Intracranial catheter assembly for precise treatment of brain tissue

• US 20040215162A1
• Filed: 04/25/2003
• Published: 10/28/2004
• Est. Priority Date: 04/25/2003
• Status: Active Grant

• Current Assignee: AD-Tech Medical Instrument Corp.
• Original Assignee: AD-Tech Medical Instrument Corp.
• Inventors: Putz, David A.
• Granted Patent: US 7,241,283 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A catheter assembly for intracranial treatment of a patient is disclosed. The assembly comprises an outer catheter having a proximal opening, at least one aperture, a lumen connecting the opening and the at least one aperture and at least one element; and an inner catheter adapted to be received within the lumen and including a passageway and at least one port for transferring fluids between the inner catheter and a tissue region within the patient'"'"'s brain. The element is preferably a contact for monitoring or stimulating brain tissue or a location marker for allowing identification of the location of the outer catheter within the brain, or both. The assembly facilitates regular accurate placement of the drug delivery catheter at the tissue region without additional extended brain contact during insertion. Drugs can administered from the drug delivery catheter through ports near the distal end of the depth electrode or fluid can be removed from the brain through the ports.

Claims

1. A method of treating a tissue region in the brain of a patient comprising:

inserting into the brain an outer catheter having at least one element, at least one aperture and a lumen;

inserting into the lumen an inner catheter having a passageway extending between a proximal end and at least one port, the outer catheter guiding the inner catheter to the tissue region; and

transferring fluids between the tissue region and the proximal end through the passageway.

2. The method of claim 1 wherein the element is a location marker and further including locating the position of the location marker in the brain.

3. The method of claim 2 wherein a stylet is positioned in the lumen during insertion of the outer catheter into the brain and further comprising removing the stylet from the outer catheter before the inner catheter is inserted into the lumen.

4. The method of claim 3 further comprising connecting the outer catheter to the patient'"'"'s skull and connecting the inner catheter to the outer catheter.

5. The method of claim 2 wherein the location marker is located by magnetic resonance imaging.

6. The method of claim 2 wherein the location marker is located by computerized x-ray tomography.

7. The method of claim 1 wherein the element is a contact and further comprising monitoring the tissue region via the contact.

8. The method of claim 7 wherein a stylet is positioned in the lumen during insertion of the outer catheter into the brain and further comprising removing the stylet from the outer catheter before the inner catheter is inserted into the lumen.

9. The method of claim 7 wherein the outer catheter includes a fitting which engages the inner catheter upon insertion into the lumen so that unintended relative movement between the outer catheter and inner catheter is prevented.

10. The method of claim 7 wherein the at least one contact provides electrical stimulation to the tissue region.

11. The method of claim 7 wherein the at least one contact senses brain activity in the tissue region.

12. The method of claim 7 wherein the inner catheter has a distal end which passes through the aperture into the tissue region beyond the outer catheter during the insertion of the inner catheter into the lumen.

13. The method of claim 7 wherein the inner catheter has a distal end and the outer catheter has a closed lumen so that the distal end is contained within the outer catheter when the inner catheter is inserted into the lumen.

14. The method of claim 7 wherein the transferring action includes delivering drugs to the tissue region through the at least one port.

15. The method of claim 7 wherein the transferring action includes withdrawing cerebral spinal fluid through the at least one port.

16. The method of claim 15 wherein the inner catheter includes a micro-dialysis membrane at the at least one port, the cerebral spinal fluid passing through the membrane during the withdrawing action.

17. The method of claim 7 wherein the outer catheter includes an inflatable balloon and further comprising inflating the balloon to seal a tract created during insertion of the assembly into the brain.

18. The method of claim 17 wherein the balloon is inflated with a drug and further comprising delivering the drug to the tissue region through the balloon.

19. The method of claim 18 further comprising delivering a second drug to the tissue region through the at least one port.

