Position confirmation with learn and test functions

• US 6,198,963 B1
• Filed: 05/14/1998
• Issued: 03/06/2001
• Est. Priority Date: 09/17/1996
• Status: Expired due to Term

• Current Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Original Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Inventors: Govari, Assaf, Fenster, Maier, Haim, Shlomo Ben
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): LIN, JEOYUH
• Application Number:
  US09/079,338
• Time in Patent Office: 1,027 Days
• Field of Search: 600/407, 600/409, 600/410, 600/411, 600/417, 600/418, 600/419, 600/422, 600/423, 600/424, 600/431, 600/429, 600/435, 600/437, 600/439, 600/440, 600/450, 600/451, 600/452, 600/455, 600/459, 600/462, 600/463, 600/466, 600/467, 600/481, 600/483, 600/484, 600/508, 600/529, 600/535, 128/653, 128/662, 128/660, 128/642, 128/644, 128/899, 607/115, 607/112
• US Class Current: 600/424
• CPC Class Codes: A61B 1/00055 for alerting the user
• CPC Class Codes: A61B 1/00057 provided with means for testing or calibration
• CPC Class Codes: A61B 1/31 for the rectum, e.g. proctoscopes, sigmoidoscopes , colonoscopes
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2017/00725 Calibration or performance testing
• CPC Class Codes: A61B 2017/22008 used or promoted
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 2090/3929 Active markers
• CPC Class Codes: A61B 2090/3958 emitting a signal
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 : for locating instruments
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/0025 : having a collapsible lumen
• CPC Class Codes: A61M 2025/0166 : Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0127 : Magnetic means; Magnetic markers
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Verification apparatus (32), for verifying the location of an object (22) in a patient'"'"'s body (20), the apparatus having learn and test modes and including a receiver (76), which receives signals from the object responsive to the location thereof. A parameter vector is derived from the signals. A memory (58) records a learn value of the parameter vector in the learn mode. A processor (54) receives a test value of the parameter vector in the test mode, and determines whether the test value is within a predetermined range of the learn values so as to verify the location of the object (22).

Claims

1. A system for determining a position of an object inserted into a patient'"'"'s body, said system comprising:

an object having a sensor, said object being inserted into said patient'"'"'s body wherein said sensor is adapted to be located within said patient'"'"'s body, said sensor providing a first sensor signal and a second sensor signal; and

a verification device for use outside of said patient'"'"'s body, said verification device having a measuring unit for receiving said first sensor signal and said second sensor signal provided by said object, said verification device also having a memory device, said verification device being operable in a learn mode and a test mode, wherein in said learn mode, said first sensor signal is provided by said object and received by said measuring unit, said measuring unit forming a control vector based on said first sensor signal, said control vector being stored in said memory device, and wherein in said test mode, said second sensor signal is provided by said object and received by said measuring unit, said measuring unit forming a test vector, said test vector being compared to said control vector in order to verify said position of said object within said patient, wherein said verification device includes a CPU for comparing said test vector to said control vector, said CPU having a predetermined value range, said CPU comparing said control vector to said predetermined value range, said control vector being stored in said memory device when said control vector is within said predetermined value range, wherein said measuring unit generates a first measuring signal and a second measuring signal, said first measuring signal and said second measuring signal being provided to said sensor of said object, said first measuring signal inducing said first sensor signal and said second measuring signal inducing said second sensor signal, said verification device including a power source, and wherein said verification device is positioned at an exterior surface of said patient'"'"'s body.

2. The system according to claim 1, wherein said verification device is operated in said test mode when said verification device is aligned with said at least one anchor point.

3. The system according to claim 2, wherein said verification device includes a guide for alignment with said at least one anchor point.

4. The system according to claim 3, wherein said verification device includes at least one visual display.

5. The system according to claim 4, wherein said verification device includes at least one audio display.

6. The system according to claim 5, wherein said verification device has a display for indicating a successful measurement and a warning display.

7. The system according to claim 6, wherein said verification device has a learn switch for activating said learn mode and a test switch for activating said test mode.

8. The system according to claim 7, wherein said verification device includes a disablement switch for disabling said learn mode.

9. The system according to claim 8, wherein said memory device has a back up power supply.

10. The system according to claim 1, wherein said object is a tube.

11. The system according to claim 10, wherein said tube has an outlet.

12. The system according to claim 11, wherein said sensor is located at said outlet of said tube.

13. The system according to claim 12, including a fluid control device operatively connected to said tube and operatively connected to said verification device.

14. The system according to claim 13, including a respiratory device operatively connected to said verification device.

15. The system according to claim 1, wherein said sensor includes at least one sensor coil and said measuring unit includes at least one measuring coil.

16. The system according to claim 1, wherein said measuring unit includes at least one ultrasonic transducer and said sensor includes at least one transponder.

17. The system according to claim 1, wherein said sensor includes at least one magnet and said measuring unit includes at least one magnetometer.

