Split type support for installing electrode contacts, directional electrode and implantable stimulation system

Abstract

The invention discloses a split type support for installing an electrode contact, a directional electrode and an implantable stimulation system, the split type support comprises a plurality of first split assemblies arranged along the axial direction, and the first split assemblies are provided with hollow inner cavities; a plurality of first installation positions distributed at intervals in the circumferential direction can be formed between every two adjacent first split assemblies in a matched mode, and the first installation positions are suitable for installing sheet-shaped electrode contacts. The split type support for installing the electrode contact can reduce the manufacturing difficulty of the directional electrode, is convenient to disassemble and assemble, simplifies the welding of the electrode contact and the guide wire, and overcomes the technical problems of high process difficulty, low manufacturing efficiency, low yield and high cost caused by the fact that the directional electrode contact is prepared by adopting a mode of preparing the electrode by grinding in the prior art.

Description

Technical Field

[0001] The present invention relates to the technical field of implantable medical instruments, and in particular to a split bracket for installing electrode contacts, a directional electrode, and an implantable stimulation system. Background Art

[0002] Deep brain stimulation (DBS) therapy is a treatment technology that uses stereoscopic precision positioning technology to implant electrodes into specific nuclei deep in the human brain. Under the control of a pulse generator, the electrodes emit electrical pulses to stimulate the target. By giving the pulse generator certain stimulation parameters through in vitro programming, the excitability of the nucleus can be changed to regulate neural function. The pulse generator can adjust stimulation parameters such as frequency, pulse width and voltage to maximize the neuroregulatory function of DBS. With the development of neurostimulation technology, more and more symptoms have been proven to be effective using DBS. Symptoms of various limb and mental diseases such as Parkinson's disease, essential tremor or Parkinson's tremor, dystonia, epilepsy and obsessive-compulsive disorder have been significantly improved after using neurostimulation therapy.

[0003] The main stimulation parameters adjusted by traditional DBS products are frequency, pulse width and voltage. In actual clinical practice, there is also a certain demand for the direction of electrode stimulation, because in the brain, not only do stimulations to different areas have different effects, but stimulations to the same area in different directions also have different effects. The traditional electrode stimulation end is a ring electrode contact, and the stimulation direction cannot be controlled, making it difficult to achieve precise stimulation and unable to obtain optimal regulation.

[0004] Chinese patent document CN105246542A discloses a segmented electrode (also called directional electrode) guide formed by a prepared electrode with a recess or perforation and a manufacturing method thereof, wherein the prepared electrode disclosed therein comprises a single segmented electrode contact joined together by a connecting material. The segmented electrode contacts are formed into a group by a plurality of them, surrounding the circumference of the electrode guide, and can control the stimulation direction. However, since the electrode contacts are formed by removing the connecting material by grinding or the like, the manufacturing process is difficult, inefficient, has a low yield, and is costly.

[0005] The present invention solves at least one of the above problems. Summary of the invention

[0006] The purpose of the present invention is to provide a split bracket for installing electrode contacts which can reduce the difficulty of manufacturing directional electrodes and is easy to disassemble and assemble, so as to overcome the technical problems of high process difficulty, low production efficiency, low yield and high cost caused by the method of grinding electrodes in the prior art to prepare directional electrode contacts.

[0007] The purpose of the present invention is achieved by the following technical solutions:

[0008] A first aspect of the present invention provides a split bracket for mounting electrode contacts, comprising:

[0009] A plurality of first sub-assemblies arranged along the axial direction, wherein the first sub-assemblies have a hollow inner cavity;

[0010] Two adjacent first split components can cooperate to form a plurality of first installation positions spaced apart along the circumferential direction, wherein the first installation positions are suitable for installing sheet-shaped electrode contacts.

[0011] Compared with the prior art, the beneficial effect of the present invention is that: by installing two adjacent first split components in a combined manner along the axial direction, a plurality of first installation positions spaced apart along the circumferential direction are formed, so that each first installation position on the split bracket can be installed with a sheet electrode contact according to actual needs, so that the sheet electrode contact on the first installation position can stimulate different targets in different directions. And whether it is two first installation positions adjacent to each other in the axial direction or two first installation positions adjacent to each other in the circumferential direction, they are spaced apart, and the two adjacent sheet electrode contacts can be insulated and blocked from a physical level, which can ensure that each sheet electrode contact can independently perform the stimulation task and avoid the problem of short circuit caused by the interaction between the sheet electrode contacts, and can also prevent signal interference between the sheet electrode contacts to a certain extent, thereby improving the stability and reliability of the implantable stimulation surgery.

[0012] In some possible implementations of the first aspect, each of the first split components is provided with a plurality of first installation grooves spaced apart along the circumferential direction, and the first installation grooves are used to form the first installation positions.

[0013] In some possible implementations of the first aspect, the first split component includes a first main body and a plurality of first support columns extending outward from one side of the first main body and arranged at intervals along the circumferential direction, and the first mounting groove is formed between two circumferentially adjacent first support columns.

[0014] In some possible embodiments of the first aspect, the first support column includes a first layer body and a second layer body protruding outward from the outer surface of the first layer body, the first layer body and the second layer body can form a bidirectional step structure, and the first mounting groove can be formed between two circumferentially adjacent bidirectional step structures.

[0015] In some possible implementations of the first aspect, the lengths of the first layer and the second layer in the axial direction can be configured to be at least one of equal and unequal.

[0016] In some possible embodiments of the first aspect, the first split component also includes a support ring extending outward from the other side of the first main body, the outer diameter of the support ring is smaller than the outer diameter of the first main body, and the support ring is used to install the annular electrode contact; or the first split component also includes a plurality of second support columns extending outward from the other side of the first main body and arranged at circumferential intervals, the second support columns include a third layer body and a fourth layer body protruding outward from the outer surface of the third layer body, and the third layer body and the fourth layer body can form the bidirectional step structure.

[0017] In some possible implementations of the first aspect, the outer surface of the support ring is provided with a plurality of fifth layers convex outwardly arranged at intervals along the circumferential direction, and the first mounting groove located on the outer surface of the support ring is formed between two circumferentially adjacent fifth layers.

[0018] In some possible implementations of the first aspect, there is a gap between two adjacent first split components.

