Root canal debridement effectiveness device and method

A method for continuously evaluating the effectiveness of debridement of a root canal of a tooth, the tooth having an open access cavity and an apex end, includes delivering a fluid to the open access cavity of the tooth, evacuating the fluid near the apex end of the tooth such that the fluid flushes most of the root canal before being evacuated, and continuously evaluating the evacuated fluid for at least one of a presence of debris, a concentration level of the debris, or a type of the debris. An apparatus for use in debriding a root canal of a tooth includes a microcannula or a macrocannula configured to evacuate a fluid in the root canal, and a sensing mechanism fluidically coupled to the microcannula or the macrocannula, the sensing mechanism configured to continuously sense debris in the evacuated fluid in real time.

FIELD OF THE INVENTION

This invention relates to a device and method for sensing the effectiveness of root canal debridement.

BACKGROUND OF THE INVENTION

A root canal treatment may be used to preserve a tooth that has or could develop a diseased pulp cavity. To prevent bacterial proliferation within the root or pulp canal of the tooth, the canal is enlarged without excessively weakening the root's wall in order to: 1) mechanically remove as much of the root canal contents as is possible and 2) allow the introduction of irrigants into the root canal space that dissolve and disinfect organic debris, thus minimizing the presence of bacteria, as well as clearing the walls of the root canal of calcific debris created during instrumentation. After completing steps 1 and 2, the root canal is typically filled or obturated with a material such as gutta-percha and a sealer to occlude the pulp cavity and thus seal the root canal.

Irrigation assists in removing debris and necrotic material remaining after the endodontic files, bores, and reamers used during the removing and shaping steps of the procedure. Although the irrigant preferably is capable of dissolving or disrupting soft tissue remnants to permit their removal, the irrigant may be any suitable liquid such as water or various alcohols. More particularly, although some degree of debridement is preferred, any fluid may be used to flush debris from the root canal. General examples of appropriate irrigants include hydrogen peroxide and sodium hypochlorite.

In essence, the procedure goal is to convert the root into a devitalized tissue autograft. As such, it is important that the root canal is properly cleared of all debris before being filled. However, it is nearly impossible to visually determine if a root canal on a tooth, or analogous tiny channels, have been fully cleaned and flushed. Further, due to the small diameter of the canal (e.g., about 0.25 mm) and the curved geometry, it cannot be easily imaged using current technology. In addition, roots have complex morphology including accessory canals. As a result, current techniques involve relying on the experience and skills of the practitioner cleaning the canals to help assure a clean canal for an effective procedure. Failing to remove all of the necrotic tissue and bacteria often causes the procedure to fail, at which point the patient must have the procedure redone or have the tooth extracted. Thus, providing an improved method of determining whether the root canal is clean before obturation will improve the efficacy of the root canal treatment.

SUMMARY OF THE INVENTION

The present invention provides a method for continuously evaluating the effectiveness of debridement of a root canal of a tooth, the tooth having an open access cavity and an apex end. The method includes delivering a fluid to the open access cavity of the tooth, evacuating the fluid near the apex end of the tooth such that the fluid flushes most of the root canal before being evacuated, and continuously evaluating the evacuated fluid for at least one of a presence of debris, a concentration level of the debris, or a type of the debris.

The present invention provides an apparatus for use in debriding a root canal of a tooth includes a microcannula or a macrocannula configured to evacuate a fluid in the root canal, and a sensing mechanism fluidically coupled to the microcannula or the macrocannula, the sensing mechanism configured to continuously sense debris in the evacuated fluid in real time.

The present invention provides a method for evaluating the effectiveness of debridement of a root canal of a tooth, the tooth having an open access cavity and an apex end. The method includes delivering a fluid to the open access cavity of the tooth, evacuating the fluid near the apex end of the tooth such that the fluid flushes the root canal before being evacuated, and evaluating the evacuated fluid for at least one of a presence of debris, a concentration level of the debris, or a type of the debris using a sensing mechanism. The sensing mechanism has a configuration that is continuous, semi-batch, or batch.

The present invention provides an apparatus for use in debriding a root canal of a tooth. The apparatus includes a delivery tube for delivering fluid to the root canal and a sensing mechanism configured to continuously sense debris in the fluid. The sensing mechanism includes a first electrode, a second electrode comprising a microcannula or a macrocannula configured to evacuate the fluid in the root canal, and a sensor coupled to the first and second electrodes.

The present invention provides a method for debriding a root canal of a tooth, the tooth having an open access cavity and an apex end. The method includes delivering a fluid to the open access cavity of the tooth, the fluid including an aqueous solution. The aqueous solution comprises an amount of CaNa2EDTA and 2.5% stabilized sodium hypochlorite.

