Ultrasound-Enhanced Reality-Peripher Endovascular Intervention-Navigation System

Description

[0001] The invention relates to an ultrasound augmented reality peripheral endovascular intervention navigation system.

[0002] The establishment of endovascular techniques has fundamentally changed the world of conventional open vascular surgery and ushered in a new era in the treatment of vascular surgery patients. Thanks to endovascular techniques, patients can now be treated minimally invasively without major access trauma. This also allows the treatment of patients who are no longer amenable to conventional open surgery for health reasons. Furthermore, endovascularly treated patients experience fewer postoperative complications and thus a shorter hospital stay.

[0003] In recent decades, the use of endovascular techniques has developed rapidly for the reasons mentioned above, not least because the industry has also discovered a new market here. Endovascular interventions are now part of the standard repertoire of every vascular surgeon and are increasingly displacing conventional open surgical procedures. Endovascular intervention is now recommended for the majority of peripheral vascular pathologies. It is estimated that by 2026, 75 to 95% of vascular surgical procedures will be performed endovascularly.

[0004] Problematic in the state of the artThe main reason is that endovascular interventions require the use of X-rays. While technological advances and compliance with radiation protection measures have already led to a significant reduction in radiation exposure, increasingly complex procedures requiring long fluoroscopy times result in a sometimes significant radiation exposure for both the patient and the surgeon. For quality assurance purposes, legal regulations therefore recommend dose area products for each procedure. Any exceedance of these dose area products must be documented and included in the quality assurance process.

[0005] Another disadvantage of the use of X-rays during endovascular interventions is the risk of kidney damage due to the application of contrast media. Contrast-media-induced hypoxic kidney damage is assumed to be the cause. The incidence of acute kidney injury in peripheral interventions is up to 10%. The guideline of the German Society of Nephrology therefore recommends a risk assessment, including, in particular, screening for pre-existing impairment of renal function, in all patients before examinations involving intravascular administration of iodinated contrast media. Intravenous volume expansion with isotonic saline or sodium bicarbonate solution, as well as oral administration of N-acetylcysteine ​​together with intravenous isotonic crystalloid solution, are recommended as protective measures.However, the best prevention is to apply the lowest possible dose of contrast medium or to consider alternative imaging methods without contrast medium.

[0006] A further problem is that fluoroscopy only allows two-dimensional navigation within a three-dimensional anatomical structure. This makes navigation difficult, especially for complex procedures, and leads to longer fluoroscopy times, thus requiring increased administration of contrast medium.

[0007] From the State of the art Various approaches to reducing radiation exposure are known. One approach involves the increased use of sonography.

[0008] In the publication Abbas A., Hansrani V., Sedgwick N. et al. (2014) "3D contrast enhanced ultrasound for detecting endoleak foolowing endovascular aneuyrism repair (EVAR)", European Journal of Vascular and Endovascular Surgery 47: 487-492, doi: 10.1016 / j.ejvs.2014.02.002, it is described that, in addition to the visualization of peripheral vessels, it is now possible to reliably detect endoleaks after aortic stent implantation using contrast-enhanced ultrasound and three-dimensional technology. Therefore, duplex sonography has now become the diagnostic tool of choice, especially in the diagnosis and follow-up of vascular pathologies. However, the quality of ultrasound examinations is highly specific to the examiner and the patient. Furthermore, not every body region is accessible for external ultrasound examination. Therefore, practical use for the navigation of endovascular interventions has not yet been implemented.

[0009] A further development is intravascular sonography. Compared to conventional angiography, this provides a detailed image of the vessel wall. Furthermore, three-dimensional reconstruction of vascular pathologies is possible. Intravascular sonography has therefore demonstrated superiority over conventional angiography in differentiating between stenosis and re-stenosis.

