The present invention relates to a guidewire torquer. A guidewire torquer is a device that is used in a number of different medical procedures to guide vascular catheters, catheter-mounted heart valves, aortic endo- grafts, endotracheal tubes, or gastric feeding tubes and the like into a patient towards a desired location within the patient. Guidewires are used in a number of diagnostic and interventional fields, such as interventional cardiol ^¬ ogy, diagnostic and interventional radiology, vascular surgery, minimally invasive vascular interventions such as angioplasty, stenting, thrombolysis, transcatheter aortic valve insertion (TAVI), and endovascular abdominal aortic aneurysm repair (EVAR) .

In vascular uses, a physician is required to navigate the guidewire through the vasculature of the patient. This is done in order to position the distal end of the guidewire at the desired location. Then a diagnostic or therapeutic catheter is fed over the guidewire to the de ^¬ sired location for the planned vascular intervention. In the text, the distal end of the guidewire is the end that is to enter the human body. The proximal end of the guide- wire is in the hands of the physician and is not inserted into the body.

The distal end of the guidewire generally has an angled tip adjusted to help steer the guidewire. Position ^¬ ing the distal end of the guidewire at the desired loca ^¬ tion can be tough and time consuming due to complex vascu- lar anatomy and due to abnormalities of the vessel lumen caused by vascular disease. The physician manipulates the distal end of the guidewire through the vasculature of the patient to the desired location by pinching and torqueing the proximal end of the guidewire with his fingers.

Guidewires are relatively fine and difficult to grip between the physician's fingers, thereby making the positioning of the guidewire challenging. Handling of the guidewire is hampered by the fact that the guidewire is often slippery particularly when wetted with saline or blood. A guidewire is also intended to be smooth by means of various kinds of coating in order to provide lubricity between the guidewire surface and the inner surface of the vessel wall.

Due to the slipperiness of the guidewire the phy ^¬ sician cannot accurately and securely rotate or move the guidewire lengthwise in and out of the body. It is also difficult to reliably feel with his fingers to what extent the guidewire follows his steering manipulations.

As such, a device called a guidewire torque de ^¬ vice, guidewire torquer, or steering handle, is often af ^¬ fixed to the guidewire in order to allow the physician to better grip and impart motion to the guidewire. That is, the guidewire torquer device is intended to allow the phy ^¬ sician to securely control the movements of the guidewire and to steer the distal end of the guidewire by rotational and longitudinal manipulation of the guidewire.

One disadvantage of prior art guidewire torquers is that they are configured to be attached from and over the proximal end of a guidewire. Generally, guidewire torquers must be back loaded over the proximal end of the guidewire, and then advanced along the guidewire until a suitable location is reached. After that a reliable fixa ^¬ tion between guidewire and torquer is required, which may be unreliable or damage the guidewire by kinking or break ^¬ age or detachment of surface particles. Furthermore, prior art guidewire torquers are com ^¬ plex, consisting of multiple moving parts, and therefore are relatively expensive.

In order to improve such prior art, the present invention provides a guidewire torquer for manually con ^¬ trolling a guidewire, and imparting motion to a guidewire in both lengthwise direction and rotational orientation, the guidewire torquer comprising:

- a handling body for handling of the guidewire torquer,

- an insertion channel for receiving the guide- wire, the insertion channel being arranged at a surface of the handling body,

- wherein the handling body comprises a shaping feature, which shaping feature provides tactile feedback as to the orientation of the guidewire, and

- wherein the insertion channel provides a contact area of frictional fixation of the guidewire relative to the handling body.

A main advantage of such a guidewire torquer is that a superior and reliable manual control of the guide- wire can be provided while the mounting of the guidewire torquer to the guidewire can be performed in a simple man ^¬ ner .

Also the mounting of the guidewire torquer to the guidewire can be performed at any spot of the guidewire as seen lengthwise to the guidewire, without the need for back loading the guidewire torquer over the proximal end of the guidewire.

Because of the frictional fixation of the guide- wire inside the guidewire torquer, forces exerted by the guidewire torquer on the guidewire are spread over the contact area of frictional fixation. Therefore, the fixa- tion is highly reliable. Also no movable parts are re ^¬ quired to provide such friction.

