File and method for manufacturing the same

Abstract

The present invention relates to a root canal file, in particular to a mechanical root canal file configured to penetrate and remove material contained in a root canal of a patient undergoing root canal treatment. The present invention also relates to a method of manufacturing the root canal file.

Description

Technical Field

[0001] This invention relates to an endodontic file, and more particularly to a mechanical endodontic file configured to penetrate and remove material contained in the root canals of a patient undergoing root canal treatment.

[0002] The present invention also relates to a method for manufacturing the root canal file. Background Technology

[0003] In the field of medical technology, especially dentistry, and more specifically endodontics, mechanical files or root canal files are a common instrument used in the intervention of patients undergoing root canal treatment.

[0004] Specifically, clinicians use these root canal instruments to perform certain procedures on the root canals of a user or patient, and these procedures vary from case to case. More specifically, root canal files can prepare the root canal for subsequent treatment, penetrate the root canal, and remove dentin debris from the root canal walls through cutting operations performed by the cutting edge of the file. The type of cut produced by the cutting edge varies depending on the geometry of the cutting edge.

[0005] In this way, the root canal file can delineate a permeable path in the root canal, thereby providing the root canal with smooth, stepless walls and unobstructed, clear channels.

[0006] However, the construction of these root canal files is a challenge due to the size limitations of the root canals. First, root canal files and their cutting edges must have specific dimensions and geometries to allow them to enter and operate on the root canals without damaging the dentin of the patient receiving root canal treatment, thereby achieving good removal of debris or residue and ensuring good accessibility to the root canals.

[0007] Other common problems with this type of instrument are, for example, difficulty in manufacturing it given the necessary precision for its dimensions, or damage due to fatigue after an uncertain number of uses.

[0008] Similarly, root canal files must have a high-hardness cutting edge to penetrate the root canal, break up, and remove debris present within it. However, excessive cutting power can damage the patient's root canal walls and / or other tooth areas, further implying significant difficulty in adapting to the tooth's anatomy. Conversely, high flexibility makes proper manipulation of the root canal impossible.

[0009] Based on the above, there are various types of root canal files available, which can generally be divided into two main categories:

[0010] High-hardness root canal files. These files have high cutting power, which is necessary to break up and remove dentin debris contained in the root canals.

[0011] However, these files have the disadvantage of high rigidity, which means they are very poorly adapted to the anatomy of teeth, especially to the geometry of the root canals, resulting in deformation of the root canals and causing serious damage to the root canal walls.

[0012] Highly flexible root canal files. These files have a high degree of deformability, which is necessary for them to adapt to the anatomy of the teeth.

[0013] However, these files have the disadvantage of low cutting power, which makes them difficult to operate inside the root canal and provides poor cleaning results.

[0014] Therefore, current root canal files cannot achieve good results without causing patients discomfort, pain, or even injury at a high risk. At the same time, these instruments are susceptible to rapid wear and breakage, which also causes harm to patients undergoing root canal treatment. Summary of the Invention

[0015] The present invention can solve the above problems by means of root canal files and by means of manufacturing root canal files (such as the method shown).

[0016] Therefore, the first aspect of the invention relates to a file for root canal treatment, extending along a longitudinal direction X-X' between a first end and a second end, characterized in that the file further comprises, between the first end and the second end:

[0017] - The cutting area, configured to break up material from the root canal, includes a cutting edge.

[0018] - Transition area, and

[0019] - Support area,

[0020] in:

[0021] - The cutting region extends along the longitudinal direction X-X' between the first end and the transition region, and

[0022] - The support region extends along the longitudinal direction X-X' between the transition region and the second end.

[0023] The cutting area further includes:

[0024] - The first part includes the penetrating tip located at the first end.

[0025] - The second part is located after the first part and separated from the first part by an interface.

[0026] The first part includes austenitic materials, and the second part includes martensitic materials.

[0027] Thus, the file includes a total length defined between the first end and the second end, and the file and therefore the total length extend primarily along the longitudinal direction X-X', such that the file follows a path along the longitudinal direction X-X'.

[0028] Advantageously, the path is substantially consistent with the path defining the root canal, which is configured to receive the file, such that, during operations performed within the root canal, the path of extension of the instrument and the path that the instrument must follow are substantially consistent.

