System for tracking real-time position of a mobile sensor within a patient's body - Patents.com

Abstract

The present invention relates to a tracking system 10 comprising an emission device 12 configured to establish a measurement volume in at least a portion of a patient's body, the patient's body having a median plane, a transverse plane, and a coronal plane, a movable sensor 14 movable within the measurement volume, a first reference sensor 16 establishing a global coordinate system within the measurement volume, the global coordinate system having an origin, an x-axis, a y-axis, and a z-axis, and a controller 18. The controller 18 is configured to detect a real-time position of the movable sensor 14 within a global coordinate system, set the origin of the global coordinate system as an anchor point relative to the patient's body, extend a first reference plane parallel to the median plane in the x-axis and z-axis directions, extend a second reference plane parallel to the transverse plane in the y-axis and z-axis directions, extend a third reference plane parallel to the coronal plane in the x-axis and y-axis directions, and translate at least one of the first, second, and third reference planes in parallel, preferably based on an expected movement path of the movable sensor.

Description

[Technical field]

[0001] The present invention relates to a tracking system comprising an emission device, a movable sensor, a first reference sensor and a controller. The present invention further relates to a method for tracking a real-time position of the movable sensor in a patient's body by means of the tracking system. In particular, the tracking system is for use when introducing a blood pump or a guidewire for a blood pump into a patient's body. The blood pump may be a catheter pump, in particular an intravascular blood pump, an intracardiac blood pump or any other type of ventricular assist device. [Background technology]

[0002] Various types of such blood pumps are known from the prior art and are intended to support the function of a patient's heart, either in short-term applications, where the intravascular blood pump is placed in the patient's body for days or weeks, or in long-term applications, where the intravascular blood pump is placed in the patient's body for weeks or months. The blood pump may be inserted into the patient's body, for example, through the aorta by using a catheter, or may be placed in the thoracic cavity. During planned surgery, the intravascular blood pump is often introduced into the patient's body using a guide wire, which acts as a track for the intravascular blood pump. To ensure the correct positioning of the intravascular blood pump, for example, in the patient's left ventricle, the guide wire and the intravascular blood pump are introduced into the patient's body using fluoroscopy. Typically, fluoroscopy uses X-rays.

[0003] However, fluoroscopy, and especially X-ray, has several drawbacks: X-rays are not always available without restrictions during planned procedures to place blood pumps or guidewires, respectively. In addition, patients and physicians are exposed to large amounts of radiation when performing X-rays. Summary of the Invention [Problem to be solved by the invention]

[0004] Therefore, there is a need to provide an improved solution for tracking the position of a blood pump or a guidewire for a blood pump as it is introduced into a patient's body. [Means for solving the problem]

[0005] According to a first aspect, a tracking system includes an emission device configured to establish a measurement volume at least in a portion of a patient's body, a movable sensor movable within the measurement volume, and a first reference sensor that establishes a global coordinate system within the measurement volume. The global coordinate system includes an origin, an x' axis, a y' axis, and a z' axis. The patient's body has a median plane, a transverse plane, and a coronal plane.

[0006] The tracking system according to the first aspect further comprises a controller configured to detect a real-time position of the movable sensor in a global coordinate system, set an origin of the global coordinate system as an anchor point relative to the patient's body, extend a first reference plane parallel to the median plane in the direction of the x' and z' axes, extend a second reference plane parallel to the transverse plane in the direction of the y' and z' axes, extend a third reference plane parallel to the coronal plane in the direction of the x' and y' axes, and translate at least one of the first, second, and third reference planes in parallel based on an expected movement path of the movable sensor. The first reference sensor may be attached to the patient's skin and may be positioned on the top of the sternum on the manubrium.

[0007] Here, the median plane, transverse plane, and coronal plane of the patient's body are the three main planes of the human body, and the controller can set a reference plane parallel to the main planes since the first reference sensor is an anchor point for the tracking procedure. The movable sensor is introduced into the patient's body, for example, via a right axillary access, a left axillary access, or a right or left femoral access, so that the expected movement path of the movable sensor is known to the physician. Thus, at least one reference plane can be moved in parallel to delimit a volume within the measurement volume where the movable sensor does not come out, for example, during the insertion of an intravascular blood pump or a guidewire to which the movable sensor is attached. Furthermore, since the ejection device can generate a measurement volume and detect the position of the movable sensor and the first reference sensor within the measurement volume, it is also possible to track whether the movable sensor is located within the delimited volume obtained by moving at least one of the reference planes. This provides a better orientation and support when the physician inserts the guidewire or the intravascular blood pump, respectively.

[0008] To set the origin of the global coordinate system as an anchor point relative to the patient's body, the origin of the global coordinate system can be defined as the intersection of the median, lateral, and coronal planes.

[0009] Preferably, the first, second and third reference planes establish eight octants within the measurement volume. Preferably, the controller is configured to adjust the division of the octants based on the expected path of movement of the movable sensor. When moving one or more of the reference planes, the size of each of the octants can be changed. For example, one of the octants may be of particular interest to the physician as it covers the expected path of movement of the movable sensor, and thus the delimited space. This may provide a better orientation since the physician can directly recognize that the movable sensor is "leaving" in the octant of interest. For example, if a guidewire with a movable sensor is introduced into the patient's body via the left axillary access, the octant covering the left axillary access is sized or enlarged, respectively, by moving the respective reference planes to cover the entire vasculature and left ventricle of interest.

[0010] Preferably, the tracking system comprises a second reference sensor, and the controller is configured to detect the position and / or orientation of the second reference sensor in the global coordinate system. The second reference sensor may be used as an additional aid for the physician, since its position is known to the physician. For example, the second reference sensor may be positioned on the patient's skin above the apex of the heart.

[0011] The controller may be further configured to align the x' axis parallel to the intersection line of the coronal and median planes, and / or to align the y' axis parallel to the intersection line of the transverse and coronal planes, and / or to align the z' axis parallel to the intersection line of the median and transverse planes.

