Patent ID: 12186505

In the following, embodiments and the technical background of the present invention are presented in detail by taking reference to accompanyingFIGS.1to15. Identical or equivalent elements and elements which act identically or equivalently are denoted with the same reference signs. Not in each case of their occurrence a detailed description of the elements and components is repeated.

The depicted and described features and further properties of the invention's embodiments can arbitrarily be isolated and recombined without leaving the gist of the present invention. It is also noted that the figures are not necessarily drawn in scale.

In the following a catheter assembly10with a catheter1according to a first embodiment of the present invention will be described with reference toFIGS.1to12.

As can be seen fromFIGS.1a,1band2a,2b, the catheter assembly10comprises the catheter1and a guidewire100. The guidewire100acts as a guide which the catheter1can rapidly follow for easier delivery to a target site in the body of a patient. The target site can be e.g. a vessel with a lesion or in general any body lumen that requires a treatment.

The catheter assembly10also has an adapter9, which is connected to a catheter shaft2at a proximal region of the catheter shaft2, preferably at a proximal end25of the catheter shaft2. The proximal region of the catheter shaft2is the region of the catheter shaft2which is further away from the patient's body when the catheter1is inserted in the patient's body. Accordingly, the proximal end25is the end of the catheter shaft2which is further away from the patient's body when the catheter1is inserted in the patient's body. The adapter9is configured to connect other instruments or devices with the catheter1. For example, a syringe can be connected via the adapter9to the catheter shaft2in order to remove the air from the first lumen (during the preparation of the catheter, before it is inserted in the patient's body) and/or deliver radiopaque contrast media or medication.

In detail, the catheter1comprises the catheter shaft2with a shaft opening. The shaft opening comprises a first shaft opening26and a second shaft opening20. The catheter shaft2, which has a longitudinal axis103, is preferably of cylindrical shape. Advantageously, the catheter shaft2is made of flexible material, so that it can follow the shape of the body lumen, into which the catheter shaft2is inserted. Furthermore, the catheter shaft2is advantageously partially made of a radiopaque material.

The catheter1also comprises a deflection element3, which is rotatably arranged inside the catheter shaft2, and configured to deflect the guidewire100through the shaft opening.

By deflecting the guidewire100through the shaft opening, an exit angle (deflection angle) of the guidewire100can be changed so that the catheter1can be placed into body lumens with orifices of significant angulations.

In order to deflect the guidewire100, a controlling element4is provided. The controlling element4is operably connected with the deflection element3and configured to rotate the deflection element3in a first rotating direction101. Preferably, the controlling element4is also configured to rotate the deflection element3in a second rotating direction106. The second rotating direction106is opposite to the first rotating direction101.

It is noted thatFIGS.1band2bdiffer from theFIGS.1aand2a, respectively, in that inFIGS.1band2bthe catheter shaft2is removed for illustrative purposes, thereby revealing the controlling element4.

Also,FIGS.1aand1bshow the catheter1in an un-deflected state (first state) A of the guidewire100, whereas the guidewire100is presented in a deflected state (second state) B inFIGS.2aand2b. The arrows referring to the first rotating direction101inFIGS.1aand1bindicate how the deflection element3should be rotated so that the guidewire100is brought from the un-deflected state A to the deflected state B inFIGS.2aand2b. Accordingly, the arrows referring to the second rotating direction106inFIGS.2aand2bindicate how the deflection element3should be rotated so that the guidewire100is brought from the deflected state B to the un-deflected state A inFIGS.1aand1b.

Advantageously, the catheter shaft comprises a first lumen23configured to receive part of the guidewire100, and a second lumen24configured to receive part of the controlling element4(FIGS.3and4). More specifically, the first lumen23and the second lumen24extend in the direction of the longitudinal axis103of the catheter shaft2. Especially, the first lumen23and/or the second lumen24are formed by removing material from the catheter shaft2, in particular by drilling. Thus, the catheter shaft2is preferably formed as a solid element having hollow areas corresponding to the first lumen23and the second lumen24. Most preferably, the fist lumen23extends from the proximal end25of the catheter shaft2till the beginning of the deflection element3in the direction of the longitudinal axis103, when seeing the deflection element3from the distal end of the catheter shaft2. Further, the second lumen24is preferably shorter in length in the direction of the longitudinal axis103than the first lumen23.

The catheter shaft2preferably comprises a tip21, wherein the tip21is shaped as a frustum of an oblique cone (FIGS.1, to4and10to12). This specific shape of the tip21facilitates the insertion and the advancement of the catheter1into a body lumen. The tip21of the catheter shaft2receives the deflection element3in its interior. To serve this purpose, the tip21is preferably hollow. Further, the tip21can be attached to or be made integral with the rest of the catheter shaft2. The tip21corresponds to the distal region of the catheter shaft2.

As already described, the shaft opening comprises a first shaft opening26and a second shaft opening20. The first shaft opening26and the second shaft opening20are formed at the tip21of the catheter shaft2.

More specifically, the first shaft opening26is arranged at a distal end27of the catheter shaft2. The first shaft opening26is arranged essentially vertically to the longitudinal axis103of the catheter shaft2. The distal end27of the catheter shaft2corresponds to the distal face of the tip21of the catheter shaft2.

Further, the second shaft opening20extends in the direction of the longitudinal axis103of the catheter shaft2and is formed on a peripheral area22of the catheter shaft2. More specifically, the second shaft opening20is arranged at the side/region of the tip21where the frustum of the oblique cone has a smaller inclination.

Thus, the guidewire100can be easily deflected through the shaft opening20when the deflection element3is rotated.