[0029] The file consists of three distinct parts or regions: a cutting region, a support region, and a transition region between the cutting and support regions.

[0030] Specifically, these three regions are distributed between the first and second ends of the file, positioned one after the other. Specifically, the cutting region is located between the first end and the transition region, and the support region is located between the second end and the transition region.

[0031] Similarly, the regions shown all extend along the path defined in the longitudinal direction X-X'. This path is particularly relevant to the cut regions.

[0032] In a particular embodiment, the cutting region, transition region, and support region are continuous and integral. This advantageously allows the file to be manufactured from a single component and improves the fatigue strength of the file.

[0033] The cutting area includes the penetrating tip located at the first end of the file and the cutting edge that also extends in the longitudinal direction X-X'.

[0034] In this way, the cutting area of ​​the file is configured to be introduced into the root canal by means of a penetrating tip, and the material present in the root canal, particularly dentin residue contained therein, is broken up by means of a cutting operation performed by the cutting edge. That is, the cutting area is configured to, in operation, scratch and cut the root canal into which the cutting area of ​​the file is inserted.

[0035] In addition, the cutting area also includes a first part and a second part located after the first part.

[0036] The penetrating tip is located in the first portion, coinciding with the first end of the file, while the first and second portions are separated from each other by an interface. In a particular embodiment, the first and second portions are integral with the interface.

[0037] Furthermore, the first part of the cut area comprises austenitic material, while the second part of the cut area comprises martensitic material.

[0038] According to the construction of this file, the first portion of the cutting area advantageously comprises a harder and more rigid material, which means greater cutting power in the first portion. This is an advantage because once the file has been inserted into the root canal (operating state), the first portion of the cutting area comprises material with greater crushing power by cutting the waste contained in the root canal. When the file is in the operating state, the first portion of the cutting area is the first part of the file that contacts the material to be removed from the root canal.

[0039] Similarly, the second part of the cutting area advantageously comprises a softer material, meaning that the second part has greater flexibility and adaptability. This is an additional advantage because once the file has been inserted into the root canal (operating condition), the second part of the cutting area, comprising a more adaptable material, conforms to the cross-section of the root canal and thus adapts to the path of the root canal without breaking. When the file is in operating condition, the second part of the cutting area is the part that allows progress in the root canal because the first part of the cutting area removes obstacles present in the root canal, breaks them, and removes accumulated material.

[0040] Advantageously, this file, through a combination of properties such as high flexibility, high cutting ability, and greater fatigue strength, can better target the patient's root canal.

[0041] In this way, the file according to the first aspect of the invention, through the first portion of the cutting region having austenitic properties, can have high cutting power on waste contained in the root canal, thereby improving the efficiency of removing material from inside the root canal. Similarly, the second portion of the cutting region having martensitic properties provides the instrument with high flexibility, which allows the file to adapt to the path defined by the root canal, reducing damage to the root canal wall caused by the file and thus protecting the patient's dentin.

[0042] Furthermore, the file structure according to the first invention enables improved cleaning of the root canal during root canal surgery.

[0043] In a particular embodiment, the cutting edge of the cutting region extends along a helical path. That is, the cutting region includes a helical structure, preferably defined by helical grooves.

[0044] Advantageously, this allows for a larger cutting edge cross section, and once cut by the cutting edge, waste material can be better discharged, making it easier to remove waste material from the root canal.

[0045] In a particular embodiment, the cross-section of the first portion of the cutting region along the direction perpendicular to the longitudinal direction X-X' is smaller than the cross-section of the second portion of the cutting region along the direction perpendicular to the longitudinal direction X-X'. That is, the cutting region includes a tapered cross-section along its entire extension, and therefore, the file includes a tapered cross-section from the transition region to its first end.

[0046] This advantageously allows the file to enter the root canal more easily and less aggressively, performing the most demanding cutting operations through the first part of the cutting area, which is harder and has a smaller cross-section than the second part of the cutting area.

[0047] In a particular embodiment, the file also includes a handle extending longitudinally X-X' after the second end, the handle being configured for gripping the file. This advantageously allows the user of the file to grip it during operation, thereby providing better control over its movement.

[0048] In a particular embodiment, the file further includes a coupling device located between the second end and the handle, the coupling device being configured to maintain the position of the handle relative to the second end of the file and to connect the handle to a support area of ​​the file.

