WO2023236904A1

WO2023236904A1 - State configurator of implanted electrode, electrostimulation system and configuration method therefor

Info

Publication number: WO2023236904A1
Application number: PCT/CN2023/098319
Authority: WO
Inventors: 吕依蔓; 夏俊伟; 唐龙军; 赵思敏; 郑德恩
Original assignee: 上海神奕医疗科技有限公司
Priority date: 2022-06-06
Filing date: 2023-06-05
Publication date: 2023-12-14
Also published as: CN114949603A

Abstract

The present invention provides a state configurator of an implanted electrode, an electrostimulation system and a configuration method therefor. The state configurator of the implanted electrode comprises: a contact group composed of at least one first contact, and a second contact. The states of the first contact and the second contact are any one of a first electrode, a second electrode, and an inactivity; the first electrode is a positive electrode or a negative electrode, and the second electrode has a polarity opposite to that of the first electrode; the contact group is switched between a folding mode and an unfolding mode; the contact group, when in the folding mode, serves as a whole contact, the state of the whole contact is any one of the first electrode, the second electrode and the inactivity, and the state of each first contact in the contact group is configured to be associated with each other; when the contact group is in the unfolding mode, the state of each first contact in the contact group is configured to be independent of each other; the contact group, when being switched between the folding mode and the unfolding mode, is configured according to a preset condition based on the current state of the second contact and the current state of each first contact in the contact group.

Description

State configurator for implanted electrodes, electrical stimulation system and configuration method thereof

Technical field

The present invention relates to the technical field of medical devices, and in particular to a state configurator for implanted electrodes, an electrical stimulation system and a configuration method thereof.

Background technique

With the development of brain surgery technology and neuroelectronic science and technology, deep brain stimulation (DBS) has better clinical effects than damaging surgery, a minimally invasive surgical process that does not damage brain tissue, and a reversible treatment plan. It has become the first choice treatment method for advanced Parkinson's disease worldwide. Existing deep brain electrical stimulation systems mainly include an implanted part in the body and a programmable part outside the body. As shown in Figures 1a and 1b, the implanted part in the body includes three parts: implantable pulse generator 1 (hereinafter referred to as IPG), electrode extension lead 2, and implanted electrode 3. The IPG is used to provide electrical stimulation pulse signals to the implanted electrode 3; the electrode extension wire 2 is used to connect the implanted electrode 3 and the IPG; the implanted electrode 3 is used to be implanted into human brain tissue to stimulate the predetermined treatment target area in the brain tissue. After implantation into the human body, the electrode distal end 32 of the implanted electrode 3 is placed in the patient's predetermined treatment target area; the implanted electrode 3 is fixed on the skull surface through the skull fixation device 4; the connector 38 at the proximal end of the implanted electrode 3 It is connected to the distal end 27 of the electrode extension lead 2; the electrode extension lead 2 extends through the subcutaneous tunnel to near the clavicle; and the proximal end 28 of the electrode extension lead 2 is connected to the IPG.

The electrode distal end 32 of the implanted electrode 3 has multiple stimulation contacts, which are implanted in the intracranial brain tissue, and their main function is to output electrical signals to the treatment target to achieve neuromodulation. Most of the stimulation contacts at the distal end 32 of electrodes currently on the market are ring-shaped contacts, and their stimulation range is a 360° ring stimulation, and the direction of the electric field generated is evenly distributed around the ring. At this time, relevant electric field coverage, that is, electrical stimulation, can be provided to relevant nerve nuclei, such as the subthalamic nucleus (STN) and the globus pallidus medial nucleus (GPi), but at the same time, it also produces electrical stimulation to other surrounding nerve nuclei, which is easy to It produces side effects and increases power consumption, making patients feel uncomfortable and requiring frequent charging, which reduces the service life of the product.

In order to reduce the side effects of stimulation and product power consumption, directional electrodes are more advanced. Directional electrodes mean that the stimulation contacts are arranged in a non-continuous ring around the electrode distal end 32, that is, the stimulation direction can be 360° circumferentially. The electrode implantation position can be adjusted relative to the treatment target position.

However, existing directional electrodes and ring electrodes are incompatible, resulting in low treatment flexibility and reducing outpatient control efficiency.

Contents of the invention

The purpose of the present invention is to provide a state configurator for implanted electrodes, an electrical stimulation system and a configuration method thereof, so as to solve the problem of incompatibility between directional electrodes and ring electrodes in existing deep brain stimulation medical devices.

In order to solve the above technical problems, the present invention provides a state configurator for implanted electrodes, which includes: a contact group composed of at least one first contact point and a second contact point, the first contact point and the second contact point. The state of the contact is any one of the first pole, the second pole and inactive; the first pole is positive or negative, and the second pole is the opposite polarity to the first pole; the contact The group switches between collapsed and expanded modes;

When the contact group is in the retracted mode, it serves as an integral contact, and the state of the integral contact is any one of first pole, second pole, and inactive. Each of the contacts in the contact group The states of the first contacts are configured to be correlated;

When the contact group is in the expansion mode, the state of each first contact in the contact group is configured to be independent;

The contact group is configured when switching between the retracted mode and the unfolded mode based on the current state of the second contact and the current state of each first contact in the contact group. , configure the state of the first contact according to preset conditions.