As can mainly be seen fromFIGS.10to12, the first shaft opening26communicates with the second shaft opening20.

A maximum angle105of rotation of the deflection element3between the un-deflected state A and the deflected state B of the guidewire100is preferably 170°. In the un-deflected state A, the guidewire100has an exit angle of Go. In other words, in the un-deflected state A the guidewire100extends in the direction of the longitudinal axis103of the catheter shaft2. The un-deflected state A corresponds to a start position of the deflection element3. In the start position the deflection element3has a rotation angle of Go. An end position of the deflection element3corresponds to the deflected state B of the guidewire100. Thus, a maximum exit angle of the guidewire100through the shaft opening is preferably 170°.

The deflection element3and the guidewire100can have a rotation angle and an exit angle, respectively, between 0o and 170o.

Therefore, the guidewire100can be navigated into a wide range of lumens with orifices of significant angulations and thus the catheter1can be used for many different applications.

The deflection element3is preferably configured to rotate around a rotational axis102which is vertical to a longitudinal axis103to of the catheter shaft2(FIGS.1and3). When the longitudinal axis103of the catheter shaft2lies in a horizontal plane, the deflection element3is preferably arranged in such a way that the rotational axis102also lies in a horizontal plane.

Further, the deflection element3is preferably rotatably arranged inside the tip21of the catheter shaft2. For this reason, the deflection element3preferably comprises supports92, which are each in the form of a shaft. The tip21is provided with plain bearings, which are preferably formed as openings in the tip21.

As best seen fromFIGS.1and3, the controlling element4is preferably formed as a closed-loop transmission element40. The closed-loop transmission element40is configured to transmit a rotation from a rotating element41to the deflection element3, wherein the rotating element41is operably connected to the closed-loop transmission element40. The closed-loop transmission element40is basically a linear transmission element, which means that the closed-loop element40basically makes a linear motion. This is denoted by arrows111and112inFIGS.1(b) and2(b), respectively.

The rotating element41is more particularly formed as a first rotating disc.

Preferably, the rotating element41is connected with a rotating button7(rotating remotely steering button) via an axis70(FIGS.3and7), so that rotating the rotating button7causes a rotation of the rotating element41, more specifically in the same direction. This means that a rotation of the rotating button7in the first rotating direction101(in the second rotating direction106) causes a rotation of the first rotating element41in the first rotating direction101(in the second rotating direction106).

As can be seen fromFIG.4, the catheter shaft2comprises a third lumen28which extends to the periphery of the catheter shaft2and through which the axis70passes. The third lumen28may also communicate with the second lumen24

Furthermore, a diameter of the rotating button7is larger than the diameter of the rotating element41. Due to the bigger size of the rotating button7it is easier for the user to adjust the exit angle of the guidewire100, while the catheter shaft2can be made more compact due to the smaller size of the rotating element41.

Moreover, the deflection element3preferably comprises a second rotating disc42, which is operably connected with the first rotating disc (rotating element41) by the closed-loop transmission element40.

In particular, a diameter of the first rotating disc is equal to or greater than a diameter of the second rotating disc42. The transmission ratio between the first rotating disc and the second rotating disc42, which can be defined as the ratio of the diameter of the first rotating disc to the diameter of the second rotating disc42, is preferably equal or greater than 1.

Alternatively, the deflection element3may comprise a ring-shaped nut, at the position of which the closed-loop transmission element40is wound up around the deflection element3.

The rotating button7further comprises an orientation indicator71that indicates the orientation of the deflection element3and thus the orientation of the guidewire100. The orientation indicator71can be e.g. an arrow-like element attached to the rotating button7or an arrow-like marker painted or formed on the rotating button7. Therefore, the user of the catheter assembly1can at any time identify whether the guidewire100is deflected and get at least a general idea of the extent to which the guidewire100is deflected. A scale showing values for the exit angle of the guidewire100can also be provided. The orientation indicator71together with the scale could then be understood as a position indicator.

Preferably, the catheter2further comprises a handle6which is arranged around the catheter shaft2. In particular, the handle6envelopes a region of the catheter shaft2. The handle6provides the user with an increased holding control of the catheter1for a safe, efficient, and consistent procedure. Further, the handle6comprises a channel which communicates with the third lumen28and through which the axis70passes to connect to the rotating button7. Thus, the rotating button7is arranged at the handle6.

The transmission element40is preferably arranged in such a way that the rotating element41and the deflection element3are rotated together in the same direction. This means that, for example, when the rotating element41is rotated in the first rotating direction101by rotating the rotating button7in the first rotating direction101, the deflection element3is also rotated in the first rotating direction101. Accordingly, a rotation of the rotating element41in the second rotating direction106causes a rotation of the deflection element3also in the second rotating direction106.

A different configuration is also possible. For instance, the transmission element40can be arranged in such a way that the rotating element41and the deflection element3are rotated in opposite directions. This would for example be the case, when the transmission element40is arranged in a cross-wise manner so that a rotation of the rotating element41in the first rotating direction101causes a rotation in the second rotating direction106.

More specifically, the closed-loop transmission element40is a synthetic thread. Using a synthetic thread is advantageous as it is a high-tensile strength and lightweight material. Therefore, a fail-safe operation of the deflection element3can be ensured without an increase in the overall weight of the catheter1.

Advantageously, the deflection element3comprises a main body35, in which a recess30is formed in the direction of the longitudinal axis103of the catheter shaft2. The main body35of the deflection element3is of spherical shape in the present embodiment. To be more concrete, the outer shape of the main body35is a sphere.

FIGS.5and6show that the recess30is preferably formed centrally in a widthwise direction of the deflection element3, wherein the widthwise direction corresponds to the rotational axis102of the deflection element3.

