Programming device and system for selectively testing the treatment window of a directional electrode

Abstract

The present invention provides a programming device and system for selectively testing the treatment window of a directional electrode. The programming device includes an interaction unit for presenting a main interaction interface, which includes an electrode selection area, an amplitude adjustment area, and a treatment effect selection area. The electrode selection area includes a stimulation ring pattern composed of a plurality of contact patterns. The amplitude adjustment area includes a step parameter setting unit. The treatment effect selection area includes a stimulation effect feedback unit; a processor for determining the contact pattern or stimulation ring pattern selected by the user, and the step parameters set by the user in the amplitude adjustment area; a communication unit for sending the step parameters to the stimulator, so that the stimulator performs step-by-step stimulation output according to the step parameters; the processor is further used to record the stimulation effect information provided by the user in the treatment effect selection area for the step-by-step stimulation output to determine the treatment window.

Description

Technical Field

[0001] The present invention relates to the field of electronic medical devices, and particularly to a programming device and system for selectively testing the treatment window of a directional electrode. Background Art

[0002] A programming device (programmer) in an implantable medical system is an extracorporeal device for neuromodulation. This device can communicate with a pulse generator implanted in a patient to select stimulation contacts, set stimulation parameters, control stimulation functions, etc.

[0003] Deep brain stimulation therapy is an effective means for treating diseases such as Parkinson's disease, essential tremor, dystonia, and obsessive-compulsive disorder. By means of a stimulator (pulse generator), an extension wire, and an electrode, electrical pulses are emitted to a specific area of the brain to control disease symptoms, which is a kind of "electronic medicine". When applying stimulation, the stimulation parameters can be adjusted through an extracorporeal device. An overly low stimulation amplitude may not be able to achieve the effect of alleviating symptoms, while an overly high stimulation amplitude may bring additional side effects. Therefore, it is necessary to select an appropriate amplitude that can not only ensure good treatment effects but also avoid side effects. The amplitude range within this interval is called the treatment window.

[0004] It is very necessary to understand the treatment windows of different contacts of the electrode. By comparing the effective stimulation parameters of each contact, it is convenient to select an appropriate contact or combination of contacts, and to select the most suitable stimulation parameters. A small effective stimulation can reduce power consumption, save electricity, and extend the service life of the pulse generator (especially non-rechargeable pulse generators).

[0005] However, when using a programming device for testing, it is necessary to manually adjust the output amplitude, and the doctor records the treatment window range. The operation is complex and the data is easily lost, making it difficult to guide subsequent programming. Summary of the Invention

[0006] In view of this, the present invention provides a programming device for selectively testing the treatment window of a directional electrode, including:

[0007] An interaction unit for presenting a main interaction interface, which includes an electrode selection area, an amplitude adjustment area, and a treatment effect selection area. The electrode selection area includes a stimulation ring graph composed of multiple contact graphs, and the arrangement of the graphs is consistent with the contacts and the distribution of the stimulation ring of the stimulator electrode. The amplitude adjustment area includes a step parameter setting unit, and the treatment effect selection area includes a stimulation effect feedback unit;

[0008] A processor for determining the contact graph or stimulation ring graph selected by the user, and the step parameter set by the user in the amplitude adjustment area;

[0009] A communication unit for sending the step parameters to the stimulator, enabling the stimulator to perform stepped stimulation output according to the step parameters; the processor is further configured to record the stimulation effect information provided by the user in the efficacy selection area for the stepped stimulation output to determine the treatment window.

[0010] Optionally, during the process of the stimulator performing stepped stimulation output according to the step parameters, when the processor first obtains the beneficial effect feedback information, the current stimulation amplitude value is determined as the lower limit of the treatment window, and the stepped stimulation output continues. After obtaining the side effect feedback information, the current stimulation amplitude value is determined as the upper limit of the treatment window, and the stepped stimulation output stops; the processor generates a treatment window test record based on the lower limit and the upper limit of the treatment window.

[0011] Optionally, the main interaction interface further includes a record viewing unit, and the processor is configured to respond to the user's operation on the record viewing unit and display the treatment window test record, including contact and / or stimulation ring information, and the corresponding treatment window information.

[0012] Optionally, the treatment window test record further includes the pulse width, frequency, impedance value between the contact and the housing during stepped output, impedance information, and window width information corresponding to the treatment window.

