SYSTEMS AND METHODS FOR ORGAN MONITORING

• US 20080287788A1
• Filed: 05/14/2007
• Published: 11/20/2008
• Est. Priority Date: 05/14/2007
• Status: Active Application

• Current Assignee: Complete Medical Solutions LLC
• Original Assignee: Lifesciences Solutions LLC
• Inventors: Richardson, Charles L., Kellar, Franz W., Smith, Michael L.
• Application Number:
  US11/748,425
• Publication Number:
  US 20080287788A1
• Time in Patent Office: Days
• US Class Current: 600/437
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4472 Wireless probes
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A method for monitoring a patient'"'"'s organ includes: inputting an electrical signal into the organ; receiving the electrical signal from the organ; and comparing the received electrical signal to a reference electrical signal to determine whether the patient'"'"'s organ is functioning properly. The electrical signals may be representative of flow characteristics. In one aspect, a system for monitoring a patient'"'"'s organ includes a sensor sock having a flexible body adapted to at least partially surround an organ, the sock carrying a plurality of spaced-apart electrodes. In another aspect, the system includes at least one flow transducer adapted to be attached to a blood vessel connected to the organ. A sensor unit is adapted to be implanted into the patient'"'"'s body and to transmit and receive electrical signals from the electrodes or transducers. A computer may be programmed to compare the received electrical signal to the reference electrical signal.

Claims

1. A method for monitoring a patient'"'"'s organ, comprising:

(a) inputting an electrical signal into the organ at a first location;

(b) receiving the electrical signal from the organ at a second location spaced-apart from the first location; and

(c) comparing the received electrical signal to a reference electrical signal to determine whether the patient'"'"'s organ is functioning properly.

2. The method of claim 1 wherein the organ is a kidney.

3. The method of claim 1 wherein the signal is representative of an impedance of the organ.

4. The method of claim 1 wherein the comparing step comprises:

(a) generating a first waveform corresponding to the reference electrical signal;

(b) generating a second waveform corresponding to the received electrical signal; and

(c) measuring an area between the first waveform and the second waveform to determine whether the patient'"'"'s heart is functioning properly.

5. The method of claim 1 wherein the comparing step comprises:

(a) generating a first waveform corresponding to the reference electrical signal;

(b) generating a second waveform corresponding to the received electrical signal;

(c) identifying a plurality of comparison points for the first waveform;

(d) identifying a plurality of comparison points for the second waveform, each of the plurality of comparison points for the second waveform corresponding to one of the comparison points for the first waveform; and

(e) measuring differences between each of the corresponding plurality of comparison points for the first waveform and the second waveform to determine whether the patient'"'"'s heart is functioning properly.

6. A method for monitoring a patient'"'"'s organ, comprising:

(a) measuring a first flow characteristic within a blood vessel which is connected to the organ; and

(b) comparing the first flow characteristic to a reference flow characteristic to determine whether the patient'"'"'s organ is functioning properly.

7. The method of claim 6 wherein the organ is a kidney.

8. The method of claim 6 wherein the first flow characteristic is a fluid flow rate within the vessel.

9. The method of claim 6 wherein the blood vessel is joined by an anastomosis on a first side of the anastomosis, and the first flow characteristic is measured on a first side of the anastomosis, and wherein the reference flow characteristic is a flow characteristic measured in the blood vessel on a second side of the anastomosis.

10. The method of claim 6 wherein the step of measuring a first flow characteristic is carried out by:

(a) inputting a first sound wave into the blood vessel;

(b) receiving a first reflected sound wave from the blood vessel;

(c) generating a first electrical signal in response to the reflected sound wave.

11. A system for monitoring a patient'"'"'s organ, comprising:

(a) A sensor sock comprising a flexible body adapted to at least partially surround an organ, the sock carrying a plurality of spaced-apart electrodes; and

(b) a sensor unit adapted to be implanted into the patient'"'"'s body, the sensor unit connected to the electrodes and adapted to transmit and receive electrical signals from the electrodes.

