Method of sensing forces on a working instrument

• US 8,052,621 B2
• Filed: 02/22/2007
• Issued: 11/08/2011
• Est. Priority Date: 02/22/2006
• Status: Active Grant

• Current Assignee: Auris Health, Inc. (Johnson & Johnson)
• Original Assignee: Hansen Medical Incorporated (Johnson & Johnson)
• Inventors: Camarillo, David, Stahler, Gregory, Clopp, Mathew, Reis, Gene, King, Toby St. John, Wallace, Daniel T., Goldenberg, Alex, Younge, Robert G.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): TOWA, RENE T
• Application Number:
  US11/678,016
• Publication Number:
  US 20070197939A1
• Time in Patent Office: 1,720 Days
• Field of Search: 600587-595, 606/130
• US Class Current: 600/587
• 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 17/3476 Powered trocars, e.g. electrosurgical cutting, lasers, powered knives
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence

Abstract

A method for estimating the force on a distal end of a working catheter includes positioning a portion of a robotically controlled guide catheter and working catheter into a body lumen wherein a distal end of the working catheter projects distally from a distal end of the guide catheter. The working catheter and guide catheter are dithered with respect to one another using a dithering device operatively connected to a proximal portion of the working catheter. The coupling may occur directly to the working catheter or via a seal such as a Touhy seal. The force experienced by the working catheter at a proximal region is measured through at least one dithering cycle. The force at the distal end of the working catheter is then estimated based on the measured force at the proximal region. The estimated force may be displayed to a physician on, for example, a monitor.

Claims

1. A method of estimating the force on a distal end of a working catheter passing through a robotically controlled guide catheter adapted for insertion into a body lumen comprising:

positioning a portion of the robotically controlled guide catheter and working catheter into the body lumen, wherein the distal end of the working catheter projects distally from a distal end of the guide catheter;

dithering the working catheter with respect to the guide catheter using a dithering device operatively connected to a proximal portion of the working catheter, said dithering comprising longitudinal insertion of the working catheter relative to the guide catheter followed by longitudinal withdrawal of the working catheter relative to the guide catheter;

measuring an insertion force with a first force sensor, wherein the insertion force is obtained from a plurality of force measurements taken during a time interval when the insertion force exhibits a substantial plateau;

measuring a withdrawal force with a second force sensor, wherein the withdrawal force is obtained from a plurality of force measurements taken during a time interval when the withdrawal force exhibits a substantial plateau; and

estimating the force on the distal end of the working catheter based on the measured insertion force and the measured withdrawal force over the at least one dithering cycle.

2. The method of claim 1, wherein the dithering device is driven in a reciprocating manner by one of a speaker coil, air cylinder, hydraulic actuator, electric motor, solenoid, and piezoelectric element.

3. The method of claim 1, further comprising:

subtracting the measured insertion and withdrawal forces from baseline insertion and withdrawal forces obtained from a plurality of force measurements taken during a time interval when the insertion and withdrawal forces respectively exhibit a substantial plateau with no force being applied to the distal end of the working catheter to generate an insertion update and a withdrawal update; and

estimating the force on the distal end of the working catheter based on the insertion update and the withdrawal update.

4. The method of claim 3, wherein the measured insertion, withdrawal forces, baseline insertion, and baseline withdrawal forces comprise average forces.

5. The method of claim 1, further comprising determining an error associated with the estimated force, the error being based on one or more parameters of the group consisting of sheath angle, articulating angle, rate of change of articulating angle, insertion distance, and magnitude of force applied to the distal end of the working catheter.

6. The method of claim 1, further comprising the step of displaying the estimated force on a display.

7. The method of claim 6, wherein the estimated force is displayed along with a visual cue indicative of the estimated error in the estimated force.

8. The method of claim 7, wherein the visual cue comprises one or more colors.

9. The method of claim 7, wherein the visual cue comprises one or graphical elements displayed on the display.

10. The method of claim 9, wherein the graphical element is selected from the group consisting of an error bar, a warning indicator, a textual message, and a pointer.

11. The method of claim 1, further comprising comparing the estimated force against a pre-determined threshold value and initiating a warning when the estimated force exceeds the pre-determined threshold value.

12. The method of claim 11, wherein the warning comprises an audible signal.

13. The method of claim 11, wherein the warning comprises a visual signal displayed on a display.

14. The method of claim 11, wherein the warning comprises a haptic signal.

15. The method of claim 1, further comprising comparing the estimated force against a pre-determined threshold value and temporarily disabling one or both of the robotically controlled guide catheter and working catheter if the estimated force exceeds the pre-determined threshold value.

16. The method of claim 1, wherein the distal end of the working catheter is dithered through a stroke displacement of 1.5 mm or less.

17. The method of claim 1, wherein the robotically controlled guide catheter comprises an articulating inner guide catheter and an outer sheath.

