Methods and apparatus for measuring the volume of fluid in the peritoneal cavity
First Claim
1. A method for determining the volume of fluid in the peritoneal cavity of a subject comprising:
- (a) placing measuring electrodes MLL and MRL on the loins of the subject, MLL being placed on the left loin and MRL being placed on the right loin, MLL and MRL defining a loin plane;
(b) placing measuring electrodes MLB and MRB on the buttocks of the subject, MLB being placed on the left buttock and MRB being placed on the right buttock, MLB and MRB defining a buttock plane;
(c) placing upper current-providing electrodes ILU and IRU on the subject, ILU being outboard of measuring electrode MLL and IRU being outboard of measuring electrode MRL;
(d) placing lower current-providing electrodes IRL and ILL on the subject, IRL being outboard of measuring electrode MRB and ILL being outboard of measuring electrode MLB;
(e) connecting upper current-providing electrode ILU to upper current-providing electrode IRU;
(f) connecting lower current-providing electrode ILL to lower current-providing electrode IRL;
(g) applying current I between the connected upper current-providing electrodes and the connected lower current-providing electrodes;
(h) measuring the voltage Φ
L between MLL and MLB while current I is applied;
(i) measuring the voltage Φ
R between MRL and MRB while current I is applied; and
(j) determining the volume V of fluid in the peritoneal cavity based on the equation;
V=(KP/σ
)·
(LP2/R)where;
(1) KP is a subject-specific calibration constant;
(2) σ
is the conductivity of the fluid in the peritoneal cavity;
(3) LP is the distance between the loin plane and the buttock plane; and
(4) R is the average of RL and RR, where
RL=Φ
L/I, and
RR=Φ
R/I.
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Accused Products
Abstract
Methods and apparatus for determining peritoneal cavity fluid volume include four groups of two electrodes applied to a subject'"'"'s skin. Measuring electrodes (MLL, MRL) are applied to the subject'"'"'s loins, measuring electrodes (MLB, MRB) are applied to the subject'"'"'s buttocks, and upper and lower current-providing electrodes (IRU, ILU, IRL, ILL) are applied to the subject'"'"'s left and right sides distal from the measuring electrodes (MLL, MRL, MLB, MRB). The resistance between left measuring electrodes (MLL, MLB) is measured and the resistance between right measuring electrodes (MRL, MRB) is measured while current is applied between the upper and lower current-providing electrodes. By averaging resistance values, in combination with a calibration procedure, measurements of peritoneal cavity fluid volume are obtained. The measurement techniques can be used in continuous flow peritoneal dialysis to control or adjust dialysis parameters based on peritoneal cavity fluid.
43 Citations
40 Claims
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1. A method for determining the volume of fluid in the peritoneal cavity of a subject comprising:
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(a) placing measuring electrodes MLL and MRL on the loins of the subject, MLL being placed on the left loin and MRL being placed on the right loin, MLL and MRL defining a loin plane; (b) placing measuring electrodes MLB and MRB on the buttocks of the subject, MLB being placed on the left buttock and MRB being placed on the right buttock, MLB and MRB defining a buttock plane; (c) placing upper current-providing electrodes ILU and IRU on the subject, ILU being outboard of measuring electrode MLL and IRU being outboard of measuring electrode MRL; (d) placing lower current-providing electrodes IRL and ILL on the subject, IRL being outboard of measuring electrode MRB and ILL being outboard of measuring electrode MLB; (e) connecting upper current-providing electrode ILU to upper current-providing electrode IRU; (f) connecting lower current-providing electrode ILL to lower current-providing electrode IRL; (g) applying current I between the connected upper current-providing electrodes and the connected lower current-providing electrodes; (h) measuring the voltage Φ
L between MLL and MLB while current I is applied;(i) measuring the voltage Φ
R between MRL and MRB while current I is applied; and(j) determining the volume V of fluid in the peritoneal cavity based on the equation;
V=(KP/σ
)·
(LP2/R)where; (1) KP is a subject-specific calibration constant; (2) σ
is the conductivity of the fluid in the peritoneal cavity;(3) LP is the distance between the loin plane and the buttock plane; and (4) R is the average of RL and RR, where
RL=Φ
L/I, and
RR=Φ
R/I.- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
where RB=(Φ
LB+Φ
RB)/(2I), andRA=(Φ
LA+Φ
RA)/(2I).