DETAILED DESCRIPTION

Referring first toFIG. 1, in an embodiment of the invention, a system10for determining the effectiveness of root canal debridement or the presence of bacteria in fluids evacuated from a root canal includes a canal evacuation system12, a sensing mechanism, shown as a spectrometer14, and a controller16. The system10is used during a root canal treatment of a tooth18after the root20has been shaped. The root20extends through the gums22. In approximately the middle of the root20extending almost the entire length of the root20is the root canal24, which extends from one end near the crown portion of the tooth18to an apex26at the tip of the root20. As shown inFIG. 1, the non-visible portion of the tooth18extending past the gums22is surrounded by periapical tissue27. Stripping the root20results in a large quantity, both in terms of size and amount, of debris within the root canal24. The canal evacuation system12is used to cleanse the stripped root canal24by delivering an irrigant to an open access cavity25of the tooth18. The irrigant, which mixes with the debris, is then evacuated from the root canal24by the canal evacuation system12, which applies a negative pressure within the root canal24. The debris in the evacuated irrigant may include viable tissue (e.g., dental pulp, dentin, and blood), cells, necrotic tissue, and bacteria, among other things. The evacuated material is then directed to the spectrometer14to evaluate the absorbance (e.g., UV wavelength, visible wavelength, infrared wavelength) of the evacuated material. The controller16then analyzes the data from the spectrometer14to determine if debris is present in the evacuated material. Depending on the results, the controller16may determine the flushing of the root canal24should continue or that the root canal24is sufficiently cleansed. The system10is described in further detail below.

With reference now toFIGS. 1 and 2, in an embodiment, the canal evacuation system12includes a reservoir28, a selector valve30, and a delivery tube32. The reservoir28may include, for example, a concentrated detergent suitable for use in debriding a root canal. The selector valve30is coupled to the reservoir28, a bleach source34, and optionally an air source36. The bleach may be used to clean the root canal24, and the air may be used to clear out the root canal24before a reading is taken by the sensing mechanism (described further below). One of ordinary skill will recognize that a number of bio-compatible irrigants may be used to flush the root canal24and determine whether debris is present. For example, the irrigant may be water, saline, phosphate-buffered saline, sodium hypochlorite (NaClO), ethylenediaminetetraacetic acid (EDTA), modified EDTA, or a mixture of concentrated detergent and water. The irrigant is delivered to the root canal24via the delivery tube32. In an embodiment, a second reservoir (not shown) contains a second irrigant. For example, the reservoir28may contain EDTA, and the second reservoir may contain NaClO. A first flush of EDTA may be used to remove inorganic matter, and a second flush of NaClO may be used to remove the remaining organic matter.

The canal evacuation system12further includes a microcannula38and a vacuum source39. While the system12is shown as including the microcannula38, a system according to another embodiment may include a macrocannula. As described in U.S. Pat. No. 8,827,705, which is incorporated by reference herein in its entirety, the microcannula38is typically made of a metallic material such as stainless steel or titanium and, in an embodiment therein, has an outside diameter of 0.014 inches. The microcannula38has a tip40that is welded shut and rounded and includes a side vent42. In an embodiment therein, the side vent42is approximately 0.75 mm long beginning at a point approximately 0.5 mm from the end of the tip40. Further, the microcannula38may be sized so as to be able to fit into the root canal24so that it extends towards the apex26with the side vent42extending as close to the end of the root canal24as possible but without extending into the periapical tissue27. A vacuum is applied to the microcannula38during or after delivery of the irrigant. In this manner, the irrigant is drawn down through the root canal24into the apical portion, that is, the bottom approximately 4-5 mm portion of the root canal24ending at the apex26. Since the tip40is closed, the irrigant is drawn into the side vent42. In this manner, the irrigant does not extend past the tip40and cannot be drawn into the periapical tissue27due to the vacuum which exists at the side vent42. By this technique, the irrigant creates shear forces along the walls of the root canal24to dislodge debris on the wall and to clean and disinfect the root canal24. Further, the irrigant flushes the apical portion of the root canal24, removing any remnants of debris and does not allow the irrigant to enter the periapical tissue27. In other embodiments, throughout the procedure, the irrigant may be delivered to the open access cavity25at the coronal side or at a different depth of the root canal24. Further, the fluid may be evacuated near the apex26or at different depth in the root canal24.

