MICROCATHETER GUIDEWIRE UNIT, ROBOTIC CATHETER SYSTEM, AND MEDICAL SYSTEM

Abstract

For improved treatment of occlusions, a microcatheter guidewire unit for use in a hollow organ including a catheter body with a distal end, a proximal end, and at least two guidewires with guidewire tips is provided. The first guidewire and/or a tip of the first guidewire has a higher rigidity than a second guidewire and/or a tip of the second guidewire. The first guidewire and the second guidewire are passed through the catheter body and arranged such that the tip of the first guidewire and the tip of the second guidewire may be advanced or retracted independently of one another along longitudinal axes.

Claims

1. A microcatheter guidewire unit for use in a hollow organ, the microcatheter guidewire unit comprising: a catheter body with a distal end and a proximal end; and at least two guidewires with guidewire tips, wherein a first guidewire of the at least two guidewire, a tip of the first guidewire, or the first guidewire and the tip of the first guidewire have a higher rigidity than a second guidewire of the at least two guidewires, a tip of the second guidewire, or the second guidewire and the tip of the second guidewire, and wherein the first guidewire and the second guidewire are passed through the catheter body and are arranged such that the tip of the first guidewire and the tip of the second guidewire are advanceable or retractable independently of one another along corresponding longitudinal axes.

2. The microcatheter guidewire unit of claim 1, wherein the catheter body comprises at least two channels or two lumens, and each guidewire of the at least two guidewires is arranged at least partially individually in a respective one of the at least two channels or two lumens.

3. The microcatheter guidewire unit of claim 1, wherein rigidities of the first guidewire and the second guidewire, the tip of the first guidewire and the tip of the second guidewire, or the first guidewire and the second guidewire and the tip of the first guidewire and the tip of the second guidewire, respectively, differ by a factor of at least 1.5.

4. The microcatheter guidewire unit of claim 3, wherein the rigidities of the first guidewire and the second guidewire, the tip of the first guidewire and the tip of the second guidewire, or the first guidewire and the second guidewire and the tip of the first guidewire and the tip of the second guidewire, respectively, differ by a factor of at least 2.

5. The microcatheter guidewire unit of claim 1, further comprising at least one further guidewire.

6. A robotic catheter system comprising: a microcatheter guidewire unit for use in a hollow organ, the microcatheter guidewire unit comprising: a catheter body with a distal end and a proximal end; and at least two guidewires with guidewire tips, wherein a first guidewire of the at least two guidewire, a tip of the first guidewire, or the first guidewire and the tip of the first guidewire have a higher rigidity than a second guidewire of the at least two guidewires, a tip of the second guidewire, or the second guidewire and the tip of the second guidewire, and wherein the first guidewire and the second guidewire are passed through the catheter body and are arranged such that the tip of the first guidewire and the tip of the second guidewire are advanceable or retractable independently of one another along corresponding longitudinal axes; at least one control unit; and a robot-assisted drive system with a drive and a drive mechanism, wherein the robot-assisted drive system is detachably coupled to one or more of the at least two guidewires, and wherein the robot-assisted drive system is configured to automatically or semi-automatically advance and retract the one or more guidewires in an axial direction independently of other guidewires of the at least two guidewires.

7. The robotic catheter system of claim 6, wherein the drive system is detachably coupled to the one or more guidewires in a region of a proximal end of the at least two guidewires.

8. The robotic catheter system of claim 6, wherein the catheter body is detachably coupleable to the robot-assisted drive system, and wherein the robot-assisted drive system is configured such that, when actuated automatically or semi-automatically, the catheter body is advanceable and retractable in an axial direction.

9. The robotic catheter system of claim 6, wherein the robot-assisted drive system is a first robot-assisted drive system, wherein the robotic catheter system further comprises a second robot-assisted drive system with at least one drive and at least one drive mechanism, or the first robot-assisted drive system has two drives and two drive mechanisms, wherein each guidewire of the at least two guidewires is detachably coupled to the first robot-assisted drive system or the second robot-assisted drive system, or one of the drive mechanisms, and wherein the first robot-assisted drive system and the second robot-assisted drive system or the drive mechanisms are configured to automatically or semi-automatically advance and retract the at least two guidewires independently of one another in an axial direction.