Optionally, before configuring the status of each first contact in the contact group according to preset conditions, the contact group satisfies:

When the contact group is switched from the retracted mode to the expanded mode, the state of each first contact in the contact group is configured to be inactive;

When the contact group is switched from the unfolded mode to the retracted mode, the entire contact group is configured to be inactive.

Optionally, the preset conditions include: when the stimulation output mode of the implanted electrode is the current mode, all the first contacts, the second contacts and the overall contacts satisfy: the status is described The sum of the number of the first contact point, the second contact point and the overall contact point of the first pole = 1, and the state is the first contact point, the second contact point of the second pole The sum of the number of points and the overall contacts is ≥1.

Optionally, the preset conditions include: when the stimulation output mode of the implanted electrode is voltage mode, all the first contacts, the second contacts and the overall contacts satisfy: the status is The total number of the first contact point, the second contact point and the overall contact point of the first pole is ≥ 1, and the state is the first contact point, the third contact point of the second pole The sum of the number of two contacts and the overall contact is ≥1.

Optionally, the status configurator includes two contact point groups and two second contact points, each of the contact point groups includes three first contact points; two contact points The group and the two second contacts are arranged along the length direction of the status configurator, and the two contact groups are arranged between the two second contacts.

In order to solve the above technical problems, the present invention also provides an electrical stimulation system, which includes implanted electrodes, implanted pulse generators, and the state configurator of the implanted electrodes as described above, and also includes the state configurator. A connected switching module is used to switch the mode of the contact group; the state configurator is communicatively connected to the implantable pulse generator.

Optionally, the electrical stimulation system further includes an input module; the input module is used to receive an input stimulation instruction, and the switching module determines the stimulation instruction received by the input module and the current contact point in the contact group. The state of each first contact switches the mode of the contact group.

Optionally, the stimulation instructions are directional stimulation instructions;

If the contact group is in the expanded mode, the switching module is configured to maintain the contact group in the expanded mode;

If the contact group is in the retracted mode, the switching module is configured to switch the contact group to the expanded mode.

Optionally, the stimulation instruction is a ring stimulation instruction;

If the contact group is in the unfolded mode, the switching module is configured to switch the contact group to the retracted mode;

If the contact group is in the retracted mode, the switching module is configured to maintain the contact The point group is in the collapsed mode.

Optionally, the electrical stimulation system includes two of the implanted electrodes, two of the state configurators and two of the switching modules, and the implanted electrodes, the state configurator and the switching module are one In one correspondence, the modes of the contact groups of the state configurator corresponding to the two implanted electrodes are switched independently.

Optionally, each implanted electrode includes a circumferential electrode and an electrode group, wherein the electrode group includes a plurality of directional electrodes in the same circumferential direction, and the circumferential electrodes are spaced apart from the electrode group along the axial direction.

Optionally, each first contact point in the contact point group corresponds one-to-one to a direction electrode in a corresponding electrode group among the implanted electrodes.

In order to solve the above technical problems, the present invention also provides a configuration method of an electrical stimulation system, which is applied to the above-mentioned electrical stimulation system; the configuration method of the electrical stimulation system includes: according to the received stimulation instruction and the current contact group According to the state of each first contact, the mode of the contact group is switched.

Optionally, when the stimulation instruction is a directional stimulation instruction, if the contact point group is in the expansion mode, the contact point group is maintained in the expansion mode. If the contact point group is in the expansion mode, In the retracted mode, switch the contact group to the expanded mode;

In the case where the stimulation instruction is a ring stimulation instruction, if the contact point group is in the expansion mode, switch the contact point group to the retraction mode; if the contact point group is in the retraction mode, Then the contact group is maintained in the retracted mode.

To sum up, in the state configurator of implanted electrodes, the electrical stimulation system and the configuration method thereof provided by the present invention, the state configurator of implanted electrodes includes: a contact group composed of at least one first contact point. and a second contact, the state of the first contact and the second contact is any one of the first pole, the second pole, and inactive; the first pole is positive or negative, and the third pole The second pole has a polarity opposite to the first pole; the contact group switches between the retracted mode and the expanded mode; when the contact group is in the retracted mode, it serves as an integral contact, and the integral contact The state is any one of first pole, second pole and inactive, and the states of each first contact in the contact group are configured to be related to each other; when the contact group is in the expansion mode , the state of each first contact point in the contact point group is configured to be independent; the contact point group is configured when switching between the folding mode and the unfolding mode. Set to configure the state of the first contact according to preset conditions based on the current state of the second contact and the current state of each first contact in the contact group.