[0012] The first reference sensor may further be configured to be manually aligned with the median and / or transverse and / or coronal planes such that the x'-axis is parallel to the intersection line of the coronal and median planes, and / or the y'-axis is parallel to the intersection line of the transverse and coronal planes, and / or the z'-axis is parallel to the intersection line of the median and transverse planes. For example, the first reference sensor may include a mark or indicia indicating the x'-axis and / or the y'-axis, such as the intersection line. The mark or indicia may be made visible on an outer surface of the housing of the first reference sensor. Furthermore, the first reference sensor may include a spirit level for aligning the z'-axis. The spirit level may be attached, for example, to the housing of the first reference sensor.

[0013] The tracking system may further comprise a third reference sensor, and the controller may be configured to set the orientation of the median plane, the transverse plane, and / or the coronal plane in the measurement volume based on the orientation of the third reference sensor. Generally, the patient lies on an operating table or the like, and thus the coronal plane is parallel to the surface of the operating table, and the median plane and the transverse plane are perpendicular to the operating table. When the ejection device is placed in or on the operating table, the three main planes of the patient's body can be easily set. However, when a moving ejection device is used, the position of the ejection device relative to the patient's body may not be precisely known. By using a third reference sensor, for example, fixed to the surface of the operating table, the three main planes can be easily set by the controller, since the orientation of the main planes in the measurement volume is thereby known. Preferably, the third reference sensor is a sensor with at least three degrees of freedom pointing in the x-, y-, and z-directions.

[0014] Preferably, the controller is configured to detect crossing of the movable sensor with at least one of the first, second and third reference planes. The controller may be configured to emit a warning signal to the physician if a crossing is detected. This allows the physician to be directly aware that the movable sensor has "left" its expected path of movement.

[0015] The controller may be configured to establish a target volume in the global coordinate system. The target volume may be a suitable volume that points to the final location of the movable sensor along the expected path of movement, e.g., the left ventricle of the patient's heart. The controller may virtually generate a volume or region of interest, i.e., the target volume that points to the final location of the movable sensor. The target volume may have any suitable shape, e.g., a cylindrical, ball, cone, football, or egg shape. This may further aid the physician in locating, e.g., a guidewire with the movable sensor attached thereto, in its final location.

[0016] The controller may be further configured to establish a spatially limited auxiliary plane, which may represent a specific structure within the patient's body. For example, the specific structure may be the aortic valve, and the auxiliary plane may be virtually generated by the controller such that the aortic valve at its location approximately corresponds to the location of the auxiliary plane. This may further aid the physician in, for example, placing a guidewire with a movable sensor attached thereto in its final location.

[0017] The first reference sensor may be a six degree of freedom sensor. The second reference sensor may be a six degree of freedom sensor. The third reference sensor may be a six degree of freedom sensor. The movable sensor, the first reference sensor, the second reference sensor, and / or the third reference sensor may be embedded electromagnetic sensors. The movable sensor may be a five degree of freedom sensor or a six degree of freedom sensor. This allows for high overall resolution.

[0018] Preferably, the tracking system further comprises a medical device, and the movable sensor is attached to the medical device. The medical device may be an intravascular blood pump, an intracardiac blood pump, a catheter blood pump, or a guidewire for an intravascular blood pump, for example.

[0019] The emission device may be an electromagnetic field generator. The electromagnetic field generator is preferably configured to emit a low intensity fluctuating electromagnetic field that establishes a measurement volume. The electromagnetic field induces small currents in the sensors, i.e. the movable sensor, the first reference sensor, the second reference sensor, and / or the third reference sensor. The induced currents are relayed to a controller, which is preferably configured to amplify and digitize the currents for further processing as a digital signal.

[0020] The tracking system may further comprise a display device. The display device may be a suitable device, for example a TFT or LCD device. The display device may be configured to display the real-time position of the movable sensor, and / or to display the first reference plane, and / or to display the second reference plane, and / or to display the third reference plane, and / or to display the target volume, and / or to display the auxiliary plane in the global coordinate system, and / or to display the octant. The display device may be configured in particular to display the real-time position of the movable sensor relative to the first reference plane, and / or relative to the second reference plane, and / or relative to the third reference plane, and / or relative to the target volume, and / or relative to the auxiliary plane in the global coordinate system, and / or relative to the octant. Thus, the real-time position of the movable sensor relative to further entities may be visualized to the physician via the display device. This may further provide a better orientation when the physician inserts, for example, a guidewire with the movable sensor attached thereto into the patient's body.

[0021] The tracking system may further comprise an input device. The input device may be configured to communicate with the controller. The input device may be any suitable device, such as a remote control, a smartphone, a keyboard, a terminal, a personal computer, a tablet, etc. Furthermore, the display device may be an input device, such as a touch screen.

[0022] According to a second aspect, a method for tracking a real-time position of a movable sensor by a tracking system, e.g. by a tracking system according to the first aspect, comprises the steps of providing an emission device configured to establish a measurement volume in at least a portion of a patient's body, the patient's body having a median plane, a transverse plane, and a coronal plane; providing a movable sensor movable within the measurement volume; providing a first reference sensor establishing a global coordinate system within the measurement volume, the global coordinate system having an x'-axis, a y'-axis, and a z'-axis; providing a controller; and attaching the reference sensor to the skin of the patient's body. the controller extending a first reference plane parallel to the median plane in the direction of the x'-axis and the z'-axis, the controller extending a second reference plane parallel to the transverse plane in the direction of the y'-axis and the z'-axis, the controller extending a third reference plane parallel to the median plane in the direction of the x'-axis and the y'-axis, the controller translating in parallel at least one of the first reference plane, the second reference plane, and the third reference plane based on an expected path of movement of the movable sensor, and the controller detecting a real-time position of the movable sensor in a global coordinate system. The first reference sensor may be positioned at the manubrium at the top of the sternum.

[0023] To set the origin of the global coordinate system as an anchor point relative to the patient's body, the origin of the global coordinate system may be defined as the intersection of the median, lateral, and coronal planes.

[0024] Here, the median, transverse and coronal planes of the patient's body are the three main planes of the human body, and the reference planes are set parallel to these main planes, since the first reference sensor is the anchor point for the tracking procedure. The expected movement path of the movable sensor is known to the physician, since the movable sensor is introduced into the patient's body, for example, via the right axillary access, the left axillary access, or the right or left femoral access. Thus, at least one reference plane is moved in parallel to delimit a volume within the measurement volume in which the movable sensor does not come out during the introduction of an intravascular blood pump, a guidewire, etc., to which the movable sensor may be attached. Furthermore, since the ejection device generates the measurement volume and can detect the position of the movable sensor and the first reference sensor within the measurement volume, it is also possible to track whether the movable sensor is located within the delimited area obtained by moving at least one of the reference planes. This gives the physician a better orientation and assistance when inserting the guidewire or the intravascular blood pump, respectively.

