# US 11,992,642 B2 · Implantable medical device for delivery of pharmacological agents to the deep brain structures

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- Number: US 11,992,642 B2
- Document ID: US11992642B2
- Status: Granted
- Kind: B2
- Application number: 17/085,360
- Filed: 2020-10-30
- Published: 2022-05-05
- Granted: 2024-05-28
- Earliest claimed: 2020-10-30
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Jeffrey Bodner
- Web page: https://patentgrep.com/patent/US11992642B2

## CPC

- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- A61M 5/14276: {specially adapted for implantation}
- A61M 2039/027: {having a particular valve, seal or septum}
- A61M 2039/0273: {for introducing catheters into the body}
- A61M 2039/0276: {for introducing or removing fluids into or out of the body}
- A61M 2039/0282: {with implanted tubes connected to the port}
- A61M 2205/04: implanted
- A61M 2205/18: with alarm
- A61M 2205/8206: battery-operated
- A61M 2210/1003: Spinal column
- 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)}

## Abstract

An intrathecal drug delivery system includes: an intrathecal drug delivery device configured to deliver a fluid containing one or more pharmaceutical agents intrathecally to the cerebrospinal fluid (CSF) within a spinal canal of a patient and a deep brain catheter having an elongated body, extending from a distal end implanted within a deep brain structure of a patient and a proximal end positioned within the subarachnoid space directly adjacent to the brain to provide a passageway, via an inner lumen, between the subarachnoid space and the deep brain structure. The drug delivery system is configured to transport the pharmaceutical agent(s), using diffusion and the pulsatile flow of the CSF, through the deep brain catheter from the subarachnoid space to the deep brain structure.

## Claims

### Claim 1

An intrathecal drug delivery system comprising:
an intrathecal drug delivery device to intrathecally diffuse a pharmaceutical agent into a cerebrospinal fluid (CSF) within a spinal canal of a patient; and
a deep brain catheter comprising an elongated body extending from a proximal end to a distal end and defining an inner lumen, wherein when the system is implanted in the patient, the distal end is implanted within a deep brain structure of the patient and the proximal end is positioned within a subarachnoid space directly adjacent to a brain of the patient to provide a fluid passageway between the subarachnoid space and the deep brain structure,
wherein the proximal end of the deep brain catheter is not coupled to the intrathecal drug delivery device; and
wherein the drug delivery system relies only on a natural pulsatile flow of the CSF to transport the pharmaceutical agent from the spinal canal to the subarachnoid space, through the deep brain catheter, and to the deep brain structure.

### Claim 2 (depends on 1)

The intrathecal drug delivery system of claim 1, wherein when the system is implanted in the patient, the intrathecal drug delivery device comprises:
a drug reservoir to receive the pharmaceutical; and
an intrathecal catheter comprising a first end coupled to the intrathecal drug delivery device and a second end implanted within the spinal canal of the patient to deliver the pharmaceutical agent from the drug reservoir to the CSF, wherein the second end of the intrathecal catheter is not coupled to the proximal end of the deep brain catheter.

### Claim 3 (depends on 2)

The intrathecal drug delivery system of claim 2, wherein the intrathecal drug delivery device comprises a drug pump comprising:
a pump mechanism to pump the pharmaceutical agent from the drug reservoir through the intrathecal catheter into the CSF continuously at a predetermined flow rate or periodically according to a delivery schedule;
an exterior housing defining an access port; and
a self-sealing septum disposed across the access port, wherein the self-sealing septum can provide a needle with access to the drug reservoir percutaneously.

### Claim 4 (depends on 2)

The intrathecal drug delivery system of claim 2, wherein the intrathecal drug delivery device comprises a drug port comprising:
an exterior housing defining an access port; and
a self-sealing septum disposed across the access port, wherein the self-sealing septum can provide a needle with access to the drug reservoir percutaneously.

### Claim 5 (depends on 1)

The intrathecal drug delivery system of claim 1, wherein the distal end of the deep brain catheter comprises one or more openings to release the pharmaceutical agent diffused within the CSF into the deep brain structure.

### Claim 6 (depends on 1)

The intrathecal drug delivery system of claim 1, wherein the deep brain catheter defines an overall length of greater than about 10 millimeters (mm).

### Claim 7 (depends on 6)

The intrathecal drug delivery system of claim 6, wherein the deep brain catheter defines an overall length of less than about 150 mm.

### Claim 8 (depends on 1)

The intrathecal drug delivery system of claim 1, wherein the deep brain catheter defines an inner lumen diameter of greater than about 0.5 millimeters (mm).

### Claim 9 (depends on 8)

The intrathecal drug delivery system of claim 8, wherein the deep brain catheter defines an inner lumen diameter of less than 2.5 mm.

### Claim 10

A method for treating a medical condition, the method comprising:
implanting a distal end of a deep brain catheter within a deep brain structure of a patient and a proximal end of the deep brain catheter within a subarachnoid space directly adjacent to a brain of the patient; and
diffusing, via an intrathecal drug delivery device that is not coupled to the deep brain catheter, a pharmaceutical agent into a cerebrospinal fluid (CSF) within a spinal canal of the patient such that a natural pulsatile flow of the CSF transports the pharmaceutical agent from the spinal canal to the subarachnoid space through the deep brain catheter, and to the deep brain structure.

### Claim 11 (depends on 10)

The method of claim 10, further comprising implanting the intrathecal drug delivery device within a torso of the patient.

### Claim 12 (depends on 11)

The method of claim 11, wherein the intrathecal drug delivery device comprises:
a drug reservoir to receive the pharmaceutical agent; and
an intrathecal catheter having a first end connected to the drug delivery device and a second end positioned in the CSF within the spinal canal of the patient to facilitate transport of the pharmaceutical agent from the drug reservoir to the CSF, wherein the second end of the intrathecal catheter is not coupled to the proximal end of the deep brain catheter.

### Claim 13 (depends on 10)

The method of claim 10, wherein the pharmaceutical agent treats chronic pain, epilepsy, tremors, or a brain disorder of the patient.

### Claim 14 (depends on 10)

The method of claim 10, wherein the deep brain catheter defines an overall length of greater than about 10 millimeters (mm).

### Claim 15 (depends on 14)

The method of claim 14, wherein the deep brain catheter defines an overall length of less than about 150 mm.

### Claim 16 (depends on 10)

The method of claim 10, wherein the deep brain catheter defines an inner lumen diameter of greater than about 0.5 millimeters (mm).

### Claim 17 (depends on 16)

The method of claim 16, wherein the deep brain catheter defines an inner lumen diameter of less than 2.5 mm.

### Claim 18 (depends on 10)

The method of claim 10, wherein implanting the distal end and the proximal end of the deep brain catheter comprises implanting the deep brain catheter entirely within a cranium of the patient, and physically separate from the intrathecal drug delivery device.

### Claim 19 (depends on 1)

The intrathecal drug delivery system of claim 1, wherein the deep brain catheter is insertable into the brain using a guide member.

### Claim 20 (depends on 19)

The intrathecal drug delivery system of claim 19, wherein the guide member is removable after placement of the catheter, such that, once implanted, the deep brain catheter is fully contained within the subcranial space without the need for an access point.
