Immediate obturation following vacuum suction irrigation of the root canal system using a single staging assembly

Abstract

An embodiment of the present disclosure provides a staging assembly (10) for multi-canal irrigation of a root canal system using negative pressure followed by obturation. The staging assembly may be part of a kit that includes multiple catheters (50) sized for insertion into the root canal system. To hold the catheters in the appropriate position within the canal, the catheters may include stops (37), and the staging assembly may include corresponding stop retainers (36). The distal end (51) of the catheter may be positioned 2 mm to 5 mm from the end of the root canal. The staging assembly is then sealed, creating a closed system. Irrigation fluid is evacuated from the end of the catheter, and debris is expelled through the vacuum port on the staging assembly. No manual intervention by the clinician is required during irrigation. After irrigation, the vacuum is reversed to dry the canal. Obturation is achieved through the vacuum port.

Description

[Technical field]

[0001] CROSS-REFERENCE TO CO-PENDING APPLICATIONS This application claims priority to U.S. Patent No. 62 / 987,463, filed March 10, 2020, and U.S. Patent No. 63 / 091,872, filed October 14, 2020, the contents of each of which are incorporated herein by reference.

[0002] The present disclosure is in the field of dentistry, and more particularly, to devices, systems, and methods designed to deliver fluids to clean, flush, disinfect, or debride the root canal system and seal the root canal system after it has been shaped by rotary mechanical instruments such as reamers and files. [Background technology]

[0003] The dentin tooth structure is formed from its periphery inwards by the dental pulp. When tooth development is complete, a space remains within the crown containing this forming organ and the root structure. This space includes the pulp chamber, which is inside the crown, and one or more primary canals that extend from the floor of the pulp chamber through the relative center of the root to the apex. Often, when there are two primary canals in a root, there are lateral canals, fins, loops, isthmuses, etc., that project from these primary canals.

[0004] When dental pulps are damaged by physical trauma to the tooth or infected by bacteria that have entered these spaces through dental caries, they often degenerate and become necrotic because the pulp's blood supply has few entry points from the well-perfused periradicular tissues. During this degenerative process, patients often experience very intense pain as the inflammatory swelling associated with pulp disease is contained within the hard tissue nesting of the dentin root structures. After this degenerative process progresses to pulp necrosis, bacteria (which are safe from immune cells and antibiotics because their blood supply is interrupted) invade the root canal space, replicate, and spread from the inside of the root to the outside through the exit canalicular portals, causing infection in the surrounding alveolar bone and causing intense pain when these infections become acute.

[0005] Root canal therapy is performed in the short term to relieve pulpal or periradicular pain due to pressure. In the long term, the goal of root canal therapy is to restore the patient's tooth to a functional, disease-free state. Both of these necessary outcomes are achieved by entering the root canal system using mechanical instruments such as manual and motor-driven endodontic files and reamers to digest the dying pulp debris, disinfect the cavities with irrigation solutions, and then sealing these spaces with a filling material to prevent reinfection.

[0006] The root canal system has a complex geometry and cannot be completely prepared by mechanical means such as reamers and files alone. For example, reamers and files cannot remove pulp tissue from long (3 mm) and narrow (0.1 mm) canals such as the isthmus canals. Therefore, the most challenging aspect of root canal treatment is to thoroughly clean the root canal system to its apical and lateral extent, and the success rate of root canal treatment is directly related to the completeness of this procedure.

[0007] Irrigation of the root canal system is difficult because reamers and files cannot clear pulp tissue and infection from root canal areas outside the primary canal, nor can they disinfect any part of these spaces. Clinicians must use caustic sodium hypochlorite ("NaOCl") solutions to accomplish these important objectives. Although there have been iatrogenic outcomes from misuse of NaOCl irrigants during root canal treatment reported in the endodontic literature, it is the only known irrigant capable of killing all bacteria within the mucous biofilm that colonizes the RC system. See, for example, Costerton et al., "How bacteria stick, Sci Am 1978; Bacterial biofilms: A cause of persistent infections Science 1999."

[0008] Furthermore, not only are reamers and files unable to disinfect the root canal system, but whenever they are used to prepare the root canal, they actually make the canal more soiled because they leave a smear layer of cut organic and inorganic debris on the dentin walls that can only be removed with mildly acidic irrigants such as ethylenediaminetetraacetic acid ("EDTA") or citric acid. See, for example, J. 50. Baumgartner & 50. L. Mader, "A scanning electron microscopic evaluation of four different root canal irrigation regimens, J. Endo, 13:4, 1987." Thus, the prior art utilizes liquids to clean, flush, disinfect, or debride the root canal system.

[0009] Irrigants and disinfectants known in the art, such as NaOCl, hydrogen peroxide, and EDTA, can reach areas of the canal system that cannot be reached by reamers and files, and can clean the canal walls of calcified debris created by reamers and files, as well as dissolve and disinfect organic debris. However, for the irrigants to be effective, the needle delivering the fluid must be placed near the apex of the canal, and under positive pressure there is an increased risk of inadvertently injecting the irrigant or disinfectant beyond the apex and into the periapical tissues, causing extreme swelling and pain to the patient. These and other types of complications are reviewed in M. Hulsmann & W. Hahn, "Complications during root canal irrigation-literature review and case reports, 33 Intl. Endo. J. 186 (2000), the contents of which are incorporated herein by reference.

[0010] The chemical dynamics that limit its ability to digest pulp in the lateral recesses of the root canal system are simply this: as soon as NaOCl hydrolyzes some of the connective tissue, it loses oxygen ions in the process and becomes inactive. Although the pool of NaOCl can continually provide fresh, active chemicals, the amount of solution available in the canals at the dissolution front is severely limited. Irrigation effectiveness in the root canal system cavity is further limited by the accumulation of gases released by this process.

[0011] One of the most important things to understand about NaOCl is that while it can kill pathogens on a countertop or dissolve an entire broached pulp in a Dappan dish in just 10 minutes, it takes much longer to achieve the same effect in a root canal. Research and clinical experience have shown that when applying NaOCl to the canal geometry using traditional passive irrigation techniques, approximately 40 minutes of passive NaOCl irrigation is required to kill 100% (or nearly 100%) of the resident bacteria and adequately remove the remaining pulp. See, for example, HK Haapasalo et al., "Inactivation of local root canal medicaments by dentine: an in vitro study, Int Endo J 2000;33:126-31"; and B. Retamozo et al., "Minimum contact time and concentration of sodium hypochlorite required to eliminate Enterococcus faecalis, J Endo.2010;36(3):520-523".

[0012] In general, irrigation efficiency declines in proportion to the time saved by rotary instrumentation. If it took 10-20 minutes to shape the root canal with a hand file (with NaOCl flushing between instruments), the irrigant would be present in the molar root canal system for a total of 30-80 minutes, and the root canal system would be very clean by the time cone fitting and filling began. However, the savings in procedure time with the advent of motor-driven root canal preparation in the late 1990s indirectly increased the failure rate of root canal treatment. When shaping times were reduced to 1-2 minutes using rotary files, endodontists began to notice an increase in short-term failures. Many endodontists returned to root canal treatments they had seen countless times, where unrecognized irrigation inadequacies were resolved by applying calcium hydroxide paste (a caustic analogue of NaOCl) to the root canal system between appointments. See M. Manfredi et al., "Single versus multiple visits for endodontic treatment of permanent teeth, Cochrane Database Syst Rev., Dec 1;12, 2016."

[0013] Irrigation failure is vague and difficult to diagnose. Usually, patients visit the endodontist after root canal treatment is completed with the same pain as before treatment. 11% of endodontist cases reported in the National Dental Network were not pain-free within 6 months after treatment completion. See DRNixdorf et al., Differential diagnosis for persistent pain after root canal treatment: A study in the National Dental Practice-based Research Network, JOE, 41:4, 2015. Half of these cases are due to a misdiagnosis of myofascial pain syndrome of irreversible pulpitis, leading to unnecessary root canal treatment without addressing the original etiology. See intermediate description. In the experience of one of the co-inventors (Buchanan), the other half was due to incomplete removal of inflamed pulp debris.

[0014] Persistent pain after root canal treatment with residual pulp is typified by referred pain within the endodontic region (between the buccal eminence and the lower border of the mandible), which does not improve with antibiotics, and no periradicular lucency is seen on cone beam computed topography (CBCT) imaging. Even worse are patients who present with a history of moderate to severe pulpitis. Remnants of inflamed pulp may be too damaged to recover, but remain vital if located near a rich periradicular blood supply.

