A protection structure for electrode connection

Abstract

The utility model discloses a protection structure of electrode connection belongs to medical instrument technical field. Protection structure of electrode connection is used for connecting extension wire and electrode wire, and protection structure of electrode connection includes protection cover and developing ring, and protection cover is the light -transmitting structure, and the both ends of protection cover are equipped with first connecting end and second connecting end respectively, and the first connecting end is set up and is connected in the connecting portion of electrode wire, and the second connecting end is set up and is connected in extension wire, and the connecting place of extension wire and electrode wire is located in the protection cover, and developing ring is embedded in the protection cover and is used for the convenient identification protection cover, and developing ring is set up in electrode wire. The utility model discloses a protection structure of electrode connection, realizes the distinction, and is convenient for identifying whether extension wire and electrode wire are installed in place.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a protective structure for electrode connections. Background Technology

[0002] In recent years, deep brain stimulation (DBS) combined with medication has become a common treatment strategy in clinical practice for motor dysfunction disorders such as Parkinson's disease, epilepsy, dystonia, and spinal cord pain, as well as mental illnesses such as depression, drug addiction, and obsessive-compulsive disorder. In most current DBS systems, an extension lead connects the IPG (Implantable Pulse Generator) and electrode leads to transmit signals. DBS systems typically use multiple electrode leads and multiple extension leads, connected in a one-to-one correspondence. Multiple electrode leads are implanted in the left and right hemispheres of the brain respectively, then exit from one side and connect to their corresponding extension leads. In related technologies, a protective structure covers the electrode leads and extension leads to achieve a sealed protection. This protective structure is made of two different materials to distinguish between the electrode leads in the left and right hemispheres. However, some opaque materials make it difficult to identify whether the extension wires and electrode wires are installed correctly during installation. If they are not installed correctly, there is a risk of seal failure, which in turn leads to poor contact effect of the electrode wires and extension wires after they are connected, affecting the product function. Utility Model Content

[0003] The purpose of this utility model is to provide a protective structure for electrode connections, enabling differentiation and facilitating the identification of whether extension wires and electrode wires are installed in place.

[0004] To achieve this objective, the present invention adopts the following technical solution:

[0005] A protective structure for an electrode connection, used to connect an extension wire and an electrode wire, the protective structure for the electrode connection comprising:

[0006] A protective sleeve, the protective sleeve having a light-transmitting structure, the two ends of the protective sleeve respectively having a first connecting end and a second connecting end, the first connecting end being sleeved and connected to the connecting part of the electrode wire, the second connecting end being sleeved and connected to the extension wire, the connection point of the extension wire and the electrode wire being located inside the protective sleeve;

[0007] A developing ring is embedded in the protective sleeve for easy identification of the protective sleeve, and the developing ring is sleeved on the electrode wire.

[0008] In some embodiments, the developing ring is interference-fitted with the electrode wire.

[0009] In some embodiments, the light transmittance of the protective cover is greater than or equal to 50%.

[0010] In some embodiments, the developing ring and the protective sleeve are integrally formed or separate structures.

[0011] In some embodiments, the inner wall of the first connecting end is provided with a sealing rib, and the sealing rib and the electrode wire are interference-fitted; and / or, the inner wall of the second connecting end is a smooth structure, and its inner diameter is smaller than the outer diameter of the connecting portion of the extension wire, so that the second connecting end and the connecting portion of the extension wire are interference-fitted.

[0012] In some embodiments, the first connecting end is provided with two sealing ribs, and the developing ring is embedded in the transition connection between the two sealing ribs.

[0013] In some embodiments, the protective sleeve is made of polyurethane or silicone rubber; and / or the developing ring is made of barium sulfate, titanium dioxide, gold, silver, platinum-iridium, nickel-titanium, or stainless steel.

[0014] In some embodiments, the outer periphery of the connecting portion of the extension wire is provided with an annular boss, and the inner diameter of the second connecting end is smaller than the outer diameter of the annular boss, so that the second connecting end and the annular boss are interference-fitted.

[0015] In some embodiments, the outer side wall of the second connection end is provided with a tying position for tying wires.

[0016] In some embodiments, the outer side wall of the second connection end is provided with at least two annular protrusions, and the tying position is formed between the two annular protrusions.

