Multi-directional microfluidic drug delivery device

• US 10,434,251 B2
• Filed: 08/01/2012
• Issued: 10/08/2019
• 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
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US13/563,785
• Publication Number:
  US 20130035560A1
• Time in Patent Office: 2,624 Days
• Field of Search: 604 20, 604506, 604507
• 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:

a body having a tip extending distally from the body and first and second legs extending proximally from the body;

a first channel extending along the first leg, across the body, and along the tip, the first channel having a first fluid outlet port disposed in a portion of the first channel that extends along the tip;

a second channel extending along the second leg, across the body, and along the tip, the second channel having a second fluid outlet port disposed in a portion of the second channel that extends along the tip; and

a nose that is disposed on a distal end of the body and that is cone-shaped, the tip of the body protruding distally beyond a vertex of the cone-shaped nose, the nose being configured to contact tissue when the device is inserted into said tissue,

wherein the legs, body, and tip are formed from a monolithic substrate and the first and second channels are formed on an outer surface of the monolithic substrate.

2. The device of claim 1, wherein the body has a length of 1.5 mm.

3. The device of claim 1, wherein the channels are formed from parylene.

4. The device of claim 1, wherein the body, tip, and legs are formed from silicon.

5. The device of claim 1, wherein the channels include 90 degree turns at their distal ends such that the outlet ports of the channels are aimed in a direction perpendicular to a longitudinal axis of the tip.

6. The device of claim 1, further comprising a proximal catheter portion having a double-bore body in which first and second bores are formed, the first and second legs being disposed within the first and second bores of the double-bore body.

7. The device of claim 6, further comprising first and second micro capillary tubes in fluid communication with the bores of the double-bore body.

8. The device of claim 6, further comprising an adhesive that couples and seals the double-bore body to the first and second legs.

9. The device of claim 1, wherein the nose has a maximum outside diameter of 1 mm to 1.5 mm.

10. The device of claim 1, wherein the nose is formed from epoxy.

11. The device of claim 1, wherein the nose is micro-machined.

12. The device of claim 1, wherein the channels have a height of 10 microns.

13. The device of claim 1, wherein the channels have a width of 20 microns.

14. The device of claim 1, wherein the channels have a diameter of 20 microns.

15. The device of claim 1, wherein the nose circumferentially surrounds the tip.

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

a body having a tip extending distally from the body and first and second legs extending proximally from the body;

a first channel extending along the first leg, across the body, and along the tip, the first channel having a first fluid outlet port disposed in a portion of the first channel that extends along the tip;

a second channel extending along the second leg, across the body, and along the tip, the second channel having a second fluid outlet port disposed in a portion of the second channel that extends along the tip; and

a nose that is disposed on a distal end of the body and that is cone-shaped, the tip of the body protruding distally beyond a vertex of the cone-shaped nose, the nose being configured to contact tissue when the device is inserted into said tissue,

wherein the legs, body, and tip are formed from a monolithic silicon substrate.

17. The device of claim 16, further comprising a proximal catheter portion having a double-bore body in which first and second bores are formed, the first and second legs being disposed within the first and second bores of the double-bore body.

18. The device of claim 17, further comprising first and second micro capillary tubes in fluid communication with the bores of the double-bore body.

19. The device of claim 17, further comprising an adhesive that couples and seals the double-bore body to the first and second legs.

20. The device of claim 16, wherein the nose has a maximum outside diameter of 1 mm to 1.5 mm.

21. The device of claim 16, wherein the first and second legs are attached to the body at only one end of each of the first and second legs.

22. The device of claim 16, wherein the first and second legs are separated from one another by a space therebetween.

23. The device of claim 16, wherein the nose circumferentially surrounds the tip.