18. The method of claim 1, wherein the working catheter comprises an ablation catheter.

19. The method of claim 1, wherein the dither rate is adjustable.

20. The method of claim 1, wherein the dither rate between 0 to 10 Hz.

21. A method of sensing force on a distal end of a working catheter passing through a robotically controlled guide catheter adapted for insertion into a body lumen comprising:

positioning a portion of the robotically controlled guide catheter and working catheter into the body lumen, wherein the distal end of the working catheter projects distally from a distal end of the guide catheter;

dithering the working catheter longitudinally with respect to the guide catheter using a dithering device operatively connected to a proximal portion of the working catheter, wherein the working catheter is not in contact with any tissue of the body lumen;

measuring a baseline insertion force on the proximal portion of the working catheter using a first force sensor;

measuring a baseline withdrawal force on the proximal portion of the working catheter using a second force sensor;

dithering the working catheter longitudinally with respect to the guide catheter using the dithering device, wherein the working catheter is in contact with tissue of the body lumen;

measuring an observed insertion force on the proximal portion of the working catheter using the first force sensor, wherein the working catheter is in contact with tissue of the body lumen;

measuring an observed withdrawal force on the proximal portion of the working catheter using the second force sensor, wherein the working catheter is in contact with tissue of the body lumen;

determining a differential between the observed insertion force and the baseline insertion force and a differential between the observed withdrawal force and the baseline withdrawal force; and

estimating the force at the distal end of the working catheter based on the differential between the observed insertion force and the baseline insertion force and a differential between the observed withdrawal force and the baseline withdrawal force.

22. The method of claim 21, wherein the baseline insertion and withdrawal forces comprise average forces and wherein the observed insertion and withdrawal forces comprise average forces.

23. The method of claim 22, wherein the average baseline insertion and withdrawal forces are obtained from a plurality of force measurements taken during a time interval when the respective insertion and withdrawal forces exhibit a substantial plateau and wherein the average observed insertion and withdrawal forces are obtained from a plurality of force measurements taken during a time interval when the respective insertion and withdrawal forces exhibit a substantial plateau.

24. The method of claim 23, further comprising determining an error associated with the estimated force, the error being based on one or more parameters of the group consisting of sheath angle, articulating angle, rate of change of articulating angle, insertion distance, and magnitude of force applied to the distal end of the working catheter.

25. The method of claim 23, further comprising the step of displaying the estimated force on a display.

26. The method of claim 25, wherein the estimated force is displayed along with a visual cue indicative of the estimated error in the estimated force.

27. The method of claim 26 wherein the visual cue comprises one or more colors.

28. The method of claim 26, wherein the visual cue comprises one or graphical elements displayed on the display.

29. The method of claim 28, wherein the graphical element is selected from the group consisting of an error bar, a warning indicator, a textual message, and a pointer.

30. The method of claim 23, further comprising comparing the estimated force against a pre-determined threshold value and initiating a warning when the estimated force exceeds the pre-determined threshold value.

31. The method of claim 30, wherein the warning comprises an audible signal.

32. The method of claim 30, wherein the warning comprises a visual signal displayed on a display.

33. The method of claim 30, wherein the warning comprises a haptic signal.

34. The method of claim 23, further comprising comparing the estimated force against a pre-determined threshold value and temporarily disabling one or both of the robotically controlled guide catheter and working catheter if the estimated force exceeds the pre-determined threshold value.

35. The method of claim 21, wherein the distal end of the working catheter is dithered through a stroke displacement of about 1.5 mm or less.

36. The method of claim 21, wherein the robotically controlled guide catheter comprises an articulating inner guide catheter and an outer sheath.

37. A method of sensing force on a distal end of a working catheter passing through a robotically controlled guide catheter adapted for insertion into a body lumen comprising:

positioning a portion of the robotically controlled guide catheter and working catheter into the body lumen, wherein the distal end of the working catheter projects distally from a distal end of the guide catheter;

dithering the working catheter longitudinally with respect to the guide catheter using a dithering device operatively connected to a sealing member disposed on a proximal portion of the guide catheter via a moveable bellows, the sealing member being fixedly secured to the working catheter;

measuring an insertion force on the sealing member using a first force sensor;

measuring a withdrawal force on the sealing member using a second force sensor; and

estimating the force at the distal end of the working catheter based at least in part on the measured insertion force and the measured withdrawal force.

38. The method of claim 37, wherein the measured insertion and withdrawal forces comprise average forces.

39. The method of claim 38, further comprising the step of subtracting a baseline average of the insertion and withdrawal forces on the sealing member over the portion of the one insertion and one withdrawal cycle from the average of non-baseline insertion and withdrawal forces, the baseline average being obtained when the distal end of the working catheter is not in contact with a surface.

40. The method of claim 37, further comprising determining an error associated with the estimated force, the error being based on one or more parameters of the group consisting of sheath angle, articulating angle, rate of change of articulating angle, insertion distance, and magnitude of force applied to the distal end of the working catheter.

41. The method of claim 37, further comprising the step of displaying the estimated force on a display.

42. The method of claim 41, wherein the estimated force is displayed along with a visual cue indicative of the estimated error in the estimated force.

43. The method of claim 42, wherein the visual cue comprises one or more colors.

44. The method of claim 42, wherein the visual cue comprises one or graphical elements displayed on the display.

45. The method of claim 44, wherein the graphical element is selected from the group consisting of an error bar, a warning indicator, a textual message, and a pointer.

46. The method of claim 37, further comprising comparing the estimated force against a pre-determined threshold value and initiating a warning when the estimated force exceeds the pre-determined threshold value.

47. The method of claim 46, wherein the warning comprises an audible signal.

48. The method of claim 46, wherein the warning comprises a visual signal displayed on a display.

49. The method of claim 46, wherein the warning comprises a haptic signal.

50. The method of claim 37, further comprising comparing the estimated force against a pre-determined threshold value and temporarily disabling one or both of the robotically controlled guide catheter and working catheter if the estimated force exceeds the pre-determined threshold value.

51. The method of claim 37, wherein the distal end of the working catheter is dithered through a stroke displacement of 1.5 mm or less.

52. The method of claim 37, wherein the robotically controlled guide catheter comprises an articulating inner guide catheter and an outer sheath.