12. The system of claim 11 wherein at least two of the electrodes are disposed at opposed ends of the sock.

13. The system of claim 11 wherein the sock is at least partially elastic.

14. The system of claim 11 wherein the sensor unit comprises:

(a) a controller operable to transmit electrical signals to and receive electrical signals from the electrodes;

(b) a transceiver operably connected to the controller; and

(c) an transducer operably connected to the transceiver.

15. The system of claim 11 wherein one of the electrodes is a signal electrode adapted to transmit a signal;

and

a plurality of the electrodes are sensor electrodes adapted to receive a signal originating at the signal electrode;

The sensor electrodes being disposed in a spaced-apart arrangement to as to permit propagation of electrical signals throughout substantially all of interior of the organ.

16. The system of claim 15 further comprising a computer programmed to receive the electrical signals from the sensor unit corresponding to a received electrical signal and to compare the registered electrical signal to a reference electrical signal to determine whether the patient'"'"'s organ is functioning properly.

17. The system of claim 16 further comprising a local data unit configured to receive data from the sensor unit and to transmit the received data to the computer.

18. The system of claim 17 further comprising a relay unit adapted to receive data from the sensor unit through inductive coupling therewith and to transmit the received data to the local data unit.

19. A system for monitoring a patient'"'"'s organ, comprising:

(a) At least one transducer adapted to be attached to a blood vessel connected to the organ, and to sense at least one characteristic of flow inside the blood vessel; and

(b) a sensor unit adapted to be implanted into the patient'"'"'s body, the sensor unit connected to the transducer and adapted to transmit and receive electrical signals from the transducer.

20. The system of claim 19 wherein the transducer comprises an ultrasonic sensor operable to:

(a) inputting a sound wave into the blood vessel;

(b) receiving a reflected sound wave from the blood vessel; and

(c) generating an electrical signal in response to the reflected sound wave.

21. The system of claim 19 further comprising a computer programmed to receive the electrical signals from the sensor unit corresponding to a received electrical signal and to compare the registered electrical signal to a reference electrical signal to determine whether the patient'"'"'s organ is functioning properly.

22. The system of claim 19 further comprising a relay unit adapted to receive data from the sensor unit through inductive coupling therewith and to transmit the received data to the local data unit.

23. A system for monitoring a patient'"'"'s organ, comprising:

(a) a sensor unit adapted to be implanted into the patient'"'"'s body, and to register an electrical signal from the patient'"'"'s organ; and

(b) a local data unit in operable communication with the sensor unit, the local data unit configured to receive and store data from the sensor unit and to selectively transmit the received data over a communications path.

24. The system of claim 23 further comprising a computer programmed to receive the electrical signals over the communications path corresponding to a registered electrical signal, and to compare the received electrical signal to a reference electrical signal to determine whether the patient'"'"'s organ is functioning properly.

25. The system of claim 24 wherein the computer is a server including:

(a) a data receiving software module configured to receive data from the local data unit;

(a) an analysis software module configured to compare the registered electrical signal to a reference electrical signal to determine whether the patient'"'"'s organ is functioning properly;

(b) a database configured to store data processed by the analysis software module; and

(c) an electronic medical records software module configured to provide access to the data stored in the database.

26. A method of monitoring a transplanted organ, comprising:

(a) during a first data collection session occurring at a reference time, injecting a predetermined electrical signal into a patient'"'"'s organ;

(b) during the first data collection session, registering a resulting electrical signal from the organ, the resulting electrical signal configured as a first series of waveforms;

(c) generating from the first series of waveforms, a reference waveform representative of the average characteristics of the waveforms collected during the first data collection session;

(d) during a subsequent data collection session occurring at a time subsequent to the reference time, injecting the predetermined electrical signal into the patient'"'"'s organ;

(e) during the subsequent data collection session, registering a resulting electrical signal from the organ, the electrical signal configured as a second series of waveforms;

(f) generating from the second series of waveforms, a registered waveform representative of the average characteristics of the waveforms collected during the subsequent data collection session; and

(g) comparing the registered waveform to the reference waveform to determine whether the organ is functioning properly.

