Patent Description:
Accordingly, there is a need in the art for devices, systems, and methods that provide an early indication of catheter occlusion and allow a clinician to establish a new intravenous line before an old intravenous line is ineffective or dangerous to a patient. Such devices, systems, and methods are disclosed in the present disclosure. <CIT> discloses an aspiration monitoring system. <NPL> discloses a detection of peripherally inserted central catheter occlusion by in-line pressure monitoring. <CIT> discloses a catheter system with integral sensing and clearing of occlusions. <NPL> discloses monitoring central venous catheter resistance to predict imminent occlusion. <CIT> discloses an acoustic excess disconnection system for detecting needle or catheter dislodgement during dialysis therapy.

The present disclosure relates generally to detection of IV catheter occlusion. In particular, the present disclosure relates to devices, systems, and associated methods to detect IV catheter occlusion. In some embodiments, a system to detect occlusion of an intravenous catheter may include a housing, which may include a distal end, a proximal end, and an inner lumen forming a fluid pathway. In some embodiments, the inner lumen may extend between the distal end and the proximal end of the housing.

In some embodiments, the system may include a catheter adapter. In some embodiments, the catheter may extend distally from a distal end of the catheter adapter. In some embodiments, the fluid pathway may extend through an inner lumen of the catheter and the catheter adapter. In some embodiments, the distal end of the housing may be configured to couple to a proximal end of the catheter adapter. In some embodiments, the housing may be integrally formed with the catheter adapter and/or may include or correspond to a portion of the catheter adapter.

In some embodiments, the housing may include one or more wave transmitters, which may transmit electromagnetic or energy waves along a length of the catheter of the catheter adapter. In some embodiments, the housing may include one or more transducers, which may detect a portion of the energy waves that are reflected back from the catheter. In some embodiments, the one or more transducers may be disposed in any location within the housing that allows the one or more transducers to detect the portion of the energy waves that are reflected back from the catheter. In some embodiments, one or more transmitters may be disposed in any location within the housing that allows them to transmit the energy waves along the length of the catheter. In some embodiments, the one or more transducers may be embedded or encapsulated in a wall of the inner lumen of the housing. In some embodiments, the one or more transducers may be disposed in the fluid pathway, disposed partially within the fluid pathway, or separated from the fluid pathway by a buffer element, such as, for example, a membrane, coating, adhesive, or another suitable element.

In some embodiments, the system may include a processor, which may be coupled to the one or more transducers. In some embodiments, the processor may receive an electrical signal corresponding to the portion of the energy waves that are reflected back from the catheter. In some embodiments, the processor may compare the electrical signal to a baseline electrical signal to determine a difference between the electrical signal and the baseline electrical signal.

In some embodiments, the system may include an indicator unit, which may be coupled to the processor. In some embodiments, in response to the difference between the electrical signal and the baseline electrical signal meeting a threshold value, the indicator unit may alert a user. For example, the indicator unit may sound an alarm and/or generate a warning message, which may be displayed and/or audibly conveyed to the user.

In some embodiments, the one or more wave transmitters may include an ultrasound wave transmitter that transmits ultrasonic waves. In some embodiments, the one or more wave transmitters may include an sonic wave transmitter that transmits sonic waves. In some embodiments, the one or more wave transmitters may include an electromagnetic wave transmitter that transmits electromagnetic waves, including, radio waves, microwaves, infrared, visible light, ultraviolet, X-rays, or gamma rays. In some embodiments, the electromagnetic wave transmitter may include an invisible light source, such as, for example, an infrared or ultraviolet laser, emitting an invisible light beam. In some embodiments, the electromagnetic wave transmitter may include a visible light source, such as, for example, a He-Ne laser, emitting a visible light beam.

In some embodiments, the one or more transducers may each include an ultrasound transducer that may detect ultrasound waves reflected from the catheter. In some embodiments, the one or more transducers may each include a sonic transducer that may detect sonic waves reflected from the catheter. In some embodiments, the one or more transducers may include an electromagnetic wave transducer. For example, the one or more transducers may each include a light transducer, such as, for example, a photodiode, that may detect light waves reflected from the catheter. In some embodiments, the one or more transducers may convert the portion of the energy waves that are reflected back from the catheter to the electrical signal.

In some embodiments, the one or more transducers may each include a piezoelectric element, such as, for example, a piezoelectric crystal. In some embodiments, a particular piezoelectric element may transmit ultrasonic waves along the length of the catheter. In some embodiments, a same or different piezoelectric element may receive the portion of the ultrasonic waves that are reflected back from the catheter and convert the portion to a corresponding electrical signal.