With reference again toFIG. 1, the microcannula38is fluidically coupled to the spectrometer14. In an embodiment, the spectrometer14is a mini UV long pathlength spectrometer. The evacuated material is delivered from the root canal24to the spectrometer14to determine whether debris is still being flushed from the root canal24. Bubbles generated from the turbulence of the irrigant flowing through the root canal24generate signal noise. To account for this, in an embodiment, the evacuated material may flow through a bubble trap44to eliminate the bubbles, which should substantially stabilize the signal. The bubble trap44may be a vacuum assist bubble trap or a non-vacuum assist bubble trap. Further, depending on the configuration of the spectrometer14, a sample of the evacuated material may optionally be directed to the spectrometer14with the remainder being treated as waste. As the evacuated material passes through the sensing mechanism, the spectrometer14evaluates the UV absorbance of the evacuated material. More specifically, the spectrometer14includes a light source46, a liquid waveguide capillary cell or a long pathlength capillary cuvette48, a diffraction grating50, and a sensor52. As the evacuated material flows through the long pathlength capillary cuvette48, the light source46emits UV light, which is separated into the different wavelengths of light by the diffraction grating50. The sensor52measures the characteristics of the light that passes through the evacuated material. The pathlength of the capillary cuvette48may be from about 50 mm to about 100 mm, and this relatively long pathlength results in increased sensitivity to permit reading the low concentration levels of the debris in the evacuated material. The diameter of the capillary cuvette48may be, for example, from about 50 micron to about 4 mm, about 50 micron to about 1 mm or from about 200 to about 400 micron. The capillary cuvette48may be coated to reduce stray light from interfering with the sensing mechanism. After the evacuated material has flown through the spectrometer14, the evacuated material is sent to a waste receptacle54. Before or after use, the system10may be configured to flush the system with the irrigant in which the irrigant bypasses the sensing mechanism.

With reference again toFIG. 1, the controller16is coupled to the sensing mechanism and is configured to determine if debris is present in the evacuated material based on data received from the sensor52. In one embodiment, the sensor52outputs a signal to the controller16such as a voltage, a digital absorbance value, or a digital transmittance value. During the cleaning of the root canal24, the signal will drop as the amount of debris in the evacuated material decreases. The controller16measures the change in signal output. The change in the signal is an indication of the progress of the cleaning and disinfecting of the root canal24. Because the irrigant is evacuated from near the apex26, the signal relates to the cleanliness of the entire root canal24as opposed to a signal from a sample taken from one location in the root canal24. Further, because the sampling is continuous and in real time, the clinician is not required to interrupt the cleaning process to take a measurement. Additionally, the risk of sample contamination is mitigated compared to taking a sample manually. While the evaluation may include continuous real time monitoring, the evaluation may alternatively include a discrete (high/low) sampling rate.

When the signal baselines, the controller16may be configured to alert the clinician. In an embodiment, the signal given by the irrigant without any debris present may be programmed into the controller16or set as a tare or used in a “zeroing” function. In various embodiments, the signal may baseline at or near the tare signal or the rate of change of the signal may be monitored and the signal may baseline when the rate of change decreases. The alert could be, for example, an audible tone. In an embodiment, the audible tone may be continuously emitted or emitted on command. Further, in an embodiment, the controller16is configured to differentiate between various types of debris. For example, the controller16may be configured to differentiate between different signals sent by the sensor52indicating the presence of tissue content or blood content in the irrigant. In such an embodiment, the controller16may include a duo-tone feature, which could tonally differentiate between, for example, tissue content and blood content in the evacuated material. For example, a sinewave tone could indicate by pitch the level of blood debris, while a sawtooth wave could indicate by pitch the level of protein debris. Together, these tones would be disharmonious indicating a dirty root canal24and harmonic for a clean root canal24. One of ordinary skill will recognize that the controller16may be configured to alert the clinician to the presence, concentration level, size, and/or type of debris using a variety of techniques.

With reference toFIGS. 3A and 3B, in an embodiment, the system10includes an in-line handle56containing the spectrometer14, the controller16, and a visual graphic user interface (“GUI”)58. The handle56may also include a speaker60for emitting an auditory tone. The controller16is configured to display the presence and/or concentration level of debris in the evacuated material using the GUI58. The GUI58may also be used to visually differentiate between sizes and types of debris (not shown). The GUI58may include a variety of visual indicators. In an embodiment, the GUI58includes a status indicator62, function buttons64, and a cleanliness indicator66. The status indicator62displays whether the system10is powered on, ready to analyze a sample from the evacuated material, or currently analyzing a sample. The function buttons64may be used to initiate a variety of functions on the handle56, such as to “zero” the signal. The cleanliness indicator66alerts the clinician to the relative cleanliness of the evacuated sample. In an embodiment, the cleanliness indicator66includes a row of indicator bars68. A first indicator bar70indicates a dirty sample, and a last indicator bar72indicates a clean sample. The indicator bars68may range in color from, for example, red at the first indicator bar70to green at the last indicator bar72. The controller16may be configured to light up the appropriate indicator bar68based on the signal received from the sensor52. While the GUI58is illustrated as a part of the in-line handle56, the GUI58may be located elsewhere. In various embodiments (not shown), the GUI58may be located in a docking station for the system10, computer in the dental suite, or an electronic device such as Google Glass or Microsoft Hololens.