In this configuration, based on the expansion mode of the contact group, the states of all first contacts are configured to be independent, and each first contact is independently configured to present a different state, so that the corresponding implanted electrode is in the same state. The directional electrodes in the circumferential direction have different states and can generate directional stimulation electric fields when directional stimulation is required. Based on the shrinking mode of the contact group, the entire contact group is configured as an integral contact, so that the electrodes in the same circumferential direction in the corresponding implanted electrodes are in the same state, and can act as a ring electrode, so they can be When annular stimulation is required, an annular stimulation electric field is generated. Therefore, ring-shaped stimulation output or directional stimulation output can be used for different treatment scenarios. The stimulation output is more in line with the needs of the treatment scenario, reduces power consumption, and reduces the occurrence of side effects. Furthermore, when the mode of the contact group is switched, it can be automatically configured according to the preset conditions according to the status of the second contact and the current status of the first contact in the contact group, so that different doctors can freely switch under different conditions. Switch modes to increase treatment flexibility and improve outpatient control efficiency.

Description of drawings

Those of ordinary skill in the art will understand that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. in:

Figures 1a and 1b are schematic diagrams of an implanted electrical stimulation system and its implantation application scenarios;

Figure 2 is a schematic diagram of an implanted electrode according to an embodiment of the present invention;

Figure 3 is a schematic diagram of a state configurator of an implanted electrode according to an embodiment of the present invention, in which the contact group is in an expanded mode;

Figure 4 is a schematic diagram of a state configurator of an implanted electrode according to an embodiment of the present invention, in which the contact group is in a retracted mode;

Figure 5 is an equivalent diagram of the state configurator of the implanted electrode shown in Figure 4;

Figure 6a is a schematic diagram of the contact group switching from the expanded mode to the collapsed mode according to the embodiment of the present invention;

Figure 6b is a schematic diagram of the contact group switching from the collapsed mode to the expanded mode according to the embodiment of the present invention;

Figure 7 is a schematic diagram of an electrical stimulation system according to an embodiment of the present invention.

Figure 8 is a circuit schematic diagram when the switching module receives a directional stimulation instruction.

Figure 9 is a schematic diagram of the circuit when the switching module receives ring stimulation.

In the attached picture:
1-Implantable pulse generator; 2-Electrode extension lead; 27-Distal end of lead; 28-Proximal end of lead; 3-
Implanted electrode; 30-circumferential electrode; 31-electrode group; 311-directional electrode; 32-electrode distal end; 38-connector; 4-cranial fixation device;
10-contact group; 11-first contact; 21-second contact; 40-input module; 50-switching module.

Detailed ways

In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, each drawing needs to display different emphasis, and sometimes uses different proportions.

As used in this invention, the singular forms "a", "an" and "the" include plural referents, the term "or" is generally used in its sense including "and/or", and the term "several" The term "at least two" is usually used in a meaning including "at least one", and the term "at least two" is usually used in a meaning including "two or more". In addition, the terms "first" and "th "Second" and "third" are used for descriptive purposes only and cannot be understood as indicating or implying the relative importance or implicitly indicating the quantity of the technical features indicated. Therefore, the features defined as "first", "second" and "third" may explicitly or implicitly include one or at least two of these features, "one end" and "other end" and "proximal end" and "Remote" usually refers to the two corresponding parts, which includes not only the endpoint. The terms "proximal end" and "distal end" are defined herein with respect to an implanted electrode having one end for insertion into the human body and a control end extending outside the body. The term "proximal end" refers to the position of the component closer to the control end of the implanted electrode that protrudes outside the body, and the term "distal end" refers to the end of the component closer to the implanted electrode inserted into the human body and therefore further away from the implanted electrode. The location of the control end. Optionally, in manual or hand-operated applications, the terms "proximal" and "distal" are defined herein with respect to an operator such as a surgeon or clinician. The term "proximal" refers to the location of the element closer to the operator, and the term "distal" refers to the location of the element closer to the implanted electrode and therefore farther from the operator. In addition, as used in the present invention, "installation", "connection", "connection" "Connected" means that one element is "disposed" on another element, which should be understood broadly. It usually only means that there is a connection, coupling, matching or transmission relationship between the two elements, and the relationship between the two elements can be direct or indirect through an intermediate element. connection, coupling, matching or transmission, and cannot be understood as indicating or implying the spatial positional relationship between two elements, that is, one element can be in any position inside, outside, above, below or to one side of another element, unless the content indicates otherwise Unless clearly indicated. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. In addition, terms such as above, below, up, down, up, down, left, right, etc. Directional terms are used with respect to the exemplary embodiments as they are depicted in the figures, with an upward or upward direction being toward the top of the corresponding figure and a downward or downward direction being toward the bottom of the corresponding figure.

The purpose of the present invention is to provide a state configurator for implanted electrodes, an electrical stimulation system and a configuration method thereof, so as to solve the problems of existing deep brain stimulation medical devices in which ring stimulation easily produces side effects and increases power consumption.

Description will be made below with reference to the drawings.

Please refer to Figure 2, which shows an implanted electrode 3, which includes a circumferential electrode 30 and an electrode group 31. The electrode group 31 includes a plurality of directional electrodes 311 in the same circumferential direction. The inventor found that although directional electrodes have advantages over circumferential electrodes, the application of directional electrodes is also subject to certain limitations. On the one hand, it is difficult for some doctors who are not familiar with directional control methods to use directional electrodes. On the other hand, in some cases When a ring stimulation mode is required in an application scenario, the application of directional electrodes is limited, and the polarity configuration of the stimulation contacts is relatively complex and cannot be applied conveniently.

