INTRATHECAL CATHETER WITH MEANS TO MEASURE QUALITY OF DRUG DISPERSION

Abstract

A method of determining a local cerebrospinal fluid flow rate. The method including the steps of positioning a distal end of the catheter in a flow of cerebrospinal fluid of the patient, the catheter including an infusion port and at least one temperature sensor positioned at a fixed distance from the infusion port, infusing a bolus of a temperature controlled fluid through the infusion port into the flow of cerebrospinal fluid, and monitoring a temperature sensed by the at least one temperature sensor, wherein a change in the temperature sensed by the at least one temperature sensor over time is representative of a local cerebrospinal fluid flow rate in proximity to the infusion port.

Claims

1. A method of determining a local cerebrospinal fluid flow rate, the method comprising: positioning a distal end of a catheter in a flow of cerebrospinal fluid of a patient, the catheter including an infusion port and at least one temperature sensor positioned at a fixed distance from the infusion port; infusing a bolus of temperature controlled fluid through the infusion port into the flow of cerebrospinal fluid; and monitoring a temperature sensed by the at least one temperature sensor, wherein a change in the temperature sensed by the at least one temperature sensor over time is representative of a local cerebrospinal fluid flow rate in proximity to the infusion port.

2. The medical device of claim 1, wherein the temperature controlled fluid is saline solution.

3. The medical device of claim 1, wherein the temperature controlled fluid has a temperature in a range of between about 35 F. and about 46 F.

4. The medical device of claim 1, wherein the temperature controlled fluid is a contrast agent visible through magnetic resonance imaging.

5. The medical device of claim 1, wherein the bolus of temperature controlled fluid is infused via a syringe pump.

6. The medical device of claim 1, further comprising graphically displaying the temperature sensed by the at least one temperature sensor over a period of time.

7. The medical device of claim 1, wherein the period of time has a predefined duration between about 10 seconds and about 300 seconds.

8. The medical device of claim 1, further comprising repeating the procedure at a different location within an intrathecal space of a patient to determine a local cerebrospinal fluid flow rate at the different location.

9. A method of mapping a fluid flow rate within the cerebrospinal fluid of a patient, the method comprising: inserting an intrathecal catheter into a patient, the intrathecal catheter having a distal end configured to be positioned within a flow of cerebral spinal fluid, a proximal end, and a body defining a lumen extending lengthwise along the catheter configured to enable a delivery of a bolus of temperature controlled fluid from the proximal end to an infusion port positioned in proximity to the distal end, the intrathecal catheter further including at least one temperature sensor positioned at a fixed distance from the infusion port; infusing a bolus of temperature controlled saline solution through the infusion port into the flow of cerebrospinal fluid; and monitoring a temperature sensed by the at least one temperature sensor over a duration of time between about 10 seconds and about 300 seconds, wherein a change in the temperature sensed by the at least one temperature sensor over time is representative of a local cerebrospinal fluid flow rate in proximity to the infusion port.

10. A medical device comprising: a catheter having a distal end configured to be positioned within a flow of cerebrospinal fluid of a patient, a proximal end, and a body defining a lumen extending lengthwise along the catheter configured to enable a delivery of a bolus of temperature controlled fluid from the proximal end to an infusion port positioned in proximity to the distal end, the catheter further including at least one temperature sensor positioned a fixed distance from the infusion port; and a processor configured to receive and process data sensed by the at least one temperature sensor over a period of time to determine a velocity of the temperature controlled fluid exiting the infusion port, wherein the velocity of the temperature controlled fluid is representative of a flow rate of the cerebrospinal fluid in proximity to the infusion port.

11. The medical device of claim 1, wherein the temperature controlled fluid is saline solution.

12. The medical device of claim 1, wherein the temperature controlled fluid has a temperature in a range of between about 35 F. and about 46 F.

13. The medical device of claim 1, wherein the temperature controlled fluid is a contrast agent visible through magnetic resonance imaging.

14. The medical device of claim 1, wherein the temperature controlled fluid is injected via a syringe pump.

15. The medical device of claim 1, wherein the period of time begins upon initiating infusion of the bolus of temperature controlled fluid and ends after a predefined duration.

16. The medical device of claim 1, wherein the predefined duration is in a range of between about 10 seconds and about 300 seconds.

