Patent Description:
<CIT> discloses pressure-sensing medical devices, systems and methods, and methods of forming medical devices.

<CIT> discloses a temperature sensing catheter.

In an aspect of the present invention, there is provided an assembly according to claim <NUM>.

Briefly summarized, embodiments of the present disclosure are directed to a catheter assembly or other elongate tubular device for use in establishing vascular or other access within the body of a patient. The catheter assembly is equipped with one or more sensors that enable monitoring of one or more physiological aspect or other parameter of the patient, and/or physical aspects of the catheter assembly itself or its operation, when the catheter assembly is disposed within the patient. Such parameters include central venous pressure, body temperature, ECG heart signals, oxygen levels, ultrasound data, glucose, etc. The catheter assembly includes the ability to wirelessly transmit or otherwise forward data relating to the detected physiological/physical aspects to another location, such as a patient electronic medical record, smartphone or other mobile device, nurse station, etc. Catheter assemblies configured to detect the frequency of catheter flushing, flushing quality, etc., are also disclosed.

In one embodiment, therefore, a catheter assembly for insertion into a body of a patient is disclosed and comprises an elongate catheter tube defining at least one lumen extending between a proximal end and a distal end, a bifurcation hub operably attached to the catheter tube, and an extension leg operably attached to the bifurcation hub, the bifurcation hub and extension leg defining at least one fluid passageway in fluid communication with the at least one lumen of the catheter tube. At least one sensor is included with the catheter assembly, the at least one sensor being configured to detect a physiological aspect of the patient and/or physical aspect of the catheter assembly. A communication module is also included and is configured to wirelessly transmit data sensed by the at least one sensor to a receipt location.

These and other features of embodiments of the present disclosure will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments of the disclosure as set forth hereinafter.

It is appreciated that these drawings depict only typical embodiments of the disclosure and are therefore not to be considered limiting of its scope. Example embodiments of the disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:.

Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present disclosure, and are neither limiting nor necessarily drawn to scale.

For clarity it is to be understood that the word "proximal" refers to a direction relatively closer to a clinician using the device to be described herein, while the word "distal" refers to a direction relatively further from the clinician. For example, the end of a catheter placed within the body of a patient is considered a distal end of the catheter, while the catheter end remaining outside the body is a proximal end of the catheter. Also, the words "including," "has," and "having," as used herein, including the claims, shall have the same meaning as the word "comprising.

Embodiments of the present disclosure are generally directed to a catheter assembly or other elongate tubular device for use in establishing vascular or other access within the body of a patient, together with associated components. Examples of such catheters include PICCs, central venous catheters, arterial catheters, Foley-type and urinary catheters, peripheral IVs, midline catheters, intermediate-dwell catheters, feeding tubes, etc..

The catheter assembly or associated component is equipped with one or more sensors that enable monitoring of one or more physiological aspect or other parameters of the patient, and/or physical aspects of the catheter assembly itself or its operation, when the catheter assembly is disposed within the patient. Such aspects include central venous pressure, body temperature, ECG heart signals, oxygen levels, ultrasound data, etc. The sensor(s) included with the catheter assembly are placed so as to enable detection of data related to these and/or other parameters. In one embodiment, the one or more sensors are disposed in or proximate to a hub of the catheter assembly, though a variety of other locations are also possible. Moreover, other components and structures associated with the catheter assembly, such as a needleless connector for instance, can include one or more sensors for monitoring physiological/physical aspects.

Further, the catheter assembly includes the ability to wirelessly transmit or otherwise forward data relating to the detected physiological aspects/physical aspect to another location, also referred to herein as a receipt location. Examples of data receipt locations include an patient electronic medical record ("EMR"), a patient monitoring apparatus, a smartphone or other mobile device, a tablet, a storage location, a computer server, a nurse station, or a variety of other destinations.

Reference is first made to <FIG>, which depicts various details of a catheter assembly ("catheter"), generally designated at <NUM>, in accordance with one embodiment. As shown, the catheter <NUM> includes an elongate catheter tube <NUM> defining one or more lumens <NUM> extending between a proximal end 12A and a distal end 12B thereof. The proximal end 12A of the catheter tube is operably connected to a bifurcation hub ("hub") <NUM>, which in turn is operably connected to one or more extension legs <NUM>. A connector <NUM>, such as a luer connector, is disposed on a proximal end of the extension leg <NUM>. The hub <NUM> includes two suture wings <NUM> that oppositely extend from the body of the hub <NUM>. Each suture wing <NUM> includes a suture hole <NUM>. Note that the hub <NUM> is also referred to herein as a "bifurcation hub" even in cases where only one fluid passageway is defined therethrough.