[0025] The method may further include the steps of establishing, by the controller, eight octants in the measurement volume based on the first, second and third reference planes, and adjusting, by the controller, the division of the octants based on the expected movement path of the movable sensor. One of the octants may be of particular interest to the physician as covering the expected movement path of the movable sensor and thus the partitioned space. This may provide a better orientation, since the physician may directly recognize that the movable sensor is "leaving" in the octant of interest. For example, when a guidewire with a movable sensor is introduced into the patient's body via the left axillary access, the octant covering the left axillary access is sized or enlarged, respectively, by moving the respective reference planes to cover the entire vasculature of interest and the left ventricle of the heart.

[0026] The method may further include providing a second reference sensor and detecting, by the controller, a position of the second reference sensor in the global coordinate system. The second reference sensor is used as an additional aid for the physician because its position is known to the physician. For example, the second reference sensor may be positioned on the patient's skin above the apex of the heart.

[0027] The method may further include aligning the x' axis parallel to the intersection line of the coronal and median planes, and / or aligning the y' axis parallel to the intersection line of the transverse and coronal planes, and / or aligning the z' axis parallel to the intersection line of the median and transverse planes.

[0028] The method may further include manually aligning the first reference sensor with the median plane and / or the transverse plane and / or the coronal plane such that the x' axis is parallel to the intersection line of the coronal and median planes, and / or such that the y' axis is parallel to the intersection line of the transverse and coronal planes, and / or such that the z' axis is parallel to the intersection line of the median and transverse planes.

[0029] The method may further include providing a third reference sensor and setting, by the controller, the orientation of the median plane, the transverse plane, and / or the coronal plane in the measurement volume based on the orientation of the third reference sensor. Generally, the patient lies on an operating table or the like, so that the coronal plane is parallel to the surface of the operating table, and the median plane and the transverse plane are perpendicular to the operating table. If the ejection device is placed in or on the operating table, the three main planes of the patient's body can be easily set. However, if a moving ejection device is used, the position of the ejection device relative to the patient's body may not be precisely known. By using a third reference sensor, for example fixed to the surface of the operating table, the three main planes can be easily set, since the orientation of the main planes in the measurement volume is thereby known. Preferably, the third reference sensor is a sensor with at least three degrees of freedom pointing in the x-, y-, and z-directions.

[0030] The method may further include detecting, by the controller, a crossing of the movable sensor relative to at least one of the first reference plane, the second reference plane, and the third reference plane.

[0031] The method may further include establishing, by the controller, a target volume in the global coordinate system. The target volume may be a suitable volume that points to the final location of the movable sensor along the expected path of movement, e.g., the left ventricle of the patient's heart. The target volume may be virtually generated by the controller to indicate a volume or region of interest, i.e., the final location of the movable sensor. The target volume may have any suitable shape, e.g., a cylindrical, ball, cone, football, or egg shape. This may further aid the physician, for example, in introducing a guidewire with the movable sensor attached thereto to its final location.

[0032] The method may further include establishing, by the controller, a spatially limited auxiliary plane, the auxiliary plane representing a specific structure within the patient's body. For example, the specific structure may be the aortic valve, and the auxiliary plane may be virtually generated such that the aortic valve at its location approximately corresponds to the location of the auxiliary plane. This may further assist the physician, for example, in introducing a guidewire with a movable sensor attached thereto to its final location.

[0033] The method may further comprise the steps of displaying the real-time position of the movable sensor on the display device, and / or displaying the first reference plane on the display device, and / or displaying the second reference plane on the display device, and / or displaying the third reference plane on the display device, and / or displaying the target volume on the display device, and / or displaying an auxiliary plane in the global coordinate system on the display device, and / or displaying the octant on the display device. In particular, the real-time position of the movable sensor relative to the first reference plane, and / or relative to the second reference plane, and / or relative to the third reference plane, and / or relative to the target volume, and / or relative to the auxiliary plane in the global coordinate system, and / or relative to the octant may be displayed. Thus, the real-time position of the movable sensor relative to further entities may be visualized to the physician. This further gives a better orientation when the physician inserts, for example, a guidewire with the movable sensor attached thereto into the patient's body.

[0034] The mobile sensor may be introduced into the patient's body via the femoral artery or via the axillary artery.

[0035] The foregoing summary, as well as the following detailed description of exemplary embodiments, will be better understood when read in conjunction with the appended drawings, to which reference is made for purposes of explaining the present disclosure, but the disclosure is not limited in scope to the specific embodiments disclosed in the drawings. [Brief description of the drawings]

[0036] [Figure 1] FIG. 1 is a functional block diagram of an exemplary tracking system according to an aspect of the present disclosure. [Diagram 2] FIG. 1 is a schematic diagram of a patient's body with reference sensors placed thereon. [Diagram 3] FIG. 1 is a schematic diagram of the alignment of the global coordinate system with the three cardinal planes of the human body. [Figure 4] FIG. 2 is a schematic diagram of a virtual model of a patient's body with reference planes located thereon. [Diagram 5] FIG. 5 is the diagram of FIG. 4 with the target volume further disposed. [Figure 6] 5 as a top view along the z axis. [Figure 7] FIG. 5 is the view of FIG. 4 in which the auxiliary plane was further positioned and the position tracked for right axillary access. [Figure 8] 8 is a top view of FIG. 7 taken along the z axis. [Figure 9] FIG. 8 is the view of FIG. 7 without the virtual model of the patient's body. [Figure 10] 9 as a top view along the z-axis. [Figure 11] FIG. 10 is a view similar to FIG. 9 with positions tracked for right axillary access, left axillary access, and femoral access. [Figure 12] FIG. 11 is a top view along the z axis. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0037] The embodiments of the present disclosure will be described in detail with reference to the figures. In these figures, the same reference numbers identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be implemented in various forms. Well-known functions or structures are not described in detail to avoid obscuring the present disclosure with unnecessary details. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limitations, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art to use the present disclosure in various forms in virtually any appropriately detailed structure.

