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Title:
SCREW FITTING DEVICE FOR MEDICAL APPLICATIONS
Document Type and Number:
WIPO Patent Application WO/2013/183069
Kind Code:
A1
Abstract:
Screw fitting device for medical applications, in particular for endosseous implantology, comprising at least one torque wrench (1) for screwing at least one screw, being present a sensor (2) integral to said torque wrench suitable for registering the entity of the force given to said torque wrench. It is further present an external unit (3) connected to said torque wrench, suitable for receiving the signals generated by said sensor on the basis of the data registered by it. The torque wrench foresees an energy generation and storage unit, such as a battery (12) or the like, and also a device (13) suitable for recharging the battery.

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Inventors:
TIRINATO MARCO (IT)
Application Number:
PCT/IT2012/000168
Publication Date:
December 12, 2013
Filing Date:
June 05, 2012
Export Citation:
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Assignee:
VYRON S R L (IT)
TIRINATO MARCO (IT)
International Classes:
B25B13/46; A61B17/88; A61C8/00; B25B23/142
Foreign References:
DE202007012866U12008-01-17
DE202006017235U12007-01-11
DE10129487A12003-01-02
US20060254638A12006-11-16
EP2221022A12010-08-25
JP2011218140A2011-11-04
US6536536B12003-03-25
ITMI20090225A2009-02-19
Attorney, Agent or Firm:
TURINI, Laura (Firenze, IT)
Download PDF:
Claims:
CLAIMS

1. Screw fitting device for medical applications, in particular for endosteal implantology, comprising at least one torque wrench (1) for screwing at least one screw, said torque wrench (1) presenting at least one handle (11) suitable for the manual activation of said torque wrench ( 1 ) ,

being present a sensor (2) integral to said torque wrench (1) suitable for registering the entity of the force given to said torque wrench (1)

and being present an external unit (3) connected to said torque wrench (1), suitable for receiving the signals generated by said sensor (2) on the basis of the data registered by it,

characterized in that

said torque wrench (1) includes an energy generation and storage unit, such as a battery (12) or the like,

the said torque wrench (1) having a device suitable for recharging said battery (12) .

2. Screw fitting device for medical applications, according to claim 1, wherein said device suitable for the recharge of the battery (12) is constituted of an induction device.

3. Screw fitting device for medical applications, according to claim 1, wherein said device suitable for the recharge of the battery (12) is constituted of an electro-thermal device (13), of the Peltier cell type or the like.

4. Screw fitting device for medical applications, according to one or more of the preceding claims, wherein said external unit (3) is connected in a removable manner to said torgue wrench (1) .

5. Device according to one or more of the preceding claims, wherein said torque wrench (1) communicates with said external unit (3) through a communication without wires, of the wireless type or the like,

being present reception/transmission means (14) within said torque wrench (1) that communicate with corresponding reception/transmission means within said external unit (3) .

6. Device according to one or more of the preceding claims, wherein said torque wrench (1) foresees a control electronics (15) suitable for the adjustment of the functioning of said torque wrench (1) -

7. Device according to one or more of the preceding claims, wherein said torque wrench (1) comprises a one-sense free-release torque ratchet element (17) .

8. Device according to claim 7, wherein said ratchet element (17) is foreseen removable, presenting said torque wrench (1) at least a lodging seat (18) for lodging said ratchet element (17) and fixing means for fixing said ratchet element (17) .

9. Device according to one or more of the preceding claims, wherein said external unit (3) comprises a control unit (4) suitable for adjusting the functioning of said torque wrench (1) through the setting of threshold values relative to the entity of the force given to said torque wrench (1) .

10. Device according to claim 9, wherein said control unit (4) presents luminous and/or acoustic signalling means, said signalling means activate when the threshold value set is reached.

11. Device according to claim 10, wherein said acoustic signalling means generate an intermittent sound, whose intermittence presents gradually increasing frequencies, up to the generation of a continuous sound when the threshold value set is reached.

12. Device according to one or more of the preceding claims, wherein said control unit (4) comprises at least a display interface (42) for the display of at least the data registered by said sensor (2), an input/output interface for the entry of commands by a user and processing means for the executive of a logical programme.

13. Device according to one or more of the preceding claims, wherein said torque wrench (1) presents a further accelerometer sensor, said accelerometer sensor activates/deactivates at least said transmission/reception means.