In some embodiments, the baseline electrical signal may be determined by transmitting, via the wave transmitter, which may include the one or more ultrasonic transducers, other ultrasonic waves along the length of the catheter when the catheter is open or unoccluded and converting a portion of the other ultrasonic waves that are reflected back from the catheter to the baseline electrical signal. In some embodiments, the baseline electrical signal may be determined prior to transmitting the energy waves along the length of the intravenous catheter and/or converting the portion of the energy waves that are reflected back from the intravenous catheter to the corresponding electrical signal. For example, the baseline electrical signal may be determined immediately after or shortly after insertion of the catheter into a vein of the patient.

In some embodiments, an outer surface of a distal tip of the intravenous catheter may be facetted, including one or more facets, which may improve reflection of the energy waves. In some embodiments, a wall forming the inner lumen of the catheter may be facetted, including one or more facets, which may improve reflection of the energy waves.

In order that the manner in which the above-recited and other features and advantages of the invention will be readily understood, a more particular description of the systems and methods to detect catheter occlusion briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the appended Figures. Understanding that these Figures depict only typical embodiments and are not, therefore, to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying Figures in which:.

The presently preferred embodiments of the described invention will be best understood by reference to the Figures, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present invention, as generally described and illustrated in the Figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments, represented in <FIG>, is not intended to limit the scope of the invention, as claimed, but is merely representative of some embodiments of the invention.

Generally, the present disclosure relates generally to detection of IV catheter occlusion or conditions within an IV catheter that may lead to occlusion. In particular, the present disclosure relates to devices, systems, and associated methods to detect IV catheter occlusion or conditions within the IV catheter that may lead to occlusion. Referring now to <FIG>, in some embodiments, a self-diagnosing catheter assembly or system <NUM> may include a wave transmitter <NUM>, which may transmit electromagnetic or energy waves along a length of an intravenous catheter of a catheter adapter. In some embodiments, the wave transmitter <NUM> may generate and/or transmit the energy waves along the length of the catheter when the catheter is tested for occlusion. In some embodiments, the catheter may be tested for occlusion after the catheter has been inserted into a vein of a patient for any period of time.

In some embodiments, the system <NUM> may include one or more transducers <NUM>. In some embodiments, the wave transmitter <NUM> and/or the transducers <NUM> may be in a fluid pathway of a housing, partially within the fluid pathway, or separated from the fluid pathway by a buffer element, such as, for example, a membrane, coating, adhesive, or another suitable element. In some embodiments, the housing may be coupled with the catheter adapter. In some embodiments, the housing may be integrally formed with the catheter adapter and/or may include or correspond to a portion of the catheter adapter. In some embodiments, the one or more transducers <NUM> may detect a portion of the energy waves that are reflected back from the catheter. In some embodiments, the wave transmitter <NUM> and/or the one or more transducers <NUM> may be coupled with a power supply <NUM>. In some embodiments, the system <NUM> may not include the housing. In these and other embodiments, the one or more transducers <NUM> and/or the wave transmitter <NUM> may be disposed within the catheter adapter <NUM>.

In some embodiments, the system <NUM> may include a processor <NUM>, which may be coupled to the one or more transducers <NUM>. In some embodiments, the processor <NUM> may receive an electrical signal corresponding to the portion of the energy waves that are reflected back from the catheter. In some embodiments, the processor <NUM> may compare the electrical signal to a baseline electrical signal to determine a difference between the electrical signal and the baseline electrical signal.

In some embodiments, the baseline electrical signal may be determined by transmitting, via the wave transmitter <NUM>, which may include the ultrasonic transducer, other ultrasonic waves along the length of the catheter when the catheter is unoccluded and converting a portion of the other ultrasonic waves that are reflected back from the catheter to the baseline electrical signal. In some embodiments, the baseline electrical signal may be determined prior to transmitting the energy waves along the length of the catheter and/or converting the portion of the energy waves that are reflected back from the catheter to the corresponding electrical signal. For example, the baseline electrical signal may be determined immediately after or shortly after insertion of the catheter into the vein of the patient. In some embodiments, the baseline electrical signal may be determined using another catheter similar or identical to the catheter. In some embodiments, the other ultrasonic waves may be equivalent to the ultrasonic waves. For example, the other ultrasonic waves and the ultrasonic waves may have the same frequency, amplitude, etc..

