pump according to claim 27, wherein the actuation system includes:
a positive-pressure reservoir;
a negative-pressure reservoir; and a valving mechanism for controlling the flow of control fluid between the actuation chamber and each of the reservoirs.

29. A reciprocating positive-displacement pump according to claim 28, wherein the valving mechanism includes one of:
separate positive and negative supply valves for controlling the flow of control fluid between the actuation chamber and the reservoirs;wherein each supply valve is one of a binary on-off valve and a variable-restriction valve; and a three-way supply valve for controlling the flow of control fluid between the actuation chamber and the reservoirs.

30. A reciprocating positive-displacement pump according to claim 28, further including:

an actuation-chamber pressure transducer for measuring the pressure of the actuation chamber; and a controller that receives pressure information from the actuation-chamber pressure transducer and controls the valving mechanism.

31. A reciprocating positive-displacement pump according to claim 30, wherein the controller causes dithering of the valving mechanism and determines when a stroke ends from pressure information from the actuation-chamber pressure transducer.

32. A reciprocating positive-displacement pump according to claim 31, wherein the controller controls the valving mechanism to cause the flexible membrane to reach either the rigid chamber wall or the rigid limit structure at each of a stroke's beginning and end, wherein the controller determines the amount of flow through the pump based on a number of strokes.

33. A reciprocating positive-displacement pump according to claim 30 wherein the controller integrates pressure information from the actuation-chamber pressure transducer over time during a stroke to detect an aberrant flow condition.

34. A reciprocating positive-displacement pump according to claim 30, further including:
a positive-pressure-reservoir pressure transducer for measuring the pressure of the positive-pressure reservoir; and a negative-pressure-reservoir pressure transducer for measuring the pressure of the negative-pressure reservoir, wherein the controller receives pressure information from the positive-pressure-reservoir and negative-pressure-reservoir pressure transducers.

35. A reciprocating positive-displacement pump according to claim 34, wherein the controller compares the pressure information from the actuation-chamber, positive-pressure-reservoir, and negative-pressure reservoir pressure transducers to determine whether any of the pressure transducers are malfunctioning.

36. A reciprocating positive-displacement pump according to any of claims 1, 2, 3, or 4, further including an inlet valve for preventing flow out of the pumping chamber through the inlet and an outlet valve for preventing flow into the pumping chamber through the outlet.

37. A reciprocating positive-displacement pump according to claim 36, wherein the inlet valve and the outlet valve are passive check valves.

38. A reciprocating positive-displacement pump according to claim 36, wherein the inlet valve and the outlet valve are actively controlled valves.

39. A reciprocating positive-displacement pump according to any of claims 1, 2, 3, or 4, wherein the pump is adapted for pumping a liquid.

40. A reciprocating positive-displacement pump according to any of claims 1, 2, 3, or 4, wherein the pump is adapted for pumping a biological liquid.

41. A reciprocating positive-displacement pump according to any of claims 1, 2, 3, or 4, wherein the pump is adapted for pumping blood.

42. A reciprocating positive-displacement pump according to any of claims 1, 2, 3, or 4, wherein the pump is adapted for pumping heated blood.

43. A reciprocating positive-displacement pump according to any of claims 1, 2, 3, or 4, further comprising:
a purge port in fluid communication with the pumping chamber, the purge port permitting expulsion of air from the pumping chamber.

44. A reciprocating positive-displacement pump according to any of claims 1, 2, 3, or 4, further comprising:
a secondary inlet in fluid communication with the pumping chamber, the secondary inlet permitting introduction of a secondary fluid into the pumping chamber.

45. A reciprocating positive-displacement pump according to claim 44, wherein the secondary inlet comprises one of:
a luer port;
a syringe port; and a hollow spike.

46. A reciprocating positive-displacement pump according to claim 44, wherein the secondary fluid includes one of:
a medical solution;
a chemical solution;
a dilutant, a blood thinner; and an anticoagulant.

47. A system for pumping comprising:
a pair of reciprocating positive-displacement pumps as in any of the preceding claims;
an inlet line coupled to both pumps' inlets; and an outlet line coupled to both pumps' outlets.

48. A system according to claim 47, wherein the pair of reciprocating positive-displacement pumps are configured to permit independent operation of the pumps for providing different flow-patterns through the inlet and outlet lines.

49. A system according to claim 48, wherein the pumps are pneumatically or hydraulically actuated, and wherein the system includes an independent actuation port for each pump.

50. A system according to claim 47, wherein the pumps are pneumatically or hydraulically actuated, and wherein the system includes a single actuation port for both pumps.

51. A system for pumping a biological fluid, the system comprising:

a disposable unit including an inlet line for the biological fluid, an outlet line for the biological fluid, and first and second spheroid pump pods, each pump pod including a hemispherical rigid chamber wall, a hemispherical rigid actuation wall, a flexible membrane attached to the chamber wall and the actuation wall, so that the flexible membrane and chamber wall define a pumping chamber, and so that the flexible membrane and the actuation wall define an actuation chamber, an inlet valve for permitting flow from the inlet line into the pumping chamber but preventing flow out of the pumping chamber into the inlet line, an outlet valve for permitting flow from the pumping chamber into the outlet line but preventing flow from the outlet line into the pumping chamber, and an actuation port providing fluid communication with the actuation chamber;
and a base unit including receptacle means for receiving and holding the disposable unit, and an actuation system for providing a control fluid under positive or negative pressure to each of the actuation ports.

52. A system according to claim 51, wherein the first and second pump pods are rigidly attached to each other, and wherein the receptacle means includes means for receiving both the first and second pump pods in a single step.

53. A system according to one of claims 51 or 52, wherein the base unit further includes first and second pressure transducers for measuring respectively pressures of the control fluid provided to first pump pod's actuation port and of the control fluid provided to the second pump pod's actuation port; and a controller for receiving pressure information from the first and second pressure transducers and for controlling the actuation system.

54. A system according to claim 53, wherein the controller causes the actuation system to actuate the pump pods out of phase with each other, such that when one pump pod's pumping chamber is substantially full the other pump pod's pumping chamber is substantially empty.

55. A disposable unit for use in a system for pumping a biological fluid, the disposable unit comprising:
an inlet line for the biological fluid;
an outlet line for the biological fluid; and first and second spheroid pump pods, each pump pod including a hemispherical rigid chamber wall, a hemispherical rigid actuation wall, a flexible membrane attached to the chamber wall and the actuation wall, so that the flexible membrane and chamber wall define a pumping chamber, and so that the flexible membrane and the actuation wall define an actuation chamber, an inlet valve for permitting flow from the inlet line into the pumping chamber but preventing flow out of the pumping chamber into the inlet line, an outlet valve for permitting flow from the pumping chamber into the outlet line but preventing flow from the outlet line into the pumping chamber, and an actuation port providing fluid communication with the actuation chamber.

