Method and system for delivering a medical device to a selected position within a lumen

• US 20060058647A1
• Filed: 09/16/2005
• Published: 03/16/2006
• Est. Priority Date: 05/18/1999
• Status: Active Grant

• Current Assignee: ST JUDE MEDICAL INTERNATIONAL HOLDING S. R.L.
• Original Assignee: MediGuide Ltd (Abbott Laboratories)
• Inventors: Strommer, Gera, Eichler, Uzi
• Granted Patent: US 8,442,618 B2
• Time in Patent Office: Days
• US Class Current: 600/434
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• 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 2034/742 Joysticks
• CPC Class Codes: A61B 2090/364 Correlation of different images or relation of image positions in respect to the body
• CPC Class Codes: A61B 2090/3958 emitting a signal
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 2560/066 catheters therefor
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• 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 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 5/015 By temperature mapping of body part
• 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 5/062 using magnetic field
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/706 Indicia not located on the patient, e.g. floor marking
• CPC Class Codes: A61B 5/7285 for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61B 6/0492 : using markers or indicia for aiding patient positioning
• CPC Class Codes: A61B 6/12 : Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/4441 : the rigid structure being a C-arm or U-arm
• CPC Class Codes: A61B 6/465 : adapted to display user selection data, e.g. graphical user interface, icons or menus
• CPC Class Codes: A61B 6/466 : adapted to display 3D data
• CPC Class Codes: A61B 6/469 : for selecting a region of interest [ROI]
• CPC Class Codes: A61B 6/5235 : combining images from the same or different ionising radiation imaging techniques, e.g. PET and CT
• CPC Class Codes: A61B 6/5247 : combining images from an ionising-radiation diagnostic technique and a non-ionising radiation diagnostic technique, e.g. X-ray and ultrasound
• CPC Class Codes: A61B 6/541 : involving acquisition triggered by a physiological signal
• CPC Class Codes: A61B 8/0833 : involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/40 : Positioning of patients, e.g. means for holding or immobilising parts of the patient's body
• CPC Class Codes: A61B 8/5238 : for combining image data of patient, e.g. merging several images from different acquisition modes into one image for image registration algorithms G06T7/30
• CPC Class Codes: A61B 8/543 : involving acquisition triggered by a physiological signal
• CPC Class Codes: A61B 90/10 : for stereotaxic surgery, e.g. frame-based stereotaxis
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for

Abstract

Method for delivering a medical device coupled with a catheter, to a selected position within a lumen of the body of a patient, the method comprising the procedures of: registering a three-dimensional coordinate system with a two-dimensional coordinate system, the three-dimensional coordinate system being associated with a medical positioning system (MPS), the two-dimensional coordinate system being associated with a two-dimensional image of the lumen, the two-dimensional image being further associated with an organ timing signal of an organ of the patient; acquiring MPS data respective of a plurality of points within the lumen, each of the points being associated with the three-dimensional coordinate system, each of the points being further associated with a respective activity state of the organ; determining a temporal three-dimensional trajectory representation for each the respective activity states from the acquired MPS data which is associated with the respective activity state; superimposing the temporal three-dimensional trajectory representations on the two-dimensional image, according to the respective activity state; receiving position data respective of the selected position, by selecting at least one of the points along the temporal three-dimensional trajectory representation; determining the coordinates of the selected position in the three-dimensional coordinate system, from the selected at least one point; determining the current position of the medical device in the three-dimensional coordinate system, according to an output of an MPS sensor attached to the catheter in the vicinity of the medical device; maneuvering the medical device through the lumen, toward the selected position, according to the current position relative to the selected position; and producing a notification output when the current position substantially matches the selected position.

Claims

1. Method for delivering a medical device coupled with a catheter, to a selected position within a lumen of the body of a patient, the method comprising the procedures of:

registering a three-dimensional coordinate system with a two-dimensional coordinate system, said three-dimensional coordinate system being associated with a medical positioning system (MPS), said two-dimensional coordinate system being associated with a two-dimensional image of said lumen, said two-dimensional image being further associated with an organ timing signal of an organ of said patient;

acquiring MPS data respective of a plurality of points within said lumen, each of said points being associated with said three-dimensional coordinate system, each of said points being further associated with a respective activity state of said organ;

determining a temporal three-dimensional trajectory representation for each said respective activity states from said acquired MPS data which is associated with said respective activity state; and

superimposing said temporal three-dimensional trajectory representations on said two-dimensional image, according to said respective activity state;

receiving position data respective of said selected position, by selecting at least one of said points along said oral three-dimensional trajectory representation;

determining the coordinates of said selected position in said three-dimensional coordinate system, from said selected at least one point;

producing a real-time navigation image of said lumen, said real-time navigation image being associated with said three-dimensional coordinate system, said real-time navigation image including a real-time medical device image of a medical device, located at the tip of a catheter, which is being maneuvered within said lumen; and

superimposing a representation respective of said selected position, on said real-time navigation image, thereby enabling an operator to visually navigate said medical device toward said selected position.

