SENSING FOLEY CATHETER

• US 20130066166A1
• Filed: 03/07/2012
• Published: 03/14/2013
• Est. Priority Date: 03/07/2011
• Status: Active Grant

• Current Assignee: Theranova, Llc
• Original Assignee: Theranova, Llc
• Inventors: Burnett, Daniel R., O'Connor, Richard W., Lee, Greg, Mensh, Brett
• Granted Patent: US 9,662,058 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/16 Devices for psychotechnics using teaching or educational appliances G09B1/00 - G09B7/00; Testing reaction times ; Devices for evaluating the psychological state
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/207 Sensing devices adapted to collect urine
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/392 : Detecting gastrointestinal contractions
• CPC Class Codes: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61B 5/6852 : Catheters
• CPC Class Codes: A61B 5/6853 : with a balloon
• CPC Class Codes: A61B 5/7278 : Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61M 2025/0003 : having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 25/0017 : specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

Foley type catheter embodiments for sensing physiologic data from a urinary tract of a patient are disclosed. The system includes the catheter and a data processing apparatus and methods for sensing physiologic data from the urinary tract. Embodiments may also include a pressure sensor having a pressure interface at a distal end of the catheter, a pressure transducer at a proximal end, and a fluid column disposed between the pressure interface and transducer. When the distal end is residing in the bladder, the pressure transducer can transduce pressure impinging on it into a chronological pressure profile, which can be processed by the data processing apparatus into one or more distinct physiologic pressure profiles, for example, peritoneal pressure, respiratory rate, and cardiac rate. At a sufficiently high data-sampling rate, these physiologic data may further include relative pulmonary tidal volume, cardiac output, relative cardiac output, and absolute cardiac stroke volume.

Claims

1. A method for monitoring physiologic data of a patient comprising:

providing a physiologic data monitoring system comprising a Foley type catheter and a data processing apparatus, the Foley type catheter comprising a pressure sensor, the pressure sensor comprising a pressure interface disposed at a distal end of the catheter, a pressure transducer at a proximal end of the catheter, and a fluid column disposed between the pressure interface and the pressure transducer, and

wherein the pressure transducer is able to transduce pressure impinging on it from the fluid column into physiological data comprising a chronological pressure profile; and

inserting the Foley type catheter in the urinary tract such that the pressure interface is residing within the patient'"'"'s bladder;

transferring pressure sensed in the bladder into a transducible chronological pressure profile;

processing the chronological pressure profile into one or more physiologic pressure profiles selected from the group consisting of peritoneal pressure, respiratory rate, and cardiac rate.

2. The method of claim 1 further comprising tuning a level of pressure being applied from a proximal side of the pressure interface toward equivalence with a baseline physiologic pressure being applied to a distal side of the pressure interface.

3. The method of claim 2 further comprising repeating the tuning step, as needed, to maintain equivalence between the level of pressure being applied from the proximal side of the pressure interface and the baseline physiologic pressure being applied to a distal side of the pressure interface.

4. The method of claim 2 wherein the tuning step comprises monitoring a physiologic pressure profile, and adjusting the pressure being applied from a proximal side of the pressure interface to a level such that a quality of a physiologic pressure profile being processed by the system is optimized.

5. The method of claim 4 further wherein the quality of a physiologic pressure profile being processed comprises an amplitude of the respiratory rate.

6. The method of claim 4 further wherein the monitoring step is performed automatically by the data processor, and the adjusting step is performed by an automatic controller in communication with the data processor.

7. The method of claim 1 further comprising applying pressure to the proximal side of the pressure interface by delivering gas under pressure a space proximal to the pressure interface.

8. The method of claim 1 wherein the gas is air.

9. The method of claim 1 wherein the gas is carbon dioxide.

10. The method of claim 1, wherein the pressure interface comprises a balloon formed from an inelastic membrane, the method further comprising priming the fluid column from the proximal end of the catheter to maintain the balloon at a size that places no substantial strain on the inelastic membrane.

11. The method of claim 1, wherein the pressure interface comprises a balloon formed from an inelastic membrane having a total surface area, the method further comprising inflating the balloon to a level such that the total surface area of the membrane is substantially taut.

12. The method of claim 1 comprising sampling the pressure profile impinging on the transducer at a frequency of at least 1 Hz, the method further comprises quantifying respiratory excursions relative to a baseline magnitude of excursions proximate the time of catheter insertion.

13. The method of claim 12 further comprising monitoring the relative amplitude of respiratory pressure wave excursions, and relating such relative amplitude to relative respiratory tidal volumes.

14. The method of claim 1 comprising sampling the pressure profile impinging on the transducer at a frequency of at least 5 Hz, the method further comprising quantifying peaks on the respiratory pressure wave that are associated with the cardiac rate.

15. The method of claim 14 wherein, against a background of a substantially stable peritoneal pressure, the method further comprises determining any of cardiac output, relative cardiac output, respiratory tidal volume, or absolute cardiac stroke volume.

16. The method of claim 1 wherein the one or more physiologic pressure profiles yielded by processing the chronological pressure profile comprises monitoring of body movement.

17. The method of claim 16 wherein monitoring of body movement comprises notifying a health care provider of the level of movement of a patient that has a decubitis ulcer or who is at risk of developing a decubitis ulcer.

18. The method of claim 1 wherein the catheter further comprises an expandable pressure delivery balloon, a light source and a light sensor proximate the expandable pressure balloon, the light sensor configured to capture light from the light source, the method further comprising inflating the pressure delivery balloon to a desired pressure, and monitoring the pressure within the expandable balloon to determine the pressure level required to blanche the tissue, said blanching pressure being reflective of a tissue perfusion pressure.

19. The method of claim 1 wherein the Foley type catheter further comprises a temperature sensor, the method further comprising monitoring the body temperature of the patient.

20. The method of claim 1 wherein the Foley type catheter further comprises an analyte sensor, the method further comprising monitoring a level of the analyte within the urine of the patient.