[0013] Optionally, the processor is configured to determine the electrode mode selected by the user, including the stimulation ring mode and the contact mode; in the stimulation ring mode, determine the selected stimulation ring pattern, and apply the step parameters set by the user in the amplitude adjustment area to all contacts corresponding to the stimulation ring pattern; in the contact mode, determine the selected contact pattern, and apply the step parameters set by the user in the amplitude adjustment area to the corresponding contacts.

[0014] Optionally, the processor is configured to determine the output mode selected by the user, including the voltage mode and the current mode; in the voltage mode, enable the stimulator to output a stimulation signal with a constant voltage, and the step parameters act on the output voltage; in the current mode, enable the stimulator to output a stimulation signal with a constant current, and the step parameters act on the output current.

[0015] Optionally, the amplitude adjustment area further includes a step control unit, and the processor is configured to respond to the user's operation on the step control unit and send a corresponding instruction to the stimulator through the communication unit to enable the stimulator to change the state of the stepped stimulation output, and the instruction includes at least one of increasing the amplitude, decreasing the amplitude, pausing the stimulation output, continuing the stimulation output, setting the amplitude to zero, and maintaining the current amplitude.

[0016] Optionally, the stimulation effect feedback unit includes a benefit unit and a side effect unit. The processor is configured to respond to the user's operations on the benefit unit and the side effect unit. When the user selects the benefit unit, a plurality of optional benefit effect feedback messages are provided. When the user selects the side effect unit, a plurality of optional side effect feedback messages are provided.

[0017] Optionally, the step parameters include a starting amplitude, a maximum target amplitude, a step size, and a step time interval.

[0018] The present invention also provides an implantable medical system, including the above-mentioned programming device and an implantable medical device. The implantable medical device includes a directional electrode and a communication unit, and is configured to receive the step parameters sent by the programming device and perform stepwise stimulation output.

[0019] According to the programming device and system provided by the present invention, the user can select each contact or stimulation ring in the device interface, set the corresponding step parameters, and control the stimulator to automatically perform amplitude stepwise stimulation output through the communication unit. At the same time, the user can feedback the treatment effect of the patient for each stimulation amplitude in the device interface. The processor automatically determines and records the treatment window range of the electrode contact according to the information feedback by the user, improving the convenience of the treatment window test work, and accurately obtaining the treatment window of each contact. The generated test record can play a guiding role in subsequent programming. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the following drawings are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0021] Figure 1 Schematic diagram of the implantable medical system in the embodiment of the present invention;

[0022] Figure 2 Structural diagram of a directional electrode;

[0023] Figure 3 Schematic diagram of the main interaction interface for treatment window test of the programming device;

[0024] Figure 4 Schematic diagram of the main interaction interface for treatment window test of switching to another electrode;

[0025] Figure 5 Schematic diagram of the interface for selecting the directional electrode contact;

[0026] Figure 6Schematic diagram of the step parameter setting interface for the voltage mode;

[0027] Figure 7 Schematic diagram of the step parameter setting interface for the current mode;

[0028] Figure 8 Schematic diagram of the pulse width setting interface;

[0029] Figure 9 Schematic diagram of the frequency setting interface;

[0030] Figure 10 Schematic diagram of the feedback interface for the beneficial effect information;

[0031] Figure 11 Schematic diagram of the feedback interface for the side effect information;

[0032] Figure 12 Schematic diagram of the treatment window record selection interface;

[0033] Figure 13 Schematic diagram of the treatment window record display interface. Detailed implementation manners

[0034] Next, the technical solutions of the present invention will be clearly and completely described in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0035] In addition, the technical features involved in different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0036] The embodiment of the present invention provides an implantable medical system, as Figure 1 shown, the system includes a programming device 11 and an implantable medical device 12. The implantable medical device described in this application specifically refers to a nerve stimulation device, such as a deep brain stimulation device. The implantable medical device 12 includes a directional electrode, a pulse generator, and a communication unit. The structure of the directional electrode is as Figure 2 shown. Since the electrode is provided with independent contacts 21 facing different directions, it is called a directional electrode.

[0037] The programming device 11 in this embodiment is provided with a communication unit, an interaction unit, a processor, and a memory. Among them, the communication unit can be a PPM communication module or a Bluetooth communication module, and performs data interaction with the implantable medical device 12 through wireless communication; the interaction unit can be an ordinary display and input keys, or a touch screen.