[0015] Virtually all attempts to improve endodontic irrigation capabilities have revolved around more effective application and activation of NaOCl and EDTA solutions. See, for example, HK Haapasalo et al., "Inactivation of local root canal medicaments by dentine: an in vitro study, Int Endo J 2000;33:126-31" and B. Retamozo et al., "Minimum contact time and concentration of sodium hypochlorite required to eliminate Enterococcus faecalis, J Endo. 2010;36(3):520-523."

[0016] The length of time required for NaOCl to be effective in a root canal is a matter of root canal geometry and fluid dynamics, coupled with the chemical dynamics of connective tissue hydrolysis. Because the root canal system harbors pulp tissue in a longitudinal space that can only be rinsed from the coronal direction, the pulp interface available for digestion by NaOCl may have a circumference of approximately 0.1 or 0.2 mm. Compare this relatively small irrigation front to a broached pulp that has been dropped into a pool of bleach. The pulp, stripped from its root covering, is actively dissolved on all sides and is gone in 5 to 10 minutes.

[0017] The chemical dynamics that limit the ability of NaOCl to digest the pulp in the outer recesses of the root canal system are simply this: as soon as NaOCl hydrolyzes some of the connective tissue, it loses oxygen ions in the process and becomes inactive. 50. See Estrella et al., Mechanism of Action of Sodium Hypochlorite, Braz Dent J, 13(2):113-117, 2002. Although the pool of NaOCl can continually provide fresh, active chemicals, the amount of solution available in the canals at the dissolution front is severely limited. As mentioned above, the irrigation effect in the root canal system cavity is further limited by the accumulation of gases released by this process.

[0018] The accumulation of gas released by this chemical process can lead to vapor lock, leading some endodontists to employ negative pressure irrigation ("negative pressure irrigation"). Negative pressure irrigation systems (such as those disclosed in U.S. Pat. No. 4,276,880 to Malmin et al., U.S. Pat. App. Pub. No. 2005 / 0287498 to Schoeffel et al., U.S. Pat. App. Pub. No. 2018 / 0153644 to Bosisio et al., U.S. Pat. App. Pub. No. 2005 / 0170312 to Pond et al., and U.S. Pat. No. 6,971,878 to Pond) aim to reduce or eliminate potential complications such as vapor lock during irrigation. Multi-tube systems such as those disclosed by Pond present difficulties for the clinician. For example, his preferred embodiment has a fixed working length that cannot be adjusted (cutting the needle allows the end to close), and in some embodiments, a screen designed to hold the needle in alignment obscures the view, making it difficult to place the needle to the proper depth within each tube. Additionally, Pond requires the clinician to place a layer of adhesive (light-curable or otherwise) over a screen-type material without blocking the needle or causing fluid leakage, which makes it virtually impossible to establish a negative pressure system.

[0019] Scientific studies and clinical experience have demonstrated that NPIs are (1) one of the most effective methods of irrigating or debriding root canals, (2) very inexpensive because they use NaOCl, the least expensive and most commonly accepted endodontic irrigation solution and suction system found in every dental office, and (3) the safest method of applying NaOCl to root canals. Despite the extraordinary effectiveness shown by studies and clinical experience, prior art NPI systems, such as the Kerr Endodontics ENDOVAC™ System ("Kerr System"), contain several design features that severely limit their use in clinical practice.

[0020] The first limiting feature is the needle, which contains 12 microports within the first mm near the distal end (see Figure 1 for an example). The ports often become clogged during use because pulp debris or cut dentin fragments are drawn into the ports. For example, the needle of the Kerr system is a non-tapered needle sized 0.32 mm outside diameter with four sets of three laser-cut, laterally-spaced offset holes located just near the closed distal end (about the first 0.70 mm). Each hole in the set is 100 μ in diameter (0.1 mm, smaller than the inner diameter of the needle) and spaced 100 μ apart. To reduce the chance of clogging, the system requires two stages: a global evacuation stage in the coronal region of the canal and an evacuation stage in the apical region of the canal using the smaller microport needle.

[0021] A second limiting feature is the time required by the clinician when using the system in multi-canal teeth, since the clinician must actively hold the NPI needle at the end of a particular canal as the solution is drained into the canal and then into the suction system attached to the NPI needle.

[0022] Current NPI systems are limited to single canal efficacy where only one canal at a time can be actively cleaned with the NPI. Because of this, prior art NPI systems actually increase the dentist's workload in multi-canal teeth. Currently, using an NPI instead of a PPI can reduce the time required to complete a root canal cleaning with NaOCl from 40 minutes (PPI) to 5 minutes (NPI), but if an NPI requires 5 minutes of constant NPI cleaning per canal, that requirement is four times as long, equating to 20 minutes of continuous attention required by the dentist in addition to the 10 minutes of time the dentist would spend actively cleaning with the PPI.

[0023] A third limiting feature is that NPI currently requires constant attention from the clinician, repeatedly adding NaOCl to the access cavity as the solution is drawn into the end of the tube and expelled from the NPI needle. Whether the tooth being treated requires 5 minutes or 20 minutes of constant attention during an NPI irrigation, a lot of effort is expended on a very simple need: refilling the solution. Thus, although aspirating NaOCl solution with an irrigation needle is safe, it is not necessarily effective.

[0024] One of the reasons that studies on the Kerr system have shown such good results is that users of the Kerr system tend to irrigate continuously, unlike most clinicians who irrigate for a few seconds at a time. A constant flow rate of irrigation is important for soft tissue breakdown because tissue hydrolysis stops as soon as sodium hypochlorite comes into contact with the tissue.

[0025] Almost all prior art irrigation systems work on one tube at a time, i.e., they are single-tube in function. When used on multi-tube teeth, the clinician must persist with the activation appliance for 20-40 minutes on a four-tube molar instead of using a longer passive soak time (e.g., 40 minutes) that requires less hands-on time.

[0026] To improve the efficiency and effectiveness of NPI systems, US Pat. No. 10,779,920 B2 to Buchanan discloses a multi-channel NPI system, the contents of which are incorporated herein by reference.

[0027] Sonendo Inc.'s GENTLEWAVE® System ("Sonendo System"), a multisonic endodontic irrigation device, includes a multi-canal approach. See also G. Olivi & E. DiVito, "Photoacoustic Endodontics using PIPS: Experimental background and clinical protocol, J Laser Health Acad, 1, 2012," which discusses the multi-canal approach using light-activated photoacoustic streaming. The procedure involves using a light-cured polymer to create a custom gasket (platform) on the treated tooth, which allows the procedure instruments to be placed on top and operate as a closed system in the root canal system. The procedure instruments create a negative pressure environment within the root canal system, allowing the instruments to spray NaOCl at very high counter pressure without risking a hypochlorous acid accident with the solution passing the edge of the root canal and entering the periradicular tissues. At the end of the molar instrument, a titanium tube projects into the pulp chamber just short of the chamber floor, which transmits multisonic energy and reverberates along the hard tissue dentin surface into the canal, very effectively loosening intracanal debris. See M. Khakpour et al., "Tissue dissolution by a Novel Multisonic Ultracleaning System and Sodium Hypochlorite, JOE, 40(8), 2014. See also U.S. Patent No. 8,753,121 to Gharib et al.

[0028] The Sonendo system uses degassed (or substantially degassed) liquids for the following reasons: a. Reducing vapor lock by suppressing, reducing or preventing air bubbles from coming out of solution during treatment.

[0029] b. The sound waves generated by the pressure wave generator propagate through the degassed liquid and can reach surfaces, cracks, tooth grooves and cavities for better cleaning. 50. Degassed liquids can penetrate small spaces of approximately 500 microns, 200 microns, 100 microns, 10 microns, 5 microns, 1 micron, or even smaller because air bubbles are inhibited from coming out of solution and blocking these spaces. Please refer to the intermediate description.

[0030] The Sonendo System's cleaning effectiveness is at a level never before seen with rotary mechanical instruments, allowing the canals to be cleaned with little to no instrumentation during an 8-minute procedure time consisting of a 1.5-minute cycle of distilled water irrigation, followed by a 5-minute cycle of 3.5% NaOCl irrigation, and a final 2-minute cycle of 8% EDTA irrigation. The Sonendo System is more effective than other prior art methods, but requires a significant capital investment by the practitioner in addition to ongoing per-procedure fees. It also requires 3-5 minutes of hands-on time to build and calibrate the platform prior to the 8-minute hands-on Sonendo procedure time.