2. The method according to claim 1, further comprising a procedure of acquiring said two-dimensional image, after performing said procedure of registering.

3. The method according to claim 1, wherein said procedure of acquiring is performed by said MPS, according to an output of an MPS sensor located at the tip of an MPS catheter moving within said lumen.

4. The method according to claim 1, wherein said two-dimensional image is a real-time image.

5. The method according to claim 1, wherein said two-dimensional image is a previously acquired cine-loop image.

6. The method according to claim 1, wherein said two-dimensional image is a previously acquired still image frame.

7. The method according to claim 1, further comprising a procedure of providing a quantitative assessment of the length of said lumen, to said operator.

8. The method according to claim 1, further comprising a preliminary procedure of acquiring said organ timing signal.

9. The method according to claim 8, wherein said procedure of acquiring said organ timing signal, is performed by an organ timing signal monitor.

10. The method according to claim 8, wherein said procedure of acquiring said organ timing signal comprises the procedures of:

measuring by an MPS sensor located at the tip of an MPS catheter moving within said lumen, the movements of said lumen due to an organ cycle of said organ; and

determining said real-time organ timing signal by said MPS.

11. System for delivering a medical device to a selected position within a lumen of the body of a patient, the medical device being attached to a medical device catheter, the system comprising:

a medical positioning system (MPS) for acquiring MPS data respective of a plurality of points within said lumen, according to an output of an MPS sensor located at the tip of an MPS catheter moving within said lumen, each of said MPS points being associated with a three-dimensional coordinate system, said three-dimensional coordinate system being associated with said MPS, each of said points being further associated with a respective activity state of an organ of said patient;

a user interface for receiving position data respective of said selected position, said position data being associated with at least one MPS representation, each of said at least one MPS representation being associated with a respective one of said points; and

a processor coupled with said user interface and with said MPS, said processor determining a plurality of temporal three-dimensional trajectory representations, according to said MPS data, each of said temporal three-dimensional trajectory representations corresponding to said respective activity state, said processor producing a superimposed image by superimposing said temporal three-dimensional trajectory representations on a two-dimensional image, according to respective activity states of said organ, said two-dimensional image being associated with a two-dimensional coordinate system, said two-dimensional image being further associated with an organ timing signal of said organ, said two-dimensional coordinate system being registered with said three-dimensional coordinate system, thereby enabling an operator to visually navigate said medical device toward said selected position, when said two dimensional image is a real-time image.

12. The system according to claim 11, wherein said two-dimensional image is a real-time image.

13. The system according to claim 11, wherein said two-dimensional image is a cine-loop image.

14. The system according to claim 11, wherein said two-dimensional image is a still image.

15. The system according to claim 11, further comprising a display coupled with said processor, said display displaying said superimposed image.

16. The system according to claim 11, further comprising an image acquisition device coupled with said processor, said image acquisition device acquiring said two-dimensional image.

17. The system according to claim 16, wherein said image acquisition device is an X-ray machine.

18. The system according to claim 16, wherein said image acquisition device is a C-arm.

19. The system according to claim 16, wherein said image acquisition device is a guided intra-vascular ultrasound.

20. The system according to claim 16, wherein said image acquisition device is an external ultrasound image detector.

21. The system according to claim 11, further comprising:

an image acquisition device coupled with said processor, said image acquisition device acquiring said two-dimensional image;

a radio-opaque marker attached to said medical device catheter in the vicinity of said medical device; and

a display coupled with said processor, said display displaying a marker image of said radio-opaque marker in said two-dimensional image.

22. The system according to claim 11, further comprising an organ timing signal monitor coupled with said processor and with the body of said patient, said organ timing signal monitor monitoring said organ timing signal, said processor determining said organ timing signal, according to an output of said organ timing signal monitor.

23. Method for delivering a medical device coupled with a catheter, to a selected position within a lumen of the body of a patient, the method comprising the procedures of:

registering a three-dimensional coordinate system with a two-dimensional coordinate system, said three-dimensional coordinate system being associated with a medical positioning system (MPS), said two-dimensional coordinate system being associated with a two-dimensional image of said lumen, said two-dimensional image being further associated with an organ timing signal of an organ of said patient;

acquiring MPS data respective of a plurality of points within said lumen, each of said points being associated with said three-dimensional coordinate system, each of said points being further associated with a respective activity state of said organ;

determining a temporal three-dimensional trajectory representation for each said respective activity states from said acquired MPS data which is associated with said respective activity state;

superimposing said temporal three-dimensional trajectory representations on said two-dimensional image, according to said respective activity state;

receiving position data respective of said selected position, by selecting at least one of said points along said oral three-dimensional trajectory representation;

determining the coordinates of said selected position in said three-dimensional coordinate system, from said selected at least one point;

determining the current position of said medical device in said three-dimensional coordinate system, according to an output of an MPS sensor attached to said catheter in the vicinity of said medical device;

maneuvering said medical device through said lumen, toward said selected position, according to said current position relative to said selected position; and

producing a notification output when said current position substantially matches said selected position.