10. The robotic catheter system of claim 9, wherein the first robot-assisted drive system or one of the drive mechanisms is coupled to the first guidewire, and the second robot-assisted drive system or one of the drive mechanisms is coupled to the second guidewire, and wherein the robotic catheter system is configured to advance the second guidewire within the hollow organ as far as an occlusion, then to advance the first guidewire as far as the occlusion and to cause a plurality of short-stroke alternating advance and retraction movements to be executed in rapid succession so that a force is exerted on the occlusion.

11. The robotic catheter system of claim 6, wherein the robot-assisted drive system or the drive mechanism is coupled to the first guidewire and is configured to drive the first guidewire, such that the first guidewire executes a plurality of short-stroke alternating advance and retraction movements in succession so that a force is exertable by the advance movements on an object in the hollow organ.

12. A medical system comprising: a robotic catheter system comprising: a microcatheter guidewire unit for use in a hollow organ, the microcatheter guidewire unit comprising: a catheter body with a distal end and a proximal end; and at least two guidewires with guidewire tips, wherein a first guidewire of the at least two guidewire, a tip of the first guidewire, or the first guidewire and the tip of the first guidewire have a higher rigidity than a second guidewire of the at least two guidewires, a tip of the second guidewire, or the second guidewire and the tip of the second guidewire, and wherein the first guidewire and the second guidewire are passed through the catheter body and are arranged such that the tip of the first guidewire and the tip of the second guidewire are advanceable or retractable independently of one another along corresponding longitudinal axes; at least one control unit; and a robot-assisted drive system with a drive and a drive mechanism, wherein the robot-assisted drive system is detachably coupled to one or more of the at least two guidewires, and wherein the robot-assisted drive system is configured to automatically or semi-automatically advance and retract the one or more guidewires in an axial direction independently of other guidewires of the at least two guidewires; and a medical imaging device.

13. The medical system of claim 12, further comprising a sensor configured to detect an occlusion in the hollow organ, wherein the robot-assisted drive system or one of the drive mechanism is coupled to the first guidewire, and a second robot-assisted drive system or another drive mechanism is coupled to the second guidewire, and wherein the robotic catheter system is configured to advance the second guidewire within the hollow organ as far as the occlusion, then to advance the first guidewire as far as the occlusion and to cause a plurality of short-stroke alternating advance and retraction movements to be executed in rapid succession so that a force is exerted on the occlusion.

14. The medical system of claim 13, wherein the sensor is formed by a torque sensor arranged on the robot-assisted drive system or the robotic catheter system and is configured to detect the occlusion based on an advancing behavior of the second guidewire.

15. The medical system of claim 14, wherein the medical system is configured to execute a pre-trained machine-learning algorithm that determines a size of a respective next stroke based on imaging information of an imaging or a behavior of the first guidewire with previous strokes or values of the torque sensor.

16. The medical system of claim 12, wherein the medical imaging device is an X-ray device.

17. A method for automatic or semi-automatic advance of a microcatheter guidewire unit with two guidewires in a hollow organ, wherein a first guidewire of the two guidewires, a tip of the first guidewire, or the first guidewire and the tip of the first guidewire have a higher rigidity than a second guidewire of the two guidewires, a tip of the second guidewire, or the second guidewire and the tip of the second guidewire, the method comprising: advancing the second guidewire within the hollow organ; detecting an occlusion impeding the advance of the second guidewire within the hollow organ; advancing the first guidewire as far as the occlusion; optionally retracting the second guidewire; and executing a plurality of short-stroke alternating advance and retraction movements of the first guidewire in rapid succession, wherein the advance movement executes a force on the occlusion.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG. 1 is a view of a blood vessel of a patient with an occlusion and an inserted known catheter guidewire unit;

[0022] FIG. 2 is a view of a microcatheter guidewire unit according to an embodiment with two guidewires with different properties;

[0023] FIG. 3 shows a medical system with one embodiment of a robotic catheter system with a drive system;

[0024] FIG. 4 is a view of a further robotic catheter system with two drive systems arranged separately;

[0025] FIG. 5 is a view of a drive system coupled to an individual guidewire;

[0026] FIG. 6 is a view of a drive system that may be coupled to two guidewires; and

[0027] FIG. 7 shows a sequence of acts of one embodiment of a method for use with a robotic catheter system.

