Catheter system for intracranial treatment

• US 20060079857A1
• Filed: 10/28/2005
• Published: 04/13/2006
• 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 7,465,292 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 system is provided having an outer catheter and at least one inner catheter chosen from a plurality of different inner catheters for delivery of a treatment agent to a selected tissue region of the brain. The outer catheter has a lumen in communication with an opening and at least one aperture. Each inner catheter is sized to be received within the lumen and has a passageway and at least one port in communication with that passageway. The system preferably has inner catheters having different lengths and/or passageways with different diameters. The outer catheter can include an element that monitors brain activity. The outer catheter can also have an inflatable balloon proximal to an element. A method of delivering a treatment agent, preferably a drug, to a select tissue region of a targeted area of the brain for intracranial treatment of a patient is also disclosed.

Claims

1. A catheter system for intracranial treatment of a patient comprising:

an outer catheter having an opening, at least one aperture and a lumen in communication with respect to the opening and the at least one aperture; and

at least one inner catheter chosen from a plurality of different inner catheters for delivering a treatment agent to a select tissue region of the patient'"'"'s brain, each inner catheter being sized to be received within the lumen and having a passageway and at least one port in communication with the passageway.

2. The catheter system of claim 1 wherein at least first and second inner catheters are chosen from the plurality of inner catheters, the first inner catheter having a first length for delivering the treatment agent to a first tissue region and the second inner catheter having a second length for delivering the treatment agent to a second tissue region.

3. The catheter system of claim 2 wherein each inner catheter is adapted to extend through the aperture when the inner catheter is inserted into the lumen.

4. The catheter system of claim 3 wherein the outer catheter has a distal end and the aperture is positioned at the distal end.

5. The catheter system of claim 4 wherein the second length is greater than the first length such that the second tissue region is at a greater distance distal from the aperture than the first tissue region.

6. The catheter system of claim 4 wherein each inner catheter has a distal end and the port on each inner catheter is positioned at the distal end.

7. The catheter system of claim 4 wherein each inner catheter has a different arrangement of a plurality of ports.

8. The catheter system of claim 2 wherein the treatment agent is a fluid.

9. The catheter system of claim 8 wherein the fluid is a drug.

10. The catheter system of claim 8 wherein the passageway of the first inner catheter has a first diameter and the passageway of the second inner catheter has a second diameter, the second diameter being greater than the first diameter such that the delivery of the fluid to the second tissue region is at a different flow rate than the delivery of the fluid to the first tissue region.

11. The catheter system of claim 1 wherein the at least one aperture is at least first and second apertures and the outer catheter has an axis and an exterior, the first and second apertures being spaced axially along the exterior.

12. The catheter system of claim 11 wherein the first and second apertures are spaced radially about the axis along the exterior.

13. The catheter system of claim 1 wherein the outer catheter includes an element.

14. The catheter system of claim 13 wherein the element is a contact that monitors brain activity.

15. The catheter system of claim 14 wherein the brain activity being monitored is electrical activity.

16. The catheter system of claim 14 wherein the contact is a micro-contact.

17. The catheter system of claim 13 wherein the element is a contact that stimulates brain activity.

18. The catheter system of claim 13 wherein the element is a sensor.

19. The catheter system of claim 18 wherein the sensor senses chemical activity.

20. The catheter system of claim 13 wherein the element is a location marker to identify the position of the outer catheter within the brain.

21. The catheter system of claim 1 wherein the outer catheter further includes a proximal portion, an exterior, and a conduit extending from the proximal portion to an inflatable balloon secured to the exterior.

22. The catheter system of claim 21 wherein the balloon is inflatable with at least one drug and the balloon is formed from a material permeable to the drug such that the drug can be introduced into the brain through the balloon.

23. The catheter system of claim 21 wherein the balloon is positioned along the outer catheter proximally adjacent to the aperture, the balloon being adapted to seal upon inflation a tract created upon insertion of the outer catheter into the brain.

24. The catheter system of claim 21 wherein the balloon is positioned along the outer catheter proximal to at least one element.

25. The catheter system of claim 1 wherein the outer catheter has a proximal end and the opening is positioned at the proximal end.

26. The catheter system of claim 25 wherein the outer catheter has a tapered fitting at the proximal end, the tapered fitting being configured for removable engagement to a fitting at a proximal end of each inner catheter.