24. The method according to claim 23, further comprising a procedure of acquiring said two-dimensional image, after performing said procedure of registering.

25. The method according to claim 23, wherein said procedure of acquiring is performed by said MPS, according to an output of an MPS sensor located at the tip of an MPS catheter moving within said lumen.

26. The method according to claim 23, wherein said two-dimensional image is a real-time image.

27. The method according to claim 23, wherein said two-dimensional image is a previously acquired cine-loop image.

28. The method according to claim 23, wherein said two-dimensional image is a previously acquired still image frame.

29. The method according to claim 23, further comprising a procedure of providing a quantitative assessment of the length of said lumen, to said operator.

30. The method according to claim 23, further comprising a preliminary procedure of acquiring said organ timing signal.

31. The method according to claim 30, wherein said procedure of acquiring said organ timing signal, is performed by an organ timing signal monitor.

32. The method according to claim 30, wherein said procedure of acquiring said organ timing signal comprises the procedures of:

measuring by an MPS sensor located at the tip of an MPS catheter moving within said lumen, the movements of said lumen due to an organ cycle of said organ; and

determining said real-time organ timing signal by said MPS.

33. The method according to claim 23, wherein said procedure of maneuvering is performed manually.

34. The method according to claim 23, wherein said procedure of maneuvering is performed automatically.

35. The method according to claim 23, further comprising a procedure of increasing an amplitude of said notification output, when said current position approaches said selected position, and decreasing said amplitude, when said current position recedes from said selected position.

36. System for delivering a medical device to a selected position within a lumen of the body of a patient, the medical device being attached to a medical device catheter, the system comprising:

a medical positioning system (MPS) for acquiring MPS data respective of a plurality of points within said lumen, according to a first output of a first MPS sensor located at the tip of an MPS catheter moving within said lumen, each of said MPS points being associated with a three-dimensional coordinate system, said three-dimensional coordinate system being associated with said MPS, each of said points being further associated with a respective activity state of an organ of said patient, said MPS determining the current position of said medical device within said lumen, in said three-dimensional coordinate system, according to a second output of a second MPS sensor attached to said medical device catheter in the vicinity of said medical device;

a user interface for receiving position data respective of said selected position, said position data being associated with at least one MPS representation, each of said at least one MPS representation being associated with a respective one of said points; and

a processor coupled with said user interface and with said MPS, said processor producing a superimposed image, by superimposing a plurality of MPS representations respective of said MPS data, on a two-dimensional image of said lumen, thereby enabling said user interface to receive said position data from an operator, said two-dimensional image being associated with a two-dimensional coordinate system, said two-dimensional image being further associated with an organ timing signal of said organ, said two-dimensional coordinate system being registered with said three-dimensional coordinate system, said processor determining the coordinates of said selected position in said three-dimensional coordinate system, according to said position data, said processor producing a notification output, when said processor determines that said current position substantially matches said selected position.

37. The system according to claim 36, wherein said processor determines a plurality of temporal three-dimensional trajectory representations, according to said MPS data, each of said temporal three-dimensional trajectory representations corresponding to said respective activity state, said processor further superimposing said temporal three-dimensional trajectory representations on said two-dimensional image, according to respective activity states of said organ.

38. The system according to claim 36, wherein said two-dimensional image is a real-time image.

39. The system according to claim 36, wherein said two-dimensional image is a cine-loop image.

40. The system according to claim 36, wherein said two-dimensional image is a still image.

41. The system according to claim 36, further comprising a display coupled with said processor, said display displaying said superimposed image.

42. The system according to claim 36, further comprising an image acquisition device coupled with said processor, said image acquisition device acquiring said two-dimensional image.

43. The system according to claim 42, wherein said image acquisition device is an X-ray machine.

44. The system according to claim 42, wherein said image acquisition device is a C-arm.

45. The system according to claim 42, wherein said image acquisition device is a guided intra-vascular ultrasound.

46. The system according to claim 42, wherein said image acquisition device is an external ultrasound image detector.

47. The system according to claim 36, further comprising an organ timing signal monitor coupled with said processor and with the body of said patient, said organ timing signal monitor monitoring said organ timing signal, said processor determining said organ timing signal, according to an output of said organ timing signal monitor.

48. The method according to claim 36, wherein said procedure of maneuvering is performed manually.

49. The method according to claim 36, wherein said procedure of maneuvering is performed automatically.