Preferably, the recess30comprises a bottom face33, which is curved, more particularly concave when viewed from a longitudinal axis104of the recess30. The longitudinal axis104of the recess30is preferably parallel to the longitudinal axis103of the catheter shaft2when the deflection element3is in its start position, where the guidewire100is not deflected.

The bottom face33connects a first wall38of the recess30and a second wall39of the recess30. The first wall38and the second wall39are preferably parallel to each other and extend vertically to the longitudinal axis103of the catheter shaft2and the rotational axis102of the deflection element3.

The bottom face33comprises in particular a first plane107of curvature which is defined by the longitudinal axis104of the recess30and an axis vertical to the longitudinal axis104of the recess30and the rotational axis102of the deflection element3(FIG.6). An intersection108of the bottom face33and the first plane107is a concave curve when viewed from the longitudinal axis104of the recess30.

Also, the bottom face33of the recess30further comprises a second plane109of curvature, which is vertical to the first plane of curvature107and defined by the longitudinal access104of the recess30and the rotational axis102of the deflection element3. An intersection110of the bottom face33and the second plane109is a concave curve when viewed from the rotational axis102of the deflection element3. More specifically, the curvature in the second plane109of curvature is chosen to be at least equal to the curvature of the guidewire100.

The recess30is preferably formed in such a way, that the guidewire100partially touches the bottom face33of the recess30, when the guidewire100extends in the longitudinal axis103of the catheter shaft2. In this position, the guidewire100is not deflected. In other words, the recess30is preferably formed in such a way that a bottom part of the guidewire100facing the bottom face33of the recess30touches only a proximal edge36and a distal edge37of the recess30(FIG.6), when the guidewire100presents zero deflection. In that sense, the proximal edge36and the distal edge37of the recess30are considered part of the bottom face33.

Most preferably, the recess30is formed in such a way that the recess30always faces and/or communicates with the first lumen23between the start position and the end position of the deflection element3.

Preferably, a guiding element31configured to guide the guidewire100is arranged at a distal end91of the recess30(FIG.6). More particularly, the guiding element31is formed as an integral part of the deflection element3. In this case, the recess30preferably extends in the direction of the longitudinal axis104from a proximal end90of the deflection element3to the guiding element31. The proximal end90of the deflection element3corresponds to a proximal end of the recess30.

More specifically, the guiding element31is formed as a ring, arranged in such a way that a central axis of the ring coincides with the longitudinal axis104of the recess30. The guidewire100goes through the guiding element31in order to be guided.

Alternatively, the guiding element31can be a separate element attached to the deflection element3at a distal end of the deflection element3. In this case, the recess30preferably extends in the direction of the longitudinal axis104over the whole length of the deflection element3from the proximal end90to the distal end of the deflection element3.

As shown inFIG.7, in order to secure the position of the guidewire100, the catheter shaft2is provided with a stop mechanism8. The stop mechanism allows for increased maneuvering or handling abilities for the user of the catheter1, as the user does not need to constantly hold the rotating button7for securing a chosen position of the guidewire100. The stop mechanism8is explained in more details with reference toFIGS.8and9. For the sake of a better overview, the stop mechanism8has been omitted fromFIGS.3and4.

According toFIG.8, the stop mechanism8preferably comprises a body80with a first opening81and a second opening82for the axis70to go through. The body80is preferably cylindrical and hollow. The body80is preferably attached to the catheter shaft2, what is not drawn for illustrative purposes.

The first opening81is bigger in terms of its cross-section than the second opening82. More particularly, the second opening82is circular and has a diameter (slightly) bigger than the diameter of the axis70. Preferably, the diameter of the second opening82is 10% to 15% bigger than the diameter of the axis70. Thus, the second opening82is formed so that it allows the axis70to slightly deviate from its position. On the other hand, the first opening81is formed in such a way, that it allows part of the axis70to basically move in a direction vertical to the longitudinal axis103of the catheter shaft2. More specifically, the first opening81is elongated in a direction vertical to the longitudinal axis103and preferably formed as a rounded rectangular, whose rounded corners each have a radius approximately equal to the radius of the axis70. Due to this specific configuration of the first opening81and the second opening82, pushing the axis70vertically in relation the longitudinal axis103of the catheter shaft2causes the axis70to slightly deviate from its position. The sizes of the first opening81and the second opening82are chosen in such a way, that the deviation of the axis70is so small that the transmission of a rotation of the rotating element41to the deflection element3is not impaired.

InFIG.8the axis70is shown in an intermediate position with regard to the first opening81.

FIG.9shows a part of the stop mechanism8ofFIG.8.

In detail, a first gripping element83and a second gripping element84are provided inside the body80. The first gripping element83and the second gripping element84are preferably positioned on diametrically opposed parts of an inner wall of the body80. Further, the first gripping element83is directly arranged on the inner wall of the body80, while the second gripping element84is connected to the inner wall of the body80via a spring element85. The spring element85has in particular a first state and a second state. In its first state the spring element85is preferably partially compressed so that the spring element85pushes the axis70against the first gripping element83via the second gripping element84. In its second state the spring element85is more, preferably fully, compressed than in its first state. In order for the spring element85to be brought from its first state into its second state, an external force applied by the user of the catheter assembly1is required.

Alternatively, the first state of the spring element85can correspond to the natural state of the spring element85, where the spring element85is uncompressed. In this case the spring constant of the spring element85should most preferably be chosen so that the spring element85will not be compressed by the weight of the axis70, should the catheter assembly1be oriented in such a way that the weight of the axis70acts on the spring element85.