17. The medical device of claim 1, further including a display configured to represent a graphical plot the data sensed by the temperature sensor over a period of time.

18. The medical device of claim 1, wherein the medical device includes a first temperature sensor and a second temperature sensor.

19. The medical device of claim 18, wherein the first temperature sensor is positioned proximally to the infusion port and the second temperature sensor is positioned distally to the infusion port.

20. The medical device of claim 1, wherein the medical device is configured to produce a cerebrospinal fluid flow rate map of an intraspinal space of the patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The disclosure can be more completely understood in consideration of the following detailed description of various embodiments of the disclosure, in connection with the accompanying drawings, in which:

[0016] FIG. 1 is a schematic diagram depicting a medical device configured to determine a local cerebrospinal flow rate, in accordance with an embodiment of the disclosure.

[0017] FIG. 2 is a partial, perspective view depicting a portion of a catheter, in accordance with an embodiment of the disclosure.

[0018] FIG. 3A is a lengthwise sectional view depicting a catheter, in accordance with an embodiment of the disclosure.

[0019] FIG. 3B is a crosswise sectional view depicting the catheter of FIG. 3A.

[0020] FIG. 4A is a perspective view depicting a catheter inserted into a subarachnoid space of a patient, in accordance with an embodiment of the disclosure.

[0021] FIG. 4B depicts the dispersion of fluid within the cerebrospinal fluid of the patient after approximately 7.5 seconds of initiating infusion from the catheter of FIG. 4A.

[0022] FIG. 4C depicts dispersion of fluid within the cerebrospinal fluid of the patient after approximately 15 seconds of initiating infusion from the catheter of FIG. 4A.

[0023] FIG. 5 is a graphical representation depicting the measured temperature at a local infusion site over a dispersion time.

[0024] FIG. 6A is a graphical representation depicting a plan view map of the intrathecal space of a patient representing cerebrospinal fluid flow rates, in accordance with an embodiment of the disclosure.

[0025] FIG. 6B is a graphical representation depicting a profile view map corresponding to the plan view map of FIG. 6A.

[0026] FIG. 7 is a partial, perspective view depicting a portion of a catheter having two or more temperature sensors, in accordance with an embodiment of the disclosure.

[0027] While embodiments of the disclosure are amenable to various modifications and alternative forms, specifics thereof shown by way of example in the drawings will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.

DETAILED DESCRIPTION

[0028] Referring to FIG. 1, a medical device 100 configured to measure the mixing of a temperature-controlled fluid with the cerebrospinal fluid near an intended intrathecal infusion site to determine a quality of an anticipated intrathecal medicament delivery is depicted in accordance with an embodiment of the disclosure. The medical device 100 can include a catheter 102 and an optional processor 104 and memory 105, which in some embodiments can double as an infusion pump 106. In some embodiments, a distal tip 108 of the catheter 102 can be inserted within the subarachnoid space of a spine S in the body B of a patient.

[0029] With additional reference to FIG. 2, a close-up, partial perspective view of the catheter 102 is depicted in accordance with an embodiment of the disclosure. FIGS. 3A-B provide cross-sectional views of the catheter 102 in accordance with an embodiment of the disclosure. The catheter 102 can generally include a distal end 108 configured to be positioned within a flow of cerebrospinal fluid of the patient, a proximal end 110, and a body 112 defining a lumen 114 (as depicted in FIG. 3B) extending lengthwise along the catheter 102. The lumen 114 can be configured to enable a delivery of fluid from the proximal end 110 to an infusion port 116 positioned in proximity to the distal end 108, as well as a withdrawal of fluid from the infusion port 116 to the proximal end 110 of the catheter 102. In some embodiments, the catheter 102 can be a single use transcutaneous catheter. In other embodiments, the catheter 102 can be a surgically-implantable subcutaneous catheter.

[0030] With continued reference to FIG. 2, in one embodiment, the catheter 102 can further include at least one temperature sensor 118 positioned a fixed distance D.sub.1 from the infusion port 116. For example, in some embodiments, the temperature sensor 118 can be positioned between about 5 mm and about 10 mm from the infusion port 116; although other distances D.sub.1 are also contemplated. The temperature sensor 118 can be any sensor configured to detect or sense a change in the temperature of a fluid, for example, a thermocouple or thermistor; although other types of temperature sensors are also contemplated. In some embodiments, the catheter 102 can include two or more of temperature sensors 118 positioned lengthwise along the catheter 102.