[0049] In a particular embodiment, the handle is coupled to a rotating device configured to rotate the cutting region, transition region, and support region as a whole around the longitudinal direction X-X'. Advantageously, in operation, the rotating device allows for automatic use of the file, rather than manual use.

[0050] In a second aspect of the invention, a method for manufacturing a file according to the first aspect of the invention is defined, comprising the following steps:

[0051] a) Provide at least one rod extending substantially in the longitudinal direction X-X' between a first end and a second end, wherein the first end of the rod is a first end of a file and the second end of the rod is a second end of a file.

[0052] b) A cutting area is machined along a predetermined length of at least one rod, the cutting area comprising a first portion and a second portion.

[0053] c) Apply an austenitic treatment to the first portion of the cut area to obtain an austenitic material.

[0054] d) Apply martensitic treatment to the second part of the cut area to obtain martensitic material, and

[0055] e) Obtain a file.

[0056] Thus, firstly, according to step a) of the method, raw materials are provided, said raw materials being at least one element in the form of a rod. The at least one rod forms the basis for performing manufacturing operations to ultimately obtain a file according to the first aspect of the invention in the final step of this method.

[0057] In a particular embodiment, the file is obtained by attaching a plurality of rods. In a particular embodiment, the file according to the first aspect of the invention is obtained integrally from a single rod.

[0058] In this way, at least one rod extends a predetermined length substantially along the longitudinal direction X-X' between a first end and a second end defining the length. In a particular embodiment where the file is configured as a single component, the length between the first end and the second end determines the length of the file according to the first aspect of the invention. Thus, the first end of the rod corresponds to the first end of the file, and the second end of the rod is the second end of the file.

[0059] In a particular embodiment, at least one rod provided in step a) is made of NiTi or nickel-titanium.

[0060] The method according to the second aspect of the invention further includes, in step b), an operation of processing or scribing a cutting area over a predetermined length of at least one rod, the cutting area comprising a first portion and a second portion in sequence.

[0061] In other words, based on the required length of the cutting area, which is determined by the root canal into which the file is inserted during operation, the cutting edge is machined in the first and second parts to produce the cutting area defined by the indicated length.

[0062] In a particular embodiment, step b) includes machining a helical groove along a predetermined length of at least one rod to obtain a helical cutting edge along the predetermined length.

[0063] Advantageously, this makes it possible to machine spiral grooves on the cutting area, which, under operating conditions, create a more efficient cutting edge for the file's cutting operation.

[0064] In a particular embodiment, the spiral grooves are uniform in the first and second portions of the cutting area, maintaining a constant pitch.

[0065] Furthermore, the method according to the second aspect of the invention further includes, in steps c) and d), applying an austenitic treatment to a first portion of the cutting region to obtain an austenitic material in the first portion, and applying a martensitic treatment to a second portion of the cutting region to obtain a martensitic material in the second portion.

[0066] Once the treatment is applied, preferably heat treatment, the file according to the first aspect of the invention is obtained in step e) of this method.

[0067] Advantageously, this makes it possible to obtain cutting regions with different properties from the double heat treatment, thereby constructing a file in which a first portion of the cutting region has high cutting capability, while a second portion of the cutting region includes high flexibility, the portions being separated by an interface combining the two properties.

[0068] In a particular embodiment, steps c) and d) begin simultaneously.

[0069] In a particular embodiment, the heat treatment in step d) includes parameter values ​​for temperature (T) and time (t) that are higher than those in step c).

[0070] That is, in a particular embodiment, the first part is treated at a predetermined temperature for a predetermined time to obtain austenitic properties in the material constituting the first part, while the second part is treated at a higher temperature for a longer time interval to obtain martensitic properties in the material constituting the second part.

[0071] In a particular embodiment, the predetermined time value (t) for each heat treatment is between 1 and 5 hours, more specifically between 2 and 4 hours.

[0072] In a particular embodiment, the predetermined temperature (T) value for each heat treatment is between 200°C and 500°C, more specifically between 250°C and 400°C.

[0073] In addition, in a particular embodiment, a surface treatment is performed on the first portion.

[0074] In a particular embodiment, the support area of ​​the file is also derived from at least one unprocessed rod.