Both the first and the second gripping elements83,84are advantageously formed by shape-complementary to the axis70. Thus, the gripping elements83,84can provide a tight grip on the axis70. Especially, both the gripping elements83,84are arranged at a side of the body80which faces the rotating button7. This means that one of their ends is each closer to the side of the body80facing the rotating button7. Preferably, the first gripping element84extends and is longer than the second gripping element84in the direction of the axis70. More preferably, the first gripping element83extends over the whole length of the body80in the direction of the axis70.

The first gripping element83is made of a material with a first friction coefficient at a surface of contact with the axis70, while the second gripping element84is made of a material with a second friction coefficient at a surface of contact with the axis70which is lower than the first friction coefficient. This happens in order to allow to the axis70to rotate when in contact only with the second gripping element84, whereas the axis70cannot rotate when in contact with the first gripping element83. In other words, the first friction coefficient is chosen such that the axis70cannot rotate when in contact with the first gripping element83, whereas the second friction coefficient is chosen such that the axis70is able to rotate when in contact with the second gripping element84but not in contact with the first gripping element85.

The catheter shaft2may have a lining of lubricious material, such as Teflon, on its outer surface (outer lining) in order to reduce friction between the catheter shaft2and the body lumen and thus facilitate insertion of the catheter1into the body lumen. Such a lining of lubricious material can also be provided in the first lumen23on its inner wall (inner lining), so that movement of the guidewire23along the first lumen23is facilitated.

Furthermore, a first blocking element and/or a second blocking element are preferably provided. The first blocking element is configured to block the deflection element3from rotating in the first rotating direction beyond its end position. Hence, it can be ensured that no harm will be done to the guidewire100and due to that potentially also to the catheter1, even if the user of the catheter assembly10accidentally tries to rotate the rotating button7to a position that would cause the deflection element3rotate further than its end position. Accordingly, the second blocking element is configured to block the deflection element3from rotating in the second rotating direction beyond its start position. By that it can be ensured that an over-rotation of the deflection element3in the second rotating direction106that could probably damage the guidewire100is not possible. The first and/or the second blocking elements are preferably arranged at the axis70. Alternatively, the first and/or the second blocking elements are provided at the deflection element3, more specifically at the main body35.

In the following the use of the catheter assembly10will be explained with reference toFIGS.1,2,3,6,8and9in an endovascular application for a human patient.

In a first step the doctor chooses an entry point into the human's body for the catheter assembly10. For example, the entry point can be the femoral artery.

After having made an incision, the doctor introduces the guidewire100into the lumen of the femoral artery and then the catheter assembly10is loaded on the guidewire100supporting and steering the guidewire100forward with the aim of reaching the affected target site. The catheter assembly10, depending on the case, can be inserted inside the patient's body up to the handle6which always remains outside the patient's body and is thus accessible for manipulations by the doctor.

When the doctor comes across a branch on the way to the affected target site, the doctor operates the rotating button7in order to rotate the deflection element3and thus change the exit angle of the guidewire100through the shaft opening. Usually, the guidewire100is placed inside the catheter shaft2so that it extends through the first shaft opening26in the un-deflected state A. It is also possible that the guidewire100is placed in the catheter shaft2so that it does not extend through the first shaft opening26in the un-deflected state A. In this case, the guidewire100ends in the un-deflected state A before the first shaft opening26.

In order to deflect the guidewire100, the doctor pushes the rotating button7in the direction of the longitudinal axis103of the catheter shaft2. By doing so, the second gripping element84is pushed by the axis70so that the spring element85is compressed. The axis70is then no longer in contact with the first gripping element83. As long as this situation is maintained, the axis70can be rotated by rotating the rotating button7. As the axis70connects the rotating button7with the rotating element41, which is in turn operably connected via the controlling element4with the deflection element3, the rotation of the rotating button7will cause a rotation of the deflection element3. Due to its design the deflection element3will deflect the guidewire100thereby achieving the exit angle needed for entering into the body lumen branch.

More specifically, by rotating the deflection element3a force is applied through the distal edge37of the recess30to the guidewire100which together with the arrangement of part of the guidewire100in the first lumen23causes the guidewire100to deflect. When the guidewire100is deflected, the part of the guidewire100that is in the recess30is deformed so that it touches the bottom face33of the recess30. Hence, during the rest of the deflection of the guidewire100, sharp bends or kinks in the guidewire100are avoided.

Then, the doctor may remove its hand from the rotating button7. As a result of this, the spring element85goes from its second state to its first state, where the axis70is pressed against the first gripping element83by the second gripping element84. Thus, the position of the deflection element3and consequently the exit angle of the guidewire100are secured. Due to the specific choice of the first friction coefficient of the material of which the first gripping element83is made so that no rotation of the deflection element3occurs, when the axis70is pressed against the first gripping element83by the second gripping element84, the exit angle of the guidewire100can be secured without the need of the doctor holding the rotating button7.

Then, the doctor can push the guidewire100further into the branch in order to reach the affected target site.

If during the adjustment of the exit angle of the guidewire100the doctor rotates the deflection element3more than needed (but still in the allowable range), has accidentally rotated the deflection element3when not required or if for some reason the procedure has to be abandoned, the doctor can rotate the rotating button7in the second rotating direction106to bring the deflection element3either to the wished position or its initial position, respectively.

The return of the guidewire100may happen due to its elastic properties and/or to the guiding element31, which applies a force to the guidewire100.

In the case that the catheter assembly10is placed in the lumen in a different orientation that what is needed for entering the branch, the doctor may turn the catheter assembly1around the longitudinal axis103of the catheter shaft2before entering the branch till the needed orientation is achieved. Then, the doctor may operate the rotating button7, as described above.