56. A disposable unit according to claim 55, wherein each pump pod includes:
an inlet for directing flow through the rigid chamber wall into the pumping chamber in a direction that provides low-shear flow into the pumping chamber;
and an outlet for directing flow through the rigid chamber wall out of the pumping chamber in a direction that provides low-shear flow out of the pumping chamber.

57. A disposable unit according to claim 56, wherein each pump pod includes:
an inlet for directing flow through the rigid chamber wall into the pumping chamber in a direction that is substantially tangential to the rigid chamber wall; and an outlet for directing flow through the rigid chamber wall out of the pumping chamber in a direction that is substantially tangential to the rigid chamber wall.

58. A disposable unit according to one of claims 55-57, further including a heat-exchanger component in fluid communication with first and second spheroid pump pods, the heat-exchanger component being adapted to be received by a heat exchanger for heating the biological fluid.

59. A disposable unit according to claim 58, wherein the heat-exchanger component includes a flexible bag defining a fluid path.

60. A system for pumping a biological fluid, the system comprising:
a disposable unit including an inlet line for the biological fluid, an outlet line for the biological fluid, and first and second pump pods, each pump pod being capable of delivering a stroke volume during each stroke, and each pump pod having a rigid pod wall enclosing a pump chamber, a reciprocating member adjacent the pump chamber, an inlet valve for permitting flow from the inlet line into the pumping chamber but preventing flow out of the pumping chamber into the inlet line, an outlet valve for permitting flow from the pumping chamber into the outlet line but preventing flow from the outlet line into the pumping chamber, arid an actuation port defined by the rigid pod wall; and a base unit including receptacle means for receiving and holding the disposable unit, and an actuation system for providing a control fluid under positive or negative pressure to each of the actuation ports, wherein the base unit is capable of receiving and holding disposable units having pod pumps with different stroke volumes.

61. A base unit for pumping a biological fluid, the base unit comprising:
receptacle means for receiving and holding a disposable unit, and an actuation system for providing a control fluid under positive or negative pressure to the disposable unit, wherein the base unit is capable of receiving and holding disposable units having pod pumps with different stroke volumes, and wherein the disposable units include first and second pump pods, each pump pod being capable of delivering a stroke volume during each stroke, and each pump pod having a rigid pod wall enclosing a pump chamber, and an actuation port defined by the rigid pod wall for permitting fluid communication between the actuation system and the reciprocating member.

62. A pump comprising:
means for drawing fluid into or urging fluid out of a pumping chamber;
means for determining a flow rate through the pumping chamber; and a controller for determining an amount of work required to achieve the flow rate and for generating an alarm if the amount of work indicates an aberrant flow condition.

63. A reciprocating positive-displacement pump comprising:
a rigid chamber wall;
a flexible membrane attached to the rigid chamber wall, so that the flexible membrane and rigid chamber wall define a pumping chamber;
an inlet for directing flow through the rigid chamber wall into the pumping chamber;
an outlet for directing flow through the rigid chamber wall out of the pumping chamber;
a rigid limit wall for limiting movement of the membrane and limiting the maximum volume of the pumping chamber, the flexible membrane and the rigid limit wall forming an actuation chamber, the rigid chamber wall and the rigid limit wall providing physical limits to the movement of the flexible membrane through a stroke;
an actuation system that intermittently provides either positive or negative pressure to the actuation chamber;
an actuation-chamber pressure transducer for measuring the pressure of the actuation chamber; and a controller that receives pressure information from the actuation-chamber pressure transducer and controls the actuation system to cause the flexible membrane to reach the physical limits at a stroke's beginning and end, wherein the controller determines the amount of flow through the pump based on a number of strokes, and wherein the controller integrates pressure information from the actuation-chamber pressure transducer over time during a stroke to detect an aberrant flow condition.

64. A reciprocating positive-displacement pump according to claim 63, wherein the actuation system alternately provides positive and negative pressure to the actuation chamber.

65. A reciprocating positive-displacement pump according to claim 64, wherein the pneumatic actuation system includes:
a positive-pressure reservoir;
a negative-pressure reservoir; and a valving mechanism for controlling the flow of control fluid between the actuation chamber and each of the reservoirs.

66. A reciprocating positive-displacement pump according to claim 65, further including a positive-pressure-reservoir pressure transducer for measuring the pressure of the positive-pressure reservoir, and a negative-pressure-reservoir pressure transducer for measuring the pressure of the negative-pressure reservoir, wherein the controller receives pressure information from the positive-pressure-reservoir and negative-pressure-reservoir pressure transducers.

67. A reciprocating positive-displacement pump according to claim 66, wherein the controller compares the pressure information from the actuation-chamber, positive-pressure-reservoir and negative-pressure-reservoir pressure transducers to determine whether any of the pressure transducers are malfunctioning.

68. A reciprocating positive-displacement pump according to claim 63, wherein the actuation system includes:

a reservoir containing a control fluid at either a positive or a negative pressure;
and a valving mechanism for controlling the flow of control fluid between the actuation chamber and the reservoir.

69. A reciprocating positive-displacement pump according to claim 68, further including-a reservoir pressure transducer for measuring the pressure of the pressure of control fluid in the reservoir, wherein the controller receives pressure information from the reservoir pressure transducer.

70. A reciprocating positive-displacement pump according to claim 69, wherein the controller compares the pressure information from the actuation-chamber and reservoir pressure transducers to determine whether either of the pressure transducers are malfunctioning.

71. A reciprocating positive-displacement pump according to any of claims 65 or 68, wherein the controller causes dithering of valving mechanism and determines when a stroke ends from pressure information from the actuation-chamber pressure transducer.

72. A reciprocating positive-displacement pump according to claim 63, further including an inlet valve for preventing flow out of the pump and an outlet valve for preventing flow into the pump.

73. A reciprocating positive-displacement pump according to claim 63, wherein the pump is adapted for pumping a liquid.

74. A method for controlling flow comprising:
pumping fluid through a pumping chamber by at least one of drawing fluid into the pumping chamber and urging fluid out of a pumping chamber;
determining a flow rate through the pumping chamber;
determining an amount of work required to achieve the flow rate; and generating an alarm if the amount of work in relation to the flow rate indicates an aberrant flow condition.

75. A method according to claim 74, wherein pumping the fluid, determining the flow rate, and determining the amount of work comprises:
providing a rigid chamber wall, a flexible membrane attached to the rigid chamber wall, so that the flexible membrane and rigid chamber wall define the pumping chamber;
providing an inlet for directing flow through the rigid chamber wall into the pumping chamber and an outlet for directing flow through the rigid chamber wall out of the pumping chamber;
providing a rigid limit wall for limiting movement of the membrane and limiting the maximum volume of the pumping chamber, the flexible membrane and the rigid limit wall forming an actuation chamber, the rigid chamber wall and the rigid limit wall providing physical limits to the movement of the flexible membrane through a stroke;
providing an actuation system that intermittently provides either positive or negative pressure to the actuation chamber;
providing an actuation-chamber pressure transducer for measuring the pressure of the actuation chamber;
receiving pressure information from the actuation-chamber pressure transducer;
controlling the actuation system to cause the flexible membrane to reach the physical limits at a stroke's beginning and end;
determining the amount of flow through the pump based on a number of strokes; and integrating pressure information from the actuation-chamber pressure transducer over time during a stroke to detect an aberrant flow condition.

