Directional electrode and implantable stimulation system

Abstract

Provided are a directional electrode and an implantable stimulation system. The directional electrode comprises: a wire main body (110), the wire main body (110) being provided with at least one set of directional electrode contacts (130); and a direction identifier (120), the direction identifier (120) being disposed on the wire main body (110) in the shape of an arc, the direction identifier (120) comprising a first identification arc (121) and a second identification arc (122), and a first notch (123) being arranged between the first identification arc (121) and the second identification arc (122).

Description

A directional electrode and implantable stimulation system

[0001] This disclosure claims priority to Chinese Patent Application No. 202411856067.5, filed with the Chinese Patent Office on December 16, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to the field of electrode technology, such as a directional electrode and an implantable stimulation system. Background Technology

[0003] Deep brain stimulation (DBS) is an invasive neuromodulation technique that uses stereotactic surgery to implant stimulating electrodes into specific neural structures in the human brain. A neurostimulator is then implanted in the body to connect to the electrodes, delivering adjustable and controllable weak electrical pulses. This alters the electrical activity and function of the brain's neural circuits and networks, thereby controlling and improving the user's symptoms.

[0004] Traditional DBS electrodes have their stimulation output metal contacts arranged in a ring on the conductor body. The entire electrode is rotationally symmetrical at any angle and has no specific orientation. However, this structure can only create an approximately spherical electric field, which may stimulate undesirable tissues or structures, producing certain side effects. Newer DBS electrode designs allow the previously ring-shaped stimulation output metal contacts to be divided into multiple pieces, typically into thirds. This enables directional stimulation, creating a stimulation field with a specific orientation, precisely releasing electrical stimulation to a specific area, while also achieving efficient energy utilization. These new DBS electrodes even allow for designs with irregularly shaped contacts. Therefore, the new DBS electrodes support independent control of the stimulation output parameters of at least one piece, thereby achieving stimulation of brain tissue in a specific direction. Thus, these new DBS electrodes can be called directional electrodes.

[0005] However, the current structure of directional electrodes is insufficient to meet the requirements for orientation recognition, and this issue urgently needs to be addressed. Summary of the Invention

[0006] This disclosure provides a directional electrode and an implantable stimulation system to achieve orientation recognition of the directional electrode.

[0007] In a first aspect, this disclosure provides a directional electrode, comprising:

[0008] The conductor body has at least one set of directional electrode contacts.

[0009] A directional marker, which is an arc shape, is set on the conductor body. The directional marker includes a first marking arc and a second marking arc, and there is a first gap between the first marking arc and the second marking arc.

[0010] Secondly, this disclosure provides a method for designing directional signs, including:

[0011] Determine at least one set of alternative sign design schemes, and for each of the alternative sign design schemes in the at least one set of alternative sign design schemes, simulate alternative simulation images of alternative sign design schemes, wherein alternative simulation images are images obtained by simulating alternative signs, and alternative signs are signs corresponding to alternative sign design schemes of the directional sign to be designed.

[0012] Based on the candidate simulation images corresponding to at least one set of candidate sign design schemes, a target sign design scheme for the directional sign is determined from at least one set of candidate sign design schemes, so as to determine the structure of the directional electrode provided in the first aspect of this disclosure based on the target sign design scheme.

[0013] Thirdly, this disclosure provides a method for identifying the orientation of directional electrodes, including:

[0014] Acquire medical images of a user who has been implanted with the directional electrodes provided in the first aspect of this disclosure, multiple reference simulation images corresponding to the directional markers in the directional electrodes, and a reference orientation corresponding to each reference simulation image;

[0015] The medical images are matched with multiple reference simulation images, and the electrode orientation of the directional electrode implanted in the user's body is identified based on the reference orientation corresponding to the successfully matched reference simulation images.

[0016] Fourthly, this disclosure provides a directional electrode orientation identification device, comprising:

[0017] The reference orientation acquisition module is configured to acquire medical images of a user who has been implanted with the directional electrodes provided in the first aspect of this disclosure, multiple reference simulation images corresponding to the orientation markers in the directional electrodes, and the reference orientation corresponding to each reference simulation image.

[0018] The electrode orientation recognition module is configured to perform image matching between medical images and multiple reference simulation images, and identify the electrode orientation of the directional electrode implanted in the user's body based on the reference orientation corresponding to the successfully matched reference simulation image.

[0019] Fifthly, this disclosure provides an implantable stimulation system, comprising:

[0020] Implantable stimulator, which is implanted into the user's body;

[0021] The first aspect of this disclosure provides a directional electrode that is connected to an implantable stimulator, wherein at least one set of directional electrode contacts is implanted at a tissue target site in the user's body.

[0022] Sixthly, this disclosure provides an electronic device, including:

[0023] At least one processor; and

[0024] A memory that is communicatively connected to at least one processor; wherein,

[0025] The memory stores a computer program that can be executed by at least one processor, such that when the at least one processor executes the program, it implements the orientation marking design method provided in the second aspect of this disclosure or the directional electrode orientation identification method provided in the third aspect of this disclosure. Attached Figure Description

[0026] Figure 1 is an example diagram of the cross-sectional structure of a metal contact.

[0027] Figure 2 is an example image obtained by simulating CT images of metal contacts.

[0028] Figure 3 is an example of a medical image of a directional electrode taken by a medical CT scanner under standard cranial scanning parameters.

[0029] Figure 4 is a structural block diagram of a directional electrode provided according to an embodiment of the present disclosure;

[0030] Figure 5 is a top view of a direction indicator in a directional electrode according to an embodiment of the present disclosure;

[0031] Figure 6 is a top view and a schematic diagram of a CT image of another direction marker in a directional electrode provided according to an embodiment of the present disclosure;

[0032] Figure 7 is a perspective view of a directional marking in a directional electrode according to an embodiment of the present disclosure;

[0033] Figure 8 is a schematic diagram of an alternative example of a directional electrode provided according to an embodiment of the present disclosure;

[0034] Figure 9 is a flowchart of a directional sign design method according to an embodiment of the present disclosure;

[0035] Figure 10 is an example diagram of an alternative sign design scheme in a directional sign design method provided according to an embodiment of the present disclosure;

[0036] Figure 11 is an example diagram of an alternative sign design scheme and an alternative simulation image in a directional sign design method provided according to an embodiment of the present disclosure.

[0037] Figure 12 is an example diagram of another alternative sign design scheme and alternative simulation image in a directional sign design method provided according to an embodiment of the present disclosure;

[0038] Figure 13 is an example diagram of another alternative sign design scheme and alternative simulation image in a directional sign design method provided according to an embodiment of the present disclosure.

[0039] Figure 14 is an example diagram of the structure of a directional sign in a cross-section in a directional sign design method provided according to an embodiment of the present disclosure;

[0040] Figure 15 is an example diagram of a sign image in a directional sign design method provided according to an embodiment of the present disclosure;

[0041] Figure 16 is a flowchart of a directional electrode orientation identification method provided according to an embodiment of the present disclosure;

[0042] Figure 17 is a structural block diagram of a directional sign design device according to an embodiment of the present disclosure;

[0043] Figure 18 is a structural block diagram of a directional electrode orientation identification device provided according to an embodiment of the present disclosure;

[0044] Figure 19 is a structural block diagram of an implantable stimulation system provided according to an embodiment of the present disclosure;

[0045] Figure 20 is a schematic diagram of the structure of an electronic device that implements the directional marker design method or directional electrode orientation recognition method of the present disclosure. Detailed Implementation

[0046] To enable those skilled in the art to better understand the present disclosure, the technical solutions in the embodiments of the present disclosure will be clearly and completely described below with reference to the accompanying drawings.

[0047] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this disclosure are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of this disclosure described herein can be implemented in orders other than those illustrated or described herein. The same applies to "target," "original," etc., and will not be repeated here. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that includes a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0048] Before introducing the embodiments of this disclosure, we will first provide an exemplary description of the current application scenarios of directional electrodes, the current directional electrode schemes, and the reasons why they have the problem of failing to meet the requirements of directional electrode orientation recognition, so as to better understand why the directional electrode scheme proposed in the embodiments of this disclosure can achieve directional electrode orientation recognition.

[0049] For example, implantable medical systems include implantable neurostimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead transfer systems. Examples of implantable neurostimulation systems include deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS). An implantable neurostimulation system comprises a stimulator implanted in the user's body (i.e., an implantable neurostimulator) and a programmed device placed outside the user's body; that is, the stimulator is a medical device, or a medical device includes a stimulator. The relevant neuromodulation technology mainly involves implanting directional electrodes (in the form of wires, for example) at specific sites (i.e. target points) in the tissues of an organism through stereotactic surgery. The electrodes then send discharge pulses to the target points to modulate the electrical activity and function of the corresponding neural structures and networks.

