Patent Description:
The present disclosure relates to systems, catheters, and methods for treating along the central nervous system.

A wide variety of medical devices have been developed for medical use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices. Systems, devices and catheters for treating along the central nervous system are disclosed in <CIT> and <CIT>.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. A sampling system is disclosed. The sampling system comprises: a controller assembly including a socket, a filter cassette designed to filter cerebrospinal fluid and configured to be housed in the socket, the filter cassette having an inlet region configured to be coupled to a catheter and configured to receive cerebrospinal fluid, one or more filters, and an outlet region configured to be coupled to an outlet of the catheter and to direct filtered cerebrospinal fluid to the catheter; a sampling port in fluid communication with the filter cassette; wherein the sampling port has a first end region configured to receive cerebrospinal fluid, a stopcock, a syringe port, and a second end region; and wherein the stopcock is configured to shift between a first position where cerebrospinal fluid is directed from the first end region to the second end region and a second position where cerebrospinal fluid is directed from the first end region to the syringe port.

Alternatively or additionally to any of the embodiments above, when the stopcock is in the first position, the cerebrospinal fluid is substantially blocked from the syringe port.

Alternatively or additionally to any of the embodiments above, when the stopcock is in the second position, the cerebrospinal fluid is substantially blocked from the second end region.

Alternatively or additionally to any of the embodiments above, the one or more filters include a tangential flow filter.

Alternatively or additionally to any of the embodiments above, further comprising a syringe releasably coupled to the syringe port.

Alternatively or additionally to any of the embodiments above, the sampling port is in fluid communication with the inlet region of the filter cassette.

Alternatively or additionally to any of the embodiments above, the sampling port is configured to receive cerebrospinal fluid from the inlet region of the filtering cassette.

Alternatively or additionally to any of the embodiments above, the sampling port is configured to receive unfiltered cerebrospinal fluid from the inlet region of the filtering cassette.

Alternatively or additionally to any of the embodiments above, the sampling port is in fluid communication with the outlet region of the filter cassette.

Alternatively or additionally to any of the embodiments above, the sampling port is configured to receive cerebrospinal fluid from the outlet region of the filtering cassette.

Alternatively or additionally to any of the embodiments above, the sampling port is configured to receive filtered cerebrospinal fluid from the outlet region of the filtering cassette.

Alternatively or additionally to any of the embodiments above, the sampling port is in fluid communication with a waste outlet.

A sampling system is disclosed. The sampling system comprises: a controller assembly including a socket, a filter cassette designed to filter cerebrospinal fluid and configured to be housed in the socket, the filter cassette having an inlet region configured to be coupled to a catheter and configured to receive cerebrospinal fluid, one or more filters, and an outlet region configured to be coupled to an outlet of the catheter and to direct filtered cerebrospinal fluid to the catheter; a sampling port in fluid communication with the outlet region; the sampling port having a first end region configured to receive filtered cerebrospinal fluid, a stopcock, a syringe port, and a second end region; and wherein the stopcock is configured to shift between a first position where filtered cerebrospinal fluid is directed from the first end region to the second end region and a second position where filtered cerebrospinal fluid is directed from the first end region to the syringe port.

Alternatively or additionally to any of the embodiments above, when the stopcock is in the first position, the filtered cerebrospinal fluid is substantially blocked from the syringe port.

Alternatively or additionally to any of the embodiments above, when the stopcock is in the second position, the filtered cerebrospinal fluid is substantially blocked from the second end region.

A method for collecting a sample from a cerebrospinal fluid system, which is not part of the invention, is disclosed. The method comprises: withdrawing cerebrospinal fluid from a patient with a cerebrospinal fluid system; wherein the cerebrospinal fluid system includes: a filter cassette designed to filter cerebrospinal fluid, the filter cassette having an inlet region configured to be coupled to a catheter and configured to receive cerebrospinal fluid, one or more filters, and an outlet region configured to be coupled to an outlet of the catheter and to direct filtered cerebrospinal fluid to the catheter, a sampling port in fluid communication with the outlet region, wherein sampling port has a first end region configured to receive filtered cerebrospinal fluid, a stopcock, a syringe port, and a second end region, and wherein the stopcock is configured to shift between a first position where filtered cerebrospinal fluid is directed from the first end region to the second end region and a second position where filtered cerebrospinal fluid is directed from the first end region to the syringe port; and shifting the stopcock from the first position to the second position.

