SENSING FOLEY CATHETER

• US 20130030262A1
• Filed: 03/07/2012
• Published: 01/31/2013
• Est. Priority Date: 03/07/2011
• Status: Active Grant

• Current Assignee: Theranova, Llc
• Original Assignee: Theranova, Llc
• Inventors: BURNETT, Daniel R., LEE, Greg J., O'CONNOR, Richard W., MENSH, Brett
• Granted Patent: US 9,655,555 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• 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 Foley type catheter for sensing physiologic data from a urinary tract of a patient comprising:

a 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,

wherein, when the catheter is inserted into the urinary tract and the distal end is residing in the bladder, the pressure transducer can transduce pressure impinging on it from the pressure interface into a chronological pressure profile, the pressure profile having sufficient resolution to be processed into one or more distinct physiologic pressure profiles, said physiologic pressure profiles selected from a group consisting of peritoneal pressure, respiratory rate, and cardiac rate.

2. The Foley type catheter of claim 1 wherein the pressure profile has sufficient resolution such that, when sampled by a transducer at a frequency of at least about 1 Hz, it can be processed to yield a relative pulmonary tidal volume profile.

3. The Foley type catheter of claim 1 wherein the pressure profile has sufficient resolution such that, when sampled by a transducer at a frequency of at least about 5 Hz, it can be processed to yield physiologic pressure profiles selected from a group consisting of cardiac output, relative cardiac output, and absolute cardiac stroke volume.

4. The Foley type catheter of claim 1 wherein the fluid a gas.

5. The Foley type catheter of claim 1 wherein the fluid comprises a liquid.

6. The Foley type catheter of claim 1 wherein the pressure interface comprises an elastic membrane.

7. The Foley type catheter of claim 1 wherein the pressure interface comprises a substantially inelastic membrane.

8. The Foley type catheter of claim 1 wherein the pressure interface comprises an expandable balloon.

9. The Foley type catheter of claim 1 wherein the pressure interface comprises a membrane arranged across an opening.

10. The Foley type catheter of claim 1 further comprising a temperature sensor to monitor a body core temperature of the patient.

11. The Foley type catheter of claim 1 further comprising an analyte sensor.

12. The Foley type catheter of claim 11 wherein the analyte sensor is able to sense an analyte selected from a group consisting of pH, a gas, an electrolyte, a metabolic substrate, a metabolite, an enzyme, or a hormone.

13. The Foley type catheter of claim 1 further comprising one or more electrical activity sensors.

14. The Foley type catheter of claim 1 further comprising a light source and a light sensor, the sensor configured to capture light emitted from the light source.

15. The Foley type catheter of claim 1 further comprising:

an expandable pressure-delivery balloon disposed on the catheter so as, upon expansion, to contact a wall of the bladder or the urethra; and

a light source and a light sensor disposed proximate the tissue-compressing balloon, wherein, when the expandable pressure balloon is expanded so as to blanche a tissue surrounding it as detected by the light sensor, a light-based signal from the light sensor may be processed to yield a perfusion pressure on a urinary bladder wall or a urethra.

16. A Foley type catheter for sensing physiologic data from a urinary tract of a patient comprising:

a 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;

an expandable pressure-delivery balloon disposed on the catheter so as, upon expansion, to contact a wall of the bladder or the urethra; and

a light source and a light sensor disposed proximate the tissue-compressing balloon, wherein, when the catheter is inserted into the urinary tract and the distal end is residing in the bladder, the pressure transducer can transduce pressure impinging on it from the pressure interface into a chronological pressure profile, the pressure profile having sufficient resolution to be processed into one or more distinct physiologic pressure profiles, said physiologic pressure profiles selected from a group consisting of peritoneal pressure, respiratory rate, and cardiac rate, and

when the expandable pressure balloon is expanded so as to blanche a tissue surrounding it as detected by the light sensor, a light-based signal from the light sensor may be processed to yield a perfusion pressure on a urinary bladder wall or a urethra.

17. A system for sensing physiologic data from a urinary tract of a patient comprising:

a Foley type catheter comprising a pressure sensor, wherein the pressure sensor comprises 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, when the catheter is inserted into the urinary tract and the distal end is residing in the bladder, the pressure transducer transduces pressure impinging on it from the fluid column into physiological data comprising a chronological pressure profile; and

a data processing apparatus in communication with the pressure transducer so as to be able to acquire the physiological data, the data processing apparatus configured to process the chronological pressure profile into one or more physiologic pressure profiles from the group consisting of peritoneal pressure, respiratory rate, and cardiac rate.

18. The system of claim 17, wherein the pressure transducer is operable to sample pressure impinging on it at a rate of at least about 1 Hz.

19. The system of claim 17, wherein the pressure transducer is operable to sample pressure impinging on it at a rate of at least about 5 Hz.

20. A system for sensing physiologic data from a urinary tract of a patient comprising:

a Foley type catheter comprising sensing elements, said elements comprising a pressure sensor, a temperature sensor, and one or more analyte sensors;

wherein the pressure sensor comprises 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, when the catheter is inserted into the urinary tract and the distal end is residing in the bladder, the pressure transducer transduces pressure impinging on it from the fluid column into physiological data comprising a chronological pressure profile; and

a data processing apparatus in communication with the pressure transducer so as to be able to acquire the physiological data, the data processing apparatus configured to process the chronological pressure profile into one or more physiologic pressure profiles from the group consisting of peritoneal pressure, respiratory rate, and cardiac rate,

wherein the data processing apparatus is further configured to acquire and process signals from the one or more analyte sensors and to acquire and process signals from the temperature sensor.