76. A reciprocating positive-displacement pump comprising:
a reciprocating member having a first face towards a pumping chamber and a second face towards an actuation chamber;
an inlet for directing flow into the pumping chamber;
an outlet for directing flow out of the pumping chamber;

an actuation-chamber pressure transducer for measuring the pressure of the actuation chamber;
an actuation system that intermittently provides positive or negative pressure to the actuation chamber, wherein the actuation system includes a reservoir containing control fluid under positive or negative pressure, a valving mechanism for controlling the flow of control fluid between the actuation chamber and the reservoir, and a reservoir pressure transducer for measuring the pressure of the control fluid in the reservoir, and a controller that controls the actuation system to move the reciprocating member, receives pressure information from the actuation-chamber and reservoir pressure transducers, and compares the pressure information to determine whether either of the pressure transducers are malfunctioning.

77. A pump according to claim 76, wherein the controller controls the pressure of the reservoir to ensure it does not exceed a pre-set limit.

78. A reciprocating positive-displacement pump comprising:
a rigid chamber wall;
a flexible membrane attached to the rigid chamber wall, so that the flexible membrane and rigid chamber wall define a pumping chamber;
an inlet for directing flow through the rigid chamber wall into the pumping chamber;
an outlet for directing flow through the rigid chamber wall out of the pumping chamber;
a rigid actuation wall, the flexible membrane and the rigid limit wall forming an actuation chamber;
an actuation-chamber pressure transducer for measuring the pressure of the actuation chamber;
an actuation system that alternately provides positive and negative pressure to the actuation chamber, wherein the actuation system includes a positive-pressure reservoir, a negative-pressure reservoir, a valving mechanism for controlling the flow of control fluid between the actuation chamber and each of the reservoirs, a positive-pressure-reservoir pressure transducer for measuring the pressure of the positive-pressure reservoir, and a negative-pressure-reservoir pressure transducer for measuring the pressure of the negative-pressure reservoir; and a controller that controls the actuation system to move the flexible membrane, receives pressure information from the actuation-chamber, positive-pressure-reservoir and negative-pressure-reservoir pressure transducers, and compares the pressure information to determine whether any of the pressure transducers are malfunctioning.

79. A valving system including:
a valve cassette containing a plurality of valves, each valve including a valving chamber and an actuation chamber, each valve being actuatable by a control fluid in the actuation chamber;
a control cassette having a plurality of fluid-interface ports for providing fluid communication with a control fluid from a base unit; and a plurality of tubes extending between the valve cassette and the control cassette, each tube providing fluid communication between a fluid-interface port and at least one actuation chamber, such that the base unit can actuate a valve by pressurizing control fluid in a fluid interface port.

80. A valving system according to claim 79, wherein the valve cassette includes a pump actuatable by a control fluid, and wherein the plurality of tubes includes a tube providing fluid communication between a fluid-interface port and the pump, such that the base unit can actuate the pump by pressurizing control fluid in a fluid interface port.

81. A pumping system including:
a pump cassette containing a plurality of pumps, each pump including a pumping chamber and an actuation chamber, each pump being actuatable by a control fluid in the actuation chamber;
a control cassette having a plurality of fluid-interface ports for providing fluid communication with a control fluid from a base unit; and a plurality of tubes extending between the pump cassette and the control cassette, each tube providing fluid communication between a fluid-interface port and at least one actuation chamber, such that the base unit can actuate a pump by pressurizing control fluid in a fluid interface port.

82. A pumping system according to claim 81, wherein the pump cassette includes a valve actuatable by a control fluid, and wherein the plurality of tubes includes a tube providing fluid communication between a fluid-interface port and the valve, such that the base unit can actuate the valve by pressurizing control fluid in a fluid interface port.

83. A diaphragm for use in a reciprocating positive-displacement pump, the diaphragm having a circular rim and a pre-formed hemispheroid membrane attached to the rim.

84. A diaphragm according to claim 83, wherein the membrane includes a configuration of raised structures on a pump chamber side.

85. A diaphragm for use in a reciprocating positive-displacement pump, the diaphragm having a rim and a membrane attached to the rim, the membrane including a configuration of raised structures on a pump chamber side.

86. A diaphragm according to any of claims claim 84 or 85, wherein the raised structures include raised bumps.

87. A diaphragm according to claim 86, wherein the raised structures are located away from the rim.

88. A diaphragm according to any of claims 83 or 85, wherein the rim is adapted for interconnection with at least one of a pump chamber wall and an actuation chamber wall.

89. A diaphragm according to any of claims 83 or 85, wherein the rim and the membrane are made from silicone.

90. A diaphragm according to claim 89, wherein the rim and the membrane are made from high-elongation silicone.

91. A diaphragm according to any of claims 83 or 85, wherein the rim and the membrane are integral.

92. A pumping system comprising:
an actuation system for operating a pump pod, the actuation system including a standardized actuation interface for interconnection with pump pods having different pump volumes, an actuation-chamber pressure transducer for measuring pressure in an actuation chamber of the pump pod; and a controller that controls the actuation system to operate the pump pod based on pressure information received from the actuation-chamber pressure transducer, whereby operation of pump pods is independent of pump volume.

93. A pumping system comprising:
an actuation system for operating a pump pod, the actuation system including a standardized actuation interface for interconnection with pump pods having different stroke lengths;
an actuation-chamber pressure transducer for measuring pressure in an actuation chamber of the pump pod; and a controller that controls the actuation system to operate the pump pod based on pressure information received from the actuation-chamber pressure transducer, whereby operation of pump pods is independent of stroke length.

94. A pod pump comprising:
a three-piece housing defining an interior chamber, the housing having a two-piece pumping chamber wall coupled to an actuation chamber wall; and a diaphragm secured to the housing within the interior chamber, the diaphragm dividing the interior chamber into a pumping chamber and an actuation chamber, the housing including a first port in fluid communication with the actuation chamber and at least one second port in fluid communication with the pumping chamber.

95. A pod pump according to claim 94, wherein the three pieces of the housing are interconnected by ultrasonic welding.

96. A pod pump according to claim 94, further including, for each second port, a valve secured between the two pumping chamber wall pieces.

97. A pod pump comprising:
a housing defining an interior chamber; and a diaphragm secured to the housing within the interior chamber, the diaphragm dividing the interior chamber into a pumping chamber and an actuation chamber, the housing including a single port in communication with the pumping chamber for use as both a fluid inlet and a fluid outlet.

98. A pod pump comprising:
a housing defining an interior chamber;
a diaphragm secured to the housing within the interior chamber, the diaphragm dividing the interior chamber into a pumping chamber and an actuation chamber; and a component disposed in the actuation chamber for at least one of limiting motion of the diaphragm, damping the diaphragm's travel, filtering fluid entering or leaving the actuation chamber, damping sound or vibration in the pod pump, and performing fluid management system measurements on fluid in the pumping chamber.