14. Device according to one or more of the preceding claims, wherein mechanical means for adjusting the functioning of said ratchet element are foreseen.

15. Device according to one or more of the preceding claims, wherein the executive of said logical programme foreseen the possibility of setting the threshold values through vocal commands.

16. Device according to one or more of the preceding claims, wherein said external unit presents at least a memorization unit suitable for memorizing the values registered by the torque wrench (1), in such a way that the data registered are displayed under the form of a graph, in real time modality and/or in differed modality.

Description:
TITLE

SCREW FITTING DEVICE FOR MEDICAL APPLICATIONS The present invention refers to a screw fitting device for medical applications, in particular for endosteal implantology, comprising at least one torque wrench for screwing at least one screw, said torque wrench presenting at least one handle suitable for the manual activation of said torque wrench.

The device further presents a sensor integral to the torque wrench suitable for registering the entity of the force given to said torque wrench.

It is further present an external unit connected to the torque wrench, suitable for receiving the signals generated by the sensor on the basis of the data registered by said torque wrench.

There exist different types of screw fitting devices for medical applications, of which the main advantage is that of controlling the tightening torque in order to have a correct value that does not compromise the good result of the implant on which work is done.

Currently, there exist two types of solutions for controlling the correct tightening torque, a mechanical and an electronic one.

- The first solution is that known that foresees the use of one-sense free-release torque ratchet keys, which do not allow to increase the tightening torque once certain threshold values have been reached, making the key turn "idle".

Nevertheless, such a solution presents wear problems of the mechanical components, provoked both by the long use and by the particular environment in which work is done, for example oral cavities, which results particularly aggressive for the mechanical components .

Moreover, the worn components render the sterilization process more difficult, which is an aspect of fundamental importance for medical application .

The wear of the mechanical components, apart from creating the malfunctioning of the devices known in the state of the art, implies a lack of precision of the movement of the ratchet, rendering the correct functioning of the screws in the implant impossible.

Such problems are resolved with the use of a torque wrench that interfaces with an electronic control unit, that is a torque wrench that presents a sensor that registers the tightening torque given to said key and communicates such a value to an external electronic control unit.

A solution of this type is illustrated in patent application no. MI2009A000225, the contents of which are to be considered an integral part of the present patent application.

The screw fitting devices for medical applications known in the state of the art must face various problems; first of all, they must be constituted of materials that do not wear due to the external agents present in the environment in which they operate; secondly, they must present such dimensions as to result manageable by medical staff.

In addition, the materials of the various components and the dimensions must be such that the screw fitting devices are easily sterilizable, for example through devices of the autoclave type.

The screw fitting devices known in the state of the art are not able to meet completely the requirements just described; they are able to be manageable and highly adaptable to the different types of implant, but they result difficult to sterilize, or are realized to function at their best within the environment in which they operate, but present problems of duration and adaptability.

As a consequence, there exists the unsatisfied need of realizing a screw fitting device for medical applications, in particular for endosteal implantology, which allows to resolve the drawbacks just described, which are typical of screw fitting devices known in the state of the art.

The present invention reaches the aims mentioned above by realizing a screw fitting device as described before wherein the torque wrench foresees an energy generation and storage unit, of the battery type or similar, said torque wrench presenting also a device suitable for recharging the battery.

It is possible to foresee different types of devices suitable for recharging the battery, according to a first embodiment, the device is constituted of an induction device.

Thanks to the induction device, it is possible to recharge the battery without the need of connecting the torque wrench to the electricity network; the torque wrench is immersed in a magnetic field and the necessary current to recharge the battery, through the induction device, is induced in said torque wrench.

Alternatively, the device suitable for recharging the battery can be constituted of an electro-thermal device, of the Peltier cell type or similar.

The presence of the battery as a source of electrical feeding of the device that is the object of the present invention allows to eliminate the feeding wires that render the sterilization process difficult and that, further, can create inconveniences at manageability level.

Further, the presence of a battery does not imply the need of connecting the screw fitting device to the electric current to recharge the battery,- but an electro-thermal device is foreseen, that is a device that takes advantage of the Peltier effect and/or the Seebeck effect, which allow to generate a current through the heat displacement, from a hotter area to a colder area and vice versa.

The current generated by this difference of temperature allows to recharge the battery.

