A system for treating along the central nervous system

Abstract

A sampling system for accessing and treating the central nervous system is disclosed. The sampling system includes a filter cassette (16) designed to filter cerebrospinal fluid. The filter cassette is configured to couple to a catheter and has an inlet region (18) configured to receive cerebrospinal fluid, one or more filters, and an outlet region (20) configured to couple to the catheter's outlet and direct filtered cerebrospinal fluid to the catheter. The system includes a sampling port (26a) in communication with the filter cassette. The sampling port has a first end region (32) configured to receive cerebrospinal fluid, a stopcock (44), a syringe port (36), and a second end region (28). The stopcock is configured to switch between a first position in which cerebrospinal fluid is directed from the first end region to the second end region and a second position in which cerebrospinal fluid is directed from the first end region to the syringe port.

Description

Technical Field

[0001] The present disclosure relates to systems, catheters, and methods for treating along the central nervous system.

Background Art

[0002] Various types of medical devices are being 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 can be used according to any one of a variety of methods. Each of the known medical devices and methods has distinct advantages and disadvantages. There is a continuing need to provide alternative methods for manufacturing and using medical devices as well as alternative medical devices.

Summary of the Invention

[0003] The present disclosure provides designs, materials, manufacturing methods, and use alternatives for medical devices. A sampling system is disclosed. The sampling system includes a filter cassette designed to filter cerebrospinal fluid, configured to be connected to a catheter and configured to receive cerebrospinal fluid, an inlet region; one or more filters; an outlet region configured to be connected to an outlet of the catheter and configured to guide the filtered cerebrospinal fluid to the catheter; the filter cassette having the inlet region, the one or more filters, and the outlet region; and a sampling port in communication with the filter cassette. The sampling port has a first end region configured to receive cerebrospinal fluid, a stopcock, a syringe port, and a second end region. The stopcock is configured to switch between a first position in which cerebrospinal fluid is directed from the first end region to the second end region and a second position in which cerebrospinal fluid is directed from the first end region to the syringe port.

[0004] <00000i7>In an alternative or additional embodiment of any of the above, when the stopcock is in the first position, the cerebrospinal fluid is substantially blocked from the syringe port.

[0005] In an alternative or addition to any of the above embodiments, when the stopcock is in the second position, the cerebrospinal fluid is substantially blocked from the second end region.

[0006] In addition to or as an alternative to any of the embodiments described above, one or more of the filters include tangential flow filters.

[0007] An alternative or addition to any of the above embodiments further comprises a syringe detachably connected to the syringe port.

[0008] In any of the above embodiments, or in addition, the sampling port communicates with the inlet area of ​​the filter cassette.

[0009] In an alternative or addition to any of the above embodiments, the sampling port is configured to receive cerebrospinal fluid from the inlet region of the filter cassette.

[0010] In an alternative or addition to any of the above embodiments, the sampling port is configured to receive unfiltered cerebrospinal fluid from the inlet region of the filter cassette.

[0011] In any of the embodiments described above, the sampling port communicates with the output region of the filter cassette.

[0012] In an alternative or addition to any of the above embodiments, the sampling port is configured to receive cerebrospinal fluid from the outlet region of the filter cassette.

[0013] In an alternative or addition to any of the above embodiments, the sampling port is configured to receive cerebrospinal fluid filtered from the outlet region of the filter cassette.

[0014] In any of the embodiments described above, or in addition to the above, the sampling port communicates with a drain.

[0015] A sampling system is disclosed. The sampling system comprises a filter cassette designed to filter cerebrospinal fluid, the filter cassette having an inlet region configured to be connected to a catheter and to receive cerebrospinal fluid, one or more filters, and an outlet region configured to be connected to the outlet of the catheter and to guide filtered cerebrospinal fluid into the catheter; and a sampling port communicating 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, the stopcock configured to switch between a first position in which filtered cerebrospinal fluid is guided from the first end region to the second end region and a second position in which filtered cerebrospinal fluid is guided from the first end region to the syringe port.

[0016] In an alternative or addition to any of the above embodiments, when the stopcock is in the first position, the filtered cerebrospinal fluid is substantially blocked from the syringe port.

[0017] In an alternative or addition to any of the above embodiments, when the stopcock is in the second position, the filtered cerebrospinal fluid is substantially blocked from the second end region.