[0031] In some embodiments, the temperature sensor 118 can be in electrical communication with the processor 104. For example, in one embodiment, one or more electrical conduit 120 extending lengthwise along the catheter 102 parallel to the lumen 114 can electrically couple the temperature sensor 118 to the processor 104. As depicted in FIG. 3B, in one embodiment, the body 112 of the catheter 102 can further define one or more electrical conduit lumens 122A/B through which the one or more electrical conduits 120A/B can traverse. Accordingly, in some embodiments, the catheter 102 can have a tri-lumen configuration, including the first lumen 114, through which fluid can pass, and a second and third lumen 122A/B configured to house the temperature sensor cables or wires 120A/B. In other embodiments, the temperature sensor 118 can be in wireless communication with the processor 104.

[0032] FIG. 4A depicts a catheter 102 positioned within a subarachnoid space of the patient. In particular, the catheter 102 enters the subarachnoid space at an insertion site I, and extends substantially parallel to a longitudinal axis A of the patient's spinal column S, thereby enabling delivery of a fluid 200 through an infusion port 116 of the catheter 102. FIGS. 4B and 4C depict the catheter 102 as the fluid 200 exits the infusion port 116 and flows into the subarachnoid space. Specifically, FIG. 4B depicts a theoretical dispersion of fluid 200 after approximately 7.5 seconds of initiating infusion, and FIG. 4C depicts a theoretical dispersion of fluid 200 after approximately 15 seconds of initiating infusion.

[0033] The dispersion of fluid 200 delivered by a catheter 102 into the subarachnoid space (and other areas within the human body) can be simulated using fluid dynamics modeling methods such as finite volume, finite element, or finite difference techniques for finding approximate solutions to systems involving partial equations. In the case of intrathecal delivery, the system of partial differential equations that can model conservation of mass and momentum, also known as Navier-Strokes equations, can simulate cerebrospinal fluid flow. To be more precise, the equations for laminar, oscillating flow of an incompressible fluid with properties similar to water at body temperature can be used to simulate fluid 200 delivery scenarios. Fluid 200 dispersion can further be modeled using various techniques including the Eulerian passive scaler approach or the Lagrangian particle approach.

[0034] As depicted in FIGS. 4A-C, when the fluid 200 exits the infusion port 116 and flows into the subarachnoid space, the fluid 200 begins mixing with the cerebrospinal fluid. Where the fluid 200 is expelled from the infusion port at a relatively slow rate (e.g., a flow rate of 1 mL per hour) the fluid 200 may have a tendency to stagnate in the slow-moving cerebrospinal fluid immediately surrounding the catheter. Thereafter, a natural pulsatile flow of the cerebrospinal fluid eventually causes the fluid 200 to drift away from the catheter 102 into faster moving cerebrospinal fluid. Proper mixing of the fluid 200 into the cerebral spinal fluid can take several minutes. A slow or delayed mixing of the medicament with the cerebrospinal fluid can decrease the efficacy of medicament treatments, as well as the resultant therapeutic effects.

[0035] Unfortunately, the flow rate of cerebrospinal fluid within the intrathecal space of a given patient may vary significantly based on the patient's anatomy. That is, some areas in the intrathecal space may have a high cerebrospinal fluid flow rate (with desirable medicament mixing qualities), while other areas may have a low cerebrospinal fluid flow rate (with undesirable medicament mixing qualities). As patient anatomies differ, it is further believed that areas with higher cerebral fluid flow rates may vary from patient to patient. As few options exist for determining the cerebrospinal fluid flow rate, most intrathecal catheters are positioned without knowing the flow rate of the cerebrospinal fluid at the intended infusion site. Unknowingly positioning an intrathecal catheter 102 in an area with low cerebrospinal flow may result in a less than ideal treatment outcome, and certainly results in less than optimal mixing of infusate.

