Patent Description:
<CIT> discloses a surgical screwdriver according to the preamble of claim <NUM>.

Surgical screwdrivers are used to screw/unscrew clamping screws ir various applications such as anterior interbody arthrodesis, where it is necessary to bind appropriate inserts to the vertebrae using the above-mentioned clamping screws.

In this specific case, the operator pierces the patient's skin by making an incision of just a few centimetres in order to insert the surgical tools, including the screwdriver.

In order to carry out an operation that is as minimally invasive as possible, therefore, the screwdrivers and other tools are kept coincident with the axis of the hole defined by the incision, i.e. with their development axis perpendicular to the surface on which the incision is made.

In this situation, in fact, the screwdriver must not be tilted in order to avoid widening the incision and, thus, tearing the skin tissue.

However, the clamping screws may have their own rotation axis, at the respective application site, that does not coincide with the axis of the hole defined by the incision.

In this situation, tilted-axis surgical screwdrivers are used and equipped with a longitudinal rod from which a shaped tip extends that is designed be inserted into the head of the screw and extending transversely to the rod. In particular, the rod has a first end that is intended to remain outside the patient's body and on which the operator transmits the rotational motion. On the opposite side of the first end, a second end of the rod extends and is rotatably engaged with the shaped tip.

Between the second end of the rod and the shaped tip, a joint, typically a cardan joint, extends, which is capable of transferring the rotational motion of the rod to the shaped tip.

In particular, the joint consists of a first fork extending from the second end of the rod and a second fork from which the shaped tip extends. The forks are mutually pivoted using a cross-shaped element that enables the connection of the forks and the possibility of staggering the tip with respect to the rod.

In this way, the joint allows the rod to be kept aligned with the incision hole and, at the same time, to operate by screwing/unscrewing the screw positioned along an axis that is tilted with respect to the longitudinal extension of the rod itself.

The surgical screwdrivers described above, although capable of transferring the rotational motion between two transverse axes (rod axis and shaped tip axis), have, in any case, significant drawbacks.

A first, significant drawback is the transmission ratio between the rod and the shaped tip. It is well known that in this type of transmission the instantaneous angular velocity of the shaped tip (driven shaft) is not constant during a complete rotation but is a function of the misalignment angle of the shaped tip (driven shaft) axis with respect to the shaft axis (drive shaft). As the angle of incidence increases, the amplitude of oscillation of the angular velocity also increases.

There is, therefore, a non-fluid transmission between the rod and the shaped tip, which can generate vibrations and, during the operation on the screw, misalign the shaped tip with respect to the screw head. In this context, it is particularly uncomfortable for the operator to operate precisely and efficiently on the clamping screws.

Another significant drawback of the prior art described above is the overall dimensions of the cardan joint. In this context, it is very difficult to insert the screwdriver through small incisions. The presence of the two forks connected to each other means, in fact, that the screwdriver is considerably enlarged in a direction transverse to the longitudinal extension of the rod. For this reason, in order to enable the complete insertion of the joint, the surgical operator cannot keep the incision very small.

Finally, a further drawback, which is again linked to the presence of the cardan joint, is the presence of projecting elements that, in certain applications, may inadvertently interfere with the tissues surrounding the clamping screw.

In this case, in fact, the two forks of the cardan joint cause transverse projections that, during rotation, may engage the soft tissues close to the operating site and damage them.

The purpose of the present invention is, therefore, to make a surgical screwdriver available that overcomes the drawbacks of the prior art described above.

A first purpose of the present invention, in fact, is to propose a surgical screwdriver with a tilted axis capable of transmitting, in an almost constant way, the angular velocity transmitted by the surgeon, therefore ensuring a stable and precise operation on the clamping screw.

An additional purpose of the present invention is to propose a surgical screwdriver of limited dimensions in cross-section, in order to make the surgical operation as non-invasive as possible.

Finally, one purpose of the present invention is to propose a surgical screwdriver with tilted axes and equipped with a compact transmission joint without any roughness or projections that could interfere with the soft tissues surrounding the operating site.

These and other purposes are substantially attained by a surgical screwdriver, in particular with a tilted axis according to what is described in one or more of the accompanying claims.

In particular, the present invention concerns a surgical screwdriver as defined in claim <NUM>.

Additional features and advantages will emerge in greater detail in the description of a preferred, but not exclusive, embodiment of a surgical screwdriver, according to the present invention and the dependent claims.

The present invention will be made clearer by the following detailed description, with reference to the attached drawings provided by way of example only, wherein:.

In the above figures, the reference number <NUM> designates, in its entirety, a surgical screwdriver.