[0018] In addition to or as an alternative to any of the embodiments described above, one or more of the filters include tangential flow filters.

[0019] An alternative or additional embodiment to any of the above embodiments further comprises a syringe detachably connected to the syringe port.

[0020] A method for collecting a sample from a cerebrospinal fluid system is disclosed. The method includes extracting cerebrospinal fluid from a patient using a cerebrospinal fluid system, the cerebrospinal fluid system comprising: a filter cassette designed to filter cerebrospinal fluid, configured to be connected to a catheter and having an inlet region configured to receive cerebrospinal fluid; one or more filters; and an outlet region configured to be connected to the outlet of the catheter and having filtered cerebrospinal fluid directed to the catheter; and a sampling port communicating with the outlet region, the sampling port comprising a first end region configured to receive filtered cerebrospinal fluid; a stopcock; a syringe port; and a second end region, the stopcock configured to switch between a first position in which filtered cerebrospinal fluid is directed from the first end region to the second end region and a second position in which filtered cerebrospinal fluid is directed from the first end region to the syringe port, and the method includes switching the stopcock from the first position to the second position.

[0021] In an alternative or addition to any of the above embodiments, when the stopcock is in the first position, the filtered cerebrospinal fluid is substantially blocked from the syringe port.

[0022] In an alternative or addition to any of the above embodiments, when the stopcock is in the second position, the filtered cerebrospinal fluid is substantially blocked from the second end region.

[0023] In an alternative or addition to any of the embodiments described above, one or more of the filters include tangential flow filters.

[0024] An alternative or addition to any of the above embodiments further comprises detachably attaching a syringe to the syringe port.

[0025] As an alternative or addition to any of the above embodiments, removably attaching the syringe to the syringe port includes removably attaching the syringe to the syringe port before switching the stopcock from the first position to the second position.

[0026] As an alternative or addition to any of the above embodiments, switching the stopcock from the first position to the second position directs the filtered cerebrospinal fluid into the syringe.

[0027] As an alternative or addition to any of the above embodiments, switching the stopcock from the first position to the second position automatically directs the filtered cerebrospinal fluid into the syringe.

[0028] The above summary of some embodiments is not intended to describe every disclosed embodiment or all implementations of the present disclosure. The following drawings and detailed description illustrate these embodiments in more detail. [[ID=***]]

Brief Description of the Drawings

[0029] The present disclosure can be more fully understood by considering the following detailed description in connection with the accompanying drawings.

[0030] [Figure 1] It is a perspective view of a part of an example system.

[0031] [Figure 2] It is a side view of a part of an example system.

[0032] [Figure 3] It is a side view of a part of an example system.

[0033] [Figure 4] It is a side view of a part of an example system.

[0034] [Figure 5]This is a side view of a part of an example system.

[0035] [Figure 6] This is a side view of a part of an example system.

[0036] This disclosure accepts various modifications and alternative forms, the details of which are illustrated by the drawings and may be described in detail. However, it should be understood that the intent is not to limit the disclosure to the specific embodiments described. In contrast, the intent is to protect all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure. [Modes for carrying out the invention]

[0037] In this specification, all numerical values, whether explicitly indicated or not, are presumed to be modified by the term “approximately.” The term “approximately” generally indicates a range of numbers that a person skilled in the art could consider equivalent to the listed values ​​(e.g., having the same function or result). In many examples, the term “approximately” may include numbers rounded to the nearest significant figure.

[0038] In an enumeration of a range of numbers with defined endpoints, all numbers within that range are included (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0039] As used herein and in the appended claims, unless explicitly stated otherwise, the singular forms "a," "an," and "the" refer to multiple subjects. As used herein and in the appended claims, unless explicitly stated otherwise, the term "or" is generally used to mean "and / or."

[0040] In this specification, references to “one embodiment,” “several embodiments,” and “other embodiments” indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such enumeration does not necessarily imply all embodiments that include a particular feature, structure, and / or characteristic. Furthermore, when a particular feature, structure, and / or characteristic is described in relation to one embodiment, it should be understood that, unless otherwise stated, such feature, structure, and / or characteristic may also be used in relation to other embodiments, whether explicitly stated or not.

