Catheter assembly for intracranial treatment using dual lumens

• US 20060079830A1
• 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 7,322,954 B2
• Time in Patent Office: Days
• US Class Current: 604/28
• 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 is provided for intracranial treatment having outer and inner catheters. The outer catheter has a first lumen communicating between a first opening and at least one aperture and a second lumen in communication with a second opening. The first and second openings are distal to the proximal portion of the outer catheter. The inner catheter, preferably a micro-dialysis catheter, is sized to be received within the first lumen and includes at least one passageway in communication with at least one port for transfer of a fluid with a tissue region in the brain of the patient. The assembly preferably also includes a stylet sized to be received within the second lumen to provide rigidity to the outer catheter for its precise positioning within the brain. The outer catheter can include an element that is preferably a contact for monitoring brain activity. A method of transferring a fluid with a brain tissue region is also disclosed.

Claims

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

an outer catheter having a proximal portion, a first lumen in communication with respect to a first opening and at least one aperture, and a second lumen in communication with respect to a second opening, the first and second openings being distal to the proximal portion; and

an inner catheter sized to be received within the first lumen and including at least one passageway and at least one port in communication with respect to the passageway for transferring at least one fluid with a tissue region of the brain of the patient.

2. The catheter assembly of claim 1 further comprising a rigid stylet and a plug member, the stylet being sized to be received within the second lumen whereby the stylet can be positioned within the second lumen for insertion of the outer catheter into the brain, and the plug member being adapted to snugly engage the second opening whereby the plug member can close off the second lumen following insertion of the outer catheter and the removal of the stylet.

3. The catheter assembly of claim 2 wherein the second lumen is in communication with respect to the aperture.

4. The catheter assembly of claim 1 wherein the outer catheter has a closed distal end and an exterior, the aperture being spaced from the distal end along the exterior.

5. The catheter assembly of claim 4 wherein the outer catheter has an axis and at least first and second apertures in communication with respect to the first lumen, the first and second apertures being spaced axially along the exterior.

6. The catheter assembly of claim 4 wherein the outer catheter has an axis and at least first and second apertures in communication with respect to the first lumen, the first and second apertures being spaced radially about the axis along the exterior.

7. The catheter assembly of claim 4 wherein the inner catheter is a micro-dialysis catheter having a dialysis membrane at the port, the membrane being adapted to receive cerebral spinal fluid withdrawn from the tissue region through the aperture.

8. The catheter assembly of claim 7 wherein the inner catheter includes at least first and second passageways in communication with respect to the port, the second passageway including the dialysis membrane, whereby a liquid agent can be transferred to the tissue region through the first passageway and the cerebral spinal fluid can be withdrawn through the second passageway.

9. The catheter assembly of claim 1 wherein the aperture is at a distal end of the outer catheter.

10. The catheter assembly of claim 9 wherein the inner catheter is chosen from a plurality of inner catheters, each inner catheter having a different length for transferring the fluid with a select tissue region of the patient'"'"'s brain and being sized to extend through the aperture when inserted into the outer catheter.

11. The catheter assembly of claim 10 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 transferring the fluid with a first tissue region and the second inner catheter having a second length for transferring the fluid with a second tissue region, the second length being 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.

12. The catheter assembly of claim 11 wherein each inner catheter is a micro-dialysis catheter having a dialysis membrane adapted to receive cerebral spinal fluid at the port.

13. The catheter assembly of claim 1 wherein the outer catheter further includes an axis and a distal end, the outer catheter being flexibly deformable such that the outer catheter can be selectively configured to form a bend proximal to one of the openings to position that opening in axial alignment with the distal end.

14. The catheter assembly of claim 1 wherein the outer catheter further includes a distal portion having at least one element.

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

16. The catheter assembly of claim 15 wherein the contact monitors electrical activity within the brain.

17. The catheter assembly of claim 15 wherein the contact is a micro-contact.

18. The catheter assembly of claim 14 wherein the element is a location marker to identify the position of the outer catheter when inserted within the brain.

19. The catheter assembly of claim 14 wherein the outer catheter has at least two elements spaced along the distal portion.

20. The catheter assembly of claim 14 wherein the proximal portion includes at least one proximal-contact, the proximal-contact conductively connected with at least one element.

21. A method of transferring a fluid with a tissue region in the brain of a patient comprising:

inserting a distal portion of an outer catheter into a targeted area of the brain of the patient, the outer catheter having a proximal portion, a first lumen in communication with respect to a first opening and at least one aperture, and a second lumen in communication with respect to a second opening, the first and second openings being distal to the proximal portion;

inserting into the first lumen at the first opening an inner catheter having at least one passageway and at least one port in communication with respect to the passageway, the outer catheter guiding the inner catheter to the tissue region within the targeted area; and

transferring the fluid with the tissue region through the aperture of the outer catheter and the port of the inner catheter.