DETAILED DESCRIPTION

[0028] FIG. 2 shows a microcatheter guidewire unit 5 for use in a hollow organ (e.g., a vessel or vascular system) of a patient. The microcatheter guidewire unit 5 includes a catheter body 9 with a distal end 11 and a proximal end 12 and at least two guidewires 4.1, 4.2 with guidewire tips 8.1; 8.2. In one embodiment, a first guidewire 4.1 and a second guidewire 4.2 are passed through the catheter body 9. The first guidewire 4.1 is arranged in a first channel 6.1, and the second guidewire 4.2 is arranged in a second channel 6.2. The first guidewire-tip 8.1 and the second guidewire-tip 8.2 may be advanced beyond the distal end 11 of the catheter body 9 and retracted again. The first guidewire 4.1 and the second guidewire 4.2 are passed through the channels and arranged such that the guidewires or guidewire tips may be advanced and retracted again independently of one another along corresponding longitudinal axes. At the same time, the guidewires may also be additionally moved rotationally independently of one another, which provides navigation through curvatures in hollow organs. The entire microcatheter guidewire unit 5 may also be moved translationally and/or rotationally forward in order to be navigated into a hollow organ.

[0029] Herein, the first guidewire 4.1 and/or the first guidewire-tip 8.1 of the first guidewire 4.1 have a higher rigidity than the second guidewire 4.2 and/or the second guidewire-tip 8.2 of the second guidewire. Thus, it may be advantageous for the rigidities of the two guidewires and/or guidewire tips to differ by a factor of at least 1.5 or 2.0. This provides that the two guidewires may be used particularly efficiently for different purposes (e.g., probing for the less rigid guidewire and drilling for the more rigid guidewire).

[0030] The rigidity of guidewires may, for example, be established by different thicknesses, material properties (e.g., hardness) or the structure (e.g., core material, coating). The thickness of the guidewires may be, but does not have to be, different, and the sharpness of the guidewires may be, but does not have to be, different. With guidewires, the flexural rigidity, for example, is relevant. This is made up of the modulus of elasticity and the area moment of inertia. All standard commercially available guidewires may be used as guidewires, such as, for example, a Pilot 50, an Asahi Gaia Second, or an Asahi Confianza as a hard wire. The usual thickness of guidewires is about 0.26-0.36 mm. The guidewires may also be thicker or thinner. Some guidewires may be made hydrophilic by pre-treatment or coating; a known coating is, for example, Teflon.

[0031] It is also possible for further guidewires to be arranged in the microcatheter guidewire unit 5 (e.g., in further channels) and likewise to be independently movable. Such a further guidewire may, for example, have a more strongly curved guidewire-tip, which is embodied to overcome strong curvatures (e.g., bifurcations, ostia, left atrium, etc.), for example.

[0032] If the microcatheter guidewire unit 5 is introduced into a hollow organ (e.g., a vascular system of a patient), the microcatheter guidewire unit 5 may easily be used at the same time to probe toward an occlusion (e.g., a CTO) through, for example, microchannels with the less rigid guidewire and to drill into the occlusion (e.g., with the more rigid guidewire). This makes it possible to probe or drill a route through the occlusion without replacing the apparatus and hence much more quickly. Herein, the second less rigid guidewire 4.2 is the “pathfinder wire”, and the first rigid guidewire 4.1 is the “hammer drill”. The two guidewires 4.1, 4.2 may be moved against one another. Thus, during an intervention, the second less rigid guidewire may first be used to probe out a microchannel in the occlusion (e.g., CTO or other constriction). If no further progress is possible, the first guidewire is pushed up to contact, the second guidewire is retracted, and then, the first more rigid guidewire is pushed forward and back with minimal impact and retraction movements in order to penetrate the occlusion. This may, for example, be performed manually.

[0033] The following describes an apparatus for the semi-automatic or automatic advance of the guidewires. Herein, semi-automatic actuation may also, for example, be actuation that may be transmitted to the control unit by an operator via an input unit (e.g., joystick, touchpad, etc.). FIG. 3 shows one embodiment of a robotic catheter system with a microcatheter guidewire unit 5, at least one robot-assisted drive system 7, and a control unit 10. The robot-assisted drive system 7 has at least one drive and at least one drive mechanism, shown in more detail in FIGS. 5 and 6, and is detachably coupled to at least one of the guidewires 4.1, 4.2. The drive system 7 is also embodied to automatically or semi-automatically advance or retract the at least one guidewire independently of the other guidewire in an axial direction and, for example, also to move the at least one guidewire rotationally. In principle, robotic catheter systems are known by which a (semi)automatic advance of a (micro)catheter and/or guidewire in a cavernous organ of a patient may be effected (e.g., such as those made by the company Corindus Inc.; see EP 3406291 B1).