[0038] The interaction unit is used to present the main interaction interface, which includes an electrode selection area. The electrode selection area includes a stimulation ring pattern composed of multiple contact patterns, and the arrangement of the patterns is consistent with the contacts of the stimulator electrodes and the stimulation ring distribution. This interface is for Figure 2 the interface of the electrodes in the indicated direction, and the presentation form of the pattern can be two-dimensional or three-dimensional.

[0039] Figure 3 The figure shows an example of an interface using three-dimensional graphics. In the electrode selection area 31, a three-dimensional electrode model is shown. There are 8 contact patterns, namely contact 1 - contact 8, in this electrode model. Among them, the contact patterns 2, 3, and 4 are isolated sheet-like patterns, which are distributed in a ring to form the stimulation ring pattern R2; similarly, the contact patterns 5, 6, and 7 are distributed in a ring to form the stimulation ring pattern R3; the contact pattern 1 and the contact pattern 8 are two ring patterns (the contact pattern 1 is the stimulation ring pattern R1, and the contact pattern 8 is the stimulation ring pattern R4). The three-dimensional contact patterns completely follow the style of the stimulator electrodes, and the corresponding contacts E2 - E4, E5 - E7 are arranged radially in a circle on the electrode body.

[0040] The positional relationship of these patterns is consistent with the contact distribution on the electrodes of the implanted device. For example, the contact pattern 1 is located at the bottom end of the electrode model, and the corresponding contacts on the stimulator electrodes are distributed at the end of the electrode. To enable users to more clearly distinguish each contact or stimulation ring, in this embodiment, numbers are shown on the contacts and stimulation ring patterns, that is, the above numbers 1 - 8 and R1 - R4 are visible to the user.

[0041] The main interaction interface also includes an amplitude adjustment area 32, which includes a step parameter setting unit. The unit can specifically be a button for human-computer interaction or an input field. Users can set the range of the stimulation amplitude in this unit. According to different amplitude modes of the stimulator, the amplitude can be the voltage amplitude or the current amplitude. Figure 3 The figure shows the voltage amplitude range. The user sets the amplitude range to 0 - 4V, and the corresponding display is made in the amplitude adjustment area 32.

[0042] The main interaction interface also includes a therapeutic effect selection area 33, which includes a stimulation effect feedback unit. The unit can specifically be a button for human-computer interaction or an input field. Users can feedback the subjective feelings of the patient about the stimulation output in this unit. For example, they can feedback that the patient benefits from the current amplitude of the stimulation output or has side effects.

[0043] The processor is used to determine the contact pattern or stimulation ring pattern selected by the user, as well as the step parameter set by the user in the amplitude adjustment area 32, and send the step parameter and instruction to the stimulator through the communication unit, so that it performs corresponding stepped stimulation output. For example, if the amplitude range in the step parameter is 0 - 4V, the step size is 0.05V, and the time interval is 5s, then the stimulator first outputs a stimulation signal with an amplitude of 0.05V for 5 seconds, then increases to an amplitude of 0.1V and outputs a stimulation signal for 5 seconds, and so on, stepping up until reaching an amplitude of 4V and then stopping the output of the stimulation signal, completing a stepped output.

[0044] During this period, the user can feedback the stimulation effect through the efficacy selection area 33 at any time, and the processor records the user's feedback information, thereby determining the amplitude interval (i.e., the treatment window) beneficial to the patient (symptom improvement) in the preset amplitude range. This solution conducts treatment window tests for each contact. The user can perform stepped stimulation output for each contact separately, and each contact has a corresponding treatment window. The ranges (window widths) and extreme values of the treatment windows of different contacts may be different.

[0045] The processor can generate records according to the treatment windows of each contact, which at least include contact and / or stimulation ring information, as well as corresponding treatment window information, such as window width and extreme values, etc. For example, the extreme values of contact E1 (stimulation R1) are 1.8V and 3.5V, and the window width is 1.7V, indicating that the patient benefits from this amplitude range, and there is no effect or adverse effect (side effect) at other amplitudes; the extreme values of contact E2 are 1.2V and 4.25V, and the window width is 3.05V, and so on.