22. The method of claim 21 wherein a rigid stylet is positioned within the second lumen during the step of inserting the outer catheter into the brain, the method further comprising removing the stylet and positioning a plug member within the second lumen.

23. The method of claim 21 wherein the outer catheter is flexibly deformable and has an axis and a distal end, the method further comprising bending the outer catheter proximal to the openings to position the second opening in axial alignment with the distal end.

24. The method of claim 21 wherein the outer catheter has a closed distal end and an exterior, the aperture being spaced from the distal end along the exterior.

25. The method of claim 24 wherein the inner catheter is a micro-dialysis catheter having a dialysis membrane secured with respect to the port, the membrane being adapted to receive cerebral spinal fluid, and the transferring step includes withdrawing cerebral spinal fluid from the tissue region through the membrane.

26. The method of claim 25 wherein the micro-dialysis catheter includes a tapered fitting at a proximal end, the fitting being adapted to connect to a pumping instrument during the withdrawing step to withdraw cerebral spinal fluid through the passageway for transfer to an external location for analysis.

27. The method of claim 21 wherein the aperture is at a distal end of the outer catheter.

28. The method of claim 27 wherein the inner catheter is a micro-dialysis catheter having a dialysis membrane secured with respect to the port, the membrane being adapted to receive cerebral spinal fluid, and the method further comprising extending the micro-dialysis catheter through the aperture into the tissue region to withdraw cerebral spinal fluid from the tissue region through the membrane.

29. The method of claim 27 further comprising choosing the inner catheter from a plurality of inner catheters having different lengths, the inner catheter chosen having a length for reaching the tissue region and wherein the step of inserting the inner catheter includes extending the inner catheter through the aperture into the tissue region.

30. The method of claim 29 wherein each inner catheter of the plurality is a micro-dialysis catheter having a dialysis membrane secured with respect to the port, the membrane being adapted to receive cerebral spinal fluid, and the transferring step further includes withdrawing cerebral spinal fluid from the tissue region through the membrane.

31. The method of claim 21 wherein the outer catheter further includes a distal end and at least one element mounted proximal to the distal end upon an exterior surface of the distal portion.

32. The method of claim 31 wherein the element is a contact and further comprising monitoring brain activity within the tissue region utilizing the contact.

33. The method of claim 32 wherein the brain activity being monitored is electrical activity.

34. The method of claim 31 wherein the element is a contact and further comprising providing electrical stimulation to the tissue region utilizing the contact.

35. The method of claim 31 wherein the proximal portion includes at least one proximal-contact, the proximal-contact being conductively connected with at least one element.

36. A depth probe for intracranial treatment of a patient comprising:

a body extending from a proximal end to a distal end, the body having first and second openings and at least one aperture;

a first lumen defined by the body in communication with respect to the first opening and the aperture, the first lumen being sized to receive an inner catheter adapted to transfer fluids with a tissue region of the brain of the patient;

a second lumen defined by the body in communication with respect to the second opening, the second lumen being sized to receive a stylet adapted to facilitate insertion of the depth probe into the tissue region; and

a proximal portion at the proximal end, the openings being distal to the proximal portion.

37. The depth probe of claim 36 wherein the second opening is sized to receive and snugly engage a plug member such that the second lumen can be closed off by the plug member.

38. The depth probe of claim 36 wherein the body has an exterior and an axis and includes at least first and second apertures in communication with respect to the first lumen, the first and second apertures being spaced axially along the exterior.

39. The depth probe of claim 36 wherein the body has an exterior and an axis and includes at least first and second apertures in communication with respect to the first lumen, the first and second apertures being spaced radially about the axis along the exterior.

40. The depth probe of claim 36 wherein the body has an axis and is flexibly deformable such that the outer catheter can be selectively configured to form a bend proximal to one of the openings to position that opening in axial alignment with the distal end.

41. The depth probe of claim 36 further comprising a distal portion at the distal end, the openings being proximal to the distal portion, and the distal portion having at least one element.

42. The depth probe of claim 41 wherein the element is a contact that monitors brain activity within the tissue region.

43. The depth probe of claim 41 wherein the element is a micro-contact.

44. The depth probe of claim 41 wherein the element is a location marker to identify the position of the distal portion when the body is inserted within the brain.

45. The depth probe of claim 41 further comprising at least two elements spaced along the distal portion.