# US 10,441,770 B2 · Systems and methods for drug delivery, treatment, and monitoring

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- Number: US 10,441,770 B2
- Document ID: US10441770B2
- Status: Granted
- Kind: B2
- Application number: 14/447,734
- Filed: 2014-07-31
- Published: 2015-02-05
- Granted: 2019-10-15
- Earliest claimed: 2013-07-31
- Assignees: Alcyone Lifesciences, Inc.
- Applicants: Alcyone Lifesciences, Inc.
- Inventors: Deep Arjun Singh; PJ Anand; Andrew East
- Web page: https://patentgrep.com/patent/US10441770B2

## CPC

- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/6849: {in combination with a needle set}
- A61B 5/6852: {Catheters}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61N 1/0529: {Electrodes for brain stimulation}
- A61B 5/6868: {Brain}
- A61B 5/6882: {Anchoring means}
- A61B 2018/00577: {Ablation}
- A61B 2018/00648: {using more than one sensed parameter}
- A61B 2018/00744: {Fluid flow}
- A61B 2090/062: {penetration depth}
- A61B 2562/0209: Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
- A61B 2562/166: the sensor is mounted on a specially adapted printed circuit board
- A61B 2562/222: Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
- A61M 2039/025: {through bones or teeth, e.g. through the skull}
- 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}
- A61M 2039/0273: {for introducing catheters into the body}
- A61M 2205/3324: PH measuring means
- A61M 2205/3331: Pressure; Flow
- A61M 2210/0687: Skull, cranium
- A61M 2230/005: Parameter used as control input for the apparatus
- A61M 2230/50: Temperature
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N 1/36025: {for treating a mental or cerebral condition}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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.

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 1)

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.

### Claim 12 (depends on 1)

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.

### Claim 13 (depends on 1)

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

### Claim 14 (depends on 1)

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.

### Claim 15 (depends on 1)

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.

### Claim 16 (depends on 1)

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

### Claim 17 (depends on 1)

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.

### Claim 18 (depends on 1)

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.

### Claim 19 (depends on 1)

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

### Claim 20 (depends on 1)

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.