[0019] In some possible implementations of the first aspect, a slot is provided on the inner side of the first body, and in two adjacent first bodies, a portion of the first layer of one of the first bodies that is longer than the second layer can be accommodated in the slot of the other first body.

[0020] In some possible embodiments of the first aspect, the split bracket also includes a second split component, the second split component includes a second main body and a third support column extending outward from the second main body, the circumferential diameter surrounded by the third support column is smaller than the outer diameter of the second main body, and the end of the third support column can be received in a slot of an adjacent first main body or second main body to form a second mounting position on the outer periphery of the third support column, and the second mounting position is used to install an annular electrode contact.

[0021] In some possible implementations of the first aspect, in two adjacent first sub-assemblies, two axially adjacent first installation grooves can cooperate to form the first installation position.

[0022] In some possible implementations of the first aspect, the first mounting groove can form the first mounting position.

[0023] A second aspect of the present invention provides a directional electrode, comprising:

[0024] A stimulation segment, comprising the split bracket according to the first aspect and electrode contacts mounted on the split bracket, wherein the electrode contacts include sheet electrode contacts and / or ring electrode contacts;

[0025] A connecting section, the connecting section comprising a plurality of connecting contacts insulated from each other;

[0026] The middle section connects the stimulation section and the connection section, and the middle section includes a plurality of electrode wires, and the connection contacts and the electrode contacts are electrically connected in a one-to-one correspondence through the electrode wires.

[0027] A third aspect of the present invention provides an implantable stimulation system, comprising a pulse generator and the directional electrode described in the second aspect, wherein the connecting contacts of the pulse generator and the directional electrode are electrically connected.

[0028] In some possible implementations of the third aspect, the implantable stimulation system further includes an extension wire, and the pulse generator is electrically connected to the directional electrode via the extension wire. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is a schematic structural diagram of the first split component of the second implementation mode in the first technical solution of an embodiment of the present invention;

[0030] Figure 2 This is a schematic structural diagram of a first split component in a first implementation manner in a first technical solution of an embodiment of the present invention;

[0031] Figure 3 This is a schematic structural diagram of the first split component of the third implementation mode in the first technical solution of an embodiment of the present invention;

[0032] Figure 4 It is a structural schematic diagram of the first split component of the first implementation mode and / or the second implementation mode in the second technical solution of an embodiment of the present invention;

[0033] Figure 5 This is a schematic structural diagram of the first split component of the third implementation mode in the second technical solution of an embodiment of the present invention;

[0034] Figure 6 This is a schematic structural diagram of a directional electrode according to a second aspect of an embodiment of the present invention;

[0035] Figure 7 This is a schematic structural diagram of a 1-3-3-1 type 8-contact direction electrode according to Example 1 of the present invention;

[0036] Figure 8 This is a schematic diagram of the structure of another 1-3-3-1 type 8-contact direction electrode according to Embodiment 3 of the present invention;

[0037] Fig. 9 This is a schematic structural diagram of a 3-3-3-3 type 8-contact direction electrode according to Embodiment 5 of the present invention;

[0038] Fig.10 This is a schematic diagram of the structure of another 3-3-3-3 type 8-contact direction electrode according to Example 6 of the present invention.

[0039] In the figure, 11, first body; 111, slot; 12, first support column; 121, first layer body; 122, second layer body; 13, second support column; 131, third layer body; 132, fourth layer body; 14, support ring; 15, fifth layer body; 21, second body; 22, third support column; 10, stimulation segment; 20, connecting segment; 30, middle segment; 40, sheet electrode contact; 50, ring electrode contact; 60, contact segment; 70, first joint segment; 80, second joint segment; 90, third joint segment; 100, fourth joint segment; 201, connecting contact. DETAILED DESCRIPTION

[0040] Example embodiments will now be described more fully with reference to the accompanying drawings. However, example embodiments can be implemented in a variety of forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided to make the present invention more comprehensive and complete and to fully convey the concepts of example embodiments to those skilled in the art. The same reference numerals in the figures represent the same or similar structures, and thus their repeated description will be omitted.

[0041] Combined with Figure 1-5 As shown in 7-10, in the first aspect of this embodiment, a split bracket for mounting electrode contacts is provided, comprising a plurality of first split components arranged along the axial direction. It should be noted that the first split components in this application are made of insulating material.

[0042] The first split component has a hollow inner cavity, which can be used to sheath the electrode wire to achieve the bundling of the electrode wire.

[0043] Two adjacent first split components can cooperate to form a plurality of first installation positions spaced apart along the circumferential direction, and the first installation positions are suitable for installing the sheet electrode contacts 40. It should be noted that two adjacent first installation positions along the axial direction are also spaced apart.

[0044] It should be noted that the sheet-shaped design of the sheet-shaped electrode contact 40 may be a segmented design, that is, the annular electrode contact 50 is divided into a plurality of independent sheet-shaped structures.

[0045] The present application uses two adjacent first split components to be installed in a combined manner along the axial direction, and cooperates to form a plurality of first installation positions spaced apart along the circumferential direction, so that each first installation position on the split bracket can be installed with a sheet electrode contact 40 according to actual needs, so that the sheet electrode contact 40 on the first installation position can stimulate different targets in different directions. And whether it is two first installation positions adjacent to each other in the axial direction or two first installation positions adjacent to each other in the circumferential direction, they are spaced apart, and the two adjacent sheet electrode contacts 40 can be insulated and blocked from a physical level, which can ensure that each sheet electrode contact 40 can independently perform the stimulation task and avoid the problem of short circuit caused by the interaction between the sheet electrode contacts 40, and can also prevent signal interference between the sheet electrode contacts 40 to a certain extent, thereby improving the stability and reliability of the implantable stimulation surgery.

[0046] Furthermore, through the combined installation and split disassembly between the first split components, not only can a new sheet electrode contact 40 be conveniently and promptly replaced when a sheet electrode contact 40 is damaged, but also a new first split component can be conveniently and promptly replaced when a first split component of the split bracket is damaged, which greatly improves the efficiency of installation and disassembly and makes the installation and disassembly of the split bracket for electrode contacts more flexible.