[0038] In order to provide a general understanding of the systems, methods, and devices described herein, certain illustrative examples are described. Although intravascular blood pumps may be described in various examples, it will be understood that the improvements of the present technology may also be adapted and applied to other types of medical devices, such as electrophysiology and catheter ablation devices, angioplasty and stenting devices, angiography catheters, peripherally punctured central catheters, central venous catheters, midline catheters, peripheral catheters, inferior vena cava filters, abdominal aortic aneurysm treatment devices, thrombus removal devices, TAVR delivery systems, cardiac therapy and cardiac assist devices including balloon pumps, cardiac assist devices implanted using surgical incisions, and any other venous or arterial based introduced catheters and devices. As is known, intravascular blood pumps can be surgically or percutaneously introduced into a patient's body to deliver blood from one location in the heart or circulatory system to another location in the heart or circulatory system. For example, when deployed in the left ventricle, the intravascular blood pump can pump blood from the left ventricle of the heart into the aorta. When deployed in the right ventricle, the intravascular blood pump can pump blood from the inferior vena cava into the pulmonary artery.

[0039] FIG. 1 shows a schematic block diagram of a tracking system 10 according to the present invention. The tracking system 10 comprises an emission device 12, a movable sensor 14, a first reference sensor 16, a second reference sensor 20, a third reference sensor 22, a controller 18, a medical device 24, a display device 26, and an input device 28. Preferably, the movable sensor 14 is attached to the medical device 24. The medical device 24 may be an intravascular blood pump or a guidewire for a blood pump. Hereinafter, the medical device 24 is considered as a guidewire for an intravascular blood pump.

[0040] The first reference sensor 16 may include markings or indicia, which will be described in more detail below. The markings or indicia may be made visible on an exterior surface of the housing of the first reference sensor 16. Additionally, the first reference sensor 16 may include a spirit level, which may be attached to the housing of the first reference sensor 16, for example.

[0041] In this embodiment, the emission device 12 is an electromagnetic field generator configured to emit a low intensity fluctuating electromagnetic field that induces small currents in the movable sensor 14, the first reference sensor 16, the second reference sensor 20, and the third reference sensor 22 when positioned within the measurement volume, thereby establishing the measurement volume. The emission device 12, the movable sensor 14, the first reference sensor 16, the second reference sensor 20, and the third reference sensor 22 are all connected by suitable means, for example by cable or wirelessly, to the controller 18. The controller 18 amplifies and digitizes the received currents and calculates the positions of the movable sensor 14, the first reference sensor 16, the second reference sensor 20, and the third reference sensor 22, as described in more detail below.

[0042] The display device 26 is also connected to the controller 18, which may be configured to display various information on the display device 26. The display device 26 may be a TFT display. To operate the tracking system 10, an input device 28 is provided. The input device 28 may be a keyboard, a terminal, a smartphone, a tablet, etc., and is connected to the controller 18 in a suitable manner. The display device 26 may comprise the input device 28 and thus may be a touch screen. The illustrations shown in Figs. 4-12 also show examples of possible visualizations on the display device 26.

[0043] Prior to introduction of guidewire 24 into the patient's body B, the patient is positioned on an operating table or the like with the patient's coronal plane CP parallel to the surface of the operating table and the patient's median plane MP perpendicular to the surface of the operating table. The patient's transverse plane TP is perpendicular to the patient's coronal plane CP and the patient's median plane MP. Figure 4 shows a view of a virtual model of the patient's body showing the patient's coronal plane CP, the patient's median plane MP, and the patient's transverse plane TP.

[0044] The first reference sensor 16 may then be placed on the patient's body B, on the manubrium, at the top of the sternum. See FIG. 2. The first reference sensor 16 may be a 5-DOF or 6-DOF sensor. To improve accuracy and to accommodate the patient's individual anatomy, the second reference sensor 20 may be placed on the patient's body B, above the apex of the heart. See FIG. 2. The second reference sensor 20 may be a 5-DOF or 6-DOF sensor. To ensure the correct positioning of the second reference sensor 20, the apex of the heart may be determined before surgery, for example by transthoracic echocardiography or ultrasound imaging.

[0045] The electromagnetic field generator 12 may be placed in the vicinity of the patient's body B such that the part of interest of the patient's body B is located within a measurement volume established by the electromagnetic field generator 12. In particular, there are two possible solutions for the electromagnetic field generator 12, namely the electromagnetic field generator 12 is fixed in a known manner in space or the electromagnetic field generator is fixed in an unknown manner in space. The electromagnetic field generator 12 may be fixed to the operating table such that its position in space, in particular its position relative to the operating table, is known. Furthermore, the electromagnetic field generator 12 may also be a mobile electromagnetic field generator, for example movably attached to an arm or the like, such that its position in space, in particular its position relative to the operating table, is not precisely known.

[0046] When a moving electromagnetic field generator 12 is used, the third reference sensor 22 may be required to determine the surface of the operating table on which the patient's body lies. The third reference sensor 22 may therefore be placed on the surface of the operating table. Since the third reference sensor 22 is used only as an auxiliary resource, it is sufficient for the third reference sensor 22 to be a three-degree-of-freedom sensor. Of course, it is also possible to use a five-degree-of-freedom or six-degree-of-freedom sensor as the third reference sensor 22. With the third reference sensor 22, the coordinate system underlying the measurement volume is aligned by the controller 18 so that the xy plane is parallel to the surface of the operating table. The coordinate system of the measurement volume has an x-axis, a y-axis, and a z-axis.

[0047] The position of the first reference sensor 16 is then an anchor point and establishes a global coordinate system COS having x', y', and z' axes. Additionally, the first reference sensor 16 establishes the anatomy of the patient's body B relative to the global coordinate system COS. All other positions of the movable sensor 14, for example, are indicated and calculated by the controller 18 relative to the global coordinate system COS.

[0048] Because the patient typically lies on the operating table such that the orientations of the coronal plane CP, the lateral plane TP, and the median plane MP correspond to the orientation of the operating table, the orientation of the patient's coronal plane CP, the orientation of the patient's lateral plane TP, and the orientation of the patient's median plane MP may be known to the physician.