[0050] DBS (Deep Brain Stimulation System) may include an IPG (Implantable Pulse Generator), extension leads, and a lead body. The IPG is connected to the lead body via the extension leads. The IPG can be implanted in the user's body, for example, in a tin-plated chest area or other internal location. Alternatively, DBS may include an IPG and a lead body, with the IPG directly connected to the lead body. The IPG is implanted in the user's head, for example, by creating a groove in the skull and then placing the IPG within that groove. In this case, the IPG may not protrude from the skull surface or may partially protrude. The IPG responds to programmed commands from a programmable device, using a sealed battery and circuitry to provide controllable electrical stimulation (or electrical stimulation energy) to internal tissues. The IPG delivers one or more controllable electrical stimuli to specific areas of the internal tissue via the lead body. The extension leads, used in conjunction with the IPG, act as a medium for transmitting the electrical stimulation, conveying the electrical stimulation generated by the IPG to the lead body.

[0051] Electrical stimulation can be delivered in the form of pulsed signals or non-pulsed signals. For example, electrical stimulation can be delivered as signals with various waveforms, frequencies, and amplitudes. Therefore, non-pulsed electrical stimulation can be a continuous signal, which can have a sinusoidal waveform or other continuous waveforms. After receiving electrical stimulation transmitted by the IPG or extension leads, the lead body delivers the electrical stimulation to a specific area of ​​the body tissue through multiple electrode contacts. The stimulator may have one or more lead bodies on one or both sides, with multiple electrode contacts on the lead body. The electrode contacts can be uniformly or non-uniformly arranged around the circumference of the lead body. The electrode contacts can be arranged in a 4x3 array (a total of 12 electrode contacts) around the circumference of the lead body. The electrode contacts may include stimulating electrode contacts and / or collecting electrode contacts, and the electrode contacts may be in the form of sheets, rings, or dots.

[0052] The stimulated tissue can be the user's brain tissue, and the stimulated site can be a specific area of ​​the brain tissue. Generally, the stimulated site differs from users. The number of stimulation contacts (single-source or multi-source), the application of one or more specific electrical stimulation pathways (single-channel or multi-channel), and the stimulation parameters (values) also vary. There are no restrictions on the type of user tissue to which stimulation is applicable; it can include deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, and the types of diseases for which functional electrical stimulation is applicable.

[0053] When a programmed connection is established between the programmed device and the stimulator, at least one stimulation parameter of the stimulator (or at least one stimulation parameter of the pulse generator, as different stimulation parameters correspond to different electrical stimuli) can be adjusted using the programmed device. Alternatively, the stimulator can sense the user's electrophysiological activity to collect electrophysiological signals, and the collected electrophysiological signals can be used to further adjust the stimulator's stimulation parameters, achieving closed-loop control (or adaptive adjustment) of the stimulation parameters. Stimulation parameters may include at least one of the following: electrode contact identifiers for delivering electrical stimulation (e.g., electrode contacts #2 and #3), frequency (e.g., the number of electrical stimulation pulses per second, in Hz), pulse width (duration of each pulse, in μs), amplitude (generally expressed as voltage, i.e., the intensity of each pulse, in V), timing (e.g., continuous or bursty, bursty referring to discontinuous temporal behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode), upper and lower limits for physician control (the range adjustable by the physician), and upper and lower limits for user control (the range adjustable by the user). The stimulation parameters of the stimulator can be adjusted in either current or voltage mode. Programmable devices can include physician-controlled devices (i.e., devices used by physicians) and / or user-controlled devices (i.e., devices used by users). Physician-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software. User-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software; user-controlled devices can also be other electronic devices with programming functions (e.g., chargers with programming functions, electrophysiological acquisition devices, etc.).

[0054] Currently, the feasible methods for determining the orientation of directional electrodes after implantation are all based on plain cranial X-rays. This involves comparing the plain cranial X-ray with pre-taken or drawn standard images to obtain electrode orientation information. However, this method has the following drawbacks: it relies on doctors manually comparing the plain cranial X-ray with the standard images, and cannot be automated; the angular difference between two adjacent standard images determines the minimum accuracy of the directional electrode angle that this method can determine. The current mainstream method divides 360° into 8 images, so the minimum resolvable angle is 45°; plain cranial X-rays can only clearly visualize bony structures such as the skull, and cannot show soft tissues or fluid structures such as brain tissue and ventricles, so they cannot identify the position of the directional electrode relative to the brain nuclei; not all human users will have a plain cranial X-ray taken after directional electrode implantation. The more common method is to take computed tomography (CT) images after directional electrode implantation.

[0055] However, the current method of determining the orientation of directional electrodes by analyzing their imaging characteristics in CT images acquired after implantation has the following drawbacks: While the most common type of directional electrode uses a three-part contact design, and both the contact design and orientation markings exhibit a degree of mechanical structural asymmetry, the artifacts resulting from these asymmetric structures in CT scans fail to accurately indicate electrode orientation. For example, referring to the cross-sectional structure of the metal contact in Figure 1 and the simulated image obtained from the CT image of the metal contact in Figure 2, the artifacts in the imaging of the three-part metal contact appear as six alternating bright and dark rays at equal angles, each with a bright... The direction of the line corresponds to the center of the metal contact or the gap between two metal contacts. This is because the connection between the two ends of the same metal contact produces a dark line, and each gap produces two dark lines, which are respectively emanated from the edges of the two adjacent metal contacts. See Figure 3 for the medical image of the directional electrode taken by a medical CT under the conventional cranial scanning parameters. The resolution of the current mainstream medical CT cannot identify the details of the emanation location of the two dark lines. Therefore, it is impossible to know whether the bright area between the two dark lines corresponds to a metal contact or a gap. In other words, of the two adjacent bright areas, one corresponds to a contact and the other corresponds to a gap, but which one corresponds to the contact cannot be determined from the CT image.

[0056] In summary, there are many shortcomings in using directional electrodes for orientation identification on cranial X-ray films, and the current mechanical structure of the directional electrode markers in CT images is difficult to meet the requirements for directional electrode orientation identification.

[0057] To address this, this embodiment of the present disclosure provides an arc-shaped directional marker, including a first notch, on the directional electrode. This allows an artifact corresponding to the directional marker to be visible in the medical image, indicating the orientation of the directional electrode. The orientation of the directional electrode is thus identified through this artifact. This will be described in detail below.

[0058] Figure 4 is a structural block diagram of a directional electrode provided in an embodiment of this disclosure. This embodiment is applicable to situations where the orientation of the directional electrode is identified.

[0059] Referring to Figure 4, the directional electrode of this embodiment includes:

[0060] The conductor body 110 is provided with at least one set of directional electrode contacts 130;

[0061] A directional marker 120, in an arc shape, is disposed on the lead body 110. The directional marker 120 includes a first marking arc 121 and a second marking arc 122, with a first notch 123 between the first marking arc 121 and the second marking arc 122. The lead body 110 is the main body of the lead for setting the directional electrode contact 130 and the directional marker. The electrode contact is a contact capable of electrical stimulation or data acquisition. The directional marker 120 is a marker used to determine the orientation of the directional electrode through medical imaging. For example, the directional marker 120 can cause an artifact corresponding to the directional marker 120, indicating the orientation of the directional electrode, to be visible in the medical image, thereby achieving orientation identification of the directional electrode through this artifact. The material of the directional marker 120 can be metal or other materials capable of presenting corresponding artifacts in medical images. The first marking arc 121 is one arc constituting the directional marker 120. The second marking arc 122 is the other arc constituting the directional marker 120. The first gap 123 is the gap between the first marking arc 121 and the second marking arc 122. The position of the first gap 123 can be located in the center of the direction marking 120 or it can be off to one side. That is, the angle ranges corresponding to the first marking arc 121 and the second marking arc 122 can be the same or different. In this embodiment of the disclosure, the position of the first gap 123 in the direction marking 120 is not limited.

[0062] In this embodiment of the disclosure, the direction mark 120 may be an additional mark provided on the conductor body 110, or the directional electrode contact 130 may be used as the direction mark 120.

[0063] Optionally, the arc shape angle range corresponding to the direction indicator is [145°, 270°]; and / or, the notch arc angle range corresponding to the first notch is [30°, 90°].

[0064] The arc shape angle range refers to the range of angles of the arc corresponding to direction marker 120. This can be understood as the range of arcs between the two circumferentially distant ends of the first marker arc 121 and the second marker arc 122. The notch arc angle is the range of angles of the arc corresponding to the notch, that is, the range of arcs between the two circumferentially close ends of the first marker arc 121 and the second marker arc 122. Generally, there are two notches between the first marker arc 121 and the second marker arc 122 in the circumferential direction. A notch not exceeding 90° can be defined as the first notch 123.

[0065] In one embodiment of this disclosure, when the arc shape angle range is [145°, 270°] and / or the notch arc angle range is [30°, 90°], that is, when the arc angle of the overall arc corresponding to the direction identifier 120 is less than or equal to 270 degrees and greater than or equal to 145 degrees, and / or the arc angle of the arc corresponding to the first notch 123 is less than or equal to 90 degrees and greater than or equal to 30 degrees, the optimal pointing effect of the directional electrode can be obtained. Optionally, the arc shape angle and the first notch 123 can be combined in the following form: [180°~240°, 30°~60°].