[0047] It should be further explained that, since the sheet electrode contact 40 usually has a smaller area, it can more accurately locate and stimulate the target target, reducing interference with surrounding non-target targets. At the same time, the design of the sheet electrode contact 40 often allows doctors to flexibly adjust the position of the electrode contact and the stimulation direction according to the specific situation of the patient to achieve the best treatment effect. For example, in some directional electrode systems, by independently controlling the current of each sheet electrode contact 40, doctors can accurately control the direction and intensity of the stimulation to achieve the treatment goal of "maximizing the therapeutic effect and minimizing the side effects".

[0048] As a more specific implementation of this embodiment, each first split component is provided with a plurality of first installation grooves spaced apart along the circumferential direction, and the first installation grooves are used to form a first installation position.

[0049] As a more specific implementation of this embodiment, the first split component includes a first body 11 and a plurality of first support columns 12 extending outward from one side of the first body 11 and arranged at intervals along the circumferential direction, and a first installation groove is formed between two adjacent first support columns 12 along the circumferential direction.

[0050] The first support column 12 can not only play the role of a radial dividing segment to achieve physical insulation barrier between the sheet-like electrode contacts 40 in the circumferential direction, but also form a first installation groove to achieve stable installation and fixation of the sheet-like electrode contacts 40 .

[0051] As a more specific implementation of this embodiment, the first support column 12 includes a first layer body 121 and a second layer body 122 protruding outward from the outer surface of the first layer body 121. The first layer body 121 and the second layer body 122 can form a bidirectional step structure, and a first installation groove can be formed between two circumferentially adjacent bidirectional step structures.

[0052] The bidirectional step structure design of the first layer 121 and the second layer 122 enables each step to provide a solid support point. When two adjacent step structures are combined together, they together form a more stable installation base, which can ensure that the sheet electrode contact 40 installed thereon remains stable and is not prone to shaking or tilting.

[0053] The second layer 122 can not only act as a radial partition to achieve circumferential insulation between the sheet-like electrode contacts 40 , but also cooperate with the first layer 121 to form a bidirectional step structure to improve the stability of the installation of the sheet-like electrode contacts 40 .

[0054] It should be particularly noted that, since there is a gap between the adjacent second layers 122 in the circumferential direction, space is provided for the connection between the electrode wire and the sheet electrode contact 40 , so that the sheet electrode contact 40 at the first installation position can be smoothly connected to the electrode wire.

[0055] As a first technical solution of the above embodiment, in two adjacent first split components, two first mounting grooves adjacent to each other along the axial direction can cooperate to form a first mounting position, that is, the first mounting groove of one of the first split components can be combined with the first mounting groove of the other first split component through a combined installation to form a first mounting position, that is to say, one end of the sheet electrode contact 40 can be embedded in the first mounting groove of one of the first split components, and the other end of the sheet electrode contact 40 can be embedded in the first mounting groove of the other first split component.

[0056] Combined with Figure 2 As shown, as a first implementation of the first technical solution, the first split component also includes a support ring 14 extending outward from the other side of the first body 11, the outer diameter of the support ring 14 is smaller than the outer diameter of the first body 11, and the support ring 14 is used to install the annular electrode contact 50.

[0057] By adding a support ring 14 to the first split component, and the outer diameter of the support ring 14 is smaller than the outer diameter of the first main body 11, when the annular electrode contact 50 is sleeved on the support ring 14, the outer surface of the entire electrode is in the same plane, ensuring the flatness of the outer surface of the electrode; the composite installation of the annular electrode contact 50 and the sheet electrode contact 40 is also realized on the split bracket, which can enable the split bracket to meet different stimulation requirements at the same time. It should be noted that the first main body 11 plays the role of an axial segment, so that the annular electrode contact 50 and the sheet electrode contact 40 are insulated and blocked.

[0058] For example, the annular electrode contact 50 can provide omnidirectional stimulation to the stimulation target. Since the annular electrode contact 50 is designed to cover a 360-degree range, it can provide omnidirectional stimulation, which is very beneficial for scenarios that require extensive stimulation of peripheral nerve tissue. And since the stimulation distribution of the annular electrode contact 50 is uniform, it can ensure that the stimulation signal is evenly propagated in the surrounding tissue, reducing discomfort or complications caused by uneven stimulation.

[0059] Combined with Figure 1 and 2 As shown, as the second implementation of the first technical solution, the outer surface of the support ring 14 is provided with a plurality of fifth layers 15 convex outwardly arranged at intervals along the circumferential direction, and a first mounting groove located on the outer surface of the support ring 14 is formed between two circumferentially adjacent fifth layers 15.

[0060] By protruding the fifth layer 15 on the outer surface of the support ring 14, a first mounting groove can also be formed to ensure stable mounting and fixation of the first pair of sheet electrode contacts 40; at the same time, the fifth layer 15 acts as a radial dividing segment to achieve insulation barrier between two circumferentially adjacent sheet electrode contacts 40.

[0061] As some specific embodiments of the second embodiment, there is a gap between two adjacent first split components. In the two adjacent first split components, the first installation grooves of the two first split components are both formed by the second embodiment. The purpose of setting the gap is to provide space for the connection between the electrode wire and the sheet electrode contact 40, so as to facilitate the smooth connection between the sheet electrode contact 40 and the electrode wire on the second installation position.

[0062] Combined with Figure 3 As shown, as the third implementation mode of the first technical solution, the first split component also includes a plurality of second support columns 13 extending outward from the other side of the first main body 11 and arranged at intervals along the circumferential direction, the second support columns 13 include a third layer body 131 and a fourth layer body 132 protruding outward from the outer surface of the third layer body 131, and the third layer body 131 and the fourth layer body 132 can form a bidirectional step structure.

[0063] That is to say, the first support column 12 and the second support column 13 can be symmetrical with respect to the first body 11, and both can realize the support and installation of the sheet electrode contact 40 through the bidirectional step structure. It should be noted that the first body 11 plays the role of an axial segmentation section, so that two sheet electrode contacts 40 adjacent to each other in the axial direction are insulated and blocked. The fourth layer 132 plays the role of a radial segmentation section, so that two sheet electrode contacts 40 adjacent to each other in the circumferential direction are insulated and blocked.

[0064] As a preferred implementation of the first technical solution, the lengths of the first layer 121 and the second layer 122 in the axial direction are equal, and the lengths of the third layer 131 and the fourth layer 132 in the axial direction are equal.