In accordance with a first embodiment shown in <FIG>, the surgical screwdriver <NUM> is of the fixed tilted-axis type. In this case, in fact, as will be better clarified later in this discussion, the angle of incidence between the screwing operating axis and the motion actuation axis is predetermined and preferably <NUM>°.

In more detail, the surgical screwdriver <NUM> comprises a first rotating shaft <NUM> configured to be rotated about a respective longitudinal extension axis "X". The first shaft <NUM> can be rotated manually by the surgical operator, or using appropriate electromechanically controlled motorized systems.

The first shaft <NUM>, made in the form of a stem, defines the "input" axis of the rotational motion and, in use, is kept coincident with the incision made in the patient.

The screwdriver <NUM> also comprises a second rotating shaft <NUM> extending along a respective development axis "Y" that is transverse to the longitudinal axis "X" of the first shaft <NUM>. The second shaft <NUM> has a shaped end tip <NUM> to insert into the screw head (not shown in the attached figures as it is not part of the present invention).

The end tip <NUM> can have any shape (slotted, cross-shaped, or Allen-shaped, for instance) depending on the seat located on the screw head or other threaded member to be screwed/unscrewed. In the attached figures a Torx-type shaped tip <NUM>, configured, therefore, in the shape of a six-pointed star, is shown for purely illustrative, non-limiting, purposes.

The development axis "Y" of the second shaft <NUM> therefore defines an "output" axis of the rotational motion and, in use, is arranged coaxially to the longitudinal extension of the screw in order to operate on the screw itself.

Between the first and second shaft <NUM>, <NUM>, there is also a transmission member <NUM>, which is designed to transfer the rotation from the first shaft <NUM> to the second shaft <NUM>.

The transmission member <NUM> is interposed between respective first ends 2a, 3a, of the shafts <NUM>, <NUM>, opposite, respectively, the second end 2b of the first shaft <NUM> and the shaped tip <NUM> of the second shaft <NUM>.

The transmission member <NUM> comprises a homokinetic spherical joint <NUM>, which is therefore able to keep the transmission ratio between the first shaft (input axis) and the second shaft (output axis) constant.

As better shown in <FIG> and <FIG>, the spherical joint <NUM> comprises a spherical head <NUM> having at least one lateral facet <NUM>.

A plurality of lateral facets <NUM> adjacent to each other, each of which defines a respective segment of the spherical head <NUM>, is preferably provided.

Between each pair of adjacent facets <NUM>, there is also an edge <NUM>, which has an arched profile. As a result, the spherical head <NUM> has a series of arched edges <NUM> on the outside; these alternate with the facets <NUM> and extend from two opposite poles of the spherical profile.

The spherical head <NUM> is joined to the first end 2a, 3a of one of the shafts <NUM>, <NUM>. The head <NUM> is advantageously made of one piece with the first end 2a of the first shaft <NUM>. In addition, the spherical head <NUM> has a circular profile along a section plane coinciding with the longitudinal axis "X" (section plane in <FIG> and <FIG>) and a polygonal, preferably hexagonal, profile along a section plane perpendicular to the longitudinal axis "Y".

The homokinetic spherical joint <NUM> also comprises a cavity <NUM> counter-shaped to the spherical head <NUM> and partially surrounding the head <NUM> itself. In other words, the cavity <NUM> is in the shape of a cap and is arranged about a substantially hemispherical portion of the head <NUM>.

The cavity <NUM> is advantageously located on the first end 3a of the second shaft <NUM> and preferably made of one piece with the second shaft <NUM>. Furthermore, the cavity <NUM> has, inside, a lateral wall <NUM> defining a polygonal, preferably hexagonal, profile and a hemispherical back wall <NUM>. In this way, the head <NUM> and the cavity <NUM> are bound in rotation (about the axes "X", "Y" of the respective shafts <NUM>, <NUM>) but free to relatively slide to keep the transverse angle of incidence (at <NUM>° in this embodiment) between the two axes "X", "Y".

As is better shown in <FIG>, the second shaft has a hemispherical enlargement <NUM> at the first end 3a, which is designed to internally define the above-mentioned cavity <NUM>. From the hemispherical enlargement <NUM> the second shaft <NUM>, which terminates in the above-mentioned shaped tip <NUM>, extends in the form of a stem.

The screwdriver <NUM> also comprises an internally hollow cylindrical sleeve <NUM>, which has a tubular shape and extends along the longitudinal axis "X" of the first shaft <NUM>.

In particular, the sleeve <NUM> internally accommodates the homokinetic spherical joint <NUM> and, at least partially, the shafts <NUM>, <NUM>.