A method of evaluating the effectiveness of debridement of the root canal24is now described with reference toFIGS. 1-3B. In an embodiment, the reservoir28contains a flush solution of EDTA, which is used to debride root canals. The clinician may optionally clear out the root canal24with air from the air source36before delivering the EDTA solution and taking a reading with the spectrometer14. To flush the root canal24, the EDTA solution is delivered to the root canal24via the delivery tube32. The vacuum source39is activated to draw the irrigant through the root canal24and out of the microcannula38. The evacuated irrigant may then pass through the bubble trap44to reduce or eliminate any bubbles. Depending on the configuration of the sensing mechanism, the evacuated material may optionally be divided where a sample is sent through the handle56and the remainder is sent to the waste receptacle54. As the sample enters the handle56, it passes through the long pathlength capillary cuvette48of the spectrometer14. Light from the light source46is directed through the sample and is sensed by the sensor52. The debris in the sample may absorb the UV light at distinct wavelengths. For example, proteins may heavily absorb at 280 nm, oxyhemoglobin may heavily absorb at 420 nm or 540 nm, and an iron-EDTA chromophore complex may absorb at 254 nm or 290 nm. Root canal tissue may be sensed with good resolution at a wavelength in a range from 296 nm to 320 nm, as described in further detail in Example 1. Thus, the controller16may evaluate the signal from the sensor52to determine if debris is present in the evacuated material. The sensor52delivers a signal to the controller16. The controller16may cause the speaker60to emit an auditory tone or the GUI58to indicate the cleanliness of the sample. Depending on the results, the controller16may determine the flushing of the root canal24should continue because the root canal24is not sufficiently cleansed or that flushing may cease because the root canal24is sufficiently cleansed. When the controller16indicates that the sample is sufficiently clean, the clinician may stop the delivery of the irrigant to the root canal24.

Referring again toFIG. 1, in an embodiment of the invention, the canal evacuation system12is configured to deliver a reagent to the root canal24, which will react in the presence of debris. More particularly, the reservoir28may include, for example, a protein reagent. The circulation of the reagent in the root canal24is ideal to expose the reagent to pulp, blood, and marrow remnants that cause a change in a detectable property in the reagent, such as a color change. The reagent is evacuated by the canal evacuation system12and directed to the spectrometer14to evaluate the color absorbance of the reagent. As described above, the controller16then analyzes the data received by the spectrometer14to determine if debris is present in the root canal24.

Because the level of debris in the root canal24may be on the level of micrograms, a purpose of the reagent is to chemically magnify the signal caused by debris in the root canal24. One of ordinary skill will recognize that a number of bio-compatible reagents may be used to evaluate the cleanliness of the root canal24. For example, the reagent may be Folin Ciolcateau reagent, bicinconic acid reagent, or Bradford reagent (Coomassie stain). The reagent may also be Folin Ciolcateau or bicinconic acid reagent with a nonionic surfactant. In one embodiment, the reagent may include a bicinchonic acid/cuprous (++) sulfate system, which will not stain dentition.

Further, in an embodiment, the reagent may be a luminescence mediated indicator, such as a fluorescent dye. As described in U.S. Patent Application Publication No. US2012/0034579A1, which is incorporated by reference herein in its entirety, such an indicator is capable of exhibiting a detectable and/or measurable change in the presence of a cell or cell population. As described therein, the measurable or detectable change may be the quenching or activation of a certain luminescent behavior (e.g. luminescence, intensity of luminescence above a predetermined threshold or a certain distinct wavelength of luminescence). The change may indicate a variety of results including, for example: presence or absence of viable cells, presence or absence at predetermined threshold of viable cells, risk factor of presence of viable cells, population or concentration of viable cell population, or presence and type of viable cells. As further described therein, a fluorescence mediated indicator is biocompatible and, preferably, is a vital dye (i.e., the indicator itself does not cause cell death). Thus, in accordance with the present embodiment, when the indicator is delivered to the root canal24via the delivery tube32, the indicator begins interacting with any debris that may be present. The clinician or the controller16may then activate the vacuum source39to draw the reagent through the root canal24and out of the microcannula38. As the evacuated sample moves through the sensing mechanism, the sensing mechanism examines the evacuated sample for the expected detectable and/or measurable change of the indicator. The controller16may then alert the clinician to indicate whether the indicator changed due to the presence of debris in the root canal24.

