Patent Application
20210298772
This application claims the benefit of German Patent Application No. DE 10 2020 204 155.5, filed Mar. 31, 2020, which is hereby incorporated by reference in its entirety.
The present embodiments relate to a microcatheter guidewire unit for use in a hollow organ, a robotic catheter system, and a medical system.
A chronic total occlusion (CTO) designates the occlusion of an arterial blood vessel that impedes blood flow beyond the blockage. This may result in muscles and also vital organs being undersupplied. A CTO may occur in both coronary and peripheral arteries and may lead to severe disease and even death. The cause of a CTO is generally atherosclerosis.
To reverse the effects of a CTO, it is necessary to restore an adequate blood flow. This may be achieved in two ways: either the CTO is recanalized or the blood flow is restored at the distal end of the CTO via a bypass, if anatomically possible. With recanalization, in a first act, the CTO is passed with the aid of a medical device, such as, for example, a guidewire.
The scope of the present invention is defined solely by the appended claims and is not affected to any degree by the statements within this summary.
The present embodiments may obviate one or more of the drawbacks or limitations in the related art. For example, an apparatus that enables an interventionalist to drill through a CTO quickly and with the lowest possible risk to the blood vessel is provided.
A microcatheter guidewire unit according to the present embodiments for use in a hollow organ includes a catheter body with a distal end and a proximal end and at least two guidewires with guidewire tips. A first guidewire of the at least two guidewires and/or a tip of the first guidewire has a higher rigidity than a second guidewire of the at least two guidewires and/or a tip of the second guidewire. 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 may be advanced and/or retracted (e.g., additionally rotated) independently of one another along corresponding longitudinal axes, respectively. A microcatheter guidewire unit of this kind with two guidewires of different rigidity may easily be used simultaneously to probe toward an occlusion (e.g., a CTO) (e.g., through 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. The independent mobility of the two guidewires has the advantage that the guidewires may be used alternately as required and do not impede one other when the respective other one may be retracted. However, the two guidewires are at least partially passed together through the catheter body and may thus also be navigated together to a site of use in a cavernous organ.
According to one embodiment, the catheter body includes at least two channels or two lumens, and each guidewire is arranged at least partially individually in a respective one of the channels or lumens. This provides that the two guidewires are unable to get caught in one another, do not impede one other, do not create friction against one another, and thus may always be used reliably independently of one another.
According to a further embodiment, the rigidities of the two guidewires and/or tips differ by a factor of at least 1.5 or by a factor of 2.0. This provides that the two guidewires may be used for different purposes (e.g., probing for the less rigid guidewire and drilling for the more rigid guidewire). 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).
According to a further embodiment, the microcatheter guidewire unit includes at least one further guidewire (e.g., a third guidewire). It is also possible for a plurality of guidewires to be provided. These may all have different properties (e.g., rigidities) or resemble one of the two first guidewires in a redundant manner.
The robotic catheter system according to the present embodiments with the microcatheter guidewire unit includes 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 in an axial direction independently of the other guidewire and/or also additionally to move the at least one guidewire rotationally.
In principle, robotic catheter systems are known, for example, from EP 3406291 B1, by which an automatic or semiautomatic advance of an object (e.g., a catheter and/or guidewire) in a cavernous organ of a patient may be effected. Coupling a robotic catheter system of this kind to a microcatheter guidewire unit as described above and embodying the robotic catheter system to move the microcatheter guidewire unit enables the advantages of the microcatheter guidewire unit according to the present embodiments to be potentiated. While the robot-assisted drive system and the control unit are arranged outside the body of the patient, the microcatheter guidewire unit is, for example, inserted via an introducer sheath at an entry point into the hollow organ of the patient and is at least partially located therein in the event of an examination or treatment. A robotic catheter system according to the present embodiments enables occlusions in the cavernous organ of the patient to be treated quickly and with particularly low risk to the patient.
The robot-assisted drive system is, for example, coupled to the first more rigid guidewire (e.g., in that the proximal end of this guidewire partially engages with the drive mechanism). This may, for example, be achieved in that the drive system includes a cassette through which the guidewire is passed and motion-coupled to one or more actuators of the drive mechanism. This may effect an advance or retraction movement and a rotational movement of the guidewire in the hollow organ. The movements are actuated by the control unit. This may be operated by a user (e.g., by remote manipulation), for example, via an operating unit, such as, for example, an input field, a keyboard, or a lever. It is also possible for a fully automatic control system to be present, which, for example, uses a previously planned path or is automatically actuated and regulated based on parameters.
