Method of navigating medical devices in the presence of radiopaque material

1. A method of navigating the distal end of a medical device through an operating region in a subject's body, the method comprising:

introducing the distal end of an elongate medical device having at least one magnetically responsive element fixed thereon into the subiect's body;

navigating the distal end of the medical device to the desired site of delivery;

expelling a flowable radiopague substance from the medical device at the desired site of delivery;

displaying an X-ray image of the operating region, including the distal end of the medical device;

determining the location of a localization coil in the distal end of the medical device relative to at least two transmitters at known reference locations, to establish a distal end location in a reference frame translatable to the displayed image; and

displaying an enhanced indication of the distal end of the medical device on the X-ray image of the operating region in which the distal end of the medical device is in the presence of the expelled flowable radiopague substance, to facilitate the navigation of the distal end of the device in the operating region.

2. The method according to claim 1 , wherein the step of determining the location of the distal end of the medical device comprises transmitting signals between at least one reference location and the distal end of the medical device.

3. The method according to claim 2 wherein the step of transmitting signals between at least one reference location and the distal end of the device comprises transmitting signals from a plurality of transmitters in more than one reference relocation, and a receiver on the magnetic medical device.

4. The method according to claim 2 wherein the medical device has a transmitter or receiver coil made from a radio opaque material.

5. The method according to claim 4 wherein the coil is made from at least one of gold or platinum, or an alloy containing gold or platinum.

6. The method according to claim 1 , wherein the step of determining the location of the distal end of the medical device comprises moving the distal end of the medical device, and processing x-ray images before and after the movement to determine the location of the distal tip.

7. The method according to claim 6 , wherein the distal end of the medical device includes a magnetically responsive element, and wherein the step of moving the distal end of the medical device comprises applying a magnetic field or gradient from a magnet outside the subject's body to move the magnetically responsive element and thus the distal end of the medical device.

8. The method according to claim 7 wherein the medical device has a magnetically responsive element, wherein the medical device is oriented by the applying a magnetic field from a magnetic surgery system outside the subject's body, and wherein the step of displacing the distal tip comprises changing the magnetic field applied by the magnetic surgery system to the magnetically responsive element.

9. The method according to claim 1 wherein the medical device includes at least one coil, and wherein the step of displacing the medical device comprises applying a current to the at least one coil to displace the at least one coil, and thus the medical device.

10. A method of navigating the distal end of a medical device through an operating region in a subject's body, in which radiopaque flowable substances in the operating region make it difficult to visualize the distal end of the medical device, the method comprising:

navigating the distal end of an elongate medical device having at least one magnetically responsive element fixed thereon to a desired site of delivery;

displaying an x-ray image of the operating region, including the distal end of the medical device having a radiopaque substance therein;

expelling a flowable radiopague substances from the end of the medical device into the operating region;

determining the location of a localization coil in the distal end of the medical device relative to at least two transmitters at known reference locations, to establish a distal end location in a reference frame translatable to the displayed x-ray image; and

displaying an enhanced indication of the distal end of the medical device on the x-ray image of the operating region in which the distal end of the medical device is in the presence of the expelled flowable radiopague substance, based on the determined location of the distal end relative to at least one reference location in the reference frame, to provide a positive visible indication of the distal end when the distal end may be difficult to see in the x-ray image, to facilitate the navigation of the distal end of the device in the operating region.

11. The method according to claim 10 wherein the radiopaque objects in the operating region include objects that have been expelled from the magnetic medical device and/or objects in the medical device.

12. The method according to claim 11 wherein the radiopaque objects in the operating region include objects that have been expelled from the magnetic medical device.

13. The method according to claim 11 wherein the radiopaque objects in the operating region include objects in the medical device.

14. The method according to claim 11 , wherein the step of determining the location of the distal end of the medical device comprises transmitting signals between at least one reference location and the distal end of the medical device.

15. The method according to claim 12 wherein the step of transmitting signals between at least one reference location and the distal end of the device comprises transmitting signals from a plurality of transmitters in more than one reference relocation, and a receiver on the magnetic medical device.

16. The method according to claim 14 wherein the medical device has a transmitter or receiver coil made from a radio opaque material.

