Electrode fixing device

Abstract

The utility model relates to an electrode fixing device, and belongs to the field of medical instruments. The electrode fixing device comprises a bone nail, a silica gel plug, a clamping piece and an electrode cap, threads of a screw rod on the bone nail can enable the bone nail to be fixed to the skull, an electrode sequentially penetrates through a channel and a through hole of the silica gel plug and extends into the skull from the outside of the skull, the clamping piece applies inward contraction pressure to the silica gel plug, the electrode in the silica gel plug can be tightly held, and therefore the electrode can be fixed to the skull. And a sealing effect is achieved. Meanwhile, due to the fact that related structures are all arranged in the cavity inside the bone nail, when the electrode fixing device is used, the diameter of a drilled hole above the skull is small, the height of the drilled hole is low, trauma of an operation to a patient can be reduced, and the infection risk is reduced.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, and in particular relates to an electrode fixation device. Background Technology

[0002] Deep brain stimulation (DBS) is a widely used neuromodulation method in clinical practice. It applies electrical stimulation to target nuclei through a neurostimulator to achieve the effect of treating diseases. It has become a major surgical treatment for movement disorders (such as Parkinson's disease, dystonia, essential tremor, and intractable obsessive-compulsive disorder) and is also a potential treatment for many neuropsychiatric diseases.

[0003] During the implantation surgery, the doctor first uses a three-dimensional stereotactic positioning device to determine the target location in the patient's brain. Based on this location, the doctor makes a small incision in the appropriate area of ​​the skull and inserts the brain electrode through the incision. The doctor then uses a testing stimulator to test the implanted target. If the stimulation treatment is effective, the brain electrode is reliably fixed to the skull using a fixation device. With the development of deep brain stimulation systems, medical professionals aim to make the holes drilled in the skull as small as possible and the electrode fixation device as low as possible, to reduce trauma to the patient, decrease the risk of infection, and accelerate postoperative healing.

[0004] Existing technologies, such as Chinese utility model patent document CN209333015U, disclose an intracranial electrode fixation base, belonging to the field of implantable medical system technology; Chinese invention patent document CN110215605A discloses a brain electrode fixation device and kit; and Chinese patent CN108325072A discloses a medical device fixation device. In the aforementioned three patent documents, the brain electrode fixation device requires drilling a 14mm diameter hole in the skull, and the device needs to protrude a considerable height from the skull, approximately 3.5-4mm. The fixation devices in these documents involve a large hole drilled in the skull and a significant protrusion from the skull. Utility Model Content

[0005] The technical problem to be solved by this utility model is to provide an electrode fixation device with a small diameter and low height for drilling holes above the skull, in order to overcome the shortcomings of the prior art.

[0006] The technical solution adopted by this utility model to solve its technical problem is:

[0007] An electrode fixing device, comprising:

[0008] A bone screw includes a head and a screw rod; the screw rod has a through hole in the middle and threads formed on its outer wall; the middle of the head and the middle of the screw rod near the head together form a cavity, and at least one fixing groove is provided at the top of the head.

[0009] A silicone plug is disposed in the cavity, the silicone plug has a channel in the middle, and a clamping groove is also provided on the outer wall of the silicone plug;

[0010] A clamping element, disposed within a clamping groove, is used to apply inward contraction pressure to the silicone plug;

[0011] An electrode cap, disposed on the head, is used to cover the cavity. The electrode cap has a fixing wing that mates with the fixing groove. When the fixing wing is installed in the fixing groove, it can clamp and fix the electrode.

[0012] Preferably, in the electrode fixing device of this utility model, a circular ring is provided above the silicone plug inside the cavity.

[0013] Preferably, in the electrode fixing device of this utility model, a boss that mates with the annular body is provided in the cavity.

[0014] Preferably, in the electrode fixing device of this utility model, the channel is a dumbbell-shaped hole, a cylindrical hole with a smooth inner wall, or a circular cylindrical hole with threads on the inner wall.

[0015] Preferably, in the electrode fixing device of this utility model, the clamping element is a slanted coil spring.

[0016] Preferably, in the electrode fixing device of this utility model, the outer wall of the silicone plug is further provided with two parallel clamping grooves, and each clamping groove is provided with a clamping element.