[0031] The method of operation is driven by a console handled by a circular wastegate around the instrument head, pumped to 9,000 psi, injected or injected through the instrument tube and the instrument itself, impinging on a so-called impingement plate, whose curved inner surface reflects that strong fluid flow back 180 degrees, washing the solution. This is sensible for several reasons. First, the Bernoulli effect creates a negative pressure within the root canal system, which acts as a safety net to keep the NaOCl contained within the root canal and not pass through the ends of the canal. Second, at the same time, the impingement plate is vibrated by the impinging fluid jet, and because water is incompressible, this acoustic energy is transferred very effectively to the ends of the canal.

[0032] As an experiment, and because one of the co-inventors on this application (Buchanan) was having difficulty finding the MB2 canal orifices, the inventors deployed the Sonendo platform and tapped the pulp chamber using a 90 second distilled water cycle at the beginning of the Sonendo procedure. The Sonendo system sonics opened up the MB2 that was hidden under the dense calcareous material. The acoustic energy reaches all the way to the edge of each canal opening. Because dentin is a hard tissue, it is an excellent reflector of sound energy, and because most root canals are tapered in shape, this sound energy tends to be amplified as the canal diameter decreases, which makes the hypochlorite transfer very effective.

[0033] For example, in another test performed by Buchanan, an uninstrumented MB2 canal was cleaned with the Sonendo system. Postoperative radiographs showed effective cleaning and filling. In another test of the Sonendo system performed by Buchanan, a tooth was presented with extensive cervical internal resorption that reached the external surface in some areas. Buchanan instrumented the molar by constructing a chamber over the cavity surface of an access cavity large enough to fit an acoustic extension inside. Bioceramic sealer, treated in one visit, worked its way through numerous resorption cavities.

[0034] With the efficacy of the sonic energy of the Sonendo system, root canal shaping requirements are altered in some very fundamental ways, abandoning the concept of clearing the root canal by shaping it, and transforming the shaping object into a “just right shape” that allows for cleaning and filling, primarily minimally invasive endodontic .03 and .04 angled canal shapes.

[0035] However, every new technology has its own limitations. For example, C-shaped molars treated by Buchanan using the Sonendo system showed referred pain and painful reactions even after treatment. Development of the Conceptual Basis for This Disclosure With the anatomy of the C-shaped molar in mind, Buchanan's best theory for the etiology of continued pain after treatment revolved around inflamed pulp debris remaining in a very large area of ​​the isthmic space between the ML and the distal canal. To test this theory, Buchanan assembled an isthmic study block with a ham in the isthmic space, placed it in a vice, constructed a Sonendo platform, and observed the Sonendo system in action. The Sonendo system begins with a 90-second distilled water cycle that performs a leak check. The acoustic energy released in the presence of distilled water is very capable of shaking things up, but nothing happens to the dental pulp analog.

[0036] Buchanan then filmed the effect of this sonic energy in the presence of sodium hypochlorite. When this footage is viewed in time lapse, it becomes very clear that the 5-minute Sonendo system NaOCl cycle ends just before the pulp analog is all digested, literally melting and shrinking. However, unexpectedly and surprisingly, nothing happens to the pulp remnants during the subsequent distilled water and EDTA cycles. Thus, it is actually the sodium hypochlorite that is doing the job of digesting the pulp tissue in the lateral spaces. Indeed, Sonendo's multisonic energy greatly accelerates the saponification of the soft tissues in the root canal. In any case, we reiterate that sodium hypochlorite is the primary event in the success of root canal treatment.

[0037] To further test this theory, Buchanan hooked up another Sonendo instrument and, once the NaOCl cycle had begun, completely removed the remains of the pulp analog for an extra 2.5 minutes, which led Buchanan to conclude that the world's most sophisticated agitation would not digest the pulp tissue in the lateral spaces without NaOCl.

[0038] Multisonic energy without NaOCl does not break down and remove pulp tissue because this soft tissue actually absorbs and dissipates the sound energy. Tests have shown that the isthmus block pulp analog was not affected at all during the Sonendo procedure with H2O or EDTA. Only during the NaOCl irrigation cycle was the pulp tissue digested. This suggests that the pulp tissue was dissolved by NaOCl rather than by agitation.

[0039] In summary, the Sonendo system is highly effective but has limitations in minimal avoidable endodontic access size and is expensive (e.g., $80,000 per console, $5,000 per year, and $100 for each treatment instrument in maintenance after the first year). In other tests conducted by the inventors of the system disclosed in Buchanan's U.S. Patent Application Publication No. 2018 / 033821, an ENDOVAC™ microcannula placed near the end of each cannula was able to draw NaOCl irrigant solution down the cannula in succession, sealed at the cavity surface of the tooth, aspirated, and injected into the pulp chamber, as it was evacuated from the tooth through the cannula into a vacuum system. The advantage of this approach is that it is multi-canal, requires little hands-on time from the clinician, and is completely safe. In a test of the closed irrigation system, a canine was cut into a 30-.4 shape and the system was flushed with constant negative pressure NaOCl irrigant for 30 minutes, irrigated with EDTA for 15 seconds, and then the tooth was split. Scanning electron micrographs confirmed no signs of debris in the coronal, mid-root, or apical regions. Contrary to the findings of some investigators, Buchanan found no "over-etching" of dentin with a 30-minute irrigation time with NaOCl. The only problem was that the needle had to be flushed with EDTA every 5 minutes or the solution would slow down if debris collected around the microport. This was very time-consuming and careful, given that the aim was to perform it without an endodontist or assistant in the operating room. It took 40 minutes to match the isthmus irrigation results seen with the Sonendo system. This was because the vacuum needle opening became clogged with pulp debris in the analog, severely restricting the flow of irrigation solution.

[0040] Therefore, what is needed is an endodontic cleaning and filing system and method that avoids the complexities and costs associated with prior art systems and methods, yet provides overall drainage and cleaning in a shorter time than those prior art systems and methods. Summary of the Invention

[0041] An embodiment of the present disclosure provides a staging assembly for negative pressure, multi-canal irrigation and subsequent obturation of a root canal system. The staging assembly can be sized for anterior, premolar, or molar teeth (and their respective root canal systems) and is sealed to the tooth. The staging assembly is bonded to the lingual surface of an anterior tooth or the occlusal surface of a posterior tooth, over and around the tooth's access cavity (previously cut as part of the overall root canal procedure).

[0042] The staging assembly may be part of a kit that includes multiple catheters sized for insertion into the root canal system. The embodiment passively draws irrigation solution out of the end of the catheter in a completely safe manner. Then, once the root canal has been irrigated, by switching the needle and applying vacuum pressure, the sealer can be drawn into the pulp chamber all the way to the end of the root canal, allowing obturation of complex root canal systems to be performed within 1-2 seconds.

[0043] To hold the catheter in the proper position within the canal, the catheter may include a stop, and the staging assembly may include a corresponding stop retainer. The distal end of the catheter may be positioned 2mm to 4mm from the end of the root canal. The catheter may be a thin-walled catheter ranging from 29 gauge to 31 gauge for adequate flow rate and clearance. The staging assembly is then sealed, creating a closed system.

[0044] The irrigation fluid is drawn through the end of the catheter by vacuum and debris is expelled through the vacuum port on the staging assembly. (Due to the negative pressure suction, flow automatically stops if the distal tip of the catheter locks in any way against the canal wall or reaches or goes beyond the end of the root.) No hands-on time is required by the clinician during irrigation.

[0045] Prior to use, air is injected into the irrigation solution and when the clinician physically shakes, the surfactants in the NaOCl foam the solution until air bubbles out. Buchanan's research revealed that running a foamy irrigant through the catheter cuts the time to dissolve pulp tissue debris in half due to the shear effect of the air bubbles expanding outside the end of the catheter. The irrigation solution can also be heated. In embodiments, ultrasonic energy or multiple sonic waves do not need to be applied to the irrigation solution for the system and method to be effective in removing debris from the canal, including the lateral regions of the canal. In some embodiments, aeration as described above can be applied, or the solution can be heated, or heating and aeration can be applied to speed up irrigation.

[0046] After cleaning, the vacuum is reversed to dry the tube. Occlusion is performed through the vacuum port. Bioceramic (premixed) filler can be used for occlusion. Bioceramic materials can be further optimized for vacuum delivery by modifying their flow properties, as evidenced by increasing carrier concentration in benchtop experiments.

[0047] An embodiment of the staging assembly may include a stage having a flexible staging skirt attached to a hard plastic staging ring. The flexible staging skirt is adapted to the particular tooth being treated and is sealed to the tooth with a viscous light-cured (or chemically cured) polymer or sealant. The staging ring includes a catheter fence that secures the catheter and a rubber catheter stop (to control the position of each catheter within each root canal). The hard plastic stage ring may also include an alignment socket for a top plate with a vacuum port. The top plate is fitted into the hard plastic staging ring and sealed in place with a light-cured polymer, completing the closed system vacuum seal.