27. The method of claim 26 in which step (e) is carried out by:

(a) measuring the difference between at least one element of the registered waveform and a corresponding element of the reference waveform; and

(b) characterizing the difference in a scale of rejection in which a greater degree of difference corresponds to a greater degree of allograft rejection.

28. The method of claim 26 further comprising repeating steps (c)-(e) at selected intervals after the reference time so as to generate a plurality of registered waveforms.

29. The method of claim 26 in which step (e) is carried out by:

(a) adding the plurality of registered waveforms to a statistical database to create a data population;

(b) determining at least one difference between the registered waveforms and the reference waveform based on a statistical analysis of a plurality of elements of the registered waveforms and corresponding elements of the reference waveform; and

(c) characterizing the difference in a scale of rejection in which a greater degree of difference corresponds to a greater degree of allograft rejection.

30. The method of claim 26 further comprising:

(h) prior to step (b), evaluating whether each of the waveforms in the first series is usable according to a predetermined standard;

(i) discarding waveforms from the first series which are not usable; and

(j) storing the remaining waveforms of the first series in a database for use in generating the reference waveform;

31. The method of claim 26 further comprising:

(f) prior to step (b), evaluating whether each of the waveforms in the subsequent series is usable according to a predetermined standard;

(g) discarding waveforms from the subsequent series which are not usable; and

(h) storing the remaining waveforms of the subsequent series in a database for use in generating the registered waveform.

32. A method of monitoring a transplanted organ, comprising:

(a) during a data collection session, injecting a predetermined electrical signal into a patient'"'"'s organ, the electrical signal configured as a series of waveforms;

(b) during the data collection session, registering a resulting electrical signal from a patient'"'"'s organ, the electrical signal configured as a series of waveforms;

(c) evaluating whether each of the waveforms is usable according to a predetermined standard;

(d) discarding waveforms which are not usable;

(e) storing the remaining waveforms in a database for evaluation; and

(f) comparing the stored waveforms to a reference waveform to determine whether the organ is functioning properly.

33. The method of claim 32 further comprising:

(a) incrementing a discard counter each time a waveform is discarded;

(b) comparing the value of the discard counter to a predetermined limit; and

(c) setting an error flag if the discard counter exceeds a predetermined limit.

34. The method of claim 32 further comprising generating, from the remaining waveforms, an average waveform representative of the average characteristics of all of the waveforms collected during the data collection session.

35. The method of claim 32 further comprising:

(f) storing a first set of waveforms according to steps (a)-(e) during a first data session occurring at a reference time;

(g) generating from the remaining waveforms in the first data collection session, the reference waveform, wherein the reference waveform is representative of the average characteristics of the waveforms stored during the first data collection session;

(h) storing a subsequent set of waveforms according to steps (a)-(e) during a subsequent data collection session occurring at a time subsequent to the reference time; and

(i) generating from the remaining waveforms in the subsequent data collection session, a registered waveform representative of the average characteristics of the waveforms stored during the subsequent data collection session.

36. The method of claim 35 comprising repeating steps (h) and (i) at selected intervals after the reference time so as to generate a plurality of registered waveforms.

37. The method of claim 35 wherein the reference time is shortly after the organ is transplanted into the patient.

38. A method of processing data for monitoring a patient'"'"'s organ, comprising:

(a) during a data collection session, injecting an electrical signal into a patient'"'"'s organ;

(b) during the data collection session, registering a resulting electrical signal from the organ, the electrical signal configured as a series of waveforms, wherein each of said waveform includes at least one upslope element extending to a peak;

(c) establishing a minimum slope value;

(d) comparing the actual slope value of each portion of the upslope to the minimum slope value; and

(e) designating any point within the waveform in which the actual slope value is less than the minimum slope value to be a peak.

39. The method of claim 38 further comprising:

(a) establishing the time value at which the peak occurs;

(b) applying a hysteresis band with predetermined upper and lower voltage limits to the waveform;

(c) calculating a voltage-time slope for a segment of the upslope immediately preceding the peak;

(d) using the calculated voltage-time slope, linearly extrapolating the upslope to a point at which a voltage value thereof intercepts the upper limit of the hysteresis band; and

(e) establishing the time value at which the interception occurs.