In some embodiments, the difference between the electrical signal and the baseline electrical signal may correspond to a difference in amplitude and/or frequency between the portion of the ultrasonic waves that are reflected back from the catheter when the catheter is tested for occlusion and the portion of the other ultrasonic waves that are reflected back from the intravenous catheter when the catheter is unoccluded. In some embodiments, the difference between the electrical signal and the baseline electrical signal may be due to a state change within the catheter. For example, a larger difference between the electrical signal and the baseline signal may occur in response to presence of one or more blood clots within the catheter. In some embodiments, the larger the difference, the more likely the catheter is occluded or likely to become occluded.

In some embodiments, the system <NUM> may include an indicator unit <NUM>, which may be coupled to the processor <NUM>. In some embodiments, in response to the difference between the electrical signal and the baseline electrical signal meeting a threshold value, the indicator unit <NUM> may alert a user. For example, the indicator unit <NUM> may sound an alarm and/or generate a warning message, which may be displayed and/or audibly conveyed to the user. In some embodiments, the alarm and/or the message may indicate to the user that the catheter should be changed to a new catheter. In some embodiments, the indicator unit <NUM> may include a display, which may be disposed on the housing or another element of the system, and which may be configured to present the warning message to the user. In some embodiments, the threshold value may indicate a likelihood of occlusion of the catheter or a state of the blood within the catheter that is likely to lead to occlusion.

In some embodiments, the wave transmitter <NUM> may include an ultrasound wave transmitter that transmits ultrasonic waves. In some embodiments, the wave transmitter <NUM> may include a sonic wave transmitter that transmits sonic waves. In some embodiments, the wave transmitter <NUM> may include an electromagnetic wave transmitter that transmits electromagnetic waves including, radio waves, microwaves, infrared, visible light, ultraviolet, X-rays, or gamma rays. In some embodiments, the electromagnetic wave transmitter may include an invisible light source, such as, for example, an infrared or ultraviolet laser, emitting an invisible light beam. In some embodiments, the electromagnetic wave transmitter may include a visible light source, such as, for example, a He-Ne laser or another type of laser, emitting a visible light beam.

In some embodiments, the one or more transducers <NUM> may each include an ultrasound transducer that may detect ultrasound waves reflected from the catheter. In some embodiments, the one or more transducers may include an electromagnetic wave transducer. For example, the one or more transducers <NUM> may each include a light transducer, such as, for example, a photodiode, that may detect light waves reflected from the catheter. In some embodiments, the one or more transducers <NUM> may convert the portion of the energy waves that are reflected back from the catheter to the electrical signal.

Referring now to <FIG>, in some embodiments, the one or more transducers <NUM> of <FIG> may each include a piezoelectric element <NUM>, such as, for example, a piezoelectric crystal. In some embodiments, one or more piezoelectric elements <NUM> may act as the wave transmitter <NUM>. In some embodiments, a particular piezoelectric element <NUM> may transmit ultrasonic waves along the length of the catheter. In some embodiments, a same or different piezoelectric element <NUM> may receive the portion of the ultrasonic waves that are reflected back from the catheter and convert the portion to a corresponding electrical signal.

In some embodiments, the system <NUM> may include a signal generator <NUM>, which may be coupled to the power supply <NUM> and the one or more piezoelectric elements. In some embodiments, the signal generator <NUM> may excite the one or more piezoelectric elements, which may result in propagation of the ultrasonic waves throughout the inner lumen of the catheter and/or one or more other portions of the fluid pathway. The propagation of the ultrasonic waves may provide vibration of fluid within the fluid pathway, which may be easily altered by presence of one or more clots within the catheter.

Referring now to <FIG>, in some embodiments, the system <NUM> to detect occlusion of the catheter <NUM> may include a housing <NUM>, which may include a distal end <NUM>, a proximal end <NUM>, and an inner lumen <NUM> forming a fluid pathway. In some embodiments, the inner lumen <NUM> may extend between the distal end <NUM> and the proximal end <NUM> of the housing <NUM>.

In some embodiments, the system <NUM> may include a catheter adapter <NUM>. In some embodiments, the catheter <NUM> may extend distally from a distal end <NUM> of the catheter adapter <NUM>. In some embodiments, the fluid pathway may extend through an inner lumen <NUM> of the catheter <NUM> and an inner lumen <NUM> of the catheter adapter <NUM>, which may be continuous. In some embodiments, the distal end <NUM> of the housing <NUM> may be configured to couple to a proximal end <NUM> of the catheter adapter <NUM>. In some embodiments, the proximal end <NUM> of the catheter adapter <NUM> and the distal end <NUM> of the housing <NUM> may be threadedly coupled together. In some embodiments, the proximal end <NUM> of the housing <NUM> may be configured to receive an IV line via a Luer device <NUM>, which may be threadedly coupled to the proximal end <NUM>.