It is noted that the stop mechanism8is optional and can thus be omitted. In this case, the doctor may have to stabilize the rotating button7by his/her hand, as the guidewire100usually has elastic properties and tends to return to its un-deflected state if no force is applied thereto anymore.

The catheter assembly10with the catheter1according to the present invention facilitates the exact positioning and crossing of a guidewire through significant tortuous body lumens, branch orifices with high angulation and generally helps in all cases where the guidewire needs the maximal possible steering support of the catheter. The catheter can have several applications in the treatment of pathologies by catheterisation of arteries and veins as well as other lumens of the human body, including the ureter and urethra, the cholangi, the esophagus and the tracheobronchial tree. It may also be used for the deployment of embolisation materials, such as coils, or even as an aid for the re-entry of the wire into the true lumen of the vessel during a sub-intimal technique procedure. It can also be understood that the catheter of the present invention can be used not only for humans but also animals, where a catheterization is applied as a technique.

FIG.13shows a deflection element3of a catheter assembly10according to a second embodiment of the present invention.

The main difference of the catheter assembly10according to the second embodiment from the one of the first embodiment lies in the shape of the main body35of the deflection element3. In this case the main body35is substantially formed as a cylinder. In more concrete terms, the outer shape of the main body35is substantially a cylinder. More specifically, the main body35is barrel-shaped. A barrel is a cylinder bulging in a middle portion between the cylinder bases. The cylinder axis preferably extends in the direction of the rotational axis102of the deflection element3.

The cylindrical or barrel shape of the deflection element3can be advantageous over the spherical design of the deflection element3according to the first embodiment due to its more compact size. Thus, for the same size of the guidewire100and consequently for the same size of the recess30, a smaller deflection element3is needed. This enables the reduction of the overall size of the catheter1, more specifically of the tip21of the catheter shaft2but thus in general the catheter shaft2. Therefore, the catheter1according to the second embodiment can be used in even smaller lumens in the human body.

FIGS.14and15show a tip21of a catheter assembly10according to a third embodiment of the present invention.

In the tip21of the catheter assembly10according to the third embodiment the shaft opening comprises only the first shaft opening26at the distal end27of the catheter shaft2. The tip21is arranged in such a way that the dimension of the tip21in the direction of the longitudinal axis103of the catheter shaft2is approximately the same as the dimension of the deflection element3in the direction of the longitudinal axis103. The deflection element3is configured to deflect the guidewire100through the first shaft opening26.

In addition to the foregoing description of the present invention, for an additional disclosure explicit reference is taken to graphic representation ofFIGS.1to15.

An idea for an endovascular remotely steerable guidewire catheter is described as follows:

The idea refers to minimally invasive surgical devices and methods, and specifically to endovascular catheters, the purpose of which is the steering of the guidewire, as well as useful vascular intervention methods during endovascular surgery. Specifically, the present idea relates to endovascular steerable guidewire catheters that are used for the precise positioning of the guidewire within the target vessel or the crossing of the guidewire through significant tortuosity, demanding vascular bifurcation, and generally in cases where the guidewire needs the catheter to provide the best possible steering.

Endovascular surgery is a useful and effective method of dealing with most types of vascular diseases. Generally, the appropriate endovascular device is inserted into the patient's circulatory system, and guided through the vessels, reaches the target lesion. With the use of endovascular surgery we can reach most parts of the patient's circulatory system, including the heart's coronary vessels, the brain vessels and the peripheral vessels.

Endovascular surgery is a minimally invasive surgical method that was designed to reach, diagnose and treat vessels from within. The recanalization of stenoses or blocked vessels is achieved without the use of general anesthesia, long hospitalization and considerable postoperative pain.

Angioplasty, with or without the deployment of a stent is used for the treatment of chronic blockages, stenoses and other vessel pathologies. During the angioplasty of the coronary, brain or peripheral vessels, an endovascular catheter placed over a guidewire is led to the desired area via the patient's circulatory system. Next, the guidewire, supported by the catheter, is guided through the distal opening of the catheter into the target artery (e.g. coronary, brain, renal artery etc.) until it crosses the stenosis or blockage in need of treatment. Following that, a balloon catheter is moved forward over the guidewire that has already crossed the stenosis and is carefully positioned within the blockage. After the catheter has been carefully positioned, the balloon is inflated to a predefined width, pushing the atheromatic material that causes the blockage outwards and opening the artery. The balloon is then deflated, the blood begins to circulate via the opened artery, and the balloon catheter is removed. When needed, after the artery has been opened, a stent may be deployed at the point of the stenosis in order to keep the vessel open for a longer period of time.

Endovascular catheters with or without the ability to remotely steer the guidewire have been used for years in most endovascular applications and are a basic tool in these treatment approaches. Today, many such different catheters are known and used, and each has certain advantages but also disadvantages. For this reason, there is a great need to develop alternative innovative guide catheters that will have the advantages of the older ones but will be improved regarding their disadvantages, acquiring greater and new potential.

Endovascular guide catheters are necessary tools in endovascular surgery, one of their most important uses is the backup support and the steering of the guidewire in the surgeon's effort to cross through the stenosis—vessel blockage with it. This step proves quite difficult in the cases with important tortuosity, bifurcation and vasculature disorders and generally in cases where the guidewire needs the catheter to provide the maximum possible steering support.

Today, there are endovascular guide catheters that use modern materials and development techniques that achieve improved characteristics.