[0041] The following detailed description should be read with reference to the drawings, and similar elements in different drawings are numbered the same. Drawings that are not necessarily to scale illustrate exemplary embodiments and are not intended to limit the scope of the invention.

[0042] Cerebrospinal fluid (CSF) is a generally clear, colorless fluid with a water-like viscosity, produced within the choroid plexus located in the ventricles of the brain. The total amount of CSF is estimated to range from approximately 150 to 300 milliliters in a healthy adult. The choroid plexus is believed to produce approximately 500 milliliters of CSF daily to flush out or reuse CSF to remove toxins or metabolites. The total amount of CSF is replenished several or more times a day during sleep cycles and other activities. CSF also helps to afloat delicate brain tissue by Archimedes' principle, protecting the brain from sudden movements through its buffering effect on the tissues. CSF flows slowly from the choroid plexus into the space surrounding the brain and spine through a series of openings, and then into the body through multiple outflow pathways, including the arachnoid granules, cribriform plate, dural lymphatic vessels, spinal nerve root sleeves, and other possible pathways into brain tissue. The CSF (Central Stomach Fluid) is found in the space between the pia mater and the arachnoid mater, called the subarachnoid space, and is also present in a series of cisterns located within and outside the brain's ventricular system. In addition to the net generation and absorption of CSF flow, CSF fluctuates due to anterior-posterior movements synchronized with the cardiac and respiratory cycles. The magnitude of these fluctuations varies depending on the specific region of the CSF. CSF flow can also change intermittently based on various actions such as Valsalva maneuvers, coughing, sneezing, playing musical instruments, and exercise. In a healthy adult, CSF pressure is approximately 10 millimeters of mercury in a supine position. In an upright position, CSF pressure changes due to hydrostatic gradients along the CSF system and can also be temporarily affected by actions such as coughing.

[0043] Studies have shown that alterations in the biological composition of CSF are indicated and / or involved in the pathological processes of many central nervous system disease states. For example, in the event of a stroke or other brain trauma, blood enters the CSF system and, through blood clotting and other biological processes, can then potentially damage the brain. In the context of amyotrophic lateral sclerosis (ALS), it has been found that several chemicals (inflammatory proteins or cytokines such as CHIT1) are abnormally elevated and may contribute to the disease pathogenesis. Similarly, in several sclerosis proteins, cytokines and chemokines are elevated, and it has been found that the underlying disease progresses. Therefore, in principle, removing CSF with an abnormal biological composition may be beneficial. However, direct removal of CSF is limited so that only relatively small amounts can be safely removed. Therefore, it may be desirable to remove CSF from one location (e.g., the cervical region of the spine or the ventricles), modify it (e.g., filter it), and then return it to the CSF space at a second location (e.g., the lumbar region of the spine). This process could potentially be used to remove undesirable biological products while maintaining a similar total CSF level.

[0044] The process known as neurapheresis can be understood as modifying substances from CSF (e.g., removing microorganisms, cells, viruses, foreign bodies, drugs, and combinations thereof). The above and other therapeutic techniques may be used to treat many neurological diseases and conditions, such as Alzheimer's disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), encephalitis of various causes, meningitis of various causes, Guillain-Barré syndrome (GBS), multiple sclerosis (MS), HIV-related neurocognitive disorders, spinal cord injury, traumatic brain injury, cerebral vasospasm, stroke, and other diseases and conditions. Furthermore, neurapheresis may be used, for example, during spinal or brain surgery using incisions or endoscopy to remove blood that may be mixed into the CSF during surgery.

[0045] It is desirable to collect CSF samples during medical interventions such as neurapheresis. For example, it is desirable to collect CSF samples to perform analysis of the samples, quantify one or more substances in the CSF (e.g., pathogens, prokaryotes, eukaryotes, viruses, contaminants, and / or drugs), monitor drug levels in the CSF, monitor the progress of the procedure, and / or a combination thereof. Disclosure herein is a system that enables the collection of CSF samples during an intervention.