[0010] A similar technique is optical coherence tomography. This technique uses light rather than ultrasound to image the vessel. The resulting image is similar to that obtained with intravascular sonography, but with significantly better resolution. Both intravascular sonography and optical coherence tomography are described in peripheral interventions, for example, in Secco G., Garatoni C., Parisi R. et. al. (2015), "Optical Coherence Tomography Guidance during Peripheral Vascular Intervention", Cardiovascular and Interventional Radiology 38: 768-772, doi: 10.1007 / s00270-014-0868-3, or in Karnabatidis D., Katsanos K., Paraskevopoulos I. et. al. (2015). (2011), "Frequency-domain intravascular optical coherence tomography of the femoropopliteal artery", Cardiovascular and Interventional Radiology 34: 1172-1181, doi: 10.1007 / s00270-010-0092-8.

[0011] However, both techniques have so far only been used as an additive application within a conventional intervention. X-rays are still required for navigation during endovascular intervention. Nevertheless, both techniques provide differentiated information about the internal structure of the vessel.

[0012] The medical benefit for the patient is therefore still offset by the radiation exposure, with all its associated risks to the organism. Whether health damage occurs depends on the amount of radiation absorbed, the type of radiation, and which organ or tissue of the body is primarily affected. Radiation damage is generally divided into deterministic and stochastic damage.

[0013] Deterministic damage is usually the result of massive cell killing in an organ or tissue system through apoptosis or necrosis. If too many cells are killed in a tissue or organ, the affected organ loses function. Deterministic radiation damage is caused by high doses of ionizing radiation and occurs when a threshold value is exceeded.

[0014] Stochastic radiation damage occurs when radiation exposure leads to inadequate or faulty DNA repair, altering a cell's genetic information. During the natural process of cell division, the altered / mutated cells then multiply. This process can lead to the development of cancer in body cells years after radiation exposure. If the genetic information in the germ cells produced in the testes or ovaries is altered, this can lead to genetic defects in subsequent generations. Radiation-induced genetic defects have not yet been observed in humans, but have been observed in animal studies. Stochastic radiation damage can occur in body cells and germ cells, even at low doses of ionizing radiation. This means that stochastic damage can, but does not always, occur at both low and high doses.The likelihood of such radiation damage increases with increasing radiation exposure. A long time can pass between exposure to radiation and the onset of illness.

[0015] The development of new X-ray-free navigation systems for performing vascular interventions is therefore of high clinical relevance.

[0016] From the BMBF-funded Nav-EVAR project (BMBF FKZ: 13GW0228A) and the resulting publications: Garcia-Vasquez V., Haxthausen v. F. et. al. (2018), "Navigation and Visualisation with HoloLens in endovascular Aortic repair", Innovative Surgical Sciences 3 (3): 167-177, doi: 10.1515 / iss-2018-2001 and Horn M., Nolde J. et. al. (2015), "A prototype for the navigated implantation of aortic stent prostheses to reduce contrast medium and radiation exposure: The Nav-CARS-EVAR concept", Zentralblatt für Chirurgie 140: 493-499, doi: 10.1055 / s-0035-1546261 is a navigation system known by which endovascular interventions with reduced use of contrast medium and radiation dose are to be carried out through the use of augmented reality.Using HoloLens / augmented reality glasses, the vessel segment to be treated, including the access area, will be projected onto the patient, enabling endovascular navigation of the interventional elements. The dataset for the computer-generated reconstruction of the vessel segment will be taken from a standard pre-interventional CT angiography. The position of the catheter used for the intervention will be mapped in real time via an electromagnetic tracking system via the augmented reality glasses in a virtual angiography generated from the acquired data.

[0017] WO 2018 / 211235 A1 discloses a visualization system for needling. The visualization system allows the user, who may be a surgeon, to identify the position of the needle and the position of the organs within the volume where the procedure is being performed.