In this situation, the second end 2b of the first shaft <NUM> projects outside a first opening 14a of the sleeve <NUM>. This second end 2b is handled by the operator to actuate the rotation of the first shaft <NUM> or is engaged in torque limiters or other appropriate transmission and/or motorization systems (not shown as they are not part of the present invention).

In addition, the shaped tip <NUM> of the second shaft <NUM> also projects outside a second opening 14b of the sleeve <NUM> opposite to the first opening 14a and opposite to the second end 2b of the first shaft <NUM>.

In this situation, it should be noted that the openings 14a, 14b of the sleeve are not mutually coaxial, but staggered to define the angle of incidence between the "X, Y" axes.

In fact, the second opening 14b defines the orientation of the development axis "Y" of the second shaft <NUM>, binding this position with respect to the longitudinal axis "X" of the first shaft.

In use, keeping the sleeve <NUM> fixed, it is possible to rotate the first shaft <NUM> and therefore also the shaped tip <NUM>, using the transmission member <NUM> placed inside the sleeve <NUM> itself.

It should also be noted that the sleeve <NUM> comprises a projection <NUM> defining a spherical outer surface for accommodating the homokinetic spherical joint <NUM>. The projection <NUM> preferably consists of two hemispheres that can be coupled to each other as highlighted in the exploded view in <FIG>.

The second opening 14b of the sleeve <NUM> is located on the outer surface of the projection <NUM>. In addition, the projection accommodates the enlargement <NUM> of the second shaft <NUM> so that the entire joint <NUM>, during rotation, does not come into contact with the patient's soft tissue surrounding the clamping screw. In other words, only the shaped tip <NUM> projecting from the sleeve <NUM> is the only rotating member inside the patient's body. All the rotating members (the shafts and the joint) are advantageously protected inside the sleeve <NUM>. In this situation, it should be noted that the second end 2b of the first shaft <NUM> remains outside the patient's body.

In addition, an ergonomic portion <NUM>, which is located on the outer surface of the sleeve <NUM> near the second end 2b of the first shaft <NUM>, is provided to hold the screwdriver <NUM> in place.

The ergonomic portion <NUM> enables you to manually hold the sleeve with respect to the incision and with respect to the patient, and, at the same time, to unscrew/screw the screw by operating on the first shaft <NUM>.

Again, in accordance with the first embodiment (<FIG>), the first shaft <NUM> is made of two portions <NUM>, <NUM> coaxially joined to each other inside the sleeve <NUM> and made in the form of respective rods.

In this situation, the second end 2b of the first shaft <NUM> is located in a first portion <NUM> distal from the second shaft <NUM>.

The first portion <NUM> also has a shaped pin 17a, which can be reversibly joined to a respective shaped seat 18a of the second portion <NUM>.

In turn, the second portion <NUM> has, on the opposite side of the shaped seat 18a, the above-mentioned spherical head <NUM>. The second portion <NUM> is advantageously held inside the sleeve <NUM> by means of a connector <NUM> (<FIG>) that can be inserted into transverse holes located in the sleeve <NUM> and through an annular guide <NUM> located on the second portion <NUM>. The first portion <NUM>, instead, is held manually inside the sleeve <NUM> and pushed against the second portion <NUM> to define the coupling between the pin 17a and the seat <NUM>, which guarantees the transmission of the rotation between the first and second portion <NUM>, <NUM>.

The first portion <NUM> can be removed from the sleeve <NUM> and possibly replaced with other functionally equivalent rods.

In accordance with a second embodiment not conform to the claimed invention and shown in <FIG>, a variably tilted-axis screwdriver is provided.

In this situation, the orientation of the shaped tip <NUM>, and the entire second shaft <NUM>, can be changed according to the various needs of their use and within a predetermined range of angles between the two axes "X, Y".

The sleeve <NUM> can also be used for this embodiment. However, for the sake of clarity, the second embodiment, without the sleeve <NUM>, is shown in the attached figures.

In particular, in this solution, in contradiction with the claimed invention, the first shaft <NUM> is made of one piece and the respective first end 2a is equipped with a circular seat <NUM> coaxial to the longitudinal axis "X".

As better shown in <FIG> and <FIG>, the spherical head <NUM> is equipped with a coupling pin <NUM> projecting from the opposite side of the cavity <NUM> and accommodated inside the circular seat <NUM>.

In addition, an elastic thrust member <NUM> is provided, interposed between the circular seat <NUM> and the coupling pin <NUM>, to enable the movement of the spherical head <NUM> towards the first shaft <NUM> as better explained later on.