99. A sensing probe comprising:
a probe housing;
a thermal sensor in said probe housing having a sensing end and a connector end;
a probe tip thermally coupled to said sensing end of the thermal sensor and attached to said probe housing, the probe tip adapted for thermal coupling with an inner surface of a thermal well; and at least two leads connected to said connector end of said thermal sensor, whereby thermal energy is transferred from said thermal well to said thermal sensor and whereby temperature information is conveyed through said leads.

100. A sensing probe according to claim 99, further comprising a third lead attached to one of the probe housing, the thermal sensor, and the probe tip for permitting conductivity sensing.

101. A sensing probe according claim 99, further comprising urethane resin between said probe tip and said probe housing.

102. A sensing probe comprising:
a probe housing having a probe tip adapted for thermal coupling with an inner surface of a thermal well;
a thermal sensor in said housing having a sensing end and a connector end, said sensing end thermally coupled to said probe tip; and at least three leads, wherein said leads transfer electrical signals and whereby said signals are used to determine temperature and conductivity.

103. A sensing probe according to any of claims 99-102, further comprising thermal epoxy between said thermal sensor and said probe tip.

104. A sensing probe according to any of claims 99-102, where said probe tip is copper.

105. A sensing probe according to any of claims 99-102, wherein said probe tip is steel.

106. A sensing probe according to any of claims 99-102, wherein the probe tip is a metal including at least one of silver, copper, steel, and stainless steel.

107. A sensing probe according to any of claims 99-102, where said probe housing is plastic.

108. A sensing probe according to any of claims 99-102, wherein said probe housing is metal.

109. A sensing probe according to any of claims 99-102, wherein said housing further comprises a flange disposed about said probe housing.

110. A sensing probe according to claim 109, further comprising a spring in communication with the flange.

111. A sensing probe according to claim 99, wherein the probe tip includes a flange for mating with the housing.

112. A sensing probe according to claim 99, further comprising:
a conductivity sensor attached to one of the probe housing, the thermal sensor, and the probe tip for permitting conductivity sensing; and a third lead attached to the conductivity sensor for transmitting conductivity information.

113. A sensing probe according to claim 102, further comprising a conductivity sensor attached to the housing, wherein at least one of the leads is attached to the conductivity sensor for transmitting conductivity information.

114. A sensing probe according to any of claims 99-102, wherein the housing includes an integrated flexible member.

115. A sensor apparatus comprising:
a probe housing having a probe tip;
a thermal sensor in said housing having a sensing end and a connector end, said sensing end thermally coupled to said probe tip; and at least three leads, wherein said leads transfer electrical signals and whereby said signals are used to determine a temperature and conductivity.

116. The sensor apparatus of claim 115 further comprising a thermal well of a predetermined size and shape wherein said thermal well mates with said probe and said probe tip is thermal coupled to said thermal well.

117. A thermal well comprising:
a hollow housing of a thermally conductive material, said housing having an outer surface and an inner surface, said inner surface of a predetermined shape so as to form a mating relationship with a sensing probe, whereby said mating thermally couples the inner surface with a sensing probe.

118. The thermal well of claim 117 further comprising a predetermined volume of thermal grease on said inner surface.

119. A method for determining temperature and conductivity of a subject media, said method comprising the steps of:
thermally coupling a thermal well and a sensing probe such that temperature and conductivity can be determined;
transferring thermal and conductivity signals through at least 3 leads from said sensing probe; and determining temperature and conductivity using said signals.

120. A method for detecting air in a fluid line, said method comprising:
thermally coupling at least two thermal wells located in a fluid line to sensing probes such that temperature and conductivity can be determined;
transferring conductivity signals through at least 3 leads from said sensing probes;
determining conductivity for each sensing probe;
calculating the difference of conductivity from each sensing probe; and determining if said difference exceeds a threshold.

121. Apparatus comprising a fluid conduit including a well for at least one of transmitting temperature and permitting conductivity sensing of fluid passing through the conduit, wherein the well is adapted for interconnection with a sensor.

122. Apparatus according to claim 121, configured so that a portion of the well comes into contact with fluid in the conduit.

123. Apparatus according to claim 121, configured so that no portion of the well comes into contact with fluid in the conduit.

124. Apparatus according to claim 121, wherein the fluid conduit comprises plastic tubing.

125. Apparatus according to claim 121, wherein the fluid conduit comprises metal tubing.

126. Apparatus according to claim 121, wherein the well and the conduit are integrally formed from the same material.

127. Apparatus according to claim 121, wherein the well is coupled to the fluid conduit.

128. Apparatus according to claim 127, wherein the well is coupled to the fluid conduit using at least one of press fit connection, flexible tabs, adhesive, ultrasonic weld, and a retaining plate and fastener.

129. Apparatus according to claim 127, further including an o-ring between the well and the fluid conduit.

130. Apparatus according to claim 128, wherein the o-ring includes one of a round cross-section, a square cross-section, and an X-shaped cross-section.

131. Apparatus according to claim 129, wherein the well includes a groove to receive a portion of the o-ring.

132. Apparatus according to claim 127, wherein a portion of the well in contact with the conduit is flexible so as to deform the conduit.

133. Apparatus according to claim 132, wherein the portion of the well in contact with the conduit includes a plurality of cuts to provide such flexibility.

134. Apparatus according to claim 121, wherein the well is embedded in the fluid conduit.

135. Apparatus according to claim 134, wherein the well is insert molded into the fluid conduit.

136. Apparatus according to claim 121, wherein the well and the conduit are made of different materials.

137. Apparatus according to claim 136, wherein the conduit is plastic and the well is metallic.

138. Apparatus according to claim 127, wherein the well includes protrusions to help secure the well to the conduit.

139. Apparatus according to claim 121, wherein the conduit has an inner surface and an outer surface and wherein a sensor end of the well is flush with the outer surface.

140. Apparatus according to claim 121, wherein the conduit has an inner surface and an outer surface and wherein a sensor end of the well protrudes beyond the outer surface.

141. Apparatus according to claim 121, wherein the conduit has an inner surface and an outer surface and wherein a sensor end of the well is recessed from the outer surface.

142. A fluid pumping apparatus comprising at least one pump and a well for at least one of transmitting temperature and permitting conductivity sensing of fluid passing through the conduit, wherein the well is adapted for interconnection with a sensor.

143. A fluid pumping apparatus according to claim 142, wherein the at least one pump includes at least one pod pump.

144. A fluid pumping apparatus according to claim 143, wherein the at least one pod pump comprises a pair of pod pumps.

145. A fluid pumping apparatus according to claim 142, wherein the at least one pump and the well are integrated into a cassette.

146. A sensing system comprising:
a sensing probe as in any of claims 99-114; and a well as in any of claims 121-141, the well in communication with the sensing probe for at least one of thermal sensing and conductivity sensing.

