Methods and systems for treating hydrocephalus

• US 10,279,154 B2
• Filed: 08/03/2017
• Issued: 05/07/2019
• Est. Priority Date: 10/31/2014
• Status: Active Grant

• Current Assignee: CereVasc, Inc.
• Original Assignee: Cerevasc, LLC
• Inventors: Heilman, Carl, Malek, Adel M., Rezac, David A., Robinson, Timothy W., Ting, Joseph
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US15/668,657
• Publication Number:
  US 20180015267A1
• Time in Patent Office: 642 Days
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 2018/00446 Brain
• CPC Class Codes: A61B 2018/00619 Welding
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2039/2426 Slit valve
• CPC Class Codes: A61M 2210/06 Head
• CPC Class Codes: A61M 25/0067 characterised by the distal end, e.g. tips A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0155 with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: 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
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 39/24 Check- or non-return valves

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

1. 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 secured within, a cerebellopontine (CP) angle cistern of the patient via the IPS, the CP angle cistern containing cerebrospinal fluid (CSF); and

a main body portion configured for being disposed within the IPS, the main body portion including a shunt lumen, wherein the shunt lumen is in fluid communication with one or more CSF intake openings located in the distal portion; and

a CSF outflow opening in fluid communication with the shunt lumen,

such that, when the shunt is deployed in the IPS with the distal portion of the shunt disposed within the CP angle cistern and the main body portion of the shunt disposed within the IPS, CSF flows from the CP angle cistern through the one or more CSF intake openings, shunt lumen, and CSF outflow opening, respectively, into the venous system of the patient.

2. The shunt of claim 1, wherein the distal portion of the shunt self-expands from a collapsed delivery configuration to an expanded deployed configuration after it is deployed within the CP angle cistern.

3. The shunt of claim 1, wherein the distal portion of the shunt comprises a distal anchoring mechanism configured to position the distal portion of the deployed shunt so as to maintain the one or more CSF intake openings separated, apart and/or directed away from an arachnoid layer of the CP angle cistern.

4. The shunt of claim 1, wherein a respective length and inner diameter of the shunt lumen are dimensioned to achieve a target flow rate of 5 ml of CSF per hour to 15 ml of CSF per hour through the shunt lumen under normal differential pressure conditions between the CP angle cistern and venous system of the patient, after the shunt has been deployed.

5. A system for treating hydrocephalus, including normal pressure hydrocephalus, and/or elevated intracranial pressure, the system comprising the shunt of claim 1, and further comprising a delivery system configured to introduce the shunt into the patient'"'"'s body through a femoral vein access point, to navigate the shunt into the IPS, and to introduce the distal portion of the shunt into the CP angle cistern.

6. The system of claim 5, the delivery system comprising a delivery catheter, wherein a distal end of the delivery catheter comprises 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 shunt is delivered through the delivery catheter lumen for deployment of the distal portion of the shunt in the CP angle cistern using the tissue penetrating distal tip.

7. The system of claim 6, further comprising a penetration stop coupled to a distal portion of the delivery catheter to limit a distance in which the tissue penetrating distal tip may be advanced distally into the patient'"'"'s CP angle cistern.

8. A method for treating hydrocephalus, including normal pressure hydrocephalus, and/or elevated intracranial pressure, the method comprising:

positioning a shunt so that a distal end portion of the shunt is deployed in a cerebellopontine (CP) angle cistern of a patient, and a body of the shunt is at least partially positioned in an inferior petrosal sinus (IPS) of the patient, the CP angle cistern containing cerebrospinal fluid (CSF), the distal end portion of the shunt comprising one or more CSF fluid intake openings, the shunt comprising a CSF outflow opening, and the body of the shunt comprising a shunt lumen in fluid communication with the one or more CSF fluid intake openings and with the CSF outflow opening,

such that CSF flows from the CP angle cistern through the one or more CSF intake openings, shunt lumen, and CSF outflow opening, respectively, into the venous system of the patient.

9. The method of claim 8, wherein the distal portion of the shunt self-expands from a collapsed delivery configuration to an expanded deployed configuration after being deployed within the CP angle cistern.

10. The method of claim 8, wherein the distal portion of the shunt comprises a distal anchoring mechanism configured to position the distal portion of the deployed shunt so as to maintain the one or more CSF intake openings separated, apart and/or directed away from an arachnoid layer of the CP angle cistern.

11. The method of claim 8, wherein a respective length and inner diameter of the shunt lumen are dimensioned to achieve a target flow rate of 5 ml of CSF per hour to 15 ml of CSF per hour through the shunt lumen under normal differential pressure conditions between the CP angle cistern and venous system of the patient.