Due to the fact, that forces exerted by the guide- wire torquer on the guidewire are spread over the contact area, the following known problem of the prior art is prevented. In prior art devices clamping elements such as screws or claws pose a risk of detachment of particles from the coating of the guidewire, which is especially so in case of slippage of the guidewire relative to the torquer. Such damage, also known as local stripping of surface material or coating from the guidewire may pose health risks to patients being operated on, when such particles reach the inside of the human body.

Another aspect of possible damage by prior art de- vices to the guidewire is that a point force exerted by the guidewire torquer leads to deformation of the contour and shape of the guidewire, which could even lead to kinking or breakage of the wire. Such damages are prevent ^¬ ed with the present guidewire torquer.

Also, the presented guidewire torquer provides a reliably visible and/or tactile feedback to the physician concerning the rotational orientation of the guidewire within the guidewire torquer, and a visible feedback concerning the insertion depth of the guidewire. According to the prior art such feedback to the physician is missing as the technical development of those devices has been di ^¬ rected solely at the capability to attach the device to the guidewire.

A first preferred embodiment according to the pre- sent invention provides a guidewire torquer wherein the insertion channel is accessible over the whole length thereof. An advantage of said insertion channel is that the guidewire can be laid or pushed into the insertion channel over the whole length of the channel, allowing for easy insertion of the guidewire into the insertion channel and therefore into the handling body of the guidewire torquer .

Further preferably, the insertion channel has a curved shape. The curved shape provides for an enhancement of the frictional fixation as the structural integrity of the guidewire provides pushing and pulling forces towards bends and inflection areas of the curved shape. The struc- tural integrity of the guidewire provides the guidewire with an inclination to straighten out. Therefore, the guidewire will exert a force to an inner apex of a bend as well as to outer inflection points in between the apex bends. Such forces enhance the friction between the guide- wire torquer and the guidewire. The fact, that a guidewire is kept in the curved shape of the insertion channel, pro ^¬ vides both a lengthwise and a rotational fixation of the guidewire to the handling body. The forces, provided by the heights of the bends in the insertion channel, exerted on to the guidewire make the guidewire rotating directly in response to any rotational handling of the guidewire torquer. This provides the physician with the ability to precisely manipulate the tip at the distal end of the guidewire .

Another preferred embodiment provides an insertion channel being shaped in the form of a sinusoid curve. Such curvature allows for a natural formation of curves and bends in the guidewire. Preferably the insertion channel comprises at least one bend up to multiple bends. The amount of friction between guidewire torquer and guidewire depends on the number and the amplitude of the curves (i.e. height of the bends) . Generally, a higher bend pro ^¬ vides in itself a higher friction than a lower bend. Fur- thermore, more bends exert more friction on the guidewire than less bends. Therefore, for the same magnitude of friction, multiple curves need less amplitude than a sin ^¬ gle curve.

An advantageously preferred embodiment provides a sinusoid insertion channel wherein the insertion channel is relatively wider at the apices of the bends. Such local widening of the insertion channel facilitates the inser ^¬ tion of the guidewire into the insertion channel, without substantially changing effectiveness of the frictional fixation of the guidewire in the insertion channel.

According to a further preferred embodiment, the insertion channel provides a gradual friction force to the guidewire over a substantial portion of the length there- of, thereby preferably preventing point forces to the guidewire or pinching of the guidewire. Because the guide- wire is making contact with the walls of the insertion channel over such large portion of the length of the insertion channel, the friction force is spread out over this portion. This provides a clear improvement compared to the highly focused or point friction forces of prior art devices.

A preferred embodiment, in which the insertion channel has at least one portion in which the open side of the insertion channel is narrower than the base of the insertion channel, provides advantageously that the inwardly extending walls of the insertion channel urge the guide- wire to stay in the insertion channel during operations.

A further advantageous shape in this context is a trapezoidal profile of the insertion channel with the open side being narrower than the base of the insertion channel . In order to improve tactile feedback as to the orientation of the guidewire torquer, the handling body preferably provides a flat surface at at least one side, wherein the handling body is preferably oval shaped or rectangular shaped with dimensions resembling those of a credit card. Also the shape preferably has bulges or in ^¬ dentations that further improve tactile feedback as well as improve the grip on the guidewire torquer by the fin ^¬ gers of the user. Holding such a substantially flat device makes it easy to discern rotation during handling thereof. When the flat guidewire torquer is rotated, the degree of rotation is readily visible and tactile. Consequently, the degree of rotation of the guidewire that is fixated inside the guidewire torquer is visualized by the visible orien- tation of the shape of the guidewire torquer. Also, with ^¬ out looking at the guidewire torquer, the orientation of the hand holding the handling body provides tactile infor ^¬ mation as to the rotational orientation of the guidewire.