147. A method for heating or cooling a fluid, the method comprising:
providing at least one reciprocating positive-displacement pump, each pump having:
a curved rigid chamber wall;
a flexible membrane attached to the rigid chamber wall, so that the flexible membrane and rigid chamber wall define a pumping chamber;
an inlet for directing fluid through the rigid chamber wall into the pumping chamber in at least one of (a) a direction that is substantially tangential to the rigid chamber wall and (b) a direction that provides low-shear flow into the pumping chamber;
and an outlet for directing fluid through the rigid chamber wall out of the pumping chamber in at least one of (a) a direction that is substantially tangential to the rigid chamber wall and (b) a direction that provides low-shear flow out of the pumping chamber;
providing a heat exchanger; and pumping.the fluid from a source using the at least one reciprocating positive-displacement pump so as to cause the fluid to pass through the heat exchanger.

148. A method according to claim 147, wherein each pump is provided with a rigid chamber wall that is hemispheroid.

149. A method according to claim 147, wherein each pump is provided with a rigid limit structure for limiting movement of the membrane and limiting the maximum volume of the pumping chamber, the flexible membrane and the rigid limit structure defining an actuation chamber.

150. A method according to claim 149, wherein each pump is provided with a rigid chamber wall that is hemispheroid and a rigid limit structure that is hemispheroid, such that the pumping chamber is spheroid when the membrane is urged against the rigid limit structure and the actuation chamber is spheroid when the membrane is urged against the rigid chamber wall.

151. A method according to claim 147, wherein providing the at least one reciprocating positive-displacement pump comprises:
providing a pair of reciprocating positive-displacement pumps as in any of the preceding claims.

152. A method according to claim 151, wherein pumping the fluid comprises:
operating the pair of pumps out of phase so as to produce a substantially continuous fluid flow.

153. A method according to claim 147, wherein pumping the fluid comprises:
providing a disposable unit including a heat-exchanger component;
placing the heat-exchanger component in proximity with the heat exchanger;
and pumping the fluid through the heat-exchanger component so as to heat or cool the fluid in the heat-exchanger component.

154. A method according to claim 153, wherein the heat-exchanger component includes at least one of a heat-exchanger bag, a length of tubing, and a radiator.

155. A method according to claim 147, wherein the source is a patient and wherein the fluid is a bodily fluid.

156. A method according to claim 147, further comprising:
pumping the heated fluid to a patient.

157. A method according to claim 156, further comprising:
monitoring the patient's temperature; and controlling operation of at least one of (a) the at least one pump and (b) the heat exchanger in order to attain a predetermined patient temperature.

158. A method according to claim 157, wherein monitoring the patient's temperature comprises:
taking a temperature reading from a first location in the patient's body;
taking a temperature reading from a second location in the patient's body;
comparing the temperature readings from the first and second locations;
generating a first alarm signal indicating faulty temperature readings, if the temperature reading at the first location is not within a pre-set range from the temperature reading at the second location;
determining if the temperature reading from the first location is above a pre-set upper limit; and generating a second alarm signal indicating an overheated condition, if a reading is above the pre-set upper limit.

159. A method according to claim 149, further comprising:
providing a pneumatic actuation system for intermittently providing either a positive or a negative pressure to the actuation chamber of each pump.

160. A method according to claim 159, wherein the pneumatic actuation system is provided with:
a reservoir containing a gas at either a positive or a negative pressure, and a valving mechanism for controlling the flow of gas between the gas reservoir and the actuation chamber of each pump.

161. A method according to claim 160, wherein the pneumatic actuation system is further provided with at least one actuation-chamber pressure transducer for measuring the pressure of the actuation chamber of each pump, and a controller that receives pressure information from the at least one actuation-chamber pressure transducer and controls the valving mechanism.

162. A method according to claim 161, wherein the pneumatic actuation system is further provided with a reservoir pressure transducer for measuring the pressure of the gas in the reservoir, and wherein the controller receives pressure information from the reservoir pressure transducer.

163. A method according to claim 162, wherein the controller compares the pressure information from the actuation-chamber and reservoir pressure transducers to determine whether any of the pressure transducers is malfunctioning.

164. A method according to claim 149, further comprising:
providing a pneumatic actuation system for alternately providing positive and negative pressure to the actuation chamber of each pump.

165. A method according to claim 164, wherein the pneumatic actuation system is provided with:
a positive-pressure gas reservoir;
a negative-pressure gas reservoir; and a valving mechanism for controlling the flow of gas between the gas reservoirs and the actuation chamber of each pump.

166. A method according to claim 165, wherein the pneumatic actuation system is further provided with:
at least one actuation-chamber pressure transducer for measuring the pressure of the actuation chamber of each pump, and a controller that receives pressure information from the at least one actuation-chamber pressure transducer and controls the valving mechanism.

167. A method according to claim 166, wherein the pneumatic actuation system is further provided with:
a positive-pressure-reservoir pressure transducer for measuring the pressure of the positive-pressure gas reservoir; and a negative-pressure-reservoir pressure transducer for measuring the pressure of the negative-pressure gas reservoir, wherein the controller receives pressure information from the positive-pressure-reservoir and negative-pressure-reservoir pressure transducers.

168. A method according to claim 167, wherein the controller compares the pressure information from the actuation-chamber, positive-pressure-reservoir, and negative-pressure reservoir pressure transducers to determine whether any of the pressure transducers are malfunctioning.

169. A method according to claim 168, wherein the controller causes dithering of the valving mechanism and determines an end of stroke from pressure information received from the at least one actuation-chamber pressure transducer.

170. A method according to claim 169, wherein the controller controls the valving mechanism to cause the flexible membrane of each pump to reach either the rigid chamber wall or the rigid limit structure at each of a stroke's beginning and end, and wherein the controller determines the amount of flow through each pump based on a number of strokes.

171. A method according to claim 170, wherein the controller integrates pressure information an actuation-chamber pressure transducer over time during a stroke to detect an aberrant flow condition.

172. A method according to claim 147, wherein the inlet of each pump is provided with an inlet valve for preventing flow out of the pumping chamber through the inlet and the outlet of each pump is provided with an outlet valve for preventing flow into the pumping chamber through the outlet.

173. A method according to claim 172, wherein the inlet valve and the outlet valve are passive check valves.

174. A method according to claim 172, wherein the inlet valve and the outlet valve are actively controlled valves, and wherein pumping the fluid comprises operating the valves.

175. A disposable unit for use in a heat exchanger system, the disposable unit comprising:
at least one reciprocating positive-displacement pump, each pump having a curved rigid chamber wall;
a flexible membrane attached to the rigid chamber wall, so that the flexible membrane and rigid chamber wall define a pumping chamber;
an inlet for directing fluid through the rigid chamber wall into the pumping chamber in at least one of (a) a direction that is substantially tangential to the rigid chamber wall and (b) a direction that provides low-shear flow into the pumping chamber; and an outlet for directing fluid through the rigid chamber wall out of the pumping chamber in at least one of (a) a direction that is substantially tangential to the rigid chamber wall and (b) a direction that provides low-shear flow out of the pumping chamber; and a heat-exchanger component, in fluid communication with the at least one pump and adapted to be received by a heat exchanger.