[0018] US 2019 / 0 223 958 A1 discloses a system and method for enhanced navigation of medical devices, wherein an example system may include a processor configured to determine a placement of a 2D medical image in a virtual 3D space, determine a placement of a virtual medical device in the 3D space, determine an intersection point based on the placement of the 2D medical image and the placement of the virtual medical device, and / or determine a dynamic projection point for the virtual medical device based at least in part on the determined intersection point. The processor may cause a display to display a rendering of the 2D medical image and a projection of the virtual medical device onto the 2D medical image from a perspective of the dynamic projection point.The display may comprise a display communicatively coupled to a medical imaging device. The field of view of the device may be parallel to a 2D region associated with the 2D medical image.

[0019] Furthermore, from the document DE 10 2014 226 240 A1 a system and a method for robot-assisted medical treatment of a patient are known, wherein the system comprises a manipulator, a medical visualization device which is attached to the manipulator in order to be moved by the manipulator, and a medical instrument which is provided with at least one marker in order to be able to detect the position of the medical instrument, and wherein the manipulator is intended to move the visualization device in such a way that it is oriented depending on the position of the medical instrument.

[0020] Furthermore, the document DE 10 2011 005 917 A1 discloses a medical workstation comprising a medical instrument intended to be introduced at least partially into the interior of a living being for the treatment thereof, an imaging device configured to create image data sets of the interior of the living being during the treatment, and a robot, wherein the robot comprises a robot arm having a plurality of links arranged one behind the other, on which the imaging device or the medical instrument can be arranged, and a control device provided for moving the robot arm, which control device is configured to move the robot arm in such a way that the imaging device attached to the robot arm follows a movement of the medical instrument or the medical instrument attached to the robot arm follows a movement of the imaging device.

[0021] The Problems while standing the TechnologyAs previously described, the main drawback is that, to date, it has not been possible to avoid X-rays and the associated administration of contrast agents for navigation in peripheral endovascular interventions. Initial approaches to reducing radiation exposure through alternative procedures have been described in the literature, but a complete elimination is not yet possible.

[0022] The present invention is based on the Task The aim is to provide an X-ray-free and contrast-free navigation system for performing a peripheral endovascular intervention.

[0023] Solved This task is carried out with an ultrasound-augmented reality-peripheral endovascular intervention-navigation arrangement according to the main claim.

[0024] The ultrasound augmented reality peripheral endovascular intervention navigation assembly comprises an augmented reality device according to claim 1.

[0025] The computer can also have access to the material logistics system, whereby material suggestions for the intervention material are issued via the system database of the material logistics system based on the ultrasound results and used material is marked.

[0026] The ultrasound augmented reality peripheral endovascular intervention navigation method, which is not part of the present invention, comprises the following steps: a. Entering patient data of a patient into a computer with a patient management system, b. Placing the patient, c. Setting up an augmented reality device connected to the computer, d. Preparing a robot system connected to the computer and the augmented reality device and having a robot arm with an ultrasound head and placing it on the patient, e. Defining an ultrasound range for a peripheral endovascular intervention on the patient, f. Automatically performing an ultrasound via the robot arm in the ultrasound range, g. Evaluating the ultrasound results and visualizing them via the augmented reality device, h. Automatically returning the robot arm to the beginning of the ultrasound range, i.Performing the peripheral endovascular intervention, comprising: manually inserting interventional material into the patient using data from the augmented reality device, detecting the interventional material by the robotic arm, and automatically performing an ultrasound scan during the insertion; j. automatically performing an ultrasound scan via the robotic arm in the ultrasound area after the end of the intervention procedure; and k. post-interventional processing of the ultrasound data obtained during the intervention.

[0027] The robot arm with ultrasound head is placed on the patient either manually or automatically. Before the robot arm with ultrasound head is placed on the patient, the robot arm is manually positioned on the opposite side of the patient's organ system to be treated. A system check is then performed to verify that the robot system is functioning correctly. If the robot arm is functioning flawlessly, the ultrasound head is connected to the robot arm. If the final placement of the robot arm with ultrasound head on the patient is performed manually, the first waypoint, i.e. the starting position, is set manually or virtually using voice control. Alternatively, the robot arm with ultrasound head can be placed automatically with the help of an optical patient recognition system. The target organ is located via the robot arm and automatically recognized as such.