Based on the above research, please refer to Figures 3 and 4, and in conjunction with Figure 2, an embodiment of the present invention provides a state configurator for implanted electrodes, which includes a contact group 10 composed of at least one first contact 11 and a second Contact 21. In this embodiment, the state of the first contact 11 and the second contact 21 is any one of the first pole, the second pole, and inactive; the first pole is the positive pole or the negative pole, and the second pole is the same as the positive pole. The polarity of the first pole is opposite; the contact group 10 switches between the retracted mode and the unfolded mode. Preferably, the second contact 21 is located outside the contact group 10 and does not affect each first contact 11 in the contact group 10 The relationship between them is to form a collapse mode and an expansion mode. When the contact group 10 is in the retracted mode, it serves as an integral contact. The state of the entire contact is any one of first pole, second pole, and inactive. The state of each first contact 11 in the contact group 10 is are configured to be related to each other; when the contact group 10 is in the expanded mode, the status of each first contact 11 in the contact group 10 is configured to be independent; the contact group 10 is configured when switching between the collapsed mode and the expanded mode To configure the state of the first contact 11 according to preset conditions based on the current state of the second contact 21 and the current state of each first contact 11 in the contact group 10 . Among them, the inactive state means that the electrode in the implanted electrode 3 corresponding to the finger contact (referring to any one of the first contact 11, the second contact 21 and the overall contact) is at the same potential or at the same potential relative to the human body. Hanging state. It should be noted that the state configurator of the implanted electrode can be a physical module such as a remote control, or a virtual module in a program controller connected to the IPG communication, and the present invention is not limited to this.

Optionally, the above-mentioned second contact point 21 is configured to correspond to one circumferential electrode 30 in the implanted electrode 3; the contact point group 10 includes at least two first contacts 11, and each first contact point 11 in the contact point group 10 The contact 11 corresponds one-to-one with the directional electrode 311 in the same circumferential direction among the implanted electrodes; the states of the first contact 11, the second contact 21 and the overall contact correspond to the states of the electrodes they are adapted to; the state configurator For example, the communication connection with the IPG can be realized through wired or wireless means, and the corresponding electrodes of the implanted electrode 3 can be configured. In particular, each first contact 11, second contact 21 and overall contact on the status configurator refers to the analog point corresponding to each electrode on the implanted electrode 3, which belongs to the program control part and is not directly related to patient contact. Each electrode on the implanted electrode 3 is in direct contact with the patient and is used to release electrical stimulation.

In this configuration, based on the expansion mode of the contact group 10, the states of all the first contacts 11 are configured to be independent, and each first contact 11 and the second contact 21 are independently configured to present different states, so that corresponding The directional electrodes 311 in the same circumferential direction among the implanted electrodes 3 are in different states, and can generate a directional stimulation electric field when directional stimulation is required. Based on the folding mode of the contact group 10, the entire contact group 10 is configured as an integral contact, so that the corresponding directional electrodes 311 in the same circumferential direction in the corresponding implanted electrode 3 are in the same state, and can function as a ring electrode. , so annular stimulation electric fields can be generated when annular stimulation is required. Therefore, ring-shaped stimulation output or directional stimulation output can be used for different treatment scenarios. The stimulation output is more in line with the needs of the treatment scenario, reduces power consumption, and reduces the occurrence of side effects. Furthermore, when the mode of the contact group 10 is switched, the configuration can be automatically performed according to the preset conditions according to the current state of the second contact 21 and the current state of each first contact 11 in the contact group 10, which is convenient for different doctors. Freely switch modes under different conditions to increase treatment flexibility and improve outpatient control efficiency.

As shown in Figures 3 and 4, in an example, the state controller of the implanted electrode includes two contact groups 10 and two second contacts 21. The two contact groups 10 are along the length of the state controller. The direction is arranged between the two second contacts 21 . As shown in Figure 2, it is an implanted electrode 3 corresponding to the state controller shown in Figures 3 and 4, which is axially oriented from the distal end (the left end of Figure 2) to the proximal end (the right end of Figure 2), Arranged in the order of circumferential electrode 30, electrode group 31, electrode group 31, and circumferential electrode 30, two second contacts 21 are respectively configured to correspond to one circumferential electrode 30, and the two contact groups 10 corresponds to the two electrode groups 31 one-to-one, and can be configured according to the mode it is in, so that the electrode group 31 presents a whole electrode to achieve a ring stimulation mode or presents multiple directional electrodes to achieve directional stimulation. mode.