Alternatively or additionally to any of the embodiments above, further comprising releasably attaching a syringe to the syringe port.

Alternatively or additionally to any of the embodiments above, releasably attaching a syringe to the syringe port includes releasably attaching the syringe to the syringe port prior to shifting the stopcock from the first position to the second position.

Alternatively or additionally to any of the embodiments above, shifting the stopcock from the first position to the second position directs filtered cerebrospinal fluid into the syringe.

Alternatively or additionally to any of the embodiments above, shifting the stopcock from the first position to the second position automatically directs filtered cerebrospinal fluid into the syringe.

On the contrary, the intention is to cover all modifications falling within the scope of the disclosure.

Cerebrospinal fluid (CSF) is a generally clear, colorless fluid with viscosity similar to water that is produced within the choroid plexus located in the ventricles of the brain. Total CSF volume has been estimated to range from approximately <NUM> to <NUM> milliliters in healthy adults. The choroid plexus is believed to produce approximately <NUM> milliliters of CSF daily in order to accommodate flushing or recycling of CSF to remove toxins and metabolites. The total volume of CSF is replenished several times per day or possibly more during sleep cycles and other activities. CSF also serves to float the delicate brain tissue by the Archimedes principle, and it protects the brain from sudden movements by cushioning the tissue. From the choroid plexus, CSF flows slowly through a series of openings into the space surrounding the brain and spinal column, and then into the body through multiple outflow pathways that include arachnoid granulations, cribiform plate, dural lymphatics, spinal cord nerve root sleeves, and possibly other pathways within the brain tissue. CSF is found in the space between the pia mater and the arachnoid mater, known as the subarachnoid space and also located within the ventricular system of the brain and in a series of cisterns located external to the brain. In addition to the net production and absorption of CSF flow, the CSF oscillates with a back-and-forth motion in synchrony with the cardiac and respiratory cycle. The magnitude of these oscillations is variable depending on the specific region of CSF. CSF flow can also be intermittently altered based on various maneuvers such as valsalva, coughing, sneezing, playing a musical instrument, and athletic activities. CSF pressure in a healthy adult is approximately <NUM> millimeters of mercury in the supine position. CSF pressure is altered in the standing position by hydrostatic pressure gradient along CSF system and can also be transiently affected by maneuvers such as coughing.

Research has indicated that alterations of the biochemical composition of CSF can be indicative and/or involved in the pathological processes of a plethora of central nervous system disease states. For example, in the event of a stroke or other brain trauma, blood can enter the CSF system leading to subsequent injury to the brain due to blood clotting and other biological processes. In context of amyotrophic lateral sclerosis, several chemicals (inflammatory proteins or cytokines such as CHIT1) have been found to be abnormally elevated potentially contributing to the disease pathology. Similarly, in multiple sclerosis proteins, cytokines and chemokines have been found to be elevated and potentially underlying disease progression. As such, in principle, it could be beneficial to remove CSF with abnormal biochemical composition; however, direct removal of CSF is limited as only relatively small amounts can be safely removed. Thus, it can be desirable to remove the CSF from one location (e.g., the cervical region of the spine, or a brain ventricle), alter it (e.g., filter), and return it to the CSF space at a second location (e.g., the lumbar region of the spine). This process can be used to remove the unwanted biochemical products while maintaining similar total CSF volume.

