A percutaneous minimally invasive flexible electrode, component and system

Abstract

The present application provides a percutaneous minimally invasive flexible electrode, assembly and system. The percutaneous minimally invasive flexible electrode includes an internal component, an external component and a percutaneous connection portion. The internal component is made of a flexible material, and the internal component includes at least one stimulation electrode site for applying electrical stimulation to the target tissue. The distal end of the internal component is provided with an auxiliary implantation portion, which is used to implant the internal component toward the target target area corresponding to the target tissue. The external component includes contacts corresponding to the stimulation electrode sites of the internal component, and the external component is used to be electrically connected to an external device. The percutaneous connection portion is used to electrically connect the stimulation electrode sites of the internal component to the contacts of the external component, and the thickness of the percutaneous connection portion along the stacking arrangement direction is not more than 0.2 mm. In this way, the functionality and reliability of percutaneous minimally invasive flexibility are effectively enhanced, damage to surrounding tissues is reduced, trauma and pain to patients are alleviated, and the risk of infection during the implantation process is reduced.

Description

Technical Field

[0001] The present application relates to the technical field of biomedical engineering, and in particular, to a percutaneous minimally invasive flexible electrode, component and system. Background Art

[0002] As a neuromodulation therapy, nerve stimulation technology has been widely used in the treatment of various diseases in recent years. In particular, sacral nerve stimulation technology has been widely used in the treatment of various urinary system and intestinal diseases. Specifically, by generating electrical pulses acting on the sacral nerves, sacral nerve stimulators can effectively improve symptoms such as urinary retention, urinary incontinence, chronic pelvic pain and constipation.

[0003] However, the current percutaneous minimally invasive flexible electrodes have poor flexibility and are prone to damage surrounding tissues during implantation in the human body. They are also prone to displacement after implantation, thus affecting the therapeutic effect of the disease. Although sacral nerve stimulation can improve patient symptoms in the short term, its long-term efficacy and stability remain uncertain. In addition, if the size of the percutaneous part of this type of electrode is large, it will increase damage to surrounding tissues, thereby increasing the risk of infection during the implantation process and causing serious discomfort to patients. Summary of the invention

[0004] In response to the above-mentioned technical problems existing in the prior art, the present application provides a percutaneous minimally invasive flexible electrode, component and system, which can effectively reduce the percutaneous wound during the implantation process, reduce the patient's pain and infection risk, and improve the flexibility and implantation safety of the percutaneous minimally invasive flexible electrode.

[0005] The present application provides a percutaneous minimally invasive flexible electrode, which includes an internal component, an external component and a percutaneous connection portion. The internal component is made of a flexible material, and the internal component includes at least one stimulation electrode site for applying electrical stimulation to the target tissue. The distal end of the internal component is provided with an auxiliary implantation portion, which is used to implant the internal component toward the target target area corresponding to the target tissue. The external component includes contacts corresponding to the stimulation electrode sites of the internal component, and the external component is used to be electrically connected to an external device. One end of the percutaneous connection portion is connected to the proximal end of the internal component, and the other end is connected to the distal end of the external component, which is used to electrically connect the stimulation electrode sites of the internal component to the contacts of the external component. The percutaneous connection portion includes a first flexible insulating layer, a conductive lead layer and a second flexible insulating layer which are sequentially stacked, and the thickness of the percutaneous connection portion along the stacking direction is not more than 0.2 mm.

[0006] In some embodiments, an auxiliary fixing portion is provided on the transdermal connection portion, the auxiliary fixing portion has a thorn-like structure and / or a hollow structure, the thorn-like structure extends from the auxiliary fixing portion in a direction away from the transdermal connection portion, and the hollow structure is located on the side of the transdermal connection portion and / or on the transdermal connection portion.

[0007] In some embodiments, the auxiliary fixing portion has a thorn-like structure, and the thorn-like structure is arranged obliquely relative to the transcutaneous connecting portion toward the direction where the external component is located.

[0008] In some embodiments, the auxiliary fixing portion is formed on the first flexible insulating layer and / or the second flexible insulating layer.

[0009] In some embodiments, the first flexible insulating layer and the second flexible insulating layer are made of one or a combination of the following materials: SU-8 photoresist, polyparaxylene, fluorinated polymer and polyimide; and / or the conductive lead layer is made of metal material.

[0010] In some embodiments, the conductive lead layer includes a first conductive lead layer arranged in contact with the first flexible insulating layer and a second conductive lead layer arranged in contact with the second flexible insulating layer. The through-skin connection part also has a third flexible insulating layer along its thickness direction, and the third flexible insulating layer is placed between the first conductive lead layer and the second conductive lead layer.

[0011] In some embodiments, there are multiple first conductive lead layers, the multiple first conductive lead layers are arranged in parallel, and a fourth flexible insulating layer is arranged between adjacent first conductive lead layers; and / or, there are multiple second conductive lead layers, the multiple second conductive lead layers are arranged in parallel, and a fourth flexible insulating layer is arranged between adjacent second conductive lead layers.

