Method for intracranial catheter treatment of brain tissue

• US 7,241,283 B2
• Filed: 04/25/2003
• Issued: 07/10/2007
• Est. Priority Date: 04/25/2003
• Status: Expired due to Term

• Current Assignee: AD-Tech Medical Instrument Corp.
• Original Assignee: AD-Tech Medical Instrument Corp.
• Inventors: Putz, David A.
• Primary Examiner(s): Luchessi; Nicholas
• Assistant Examiner(s): Stigell; Theodore J.
• Application Number:
  US10/423,587
• Publication Number:
  US 20040215162A1
• Time in Patent Office: 1,537 Days
• Field of Search: 604/500, 604/103.1, 604/164.09, 604/164, 604/165, 604/167, 604/93.01, 604/96.01, 604158-159, 604/503, 604506-507, 604508-509, 604/103, 604/103.01, 604/171, 604/523, 604/529, 604/538, 604/378, 607/116, 600/407, 600/411, 600/424, 600/585
• 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 method for intracranial treatment of a patient is disclosed. The method comprises the steps of inserting into the brain an outer catheter having an exterior surface, an inflatable balloon mounted upon the exterior surface, at least one element distal to the balloon upon the exterior surface, at least one aperture and a lumen; inflating the balloon to seal a tract created during insertion; inserting an inner catheter into the lumen which has a passageway and at least one port, the outer catheter guiding the inner catheter to the desired tissue region; and transferring fluids between the proximal end of the inner catheter and the tissue region through the passageway. Each element is adapted for monitoring or electronically stimulating brain tissue or for allowing identification of the location of the element catheter within the brain. The method facilitates regular accurate placement of the drug delivery catheter at the tissue region without additional extended brain contact during insertion. Drugs can be administered through ports near the distal end of the inner catheter or fluid can be removed from the brain through these 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 an exterior surface, an inflatable balloon mounted upon the exterior surface, at least one element distal to the balloon, at least one aperture and a lumen, the element being adapted to monitor brain activity within the tissue region, to electronically stimulate the tissue region, or to provide information on a precise position of the element when the element is located entirely within the brain and being mounted proximal to a distal end of the outer catheter upon an exterior surface of a distal portion of the outer catheter;

inflating the balloon to seal a tract created during insertion of the outer catheter into the brain;

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 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.

3. The method of claim 2 further comprising connecting the outer catheter to the patient'"'"'s skull and connecting the inner catheter to the outer catheter.

4. The method of claim 1 wherein the element is a location marker and further including locating the position of the location marker within the brain by utilizing magnetic resonance imaging.

5. The method of claim 1 wherein the element is a location marker and further including locating the position of the location marker within the brain by utilizing computerized x-ray tomography.

6. The method of claim 1 wherein the outer catheter includes a tapered fitting at a proximal end of the lumen, the fitting engaging the inner catheter upon insertion into the lumen so that unintended relative movement between the outer catheter and inner catheter is prevented.

7. The method of claim 1 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.

8. The method of claim 1 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.

9. The method of claim 1 wherein the transferring action includes delivering drugs to the tissue region through the at least one port.

10. The method of claim 1 wherein the transferring action includes withdrawing cerebral spinal fluid through the at least one port.

11. The method of claim 10 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.

12. The method of claim 1 wherein the balloon is inflated with a drug and further comprising delivering the drug to the tissue region through the balloon.

13. The meted of claim 12 further comprising delivering a second drug to the tissue region through the at least one port.

14. The method of claim 1 wherein the element monitors brain activity and further comprising sensing chemical changes at the tissue region via the element.

15. The method of claim 1 wherein the element monitors brain activity and further comprising sensing electrical changes at the tissue region via the element.

16. The method of claim 1 wherein the element is a fiber optic contact.

17. 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 adapted to monitor brain activity within the tissue region, to electronically stimulate the tissue region, or to provide information on a precise position of the element when the element is located entirely within the brain, 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 lumen snugly receiving the inner catheter and guiding the inner catheter to the tissue region and the outer catheter including a tapered fitting at a proximal end of the lumen, the fitting being adapted to be frictionally received by the inner catheter upon non-radial and substantially axial insertion of the inner catheter into the lumen and to be engaged by the inner catheter following insertion so that unintended relative movement between the outer catheter and inner catheter upon engagement is avoided; and

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

18. 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 adapted to monitor brain activity within the tissue region or to electronically stimulate the tissue region, an inflatable balloon proximal to the at least one element and mounted upon an exterior surface of the outer catheter, at least one aperture and a lumen;

sensing or stimulating brain activity in the tissue region via the element;

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.

19. The method of claim 18 further comprising the step of inflating the balloon to seal a tract created during insertion of the assembly into the brain.

20. The method of claim 19 wherein the tissue region is distal to the balloon along the tract and the fluids are drugs being delivered to the tissue region through the port such that the at least one element distal to the balloon is sensing and stimulating brain activity in the tissue region treated with the drugs.