Such a feature presents an unquestionable advantage precisely for the sterilization that is requested to the screw fitting devices for medical applications; in fact, the electro-thermal device takes advantage of the heat developed during the autoclave cycle for recharging the battery, avoiding to charge the torque wrench once sterilized, an activity that would probably require a second sterilization.

Further, such an embodiment presents advantages also for period of long idleness of the torque wrench, since once sterilized, also in case of exhaustion of the charge of the battery, will be enough to create a difference of temperature for recharging it.

The heat developed during the autoclave cycle is surely one of the preferred methods for recharging the battery, but all the heat flows that provoke sudden changes of temperature can be used.

For example, a method for realizing a heat source can be obtained through the use of the features of supersaturated solutions of sodium acetate, commonly used in hand warmers or "self- heating" drink containers through the pressure of a specific area of the container.

Another method for recharging the battery can be obtained by positioning the torque wrench in a cold environment, such as a fridge or similar, and to create the sudden change of temperature once an operator grasps the torque wrench to use it.

The presence of the electro-thermal device results particularly advantageous if it is foreseen in combination with the fact that the external control unit belonging to the device that is the object of the present invention is connected in a removable manner to the torque wrench.

In particular, it will be possible to pull out the torque wrench from the external control unit during the sterilization, eliminating the presence of a difficult to sterilize element.

According to the improvement of the device that is the object of the present invention, the torque wrench communicates with the external control unit through a communication without wires, of the wireless type or similar, reception/transmission means being present inside the torque wrench that communicate with corresponding reception/transmission means foreseen inside the external unit.

As will be shown afterwards in a detailed manner through the description of some executive examples, the presence of a wireless technology renders possible the creation of a single body that constitutes the torque wrench, allowing in an easy manner the sterilization of it and eliminating the encumbrance of any type of wire, both in the case of a wire for the transmission of the signals or a feeding wire. Preferably, the torque wrench foresees a locker controller suitable for adjusting the functioning of said torque . wrench .

The locker controller receives the data registered by the sensor and transmits them through the wireless transmission means to the external control unit. It is possible to foresee that the processing of the signals made by the locker controller present inside the torque wrench is included.

Advantageously, the torque wrench comprises a one-sense free-release torque ratchet element.

According to an implementation form, the ratchet element should be removable, the torque wrench foresees at least one lodging seat for lodging the ratchet element and fixing means for fixing it.

Such a solution allows to adapt the screw fitting device that is the object of the present invention to the different methodologies of screws known in the state of the art, different both in dimensions and in shape.

According to an executive variant, the external unit comprises a control unit suitable for adjusting the functioning of the torque wrench through the setting of threshold values relative to the entity of the force given to the torque wrench.

This improvement allows top re-set correct threshold values on the basis of the type of implant, both on the basis of the type of bone on which the operation will take place, rendering adaptable the torque wrench to different types of implant.

Preferably, the control unit can present luminous and/or acoustic signalling means, which are activated when the threshold value set is reached. The use of such signalling means in combination to the threshold values set is a fundamental aspect since it is possible to foresee that such signalling means vary the intensity of both the luminous signal and the acoustic signal when coming near the threshold value.

The operator will thus be able to be acquainted with when the values of the tightening torque come near to the threshold values set.

Advantageously, in fact, the acoustic signalling means generate an intermittent sound, the intermittence of which presents gradually increasing frequencies, until the generation of a continuous sound when the threshold value set is reached.

As it will be subsequently shown through the illustration of some executive examples, the control unit comprises at least one display interface for the display of at least the data registered by the sensor, one input/output interface for the entry of commands by a user and processing means for the executive of a logical programme.

The display and input/output interfaces can be realized in any form known in the state of the art, in particular it is possible to foresee interfaces of acquisition of vocal commands for setting the threshold values according to the implant.

According to a further executive form, the torque wrench presents a further accelerometer sensor, which activates/deactivates at least said transmission/reception means of the data registered by the sensor.

In addition to the sensor that registers the tightening torque, it is possible to foresee a sensor of the accelerometer type that registers the use of the torque wrench. The functioning of the sensor is such that when the torque wrench is not used, such a sensor does not register activity, therefore it deactivates . the transmission/reception means of the torque wrench and all the components of the device that require electric energy to function, in such a way as to diminish the consumptions and lengthen the period of duration of the battery.

The accelerometer sensor, therefore, causes long disuse of the torque wrench, puts in stand-by the electronic components of the torque wrench, in particular it deactivates the transmission/reception means and puts in stand-by the electronic card.