If a certain contact point group 10 is in the collapsing mode, the states of each first contact point 11 in the contact point group 10 are configured to be related to each other and remain the same. At this time, the contact group 10 is configured as an integral contact, that is, the corresponding entire electrode group 31 is regarded as a ring electrode. It can be understood that when both contact groups 10 are in the retracted mode, in the example shown in FIG. 2 , the entire implanted electrode can be regarded as including 4 electrodes, and the 4 electrodes vary according to their axial positions. Arranged in a 1, 1, 1, 1 pattern. Optionally, the two separate circumferential electrodes 30 are respectively ring-shaped electrodes, and the electrode group 31 includes at least two circumferentially arranged directional electrodes 311. The circumferential electrodes 30 and the directional electrodes 311 are respectively connected to the implantable pulse generator. Device 1, therefore, the entire electrode group 31 can also be regarded as a ring electrode, and the entire implanted electrode can be used to deliver ring-shaped electrical stimulation.

If a certain contact point group 10 is in the expansion mode, the status of each first contact point 11 in the contact point group 10 is configured to be independent, and the status of each independent first contact point 11 can be configured separately. In an example, each contact group 10 includes three independently arranged first contacts 11 that can be gathered or dispersed. It can be understood that corresponding to the example shown in Figure 2, when both contact groups 10 are in the deployment mode, the entire implanted electrode 3 can be regarded as including 8 electrodes, and the 8 electrodes are arranged according to the axial position. Different, arranged in the form of 1, 3, 3, 1. Further, each first contact point 11 can be connected to the implanted pulse generator 1 respectively, and each first contact point 11 can be independently controlled to release electrical stimulation, whereby the implanted electrode 3 can be used to release electrical stimulation. Directional electrical stimulation. It should be noted that the modes of the two contact groups 10 may be the same or different, that is, one may be in the expanded mode and the other may be in the retracted mode, and the invention is not limited thereto.

Mode switching of the contact group 10 of the implanted electrode will be described below with reference to FIGS. 3 and 4 . In Figures 3 and 4, "+" represents the status of a certain contact as the positive pole, "-" represents the status of a certain contact as the negative pole, and "X" represents the status of a certain contact as inactive. For the convenience of description, the two second contacts 21 are respectively identified as contact No. ① and contact No. 8, and the three first contacts 11 in a contact group 10 are identified as contact No. ②, No. 3 and No. 4. point, the three first contacts 11 in another contact group 10 are identified as contacts No. 5, No. 6 and No. 7. It should be noted that in Figures 3 and 4, the arrangement of the three first contacts 11 in the contact group 10 in a Z-shaped pattern is only for illustration and does not represent the actual arrangement state of the corresponding direction electrodes 311. In practice, The three direction electrodes 311 in the electrode group 31 are arranged along the circumferential direction of the implanted electrode 3. Please refer to Figure 2 for details. The arrangement of the three first contacts 11 in the contact group 10 can also be in other forms, and is not limited to a square shape. For example, it can also be arranged to simulate the appearance of the implanted electrode 3 .

In the example shown in FIG. 3 , the status of the eight contacts is inactive, and both contact groups 10 are in the expanded mode. In the example shown in FIG. 4 , the status of the eight contacts is inactive, while one contact group 10 is in the collapsed mode (enclosed by a box in the figure), and the other contact group 10 is in the expanded mode. It can be understood that the state configurator shown in FIG. 4 is equivalent to the six-contact state configurator shown in FIG. 5 .

In the examples shown in Figures 3 to 5, the status of all contacts is inactive, and it can be understood that the electrodes corresponding to them are in a state of not releasing electrical stimulation. In actual use, the stimulation output mode of the implanted electrode 3 includes current mode and voltage mode. In the current mode and voltage mode, the electrodes need to include at least positive and negative electrodes at the same time to form a loop. Therefore, correspondingly, each contact in the status configurator needs to include both positive and negative electrodes. It can be understood that the contact point here may be the second contact point 21, the first contact point 11 in the contact point group 10 in the expanded mode, or it may be integrally formed by the contact point group 10 in the retracted mode. For the overall contact, please refer to the above description for details and will not be repeated here.

Optional, preset conditions include: when the stimulation output mode of the implanted electrode is current mode, all contacts meet: the first contact 11, the second contact 21 and the number of overall contacts whose status is the first pole. The sum=1, and the sum of the numbers of the first contact 11, the second contact 21 and the overall contact in the second pole state is ≥1. For a certain implanted electrode 3, when its stimulation output mode is current mode, there are the following rules:

1) When the number of positive electrodes is greater than 1, the number of negative electrodes must be equal to 1; when the number of negative electrodes is greater than 1, the number of positive electrodes must be equal to 1.

2) When the number of positive electrodes is equal to 1, the number of negative electrodes can be greater than or equal to 1; when the number of negative electrodes is equal to 1, the number of positive electrodes can be greater than or equal to 1.

3) In current mode, there is no situation where the number of positive electrodes is greater than 1 and the number of negative electrodes is greater than 1.

It can be obtained that the sum of the number of contacts in the first pole state = 1, and the sum of the number of contacts in the second pole state ≥ 1. When the first pole here is positive, the second pole is negative. On the other hand, if the first pole is negative, the second pole is positive.