In accordance with one embodiment, one or more sensors, also referred to herein as a "sensor array" <NUM>, are included with the catheter <NUM> to enable the detection of date relating to one or more physiological aspects of the patient and/or physical aspects of the catheter when the catheter tube <NUM> is disposed in the vasculature (as discussed here) or other suitable internal portion of the body of the patient. In the present embodiment, multiple sensors are included with the catheter <NUM>, though the number, type, size, placement, function, and desired uses of the various sensors can vary from what is shown and described herein. Note that the sensor array <NUM> can, in one embodiment, include only one sensor. Note also that, where only one of a particular sensor is discussed below, it is appreciated that more than one of a particular type of sensor can be included, in the same or different locations within the catheter assembly.

As shown in <FIG>, a pressure sensor <NUM> is included as part of the sensor array <NUM>. In the present embodiment, the pressure sensor <NUM> includes a central venous pressure ("CVP") sensor and is disposed so as enable venous pressure of the patient to be sensed via the fluid (such as blood and/or saline) typically present within the lumen <NUM> of the catheter tube <NUM>. As shown, in the present embodiment the pressure sensor <NUM> is disposed within the hub <NUM> so as to be in operable communication with a fluid passageway <NUM> within the hub that is in turn in fluid communication with the lumen <NUM> of the single-lumen catheter tube <NUM> shown in <FIG>. Other pressure sensor locations can also employed, including within the catheter tube <NUM>, the extension leg <NUM>, etc. In one embodiment, the pressure sensor <NUM> is a medical pressure sensor NPC-<NUM> or NPC-<NUM>, manufactured by Amphenol Corporation, though other pressure sensors may also be employed. In another embodiment, the pressure sensor includes a strain-sensitive Wheatstone bridge. The sensing surface of the pressure sensor <NUM> in the present embodiment is in direct contact with fluid present in the fluid passageway of the hub <NUM>. Note that the size, shape, and other configuration of the hub <NUM> may be increased from what is shown and described herein in order to accommodate the sensor array <NUM>, in one embodiment.

An ECG sensor <NUM>, also referred to herein as an ECG electrode or electrical sensor, is also included with the catheter assembly to enable ECG signals emanating from the heart of the patient to be detected, in conjunction with an additional ECG sensor/electrode located on the patient's skin or external portion of the catheter assembly/proximate the catheter assembly, in one embodiment. As shown, in the present embodiment the ECG sensor <NUM> is also disposed within the hub <NUM> so as to be in direct contact with fluid present in the hub fluid passageway <NUM> and the lumen <NUM> of the catheter tube <NUM>. Other ECG sensor locations can also be employed, including within the catheter tube <NUM>, the extension leg <NUM>, etc. In the present embodiment, the ECG sensor <NUM> includes a conductive wire that is able to detect ECG signals of the patient heart that are present in the fluid of the hub fluid passageway <NUM> and catheter tube lumen <NUM>, though other types of ECG sensors can be employed. Further details regarding a system and method for using an ECG sensor for guiding the catheter assembly to a desired position within the body of a patient can be found in <CIT>, entitled "Apparatus and Display Methods Relating to Intravascular Placement of a Catheter".

As described, the sensor array <NUM> - including here the pressure sensor <NUM> and the ECG sensor <NUM> - is disposed within the hub <NUM>, which is sized to provide the needed volume for such sensors. Note that the size, shape, and configuration of the hub <NUM> can vary from what is shown and described in order to house the sensor(s). In other embodiments, the sensors can be located in other portions of the catheter <NUM>, including along or at either end of the catheter tube <NUM>, the extension leg(s) <NUM>, etc. Also note that a variety of sensors for detecting body measurements, physiological aspects of the patient, and/or physical aspects of the catheter can be included with the catheter assembly, some of which are discussed further below.

<FIG> further shows that the hub <NUM> (or other suitable location) includes a printed circuit board ("PCB") <NUM> that is configured to govern operation of the sensor array <NUM>, here including the pressure sensor <NUM> and the ECG sensor <NUM>. In one embodiment, the PCB <NUM> includes a microprocessor for governing sensor operation. In one embodiment, the PCB <NUM> can further include a power source for powering the sensor array <NUM>, though in other embodiments the power source can be remotely disposed from the PCB, and even the catheter <NUM>. A non-volatile memory storage location, such as flash memory for instance, can also be included on the PCB <NUM> to enable data sensed by the sensors of the sensor array <NUM> to be temporarily or permanently stored thereon. The storage location can be accessible by a user or can be transmitted to a desired location in a manner described below.

In the present embodiment, the PCB <NUM> further includes a transmission module, such as a radio for enabling the PCB to transmit sensor data wirelessly to another receipt location, such as those referred to further above. Such wireless transmission can occur via Bluetooth, Wi-Fi, radiofrequency, near-field communication ("NFC"), GPS, ANT, ZigBee, or other manner utilizing electromagnetic radiation. In another embodiment, the sensor data can be transmitted from the catheter <NUM> via a physical connection, such as via a removable physical connection, wires, etc. In another embodiment and as mentioned, sensor data, e.g., central venous pressure, ECG signals, temperature, etc., are stored in a memory location included on the PCB <NUM>, or other location on the catheter <NUM>. In yet another embodiment, the PCB <NUM> includes a clock/timer circuit.