Last, according to an actuation variant of the device that is the object of the present invention, mechanical means are foreseen for adjusting the functioning of the ratchet element.

These means can be foreseen in combination to electronic means described before and this results advantageous when the typical values of the electronics, or in the case of malfunctioning of the electronic part.

Advantageously, the executive of the logical programme foresees the possibility of setting the threshold values through vocal commands.

In this case, reception and processing means of the commands themselves will be foreseen.

Last, preferably, the external unit presents at least one memorization unit suitable for memorizing the values registered by the torque wrench, in such a way that the data registered are displayed under the form of a graph, in real time modality and/or in differed modality.

These and other features and advantages of the present invention will result clearer with the description of some executive examples that are illustrative in the annexed drawings, wherein:

figures la and lb illustrate two prospective views of the screw fitting device for medical applications that is the object of the present invention according to two particular executive forms;

figures 2a and 2b illustrate two views of the torque wrench belonging to the device that is the object of the present invention, in particular the figure 2a illustrates a section of the view of figure 2b;

figure 3 illustrates an executive variant of the sensor of the torque wrench that is the object of the present invention;

figure 4 illustrates the external unit belonging to the device that is the object of the present invention according to an actuation variant.

It is here specified that the figures illustrate an executive variant of the screw fitting device for medical applications that is the object of the present invention and they are used just for exemplification purposes and do not limit in any way the inventive concept of the present application.

The more generic inventive concept, in fact, is that of realizing a screw fitting device for medical applications whose torque wrench is energetically independent and that can be recharges without the need of connecting the key itself to an electric circuit.

In particular, in the figures a torque wrench is illustrated that presents inside it a device suitable for recharging the battery.

As previously explained, such a device can be realized according to various embodiments, as for example under the form of an induction device or under the form of an electro-thermal device.

In the. subsequent figures, just the embodiment with the electro-thermal device will be illustrated, but this does not limit the generic protective scope of the present patent application, which foresees the use of any device suitable for recharging the battery of the torque wrench.

With reference to figures from la to 2b, the screw fitting device for medical applications, in particular for endosteal implantology, which is the object of the present invention, comprises a torque wrench 1 for screwing at least one screw, which presents at least one handle 11 suitable for manually activating it.

The manual activation of the torque wrench 1 activates a sensor 2 placed inside it and integral to the torque wrench 1 in such a way that the sensor itself can register the entity of the force given by the user.

The data registered by the sensor 2 are then displayed through an external unit 3 connected to the torque wrench 1.

The torque wrench 1 foresees an energy generation and storage unit 12, of the battery type or similar, which is recharges through the presence of the electro-thermal device 13, of the Peltier cell type or similar.

The battery 12 is therefore responsible for the feeding of the device, in particular for the feeding of the sensor 2 and of the eventual electronic components placed inside the torque wrench 1.

According to a possible executive variant, the external unit 3 is connected in a removable manner to the torque wrench 1. It is therefore possible to foresee a connection wire between the torque wrench 1 and the external unit 3 that presents at least at the terminal connected to the torque wrench a first part of a connector that cooperates with a corresponding second part of the same connector foreseen inside the torque wrench 1.

According to a improvement of the device that is the object of the present invention, the torque wrench 1 communicates with the external control unit 3, through a communication without wires, of the wireless type or similar.

In this case, reception/transmission means 14 are foreseen, inside the torque wrench 1, which communicate with corresponding reception/transmission means foreseen inside the external unit 3.

Preferably, a wireless transmission takes place through known technologies such as Bluetooth or similar .

An actuation variant of the device that is the object of the present invention foresees a locker controller 15, suitable for adjusting the functioning of the torque wrench 1.

Such a locker controller 15 can be constituted of an electronic card 15, which can be integrated in the wireless transmission/reception means 14.

Such a locker controller 15 is fed as well by the battery 12 and can serve for different tasks, such as receive the data registered by the sensor 2 and process them to then send them to the external unit 3, as well as adjust the wireless communication of those. data.

Figures 2a and 2b illustrate two sections, respectively according to a lateral plane and a horizontal plane, of the torque wrench 1. According to such figures, the torque wrench 1 is constituted of a cylindrical-section tubular body 16, preferably constituted of metallic material that allows the lodging of the electronic card 15, of the battery 12 of the electro-thermal device 13 and of the wireless reception/transmission means 14, in proximity of an end. of the tubular body 16, while in proximity of the opposite end a device is foreseen that allows to work on the screw and obtain the locking.