[0066] This can be understood as follows: since the positional relationship between the directional marker 120 and the directional electrode contact 130 is fixed, the directional marker 120, with its aforementioned structural design, can acquire better directional images under CT imaging. Thus, given the orientation of the directional marker 120, the orientation of the directional electrode contact 130 can be quickly determined, thereby identifying the position of the directional electrode contact 130 with different orientations in the implantation area (e.g., the user's brain nucleus). This facilitates targeted electrical stimulation by the doctor based on the user's actual condition. For example, referring to Figure 5, the directional marker 120 with an arc shape angle of 180° includes a first marking arc 121 and a second marking arc 122, with a first notch 123 between the first marking arc 121 and the second marking arc 122 having a notch arc angle of 45°.

[0067] For example, referring to Figure 6, the directional marker 120 with an arc shape angle of 180° includes a first marker arc 121 and a second marker arc 122, with a first notch 123 with an arc angle of 60° between the first marker arc 121 and the second marker arc 122. As can be seen from Figure 6, the directional marker 120 can present a metallic artifact with a directional effect under CT images. That is, in the CT image, a dark line is generated in the direction of the area corresponding to the first notch 123, and two other dark lines are generated in the areas corresponding to the first marker arc 121 and the second marker arc 122. The three dark lines together constitute a specific “⊥” shaped dark line marker with directional indication capability.

[0068] Optionally, the direction marker 120 further includes a connecting portion 124; wherein the connecting portion 124 is configured to connect the first marker arc 121 and the second marker arc 122; the number of connecting portions can be at least one, for example, the number of connecting portions can be two, to connect the first marker arc 121 and the second marker arc 122 respectively.

[0069] In this embodiment of the disclosure, referring to FIG7, the directional marker 120 may further include a connecting portion 124, which connects the first marker arc 121 and the second marker arc 122, so that the directional marker 120 is integrally formed through the connecting portion 124, thereby facilitating the manufacturing and assembly of the directional marker 120.

[0070] For example, the material of the connector can be a non-metallic material, such as rubber or plastic, so that the non-metallic connector will not affect the imaging during CT image acquisition. This avoids the material of the connector affecting the imaging and marking effect of the directional marker 120 during CT image acquisition. It also avoids the metal connector causing a short circuit when the directional electrode contact 130 delivers electrical stimulation, which would cause discomfort to the user.

[0071] In this embodiment of the disclosure, the position of the connecting part 124 is not limited; for example, the connecting part 124 may be located at the same position as the first notch 123 in the length direction parallel to the conductor body 110 and at different positions in the length direction perpendicular to the conductor body 110; for another example, the connecting part 124 may be located at different positions as the first notch 123 in the length direction parallel to the conductor body 110.

[0072] Optionally, the curvature of the first marking arc 121 and the curvature of the second marking arc 122 are equal, that is, the angle ranges corresponding to the first marking arc 121 and the second marking arc 122 are the same. It can be understood that by setting the first notch 123 in the middle position of the two marking arcs, a relatively symmetrical imaging effect can be achieved, which can improve the recognition accuracy of the direction marking 120 under CT imaging conditions to a certain extent, thereby improving the accuracy of orientation recognition of the directional electrode.

[0073] Optionally, in the image acquired for the directional electrode, the region corresponding to the direction marker has at most one axis of symmetry to avoid the situation where multiple axes of symmetry exist, thus making it impossible to identify the orientation of the directional electrode. The image is obtained by acquiring images for the directional electrode; the acquired images can be obtained using medical imaging techniques.

[0074] Optionally, the image is a computed tomography (CT) scan image, and the acquisition direction of the image is perpendicular to the length of the conductor body, so that the orientation of the directional electrode can be easily identified using the image, avoiding the occurrence of orientation identification errors due to deviation of the image acquisition angle. Optionally, the length direction perpendicular to the conductor body 110 in the acquisition direction can be understood as approximately perpendicular or close to perpendicular, because there may be some deviation in actual operation.

[0075] This can be understood as follows: taking DBS as an example, electrodes are generally implanted into the user's brain at an angle. When taking CT images, the user's head is generally used as the basis for acquisition, for example, acquisition is carried out from the user's jaw to the top of the skull. During acquisition, the direction of the directional electrode is actually not perpendicular. Therefore, the direction marker 120 needs to have a relatively strong marking effect when the directional electrode is approximately perpendicular or close to perpendicular (e.g., between 80° and 100°). Therefore, the positional and angular relationship between the first marking arc 121 and the second marking arc 122 in the direction marker 120 also needs to have a good marking effect when the directional electrode is approximately perpendicular or close to perpendicular, so as to achieve targeted orientation recognition.

[0076] Optionally, the distance between the directional electrode contact 130 and the directional marker 120 is in the range of [2 mm, 12 mm].

[0077] In this embodiment, the direction marker 120 can be located above the directional electrode contact 130 at the implantation end of the lead body 110. If the distance between the directional electrode contact 130 and the direction marker 120 is too short, the artifacts corresponding to the directional electrode contact 130 and the direction marker 120 may interfere with each other. If the distance between the directional electrode contact 130 and the direction marker 120 is too long, the accuracy of the orientation recognition of the directional electrode may be reduced due to the twisting of the lead body 110. Therefore, the directional electrode contact 130 and... The distance between the directional markers 120 can be in the range of [2 mm, 12 mm], that is, the distance between the directional electrode contact 130 and the directional marker 120 is less than or equal to 12 mm and greater than or equal to 2 mm, so as to obtain the best pointing effect of the directional electrode orientation. Optionally, the distance between the directional electrode contact 130 and the directional marker 120 can be, for example, 3 mm, 4 mm, 6 mm or 8 mm, etc. The value of the distance can be determined with factors such as the spacing between the directional electrode contacts in the directional electrode and / or the implantation environment, and is not limited in this embodiment.

[0078] In some other embodiments, the direction marker 120 further includes at least one third marker arc, which has at least one second gap between the at least one third marker arc and the first marker arc and / or the second marker arc.

[0079] The third marking arc is another arc constituting the direction marking 120. The second notch is a notch on the direction marking 120; the position of the second notch can be located in the center of the direction marking 120 or off to one side, that is, the angle ranges corresponding to the first marking arc 121, the second marking arc 122 and the third marking arc can be the same or different. In this embodiment of the disclosure, the position of the second notch in the direction marking 120 is not limited.

[0080] In this embodiment of the disclosure, the direction marker 120 further includes at least one second notch to divide the direction marker 120 into a first marker arc 121, a second marker arc 122 and at least one third marker arc through the first notch 123 and the second notch, thereby improving the accuracy of orientation identification of the directional electrode.

[0081] Optionally, the thicknesses of the first and second marking arcs are different, and / or the arc lengths of the first and second marking arcs are different.

[0082] In this embodiment of the disclosure, the first marking arc 121, the second marking arc 122 and / or at least one third marking arc can be globally or locally thickened or thinned, and the arc lengths of the first marking arc 121, the second marking arc 122 and / or at least one third marking arc can be different, thereby improving the accuracy of orientation identification of the directional electrode.

[0083] In this embodiment of the disclosure, the direction mark 120 may also be an arc-shaped mark without a notch, that is, the direction mark 120 may also include only the first mark arc 121 or the second mark arc 122.

[0084] In this embodiment of the disclosure, the direction marker 120 may also be a marker of a variety of feasible configurations with different imaging characteristics, or a marker of a variety of feasible configurations with different imaging characteristics may be vertically spliced ​​together to form a whole to achieve the effect of orientation indication. In this case, the markers of different configurations can be used to cross-verify the orientation they indicate, thereby improving the accuracy of orientation indication.

[0085] Optionally, the direction marker is made of metal or the surface of the direction marker is metal-plated, so that the orientation of the directional electrode can be identified by utilizing the development effect of metal in the image.

[0086] The technical solution of this disclosure embodiment provides at least one set of directional electrode contacts on the conductor body so that the directional electrodes can be electrically stimulated; the directional marker is provided on the conductor body in an arc shape, the directional marker includes a first marker arc and a second marker arc, and there is a first gap between the first marker arc and the second marker arc, so that an artifact corresponding to the directional marker and capable of indicating the orientation of the directional electrodes can be seen in the medical image, thereby realizing the orientation identification of the directional electrodes through the artifact.

[0087] To better understand the technical solutions of the above-described embodiments of this disclosure, an optional example is provided here. For example, referring to FIG8, the directional electrode includes a conductor body 110 and a direction marker 120. At least one set of directional electrode contacts 130 is disposed on the conductor body 110. The direction marker 120 is arranged in an arc shape on the conductor body 110. The direction marker 120 includes a first marking arc 121, a second marking arc 122, and a connecting portion 124. A first notch 123 is present between the first marking arc 121 and the second marking arc 122. The distance between the directional electrode contacts 130 and the direction marker 120 ranges from [2 mm to 12 mm].