[0048] In an embodiment of the disclosed method, a staging assembly is bonded to the tooth, a catheter is placed in the canal, and a top plate is inserted into the staging ring and sealed, thus creating a closed system inside the tooth. A short length of plastic tubing with a luer connector on the other end is bonded to a barbed port coming out of the top plate. One end of a vacuum line is inserted into a dental suction source on the chair side, and the other end is connected to this luer connector coming from the vacuum port on the top plate. The catheter manifold line is connected to a mini IV bag of NaOCl. Vacuum pressure is then applied to the root canal system through the vacuum port on the top plate, drawing irrigation fluid out of the end of the catheter in a constant flow without the risk of inadvertently injecting irrigation fluid beyond the apex and into the periapical tissues. This unique delivery of irrigation fluid (1) prevents clogging of the catheter with debris expelled from the canal and (2) creates a flow that travels in front of the catheter, thereby irrigating to the end of the canal without the need to enlarge the canal sufficiently to allow the catheter to be fully placed in the canal (as is required in conventional negative pressure irrigation procedures).

[0049] The port in the top plate also serves as an injection port for the filling material after the irrigation procedure is completed, at which point suction is reversed from the pulp chamber to the catheter, drawing the filling material from the pulp chamber to the end of the catheter, thereby almost instantly sealing each canal as well as the lateral recesses of the root canal system, completely filling the root canal space previously occupied by pulp tissue.

[0050] An embodiment of a system for use in irrigating and obturating the root canal system of a human tooth includes a staging assembly including a connected staging skirt and a staging ring, the staging skirt made of a first material and being flexible and the staging ring made of a second material and being rigid, the staging skirt further including a flap defining a cavity having a predetermined size for connection to the human tooth, the staging ring further including a catheter fence including a plurality of spaced apart catheter openings and a catheter stop retainer, the catheter fence defining a fenced-in open area, at least one port in communication with the fenced-in open area, and a plurality of catheters including a catheter stop sized to be captured by the catheter stop retainer, the stop being movable along the length of the catheter.

[0051] An embodiment of the system may also include a top plate sized to insert into the fenced open area, the top plate including at least one port. The top plate may include a pair of outrigger pegs, and the staging ring may include a pair of alignment slots, such that the outrigger pegs reside in the alignment slots when the top plate is connected to the staging ring. A vacuum line is connected to the at least one port, and an IV bag containing an irrigation solution including sodium hypochlorite is connected to the multiple catheters. Each catheter is a thin-walled catheter ranging from 29-31 gauge, has a blunt cut end with rounded edges, and can be cold drawn or heat treated or annealed to modify stiffness or ductility. Having an annealed catheter is advantageous in endodontic therapy because it increases the catheter's flexibility for improved placement at the end. However, using a catheter with improved ductility also increases the chance of the catheter collapsing or crimping during placement. This can be solved by encasing the proximal portion of the thin-walled catheter by a tube having a different gauge and being stiffer than the thin-walled catheter.

[0052] The system may also include at least one syringe containing either a dental sealant including a light-cured polymer, a liquid solution including ethylenediaminetetraacetic acid, or a bioceramic. A three-way valve may be disposed between the syringe, the catheter, and the IV bag. One end of the three-way valve is connectable to a vacuum pump (via a vacuum line connected to a port), the other end of the three-way valve is connectable to an IV bag, and yet another end of the three-way valve is connectable to a syringe.

[0053] An embodiment of the disclosed method for irrigating and obturating the root canal system of a human tooth using the disclosed system includes: After the access cavity to the root canal system has been prepared, bonding a staging assembly onto a cavity surface of the human tooth; placing at least one catheter through the staging device into each canal of the root canal system, where at least one catheter (one or more catheters positioned at the coronary access to allow irrigation to reach each canal) passes through the staging assembly and into the root canal system, with a distal end of the at least one catheter within 2-5 mm of the tip of their respective canal; enclosing the staging apparatus to form a closed system; connecting at least one catheter, a source of irrigation solution containing sodium hypochlorite, and a syringe containing ethylenediaminetetraacetic acid to the three-way valve; attaching a vacuum line to a port of the staging assembly; flushing at least one catheter with ethylenediaminetetraacetic acid; After the flushing step, irrigating the root canal system by providing an irrigation solution through the at least one catheter, the irrigation solution being drawn from the ends of the at least two catheters by applying a vacuum to the vacuum line, the irrigation being in the range of 10 to 30 minutes; During the irrigating step, evacuating the irrigation fluid delivered by the at least one catheter, together with tissue dissolved by the irrigation fluid, from the root canal system by applying a vacuum, wherein irrigation and evacuation occur continuously and simultaneously; After cleaning and draining, Disconnect the supply of cleaning fluid from the three-way valve. Remove the syringe containing ethylenediaminetetraacetic acid from the valve. Disconnect the vacuum line from the staging device and connect the vacuum line to the three-way valve. Apply vacuum to at least two catheters through the vacuum lines drying the root canal system by After the drying step, obturating the root canal system through the staging assembly by connecting a syringe containing a bioceramic filler to the three-way valve and injecting the bioceramic filler into the pulp chamber of the human tooth; Includes.

[0054] For anterior and premolar teeth, the method may include, prior to the step of joining the staging assembly, placing the staging assembly on the person's tooth with a placement tool, the placement tool including a head shaped complementary to the fenced open area of ​​the staging ring and tines that pass through the fenced open area.

[0055] Apparatus, system, and method embodiments of the present disclosure include, but are not limited to, those embodiments comprising: a) Safely deliver caustic irrigation and disinfecting solutions to the apical and outermost regions of the root canal through the end of an irrigation catheter aspirated by negative pressure applied to the pulp chamber of the root canal system; b) as filling material is placed into the pulp chamber through the previous vacuum port, it is pulled in reverse by the negative pressure applied through the end of the irrigation catheter to rapidly deliver filling material to the most apical and outer regions of the root canal; c) creating a closed system for achieving the desired effect; d) Assist in controlling the placement and length of the catheter within the primary canal of the tooth being treated; e) Catheters only allow fluid to flow out, thus preventing catheter clogging; f) Providing positive outflow to clear the front of the catheter, which is important with respect to minimally invasive endodontic therapy; g) Achieving extensive lateral pulp removal within 10 minutes for large anterior or premolar teeth, 15 minutes for lateral recesses between the small canals, 20 minutes for molars (widest isthmus space), and up to 30 minutes; g) requires only 2 minutes of hands-on time (no clinician time is required after staging is completed); h) multitubular; i) Support one root canal treatment; j) requires no capital or maintenance costs; k) 100% disposable after the procedure; l) No power required other than chair side suction; m) Supporting minimally invasive endodontic canal geometries In this respect, it is novel and inventive. [Brief description of the drawings]