In the present embodiment of <FIG>, the suture holes <NUM> of the suture wings <NUM> are configured to include electrical contacts to provide power to the sensors <NUM> and <NUM> of the sensor array <NUM>, as well as to the PCB <NUM>. In particular, an annular electrical contact <NUM> is included in each suture hole <NUM> of the bifurcation hub suture wings <NUM>, with the electrical contacts being operably connected to the PCB <NUM> and sensor array <NUM>. A securement device, such as the securement device <NUM> shown in <FIG>, is configured to be placed on the skin of the patient and operably connect with and secure in place the catheter <NUM> once the distal portion of the catheter has been inserted into the patient. To that end, the securement device <NUM> includes a retainer <NUM> mounted to an adhesive pad, and securement arms that are hinged so as to removably pivot atop the suture wings <NUM> of the bifurcation hub <NUM> (in a snap-fit arrangement) to secure the bifurcation hub in place.

In the present embodiment, the securement device <NUM> includes additional functionality to provide power to the sensor array <NUM> and PCB <NUM>. In detail, the securement device <NUM> includes two posts <NUM>, each of which is configured to serve as an electrical contact <NUM> and each of which is operably connected with a battery <NUM>, also included in the securement device. The posts <NUM> are configured to be received within the corresponding suture holes <NUM> of the catheter suture wings <NUM> such that electrical contact is established with the electrical contacts <NUM> of the suture holes. The battery <NUM> included on the securement device <NUM> can, in this way, provide electrical power to the sensors <NUM>, <NUM> and the PCB <NUM> of the catheter hub <NUM>. Of course, other external power sources can be employed. In one embodiment, electrical contacts between the catheter and the securement device can also be utilized to transfer sensor data therebetween. In another embodiment, the securement device can include a radio or other mode for transmitting sensor data received from the catheter. In yet another embodiment, the PCB or a sensor can be included on the securement device. It is appreciated that the size, shape, and other configuration of the securement device can vary from what is shown and described herein.

<FIG> depict details of the securement device <NUM> according to another embodiment, wherein the securement device includes a pod <NUM> that includes a PCB and a battery for use with the sensor array <NUM> included on the catheter <NUM>, for instance. This eliminates the need for the PCB and/or battery to be disposed on the catheter <NUM> itself. <FIG> show that the pod <NUM> includes the electrical contact <NUM> on an upper surface of the retainer <NUM>, where it is configured to electrically connect with a corresponding electrical contact on the hub <NUM> of the catheter <NUM>. Thus, when the hub <NUM> is removably retained by the securement arms <NUM> of the securement device <NUM>, the sensor array <NUM> is powered and governed by the battery and PCB of the pod <NUM>. In one embodiment, the pod <NUM> is configured to be removable from the securement device <NUM>, thus enabling it to be reusable with successive securement devices. This may be helpful when the catheter <NUM> and/or the securement device <NUM> are changed out. Thus, the pod <NUM> - including the PCB, battery, and/or one or more sensors, etc. - can be removed from the securement device and placed in another, thus saving resources and cost. Note also that battery and PCB can be disposed in other locations as well. These and other variations are therefore contemplated. Further details regarding a catheter securement device related to those described herein can be found in <CIT>, entitled "Universal Catheter Anchoring System".

Additionally, in one embodiment the securement device <NUM> can include an ECG sensor (e.g., an electrode) that can cooperate with the ECG sensor <NUM> of the catheter <NUM>, thus enabling dual ECG signals to be detected and used to determine proximity of the distal end 12B of the catheter tube <NUM> with respect to the heart. This configuration can also be used to determine malposition of the catheter tube distal end 12B, both during initial catheter placement and subsequently during the indwelling of the catheter within the patient. Sensor data from the pressure sensor <NUM> can also be used in connection with the ECG signals to further detect catheter tube distal end malpositions, in one embodiment.

<FIG> and <FIG> show dual and triple-lumen catheter configurations, respectively, in contrast to the single-lumen configuration of <FIG>. As with that of <FIG>, the catheters <NUM> shown in <FIG> and <FIG> each include sensor arrays <NUM> similar to that shown in <FIG>, including corresponding pressure sensors <NUM>, ECG sensors <NUM>, and PCBs <NUM>. The electrical contacts <NUM> for electrical connection with electrical contacts <NUM> of the securement device <NUM> (<FIG>) are also shown. Note that each extension leg <NUM> of the catheters <NUM> in <FIG> and <FIG> includes a corresponding one of the pressure sensors <NUM> such that pressure data may be sensed in each extension leg. In other embodiments, more or fewer sensors than what is shown here can be employed for sensing physiological aspects of the patient and/or physical aspects of the catheter assembly including, for instance, lactic acid sensors, oxygen sensors, ultrasound componentry, GPS location sensors, temperature sensors, sizing sensors to measure intraluminal diameter, fluid velocity sensors, glucose meters, oxygen sensors, lactic acid sensors, cardiac output sensors, accelerometers, blood volumetric and cardiac output sensors, etc..

