Prolapse detection and tool dislodgement detection

• US 9,675,302 B2
• Filed: 12/31/2009
• Issued: 06/13/2017
• Est. Priority Date: 12/31/2009
• Status: Active Grant

• Current Assignee: ST JUDE MEDICAL INTERNATIONAL HOLDING S. R.L.
• Original Assignee: MediGuide Ltd (Abbott Laboratories)
• Inventors: Kariv, Itay, Cohen, Amit
• Primary Examiner(s): COOK, CHRISTOPHER L
• Application Number:
  US12/651,148
• Publication Number:
  US 20110160570A1
• Time in Patent Office: 2,721 Days
• Field of Search: None
• 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 5/1114 Tracking parts of the body
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• CPC Class Codes: A61B 5/7289 Retrospective gating, i.e. associating measured signals or images with a physiological event after the actual measurement or image acquisition, e.g. by simultaneously recording an additional physiological signal during the measurement or image acquisition
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/527 using data from a motion artifact sensor
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/5276 due to motion

Abstract

A tool dislodgement detection apparatus includes an MPS outputting position and orientation (P&O) readings for determining tool motion. A control generates an alarm based on the tool motion and dislodgement criteria. The criteria includes whether the tool motion meets a condition based on the type of medical procedure or tool, the tool parking position, a patient characteristic (e.g., age, weight, gender) or a physician preference. The criteria includes when the correlation between the tool motion and the cardiac, respiration and patient motion changes abruptly. In a prolapse detection apparatus, guidewire tip P&O readings determine a tip motion vector. The control generates an alarm using the motion vector and predetermined criteria. The criteria include a substantial change in the tip orientation not accompanied by a corresponding position change and a change in the motion vector by about 180° accompanied by a corresponding position change no greater than a threshold.

Claims

1. An apparatus for detecting dislodgement of a medical tool from a reference location within a patient'"'"'s body, comprising:

a localization system configured to output a location reading indicative of a location of the medical tool in a coordinate system based on a signal from a location sensor included in the medical tool, wherein said location reading comprises at least one of a position and orientation (P&

O); and

a control configured to determine a motion of the medical tool as a function of a plurality of said location readings, said control being further configured to determine when said determined medical tool motion satisfies predetermined tool motion conditions indicative of dislodgement based on at least one of said plurality of location readings of said medical tool and generating an alarm signal, wherein said predetermined motion conditions comprise at least a predetermined threshold distance beyond which the medical tool must move away from the reference location wherein the reference location within the patient'"'"'s body has a reference coordinate in said coordinate system, and wherein the reference location comprises an initial one of said medical tool location readings according to an initialization event, and wherein said control compares a medical tool coordinate and said reference coordinate with respect to said predetermined threshold distance to determine when said predetermined motion conditions are satisfied, said predetermined motion conditions are determined according to at least one factor selected from the group comprising a type of medical procedure, a type of medical tool, a parking position of the medical tool, and a preference of a physician.

2. The apparatus of claim 1 wherein said medical tool includes a first location sensor and a second location sensor, said localization system being configured to produce a first plurality of location readings in accordance with said first location sensor output and a second plurality of location readings in accordance with said second location sensor output.

3. The apparatus of claim 2 wherein said control is configured to determine the presence of an external force on the medical tool by detecting a displacement between the tool and the reference location using the motions indicated by the first and second plurality of location readings.

4. The apparatus of claim 2 wherein said control is configured to determine said tool motion further as a function of said first plurality and said second plurality of location readings.

5. The apparatus of claim 1 wherein said location sensor comprises a magnetic field sensor configured to detect one or more characteristics of a magnetic field in which said location sensor is disposed, said signal from said location sensor being indicative of said detected one or more characteristics.

6. The apparatus of claim 5 wherein said magnetic field comprises an alternating current (AC) magnetic field.

7. The apparatus of claim 1 wherein said reference location is an anatomical location within said patient'"'"'s body.

8. An apparatus for detecting dislodgement of a medical tool from a reference location corresponding to an anatomical location within a patient'"'"'s body, comprising:

a localization system configured to output a tool location reading indicative of a location of the medical tool in a coordinate system wherein said tool location reading comprises at least one of a position and orientation (P&

O);

at least one of (i) a patient reference sensor for affixation to the patient and configured to be coupled to said localization system to produce said plurality of patient reference sensor location readings indicative of patient respiration-induced and patient body movement-induced components of the reference location motion and (ii) an electrocardiogram monitor configured to produce said electrocardiogram signals indicative of a heartbeat-induced movement component of the reference location motion;

a control configured to determine a motion of the medical tool as a function of a plurality of said tool location readings, said control being configured to determine a first correlation between the tool motion and the motion of the reference location during a learning stage when the medical tool is parked at the reference location, wherein the reference location within the patient'"'"'s body has a reference coordinate in said coordinate system, and wherein the reference location comprises an initial one of said medical tool location readings according to an initialization event, wherein said control is configured to determine said first correlation by calculating the first correlation between the tool location readings and said at least one of (i) said plurality of patient reference sensor location readings and (ii) said electrocardiogram signals wherein said control is further configured to determine said first correlation by comparing said plurality of said tool location readings and said at least one of said patient reference sensor location readings and said electrocardiogram signals relative to a common time-line, said control being further configured to determine, after the learning stage, a second correlation between the tool motion and reference location motion, said control being further configured to generate an alarm signal indicative of dislodgement when a comparison of the first correlation and the second correlation meets predetermined dislodgement detection criteria.

