The present invention refers to a handpiece with a surgical tool to perform holes of various shapes in bone tissues, adapted to receive various fixing systems (single screws, screws for fixing plates) and/or dental implants.
According to the prior art, the sites (that is the holes or the seats) for the insertion of screws and/or of various fixing systems in the bone are prepared through the use of rotating instruments or tools driven by micromotors. Said rotating tools generally have helical shaped tips (twist-drills), cutters or reamers.
These instruments, however, have severe limitations, especially when they are used in complex anatomical situations, in particular:
Another limiting aspect of such rotating instruments is represented by the high mechanical energy produced by the rotation, which requires a certain pressure to be applied to the tool, causing friction loss and thus heat generation. This results in a risk of overheating of the tissues involved in the operation, with possible impairment of healing.
Normally, the amount of heat generated by friction is directly related to the intensity of the pressure applied to the rotating tool, to the speed of rotation, to the size and to the shape of the tip/cutter/reamer and to the time taken to make the hole. Perforation of the bone therefore involves the use of irrigation to reduce the heat generated. This irrigation can be external or internal.
Moreover, the irrigating solution must be able to act on the whole contact surface present in the bone-tool interface, that is, on the cutting front part and on the side part. This action might not be achieved if the tool (the cutter) is not removed from the hole every so often, so as to allow both the removal of the bone fragments and the entry of the irrigating fluid into the site.
It must be considered that the temperature increase is not caused only by the incomplete accessibility of the cooling fluid into the hole, but also by the obstruction caused by bone debris depositing on the cutting edges of the cutter, which makes the drilling action less efficient and prolongs the time necessary to make the hole. Furthermore, the rotating action of the cutter compresses the bone debris against the wall of the hole, forming a smear layer, which obstructs the natural sinuses of the spongy bone to the detriment of osteoregenerative processes.
Cutters rotating at low speeds (1500-1800 rpm) require the operator to apply a considerable pressure on the handpiece (from 1.8 to 2.5 kg) in order to cut the bone. This gives rise to two types of problem:
a) Reduced Surgical Control.
The operator must exert a considerable pressure during the drilling action, which is not compatible with the precision, especially when passing through a bone tissue with uneven mineralization. This aspect leads to a considerable risk of injury in delicate anatomical situations, such as near vessel or nerve endings which, in contact with the cutting action of the rotating cutters/tips, may be torn.
b) Overheating.
The macro vibrations of the rotating tools give rise to overheating of the bone surface, which spreads centrifugally into the bone part surrounding the hole. This fact, together with the presence of bone debris, which remains in the sinuses, slows and/or limits the bone regeneration.
Object of the present invention is to overcome the drawbacks of the prior art by providing a handpiece with a special surgical tool, so that the particular geometry of the tool and its mode of operation allow holes to be made in the bone tissue with extreme precision.
Another object of the present invention is to provide such a handpiece with a surgical tool for making holes in a bone tissue that is versatile and able to form holes of shapes other than circular, according to requirements.
Another object of the present invention is to provide such a handpiece with a surgical tool for making holes in bone tissue that is able to improve the subsequent osteoregenerative processes.
These objects are achieved in accordance with the invention with the characteristics listed in appended independent claim 1.
Advantageous embodiments of the invention are apparent from the dependent claims.
According to the invention, the handpiece for performing holes in bone tissues comprises a surgical tool provided with a tip (or head) adapted to make a hole in the bone. The handpiece works by ultrasound, and the tip of the tool comprises a plurality of cutting elements defining the profile of the hole to be made in the bone. A main channel which ends in an outlet hole opening into the tool tip is provided in the body of the tool for the passage of a cooling fluid, so as to cool the working area affected by the tool tip.
The ultrasound handpiece provided with the tool according to the invention presents the following advantages with respect to the prior art:
1. Greater Precision.
The action of the conventional devices (micromotors combined with tips, cutters) is associated with macro vibrations, which make the performance of the operation imprecise, whilst that of the ultrasound handpiece according to the invention is characterised by micro vibrations of the tools, which allow the operator a greater tactile sensitivity and a greater intraoperative precision. The handpiece according to the invention, thanks to the ultrasonic micro vibrations of the tool and to the special design of the cutting elements and of the outlets between the cutting elements of the tip of the tool, produces holes in the bone through a process of micronization of the tissue, which is removed immediately by the mechanical action of the irrigation fluid which, subjected to ultrasonic vibrations, produces a cavitation effect, the result of which is a perfect cleansing of the bone surface representing the seat of the hole. The removal and irrigation action is also supported by the particular geometrical shape of the tip. Removal of the bone takes place through micro vibrations. In this manner the centrifugal overheating effect is less extensive than that produced by the macro vibrations generated by rotation of the tips/cutters.