The method of evaluating the effectiveness of debridement of the root canal24as described above with reference toFIGS. 1-3Bapplies equally to the use of a reagent. In various embodiments, the reagent may be delivered continuously or in a pulsatile manner. Compared to a continuous delivery of the reagent, a pulsatile feature reduces the amount of reagent required, which reduces the cost of the procedure and reduces risk of exposing patient to a possibly bad taste of the reagent. During the cleaning of the root canal24, the amount of debris in the evacuated material decreases, which causes less of a change in the reagent (e.g., color, luminescence, fluorescence, etc.) and results in a signal drop. When the signal baselines, the controller16may be configured to alert the clinician that the evacuated material is sufficiently free of debris.

While the sensing mechanism shown inFIG. 1is a UV spectrometer, it should be recognized that the configuration of the sensing mechanism, as well as the measured attribute, may vary based on the application. In an embodiment, the light source46may be a RGB LED, and the sensor52may be a photo detector, such as a photodiode. Additionally, the light source46and the sensor52may be integrated in one component. In an embodiment, a transmissive sensor includes the light source46, which may be an infrared (IR) emitter, and the sensor52, which may be a photo detector, in which the evacuated material flows through an aperture between the light source46and the sensor52. As debris passes through the optical beam, the light energy reaching the sensor52decreases, which indicates that debris is present. In another embodiment, the turbidity (i.e., the light scattering) of the evacuated material is measured by the sensor52. The turbidity signal may be increased by adding a volume exclusion compound, such as liposomes or a long molecular weight polyethylene glycol (e.g., PEG-1000 to 8000). In an embodiment, the irrigant is an aqueous solution including 15% PEG-8000 and 17% Na2EDTA (disodium salt of EDTA), which results in an increased strength of the turbidity signal compared to an EDTA solution. In other various embodiments, the sensing mechanism may include cell trapping, such as mechanical traps, ultrasonic wave traps, electrical traps, antibodies capture, and optical traps.

In an embodiment, a sensing mechanism including optics elements and electronics may have dimensions of 50 mm×50 mm×30 mm or less. A lock-in detection method may be used to reduce the electrical noise of unwanted ambient light. Further, the sensing mechanism may include a secondary photodiode, which may, for example, be used to monitor the light source power for an intensity measurement or as a reference for the lifetime measurement. This configuration may, for example, detect a scattered light intensity from or a fluorescence marker in a 200 to 10 μm (or smaller) particle in microfluidic channels coupled to the sensor (e.g., 1 mm channel or preferably 500 μm or less at a 500 Hz sampling frequency). In an embodiment, the sensing mechanism may allow the spectral filters to be exchanged according to the intended application.

Referring now toFIG. 4, in an embodiment, a sensing mechanism80includes an emitter or light source82and a photo detector or sensor84adjacent one another. In an embodiment, the light source82emits infrared light. When debris passes through the optical beam, such as a particle86, light reflects off of the particle86and is detected by the sensor84. Thus, the amount of light energy that reaches the sensor84increases when the particle86passes through the optical beam. As the amount of debris in the evacuated material decreases, fewer particles are present to reflect light resulting in a signal drop.

With reference toFIGS. 5A and 5B, in another embodiment, a sensing mechanism90includes a laser92, a first photo detector or sensor94, a reflector96, and a second photo detector or sensor98. The evacuated material is flowing through a capillary cuvette91. The diameter of the capillary cuvette91may be, for example, from about 50 micron to about 1 mm or from about 200 to about 500 micron. The laser92emits light that passes perpendicularly through the flowpath of the evacuated material and is detected by the first sensor94. The amount of light energy that reaches the first sensor94decreases when the particle86passes through the optical beam. When the particle86passes through the light, it scatters the light. The light scatter reflects off of the reflector96, and the reflected light is detected by the second sensor98. The amount of light energy that reaches the second sensor98increases when debris passes through the optical beam. As the amount of debris in the evacuated material decreases, fewer particles are present to pass through the optical beam from the laser92resulting in a signal drop. Although one reflector96and sensor98pair is shown, it should be recognized that more than one sensor or sensor and reflector pair may be used to sense scattered light. The sensors may be at different angles to that shown. The evaluation by the controller16of the data outputs from the sensors detecting scattered light may take into account the particular configuration of the sensing mechanism (e.g., the angle of the sensor(s) to the axis of the light).