[0046] According to the programming control device provided by the embodiment of the present invention, the user can select each contact or stimulation ring in the device interface, set the corresponding step parameter, control the stimulator to automatically perform amplitude stepped stimulation output through the communication unit. At the same time, the user can feedback the treatment effect of the patient for each stimulation amplitude in the device interface, and the processor automatically determines and records the treatment window range of the electrode contact according to the information feedback by the user, improving the convenience of the treatment window test work, and accurately obtaining the treatment windows of each contact. The test records generated therefrom can play a guiding role in subsequent programming control.

[0047] The following combines Figures 4 - 13 to introduce a preferred programming control device. The stimulator in this embodiment includes two electrodes. The user can click the electrode switching button in the main interaction interface to switch the electrode model displayed in the electrode display area. As Figure 4 shown, when the user clicks the electrode switching button to switch to electrode 2, the electrode display area in the main interaction interface displays the model of electrode 2, which includes contact patterns 9 - 16 and stimulation ring patterns R5 - R8, so as to set the corresponding step parameter.

[0048] The programmable device in this embodiment supports two electrode modes, namely the stimulation ring mode and the contact mode. Regarding the stimulation ring mode, it means that the states of all contacts forming the same stimulation ring are the same. For example, the contacts E2 - E4 forming the stimulation ring R2 should be turned on, off, or adopt the same step parameters simultaneously; the contact mode means that the states of all contacts can be different.

[0049] The processor is used to determine the electrode mode selected by the user. When the user needs to perform a treatment window test, a mode should be selected. In the stimulation ring mode, determine the stimulation ring pattern selected by the user, and apply the step parameters set by the user in the amplitude adjustment area 32 to all contacts corresponding to the stimulation ring pattern. Figure 3 For example, the word "Stimulation Ring" is displayed in the interface to prompt the user of the current mode (which can also be used as a mode switching button). The entire stimulation ring pattern is used as an operable area, and the step parameters set by the user are applied to all contacts therein simultaneously. For example, when the user clicks on any position in the stimulation ring pattern R2 through the touch screen, it is regarded that the user needs to synchronously set the contacts E2 - E4 in the stimulation ring R2, thereby generating the treatment window of the stimulation ring R2.

[0050] In the contact mode, determine the contact pattern selected by the user, and apply the step parameters set by the user in the amplitude adjustment area to the corresponding contacts. The treatment windows of each contact in the generated treatment window record can be different. In this mode, each contact pattern is used as an independent operable area, and the word "Contact" is displayed in the interface to prompt the user of the current mode. For an interface using a three - dimensional view, the individual contact patterns forming the stimulation ring pattern cannot be fully displayed. Considering the problem of inconvenient user operation, this embodiment adopts the Figure 5 presentation method as shown. First, determine the three - dimensional stimulation ring pattern selected by the user. For example, the user selects the stimulation ring pattern R2, and then present the sub - interface 51, which includes an enlarged three - dimensional stimulation ring pattern and two - dimensional contact patterns distributed according to the actual positional relationship of the contacts, that is, the enlarged stimulation ring pattern R2, and display the contact patterns 2 - 4 according to the actual orientation of the contacts, so that the user can select any one of these contact patterns.

[0051] In this embodiment, the user can also use the left / right buttons in the region electrode display region to select the stimulation ring or stimulation contacts. In the stimulation ring mode, the switching is performed in the order of R1 / E1, R2, R3, R4 / E8 or R5 / E9, R6, R7, R8 / E16; in the contact mode, the switching is performed in the order of R1 / E1, R2-E2, R2-E3, R2-E4, R3-E5, R3-E6, R3-E7, R4 / E8 or R5 / E9, R6-E10, R6-E11, R6-E12, R7-E13, R7-E14, R7-E15, R8 / E16.

[0052] The user can test the treatment windows of the contacts and the stimulation ring in the above two modes respectively. Therefore, for a certain stimulation ring, the overall treatment window of the stimulation ring and the treatment windows of each contact therein can be obtained, and these treatment windows may all be different. The user can set appropriate stimulation parameters in combination with the conditions of each treatment window.

