ITBA20110054A1 - "EQUIPMENT FOR THE COMPOSITION OF BONE FRACTURES IN ORTHOPEDIC SURGERY" - Google Patents

Description

â € œSet for the composition of bone fractures in orthopedic and non-orthopedic surgeryâ €

The invention is placed in the field of medical-surgical devices suitable for assisting the physician during a surgical operation.

More particularly, the invention relates to a set, comprising everything necessary to allow a surgeon to proceed with the composition of a bone fracture, with an acceptable compression of the peri-implant vascular bed.

As is known, in orthopedic and non-orthopedic surgery, one of the techniques used for the composition of a bone fracture is that which involves the implantation of stabilizing screws possibly associated with a stabilizing plate. For this purpose, a drill is used as a surgical instrument that perforates and threads the implantation sites of the screws.

The correct implantation of the screws is completely entrusted to the sensitivity and professional experience of the surgeon who will operate on the basis of personal assessments on the quality of the bone which, as is known, can also be extremely different from one implantation site to another for the same bone.

The surgeon, therefore, will have to adapt the intervention procedure to the type of bone that he believes he has identified in such a way as to achieve a physiological balance between primary stability of the implant screw and compression of the vascular bed of the peri-implant site.

Therefore, for the execution of a stable and safe implantation for the patient, the surgeon must correctly estimate the degree of consistency of the bone tissue on which he intervenes.

It follows that, the speed and torque of rotation of the drill (from which the power is obtained), the diameter of the milling and / or tapping bit of the drill, must be adapted to the degree of bone consistency, from time to time, subjectively. estimated by the surgeon.

The purpose of the present invention is, therefore, to create a set of orthopedic and non-orthopedic surgery which, by exploiting the â € œpowerâ € and â € œelectricityâ € and the analysis of the processing â € œsound wavesâ €, it becomes particularly advantageous for the composition of a bone fracture, allowing the technical drawbacks complained of by the known art to be overcome.

Within the scope of this task, a further object of the invention is to provide a set for orthopedic and non-orthopedic surgery, for the composition of a bone and non-bone fracture, which allows to assist the surgeon in the correct success of the operation.

A further object of the invention is that of realizing an orthopedic and non-orthopedic surgery set, particularly for the composition of a bone and non-bone fracture, which achieves the desired primary stability of the implant with an acceptable compression of the peri-implant vascular bed.

Another object of the invention is to realize a set of orthopedic and non-orthopedic surgery, particularly for the composition of a bone and non-bone fracture, which allows to accelerate the regeneration process and limit the infectious power of the implanted and operating instruments.

Further characteristics and advantages of the description of a preferred but not exclusive embodiment of the set for the composition of a bone and non-bone fracture, according to the invention, is illustrated by way of non-limiting example in the attached drawings, of which: Figure 1, shows a schematic view of the orthopedic and non-orthopedic surgery set, according to the present invention, at the moment of its use during an orthopedic surgery for the composition of a bone fracture;

figure 2 shows an enlargement of the working area of the surgical instrument; Figure 3 shows a representation of the surgical instrument;

figure 4, shows a diagram of the orthopedic surgery set with all its components; figure 5, shows the image of the FFT (Fast Fourier Transform) analysis on the spectrum of a laboratory recording of the background noise, in a three-dimensional graph;

figure 6, shows the image of the FFT analysis on the spectrum of a laboratory recording of the background noise in a two-dimensional graph;

figure 7, shows the image of the FFT analysis on the spectrum of a recording in the laboratory of background noise, with the engine running, in a three-dimensional graph, in this figure the same characterizations of figures 5 and 6 are present, with the '' addition of a characteristic just below 40 kHz, which represents the engine noise;

figure 8, shows the image of the FFT analysis on the spectrum of a recording in the laboratory of background noise, with the engine running, in a two-dimensional graph, in this figure the same characterizations of figure 5 and 6 are present with the addition of a characteristic just below 40 kHz, which represents engine noise;

figure 9, shows the image of the FFT analysis on the spectrum of a recording in the laboratory, of a processing with a dedicated endodontic motor, with preset number of revolutions and force for rotating or reciprocating instruments in Nickel-Titanium (NiTi) and breaking , of an endodontic instrument, engaged in a canal of a freshly extracted and suitably prepared human tooth, in a three-dimensional graph, the vertical characterization is noted at 13.45 seconds, indicating the moment of rupture, some peaks are noted at the instant of rupture corresponding to some frequencies, similar characteristics are also recorded at other instants, prior to the moment of rupture, but without there having been rupture;

