Intracardiac drug delivery

• US 20020013615A1
• Filed: 07/12/2001
• Published: 01/31/2002
• Est. Priority Date: 02/05/1998
• Status: Active Grant

• Current Assignee: Avraham Matcovitch, Shlomo Ben Haim, Uri Yaron
• Original Assignee: Avraham Matcovitch, Shlomo Ben Haim, Uri Yaron
• Inventors: Matcovitch, Avraham, Yaron, Uri, Haim, Shlomo Ben
• Granted Patent: US 6,702,777 B2
• Time in Patent Office: Days
• US Class Current: 607/120
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2025/0076 Unidirectional valves
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

Apparatus for intracardiac drug administration, including a catheter which is inserted into a chamber of the heart and brought into engagement with a site in the heart wall. The catheter includes at least one position sensor, which generates signals responsive to the position of the catheter within the heart, and a drug delivery device, which administers a desired dose of a therapeutic drug at the site determined responsive to the signals from the position sensor.

Claims

1. Apparatus for intracardiac drug administration, comprising a catheter which is inserted into a chamber of the heart and brought into engagement with a site in the heart wall, the catheter comprising:

at least one position sensor, which generates signals responsive to the position of the catheter within the heart; and

a drug delivery device, which administers a desired dose of a therapeutic drug at the site determined responsive to the signals from the position sensor.

2. Apparatus according to claim 1, wherein the therapeutic drug comprises a growth factor.

3. Apparatus according to claim 1, wherein the drug is contained in a slow-release matrix.

4. Apparatus according to claim 3, wherein the matrix comprises a solid capsule.

5. Apparatus according to claim 1, wherein the catheter comprises a contact sensor disposed on a distal surface of the catheter, which senses contact of the surface with the heart wall.

6. Apparatus according to claim 5, wherein the contact sensor comprises a pressure sensor.

7. Apparatus according to claim 1, wherein the position sensor comprises a magnetic position sensor, which generates signals responsive to an externally-applied magnetic field.

8. Apparatus according to claim 1, wherein the position sensor signals are used to generate position and orientation coordinates, responsive to which the drug dose is delivered.

9. Apparatus according to claim 1, wherein the catheter comprises at least one physiological sensor, which generates signals indicative of the viability of heart tissue at the site.

10. Apparatus according to claim 9, wherein the at least one physiological sensor comprises an electrode.

11. Apparatus according to claim 9, wherein the apparatus generates a viability map of the heart based on the signals and administers the drug responsive thereto.

12. Apparatus according to claim 1, and comprising a radiation source for irradiation of the myocardial tissue, wherein the catheter comprises a waveguide, which communicates with the radiation source.

13. Apparatus according to claim 12, wherein the drug delivery device administers the drug into a channel produced in the tissue by the irradiation.

14. Apparatus according to claim 13, wherein the drug delivery device inserts a solid capsule into the channel.

15. Apparatus according to claim 1, wherein the drug delivery device comprises a hollow needle, which extends distally from the catheter and penetrates the heart tissue to deliver the drug dose.

16. Apparatus according to claim 15, wherein the needle has a helical shape.

17. Apparatus according to claim 16, wherein the needle is fastened to the site in the heart wall by a rotational movement of the needle.

18. Apparatus according to claim 15, wherein the needle is retracted into the catheter before and after the drug dose is delivered.

19. Apparatus according to claim 18, wherein the needle extends from the catheter through an opening in the catheter, which opening is covered by a puncture seal.

20. Apparatus according to claim 19, wherein the drug delivery device comprises a displacement mechanism, which extends and retracts the needle.

21. Apparatus according to claim 20, wherein the displacement mechanism controls the distance by which the needle extends from the catheter, so as to administer the drug at a predetermined depth within the heart wall.

22. Apparatus according to claim 1, wherein the drug administration is controlled responsive to variations in the thickness of the heart wall at the site.

23. Apparatus according to claim 22, wherein the catheter comprises an ultrasound transducer, which generates signals indicative of the thickness of the heart wall.

24. Apparatus according to claim 22, wherein the drug delivery device is gated to administer the drug when the wall at a predetermined thickness.

25. Apparatus for intracardiac therapy, comprising:

a catheter, which is inserted into a chamber of the heart for administration of therapeutic treatment to the heart wall;

a sensor, which generates signals responsive to the thickness of the heart wall; and

a controller, which receives the signals from the sensor and controls the treatment responsive the thickness of the heart wall.

26. Apparatus according to claim 25, wherein the sensor comprises an ultrasound transducer.

27. Apparatus according to claim 26, wherein the transducer is fixed to the catheter adjacent to a distal end thereof.

28. Apparatus according to claim 25, wherein the sensor comprises a position sensor, which is fixed to the catheter adjacent to a distal end thereof.