[0017] Preferably, in the electrode fixing device of this utility model, the screw has a self-tapping thread.

[0018] Preferably, in the electrode fixing device of this utility model, the fixing groove is further formed with an inclined surface, and the side of the fixing wing is provided with an inclined surface that matches the inclined surface to form a self-locking surface.

[0019] Preferably, in the electrode fixing device of this utility model, the two sides of the fixing groove are symmetrically provided with semi-circular grooves, and the fixing wing is provided with a semi-circular boss that can be inserted into the semi-circular groove.

[0020] The beneficial effects of this utility model are:

[0021] The electrode fixation device of this application includes a bone screw, a silicone plug, a clamping member, and an electrode cap. The threads of the screw on the bone screw allow it to be fixed to the skull. The electrode passes sequentially through the channel and through-hole of the silicone plug, extending from the outside of the skull into the skull. The clamping member applies inward contraction pressure to the silicone plug, thus "holding" the electrode inside the silicone plug and providing a seal. Furthermore, since all the relevant structures are located within the cavity of the bone screw, the diameter and height of the hole drilled above the skull are small when using the electrode fixation device of this embodiment, reducing surgical trauma to the patient and minimizing the risk of infection. Attached Figure Description

[0022] The technical solution of this application will be further described below with reference to the accompanying drawings and embodiments.

[0023] Figure 1 This is an exploded structural diagram of the electrode fixing device of this application;

[0024] Figure 2 This is a schematic diagram of one possible structure of the bone nail of this application;

[0025] Figure 3 for Figure 2 Another structural diagram of the central bone screw;

[0026] Figure 4 This is another structural schematic diagram of the bone nail of this application;

[0027] Figure 5 This is a schematic diagram of the silicone plug of this application;

[0028] Figure 6 for Figure 5 A schematic diagram of the structure with a cylindrical through hole for clamping in the middle AA section;

[0029] Figure 7 for Figure 5 A schematic diagram of the structure with dumbbell-shaped clamping holes in the middle AA section;

[0030] Figure 8 for Figure 5 A schematic diagram of the structure with spiral clamping holes in the middle AA section;

[0031] Figure 9 This is a schematic diagram of the inclined coil spring of the present invention;

[0032] Figure 10 This is a schematic diagram of the structure of the silicone plug of the present invention with two inclined coil springs;

[0033] Figure 11 For the purposes of this application and Figure 2 A schematic diagram of the electrode cap used with the cranial screw;

[0034] Figure 12 For the purposes of this application and Figure 4 A schematic diagram of the electrode cap used with the cranial screw;

[0035] Figure 13 This is a schematic diagram of the structure of the cannula needle of the electrode in this application;

[0036] Figure 14 This is a schematic diagram of the structure in this application where the bone screw is installed on the skull and the cannula is advanced into the cranium;

[0037] Figure 15 This is a schematic diagram of the structure in this application where the electrode is inserted into the outer sleeve and advanced to the target nucleus.

[0038] Figure 16 This is a schematic diagram of the structure in which the fixation electrode is fixed to the skull after the operation.

[0039] The attached figures are labeled as follows:

[0040] 10 bone screws;

[0041] 101. Head;

[0042] 1011 Fixing slot;

[0043] 1012 bevel;

[0044] 1013 Semicircular groove;

[0045] 102 Screw;

[0046] 1021 Through hole;

[0047] 1022 Cavity;

[0048] 1023 convex platform;

[0049] 1024 thread;

[0050] 20 silicone stoppers;

[0051] 210 channels;

[0052] 211 Clamping groove;

[0053] 30 Clamping components;

[0054] 40 Electrode Caps;

[0055] 41. Fixed-wing aircraft;

[0056] 42. Semicircular boss;

[0057] 43. Gap;

[0058] 44. Flange;

[0059] 45. Upper plane;

[0060] 46. ​​Inclined surface;

[0061] 50. Toroidal body;

[0062] 51. Outer tube;

[0063] 52. Liner core;

[0064] 53. Sleeve. Detailed Implementation

[0065] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other.

[0066] In the description of this application, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the scope of protection of this application. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this utility model, unless otherwise stated, "a plurality of" means two or more.