2. Greater Stability of the Tool at the Start of the Drilling.
Rotating tools are unstable at the start of the drilling because of a centrifugal drift component, which causes the tool to deviate from the desired drilling axis. In fact, according to the prior art, in the field of implant surgery in order to engage the bone surface to be drilled a special tip is used (commonly known as a rose tip) to produce an entry guide hole. Instead, the particular configuration of the tool tip according to the invention makes it possible to give greater stability. In fact the tool tip has a concave type sharpening with cusp-shaped cutting elements protruding peripherally towards the tip. Thanks to this configuration of the tool tip and to its ultrasonic vibrations, at the time of starting the hole in the bone there is no centrifugal drift component that causes the tool to deviate from the desired drilling axis.
3. Greater Cleaning of the Tool/Bone Interface and Consequent Improvement in Osteoregenerative Processes.
According to the invention, the particular geometry of the tool tip (longitudinal outlets in the side surface of the tip) together with the ultrasonic vibrations which cause the cavitation effect of the irrigation fluid, allow the removal of the bone debris from the side walls of the hole made by the tool, leaving the tool/bone interface clean. In this manner the typical smear layer of the twist drills and of the cutters is not formed, thus favouring osteoregenerative processes.
4. Smaller Temperature Increase, Due to the Friction Between the Tool and the Bone, on the Work Surfaces During the Drilling of the Bone.
The tool according to the invention has an axial duct, which allows the passage of the irrigation liquid, which flows out through a central hole in the tool tip and washes away the bone debris, carrying it through the radial channels of the tip until it reaches the longitudinal outlets in the tip, which allow the removal of the debris. In this manner a considerable temperature reduction is achieved in the work area. Furthermore, the cleansing and cooling action performed by the tip on the sidewalls of hole is enhanced by the presence of a second lateral duct situated near the tip, which allows the outflow of the irrigation liquid. Furthermore, the ultrasonic frequency micro vibrations of the tool, which cause the cavitation phenomenon of the irrigation fluid, contribute to the washing of the walls of the hole formed by the tool.
5. Selective Drilling of the Bone Tissues.
Ultrasonic micro vibrations at low frequency (from 20 KHz to 30 KHz) act on the tool according to the invention, which are therefore optimal for drilling the bone tissue but ineffective for soft tissues, contact with which does not cause any tearing action but only a momentary release of heat. These vibrations are not able to cut mineralised tissues. In fact it is known that ultrasonic vibrations capable of cutting soft tissues use a greater frequency (50/60 KHz). Therefore the tools according to the invention, thanks to their particular geometric/structural shape and to the fact that they work at ultrasonic frequencies, are capable of making holes in the bone material through the action of micro vibrations acting on the cutting edges (not through the rotary action typical of the tools used in the prior art) with obvious clinical advantages.
6. Reduction of the Sources of Contamination During the Surgical Procedure.
Lastly, the ultrasound handpiece with the tools according to the invention, not having rotating parts, reduces the number of possible sources of contamination during the surgical procedure compared with the conventional systems with cutters. In fact in the conventional art the tips/cutters etc. are driven by micromotors, which require lubrication of the transmission members.
Further characteristics of the invention will be made clearer by the detailed description that follows, referring to purely exemplifying and therefore non limiting embodiments thereof, illustrated in the appended drawings, in which:
In
The body 2 of the handpiece is connected to an external connector member 4. The external connector 4 carries electrical and hydraulic supply cables 5 destined to be connected respectively to an electrical power supply, to a hydraulic supply and to a peristaltic pump provided on a console. The console provides a control panel for operation of the handpiece 1.
A transducer connected to the tool 3 is provided inside the handpiece 1. The transducer is preferably of the piezoelectric type and can be a piezoceramic resonator able to convert the electrical input signal into a vibration in the ultrasonic frequency so as to make the tool 3 vibrate. The oscillating frequency goes from 25 kHz to 30 kHz. A basic working ultrasonic frequency of 27 KHz is preferably chosen.
According to the requirements, the supply signal of the transducer having a basic ultrasonic frequency can be modulated or overmodulated with a low frequency signal (6-40 Hz); or it can be modulated or overmodulated with low frequency bursts.
This technique, which uses the modulation of the vibration of the tool 3, allows the heat that develops in the soft tissues because of the dissipation of energy due to vibration of the tool to be minimized.
The method providing for use of a basic signal at ultrasonic frequency modulated with low frequency bursts makes it possible to have a hammering effect of the insert 3, together with an efficacy of the ultrasonic vibration that causes a clean, precise cut in the mineralised tissue, for the formation of a hole in the bone.
With particular reference to
The tang 30 is connected at the front to a smaller diameter shank 32 by means of a tapered transition element 33 whose diameter decreases going from the tang 30 to the shank 32. The shank 32 has at its distal end a tip or a head 40 composed of a plurality of cutting elements 43. The tip 40 is the working part of the tool 3.
