1. Field of the Invention
The present invention concerns a method for regulating a vascular intervention, as well as a device to regulate a vascular intervention.
2. Description of the Prior Art
A method to manually adjust a vascular intervention is known in which the vascular intervention is conducted by means of a vascular intervention unit. The success of the vascular intervention is manually determined at a location of the intervention by a treating personnel (for example a physician) purely according to morphological criteria. For example, if a constriction in a vessel is expanded, an expansion of the vessel ensues up to an internal diameter of the vessel at this location of the intervention, for instance corresponding to an inner diameter in a further or preceding curve of the vessel. However, this can easily lead to an injury to the vessel since a risk of injury rises with the internal diameter of the vessel. An intervention region of the vascular intervention can hereby be depicted for the treating personnel by means of an ultrasound unit, a magnetic resonance unit, a computer tomography unit etc.
An object of the present invention is to provide a method for a regulation of a vascular intervention that minimizes the danger of an injury to vessels during the vascular intervention.
The invention proceeds from a method for a regulation of a vascular intervention with a vascular intervention unit, wherein an intervention region of the vascular intervention is at least partially depicted by means of an imaging monitoring unit and a monitoring region is selected for monitoring of the vascular intervention.
In accordance with the invention, the vascular intervention in the intervention region is at least partially automatically regulated by means of at least one characteristic variable of a monitoring region. As used herein a vascular intervention in this context is a vascular procedure, in particular in a blood vessel, which can advantageously ensue by means of a catheter. A treatment of the blood vessel, in particular a vessel dilatation or a vessel embolization, is advantageously conducted by means of the vascular intervention. Furthermore, an intervention region means a region of the vessel in which an intervention treatment—for example a vessel embolization—ensues by means of which the blood flow in the vessel is at least partially suppressed or a vessel dilatation to a vessel expansion. A depiction of the intervention region is an imaging and/or an optical reproduction of an image of the region of the patient within which the intervention treatment takes place. A variation of a flow property (for example a perfusion) within the vessel and/or additional characteristic variables appearing to the man skilled in the art to be reasonable is advantageously identified by means of the characteristic variable. The characteristic variable can hereby be directly detected by a detection unit or can be determined from acquired data. The characteristic variable is additionally advantageously detected and/or determined within the monitoring region, wherein the monitoring region exhibits a sensitivity to the vascular intervention in the intervention region. Through the embodiment according to the invention, a duration and/or a strength of the vascular intervention can advantageously be adjusted depending on characteristic variable of the monitoring region, and therefore a danger of injury to the vessel to be treated can advantageously be at least reduced or prevented. In particular, a constriction in a vessel can be expanded until the point at which an at least partial (and particularly advantageously complete) functionality of the vessel is achieved, wherein the functionality can be determined using the characteristic variable. The regulation of the vascular intervention ensues automatically at least in part and particularly advantageously ensues automatically via a control unit. The regulation can additionally take place manually in part by the operator of the vascular intervention unit in that said operator is requested to change at least one parameter of the vascular intervention.
In accordance with the invention, the monitoring region can be arranged at least partially separate from the intervention region, so the treatment success can advantageously be detected by means of (for example) a perfusion property in the monitoring region. In particular, the monitoring region can be arranged at an easily accessible region of the patient that enables a simple monitoring. The monitoring region can be arranged (located) completely separate from the intervention region from a spatial standpoint. For example, the intervention region can be in a femoral region of a patient and the monitoring region is arranged in a foot region of the patient.
At least one vessel within the monitoring region is particularly advantageously supplied by a vessel of the intervention region that is to be treated. A dependency between the characteristic variable of the monitoring region and an intervention treatment in the intervention region can hereby be advantageously achieved, and an effective regulation of the vascular intervention can therefore be achieved. As used herein, “supplied” means that the content of the vessel (in particular blood) of the intervention region arrives in the at least one vessel of the monitoring region along a flow direction of the content of the vessel in a normal function of said vessel.
In an embodiment, the vascular intervention is conducted step by step in at least two intervention steps, whereby the characteristic variable is particularly advantageously determined in the monitoring region after each intervention step and therefore a particularly sensitive regulation of the vascular intervention can be achieved. A step by step vascular intervention is in particular advantageous given a dilatation intervention since here a detection of the characteristic variable in the monitoring region can only take place inadequately in the monitoring region during an intervention treatment. In particular, in the dilatation intervention a danger of injury to the vessel (in particular a rupture of the vessel) by a further expansion of the vessel can be at least reduced and/or prevented in that a treatment success is determined after each intervention step. A number of intervention steps is advantageously adapted to a duration and strength of the vascular intervention.