Figure 10, shows the image of the FFT analysis on the spectrum of a recording in the laboratory, of a processing with a dedicated endodontic motor, with preset number of revolutions and force for rotating or reciprocating NiTi instruments and breakage, of an endodontic instrument , engaged in a canal of a freshly extracted and suitably prepared human tooth, in a two-dimensional graph;

figure 11 shows the two-dimensional image, of the same process as in figures 9 and 10, a few seconds before the break in which similar characteristics were recorded at the moment of the break at about 10.6 s and 10.9 s;

figure 12 shows the representation of the sound spectrum of the recordings obtained with a dedicated motor, with preset number of revolutions and force for dental implantology with a pilot drill on a cancellous bone of fresh bovine, classified as D4 (softer);

Figure 13 shows the representation of the sound spectrum of the recordings obtained with a dedicated motor with preset number of revolutions and force for dental implantology with a pilot drill on a fresh bovine cortical bone, classified as D1 (harder), in the latter the spectrum shows how higher frequency sound waves are present (denser graph);

figure 14, shows the image of the FFT analysis on the spectrum of the processes in figure 12 (bone classified as D1);

figure 15 shows the image of the FFT analysis on the processing spectrum in figure 13 (bone classified as D4).

With reference to the aforementioned figures, an overall view of the orthopedic and non-orthopedic surgery set is shown, particularly for the composition of a bone and non-bone fracture, indicated as a whole with the number 1.

The set includes one or more screws 4, suitable for implantation, each in an endosseous implant site 5.

The screws 4 are obtained through a laser sintering process (one of the suitable techniques is the Selective Laser Sintering), which allows to obtain a screw whose external surface and internal volume is such as to favor a greater grip with the bone tissue in regrowth.

If circumstances require it, the equipment also includes a stabilization plate 2 which, as illustrated in figure 2, can be applied to the fractured bone 3, using the screws 4.

The set also includes a surgical instrument 7 comprising a handpiece 8 equipped with a head 9 for supporting a tool 10, a surgical motor 11 for rotating the head 9, and an external LED lighting system with cold light. 19 to illuminate the intervention area.

The handpiece 8 can be straight like the one illustrated by way of example in Figure 3, or a contra-angle, however, regardless of the shape, the handpiece 8 has a handle 15 transversal to its axis to exert an incremental axial thrust. The handle 15 of the handpiece can also have a double grip.

On the handle there are the controls 23 for clockwise rotation, anticlockwise rotation and stop. The handpiece 8 is equipped with its own lighting system 21 with light having the same characteristics as the external system 19 which, however, illuminates a narrow region in the immediate vicinity of the drilling area to obviate the decreased visibility caused by possible shadows of the handpiece 8 itself.

The set 1 also has a plurality of tools 10 different for size and function including, one or more drills of different diameter and / or length for the creation of a hole 6 calibrated at each implant site 5, one or more tappers of different diameter and / or length for the creation of a calibrated thread of each hole 6, and one or more screwdrivers for screwing different types of screws into each threaded hole 6 made.

The motor 11 is equipped with a system for detecting the resistant moment offered by the layers of bone encountered, during the penetration of the tool 10 or the screw 4, into the implant site 5. It also has means for detecting the speed of rotation of the tool (cutter or tapper). The instantaneous knowledge of the detected moment and speed values will allow to know the power used in the drilling and tapping operation.

The monitoring of the â € œpowerâ € magnitude makes the estimate of the degree of hardness independent from the constancy of the speed and, consequently, it is possible to decide to operate at variable speed, obtaining a more versatile instrument that responds well in cases in which the various physical conditions and / or mechanical changes during processing.

Finally, there is a system that allows to detect the temperature reached by the organic tissues during the drilling, tapping and screwing phases.

The set 1 also provides means 12 suitable for detecting sound waves generated by the tool and / or by the bone tissue during processing. The materials have the property of emitting particular sound waves when they are processed and / or perforated and their mechanical characteristics are altered. Bone tissue or endodontal also generates specific sounds during drilling to create the implant tunnel.

The recognition of these altered characteristics through particular sound waves, which may or may not be part of the audible field, could be synonymous, for example, with breakage of the tool or bone tissue and / or confirm the degree of hardness and consistency bone, already estimated by the given power. Anticipating the moment of rupture allows you to avoid causing damage to the surgeon's work and more precisely allows you to have a correct realization of the implant site.

The same principle could be applied to endodontic practice when shaping the root canal with rotating NiTi instruments operated by the handpiece connected to a motor. Furthermore, set 1 could be integrated with a cone beam tomography instrument (not shown in the figure) capable of detecting the shape and direction of the hole at the very moment in which it is made.