[0067] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art will understand the specific meaning of the above terms in this application based on the specific circumstances.

[0068] The technical solution of this application will now be described in detail with reference to the accompanying drawings and embodiments.

[0069] Example

[0070] This embodiment provides an electrode fixing device, such as... Figure 1 As shown, it includes:

[0071] The bone nail 10 includes a head 101 and a screw 102; the screw 102 has a through hole 1021 in the middle and a thread 1024 formed on its outer wall; the middle of the head 101 and the middle of the screw 102 near the head 101 together form a cavity 1022, and at least one fixing groove 1011 is provided at the top of the head 101.

[0072] A silicone plug 20 is disposed in the cavity 1022. The silicone plug 20 has a channel 210 in the middle and a clamping groove 211 is also provided on the outer wall of the silicone plug 20.

[0073] The clamping element 30 is disposed in the clamping groove 211 and is used to apply inward contraction pressure to the silicone plug 20;

[0074] An electrode cap 40 is disposed on the head 101 and is used to cover the cavity 1022. The electrode cap 40 has a fixing wing 41 that cooperates with the fixing groove 1011. When the fixing wing 41 is installed on the fixing groove 1011, it can clamp and fix the electrode.

[0075] In this embodiment of the electrode fixation device, the thread 1024 of the screw 102 on the bone nail 10 allows the bone nail 10 to be fixed to the skull. The electrode passes sequentially through the channel 210 and through hole 1021 of the silicone plug 20, extending from the outside of the skull into the inside. The clamping member 30 applies inward contraction pressure to the silicone plug 20, thus "holding" the electrode inside the silicone plug 20 and achieving a sealing effect. At the same time, since the relevant structures are all inside the cavity 1022 of the bone nail 10, when using the electrode fixation device of this embodiment, the diameter and height of the hole drilled above the skull are small, which can reduce surgical trauma to the patient and reduce the risk of infection.

[0076] Furthermore, an annular body 50 is provided above the silicone plug 20 inside the cavity 1022. The annular body 50 also has a hole in the middle, which can further serve to fix the silicone plug 20.

[0077] Furthermore, a boss 1023 that mates with the annular body 50 is provided inside the cavity 1022 to facilitate fixing the annular body 50 and prevent it from shifting.

[0078] Furthermore, such as Figure 6-8 As shown, the channel 210 is a dumbbell-shaped hole (large at both ends and small in the middle), a cylindrical hole with a smooth inner wall, or a circular cylindrical hole with threads on the inner wall.

[0079] Furthermore, such as Figure 9 As shown, the clamping element 30 is a helical coil spring. Helical coil springs are low-cost and can provide a stable inward clamping force. The inner diameter D2 of the helical coil spring is smaller than the diameter D1 of the clamping groove 211.

[0080] Furthermore, the outer wall of the silicone plug 20 is provided with two parallel clamping grooves 211, and each clamping groove 211 is provided with a clamping member 30.

[0081] Furthermore, the thread 1024 formed by the screw 102 is a self-tapping thread.

[0082] Furthermore, the fixing groove 1011 is also formed with an inclined surface 1012, and the side of the fixing wing 41 is provided with an inclined surface 46 that matches the inclined surface 1012 to form a self-locking surface.

[0083] Furthermore, the fixing groove 1011 has symmetrical semi-circular grooves 1013 on both sides, and the fixing wing 41 has a semi-circular boss 42 that fits into the semi-circular groove 1013, so that the bone nail 10 and the electrode cap 40 are connected to each other.

[0084] Furthermore, the electrode cap 40 is provided with a fixing wing 41 and a flange 44 on its outer periphery along the axial direction, and the distance between the upper surface 45 of the electrode cap 40 and the bottom surface of the head 101 is 1.5 to 2.5 mm. The fixing wing 41 is provided with a gap 43, which allows the fixing wing 41 to undergo elastic deformation when it is inserted into the fixing groove 1011.

[0085] In this embodiment, the silicone plug 20 is made of silicone, TPU, or TPE elastomer; the bone screw 10 and the ring 50 are made of titanium alloy, polyetheretherketone (PEEK), or polyetherketoneketone (PEKK); the clamping member 30 is made of stainless steel or nickel-cobalt alloy; and the electrode cap 40 is made of TPU, nylon, or PEEK. The bone screw 10 in this embodiment has a smaller structure, which reduces surgical trauma to the patient and the risk of infection.