A change of the characteristic variable (and therefore of a functionality of the vessel) in the intervention region can advantageously be detected if a contrast agent is injected after at least one intervention step. The characteristic variable of the monitoring region can hereby be particularly advantageously determined from a temporal standpoint after an injection of the contrast agent.
If the characteristic variable of the monitoring region is determined at least partially in parallel with the vascular intervention, a treatment success of the vascular intervention can be determined simultaneously at least in part with the vascular intervention, and the vascular intervention can be ended immediately after the appearance of the success of the treatment. For example, a temporary closure of the vessel can be effectively adapted to a desired treatment success and an additional inflation of a balloon for the vessel closure can be prevented.
In a further embodiment of the invention, an intervention speed is at least partially adapted to the characteristic variable after a detection of the characteristic variable of the monitoring region. The intervention speed in this context is a speed for supplying an intervention substance (for example, for supplying a fluid in a balloon to seal the vessel) into the intervention region. A particularly exact adjustment of the intervention treatment can be achieved via this embodiment, and a risk of injury can thereby be minimized.
Furthermore, the vascular intervention can be automatically ended at least in part by means of a control unit after the characteristic value reaches a predetermined limit value. An optimally exact adjustment of the vascular intervention can be achieved, and additionally an imprecision due to a manual control and/or regulation by an operator can advantageously be prevented. The limit value advantageously indicates a variable that is coupled to a functionality of the vessel and/or a functionality of an organ dependent on the vessel. For example, in a dilatation treatment it is sufficient to expand the vessel to a width that enables a nearly complete perfusion, for example a width of approximately 80% of a comparable width in a region of the vessel directly adjoining an intervention region. A control unit is a unit that includes a processor for a data evaluation and/or a control and/or regulation of individual components of the method. In addition, the control unit can include additional components, for example a memory element.
Moreover, if the characteristic variable does not reach a predetermined limit value an additional intervention step is started, so an effective and in particular protective vascular intervention can be achieved in a step by step approach to the limit value.
Furthermore, the invention encompasses a device to regulate a vascular intervention, with a vascular intervention unit and an imaging monitoring unit to depict an intervention region of the vascular intervention.
The device in accordance with the invention as a control unit that conducts an at least partially automatic regulation of at least one intervention step of the vascular intervention. The vascular intervention unit also includes a catheter unit. An imaging monitoring unit is a unit that detects the vascular intervention and transfers it to an imaging medium (for example a monitor) so that a current treatment can be monitored by an operator of the device (for example a physician). The imaging monitoring unit is advantageously formed by a magnetic resonance unit, a computed tomography unit, an ultrasound unit and/or additional units appearing to be reasonable to the man skilled in the art. In this embodiment a fast adjustment and/or adaptation of the vascular intervention that is at least partially independent of decisions of an operator can advantageously be achieved by means of the control unit.
Furthermore, the device can include a detection unit that is provided to detect at least one characteristic variable of a monitoring region that is arranged at least partially separate from the intervention region. The progress and/or success of the vascular intervention can advantageously be detected depending on the characteristic variable of the monitoring region, and therefore a further treatment in the intervention region with a high risk of injury can advantageously be prevented. As used herein “provided” means specially equipped and/or specially designed. The detection unit is advantageously formed by a computed tomography unit, an ultrasound unit and/or additional units appearing to be reasonable to those skilled in the art.
The control unit particularly advantageously conducts the at least partially automatic regulation using the characteristic variable of the monitoring region, whereby a duration and/or strength of the vascular intervention can be adjusted depending on the characteristic variable of the monitoring region, and therefore a danger of an injury to the vessel to be treated can at least be reduced or prevented. In particular, a constriction in a vessel can be expanded until an at least partial (and particularly advantageously complete) functionality of the vessel is achieved, wherein the functionality is determined using the characteristic value. The regulation can thereby contain a request for a manual modification of a parameter of the vascular intervention and/or can particularly advantageously ensue completely independently by means of the control unit.
If the monitoring region has at least one vessel that is supplied by a vessel of the intervention region that is to be treated, a direct dependency between the characteristic variable of the monitoring region and an intervention treatment in the intervention region can hereby be advantageously achieved. An effective regulation of the vascular intervention can therefore be additionally achieved.
The device also can include a contrast agent unit with which a contrast agent can be injected, so a change to the characteristic variable (and therefore a functionality of the vessel) in the intervention region can advantageously be detected. Control of the contrast agent unit by the aforementioned control unit advantageously ensues.
Furthermore, the device can include a valve unit with which a feed of an intervention substance for the vessel unit can be controlled. A feed of an intervention substance for a vascular intervention is a feed of a gas and/or a liquid, for example to inflate a balloon for a vessel dilatation and/or a feed of particles for an at least partial vessel closure. An optimally exact substance feed can be achieved by means of the valve unit and a risk of injury during the treatment can be minimized.