With reference toFIG. 5C, in another embodiment in which scattered light is sensed, a sensing mechanism90′ includes the laser92, the first sensor94, the second sensor98, and lenses97,99. As described above, when the particle86passes through the light from the laser92, it scatters the light. The light may be, for example, green light. The sensors94,98are each positioned at an angle to the axis of the light from the laser92. The lenses97,99are positioned between the particle86and the sensors94,98, respectively, in the paths through which the scattered light will pass. Although two sensors94,98are shown, it should be recognized that one sensor or more than two sensors may be used. The sensor(s) may be positioned at an angle in the range of 5° to 90° or 10° to 50°. For example, the angle may be 44°. As described above, the controller16may take into account the particular configuration of the sensing mechanism. Various features described herein may be combined. For example, the sensing mechanisms90,90′ may include a bubble trap to eliminate the bubbles in the evacuated material to substantially stabilize the signal. The flow dynamics may be fine-tuned to avoid air bubble presence in the evacuated fluid when it passes through the sensing mechanism.

Referring now toFIG. 6, in another embodiment, a sensing mechanism includes a micro-optofluidic cytometer100. The cytometer100includes an evacuated fluid inlet102and a restricted channel104, which is smaller in cross-sectional area than the inlet102. As the evacuated fluid enters the cytometer100from the inlet102, the reduction in cross-sectional area results in a high-shear region. Additionally, the evacuated fluid inlet102is fluidically coupled to a dye source106. One or more mixing elements108may be present to ensure the dye and evacuated fluid are sufficiently mixed so that the dye stains any debris in the evacuated fluid. The dyed fluid mixture then enters a detector110. The detector110includes a laser112, an objective lens114, an optical fiber116, and a multi-pixel photon counter (MPPC) photo sensor118. The laser112emits light, which is focused by the lens114to pass through the flowpath of the fluid mixture. As the dyed particle86enters the optical beam, the dyed particle86emits fluorescent light. The emitted fluorescent light is collected via the optical fiber116and brought to the MPPC photo sensor118. As the amount of debris in the evacuated material decreases, fewer particles are dyed resulting in a signal drop.

With reference toFIG. 7, in another embodiment, a sensing mechanism includes a real-time deformability cytometer120. The cytometer120includes an LED light source122, an objective lens124, and a complementary metal-oxide semiconductor (CMOS) camera126. The evacuated fluid passes through the optical beam from the LED light source122while in the restricted channel104. Pictures taken from the CMOS camera126of the particles under shear forces show how the particles deform. The deformation determines the nature of the particles. Different types of cells deform differently under shear forces.

Referring now toFIG. 8, in another embodiment, a sensing mechanism includes an impedance sensor or an impedance spectroscopy cytometer130. The cytometer130includes a first electrode132and a second electrode134each coupled to a sensor136. The passage of a particle86through a field between the two electrodes132,134results in a differential impedance signal. As the amount of debris in the evacuated material decreases, fewer particles pass through the field resulting in a signal drop. In an embodiment, the sensor136is not sensitive to air or gas bubbles and differentiates only the presence and amount of particles in the restricted channel104. In an embodiment, the restricted channel104may be rectangular having inner dimensions of 1.0 mm×1.0 mm or 500 μm×500 μm or less and may provide detection of particles between 200 μm and 10 μm or less. Additionally, in an embodiment, the sensing mechanism may include a lock-in amplifier (LIA) to reduce signal noise. In another embodiment, the sensing mechanism may include impedance and dielectrophoretic force spectroscopy to sort and sense the debris particles in the evacuated fluid. In another embodiment, the sensing mechanism may sort the type of debris using single-cell impedance measurement in the restricted channel104by demodulating at multiple frequencies signals received from the same debris.

With reference toFIG. 9, in another embodiment, a sensing mechanism140includes a complementary metal-oxide semiconductor (CMOS) image biosensor array142and a light source144. As the evacuated material flows through the optical beam, the CMOS image biosensor array142senses light input patterns of the evacuated material. As the amount of debris passing through the optical beam decreases, the amount of light energy that reaches the CMOS image biosensor array142increases resulting in a change in the light input patterns, which results in a signal drop. In another embodiment (not shown), a sensing mechanism may include a CMOS charge detector biosensor array, which is an array of electrodes connected to an electric circuit. The circuit may include a voltage where Voutis equal to Vinand has a high input impedance to prevent the input voltage signals from dropping and causing a low output impedance, which prevents signals from reducing due to loading device. There is also a constant current through the circuit from input to output. As the debris passes over the CMOS charge detector biosensor array, the debris particles interact with the CMOS charge detector biosensor array and create an electrical potential, which is sensed by the CMOS charge detector biosensor array. As the amount of debris passing over the CMOS charge detector biosensor array decreases, the electrical potential decreases, which results in a signal drop.