[0053] There is also a special case in the contact mode. The user can simultaneously select any number of contacts. For example, the user can simultaneously select contact 2 in stimulation ring R2 and contact 5 in stimulation ring R3. The processor applies the step parameter set by the user in the amplitude adjustment region to these contacts, and performs step output and receives user feedback, thereby recording the treatment window for the selected multiple contacts, which can be called the treatment window of the contact combination. This mode can be used as the third mode, namely the contact combination mode, or can be integrated into the contact mode. The contact combination can be pre-edited and saved by the user. The left / right buttons in the electrode display region can be used to select and switch the pre-saved contact combinations, or a dedicated menu and contact combination thumbnail can also be configured to allow the user to select the contact combination to be tested in the sub-interface.

[0054] The programming device in this embodiment supports two output modes, namely the voltage mode and the current mode. When the user sets the step parameter in the amplitude adjustment region, a display sub-interface is presented for the user to select an output mode and set the corresponding step parameter. As Figure 6 shown, when the user selects the voltage mode, the stimulator outputs a stimulation signal with a constant voltage. The step parameter set in this interface is applied to the output voltage. This interface is used to set the maximum target voltage, the starting voltage, and the step time interval. This embodiment provides two optional voltage steps, namely 0.05V and 0.1V, and two corresponding buttons are configured in the main interaction interface for the user to select; as Figure 7As shown, when the user selects the current mode, the stimulator outputs a stimulation signal with a constant current. The step parameters set in this interface act on the output current. This interface is used to set the maximum target current, starting current, and step time interval. This embodiment provides two optional current step sizes, namely 0.05 mA and 0.1 mA, and configures two corresponding buttons in the main interaction interface for the user to select.

[0055] After selecting the electrode mode and output mode, the user can then select the contact pattern or stimulation ring pattern in sequence and set the step parameters accordingly to enable the stimulator to perform stepped output. In this embodiment, the outer shell of the stimulator is kept as the positive electrode, and the stimulation ring or contact is set as the negative electrode. For the contacts that have completed the treatment window test, the corresponding contact patterns are marked in the electrode selection area, for example, the color changes to serve as a reminder.

[0056] The main interaction interface in this embodiment also includes a stimulation frequency and pulse width setting unit. The user can use these units to set the frequency and pulse width used during stepped stimulation output. When the user clicks on the frequency and pulse width display windows in the main interaction interface, the interfaces shown in Figure 8 and Figure 9 are respectively displayed, and the values are set through the interaction buttons therein.

[0057] The amplitude adjustment area in this embodiment also includes a step control unit. The processor is used to respond to the user's operation on the step control unit and send corresponding instructions to the stimulator through the communication unit to enable the stimulator to change the state of stepped stimulation output. The instructions include at least one of increasing the amplitude, decreasing the amplitude, pausing the stimulation output, continuing the stimulation output, setting the amplitude to zero, and maintaining the current amplitude. During the execution of stepped stimulation output, the user can operate multiple step control buttons 321 as shown in Figure 4 at any time to decrease the amplitude of the step interval, increase the amplitude of the step interval, set the amplitude to zero, stop the amplitude step programming, maintain the current amplitude value, and pause / continue the amplitude step programming. The step control unit can enable the user to manually control the stepped stimulation process, thereby obtaining more accurate treatment effect feedback information and further improving the accuracy of treatment window recording.

[0058] The stimulation effect feedback unit in this embodiment includes a benefit unit and a side effect unit. The processor is used to respond to the user's operation on the benefit unit and the side effect unit. When the user selects the benefit unit, multiple optional benefit effect feedback information is provided. When the user selects the side effect unit, multiple optional side effect feedback information is provided. Specifically, when the user clicks the "Benefit" button in the main interaction interface, the interface shown in Figure 10 is displayed, which includes various benefit information such as "tremor improvement", "rigidity improvement", "movement improvement", "others", etc.; when the user clicks the "Side Effect" button in the main interaction interface, the display is as shown inFigure 11 The interface shown, which includes various optional side effect information such as "numbness", "twitching", "abnormal movement", "blurred vision", etc. When the user clicks the OK button on the interface, the selected information is regarded as the feedback on the stimulation effect of the current amplitude. Optionally, if the beneficial effect feedback information and / or side effect feedback information is not sufficient to meet the feedback of the user's situation, the beneficial information and / or side effect information can also be supplemented by manual input.