In one embodiment, the catheter body may also be detachably coupled to the robot-assisted drive system, where the one or a further drive system has the effect that, when actuated automatically or semi-automatically, the catheter body may be advanced and retracted in an axial direction (e.g., also moved rotationally). 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.).
According to a further embodiment, the robotic catheter system includes a first robot-assisted drive system and a second robot-assisted drive system with at least one drive and a drive mechanism. Alternatively, the robotic catheter system includes a first robot-assisted drive system with two drives and two drive mechanisms, where each guidewire is detachably coupled with one of the robot-assisted drive systems or one of the drive mechanisms and where the drive systems or the drive mechanisms are configured to automatically or semi-automatically advance and retract the two guidewires independently of one another in an axial direction and, optionally, to move the two guidewires rotationally. Herein, the two drive systems may form a structural unit or be arranged separately from one another. In the event of a drive system with two drive mechanisms and drives, these form a structural unit. The guidewires are coupled to the respective drive systems or drive mechanisms (e.g., in that the guidewires partially engage with the respective drive mechanism). This may, for example, be achieved in that the two drive systems each include a cassette through which the respective guidewire is passed and which is motion-coupled to one or more actuators of the drive mechanism. However, it is also possible for two drive mechanisms to be arranged in a cassette. Overall, an advance or retraction movement and also a rotation movement of the guidewire may be effected in the hollow organ. In this way, both guidewires may be actuated semi- or fully automatically and moved individually as required.
In the case of a plurality of guidewires being present (e.g., three or more), it is also possible for a plurality of robot-assisted drive systems to be present or one robot-assisted drive system with a plurality of drives and drive mechanisms to be present.
According to a further embodiment, the first robot-assisted drive system or the first drive mechanism is coupled to the first guidewire and configured to drive (e.g., automatically) the first guidewire (e.g., the more rigid guidewire) such that the first guidewire executes a plurality of short-stroke alternating advance and retraction movements in rapid succession. As a result of this, the advance movements may 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, which strikes the occlusion (e.g., hardened occlusion), and in this way, may 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, for example, 1 Hz to 1000 Hz and a stroke of, for example, 0.1 mm to 1 mm may be used.
According to a further embodiment, the first robotic drive system is coupled to the first guidewire, and the second drive system is coupled to the second guidewire. The robotic catheter system is configured to advance the second guidewire within a 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. As a result of this, a force is exerted on the occlusion. The advantage of such a workflow consists in the fact that, for example, in softer occlusions or microchannels, the less rigid guidewire may first probe out a route. Here, the less rigid guidewire acts as a sort of “pathfinder wire”. Herein, the less rigid guidewire may be advanced manually, automatically, or semi-automatically; it is possible, for example, for imaging to be provided in order to check the position. If the less rigid guidewire reaches its limits due to hardening or the lack of microchannel, the more rigid guidewire is used, which then functions as a hammer drill and drills through the harder part of the occlusion. The detection of the hardened constriction may, for example, be determined by torque measurement or optically from the imaging. Then, the more rigid guidewire may be pushed as far as the constriction, and optionally, the less rigid guidewire may be retracted before the rapid strokes are executed. Then, for example, after a certain number of strokes or a certain period of time or distance, the constriction is checked. Such a check may also be performed live, for example, by imaging. Then, depending upon the result, either the non-rigid guidewire is reused, or the procedure is continued with the rigid guidewire.
The medical system according to the present embodiments includes a robotic catheter system and a medical imaging device (e.g., an X-ray device, a computed tomography X-ray device, a magnetic resonance tomography device, an ultrasound device, etc.). The imaging device is, for example, used to monitor the progress of an intervention (e.g., to remove an occlusion).
According to one embodiment, the medical system also includes a sensor for detecting an occlusion in the hollow organ. For example, the sensor is formed by a torque sensor, which is, for example, arranged on the second robotic drive system, and an occlusion is detected based on the advancing behavior of the second guidewire. Alternatively, an occlusion may also be detected by imaging (e.g., using the imaging device or by another method).
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).
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.
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.
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.
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.).
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
In the case of a single drive system 7 with two drive mechanisms and drives, these form a structural unit (see
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.
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.
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).
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.
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.
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).
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.
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.
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2020 204 155.5 | Mar 2020 | DE | national |