176. A disposable unit according to claim 175, wherein the heat-exchanger component includes at least one of a heat-exchanger bag, a length of tubing, and a radiator.

177. A disposable unit according to clam 175, wherein each pump includes a rigid chamber wall that is hemispheroid.

178. A disposable unit according to claim 175, wherein each pump includes a rigid limit structure for limiting movement of the membrane and limiting the maximum volume of the pumping chamber, the flexible membrane and the rigid limit structure defining an actuation chamber.

179. A disposable unit according to claim 150, wherein each pump includes a rigid chamber wall that is hemispheroid and a rigid limit structure that is hemispheroid, such that the pumping chamber is spheroid when the membrane is urged against the rigid limit structure and the actuation chamber is spheroid when the membrane is urged against the rigid chamber wall.

180. A disposable unit according to claim 175, wherein the at least one reciprocating positive-displacement pump comprises a pair of reciprocating positive-displacement pumps as in any of claims 175-179.

181. A disposable unit according to claim 180, wherein the pair of pumps are capable of being operated out of phase so as to produce a substantially continuous fluid flow.

182. A disposable unit according to claim 175, wherein the inlet of each pump includes an inlet valve for preventing flow out of the pumping chamber through the inlet and the outlet of each pump includes an outlet valve for preventing flow into the pumping chamber through the outlet.

183. A disposable unit according to claim 182, wherein the inlet valve and the outlet valve are passive check valves.

184. A disposable unit according to claim 182, wherein the inlet valve and the outlet valve are actively controlled valves.

185. A disposable unit according to claim 175, wherein the heat-exchanger component includes an inlet in fluid communication with the outlet of the at least one pump for pumping fluid into the heat-exchanger component for heating or cooling.

186. A disposable unit according to claim 175, wherein the heat-exchanger component includes an outlet in fluid communication with the inlet of the at least one pump for pumping heated or cooled fluid out of the heat-exchanger component.

187. A disposable unit according to claim 175, further comprising:
a filter in fluid communication with an outlet of the heat-exchanger component for filtering heated or cooled fluid flowing out of the heat-exchanger component.

188. A disposable unit according to claim 175, further comprising:
a manifold including:
at least one inlet port for providing fluidic connection to an inlet of the heat-exchanger component; and an outlet port for providing fluidic connection to an outlet of the heat-exchanger component.

189. A disposable unit according to claim 188, wherein the manifold includes a pair of inlet ports for providing fluidic connection to the inlet of the heat-exchanger component.

190. A disposable unit according to claim 189, wherein the at least one reciprocating positive-displacement pump comprises a pair of reciprocating positive-displacement pumps as in any of claims 175-179, and wherein the pair of pumps are coupled to the pair of inlet ports.

191. A disposable unit according to claim 190, wherein the outlets of the pair of pumps are coupled respectively to the pair of inlet ports.

192. A disposable unit according to claim 188, wherein the manifold further includes at least one sensor component, each sensor component disposed in a port and capable of transmitting thermal information regarding fluid passing through the port.

193. A disposable unit according to claim 192, wherein the manifold includes an inlet sensor component disposed in an inlet port and an outlet sensor component disposed in the outlet port.

194. A disposable unit according to claim 192, wherein each sensor component includes a thermal well.

195. A disposable unit according to claim 175, wherein the manifold includes:
an inlet fluid channel connector coupled to the inlet of the heat-exchanger component and in fluid communication with the at least one inlet port; and an outlet fluid channel connector coupled to the outlet of the heat-exchanger component and in fluid communication with the outlet port.

1 96. A disposable unit according to claim 175, further comprising:
a patient connection circuit coupled to the at least one pump and in fluid communication with the heat-exchanger component.

197 A disposable unit according to claim 196, wherein the patient connection circuit includes a length of tubing and a protective material covering a portion of the length of tubing.

198. A disposable unit according to claim 196, further comprising:
a fluid delivery line in fluid communication with the patient connection circuit.

199. A disposable unit according to claim 198, wherein the fluid delivery line includes a connector for coupling with a fluid source.

200. A disposable unit according to claim 175, further comprising:
a separate fluid inlet in fluid communication with the heat-exchanger component.

201. A disposable unit according to claim 200, wherein the separate fluid inlet includes at least one of a luer port, a syringe interface, and a spike.

202. A disposable unit according to claim 175, wherein the at least one pump is integrated into a cassette.

203. A heat-exchanger system comprising:
a heat exchanger for receiving a heat-exchanger component of a disposable unit according to any one of claims 175-202;
a pneumatic actuation system for operating at least one pump of the disposable unit for pumping fluid through the heat-exchanger component; and a controller for controlling the pneumatic actuation system.

204. A heat-exchanger system according to claim 203, further comprising the disposable unit.

205. A heat-exchanger system according to claim 203, further including first and second temperature probes located in a patient's body, and wherein the controller is adapted for monitoring the patient's temperature based on readings from the first and second temperature probes.

206. A heat-exchanger system according to claim 205, wherein the controller is adapted to compare the temperature readings from the first and second locations;
generate a first alarm signal indicating faulty temperature readings, if the temperature reading at the first location is not within a pre-set range from the temperature reading at the second location; determine if the temperature reading from the first or second location is above a pre-set upper limit; and generate a second alarm signal indicating an overheated condition, if a reading is above the pre-set upper limit.

207. A heat-exchanger system according to claim 203, wherein the pneumatic actuation system includes:
a reservoir containing a gas at either a positive or a negative pressure; and a valving mechanism for controlling the flow of gas between the at least one pump and the gas reservoir.

208. A heat-exchanger system according to claim 207, further including:

an actuation-chamber pressure transducer for measuring the pressure of the actuation chamber, wherein the controller is adapted to receive pressure information from the actuation-chamber pressure transducer and control the valving mechanism.

209. A heat-exchanger system according to claim 208, further including:
a reservoir pressure transducer for measuring the pressure of the pressure of gas in the reservoir, wherein the controller is adapted to receive pressure information from the reservoir pressure transducer.

210. A heat-exchanger system according to claim 209, wherein the controller is adapted to compare the pressure information from the actuation-chamber and reservoir pressure transducers to determine whether either of the pressure transducers are malfunctioning.

211. A heat-exchanger system according to claim 203, wherein the pneumatic actuation system is adapted to alternately provide positive and negative pressure to the at least one pump.

212. A heat-exchanger system according to claim 211, wherein the pneumatic actuation system includes:
a positive-pressure gas .reservoir;
a negative-pressure gas reservoir; and a valving mechanism for controlling the flow of ga.s between the at least one pump and each of the gas reservoirs.

213. A heat-exchanger system according to claim 212, further including:
an actuation-chamber pressure transducer for measuring the pressure of the actuation chamber; and a controller that receives pressure information from the actuation-chamber pressure transducer and controls the valving mechanism.