[0049] For example, the origin of the global coordinate system (COS) is defined as the intersection of the median plane MP, the lateral plane TP, and the coronal plane CP.

[0050] In a first step, the global coordinate system COS of the first reference sensor 16 is adapted to the coordinate system underlying the operating table and thus the measurement volume established by the electromagnetic field generator 12 .

[0051] Preferably, this adaptation is performed automatically by the controller 18. After placing the first reference sensor 16 on the manubrium of the patient's body B, a global coordinate system COS is established, whose x'-axis may be tilted with respect to the patient's coronal plane CP, for example due to the inclination of the thorax of the patient's body B. Thus, the x'-axis may also be tilted with respect to the surface of the operating table, which is parallel to the patient's coronal plane CP, see the left part of FIG. 3. Accordingly, the global coordinate system COS of the first reference sensor 16 is adapted such that its x'-axis is aligned with the intersection line (LI) of the patient's coronal plane CP and median plane MP. CP-MP ) and the y'-axis is the intersection line (LI) of the transverse and coronal planes TP and CP of the patient. CP-TP ) and the z' axis is the intersection line (LI MP-TP ), see the right part of Fig. 3. In other words, the global coordinate system COS is now perfectly parallel (i.e. aligned) to the coordinate system underlying the measurement volume established by the electromagnetic field generator 12, and thus to the operating table. Thus, the x'-axis of the global coordinate system COS coincides with the x-axis of the measurement volume coordinate system, the y'-axis of the global coordinate system COS coincides with the y-axis of the measurement volume coordinate system, and the z'-axis of the global coordinate system COS coincides with the z-axis of the measurement volume coordinate system.

[0052] In addition to or as an alternative to automatic adaptation of the global coordinate system COS to the operating table, the orientation of the first reference sensor 16 may be manually aligned to the orientation of the operating table using a mark or indicia on the housing of the first reference sensor 16 and further using a spirit level attached to the housing of the first reference sensor 16.

[0053] Thus, the x' axis is the intersection line (LI) of the patient's coronal plane CP and median plane MP. CP-MP ) and the y'-axis is the intersection line (LI) of the transverse and coronal planes TP and CP of the patient. CP-TP ) and the z' axis is the intersection line (LI MP-TPThe first reference sensor 16 may be manually aligned with the patient's median plane MP, the patient's lateral plane TP, and the patient's coronal plane CP so as to be parallel to the patient's median plane MP, the patient's lateral plane TP, and the patient's coronal plane CP.

[0054] Next, the controller 18 spreads three reference planes RP1, RP2, and RP3 in the global coordinate system COS. A first reference plane RP1 parallel to the patient's median plane MP in the direction of the x-axis and z-axis, a second reference plane RP2 parallel to the patient's transverse plane TP in the direction of the y-axis and z-axis, and a third reference plane RP3 parallel to the patient's coronal plane CP in the direction of the x-axis and y-axis. See FIG. 5. All three reference planes RP1, RP2, and RP3 are mutually orthogonal and collectively delimit eight areas in the measurement volume in the form of octants O1 to O8. The first reference plane RP1 may be identical to the patient's median plane MP, the second reference plane RP2 may be identical to the patient's transverse plane TP, and the third reference plane RP3 may be identical to the patient's coronal plane CP.

[0055] Of course, the expected path of travel of the movable sensor 14 within the patient's body B is known to the physician prior to surgery, as the physician is familiar with how to position the guidewire 24 with the movable sensor 14. To describe the next steps, assume that a right axillary access is used to introduce the guidewire 24 into the patient's body.

[0056] As shown in Fig. 5 and Fig. 6, the controller 18 translates in parallel at least one of the first, second and third reference planes RP1, RP2 and RP3, which are provided in the global coordinate system COS, on the expected path of movement of the guide wire 24 and thus the movable sensor 14. In so doing, the division of the octants O1 to O8 relative to one another is adjusted. In the example of a right axillary access, the upper anterior octant O1 in Fig. 5 delimits the part of interest of the patient's body within the measurement volume. Accordingly, the first reference plane RP1 is translated by a specific amount (e.g., a few millimeters) in the direction of the positive y-axis so as to separate the right axilla from the left axilla and the ascending aorta from the descending aorta. Furthermore, the second reference plane RP2 is translated by a specific amount (e.g., a few centimeters) in the direction of the negative x-axis so as to limit the insertion space in the direction of the blood vessels leading to the patient's head. Furthermore, the third reference plane RP3 is translated a characteristic amount (e.g., a few centimeters) in the direction of the negative z-axis to separate the ascending and descending aorta. The octant of interest O1 is thus enlarged to delimit a space within which the expected movement path of the movable sensor 14, and thus the guidewire 24, is depicted.

[0057] The controller 18 is further configured to detect any intersection of the movable sensor 14 and the reference planes RP1, RP2, and RP3. In other words, the controller 18 can detect if the movable sensor 14 has left the octant of interest and may emit a warning signal to the physician.

[0058] To further assist the physician during the insertion procedure of the guidewire 24 into the patient's body B, the controller 18 may be configured to establish a target volume TV and visualize the target volume TV on the display device 26, see Figs. 5-12. The target volume TV represents the most likely final location of the guidewire 24 after it has been inserted, e.g. the left ventricle. The target volume may have any suitable shape, e.g. a ball, a cone, a cylinder or a football shape. In principle, the target volume TV may be established taking into account the position of the second reference sensor 20. It is also conceivable to set the target volume TV by a suitable algorithm or manually, e.g. based on a transthoracic echocardiography or ultrasound imaging.

[0059] In addition to the target volume TV, the controller 18 may further be configured to establish a spatially limited auxiliary plane AP to further assist the physician during the insertion procedure of the guidewire 24 into the patient's body B. The position of the auxiliary plane AP indicates a specific structure in the patient's body B, for example, the aortic valve. See FIG. 7. The auxiliary plane AP may be established taking into account the position of the second reference sensor 20. It is also conceivable to set the auxiliary plane AP by a suitable algorithm or manually, for example, based on transthoracic echocardiography or ultrasound imaging. Of course, further auxiliary planes and / or target volumes may be established by the controller 18, for example, in other colors referring to the aortic arch.