[0056] [Figure 1] FIGURE 1A is an isometric view of an embodiment of a staging assembly of the present disclosure, which includes a staging skirt sized for anterior, bicuspid, or molar teeth and a complementary staging ring that provides a stable platform for irrigation catheters and suction tubes when used during an endodontic procedure. FIGURE 1B is a side view of the staging assembly of FIGURE 1A. [Figure 2A] 1 is an isometric view of another embodiment of a staging assembly of the present disclosure;A catheter fence disposed in a staging ring provides a catheter opening and a corresponding catheter stop retainer; [Figure 2B] FIG. 2B is another isometric view of the staging assembly of FIG. 2A, with the catheter not inserted into the catheter fence. [Figure 2C] FIG. 1 is an isometric view of staging assemblies of the present disclosure, one sized for anterior teeth, another sized for bicuspid teeth, and another sized for molars. [Figure 2D] FIG. 2D is an isometric side view of the staging assembly of FIG. 2C, including a top plate with a vacuum port Luer connector. [Diagram 3] 1 is an isometric view of staging assemblies of the present disclosure, one sized for anterior teeth, one sized for bicuspid teeth, and one sized for molar teeth, when bonded to teeth; [Figure 4] Figure 4A is a diagram of an embodiment of a staging assembly secured to a tooth with a micro cable tie, and Figure 4B is a diagram of the staging assembly of Figure 5A with a rubber dam in place. [Diagram 5] Figure 5A shows an embodiment of a staging device that is secured to the tooth with a micro cable tie and provides suction to the rubber dam and surgical field through a tube connected to a port in a top plate sealed to the staging device. Figure 5B shows an embodiment of a staging device that is secured to the tooth with a micro cable tie and provides suction to the rubber dam and surgical field through a spaghetti tube. No top plate is used. [Figure 6] FIG 6A is a front view of one embodiment of an irrigation catheter of the present disclosure. As a non-limiting example, the catheter is 40 mm long and made of 30 gauge thin wall stainless steel tubing with a 22 gauge stainless steel overtube to reinforce the proximal 20 mm of the catheter. FIG 6B is a detailed view of the catheter of FIG 3A. The edges of the catheter are rounded so that it glides along the curvature of the canal without scraping off dentin debris that may block the catheter. The catheter includes a blunt cutting end because a blunt cutting end appears best suited to allow the evacuated irrigation fluid to passively flow into the terminal third of the small canal in front of the catheter. [Figure 7] FIGURE 7A illustrates one embodiment of a placement tool that can be used with the forward staging assembly of the present disclosure; FIGURE 7B illustrates a close-up of the placement tool connected to the forward staging assembly; FIGURE 7C illustrates another close-up of the placement tool connected; and FIGURE 7D illustrates yet another close-up of the placement tool connected. [Figure 8] FIGURE 8A illustrates an embodiment of a placement tool that can be used with the bicuspid staging assembly of the present disclosure. FIGURE 8B illustrates a close-up of the placement tool connected to the bicuspid staging assembly. FIGURE 8C illustrates another close-up of the placement tool connected. FIGURE 8D illustrates yet another close-up of the placement tool connected. [Figure 9]1 is an embodiment of a kit for use with the disclosed systems and methods. As a non-limiting example, a disposable sterile package may be provided that includes the disclosed staging assembly, a syringe with sealant, an irrigation catheter with stopper, a manifold and three-way valve, a top plate with associated tubing and luer connectors, vacuum tubing, and irrigation fluid. [Figure 10-1] 1A-1C illustrate various steps in the disclosed method for connecting a staging device to a tooth, where each catheter is placed into a respective catheter slot of the staging device, and the entire staging assembly is sealed to form a closed system. [Figure 10-2] 1A-1C illustrate various steps in the disclosed method for connecting a staging device to a tooth, where each catheter is placed into a respective catheter slot of the staging device, and the entire staging assembly is sealed to form a closed system. [Figure 11-1] 1 illustrates various steps in the disclosed method for irrigating a root canal system. Irrigation fluid is gravity fed into the catheter and aspirated out of the end of the catheter by suctioning the suction tube. Gravity feed cannot overcome hydrostatic pressure in the tissue, eliminating the hazards associated with positive pressure irrigation, and the end of the catheter can be placed at or near the apex of the canal, 2mm to 4mm away from the apex. The system and method provide automated continuous irrigation and an alternating pressure device for irrigation and instantaneous obturation (see FIG. 12). [Figure 11-2] 1 illustrates various steps in the disclosed method for irrigating a root canal system. Irrigation fluid is gravity fed into the catheter and aspirated out of the end of the catheter by suctioning the suction tube. Gravity feed cannot overcome hydrostatic pressure in the tissue, eliminating the hazards associated with positive pressure irrigation, and the end of the catheter can be placed at or near the apex of the canal, 2mm to 4mm away from the apex. The system and method provide automated continuous irrigation and an alternating pressure device for irrigation and instantaneous obturation (see FIG. 12). [Figure 12]13A-13D illustrate various steps in the disclosed method for drying a irrigation pipe system and filling it through a staging assembly. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0057] The disclosed embodiments utilize a staging assembly that is bonded to the tooth. Staging begins after instrumentation and cone fitting are complete by scrubbing the isolated tooth with an alcohol cotton ball held in a locking pliers. The disclosed embodiments can effectively clean and fill through very tight openings and can also clean and fill fairly wide isthmus spaces (e.g., at least 3mm to 4mm wide) between the MB canals. For teeth with cervical caries but with intact occlusal surfaces, this style of minimally invasive endodontic access can leave the tooth as strong after root canal treatment as it was before. Removing the stage from the patient's tooth is easy, simply grasp the buccal and lingual sides of the staging assembly with a hemostat and roll it to the side.

[0058] The staging assembly (which can be 3D printed) provides a stable platform for placing the elongated catheter into the primary canal of the root canal system, as well as a port to which suction can be connected for negative pressure. As debris is expelled from the port, the negative pressure draws irrigation fluid out of the end of the catheter. A vacuum greater than 190.5 mmHg (7.5 in. Hg) must be used or fluid flow during irrigation may be compromised.

[0059] 1A through 5B, an embodiment of a staging assembly 10 of the present disclosure includes a staging skirt 11 made of a first material and a staging ring 13 made of a second material different from the first material, with the skirt 11 and the ring 13 having different flexibility (rigidity). In an embodiment, the staging skirt 11 is flexible and the staging ring 13 is rigid. The material of the staging skirt may be a rubber material, such as 3D printed rubber, and the material of the staging ring may be a plastic material, such as 3D printed plastic.

[0060] The staging assembly 10, and particularly the staging skirt 11, can be attached and sealed to the teeth with a viscous light-cured polymer of the type known in the art. As a non-limiting example, a light-polymerizable hydrophilic sealant can be used. The staging assembly may be a single size that accommodates anterior teeth, bicuspids, and molars. However, it may be difficult to seal the assembly across a wide range of tooth sizes. Better performance is achieved by making the staging assembly 10 a first size to accommodate anterior teeth, a second size to accommodate bicuspids, and a third size to accommodate molars. See, for example, Figures 2C-3.

[0061] The staging skirt 11 may include flaps 12 intended to cover the buccal and lingual sides of the tooth and arcuate side walls 14 that accommodate placement relative to adjacent teeth. For example, the buccal flap 12 of the staging skirt hangs over the incisal edge and is bonded to the buccal tooth surface to help stabilize the staging assembly.

[0062] The staging ring 13 may include a catheter fence 17 that provides one or more catheter openings 29 and corresponding catheter stop retainers 36. In some embodiments, up to five catheter openings 29 are provided, such as in the case of the molar staging ring 13. The anterior staging ring 13 may have two catheter openings 29 and the bicuspid staging ring 13 may have three catheter openings 29. Any unused catheter openings 29 may be sealed prior to flushing the canal.

[0063] The catheter fence 17 surrounds a central opening or fenced area 47 that provides access to the pulp chamber of the tooth. In some embodiments, the staging ring 13 includes alignment sockets 39 on the buccal and lingual sides 22 of the staging ring 13. A top plate 45 covers the fenced area 47.

[0064] Top plate 45 includes port 49. Outrigger peg 48 on the top plate resides within socket 39. Port 49 functions as an aspiration port during irrigation and as a fill port during occlusion.

[0065] The top plate 45 may be 3D printed, may be made of a third material that is the same or different than the staging skirt 11 or staging ring 13, and may have the same or different flexibility as the staging skirt 11 or staging ring 13. In an embodiment, the top plate 45 is the same material as the material of the staging ring 13. The material of the top plate may be a material selected from Table 1 below. In some embodiments, the top plate 45 may include an attached vacuum line 46 with a Luer connector 47. See, for example, FIG. 2D. The top plate 45 is attached and sealed to the staging ring 13 after the catheter 50 is placed in the tube at the appropriate length and confirmed by radiography.

[0066] [Table 1]

[0067] Unlike prior art systems that require a single, same length cannula because the hub to which the cannula is connected must be captured in an aspiration manifold placed on the tooth, the staging assembly 10 allows the catheters 50 to be placed any length into the canals and still be secured. The distal end 51 of each catheter 50 can be placed within 2 mm to 4 mm of the end of each canal, with the catheters 50 secured by the stops 37 and stop retainers 36. In some embodiments, the catheters 50 can be placed within 2-3 mm, 3-4 mm, or 4-5 mm of the end.

[0068] The gauge used for the catheter 50 is important for effective fluid dynamics. In an embodiment, the catheter 50 has a gauge size ranging from 29 to 31 and may be a 30 gauge. With reference to FIGS. 6A and 6B, the catheter 50 may be a thin-walled catheter. For example, the catheter 50 may be a 30 gauge catheter with an ID of 0.27 mm and an OD of 0.31 mm. In an embodiment, the catheter 50 includes a blunt cutting end distal end 51 for better cleaning before and after the apical placement point in each canal, and delivers a constant flow of irrigation fluid to the end of the root canal drawn out of the end 51 under vacuum. The catheter 50 has rounded edges 53 to facilitate sliding around the curvature of the canal without scraping off dentin debris that may block the catheter 50.