[0059] During the process of the stimulator performing stepped stimulation output according to the above stepped parameters, when the processor first obtains the beneficial effect feedback information, the current stimulation amplitude value is determined as the lower limit of the treatment window, and the stepped stimulation output continues. After that, when the side effect feedback information is obtained, the current stimulation amplitude value is determined as the upper limit of the treatment window, and the stepped stimulation output stops.

[0060] The processor generates a treatment window test record based on the lower limit and upper limit of the treatment window. The main interaction interface of this embodiment also includes a record viewing unit, and the processor is used to respond to the user's operation on the record viewing unit and display the treatment window test record. When the user clicks the "View Record" button on the main interaction interface, a selection interface as shown in Figure 12 is displayed, and the user can view the records saved for any previous treatment window test. Optionally, the user can distinguish the saved records according to tags such as date, stimulation parameters, etc. After selecting a record, the specific content as shown in Figure 13 is displayed, which includes contact information and / or stimulation ring information. The contact information R1 / E1 in the first row represents the stimulation ring R1 / contact E1. In this embodiment, a diagram is used to express the treatment window of 1.80V - 3.50V, the window width is 1.70V. In addition, it also includes the pulse width of 60 μs, the frequency of 150 Hz, and the impedance information of 1040 Ω between the contact E1 and the housing during stepped output; R2 - E2, R2 - E3, R2 - E4 in the third to fifth rows respectively represent the three contacts of the stimulation ring R2. Since the treatment window test is performed in the contact mode, it can be seen from the record that the treatment window information of these three contacts is different. In addition, in order to distinguish the recorded object, electrode information such as electrode 1 left brain and time information are also included in the interface as shown in Figure 13 Thus, the test records can save the records of each period and each electrode, and be associated with the patient information, which is convenient for subsequent programming and tracing.

[0061] The user can click the sorting button in the record to enable the processor to sort the treatment window information of each contact or stimulation ring according to the window width information or impedance information. Window width sorting: Arrange in the order of stimulation ring first and then directional contacts, and within each part, arrange from largest to smallest according to the window width to highlight the best stimulation ring / contact; Impedance sorting: Arrange in the order of stimulation ring first and then directional contacts, and within each part, arrange from smallest to largest according to the impedance value. This solution can intuitively display and compare the treatment window test results of different contacts, enhancing the role of programming guidance.

[0062] Those skilled in the art should understand that the embodiments of the present invention can be provided as a method, a system, or a computer program product. Therefore, the present invention can take the form of a complete hardware embodiment, a complete software embodiment, or an embodiment combining software and hardware aspects. Moreover, the present invention can take the form of a computer program product implemented on one or more computer-usable storage media (including but not limited to disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.

[0063] The present invention is described with reference to the flowcharts and / or block diagrams of methods, apparatuses (systems), and computer program products according to the embodiments of the present invention. It should be understood that each flow and / or block in the flowchart and / or block diagram can be implemented by computer program instructions, and the combination of the flows and / or blocks in the flowchart and / or block diagram can also be implemented by computer program instructions. These computer program instructions can be provided to the processor of a general-purpose computer, a special-purpose computer, an embedded processor, or other programmable data processing devices to generate a machine, so that the instructions executed by the processor of the computer or other programmable data processing devices generate a device for implementing the specified functions in Figure 1 one flow or multiple flows and / or blocks Figure 1 one block or multiple blocks.

[0064] These computer program instructions can also be stored in a computer-readable memory that can direct a computer or other programmable data processing device to work in a specific manner, so that the instructions stored in the computer-readable memory generate a manufactured article including an instruction device, and the instruction device implements the specified functions in Figure 1 one flow or multiple flows and / or blocks Figure 1 one block or multiple blocks.

[0065] These computer program instructions can also be loaded onto a computer or other programmable data processing device, so that a series of operation steps are executed on the computer or other programmable device to generate a computer-implemented process, and the instructions executed on the computer or other programmable device provide steps for implementing the specified functions in Figure 1 one flow or multiple flows and / or blocks Figure 1 one block or multiple blocks.

[0066] Obviously, the above embodiments are merely examples given for clear illustration and are not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or alterations can be made based on the above description. It is not necessary and impossible to exhaustively list all implementation manners here. And the obvious changes or alterations derived therefrom still fall within the protection scope of the present invention.