[0060] 7-10 show the path of movement P of the movable sensor 14 within the patient's body for right axillary access. RA 10 shows different views that can be visualized by the physician on the display device 26, showing the path of movement P of the movable sensor 14. RA is based on the visualized real-time data of the position of the movable sensor 14 in the global coordinate system COS. In other words, the moving path P RAis composed of a plurality of individual positions of the movable sensor 14. As shown, the physician may switch between different representations via the input device 28, for example with or without a virtual model of the patient's body, with or without a first reference plane RP1, with or without a second reference plane RP2, with or without a third reference plane RP3, with or without a target volume TV, or with or without an auxiliary plane AP.

[0061] 11 and 12 show the path of movement P of the movable sensor 14 for left axillary access. LA , and the movement path P of the movable sensor 14 for femoral access FA As described, the movable sensor 14 may be attached to a guidewire 24 or directly to an intravascular blood pump. Especially during emergency procedures, it may not be possible in time to first introduce the guidewire 24 into the patient's body. In such cases, the intravascular blood pump with the movable sensor 14 attached thereto may be introduced directly into the patient's body B, for example, via femoral access. Displaying the path of travel of the intravascular blood pump in real time greatly assists the physician in accurately positioning the intravascular blood pump within the patient's left ventricle.

[0062] Exemplary Implementations As previously discussed, the techniques described herein may be implemented in a variety of ways. In that regard, the above disclosure is intended to include, but is not limited to, the systems, methods, and combinations and subcombinations thereof set forth in the following exemplary implementations. Preferred embodiments are described in the following paragraphs. A1. A discharge device (12) configured to establish a measurement volume within at least a portion of a patient's body (B), the patient's body having a median plane (MP), a transverse plane (TP), and a coronal plane (CP); a movable sensor (14) movable within the measurement volume; a first reference sensor (16) that establishes a global coordinate system (COS) within the measurement volume, the global coordinate system (COS) having an origin, an x' axis, a y' axis, and a z' axis; and a controller (18), the controller (18) - to detect the real-time position of the movable sensor (14) in a global coordinate system, - Set the origin of the global coordinate system (COS) as an anchor point relative to the patient's body, - to extend a first reference plane (RP1) parallel to the median plane (MP) in the direction of the x' and z' axes, - to extend a second reference plane (RP2) parallel to the transverse plane (TP) in the direction of the y' and z' axes, - to extend a third reference plane (RP3) parallel to the coronal plane (CP) in the direction of the x' and y' axes, and preferably - A tracking system (10) configured to translate at least one of the first reference plane (RP1), the second reference plane (RP2), and the third reference plane (RP3) in parallel based on an expected movement path of the movable sensor (14). A2. The tracking system (10) as described in paragraph A1, wherein the first reference plane (RP1), the second reference plane (RP2), and the third reference plane (RP3) establish eight octants (O1-O8) within the measurement volume, and the controller (18) is configured to adjust the division of the octants (O1-O8) based on an expected path of movement of the movable sensor (14). A3. The tracking system (10) of paragraph A1 or A2, wherein the tracking system (10) further comprises a second reference sensor (20), and the controller (18) is further configured to detect a position of the second reference sensor (20) within a global coordinate system (COS). A4. A tracking system (10) according to any one of the preceding paragraphs A1 to A3, wherein the controller (18) - Line of intersection (LI) of the coronal (CP) and median (MP) planes CP-MP) and / or - Intersection line (LI) of transverse (TP) and coronal (CP) planes CP-TP ) and / or - Line of intersection (LI) of median plane (MP) and transverse plane (TP) MP-TP ) the tracking system (10). A5. The tracking system (10) according to any one of the preceding paragraphs A1 to A4, wherein the first reference sensor (16) is arranged such that the x'-axis is aligned with the intersection line (LI) of the coronal plane (CP) and the median plane (MP). CP-MP ) and / or the y' axis should be parallel to the intersection line (LI) of the transverse (TP) and coronal (CP) planes. CP-TP ) and / or the z' axis should be parallel to the line of intersection (LI) of the median plane (MP) and the transverse plane (TP). MP-TP A tracking system (10) configured to be manually aligned with the median plane (MP) and / or the transverse plane (TP) and / or the coronal plane (CP) so as to be parallel to the median plane (MP) and / or the transverse plane (TP) and / or the coronal plane (CP). A6. The tracking system (10) according to any one of paragraphs A1 to A5 above, further comprising a third reference sensor (22), wherein the controller (18) is configured to set the orientation of the median plane (MP), the transverse plane (TP) and the coronal plane (CP) within the measurement volume based on the orientation of the third reference sensor (22). A7. A tracking system (10) as described in any one of paragraphs A1 to A6 above, wherein the controller (18) is configured to detect an intersection of the movable sensor (14) with at least one of the first reference plane (RP1), the second reference plane (RP2), and the third reference plane (RP3). A8. The tracking system (10) of any one of paragraphs A1 to A7 above, wherein the controller (18) is further configured to establish a target volume (TV) within a global coordinate system (COS). A9. The tracking system (10) according to any one of paragraphs A1 to A8 above, wherein the controller (18) is further configured to establish a spatially restricted auxiliary plane (AP), the auxiliary plane (AP) being indicative of a unique structure within the patient's body. A10. A tracking system (10) according to any one of the preceding paragraphs A1 to A9, wherein the first reference sensor (16) is a six degree of freedom sensor and / or the second reference sensor (20) is a six degree of freedom sensor. A11. The tracking system (10) according to any one of the preceding paragraphs A1 to A8, further comprising a medical device (24), wherein the movable sensor (14) is attached to the medical device (24), and wherein the medical device (24) is preferably an intravascular blood pump or, for example, a guidewire for an intravascular blood pump. A12. The tracking system (10) according to any one of the preceding paragraphs A1 to A11, wherein the emitting device (12) is an electromagnetic field generator. A13. The tracking system (10) according to any one of the preceding paragraphs A1 to A12, wherein the movable sensor (14) is an embedded electromagnetic sensor and / or the movable sensor (14) is a five degree of freedom sensor or a six degree of freedom sensor. A14. The tracking system (10) according to any one of the preceding paragraphs A1 to A13, further comprising a display device (26) configured to display a real-time position of the movable sensor (14), and / or to display a first reference plane (RP1), and / or to display a second reference plane (RP2), and / or to display a third reference plane (RP3), and / or to display a target volume (TV), and / or to display an auxiliary plane (AP) in a global coordinate system (COS), and / or to display octants (O1 to O8), in particular to display the real-time position of the movable sensor (14) relative to the first reference plane (RP1), and / or relative to the second reference plane (RP2), and / or relative to the third reference plane (RP3), and / or relative to the target volume (TV), and / or relative to the auxiliary plane (AP) in the global coordinate system (COS), and / or relative to the octants (O1 to O8). A15. The tracking system (10) according to any one of the preceding paragraphs A1 to A14, further comprising an input device (28) configured to communicate with the controller (18). A16 A method for tracking the real-time position of a mobile sensor (14) within a patient's body (B) by a tracking system (10), for example by a tracking system according to any one of the preceding paragraphs A1 to A15, comprising: - providing an emission device (12) configured to establish a measurement volume within at least a portion of a patient's body (B), the patient's body having a median plane (MP), a transverse plane (TP), and a coronal plane (CP); - providing a movable sensor (14) movable within a measurement volume; - providing a first reference sensor (16) that establishes a global coordinate system (COS) within the measurement volume, the global coordinate system (COS) having an origin, an x' axis, a y' axis, and a z' axis; - providing a controller (18); - attaching a reference sensor (16) to the skin of the patient's body (B); - setting, by a controller (18), the origin of a global coordinate system (COS) as an anchor point relative to the patient's body; - extending, by the controller (18), a first reference plane (RP1) parallel to the median plane (MP) in the direction of the x' and z' axes; - extending, by the controller (18), a second reference plane (RP2) parallel to the transverse plane (TP) in the direction of the y' and z' axes; - extending, by the controller (18), a third reference plane (RP3) parallel to the coronal plane (CP) in the direction of the x' and y' axes; - translating, by the controller (18), at least one of the first reference plane (RP1), the second reference plane (RP2) and the third reference plane (RP3) in parallel based on an expected movement path of the movable sensor (14); - detecting, by a controller (18), a real-time position of the movable sensor (14) within a global coordinate system (COS). A17 A method according to paragraph A16, comprising the steps of: - establishing, by the controller (18), eight octants (O1 to O8) within the measurement volume based on a first reference plane (RP1), a second reference plane (RP2) and a third reference plane (RP3); - adjusting, by the controller (18), the partitioning of the octants (O1-O8) based on the expected path of movement of the movable sensor (14). A18 The method according to paragraph A16 or A17, comprising the steps of: - providing a second reference sensor (20); - detecting, by the controller (18), the position of a second reference sensor (20) in a global coordinate system (COS). A19. The method according to any one of the preceding paragraphs A16 to A18, comprising: - Line of intersection (LI) of the coronal (CP) and median (MP) planes CP-MP aligning the x′ axis parallel to the - Intersection line (LI) of transverse (TP) and coronal (CP) planes CP-TP aligning the y′ axis parallel to the - Line of intersection (LI) of the median plane (MP) and the transverse plane (TP) MP-TP aligning the z' axis parallel to the z axis. A20 The method according to any one of the preceding paragraphs A16 to A19, wherein the x'-axis is the intersection line (LI) of the coronal plane (CP) and the median plane (MP). CP-MP ) and / or the y' axis should be parallel to the intersection line (LI) of the transverse (TP) and coronal (CP) planes. CP-TP ) and / or the z' axis should be parallel to the line of intersection (LI) of the median plane (MP) and the transverse plane (TP). MP-TP ) manually aligning a first reference sensor (16) with a median plane (MP) and / or a transverse plane (TP) and / or a coronal plane (CP). A21 The method according to any one of the preceding paragraphs A16 to A20, comprising: - providing a third reference sensor (22); - setting, by the controller (18), a median plane (MP) orientation, a transverse plane (TP) orientation, and / or a coronal plane (CP) orientation within the measurement volume based on the orientation of the third reference sensor (22). A22 The method according to any one of the preceding paragraphs A16 to A21, comprising: - detecting, by a controller (18), a crossing of a movable sensor (14) with at least one of a first reference plane (RP1), a second reference plane (RP2), and a third reference plane (RP3). A23 The method according to any one of the preceding paragraphs A16 to A22, comprising: - establishing, by a controller (18), a target volume (TV) in a global coordinate system (COS). A24 The method according to any one of the preceding paragraphs A16 to A23, comprising: - establishing, by a controller (18), a spatially restricted auxiliary plane (AP), the auxiliary plane (AP) indicative of a unique structure within the patient's body (B). A25 The method according to any one of the preceding paragraphs A16 to A24, comprising: - a method comprising the steps of: displaying a real-time position of the movable sensor (14) on a display device (26), and / or displaying a first reference plane (RP1) on the display device (26), and / or displaying a second reference plane (RP2) on the display device (26), and / or displaying a third reference plane (RP3) on the display device (26), and / or displaying a target volume (TV) on the display device (26), and / or displaying an auxiliary plane (AP) in a global coordinate system (COS) on the display device (26), and / or displaying octants (O1 to O8) on the display device (26). A26 The method according to paragraph A25, wherein displaying on the display device (26) includes displaying the real-time position of the movable sensor (14) relative to a first reference plane (RP1), and / or relative to a second reference plane (RP2), and / or relative to a third reference plane (RP3), and / or relative to a target volume (TV), and / or relative to an auxiliary plane (AP) in a global coordinate system (COS), and / or relative to an octant (O1-O8). A27 The method according to any one of the preceding paragraphs A16 to A26, wherein the movable sensor (14) is introduced into the patient's body (B) via the femoral artery or via the axillary artery. [Explanation of symbols]

[0063] 10 tracking system, 12 emitting device / electromagnetic field generator, 14 movable sensor, 16 first reference sensor, 18 controller, 20 second reference sensor, 22 third reference sensor, 24 medical device, 26 display device, 28 input device, AP auxiliary plane, COS global coordinate system, CP coronal plane, LI CP-MP Intersection line between coronal and median planes, LI CP-TP Intersection line between coronal and transverse planes, LI MP-TP Intersection line between median plane and transverse plane, MP median plane, TP transverse plane, O1-O8 octants, P FA Movement path of the movable sensor for femoral access, P LA Movement path of the movable sensor for left axillary access, P RA Movement path of the movable sensor for right axillary access, RP1 first reference plane, RP2 second reference plane, RP3 third reference plane, TV target volume.