<FIG> depicts the catheter <NUM> according to one embodiment, including three pressure sensors <NUM> in specified locations in the corresponding extension legs <NUM> and an ECG sensor <NUM> disposed in one extension leg, with each sensor operably connected to the PCB <NUM> disposed in the hub <NUM>. <FIG> thus demonstrates that the number, type, and placement of the sensor(s) and PCB can vary from what has already been shown and described.

<FIG> depicts details of the sensor-equipped catheter <NUM> according to one embodiment, wherein the hub <NUM> includes an ultrasound assembly <NUM> comprising upper and lower PCBs 82A and 82B configured to control ultrasound transducers 84A and 84B, respectively. The ultrasound transducers 84A and 84B can be used to ultrasonically evaluate the fluid passageway, or lumen <NUM>, of the bifurcation hub <NUM> to determine the contents of the lumen, as shown in <FIG>. For instance, <FIG> shows that when air is present in the lumen <NUM>, no ultrasound signal is present, as depicted in an ultrasound signal graph <NUM> of <FIG>. In contrast, when a fluid, such as fluid A, is present in the lumen <NUM>, the ultrasound transducers 84A and 84B return a signal of a specified voltage consistent with the composition of fluid A, as seen by the graph <NUM> of <FIG>. If a fluid B of differing composition from fluid A is present in the lumen <NUM>, the ultrasound transducer 84A and 84B return a signal of specified voltage consistent with the composition of fluid B, as seen in the graph <NUM> of <FIG>. And when both fluid and air are present in the lumen <NUM>, the graph <NUM> of <FIG> shows that a varying voltage signal is detected by the ultrasound transducers 84A and 84B. In this way, the ultrasound transducers 84A and 84B, coupled with the battery and PCB as discussed further above, can assist the user in determining the presence of particular substances in the lumen <NUM> of the hub <NUM>, or the lumens of other catheter components, depending on placement of the ultrasound transducers. In another embodiment, only a single ultrasound transducer is employed.

<FIG> depict details of the sensor-equipped catheter <NUM> according to another embodiment, wherein the hub <NUM> includes a PCB <NUM> disposed therein and operably connected to a temperature sensor <NUM>, such as a thermocouple in one embodiment, positioned so as to measure core body temperature via blood or other fluids present in the lumen <NUM> of the catheter. As <FIG> shows, the temperature sensor <NUM> can be placed in proximity to the lumen <NUM> via a skiving or cavity <NUM> longitudinally defined in the catheter tube <NUM> and/or hub <NUM>. Potting <NUM> can be used to fill the cavity <NUM> about the temperature sensor <NUM>. In one embodiment, the temperature sensor <NUM> includes a series <NUM> Model <NUM> thermistor available from Cole-Palmer Inc. , Vernon Hills, IL.

<FIG> shows that, in one embodiment, a variety of sensors can be included as part of the sensor array <NUM> within the hub <NUM> or other suitable location. As depicted in <FIG>, in one embodiment the hub <NUM> includes disposed therein the pressure sensor <NUM>, the PCB <NUM> (including a processor 36A and a wireless communication module 36B), upper and lower ultrasound transducers 84A and 84B, a temperature sensor <NUM>, and an oxygen sensor <NUM>. The various sensors are arranged as needed in proximity to the fluid passageway <NUM> of the hub <NUM> so as to sense the relevant parameters as detected in the fluid present in the fluid passageway. The particular arrangement of the sensors can vary from what is shown here.

<FIG> shows that, in one embodiment a smartphone <NUM> can be the receipt location for wirelessly receiving data from one or more of the sensors of the sensor array, as discussed in the embodiments above. Examples of wireless modes by which the data can be transmitted include Bluetooth, Wi-Fi, radiofrequency, near-field communication (NFC), ANT, ZigBee, etc. Such data transmission can be relayed through a software-based application or other intermediary device. This enables a clinician to receive mobile updates and other sensor data <NUM> from the catheter <NUM> via a display <NUM> of the smartphone <NUM> (or by other mediums including sound, vibration, etc.) in order to be able to monitor the progress or condition of the patient. Other locations for receipt of the sensor data as described above include a patient electronic medical record ("EPR"), a patient monitoring apparatus, other mobile devices including electronic tablets and laptop computers, an electronic storage location, a computer server, a nurse station, medical equipment such as a pump attached to the catheter, and a variety of other destinations. It is appreciated that devices, components, computers, etc. that are located at the receipt location can perform operations on the received data, including analysis, trending, alarm functions, etc..