[0036] Embodiments of the present disclosure enable the mixing of a temperature controlled fluid with the cerebrospinal fluid near an intended intrathecal infusion site to determine a quality of the dispersion of the medicament within the cerebrospinal fluid. For example, in one embodiment, a cold or warm bolus of fluid can be infused into the intrathecal space. The time it takes to affect a change in temperature as measured by the temperature sensor 118 can be an indication of the quality of the anticipated medicament dispersion. Given the direct link between mass transfer (which governs transports of medicament within the intrathecal space) and heat transfer (which is utilized by the temperature sensor 118 to monitor mixing of the medicament with the cerebrospinal fluid), embodiments of the present disclosure directly measure intrathecal dispersion through well understood physical principles.

[0037] For example, in one embodiment, after positioning the distal end 108 of the catheter 102 into a flow of the cerebrospinal fluid of the patient, a bolus of chilled fluid can be infused through the infusion port 116 into the flow of cerebrospinal fluid, while monitoring a temperature with the temperature sensor 118. As the chilled fluid mixes with the cerebrospinal fluid, the temperature of the cerebrospinal fluid and later mixture of the chilled fluid and cerebrospinal fluid (as measurable via the temperature sensor 118) will decrease. Accordingly, a temperature change sensed by the temperature sensor 118 is a positive indication that some mixing of the chilled fluid with the cerebrospinal fluid has taken place. Given the fixed distance D.sub.1 between the temperature sensor 118 and the infusion port 116, the time over which the temperature changes and the magnitude of the change can be considered representative of the local cerebrospinal flow rate in proximity to the infusion port 116.

[0038] Referring again to FIG. 1, in some embodiments, the processor 104 can include a display 124 configured to display the temperature sensed by the at least one temperature sensor 118. In some embodiments, the displayed temperature can be represented as a digital readout of the temperature. In other embodiments, the temperature sensed by the temperature sensor 118 can be graphically represented over a period of time during which the temperature of the cerebrospinal fluid is monitored. For example, as depicted in FIG. 5, a graphical representation of the temperature (T) sensed by the temperature sensor 118 over a dispersion time (t.sub.d) is depicted in accordance with an embodiment of the disclosure. The dispersion time t.sub.d can vary based on the anticipated mixing. For example, in one embodiment, dispersion time t.sub.d can have a predefined duration of between about 30 seconds and about 300 seconds; although other durations of time are also contemplated.

[0039] With continued reference to FIG. 5, prior to infusion of the fluid 200, the temperature (T.sub.0) sensed by the temperature sensor 118 is of a relatively constant baseline temperature representative of the unmixed cerebrospinal fluid. The infusion of temperature controlled fluid 200 can begin at an initial time (t.sub.0) and can continue for a predetermined length of time, which may but need not correspond to the dispersion time t.sub.d. The fluid 200 can be any temperature controlled fluid, for example a chilled saline solution maintained in a temperature range of between about 35 F. (2.2 C.) and about 46 F. (7.7 C.); although other types of temperature-controlled fluids and temperature ranges are also contemplated. For example, in another embodiment, the chilled fluid can be a contrast agent, thereby enabling the use of magnetic resonance imaging as an additional aid in surveying the fluid flow within the cerebrospinal fluid of the patient.

[0040] It is expected that the temperature sensed by the temperature sensor 118 will remain at the baseline temperature T.sub.0 even after infusion of the temperature controlled fluid into the cerebrospinal fluid begins and for a short period of time (t.sub.1) thereafter until enough of the fluid 200 has mixed with the surrounding cerebrospinal fluid to lower the temperature of the mixture of fluid 200 and cerebrospinal fluid. As the mixing between the fluid 200 and the cerebrospinal fluid is largely affected by a natural flow of the cerebrospinal fluid, the duration of time t.sub.1 (alternatively referred to as initial dispersion time) is indicative of the cerebrospinal fluid flow rate. Specifically, the time t.sub.1 represents the velocity of the fluid 200 as it traverses the distance D1 between the infusion port 116 and the temperature sensor 118 over the initial dispersion time t.sub.1. A relatively longer initial dispersion time t.sub.1 is indicative of a slower cerebral spinal fluid flow rate, while a relatively shorter initial dispersion time t.sub.1 is indicative of a faster cerebral spinal fluid flow rate. Naturally, a faster cerebral spinal fluid flow rate is desirable, as it promotes a more rapid dispersion of medicament within the cerebrospinal fluid.

