Patient monitoring, diagnosis, and/or therapy systems and methods

• US 7,787,946 B2
• Filed: 09/17/2004
• Issued: 08/31/2010
• Est. Priority Date: 08/18/2003
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Siejko, Krzysztof Z, Stahmann, Jeffrey E., Hartley, Jesse W., Hatlestad, John D., Lee, Kent, Zhu, Qingsheng, Ni, Quan
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US10/943,721
• Publication Number:
  US 20050115561A1
• Time in Patent Office: 2,174 Days
• Field of Search: 607/3, 607/20, 607/42, 600/529, 600/534, 600/536
• US Class Current: 607/3
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/103 Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes A61B5/08 takes precedence; measuring aids for tailors A41H1/00; measuring instruments specially adapted for dentistry A61C19/04
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/285 Endotracheal, oesophageal or gastric probes
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/398 : Electrooculography [EOG], e.g. detecting nystagmus; Electroretinography [ERG]
• CPC Class Codes: A61B 5/4035 : Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4519 : Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4818 : Sleep apnoea
• CPC Class Codes: A61B 5/6814 : Head
• CPC Class Codes: A61B 5/6823 : Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6828 : Leg
• CPC Class Codes: A61B 5/686 : Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6891 : Furniture
• CPC Class Codes: A61B 5/7275 : Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 7/00 : Instruments for auscultation
• CPC Class Codes: A61M 16/0051 : with alarm devices
• CPC Class Codes: A61M 16/026 : specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 16/0666 : Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/10 : Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 2016/0021 : with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0036 : in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0039 : in the inspiratory circuit
• CPC Class Codes: A61M 2016/0042 : in the expiratory circuit
• CPC Class Codes: A61M 2202/0208 : Oxygen
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/10 : Electroencephalographic signals
• CPC Class Codes: A61M 2230/202 : partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/435 : partial O2 pressure (P-O2)
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 2230/60 : Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61N 1/3601 : of respiratory organs
• CPC Class Codes: A61N 1/3627 : for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/365 : controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36514 : controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36535 : controlled by body position or posture
• CPC Class Codes: A61N 1/36557 : controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36578 : controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
• CPC Class Codes: A61N 1/36585 : controlled by two or more physical parameters
• CPC Class Codes: A61N 1/36592 : controlled by the heart rate variability
• CPC Class Codes: A61N 1/37 : Monitoring; Protecting
• CPC Class Codes: G16H 20/30 : relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Systems and methods involve an implantable device configured to perform at least one cardiac-related function, a patient-external respiratory therapy device, and a communication channel configured to facilitate communication between the implantable device and the respiratory therapy device. The implantable and respiratory therapy devices operate cooperatively via the communication channel to provide one or more of patient monitoring, diagnosis, and therapy. The communication channel may be configured to facilitate communication between an external processing system and at least one of the implantable device and the respiratory therapy device. The processing system is communicatively coupled to at least one of the implantable and respiratory therapy devices via the communication channel to provide one or more of patient monitoring, diagnosis, and therapy.

Claims

1. A system, comprising:

an implantable device configured to perform at least one cardiac-related function and including first sensors;

a patient-external respiratory therapy device and including second sensors;

a processing system external of the implantable and respiratory therapy devices; and

a communication channel configured to facilitate communication between the processing system and at least one of the implantable device and the respiratory therapy device, the processing system communicatively coupled to the at least one of the implantable and respiratory therapy devices via the communication channel, the processing system configured to assess sensing characteristics of each of the first and second sensors and to select, based on the assessment of the sensing characteristics, between one and both of the implantable device and the patient-external respiratory therapy device to provide one or more of patient monitoring, diagnosis, and therapy, wherein the sensing characteristics include type, quality, reliability, repeatability, efficiency, availability, accuracy, resolution, dynamic range, specificity, sensitivity or predictive value.

2. The system of claim 1, wherein the communication channel is configured to facilitate communication between the implantable device and the respiratory therapy device.

3. The system of claim 1, wherein the communication channel is configured to facilitate communication between the processing system and one or both of the implantable and respiratory therapy devices and the processing system is configured to facilitate indirect communication between the implantable device and the patient-external device respiratory therapy device.

4. The system of claim 1, wherein the processing system is configured to manage patient-related information and is remotely located with respect to the implantable device and the patient-external device.

5. The system of claim 1, wherein the processing system is configured to coordinate one or more of initiation, modification, and termination of the therapy deliverable by one or both of the implantable and respiratory therapy devices based on interaction between the therapy and another therapy being delivered to the patient.

6. The system of claim 1, wherein the processing system is further configured to assess therapy characteristics of the implantable device and therapy characteristics of the patient-external respiratory device and to select between one and both of the implantable device and the patient-external respiratory therapy device to deliver therapy based on the assessment of the therapy characteristics.

7. The system of claim 6, wherein the one or more therapy characteristics comprises patient comfort and therapy effectiveness and the processing system is configured to coordinate therapy to decrease a level of therapy to increase patient comfort if the processing system determines that therapy effectiveness is sufficient.

8. The system of claim 1, wherein the one or more sensing characteristics comprises accuracy and the processing system is configured to assess accuracy of at least one of the first sensors and the second sensors and to select between one and both of the implantable device and the patient-external respiratory therapy device based on the assessment of accuracy.

9. The system of claim 1, wherein the one or more sensing characteristics comprises a type of sensor and the processing system is configured to assess sensing characteristics by determining the type of sensor of at least one of the first and second sensors and to select between one and both of the implantable device and the patient-external respiratory therapy device based on the type of sensor.

10. The system of claim 1, wherein the processing system is configured to implement one of the implantable device and the patient external respiratory therapy device to provide the patient monitoring and to implement another of the implantable device and the patient-external respiratory therapy device deliver the therapy, wherein the device selected to provide the patient monitoring is different from the device selected to provide the therapy.

11. The system of claim 1, wherein the processing system is configured to detect sleep and to select one or both of the implantable device and the patient-external respiratory therapy device based on the detection of sleep.

12. The system of claim 1, wherein the processing system is configured to determine a type of disordered breathing experienced by the patient and to select one or both of the implantable device and the patient external respiratory therapy device based on the type of disordered breathing.

13. The system of claim 1, wherein the processing system is configured to coordinate the therapy between one and both of the implantable device and the patient-external respiratory therapy device based on device lifetime.

14. The system of claim 1, wherein the processing system is configured to select between one and both of the implantable device and the patient-external respiratory therapy device based on patient use of the patient-external respiratory therapy device.

15. The system of claim 1, wherein the processing system is configured to select between one and both of the implantable device and the patient-external respiratory therapy device to deliver the therapy based on therapy effectiveness.

16. The system of claim 1, wherein the processing system is configured to select one or more sensors from the implantable device and to select one or more of sensors from the patient external respiratory therapy device.

17. The system of claim 1, wherein the processing system is configured to select both the implantable device and the patient-external respiratory device to deliver the therapy and the processing system is configured to coordinate the therapy between the implantable device and the patient-external respiratory device based on therapy characteristics of the implantable device and the patient-external respiratory device.

18. The system of claim 1, wherein both the implantable device and the patient-external respiratory therapy device are selected to provide the patient monitoring and the processing system is configured to coordinate the patient monitoring provided by the patient-external respiratory therapy device and the implantable device.

19. The system of claim 1, further comprising one or more additional devices including a patient input device, wherein coordination of the implantable device and the respiratory therapy device is based on information acquired from the patient input device.