<FIG> depicts the catheter <NUM> according to another embodiment, wherein the catheter is shown inserted into an arm <NUM> of the patient such that a majority portion of the catheter tube <NUM> is disposed within the vasculature of the patient. The hub <NUM>, including one or more sensors, is also shown operably connected to an auxiliary device, such as an armband <NUM>, placed around the patient arm <NUM> via a connecting wire <NUM>. The armband <NUM> is placed in proximity to the external portion of the catheter <NUM> in the present embodiment, though its location and particular shape, size, configuration, and body attachment scheme can vary in other embodiments. As shown, the armband <NUM> includes various components to work in concert with the sensor(s) of the catheter <NUM> via the connection wire <NUM>, including the PCB <NUM> and a wireless communication module <NUM> (which in other embodiments is included with the PCB). Sensor data detected by the sensor(s) of the catheter <NUM> can be forwarded from the catheter <NUM> to the components of the armband <NUM> via the connecting wire <NUM>, where the data can be processed (e.g., by the PCB <NUM>) and/or transmitted to a remote location (e.g., by the wireless communication module <NUM>). In another embodiment, the operable connection between the catheter <NUM> and the armband <NUM> is a wireless connection as well.

Placement of the PCB <NUM> and the wireless communication module <NUM> on the armband <NUM> frees up space on the catheter and may prevent the need for replacing relatively expensive components when the catheter <NUM> itself is periodically replaced with a new catheter. In such a case, the armband <NUM> can be simply connected to the new catheter, and the PCB <NUM> and wireless communication module <NUM> can begin to function with the new catheter as they did with the previous catheter. Note that various other components can also be included on the armband <NUM>, including a battery for powering the sensor(s) included on the catheter, additional sensors including an ECG sensor, etc. As mentioned, the armband <NUM> is representative of other wearable and non-wearable auxiliary devices that can be operably connected to the sensor(s) of the catheter <NUM> in order to facilitate their operation. Also note that the components included on the armband/auxiliary device can be replaceable/reusable, in one embodiment. In one embodiment, the PCB, battery, and/or wireless communication module can be included on the catheter securement device. In another embodiment, the above-described components can be included on a platform that is removably attachable to the armband. In another embodiment, the armband or similar component includes a disposable shield to isolate it from the patient and/or to provide isolation from contaminants.

Several of the above-described embodiments include the pressure sensor <NUM> that is configured to sense data relating to the central venous pressure of the patient in which the catheter <NUM> is disposed. In another embodiment, data sensed by the pressure sensor <NUM> can be further employed to detect when an occlusion, such as a fibrin sheath or thrombus, may be present in the lumen <NUM> of the catheter tube <NUM>. <FIG> shows a pressure graph <NUM> including a pressure curve <NUM> that depicts the level of pressure over time in the catheter tube lumen <NUM> as sensed by the pressure sensor <NUM>, such as in the pressure sensor configuration of <FIG>, for instance, during a flushing procedure wherein fluid is flushed through the catheter <NUM> by a user using a syringe connected to the luer connector <NUM> in order to maintain patency of the catheter tube lumen <NUM>. As shown, the pressure curve <NUM> includes various pressure peaks <NUM> that are caused by the user pulsing the syringe with moments of additional pressure. This is performed so as to clear any minor obstructions that may have formed within the catheter tube lumen <NUM> or in other areas of the catheter fluid path. When an occlusion is present at the distal end 12B of the catheter tube and/or within the lumen <NUM> (see occlusion <NUM> in <FIG> for example), the pressure curve <NUM> will be elevated (i.e., shifted vertically upward along the pressure y-axis) or widened (i.e., lengthened along the time x-axis).

In more detail, hydraulic resistance R of a fluid is generally related to the fluid flow rate Q and infusion pressure P by the relationship: <MAT> which yields: <MAT>
where V is a known volume of fluid to be infused into the catheter <NUM>, t1 is the time at the beginning of a fluid infusion process, t2 is the time at the end of the fluid infusion process (referring to <FIG>), noting that P indicates the instantaneous pressure during each moment of the fluid infusion procedure. Comparing the resistance R of the fluid infusion through the catheter tube <NUM> for a certain period of time (using the above equations) and comparing it with the resistance R<NUM> at a previous time, such as when the catheter <NUM> was first inserted into the patient and was considered un-occluded, or patent, can yield the percentage of possible occlusion in the catheter tube according to: <MAT>.

Detection of an elevated pressure within the catheter fluid path by the pressure sensor <NUM>, such as via the above-described calculations, can alert the user to a possible occlusion such that corrective measures can be taken. Further, data storage in a memory location located on the catheter <NUM> with the PCB <NUM> or remotely located in a patient electronic medical record (or other remote storage location) can be employed to measure the catheter flushing pressure over time so as to detect pressure changes over time. This data comparison over time can be performed for any one of the sensors located on the catheter <NUM>, as may be appreciated. Of course, the data sensed by the sensors and stored in a memory location can be used for a variety of other uses as well, including historical trends, etc..