[0041] Accordingly, at time t.sub.1 the temperature (T1) sensed by the temperature sensor 118 begins to decrease to reflect the temperature of the mixture of the fluid 200 and cerebrospinal fluid. Thereafter, the temperature sensed by the temperature sensor 118 may fluctuate based on the natural pulsatile flow of the cerebrospinal fluid until it returns to a final temperature (T2) representative of the baseline temperature of the unmixed cerebrospinal fluid. The rate (T) at which the temperature decreases and the maximum difference in temperature (T.sub.A) can also be indicative of the cerebrospinal fluid flow rate. For example, a steeper rate T at which the temperature decreases can represent a faster and more thorough mixing of the fluid 200 with the cerebrospinal fluid. Likewise, a larger temperature differential T.sub.A can represent a faster and more thorough mixing of the fluid 200 with the cerebrospinal fluid.

[0042] In some embodiments, multiple measurements along the spine S of a patient to map the intrathecal space can be made before selecting a final infusion site, thereby enabling the selection of an optimal site for medicament infusion to maximize the therapeutic effect of the treatment. With additional reference to FIGS. 6A-B, in one embodiment, the medical device or system 100 can be configured to receive sensor data from a plurality of localized sites (Sites.sub.1-5) to aid in the determination of an optimal infusion site 130. For example, as depicted in FIGS. 6A-B, in one embodiment, the processor 104 can utilize data from the plurality of localized sites (Sites.sub.1-5) to create a map of the intrathecal space to represent cerebrospinal fluid flow rates therewithin. In some embodiments, the processor 104 can interpolate points between the localized sites (Sites.sub.1-5) to create a heat map type graphical representation of the fluid flow rates within a patient's cerebrospinal fluid, thereby identifying the one or more optimal sites 130 to position an intrathecal catheter for infusion of medicament. Other types of graphical representations of the flow rates within the cerebrospinal fluid are also contemplated.

[0043] With reference to FIG. 7, in some embodiments, the catheter 102 can include at least a first temperature sensor 118A and a second temperature sensor 118B, respectively positioned fixed distances D.sub.1 and D.sub.2 on either side of the infusion port 116, thereby enabling the determination of a fluid flow direction, as well as a fluid velocity and mass flow rate. For example, as a flow of chilled fluid flows out of the infusion port 116 and begins mixing with the surrounding cerebrospinal fluid, a change in temperature of the fluid mixture can be sensed by either or both of the first temperature sensor 118A and the second temperature sensor 118B. A shorter initial dispersion time or greater maximum difference in temperature by either of the first or second temperature sensor 118A/B can be an indication of the fluid flow direction. In other embodiments, the first and second temperature sensors 118A-B can be positioned on the same side of the infusion port 116.

[0044] In one embodiment, the first temperature sensor 118A can be positioned in close proximity to the infusion port 116 to detect when the chilled fluid begins flowing out of the infusion port 116, thereby providing a precise point in time to treat as the start of the infusion, rather than relying on a calculated infusion start time.

[0045] Accordingly, the present disclosure provides a relatively inexpensive, easily manufactured catheter 102 that can be configured to directly measure cerebrospinal flow rates to achieve improved medicament dispersion and better clinical outcomes. As an aid in reducing costs, in some embodiments, the catheter 102 can be compatible with a variety of conventionally available processors 104 and infusion pumps 106. For example, in one embodiment, the processor 104 can be a relatively inexpensive digital display, such as a multi-meter configured to display the temperature sensor 118 output (e.g., a temperature, voltage, current, resistance, etc.). The infusion pump 106 can be a syringe pump, available from a variety of manufacturers.

[0046] In other embodiments, the system 100 can include a more complex processor 104 or combination processor-infusion pump 104/106 with cerebrospinal fluid flow calculation and/or cerebrospinal fluid mapping capabilities. In yet other embodiments, the system 100 can include an implantable pump having an access port through which the temperature controlled fluid 200 can be administered to check patency of the catheter and/or to periodically monitor cerebrospinal fluid flow conditions of the localized site in which the catheter 102 is positioned.

[0047] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0048] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0049] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term processor as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.