PROLAPSE DETECTION AND TOOL DISLODGEMENT DETECTION

• US 20110160570A1
• Filed: 12/31/2009
• Published: 06/30/2011
• 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 Incorporated)
• Inventors: Cohen, Amit, Kariv, Itay
• Granted Patent: US 9,675,302 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• 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 the location of the tool in coordinate system 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 tool as function of a plurality of said location readings, said control being further configured to determine when said tool motion satisfies predetermined tool motion conditions indicative of dislodgement and generating an 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.

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. 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 the location of the tool in a coordinate system 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 tool as function of a plurality of said 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 tool is parked at the reference location, 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.

6. The apparatus of claim 5 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 the presence of an external force on the medical tool by detecting a displacement between said tool and said reference location using the motions indicated by the first and second plurality of location readings.

7. The apparatus of claim 5 further including:

a patient reference sensor (PRS) for affixation to the patient and configured to be coupled to said localization system to produce a plurality of PRS location readings indicative of patient respiration-induced and patient body movement-induced components of the reference location motion wherein said PRS location reading comprise at least one of a position and orientation (P&

O);

an electrocardiogram (ECG) monitor configured to produce ECG signals indicative of a heartbeat-induced movement component of the reference location motion; and

wherein said control is further configured to determine said first correlation by calculating the correlation between the tool location readings and at least one of the PRS location readings and said ECG signals.

8. The apparatus of claim 7 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.

9. An apparatus for detecting a prolapse condition of a guidewire from a desired position, comprising:

a localization system configured to output a position and orientation (P&

O) reading indicative of the P&

O of a distal tip of the guidewire in a coordinate system; and

a control configured to determine a motion vector of said tip based on a plurality of said P&

O readings, said control being further configured to generate an alarm signal indicative of a prolapse condition in accordance with at least said motion vector and predetermined criteria.

10. The apparatus of claim 9 wherein said predetermined criteria includes a change in the orientation of said tip exceeding a predetermined minimum threshold that is not accompanied by a corresponding change in the position of said tip.

11. The apparatus of claim 9 wherein said predetermined criteria includes a change in the motion vector by substantially one-hundred and eighty degrees accompanied by a corresponding change in position no greater than a predetermined threshold.

12. The apparatus of claim 11 wherein said control is configured to determine said predetermined threshold based on an image or an electroanatomical model of a region of interest (ROI).

13. The apparatus of claim 12 wherein said image is a fluoroscopic image.

14. The apparatus of claim 11 wherein said guidewire is configured to travel through a bodily lumen of the patient wherein the lumen has a determined diameter, said predetermined threshold corresponding to the same order of magnitude as said determined diameter.

15. The apparatus of claim 9 wherein said guidewire includes a first location sensor disposed in a distal section and configured to be coupled to said localization system for producing said plurality of P&

O readings, said apparatus further including a proximal motion detecting device configured to detect at least one characteristic of the motion of the proximal end of said guidewire.

16. The apparatus of claim 15 wherein said predetermined prolapse detection criteria includes determining whether a first amount of advancement of the guidewire at the proximal end corresponds to a second amount of advancement of the guidewire at the distal end.

17. The apparatus of claim 15 wherein said proximal motion detecting device comprises a detector disposed at a proximal hub of said apparatus configured to optically detect the motion of the proximal end of said guidewire.

18. The apparatus of claim 9 wherein said guidewire includes a first location sensor disposed in a distal section and configured to be coupled to said localization system for producing said plurality of P&

O readings, said apparatus further including a second location sensor disposed at the proximal end of said guidewire configured to detect at least one characteristic of the motion of the proximal end of said guidewire.

19. The apparatus of claim 18 wherein said predetermined prolapse detection criteria includes determining when a P&

O difference between said first location sensor and said second location sensor is below a predetermined value.

20. The apparatus of claim 9 wherein said alarm signal comprises one of a visual indication, an audible indication, a tactile indication and a combination of one or more of the foregoing.