[0088] Figure 9 is a flowchart of a directional sign design method provided in an embodiment of this disclosure. This embodiment is applicable to directional sign design. The method can be executed by the directional sign design device provided in this embodiment of the disclosure. The device can be implemented by software and / or hardware, and can be integrated into an electronic device, which can be various user terminals or servers.

[0089] Referring to Figure 9, the method of this embodiment includes S210-S220.

[0090] S210. Determine at least one set of alternative sign design schemes, and for each alternative sign design scheme in the at least one set of alternative sign design schemes, simulate to obtain alternative simulation images of alternative sign design schemes, wherein the alternative simulation images are images obtained by simulating alternative signs, and the alternative signs are signs corresponding to alternative sign design schemes of directional signs to be designed.

[0091] The alternative identifier design scheme refers to any alternative design scheme of the directional identifier in the directional electrode provided in any embodiment of this disclosure. The alternative design scheme can be an alternative identifier scheme with an asymmetrical design in structure, so that the alternative identifier can introduce asymmetrical features in the image acquisition results, so as to realize the orientation recognition of the directional electrode. The alternative identifier is the identifier corresponding to the alternative identifier design scheme, that is, the alternative identifier is the identifier that can be manufactured according to the alternative identifier design scheme. In the embodiments of this disclosure, at least one set of alternative identifier design schemes can be designed manually; or at least one set of alternative identifier design schemes can be automatically generated according to the design scheme generation rules. For example, the design scheme generation rules are that the corresponding arc shape angle of the alternative identifier is within the range of [first angle, second angle], and the number of notches included in the alternative identifier is within the range of [0, 5], and the alternative identifier is asymmetrical. In the embodiments of this disclosure, the method of determining at least one set of alternative identifier design schemes is not limited.

[0092] In this embodiment of the disclosure, referring to Figure 10, the alternative logo design scheme can be presented, for example, in the form of a planar image, representing the structure of the alternative logo corresponding to the alternative logo design scheme in cross-section. In the planar image, the white area can be the area corresponding to the alternative logo; the gray area represents soft tissue components such as brain tissue and cerebrospinal fluid to simulate the skull; and the black area represents the air area, that is, the air area simulating the area outside the skull.

[0093] In this embodiment of the disclosure, alternative marking design schemes may include design schemes that use the electrode contacts of the directional electrode as alternative markings, that is, alternative marking design schemes that do not require additional markings on the directional electrode as alternative markings may exist.

[0094] For example, referring to Figures 11, 12, and 13, at least one set of alternative sign design schemes can be determined. Each set of alternative sign design schemes may include a textual description of the design parameters of the alternative sign design scheme, a three-dimensional image of the alternative sign, and the structure of the alternative sign in cross-section (i.e., an image obtained by medical image acquisition of the alternative sign). At least one set of alternative sign design schemes includes additional design parameters of 60°, 120°, 180°, 180° with a 30° notch, 180° with a 30° notch and the right metal plate being doubled in thickness, 180° with a 60° notch, and 180° with a 60° notch and the right metal plate being doubled in thickness. The design schemes for candidate marks include 240°, 240° with a 30° notch, 240° with a 60° notch, and 300°. A design scheme using electrode contacts as design parameters for candidate marks, with one contact doubled in thickness and three equally sized, uniformly distributed electrode contacts (i.e., the electrodes in Figure 13) is also included. For each of the candidate mark design schemes in at least one set, simulation images of the candidate mark design schemes are obtained. These simulation images are the rightmost images in Figures 11, 12, and 13. The simulation images can characterize the metallic artifact characteristics of the candidate mark configuration in CT scans. It should be noted that the examples above, such as 240° with a 60° notch, are textual descriptions of the design parameters for the candidate mark design schemes. This can be understood as the configuration of the candidate mark corresponding to the design scheme being a 240° arc with a 60° arc notch within it.

[0095] It is important to note that metals produce unique artifacts in medical imaging such as CT scans. The characteristics of these artifacts are related to the principles of CT imaging and the projection, refraction, and diffraction properties of X-rays by metals. Furthermore, since metal artifacts are particularly susceptible to environmental influences, the imaging characteristics of the physical system comprised of metals, soft tissue (simulating brain tissue and cerebrospinal fluid), and air can be utilized to simulate alternative design schemes. For example, this can be achieved by considering the principles of CT imaging, the projection characteristics of metals onto X-rays, the refraction characteristics of metals onto X-rays, the diffraction characteristics of metals onto X-rays, and the effects of soft tissue on X-rays. At least one of the imaging characteristics during a CT scan and the imaging characteristics of air regions during a CT scan is considered. Computer simulation is used to simulate alternative sign designs to obtain alternative simulation images, which predict the imaging characteristics of the alternative sign corresponding to the alternative sign design in a CT scan. Based on the alternative simulation images, it can be observed whether the metallic artifacts of the alternating bright and dark alternative sign can indicate a specific orientation. This allows for manual or automatic, active manipulation of the imaging characteristics of the physical system in a CT scan, especially utilizing imaging artifacts of metallic components to indicate the orientation of the physical system. In this embodiment, the method of obtaining the alternative simulation images of the alternative sign design is not limited.

[0096] S220. Based on the candidate simulation images corresponding to at least one set of candidate logo design schemes, determine the target logo design scheme for the directional logo from at least one set of candidate logo design schemes, so as to determine the structure of the directional electrode provided in any embodiment of this disclosure based on the target logo design scheme.

[0097] The target identifier design scheme is an alternative identifier design scheme for manufacturing the directional identifier in the directional electrode provided in any embodiment of this disclosure.

[0098] Based on the examples of at least one set of alternative sign design schemes mentioned above, and exemplarily speaking, according to the alternative simulation images corresponding to at least one set of alternative sign design schemes, the alternative sign design schemes with additional design parameters of 240° and 60° notch, 240° and 30° notch, and 180° and 60° notch respectively have the best imaging pointing effect. Among these three alternative sign design schemes, the alternative sign design scheme with additional design parameters of 240° and 60° notch has the best imaging pointing effect. Therefore, the alternative sign design scheme with additional design parameters of 240° and 60° notch can be used as the target sign design scheme, or any one of the alternative sign design schemes with additional design parameters of 240° and 60° notch, 240° and 30° notch, and 180° and 60° notch can be used as the target sign design scheme. In this embodiment of the disclosure, the method of determining the target logo design scheme from at least one set of candidate logo design schemes based on the candidate simulation images corresponding to at least one set of candidate logo design schemes is not limited.

[0099] For example, when the target sign design is an alternative sign design with additional design parameters of 240° and a 60° notch, the structure of the directional electrode provided in any embodiment of this disclosure can be determined, especially the structure of the directional sign in the directional electrode provided in any embodiment of this disclosure. The structure of the directional sign in cross-section is shown in Figure 14. Referring to Figure 15, the manufactured directional sign is captured by CT at multiple angles to obtain its sign images at multiple angles. As can be seen from Figure 15, the directional sign can generate a dark line in the 60° notch direction. The metal pieces of the sign portions on both sides of the directional sign correspond to two other dark lines. The three together constitute a specific “⊥” shaped dark line sign. The white arrow indicates the direction. Therefore, the directional sign has an imaging pointing effect and has the ability to indicate direction.

[0100] The technical solution of this disclosure involves determining at least one set of candidate identifier design schemes, and for each candidate identifier design scheme in the at least one set of candidate identifier design schemes, simulating to obtain a candidate simulation image of the candidate identifier design scheme. The candidate simulation image is an image obtained by simulating the acquired image of the candidate identifier, and the candidate identifier is the identifier corresponding to the candidate identifier design scheme of the directional identifier to be designed, so as to determine the target identifier design scheme through the candidate simulation image. Based on the candidate simulation images corresponding to the at least one set of candidate identifier design schemes, a target identifier design scheme for the directional identifier is determined from the at least one set of candidate identifier design schemes. Based on the target identifier design scheme, the structure of the directional electrode provided in any embodiment of this disclosure is determined. The directional identifier with optimal pointing direction can be determined through the target identifier design scheme. The above technical solution can determine the target identifier design scheme that achieves optimal pointing direction from the at least one set of candidate identifier design schemes through the candidate simulation images corresponding to the at least one set of candidate identifier design schemes, thereby improving the accuracy of orientation recognition of the directional electrode.

[0101] An optional technical solution involves determining a target sign design scheme for a directional sign from at least one set of candidate sign design schemes based on candidate simulation images corresponding to at least one set of candidate sign design schemes, including: determining a first sign feature parameter for each candidate simulation image corresponding to at least one set of candidate sign design schemes, wherein the first sign feature parameter includes at least the number of symmetry axes of the candidate simulation images; and selecting candidate sign design schemes with a number of symmetry axes less than or equal to 1 from at least one set of candidate sign design schemes as the target sign design scheme for the directional sign.

[0102] The first identifier feature parameter is a parameter related to the characteristics of the candidate identifier in the candidate simulation image. The number of symmetry axes is the number of symmetry axes possessed by the region corresponding to the candidate identifier in the candidate simulation image.