[0028] The ultrasound range can be defined on the patient manually or automatically. If the ultrasound range is defined manually, the start and end points are defined by manually guiding the robot arm to the corresponding positions. Automatic definition of the ultrasound range is performed based on the patient data previously imported into the system from the patient management system.

[0029] Defining an ultrasound region on a patient involves defining intervals within that ultrasound region for measuring endovascular flow velocity. The endovascular flow velocity is used to calculate virtual ultrasound angiography and generate a virtual three-dimensional vascular model.

[0030] When the ultrasound is performed in two planes, more detailed information about the organ system or vascular system under examination is obtained than when an ultrasound is performed in one plane. This results in a more realistic image as a result of the analysis of the acquired data.

[0031] By analyzing the ultrasound to create a virtual ultrasound angiography and a virtual three-dimensional vascular model in the augmented reality device, the surgeon can virtually view the patient's interior in the defined area using the created models. Virtual ultrasound angiography is used to evaluate vascular pathology, for example, to detect hemodynamically relevant stenoses, and as a basis for comparison for the final angiography. When visualizing the virtual ultrasound angiography using the augmented reality device, it is possible to display the flow kinetics in a dynamic sequence, similar to a conventional angiography, with a selectable display duration. The flow velocities are displayed color-coded, as in duplex sonography.Furthermore, the surgeon can display individual local flow velocities by pointing a finger at the virtual ultrasound angiography. The local flow velocities can be linked to a waypoint for later virtual retrieval either manually or via voice command.

[0032] Since the waypoints for the final virtual ultrasound angiography are automatically transferred, they can then be compared post-interventionally with the pre-interventional data, making it possible to quantify the success of the intervention.

[0033] The virtual three-dimensional vascular model is used as a navigation aid during manual intervention aboveThe augmented reality device displays the catheter position / ultrasound head position to the surgeon in real time during the procedure using the three-dimensional vascular model.

[0034] If the insertion of interventional material into the patient is performed from proximal to distal, the standard direction for insertion of interventional material is used. Before the intervention begins, the robotic arm with the ultrasound head automatically returns to the first waypoint / starting point. The intervention then begins with a sonographically guided manual puncture of the vessel. A sheath is manually inserted and the interventional wire is advanced. The interventional wire is detected by the system, and the tip of the wire is automatically tracked as it is advanced distally.

[0035] Because the augmented reality device can output multiple different data sets in parallel, it is possible to display both the ultrasound image (i.e., the wire tracking) and a navigation overview (i.e., the position of the ultrasound probe relative to the virtual three-dimensional vascular model) simultaneously. This simplifies the surgeon's performance of the intervention.

[0036] Since pre-interventional and / or interventional waypoints can be set in virtual ultrasound angiography and / or in the virtual three-dimensional vascular model, it is possible to compare pre-interventional and post-interventional ultrasound results.

[0037] By comparing pre-interventional and post-interventional ultrasound results, the success of the intervention can be quantified. For example, comparing virtual ultrasound angiography with final virtual ultrasound angiography can demonstrate an increase in vascular perfusion due to the intervention.

[0038] During the intervention, waypoints can be set at any location, just as before the intervention. The waypoints are visually displayed and marked on the virtual three-dimensional representation of the vessel. If necessary, the robotic arm with the ultrasound head can return to any set waypoint automatically via voice control or virtually manually by touching the waypoint. This function can also be used, for example, to determine the correct stent size by measuring the length between two waypoints and calculating the mean vessel diameter between these same waypoints. The result is displayed via the augmented reality device.