[0065] Combined with Figure 4 and 5 As shown, as a second technical solution of the above embodiment, the first mounting groove can form a first mounting position, that is, among two adjacent first split components, the first mounting groove of one first split component can be combined with the first mounting groove of another first split component (not the first mounting groove of the first split component) to form a first mounting position, that is, the sheet electrode contact 40 is embedded in the first mounting groove.

[0066] Combined with Figure 4 As shown, as the first implementation method of the second technical solution, when the lengths of the first layer 121 and the second layer 122 in the axial direction are equal, the bidirectional step structure of one of the two adjacent first bodies 11 can be fitted together with the other side of the other first body 11 (i.e., the side of the bidirectional step structure away from the first body 11) to form a first installation position.

[0067] Combined with Figure 4 As shown, as a second implementation of the second technical solution, the length of the first layer 121 in the axial direction is longer than the second layer 122, and a slot 111 is provided on the inner side of the first body 11. In two adjacent first bodies 11, the portion of the first layer 121 in one of the first bodies 11 that is longer than the second layer 122 can be accommodated in the slot 111 of the other first body 11. Or the length of the first layer 121 in the axial direction is shorter than the second layer 122, and a slot (not shown in the figure) is provided on the outer side of the first body 11. In two adjacent first bodies 11, the portion of the second layer 122 in one of the first bodies 11 that is longer than the first layer 121 can be accommodated in the slot of the other first body 11.

[0068] In two adjacent first main bodies 11, since the first layer body 121 and the second layer body 122 of one of the main bodies form a bidirectional step structure, when the portion of the first layer body 121 in the first main body 11 that is longer than the second layer body 122 is accommodated in the slot 111 of the other first main body 11, the first installation groove formed by the two circumferentially adjacent bidirectional step structures in the first main body 11 can provide space for the formation of the first installation position alone, and it can form the first installation position through a combined installation with the slot 111 side of the other first main body 11.

[0069] It should be noted that, in the above two embodiments, the first body 11 plays the role of an axial dividing segment, so that two axially adjacent sheet-shaped electrode contacts 40 are insulated and blocked.

[0070] Combined with Figure 5 As shown, as the third implementation mode of the second technical scheme, the split bracket also includes a second split component, the second split component includes a second main body 21 and a third support column 22 extending outward from the second main body 21, the circumferential diameter surrounded by the third support column 22 is smaller than the outer diameter of the second main body 21, and the end of the third support column 22 can be received in the slot 111 of the adjacent first main body 11 or the second main body 21, so that the outer periphery of the third support column 22 forms a second mounting position, and the second mounting position is used to install the annular electrode contact 50. Such a design makes it possible for the overall outer surface of the electrode to be flush after the annular electrode contact 50 is installed.

[0071] When the end of the third support column 22 can be accommodated in the slot 111 of the adjacent second body 21, and the circumferential diameter of the third support column 22 is smaller than the outer diameter of the second body 21, the annular electrode contact 50 can be sleeved on the second mounting position formed by the outer periphery of the third support column 22, so that the composite mounting of the annular electrode contact 50 and the sheet electrode contact 40 can be realized on the split bracket, so that the split bracket can meet different stimulation requirements at the same time. It should be noted that the second body 21 plays the role of an axial segment, so that the annular electrode contact 50 and the sheet electrode contact 40 are insulated and blocked.

[0072] Combined with Figure 6 As shown, in a second aspect of this embodiment, a directional electrode is provided, which includes a stimulation segment 10 , a connecting segment 20 and a middle segment 30 .

[0073] The stimulation segment 10 includes the split bracket of the first aspect and electrode contacts mounted on the split bracket, wherein the electrode contacts include sheet-shaped electrode contacts 40 and / or ring-shaped electrode contacts 50 .

[0074] The connecting section 20 includes a plurality of connecting contacts 201 which are insulated from each other.

[0075] The middle section 30 is used to connect the stimulation section 10 and the connection section 20 (i.e., one end of the middle section 30 is connected to the stimulation section 10, and the other end is connected to the connection section 20). The middle section 30 includes a plurality of electrode wires, and the connection contacts 201 are electrically connected to the electrode contacts in a one-to-one correspondence through the electrode wires.

[0076] The directional electrode of the present invention can realize the combined installation and split disassembly of the annular electrode contact 50 and / or the sheet electrode contact 40 through a split bracket; by utilizing the connecting contact 201 of the connecting section 20, it is electrically connected to the annular electrode contact 50 and / or the sheet electrode contact 40 in a one-to-one correspondence through the electrode wire, so as to provide non-conflicting stimulation signals between the annular electrode contact 50 and / or the sheet electrode contact 40.

[0077] In a third aspect of the present embodiment, an implantable stimulation system is provided, the implantable stimulation system comprising a pulse generator and the directional electrode of the second aspect, the pulse generator being electrically connected to the connection contact 201 of the directional electrode. Further, the implantable stimulation system further comprises an extension wire, the pulse generator being electrically connected to the directional electrode via the extension wire.

[0078] First, one of the application fields of the embodiment of the present application (i.e., an implantable neural stimulation system) is briefly described.

[0079] Implantable medical systems include implantable neural stimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead switching systems. Examples of implantable neural stimulation systems include deep brain stimulation (DBS), implantable cortical nerve stimulation (CNS), implantable spinal cord stimulation (SCS), implantable sacral nerve stimulation (SNS), and implantable vagus nerve stimulation (VNS).

[0080] The implantable neural electrical stimulation system includes a stimulator implanted in the patient's body (i.e., an implantable neural stimulator) and a programmable device disposed outside the patient's body. In other words, the stimulator is a medical device, or in other words, the medical device includes the stimulator. The relevant neural regulation technology mainly implants electrode contacts (electrode contacts, for example, in the form of electrode wires) in specific parts of the tissue of the organism (i.e., the target point) through stereotactic surgery, and emits discharge pulses to the target point through the electrode contacts, thereby regulating the electrical activity and function of the corresponding neural structure and network, thereby improving symptoms and relieving pain.

[0081] As an example, DBS includes an IPG (Implantable Pulse Generator), an extension wire and an electrode wire, and the IPG is connected to the electrode wire via the extension wire. The IPG is implanted in the patient's body, for example, in the patient's chest or other body parts.