9. The apparatus of claim 8 wherein said medical tool includes a first location sensor configured for coupling to said localization system for producing a first plurality of location readings and a second location sensor configured for coupling to said localization system for producing a second plurality of location readings, said control being is further configured to determine a presence of an external force on the medical tool by detecting a displacement between said medical tool and said reference location using the motions indicated by the first and second plurality of location readings.

10. The apparatus of claim 9 wherein said control is configured to assess changes in an orientation of one of said first and second location sensors, wherein said control is configured to detect impending dislodgement when changes in said orientation meet predetermined criteria.

11. The apparatus of claim 8 wherein said patient reference sensor location reading comprises at least one of a position and orientation (P&

O).

12. The apparatus of claim 11 wherein said predetermined criteria includes a change between the first correlation and the second correlation exceeding a predetermined threshold in under a predetermined time period.

13. The apparatus of claim 12 wherein said predetermined threshold and said predetermined time period are determined according to at least one factor selected from the group comprising a medical procedure type, a medical tool type, the parking position of the medical tool, a characteristic of the patient and a preference of a physician and wherein said characteristic of the patient is at least one selected from the group comprising age, weight and gender.

14. The apparatus of claim 11 wherein said medical tool includes a first location sensor configured for coupling to said localization system for producing a first plurality of location readings and a second location sensor configured for coupling to said localization system for producing a second plurality of location readings, said tool motion comprises the respective movements of said first and second location sensors,

said first correlation comprises a pair of first correlations associated with the movements of said first and second location sensors respectively and taken with respect to at least one of said patient reference sensor location readings and said electrocardiogram signals during said learning stage,

said second correlation comprises a pair of second correlations associated with the movements of said first and second location sensors respectively and taken with respect to at least one of said patient reference sensor location readings and said electrocardiogram signals during a monitoring stage,

said control being further configured to determine, for each of said first and second location sensors, a respective change between first and second correlations associated with each of said first and second location sensors and to generate said alarm signal when at least one of said determined correlation changes meet said predetermined dislodgement detection criteria.

15. The apparatus of claim 8 wherein said control is configured to begin said learning stage in response to said initialization event.

16. The apparatus of claim 15 wherein said initialization event comprises an input start signal and wherein said control includes an input/output interface configured to receive said input start signal from a user.

17. The apparatus of claim 15 wherein said control determines said initialization event automatically when said medical tool has been in a same position for a time period exceeding a predetermined value.

18. The apparatus of claim 8 wherein said control, using said predetermined dislodgement detection criteria, is configured to distinguish between a first situation where respective movements of said medical tool and the reference location indicate dislodgement and a second situation where said medical tool and said reference location are moving together but with no relative movement therebetween.

19. The apparatus of claim 8 wherein said alarm signal comprises at least one of a visual indication, a verbal audible indication, a non-verbal audible indication, a tactile indication, and a combination of one or more of the foregoing indications.

20. The apparatus of claim 8, wherein said control is further configured to determine when said tool motion satisfies predetermined tool motion conditions indicative of dislodgement and generating said alarm signal, wherein said predetermined motion conditions are determined according to at least one factor selected from the group comprising the type of medical procedure, the type of medical tool, the parking position of the medical tool, a characteristic of the patient and a preference of a physician and wherein said characteristic of the patient is at least one selected from the group comprising age, weight and gender.

21. The apparatus of claim 20 wherein said medical tool includes a first location sensor and a second location sensor, said localization system being configured to produce a first plurality of location readings in accordance with said first location sensor output and a second plurality of location readings in accordance with said second location sensor output.

22. The apparatus of claim 21 wherein said control is further configured to determine a presence of an external force on the medical tool by detecting a displacement between the tool and the reference location using the motions indicated by the first and second plurality of location readings.

23. The apparatus of claim 21 wherein said control is further configured to determine said medical tool motion further as a function of said first plurality and said second plurality of location readings.

24. The apparatus of claim 8 wherein said medical tool includes a magnetic field location sensor configured to detect one or more characteristics of a magnetic field in which said location sensor is disposed and output a signal indicative of said detected one or more characteristics, wherein said localization system is configured to output said tool location reading based on at least said signal.

25. The apparatus of claim 24 wherein said magnetic field comprises an alternating current (AC) magnetic field.