[0039] Real-time data can be accessed and displayed continuously during the procedure. For example, during an angioballoon inflation, the manometer readings can be displayed virtually via the augmented reality device. This provides the surgeon with a real-time image and balloon pressure simultaneously, eliminating the need to constantly change their viewing direction.

[0040] If the computer has access to the material logistics system, the surgeon can access it even during an intervention. If, for example, the surgeon has determined a required stent size during an intervention, the material logistics system can access the system database. The system database contains, for example, all stent sizes in stock. The system can make a material suggestion at this point. If the material is then used, it is automatically marked as used in the system. This function can be used equivalently for a wide variety of interventional materials, such as balloon sizes for angioplasties. Access to the material logistics system can be achieved either via voice control or virtually manually.

[0041] If patient data needs to be retrieved during the navigation procedure, this can be done via voice control or virtually manually. Access to the patient management system is provided via the navigation system's computer.

[0042] In the following, an embodiment of the device according to the invention is described using the example of a peripheral endovascular intervention of the superficial femoral artery (AFS).

[0043] They show: Fig. 1: a schematic representation of the detection of the superficial femoral artery followed by an automated ultrasound scan by a robotic arm; Fig. 2: a schematic representation of the automated ultrasound scan by the robotic arm from Figure 1in axial view; Fig. 3 a schematic representation of the detection of an interventional wire in the vascular system during insertion of this wire; Fig. 4 a schematic representation of the automatic tracking of the robot arm to the target lesion and automated ultrasound tracking; Fig. 5 a schematic representation of the automatic control of the ultrasound head to the intervention focus and Fig. 6 a schematic representation of the duplex sonographic control after the intervention.

[0044] At this point it should be noted that functionally identical elements are provided with the same reference symbols.

[0045] In Fig. 1A schematic representation of the detection of the superficial femoral artery 1 is shown. The origin of the deep femoral aorta 2 from the superficial femoral aorta 1 is visible. A robotic arm 5 with an ultrasound head 6 touches the patient's surface and moves along it from a starting point. The ultrasound head 5 has a defined ultrasound sector 7 and performs an ultrasound through the patient's tissue 3 to diagnose / evaluate a section of the superficial femoral artery 1. A waypoint 8 was set by the surgeon. A stenosis 4 is shown in an area of ​​the severe femoral aorta 1. This stenosis 4 is evaluated by the robotic arm 5 with ultrasound head 6 during the automated ultrasound scan.

[0046] During the automated ultrasound scan, the surgeon can set any number of waypoints (8). The start and end points for the automated ultrasound scan are either defined based on existing patient data or manually by guiding the robot arm to the appropriate positions. The automated ultrasound scan is performed from proximal to distal in two planes. During the automated ultrasound scan, flow velocity measurements are taken at predefined intervals for subsequent calculations.

[0047] Fig. 2 shows a schematic representation of the automatic ultrasound scan from Figure 1In axial view. The patient's tissue 3 shows the femur 9 and the superficial femoral aorta 1. Both the femur 9 and the superficial femoral aorta 1 are located in the ultrasound sector 7 of the robot arm 5 with ultrasound head 6.

[0048] In Fig. 3 A schematic representation of the detection of the intervention wire 10 in the vascular system during insertion of the intervention wire 10 is shown. The intervention wire 10 is inserted here through a sheath 11 into the superficial femoral aorta 1.

[0049] The tip of the intervention wire 10 is detected by the system and automatically tracked by the robot arm 5 with ultrasound head 6. The tip of the intervention wire 10 is thus continuously located in the ultrasound sector 7 of the robot arm 5 with ultrasound head 6.

[0050] Fig. 4shows a schematic representation of the automatic tracking of the robot arm 5 from the previous figures to the target lesion, i.e. stenosis 4.

[0051] During the procedure, the augmented reality device displays both the ultrasound image for wire tracking and a navigation overview for a representation of the ultrasound head 6 relative to the virtual three-dimensional vessel model to the surgeon.