[0082] As another example, DBS includes an IPG and an electrode lead, and the IPG is directly connected to the electrode lead. The IPG is implanted in the patient's head, for example, a groove is made in the patient's skull, and then the IPG is installed in the groove of the skull. In this case, the IPG may not protrude from the outer surface of the skull, or may partially protrude from the outer surface of the skull.

[0083] Among them, IPG responds to the sample brain mask information sent by the program-controlled device, relying on sealed batteries and circuits to provide controllable electrical stimulation therapy (or electrical stimulation energy) to the tissues in the body. When the battery is low, the battery needs to be charged, and the method for charging the battery can be to use electromagnetic induction coil wireless charging to charge through human skin or other epidermal tissues. IPG delivers one or more controllable specific electrical stimulations to specific areas of tissues in the body through electrode wires.

[0084] In some embodiments of the third aspect, the extension lead is used in conjunction with the IPG as a transmission medium for electrical stimulation, and transmits the electrical stimulation generated by the IPG to the electrode lead.

[0085] In some embodiments of the third aspect, the electrical stimulation may be delivered in the form of a pulse signal or in the form of a non-pulse signal. For example, the electrical stimulation may be delivered as a signal having various waveform shapes, frequencies, and amplitudes. Therefore, the electrical stimulation in the form of a non-pulse signal may be a continuous signal, which may have a sinusoidal waveform or other continuous waveform.

[0086] After receiving the electrical stimulation transmitted by the IPG or the extension wire, the electrode wire delivers the electrical stimulation to a specific area of ​​the tissue in the body through a plurality of electrode contacts. The stimulator is provided with, for example, one or more electrode wires on one side or both sides, and a plurality of electrode contacts are provided on the electrode wire, and the electrode contacts can be arranged uniformly or non-uniformly in the circumferential direction of the electrode wire. As an example, the electrode contacts can be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode wire. The electrode contacts can include stimulation electrode contacts and / or collection electrode contacts. The electrode contacts can be in the shape of sheets, rings, dots, etc., for example.

[0087] In some embodiments of the third aspect, the stimulated body tissue may be the patient's brain tissue, and the stimulated site may be a specific site of the brain tissue. When the patient's disease type is different, the stimulated site is generally different, and the number of stimulation contacts (single source or multiple sources), the use of one or more (single channel or multiple channels) of specific electrical stimulation, and the stimulation parameters (values) are also different.

[0088] The embodiments of the present application do not limit the types of diseases that can be used, and they can be the types of diseases that deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation can be used for. Among them, the types of diseases that DBS can be used to treat or manage include, but are not limited to: spastic diseases (e.g., epilepsy), pain, migraine, mental illness (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety, post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, movement disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism or other neurological or psychiatric diseases and injuries.

[0089] In the embodiment of the present application, when the programmable device and the stimulator establish a programmable connection, the programmable device can be used to adjust one or more stimulation parameters of the stimulator (or one or more stimulation parameters of the pulse generator, different stimulation parameters correspond to different electrical stimulations), and the stimulator can also sense the patient's electrophysiological activities to collect electrophysiological signals, and the collected electrophysiological signals can be used to continue to adjust the stimulation parameters of the stimulator, thereby realizing closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0090] The stimulation parameters may include at least one of the following: the electrode contact identification used to deliver electrical stimulation (for example, electrode contact #2 and electrode contact #3), frequency (for example, the number of electrical stimulation pulse signals within a unit time of 1s, in Hz), pulse width (the duration of each pulse, in μs), amplitude (generally expressed in voltage, that is, the intensity of each pulse, in V), timing (for example, it can be continuous or burst, and burst refers to discontinuous timing 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 controlled by the doctor (the range that can be adjusted by the doctor) and upper and lower limits controlled by the patient (the range that can be adjusted autonomously by the patient).

[0091] In some embodiments, various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0092] Programmable devices may include doctor programmable devices (i.e. programmable devices used by doctors) and / or patient programmable devices (i.e. programmable devices used by patients). Doctor programmable devices are, for example, tablet computers, laptop computers, desktop computers, mobile phones and other intelligent terminal devices equipped with programmable software. Patient programmable devices are, for example, tablet computers, laptop computers, desktop computers, mobile phones and other intelligent terminal devices equipped with programmable software. Patient programmable devices may also be other electronic devices with programmable functions (e.g., chargers with programmable functions, electrophysiological acquisition devices, etc.).

[0093] The embodiment of the present application does not restrict the data interaction between the doctor's programming device and the stimulator. When the doctor performs remote programming, the doctor's programming device can interact with the stimulator through the server and the patient's programming device. When the doctor performs offline programming with the patient face to face, the doctor's programming device can interact with the stimulator through the patient's programming device, and the doctor's programming device can also interact with the stimulator directly. The doctor sends a programming parameter group to the stimulator through the programming device. The programming parameter group (or the preset programming parameters mentioned below) includes multiple electrode contacts and stimulation parameters corresponding to each electrode contact.

[0094] In some embodiments, the patient programmable device may include a host (communicating with a server) and a slave (communicating with a stimulator), and the host and the slave are communicatively connected. Among them, the doctor programmable device can exchange data with the server through a 3G / 4G / 5G network, the server can exchange data with the host through a 3G / 4G / 5G network, the host can exchange data with the slave through a Bluetooth protocol / WIFI protocol / USB protocol, the slave can exchange data with the stimulator through a 401MHz-406MHz working frequency band / 2.4GHz-2.48GHz working frequency band, and the doctor programmable device can directly exchange data with the stimulator through a 401MHz-406MHz working frequency band / 2.4GHz-2.48GHz working frequency band.

[0095] The following is a detailed exemplary description of the directional electrode scheme in the present application in conjunction with specific embodiments.

[0096] Embodiment 1:

[0097] Combined with Figure 7 As shown, a 1-3-3-1 type 8-contact directional electrode is provided, including a stimulation segment 10, a connecting segment 20 and a middle segment 30.