A process termed Neurapheresis may be understood to be the modification of materials (e.g. removal of microrganisms, cells, viruses, foreign material, drugs, combinations thereof, and the like, or circulation and/or addition of materials such as pharmacologic agents) from CSF. This and other therapeutic techniques can be used to treat a number of neurological diseases or conditions, such as Alzheimer's Disease, Parkinson's Disease, Huntington's Disease, Amyotrophic Lateral Sclerosis (ALS), Encephalitis from various causes, Meningitis from various causes, Guillain-Barré Syndrome (GBS), Multiple Sclerosis (MS), HIV-associated neurocognitive disorders, Spinal Cord Injury, Traumatic Brain Injury, cerebral vasospasm, stroke and other diseases or conditions. In addition, Neurapheresis can be used during open or endoscopic spine surgery or brain surgery, for example to remove blood that may get in the CSF during the surgery.

During a medical intervention such as Neurapheresis, it may be desirable to collect a sample of CSF. For example, it may be desirable to collect a sample of CSF in order to analyze the sample, quantify one or more substances (e.g., pathogens, prokaryotic organisms, eukaryotic organisms, viruses, contaminants, drugs, and/or the like) within the CSF, monitor drug levels within the CSF, monitor progress of a treatment, combinations thereof, and/or the like. Disclosed herein are systems that allow for a sample of CSF to be collected during an intervention.

<FIG> is a perspective view of a portion of an example system <NUM>, for example a portion of a Neurapheresis system <NUM>. The system <NUM> includes a controller assembly <NUM>. The controller assembly <NUM> includes a socket or opening <NUM> designed to house a filtering member or cassette <NUM>. In at least some instances, the filtering cassette <NUM> includes one or filters (e.g., such as tangential flow filters, dead-end filters, electrofilters, combinations thereof, and/or the like) generally designed to filter CSF. Tubing may be coupled to the filtering cassette <NUM>. In some instances, the tubing may include an aspiration or inlet region <NUM> that may be coupled to the filtering cassette <NUM>. The aspiration region <NUM> may be coupled to a catheter (not shown) and may define a pathway through which CSF can be removed from a patient and be processed/filtered by the filtering cassette <NUM>. In some instances, the tubing may include a return or outlet region <NUM> that may be coupled to the filtering cassette <NUM>. The return region <NUM> may be used to return CSF (e.g., filtered CSF) to the patient. The return region <NUM> may be coupled to a catheter (not shown) and may define a pathway through which processed/filtered CSF can be returned to the patient.

The tubing coupled to the filtering cassette <NUM> may also include a first pump region <NUM>, for example, that may extend from the filtering cassette <NUM>. The first pump region <NUM> may be designed to engage a pump head (not shown) so that CSF can be pumped/circulated through the filtering cassette <NUM> and, ultimately filtered CSF can be returned to the patient. The tubing coupled to the filtering cassette <NUM> may include a second pump region <NUM>, for example, that may extend from the filtering cassette <NUM>. The second pump region <NUM> may be designed to engage another pump head (not shown) so that waste material can be pumped from the pumping cassette <NUM>.

In use, the system <NUM> may be used by coupling a catheter (not shown) to the system <NUM> and disposing the catheter within/along the cerebrospinal space (e.g., such as along lumbar cerebrospinal space). CSF may be removed/aspirated using the catheter and the removed CSF may be processed/filtered using the filtering cassette <NUM>. The filtered/conditioned CSF may then be returned to the patient using the catheter.

