Systems and methods for drug delivery, treatment, and monitoring

• US 10,441,770 B2
• Filed: 07/31/2014
• Issued: 10/15/2019
• Est. Priority Date: 07/31/2013
• Status: Active Grant

• Current Assignee: Alcyone Therapeutics, Inc.
• Original Assignee: Alcyone Lifesciences, Inc.
• Inventors: Singh, Deep Arjun, Anand, PJ, East, Andrew
• Primary Examiner(s): Carpenter, William R
• Application Number:
  US14/447,734
• Publication Number:
  US 20150038949A1
• Time in Patent Office: 1,902 Days
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00744 Fluid flow
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2562/0209 Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
• CPC Class Codes: A61B 2562/166 the sensor is mounted on a specially adapted printed circuit board
• CPC Class Codes: A61B 2562/222 Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6868 Brain
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61M 2039/025 through bones or teeth, e.g. through the skull
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2210/0687 Skull, cranium
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 39/0247 : Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61N 1/0529 : Electrodes for brain stimulation
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36025 : for treating a mental or cerebral condition

Abstract

Systems and methods for delivering a drug or other therapy over an extended period of time (e.g., several hours, days, weeks, months, years, and so forth) are disclosed herein, as are systems and methods for monitoring various parameters associated with the treatment of a patient. Systems and methods are also disclosed herein that generally involve CED devices with various features for reducing or preventing backflow.

Claims

1. A treatment method, comprising:

implanting a plurality of catheters in respective locations in a patient'"'"'s brain, each catheter having first and second discrete fluid channels therein;

attaching a skull anchor to which the plurality of catheters are coupled to the patient'"'"'s skull;

coupling a plurality of branch lines, each having a plurality of fluid lumens, to respective ones of the plurality of catheters, such that respective ones of the fluid lumens of each branch line are in fluid communication with respective ones of the first and second discrete fluid channels of the respective catheter to which that branch line is coupled, and

routing the plurality of branch lines through a manifold to a trunk line, the trunk line having a plurality of independent fluid lumens extending therethrough, each of the plurality of independent fluid lumens of the trunk line being in fluid communication with the fluid lumens of a respective branch line and with a plurality of ports formed in a crosscutaneous access device, such that the number of independent fluid lumens of the trunk line entering the manifold is equal to the total number of the plurality of fluid lumens of the plurality of branch lines; and

delivering fluid through the access device to the trunk line, the plurality of branch lines, and the plurality of catheters into the patient'"'"'s brain.

2. The method of claim 1, further comprising delivering energy to an electrode disposed in at least one of the plurality of catheters via the access device and an electrical conductor disposed in at least one of the plurality of branch lines.

3. The method of claim 1, further comprising delivering fluid through the first and second discrete fluid channels of a first catheter of the plurality of catheters and delivering energy through an electrode of the first catheter.

4. The method of claim 1, further comprising delivering fluid through the first and second discrete fluid channels of a first catheter of the plurality of catheters and delivering energy through an electrode of a second catheter of the plurality of catheters.

5. The method of claim 1, further comprising communicating the output of a sensor disposed in at least one of the plurality of catheters via an electrical conductor in at least one of the plurality of branch lines and the access device.

6. The method of claim 1, further comprising delivering fluid through a fluid channel of a first catheter of the plurality of catheters and monitoring a parameter using a sensor of the first catheter.

7. The method of claim 1, further comprising delivering fluid through a fluid channel of a first catheter of the plurality of catheters and monitoring a parameter using a sensor of a second catheter of the plurality of catheters.

8. The method of claim 1, further comprising adjusting the delivery of energy or fluid via a first catheter of the plurality of catheters based on the output of a sensor disposed in the plurality of catheters.

9. The method of claim 1, further comprising maintaining the patency of a sensor disposed in the plurality of catheters by flushing fluid through a fluid outlet port in which the sensor is disposed.

10. The method of claim 1, further comprising delivering fluid through a dedicated patency channel of a first catheter of the plurality of catheters to maintain the patency of a sensor disposed in the first catheter while delivering a drug-containing fluid through a drug-delivery channel of the first catheter.

11. The method of claim 1, further comprising at least one of:

monitoring the movement of infusate delivered through a first catheter of the plurality of catheters using a sensor disposed in a second catheter of the plurality of catheters; and

monitoring the effects of neuro-stimulation applied via the first catheter using a sensor disposed in the second catheter.

12. The method of claim 1, further comprising aspirating tissue through at least one of the plurality of catheters, at least one of the plurality of branch lines, and the access device.

13. The method of claim 1, wherein the plurality of catheters are implanted through a single burr hole in the patient'"'"'s skull.

14. The method of claim 1, wherein the plurality of catheters are implanted through first and second burr holes in the patient'"'"'s skull over which the skull anchor is disposed.

15. The method of claim 1, further comprising filtering fluid through an in-line filter disposed in at least one of the plurality of branch lines.

16. The method of claim 1, wherein delivering the fluid comprises delivering the fluid via convection-enhanced delivery.

17. The method of claim 1, wherein delivering the fluid comprises delivering the fluid to a target site within a patient over a period of hours, days, weeks, months, or years.

18. The method of claim 1, further comprising allowing a support scaffold of a first catheter of the plurality of catheters to biodegrade leaving behind only fluid conduits of the first catheter.

19. The method of claim 1, further comprising allowing upper and lower scaffolds of a first catheter of the plurality of catheters to biodegrade.

20. The method of claim 1, further comprising routing the plurality of branch lines through the skull anchor to the plurality of catheters such that the number of fluid lumens of each branch line entering the skull anchor is equal to the total number of first and second discrete fluid channels of the plurality of catheters coupled to the skull anchor.