Further preferably, the insertion channel compris- es a frictional surface, preferably comprising coarse ma ^¬ terials such as rubber and the like. Such features accord ^¬ ing to this embodiment provide additional functionality as to the aspect of friction. There would be a higher re ^¬ quirement for such materials when the number and/or ampli- tude of the curves in the insertion channel is lower and vice versa. Clearly, a substantially straight insertion channel preferably comprises an exceptionally coarse sur ^¬ face in order to still build up sufficient friction be ^¬ tween guidewire torquer and guidewire.

A highly advantageous embodiment provides the guidewire torquer being made of one part, preferably by means of a forming operation, such as injection molding or milling. Such production operation is highly reliable and cost-effective.

Another preferred embodiment provides two inser ^¬ tion channels, one on either side of the guidewire

torquer, each insertion channel preferably having a different shape and/or frictional capacity so being optimized for different guidewires according to their thickness and/or stiffness.

In order to improve upon tactile orientation dis- cernibility, a further preferred embodiment comprises a tactile marker, such as a top and/or bottom side indica ^¬ tor, that preferably comprises a coarseness at the surface of the guidewire torquer and/or a particular shape such as one or more indentations for the fingers of the user.

Further preferably, the guidewire torquer compris ^¬ es a printable surface. An advantage thereof is that in ^¬ structions and/or other information, such as relating to the use and origin of the guidewire torquer, can be pro ^¬ vided also after the guidewire torquer has been unpacked and the packaging is dismissed.

According to a further preferred embodiment, at least one end of the insertion channel comprises a guide- wire slip out prevention feature, preferably embodied as a relatively narrow open side of the insertion channel. Also an overhang of material at the side to the nearest bend of the insertion channel is considered by the inventor. Such overhang is very effective in keeping the guidewire fixat ^¬ ed in the insertion channel during operations.

Further preferably, the insertion channel compris- es clickable portions at which the top side opening of the insertion channel is slightly narrower than the diameter of the respective intended guidewire. Thereby, the guide- wire would click into the insertion channel with a sort of snapping operation when pushing it in through the slightly narrower open side of the insertion channel. Thus, the guidewire is forcibly retained in the insertion channel.

A further aspect according to the present inven- tion provides a kit of a guidewire torquer according to one or more of the preceding claims with a guidewire, preferably a guidewire having an insertion tip with a curvature for inserting into the human body, the kit provid ^¬ ing advantages as described in the above.

Preferably, in the kit, the guidewire also has an indicator tip at the other side of the wire from the in ^¬ sertion tip for indicating the direction of the insertion tip as depending from the direction of the indicator tip.

Further advantages, features and details of the present invention will be elucidated on the basis of a de ^¬ scription of one or more embodiments with reference to the accompanying figures.

Fig. 1 provides a perspective view of a first pre ^¬ ferred embodiment according to the present invention.

Fig. 2 provides four further views of the embodi ^¬ ment of figure 1.

Fig. 3 provides a further preferred embodiment ac ^¬ cording to the present invention being mounted on a guide- wire .

Fig. 4 provides two front views of a further pre ^¬ ferred embodiment according to the present invention.

Fig. 5 provides a perspective view of a further preferred embodiment according to the present invention.

Fig. 1 shows a perspective view of a guidewire torquer 1 according to a first preferred embodiment ac ^¬ cording to the invention. Figures 2A-D show further views of the guidewire torquer 1. The guidewire torquer is com ^¬ prised of a single handling body 2, which may be either molded or machined. The forming of the guidewire torquer from a single part provides a low complexity and expense of the device. The guidewire torquer 1 has the shape of a substantially flat, oval disc. The longitudinal diameter of the oval disc is about twice as long as the transverse diameter of the oval disc. The guidewire torquer 1 in ^¬ cludes a front surface 9, a back surface 9' , a top side 21, a bottom side 22, a left side 23, a right side 24 and a circumference surface 19.

An insertion channel, score or groove 3 for fixing a guidewire relative to the guidewire torquer is present in the front surface 9 of the guidewire torquer. The in ^¬ sertion channel extends along the surface through the front surface and follows a curved stretch between the left side 23 and the right side 24 of the guidewire torquer. The insertion channel 3 trepans the circumference side 19 with a left opening 17 and with a right opening 16 and has a trapezoid profile.