[0052] In Fig. 5 A schematic representation of the automatic control of the ultrasound head 6 to the intervention focus is shown. A stent 12 has been inserted in the area of ​​stenosis 4 from the previous figures. The ultrasound sector 7 of the robot arm 5 with ultrasound head 6 is located in this very area of ​​interest.

[0053] The stent 12 was inserted using the intervention wire 10.

[0054] Fig. 6shows a schematic representation of the duplex sonographic examination of the region of the superficial femoral aorta 1 into which the stent 12 was inserted, i.e., after the intervention. The ultrasound sector 7 of the robot arm 5 with ultrasound head 6 encompasses the newly inserted stent 4. In this illustration, the intervention wire 10 is being guided back out of the patient via the sheath 11.

[0055] During the duplex sonographic control, flow velocity measurements are performed again at the previously defined intervals.

[0056] A final virtual ultrasound angiography is performed and compared with the initial angiography. This allows the success of the intervention to be quantified.

[0057] The device according to the invention allows the performance of peripheral endovascular interventions that are completely X-ray-free and contrast medium-free. As previously described, this significantly minimizes health risks for both the surgeon and the patient during these procedures. List of reference symbols

[0058] 1Superficial femoral aorta 2Profunda femoric aorta 3Tissue 4Stenosis 5Robotic arm 6Ultrasound head 7Ultrasound sector 8Waypoint 9Femur 10Intervention wire 11Sheath 12Stent

Claims

1. Ultrasound-based augmented reality peripheral endovascular intervention navigation system for use on a patient on whom a peripheral endovascular intervention is to be performed, comprising: - an augmented reality device; - a robot system with a robot arm (5) with an ultrasound probe (6); - a computer with access to a patient management system in which the patient is stored; wherein - the augmented reality device is in the form of augmented reality three-dimensional glasses, - the patient is a living being or a model for simulation purposes; - the computer, augmented reality device and robot system are connected to one another and communicate via software; - the robot arm (5) and the augmented reality device are voice-controlled and / or virtually manually controlled; wherein - the robot arm (5) is designed with an ultrasound head (6) for performing an automated ultrasound on a patient, - the augmented reality device is designed for a visual representation of the results of the ultrasound, - during the intervention in the augmented reality device - various ultrasound results can be visually displayed and / or called up simultaneously in parallel and / or in combination, - real-time ultrasound results are transmitted by the robot arm (5) with the ultrasound head (6) and can be visualised, and - real-time data can be retrieved and / or displayed, wherein the navigation system is configured to carry out a navigation procedure comprising the following steps: a. recording patient data in the computer with the patient administration system; b. setting up the augmented reality device connected to the computer; c. preparing the robot system connected to the computer and the augmented reality device and placing it on the patient; d. defining an ultrasound area for a peripheral endovascular intervention on the patient, which involves defining intervals in this ultrasound area for measuring endovascular flow velocity; e. automatically performing an ultrasound in the ultrasound range via the robot arm (5); f. evaluating the ultrasound results to create a virtual ultrasound angiography and a virtual three-dimensional vascular model and visualising them via the augmented reality device, with the virtual three-dimensional vascular model serving as a navigation aid during a manual intervention; g. Automatic return of the robot arm (5) to the start of the ultrasound range; h. Performing the peripheral endovascular intervention, comprising: - Recognising, by the robotic arm, interventional material that is manually inserted into the patient using the augmented reality device data; and - automatically performing an ultrasound accompanying the insertion, whereby the position of the ultrasound probe(6) during the manual intervention is output via the augmented reality device; i. Automatically performing an ultrasound via the robotic arm (5) in the ultrasound area after the end of the intervention procedure; and j. Post-interventional processing of the ultrasound data obtained during the intervention.

2. Navigation system according to claim 1, characterised in that the computer has access to the material logistics system, whereby material suggestions for the intervention material are issued via the system database of the material logistics system on the basis of the ultrasound results and used material is marked.