<FIG> depicts various details of a pressure-sensing syringe <NUM> according to one embodiment, including a housing <NUM> that defines a cavity <NUM> with a distal end fluid outlet <NUM>. A plunger <NUM> is disposed within the cavity <NUM> and is attached to a spring <NUM>, initially disposed in a compressed state and releasable by a release button <NUM> disposed on a proximal end of the syringe <NUM>. A known quantity of <NUM>% normal saline <NUM> or other suitable liquid is disposed in the cavity distal to the plunger <NUM> such that the saline exits the fluid outlet <NUM> when the spring <NUM> is actuated by the release button <NUM>. The saline <NUM> ejected by the syringe <NUM> is injected into the extension leg <NUM> - then through the hub <NUM> and lumen <NUM> of the catheter tube - when the syringe is operably attached to the corresponding luer connector <NUM>.

A pressure sensor <NUM> is included at the fluid outlet <NUM> to measure the pressure of the known quantity of saline <NUM> as it exits the fluid outlet <NUM> and enters the catheter <NUM> to which the syringe <NUM> is connected. A processor unit <NUM> and a display/control unit <NUM> are included to measure and calculate (such as via the equations described further above) the pressure present as the saline <NUM> is ejected by the plunger <NUM> through the fluid outlet. Further calculations can be performed by the processor unit <NUM> to determine the hydraulic resistance of the injection, thus yielding the amount of occlusion present in the fluid path of the catheter <NUM>, using the known volume of injected saline <NUM>, the injection pressure as measured by the pressure sensor <NUM>, and the amount of time needed for injection of all the saline to occur. In one embodiment, the user can input the size of the catheter tube lumen <NUM> and the length thereof via the display/control unit <NUM>.

The results describing the amount of any occlusion present in the catheter fluid path (such as in % of fluid path occluded, for instance) can be depicted on the display/control unit <NUM> or wirelessly transmitted to a receipt location via a wireless communication module included with the processor unit <NUM>, for instance. Corrective measured can then be taken by the user, if needed.

Note that historical pressure/occlusion data can be stored by a memory location of the processor unit <NUM>, for instance, for call-up and depiction by the display/control unit <NUM>, in one embodiment. In one embodiment, the plunger <NUM> of the syringe <NUM> is manually depressible by the user, thus obviating the need for the spring <NUM>, or can be a pressurized gas source to push the plunger, etc. The location of the pressure sensor <NUM> can also vary from what is shown and described herein.

Note that, in another embodiment, the pressure sensor <NUM> can be used to determine when the catheter tub <NUM> has been malpositioned within the vasculature by sensing pressure differences between expected values for a proper placement and actual sensed values as detected by the pressure sensor. When this situation occurs, proper steps to correct the malposition can be taken. In another embodiment, the pressure sensor <NUM> and the electrical (ECG) sensor <NUM> can work in concert to detect catheter malposition based on venous pressure readings and ECG signal analysis.

<FIG> depicts various details of the catheter <NUM> that includes the ability to detect occlusions, such as a partial occlusion <NUM> shown at the distal end 12B of the catheter tube <NUM>, according to one embodiment. As shown, the catheter <NUM> includes a pressure detection module <NUM> operably attached to the luer connector <NUM> of the catheter <NUM>. A syringe <NUM> is attached to a proximal end of the pressure detection module <NUM> so as to provide an injection of saline or other suitable fluid through a flow lumen <NUM> of the pressure detection module <NUM> and into the extension leg <NUM> to flow through the catheter <NUM>.

As shown, the pressure detection module <NUM> includes a pressure indicator <NUM> in fluid communication with the flow lumen <NUM>. The pressure indicator <NUM> is configured to extend an indicator piece outward when a predetermined pressure is encountered in the flow lumen <NUM> of the pressure detection module. As such, when a fluid pressure in excess of the predetermined pressure is encountered in the catheter lumen <NUM> during fluid injection into the system by the syringe <NUM> (or other suitable fluid injection device), the pressure buildup extends proximally through the hub <NUM>, extension leg <NUM>, and flow lumen <NUM>, causing the indicator piece of the pressure indicator to extend outward, thus indicating to the user that an occlusion may be present. It is appreciated that indicator pieces of differing configurations can be employed. In the present embodiment, the pressure detection module <NUM> is a separate component attachable to the catheter <NUM>; in other embodiments the pressure detection module is integrally formed with the catheter.

<FIG> depicts possible locations for sensors of the sensor array <NUM> in the catheter tube <NUM>. As shown, various sensors <NUM> of the sensor array <NUM> are disposed proximate the distal end 12B of the catheter tube <NUM>, together with the pressure sensor <NUM> disposed proximally to the other sensors. <FIG> further shows that a connection wire <NUM> extends along a central portion of the catheter tube, e.g., within a septum separating the lumens <NUM> from one another, to power the sensors <NUM> of the sensor array <NUM>. In another embodiment, the connection wire <NUM> can be disposed in a dedicated lumen extending the length of the catheter tube. Note that placement of the sensor(s) a distance proximal to the catheter tube distal end 12B, such as the pressure sensor <NUM> here, enables the catheter tube <NUM> to be distally trimmable.