[0103] It is understood that candidate identifiers will produce unique artifacts in candidate simulation images. The first identifier feature parameters can be determined based on the unique characteristics of these artifacts in the candidate simulation images. For example, the first identifier feature parameters can be determined based on at least one of the following: the position, orientation, occupied area, and size of the dark lines and / or bright areas extracted from the candidate simulation images. In this embodiment, the method for determining the first identifier feature parameters of the candidate simulation images corresponding to at least one set of candidate identifier design schemes is not limited.

[0104] In this embodiment of the disclosure, for example, at least one candidate sign design scheme with a number of symmetry axes less than or equal to 1 from at least one set of candidate sign design schemes can be used as the target sign design scheme for a direction sign; or, for example, one candidate sign design scheme can be determined from at least one candidate sign design scheme with a number of symmetry axes less than or equal to 1 from at least one set of candidate sign design schemes and used as the target sign design scheme. In this embodiment of the disclosure, the method of using a candidate sign design scheme with a number of symmetry axes less than or equal to 1 from at least one set of candidate sign design schemes as the target sign design scheme for a direction sign is not limited.

[0105] In this embodiment of the disclosure, by using at least one set of candidate identifier design schemes with a number of symmetry axes less than or equal to 1 as the target identifier design scheme for the directional identifier, the target identifier design scheme that can make the directional identifier have the best directionality can be determined, thereby improving the accuracy of orientation recognition of the directional electrode.

[0106] Based on the above scheme, another optional technical solution further includes image size and image clarity as the first identifier feature parameter; taking the candidate identifier design scheme with the number of symmetry axes less than or equal to 1 in at least one set of candidate identifier design schemes as the target identifier design scheme for the direction identifier, including: when the number of candidate identifier design schemes with the number of symmetry axes less than or equal to 1 in at least one set of candidate identifier design schemes is equal to 1, taking the candidate identifier design scheme with the number of symmetry axes less than or equal to 1 as the target identifier design scheme for the direction identifier; determining the target identifier design scheme for the direction identifier from at least one set of candidate identifier design schemes based on the candidate simulation images corresponding to each of the at least one set of candidate identifier design schemes, further including: when the number of candidate identifier design schemes with the number of symmetry axes less than or equal to 1 in at least one set of candidate identifier design schemes is greater than 1, taking each candidate identifier design scheme with the number of symmetry axes less than or equal to 1 as a candidate design scheme, and determining the target identifier design scheme for the direction identifier from at least two candidate design schemes based on the image size and image clarity corresponding to each of the at least two candidate design schemes.

[0107] Here, image size refers to the dimensions of the candidate simulation image. Image clarity refers to the sharpness of the candidate simulation image. Candidate design schemes are alternative signage designs that could be considered as the target signage design.

[0108] In this embodiment of the disclosure, if the number of alternative sign design schemes with a number of symmetry axes less than or equal to 1 in at least one set of alternative sign design schemes is equal to 1, then the only alternative sign design scheme with a number of symmetry axes less than or equal to 1 can be used as the target sign design scheme for the direction sign.

[0109] In this embodiment, considering that only one target identifier design scheme is actually needed to determine the structure of the directional electrode, if the number of candidate identifier design schemes with a symmetry axis less than or equal to 1 in at least one set of candidate identifier design schemes is greater than 1, each candidate identifier design scheme with a symmetry axis less than or equal to 1 can be considered as a candidate design scheme. Based on the image size and image sharpness corresponding to the at least two candidate design schemes, the target identifier design scheme for the directional identifier is determined from the at least two candidate design schemes. For example, the candidate design scheme corresponding to the candidate simulation image with the largest image size and / or the highest image sharpness can be used as the target identifier design scheme. Alternatively, the weights corresponding to the image size and image sharpness can be determined, and the product of the quantized image size and its corresponding weight and the product of the quantized image sharpness and its corresponding weight can be added together to obtain the sum. The candidate design scheme corresponding to the candidate simulation image with the largest sum is used as the target identifier design scheme; and so on. In this embodiment, the method of determining the target identifier design scheme for the directional identifier from the at least two candidate design schemes based on the image size and image sharpness corresponding to the at least two candidate design schemes is not limited. In this embodiment of the disclosure, when the number of candidate logo design schemes with a number of symmetry axes less than or equal to 1 in at least one set of candidate logo design schemes is greater than 1, each candidate logo design scheme with a number of symmetry axes less than or equal to 1 is taken as a candidate design scheme. Based on the image size and image clarity corresponding to the at least two candidate design schemes respectively, the target logo design scheme of the directional logo can be determined from the at least two candidate design schemes. This can determine the target logo design scheme that makes the directional logo most directional, thereby improving the accuracy of orientation recognition of the directional electrode.

[0110] Figure 16 is a flowchart of a directional electrode orientation identification method provided in an embodiment of this disclosure. This embodiment is applicable to the case of directional electrode orientation identification. The method can be executed by the directional electrode orientation identification device provided in this embodiment of the disclosure. The device can be implemented by software and / or hardware and can be integrated into an electronic device, which can be various user terminals or servers.

[0111] Referring to Figure 16, the method of this embodiment includes S310-S320.

[0112] S310. Obtain medical images of a user who has been implanted with the directional electrode provided in any embodiment of this disclosure, multiple reference simulation images corresponding to the directional markers in the directional electrode, and a reference orientation corresponding to each reference simulation image.

[0113] The medical images are acquired by capturing images of the directional markers of the implanted directional electrodes within the user's body. The medical images can also be images of the directional electrodes themselves; for example, CT images. The reference simulation image is an image obtained by simulating the directional markers. For example, this simulation can be a CT simulation; the reference simulation image can be, for example, an alternative simulation image corresponding to the directional markers. The reference orientation is the orientation of the directional electrodes represented by the reference simulation image.

[0114] It should be noted that multiple reference simulation images can be obtained by simulating medical images of directional electrodes with multiple different reference orientations.

[0115] S320. Perform image matching between the medical image and multiple reference simulation images respectively, and identify the electrode orientation of the directional electrode implanted in the user's body based on the reference orientation corresponding to the successfully matched reference simulation image.

[0116] Among them, electrode orientation refers to the orientation of directional electrodes.

[0117] It is understood that the directional marking regions in medical images corresponding to directional electrodes with different orientations may differ. The difference in directional marking regions generally stems from different rotation angles. Therefore, image matching between the medical image and multiple reference simulation images involves performing similarity matching between the reference simulation images of directional electrodes with different reference orientations and the medical image, so that the reference orientation corresponding to the successfully matched reference simulation image is the electrode orientation of the directional electrode. In this embodiment, the method of identifying the electrode orientation of the directional electrode implanted in the user's body based on the reference orientation corresponding to the successfully matched reference simulation image is not limited.

[0118] For example, medical images can be matched with multiple reference simulation images, and the reference orientation corresponding to the successfully matched reference simulation images can be mapped onto the medical images. The reference orientation mapped onto the medical images can then be used as the electrode orientation.

[0119] The technical solution of this disclosure involves acquiring medical images of a user who has had a directional electrode implanted in any embodiment of this disclosure, multiple reference simulation images corresponding to the directional markers in the directional electrode, and a reference orientation corresponding to each reference simulation image, to clearly identify the medical images, reference simulation images, and reference orientations. The medical images are then matched with the multiple reference simulation images, and the electrode orientation of the directional electrode implanted in the user's body is identified based on the reference orientation of the successfully matched reference simulation image, thus achieving directional electrode orientation identification. This technical solution achieves accurate directional electrode orientation identification by matching medical images with multiple reference simulation images and identifying the electrode orientation of the directional electrode implanted in the user's body based on the reference orientation of the successfully matched reference simulation image.

[0120] An optional technical solution involves obtaining multiple reference simulation images corresponding to the directional markers in a directional electrode and a reference orientation corresponding to each reference simulation image, including: obtaining multiple reference orientations of the directional electrode based on the reference orientation of the directional electrode; obtaining reference simulation images corresponding to the directional markers of the directional electrode under the multiple reference orientations, wherein the reference simulation images include at least the portion corresponding to the directional markers in the directional electrode.

[0121] The reference orientation is the orientation that serves as the reference for the orientation of the directional electrode.

[0122] In this embodiment of the disclosure, for example, the reference orientation can be rotated at multiple angles to obtain multiple reference orientations of the directional electrode. In this embodiment of the disclosure, the method of obtaining multiple reference orientations of the directional electrode based on the reference orientation of the directional electrode is not limited.

[0123] In this embodiment of the disclosure, medical images of the directional electrode's orientation marker under multiple reference orientations can be simulated to obtain reference simulation images corresponding to the directional electrode's orientation marker under each of the multiple reference orientations. In this embodiment of the disclosure, the method for obtaining the reference simulation images corresponding to the directional electrode's orientation marker under multiple reference orientations is not limited.