214. A heat-exchanger system according to claim 213, further including:

a positive-pressure-reservoir pressure transducer for measuring the pressure of the positive-pressure gas reservoir; and a negative-pressure-reservoir pressure transducer for measuring the pressure of the negative-pressure gas reservoir, wherein the controller is adapted to receive pressure information from the positive-pressure-reservoir and negative-pressure-reservoir pressure transducers.

215. A heat-exchanger system according to claim 214, wherein the controller compares the pressure information from the actuation-chamber, positive-pressure-reservoir and negative-pressure reservoir pressure transducers to determine whether any of the pressure transducers are malfunctioning.

216 A heat-exchanger system according to one of claims 208 or 213, wherein the controller is adapted to cause dithering of the valving mechanism and determines when a pump stroke ends from pressure information received from the actuation-chamber pressure transducer.

217. A heat-exchanger system according to one of claims 207 or 212, wherein the controller is adapted to control the valving mechanism to cause complete pump strokes, and wherein the controller is adapted to determine the amount of flow through the at least one pump based on a number of strokes.

218. A heat-exchanger system according to one of claims 208 or 213, wherein the controller is adapted to integrate pressure information from the actuation-chamber pressure transducer over time during a stroke to detect an aberrant flow condition.

219. A heat-exchanger system according to claim 203, adapted for pumping and heating blood.

220. A heat-exchanger system according to claim 203, wherein the heat exchanger includes a heating or cooling plate.

221. A heat-exchanger system according to claim 220, wherein the plate is adapted to receive a heat-exchanger bag.

222. A heat-exchanger system according to claim 220, wherein the plate is adapted to receive a heat-exchanger radiator cartridge.

223. A heat-exchanger system according to claim 220, wherein the plate includes an integral radiator having a channel for receiving a length of tubing.

224. A heat-exchanger system according to claim 223, wherein the channel comprises:
an inner loop;
an outer loop; and a serpentine portion connecting the inner and outer loops, such that fluid flowing through portions of tubing disposed in the inner and outer loops of the channel flow in opposite directions.

225. A heat-exchanger system according to claim 203, further comprising:
a manifold interface for receiving a manifold of the disposable unit,

226. A heat-exchanger system according to claim 225, wherein the manifold interface includes at least one sensor for mating with a corresponding sensor component of the manifold.

227. A heat-exchanger system according to claim 226, wherein the controller is adapted to receive temperature information from the at least one sensor and control at least one of the heat exchanger and the pneumatic actuation system based on the temperature information.

228. A heat-exchanger system according to claim 226, wherein the controller is adapted to utilize the at least one sensor for measuring conductivity.

229. A heat-exchanger system according to claim 225, wherein the manifold interface includes at least one pneumatic interface for providing pneumatic pressure to the at least one pump.

230. A heat-exchanger system according to claim 225, wherein the manifold interface includes a data key interface for receiving a data key of the disposable unit, and wherein the controller is adapted to control the heat exchanger and the pneumatic interface based on information received from the data key via the data key interface.

231. A heat-exchanger system according to claim 230, wherein the controller is further adapted to transmit information to the data key via the data key interface.

232. A radiator for use in a heat-exchanger system, the radiator comprising:
a body including a thermally conductive material; and a channel disposed in the body for receiving a length of tubing.

233 A radiator according to claim 232, wherein the channel comprises:
an inner loop;
an outer loop; and a serpentine portion connecting the inner and outer loops, such that fluid flowing through portions of tubing disposed in the inner and outer loops of the channel flow in opposite directions.

234. A method of moving blood between a patient-access device and a heat exchanger for heating the blood, the method comprising:
providing a reciprocating positive-displacement pump;
providing a flow line having a first portion between the patient-access device and the pump and having a second portion between the pump and the heat exchanger;
providing for each of the first and second portions of the flow line a valve for permitting flow in only one direction of the flow line; and actuating the pump to cause the flow of blood between the patient-access device and the heat exchanger.

235 A method according to claim 234, wherein the pump is provided with a flexible membrane as a reciprocating member.

236. A method according to claim 235, wherein the pump is provided with a pneumatic actuation system for alternately providing positive and negative pressure to the membrane.

237. A method according to claim 234, further including monitoring the patient's temperature.

238. A method according to claim 237, wherein monitoring the patient's temperature includes taking a temperature reading from a first location in the patient's body;
taking a temperature reading from a second location in the patient's body;
comparing the temperature readings from the first and second locations;
generating a first alarm signal indicating faulty temperature readings, if the temperature reading at the first location is not within a pre-set range from the temperature reading at the second location;
determining if the temperature reading from the first or second location is above a pre-set upper limit; and generating a second alarm signal indicating an overheated condition, if a reading is above the pre-set upper limit.

239. A system for extracorporeal thermal therapy, the system comprising:
a heat exchanger for heating the blood;
a reciprocating positive-displacement pump for moving blood between a patient-access device and the heat exchanger, the pump having an inlet line and an outlet line;
a first valve, located in the inlet line, for preventing flow of blood out of the pump; and a second valve, located in the outlet line, for preventing flow of blood into the pump.

240. A system according to claim 239, wherein the pump includes a flexible membrane as a reciprocating member.

241. A system according to claim 240, wherein the pump is adapted to be actuated by a pneumatic actuation system that alternately provides positive and negative pressure to the membrane to cause the membrane to reciprocate.

242. A heat exchanger for heating extracorporeal blood for hyperthermia treatment, the heat exchanger comprising a pump according to one of above claims, and further including a heat-exchange flow path having an inlet for unheated blood an outlet for heated blood;
an electricity-to-heat converter that turns electrical power into heat for absorption by the blood;
a first temperature sensor located at the inlet for measuring the temperature of the blood entering the heat exchanger;
a second temperature sensor located at the outlet for measuring the temperature of the blood exiting the heat exchanger;
a metering system that measures the flow rate of blood passing through the heat exchanger; and a controller in communication with the converter, the first and second temperature sensors, and the metering system, the controller receiving information regarding the amount of power being used by the converter, receiving temperature information from the first and second temperature sensors, receiving flow-rate information from the metering system, analyzing the received information in order to determine whether a fault condition exists, and generating a signal if a fault condition is detected.

243. A heat exchanger for heating extracorporeal blood for hyperthermia treatment, the heat exchanger comprising:
an inlet for unheated blood;
an outlet for heated blood;
a flow path from the inlet to the outlet;
a set of heating elements overlapping the flow path, including at least first and second heating elements, the second heating element being located adjacent the flow path near the outlet, and the first heating element being located adjacent the flow path at a point upstream of the second heating element;

a first temperature sensor located adjacent the flow path upstream of the first heating element;
a second temperature sensor located adjacent the flow path between the first and second heating elements; and a controller for receiving temperature information from the first and second temperature sensors and for generating a signal if a temperature difference being measured by the first and second sensors exceeds a limit.

