# US 10,307,576 B2 · Systems and methods for deploying an implant in the vasculature

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- Number: US 10,307,576 B2
- Document ID: US10307576B2
- Status: Granted
- Kind: B2
- Application number: 16/212,511
- Filed: 2018-12-06
- Published: 2019-04-11
- Granted: 2019-06-04
- 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/US10307576B2

## 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 patient, comprising:
an implant configured for deployment through a venous system of the patient, the implant comprising a proximal portion, a distal portion having a distal anchoring mechanism, and a lumen providing fluid communication between the proximal portion and one or more distal openings in the distal portion; and
a delivery system configured for creating an anastomosis between an inferior petrosal sinus and a subarachnoid space of the patient, and for deploying the implant in the anastomosis with the distal portion of the implant positioned in the subarachnoid space, such that, when the implant is deployed in the anastomosis, the implant lumen provides a fluid communication pathway between the proximal portion of the implant and the subarachnoid space of the patient.

### Claim 2 (depends on 1)

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

### Claim 3 (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 implant is introduced into the subarachnoid space.

### Claim 4 (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 5 (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 implant through a passage of the venous system of the patient for deployment in the anastomosis.

### Claim 6 (depends on 5)

The system of claim 5, 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 7 (depends on 5)

The system of claim 5, 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 8

A method for treating a patient, comprising:
delivering an implant through a venous system of the patient, the implant comprising a proximal portion, a distal portion having a distal anchoring mechanism, and a lumen providing fluid communication between the proximal portion and one or more distal openings in the distal portion;
creating an anastomosis between an inferior petrosal sinus and a subarachnoid space of the patient; and
deploying the implant in the anastomosis with the distal portion of the implant positioned in the subarachnoid space so that the implant lumen provides a fluid communication pathway between the proximal portion of the implant and the subarachnoid space of the patient.

### Claim 9 (depends on 8)

The method of claim 8, further comprising anchoring the distal portion of the implant within the subarachnoid space.

### Claim 10 (depends on 9)

The method of claim 9, wherein the anchoring mechanism self-expands from a collapsed delivery configuration to an expanded deployed configuration after the distal portion of the implant is introduced into the subarachnoid space to thereby anchor the distal portion of the implant within the subarachnoid space.

### Claim 11 (depends on 10)

The method of claim 10, wherein the 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 12 (depends on 8)

The method of claim 8, wherein the implant is delivered through the patient's venous system using 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 implant through the venous system of the patient for deployment in the anastomosis.

### Claim 13 (depends on 12)

The method of claim 12, wherein a penetration stop coupled to a distal portion of the delivery catheter to limits a distance that the tissue penetrating distal tip is advanced distally into the subarachnoid space.

### Claim 14 (depends on 12)

The method of claim 12, the delivery catheter comprising one or more radiopaque markers located and dimensioned to indicate a trajectory of the tissue penetrating tip into the subarachnoid space.

### Claim 15

An implant configured for being deployed in an inferior petrosal sinus (IPS) of a patient, the implant comprising:
a distal portion configured for being introduced into, and disposed within, a cerebellopontine (CP) angle cistern of the patient via the IPS;
a proximal portion configured for being disposed within or otherwise in communication with a venous system 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 openings in the distal portion, such that, when the implant is deployed in the IPS with the distal portion of the implant disposed within the CP angle cistern and the proximal portion of the implant disposed within or otherwise in communication with the patient's venous system, the implant lumen provides a fluid communication pathway between the proximal portion of the implant and the subarachnoid space of the patient.

### Claim 16 (depends on 15)

The implant of claim 15, wherein the distal portion of the implant self-expands from a collapsed delivery configuration to an expanded deployed configuration after it is introduced into the CP angle cistern.

### Claim 17 (depends on 15)

The implant of claim 15, wherein the distal portion of the implant comprises a distal anchoring mechanism configured to anchor the distal portion of the implant within the CP angle cistern.

### Claim 18 (depends on 17)

The implant of claim 17, wherein the distal anchoring mechanism is configured to maintain the one or more fluid openings separated, apart and/or directed away from an arachnoid layer of the CP angle cistern.

### Claim 19 (depends on 15)

A system including the implant of claim 15, the system further comprising a delivery system configured to introduce the implant the patient's body through a venus access point, and to navigate the implant into the IPS.

### Claim 20 (depends on 19)

The system of claim 19, the delivery system comprising a delivery catheter having a tissue penetrating distal tip, the delivery catheter having 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 implant for deployment in the IPS.