[0098] The stimulation segment 10 includes the split bracket of the first aspect and electrode contacts installed on the split bracket, the electrode contacts include sheet electrode contacts 40 and ring electrode contacts 50; the connecting segment 20 includes a plurality of connecting contacts 201 that are insulated from each other; the intermediate segment 30 is used to connect the stimulation segment 10 and the connecting segment 20 (that is, one end of the intermediate segment 30 is connected to the stimulation segment 10, and the other end is connected to the connecting segment 20), the intermediate segment 30 includes a plurality of electrode wires, and the connecting contacts 201 are electrically connected to the electrode contacts in a one-to-one correspondence through the electrode wires.

[0099] The split bracket adopts a first split component (named as the first first split component) of the first implementation mode in the first technical scheme and two first split components (named as the second first split component and the third first split component respectively) of the second implementation mode in the first technical scheme.

[0100] The first first split component includes a first main body 11 and three first support columns 12 extending outward from one side of the first main body 11 and arranged at intervals along the circumferential direction, and a first installation groove is formed between two first support columns 12 adjacent to each other in the circumferential direction. The first support column 12 includes a first layer body 121 and a second layer body 122 protruding outward from the outer surface of the first layer body 121, and the first layer body 121 and the second layer body 122 can form a bidirectional step structure, and a first installation groove can be formed between two bidirectional step structures adjacent to each other in the circumferential direction; the first first split component also includes a support ring 14 extending outward from the other side of the first main body 11, the outer diameter of the support ring 14 is smaller than the outer diameter of the first main body 11, and three fifth layers 15 arranged at intervals along the circumferential direction are protruding outward from the outer surface of the support ring 14, and a first installation groove located on the outer surface of the support ring 14 is formed between two fifth layers 15 adjacent to each other in the circumferential direction.

[0101] The second first split assembly and the third first split assembly respectively include a first main body 11 and three first support columns 12 extending outward from one side of the first main body 11 and arranged at intervals along the circumferential direction, and a first mounting groove is formed between two first support columns 12 adjacent to each other along the circumferential direction. The first support column 12 includes a first layer body 121 and a second layer body 122 protruding outward from the outer surface of the first layer body 121, and the first layer body 121 and the second layer body 122 can form a bidirectional step structure, and a first mounting groove can be formed between two bidirectional step structures adjacent to each other along the circumferential direction; the second first split assembly and the third first split assembly also include a support ring 14 extending outward from the other side of the first main body 11, and the outer diameter of the support ring 14 is smaller than the outer diameter of the first main body 11.

[0102] The second first split component, the first first split component and the third first split component are arranged in sequence along the axial direction, and may or may not be spaced apart from each other; wherein the first first split component is located in the middle, and the first mounting grooves at both ends thereof correspond one-to-one with the first mounting grooves of the second first split component and one-to-one with the first mounting grooves of the third first split component to form a first mounting position, and each first mounting position is installed with a sheet electrode contact 40; the support rings 14 of the second first split component and the third first split component are respectively installed with a ring electrode contact 50.

[0103] Furthermore, the 1-3-3-1 type 8-contact directional electrode also includes a contact segment 60, a first joint segment 70 and a second joint segment 80. One end of the contact segment 60 is designed as an arc surface, so that the direction electrode can penetrate into the patient's brain tissue and reduce contact stimulation to the brain tissue; the other end of the contact segment 60 is embedded in one end of the first joint segment 70, and the other end of the first joint segment 70 is embedded in the annular electrode contact 50 on the second first split component; one end of the second joint segment 80 is embedded in the annular electrode contact 50 on the third first split component, and the other end of the second joint segment 80 is connected to the middle segment 30.

[0104] Embodiment 2:

[0105] The difference from Example 1 is that the first split component of the first implementation mode in the first technical solution is replaced by the first split component of the third implementation mode in the first technical solution.

[0106] Embodiment 3:

[0107] Combined with Figure 8 As shown, another 1-3-3-1 type 8-contact directional electrode is provided, including a stimulation segment 10, a connecting segment 20 and a middle segment 30.

[0108] The stimulation segment 10 includes the split bracket of the first aspect and electrode contacts installed on the split bracket, the electrode contacts include sheet electrode contacts 40 and ring electrode contacts 50; the connecting segment 20 includes a plurality of connecting contacts 201 that are insulated from each other; the intermediate segment 30 is used to connect the stimulation segment 10 and the connecting segment 20 (that is, one end of the intermediate segment 30 is connected to the stimulation segment 10, and the other end is connected to the connecting segment 20), the intermediate segment 30 includes a plurality of electrode wires, and the connecting contacts 201 are electrically connected to the electrode contacts in a one-to-one correspondence through the electrode wires.

[0109] The split bracket adopts two first split components of the second implementation mode in the second technical scheme (named as the first first split component and the second first split component respectively) and two second split components of the third implementation mode (named as the first second split component and the second second split component respectively).

[0110] The first first split assembly and the second first split assembly respectively include a first main body 11 and three first support columns 12 extending outward from one side of the first main body 11 and arranged at intervals along the circumferential direction, and a first mounting groove is formed between two first support columns 12 adjacent to each other along the circumferential direction. The first support column 12 includes a first layer body 121 and a second layer body 122 protruding outward from the outer surface of the first layer body 121. The first layer body 121 and the second layer body 122 can form a bidirectional step structure, and a first mounting groove can be formed between two bidirectional step structures adjacent to each other along the circumferential direction. The length of the first layer body 121 in the axial direction is longer than that of the second layer body 122. A slot 111 is provided on the inner side of the first main body 11. In two adjacent first main bodies 11, the portion of the first layer body 121 in one of the first main bodies 11 that is longer than the second layer body 122 is accommodated in the slot 111 of the other first main body 11.

[0111] The first second split component and the second second split component respectively include a second main body 21 and a third support column 22 extending outward from the second main body 21. The circumferential diameter surrounded by the third support column 22 is smaller than the outer diameter of the second main body 21. The end of the third support column 22 can be received in the slot 111 of the adjacent first main body 11 or the second main body 21, so that the outer periphery of the third support column 22 forms a second mounting position, and the second mounting position is used to install the annular electrode contact 50.