[0017] The beneficial effects of this utility model are:

[0018] This utility model provides a protective structure for electrode connections. Electrode leads and extension leads are connected to the two ends of a protective sleeve, with the connection point enclosed within the protective sleeve for a sealed protection. The protective sleeve is translucent, facilitating identification of whether the electrode leads and extension leads are properly installed, ensuring effective contact insulation after connection, and thus guaranteeing product functionality. A radiopaque ring on the protective sleeve forms an identification structure for easy identification of the electrode connection structure, distinguishing between left and right hemisphere electrode leads. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the protective structure provided by a specific embodiment of this utility model;

[0020] Figure 2 yes Figure 1AA section view;

[0021] Figure 3 yes Figure 1 BB cross-sectional view;

[0022] Figure 4 This is a schematic diagram of the protective sleeve provided in a specific embodiment of this utility model.

[0023] In the picture:

[0024] 100. Extension wire; 110. Annular boss; 200. Electrode wire;

[0025] 300. Protective structure for electrode connection; 310. Protective sleeve; 311. First connection end; 312. Sealing rib; 313. Transition connection; 314. Second connection end; 315. Tie-on position; 316. Annular protrusion; 320. Developing ring; 330. First protective sleeve; 340. Second protective sleeve;

[0026] 400, line. Detailed Implementation

[0027] To make the technical problems solved by this utility model, the technical solutions adopted, and the technical effects achieved clearer, the technical solutions of the embodiments of this utility model will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0028] In the description of this utility model, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; 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; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0029] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0030] The technical field and related terms of the embodiments of this application are briefly described below.

[0031] Implantable medical systems include implantable neurostimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead transfer systems. Examples of implantable neurostimulation systems include deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS).

[0032] Implantable neurostimulation systems consist of a stimulator implanted in the patient's body (i.e., an implantable neurostimulator) and a programmed device placed outside the patient's body. In other words, the stimulator is a medical device, or medical devices include stimulators. Related neuromodulation techniques primarily involve stereotactic surgery to implant electrodes (e.g., electrode wires) at specific sites (target points) in the body's tissues. Discharge pulses are then delivered through these electrodes to the target points, modulating the electrical activity and function of corresponding neural structures and networks, thereby improving symptoms and alleviating pain.

[0033] As an example, a DBS includes an IPG (Implantable Pulse Generator), extension leads, and electrode leads. The IPG is connected to the electrode leads via the extension leads. The IPG is implanted in the patient's body, for example, in the chest or other internal locations.

[0034] As another example, DBS includes an IPG and electrode leads, with the IPG directly connected to the electrode leads. The IPG is implanted in the patient's head, for example, by creating a groove in the patient's skull and then placing the IPG in the groove. In this case, the IPG may not protrude from the outer surface of the skull, or it may protrude partially from the outer surface of the skull.

[0035] In this system, the IPG responds to programmed commands sent by a programmable device, using a sealed battery and circuitry to deliver controllable electrical stimulation (or electrical stimulation energy) to tissues within the body. The IPG delivers one or more controllable electrical stimuli to specific areas of tissue via electrode leads.

[0036] In some embodiments, the extension wire is used in conjunction with the IPG as a medium for transmitting electrical stimulation, thereby transmitting the electrical stimulation generated by the IPG to the electrode wire.

[0037] In some embodiments, electrical stimulation can be delivered in the form of a pulsed signal or a non-pulsed signal. For example, electrical stimulation can be delivered as a signal with various waveform shapes, frequencies, and amplitudes. Therefore, non-pulsed signal electrical stimulation can be a continuous signal, which can have a sinusoidal waveform or other continuous waveforms.

[0038] After receiving electrical stimulation from the IPG or extension leads, the electrode leads deliver the stimulation to specific areas of tissue within the body via multiple electrode contacts. The stimulator may have one or more electrode leads on one or both sides, with multiple electrode contacts on each lead. These contacts may be evenly or non-uniformly arranged circumferentially on the electrode leads. As an example, the electrode contacts may be arranged in a 4x3 array (a total of 12 electrode contacts) circumferentially on the electrode leads. The electrode contacts may include stimulating electrode contacts and / or collecting electrode contacts. The electrode contacts may be in shapes such as sheet-like, ring-like, or dot-like.

[0039] In some embodiments, the stimulated tissue may be the patient's brain tissue, and the stimulated site may be a specific location within the brain tissue. Generally, the stimulated site differs depending on the patient's disease type, and the number of stimulation contacts (single-source or multi-source), the application of one or more specific electrical stimulation pathways (single-channel or multi-channel), and the stimulation parameters (values) also vary.