Referring now toFIG. 10, in another embodiment, a sensing mechanism150includes measuring a pressure drop to evaluate the cleanliness of the evacuated fluid. The sensing mechanism150includes a microfilter152, an ultrafilter154, and a nanofilter156serially positioned in the flowpath of the evacuated fluid. A pressure drop ΔP1, ΔP2, ΔP3across each of the filters152,154,156, respectively, is measured by sensors (not shown). As the evacuated material flows through the filters152,154,156, the flow of any debris is restricted by the filters152,154,156depending on the size of the debris. As debris builds up on one of the filters152,154,156, the pressure drop across that filter increases. As the amount of debris in the evacuated fluid decreases, the rate of change of the pressure drop decreases, which results in a signal drop. Depending on the filter sizes chosen, the presence of specific types of debris may be detected based on debris particle size. While three filters of varying sizes are illustrated, it should be recognized that the number and size of the filters may vary based on the intended application. Further, increasing the area of the filter may amplify the pressure drop signal.

While the sensing mechanisms shown inFIGS. 1 and 4-10are shown as being continuous flow techniques, it should be recognized that the sensing mechanism may be implemented in a semi-batch or batch configuration. With reference toFIGS. 11A and 11B, a sensing mechanism157is shown in a semi-batch configuration (FIG. 11A) and a batch configuration (FIG. 11B). The sensing mechanism157may have a variety of configurations, such any of those described with reference toFIGS. 1 and 4-10. As shown inFIG. 11A, in an embodiment, the sensing mechanism includes a reservoir158through which the evacuated fluid passes continuously. The reservoir158is sized such that the volume of evacuated fluid in the sensing mechanism157is increased compared to a continuous flow configuration. As shown inFIG. 11B, in an embodiment, the evacuated fluid may bypass the sensing mechanism157via three-way valves159. When a reading is to be taken, the valves159may be adjusted so that evacuated fluid flows into the sensing mechanism157. Both of the semi-batch and batch configurations allow for the evacuated fluid to have a longer residency time in the reservoir158compared to the residency time in a sensing mechanism that has a continuous configuration. A longer residence time may, for example, allow for a reaction to proceed for a desired length of time before the evacuated fluid exits the sensing mechanism157. Additionally, the larger volume of liquid contained in the sensing mechanism157may allow for an increased signal to noise ratio compared to a continuous configuration, although more data points may be obtained in the same period of time in the continuous configuration. It should be recognized that a particular sensing mechanism may be implemented in one or more of a continuous, semi-batch, or batch configuration. For example, the micro-optofluidic cytometer100, which is shown in a continuous configuration inFIG. 6, may alternately be implemented in a semi-batch or batch configuration (not shown).

Referring now toFIG. 12, in another embodiment, a sensing mechanism160includes measuring the impedance of the fluid in the root canal24. The sensing mechanism160includes a first electrode162, a second electrode164, and a sensor166. In an embodiment, the microcannula38serves a dual-purpose and acts as the first electrode162. The second electrode164may be positioned on tissue in or near the patient's mouth. In an embodiment, the second electrode164may be attached to the lip of the patient. The sensor166is capable of measuring an electric signal between the first and second electrodes162,164. In this configuration, the fluid is continuously flowing through the root canal24, and any debris is being sensed while it is still in the root canal24, which differs from the sensing mechanisms described above that sense debris in the evacuated fluid. Thus, the impedance may be measured while the root canal24is being cleaned. The change in impedance may indicate to the clinician whether the root canal24is clean or requires further flushing.

In an aspect of the present invention, a sensing mechanism may be configured to provide a distinct signal for a particular type of debris. For example, a sensing mechanism may be configured to distinguish between organic vs. inorganic debris. This may be in addition to generally sensing the presence and/or amount of debris in the evacuated irrigant. As described above, in an embodiment, a two-flush system may be used: a first flush of EDTA to remove inorganic matter, and a second flush of NaClO to remove the remaining organic matter. During the first flush, the sensing mechanism may be used to assess the presence and concentration of inorganic matter vs. organic matter. A determination by the sensing mechanism that there is no inorganic matter in the evacuated fluid indicates to the clinician that the second flush may begin. In another embodiment, a sensing mechanism may be configured to specifically sense blood There are instances where blood may overwhelm sensing data. Providing a distinct signal for the presence and/or amount of blood provides feedback for the device or the clinician to correct for the signal of the blood in the data. Additionally, the clinician may have a concern about a particular type of debris. Providing a distinct signal allows the clinician to observe whether and to what extent that debris is present throughout the procedure. This may be advantageous where, for example, the clinician is alerted if a relatively large amount of blood is in the evacuated irrigant.