29. Apparatus according to claim 25, wherein the catheter comprises a drug delivery device, and wherein the treatment comprises administration of a therapeutic substance at a site in the heart wall.

30. Apparatus according to claim 25, and comprising a radiation source, wherein the treatment comprises irradiation of the myocardial tissue using the source, and wherein the catheter comprises a waveguide, which communicates with the radiation source.

31. Apparatus according to claim 25, wherein the controller gates the treatment so that the, treatment is administered during a portion of the heart cycle.

32. Apparatus according to claim 31, wherein the controller gates the treatment so that the treatment is administered when the thickness is at a maximum.

33. Apparatus according to claim 31, wherein the controller gates the treatment so that the treatment is administered when the thickness is at a minimum.

34. A method for intracardiac drug administration, comprising:

introducing a catheter into a chamber of the heart;

sensing position coordinates of the catheter;

positioning the catheter, using the coordinates, in engagement with the heart wall at a desired site; and

administering a therapeutic drug at the site using the catheter.

35. A method according to claim 34, wherein administering the therapeutic drug comprises administering a growth factor.

36. A method according to claim 35, wherein the growth factor comprises a fibroblast growth factor (FGF).

37. A method according to claim 35, wherein the growth factor comprises a vascular endothelial growth factor (VEGF).

38. A method according to claim 35, wherein the growth factor comprises a gene encoding the growth factor.

39. A method according to claim 34, wherein administering the therapeutic drug comprises injecting a slow-release preparation of the drug into the myocardium.

40. A method according to claim 39, wherein administering the slow-release preparation comprises administering a liquid.

41. A method according to claim 39, wherein administering the slow-release preparation comprises inserting a capsule containing the drug into the myocardium.

42. A method according to claim 34, and comprising irradiating the heart wall for engendering revascularization of the myocardium.

43. A method according to claim 42, wherein irradiating the heart wall comprises generating a channel in the myocardium, and wherein administering the therapeutic drug comprises inserting the drug into the channel.

44. A method according to claim 34, wherein positioning the catheter comprises verifying contact between the catheter and the heart wall by receiving signals generated by a contact sensor disposed on the catheter.

45. A method according to claim 34, and comprising receiving physiological signals from the heart, wherein administering the therapeutic drug comprises administering the drug responsive to the physiological signals.

46. A method according to claim 45, wherein the physiological signals comprise mechano-physiological signals.

47. A method according to claim 45, wherein the physiological signals comprise electrophysiological signals.

48. A method according to claim 45, wherein administering the therapeutic drug comprises administering the drug responsive to a measure of tissue viability determined from the physiological signals.

49. A method according to claim 48, wherein administering the therapeutic drug comprises administering the drug substantially only in ischemic but viable areas of the heart.

50. A method according to claim 48, wherein administering the therapeutic drug comprises administering the drug responsive to a map of tissue viability.

51. A method according to claim 34, wherein sensing the position coordinates comprises sensing orientation coordinates of the catheter, and wherein positioning the catheter comprises orienting the catheter in a desired orientation relative to the heart wall responsive to the coordinates.

52. A method according to claim 34, wherein positioning the catheter comprises positioning the catheter relative to a grid of points delineating a zone for drug administration on a geometrical map of the heart.

53. A method according to claim 52, and comprising marking sites on the map at which the drug has been administered.

54. A method of intracardiac therapy, comprising:

receiving signals indicative of variations in the thickness of a wall of the heart; and

administering a therapeutic treatment to a site in the heart wall responsive to the thickness variations.

55. A method according to claim 54, wherein administering the treatment comprises inserting a catheter into the heart and bringing the catheter into proximity with the site.

56. A method according to claim 55, wherein administering the treatment comprises irradiating the heart wall with laser radiation conveyed via the catheter.

57. A method according to claim 55, wherein administering the treatment comprises introducing a therapeutic drug into the heart wall using the catheter.

58. A method according to claim 55, wherein receiving the signals comprises receiving signals from a sensor fixed to the catheter.

59. A method according to claim 58, wherein receiving the signals comprises receiving signals from a position sensor fixed to the catheter.

60. A method according to claim 54, wherein receiving the signals comprises receiving ultrasound signals.

61. A method according to claim 54, wherein receiving the signals comprises receiving electrophysiological signals.

62. A method according to claim 54, wherein administering the treatment comprises gating the treatment responsive to the thickness variations.

63. A method according to claim 62, wherein gating the treatment comprises administering the treatment when the thickness is substantially at a maximum thereof during a cardiac cycle.

64. A method according to claim 62, wherein gating the treatment comprises administering the treatment when the thickness is substantially at a minimum thereof during a cardiac cycle.

65. A method according to claim 62, wherein gating the treatment comprises controlling the treatment so that the treatment is applied at a desired depth within the heart wall.