MULTI-DIRECTIONAL MICROFLUIDIC DRUG DELIVERY DEVICE

• US 20130035560A1
• Filed: 08/01/2012
• Published: 02/07/2013
• Est. Priority Date: 08/01/2011
• Status: Active Grant

• Current Assignee: Alcyone Therapeutics, Inc.
• Original Assignee: Alcyone Lifesciences, Inc.
• Inventors: Anand, PJ, Singh, Deep Arjun
• Granted Patent: US 10,434,251 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

The methods, systems, and devices disclosed herein generally involve convection-enhanced delivery of drugs to a target region within a patient. Microfluidic catheter devices are disclosed that are particularly suitable for targeted delivery of drugs via convection, including devices capable of multi-directional drug delivery, devices that control fluid pressure and velocity using the venturi effect, and devices that include conformable balloons. Methods of treating various diseases using such devices are also disclosed, including methods of treating cerebral and spinal cavernous malformations, cavernomas, and hemangiomas, methods of treating neurological diseases, methods of treatment using multiple microfluidic delivery devices, methods of treating hearing disorders, methods of spinal drug delivery using microfluidic devices, and methods of delivering stem cells and therapeutics during fetal surgery. Methods of manufacturing such devices are also disclosed.

Claims

1. A microfluidic convection-enhanced-delivery (CED) device, comprising:

an insertion support scaffold having a proximal end and a distal end;

a plurality of fluid delivery conduits extending longitudinally therethrough, each conduit having an inlet port and at least one outlet port,

wherein the plurality of conduits are disposed near the distal end of the scaffold and oriented to deliver a therapeutic agent in different directions.

2. The device of claim 1, wherein each of the plurality of conduits is coupled to a respective one of a plurality of side surfaces of the scaffold.

3. The device of claim 1, wherein the plurality of conduits are positioned in a spaced relationship about a continuous circumferential side surface of the scaffold.

4. The device of claim 1, wherein the at least one outlet port comprises a plurality of outlet ports spaced a distance apart from one another between proximal and distal ends of each conduit.

5. The device of claim 4, wherein each of the plurality of outlet ports has an area that is greater than an area of any outlet port positioned proximally thereto.

6. The device of claim 1, wherein the plurality of conduits are formed from at least one of a parylene composition, a silastic composition, a polyurethane composition, and a PTFE composition.

7. The device of claim 1, wherein the plurality of conduits are disposed within a plurality of corresponding recesses formed in the scaffold.

8. The device of claim 1, further comprising a fluid reservoir in fluid communication with the inlet ports of the plurality of conduits and configured to supply a fluid thereto under positive pressure.

9. The device of claim 1, wherein the plurality of conduits are flexible.

10. The device of claim 1, wherein at least one of the plurality of conduits comprises an embedded microsensor.

11. The device of claim 10, wherein the embedded microsensor comprises at least one of an interrogatable sensor, a pressure sensor, a glutamate sensor, a pH sensor, a temperature sensor, an ion concentration sensor, a carbon dioxide sensor, an oxygen sensor, and a lactate sensor.

12. The device of claim 1, wherein the scaffold is rigid or semi-rigid.

13. The device of claim 1, wherein the distal end of the scaffold has an atraumatic shape configured to penetrate tissue without causing trauma.

14. The device of claim 1, wherein the scaffold is degradable.

15. The device of claim 14, wherein the scaffold is formed from a degradable thermoplastic polymer.

16. The device of claim 15, wherein the degradable thermoplastic polymer comprises at least one of a degradable thermoplastic polyester and a degradable thermoplastic polycarbonate.

17. The device of claim 15, wherein the scaffold is formed from poly(lactic-co-glycolic acid) (PLGA).

18. The device of claim 1, wherein the scaffold contains a quantity of a drug.

19. The device of claim 1, wherein a surface of the scaffold is coated with a drug.

20. The device of claim 1, wherein the scaffold is impregnated with at least one of an antibacterial agent and an anti-inflammatory agent.

21. The device of claim 1, wherein the scaffold is impregnated with a corticosteroid.

22. The device of claim 20, wherein the corticosteroid comprises dexamethasone.

23. The device of claim 1, wherein the plurality of conduits are configured to aspirate fluids.

24. The device of claim 1, wherein each of the plurality of conduits is in fluid communication with a respective micro-capillary tube.

25. The device of claim 1, wherein the scaffold comprises a body and an elongate distal tip, and the device further includes a nose disposed at an interface between the body and the distal tip such that the nose encapsulates a distal portion of the body.

26. A method of delivering a therapeutic agent to a patient, comprising:

advancing a scaffold into a target region of the patient;

supplying a fluid comprising the therapeutic agent under positive pressure to a plurality of fluid delivery conduits, each of the plurality of conduits being coupled to a respective side surface of the scaffold; and

ejecting the fluid from one or more outlet ports formed in each of the plurality of conduits to deliver the fluid to the target region in multiple directions.

27. The method of claim 26, further comprising allowing the scaffold to degrade and thereby release a corticosteroid impregnated in the scaffold.

28. The method of claim 26, further comprising delivering an enzyme through the plurality of conduits in unison with the fluid to enhance penetration of the therapeutic agent into the target region.

29. The method of claim 26, wherein said ejecting comprises delivering the fluid to the target region in a radial pattern substantially 360 degrees around the scaffold.

30. The method of claim 26, wherein the method is used to treat at least one condition selected from central-nervous-system (CNS) neoplasm, intractable epilepsy, Parkinson'"'"'s disease, Huntington'"'"'s disease, stroke, lysosomal storage disease, chronic brain injury, Alzheimer'"'"'s disease, amyotrophic lateral sclerosis, balance disorders, hearing disorders, and cavernous malformations.