27. The catheter system of claim 25 wherein the proximal end abuts a threaded exterior portion such that the outer catheter may be screwed into the skull of the patient after the outer catheter is placed in a targeted area within the patient'"'"'s brain.

28. The catheter system of claim 27 wherein the inner catheter is threadably received by the outer catheter to firmly secure the inner catheter to the outer catheter.

29. A method for intracranial treatment of a patient comprising:

inserting an outer catheter into a targeted area of the brain of the patient, the outer catheter having an opening, at least one aperture and a lumen in communication with respect to the opening and the at least one aperture;

inserting an inner catheter into the outer catheter at the opening, the inner catheter being chosen from a plurality of different inner catheters for delivery of a treatment agent to a select tissue region of the targeted area, each inner catheter having a passageway and at least one port in communication with the passageway;

utilizing the outer catheter to guide the inner catheter to the tissue region; and

delivering the treatment agent to the tissue region through the port.

30. The method of claim 29 wherein the inner catheter is a first inner catheter having a first length, the outer catheter guiding the first inner catheter for delivering the treatment agent to a first tissue region of the targeted area through the port of the first inner catheter, and further including inserting into the outer catheter at the opening a second inner catheter having a second length chosen from the plurality of inner catheters, the outer catheter guiding the second inner catheter for delivering the treatment agent to a second tissue region of the targeted area through the port of the second inner catheter.

31. The method of claim 30 wherein the steps of inserting the first and second inner catheters into the outer catheter include extending the inner catheter through the aperture into the targeted area.

32. The method of claim 31 wherein the outer catheter has a distal end and the aperture is positioned at the distal end.

33. The method of claim 32 wherein the second length is greater than the first length such that the second inner catheter is extended a greater distance distal from the aperture than the first inner catheter is extended.

34. The method of claim 32 wherein each inner catheter has a distal end and the port is positioned at the distal end.

35. The method of claim 32 wherein each inner catheter has a plurality of ports in a distinct arrangement.

36. The method of claim 30 wherein the treatment agent is a fluid.

37. The method of claim 36 wherein the fluid is a drug.

38. The method of claim 36 further including delivering the fluid to the passageway of each inner catheter at a select pressure and wherein the passageway of the first inner catheter has a first diameter and the passageway of the second inner catheter has a second diameter, the second diameter being greater than the first diameter such that the delivery of the fluid to the second tissue region is at a different flow rate than the delivery of the fluid to the first tissue region.

39. The method of claim 29 wherein the at least one aperture is at least first and second apertures and the outer catheter has an axis and an exterior, the first and second apertures being spaced axially and radially about the axis along the exterior.

40. The method of claim 29 wherein the opening is positioned at a proximal end of the outer catheter, the proximal end including a tapered fitting that is configured for removable engagement to a fitting at a proximal end of each inner catheter.

41. The method of claim 29 wherein a proximal end of the outer catheter abuts a threaded exterior portion and the inserting the outer catheter step includes screwing the threaded portion into the skull of the patient to retain the outer catheter in the targeted area for an extended period of time.

42. The method of claim 41 wherein the step of inserting the inner catheter into the outer catheter includes having the inner catheter threadably received by the outer catheter to firmly secure the inner catheter to the outer catheter.

43. The method of claim 29 wherein the outer catheter includes a location marker and further including identifying the position of the location marker within the brain.

44. The method of claim 29 wherein the outer catheter includes a distal portion having a distal end and at least one contact mounted proximal to the distal end upon an exterior surface of the distal portion and further including monitoring brain activity with the contact during treatment.

45. The method of claim 29 wherein the outer catheter includes a distal portion having a distal end and at least one sensor mounted proximal to the distal end upon an exterior surface of the distal portion and further including sensing brain activity with the sensor during treatment.

46. The method of claim 29 wherein the outer catheter includes an inflatable balloon secured to an exterior of the outer catheter and a conduit extending from a proximal portion of the outer catheter to the balloon and further including inflating the balloon with at least one drug and introducing the drug into the brain through the balloon, the balloon being formed from a material permeable to the drug.

47. The method of claim 29 wherein the outer catheter includes an inflatable balloon secured to an exterior of the outer catheter proximally adjacent to the aperture and a conduit extending from a proximal portion of the outer catheter to the balloon and further including inflating the balloon to seal a tract created during the insertion of the outer catheter into the brain.

48. The method of claim 29 wherein the treatment is directed against tumors.