[0069] As a non-limiting example, the catheter 50 may be 40 mm in length and made of a 30 gauge thin-walled ductile (annealed, softer) stainless steel tube 55 with a 22 gauge hardened (hardened, harder) stainless steel overtube 57 to strengthen the proximal half 56 (e.g., 20 mm) of the catheter 50. A portion 54 of the inner tube 55 remains exposed beyond an end 58 of the overtube 57. The tube 55 may be expandable in and out of the overtube 57. The overtube 57 may include predetermined spaced bands 59 to help indicate length or depth.

[0070] The irrigation fluid delivered by the catheter 50 may be a dental fluid known in the art, such as sodium hypochlorite (NaOCl) or its equivalent. In an embodiment, the anterior staging assembly 10 is connected to the irrigation fluid by a manifold 75 having a single catheter line 79, the bicuspid staging assembly 10 is connected to two catheter lines 79 via the manifold 75, and the molar staging assembly 10 is connected to four catheter lines via the manifold. A three-way valve 73 is disposed between the irrigation fluid source 83 and the manifold 75. See, for example, FIG. 9.

[0071] In some embodiments, the irrigation fluid may be heated above ambient room temperature (about 20° C. to 22° C.) in the range of about 5° C. to about 10° C. to increase the reaction rate of NaOCl. The irrigation fluid may contain a NaOCl solution containing a wetting agent, such as found in CHLOR-XTRA™, or a fluorosurfactant, an amine oxide, a disulfonate, an ethoxylated alcohol, or mixtures thereof. The IV bag or container containing the irrigation fluid may have its lower end positioned about 12 inches to 18 inches above the patient's head after the patient is positioned correctly for the procedure.

[0072] 7A-8D, the staging assembly 10 (in the case of an incisor or premolar staging assembly 10) may also include a positioning tool 60 for centering the staging assembly 10 in the access cavity. (The molar staging assembly 10 does not require a positioning tool 60). The positioning tool 60 includes a handle 61 and a head 63 located at a distal end 65 of the handle 61. The head 63 is shaped complementary to the enclosure region 47 of the staging assembly 10 and may include an outrigger peg 48. Tines 67 connected to the head 63 protrude below the staging ring 13 and function as a centering device. The positioning tool 60 also makes it easier to hold the anterior and premolar staging assembly 10 in place while the sealant cures.

[0073] 9-12, in an embodiment of a kit of the present disclosure, the kit may include a syringe 71 with an irrigation tip and containing 17% EDTA solution (e.g., a SMEAR-OFF™ syringe), a staging assembly 10, a staging placement tool 60 (premolar and anterior kit), a vacuum tube 85 adapted for saliva or high volume evacuator (HVE) suction, an apex locator, a syringe 81 with a delivery tip and containing a light curing polymer (e.g., a VACUSEAL™ light curing sealant syringe with a luer tip), an IV bag 83 containing NaOCl solution (e.g., Chlor-XTRA™ Plus enhanced 8% NaOCl solution), an empty syringe 91 for venting (e.g., a 6 cc or 12 cc syringe), an irrigant supply tube 79 with one, two, or four catheter (manifold) assemblies 75, and a bioceramic sealer. The kit may contain all the sodium hypochlorite needed for anterior, premolar, and molar cases.

[0074] Irrigation solutions like Chlor-XTRA™ Plus are superior to Clorox® bleach because they are about an 8% solution (important for soft tissue digestion) and have added buffering to stabilize them during storage and transport, so they are strong enough when the bag is first drawn. A surfactant is also added to reduce the surface tension of the solution against the dentin, facilitating penetration into the dentinal tubules. This surfactant is also what creates the foam when air is injected and the bag is shaken.

[0075] In an embodiment, a 3-tooth slit rubber dam separation stabilizes the staging assembly to extend the sealant over the adjacent marginal ridge and embrasure. If the clinician does not thoroughly scrub the tooth with an alcohol cotton ball before staging, it is difficult to achieve a predictable seal between the staging assembly and the tooth. For carious defects, all missing walls must be excavated to remove decay. The surfaces of the excavated defect and adjacent interproximal teeth are thoroughly scrubbed, and the missing walls are rebuilt with sealant. The inventors have found that conventional composites and glass ionomers are not suitable for this, as they cannot withstand vacuum pressure for several hours after curing. Reconstruction of interproximal defects requires the adjacent teeth to support the sealant in the defect.

[0076] The clinician carefully cleans and thoroughly dries the surfaces of the tooth under treatment and the adjacent teeth. Moisture on the tooth structure prior to application will prevent proper adhesion of the sealant to the tooth structure. In an embodiment, a two-stage bonding procedure may be used. A rubber dam is first sealed around the cervical area of ​​the isolated tooth, then the dam and tooth are cleaned and dried again. The sealant is injected with a syringe into the embrasures of the MB, ML, DB, and DL of the tooth under treatment, then around the buccal and lingual sides of the tooth, then across the contacts to the adjacent teeth. Finally, the lingual or occlusal surface is coated with a thickness of approximately 1 mm of sealant. The sealant is allowed to harden.

[0077] Inject sealant with a syringe onto the underside of the staging skirt, being careful not to get sealant on the positioning tines of the positioning pool. For anterior staging, place the staging assembly onto the lingual surface of the tooth and, guided by the positioning tines of the positioning tool, use a curing light to press the buccal staging skirt flap against the tooth and light it. This allows room for the staging assembly to stabilize on the tooth and cure each surface for an effective amount of time (e.g., 5 seconds). When removing the positioning tool from the staging ring, it is best to hold the staging assembly with cotton pliers while pressing it against the tooth as you pull the positioning tool out.

[0078] If the sealant has adhered to the access cavity, a little wiggling may be required to separate the placement tool from the sealant flowing under the staging skirt. If the sealant has blocked the access cavity in any way, a diamond bur can be used to trim the sealant without enlarging the access cavity. This completes the first objective of the procedure: attaching and sealing the staging assembly to the tooth. The assembly is now in place to hold the catheter stop in place during placement and alignment.

[0079] Screw the Luer connector of the NaOCl IV bag onto the valve stem opposite the manifold line attached to the IV valve. Using a patient bib clip, hang the IV bag from the microscope arm with the spout facing up if an aerated solution is desired, or facing down if NaOCl-only fluid flow is desired. Using an empty syringe included in the kit, inject a syringe full of air into the IV bag 2-4 times and shake the solution to generate an aerated foam that can energize the irrigation fluid dynamics later in the procedure.

[0080] To aid in catheter placement, a finishing file is placed on each canal to read the length required from the catheter fence to the ideal position in the canal and transfer that length (minus 2mm to 4mm) to the actual catheter to be used in the procedure. Alternatively, an apex locator of the kind known in the art can be used in canals with a terminal diameter greater than 0.3m. The apex locator probe is placed at the end of the canal so that it contacts the shank of the catheter. The catheter stop is adjusted to the height of the catheter fence at the level of the stop retainer. Take out, measure, subtract 2 to 3mm, and push the catheter stop into one of the stop retainers. In the simplest cases, there is little need to adjust the catheter depth after the confirmatory x-ray is taken. The placement of these catheters will almost always appear on the confirmatory x-ray in the ideal position, leaving no doubt that the passive fluid flow around the end of the catheter is adequate. Ideal placement is a matter of effectiveness, not safety, since if the catheter is accidentally placed too long or beyond, the vacuum will be blocked by the catheter end coupling tube or soft tissue, instantly stopping the flow of irrigation fluid from the end of the catheter. Once stop 37 is captured within retainer 36, catheter 50 can be easily adjusted to the proper length.

[0081] In small tracts, an attached catheter is used with an EDTA syringe to ideally position the catheter in the tract. The challenge in placing a catheter in a small tract is to insert the catheter as deep as possible without blocking the fluid path (e.g., within 3-5 mm of the distal length). Locking the catheter in the tract is not at all dangerous, it will only reduce the effectiveness of irrigation in that particular tract. Therefore, an EDTA syringe is attached to the attached catheter to test the fluid flow after the catheter is placed at the junction. In most cases, the catheter will bind around the curvature of the small tract, leaving enough space for backward fluid flow, which is essential to the irrigation effectiveness of this disclosure. Blocking the small tract escape path of fluid from the catheter is not at all dangerous, it will only reduce or eliminate the effectiveness of irrigation in that particular tract. When a catheter binds in a small tract, it usually does so at the curvature, not circumferentially, leaving enough space for fluid to flow backward around the end of the catheter.

