Systems and methods for draining cerebrospinal fluid
The present disclosure generally relates to systems and methods of use for draining cerebrospinal fluid (CSF) from a brain or a spinal canal in a subject, for example, to treat hydrocephalus or other conditions. In some embodiments, the disclosure relates to a device comprising a flow controller positioned within a conduit that allows CSF to flow through the conduit from a first end to a second end. This may allow the CSF to drain, for example, from an intradural space (such as a thecal sac) into, for example, a paraspinal space, paraspinal vein or other venous space, or peritoneal cavity. A variety of methods may be used to hold or anchor the device in place, for example, an expansion apparatus. In some embodiments, the device can be implanted percutaneously at a location along or within a subject's spinal column, thus reducing the need for surgery, general anesthesia, and hospitalizations.
1 . A method of treating a subject having hydrocephalus, comprising:
puncturing a dura of the subject with a spinal needle having a hollow shaft to create an opening between intradural and epidural spaces of the subject;
delivering, from the hollow shaft of the spinal needle, a first end of a device into the intradural space of the subject, the first end of the device comprising a fluid inlet and a first expansion apparatus, wherein delivery of the first end of the device into the intradural space of the subject causes the first expansion apparatus to assume an expanded configuration, larger than the opening in the dura, in which a first segment of the first expansion apparatus extends radially outward from the fluid inlet and a second segment of the first expansion apparatus extends proximally from the first segment of the first expansion apparatus so as to be positioned proximate an intradural side of the dura around the opening in the dura;
delivering, from the hollow shaft of the spinal needle, a second end of the device into the epidural space of the subject, the second end of the device comprising a fluid outlet and a second expansion apparatus, wherein delivery of the second end of the device into the epidural space of the subject causes the second expansion apparatus to assume an expanded configuration larger than the opening in the dura;
withdrawing the spinal needle from the subject; and
draining cerebrospinal fluid from the intradural space of the subject to the epidural space of the subject via the device.
2 . The method of claim 1 , wherein the device is configured to control fluid flow therethrough.
3 . The method of claim 1 , wherein the device further comprises a flow controller configured to allow the cerebrospinal fluid to flow through the device from the first end to the second end.
4 . The method of claim 1 , wherein the device is positioned to regulate pressure between the first end and the second end.
5 . The method of claim 1 , wherein in the expanded configuration of the first expansion apparatus, the second segment of the first expansion apparatus also extends further radially outward, relative to the opening, than the first segment of the first expansion apparatus.
6 . The method of claim 1 , wherein the hollow shaft has a substantially constant cross-sectional area.
7 . The method of claim 1 , wherein the device is configured to operate as a capillary valve that fluidly couples the intradural and epidural spaces to drain excess cerebrospinal fluid when a cracking pressure is reached across the device between 20 mmH 2 O and 75 mmH 2 O.
8 . The method of claim 7 , wherein delivery of the second end of the device into the epidural space of the subject also causes, in the expanded configuration of the second expansion apparatus, a first segment of the second expansion apparatus to extend radially outward from the fluid outlet, and a second segment of the second expansion apparatus to extend distally from the first segment of the second expansion apparatus so as to be positioned proximate an epidural side of the dura around the opening in the dura.
9 . The method of claim 1 , wherein in the expanded configuration of the first expansion apparatus, the first segment of the first expansion apparatus extends from the inlet both radially and distally away from the opening, and in the expanded configuration of the second expansion apparatus, the first segment of the second expansion apparatus extends from the outlet both radially and proximally away from the opening.
10 . A method of draining excess cerebrospinal fluid from a brain or spinal column in a subject, the method comprising:
puncturing a dura of the subject with a spinal needle having a hollow shaft to create an opening between intradural and epidural spaces of the subject;
delivering, from the hollow shaft of the spinal needle, a first end of a device into the intradural space of the subject, the first end of the device comprising a fluid inlet and a first expansion apparatus, wherein delivery of the first end of the device into the intradural space of the subject causes the first expansion apparatus to assume an expanded configuration, larger than the opening in the dura, in which a first segment of the first expansion apparatus extends radially outward and distally from the fluid inlet and a second segment of the first expansion apparatus extends proximally from the first segment of the first expansion apparatus so as to be positioned proximate an intradural side of the dura around the opening in the dura,
wherein the device is configured to control a volumetric flow rate of fluid between the first and second ends;
delivering, from the hollow shaft of the spinal needle, a second end of the device into the epidural space of the subject, the second end of the device comprising a fluid outlet and a second expansion apparatus, wherein delivery of the second end of the device into the epidural space of the subject causes the second expansion apparatus to assume an expanded configuration, larger than the opening in the dura,
withdrawing the spinal needle from the subject; and
draining cerebrospinal fluid from the intradural space of the subject to the epidural space of the subject via the device.
11 . The method of claim 10 , wherein the device further comprises a flow controller configured to control the volumetric flow rate of fluid between the first end and the second end of the device.
12 . The method of claim 10 , wherein the device is configured to regulate pressure between the first end and the second end.
13 . The method of claim 10 , wherein in the expanded configuration of the first expansion apparatus, the second segment of the first expansion apparatus also extends further radially outward, relative to the opening, than the first segment of the first expansion apparatus.
14 . The method of claim 10 , wherein the hollow shaft has a substantially constant cross-sectional area.
15 . The method of claim 10 , wherein the device is configured to operate as a capillary valve that fluidly couples the intradural and epidural spaces to drain excess cerebrospinal fluid when a cracking pressure is reached across the device between 20 mmH 2 O and 75 mmH 2 O.
16 . The method of claim 10 , wherein the second segment of the first expansion apparatus has a free proximal end configured to be positioned at or adjacent the intradural side of the dura when the first expansion apparatus assumes the expanded configuration upon delivery of the second end of the device into the epidural space.