Set 1 also provides for a central processing unit 16 capable of processing data detected during the use of the tools and from sensor readings. More precisely, the processing unit 16 transforms the data acquired during the use of a drill into an initial numerical information on the degree of bone consistency detected in the implant site 5. The processing unit 16 also transforms the data acquired during the use of a tap into a second numerical information of the degree of bone consistency, transforms the data acquired during the use of a screwdriver into at least a third numerical information representing the primary stability of implantation of the screw 4 together with the level of compression of the peri-implant vascular bed, and finally transforms the data acquired during all the previous operations concerning the temperatures reached, into as many numerical information representing the level of acceptability of the tissues to preserve their degradation.

The set 1 also comprises means 17 for graphic and / or alphanumeric display of the processed information, of the temperatures in the various phases and for the 3D display of the hole being made on the surrounding bone thickness.

It is evident that the processing unit 16 is connected on one side to the visualization means 17 and on the other hand it is connected to the cone beam sensing and tomography means. The processing unit 16 is also equipped with a historical storage medium (any electronic computer support) of the data collected during the entire intervention phase to make them available and viewable on request at a later time.

The processing unit 16 and the display means 17 are preferably present in a terminal 13 to which the surgical instrument 7 is connected via a communication channel 14 of the wired or wireless type.

The data sent to unit 16 include the average value recorded for the power and / or the peak value recorded for the power and / or a function expressing the trend of the power during the advancement of the tool 10, and / o the integral of the function expressing the trend of the resisting moment. Further information includes the average value recorded for the resisting moment and / or the peak value recorded for the resisting moment and / or a function expressing the trend of the resisting moment during screwing in the screw, and / or the integral of the function expressing the trend of the resisting moment.

The display means 17 comprise a screen in which 18 indicates the graph of the function expressing the trend of the power (Y) during the advancement (X) of the tool 10, while A indicates the current value of the advancement of the tool detected by the proximity sensor of the handpiece and described below (bi-uniquely correlated to the crossed bone layer), B and C respectively indicate the average and maximum value of the power, and D indicates the value of the integral of the moment resisting function in order to have a visual confirmation of the work done in drilling and / or tapping. E indicates the temperature value detected instantaneously and biunivocally linked to the tool advancement quota. In the case of the screwing operation of screw 4, on the terminal will be indicated the graph of the function expressing the trend of the tightening torque (Y) during the advancement (X) of the screw, while A indicates the current value of the advancement of the screw. screw (connected directly to the thread pitch and to the number of turns of the screw, and bi-uniquely correlated to the bone layer crossed), B and C respectively indicate the average and maximum value of the tightening torque, and D indicates the integral value of the function 18. Graphs 18 and values A, B, C, D are represented according to a color map to make the interpretation of the values more immediate: green = acceptable value, yellow = value close to the accepted limit, red = unacceptable value.

It is possible to send all or some information of more effective and rapid significance on a second display terminal 20 which can be easily consulted by the surgeon during the operation. For this purpose, this display means 20 can be represented by a projection on the visor of the surgeon's protective helmet, so as to eliminate the need for the operator to look away from the work area in order to view the information on the terminal 17 and / or 20.

In a preferred embodiment, the surgical instrument 7 comprises a system (not shown) for the injection of cooled sterile physiological solution on the implant site 5 to lower its temperature. More precisely, the injection system is connected to the processing unit 16 to activate automatically when a threshold value of one or more parameters related to the detected power and / or the detected sound waves and / or the degree of bone consistency is reached. identified or be activated and deactivated at the surgeon's discretion. An important aspect is to obtain bone regeneration through growth factors â € œPRP systemâ € or â € œPRFGâ € or similar that allow to overcome problems inherent in long healing times, high costs for operator and patient, risk of cross infections, the advantage of being able to prepare it in the office at the time of surgery, excluding administration errors that can occur if prepared in external laboratories. The growth factors are obtained from a small sample of blood from the same patient before performing the surgery and are injected at the end of the threading operation in the implant site according to a well-defined quantity and antibiotic solutions and / or antibiotic solutions can be added to them. antiseptics.

It is also possible to provide an acoustic warning device (not shown) which is activated automatically to generate a specific alarm sound when a preset temperature threshold value is reached or exceeded. This gives the surgeon a signal to stop drilling and / or retract the tool from the bone.

The surgical instrument 7 may include a proximity sensor (not shown) for detecting the approach of a tissue different from that of bone during drilling. The operation of this sensor, in particular, is based on the detection of an electrical potential difference. It is also possible to generate an acoustic alarm signal when the proximity sensor processes a positive signal. This provides the surgeon with a warning signal to stop drilling and / or retract the tool from the bone.

