Sensing foley catheter

• US 9,655,555 B2
• Filed: 03/07/2012
• Issued: 05/23/2017
• Est. Priority Date: 03/07/2011
• Status: Active Grant

• Current Assignee: Theranova, Llc
• Original Assignee: Potrero Medical, Inc
• Inventors: Burnett, Daniel R., Lee, Greg, Mensh, Brett, O'Connor, Richard W.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): PAHAKIS, MANOLIS Y
• Application Number:
  US13/414,011
• Publication Number:
  US 20130030262A1
• Time in Patent Office: 1,903 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, 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 system for sensing physiologic data from a urinary tract of a patient comprising:

a Foley type catheter comprising a pressure sensor having a pressure balloon disposed at a distal end of the catheter;

a pressure transducer in fluid communication with a proximal end of the catheter;

a fluid column disposed between the pressure balloon and the pressure transducer;

a fluid delivery system in fluid communication with the fluid column;

a retention balloon disposed at a distal end of the Foley type catheter between the pressure balloon and the pressure transducer, wherein the retention balloon is separate from the pressure sensor; and

a urine receptacle in fluid communication with the catheter, wherein the urine receptacle is configured to measure a volume of urine output from the patient;

wherein the catheter is configured to be inserted into the urinary tract such that the distal end is residing in the bladder,

wherein the pressure transducer is configured to transduce pressure impinging on the pressure transducer from the pressure balloon into a chronological pressure profile having a resolution that enables processing of the chronological pressure profile into distinct physiologic profiles,

a controller in communication with the pressure transducer and the urine receptacle configured to process the chronological pressure profile into the distinct physiologic pressure profiles, which include peritoneal pressure, respiratory rate and cardiac output,

wherein the controller is configured to automatically adjust a pressure exerted within the pressure balloon by adding or removing fluid via the 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, and

wherein the controller is configured to receive patient-specific data from a source external to the Foley type catheter and is further configured to integrate the received patient-specific data with the distinct physiologic pressure profiles.

2. The system of claim 1 wherein the pressure transducer is configured to sample the chronological pressure profile at a frequency of at least 5 Hz, wherein the controller in communication with the pressure transducer is configured to process the chronological pressure profile, wherein the processing of the controller has a resolution to yield a relative pulmonary tidal volume profile.

3. The system of claim 1 wherein the pressure transducer is configured to sample the chronological pressure profile at a frequency of at least 5 Hz, and wherein the controller in communication with the pressure transducer is configured to process the chronological pressure profile, wherein the processing of the controller has a resolution to yield physiologic pressure profiles selected from a group consisting of relative cardiac output, and absolute cardiac stroke volume.

4. The system of claim 1 wherein the fluid comprises a gas.

5. The system of claim 1 wherein the fluid comprises a liquid.

6. The system of claim 1 wherein the pressure balloon comprises an expandable balloon.

7. The system of claim 1 further comprising a temperature sensor to monitor a body core temperature of the patient.

8. The system of claim 1 further comprising an analyte sensor.

9. The system of claim 8 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.

10. The system of claim 1 wherein the pressure transducer is configured to sample the chronological pressure profile at a sampling rate and the controller further resolves the chronological pressure profile into relative pulmonary tidal volume, relative cardiac output, or absolute cardiac stroke volume.

11. The system of claim 1 further comprising a docking station in communication with the urine receptacle, wherein the docking station is configured for data transmission to the controller regarding the volume of urine output detected in the urine receptacle.

12. The system of claim 1 wherein the controller is configured to trigger an alert if the detected volume of urine output is above or below a preset range over a set period of time.