17. The method according to claim 16 wherein the coil is made from at least one of gold or platinum, or an alloy containing gold or platinum.

18. The method according to claim 10 , further comprising the step of determining the location of the distal end of the medical device comprises moving the distal end of the medical device, and processing x-ray images before and after the movement to determine the location of the distal tip.

19. The method according to claim 18 , wherein the distal end of the medical device includes a magnetically responsive element, and wherein the step of moving the distal end of the medical device comprises applying a magnetic field or gradient from a magnet outside the subject's body to move the magnetically responsive element and thus the distal end of the medical device.

20. The method according to claim 19 wherein the medical device has a magnetically responsive element, wherein the medical device is oriented by applying a magnetic field from a magnetic surgery system outside the subject's body, and wherein the step of displacing the distal tip comprises changing the magnetic field applied by the magnetic surgery system to the magnetically responsive element.

21. The method according to claim 11 wherein the medical device includes at least one coil, and wherein the step of displacing the medical device comprises applying a current to the at least one coil to displace the at least one coil, and thus the medical device.

22. The method according to claim 21 wherein the coil is also used to change the magnetic moment of the distal end of the device to orient the distal end of the device.

23. The method according to claim 11 wherein the medical device is adapted to deliver embolizing devices from its distal end to embolize a vascular defect, and further comprising the step of positioning the distal end of the medical device in the vascular defect, and ejecting an embolizing device from the distal end to embolize the vascular defect.

24. The method according to claim 11 wherein the medical device is adapted to deliver embolizing material from its distal end to embolize a vascular defect, and further comprising the step of positioning the distal end of the medical device in the vascular defect, and ejecting an embolizing material from the distal end to embolize the vascular defect.

25. A method of delivering a flowable radiopaque substance to an operating region in a subject's body, the method comprising:

introducing the distal end of an elongate medical device into the subject's body which medical device includes at least one magnetically responsive element fixed thereon and a localization coil made of a radiopague material so as to be visible in the X-ray image;

navigating the distal end of the medical device to the desired site of delivery;

expelling a flowable radiopague substance at the desired site of delivery

displaying an x-ray image of the operating region, including the distal end of the medical device;

determining the location of a localization coil in the distal end of the medical device relative to at least two transmitters at known reference locations, to establish the location of the distal end being navigated in the presence of a radiopaque substance, in a reference frame translatable to the displayed x-ray image;

displaying an enhanced indication of the distal end of the medical device on the x-ray image of the operating region in which the distal end of the medical device including a radiopague material is in the presence of the expelled flowable radiopague substance, to facilitate the navigation of the distal end of the device in the operating region; and

navigating the distal end of the device using the displayed enhanced indication of the distal end when the distal end is obscured by the radiopaque substance.

26. The method according to claim 25 wherein the radiopaque substance is a flowable, settable embolic material.

27. The method according to claim 25 wherein the radiopaque substance is at least one embolizing coil.

28. The method according to claim 25 wherein the distal end of the magnetic medical device includes a magnetically responsive element, and wherein the step of navigating the distal end of the device includes applying a magnetic field from an external source to orient the distal end of the medical device.

29. The method according to claim 25 , wherein the step of determining the location of the distal end of the medical device comprises transmitting signals between at least one reference location and the distal end of the medical device.

30. The method according to claim 25 wherein the step of transmitting signals between at least one reference location and the distal end of the device comprises transmitting signals from a plurality of transmitters in more than one reference relocation, and a receiver on the magnetic medical device.

31. The method according to claim 25 , wherein the third step of determining the location of the distal end of the medical device comprises the moving the distal end of the medical device, and processing x-ray images before and after the movement to determine the location of the distal tip.

32. The method according to claim 31 , wherein the distal end of the medical device includes a magnetically responsive element, and wherein the step of moving the distal end of the medical device comprises applying a magnetic field or gradient from a magnet outside the subject's body to move the magnetically responsive element and thus the distal end of the medical device.