If the control of the valve unit takes place by means of the control unit, an adjustment of the valve unit (and therefore the substance feed) can be adapted to currently-detected characteristic variables and advantageously can be matched to a success and/or progress of the vascular intervention.
The detection unit and/or the imaging monitoring unit can be formed by a magnetic resonance unit. The detection unit is advantageously fashioned as one part with the imaging monitoring unit. A time-consuming displacement of the patient between individual detection steps and individual monitoring steps can be advantageously avoided in that the magnetic resonance unit covers a large detection region. Different measurements in different measurement planes can additionally be realized essentially at the same time.
If the vascular intervention unit and/or the contrast agent unit and/or the valve unit are fashioned to be at least partially magnetic resonance-compatible, an unwanted interference of a magnetic resonance measurement with a detection of the characteristic variable of the monitoring region and/or with a monitoring of the intervention region can advantageously be avoided. An unwanted radiation exposure can be prevented, such that the depiction of the intervention region can take place at high quality. Furthermore, an interfering and in particular unwanted influence of a high magnetic resonance field on an effectiveness of the treatment can be prevented so that a radioactive contamination of patients and/or of an operator can be avoided.
A device 1 to regulate a vascular intervention is shown in
The imaging monitoring unit 3 is fashioned to depict the intervention region 8 of the vascular intervention (
Furthermore, the device 1 includes a detection unit 17 that is likewise formed by the magnetic resonance unit 9 and thus is fashioned in one piece with the imaging monitoring unit 3. In the operation of the device 1 the detection unit 17 is provided to detect at least one characteristic variable of a monitoring region 18 in a patient. For this purpose, the monitoring region 18 is located spatially separate from the intervention region 8. For an advantageous detection of the characteristic variable that delivers or provides at least one item of information about the intervention treatment in the intervention region 8, the monitoring region 18 contains at least one vessel 19 that is supplied by a vessel 20 of the intervention region 8 that is to be treated (
The device 1 furthermore has a contrast agent unit 21 with which a contrast agent can be injected and a valve unit 22 that controls the substance feed of the intervention substance 7 for the vascular intervention (
Two different embodiments of the device to regulate the vascular intervention are shown in
A method to regulate the vessel intervention by means of a vessel intervention unit 2 is depicted in
After the presentation 52 and/or imaging of the intervention region 8, a monitoring region 18 for a monitoring of the vessel intervention is selected that, in the present exemplary embodiments, is arranged completely separate from the intervention region 8 (
After the monitoring region 18 is selected, the actual vessel intervention treatment begins that is subdivided into individual intervention steps, wherein all intervention steps are imaged by means of the magnetic resonance unit 9 via its monitor display 16. In the following the step by step vessel intervention is shown in detail together with a dilatation treatment of a vessel constriction 25 (
In the intervention step 54, a pressure in the elastic element 23 impermeable to a particle exchange is built up via the catheter unit 5 to expand the vessel constriction. After the pressure built up in the catheter unit 5 has reached a predetermined value, and therefore after the vessel 20 has expanded at the constriction 25, an end 55 of the intervention step 54 takes place. The intervention step 54 is then endued automatically by the control unit 4. For this the valve of the valve unit 22, controlled by the control unit 4, is closed so that a further substance feed into the catheter unit 5 is prevented. In a subsequent method step pressure reduction (controlled by the control unit 4) will discharge the pressure from the elastic element 23 impermeable to a particle exchange and the catheter unit 5 via the valve unit 22, and the blood flow constriction 25 is released. For a pressure monitoring in the catheter unit 5 the control unit 4 includes a pressure sensor (not shown in detail).
As soon as the pressure in the catheter unit 5 has dissipated, a contrast agent administration 57 is started and a contrast agent is injected into the vessel 20 by means of the contrast agent unit 21. For this the contrast agent unit 21 includes an introduction means 26 that runs essentially in parallel with the catheter unit 5, next to this along the vessel 20 up to the treatment region of the vessel intervention so that the injected contrast agent is introduced directly into the treatment region. The contrast agent can be a contrast agent containing gadolinium, a contrast agent containing iron, a contrast agent containing fluorine or a hyperpolarized contrast agent for magnetic resonance measurements. In principle, a use of a contrast agent containing iodine is also conceivable, in particular if the acquisition unit comprises a computer tomography unit.