[0046] Figure 1 is a perspective view of a portion of an example system 10, for example, a portion of a neurapheresis system 10. The system 10 may include a controller assembly 12. The controller assembly 12 may include a socket or opening 14 designed to house a filter member or cassette 16. In at least some examples, the filter cassette 16 generally includes one or more filters (e.g., tangential flow filters, dead-end filters, electrofilters, and / or a combination thereof) designed to filter CSF. A tube may be connected to the filter cassette 16. In some examples, the tube may include a suction or inlet area 18 that may be connected to the filter cassette 16. The suction area 18 may be connected to a catheter (not shown) and may define a path through which CSF is removed from the patient and processed / filtered by the filter cassette 16. In some examples, the tube may include a return or outlet area 20 that may be connected to the filter cassette 16. The return area 20 may be used to return CSF (e.g., filtered CSF) to the patient. The return region 20 may be connected to a catheter (not shown) and may define a pathway through which the processed / filtered CSF can be returned to the patient.

[0047] The tube connected to the filter cassette 16 may also include, for example, a first pump region 22 that may extend from the filter cassette 16. The first pump region 22 may be designed to engage with a pump head (not shown) so that CSF is pumped / circulated by the filter cassette 16, and finally the filtered CSF can be returned to the patient. The tube connected to the filter cassette 16 may also include, for example, a second pump region 24 that may extend from the filter cassette 16. The second pump region 24 may be designed to engage with another pump head (not shown) so that waste material can be pumped from the pump cassette 16.

[0048] During use, system 10 may be used by connecting a catheter (not shown) to system 10 and positioning the catheter in / along the cerebrospinal fluid space (for example, along the lumbar cerebrospinal fluid space). CSF may be removed / aspirated using the catheter, and the removed CSF may be processed / filtered using filter cassette 16. The filtered / processed CSF may then be returned to the patient using the catheter.

[0049] The tube may include one or more sampling ports, for example, sampling ports 26a and 26b are generally located along the tube of the filter cassette 16. It is understood that the location of a given sampling port may affect the type of CSF sample collected. For example, sampling port 26a may be located adjacent to the filter cassette 16 and communicate with the aspiration area 18 so that the sample collected at sampling port 26a indicates CSF collected directly from the patient (e.g., “unfiltered” or “unprocessed” CSF). Thus, the sample collected at sampling port 26a may be used for CSF analysis, quantification of one or more substances in the CSF (e.g., pathogens, prokaryotes, eukaryotes, viruses, contaminants, and / or drugs), monitoring of drug levels in the CSF, monitoring of the progress of treatment, and / or a combination thereof. Sampling port 26b may be located adjacent to the filter cassette 16 so that waste matter (e.g., substances removed / filtered from the CSF) can be collected and / or analyzed. Therefore, it can be understood that the sampling port 26b communicates with a drain (e.g., a pathway from the filter cassette 16 to which waste material is transported). The system 10 may include additional ports to allow the clinician to evaluate filtration during neurapheresis. Such sampling ports may be located along or in communication with the return area 20. For example, one or more additional sampling ports may communicate with the return area 20 such that the sample collected at this sampling port indicates filtered / treated CSF. Thus, in general, it is considered that sampling ports may be used to collect (a) unfiltered CSF, (b) filtered / treated CSF, and / or (c) waste material.

[0050] A representative sampling port 26, representing any sampling port of system 10 (including sampling ports 26a and 26b), is shown in Figures 2 to 6. Here, it can be seen that sampling port 26 may include a first end region 32 configured to connect to an inlet region 34. Sampling port 26 may also include a second end region 28 configured to connect to an outlet region 30. In this example, the outlet region 30 communicates with the filter cassette 16. Sampling port 26 may also include a syringe port 36 configured to connect to a syringe 38. Syringe 38 may include a syringe barrel 40 and a plunger 42.

[0051] A stopcock or valve 44 may be connected to the sampling port 26. The stopcock 44 may be configured to switch between one or more positions or between multiple structures. For example, when the stopcock 44 is in the first position (e.g., shown in Figure 2), the CSF is routed from the first end region 32 to the second end region 28. In at least some examples, when the stopcock 44 is in the first position, the CSF is substantially isolated from the syringe port 36.

[0052] When the stopcock 44 is switched to or in the second position (for example, as shown in Figure 3), the CSF is guided from the first end region 32 to the syringe port 36. In at least some examples, when the stopcock 44 is in the second position, the CSF is substantially blocked from the second end region 28.