Optional, preset conditions include: when the stimulation output mode of the implanted electrode is voltage mode, all electrodes meet: the sum of the number of first contacts 11, second contacts 21 and overall contacts in the first pole state. ≥1, and the sum of the number of the first contact 11, the second contact 21 and the overall contact in the second pole state is ≥1. For a certain implanted electrode, when its stimulation output mode is the voltage mode, it includes at least one positive electrode and one negative electrode, but there is no limit on the number of positive electrodes and the number of negative electrodes. Therefore, the status of the contacts is also configured accordingly, and it is necessary to ensure that there are positive contacts and negative contacts at the same time.

Further, before configuring the state of the first contact 11 in the contact group 10 according to the preset conditions, the contact group 10 satisfies: when the contact group 10 switches from the retracted mode to the expanded mode, the contact group 10 The state of each first contact 11 is configured as inactive; when the contact group 10 is switched from the unfolded mode to the retracted mode, the entire contact group 10 is configured as inactive.

Please refer to Figure 6a and Figure 6b, taking a contact group 10 as an example for explanation. The contact group 10 includes three first contacts 11, which are marked as contact points ②, ③ and ④ respectively for the convenience of description. .

Figure 6a shows the situation when the contact group 10 is switched from the unfolded mode to the collapsed mode. When in the expansion mode, the status of contact No. 2 in the contact group 10 is positive, the status of contact No. 3 is positive, and the status of contact No. 4 is negative. Before configuring the status of each first contact 11 of the contact group 10, the entire contact group 10 needs to be configured as inactive, and then according to other contact groups other than the contact group 10 and each The state of the second contact 21 configures the contact group 10 as an integral contact.

Figure 6b shows the situation when the contact group 10 is switched from the folded mode to the unfolded mode. When in the retracting mode, the entire contact group 10 is positive. Before configuring the status of each first contact 11 of the contact group 10, the status of each first contact 11 in the contact group 10 needs to be configured as inactive. Furthermore, each first contact 11 in the contact group 10 is configured according to the status of other contact groups outside the contact group 10 and the second contacts 21 .

It should be noted that the above-mentioned FIG. 6 a and FIG. 6 b are only examples of mode switching of one contact group 10 and do not limit the state of each first contact 11 in the contact group 10 .

Please refer to Figure 7. Based on the above implanted electrode 3, an embodiment of the present invention also provides an electrical stimulation system, which includes the above implanted electrode 3 and an implanted pulse generator 1, a state configurator and an implanted pulse The generator 1 is communicatively connected and also includes a switching module 50 connected to the status configurator; the switching module 50 is used to switch the mode of the contact group 10 . The switching module 50 can be integrated into a program controller located outside the body and is communicatively connected to the implanted pulse generator 1, or can be independently attached, and the present invention is not limited thereto.

Preferably, the electrical stimulation system also includes an input module 40; the input module 40 is used to receive input stimulation instructions, and the switching module 50 switches based on the stimulation instructions received by the input module 40 and the status of each first contact 11 in the current contact group 10 , switches the mode of contact group 10. For example, the input module 40 can be integrated into a smart terminal (such as a mobile phone, etc.), and can be a hardware module or a software module, such as an APP. During use, the doctor can select the stimulation output mode through the APP, and then start editing the stimulation instructions (such as the parameters of electrical stimulation). The APP background sends the stimulation instructions to the switching module 50 according to the doctor's selection. Stimulation instructions include directional stimulation instructions or circular stimulation instructions.

Optionally, when the instruction is a directional stimulation instruction; if the contact group 10 is in the expansion mode, the switching module 50 is configured to maintain the contact group 10 in the expansion mode; if the contact group 10 is in the retracting mode, the switching module 50 Configured to switch contact group 10 to deployed mode. Then, the directional stimulation instructions input by the doctor will be transmitted to the implanted pulse generator 1, and the implanted electrodes 3 will generate corresponding directional electric fields.

Optionally, when the stimulation instruction is a ring stimulation instruction; if the contact group 10 is in the expansion mode, the switching module 50 is configured to switch the contact group 10 to the retracting mode; if the contact group 10 is in the retracting mode, the switching module 50 Configured to maintain the contact group in collapse mode. Then, the annular stimulation command input by the doctor will be transmitted to the implanted pulse generator 1, and the implanted electrode 3 will generate a corresponding annular electric field.

Referring further to FIG. 8 , FIG. 8 is a circuit schematic diagram when the switching module 50 receives a directional stimulation instruction. The switching module 50 includes a microcontroller 41 and a left brain stimulation control module 42 connected thereto, a matrix switch A, and a matrix switch B. Among them, contacts 1 and 8 are second electrodes (please refer to Figure 3, corresponding to the second contact 21), contacts 2-4 and contacts 5-7 are the first electrodes of the contact group (please refer to Figure 3, corresponding to the second contact 21). corresponds to the contact 11), contacts 9-16 also have a similar corresponding relationship, which will not be explained in detail here. The following description takes the switching module 50 switching the contact group to the expanded mode (contact 1 is set as the positive pole, and contacts 2 and 5 are set as the negative pole) as an example. When the Bluetooth communication module 60 receives an instruction issued by the APP (eg, input module 40) and determines it to be a directional stimulation instruction, the switching module 50 switches the contact group to the expansion mode. The specific working method is: the Bluetooth communication module 60 sends the directional stimulation instruction to the single-chip computer 41, and the single-chip computer 41 then sends the instruction to the matrix switch A43 through the bus C. The matrix switch first connects the contact A to the contact 1, and then connects the contact point A43 to the matrix switch A43. Point B is connected to contact 2 and contact 5. At this time, only contact 2 in the contact group has current flowing in, and contacts 3-4 have no current. Therefore, the electric field is basically distributed on one side of contact 2, and contacts 3- 4 There is no electric field on both sides, thus achieving directional stimulation.