After the contrast agent injection, a monitoring measurement 58 ensues to detect the characteristic variable in the monitoring region 18 by means of the magnetic resonance unit 9. The data acquired by means of the monitoring measurement 58 are relayed to the control unit 4 and there are evaluated in an evaluation step 59. At the same time the data can be evaluated within the magnetic resonance unit 9 for an optical depiction and/or presentation of the monitoring region 18 in addition to the presentation of the intervention region 8. In the control unit 4 the characteristic variables that represent a value for a perfusion of the monitored vessel 19 are determined from the measured data. For example, a perfusion degree at the vessel constriction 25 can be concluded using a contrast agent concentration and/or a change of the contrast agent concentration. This value also reflects a functionality of the constriction 25 treated by means of the vessel intervention since an at least partial perfusion of the vessels 19 can only be present in the monitoring region 18 if an at least partial treatment success at the constriction 25 has already occurred. The degree of the perfusion in the monitoring region 18 and/or in the monitored vessel 19 additionally indicates how large a proportional factor of the recovered functionality is measured relative to the normal functionality of the treated vessel 20. The characteristic variable is additionally compared with a predetermined limit value within the evaluation step 59. The predetermined limit value indicates a minimum value of the recovered functionality that, for example, is sufficient for a full functionality of an organ dependent on the vessel 19. The predetermined limit value can be individually adapted to the respective vessel intervention and/or to the patient by the treating personnel before an intervention treatment.
If it is determined by the control unit in the evaluation step 59 that the determined characteristic variable is smaller than the predetermined limit value, an additional intervention step 54 is automatically started by the control unit 4. For this purpose, the valve 22 (controlled by the control unit 4) is opened again so that a pressure can build in the intervention region 8 (in particular the vessel constriction 25) via the catheter unit 5 and the elastic element 23 impermeable to a particle exchange. A workflow of the second intervention step 54 and possible additional intervention steps 54 proceeds analogous to the description of the first intervention step 54, with the exception that a greater pressure is respectively built up in the catheter unit 5 and the elastic element 23 impermeable to a particle exchange than was the case in the respective, preceding intervention step 54. A pressure build-up for the feed of the intervention substance 7 can furthermore be implemented manually by the personnel operating the device 1, or can ensue automatically, at least in part, via the control unit 4. The individual intervention steps 54 with the method steps 55, 56, 57, 58, 59 interposed between them repeat within a short time period so that, upon activation of the substance unit 6, the operator (in particular the physician) only experiences a different counter-pressure upon pressing a piston of the substance unit 6, wherein the different counter-force indicates the different method steps 55, 56, 57, 58, 59.
As soon as the determined characteristic variable has reached and/or exceeded the predetermined limit value in the evaluation step 59, an end 60 of the vessel intervention ensues and the control unit 4 automatically ends the vessel intervention. In this way an over-expansion of the vessel 20 to be treated is advantageously prevented and therefore a danger of injury to a vessel is minimized. The vessel intervention is additionally likewise ended automatically by the control unit 4 as soon as the pressure in the catheter unit 5 and in the elastic element 23 impermeable to a particle exchange assumes a maximum limit value that would lead to an over-expansion of the vessel 20 and therefore would significantly increase a risk of an injury to the vessel. Instead of an automatic ending 60 of the vessel intervention by the control unit 4, it is additionally possible for the control unit 4 to request (prompt) that the operator end the vessel intervention upon reaching the predetermined limit value for the characteristic variable and/or upon reaching the maximum limit value for the pressure in the catheter unit 5 and/or in the elastic element 23 impermeable to a particle exchange.
Alternatively, the detection of the characteristic variable can ensue by using a flow-sensitive magnetic resonance frequency and/or an arterial spin labeling (ASL) measurement so that the method step of the contrast agent administration 57 can be omitted. Furthermore, in an alternative embodiment of the invention it can be provided that the monitoring region 18 and/or the intervention region 8 is monitored by means of a computer tomography unit and/or an angiography unit and/or an x-ray fluoroscopy unit and/or an ultrasound unit instead of the magnetic resonance unit 9.
As an alternative to the step by step vascular intervention, in
In
The monitoring of the monitoring region 18 also starts with the intervention step 61. A contrast agent administration 62 by means of the contrast agent unit 21 is initially started in a manner analogous to the method step 57 in the embodiments regarding
An evaluation of the measured data analogous to the statements regarding
As soon as it is clear from the characteristic variables that the desired partial vessel region is closed and/or a perfusion of the partial region is below the predetermined limit value or has been entirely suppressed, the end 66 of the vascular intervention and an end 67 of the monitoring measurement 62 take place. The end 66 of the vascular intervention ensues automatically by means of the control unit 4. At the same time the detection of the characteristic variable by means of the control unit 4 is also ended.
Although modifications and changes may be suggested by those skilled in the art, it is the intention of the inventors to embody within the patent warranted hereon all changes and modifications as reasonably and properly come within the scope of their contribution to the art.
Number | Date | Country | Kind |
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10 2009 057 930.3 | Dec 2009 | DE | national |