The trapezoid profile is shown in greater detail in figure 2C. The base 5 of the insertion channel is bounded by two walls of the insertion channel, the lower wall 7 and the upper wall 8. The base 5 is connected with the lower wall 7 by the angular transition 27 and the base 5 is connected with the upper wall 8 by the angular tran- sition 28. The lower wall 7 stretches between the angular transition 27 and the free edge 17 of the lower wall. The upper wall 8 stretches between the angular transition 28 and the free edge 18 of the upper wall. The open side of the insertion channel is bounded by the free edges 17 and 18. Due to the trapezoid profile of the insertion channel the width of the open side is smaller than the width of the base 5. The relatively narrow open side and the in ^¬ clined walls provide urging of the guidewire towards the base of the insertion channel under the urging force of the wire itself being inclined to self-straighten.

The insertion channel 3 comprises a curved section 4 having one top bend 11 and two bottom bends 12 and 13. The guidewire is forced to follow the bends of the inser ^¬ tion channel resulting in friction between the guidewire and the insertion channel. Because of the friction the guidewire is firmly fixated relative to the handling body. Therefore, the guidewire torquer substantially becomes functionally one with the guidewire.

The insertion channel is wider at the bends than at the straight sections, facilitating the insertion of the guidewire into the guidewire torquer.

Furthermore, the insertion channel may be custom- ized to be specific for selected guidewires in ways the skilled person would put the subject matter into practice based on this disclosure.

For the purpose of operation, the guidewire is in ^¬ serted into the insertion channel of the guidewire torquer in a way similar to laying it into the channel following the bends thereby fitting the guidewire along the shape of the channel into the channel. Subsequently, the physician is able to control the rotational orientation of the guidewire and a tip at the distal end thereof. So the phy- sician is able to steer and to navigate the guidewire through a vasculature of the patient. The physician is al ^¬ so able to both easily mount the guidewire torquer to the guidewire and to easily unlock the torquer from the guide- wire. Therefore the user is able to quickly move the guidewire torquer from the one to the other location on the guidewire. These features are particularly useful by saving time for performing a procedure. Fig. 3A shows a front view of a guidewire torquer 31. The guidewire torquer 31 is comprised of a handling body 32 and an insertion channel 33. Also a guidewire W with a tip W at its distal end is shown, resting in the insertion channel. The insertion channel 33 has a wavy or sinusoid shape having one top bend 34 and two bottom bends 35 and 36. Due to its natural stiffness the guidewire reaches the position in which the guidewire W firmly touches the inner apexes 37, 38 and 39 of the bends in the insertion channel 33.

Due the resulting friction between the guidewire W and the guidewire torquer 31 the guidewire substantially becomes functionally one with the guidewire torquer.

Therefore, as is illustrated in the figures 3B to 3D, the rotational orientation of the guidewire in the insertion channel is precisely defined by the rotational orientation of the guidewire torquer.

Compared to figure 3A, the guidewire torquer 31 has been tilted 45 degrees backwards in figure 3B, result- ing concurrently in a similar change in rotational orien ^¬ tation of the distal tip W backwards over 45 degrees. Likewise, in the figures 3C and 3D a backwards tilt of the guidewire torquer over 90 and 135 degrees directly causes a corresponding backwards rotation of the distal tip W over 90 and 135 degrees.

Fig. 4A shows a further preferred embodiment of a guidewire torquer 41 with a substantially flat handling body 42 in a shape having a convex right side 43 and a left side with 2 recesses 44, 45 and a protrusion 46 in between. An insertion channel 47 with multiple low amplitude bends extends from the protrusion 46 to the convex right side 43 of this embodiment. The top side 48 and the bottom side 49 of the guidewire torquer 41 are symmetri- cally and widely spaced from the insertion channel 47. Fig. 4B shows the guidewire torquer 41 mounted on a guide- wire W whose distal tip W has a curved shape.

Functionally, the configuration of this embodiment provides the guidewire torquer 41 with a stable position when positioned on a flat surface. A rotational force ex ^¬ erted to the guidewire torquer, transmitted to the torquer e.g. by the guidewire W, will not result in rotation of the guidewire torquer. Therefore, withstanding the exerted rotational force, the guidewire torquer 41 will remain un ^¬ changed in its stable position relative to the flat sur ^¬ face it has been laid upon. As described in the above, when a guidewire torquer of the present invention is mounted on a guidewire, together they form one functional unit due the firm fixation of the torquer relative to the guidewire. Therefore, the embodiment shown in figure 4, as well as other embodiments, serves as a stabilizer relative to the surface it is laid upon of the rotational orienta ^¬ tion both of the guidewire torquer 41 and of the guidewire w.