A guide catheter's most important characteristics are:1. Pushability: the degree in which the force transmitted from the proximal end of the catheter is translated into the movement of its tip, which depends on the transmission of the force along the body of the catheter.2. Trackability: the ability of a catheter to follow the guidewire in tortuous vasculature, which depends on the diameter, length and elasticity of the catheter, as well as the resistance caused by friction.3. Steering (rotation) ability: the ability to steer the guide catheter's tip (High Torque Control), which essentially means a high resistance to bending—folding during its rotation within the vessel.4. Atraumatic distal tip that protects the vessel's endothelium from damage.

Today, many different guide catheters are used in endovascular surgery, each with the above mentioned characteristics to a greater or lesser degree. An important limitation to the use of these catheters is low profile blood vessels that do not allow the guide catheters to be maneuvered within the vessel so as to steer the guidewire. Additionally, most guide catheters have a pre-shaped distal tip in order to facilitate particular catheterization angles. That means that the surgeon must choose beforehand the catheter—or the combination of catheters—that will be used during the procedure.

The idea aims to the creation of an endovascular remotely steerable guidewire catheter, as described above, that will collectively and maximally presents the advantages of an ideal catheter.

A catheter easy to build and use that will provide the guidewire with maximal steering potential—when needed—but will not lack pushability and trackability over a guidewire in tortuous vasculature.

According to the idea this is achieved with the development of an endovascular guide catheter, which, at its distal end, incorporates a custom-designed spherical mechanism that has the ability to rotate around an axis. The rotation of the spherical mechanism is accomplished with the help of a rotating button on the ergonomically designed handle of the guide catheter and an inner circuit of synthetic threads that runs along most of its length.

A guide catheter that incorporates at its distal end a custom-designed spherical mechanism that can rotate around an axis changes the picture, providing the new guide catheter with great remote steering abilities of the guidewire.

The custom-shaped rotating spherical mechanism that is incorporated in the distal end of the guide catheter changes the exit angle of the guidewire. In this way the guidewire can exit the distal end of the catheter forming at will a wide range of angles in relation to the central axis of the guide catheter. This practically means that the guidewire can be accurately steered through big angulations, with a high performance even within very low profile vessels, because the distal end does not have to be angled to steer the guidewire. A procedure can be performed with the use of one and only guide catheter, since it can replace all the rest that have a pre-shaped exit angle for the guidewire.

With this innovation, the new guide catheter can support and steer the guidewire in the effort to move through anatomically hard to cross regions of the vessels or other lumens of the human body, while—at the same time—accurately readjusting the exit angle of the guidewire.

By using the same methodology, the present invention can be modified by loading other endovascular tools such as embolization coils and facilitate their placement within the vessel, or even contribute with its steering in the reentry of the guidewire into the true lumen during a subintimal technique procedure.

In the figures that follow, the corresponding reference numbers refer to the same parts, from all different angles. The figures are not drawn necessarily in scale. Instead, the presentation of the principles of the idea has been emphasized. The figures represent typical applications of the idea and should not therefore be considered limiting as to the range of applications. The idea will be described and explained with additional details and accuracy with the use of the attached figures, where:

FIG.1andFIG.2are detailed illustrations of the endovascular guide catheter and of the inner synthetic thread circuit, that depict the controlled rotation of the custom-designed spherical mechanism that is incorporated in the distal end of the catheter, as well as its remote steering handle. The result is the change in the exit angle of the guidewire, according to the general principles of the idea.

FIGS.3and4are a complete illustration of the non-mobile and the mobile components of the endovascular remotely steering guidewire catheter with the simultaneous representation of their inner lumens. It should be noted that for the tracking of the device during the endovascular process, some of the illustrated catheter's parts are made of radiopaque material among other materials. More specifically,FIG.3is an illustration of the arrangement of the parts of the guide catheter and its custom-designed handle, along with an illustration of their inner lumens. More specifically,FIG.4an illustration of the custom-designed handle of the guide catheter with the rotating remotely steering button and of the cylindrical longitudinal catheter in detail, both inside and outside.

FIG.5illustrates the mobile parts of the endovascular guide catheter at an angle. Specifically, it depicts the custom-designed spherical mechanism that is incorporated at the distal end of the catheter along with the rotating remotely steering ring, as well as part of the inner circuit of synthetic thread that facilitates the rotation of the custom-designed spherical mechanism and part of the guidewire.

FIG.6illustrates the custom-designed spherical mechanism that is incorporated at the distal end of the catheter along with the rotating remotely steering ring, as well as part of the inner circuit of synthetic thread that facilitates the rotation of the custom-designed spherical mechanism without the guidewire.

FIG.7is an illustration of the rotating remotely steering button, of the custom-designed spherical mechanism, of its rotation ring, as well as part of the synthetic threads attached to—wound around the rotation disc.

FIGS.10and11are an illustration of the custom-shaped tip with its groove at the distal end of the guide catheter from a different angle.

FIG.13is an illustration of a variation of the custom-designed spherical mechanism in cylindrical form that can be incorporated at the distal end of the catheter along with the rotating remotely steering ring, as well as part of the inner circuit of the synthetic thread that facilitates its rotation, with the illustration of the guidewire.

It is understood that the figures are diagrammatic and schematic representation of exemplary applications of the device and are not limiting as to the range of applications. They are also not drawn in scale.

As further described below, the present device generally refers to endovascular catheters and methods of using them. More specifically, the present device relates to endovascular guide catheters that facilitate the exact positioning and crossing of a guidewire through significant tortuous vasculature, bifurcation lesions and generally help in all cases where the guidewire needs the maximal possible steering support of the catheter. It should be noted that this description is only used as an example and that the present endovascular guide catheter can have several applications in the treatment of pathologies in various lumens of the human body, including the ureter and urethra, the cholangi, the esophagus and the tracheobronchial tree.