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3. The method of claim 2 where VC is at least one liter.
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4. The method of claim 1 wherein KP is determined by:
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(i) introducing dialysis fluid into the subject'"'"'s peritoneal cavity; (ii) performing steps (g), (h), and (i) to obtain Φ
LB and Φ
RB;(iii) removing fluid from the subject'"'"'s peritoneal cavity; (iv) performing steps (g), (h), and (i) to obtain Φ
LA and Φ
RA; and(v) determining KP from the equation;
KP=(σ
C)·
(VC/LP2)·
(RBRA)/(RA−
RB)where RB=(Φ
LB+Φ
RB)/(2I),RA=(Φ
LA+Φ
RA)/(2I), andVC and σ
C are, respectively, the volume and conductivity of the fluid removed in step (iii).
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5. The method of claim 4 where VC is at least one liter.
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6. The method of claim 1 wherein the current I is alternating current having a frequency in the range from about 5 kilohertz to about 500 kilohertz.
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7. The method of claim 6 wherein the current I has a frequency of about 5 kilohertz.
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8. The method of claim 1 wherein the upper current-providing electrodes are placed on the subject'"'"'s hands and the lower current-providing electrodes are placed on the subject'"'"'s feet.
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9. The method of claim 1 wherein the upper current-providing electrodes are placed on the subject'"'"'s trunk and the tower current-providing electrodes are placed on the subject'"'"'s thighs.
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10. The method of claim 1 wherein the upper current-providing electrodes and the measuring electrodes MLL and MRL are carried by a common support which is placed on the subject'"'"'s trunk.
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11. The method of claim 1 wherein the lower current-providing electrode ILL and the measuring electrode MLB are carried by a first common support which is placed at least in part on the subject'"'"'s left leg and the lower current-providing electrode IRL and the measuring electrode MRB are carried by a second common support which is placed at least in part on the subjects right leg.
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12. A method of controlling a peritoneal dialysis procedure comprising:
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(A) continuously flowing dialysis fluid through a subject'"'"'s peritoneal cavity; (B) while step (A) is being performed, determining the volume of fluid in the peritoneal cavity by a bioimpedance measurement directed at the peritoneal cavity; and (C) controlling step (A) based on the volume of fluid in the peritoneal cavity determined in step (B). - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. Apparatus for determining the volume of fluid in the peritoneal cavity of a subject comprising:
-
(a) measuring electrodes MLL and MRL for placement on the loins of the subject, MLL to be placed on the left loin and MRL to be placed on the right loin such that, when so placed, MLL and MRL define a loin plane; (b) measuring electrodes MLB and MRB for placement on the buttocks of the subject, MLB to be placed on the left buttock and MRB to be placed on the right buttock such that, when so placed, MLB and MRB define a buttock plane; (c) upper current-providing electrodes ILU and IRU for placement on the subject; (d) lower current-providing electrodes IRL and ILL for placement on the subject; (e) means for connecting upper current-providing electrode ILU to upper current-providing electrode IRU; (f) means for connecting lower current-providing electrode ILL to lower current-providing electrode IRL; (g) means for applying a current I between the connected upper current-providing electrodes and the connected lower current-providing electrodes; (h) means for measuring the voltage Φ
L between MLL and MLB while current I is applied;(i) means for measuring the voltage Φ
R between MRL and MRB while current I is applied; and(j) means for determining the volume V of fluid in the peritoneal cavity based on the equation;
V=(KP/σ
)·
(LP2/R)where; (1) KP is a subject-specific calibration constant; (2) σ
is the conductivity of the fluid in the peritoneal cavity;(3) LP is the distance between the loin plane and the buttock plane; and (4) R is the average of RL and RR, where RL=Φ
L/I, andRR=Φ
R/I.- View Dependent Claims (23, 24, 25, 26, 27, 28)
where RB=(Φ
LB+Φ
RB)/(2I), andRA=(Φ
LA+Φ
RA)/(2I).