33. The method according to claim 32 wherein the medical device has a magnetically responsive element, wherein the medical device is oriented by applying a magnetic field from a magnetic surgery system outside the subject's body, and wherein the step of displacing the distal tip comprises changing the magnetic field applied by the magnetic surgery system to the magnetically responsive element.

34. The method according to claim 25 wherein the medical device includes at least one coil, and wherein the step of displacing the medical device comprises applying a current to the at least one coil to displace the at least one coil, and thus the medical device.

35. A method of embolizing a vascular defect in an operating region in a subject's body, comprising:

introducing the distal end of an elongate medical device having at least one magnetically responsive element fixed thereon into the subject's body;

navigating the distal end of the device to the vascular defect;

expelling the flowable radiopague substance at the site of the vascular defect;

displaying an x-ray image of the operating region, including the distal end of the medical device which includes a localization coil made of a radiopague material so as to be visible in the X-ray image;

determining the location of a localization coil in the distal end of the medical device relative to at least two transmitters at known reference locations, to establish the location of the distal end being navigated in the presence of a radiopaque substance, in a reference frame translatable to the displayed x-ray image;

displaying an enhanced indication of the distal end of the medical device on the x-ray image of the operating region in which the distal end of the medical device including a radiopapue material is in the presence of the expelled flowable radiopague substance, to facilitate the navigation of the distal end of the device in the operating region; and

navigating the distal end of the device using the displayed enhanced indication of the distal end when the distal end is obscured by the radiopaque substance.

36. The method according to claim 35 wherein distal end of the magnetic medical device includes a magnetically responsive element, and wherein the step of navigating the distal end of the device includes applying a magnetic field from an external source to orient the distal end of the medical device.

37. The method according to claim 35 wherein the vascular defect is an aneurysm.

38. The method according to claim 35 , wherein the step of determining the location of the distal end of the medical device comprises transmitting signals between at least one reference location and the distal end of the medical device.

39. The method according to claim 38 wherein the medical device has a transmitter or receiver coil made from a radio opaque material.

40. The method according to claim 39 wherein the coil is made from at least one of gold or platinum, or an alloy containing gold or platinum.

41. The method according to claim 40 wherein the step of transmitting signals between at least one reference location and the distal end of the device comprises transmitting signals from a plurality of transmitters in more than one reference relocation, and a receiver on the magnetic medical device.

42. The method according to claim 35 , wherein the step of determining the location of the distal end of the medical device comprises moving the distal end of the medical device, and processing x-ray images before and after the movement to determine the location of the distal tip.

43. The method according to claim 42 , wherein the distal end of the medical device includes a magnetically responsive element, and wherein the step of moving the distal end of the medical device comprises applying a magnetic field or gradient from a magnet outside the subject's body to move the magnetically responsive element and thus the distal end of the medical device.

44. The method according to claim 43 wherein the medical device has a magnetically responsive element, wherein the medical device is oriented by applying a magnetic field from a magnetic surgery system outside the subject's body, and wherein the step of displacing the distal tip comprises changing the magnetic field applied by the magnetic surgery system to the magnetically responsive element.

45. The method according to claim 35 wherein the medical device includes at least one coil, and wherein the step of displacing the medical device comprises applying a current to the at least one coil to displace the at least one coil, and thus the medical device.

46. The method of claim 35 wherein determining the step of determining the location of a localization coil in the distal end comprises at least two transmitters each having separate known reference relocations generating magnetic fields of about 1 Gauss at frequencies in the one to ten kilo-Hertz range, which are received by a localization coil on the magnetic medical device, such that the location of the coil in the distal end may be determined from the signals received by the coils uisng mathematical triangulation, when the tip is being magnetically navigated in the presence of radiopaque materials that obscure X-ray imaging of the tip location.

47. The method of claim 46 wherein the enhanced indication includes at least one line, which is viewable over the radiopaque material displayed in the X-ray image.

48. The method of claim 47 wherein the enhanced indication including at least one line further includes an increased brightness, distinctive color, or flashing color change.

49. The method of claim 46 wherein the enhanced indication includes a displayed object that can change from white to black in contrast on the X-ray image, to make the tip of the catheter blink to indicate its position when the tip is obscured due to the presence of a flowable radiopaque material.