Claims

1. A discharge device (12) configured to establish a measurement volume in at least a portion of the patient's body (B), wherein the patient's body has a median plane (MP), a transverse plane (TP), and a coronal plane (CP), A movable sensor (14) that moves within the measurement volume, A first reference sensor (16) that establishes a global coordinate system (COS) within the measurement volume, wherein the global coordinate system (COS) has an origin, x' axis, y' axis, and z' axis, The system comprises a controller (18), and the controller (18) - To detect the real-time position of the movable sensor (14) within the global coordinate system (COS), - Set the origin of the global coordinate system (COS) as the anchor point for the patient's body. - To widen the first reference plane (RP1) parallel to the median plane (MP) in the directions of the x' axis and the z' axis, - To widen the second reference plane (RP2) parallel to the cross-section (TP) in the directions of the y' axis and the z' axis, - A tracking system (10) configured to expand a third reference plane (RP3) parallel to the coronal plane (CP) in the directions of the x' axis and the y' axis.

2. The tracking system (10) according to claim 1, wherein the controller (18) is configured to move at least one of the first reference plane (RP1), the second reference plane (RP2), and the third reference plane (RP3) in parallel based on the expected movement path of the movable sensor (14).

3. A tracking system (10) according to claim 1, wherein the first reference surface (RP1), the second reference surface (RP2), and the third reference surface (RP3) have eight octants (O) within the measurement volume. １ ~O ８ ) establishes the controller (18) based on the expected movement path of the movable sensor (14), and the octant (O １ ~O ８ A tracking system (10) configured to adjust the section of the )

4. A tracking system (10) according to claim 1, wherein the tracking system (10) further comprises a second reference sensor (20), and the controller (18) is further configured to detect the position and / or orientation of the second reference sensor (20) in the global coordinate system (COS).

5. A tracking system (10) according to any one of claims 1 to 4, wherein the controller (18) - Intersection line (LI) of the coronal plane (CP) and the median plane (MP) ＣＰ－ＭＰ Align the x' axis parallel to ) and / or - Intersection line (LI) of the cross-section (TP) and the coronal surface (CP) ＣＰ－ＴＰ Align the y' axis parallel to ) and / or - Intersection line (LI) of the median plane (MP) and the cross-section (TP) ＭＰ－ＴＰ A tracking system (10) is further configured to align the z' axis parallel to the ).

6. The tracking system (10) according to claim 1, wherein the first reference sensor (16) is such that the x'-axis is parallel to the intersection line (LI ＣＰ－ＭＰ ) of the coronal plane (CP) and the midsagittal plane (MP), and / or the y'-axis is parallel to the intersection line (LI ＣＰ－ＴＰ ) of the transverse plane (TP) and the coronal plane (CP), and / or the z'-axis is parallel to the intersection line (LI ＭＰ－ＴＰ ) of the midsagittal plane (MP) and the transverse plane (TP), and is configured to be manually aligned with the midsagittal plane (MP) and / or the transverse plane (TP) and / or the coronal plane (CP).

7. A tracking system (10) according to claim 1, further comprising a third reference sensor (22), wherein the controller (18) is configured to set the orientation of the median plane (MP), the cross-sectional plane (TP), and / or the coronal plane (CP) within the measurement volume based on the orientation of the third reference sensor (22).

8. A tracking system (10) according to claim 1, wherein the controller (18) is configured to detect the intersection of the movable sensor (14) with respect to at least one of the first reference plane (RP1), the second reference plane (RP2), and the third reference plane (RP3).

9. A tracking system (10) according to claim 1, wherein the controller (18) is further configured to establish a target volume (TV) within the global coordinate system (COS).

10. A tracking system (10) according to claim 1, wherein the controller (18) is further configured to establish a spatially restricted auxiliary plane (AP) which represents a unique structure within the patient's body.

11. A tracking system (10) according to claim 1, wherein the first reference sensor (16) is a 6-degree-of-freedom sensor.

12. The tracking system (10) according to claim 4, wherein the second reference sensor (20) is a 6-degree-of-freedom sensor.

13. A tracking system (10) according to claim 1, further comprising a medical device (24), wherein the movable sensor (14) is attached to the medical device (24).

14. The tracking system (10) according to claim 13, wherein the medical device (24) is an intravascular blood pump or a guidewire.

15. A tracking system (10) according to claim 1, wherein the emission device (12) is an electromagnetic field generator.

16. A tracking system (10) according to claim 1, wherein the movable sensor (14) is an embedded electromagnetic sensor and / or the movable sensor (14) is a 5-degree-of-freedom sensor or a 6-degree-of-freedom sensor.

17. A tracking system (10) according to claim 1, further comprising a display device (26) configured to display the real-time position of the movable sensor (14) and / or the first reference plane (RP1) and / or the second reference plane (RP2) and / or the third reference plane (RP3), in particular the real-time position of the movable sensor (14) with respect to the first reference plane (RP1) and / or the second reference plane (RP2) and / or the third reference plane (RP3).

18. A tracking system (10) according to claim 3, further comprising a display device (26) configured to display the real-time position of the movable sensor (14) and / or to display the octants (O1 to O8), in particular to display the real-time position of the movable sensor (14) relative to the octants (O1 to O8).

19. A tracking system (10) according to claim 9, further comprising a display device (26) configured to display the real-time position of the movable sensor (14) and / or the target volume (TV), in particular to display the real-time position of the movable sensor (14) relative to the target volume (TV).

20. A tracking system (10) according to claim 10, further comprising a display device (26) configured to display the real-time position of the movable sensor (14) and / or the auxiliary plane (AP) in the global coordinate system (COS), in particular to display the real-time position of the movable sensor (14) with respect to the auxiliary plane (AP) in the global coordinate system (COS).

21. A tracking system (10) according to claim 1, further comprising an input device (28) configured to communicate with the controller (18).

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