[0124] In this embodiment of the disclosure, reference simulation images corresponding to the directional markings of the directional electrode under multiple reference orientations can be obtained, providing a basis for multiple reference simulation images required in the process of directional electrode orientation recognition, thereby facilitating the realization of directional electrode orientation recognition.

[0125] Another optional technical solution, the directional electrode orientation recognition method, further includes: acquiring a second identification feature parameter for each reference simulation image and establishing a correspondence between the second identification feature parameter and the reference orientation of the reference simulation image; performing image matching between the medical image and multiple reference simulation images respectively, including: performing image matching between the medical image and multiple reference simulation images respectively according to the second identification feature parameter corresponding to each of the multiple reference simulation images; identifying the electrode orientation of the directional electrode implanted in the user's body according to the reference orientation corresponding to the successfully matched reference simulation image, including: determining the reference orientation corresponding to the successfully matched reference simulation image as the electrode orientation of the directional electrode implanted in the user's body.

[0126] The second identifier feature parameter is a characteristic parameter of the orientation identifier in the reference simulation image, that is, the second identifier feature parameter can be used to point to the reference orientation in the reference simulation image; the second identifier feature parameter can be at least one of the following: image orientation, position of a recognizable part, and orientation of the axis of symmetry.

[0127] In this embodiment of the disclosure, the method of obtaining the second identifier feature parameter can be the same as or different from the method of determining the first identifier feature parameter. In this embodiment of the disclosure, the method of obtaining the second identifier feature parameter is not limited.

[0128] For example, when the second identifier feature parameter is the orientation of the axis of symmetry, the orientation of the axis of symmetry can be associated with a reference orientation. For instance, the direction pointed to by the dark line in the orientation of the axis of symmetry can be used as the reference orientation. Based on the established association, a correspondence between the second identifier feature parameter and the reference orientation of the reference simulation image can be established. In this embodiment of the disclosure, the method of establishing the correspondence between the second identifier feature parameter and the reference orientation of the reference simulation image is not limited.

[0129] In this embodiment of the disclosure, image features corresponding to the reference simulation image and the medical image can be identified based on the second identification feature parameter of each of the multiple reference simulation images, and the image features corresponding to the reference simulation image and the medical image can be matched. In this embodiment of the disclosure, the method of image matching between the medical image and the multiple reference simulation images based on the second identification feature parameter corresponding to each of the multiple reference simulation images is not limited.

[0130] For example, when the second identifier feature parameter is the orientation of the axis of symmetry, the axes of symmetry corresponding to the reference simulation image and the medical image are identified respectively. If the orientations of the axes of symmetry corresponding to the identified reference simulation image and the medical image are the same, then the reference simulation image and the medical image are successfully matched.

[0131] In this embodiment of the disclosure, the image features of medical images and the reference orientations corresponding to successfully matched reference simulation images can be correlated according to a correspondence. Based on the correlation result, the electrode orientation of the directional electrode implanted in the user's body can be identified. In this embodiment of the disclosure, the electrode orientation of the directional electrode implanted in the user's body is identified based on the reference orientations corresponding to successfully matched reference simulation images and the corresponding relationship.

[0132] For example, when the second identifier feature parameter is the orientation of the axis of symmetry, and the correspondence is that the direction pointed by the dark line in the orientation of the axis of symmetry is taken as the reference orientation, the direction pointed by the dark line in the orientation of the axis of symmetry of the medical image is determined according to the correspondence, and the direction pointed by the dark line is correlated with the reference orientation corresponding to the successfully matched reference simulation image. Based on the correlation result, the electrode orientation of the directional electrode implanted in the user's body is identified.

[0133] In this embodiment of the disclosure, medical images can be matched with multiple reference simulation images using the second identification feature parameter, and the electrode orientation of the directional electrode implanted in the user's body can be identified through the correspondence, which can improve the accuracy of the determined reference orientation.

[0134] Figure 17 is a structural block diagram of a directional sign design device provided in an embodiment of this disclosure. This device is configured to execute the directional sign design method provided in any of the above embodiments. This device and the directional sign design method of the above embodiments belong to the same inventive concept. Details not described in detail in the embodiments of the directional sign design device can be referred to the embodiments of the directional sign design method described above. Referring to Figure 17, the device may include: an alternative simulation image simulation module 410 and a target sign design scheme determination module 420.

[0135] The alternative simulation image simulation module 410 is configured to determine at least one set of alternative sign design schemes, and for each of the alternative sign design schemes in the at least one set of alternative sign design schemes, simulate and obtain alternative simulation images of the alternative sign design schemes. The alternative simulation images are images obtained by simulating alternative signs, and the alternative signs are the signs corresponding to the alternative sign design schemes of the directional signs to be designed.

[0136] The target identifier design scheme determination module 420 is configured to determine the target identifier design scheme of the directional identifier from the at least one set of candidate identifier design schemes based on the candidate simulation images corresponding to the at least one set of candidate identifier design schemes, so as to determine the structure of the directional electrode provided in any embodiment of this disclosure based on the target identifier design scheme.

[0137] Optionally, the target identifier design scheme determination module 420 includes:

[0138] The first identifier feature parameter determination unit is configured to determine the first identifier feature parameters of the candidate simulation images corresponding to at least one set of candidate identifier design schemes, wherein the first identifier feature parameters include at least the number of symmetry axes of the candidate simulation images.

[0139] The target sign design scheme is set as a unit, which is to use the candidate sign design scheme with the number of symmetry axes less than or equal to 1 in at least one set of candidate sign design schemes as the target sign design scheme for the direction sign.

[0140] Optionally, based on the above-mentioned device, the first identification feature parameter also includes image size and image clarity;

[0141] The target logo design scheme, as a unit, includes:

[0142] The target sign design scheme is set as a sub-unit. When the number of candidate sign design schemes with a number of symmetry axes less than or equal to 1 in at least one set of candidate sign design schemes is equal to 1, the candidate sign design scheme with a number of symmetry axes less than or equal to 1 is used as the target sign design scheme for the direction sign.

[0143] The target identifier design scheme determination module 420 also includes:

[0144] The target sign design scheme determination sub-unit is as follows: if the number of candidate sign design schemes with a number of symmetry axes less than or equal to 1 is greater than 1 in at least one set of candidate sign design schemes, each candidate sign design scheme with a number of symmetry axes less than or equal to 1 is taken as a candidate design scheme. Based on the image size and image clarity corresponding to the at least two candidate design schemes obtained, the target sign design scheme for the directional sign is determined from the at least two candidate design schemes.

[0145] The directional marker design apparatus provided in this disclosure determines at least one set of candidate marker design schemes through a candidate simulation image simulation module. For each candidate marker design scheme in the at least one set, a candidate simulation image of the candidate marker design scheme is obtained through simulation. The candidate simulation image is an image obtained by simulating a candidate marker, and the candidate marker is the marker corresponding to the candidate marker design scheme of the directional marker to be designed, so as to determine the target marker design scheme through the candidate simulation image. The target marker design scheme determination module determines the target marker design scheme of the directional marker from the at least one set of candidate marker design schemes based on the candidate simulation images corresponding to each of the at least one set of candidate marker design schemes. Based on the target marker design scheme, the structure of the directional electrode provided in any embodiment of this disclosure is determined. The directional marker with optimal pointing accuracy can be determined through the target marker design scheme. The above apparatus can determine the target marker design scheme with optimal pointing accuracy of the directional marker from the at least one set of candidate marker design schemes through the candidate simulation images corresponding to each of the at least one set of candidate marker design schemes, thereby improving the accuracy of orientation recognition of the directional electrode.

[0146] The directional sign design device provided in this disclosure can execute the directional sign design method provided in any embodiment of this disclosure and has the corresponding functional modules for executing the method.

[0147] It is worth noting that in the embodiments of the above-mentioned directional sign design device, the various units and modules included are only divided according to functional logic, but are not limited to the above division, as long as the corresponding functions can be achieved; in addition, the specific names of each functional unit are only for easy differentiation and are not used to limit the scope of protection of this disclosure.

[0148] Figure 18 is a structural block diagram of a directional electrode orientation recognition device provided in an embodiment of this disclosure. This device is configured to execute the directional electrode orientation recognition method provided in any of the above embodiments. This device and the directional electrode orientation recognition method of the above embodiments belong to the same inventive concept. Details not described in detail in the embodiments of the directional electrode orientation recognition device can be referred to the embodiments of the directional electrode orientation recognition method described above. Referring to Figure 18, the device may include: a reference orientation acquisition module 510 and an electrode orientation recognition module 520.

[0149] The reference orientation acquisition module 510 is configured to acquire medical images of users who have been implanted with directional electrodes provided in any embodiment of this disclosure, multiple reference simulation images corresponding to the directional markers in the directional electrodes, and reference orientations corresponding to each reference simulation image.

[0150] The electrode orientation recognition module 520 is configured to perform image matching between medical images and multiple reference simulation images, and to identify the electrode orientation of the directional electrode implanted in the user's body based on the reference orientation corresponding to the successfully matched reference simulation image.

