APPARATUS, SYSTEMS AND METHODS FOR DELIVERY OF MEDICATION TO THE BRAIN TO TREAT NEUROLOGICAL CONDITIONS

• US 20130267928A1
• Filed: 03/14/2013
• Published: 10/10/2013
• Est. Priority Date: 01/26/2009
• Status: Active Grant

• Current Assignee: InCube Labs LLC. (In-Cube, Inc.)
• Original Assignee: Incube LLC
• Inventors: Imran, Mir, Morgan, Phillip, Tranchina, Ben, Spher, Paul, Horlen, Kyle
• Granted Patent: US 10,507,313 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

Various embodiments provide an apparatus, system method for treating neurological conditions by delivering solid form medication to the ventricles or other areas of the brain. Particular embodiments provide an apparatus and method for treating epilepsy and other neurological conditions by delivering solid form medication to ventricles in the brain wherein the medication is contained in a diffusion chamber so as to allow the medication to dissolve in the cerebrospinal fluid of the brain and then diffuse out of the diffusion chamber to be delivered to the ventricles and brain tissue. In one or more embodiments, portions of apparatus have sufficient flexibility to conform to the shape of the ventricles of the brain when advanced into them and/or to not cause deformation of the ventricle sufficient to cause a significant physiologic effect.

Claims

1. An apparatus for delivery of medication to the ventricles within the brain of a patient, the apparatus comprising:

a flexible delivery member having a proximal end, a distal end, and a lumen for advancement of a solid form medication element through the delivery member, the medication element comprising at least one drug, wherein the delivery member is configured to be advanced into a selected ventricle of the brain from a site outside the brain; and

a diffusion chamber coupled to the distal end of the delivery member;

the diffusion chamber having a wall and an interior volume for receiving the medication element and at least one diffusion section positioned in the wall allowing cerebrospinal fluid (CSF) to enter and exit the chamber;

wherein the chamber is configured to i) retain a medication element received from the delivery member;

ii) dissolve the medication element in fluid within the interior volume to form a drug solution; and

iii) diffuse drug from the drug solution through the at least one diffusion section to CSF within the selected ventricle of the brain; and

wherein the diffusion chamber and the delivery member have sufficient flexibility such that during advancement of the apparatus into the brain, the apparatus conforms to a shape of the selected ventricle.

2. The apparatus of claim 1, wherein the diffusion chamber and the delivery member have sufficient flexibility such that during advancement of the apparatus into the brain, the apparatus does not deform a ventricular wall of the brain sufficiently to cause a significant physiological effect to brain.

3. The apparatus of claim 2, wherein the diffusion chamber deforms the ventricular wall no more than about 3 mm.

4. The apparatus of claim 2, wherein the diffusion chamber applies no more that about 20 mmHG of pressure to the ventricular wall.

5. The apparatus of claim 2, wherein the physiologic effect is a decrease in CSF production.

6. The apparatus of claim 2, wherein the physiologic effect comprises at least one of a neurological effect, loss of consciousness, pain or numbness, or change in heart rate.

7. The apparatus of claim 1, wherein the medication element has a pellet shape.

8. The apparatus of claim 1, wherein the medication element comprises a drug for the treatment of epilepsy.

9. The apparatus of claim 8, wherein the drug comprises furosemide.

10. The apparatus of claim 1, wherein the diffusion chamber includes a septum valve positioned at a proximal portion of the chamber, the septum value configured to allow advancement of the medication element into the diffusion chamber and then close to provide a fluidic seal between the diffusion chamber and the flexible member.

11. The apparatus of claim 1, wherein the at least one diffusion section is positioned around a circumference of the wall of the diffusion chamber.

12. The apparatus of claim 1, wherein the at least one diffusion section comprises at least two diffusion sections.

13. The apparatus of claim 12, wherein the at least one diffusion section comprises at least four diffusion sections.

14. The apparatus of claim 13, wherein the at least four diffusion sections are offset by about 90 degrees with respect to a longitudinal axis of the diffusion chamber.