Moreover the purpose of this embodiment is to keep the tip W of the guidewire reliably pointing to a specif ^¬ ic desired direction during advancement of the guidewire in the human body. In fig. 4B the tip W is directed into the same direction as the bottom side 49 of the guidewire torquer 41, which direction is downwards. Due to its sub ^¬ stantially flat and streamlined shape the guidewire torquer 41 will remain in parallel position to the surface it is laid upon when it is dragged to the right over the surface by the guidewire, in a procedure where the physi ^¬ cian advances the tip W of the guidewire further into the human body. An example of such procedure is a placement of a central vein catheter (CVC) . The CVC is fed over the guidewire W which tip W first has been navigated from the subclavian vein into the central vein. During the naviga- tion of the guidewire to the central vein the guidewire torquer 41 keeps the tip W of the guidewire constantly directed downwards, that is into the direction of the cen ^¬ tral vein. Consequently, the tip W preferentially enters the central vein. So, the function of the guidewire torquer 41 is to allow for the correct placement of the guidewire W in the central vein, and therefore to allow for the correct placement of the CVC that is fed over it.

By doing so the guidewire torquer 41 prevents the tip W of the guidewire to turn upwards and erroneously enter the jugular vein, resulting in the CVC erroneously being fed of the guidewire into the jugular vein as well. Such misplacement of the CVC is the most frequent compli ^¬ cation of CVC placement procedures.

Fig. 5 provides a preferred embodiment in which a guidewire torquer 51 has a thicker top side 52 than a bot ^¬ tom side 53. This asymmetry provides the user tactile in ^¬ formation as to the position of the top side 52 relatively to the position of the bottom side 53 of the guidewire torquer 51. The bottom side 53 has three indentations 54, 55 and 56, that allow for further improved tactile feed ^¬ back as well as for a firm grip on the guidewire torquer by fingers of the physician when feeling the indentations or placed therein.

The guidewire torquer 51 has an insertion channel 57 that is substantially shaped like a U-turn. Therefore, a proximal portion WP of a guidewire W that has been in ^¬ serted in the U-turn shaped insertion channel 57 points into the same direction as a distal portion WD of the guidewire W. The proximal portion WP has a proximal tip WP' with a shape that resembles the shape of the distal tip WD' .

A combination of the guidewire W and the guidewire torquer 51 provides the physician with information as to both the rotational orientation and the insertion depth of the distal end WD' of the guidewire W. In the text the in ^¬ sertion depth of a guidewire measures a distance from a distal end of the guidewire located inside the human body to a point of entry of the guidewire into the patient. In figure 5 the insertion depth of the guidewire W measures the distance 58 between the distal end WD' and the point of entry 59 of the guidewire into the human body. Without any measurement the insertion depth of the guidewire W is visually indicated by the position of the proximal tip

WP' , whenever the guidewire has been positioned in the in ^¬ sertion channel in a symmetrical way relatively to the curve of the U-turn insertion channel, which is the case in figure 5.

Using the guidewire torquer 51 can be highly advantageous because it allows the physician to substantial ^¬ ly reduce screening time and therefore the procedural ra ^¬ diation exposure. Indeed, feedback that is provided by the guidewire torquer 51 about the rotational orientation and the insertion depth of the guidewire is available for the physician without the need for additional fluoroscopy. Ob ^¬ taining such information without the said feedback inevitably requires screening of the guidewire inside the pa ^¬ tient, thereby increasing the amount of radiation exposure and prolonging the procedure time. In contrast, the rota ^¬ tional orientation and the insertion depth of the distal tip of the guidewire inside the human body can be easily and continuously derived from the rotational orientation and position of the proximal tip that is readily visible outside the human body.

The present invention is described in the forego ^¬ ing on the basis of several preferred embodiments. Differ ^¬ ent aspects of different embodiments can be combined, wherein all combinations which can be made by a skilled person on the basis of this document must be included. These preferred embodiments are not limitative for the scope of protection of this document. The rights sought are defined in the appended claims.