[0053] When the stopcock 44 is in the second position, the CSF sample 46 may flow into the syringe 38 as shown in Figure 4. For example, when a sufficient amount of sample 46 has been collected, as shown in Figure 5, the stopcock 44 may be returned to the first position as shown in Figure 6. If desired, the syringe 38 may be removed from the syringe port 36, for example, thereby allowing the sample 46 to be analyzed / processed. In the examples shown in Figures 2 to 6, it is understood that the sample collected in the syringe 38 may contain unfiltered CSF. In other examples, as in this example, the sample may contain filtered / processed CSF or waste material. In these other examples, the position of the sample port 28 may be appropriately positioned.

[0054] It should be understood that in many respects this disclosure is merely illustrative. Modifications may be made in detail, particularly with respect to shape, size, and sequence of processes, without exceeding the scope of this disclosure. This may include, to the appropriate extent, the use of any of the features of one exemplary embodiment used in other embodiments. The scope of the invention is, of course, defined in the language set forth in the appended claims.

Claims

1. A sampling system, A filter cassette designed to filter cerebrospinal fluid, comprising: an inlet region configured to connect to a first catheter and to receive unfiltered cerebrospinal fluid; one or more filters; and an outlet region configured to connect to a second catheter and to guide filtered cerebrospinal fluid to the second catheter, the filter cassette being configured to be housed in a socket of a controller assembly; A cerebrospinal fluid sampling port communicating with the inlet region of the filter cassette, A waste material sampling port is provided, which communicates with the filter cassette and is located in a tube connected to the filter cassette, and is configured to receive waste material filtered by the filter cassette from the unfiltered cerebrospinal fluid. The cerebrospinal fluid sampling port has a first end region configured to receive the unfiltered cerebrospinal fluid, a stopcock, a syringe port, and a second end region. The sampling system is configured such that the stopcock switches between a first position in which the unfiltered cerebrospinal fluid is guided from the first end region to the second end region and a second position in which the unfiltered cerebrospinal fluid is guided from the first end region to the syringe port.

2. The sampling system according to claim 1, wherein when the stopcock is in the first position, the unfiltered cerebrospinal fluid is substantially blocked from the syringe port.

3. The sampling system according to claim 1, wherein when the stopcock is in the second position, the unfiltered cerebrospinal fluid is substantially blocked from the second end region.

4. The sampling system according to claim 1, wherein the one or more filters include a tangential flow filter.

5. The sampling system according to claim 1, further comprising a detachable syringe connected to the syringe port.

6. The sampling system according to claim 1, wherein the cerebrospinal fluid sampling port is configured to receive the unfiltered cerebrospinal fluid from the inlet region of the filter cassette.

7. The sampling system according to claim 1, wherein the cerebrospinal fluid sampling port communicates with the outlet region of the filter cassette.

8. A sampling system, A filter cassette designed to filter cerebrospinal fluid, comprising: an inlet region configured to connect to a first catheter and to receive unfiltered cerebrospinal fluid; one or more filters; and an outlet region configured to connect to a second catheter and to guide filtered cerebrospinal fluid into the second catheter, wherein the filter cassette is configured to be housed in a socket of a controller assembly. A cerebrospinal fluid sampling port communicating with the aforementioned exit region, A waste material sampling port is provided, which communicates with the filter cassette and is located in a tube connected to the filter cassette, and is configured to receive waste material filtered by the filter cassette from the unfiltered cerebrospinal fluid, The cerebrospinal fluid sampling port has a first end region configured to receive the filtered cerebrospinal fluid, a stopcock, a syringe port, and a second end region. The sampling system is configured such that the stopcock switches between a first position in which the filtered cerebrospinal fluid is guided from the first end region to the second end region and a second position in which the filtered cerebrospinal fluid is guided from the first end region to the syringe port.

9. The sampling system according to claim 8, wherein when the stopcock is in the first position, the filtered cerebrospinal fluid is substantially blocked from the syringe port.

10. The sampling system according to claim 8, wherein when the stopcock is in the second position, the filtered cerebrospinal fluid is substantially blocked from the second end region.

11. The sampling system according to claim 8, wherein the one or more filters include a tangential flow filter.

12. The sampling system according to claim 8, further comprising a detachable syringe connected to the syringe port.

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