15. The apparatus of claim 1, wherein the at least one diffusion section comprises a permeable membrane.

16. The apparatus of claim 15, wherein the membrane comprises polyimide.

17. The apparatus of claim 15 wherein the diffusion chamber includes a valve for releasing pressure within the diffusion chamber.

18. The apparatus of claim 17, wherein the valve comprises a slit in the wall of the diffusion chamber.

19. The apparatus of claim 1, wherein the diffusion section comprises a section of a wall of the diffusion chamber having a plurality of openings for diffusion of CSF in and out of the diffusion chamber.

20. The apparatus of claim 19, wherein the openings comprise slits.

21. The apparatus of claim 20, wherein the slits have a length in a range of about 0.25 mm to about 5 mm.

22. The apparatus of claim 19, wherein the plurality of openings comprise 32 openings.

23. The apparatus of claim 19, wherein the openings have a diameter in a range of about 0.1 mm to about 0.5 mm.

24. The apparatus of claim 1, wherein the diffusion chamber comprises silicone.

25. The apparatus of claim 1, wherein the diffusion chamber is sufficiently flexible to bend up to about 30°

when advanced in the ventricles of the brain.

26. The apparatus of claim 1, wherein the diffusion chamber is connected to the delivery member by a necked section allowing the diffusion chamber to bend and flex when advanced into the ventricles of the brain.

27. The apparatus of claim 1, wherein the diffusion chamber wall has a plurality of channels configured for maintaining diffusion of drug from the diffusion section when the diffusion section contacts the ventricle wall.

28. The apparatus of claim 27, wherein the channels continue along a length of the delivery member so as to allow transport of the drug through the channel in a proximal direction of the delivery catheter to be delivered into brain tissue.

29. The apparatus of claim 28, wherein the channels have sufficient length so to allow drug solution to be delivered to a surface of the brain.

30. The apparatus of claim 27, wherein the channels correspond to convolutions in the wall of the diffusion chamber.

31. The apparatus of claim 27, wherein the channels correspond to slots in the wall of the diffusion chamber.

32. The apparatus of claim 27, wherein the plurality of channels comprise at least eight channels.

33. A system for the delivery of medication to the ventricles of the brain of a patient, the system comprising:

the apparatus of claim 1, and

a drug storage device operably coupled to proximal end of the delivery member, the storage device configured to store a plurality of solid form medication elements.

34-36. -36. (canceled)

37. A method for intracranial delivery of medication to a brain of a patient in need thereof, the method comprising:

positioning a diffusion chamber within a ventricle of the brain of the patient wherein the diffusion chamber conforms to the shape of ventricle without significant effect to the patient, the diffusion chamber configured to receive a solid form medication element comprising at least one drug;

advancing a solid form medication element to the diffusion chamber;

dissolving the solid form medication element within cerebrospinal fluid (C SF) within the chamber; and

diffusing the drug from the diffusion chamber to CSF within the ventricle.

38-45. -45. (canceled)

46. An apparatus for delivery of medication to the ventricles within a brain of a patient, the apparatus comprising:

a flexible delivery member having a proximal end, a distal end, and a lumen for advancement of a solid form medication element comprising at least one drug therethrough, the delivery member being configured to be advanced into a selected ventricle of the brain from a site outside the brain; and

a diffusion chamber coupled to the distal end of the delivery member, the diffusion chamber having a wall and an interior volume for receiving and retaining the medication element therein,

wherein the wall of the diffusion chamber comprises means for allowing cerebrospinal fluid (CSF) to enter into the interior volume, dissolve at least a portion of the medication element, and exit the interior volume with the at least one drug dissolved therein, and wherein the delivery member and the diffusion chamber have sufficient flexibility such that during advancement of the apparatus into the brain, the apparatus conforms to a shape of the selected ventricle.

47-81. -81. (canceled)