The use of the surgical instrument for the creation of the holes 6 and the subsequent implantation of the screws 4 takes place as follows.

At least two surgical steps are provided (at least one drilling step and at least one tapping step) for creating a hole 6 in the selected implant site 5 and at least one surgical step for inserting a screw 4 into the hole 6 made.

The drilling phase takes place by operating the handpiece 8 with a bur tool 10. As the drilling progresses through the bone layers, the system detects and acquires the moment of resistance offered by the bone and the speed in order to obtain the drilling power . Through this data and the detection of the sound waves, it processes an indication of the degree of hardness of the bone which is displayed on the screen 17 of the terminal 13 (and transmitted to the screen 20 if provided) to guide the surgical path that the surgeon must adopt in the continuation. of the milling phase that is being carried out and to carry out the subsequent phases.

If the system identifies a modest degree of hardness of the bone already in the initial phase of the milling, it automatically generates and displays a warning message for the surgeon regarding an upper limit for the speed and rotation torque that must not be exceeded in order to continue in a safe way. corrected the milling. The identification already in the milling phase of the degree of hardness of the bone also conditions the choice of the next surgical phase which can be a further milling phase with a larger diameter 10 milling tool, before the tapping phase, or it conditions the choice of the tapping tool or it also conditions the choice of the type of screw to be adopted and the tightening torque of the same.

In particular, it can be foreseen that when bones with a low degree of hardness are identified, the system may display a warning message for the arrest of the rotation of the tool 10 or for the decrease of its rotation speed if it exceeds a certain threshold. rotation speed, to avoid creating permanent damage to the implant site, moreover, it can provide for the automatic display of a warning message and / or a specific alarm sound to stop the rotation of the tool 10 or to reduce the of its rotation torque if it exceeds a certain rotation torque threshold to avoid cavitation of the screw introduced into the implant site.

The tapping phase takes place by operating the handpiece 8 with a tapping tool 10. In this tapping phase, the system processes all the data received to deliver the essential information to the surgeon to precisely define the degree of compactness of the bone tissue and decide on the subsequent surgical phases .

The insertion phase takes place by operating the handpiece 8 with a screwing tool 10. In this insertion phase, the system reworks the graph 18 which gives the surgeon the essential information to define exactly the level of primary stability of the screw, the level of compression exerted. from the screw on the vascular bed around it, and the optimal value of the tightening torque, leaving the surgeon to validate the result obtained or to intervene again to modify it. In particular, the quality of the stabilization is indicated by the average value B of the resisting moment and by the integral D of the function represented by graph 18, which substantially expresses the work carried out by the screwing tool 10 to overcome the resistance of the bone tissue.

As illustrated in figures 5 to 15, through the analysis of the sound characteristics detected during some phases of endodontic processing and of some types of bone, the orthopedic surgery set, referred to in the present invention, is able to assist in smart way the surgeon to the elimination of the human error factor. It also allows for objective information relating to the state of the bone being repaired: the patient can therefore be informed of the postoperative risk of implant disintegration through the data stored on the electronic medium.

The orthopedic surgery set thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the inventive concept; furthermore, all the details can be replaced by technically equivalent elements.

Claims (16)