The endovascular remotely steering guidewire catheter, as illustrated inFIG.1and inFIG.2, has been designed for endoluminal crossing through a vessel and for this reason it can acquire the size that will facilitate this crossing, depending on the vessel in question. For example, the use in non coronary vessels demands catheter dimensions of a greater scale than the one used for a coronary artery.

As illustrated inFIG.1,FIG.2andFIG.3, the endovascular remotely steering guidewire catheter consists of a longitudinal cylindrical catheter (FIG.3), also made of radiopaque material, at the central part of which the handle is attached, along with the rotating remotely steering button (FIG.3andFIG.4) of the custom designed spherical mechanism that is incorporated in the custom-shaped tip, at its distal end (FIGS.3,10and11). The inner thread circuit includes the custom-designed thread that connects the rotation disc of the rotating remotely steering button (FIG.1,FIG.2) with the rotation disc of the custom-designed spherical mechanism that is incorporated in the custom-shaped tip at the distal end of the guide catheter (FIG.3).

As further described below, the idea consists of mobile and non mobile components.

Non Mobile Components

As illustrated inFIG.3, the cylindrical longitudinal catheter consists of three connecting parts and includes a main cylindrical part that comprises the central opening and part of the lumen, through which the guidewire passes, a cylindrical part that includes the whole of the inner lumen, its main opening out of which the synthetic thread exits the lumen, and the cylindrical longitudinal catheter and part of the inner lumen. The distal part includes a custom-shaped tip in which the custom designed spherical mechanism is incorporated (FIG.1,FIG.2,FIG.5,FIG.6,FIG.3,FIG.10,FIG.11) at the end of the cylindrical longitudinal catheter. During the endovascular use, the Endovascular Remotely Steerable Guidewire Catheter (FIG.3,FIG.4), can be inserted into the human body through its custom-designed tip, up to the handle, which remains at all times outside the human body and is accessible to the surgeon.

The cylindrical longitudinal catheter (FIG. (3)) includes the main opening of the inner lumen that runs along its full length, beginning at the opening of the catheter and ending at the last opening of channel of its custom designed tip. Within the inner lumen, runs the guidewire during the use of the cylindrical longitudinal catheter, while through the inner lumen runs the synthetic thread in the form of a closed circuit (FIG.1,FIG.2) that transfers the movement from the rotating button to the custom-designed spherical mechanism (FIG.3).

The custom-designed tip includes channel and has a conical shape so as to move along the vessel with ease. It also includes the groove that is essentially the exposure of channel, through which the guidewire can exit at an angle in relation to the main catheter axis (FIGS.10,11).

The cylindrical longitudinal catheter includes from one to two inner lumens at its various parts. These inner lumens are parallel to one another and cover the inner part of the catheter as illustrated in the drawings of the apparatus (FIG.3).

Mobile Parts

As illustrated inFIG.1,FIG.2,FIG.4,FIG.5,FIG.6,FIG.7,FIG.3,FIG.10andFIG.11, the endovascular remotely steerable guidewire catheter also includes mobile parts. The mobile parts are attached to the cylindrical part and the distal part of the cylindrical longitudinal catheter (FIG.3). The cylindrical part includes the rotating button (11) that is attached to the handle and which facilitates the remote steering of the wire of the guide catheter (FIG.1,FIG.2,FIG.7,FIG.3, andFIG.4). The distal part includes the custom-designed spherical mechanism (14) (FIG.5,FIG.6) that is incorporated in the custom-shaped tip and can rotate around its axis at the distal end of the guide catheter (FIG.1,FIG.2andFIG.3, andFIG.4), offering the option of choosing the exit angle of the guidewire from the guide catheter after it exits the distal end of the inner lumen via the groove, the exit ring of the spherical mechanism and the channel of the custom-designed tip. The exit ring is formed by the distal part of the groove and the exit bridge (FIG.5,FIG.6). At the custom-designed spherical mechanism that is incorporated at the tip of the guide catheter (25) we find attached its rotating disc and the braces as illustrated inFIG.5andFIG.6. Around the rotating disc the thread is wound, in the form of a closed circuit (FIG.1,FIG.2,FIG.5,FIG.6, andFIG.3), that connects it to the rotation disc of the rotating button in a relative movement (FIG.1,FIG.2, andFIG.7). The range of the angle that the custom-designed spherical mechanism (FIG.1,FIG.2) rotates is around 170 degrees. Instead of the custom-designed spherical mechanism, a variation of it can be used, the custom-designed cylindrical mechanism (FIG.13).

The shape of the custom-designed tip at the distal end of the remotely steerable guidewire catheter is conical with a groove along its length (FIGS.10,11FIG.3) that allows the exit of the guidewire at an angle in relation to the main axis of the guide catheter.

This new endovascular remotely steerable guidewire catheter can have one external and one internal lining of lubricious material, such as Teflon.