The tubing may include one or more sampling ports, for example sampling ports 26a, 26b, generally disposed along the tubing of the filtering cassette <NUM>. It can be appreciated that the position of a given sampling port may impact the type of CSF sample collected. For example, sampling port 26a may be disposed adjacent to the filtering cassette <NUM> and be in fluid communication with the aspiration region <NUM> such that samples collected at the sampling port 26a represent CSF collected directly from the patient (e.g., "unfiltered" or "untreated" CSF). Samples collected at the sampling port 26a, thus, may be used to analyze the CSF, quantify one or more substances (e.g., pathogens, prokaryotic organisms, eukaryotic organisms, viruses, contaminants, drugs, and/or the like) within the CSF, monitor drug levels in the CSF, monitor progress of a treatment, combinations thereof, and/or the like. The sampling port 26b may be disposed adjacent to the filtering cassette <NUM> such that waste material (e.g., material removed/filtered from CSF) can be collected and/or analyzed. Thus, the sampling port 26b may be understood to be in fluid communication with a waste outlet (e.g., a pathway from the filtering cassette <NUM> where the waste material is transported). The system <NUM> may include additional ports that allow for a clinician to assess the filtration during a Neurapheresis procedure. Such sampling ports may be disposed along or in fluid communication with the return region <NUM>. For example, one or more additional sampling ports may be in fluid communication with the return region <NUM> such that samples collected at this sampling port represent filtered/treated CSF. Thus, collectively, sampling ports are contemplated that can be used to collect (a) unfiltered CSF, (b) filtered/treated CSF, and/or (c) waste material.

A representative sampling port <NUM>, representative of any of the sampling ports (e.g., including the sampling ports 26a, 26b) of the system <NUM>, is depicted in <FIG>. Here it can be seen that the sampling port <NUM> may include a first end region <NUM> configured to be coupled to an inlet region <NUM>. The sampling port <NUM> may also include a second end region <NUM> configured to be coupled to an outlet region <NUM>. In this example, the outlet region <NUM> is in fluid communication with the filter cassette <NUM>. The sampling port <NUM> may also include a syringe port <NUM> configured to be coupled to a syringe <NUM>. The syringe <NUM> may include a syringe barrel <NUM> and a plunger <NUM>.

A stopcock or valve <NUM> may be coupled to the sampling port <NUM>. The stopcock <NUM> may be configured to shift between one or more positions or configurations. For example, when the stopcock <NUM> is in a first position (e.g., as shown in <FIG>), CSF is directed from the first end region <NUM> to the second end region <NUM>. In at least some instances, when the stopcock <NUM> is in the first position, CSF is substantially blocked from the syringe port <NUM>.

When the stopcock <NUM> is shifted to or otherwise in a second position (e.g., as shown in <FIG>), CSF is directed from the first end region <NUM> to the syringe port <NUM>. In at least some instances, when the stopcock <NUM> is in the second position, CSF is substantially blocked from the second end region <NUM>.

When the stopcock <NUM> is in the second position, a sample <NUM> of CSF may flow into the syringe <NUM> as depicted in <FIG>. When a sufficient amount of the sample <NUM> is collected, for example as depicted in <FIG>, the stopcock <NUM> may be retumed to the first position as shown in <FIG>. As desired, the syringe <NUM> can be removed from the syringe port <NUM>, for example so that the sample <NUM> can be analyzed/processed. It can be appreciated that in the example depicted in <FIG>, the sample collected in the syringe <NUM> may include unfiltered CSF. In other examples, similar to this example, the sample may include filtered/treated CSF or waste material. In these other example, the location of the sample port <NUM> may be suitable located.

Claim 1:
A sampling system (<NUM>), comprising:
a controller assembly (<NUM>) including a socket (<NUM>);
a filter cassette (<NUM>) designed to filter cerebrospinal fluid and configured to be housed in the socket (<NUM>), the filter cassette (<NUM>) having an inlet region (<NUM>) configured to be coupled to a catheter and configured to receive cerebrospinal fluid, one or more filters, and an outlet region (<NUM>) configured to be coupled to an outlet of the catheter and to direct filtered cerebrospinal fluid to the catheter;
a sampling port (<NUM>) in fluid communication with the filter cassette (<NUM>);
wherein the sampling port (<NUM>, 26a, 26b) has a first end region (<NUM>) configured to receive cerebrospinal fluid, a stopcock (<NUM>), a syringe port (<NUM>), and a second end region (<NUM>); and
wherein the stopcock (<NUM>) is configured to shift between a first position where cerebrospinal fluid is directed from the first end region (<NUM>) to the second end region (<NUM>) and a second position where cerebrospinal fluid is directed from the first end region (<NUM>) to the syringe port (<NUM>).