<FIG> depicts another configuration for including a sensor <NUM> in the catheter tube <NUM>, wherein the sensor <NUM> is disposed in the wall of the catheter tube <NUM> within a skive cut <NUM> longitudinally defined in the wall. Potting <NUM>, such as a thermally conductive epoxy, polyurethane, or RTV potting, is included to cover the sensor <NUM>. In one embodiment, the sensor <NUM> includes a glucose sensor for sensing blood glucose levels and is not potted such that the glucose sensor has direct contact with the blood. These and other possible sensor locations are therefore contemplated.

<FIG> depicts another configuration for including a sensor in the catheter tube <NUM>, wherein the sensor <NUM> is disposed on an inner surface of one of the lumens <NUM> of the catheter tube <NUM> proximate the distal end 12B thereof. Potting <NUM> can be included to insulate and cover the sensor <NUM> as needed. In one embodiment, the potting <NUM> protects the sensor <NUM> from exposure to liquids while enabling heat to be transmitted therethrough. <FIG> further shows that wire-based electrodes <NUM> can be disposed in the wall of the catheter tube <NUM> proximate the distal end 12B of the catheter tube <NUM> so as to be exposed on an outer surface thereof. The sensors <NUM> can be formed as concentrically disposed sensors that can be employed to make volumetric measurements to determine the size of the vessel in which the catheter tube is disposed, thus assisting the user in determining a possible malposition of the catheter tube in an undesired vessel. These and other possible sensor configurations are therefore contemplated.

<FIG> depicts various details of a flush sensor <NUM> for detecting when the desired periodic flushing of the catheter <NUM> with a fluid has occurred, also referred to herein as a flush state of the catheter tube <NUM>. As shown, the flush sensor <NUM> is disposed within a cavity <NUM> of the luer connector of the catheter extension leg <NUM>, though other locations can be employed for the sensor. The flush sensor <NUM>, also referred to herein as a detection module, includes a lever <NUM> biased to an extended position by a spring <NUM>, as shown. The flush sensor <NUM> is operably connected to a processor of a PCB (such as the PCB <NUM> shown in <FIG>) or other suitable component (disposed within the luer connector <NUM>, for instance) to govern its operation and process its sensed data.

In operation, when a syringe or other component is inserted into the cavity <NUM> of the luer connector <NUM> to flush the catheter <NUM> with saline or other suitable fluid, the lever <NUM> of the flush sensor <NUM> is depressed, which causes a signal to be sent to the processor indicating that a flushing procedure is occurring. The time of flushing or other data relating to the flushing procedure can be noted, stored or used by the processor, or wirelessly transmitted to a receipt location in a manner similar to that discussed further above. In one embodiment, the flush sensor <NUM> and the processor of the PCB <NUM> are referred to as a flush sensor assembly, though it is appreciated that the assembly can include additional components. In another embodiment, an electrical sensor can be employed as the flush sensor, wherein the electrical sensor includes a circuit that is broken each time a component is inserted into the connector <NUM>. Breaking of the circuit can reset a timer circuit to measure the next period until the flush sensor is again activated.

In one embodiment, for instance, it is desired that the catheter <NUM> be flushed at least once every <NUM> hours. When the flush sensor <NUM> detects a flushing procedure as described above, a timer circuit in the processor is re-set to begin counting time to measure the next time period until the flush sensor <NUM> is again depressed to indicate a new flushing procedure.

<FIG> shows that a light array <NUM>, such as a collection of a red LED light, yellow LED light, and green LED light, can be included on a surface of the luer connector <NUM> to visually indicate the flushing status of the catheter <NUM>, in one embodiment: a green light indicates less than <NUM> hours have elapsed since the last flushing procedure was detected; a yellow light indicates more than <NUM> hours but less than <NUM> hours have elapsed since the last flushing procedure; a red light indicates that more than <NUM> hours have elapsed since the last flushing procedure. The processor governs the operation of the light array and it is understood that the lights can vary in number size, location, purpose, indicated elapsed time, etc. Further, it is appreciated that other types of sensors, including sensors that detect the presence of liquid within the luer connector cavity <NUM>, can also be employed to detect flushing procedures.

In another embodiment, the light array <NUM> can be used as follows: the green light flashes after an acceptable flushing procedure has been performed; the red light blinks after a non-acceptable or incomplete flushing procedure has occurred; the yellow light blinks or is turned on to indicate a possible occlusion present in the catheter tube <NUM>. In yet another embodiment, the yellow light (or other light) can be lit to serve as a reminder to flush the catheter10.

