Systems and methods for deploying an implant in the vasculature

• US 10,307,576 B2
• Filed: 12/06/2018
• Issued: 06/04/2019
• 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:
  US16/212,511
• Publication Number:
  US 20190105477A1
• Time in Patent Office: 180 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 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.

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

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

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.

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

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

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.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.