[0112] The first second split component, the first first split component, the second first split component and the second second split component are arranged in sequence along the axial direction; wherein the portion of the first layer 121 in the first body 11 of the first second split component that is longer than the second layer 122 is received in the slot 111 of the first body 11 of the adjacent first first split component, so that the outer periphery of the third support column 22 in the first second split component forms a second mounting position, and a ring electrode contact 50 is mounted in the second mounting position; the portion of the first layer 121 in the first body 11 of the first first split component that is longer than the second layer 122 is received in the slot 111 of the first body 11 of the adjacent first first split component The third support column 22 of the second first split component is accommodated in the slot 111 of the first main body 11 of the adjacent second second split component, and forms three first mounting positions spaced apart along the circumferential direction, and each first mounting position is installed with a sheet electrode contact 40; the third support column 22 of the second first split component is accommodated in the slot 111 of the second main body 21 of the adjacent second second split component, and forms three first mounting positions spaced apart along the circumferential direction, and each first mounting position is installed with a sheet electrode contact 40; the outer periphery of the third support column 22 in the second second split component forms a second mounting position, and one of the second mounting positions is installed with a ring electrode contact 50.

[0113] Furthermore, the 1-3-3-1 type 8-contact directional electrode also includes a contact segment 60 and a third joint segment 90. One end of the contact segment 60 is designed with an arc surface, so that the directional electrode can penetrate into the patient's brain tissue and reduce contact stimulation to the brain tissue; the other end of the contact segment 60 is embedded in the slot 111 of the second main body 21 in the first second split component; the end of the third support column 22 in the second second split component is accommodated in one end of the third joint segment 90, and the other end of the third joint segment 90 is connected to the middle segment 30.

[0114] Embodiment 4:

[0115] A 3-3-3-3 type 8-contact directional electrode is provided, which differs from Example 3 in that the two second split components of the third implementation are respectively replaced by the first split components of the second implementation in the second technical solution.

[0116] Embodiment 5:

[0117] Combined with Fig. 9As shown, another 3-3-3-3 type 8-contact directional electrode is provided, including a stimulation segment 10, a connecting segment 20 and a middle segment 30.

[0118] The stimulation segment 10 includes the split bracket of the first aspect and electrode contacts installed on the split bracket, the electrode contacts include sheet electrode contacts 40 and ring electrode contacts 50; the connecting segment 20 includes a plurality of connecting contacts 201 that are insulated from each other; the intermediate segment 30 is used to connect the stimulation segment 10 and the connecting segment 20 (that is, one end of the intermediate segment 30 is connected to the stimulation segment 10, and the other end is connected to the connecting segment 20), the intermediate segment 30 includes a plurality of electrode wires, and the connecting contacts 201 are electrically connected to the electrode contacts in a one-to-one correspondence through the electrode wires.

[0119] The split bracket adopts three first split components of the first implementation mode in the first technical scheme (named as the first first split component, the second first split component, and the third first split component respectively), one first split component of the first implementation mode in the second technical scheme (named as the fourth first split component), and one first split component of the second implementation mode in the first technical scheme (named as the fifth first split component).

[0120] The first first split component, the second first split component and the third first split component respectively include a first main body 11 and three first support columns 12 extending outward from one side of the first main body 11 and arranged at intervals along the circumferential direction, and a first mounting groove is formed between two first support columns 12 adjacent to each other in the circumferential direction. The first support column 12 includes a first layer body 121 and a second layer body 122 protruding outward from the outer surface of the first layer body 121, and the first layer body 121 and the second layer body 122 can form a bidirectional step structure, and a first mounting groove can be formed between two bidirectional step structures adjacent to each other in the circumferential direction; the first first split component also includes a support ring 14 extending outward from the other side of the first main body 11, the outer diameter of the support ring 14 is smaller than the outer diameter of the first main body 11, and three fifth layers 15 arranged at intervals along the circumferential direction are protruding outward from the outer surface of the support ring 14, and a first mounting groove located on the outer surface of the support ring 14 is formed between two fifth layers 15 adjacent to each other in the circumferential direction.

[0121] The fourth first split component includes a first main body 11 and three first support columns 12 extending outward from one side of the first main body 11 and arranged at intervals along the circumferential direction, and a first installation groove is formed between two first support columns 12 adjacent to each other along the circumferential direction. The first support column 12 includes a first layer body 121 and a second layer body 122 protruding outward from the outer surface of the first layer body 121. The first layer body 121 and the second layer body 122 can form a bidirectional step structure, and a first installation groove can be formed between two bidirectional step structures adjacent to each other along the circumferential direction. The length of the first layer body 121 in the axial direction is longer than that of the second layer body 122, and a slot 111 is provided on the inner side of the first main body 11.

[0122] The fifth first split assembly includes a first main body 11 and three first support columns 12 extending outward from one side of the first main body 11 and spaced apart in the circumferential direction, and a first mounting groove is formed between two first support columns 12 adjacent in the circumferential direction. The first support column 12 includes a first layer 121 and a second layer 122 protruding outward from the outer surface of the first layer 121, the first layer 121 and the second layer 122 can form a bidirectional step structure, and a first mounting groove can be formed between two bidirectional step structures adjacent in the circumferential direction; the second first split assembly and the third first split assembly also include a support ring 14 extending outward from the other side of the first main body 11, and the outer diameter of the support ring 14 is smaller than the outer diameter of the first main body 11.

[0123] When there is no gap between any two adjacent first split components, second first split components, and third first split components, and one of the first mounting grooves is formed by the fifth layer 15 on the support ring 14, then the other adjacent first mounting groove should be formed by the second layer 122 on the first layer; or the two adjacent first mounting grooves are respectively formed by the fifth layer 15 on the support ring 14, then the two adjacent first split components should be provided with a gap to provide space for the connection path between the electrode wire and the sheet electrode contact 40.

[0124] The fourth first split component, the first first split component, the second first split component, the third first split component and the fifth first split component are arranged in sequence along the axial direction; wherein, the first mounting groove of the fourth first split component and the first mounting groove at one end of the first first split component correspond one-to-one to form a first mounting position, and each first mounting position is installed with a sheet electrode contact 40; the first mounting groove at the other end of the first first split component and the first mounting groove at one end of the second first split component correspond one-to-one to form a first mounting position, and each first mounting position is installed with a sheet electrode contact 40; the first mounting groove at the other end of the second first split component and the first mounting groove at one end of the third first split component correspond one-to-one to form a first mounting position, and each first mounting position is installed with a sheet electrode contact 40; the first mounting groove at the other end of the third first split component and the first mounting groove of the fifth first split component correspond one-to-one to form a first mounting position, and each first mounting position is installed with a sheet electrode contact 40.

