Devices and Systems for Access and Navigation of Cerebrospinal Fluid Space
The present disclosure relates to accessing, removing, exchanging and recirculating cerebrospinal fluid (CSF). Devices, systems and methods disclosed herein are used to safely and efficiently navigate the space at and around the brain and spinal cord where the CSF flows through the body, also known as the CSF space.
1 . A system for access and navigation of a cerebrospinal fluid (CSF) space, the system comprising
an introducer sheath configured to access and align with the cerebrospinal fluid space;
an introducer coupled to a proximal end of the introducer sheath; and
a catheter having multiple lumens that is configured to be received in the introducer,
wherein, the catheter is configured to be positioned to access and navigate the cerebrospinal fluid space upon delivery of the catheter through the introducer and the introducer sheath.
2 . The system of claim 1 , wherein the introducer is configured to enable the catheter to make a bend having a radius of between approximately 0 mm and approximately 10 mm.
3 . The system of claim 2 , wherein the introducer is configured to enable the catheter to make a bend having a radius of between approximately 1 mm and approximately 10 mm.
4 . The system of claim 3 , wherein the catheter includes a spring loaded tip in a pre-deployed position during delivery through the introducer sheath and in a deployed position after exiting the introducer sheath.
5 . The system of claim 1 , further comprising at least two transducers positioned on or about the catheter, wherein at least one transducer is a pressure sensor and at least one transducer is a flow sensor.
6 . The system of claim 1 , wherein the introducer comprises a plurality of ports, each of the plurality of ports including a check valve operably associated therewith.
7 . The system of claim 1 , further comprising a strain relief and kink resistance feature formed as a sleeve and disposed on the catheter.
8 . The system of claim 7 , wherein the strain relief and kink resistance feature is a coiled wire embedded in a tube constructed from medical grade catheter material.
9 . The system of claim 8 , wherein said medical grade catheter material is flexible.
10 . The system of claim 7 , wherein the strain relief and kink resistance feature is a braided wire embedded in a tube constructed from medical grade catheter material.
11 . The system of claim 1 , further comprising a plurality of openings defined within an outer circumferential wall of the catheter to increase fluid flow through the system.
12 . The system of claim 11 , wherein the plurality of openings has a total cross-sectional surface area of at least approximately 0.6 mm 2 .
13 . The system of claim 11 , wherein the plurality of openings is positioned generally linearly along or parallel to a horizontal line defined through a central lumen of the catheter.
14 . The system of claim 8 , wherein the plurality of openings is positioned in a staggered or symmetrical pattern relative to a horizontal line defined through a central lumen of the catheter.
15 . The system of claim 1 , further comprising a receptacle to capture and retrieve blood clots within the CSF space upon deployment from a distal end of the catheter, the receptacle configured for delivery through the introducer sheath and the catheter into the CSF space.
16 . The system of claim 15 wherein the receptacle comprises a coiled microwire configured for delivery through the catheter to capture and retrieve a blood clot within the CSF space.
17 . The system of claim 15 wherein the receptacle comprises a plurality of intertwined microwires configured for delivery through the catheter to capture and retrieve a blood clot within the CSF space.
18 . The system of claim 15 wherein the receptacle comprises a sieve coupled to a distal end of a micro-catheter and configured for delivery through the catheter to capture and retrieve a blood clot within the CSF space.
19 . The system of claim 1 , further comprising a positioning device comprising a plurality of lumens and a plurality of balloons, each balloon positioned in an individual lumen, each balloon configured to be in a deflated state during delivery of the positioning device through the introducer sheath and configured to transition from a deflated state to an inflated state and back to a deflated state during advancement into the CSF space.
20 . The system of claim 1 , wherein the cerebrospinal fluid space is a space where cerebrospinal fluid flows around a ventricle of the brain.
21 . The system of claim 1 , wherein the cerebrospinal fluid space is a space where cerebrospinal fluid flows around a spinal column.
22 . The system of claim 1 , further comprising one or more openings defined within an outer circumferential wall one of an inlet lumen or an outlet lumen of the catheter to increase fluid flow through the system.
23 . The system of claim 19 , wherein at least one of the one or more openings defined within the outer circumferential wall of the inlet lumen has a total cross-sectional surface area of less than 0.01 inches 2 .
24 . The system of claim 19 , wherein at least one of the one or more openings defined within the outer circumferential wall of the outlet lumen has a total cross-sectional surface area of approximately 0.01 inches 2 .
25 . The system of claim 1 , wherein the catheter has a length of between approximately 40 cm and approximately 120 cm.
26 . The system of claim 1 , wherein the catheter is configured to bend without kinking or compromising flow within the catheter.
27 . The system of claim 26 , wherein the catheter is configured to bend without kinking or compromising flow by comprising a coiled wire having a coil pitch between approximately 0.01 inches and approximately 0.03 inches.
28 . A method of accessing and navigating a cerebrospinal fluid (CSF) space, the method comprising
introducing an introducer sheath aligning the introducer sheath with the CSF space;
deploying a catheter having multiple lumens into the introducer sheath through a multi-port introducer coupled to a proximal end of the introducer sheath, the catheter having at least two transducers positioned on or about the catheter, wherein at least one transducer is a pressure sensor and at least one transducer is a flow sensor;
delivering the catheter through an access site in the CSF space created by the introducer sheath; and
positioning the catheter to access and navigate the CSF space.
29 . The method of claim 28 , wherein the CSF space is a space where cerebrospinal fluid flows around a ventricle of the brain.
30 . The method of claim 28 , wherein the CSF space is a space where cerebrospinal fluid flows around a spinal column.
31 . The method of claim 28 , wherein the catheter has a length of between approximately 40 cm and approximately 120 cm; and wherein the catheter comprises an inlet opening and an outlet opening, the inlet opening and the outlet opening having a spacing of between approximately 10 cm and approximately 30 cm.
32 . The method of claim 28 , wherein the multiple lumens comprise a first lumen defined by an inner wall and a second lumen defined between the inner wall and an outer wall.
33 . The method of claim 32 , wherein the inner wall has an inner diameter of approximately 0.56 mm and an outer diameter of approximately 0.71 mm and the outer wall has an inner diameter of approximately 1.32 mm and an outer diameter of approximately 1.689 mm.
34 . The method of claim 32 , wherein the catheter comprises a coiled wire having a coil pitch selected to enable the catheter to be deployed and positioned without kinking or compromising flow within the catheter and to enable catheter unblocking.
35 . The method of claim 34 , wherein the coil pitch is between approximately 0.01 inches and approximately 0.03 inches.