# US 10,765,846 B2 · Methods and systems for draining cerebrospinal fluid into the venous system

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- Number: US 10,765,846 B2
- Document ID: US10765846B2
- Status: Granted
- Kind: B2
- Application number: 15/981,118
- Filed: 2018-05-16
- Published: 2018-09-20
- Granted: 2020-09-08
- Earliest claimed: 2014-10-31
- Assignees: Cerevasc, Inc.
- Applicants: Cerevasc, LLC
- Inventors: Carl Heilman; Adel M. Malek; David A. Rezac; Timothy W. Robinson; Joseph Ting
- Web page: https://patentgrep.com/patent/US10765846B2

## CPC

- A61M 27/006: {Cerebrospinal drainage; Accessories therefor, e.g. valves}
- A61B 17/3401: {Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 18/1477: {Needle-like probes}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61M 25/0067: {characterised by the distal end, e.g. tips (A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10)}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/0155: {with hydraulic or pneumatic means, e.g. balloons or inflatable compartments}
- A61M 25/09: Guide wires
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61M 39/24: Check- or non-return valves
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61M 2039/242: {designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid}
- A61M 2039/2426: {Slit valve}
- A61M 2210/06: Head
- 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)

## Abstract

Methods for treating hydrocephalus using a shunt, the shunt having one or more CSF intake openings in a distal portion, a valve disposed in a proximal portion of the shunt, and a lumen extending between the one or more CSF intake openings and the valve, the method comprises deploying the shunt in a body of a patient so that the distal portion of the shunt is at least partially disposed within a CP angle cistern, a body of the shunt is at least partially disposed within an IPS of the patient, and the proximal portion of the shunt is at least partially disposed within or proximate to a JV of the patient, wherein, after deployment of the shunt, CSF flows from the CP angle cistern to the JV via the shunt lumen at a flow rate in a range of 5 ml per hour to 15 ml per hour.

## Claims

### Claim 1

A system for treating a patent, the system comprising:
a cerebrospinal fluid shunt configured for deployment through a venous system of the patient, the shunt comprising a proximal portion, a distal portion having a distal anchoring mechanism, and a shunt lumen in fluid communication with one or more distal openings in the distal portion and one or more proximal openings in the proximal portion; and
a delivery system configured for creating an anastomosis between an inferior petrosal sinus and a CSF-filled subarachnoid space of the patient, and for deploying the shunt in the anastomosis with the distal portion of the shunt positioned in the subarachnoid space, such that, when the shunt is deployed in the anastomosis, CSF flows from the subarachnoid space through the one or more distal openings, lumen, and one or more proximal openings of the shunt, respectively, into the venous system of the patient.

### Claim 2 (depends on 1)

The system of claim 1, wherein the shunt further comprises a valve disposed within the lumen distal to the one or more proximal openings, such that CSF flowing from the subarachnoid space through the shunt lumen into the venous system passes through the valve.

### Claim 3 (depends on 2)

The system of claim 2, wherein the respective valve and shunt lumen are configured and dimensioned to achieve a target CSF flow rate of 5 ml per hour to 20 ml per hour through the shunt lumen under normal differential pressure conditions between the subarachnoid space and venous system of the patient.

### Claim 4 (depends on 2)

The system of claim 2, wherein the valve is configured to open at a pressure differential between the subarachnoid space and venous system in a range of 3 mm Hg to 5 mm Hg.

### Claim 5 (depends on 1)

The system of claim 1, wherein the distal anchoring mechanism is configured to anchor the distal portion of the shunt within the subarachnoid space.

### Claim 6 (depends on 1)

The system of claim 1, wherein the distal anchoring mechanism self-expands from a collapsed delivery configuration to an expanded deployed configuration after the distal portion of the shunt is introduced into the subarachnoid space.

### Claim 7 (depends on 1)

The system of claim 1, wherein the distal anchoring mechanism is configured to maintain the one or more distal openings separated, apart, and/or directed away from an arachnoid layer of the subarachnoid space.

### Claim 8 (depends on 1)

The system of claim 1, the delivery system further comprising a delivery catheter having a tissue penetrating distal tip, a delivery catheter lumen, and an open distal end in communication with the delivery catheter lumen, wherein the delivery catheter lumen is configured to carry the shunt through a passage of the venous system of the patient for deployment in the anastomosis.

### Claim 9 (depends on 8)

The system of claim 8, further comprising a penetration stop coupled to a distal portion of the delivery catheter to limit a distance that the tissue penetrating distal tip may be advanced distally into the subarachnoid space.

### Claim 10 (depends on 8)

The system of claim 8, the delivery catheter further comprising one or more radiopaque markers located and dimensioned to indicate a trajectory of the tissue penetrating tip into the subarachnoid space.

### Claim 11

A shunt configured for being deployed in an inferior petrosal sinus (IPS) of a patient, the shunt comprising:
a distal portion configured for being introduced into, and disposed within, a subarachnoid space of the patient via the IPS, the subarachnoid space containing cerebrospinal fluid (CSF);
a proximal portion configured for being disposed within or proximate to a jugular vein (JV) of the patient; and
a lumen extending from the distal portion to the proximal portion, wherein the lumen is in fluid communication with one or more CSF intake openings in the distal portion, and with a CSF outflow opening in the proximal portion,
such that, when the shunt is deployed in the IPS with the distal portion of the shunt disposed within the subarachnoid space and the proximal portion of the shunt disposed within or proximate to the JV, CSF flows from the subarachnoid space through the one or more CSF intake openings, shunt lumen, and CSF outflow opening, respectively, into the JV.

### Claim 12 (depends on 11)

The shunt of claim 11, further comprising a valve disposed within the lumen or otherwise coupled across the CSF outflow opening, wherein CSF flowing from the subarachnoid space into the JV through the shunt lumen passes through the valve.

### Claim 13 (depends on 12)

The shunt of claim 12, wherein the valve and shunt lumen are configured and dimensioned to achieve a target flow rate of 5 ml of CSF per hour to 20 ml of CSF per hour through the shunt lumen under normal differential pressure conditions between the subarachnoid space and venous system of the patient.

### Claim 14 (depends on 12)

The shunt of claim 12, wherein the valve is configured to open at a pressure differential between the subarachnoid space and the JV in a range of 3 mm Hg to 5 mm Hg.

### Claim 15 (depends on 11)

The shunt of claim 11, wherein the shunt further comprises a tubular body portion extending from the distal portion to the proximal portion, and wherein the tubular body portion body portion comprises a polymer material.

### Claim 16 (depends on 11)

The shunt of claim 11, wherein the distal portion of the shunt self-expands from a collapsed delivery configuration to an expanded deployed configuration after it is introduced into the subarachnoid space.

### Claim 17 (depends on 11)

The shunt of claim 11, wherein the distal portion of the shunt comprises a distal anchoring mechanism configured to anchor the distal portion of the shunt within the subarachnoid space.

### Claim 18 (depends on 17)

The shunt of claim 17, wherein the distal anchoring mechanism is configured to maintain the one or more CSF intake openings separated, apart and/or directed away from an arachnoid layer of the subarachnoid space.