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24. The apparatus of claim 22 further comprising means for determining KP, said means comprising:
-
(i) means for introducing dialysis fluid into the subject'"'"'s peritoneal cavity; (ii) means for determining the voltage Φ
LB between MLL and MLB and the voltage Φ
RB between MRL and MRB while current I is applied, said determination being made before removal of fluid from the subject'"'"'s peritoneal cavity;(iii) means for removing fluid from the subject'"'"'s peritoneal cavity; (iv) means for measuring the volume VC of fluid removed from the subject'"'"'s peritoneal cavity; (v) means for determining the voltage Φ
LA between MLL and MLB and the voltage Φ
RA between MRL and MRB while current I is applied, said determination being made after the removal of the volume VC of fluid from the subject'"'"'s peritoneal cavity; and(vi) means for determining KP from the equation;
KP=(σ
C)·
(VC/LP2)·
(RBRA)/(RA−
RB)where
RB=(Φ
LB+Φ
RB)/(2I),
RA=(Φ
LA+Φ
RA)/(2I), andσ
C is the conductivity of the fluid removed from the subject'"'"'s peritoneal cavity.
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25. The apparatus of claim 22 wherein the current I is alternating current having a frequency in the range from about 5 kilohertz to about 500 kilohertz.
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26. The apparatus of claim 25 wherein the current I has a frequency of about 5 kilohertz.
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27. The apparatus of claim 22 further comprising a support for carrying the upper current-providing electrodes and the measuring electrodes MLL and MRL.
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28. The apparatus of claim 22 further comprising a first support for carrying the lower current-providing electrode ILL and the measuring electrode MLB and a second support for carrying the lower current-providing electrode IRL and the measuring electrode MRB.
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29. Apparatus for performing a peritoneal dialysis procedure comprising:
-
(A) first means for continuously flowing dialysis fluid through a subject'"'"'s peritoneal cavity, said flowing of dialysis fluid being capable of causing the accumulation of ultrafiltrate from the subject in the peritoneal cavity; (B) second means for determining the volume of fluid in the peritoneal cavity while dialysis fluid is flowed through the subject'"'"'s peritoneal cavity, said second means comprising means for performing a bioimpedance measurement directed at the peritoneal cavity; and (C) third means for controlling the first means based on the volume of fluid in the peritoneal cavity determined by the second means. - View Dependent Claims (30, 31, 32, 33, 34)
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35. An article of manufacture comprising a computer usable medium having computer readable code means embodied therein for:
-
(a) determining the volume V of fluid in the peritoneal cavity of a subject based on the equation;
V=(KP/σ
)·
(LP2/R)where; (1) KP is a subject-specific calibration constant (2) σ
is the conductivity of the fluid in the peritoneal cavity;(3) LP is the distance between a loin plane and a buttock plane of the subject, the loin plane being established by the locations of measuring electrodes MLL and MRL placed on the subject'"'"'s left and right loins, respectively, and the buttock plane being established by measuring electrodes MLB and MRB placed on the subject'"'"'s left and right buttocks, respectively; and (4) R is the average of RL and RR, where (i) RL=Φ
L/I,(ii) RR=Φ
R/I, and(iii) I is an applied current between connected upper current-providing electrodes ILU IRU and connected lower current-providing electrodes IRL and ILL placed on the subject with ILU and IRU being outboard of measuring electrode MLL, IRU being outboard of measuring electrode MRL, IRL being outboard of measuring electrode MRB and ILL being outboard of measuring electrode MLB, and (iv) Φ
L and Φ
R are measured voltages between MLL and MLB and between MRL and MRB, respectively, while current I is applied; and(b) displaying the value of the calculated volume V to the subject and/or to a care provider and/or controlling the flow of dialysis fluid through the suibject'"'"'s peritoneal cavity using the calculated volume V.