It is appreciated that in another embodiment the luer connector <NUM> or other portion of the catheter <NUM> can include a push button (or other user-activated component) that can be depressed at the time of catheter flushing, thus re-setting the timer circuit. In this case, a counting circuit can also be included to count the number of times the connector <NUM> or other component is accessed.

<FIG> shows that the light array <NUM> can be disposed in other locations on the catheter <NUM>, including in this embodiment disposal on the hub <NUM>. These and other possible locations, such as the catheter tube or extension legs, or the armband <NUM> of <FIG> for example, are therefore contemplated. In other embodiments, the light array can be employed to alert the user to other sensed conditions, including elevated body temperature/fever, onset of sepsis (see further below), catheter occlusion, low blood oxygen levels, etc. Further, other indicia can be employed, in addition to lights, to alert the user with respect to the sensor data, including sound, vibration, etc. either on the catheter itself or at the remote receipt location to where the data is wirelessly transmitted.

Note that the flush sensor <NUM> can be included in other areas as well, including a needleless connector that is configured to operably attach to the luer connector, for instance.

In one embodiment, the pressure sensor <NUM> can be used - alone or in concert with the flush sensor <NUM> described above - to detect and/or characterize flushing procedures. For instance, in one embodiment the flush sensor <NUM> can be used to detect a flushing procedure, while the pressure sensor <NUM> can sense the amount of pressure present during the flushing procedure, thus detecting possible occlusions. Indeed, in one embodiment, the pressure sensor <NUM> can be used to determine flushing frequency of the catheter <NUM>, flushing technique, flushing time, number of times of catheter access, time expired since last catheter access, etc., by measuring pressure within the lumen <NUM> of the catheter as a function of time, using timer circuitry included on the PCB <NUM>, for instance. Such sensor data can be stored by a memory location located on the PCB <NUM>, for instance, or transmitted to another local or remote receipt location, as has been described. Processing to determine such monitoring can be performed by a processor included on the PCB <NUM> or remotely.

In one embodiment, sensor data from catheter sensors, such as the pressure sensor <NUM> and a core body temperature sensor, can be employed to detect patient conditions, such as sepsis. In particular, respiratory rate, heart rate, and body temperature can be sensed via the pressure sensor <NUM> and the core body temperature sensor <NUM> included with the catheter <NUM>, such as in the configuration shown in <FIG>. These three parameters comprise three of four parameters that are typically employed to determine the onset of sepsis. As such, monitoring of these parameters via the catheter <NUM> as described herein can be used to prevent detect and ameliorate complications from sepsis, in one embodiment.

<FIG> depicts a sensor-based catheter assembly according to another embodiment. In detail, the catheter <NUM> is shown with its catheter tube <NUM> disposed within the vasculature of the patient and the two luer connectors <NUM> operably connected to supply lines <NUM> configured to both provide fluid to and remove fluid from the lumens of the catheter. A pump unit <NUM> is included to enable fluid movement through the supply lines <NUM>. A saline fluid drip assembly <NUM> is also included to provide fluid to the pump unit for movement through the supply lines, if needed or desired. A syringe, such as the syringe <NUM>, is included to provide an additional fluid inlet in a corresponding one of the supply lines <NUM>.

<FIG> depicts further details of the pump unit <NUM> of <FIG>, including a fluid inlet 256A and a fluid outlet 256B that are configured to operably connect with the corresponding supply lines <NUM> (<FIG>) to bring blood or other fluid from within the patient vasculature via the catheter <NUM> (through the fluid inlet 256A) to the pump unit <NUM> and to return the fluid to the patient vasculature (through the fluid outlet 256B) via the catheter. A pump <NUM> is included in the pump unit <NUM> to cause the movement of the fluid. Additionally, various input ports <NUM> are included on the pump unit <NUM> in fluid communication with the fluid inlet 256A to enable additional fluids to be input, including heparin, saline, arterial input, etc..

Claim 1:
An assembly comprising a catheter assembly (<NUM>) for insertion into a body of a patient, the catheter assembly comprising:
an elongate catheter tube (<NUM>) defining at least one lumen (<NUM>) extending between a proximal end and a distal end;
a bifurcation hub (<NUM>) operably attached to the catheter tube; and
an extension leg (<NUM>) operably attached to the bifurcation hub, the bifurcation hub and extension leg defining at least one fluid passageway in fluid communication with the at least one lumen of the catheter tube; at least one sensor included with at least one of the bifurcation hub, the extension leg, and a proximal end of the catheter tube, the at least one sensor configured to detect at least one of a physiological aspect of the patient and a physical aspect of the catheter assembly;
the assembly further comprising:
a securement device configured to be placed on the skin of the patient and operably connect with and secure in place the catheter assembly, the securement device comprising a communication module (<NUM>) configured to wirelessly transmit data sensed by the at least one sensor to a receipt location.