The shank 32 has a cylindrical body whose diameter decreases (from 2.2 mm to 1.8 mm, preferably from 2.00 mm to 1.7 mm) from the transition element 33 towards the tip 40. The shank 32 has a curved intermediate portion 34 which divides it into a first proximal part 32′ and a second distal part 32″. The main reason for this shape/configuration of the shank 32 is related to optimisation of the vibration in view of the needs of the anatomy of the surgical site.
As shown in
In a variance illustrated in
As better illustrated in
As shown in
The duct 36 ends in an outlet hole 44 at the centre of the tip 40. Therefore the fluid leaving the hole 44 of the tip allows the interface area between the bone tissue and the cutting part of the tip 40 to be irrigated and cooled directly. At the same time, the physical effect of the cavitation (produced by the ultrasonic micro vibrations) is exploited in said interface between the bone tissue and the cutting part of the tip 40, allowing a greater cleaning of the surgical site and a better cooling.
Returning to
The peripheral edges of the cutting elements 43 form cusps 45 protruding towards the distal end of the tool. The cusps 45 of the cutting elements define a circumference having a diameter ranging from 1.8 mm to 2.5 mm, preferably 2.0 mm.
Each cutting element 43 has an irregular pyramid or a wedge shape with a cutting profile inclined with respect to the axis of the tip. Each tooth 43 therefore has a cutting profile which converges radially from the periphery (that is, from the cusp 45 of the tooth) to the central outlet hole 44.
The particular sharpening process used to form the cutting teeth 43 leaves/produces, between adjacent teeth, an outlet which defines a radial channel 46 which starts from the central outflow hole 44 and extends radially towards the outer edge of the tip 40. Therefore, the irrigating liquid which flows axially from the outflow hole 44 (in the centre of the tip) branches out through said radial channels 46 thus allowing the cooling of the cutting area to be maximised and the discharge of the engaged/cut material to be facilitated.
In the outside surface of the cylindrical part 41 of the tip, between one tooth and the other, an outlet is further formed, which defines a longitudinal channel 47 which starts from the radial channel 46 and branches out longitudinally towards the shank. These particular longitudinal channels 47 allow an easy removal of the cut bone material.
With reference to
With reference to
The tool 103 furthermore has a circular ring or collar 137 situated on the shank 32 near the tapered portion 42 of the tip 140. The outside diameter of the ring 137 is substantially equal to or slightly smaller (about 1/10 mm smaller) than the diameter of the circumference defined by the cusps 45 of the cutting elements. The purpose of the ring 137 is to help to keep the direction of drilling of the tool 103 congruent with that performed with the tool 3 of the first embodiment which has a tip 40 with a smaller diameter.
As shown in
Even if in the figures the ring 137 and the lateral irrigation duct 138 are illustrated only in the tool 103 of the second embodiment, it is obvious that they can be provided in any type of tool according to the invention.
It should be noted that the handpiece 1 according to the invention has cutting tools (3, 103) vibrating at ultrasonic frequencies to make holes in the bone tissue. Unlike the instruments used for the same purpose in the prior art, the tools 3 and 103 do not have to rotate and therefore, if equipped with a suitable tip, allow holes of various shapes, besides circular, to be made.
It must be considered that endosseous fixing systems (screws/pins etc.) are currently available on the market only for circular holes. In fact the rotating instruments currently available can make holes only with a circular section. For this reason, in the figures, some possible tools (3, 103) with a cylindrical shaped tip (for holes with a circular section) have been illustrated by way of example.
However, other geometries of the tool tips (for holes of shapes other than circular) are possible, using the handpiece 1 according to the invention which exploits ultrasonic micro vibrations and non-rotary movements.
To perfect the shape and the dimensions of the tool according to the invention, a finite element (FE) digital model representing the structure of the ultrasound handpiece coupled to the tool was realised, and then simulations of the dynamic behaviour of said FE model when subjected to ultrasonic vibration were done. To validate the simulations of the dynamic behaviour of the tool made with the FE method, an experimental modal analysis
(EMA) was also performed, in which:
1) the structure was excited (random excitement) with an electrical signal having a frequency between 0 and 50 kHz;
2) the electrical input signal and the vibration responses in predefined points were measured using a 3D laser vibrometer;
3) the input and output signals were acquired and processed so as to obtain frequency response functions (FRF); and
4) a method of curve fitting in the time domain was used to extract the natural frequencies and the mode shapes of the tool during the vibration.
Initially the FE model of the structure of the tool 3 of the first embodiment (
The graph of
To help the surgeon during the preparation of the holes in the bone, the tool 103 of the second embodiment has been designed (
In
As is evident from the comparison of
To provide validity of the simulations with FE models, an EMA was conducted with a 3D laser vibrometer (LDV).
Numerous changes and modifications of detail within the reach of a person skilled in the art can be made to the present embodiments of the invention, without thereby departing from the scope of the invention, as set forth in the appended claims.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IT2006/000680 | 9/25/2006 | WO | 00 | 3/5/2010 |