[0034] The present robotic catheter system may, for example, automatically or semi-automatically advance and retract both guidewires 4.1 and 4.2 independently of one another in an axial direction and may also move both guidewires 4.1 and 4.2 rotationally. For this purpose, either drive system 7 includes at least two drive mechanisms and at least two drives, where, in each case, a guidewire is detachably coupled to at least one drive mechanism; alternatively, at least two drive systems 7.1 and 7.2 are provided, where each includes at least one drive mechanism, and a drive and is detachably coupled to a respective guidewire (see FIG. 4).

[0035] FIG. 5 shows a first drive system 7.1 that is coupled to an individual guidewire (e.g., the first guidewire 4.1). The drive system includes a drive system base element 24 and a cassette element 22 (e.g., a replaceable cassette element). Further, the drive system base element 24 may include at least one (e.g., three) actuator elements 23 (e.g., an electric motor), where the control unit 10 is configured to control the at least one actuator element 23. The cassette element 22 may be coupled (e.g., mechanically and/or electromagnetically and/or pneumatically) to the drive system base element 24 and, for example, to the at least one actuator element 23. Herein, the cassette element 24 may include at least one transmission element 25 that may be moved through the coupling between the cassette element 22 and the drive system base element 24. In this way, the at least one transmission element 25 may be motion-coupled to the at least one actuator element 23. Hence, the transmission element 25 is configured to transmit a movement of the actuator element 23 to the first guidewire 4.1 such that the first guidewire 4.1 is moved in a translatory manner and/or rotated about the longitudinal extension direction. The at least one transmission element 25 may, for example, include a roller and/or roll and/or diaphragm. A second drive system 7.2 may have a same design to that of the first drive system 7.1 and be coupled to the second guidewire 4.2 for the movement thereof. Both drive systems 7.1 and 7.2 may be actuated via the control unit, where the regulation may take place separately.

[0036] In the case of a single drive system 7 with two drive mechanisms and drives, these form a structural unit (see FIG. 6). The drive system base element 24 includes at least two (e.g., six) actuator elements 23, and the control unit 10 is configured to control the at least two actuator elements 23. The cassette element 22 may be coupled to the drive system base element 24 and, for example, the at least two actuator elements 23, in that the cassette element 24 includes at least two transmission elements 25 that may be moved through the coupling between the cassette element 23 and the drive system base element 24. Hence, the transmission elements 25 are configured to transmit a movement of the actuator elements 23 to the two guidewires 4.1 and 4.2, such that the two guidewires 4.1 and 4.2 are moved independently of one another in a translatory manner and/or rotated about the longitudinal extension direction.

[0037] The drive system or drive systems 7, 7.1, 7.2 may be fastened to a fastening element 21 (e.g., a stand and/or robot arm) and attached by this to, for example, a patient bench 19.

[0038] FIG. 3 also shows a patient 20 on the patient bench 19 on which, for example, an interventional procedure for the recanalization of an occlusion (e.g., CTO) may be performed. For such a procedure, the microcatheter guidewire unit 5 may be inserted via an introducer sheath at an entry point 14 into the hollow organ (e.g., the vascular system) of the patient 20.

[0039] A medical imaging device (e.g., an X-ray device 15) with a C-arm 16 on which an X-ray source 18 and an X-ray detector 17 are arranged may also be provided and, together with the robotic catheter system, form a medical system according to the present embodiments.

[0040] The control unit 10 of the robotic catheter system may be configured to actuate the movements of the guidewires automatically and/or semi-automatically. In the case of semi-automatic actuation, the control unit may, for example, be connected to one or more input units, via which a user's control commands may be transmitted and then used by the control unit to actuate the drive systems. A fully automatic control also enables previously planned paths or movement profiles to be implemented. For example, a user may perform path planning in accordance with known methods in a 3D volume (e.g., CT or MR) in advance. It is also possible for an additional regulation unit that actuates the guidewires and regulates movements based on sensor data (e.g., via imaging, the resistance of the occlusion, torques) and parameters to be provided. It may also be possible to switch between two functionalities (e.g., automatic and/or semi-automatic).

[0041] In one embodiment, a first robot-assisted drive system or the first drive mechanism is coupled to the first guidewire and configured to drive the first guidewire, for example, automatically such that the first guidewire executes a plurality of short-stroke alternating advance and retraction movements in rapid succession. This may be actuated via the control unit. This function may thus be activated by a user or automatically when required. As a result, the advance movements exert a force on an object (e.g., an occlusion) in the hollow organ. In this way, the more rigid guidewire acts like a hammer drill or chisel that strikes the occlusion (e.g., hardened occlusion) and, in this way, is able to drill a path into the occlusion. The speed and the stroke of the respective movement may be adapted to the individual rigidity of the guidewire and hardness of the occlusion. For example, a frequency of 1 Hz to 1000 Hz and a stroke of, for example, 0.1 mm to 1 mm may be used.