The first end 2a of the first shaft <NUM> is coaxially engaged to a hollow cylindrical body <NUM> to internally gather the homokinetic spherical joint <NUM> (as better shown in <FIG>).

The cylindrical body <NUM> has a through opening <NUM> through which the second shaft <NUM> and the respective shaped tip <NUM> partially project. It should be noted that the through opening <NUM> is much wider than the thickness of the second shaft <NUM> to allow the second shaft <NUM> to move inside the opening <NUM> and to orient the shaped tip <NUM> by changing the angle of incidence between the axes "X, Y".

In other words, the second shaft <NUM> is oriented in a plurality of operating configurations, each of which is representative of a respective angle of incidence between the longitudinal axis "X" of the first shaft <NUM> and the development axis "Y" of the second shaft <NUM>. The tilt of the second shaft <NUM> can, advantageously, be adjusted according to the position of the screw to be screwed/unscrewed, regardless of the position of the first shaft <NUM>.

Finally, it should be noted that the through opening <NUM> of the cylindrical body <NUM> is defined by a perimeter rim 25a that has a width smaller than the diameter of the hemispherical enlargement <NUM>. In this way, the first end 3a of the second shaft <NUM> always remains contained inside the cylindrical body <NUM> and, during the handling of the second shaft <NUM>, the spherical surface of the enlargement <NUM> slides on the rim 25a.

It should be noted that the second shaft <NUM> is bound in rotation to the first shaft <NUM> and the head <NUM> is pushed against the cavity <NUM> by the elastic member <NUM>. In this way, it is possible to keep the screwdriver <NUM> compressed against the respective screw, defining a pre-load action of the member <NUM>, in which the shaped tip <NUM> remains inserted so it is pushed against the seat of the screw head.

In other words, the elastic member <NUM> keeps the shaped tip <NUM> pressed against the screw, defining a rotational binding between the second shaft <NUM> and the screw itself.

The screwdriver <NUM> described above overcomes the drawbacks of the prior art and entails important advantages.

First of all, the homokinetic spherical joint enables the transmission ratio between the angular velocity of the first shaft <NUM> and the second shaft <NUM> to be kept constant.

The rotational movement is, advantageously, more homogeneous, smooth, and, therefore, more precise during the tightening of the screws.

In addition, the angle of incidence can be adjusted according to the position of the screw. In accordance with the second embodiment, it is possible to orient the axis of the second shaft <NUM> according to the axial position of the screw. The screwdriver <NUM> is, therefore, very versatile and can be adjusted to the various types of screws and their insertion positions.

A further significant advantage is the very small overall size, especially in the positioning area of the transmission member <NUM>.

This advantage is due to the shape of the spherical joint <NUM>, which enables a considerable reduction in its overall size compared to the known cardan joints.

The surgical operator can, advantageously, make an incision of a very limited size, thus facilitating the minimum invasiveness of the operation. Finally, another important advantage of the present invention is due to the absence of projecting portions that, when rotating, can interfere with the tissues surrounding the clamping screws.

Claim 1:
A surgical screwdriver comprising:
- a first rotating shaft (<NUM>) configured to be rotated about a respective longitudinal axis (X);
- a second rotating shaft (<NUM>) extending along a respective development axis (Y) and having a shaped end tip (<NUM>) which can be inserted into the head of a screw;
- a transmission member (<NUM>) having a homokinetic spherical joint (<NUM>) interposed between respective first ends (2a, 3a) of the shafts (<NUM>, <NUM>) to transfer the rotation from the first shaft (<NUM>) to the second shaft (<NUM>);
- a cylindrical sleeve (<NUM>) which is internally hollow to accommodate at least partially said shafts (<NUM>, <NUM>) and said homokinetic spherical joint (<NUM>); said first shaft (<NUM>) having a second end (2b) opposite to the first (2a) and projecting out of a first opening (14a) of the sleeve (<NUM>); said shaped tip (<NUM>) of the second shaft (<NUM>) projecting out of a second opening (14b) of the sleeve (<NUM>) opposite to the first opening (14a);
characterized in that said first shaft (<NUM>) comprises a first portion (<NUM>) and a second portion (<NUM>) configured to be coaxially joined to each other inside the sleeve (<NUM>); said second end (2b) of the first shaft (<NUM>) being located in the first portion (<NUM>) which is
distal from the second shaft (<NUM>); the first portion (<NUM>) having a shaped pin (17a) configured to be
reversibly joined to a respective shaped seat (18a) of the second portion (<NUM>), so that the first portion can be removed from the sleeve (<NUM>).