Referring further to FIG. 9 , FIG. 9 is a circuit schematic diagram when the switching module 50 receives ring stimulation. Among them, contacts 1 and 8 are second electrodes, and contacts 2-4 and contacts 5-7 are respectively the first electrodes of the contact group. The following description takes the switching module 50 switching the contact group to the shrinking mode (contacts 2-4 are set as positive poles and contacts 5-7 are set as negative poles) as an example. When the Bluetooth communication module 60 receives an instruction issued by the APP (eg, input module 40) and determines that it is a ring stimulation instruction, the switching module 50 switches the contact group to the collapsing mode. The specific working method is: the matrix switch first connects contact A to each contact in the contact group (contacts 2-4), and then connects contact B to the contact group (contacts 5-7) Each contact to ensure that contact 2, contact 3, and contact 4 output the same positive stimulation parameters at the same time, and contact 5, contact 6, and contact 7 output the same negative stimulation parameters at the same time, thereby obtaining a similar ring electrode The electric field distribution is used to achieve ring-shaped stimulation in the convergence mode. Further, please refer to Figure 1. The electrical stimulation system includes two implanted electrodes 3, two state configurators and two switching modules 50 as before. The implanted electrodes 3, state configurators and switching modules 50 correspond one to one. The modes of the contact groups 10 in the status configurator corresponding to each implanted electrode 3 are switched independently. It should be noted that the one-to-one correspondence between the implanted electrode 3 , the state configurator and the switching module 50 here means that each implanted electrode 3 corresponds to a state configurator and simultaneously corresponds to a switching module 50 . In one application scenario, two implanted electrodes 3 are used to implant into the left and right brains of the patient respectively. It can be understood that the respective control logics of the two implanted electrodes 3 are independent of each other. Furthermore, the number and arrangement and combination of the electrodes of the two implanted electrodes 3 may be the same or different. According to the present invention, There are no restrictions on this.

Based on the above electrical stimulation system, the present invention also provides a configuration method of the electrical stimulation system, which Applied to the above electrical stimulation system; the configuration method of the electrical stimulation system includes: switching the mode of the contact group 10 according to the received stimulation instruction and the status of each first contact 11 in the current contact group 10 . Optionally, when the stimulation instruction is a directional stimulation instruction, if the contact group 10 is in the expansion mode, the contact group 10 is maintained in the expansion mode, and if the contact group 10 is in the retraction mode, the contact group 10 is switched. to expand mode; when the stimulation instruction is a ring stimulation instruction, if the contact group 10 is in the expansion mode, switch the contact group 10 to the retract mode; if the contact group 10 is in the retract mode, maintain the contact group 10 in Collapsing mode.

To sum up, in the state configurator of implanted electrodes, the electrical stimulation system and the configuration method thereof provided by the present invention, the state configurator of implanted electrodes includes: a contact group composed of at least one first contact point. and a second contact, the state of the first contact and the second contact is any one of the first pole, the second pole, and inactive; the first pole is positive or negative, and the third pole The second pole has a polarity opposite to the first pole; the contact group switches between the retracted mode and the expanded mode; when the contact group is in the retracted mode, it serves as an integral contact, and the integral contact The state is any one of first pole, second pole and inactive, and the states of each first contact in the contact group are configured to be related to each other; when the contact group is in the expansion mode , the status of each first contact point in the contact point group is configured to be independent; the contact point group is configured to be based on the second contact point when switching between the folding mode and the unfolding mode. The current status of the contact, as well as the current status of each first contact in the contact group, is configured according to preset conditions.

In this configuration, based on the expansion mode of the contact group, the states of all first contacts are configured to be independent, and each first contact is independently configured to present a different state, so that the corresponding implanted electrodes are in the same circumferential direction. The different directional electrode states can generate directional stimulation electric fields when directional stimulation is required. Based on the shrinking mode of the contact group, the entire contact group is configured as an integral contact, so that the electrodes in the same circumferential direction in the corresponding implanted electrodes are in the same state, and can act as a ring electrode, so they can be When annular stimulation is required, an annular stimulation electric field is generated. Therefore, ring-shaped stimulation output or directional stimulation output can be used for different treatment scenarios. The stimulation output is more in line with the needs of the treatment scenario, reduces power consumption, and reduces the occurrence of side effects. Furthermore, when the mode of the contact group is switched, it can be automatically configured according to the preset conditions according to the status of the second contact and the current status of the first contact in the contact group, so that different doctors can freely switch under different conditions. Switch modes to increase treatment flexibility and improve outpatient control efficiency.

