Methods and systems for treating hydrocephalus

• US 10,058,686 B2
• Filed: 01/04/2018
• Issued: 08/28/2018
• 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:
  US15/862,120
• Publication Number:
  US 20180126132A1
• Time in Patent Office: 236 Days
• Field of Search: 604 8, 604 9
• 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 system for treating a patent with elevated intracranial pressure, 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 C SF-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.

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

3. 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 15 ml per hour through the shunt lumen under normal differential pressure conditions between the subarachnoid space and venous system of the patient.

4. 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.

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

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. A method for treating a patent with elevated intracranial pressure, comprising:

delivering a cerebrospinal fluid shunt through a venous system of the patient, the shunt comprising a proximal portion, a distal portion, 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;

creating an anastomosis between an inferior petrosal sinus and a CSF-filled subarachnoid space of the patient; and

deploying the shunt in the anastomosis with the distal portion of the shunt positioned in the subarachnoid space, so that 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.

12. The method of claim 11, wherein the shunt further comprises a valve disposed within the lumen proximal to the one or more distal openings, such that CSF flowing from the subarachnoid space through the shunt lumen into the venous system passes through the valve.

13. The method of claim 12, wherein the respective valve and shunt lumen are configured and dimensioned to achieve a target CSF flow rate of 5 ml per hour to 15 ml per hour through the shunt lumen under normal differential pressure conditions between the subarachnoid space and venous system of the patient.

14. The method of claim 12, 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.

15. The method of claim 11, further comprising anchoring the distal portion of the shunt within the subarachnoid space.

16. The method of claim 15, wherein the distal portion of the shunt is anchored within the subarachnoid space using anchoring mechanism that 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.

17. The method of claim 16, 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.

18. The method of claim 11, wherein the shunt 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 shunt through the venous system of the patient for deployment in the anastomosis.

19. The method of claim 18, 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.

20. The method of claim 18, 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.