In another aspect of the present invention, a sensing mechanism may include more than one sensing technique, such as those described above. For example, a device may include a spectrometer to measure absorbance and a sensor to measure the angular light scattering. The different functions of the sensing mechanism may overlap or may be different. In one aspect, one of the sensing techniques may be able to sense debris of a certain size, which is not within the operable range of the other sensing technique. For example, depending on the scattering sensor configuration, debris that is too small to be effectively measured by the scattering sensor may be sensed by the spectrometer. In another embodiment, the spectrometer may be used to determine whether blood is in the evacuated irrigant, while the scattering sensor is used to generally determine whether any debris is in the evacuated irrigant. The relative level of blood may be indicated to the clinician and, as described above, the clinician may determine whether an unusual amount of blood is present in the evacuated irrigant.

With reference toFIG. 13, in another embodiment, a system for determining the effectiveness of root canal debridement includes a flexible fiber microscope170. The microscope170is used to visually inspect the root canal24during at least a portion of the root canal treatment. For example, when the microcannula38is inserted into the root canal24, the microscope170may also be inserted. In conjunction with evaluating the cleanliness of fluid evacuated from the root canal24with a sensing mechanism, the clinician will be able to evaluate the visual change from a dirty root canal24to a clean root canal24using the microscope170. Further, in an embodiment, a dye may be used to visualize specific materials, biological or other, more easily.

In an embodiment, a method for debriding may include using one irrigant to clean and etch the root canal24. The irrigant containing, for example, an aqueous solution containing an amount of calcium di sodium EDTA (CaNa2EDTA) and 2.5% stabilized sodium hypochlorite may be delivered to the root canal24. The sodium hypochlorite acts to bleach the root canal24, and the EDTA salt etches the root canal24. Because the irrigant accomplishes multiple steps (i.e., bleaching and etching), the number of solutions used during the root canal procedure is reduced. Further, in an embodiment, one irrigant may be used to accomplish the cleaning, etching, and measurement of the cleanliness of the root canal24. The irrigant may contain, for example, an aqueous solution containing an amount of CaNa2EDTA, an amount of PEG-8000, and 2.5% stabilized sodium hypochlorite. In addition to the bleaching and etching effects of the sodium hypochlorite and the EDTA salt, respectively, the PEG increases the turbidity signal of the fluid. The fluid may be evacuated from the root canal24and evaluated by a sensing mechanism.

In order to facilitate a more complete understanding of the embodiments of the invention, the following non-limiting example is provided.

A device was used to test sensing of shrimp (Litopenaeus setiferus) tissue, which is a test model for human root pulp, at different doses in a range of clinical interest. The device included a 50 mm pathlength cell, a UV/Visible light source, and a spectrophotometer detector connected with light cables. The shrimp tissue was diluted in 17% disodium EDTA. Additionally, heparinized calves blood was also diluted and sensed on the device at a higher concentration, which also is of clinical importance. The shrimp tissue and calves blood samples were prepared to represent clinical root canal treatment effluents.

The results are shown in Table 1. Table 1 shows the unprocessed signal from the detector along with the calculated transmittance and absorbance values. The signal noise was set to 100 units to determine the resolution of the readings in the range of interest.

The results show that the model root canal tissue,L. setiferus, was sensed with good resolution in a dose range of clinical interest in the range of 296 nm to 320 nm. Using the 50 mm pathlength, the absorbances are in a range of absorbance units considered excellent by chemists for analysis (e.g., 0.050 AU to 0.500 AU). The results also demonstrate that blood in moderate quantities, which sometimes is found in root canals, does not overwhelm or mask the signal in the tissue range, although it is strongly read at a wavelength typically used for blood determination (405 nm). This permits a device to read tissue values and alert the dentist to excessive blood levels simultaneously or to stop reading if a very high level of blood is detected during the procedure.

While specific embodiments have been described in considerable detail to illustrate the present invention, the description is not intended to restrict or in any way limit the scope of the appended claims to such detail. The various features discussed herein may be used alone or in any combination. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and methods and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope of the general inventive concept.