20. The method of claim 7 wherein the monitoring action includes sensing chemical changes at the tissue region.

21. The method of claim 7 wherein the monitoring action includes sensing electrical changes at the tissue region.

22. The method of claim 7 wherein the contact is a fiber optic contact.

23. A catheter assembly for intracranial treatment of a patient comprising:

an outer catheter having a proximal opening, at least one aperture and a lumen connecting the opening and the at least one aperture, the outer catheter having at least one element; and

an inner catheter adapted to be received within the lumen and including a passageway and at least one port for delivering fluids to a tissue region within the patient'"'"'s brain.

24. The catheter assembly of claim 23 further comprising a rigid stylet received within the lumen for insertion into the patient'"'"'s brain and removed before insertion of the inner catheter into the lumen.

25. The catheter assembly of claim 23 wherein the aperture is axially aligned with the inner lumen.

26. The catheter assembly of claim 25 wherein the inner catheter extends through the aperture when the inner catheter is received within the lumen.

27. The catheter assembly of claim 26 wherein at least two ports are positioned on a side of the inner catheter along a line parallel to the passageway.

28. The catheter assembly of claim 27 wherein at least two ports are radially and axially spaced about the inner catheter.

29. The catheter assembly of claim 23 wherein the outer catheter has a closed end which blocks passage of the inner catheter therethrough.

30. The catheter assembly of claim 23 wherein at least two apertures are radially and axially spaced about the outer catheter.

31. The catheter assembly of claim 23 wherein the at least one element is a contact which monitors activity in the brain.

32. The catheter assembly of claim 31 wherein the contact senses electrical activity in the brain.

33. The catheter assembly of claim 31 wherein the contact senses chemical activity in the brain.

34. The catheter assembly of claim 31 wherein the contact senses brain function in the tissue region.

35. The catheter assembly of claim 31 wherein the contact provides electrical stimulation to the tissue region.

36. The catheter assembly of claim 31 wherein the contact is a collar circumscribing the outer catheter.

37. The catheter assembly of claim 31 wherein the contact is a micro contact.

38. The catheter assembly of claim 31 wherein the contact is a macro contact.

39. The catheter assembly of claim 31 wherein the outer catheter includes an electrical lead corresponding to each contact.

40. The catheter assembly of claim 23 wherein the outer catheter and inner catheter have proximal ends, one of the proximal ends including a luer fitting, the other of the proximal ends configured for connection to the luer fitting.

41. The catheter assembly of claim 23 wherein the outer catheter further includes a conduit extending from the proximal end to an inflatable balloon, the balloon adapted to be inflated to seal a tract created during insertion of the assembly into the brain.

42. The catheter assembly of claim 23 wherein the outer catheter is adapted to connect to the patient'"'"'s skull when inserted to the targeted portion.

43. The catheter assembly of claim 42 wherein the inner catheter is adapted to connect to the outer catheter when inserted to the targeted portion.

44. The catheter assembly of claim 23 wherein the port includes a dialysis membrane adapted to receive cerebral spinal fluid.

45. The catheter assembly of claim 23 further comprising a stylet received in the lumen during insertion of the outer catheter into the brain.

46. The catheter assembly of claim 23 wherein the element is a location marker for allowing the position of the outer catheter to be located within the brain.

47. The catheter assembly of claim 46 wherein the location marker is adapted to be located by magnetic resonance imaging.

48. The catheter assembly of claim 46 wherein the location marker is adapted to be located by computerized x-ray tomography.

49. The catheter assembly of claim 23 wherein the inner catheter is a first inner catheter having a first length for delivering fluids to a first tissue region and further comprising a second inner catheter having a second length greater than the first length, the second inner catheter adapted to be received within the lumen and including a passageway and at least one port for delivering fluids to a second tissue region within the patient'"'"'s brain.

50. The catheter assembly of claim 49 further comprising a third inner catheter having a third length greater than the second length, the third inner catheter adapted to be received within the lumen and including a passageway and at least one port for delivering fluids to a third tissue region within the patient'"'"'s brain.

51. The catheter assembly of claim 50 wherein each inner catheter has a unique arrangement of ports.