In some embodiments, the system <NUM> may include one or more piezoelectric elements <NUM> or one or more other transducers, which may be disposed in the fluid pathway of the housing <NUM> or capable of sensing energy waves in the fluid pathway. In some embodiments, the one or more piezoelectric elements <NUM> may include piezoelectric crystals. In some embodiments, the one or more piezoelectric elements <NUM> or the one or more other transducers may detect a portion of the energy waves that are reflected back from the catheter <NUM>. In some embodiments, the one or more piezoelectric elements <NUM> or the one or more other transducers may be embedded or encapsulated in a wall of the inner lumen <NUM> of the housing <NUM>. In some embodiments, the piezoelectric elements <NUM> may be separated from the fluid pathway by a barrier or buffer element <NUM>, such as, for example, a membrane, coating, adhesive, or other suitable element, as illustrated in <FIG>.

In some embodiments, the one or more piezoelectric elements <NUM> may transmit energy waves along an entire length of the catheter <NUM> of the catheter adapter <NUM> and/or throughout an entire lumen <NUM> of the catheter <NUM>. Thus, in some embodiments, the one or more piezoelectric elements <NUM> may act as the wave transmitter <NUM> of <FIG> and/or the one or more transducers <NUM> of <FIG>. In some embodiments, the signal generator <NUM> may be electrically coupled to the one or more piezoelectric elements <NUM> via one or more connectors or cables <NUM>, which may extend through an opening in the housing <NUM>.

Referring now to <FIG>, in some embodiments, the wave transmitter <NUM> may be disposed in the wall of the housing <NUM>, and the energy waves may be transmitted from the wave transmitter <NUM> along the length of one or more of the following via one or more wave guides <NUM>: the housing <NUM>, the catheter adapter <NUM>, and the catheter <NUM>. In these and other embodiments, the energy waves may include infrared, visible light, ultraviolet light, or other electromagnetic waves. As illustrated in <FIG>, in some embodiments, the wave guides <NUM> may extend from the wave transmitter <NUM> through the wall of the housing <NUM> to a distal end of the housing <NUM>. In some embodiments, the energy waves travelling along the wave guides <NUM> may emerge at the distal end of the housing and continue through the catheter adapter <NUM> and/or the catheter <NUM>. In some embodiments, the wave guides <NUM> may include light guides or optical fibers.

Referring now to <FIG>, in some embodiments, the wave transmitter <NUM> may be external to the housing <NUM> and/or the catheter adapter <NUM>. In some embodiments, the energy waves may be transmitted from the external wave transmitter <NUM> through the wall of the housing <NUM> via the one or more wave guides <NUM>. In some embodiments, the wave guides <NUM> may extend through the wall of the housing <NUM> to the distal end of the housing. In some embodiments, the energy waves travelling along the wave guides <NUM> may emerge at the distal end of the housing and continue through the catheter adapter <NUM> and/or the catheter <NUM>. Referring to both <FIG>, in some embodiments, the one or more transducers <NUM> may be disposed as illustrated in <FIG> or in any location within the housing <NUM> that allows the one or more transducers <NUM> to detect the portion of the energy waves that are reflected back from the catheter <NUM>.

Referring now to <FIG>, in some embodiments, an outer surface of a distal tip <NUM> of the catheter <NUM> may include one or more outer facets <NUM> or flat surfaces, which may be angled with respect to a longitudinal axis <NUM> of the catheter <NUM>. In some embodiments, the facets <NUM> may improve reflection of the energy waves. Additionally or alternatively, in some embodiments, a wall forming the inner lumen <NUM> of the catheter <NUM> may include one or more inner facets <NUM>, which may improve the reflection of the energy waves. In some embodiments, the inner facets <NUM> may be proximal to and proximate a portion of the tip <NUM> configured to contact an introducer needle <NUM> when the introducer needle <NUM> is inserted into a vein of the patient and prior to withdrawal of the introducer needle. In some embodiments, the outer surface and/or the inner surface of the distal tip <NUM> may be symmetric about the longitudinal axis <NUM>.