[0151] Optionally, the reference orientation acquisition module 510 may include:

[0152] The reference orientation acquisition submodule is set to obtain multiple reference orientations of the directional electrode based on the reference orientation of the directional electrode.

[0153] The reference simulation image acquisition submodule is configured to acquire reference simulation images corresponding to the orientation markers of the directional electrodes under multiple reference orientations, wherein the reference simulation images include at least the portion of the directional electrodes corresponding to the orientation markers.

[0154] Optionally, the device may also include:

[0155] The correspondence establishment module is configured to obtain the second identification feature parameter of each reference simulation image and establish the correspondence between the second identification feature parameter and the reference orientation of the reference simulation image;

[0156] The electrode orientation identification module 520 may include:

[0157] The image matching submodule is configured to perform image matching between the medical image and the multiple reference simulation images based on the second identifier feature parameters corresponding to the multiple reference simulation images respectively;

[0158] The electrode orientation identification module 520 may include:

[0159] The electrode orientation recognition submodule is configured to determine the reference orientation corresponding to the successfully matched reference simulation image as the electrode orientation of the directional electrode implanted in the user's body.

[0160] The directional electrode orientation recognition device provided in this disclosure acquires, through a reference orientation acquisition module, medical images of a user with implanted directional electrodes provided in any embodiment of this disclosure, multiple reference simulation images corresponding to the orientation markers in the directional electrodes, and the reference orientation corresponding to each reference simulation image, thereby clarifying the medical images, reference simulation images, and reference orientations. Through an electrode orientation recognition module, the medical images are matched with the multiple reference simulation images, and the electrode orientation of the directional electrode implanted in the user's body is identified based on the reference orientation corresponding to the successfully matched reference simulation images. This device can achieve accurate directional electrode orientation recognition by matching medical images with multiple reference simulation images and identifying the electrode orientation of the directional electrode implanted in the user's body based on the reference orientation corresponding to the successfully matched reference simulation images.

[0161] The directional electrode orientation recognition device provided in this disclosure can execute the directional electrode orientation recognition method provided in any embodiment of this disclosure, and has the corresponding functional modules for executing the method.

[0162] It is worth noting that in the embodiments of the directional electrode orientation identification device described above, the various units and modules included are only divided according to functional logic, but are not limited to the above division, as long as the corresponding functions can be achieved; in addition, the specific names of each functional unit are only for easy differentiation and are not used to limit the scope of protection of this disclosure.

[0163] Figure 19 is a structural block diagram of an implantable stimulation system provided in an embodiment of this disclosure. This embodiment is applicable to users of implantable stimulation systems.

[0164] Referring to Figure 19, the implantable stimulation system of this disclosure embodiment includes:

[0165] Implantable stimulator 610, which is implanted into the user's body;

[0166] The directional electrode 620 provided in any embodiment of this disclosure is connected to the implantable stimulator 610, and at least one set of directional electrode contacts is implanted at a tissue target point in the user's body.

[0167] The implantable stimulator 610 is a stimulator implanted in the user's body to deliver adjustable and controllable weak electrical pulses. The user is the individual requiring electrical stimulation. The tissue target is a target point in the tissue within the user's body that requires electrical stimulation.

[0168] In this embodiment of the disclosure, the implantable stimulator is implanted into a tissue or organ such as the brain or heart within the user's body. In this embodiment of the disclosure, the location of the implantable stimulator within the user's body is not limited.

[0169] The technical solution of this disclosure involves implanting an implantable stimulator into the user's body to deliver adjustable and controllable weak electrical pulses to stimulate the user. Directional electrodes are connected to the implantable stimulator, and at least one set of directional electrode contacts is implanted at a tissue target point within the user's body to facilitate electrical stimulation of the tissue target point. The above technical solution utilizes an implantable stimulator implanted in the user's body to facilitate electrical stimulation of a tissue target point via directional electrodes connected to the implantable stimulator.

[0170] An alternative technical solution, the implantable stimulation system further includes: a medical device configured to acquire postoperative medical images of the user and acquire the electrode orientation of the directional electrode in the user's body through the directional electrode orientation recognition method provided in any embodiment of this disclosure; and a display configured to at least display the electrode trajectory and electrode orientation of the directional electrode.

[0171] Among them, the electrode trajectory is the trajectory of the directional electrode.

[0172] In this embodiment of the disclosure, medical devices can be used to acquire postoperative medical images of the user, and the orientation of the directional electrodes within the user's body can be obtained using the directional electrode orientation recognition method provided in any embodiment of the disclosure. The medical device can instruct a display to show the electrode trajectory and orientation of the directional electrodes. In this embodiment of the disclosure, by determining the electrode orientation through the medical device and by displaying at least the electrode trajectory and orientation of the directional electrodes on the display, medical personnel can more intuitively understand the state of the directional electrodes within the user's body, thereby providing support for subsequent operations such as electrical stimulation.

[0173] Figure 20 illustrates a schematic diagram of an electronic device 10 that can be used to implement embodiments of the present disclosure. The electronic device is intended to represent various forms of digital computers, such as laptop computers, desktop computers, workstations, personal digital assistants, servers, blade servers, mainframe computers, and other suitable computers. The electronic device may also represent various forms of mobile devices, such as personal digital processors, cellular phones, smartphones, wearable devices (e.g., helmets, glasses, watches, etc.), and other similar computing devices. The components shown herein, their connections and relationships, and their functions are merely illustrative and are not intended to limit the implementation of the present disclosure described and / or claimed herein.

[0174] As shown in Figure 20, the electronic device 10 includes at least one processor 11 and a memory, such as a read-only memory (ROM) 12 or a random access memory (RAM) 13, communicatively connected to the at least one processor 11. The memory stores computer programs executable by the at least one processor. The processor 11 can perform various appropriate actions and processes based on the computer program stored in the ROM 12 or loaded from storage unit 18 into the RAM 13. The RAM 13 can also store various programs and data required for the operation of the electronic device 10. The processor 11, ROM 12, and RAM 13 are interconnected via a bus 14. An input / output (I / O) interface 15 is also connected to the bus 14.

[0175] Multiple components in electronic device 10 are connected to I / O interface 15, including: input unit 16, such as keyboard, mouse, etc.; output unit 17, such as various types of displays, speakers, etc.; storage unit 18, such as disk, optical disk, etc.; and communication unit 19, such as network card, modem, wireless transceiver, etc. Communication unit 19 allows electronic device 10 to exchange information / data with other devices through computer networks such as the Internet and / or various telecommunications networks.

[0176] Processor 11 can be a variety of general-purpose and / or special-purpose processing components with processing and computing capabilities. Some examples of processor 11 include, but are not limited to, a central processing unit (CPU), a graphics processing unit (GPU), various special-purpose artificial intelligence (AI) computing chips, various processors running machine learning model algorithms, digital signal processors (DSPs), and any suitable processor, controller, microcontroller, etc. Processor 11 performs the various methods and processes described above, such as orientation marking design methods or directional electrode orientation recognition methods.

[0177] In some embodiments, the orientation marking design method or directional electrode orientation recognition method may be implemented as a computer program tangibly contained in a computer-readable storage medium, such as storage unit 18. In some embodiments, part or all of the computer program may be loaded and / or mounted on electronic device 10 via ROM 12 and / or communication unit 19. When the computer program is loaded into RAM 13 and executed by processor 11, one or more steps of the orientation marking design method or directional electrode orientation recognition method described above may be performed. Alternatively, in other embodiments, processor 11 may be configured to perform the orientation marking design method or directional electrode orientation recognition method by any other suitable means (e.g., by means of firmware).

[0178] Various embodiments of the systems and techniques described above herein can be implemented in digital electronic circuit systems, integrated circuit systems, field programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), application-specific standard parts (ASSPs), systems-on-chip (SoCs), complex programmable logic devices (CPLDs), computer hardware, firmware, software, and / or combinations thereof. These various embodiments may include implementations in one or more computer programs that can be executed and / or interpreted on a programmable system including at least one programmable processor, which may be a dedicated or general-purpose programmable processor, capable of receiving data and instructions from a storage system, at least one input device, and at least one output device, and transmitting data and instructions to the storage system, the at least one input device, and the at least one output device.

[0179] Computer programs used to implement the methods of this disclosure may be written in any combination of one or more programming languages. These computer programs may be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing apparatus, such that when executed by the processor, the computer programs cause the functions / operations specified in the flowcharts and / or block diagrams to be performed. The computer programs may be executed entirely on a machine, partially on a machine, or as a standalone software package, partially on a machine and partially on a remote machine, or entirely on a remote machine or server.

[0180] In the context of this disclosure, a computer-readable storage medium can be a tangible medium that may contain or store a computer program for use by or in conjunction with an instruction execution system, apparatus, or device. A computer-readable storage medium can be, but is not limited to, electronic, magnetic, optical, electromagnetic, infrared, or semiconductor systems, apparatus, or devices, or any suitable combination of the foregoing. Alternatively, a computer-readable storage medium can be a machine-readable signal medium. More specific examples of machine-readable storage media include electrical connections based on one or more wires, portable computer disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, compact disc-read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination of the foregoing.