[0082] Even when the tips of the blunt cut ends are circumferentially bound within the canal, it is common for the isthmus between the canals to provide a coronary vent space, but the clinician needs a way to confirm this fluid flow at the bound length. Therefore, an EDTA syringe can be attached to the test catheter or accessory catheter to test for fluid flow after the test catheter is placed at the bound point. Once fluid flow is confirmed at the bound length, the stop on the test catheter is positioned to enter the stop retainer on the catheter fence, the test catheter is removed, the length is measured, and the length is transferred to the treatment flushing catheter. The treatment catheter is then placed in the appropriate canal and the stop secured to the stop retainer.

[0083] If fluid flow is obstructed by the attached catheter at the junction in the vessel, pull the catheter back 1 mm and check fluid flow again. This process continues until fluid flow is adequate. The stop can then be adjusted and the length transferred to the catheter for use in that vessel.

[0084] An x-ray is then taken to confirm proper placement of the catheter in the tract. Adjust as necessary. If a change in catheter position is necessary, the clinician should not pull on the tubing but instead grasp the catheter with a cotton swab or hemostat. Ideally, the end of the catheter will be within 2mm to 4mm of its total length within the tract while still demonstrating optimal fluid flow. ENDO-BENDER pliers can be used to bend the end of the catheter, which can be helpful in these cases.

[0085] Once catheter placement and fluid flow are confirmed, attach the top plate to the staging ring and cement it into place using liberal amounts of sealant. It is necessary to run a bead of sealant around the outrigger pegs of the alignment socket, otherwise leakage may occur. Scrub the tooth being treated and adjacent teeth with 1-2 alcohol cotton balls, then clean and dry the site thoroughly.

[0086] The sealant is injected with a syringe around the neck of the tooth being treated, then into the embrasure above the contact points, the other side is coated and the sealant is light cured. This completes the sealant base for the tooth. The inside of the staging skirt is coated free of sealant on the positioning tines of the placement tool and placed on the tooth and light cured. Additional sealant should be added around the catheter as it exits the staging ring catheter fence. The empty catheter opening in the fence should also be sealed. Allow the sealant to cure.

[0087] Vacuum lines can now be connected to the port-ins on the top plate and to the HVE or saliva ejector. Listen for suction around the stage. If noise is heard, remove the suction lines, syringe sealant in areas where there may be a leak and allow it to cure. Then reconnect vacuum and listen. Since embodiments of the present disclosure can handle air leaks, monitor the catheter lines for fluid flow when determining if there is an intervention.

[0088] A final fluid flow check can be performed by screwing in the EDTA syringe and turning the IV valve lever (which should always point to the off position) towards the IV bag to open the line between the EDTA syringe and the manifold / catheter. Push and pull the syringe plunger to ensure fluid flows in both directions. EDTA is safe to inject with positive pressure, but caution should be exercised if fluid is not flowing adequately. Once this step is complete, turn the IV valve towards the EDTA syringe and remove it.

[0089] As soon as the valve is turned to the mid position, NaOCl flows through the catheter, into the manifold, and exits the pulp chamber through the vacuum port line. Once the procedure is complete, disconnect the patient end of the vacuum line from the vacuum port on the top of the staging assembly and reconnect it to the central stem of the IV valve before removing the staging assembly and catheter.

[0090] Rotate the IV valve tang towards the IV bag to shut off the NaOCl flow and apply vacuum pressure to the catheter manifold to dry the tubing. This should only take about 30 minutes, continuing to monitor the vacuum line to ensure fluid is no longer backing up into the chairside suction. No filler can be applied through the port.

[0091] In an embodiment of the method of the present disclosure, the method comprises: 1. Prepare the tube. The clinician prepares the tube, fits the cone, and takes an x-ray. In an embodiment, the instrumentation may include a 17% EDTA solution.

[0092] 2. Attaching the staging ring and skirt to the tooth being treated and sealing it. Scrub the tooth with an alcohol swab or use an alcohol syringe with a syringe tip to prevent the saliva film from compromising the seal on the tooth. One or two alcohol swabs may be used and held in place with locking pliers. b. Place the attached tip on the syringe and place a caulking rope of sealant over each contact area, into the embrasure, and on the buccal and lingual surfaces. The sealant should surround the periphery or occlusal surfaces. The sealant may be a light-cured dental liquid dam / gingival barrier material. c. Place the staging ring and skirt over the teeth and into the sealant. Cotton pliers can be used for this purpose, with the tines of the pliers fitting into the outrigger holes of the staging ring. d. Light cure all sides. In an embodiment, light cure can be accomplished in about 20 seconds.

[0093] 3. Placing the catheter. a. Place each catheter into each tract by length with the proximal end positioned in the respective catheter slot of the staging ring and the distal end positioned within 2mm-5mm of the end of the tract. Rubber stops may be used to indicate the proper length of each catheter and to secure each successive catheter in place before the next. The catheter stops are pressed into the stop retainer, but once in place, the catheters can be easily adjusted to the ideal length without the stop coming out of the stop retainer. b. Once all catheters are in place, set the outrigger pins on the top plate into the holes in the staging ring and seal the top plate to hold the catheters in place. c Take an x-ray to confirm proper placement relative to the ends of the tube. Adjust the catheter as needed.

[0094] 4. Use a sealer to seal the top plate to the staging ring.

[0095] 5. Install suction (after the sealant has cured to prevent leaks). Connect one end of the vacuum (suction) / fill line to the tubing on the top plate. In an embodiment, the line is 2 feet long and can be connected to the luer connector of the top plate vacuum line output port. b. Connect the other end of the line to a chairside vacuum system, either a High Volume Aspirator ("HVE") or a saliva suction valve.

[0096] 6. Connect to cleaning solution. Pull back on the plunger of an empty syringe (included in the kit), screw the syringe onto the luer connector of an IV bag containing a cleaning agent (such as sodium hypochlorite (NaOCl)), and inject the entire syringe of air into the bag. Shake the bag until all air bubbles are in solution in the bag. As a non-limiting example, injecting 2-3 12cc syringe fulls of air into a bag or container of sodium hypochlorite allows the clinician to shake the sodium hypochlorite to foam, a process made possible by the surfactant contained in the bag. b. We do this because our studies have shown that when NaOCl foam is vacuumed through the tubing and out the end of the irrigation catheter, the pulp replica is digested twice as quickly as NaOCl without the foam. c. Connect the IV bag of detergent to one end of the two-way valve manifold (the "OFF" valve lever points toward the detergent bag).

[0097] 7. Attach the EDTA syringe and flush the catheters and lines. With the valve turned off towards the IV bag, open the line between the ETDA syringe and the catheter manifold. Thread the ETDA syringe through the center valve stem and syringe a small amount of EDTA through the line, making sure fluid is flowing through the clear cannula mini-tube and check the vacuum line where fluid is returning to the chairside vacuum.

[0098] 8. Open the valve to the irrigant. Turn the valve lever to the middle position and irrigant will immediately begin to move through the irrigant supply line to the cannula manifold.

[0099] 9. Clean the entire root canal system with irrigants. Cleaning can take anywhere from 10 to 30 minutes depending on the tooth and root canal geometry, with subranges and discrete values ​​within this broad range. With an aerated heated solution, cleaning a large anterior or premolar can take as little as 10 minutes. Smaller canals may take 15 minutes because there are often lateral recesses between the canals. Molars have the widest isthmus spaces, so care must be taken to clean adequately, and may take 20-30 minutes. No clinician time is required after staging is completed.

[0100] 10. Reverse the vacuum. After step 9 is completed, turn the valve to shut off the irrigation solution, remove the EDTA syringe, disconnect the vacuum line from the top plate tubing connector and reattach it to the central stem of the IV valve that draws vacuum from the end of the catheter, and dry the root canal system. Drying can be done in 10-15 seconds without a paper point.

[0101] 11. Filling the root canal system. Once the vacuum is reversed and the root canals are dry, a single bolus injection can be used to inject the sealer into the pulp chamber, effectively placing the sealer in the posterior root canal. In an embodiment, the bioceramic sealer is threaded onto the Luer connector of a short piece of tubing attached to the top plate, and the sealer is injected into the pulp chamber until it leaks into the catheter line. Leaking typically occurs in 1-2 seconds.

[0102] 12. Remove the stage with the hemostat, rotate the entire setup off the tooth and withdraw the catheter from the canal. Removal of the catheter may leave a small linear cavity which can be removed by placing a gutta-percha point. The gutta-percha can be burned off by heat and condensed at the opening of the canal.