[0075] In a particular embodiment, the method further includes step f), using a coupling device to attach the handle to the second end of the file obtained in step e). In a particular embodiment, the coupling device is attached to the second end of the file. Attached Figure Description

[0076] For the purpose of completing the description and to help to make the features of the invention more readily understood, this specification is accompanied by a set of drawings that form an integral part thereof, which illustrate the following in an illustrative rather than restrictive manner:

[0077] Figure 1A A perspective view of a first specific embodiment of a file according to the first aspect of the invention is shown;

[0078] Figure 1B It shows Figure 1A Detailed view of the file shown;

[0079] Figure 2 A perspective view of a second specific embodiment of a file according to the first aspect of the invention is shown. Detailed Implementation

[0080] Figure 1A A perspective view of a straight manual root canal file (1) is shown, which extends along the X-X' direction.

[0081] As can be seen, the file (1) comprises an integral portion extending from the first end (1.1) to the second end (1.2), in which three distinct regions are distributed sequentially. This integral portion is made of NiTi (nickel-titanium).

[0082] First, the file (1) includes a cutting area (2). The cutting area (2) includes uniform helical grooves that provide a constant helical pitch from the beginning to the end of the cutting area (2).

[0083] Accordingly, the cutting area (2) has a tapered cross section along its entire extension.

[0084] In addition, the cut area comprises two distinct parts: a first part (2.1) and a second part (2.3), one following the other and separated by an interface (2.2).

[0085] The first part (2.1) extends from the first end (1.1) of the file (1) to the interface (2.2), while the second part (2.3) extends from the second end (1.2) of the file (1) to the interface (2.2).

[0086] Thus, the cross-section of the file (1) decreases from the second part to the first part (2.1), that is, the first end (1.1) is the point where the cross-section of the file (1) is the smallest.

[0087] like Figure 1B ( Figure 1A As shown in the enlarged details, the first part (2.1) is made of a different material than the second part (2.2), as indicated by the different graphic markings of the parts (2.1, 2.2). In particular, the material of the first part (2.1) is austenitic, while the material of the second part (2.2) is martensitic.

[0088] In this case, the first part (2.1) comprises austenitic material because it has been subjected to a heat treatment at a predetermined temperature (T) between 250 and 350°C for a predetermined time (T) between 2 and 3 hours, and the second part comprises martensitic material because it has been subjected to a heat treatment at a predetermined temperature (T) between 300 and 400°C for a predetermined time (T) between 3 and 4 hours.

[0089] also, Figure 1AA support region (4) of the file (1) is also shown, which is located after the cutting region (2) and separated from the cutting region by a transition region (3). The support region (4) is smooth and does not contain any grooves.

[0090] It can be seen that the support area (4) is defined between the second end (1.2) of the file (1) and the transition area (3).

[0091] In this way, the transition region (3) establishes a separation between the cutting region (2) with spiral grooves and the support region (4) with smooth surfaces, so spiral processing begins from the transition region (3).

[0092] In addition, the file (1) includes a connecting device (5) connected to the second end (1.2) of the file (1) and a handle (6) connected to the connecting device.

[0093] In this way, the handle (6) is attached to the second end (1.2) of the file (1) via the connecting device (5), which allows the user of the file (1) to hold it and keep it in the proper position. Similarly, the handle also protects the user of the file (1) from injury to its cutting area (2).

[0094] on the other hand, Figure 2 It shows the relationship with Figure 1A and 1B The file (1) shown has the same construction as the file (1), but in this case, the cutting area (2) extends along a curved path defined by the longitudinal direction X-X'.

[0095] Therefore, the cutting region (2) also includes uniform helical processing, which is sequentially distributed along a curved path defined by the longitudinal direction X-X'. Accordingly, the cutting region (2) includes a first part (2.1) and an opposite second part (2.3), the first part (2.1) comprising austenitic material and the second part (2.3) comprising martensitic material. The first part (2.1) and the second part (2.3) are separated from each other by an interface (2.2), which is also located on the curved path of the cutting region (2).

[0096] Advantageously, such as Figure 2 The cutting area (2) with a curved path shown allows the root canal file (1) to enter the root canal with a curved cross section more effectively and avoids damage to the patient's dentin due to related root canal treatment.

[0097] On the other hand, the transition region (3) defines the starting point of the spiral processing region and separates the cutting region (2) from the support region (4). In this case, the support region (4) is smooth, cylindrical and extends along the longitudinal direction X-X', and the support region is straight in this section.