[0086] The structure of the electrode sleeve 53 is as follows Figure 13 Includes: outer tube 51, lining core 52.

[0087] The procedure for using the electrode fixation device in this embodiment (surgery):

[0088] S1. Based on the patient's preoperative MRI, make a plan and determine the target coordinates;

[0089] S2. Under local anesthesia, drill a hole in the skull that fits the skull screw, install the head frame, and then screw the skull screw with the silicone plug and ring installed into the drilled hole. Install the microelectrode driver on the head frame.

[0090] S3. Perform intraoperative electrophysiology to accurately determine the target location of the electrode implantation nucleus;

[0091] S4. Install the cannula onto the microelectrode driver, then advance the cannula through the bone screw (cranioscrew screw) to the vicinity of the target point, such as... Figure 13 As shown;

[0092] S5. Remove the liner of the cannula, insert the electrode into the outer cannula of the cannula needle, and advance it toward the target nucleus. Figure 14 As shown;

[0093] S6. Perform intraoperative test stimulation and observe the effect. If the effect is ideal, slowly pull out the outer cannula. During the process of pulling out the outer cannula, keep the electrode still. When the outer cannula is pulled out of the silicone plug, since the inner diameter of the silicone plug is smaller than the outer diameter of the electrode, the silicone plug can clamp the electrode.

[0094] S7. Insert the electrode into the locking slot of the skull screw, cover it with the electrode cap, and complete the electrode implantation surgery. Figure 15 As shown, the electrode bent at this point.

[0095] Based on the above-described preferred embodiments according to this application, and through the foregoing description, those skilled in the art can make various changes and modifications without departing from the technical concept of this application. The technical scope of this application is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. An electrode fixing device, characterized in that, include: A bone nail (10) includes a head (101) and a screw (102); the screw (102) has a through hole (1021) in the middle and a thread (1024) formed on its outer wall; the middle of the head (101) and the middle of the screw (102) near the head (101) together form a cavity (1022), and at least one fixing groove (1011) is provided at the top of the head (101); A silicone plug (20) is disposed in the cavity (1022). The silicone plug (20) has a channel (210) in the middle and a clamping groove (211) is provided on the outer wall of the silicone plug (20). A clamping element (30) is disposed in a clamping groove (211) for applying inward contraction pressure to the silicone plug (20); An electrode cap (40) is disposed on the head (101) for covering the cavity (1022). The electrode cap (40) has a fixing wing (41) that cooperates with the fixing groove (1011). When the fixing wing (41) is installed on the fixing groove (1011), it can clamp and fix the electrode.

2. The electrode fixing device according to claim 1, characterized in that, An annular body (50) is provided above the silicone plug (20) inside the cavity (1022).

3. The electrode fixing device according to claim 2, characterized in that, The cavity (1022) is provided with a boss (1023) that mates with the annulus (50).

4. The electrode fixing device according to claim 1, characterized in that, The channel (210) is a dumbbell-shaped hole, a cylindrical hole with a smooth inner wall, or a circular cylindrical hole with threads on the inner wall.

5. The electrode fixing device according to claim 1, characterized in that, The clamping element (30) is a helical coil spring.

6. The electrode fixing device according to claim 1, characterized in that, The outer wall of the silicone plug (20) is also provided with two parallel clamping grooves (211), and each clamping groove (211) is provided with a clamping member (30).

7. The electrode fixing device according to claim 1, characterized in that, The thread (1024) formed by the screw (102) is a self-tapping thread.

8. The electrode fixing device according to claim 1, characterized in that, The fixing groove (1011) is also formed with an inclined surface (1012), and the side of the fixing wing (41) is provided with an inclined surface (46) that matches the inclined surface (1012) to form a self-locking surface.

9. The electrode fixing device according to claim 1, characterized in that, The fixing groove (1011) is provided with symmetrical semi-circular grooves (1013) on both sides, and the fixing wing (41) is provided with a semi-circular boss (42) that can be inserted into the semi-circular groove (1013).

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