[0181] To provide interaction with a user, the systems and techniques described herein can be implemented on an electronic device having: a display device for displaying information to the user (e.g., a CRT (Cathode Ray Tube) or LCD (Liquid Crystal Display) monitor); and a keyboard and pointing device (e.g., a mouse or trackball) through which the user provides input to the electronic device. Other types of devices can also be used to provide interaction with the user; for example, feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user can be received in any form (including sound input, voice input, or tactile input).

[0182] The systems and technologies described herein can be implemented in computing systems that include backend components (e.g., as data servers), or computing systems that include middleware components (e.g., application servers), or computing systems that include frontend components (e.g., user computers with graphical user interfaces or web browsers through which users can interact with implementations of the systems and technologies described herein), or any combination of such backend, middleware, or frontend components. The components of the system can be interconnected via digital data communication (e.g., communication networks) of any form or medium. Examples of communication networks include local area networks (LANs), wide area networks (WANs), blockchain networks, and the Internet.

[0183] A computing system can include clients and servers. Clients and servers are generally located far apart and typically interact through communication networks. The client-server relationship is created by computer programs running on the respective computers and having a client-server relationship with each other. The server can be a cloud server, also known as a cloud computing server or cloud host, which is a hosting product within the cloud computing service system. It addresses the shortcomings of traditional physical hosts and Virtual Private Server (VPS) services, such as high management difficulty and weak business scalability.

[0184] It should be understood that the various forms of processes shown above can be used to rearrange, add, or delete steps. For example, the steps described in this disclosure can be executed in parallel, sequentially, or in different orders, as long as the desired result of the technical solution of this disclosure can be achieved, and this is not limited herein.

[0185] The specific embodiments described above do not constitute a limitation on the scope of protection of this disclosure. Those skilled in the art should understand that various modifications, combinations, sub-combinations, and substitutions can be made according to design requirements and other factors. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this disclosure should be included within the scope of protection of this disclosure.

Claims

1. A directional electrode, comprising: The conductor body has at least one set of directional electrode contacts. A direction marker, which is arc-shaped and disposed on the conductor body, includes a first marking arc and a second marking arc, with a first gap between the first marking arc and the second marking arc.

2. The directional electrode according to claim 1, wherein, The directional electrode satisfies at least one of the following: The arc shape angle range corresponding to the direction indicator is [145°, 270°]; The range of the notch arc angle corresponding to the first notch is [30°, 90°].

3. The directional electrode according to claim 1, wherein, The direction marker further includes a connecting portion; wherein the connecting portion is configured to connect the first marker arc and the second marker arc.

4. The directional electrode according to claim 1, wherein, The arc of the first marking arc is equal to the arc of the second marking arc.

5. The directional electrode according to claim 1, wherein, In the image acquired for the directional electrode, the region corresponding to the directional marker has at most one axis of symmetry.

6. The directional electrode according to claim 5, wherein, The image is a computed tomography (CT) scan image, and the image is acquired in a direction perpendicular to the length of the conductor body.

7. The directional electrode according to claim 1, wherein, The distance between the directional electrode contact and the directional marker is in the range of [2 mm, 12 mm].

8. The directional electrode according to claim 1, wherein, The direction marker further includes at least one third marker arc, which has at least one second gap between it and at least one of the first marker arc and the second marker arc.

9. The directional electrode according to claim 1, wherein, The first marking arc and the second marking arc satisfy at least one of the following: The thicknesses of the first and second marking arcs are different; The first and second marking arcs have different arc lengths.

10. The directional electrode according to claim 1, wherein, The directional marker is made of metal or the surface of the directional marker is metal-plated.

11. A method for designing directional signs, comprising: At least one set of alternative sign design schemes is determined, and for each of the at least one set of alternative sign design schemes, an alternative simulation image of the alternative sign design scheme is obtained by simulation of the alternative sign, wherein the alternative simulation image is an image obtained by simulation of the alternative sign, and the alternative sign is the sign corresponding to the alternative sign design scheme of the directional sign to be designed. Based on the candidate simulation images corresponding to the at least one set of candidate logo design schemes, a target logo design scheme for the directional logo is determined from the at least one set of candidate logo design schemes, so as to determine the structure of the directional electrode as described in any one of claims 1-10 based on the target logo design scheme.

12. The method according to claim 11, wherein, The step of determining the target sign design scheme for the directional sign from the at least one set of candidate sign design schemes based on the candidate simulation images corresponding to each of the at least one set of candidate sign design schemes includes: Determine the first identifier feature parameters of the candidate simulation images corresponding to the at least one set of candidate identifier design schemes, wherein the first identifier feature parameters include at least the number of symmetry axes of the candidate simulation images; The candidate logo design scheme with a number of symmetry axes less than or equal to 1 in the at least one set of candidate logo design schemes shall be used as the target logo design scheme for the direction logo.

13. The method according to claim 12, wherein, The first identification feature parameter also includes the image size and image clarity of the candidate simulation image; The step of selecting candidate signage designs with a number of axes of symmetry less than or equal to 1 from the at least one set of candidate signage designs as the target signage design for the direction signage includes: In response to the fact that the number of alternative sign design schemes with a number of symmetry axes less than or equal to 1 in the at least one set of alternative sign design schemes is equal to 1, the alternative sign design scheme with a number of symmetry axes less than or equal to 1 is taken as the target sign design scheme of the direction sign. The step of determining the target sign design scheme for the directional sign from the at least one set of candidate sign design schemes based on the candidate simulation images corresponding to each of the at least one set of candidate sign design schemes further includes: In response to the fact that the number of candidate sign design schemes with a number of symmetry axes less than or equal to 1 in the at least one set of candidate sign design schemes is greater than 1, each candidate sign design scheme with a number of symmetry axes less than or equal to 1 is taken as a candidate design scheme, and the target sign design scheme of the direction sign is determined from the at least two candidate design schemes based on the image size and image clarity corresponding to the at least two candidate design schemes respectively.

14. A method for identifying the orientation of directional electrodes, comprising: Acquire medical images of a user who has had a directional electrode implanted according to any of claims 1-10, multiple reference simulation images corresponding to the directional markers in the directional electrodes, and a reference orientation corresponding to each of the reference simulation images; The medical image is matched with multiple reference simulation images, and the electrode orientation of the directional electrode implanted in the user's body is identified based on the reference orientation corresponding to the successfully matched reference simulation image.

15. The method according to claim 14, wherein, The step of obtaining multiple reference simulation images corresponding to the direction markers in the directional electrodes and the reference orientation corresponding to each of the reference simulation images includes: Based on the reference orientation of the directional electrode, multiple reference orientations of the directional electrode are obtained; Obtain reference simulation images corresponding to the orientation marks of the directional electrode under multiple reference orientations, wherein the reference simulation images include at least the portion of the directional electrode corresponding to the orientation marks.

16. The method of claim 14, further comprising: Obtain the second identification feature parameter for each of the reference simulation images, and establish the correspondence between the second identification feature parameter and the reference orientation of the reference simulation image; The step of performing image matching between the medical image and multiple reference simulation images includes: Based on the second identifier feature parameters corresponding to the plurality of reference simulation images respectively, the medical image is matched with the plurality of reference simulation images respectively; The step of identifying the electrode orientation of the directional electrode implanted in the user's body based on the reference orientation corresponding to the successfully matched reference simulation image includes: The reference orientation corresponding to the successfully matched reference simulation image is determined as the electrode orientation of the directional electrode implanted in the user's body.

17. A directional electrode orientation identification device, comprising: The reference orientation acquisition module is configured to acquire medical images of a user who has had a directional electrode implanted as described in any of claims 1-10, multiple reference simulation images corresponding to the orientation markers in the directional electrodes, and a reference orientation corresponding to each of the reference simulation images. The electrode orientation recognition module is configured to perform image matching between the medical image and multiple reference simulation images, and identify the electrode orientation of the directional electrode implanted in the user's body based on the reference orientation corresponding to the successfully matched reference simulation image.

18. An implantable stimulation system, comprising: An implantable stimulator, which is configured to be implanted into the user's body; The directional electrode as described in any one of claims 1-10, wherein the directional electrode is connected to the implantable stimulator, and at least one set of directional electrode contacts of the directional electrode is configured to be implanted into a tissue target point within the user's body.

19. The system of claim 18, further comprising: A medical device configured to acquire postoperative medical images of the user and acquire the electrode orientation of the directional electrode in the user's body using the directional electrode orientation recognition method as described in any one of claims 14-16. A display configured to at least display the electrode trajectory and electrode orientation of the directional electrodes.

20. An electronic device, comprising: At least one processor; as well as A memory communicatively connected to the at least one processor; wherein, The memory stores a computer program that can be executed by the at least one processor, the computer program being executed by the at least one processor to cause the at least one processor to perform the orientation marking design method as described in any one of claims 11-13 or the directional electrode orientation identification method as described in any one of claims 14-16.

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