[0040] This application does not limit the applicable disease types, but can be any disease type applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, or functional electrical stimulation. Among these, DBS can be used to treat or manage diseases including, but not limited to: spastic disorders (e.g., epilepsy), pain, migraines, mental illnesses (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, mobility 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 impairments.

[0041] In this embodiment of the 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, with different stimulation parameters corresponding to different electrical stimuli). Alternatively, the stimulator can sense the patient's electrophysiological activity to collect electrophysiological signals, and the collected electrophysiological signals can be used to continue adjusting the stimulation parameters of the stimulator to achieve closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0042] Stimulation parameters may include at least one of the following: electrode contact identification for delivering electrical stimulation (e.g., electrode contact #2 and electrode contact #3), frequency (e.g., the number of electrical stimulation pulse signals per second, in Hz), pulse width (duration of each pulse, in μs), amplitude (generally expressed as voltage, i.e., the intensity of each pulse, in V), timing (e.g., continuous or bursty, bursty refers to discontinuous temporal behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode), physician control upper and lower limits (the range that the physician can adjust), and patient control upper and lower limits (the range that the patient can adjust independently).

[0043] In some embodiments, the stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0044] Programmable devices can include physician-controlled devices (i.e., devices used by physicians) and / or patient-controlled devices (i.e., devices used by patients). Physician-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software. Patient-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software; patient-controlled devices can also be other electronic devices with programming functions (e.g., chargers with programming functions, electrophysiological acquisition devices, etc.).

[0045] like Figures 1-4 As shown, this embodiment provides a protective structure for connecting an extension wire 100 and an electrode wire 200. The protective structure 300 includes a protective sleeve 310 and a developing ring 320. The two ends of the protective sleeve 310 are respectively provided with a first connecting end 311 and a second connecting end 314. The first connecting end 311 is sleeved and connected to the electrode wire 200, and the second connecting end 314 is sleeved and connected to the connecting part of the extension wire 100. The connection point between the extension wire 100 and the electrode wire 200 is located inside the protective sleeve 310. The protective sleeve 310 is a light-transmitting structure. The developing ring 320 is embedded in the protective sleeve 310 for easy identification of the protective sleeve 310. The developing ring 320 is sleeved on the electrode wire 200.

[0046] Electrode leads 200 and extension leads 100 are connected to the two ends of the protective sleeve 310, respectively. The connection point is enclosed within the protective sleeve 310 for a sealed protection. The protective sleeve 310 is light-transmitting, facilitating identification of whether the electrode leads 200 and extension leads 100 are properly installed within it, ensuring effective contact and thus product functionality. Optionally, the light transmittance of the protective sleeve 310 is greater than or equal to 50%, specifically 50%, 60%, 70%, 80%, or 90%, etc. The transmittance value can be set according to actual needs; higher transmittance makes identification easier. Figure 1 As shown, a DBS system typically uses multiple electrode leads 200 and multiple extension leads 100, which are connected one-to-one. The multiple electrode leads 200 are implanted in the left and right hemispheres of the patient's brain, respectively, and then connected to the corresponding extension leads 100. During connection, it is necessary to distinguish the electrode leads 200 for the left and right hemispheres. For this purpose, the protective sleeve 310 is provided with a radiopaque ring 320 to form an identification structure, which is used to facilitate the identification and differentiation of the protective structures 300 for different electrode connections and the different electrode leads 200.

[0047] Optionally, the protective sleeve 310 is divided into a first protective sleeve 330 and a second protective sleeve 340. The two protective sleeves 310 are provided with different developing rings 320 for identification. For example, the developing rings 320 of the two protective sleeves 310 are different colors. The first protective sleeve 330 is inlaid with a white developing ring 320, and the second protective sleeve 340 is inlaid with a green developing ring 320.

[0048] Optionally, the first protective sleeve 330 and the second protective sleeve 340 may have one with a imaging ring 320 and the other without, thus distinguishing the two protective sleeves 310, i.e., the protective structures 300 for two different electrode connections. This simplifies the structure and reduces costs. In use, the electrode wires 200 for the left and right hemispheres are connected using the first protective sleeve 330 and the second protective sleeve 340, respectively. This clearly distinguishes the different electrode wires 200 and facilitates identification of whether the protective sleeves 310 are properly installed.

[0049] Optionally, the developing ring 320 is fitted with the electrode wire 200 with a clearance, so as not to affect the connection between the protective sleeve 310 and the electrode wire 200. Optionally, the developing ring occupies only a small part of the protective sleeve 310, so as not to block the extension wire 100 during installation, making it easy to identify whether it is installed in place.