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36. An article of manufacture comprising a computer usable medium having computer readable code means embodied therein for:
-
(a) determining a subject-specific for use in determining the volume of fluid in the subject'"'"'s peritoneal cavity calibration constant KP from the equation;
KP=(σ
C)·
(VC/LP2)·
(RBRA)/(RB−
RA)where (i) RB=(Φ
LB+Φ
RB)/(2I);(ii) RA=(Φ
LA+Φ
RA)/(2I);(iii) VC and σ
C are, respectively, the volume and conductivity of a predetermined volume of dialysis fluid;(iv) LP is the distance between a loin plane and a buttock plane of the subject, the loin plane being established by the locations of measuring electrodes MLL and MRL placed on the subject'"'"'s left and right loins, respectively, and the buttock plane being established by measuring electrodes MLB and MRB placed on the subject'"'"'s left and right buttocks, respectively; (v) I is an applied current between connected upper current-providing electrodes ILU and IRU connected lower current-providing electrodes IRL and ILL placed on the subject with ILU being outboard of measuring electrode MLL, IRU being outboard of measuring electrode MRL, IRL being outboard of measuring electrode MRB and ILL being outboard of measuring electrode MLB, (vi) Φ
LA and Φ
RA are measured voltages between MLL and MLB and between MRL and MRB, respectively, obtained before introduction of the predetermined volume of dialysis fluid into the subject'"'"'s peritoneal cavity and while current I is applied; and(vii) Φ
LA and Φ
RA are measured voltages between MLL and MLB and between MRL and MRB, respectively, obtained after introduction of the predetermined volume of dialysis fluid into the subject'"'"'s peritoneal cavity and while current I is applied; and(b) displaying the value of the calculated subject-specific calibration constant KP to the subject and/or to a care provider and/or controlling the flow of dialysis fluid through the subject'"'"'s peritoneal cavity using the calculated subject-specific calibration constant KP.
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37. An article of manufacture comprising a computer usable medium having computer readable code means embodied therein for:
-
(a) determining a subject-specific for use in determining the volume of fluid in the subject'"'"'s peritoneal cavity calibration constant KP from the equation;
KP=(σ
C)·
(VC/LP2)·
(RBRA)/(RB−
RA)where (i) RB=(Φ
LB+Φ
RB)/(2I);(ii) RA=(Φ
LA+Φ
RA)/(2I);(iii) LP is the distance between a loin plane and a buttock plane of the subject, the loin plane being established by the locations of measuring electrodes MLL and MRL placed on the subject'"'"'s left and right loins, respectively, and the buttock plane being established by measuring electrodes MLB and MRB placed on the subject'"'"'s left and right buttocks, respectively; (iv) I is an applied current between connected upper current-providing electrodes ILU and IRU and connected lower current-providing electrodes IRL and ILL placed on the subject with ILU being outboard of measuring electrode MLL, IRU being outboard of measuring electrode MRL, IRL being outboard of measuring electrode MRB and ILL being outboard of measuring electrode MLB, (v) Φ
LB and Φ
RB are measured voltages between MLL and MLB and between MRL and MRB, respectively, obtained after introduction of dialysis fluid into the subject'"'"'s peritoneal cavity and while current I is applied;(vi) Φ
LA and Φ
RA are measured voltages between MLL and MLB and between MRL and MRB, respectively, obtained after removal of fluid from the subject'"'"'s peritoneal cavity and while current I is applied; and(vii) VC and σ
C are, respectively, the volume and conductivity of the fluid removed from the subject'"'"'s peritoneal cavity; and(b) displaying the value of the calculated subject-specific calibration constant KP to the subject and/or to a care provider and/or controlling the flow of dialysis fluid through the subject'"'"'s peritoneal cavity using the calculated subject-specific calibration constant KP.
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38. Apparatus comprising a computer which has been programmed to:
-
(a) determine the volume V of fluid in the peritoneal cavity of a subject based on the equation;
V=(KP/σ
)·
(LP2/R)where; (1) KP is a subject-specific calibration constant, (2) σ
is the conductivity of the fluid in the peritoneal cavity;(3) LP is the distance between a loin plane and a buttock plane of the subject, the loin plane being established by the locations of measuring electrodes MLL, and MRL, placed on the subject'"'"'s left and right loins, respectively, and the buttock plane being established by measuring electrodes MLB and MRB placed on the subject'"'"'s left and right buttocks, respectively; and (4) R is the average of RL and RR, where (i) RL=Φ
L/I,(ii) RR=Φ
R/I, and(iii) I is an applied current between connected upper current-providing electrodes ILU and IRU and connected lower current-providing electrodes IRL and ILL placed on the subject with ILU being outboard of measuring electrode MLL, IRU being outboard of measuring electrode MRL, IRL being outboard of measuring electrode MRB and ILL being outboard of measuring electrode MLB, and (iv) Φ
L and Φ
R are measured voltages between MLL and MLB and between MRL and MRB, respectively, while current I is applied; and(b) display the value of the calculated volume V to the subject and/or to a care provider and/or control the flow of dialysis fluid through the subject'"'"'s peritoneal cavity using the calculated volume V.