Referring now to <FIG>, in some embodiments, an outer surface of the distal tip <NUM> of the catheter <NUM> may include one or more outer curved portions <NUM>, which may improve reflection of the energy waves. Additionally or alternatively, in some embodiments, the wall forming the inner lumen <NUM> of the catheter <NUM> may include one or more inner curved portions <NUM>, which may improve the reflection of the energy waves. In some embodiments, the inner curved portions <NUM> may extend from a portion of the tip <NUM> configured to contact an introducer needle <NUM> proximally to a proximal end of the catheter <NUM>. The contact between the portion of the tip <NUM> and the introducer needle <NUM> may occur when the introducer needle <NUM> is inserted into a vein of the patient and prior to withdrawal of the introducer needle.

Referring now to <FIG>, in some embodiments, the distal tip <NUM> may include the outer curved portions <NUM> and the inner facets <NUM>, which may improve the reflection of the energy waves. Referring now to <FIG>, in some embodiments, the distal tip <NUM> may include the outer facets <NUM> and the inner curves <NUM>, which may improve the reflection of the energy waves.

Referring now to <FIG>, an example method <NUM> of detecting IV catheter occlusion or conditions within an IV catheter that may lead to occlusion may begin at block <NUM> in which energy waves may be transmitted along a length of an IV catheter coupled with a catheter adapter. In some embodiments, the catheter and catheter adapter may include or correspond to the catheter <NUM> and the catheter adapter <NUM> of <FIG>. Block <NUM> may be followed by block <NUM>.

At block <NUM>, a portion of the energy waves that are reflected back from the catheter may be converted to a corresponding electrical signal. Block <NUM> may be followed by block <NUM>.

At block <NUM>, the electrical signal may be received at a processor. Block <NUM> may be followed by block <NUM>. The processor may include or correspond to the processor <NUM> of <FIG>. At block <NUM>, the electrical signal may be compared to a baseline electrical signal to determine a difference between the electrical signal and the baseline electrical signal. Block <NUM> may be followed by block <NUM>.

At block <NUM>, in response to the difference between the electrical signal and the baseline electrical signal meeting a threshold value, a user may be alerted.

Although illustrated as discrete blocks, various blocks may be divided into additional blocks, combined into fewer blocks, or eliminated, depending on the desired implementation. In some embodiments, the method <NUM> may include additional blocks. For example, in some embodiments, the method <NUM> may include providing one or more of the following: a housing, a transducer, and the catheter adapter. In some embodiments, the housing may include or correspond to the housing <NUM> of <FIG>, and the transducer may include or correspond to the transducer <NUM> of <FIG>. As another example, in some embodiments, the method <NUM> may include determining the baseline electrical signal, wherein determining the baseline electrical signal comprises transmitting other energy waves along the length of the intravenous catheter when the intravenous catheter is unoccluded and converting a portion of the other energy waves that are reflected back from the intravenous catheter to the baseline electrical signal.

Claim 1:
A system to detect occlusion of an intravenous catheter (<NUM>), comprising:
a catheter adapter (<NUM>) having a distal end (<NUM>) and a proximal end (<NUM>), an intravenous catheter (<NUM>) extending distally from the distal end (<NUM>), an inner lumen (<NUM>) of the intravenous catheter (<NUM>) and an inner lumen (<NUM>) of the catheter adapter (<NUM>) forming a fluid pathway;
a housing (<NUM>) having a distal end (<NUM>), a proximal end (<NUM>), and an inner lumen (<NUM>) that extends between the distal end (<NUM>) and the proximal end (<NUM>), the distal end (<NUM>) of the housing (<NUM>) being coupled to the proximal end (<NUM>) of the catheter adapter;
a wave transmitter (<NUM>) disposed in a wall of the housing (<NUM>), wherein the wave transmitter (<NUM>) transmits energy waves along a length of the intravenous catheter (<NUM>) and through the inner lumen (<NUM>) of the intravenous catheter (<NUM>) via wave guides (<NUM>) that extend through the wall of the housing (<NUM>) to the distal end (<NUM>) of the housing (<NUM>);
a transducer (<NUM>) disposed within the wall of the housing (<NUM>), wherein the transducer (<NUM>) detects a portion of the energy waves corresponding to the energy waves that are reflected back from the intravenous catheter (<NUM>);
a processor coupled to the transducer (<NUM>), wherein the processor receives an electrical signal corresponding to the portion of the energy waves that are reflected back from the intravenous catheter (<NUM>) and compares the electrical signal to a baseline signal to determine a difference between the electrical signal and the baseline signal; and
an indicator unit (<NUM>) coupled to the processor, wherein in response to the difference between the electrical signal and the baseline signal meeting a threshold value, the indicator unit (<NUM>) alerts a user.