Sensing Foley catheter

• US 9,662,058 B2
• Filed: 03/07/2012
• Issued: 05/30/2017
• Est. Priority Date: 03/07/2011
• Status: Active Grant

• Current Assignee: Theranova, Llc
• Original Assignee: Potrero Medical, Inc
• Inventors: Lee, Greg, Mensh, Brett, Burnett, Daniel R., O'Connor, Richard W.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): PAHAKIS, MANOLIS Y
• Application Number:
  US13/414,307
• Publication Number:
  US 20130066166A1
• Time in Patent Office: 1,910 Days
• Field of Search: None
• 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 controller apparatus having a memory component, the Foley type catheter comprising a pressure sensor, the pressure sensor comprising a pressure interface balloon disposed at a distal end of the Foley type catheter, a pressure transducer in fluid communication with a proximal end of the Foley type catheter, a fluid column disposed between the pressure interface balloon and the pressure transducer, and a retention balloon disposed at a distal end of the Foley type catheter between the pressure interface balloon and the pressure transducer, wherein the retention balloon is separate from the pressure sensor, and wherein the pressure transducer is able to transduce pressure impinging on the pressure transducer from the fluid column into a chronological pressure profile;

inserting the pressure interface balloon of the Foley type catheter within the patient'"'"'s bladder;

receiving pressure from the bladder by the pressure transducer, through the pressure interface balloon and the fluid column, and transducing said pressure from the bladder into a chronological pressure profile with the pressure transducer;

collecting urine from the bladder in a urine receptacle in fluid communication with the catheter;

measuring a volume of the urine within the urine receptacle;

receiving patient-specific data into the memory component from a remote source external to the Foley type catheter;

processing via the controller the chronological pressure profile into distinct physiologic pressure profiles which include peritoneal pressure, respiratory rate and cardiac output, wherein the chronological pressure profile has a resolution for said processing;

integrating via the controller the patient-specific data and the distinct physiologic pressure profiles; and

adjusting a pressure exerted within the pressure interface balloon by adding or removing fluid via a fluid delivery system from the fluid column through the proximal end of the catheter until the pressure exerted within the balloon equilibrates with a baseline of the chronological pressure profile.

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

3. The method of claim 2 wherein the fluid is air.

4. The method of claim 2 wherein the fluid is carbon dioxide.

5. The method of claim 1, wherein the pressure interface balloon 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.

6. The method of claim 1, wherein the pressure interface balloon 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.

7. 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 comprises quantifying respiratory excursions relative to a baseline magnitude of excursions proximate a time of catheter insertion.

8. The method of claim 7 further comprising monitoring a relative amplitude of respiratory pressure wave excursions, and relating such relative amplitude to relative respiratory tidal volumes.

9. 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 a respiratory pressure wave that are associated with a cardiac rate.

10. The method of claim 9 wherein against a background of a stable peritoneal pressure, the method further comprises determining any of, relative cardiac output, respiratory tidal volume, or absolute cardiac stroke volume.

11. 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.

12. The method of claim 11 wherein monitoring of body movement comprises notifying a health care provider of a level of movement of a patient that has a decubitis ulcer or who is at risk of developing a decubitis ulcer.

13. The method of claim 1 wherein the Foley type 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.

14. 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.

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

16. The method of claim 1 further comprising sampling the chronological pressure profile at a sampling rate wherein the chronological pressure profile is further resolved into relative pulmonary tidal volume, relative cardiac output, or absolute cardiac stroke volume.

17. The method of claim 1 wherein the Foley type catheter further comprises a blood pressure sensing element disposed in a urethra-residing portion of the Foley type catheter between the pressure transducer and the retention balloon, wherein the blood pressure sensing element is configured to determine a perfusion pressure of tissue abutting the blood pressure sensing element.

18. The method of claim 1 further comprising triggering an alert if the volume of urine detected is above or below a preset range over a set period of time.

19. The method of claim 1 wherein the physiologic pressure profiles further include at least one of relative pulmonary tidal volume, relative cardiac output, or absolute cardiac stroke volume.