[0042] The robotic catheter system may be configured to advance the second guidewire within a hollow organ as far as the occlusion, then to advance the first guidewire as far as the occlusion and cause a plurality of short-stroke alternating advance and retraction movements to be executed there in rapid succession; as a result of this, a force is exerted on the occlusion.

[0043] FIG. 7 describes a method that may be carried out semi-automatically or automatically by the robotic catheter system or the medical system. For the method, the microcatheter guidewire unit 5 has already been inserted in the hollow organ (e.g., the vascular system) of the patient 20, and, for example, with the aid of imaging, the guidewire tips are positioned as perpendicular as possible to the obstruction or, if the hollow organ is curved, to target the distal end of the occlusion. In a first act S1, the second less rigid guidewire is advanced in the direction of the occlusion or in the region of the occlusion through microchannels. This may, for example, be supported by imaging. In a second act S2, an occlusion that cannot be passed by the non-rigid guidewire is detected. This may, for example, also be performed by imaging or also by a torque sensor 26 positioned, for example, on the drive system or the catheter system (e.g., the guidewire tip). In a third act S3, the first more rigid guidewire is advanced as far as the contact (e.g., likewise performed by a torque sensor, by imaging or distance measurement). Then, optionally, the second guidewire may be retracted in a fourth act S4. Then, in a fifth act S5, the first guidewire a executes a plurality of short-stroke alternating advance and retraction movements in rapid succession in order to drill through the occlusion. The stroke may, for example, be defined by a user, or the required size of the respective next stroke may be determined by a pre-trained machine-learning algorithm based on image information from the imaging, the behavior of the guidewire with previous strokes, or the values of the torque sensor. It is also possible to infer the histology of the occlusion based on information from imaging, the sensors, or the course of the previous method, and for impact depth and energy to be determined on the basis thereof.

[0044] The robotic catheter system may, for example, be configured for the fully automatic performance of the method based on a planned path. The robotic catheter system may be configured to advance the second guidewire within a hollow organ as far as the occlusion, then to advance the first guidewire as far as the occlusion, and to cause a plurality of short-stroke alternating advance and retraction movements to be executed in rapid succession there. As a result of this, a force is exerted on the occlusion. The robotic catheter system may also be configured, in dependence on the measured resistance of the occlusion, to use the respective appropriate guidewire (e.g., the second less rigid guidewire when measuring a soft resistance and the first rigid guidewire when measuring a hard resistance).

[0045] The present embodiments may be briefly summarized as follows: for improved treatment of occlusions (e.g., CTOs) in cavernous organs, a microcatheter guidewire unit for use in a hollow organ is provided. The microcatheter guidewire unit includes a catheter body with a distal end and a proximal end, and at least two guidewires with guidewire tips. The first guidewire and/or the tip of the first guidewire have a higher rigidity than the second guidewire and/or the tip of the second guidewire. The first guidewire and the second guidewire are passed through the catheter body and arranged such that the tip of the first guidewire and the tip of the second guidewire may be advanced and/or retracted independently of one another along longitudinal axes and/or be rotated. Also provided is a robotic catheter system with a microcatheter guidewire unit including at least one control unit and one robot-assisted drive system with a drive and a drive mechanism. The drive system (e.g., in the region of the proximal end of the two guidewires) is detachably coupled to at least one of the guidewires. The drive system is configured to automatically or semi-automatically advance and retract the at least one of the two guidewires independently of the other guidewire in the axial direction and to rotate the at least one guidewire.

[0046] The exemplary embodiments were selected and described in order to be able to describe the principles on which the invention is based and possible applications in practice in the best possible manner. As a result, experts may modify and use the invention and various exemplary embodiments of the invention in an optimum manner with respect to the intended purpose.

[0047] The elements and features recited in the appended claims may be combined in different ways to produce new claims that likewise fall within the scope of the present invention. Thus, whereas the dependent claims appended below depend from only a single independent or dependent claim, it is to be understood that these dependent claims may, alternatively, be made to depend in the alternative from any preceding or following claim, whether independent or dependent. Such new combinations are to be understood as forming a part of the present specification.