[0050] The protective sleeve 310 is made of a biocompatible polymer material, such as polyurethane or silicone rubber. The developing ring 320 can be made of materials such as barium sulfate, titanium dioxide, or metals such as gold, silver, platinum-iridium, nickel-titanium, or stainless steel. The developing ring 320 can be white or any other color.

[0051] The developing ring 320 and the protective sleeve 310 can be either integrally molded or separate structures. When the developing ring 320 and the protective sleeve 310 are integrally molded, they can be manufactured using methods such as injection molding or 3D printing. When the developing ring 320 and the protective sleeve 310 are separate structures, the developing ring 320 can be pre-molded and then the protective sleeve 310 can be completely encapsulated. The developing ring 320 can be formed using methods such as injection molding, compression molding, die molding, or 3D printing.

[0052] The inner wall of the first connecting end 311 is provided with a sealing rib 312, which is interference-fitted with the electrode wire 200, thereby achieving a sealed connection between the first connecting end 311 and the electrode wire 200 through the sealing rib 312. The end of the extension wire 100 connected to the electrode wire 200 is a connecting part. The inner wall of the second connecting end 314 has a smooth structure, and its inner diameter is smaller than the outer diameter of the connecting part of the extension wire 100, so that the second connecting end 314 and the connecting part of the extension wire 100 are interference-fitted, thereby achieving a sealed connection between the second connecting end 314 and the extension wire 100.

[0053] Electrode lead 200 is interference-fitted to the first connecting end 311, achieving a sealed connection between electrode lead 200 and the first connecting end 311. Extension lead 100 is interference-fitted to the second connecting end 314, achieving a sealed connection between extension lead 100 and the second connecting end 314. This forms a sealed cavity with electrode lead 200, extension lead 100, and protective sleeve 310. The connection point between electrode lead 200 and extension lead 100 is located within this sealed cavity, ensuring sealing and insulation at the connection point. This guarantees the contact connection effect after the electrode lead 200 and extension lead 100 are connected, thus ensuring product functionality. The first connecting end 311 has a sealing rib 312 on its inner wall for interference fit with electrode lead 200, and the inner diameter of the second connecting end 314 is smaller than that of extension lead 100 to achieve interference fit. This interference fit sealing connection relies on the dimensional interference of the components themselves, reducing reliance on the doctor's technique. It eliminates the need for additional sealing elements such as sealing rings or sealant structures, simplifying the number of parts and assembly process, and preventing seal failure due to aging, deformation, or detachment of sealing elements. The interference fit has a large frictional force generated by radial pressure at the mating surface, which can effectively resist dynamic loads such as vibration and impact, and has good reliability.

[0054] Optionally, two or more sealing ribs 312 are provided. By increasing the number of sealing ribs 312, the sealing connection effect between the sealing ribs 312 and the electrode wire 200 is improved. In one embodiment, the first connection end 311 is provided with two sealing ribs 312, and a developing ring 320 is embedded in the transition connection 313 between the two sealing ribs 312.

[0055] The outer wall of the second connecting end 314 is provided with a tying position 315 for tying the wire 400. Tying the wire 400 ensures a tighter fit between the inner wall of the second connecting end 314 and the extension wire 100, further improving the sealing effect. The outer wall of the second connecting end 314 is provided with at least two annular protrusions 316, forming the tying position 315 between them. By setting the tying position 315, the wire 400 is positioned in a preset position, improving the accuracy of the tying and further ensuring the sealing effect. Optionally, two annular protrusions 316 are provided, with the wire 400 tying between them, resulting in a simple and reliable structure. Optionally, three or more annular protrusions 316 can be provided. When three annular protrusions 316 are provided, two tying positions 315 are formed, each used for tying the wire 400. Increasing the number of tying positions further improves the sealing effect. In addition, by setting the tie point 315, it can be distinguished from the first connection end 311 in appearance, which facilitates installation.

[0056] The connecting portion is provided with an annular boss 110. The inner diameter of the second connecting end 314 is smaller than the outer diameter of the annular boss 110, so that the second connecting end 314 and the annular boss 110 are in an interference fit. By providing the annular boss 110, the contact area of ​​the interference fit between the extension wire 100 and the protective sleeve 310 is reduced, the difficulty of relative movement between the two is reduced, and installation and disassembly are facilitated. The number of annular bosses 110 can be one or more. In one embodiment, the number of annular bosses 110 is the same as the number of annular protrusions 316 and they are arranged in a one-to-one correspondence. The position between two annular bosses 110 is the connecting portion. The connecting portion and the second connecting end 314 are in a transition fit or clearance fit. By tying a wire 400 at this position, the connecting portion and the second connecting end 314 are brought into contact, increasing the contact area between the extension wire 100 and the second connecting end 314, and further improving the sealing effect.