[0125] Furthermore, the 3-3-3-3 type 8-contact directional electrode also includes a contact segment 60 and a fourth joint segment 100. One end of the contact segment 60 is designed with an arc surface to enable the directional electrode to penetrate into the patient's brain tissue and reduce contact stimulation to the brain tissue. The other end of the contact segment 60 is embedded in the slot 111 of the first main body 11 in the fourth first split component. The support column of the fifth first split component is embedded in the middle segment 30.

[0126] Embodiment 6:

[0127] Combined with Fig.10 As shown, another 3-3-3-3 type 8-contact directional electrode is provided, which differs from Example 5 in that one or more of the three first split components of the first implementation manner in the first technical solution are replaced by the first split component of the third implementation manner in the first technical solution.

[0128] It needs to be further explained that the above-mentioned directional electrodes need to be packaged after the electrode contacts are installed. On the one hand, this is to strengthen the fixation of the electrode contacts in the installation position. On the other hand, it is to fill the gaps on the surface of the distributed bracket to ensure the flatness of the surface of the directional electrode and reduce the contact stimulation of the directional electrode entering the human tissue. The packaging generally adopts the method of glue filling. After the glue filling, the glue on the electrode contacts is removed to expose the electrode contacts so that the electrode contacts can contact the human tissue for electrical stimulation.

[0129] Although the embodiments of the present invention have been shown and described above, it is to be understood that the above embodiments are exemplary and are not to be construed as limitations on the present invention. A person skilled in the art may change, modify, substitute and modify the above embodiments within the scope of the invention without departing from the principles and purpose of the present invention. All such changes should fall within the scope of protection of the claims of the present invention.

Claims

1. A split bracket for mounting electrode contacts, characterized in that: include: A plurality of first sub-assemblies arranged along the axial direction, wherein the first sub-assemblies have a hollow inner cavity; Two adjacent first split components can cooperate to form a plurality of first installation positions spaced apart along the circumferential direction, wherein the first installation positions are suitable for installing sheet-shaped electrode contacts (40).

2. The split bracket according to claim 1, characterized in that: Each of the first split components is provided with a plurality of first installation grooves spaced apart along the circumferential direction, and the first installation grooves are used to form the first installation positions.

3. The split bracket according to claim 2, characterized in that: The first split component comprises a first main body (11) and a plurality of first support columns (12) extending outward from one side of the first main body (11) and arranged at intervals along the circumferential direction, and the first installation groove is formed between two first support columns (12) adjacent to each other along the circumferential direction.

4. The split bracket according to claim 3, characterized in that: The first support column (12) comprises a first layer body (121) and a second layer body (122) protruding outward from the outer surface of the first layer body (121), the first layer body (121) and the second layer body (122) can form a bidirectional step structure, and the first installation groove can be formed between two bidirectional step structures adjacent to each other in the circumferential direction.

5. The split bracket according to claim 4, characterized in that: The lengths of the first layer (121) and the second layer (122) in the axial direction can be configured to be at least one of equal and unequal.

6. The split bracket according to claim 4, characterized in that: The first split component also includes a support ring (14) extending outward from the other side of the first main body (11), the outer diameter of the support ring (14) is smaller than the outer diameter of the first main body (11), and the support ring (14) is used to install the annular electrode contact (50); or the first split component also includes a plurality of second support columns (13) extending outward from the other side of the first main body (11) and arranged at intervals along the circumferential direction, the second support columns (13) include a third layer body (131) and a fourth layer body (132) protruding outward from the outer surface of the third layer body (131), and the third layer body (131) and the fourth layer body (132) can form the bidirectional step structure.

7. The split bracket according to claim 6, characterized in that: The outer surface of the support ring (14) is provided with a plurality of fifth layers (15) convex outwardly and arranged at intervals in the circumferential direction, and the first mounting groove located on the outer surface of the support ring (14) is formed between two fifth layers (15) adjacent to each other in the circumferential direction.

8. The split bracket according to claim 7, characterized in that: There is a gap between two adjacent first split components.

9. The split bracket according to claim 5, characterized in that: A slot (111) is provided on the inner side of the first body (11); in two adjacent first bodies (11), a portion of the first layer (121) of one of the first bodies (11) that is longer than the second layer (122) can be accommodated in the slot (111) of the other first body (11).

10. The split bracket according to claim 5, characterized in that: The split bracket also includes a second split component, which includes a second body (21) and a third support column (22) extending outward from the second body (21), wherein the circumferential diameter formed by the third support column (22) is smaller than the outer diameter of the second body (21), and the end of the third support column (22) can be received in a slot (111) of an adjacent first body (11) or second body (21), so that the outer periphery of the third support column (22) forms a second mounting position, and the second mounting position is used to mount an annular electrode contact (50).

11. The split bracket according to any one of claims 3 to 8, characterized in that: In two adjacent first split components, two first installation grooves adjacent to each other along the axial direction can cooperate to form the first installation position.

12. The split bracket according to any one of claims 3-5, 9-10, characterized in that: The first mounting groove can form the first mounting position.

13. A directional electrode, characterized in that: include: A stimulation segment (10), comprising a split bracket as claimed in any one of claims 1 to 12 and electrode contacts mounted on the split bracket, wherein the electrode contacts comprise sheet electrode contacts (40) and / or ring electrode contacts (50); A connecting section (20), the connecting section (20) comprising a plurality of connecting contacts (201) which are insulated from each other; The middle section (30) connects the stimulation section (10) and the connection section (20), and the middle section (30) includes a plurality of electrode wires, and the connection contacts (201) and the electrode contacts are electrically connected in a one-to-one correspondence through the electrode wires.

14. An implantable stimulation system, characterized in that: The implantable stimulation system comprises a pulse generator and the directional electrode according to claim 13, wherein the pulse generator and the connection contact (201) of the directional electrode are electrically connected.

15. The implantable stimulation system according to claim 14, characterized in that: The implantable stimulation system also includes an extension wire, and the pulse generator is electrically connected to the directional electrode through the extension wire.

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