Preferably, such a device is constituted of a one-sense free-release torque ratchet element 17.

The ratchet element 17 is realized according to the features known in the state of the art; for example, it can be constituted of a tubular body whose internal surface is engaged with the external surface of the screw, whose tubular body results appropriately dented on the external surface and arranged to cooperate with a device suitable for allowing the rotation of the tubular body itself in a single direction through the presence of appropriate teeth suitable for cooperating with the external toothing .

Advantageously, with particular reference to figure la, the ratchet element 17 is foreseen removable, the torque wrench 1 presenting a lodging set 18 for lodging it, and also fixing means for fixing it.

Figure 3 illustrates a possible executive form of the sensor 2 belonging to the torque wrench 1.

Such a sensor 2 is lodged inside the tubular body 16 and one of its first terminals 21 is fixed in proximity of the ratchet element 17, while a second terminal 22 is fixed in proximity of the battery 12. In the particular case illustrated in figure 3, the sensor 2 is constituted of a load cell that measures the force applied to the tubular body 16 through the measure o fan electric signal that varies due to the deformation that such a force produces on the sensor 2.

The load cell foresees a body 23 of conducting material on which at least one extensometer 24 is positioned that reads the mechanical deformation of the body 23 through the variation of electrical resistance that such a deformation causes on the electric circuit of the extensometer 24.

In the particular case of figure 3, the extensometers are four, connected between them, in a Wheatstone bridge configuration to amplify the signal transmitted, which is sent to the electronic card 15 through the connection wires 241.

Advantageously, the sensor 2 is inserted into the tubular body 16 and drowned in an insulating material of the silicon type or similar, to avoid the formation of rust or other deteriorating events during the autoclave cycle.

Further, the executive variant illustrated in figures from la to 3, presents a torque wrench realized in a single piece, but it is possible to foresee, according to an actuation variant, to connect the components described to a pre-existing ratchet element, to improve the adaptability with the torque wrenches currently in use.

With particular reference to figures 2a and 2b, it is here highlighted the particular solution foreseen for the tubular body 16, which foresees to diminish the thickness of the metallic materials in correspondence of the electro-thermal device 13 in such a way as to optimize the functioning of it. A further executive form foresees the use of a further accelerometer sensor inserted into the tubular body 16, said sensor activates or deactivates the controller of at least the transmission/reception means on the basis of the use of the torque wrench, that is puts in stand-by the components of the device that is the object of the present invention that require an electric feeding, in case of a long disuse of the torque wrench 1.

Last, mechanical means for adjusting the functioning of the ratchet element 17 can be foreseen, of those known in the state of the art.

Figure 4 illustrates a possible implementation form of the external unit 3 belonging to the device that is the object of the present invention.

In particular, the external unit 3 can comprise, or be constituted of a control unit 4 suitable for adjusting the functioning of the torque wrench 1 through the setting of threshold values relative to the entity of the force given to the torque wrench 1.

The control unit 4 is connected wireless to the torque wrench 1 and receives the signals transmitted by it through the transmission/reception means 14, said means 15 allow the dialogue between the torque wrench and the control unit 3.

The signal registered by the sensor 2 can be processed at different levels, which can be foreseen alternatively or in combination, that is it can go through a first processing made by the electronic card 15, a second processing made by the control unit 4 and a further processing made by the external unit 3 that can in this case be constituted of a PC or similar connected in any manner, wireless or via wire . It is here specified that the control unit 4 can be completely integrates within the external unit 3.

Independently of the embodiment, the control unit 4 illustrated in figure 4 presents the common commands of the peripherals known in the state of the art, in particular it presents keys 41 for setting pre-determined threshold values relative to the tightening torque with which to lock the screws of the various implants.

Moreover, the control unit 4 comprises at least one display interface 42 for the display of at least the data registered by the sensor 2, one input/output interface for the entry of the commands by the user and processing means for the executive of a logical programme .

The executive of the logical programme allows various activities, such as the setting and the modification of the threshold values or the possibility of entering vocal commands.

Last, according to an executive variant, the control unit 4 presents luminous and/or acoustic signalling means, said signalling means being activated when the threshold values set are reached.