Claims

1. A programming control device for selectively testing the treatment window of a directional electrode, characterized in that, it includes: An interaction unit for presenting a main interaction interface, which includes an electrode selection area, an amplitude adjustment area, and a therapeutic effect selection area. The electrode selection area includes a stimulation ring graph composed of multiple contact graphs, and the arrangement of the graphs is consistent with the contacts and the distribution of the stimulation rings of the stimulator electrodes. The amplitude adjustment area includes a step parameter setting unit, and the therapeutic effect selection area includes a stimulation effect feedback unit; A processor for determining the contact graph or stimulation ring graph selected by the user, and the step parameters set by the user in the amplitude adjustment area. The step parameters include a starting amplitude, a maximum target amplitude, a step size, and a step time interval; A communication unit for sending the step parameters to the stimulator, so that the stimulator performs step-by-step stimulation output according to the step parameters. The step-by-step stimulation output means starting from the starting amplitude, gradually increasing the stimulation amplitude according to the step size, and continuously outputting a stimulation signal according to the step time interval after each increase in the stimulation amplitude until the maximum target amplitude; The amplitude adjustment area further includes a plurality of step control buttons, including a button for pausing / resuming amplitude step programming, a button for decreasing the amplitude of the step interval, a button for increasing the amplitude of the step interval, a button for setting the amplitude to zero, and a button for stopping amplitude step programming. The processor is used to respond to the user's operation on the step control buttons and send corresponding instructions to the stimulator through the communication unit during the execution of the step-by-step stimulation output, so that the stimulator changes the state of the step-by-step stimulation output and realizes the user's manual control of the step stimulation process; The processor is further used to record the stimulation effect information provided by the user in the therapeutic effect selection area for the step-by-step stimulation output to determine the treatment window of each contact or stimulation ring. The treatment window is an amplitude interval that is beneficial to the patient. Among them, During the process of the stimulator performing step-by-step stimulation output according to the step parameters, when the processor first obtains the beneficial effect feedback information, the current stimulation amplitude value is determined as the lower limit of the treatment window, and the step-by-step stimulation output continues. After obtaining the side effect effect feedback information, the current stimulation amplitude value is determined as the upper limit of the treatment window, and the step-by-step stimulation output is stopped; the processor generates a treatment window test record according to the lower limit and the upper limit of the treatment window.

2. The programming control device according to claim 1, characterized in that, The main interaction interface further includes a record viewing unit, and the processor is used to respond to the user's operation on the record viewing unit and display the treatment window test record, which includes contact and / or stimulation ring information, and corresponding treatment window information.

3. The programming control device according to claim 1 or 2, characterized in that, The treatment window test record further includes the pulse width, frequency, impedance value between the contact and the housing, impedance information, and window width information corresponding to the treatment window during the step-by-step output.

4. The programming control device according to claim 1, characterized in that, The processor is used to determine the electrode modes selected by the user, including the stimulation ring mode and the contact mode; in the stimulation ring mode, determine the stimulation ring pattern selected by the user, and apply the step parameter set by the user in the amplitude adjustment area to all contacts corresponding to the stimulation ring pattern; in the contact mode, determine the contact pattern selected by the user, and apply the step parameter set by the user in the amplitude adjustment area to the corresponding contacts.

5. The programming control device according to claim 1, wherein, the processor is used to determine the output modes selected by the user, including the voltage mode and the current mode; in the voltage mode, enable the stimulator to output a stimulation signal with a constant voltage, and the step parameter acts on the output voltage; in the current mode, enable the stimulator to output a stimulation signal with a constant current, and the step parameter acts on the output current.

6. The programming control device according to claim 1, wherein, the instructions include at least one of increasing the amplitude, decreasing the amplitude, pausing the stimulation output, resuming the stimulation output, setting the amplitude to zero, and maintaining the current amplitude.

7. The programming control device according to claim 1, wherein, the stimulation effect feedback unit includes a benefit unit and a side effect unit, and the processor is used to respond to the user's operations on the benefit unit and the side effect unit. When the user selects the benefit unit, provide multiple optional benefit effect feedback information; when the user selects the side effect unit, provide multiple optional side effect feedback information.

8. An implantable medical system, wherein, comprising: the programming control device according to any one of claims 1-7, and an implantable medical device, the implantable medical device includes a directional electrode and a communication unit, and is used to receive the step parameter sent by the programming control device and perform stepped stimulation output.

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