13. The system 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.

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

a Foley type catheter comprising a pressure sensor and a temperature sensor, wherein the pressure sensor comprises a pressure balloon disposed at a distal end of the catheter;

a pressure transducer in fluid communication with a proximal end of the catheter;

a fluid column disposed between the pressure balloon and the pressure transducer;

a fluid delivery system in fluid communication with the fluid column;

a retention balloon disposed at a distal end of the Foley type catheter between the pressure balloon and the pressure transducer, wherein the retention balloon is separate from the pressure sensor, and wherein, the catheter is configured to be inserted into the urinary tract such that the distal end is residing in the bladder, wherein the pressure transducer is configured to transduce pressure impinging on the pressure transducer from the fluid column into physiologic data comprising a chronological pressure profile having a resolution that enables processing of the chronological pressure profile into distinct physiologic profiles;

a urine receptacle in fluid communication with the catheter, wherein the urine receptacle is configured to measure a volume of urine output from the patient;

a controller apparatus in communication with the pressure transducer and the urine receptacle and capable of acquiring the physiological data, wherein the controller apparatus is configured to process the chronological pressure profile into the distinct physiologic pressure profiles, which include peritoneal pressure, respiratory rate and cardiac rate;

wherein the controller apparatus is configured to automatically adjust a pressure exerted within the pressure balloon by adding or removing fluid via the 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, and

wherein the controller is configured to receive patient-specific data from a source external to the Foley type catheter and is further configured to integrate the received patient-specific data with the distinct physiologic pressure profiles.

15. The system of claim 14, wherein the pressure transducer is operable to sample pressure impinging on the pressure transducer at a rate of at least 5 Hz.

16. The system of claim 14 wherein the fluid comprises a gas.

17. The system of claim 14 further comprising a docking station in communication with the urine receptacle, wherein the docking station is configured for data transmission to the controller regarding the volume of urine output detected in the urine receptacle.

18. The system of claim 14 wherein the controller is configured to trigger an alert if the detected volume of urine output is above or below a preset range over a set period of time.

19. The system of claim 14 wherein the physiologic pressure profiles further include at least one of relative pulmonary tidal volume, relative cardiac output, or absolute cardiac stroke volume.

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

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

a fluid delivery system in fluid communication with a fluid column;

wherein the pressure sensor comprises a pressure balloon disposed at a distal end of the catheter, a pressure transducer in fluid communication with a proximal end of the catheter, the fluid column disposed between the pressure balloon and the pressure transducer, and a retention balloon disposed at a distal end of the Foley type catheter between the pressure balloon and the pressure transducer, wherein the retention balloon is separate from the pressure sensor, and wherein, the catheter is configured to be inserted into the urinary tract such that the distal end is residing in the bladder, wherein the pressure transducer is configured to transduce pressure impinging on the pressure transducer from the fluid column into physiologic data comprising a chronological pressure profile having a resolution that enables processing of the chronological pressure profile into distinct physiologic profiles;

a urine receptacle in fluid communication with the catheter, wherein the urine receptacle is configured to measure a volume of urine output from the patient; and

a controller apparatus in communication with the pressure transducer and the urine receptacle so as to be able to acquire the physiological data,

wherein the controller apparatus is configured to process the chronological pressure profile into the distinct physiologic pressure profiles, which include peritoneal pressure, respiratory rate and cardiac output,

wherein the controller 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; and

wherein the controller apparatus is configured to automatically adjust a pressure exerted within the pressure interface by adding or removing fluid via the fluid delivery system from the fluid column through the proximal end of the catheter the pressure exerted within the balloon equilibrates with a baseline of the chronological pressure profile, and

wherein the controller is configured to receive patient-specific data from a source external to the Foley type catheter and is further configured to integrate the received patient-specific data with the distinct physiologic pressure profiles.

21. The system of claim 20 wherein the fluid comprises a gas.

22. The system of claim 20 further comprising a docking station in communication with the urine receptacle, wherein the docking station is configured for data transmission to the controller regarding the volume of urine output detected in the urine receptacle.

23. The system of claim 20 wherein the controller is configured to trigger an alert if the detected volume of urine output is above or below a preset range over a set period of time.

24. The system of claim 20 wherein the physiologic pressure profiles further include at least one of relative pulmonary tidal volume, relative cardiac output, or absolute cardiac stroke volume.