[0103] 13. Taking an X-ray. One of the biggest advantages of vacuum positive outflow irrigation is that it irrigates 4-5mm beyond the tip of the catheter. This means that a 30 gauge thin walled catheter with an outer diameter of 0.3mm can be used to adequately irrigate a 15-.03 minimally invasive endodontic canal prep that is 0.3mm in diameter and 5mm from the tip.

[0104] System and method testing As an example, one of the co-inventors (Buchanan) treated a patient in an emergency situation, used intraosseous anesthesia, quickly used a rotary negotiation file to lengthen three canals, and placed a sponge over the access to keep it open. When the patient returned for examination 3 days later, on a pain scale of 10, her pain had gone from an 8 or 9 to a 5, and Buchanan expected it to go down to a 1 or 2. This was so rare in Buchanan's experience that he was puzzled as to the etiology of her continuing pain until he had completed the case.

[0105] The distal canal had a mid-root furcation, and the rotary negotiation file only transected and extracted pulp from one of them. Buchanan was unaware of the DL canal, so he only instrumented the MB, ML, and DB canals. So, using this case as a test to determine if the system and method would work for its intended purpose, he set a second catheter midway to the root of that canal, ran it for 20 minutes, and then used it to fill the canal space with bioceramic sealer, followed by gutta-percha points in three canals. The prototype system and method cleaned and filled a 5 mm canal where no instruments had been used, and cleaned and filled an accessory canal 4 mm long from the primary MB canal. Again, this was a lumen containing inflamed, vital pulp tissue, which had not been touched by the file, but was cleaned and filled by the treatment r system.

[0106] Another test case with unusual anatomy had CBCT images that showed it was very close to the mental foramen. Unaware of another canal with a larger distal curvature, Buchanan cut a minimally invasive endodontic access cavity approximately 1.1 mm wide, using the CBCT to calculate the initial canal length, used one 18-.06 horizontal rotary negotiating file to cut it to length in approximately 5 cuts, measured the terminal diameter with a #25 NTKF, and cut one 30-.05 MiniKut rotary file along the lingual curvature of the canal. Buchanan then connected the prototype embodiment and let it run for 15 minutes. A photo of the catheter length shows it set 4 mm short of the root canal end (studies on the block showed that cleaning could be done 4 mm to 5 mm beyond the catheter). The vacuum was reversed and the canal filled using a vacuum suction sealer, even before the gutta-percha cone was placed and condensed. The result was a distal bifurcation. Bioceramic sealers are highly biocompatible. The Bioceramic Sealer will either dissipate or harden over a period of one to two months. In the inventor's experience, the Bioceramic Sealer never causes any problems and is not going anywhere.

[0107] In additional testing of embodiments of the present disclosure, in one test the central canal was highly calcified. Once the canal was found, there was already a decent sized passage there, so Buchanan cut a 25-.05 MiniKut file to length and measured the length with a #25KF, so this was the only tool needed. Buchanan then connected the prototype embodiment and ran it for 20 minutes, then filled the canal and four lateral canals. In another test, the immature central incisors of a 9-year-old boy had not been touched by any files before Buchanan connected the two catheters and ran the prototype for the full 20 minutes, leaving a perfectly clean canal.

[0108] The prototype was tested on both study blocks and patient tooth structures. It is simple to operate and has no dedicated electrical cord, rather it is powered by an evacuation system on the side of the chair; No capital investment risk and no risk to patients; Low maintenance costs; All staging gear, sealants, cleaners, and bio-ceramic sealers can be included in one kit; All root canals of a tooth can be treated simultaneously; The hands-on time is only 2-4 minutes; The cleaning procedure takes less than 20 minutes (large anterior and premolar tubes: approx. 10 minutes or less / 50 ml NaOCl, small anterior and premolar tubes: approx. 15 minutes or less / 75 ml NaOCl, molar tubes: approx. 20-30 minutes or less / 100 ml NaOCl); It is a single-use device, with no cleaning, infection control or barriers; Vacuumed sodium hypochlorite is 100% safe; The embodiment provides CaOH level disinfection in a single visit; Obturation is extremely fast, capturing the complete apical and lateral extent of the root canal system with a vacuum suction sealer propelled into the root canal system It was shown that.

Claims

1. 1. A system for use in irrigating the root canal system of a human tooth, comprising: A staging assembly (10), comprising: Staging skirt (11) and a staging ring (13) adjacent to and connected to the staging skirt (11); Including, said staging skirt (11) being made of a first material and being flexible, and said staging ring (13) being made of a second material and being rigid; The staging skirt (11) further includes a flap (12) defining a cavity (15) having a predetermined size for connection to a human tooth; The staging ring (13) is a catheter fence (17) including a plurality of spaced catheter slots (29) and a catheter stop retainer (36); The catheter fence (17) defines an open area (47) surrounded by the catheter fence (17); at least one catheter (50), said at least one catheter (50) including a catheter stop (37) sized to be captured by said catheter stop retainer (36), said catheter stop (37) being movable along a length of said at least one catheter (50) such that an entire length of said at least one catheter (50) can pass through said catheter stop retainer (36) and into and out of said open area (47); a top plate (45) sized for insertion into the open area (47) of the catheter fence (17), the top plate (45) including ports (49) in communication with the open area (47), the top plate (45) forming a single chamber for receiving the at least one catheter (50) when inserted into the open area (47) of the catheter fence (17); Equipped with The system requires no power other than the chair side suction. system.

2. said top plate (45) including a pair of outrigger pegs (48); the staging ring (13) including a pair of alignment slots (39); Further equipped with When a top plate (45) is connected to the staging ring (13), the outrigger pegs (48) are in the alignment slots (39); The system of claim 1 .

3. The system of claim 1, further comprising a vacuum line (46, 85) connected to the port (49) of the top plate (45).

4. The system of claim 1, further comprising at least one syringe (71, 81) containing either a dental sealant comprising a light-cured polymer, a solution comprising ethylenediaminetetraacetic acid, or a bioceramic.

5. The system of claim 4, further comprising a three-way valve (73), one end of which is connectable to a vacuum pump, the other end of which is connectable to an IV bag containing a cleaning solution including sodium hypochlorite, and the other end of which is connectable to the syringe (71, 81).

6. The system of claim 1, further comprising an IV bag (83) containing a cleaning solution including sodium hypochlorite, the IV bag (83) being connected to the at least one catheter (50).

7. A staging assembly (10) for use in cleaning the root canal system of a human tooth, comprising: Staging skirt (11) and a staging ring (13) adjacent to and connected to the staging skirt (11); Equipped with the staging skirt (11) is made of a first material having a first flexibility, and the staging ring (13) is made of a second material having a second flexibility different from the first flexibility; The staging skirt (11) further includes a flap (12) defining a cavity (15) having a predetermined size for connection to a human tooth; The staging ring (13) is a catheter fence (17) having a proximal side with a greater height than a distal side, the catheter fence including a plurality of spaced apart catheter slots (29) and a catheter stop retainer (36) disposed along the proximal side of the catheter fence (17), the catheter slots (29) being open toward the distal side of the catheter fence (17) to define an open area (47) surrounded by the catheter fence (17) between the proximal and distal sides; a top plate (45) sized for insertion into the open area (47) of the catheter fence (17), the top plate (45) being surrounded by the catheter fence (17) and including a vacuum / fill port (49) facing the proximal side of the catheter fence (17) opposite the catheter slot (29); Further comprising: The vacuum / fill port (49) and the catheter slot (29) are in communication with the open area (47). Staging assembly.

8. A staging assembly as described in claim 7, further comprising at least one catheter (50), the at least one catheter (50) including a catheter stop (37) sized to be captured by the catheter stop retainer (36), the catheter stop (37) being movable along the length of the catheter (50) such that the entire length of the at least one catheter (50) can pass through the catheter stop retainer (36) and enter and exit the open area (47) of the catheter fence (17).

9. A staging assembly as described in claim 8, wherein the upper plate (45), when inserted into the open area (47) of the catheter fence (17), forms a sealed single chamber containing at least one catheter (50).

10. The upper plate (45) including a pair of outrigger pegs (48); the staging ring (13) including a pair of alignment slots (39); Further equipped with When a top plate (45) is connected to the staging ring (13), the outrigger pegs (48) are in the alignment slots (39); The staging assembly of claim 7.

11. A staging assembly as described in claim 7, further comprising a vacuum line (46, 85) connected to the vacuum / fill port (49) of the upper plate (45).

12. A staging assembly as described in claim 7, further comprising an IV bag (83) containing a cleaning solution including sodium hypochlorite, the IV bag (83) being connected to at least one catheter (50).

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