18. The system according claim 17, wherein said at least one magnet is rotatable and said measuring unit includes a measuring magnet.

19. A method for determining a position of an object inserted into a patient'"'"'s body comprising the steps of:

inserting an object having a sensor within a patient'"'"'s body wherein said sensor is adapted to be located within said patient'"'"'s body;

placing a verification device outside of said patient'"'"'s body against an exterior surface of said patient'"'"'s body by placing at least one anchor point on said exterior surface of said patient'"'"'s body for aligning said verification device;

initiating a learning mode with said verification device by taking a first measurement of a position of said object with respect to said verification device by forming a control vector;

initiating a test mode with said verification device by taking a second measurement of said position of said object with respect to said verification device by forming a test vector; and

comparing said test vector to said control vector in order to verify said position of said object.

20. The method according to claim 19, including storing said control vector in said verification device.

21. The method according to claim 20, providing a predetermined parameter range in said verification device and comparing said control vector to said predetermined parameter range.

22. The method according to claim 21, including providing a warning signal when said control vector is not within said predetermined parameter range.

23. The method according to claim 22, including comparing said test vector to said predetermined parameter range.

24. The method according to claim 23, including providing a warning signal when said test vector is not within said predetermined parameter range.

25. The method according to claim 21, including storing said control vector in said verification device when said control vector is in said predetermined parameter range.

26. The method according to claim 25, including disabling said learning mode of said verification device after said control vector is stored in said verification device.

27. The method according to claim 26, wherein said object is a tube having an outlet and said sensor is located at said outlet.

28. The method according to claim 27, including providing a fluid to said patient through said tube.

29. At The method according to claim 28, including controlling a delivery of said fluid to said patient through a fluid control device.

30. The method according to claim 29, including operatively controlling said fluid delivery through said fluid control device with said verification device.

31. The method according to claim 30, including providing a respiratory device for taking said first measurement and said second measurement with said verification device.

32. The method according to claim 28, including feeding said patient through said tube.

33. The method according to claim 19, including inducing a first signal from said sensor and inducing a second signal from said sensor with said verification device for taking said first measurement and said second measurement respectively.

34. The method according to claim 19, including taking said first measurement and said second measurement ultrasonically.

35. The method according to claim 19, including taking said first measurement and said second measurement magnetically.

36. A system for determining a position of a tube inserted into a patient'"'"'s body, said system comprising:

a tube having an outlet and a sensor located at said outlet, said tube being inserted into said patient'"'"'s body wherein said sensor is adapted to be located within said patient'"'"'s body, said sensor providing a first sensor signal and a second sensor signal;

a verification device for use outside of said patent'"'"'s body;

said verification device having a measuring unit for receiving said first sensor signal and said second sensor signal provided by said tube, said verification device also having a memory device, said verification device being operable in a learn mode and a test mode, wherein in said learn mode, said first sensor signal is provided by said tube and received by said measuring unit, said measuring unit forming a control vector based on said first sensor signal, said control vector being stored in said memory device, and wherein in said test mode, said second sensor signal is provided by said tube and received by said measuring unit, said measuring unit forming a test vector, said test vector being compared to said control vector in order to verify said position of said tube within said patient;

a fluid control device operatively connected to said tube and operatively connected to said verification device; and

a respiratory device operatively connected to said verification device.

37. A system for determining a position of an object inserted into a patient'"'"'s body, said system comprising:

an object having a sensor, said object being inserted into said patient'"'"'s body wherein said sensor is adapted to be located within said patient'"'"'s body, said sensor providing a first sensor signal and a second sensor signal; and

a verification device for use outside of said patent'"'"'s body, said verification device having a measuring unit for receiving said first sensor signal and said second sensor signal provided by said object, said verification device also having a memory device, said verification device being operable in a learn mode and a test mode, wherein in said learn mode, said first sensor signal is provided by said object and received by said measuring unit, said measuring unit forming a control vector based on said first sensor signal, said control vector being stored in said memory device, and wherein in said test mode, said second sensor signal is provided by said object and received by said measuring unit, said measuring unit forming a test vector, said test vector being compared to said control vector in order to verify said position of said object within said patient, wherein said sensor includes at least one sensor coil and said measuring unit includes at least one measuring coil.

38. A method for determining a position of an object inserted into a patient'"'"'s body comprising the steps of:

inserting an object having a sensor including at least one sensor coil within a patient'"'"'s body wherein said sensor is adapted to be located within said patient'"'"'s body;

placing a verification device having a measuring unit including at least one measuring coil outside of said patient'"'"'s body against an exterior surface of said patient'"'"'s body;

initiating a learning mode with said verification device by taking a first measurement of a position of said object with respect to said verification device by forming a control vector;

initiating a test mode with said verification device by taking a second measurement of said position of said object with respect to said verification device by forming a test vector; and

comparing said test vector to said control vector in order to verify said position of said object.