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39. Apparatus comprising a computer which has been programmed to:
-
(a) determine a subject-specific for use in determining the volume of fluid in the subject'"'"'s peritoneal cavity calibration constant KP from the equation;
KP=(σ
C)·
(VC/LP2)·
(RBRA)/(RB−
RA)where (i) RB=(Φ
LB+Φ
RB)/(2I);(ii) RA=(Φ
LA+Φ
RA)/(2I);(iii) VC and σ
C are, respectively, the volume and conductivity of a predetermined volume of dialysis fluid;(iv) LP is the distance between a loin plane and a buttock plane of the subject, the loin plane being established by the locations of measuring electrodes MLL and MRL placed on the subject'"'"'s left and right loins, respectively, and the buttock plane being established by measuring electrodes MLB and MRB placed on the subject'"'"'s left and right buttocks, respectively; (v) I is an applied current between connected upper current-providing electrodes ILU a IRU and connected lower current-providing electrodes IRL and ILL placed on the subject with ILU being outboard of measuring electrode MLL, IRU being outboard of measuring electrode MRL, IRL being outboard of measuring electrode MRB and ILL being outboard of measuring electrode MLB, (vi) Φ
LB and Φ
RB are measured voltages between MLL and MLB and between MRL and MRB, respectively, obtained before introduction of the predetermined volume of dialysis fluid into the subject'"'"'s peritoneal cavity and while current I is applied; and(vii) Φ
LA and Φ
RA are measured voltages between MLL and MLB and between MRL and MRB, respectively, obtained after introduction of the predetermined volume of dialysis fluid into the subject'"'"'s peritoneal cavity and while current I is applied; and(b) display the value of the calculated subject-specific calibration constant KP to the subject and/or to a care provider and/or control the flow of dialysis fluid through the subject'"'"'s peritoneal cavity using the calculated subject-specific calibration constant KP.
-
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40. Apparatus comprising a computer which has been programmed to:
-
(a) determine a subject-specific for use in determining the volume of fluid in the subject'"'"'s peritoneal cavity calibration constant KP from the equation;
KP=(σ
C)·
(VC/LP2)·
(RBRA)/(RB−
RA)where (i) RB=(Φ
LB+Φ
RB)/(2I);(ii) RA=(Φ
LA+Φ
RA)/(2I);(iii) LP is the distance between a loin plane and a buttock plane of the subject, the loin plane being established by the locations of measuring electrodes MLL and MRL placed on the subject'"'"'s left and right loins, respectively, and the buttock plane being established by measuring electrodes MLB and MRB placed on the subject'"'"'s left and right buttocks, respectively (iv) I is an applied current between connected upper current-providing electrodes ILU and IRU and connected lower current-providing electrodes IRL and ILL placed on the subject with ILU being outboard of measuring electrode MLL, IRU being outboard of measuring electrode MRL, IRL being outboard of measuring electrode MRB and ILL being outboard of measuring electrode MLB, (v) Φ
LB and Φ
RB are measured voltages between MLL and MLB and between MRL and MRB, respectively, obtained after introduction of dialysis fluid into the subject'"'"'s peritoneal cavity and while current I is applied;(vi) Φ
LA and Φ
RA are measured voltages between MLL and MLB and between MRL and MRB, respectively, obtained after removal of fluid from the subject'"'"'s peritoneal cavity and while current I is applied; and(vii) VC and σ
C are, respectively, the volume and conductivity of the fluid removed from the subject'"'"'s peritoneal cavity; and(b) display the value of the calculated subject-specific calibration constant KP to the subject and/or to a care provider and/or control the flow of dialysis fluid through the subject'"'"'s peritoneal cavity using the calculated subject-specific calibration constant KP.
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Specification