CLAIMS 1. Set for the composition of bone fractures in orthopedic and non-orthopedic surgery, comprising: - a surgical instrument (7) comprising a handpiece (8) having a head (9) for the selective support of a tool among a plurality of tools (10), a handle (15) according to the transverse axis, commands (23) of clockwise rotation, anticlockwise rotation and stop, a local lighting system (21), a surgical motor (11) for the rotation control of said head (9), said motor (11) having means for detecting the resisting moment offered by the layers of bone encountered during the penetration of said tool (10) or of the screw (4), means for detecting the rotation speed of said tool (10), as well as means for detecting the temperature of the bone tissues during processing ; - a plurality of tools (10) comprising at least one cutter for creating a hole (6) in correspondence with an endosseous implant site (5), at least one tapper for threading said hole (6), at least one screwdriver for the screwing said screw (4) into said threaded hole (6); - at least one screw (4) obtained for â € œSLS Selective Laser Sinteringâ €, suitable for being applied in said endosseous implant site (5); - a general lighting system (19) with cold light LEDs; - a device (12) for detecting and monitoring sound waves; - means for acquiring data from said detection means; - hardware and software processing means of said acquired data, suitable for transforming said data acquired during the use of said at least one cutter into a first numerical information on the degree of bone consistency detected in said implant site, to transform said acquired data during the use of said at least one tap into a second detailed numerical information of said degree of bone consistency, to transform said data acquired during the use of said at least one screwdriver into at least a third numerical information representing the primary implantation stability of said at least one screw together with the compression level of the peri-implant vascular bed, to transform said data acquired during the temperature measurement in said drilling, tapping and screwing phases into as many said numerical information representing the degradation of the bone tissue; - graphic and / or alphanumeric display means (17, 19) of said first, second, at least third information and information on temperatures characterized by the fact that the power of the surgical motor (11) is managed by a central processing unit (16) which allows to control the speed and torque of said motor (11) by continuously varying its parameters in real time, after appropriate calculations and procedures according to predefined algorithms, according to the electrical absorption and the analysis of the noise generated in the various processing phases; said central processing unit (16) being also suitable for relating the results from the resisting torque and the noise generated by the tools (10), in order to verify correspondence of results and / or discrepancies, and being suitable for comparing said results , and in particular those deriving from said noise, with a database of values studied and tested in specific literature in order to draw considerations on critical situations and bone consistency. 2. Set according to claim 1, characterized in that the motor (11) is a medical device. 3. Set according to one or more preceding claims, characterized in that the data processing and display means are contained in a central processing unit (16) to which said surgical instrument (7) is connected. 4. Set according to one or more preceding claims, characterized in that the information processed by said central processing unit (16) includes the average value of the power delivered by the engine (11) and the average recorded temperature value, as well as the value peak recorded for said power and / or for said temperature. 5. Set according to claims 1, 3 and 4, characterized in that the information processed by said central processing unit (16) comprises a function expressing the trend of said power as the penetration of said tool (10) or said screw (4) in said implant site (5) and a function expressing the temperature trend as the penetration of said tool (10) or said screw (4) into said implant site (5) progresses. 6. Set one or more preceding claims, characterized in that the information processed by said central processing unit (16) comprises the integral of the function expressing the trend of the moment resistant to the progress of the penetration of said tool (10) or of said screw (4) in said implant site (5). 7. Set according to one or more preceding claims, characterized in that the speed of the motor (11) varies, during the processing phase, according to the temperature and / or the power and / or the noise or other parameters managed by said unit central processing (16). 8. Set according to one or more preceding claims, characterized in that the devices for displaying the information processed by said central processing unit (16) consist of a first screen (20) positioned at the eye level of the surgeon, a second screen (17) in a remote location from said first screen and / or projection means on the glass of the surgeon's protective helmet; said power graphs of the resisting moment, average values, peak values, temperature values being represented according to maps of at least 3 colors: green = acceptable value, yellow = value close to the established limit value, red = unacceptable value. 9. Set according to one or more preceding claims, characterized in that said surgical instrument (7) comprises an injection system of sterile physiological solution on the implant site for its cooling, which is activated automatically, or at the discretion of the surgeon, upon the achievement of a threshold value of one or more parameters correlated to said temperature values. 10. Set according to one or more preceding claims, characterized in that said surgical instrument (7) comprises a thermal sensor for detecting the bone temperature reached during drilling, and an acoustic alarm which is activated automatically to generate a specific alarm sound upon reaching or exceeding a preset threshold for said temperature. 11. Set according to one or more preceding claims, characterized in that said surgical instrument (7) has a proximity sensor for detecting the approach of a tissue different from the bone one during the drilling of the bone tissue, and an acoustic warning device which it is activated automatically to generate a specific alarm sound when said proximity sensor processes a positive signal. 12. Set according to one or more preceding claims, characterized by the fact that said surgical instrument (7) provides an acoustic alarm for emitting a specific alarm sound when bones with a low degree of hardness are identified for stopping the rotation of the € ™ tool (10) and / or for the decrease of its rotation torque. 13. Set according to one or more preceding claims, characterized by the fact that said surgical instrument (7) could use a tomography device type â € œcone beamâ € which generates a three-dimensional representation of the hole (6) and of the thickness of said bone tissue in the intervention area, to immediately obtain information on the accuracy of the drilling direction, on the creation of a hole free from imperfections and on the awareness of a sufficient thickness of bone tissue suitable for housing said screw (4). 14. Set according to one or more preceding claims, characterized in that said surgical instrument (7) has a sound wave detector (12), capable of preventing the tools (10) from breaking, damaging the implant site (5) and to discriminate the hardness of said bone tissue on which one is operating. 15. Set according to one or more preceding claims, characterized in that all the operations and values of the variables under control are stored on an electronic recording medium for medical legal purposes. 16. Set according to one or more of the preceding claims, characterized in that the clockwise rotation, counterclockwise rotation and stop (23) commands present on the central processing unit (16) and / or on the handpiece (8), can be replaced or supplemented by a foot pedal.