244. A heat exchanger for heating extracorporeal blood for hyperthermia treatment, the heat exchanger comprising:
an inlet for unheated blood;
an outlet for heated blood;
a flow path from the inlet to the outlet;
a set of heating elements overlapping the flow path, including at least first, second and third heating elements, the third heating element being located adjacent the flow path near the outlet, the second heating element being located adjacent the flow path at a point prior to the third heating element, and the first heating element being located adjacent the flow path at a point prior to the second heating element;
a first temperature sensor located adjacent the flow path between the first and second heating elements;
a second temperature sensor located adjacent the flow path between the second and third heating elements; and a controller for receiving temperature information from the first and second temperature sensors and for generating a signal if a temperature difference being measured by the first and second sensors exceeds a limit.

245. A heat exchanger according to claim 244, wherein the flow path courses through a substantially planar disposable unit.

246. A heat exchanger according to claim 245, further including at least a first thermally conductive /late located between the heating elements and the disposable unit.

247. A heat exchanger according to claim 246, further including a second thermally conductive plate located adjacent the disposable unit opposite the first thermally conductive plate;
a second set of heating elements located on a side of the second plate opposite the disposable unit and overlapping the flow path, including at least fourth, fifth and sixth heating elements, the sixth heating element being located adjacent the flow path near the outlet, the fifth heating element being located adjacent the flow path at a point prior to the sixth heating element, and the fourth heating element being located adjacent the flow path at a point prior to the fifth heating element;
a third temperature sensor located adjacent the flow path between the fourth and fifth heating elements; and a fourth temperature sensor located adjacent the flow path between the fifth and sixth heating elements;
wherein the controller receives temperature information from the third and fourth temperature sensors and generates a signal if a temperature difference being measured by the third and fourth sensors exceeds a limit.

248. A heat exchanger according to claim 247, wherein the first and second plates are adapted to squeeze together, upon actuation by the controller, in order to urge blood out of the disposable.

249. A heat exchanger according to one of claims 244 or 247, wherein the signal generated by the controller causes an alarm indication.

250. A heat exchanger according to one of claims 244 or 247, wherein the signal generated by the controller causes the hyperthermia treatment to end.

251. A heat exchanger according to one of claims 244 or 247, further including additional heating elements being located at points along the flow path prior to the first heating element.

252. A heat exchanger according to one of claims 244 or 247, further including additional heating elements being located at points along the flow path between the first and third heating elements.

253. A heat exchanger according to claim 244, wherein the flow path is defined by a flexible bag.

254. A heat exchanger for heating extracorporeal blood for hyperthermia treatment, the heat exchanger comprising:
an inlet for unheated blood;
an outlet for heated blood;
an electricity-to-heat converter that turns electrical power into heat for absorption by the blood;
a first temperature sensor located at the inlet for measuring the temperature of the blood entering the heat exchanger;
a second temperature sensor located at the outlet for measuring the temperature of the blood exiting the heat exchanger;
a metering system that measures the flow rate of blood passing through the heat exchanger; and a controller in communication with the converter, the first and second temperature sensors, and the metering system, the controller receiving information regarding the amount of power being used by the converter, receiving temperature information from the first and second temperature sensors, receiving flow-rate information from the metering system, analyzing the received information in order to determine whether a fault condition exists, and generating a signal if a fault condition is detected.

255. A heat exchanger according to claim 254, further including a disposable unit containing a flow path of the blood from the inlet to the outlet, the disposable unit being made primarily of a thermoplastic material and containing a metal thermowell at each of the inlet and outlet to improve thermal conductivity between the first temperature sensor and the blood in the inlet and between the second temperature sensor and the blood in the outlet.

256. A heat exchanger according to claim 255, further including at least a first thermally conductive plate for conducting heat from the converter to the disposable.

257. A heat exchanger according to claim 256, further including an electrical-conductivity sensor for measuring the resistance between a thermowell and the first plate, the controller being in communication with the electrical-conductivity sensor and generating a second signal if the measured resistance is too low.

258. A heat exchanger according to claim 257, further including a second thermally conductive plate for conducting heat from the converter to a side of the disposable opposite the first plate.

259. A heat exchanger according to claim 258, wherein the electrical-conductivity sensor for measuring the resistance between a thermowell and the second plate, the controller being in communication with the electrical-conductivity sensor and generating a second signal if the measured resistance between the thermowell and second plate is too low.

260. A heat exchanger according to claim 259, wherein the first and second plates are adapted to squeeze together, upon actuation by the controller, in order to urge blood out of the disposable.

261. A heat exchanger according to one of claims 254, 257, or 259, wherein the signal generated by the controller causes an alarm indication.

262. A heat exchanger according to one of claims 254, 257, or 259, wherein the signal generated by the controller causes the hyperthermia treatment to end.

263. A heat exchanger for heating extracorporeal blood for hyperthermia treatment, the heat exchanger comprising:
an inlet for unheated blood;
an outlet for heated blood;
an electricity-to-heat converter that turns electrical power into heat for absorption by the blood;
a disposable unit containing a flow path of the blood from the inlet to the outlet, the disposable unit being made primarily of a thermoplastic material;

an electrical-conductivity sensor for measuring the resistance between the blood in the flow path a thermowell and the converter; and a controller in communication with the electrical-conductivity sensor and generating a signal if the measured resistance does not satisfy a safety parameter.

264. A heat exchanger according to claim 263, wherein the controller generates a signal if the measured resistance is too low.

265. A heat exchanger according to claim 263, wherein the controller generates a signal if the measured resistance is too high.

266. A heat exchanger for heating extracorporeal blood for hyperthermia treatment, the heat exchanger comprising:
a disposable unit having an inlet for unheated blood, an outlet for heated blood, and a flow path of the blood from the inlet to the outlet; and a base unit having a heater for heating blood in the flow path, the heater including a first thermally conductive plate for conducting heat to a first side of the disposable unit, and a second thermally conductive plate for conducting heat to a second side of the disposable unit opposite the first plate, the first and second plates being adapted to squeeze together, upon actuation by a controller, in order to urge blood out of the disposable.

267. A method of locating temperature probes for monitoring a patient's temperature, the method comprising:
taking temperature readings from a first temperature probe to be located at a first location in the patient's body;
taking temperature readings from a second temperature probe to be located at a second location in the patient's body;
comparing the temperature readings from the first and second probes;
positioning the first and second temperature probes in the patient's body;

determining if the temperature reading from the first or second location is above a pre-set limit; and generating a placement signal, if the temperature reading from the first probe is within a pre-set range from the temperature reading from the second probe, and if the reading from the first or second location is above a pre-set limit.

268. A method of providing a hyperthermic treatment to a patient, the method comprising:
providing a heat-exchanger system for heating blood from the patient and pumping heated blood to the patient;
connecting a first temperature probe from the patient to the heat-exchanger system, the heat-exchanger system controlling the blood heating and pumping based on temperature information received from the first temperature probe and displaying the temperature information received from the first temperature probe to an operator;
monitoring patient temperature by the operator using an independent second temperature probe; and terminating the treatment if either of the temperature probes conveys an unacceptable temperature reading.