It should be noted that the above-mentioned embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention in any way. Any changes or modifications made by those of ordinary skill in the field of the present invention based on the above disclosure shall fall within the scope of the claims.

Claims

A state configurator for implanted electrodes, characterized by including:

a contact group consisting of at least one first contact and a second contact, the state of the first contact and the second contact being any one of first pole, second pole and inactive; The first pole is a positive pole or a negative pole, and the second pole has a polarity opposite to the first pole; the contact group switches between the retracted mode and the expanded mode;

When the contact group is in the retracted mode, it serves as an integral contact, and the state of the integral contact is any one of first pole, second pole, and inactive. Each of the contacts in the contact group The states of the first contacts are configured to be correlated;

When the contact group is in the expansion mode, the state of each first contact in the contact group is configured to be independent;

The contact group is configured when switching between the retracted mode and the unfolded mode based on the current state of the second contact and the current state of each first contact in the contact group. , configure the state of the first contact according to preset conditions.
The state configurator for implanted electrodes according to claim 1, characterized in that, before configuring the state of each first contact in the contact group according to a preset condition, the contact group satisfy:

When the contact group is switched from the retracted mode to the expanded mode, the state of each first contact in the contact group is configured to be inactive;

When the contact group is switched from the unfolded mode to the retracted mode, the entire contact group is configured to be inactive.
The state configurator of implanted electrodes according to claim 1, characterized in that the preset conditions include: when the stimulation output mode of the implanted electrode is the current mode, all the first contacts, all The second contact and the integral contact satisfy: the sum of the numbers of the first contact, the second contact and the integral contact whose state is the first pole = 1, and the state is the The sum of the numbers of the first contacts, the second contacts and the overall contacts of the second pole is ≥1.
The state configurator for implanted electrodes according to claim 1, characterized in that the preset The conditions assumed include: when the stimulation output mode of the implanted electrode is the voltage mode, all the first contacts, the second contacts and the overall contacts satisfy: the status is all of the first pole. The sum of the number of the first contact, the second contact and the integral contact is ≥ 1, and the state is the first contact, the second contact and the integral of the second pole The sum of the number of contacts is ≥1.
The state configurator for implanted electrodes according to claim 1, wherein the state configurator includes two contact point groups and two second contact points, each of the contact point groups includes Three first contacts; two contact groups and two second contacts are arranged along the length direction of the status configurator, and two contact groups are arranged on two between the second contacts.
An electrical stimulation system, characterized by comprising an implanted electrode, an implanted pulse generator, and a state configurator of the implanted electrode according to any one of claims 1 to 5, further comprising: A switching module connected to the configurator, the switching module is used to switch the mode of the contact group; the status configurator is communicatively connected to the implantable pulse generator.
The electrical stimulation system according to claim 6, characterized in that, the electrical stimulation system further includes an input module; the input module is used to receive input stimulation instructions, and the switching module responds to the input stimulation instructions received by the input module. The mode of the contact group is switched according to the stimulation instruction and the current status of each first contact in the contact group.
The electrical stimulation system according to claim 7, wherein the stimulation instruction is a directional stimulation instruction;

If the contact group is in the expanded mode, the switching module is configured to maintain the contact group in the expanded mode;

If the contact group is in the retracted mode, the switching module is configured to switch the contact group to the expanded mode.
The electrical stimulation system according to claim 7, wherein the stimulation instruction is a ring stimulation instruction;

If the contact group is in the unfolded mode, the switching module is configured to switch the contact group to the retracted mode;

If the contact group is in the retracted mode, the switching module is configured to maintain the contact group in the retracted mode.
The electrical stimulation system according to claim 6, characterized in that the electrical stimulation system includes two implanted electrodes, two state configurators and two switching modules, and the implanted electrodes, The state configurator corresponds to the switching module one-to-one, and the modes of the contact groups of the state configurator corresponding to the two implanted electrodes are switched independently.
The electrical stimulation system according to claim 6, wherein the implanted electrodes include circumferential electrodes and an electrode group, wherein the electrode group includes a plurality of directional electrodes in the same circumferential direction, and the circumferential electrodes arranged axially apart from the electrode group.
The electrical stimulation system according to claim 11, wherein each first contact point in the contact point group corresponds to a direction electrode in a corresponding electrode group in the implanted electrode.
A configuration method of an electrical stimulation system, characterized in that it is applied to the electrical stimulation system according to any one of claims 6 to 10; the configuration method of the electrical stimulation system includes:

Switch the mode of the contact point group according to the received stimulation instruction and the status of each first contact point in the current contact point group.
The configuration method of the electrical stimulation system according to claim 11, characterized in that:

In the case where the stimulation instruction is a directional stimulation instruction, if the contact point group is in the expansion mode, the contact point group is maintained in the expansion mode, and if the contact point group is in the retraction mode , then switch the contact group to the expansion mode;

In the case where the stimulation instruction is a ring stimulation instruction, if the contact point group is in the expansion mode, switch the contact point group to the retraction mode; if the contact point group is in the retraction mode, Then the contact group is maintained in the retracted mode.