[0057] Optionally, the extension wire 100 and the second connecting end 314 are slightly interference-fitted to ensure that they do not easily move relative to each other. The slightly interference fit reduces the requirements for the binding wire 400, allowing it to maintain a tight seal under stress, and also facilitates installation and disassembly. Optionally, the interference between the two is 0.01mm-0.05mm, such as 0.01mm, 0.02mm, 0.03mm, 0.04mm, or 0.05mm, etc., and is not limited.

[0058] This embodiment also provides an implantable electrical stimulation system, including a protective structure 300 for electrode connection as described above. The protective sleeve 310 is press-fitted to the electrode wire 200 and the extension wire 100 to achieve sealing, thereby reducing reliance on the doctor's technique. Furthermore, by making the protective sleeve 310 a light-transmitting structure and installing a radiopaque ring 320 on the protective sleeve 310, it is easy to distinguish between different electrode wires 200 and the protective structure 300 for electrode connection, and it is also easy to identify whether the electrode wire 200 and the extension wire 100 are properly installed with the protective sleeve 310.

[0059] Obviously, the above embodiments of this utility model are merely examples for clearly illustrating the present utility model, and are not intended to limit the implementation of the present utility model. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this utility model should be included within the protection scope of the claims of this utility model.

Claims

1. A protective structure for an electrode connection, used to connect an extension wire (100) and an electrode wire (200), characterized in that, The protective structure for the electrode connection includes: A protective sleeve (310) is a light-transmitting structure. The two ends of the protective sleeve (310) are respectively provided with a first connecting end (311) and a second connecting end (314). The first connecting end (311) is sleeved and connected to the electrode wire (200), and the second connecting end (314) is sleeved and connected to the connecting part of the extension wire (100). The connection between the extension wire (100) and the electrode wire (200) is located inside the protective sleeve (310). A developing ring (320) is embedded in the protective sleeve (310) for easy identification of the protective sleeve (310), and the developing ring (320) is sleeved on the electrode wire (200).

2. The protective structure for electrode connection according to claim 1, characterized in that, The developing ring (320) is interference-fitted with the electrode wire (200).

3. The protective structure for electrode connection according to claim 1, characterized in that, The light transmittance of the protective cover (310) is greater than or equal to 50%.

4. The protective structure for electrode connection according to claim 1, characterized in that, The developing ring (320) and the protective sleeve (310) are either integrally formed or separate structures.

5. The protective structure for electrode connection according to claim 1, characterized in that, The inner wall of the first connecting end (311) is provided with a sealing rib (312), and the sealing rib (312) and the electrode wire (200) are interference-fitted; and / or, the inner wall of the second connecting end (314) is a smooth structure, and its inner diameter is smaller than the outer diameter of the connecting part of the extension wire (100), so that the connecting part of the second connecting end (314) and the extension wire (100) are interference-fitted.

6. The protective structure for electrode connection according to claim 5, characterized in that, The first connecting end (311) is provided with two sealing rib positions (312), and the developing ring (320) is embedded in the transition connection (313) between the two sealing rib positions (312).

7. The protective structure for electrode connection according to claim 1, characterized in that, The protective sleeve (310) is made of polyurethane or silicone rubber; and / or the developing ring (320) is made of barium sulfate, titanium dioxide, gold, silver, platinum-iridium, nickel-titanium or stainless steel.

8. The protective structure for electrode connection according to claim 1, characterized in that, The outer periphery of the connecting portion of the extension wire (100) is provided with an annular boss (110), and the inner diameter of the second connecting end (314) is smaller than the outer diameter of the annular boss (110), so that the second connecting end (314) and the annular boss (110) are interference fit.

9. The protective structure for electrode connection according to any one of claims 1-8, characterized in that, The outer wall of the second connecting end (314) is provided with a tying position (315), which is used to tie the wire (400).

10. The protective structure for electrode connection according to claim 9, characterized in that, The outer wall of the second connecting end (314) is provided with at least two annular protrusions (316), and the binding position (315) is formed between the two annular protrusions (316).

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