The idea of the endovascular remotely steerable guidewire catheter can be DEFINED by the following clauses:

CLAUSES

1. The Endovascular Remotely Steerable Guidewire Catheter consists of:

a cylindrical longitudinal catheter, developed also by radiopaque material, that is comprised of three interconnecting parts and includes a proximal cylindrical part that consists of the proximal opening of the inner lumen, where the guidewire passes through, a cylindrical part that incorporates part of the inner lumen and the whole of the inner lumen. The proximal opening of the inner lumen communicates with the outer surface of the cylindrical longitudinal catheter via the opening that is found on the body of the cylindrical longitudinal catheter close to the main opening of the inner lumen. Last, a custom-designed tip is found at the distal part of the cylindrical longitudinal catheter. The cylindrical longitudinal catheter includes two inner lumens, which are parallel to one another and to the main axis of the cylindrical longitudinal catheter. The custom-designed handle with the rotating remotely steering button envelops parts of the cylindrical parts. At the distal part of the cylindrical longitudinal catheter, and in particular within its custom-designed tip, the custom-designed spherical mechanism for the steering of the guidewire is incorporated. Alternatively, the custom-designed spherical mechanism can have the form of a cylindrical mechanism. The movement of the rotating button and the custom-made spherical mechanism is dependent, since with the rotation of the button around its main axis, the spherical mechanism rotates around its axis. The rotation angles of the button and the spherical mechanism are not typically the same, but they are in a standard and dependent correlation/linked relationship. During a surgical procedure, the cylindrical longitudinal catheter is inserted into the patient via its custom-made tip, up to the custom-designed handle, which is outside the human body, accessible for surgical manipulations by the doctor.
2. The endovascular remotely steerable guidewire catheter according to clause 1 is characterized by the fact that the rotating button and the custom-designed spherical mechanism are connected to each other with synthetic thread in the form of closed inner circuit. Indeed, the rotating button and the custom-designed spherical mechanism are connected to each other with the inner circuit of the synthetic thread through their rotating discs. The synthetic rotation thread, in the form of closed circuit, passes through the inner lumen and ends up at the rotation discs, which are placed close to the two openings/mouths of the inner lumen, where they are wound.
3. According to clause 2, the endovascular remotely steerable guidewire catheter is characterized by the fact that the synthetic rotation thread is wound up in the form of closed circuit around the rotation discs of the rotating button and the custom-designed spherical mechanism, in such a way as to transfer the rotating movement of the first to the latter in the same direction in some kind of standard correlation. That is, by rotating the rotating button at an angle φ, the custom-made spherical mechanism also rotates at the same time at an angle X by φ, where X is some intended number.
4. The custom-designed spherical mechanism according to clause, 1 consists of a sphere, at the center of which a through lumen has been opened. This lumen can be curved, while it extends widthwise towards its curved part until it is completely exposed, creating a groove. At the distal end of the groove of the spherical mechanism (14) the exit ring can optionally be placed, created by the bridge, through which the guidewire passes.
5. According to clause 1, the custom-designed cylindrical mechanism, which can be used instead of the spherical mechanism (14), consists of a cylinder at the center of which a through lumen has been opened. This lumen can be curved, while it extends widthwise towards is curved part until it becomes completely uncovered/conspicuous, creating a groove (v shape), u shape cut. At the distal end of the cut of the cylindrical mechanism the exit ring can optionally be placed, created by the bridge, through which the guidewire passes.
6. According to clause 1, the custom-designed tip incorporates at its wide part the custom-designed spherical mechanism which is affixed with the help of braces in a way so that the inner lumen is always in alignment and communication with the groove, during the whole breadth of the rotation around its axis. In this way, the guidewire coming out of the distal opening of the inner lumen is always inserted in the groove and forwarded within the exit ring. Additionally, the synthetic thread exiting the peripheral opening of the inner lumen in the form of a closed circuit is wound around the rotation ring. In this way, the change in the exit angle of the guidewire is achieved with the rotation of the custom-designed spherical mechanism, through the rotation ring, at the desired angle. Additionally, the custom-designed tip carries the groove that creates the channel that is basically the continuation of the inner lumen at the distal part that has been exposed, so that the guidewire can come out of the guide catheter at an angle.
7. According to clause 1, the custom-designed handle of the guide catheter envelops the cylindrical longitudinal catheter in the cylindrical parts. It incorporates the rotating remote steering button, the axis and the rotation disc, which is found near the opening where the synthetic thread comes out in the form of a closed circuit and is wound up in the rotation disc.
8. According to clause 1, the endovascular remotely steerable guidewire catheter can be used for the catheterization of arteries and veins, as well as other lumens in the bodies of animals or people, such as the cholangi, urinary lumens, lumens of the tracheobronchial tree etc. It can also be used for the deployment of embolization materials or can even be used as an aid for the reentry of the wire within the true lumen during a subintimal technique procedure.

LIST OF REFERENCE SIGNS

1catheter/(endovascular remotely steering catheter)2catheter shaft/(cylindrical longitudinal catheter)3deflection element/(custom-designed spherical/cylindrical mechanism)4controlling element/(custom-designed thread, synthetic thread)5adapter6handle/(custom-designed handle)7rotating button or knob/(rotating remotely steering button)8stop mechanism10catheter assembly20second shaft opening/(channel)21tip/(custom-shaped tip)22peripheral area of the catheter shaft23first lumen/(inner lumen)24second lumen/(inner lumen)25proximal end of the catheter shaft26first shaft opening27distal end of the catheter shaft28third lumen30recess/(groove)31guiding element/(bridge, exit bridge)33bottom face of the recess34rotating disc of deflection element35main body of deflection element36proximal edge of the recess (bottom face)37distal edge of the recess (bottom face)38first wall of the recess39second wall of the recess40closed-loop transmission element41rotating element (first rotating disc)/(rotation disc)42second rotating disc70axis71orientation indicator80body of stop mechanism81first opening82second opening83first gripping element84second gripping element85spring element90proximal end of the deflection element91distal end of the recess92support/(brace)100guidewire/(guidewire, wire)101first rotating direction102rotational axis103longitudinal axis of the catheter shaft104longitudinal axis of the recess105angle of rotation of the deflection element106second rotating direction107first plane of curvature108first intersection109second plane of curvature110second intersection111arrow112arrow