[0098] Similarly, the cutting area (2), the transition area (3) and the support area (4) extend between the first end (1.1) and the second end (1.2) of the file (1), wherein the connecting device (5) is attached to the second end for connecting the handle (6) to the cutting area (2), the transition area (3) and the support area (4) of the file (1).

[0099] and Figure 1A and 1B The same applies to the file (1) shown; this file (1) is also manual.

[0100] In certain embodiments not shown in these figures, the file (1) also includes an automatic rotation device, which enables automated use of the file (1) during operation.

Claims

1. A file (1) for root canal treatment, said file extending in a longitudinal direction X-X' between a first end (1.1) and a second end (1.2), characterized in that, The file (1) further includes, between the first end (1.1) and the second end (1.2): - Cutting area (2), configured to break up material from the root canal, including cutting edges, - Transition region (3), and - Support area (4). in: - The cutting region (2) extends along the longitudinal direction X-X' between the first end (1.1) and the transition region (3), and - wherein the support region (4) extends along the longitudinal direction X-X' between the transition region (3) and the second end (1.2), The cutting area (2) further includes: - The first part (2.1) includes a penetrating tip located at the first end (1.1). - The second part (2.3) follows the first part (2.1) and is separated from the first part (2.1) by interface (2.2). The first part (2.1) includes austenitic material, and the second part (2.3) includes martensite material.

2. The file (1) according to claim 1, wherein, The cutting edge of the cutting area (2) extends along a spiral path.

3. The file (1) according to claim 1, wherein, The cross-section of the first part (2.1) of the cutting region (2) is smaller than the cross-section of the second part (2.3) of the cutting region (2).

4. The file (1) according to claim 1, wherein, The cutting area (2), the transition area (3), and the supporting area (4) are continuous and integral.

5. The file (1) according to claim 1, wherein, The first part (2.1) and the second part (2.3) are integral.

6. The file (1) according to claim 1 further includes a handle (6) extending along the longitudinal direction X-X' and located after the second end (1.2), the handle (6) being configured for holding the file (1).

7. The file (1) according to claim 6 further includes a connecting device (5) located between the second end (1.2) and the handle (6), the connecting device (5) being configured to maintain the position of the handle (6) relative to the second end (1.2) of the file (1).

8. The file (1) according to any one of claims 6 or 7, wherein, The handle (6) is connected to a rotating device configured to rotate the cutting area (2), the transition area (3) and the support area (4) as a whole around the longitudinal direction X-X'.

9. A method for manufacturing a file (1) according to any one of claims 1 to 7, comprising the following steps: a) Provide at least one rod that extends generally along the longitudinal direction X-X' between a first end and a second end. b) A cutting region (2) is machined along a predetermined length of the at least one rod, the cutting region comprising a first part (2.1) and a second part (2.3). c) Apply an austenitic treatment to the first portion (2.1) of the cut region (2) to obtain an austenitic material. d) Apply martensitic treatment to the second portion (2.3) of the cut region (2) to obtain a martensitic material, and e) Obtain the file (1).

10. The manufacturing method according to claim 9, wherein, Step b) includes machining a helical groove along the predetermined length of the at least one rod to obtain a helical cutting edge along the predetermined length.

11. The manufacturing method according to claim 9, wherein, The processing in step d) includes temperature (T) and time (t) parameter values ​​that are greater than those in step c).

12. The manufacturing method according to claim 9, wherein, Steps c) and d) begin simultaneously.

13. The manufacturing method according to claim 9, wherein, At least one of the processes in step c) and / or step d) includes the following values: - Temperature (T) between 200℃ and 500℃, and - Time (t) is between 1 and 5 hours.

14. The manufacturing method according to claim 13, wherein, At least one of the processes in step c) and / or step d) includes the following values: - Temperature (T) between 250℃ and 400℃, and - Time (t) is between 2 and 4 hours.

15. The manufacturing method according to claim 9, further comprising the following steps: f) Use the connecting device (5) to connect the handle (6) to the second end (1.2).

16. The manufacturing method according to claim 9, wherein, The at least one rod provided in step a) is made of NiTi.

17. The manufacturing method according to claim 9, wherein, The first end of the rod is the first end (1.1) of the file (1), and the second end of the rod is the second end (1.2) of the file (1).

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