[0012] In some embodiments, the outer contour edge of the thorn-like structure is in a straight line or an arc shape.

[0013] In some embodiments, the hollow structure has a polygonal and / or curved shape.

[0014] In some embodiments, the auxiliary implantation portion is configured as an auxiliary implantation hole or a groove.

[0015] In some embodiments, the in-vivo component further comprises at least one recording electrode site, the recording electrode site being used to record the first potential signal of the target tissue.

[0016] In some embodiments, the shape of the stimulation electrode site is a combination of one or more of the following: circle, ellipse and polygon; and / or the shape of the recording electrode site is a combination of one or more of the following: circle, ellipse and polygon.

[0017] In some embodiments, the auxiliary fixation portion is located inside and / or outside the target tissue.

[0018] The present application also provides a percutaneous minimally invasive flexible electrode assembly, including a traction member and a percutaneous minimally invasive flexible electrode as described above, wherein the distal end of the traction member forms a traction portion, which acts on an auxiliary implantation portion of the percutaneous minimally invasive flexible electrode to implant the percutaneous minimally invasive flexible electrode toward a target area via the auxiliary implantation portion.

[0019] In some embodiments, the traction member is used to drive the traction portion to separate from the auxiliary implant portion of the percutaneous minimally invasive flexible electrode when a force is applied toward the proximal end.

[0020] The present application also provides a percutaneous minimally invasive flexible electrode system, including a stimulator and a percutaneous minimally invasive flexible electrode as described above, wherein the stimulator includes at least one stimulation unit, which is used to deliver pulse signals to at least two stimulation electrode sites in the percutaneous minimally invasive flexible electrode after being electrically connected to the percutaneous minimally invasive flexible electrode.

[0021] In some embodiments, the stimulator also includes at least one sensing unit, and the in vivo component of the percutaneous minimally invasive flexible electrode also includes at least one recording electrode site. The stimulation unit is used to record the first potential signal collected by the above-mentioned recording electrode site after being electrically connected to the percutaneous minimally invasive flexible electrode.

[0022] In some embodiments, the stimulator also includes a switching module, which is used to switch the stimulation unit between a first working state and a second working state; wherein the stimulation unit in the first working state is used to deliver a pulse signal to the stimulation electrode site, and the stimulation unit in the second working state is used to record a second potential signal of the target tissue through the stimulation electrode site.

[0023] Compared with the prior art, the beneficial effects of the embodiments of the present application are: the internal component made of flexible material of the present application has better flexibility, can reduce the damage to the surrounding tissues during the implantation process, and can be more adaptable to the surrounding target tissue structure, so that the internal component is not easy to shift after implantation, which can significantly improve the treatment effect, and the electric pulses released by the external device can be transmitted to the internal component via the external component and the percutaneous connection part in sequence, and the target tissue is electrically stimulated by the stimulation electrode sites located on the internal component, which effectively enhances the functionality and reliability of the percutaneous minimally invasive flexibility, and the first flexible insulating layer and the second flexible insulating layer in the percutaneous connection part can protect the conductive lead layer, effectively ensure the conductive efficiency of the percutaneous connection part, and reduce the loss of electric pulses. By limiting the thickness of the percutaneous connection part along the stacking arrangement direction, that is, the thickness of the percutaneous connection part along the stacking arrangement direction is not more than 0.2 mm, the percutaneous wound during the implantation process can be effectively reduced, ensuring the flexibility and stability of the percutaneous minimally invasive flexible electrode when entering the target tissue, reducing damage to the surrounding tissues, reducing patient trauma and pain, and reducing the risk of infection during the implantation process. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In the drawings, which are not necessarily drawn to scale, the same reference numerals may describe similar components in different views. The drawings generally illustrate various embodiments by way of example and not limitation, and together with the description and claims, serve to illustrate the disclosed embodiments. When appropriate, the same reference numerals are used throughout the drawings to refer to the same or similar parts. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the present apparatus or method.

[0025] Figure 1 A schematic structural diagram of a percutaneous minimally invasive flexible electrode system according to an exemplary embodiment of the present application is shown;

[0026] Figure 2 A schematic diagram of a percutaneous minimally invasive flexible electrode after implantation according to an exemplary embodiment of the present application is shown;

[0027] Figure 3 A schematic structural diagram of a transdermal connection portion according to an exemplary embodiment of the present application is shown;

[0028] Figure 4 A schematic structural diagram of a percutaneous minimally invasive flexible electrode assembly according to an exemplary embodiment of the present application is shown;

[0029] Figure 5 for Figure 4 A partial enlarged view of

[0030] Figure 6A schematic flow chart of a percutaneous minimally invasive flexible electrode implantation process according to an exemplary embodiment of the present application is shown.

[0031] The components indicated by the reference numerals in the figures are:

[0032] 1. In-body component; 11. Stimulating electrode site; 12. Recording electrode site; 13. Auxiliary implantation part; 2. In-body component; 21. Contact; 3. Transcutaneous connection part; 31. First flexible insulating layer; 32. Second flexible insulating layer; 33. Conductive lead layer; 331. First conductive lead layer; 332. Second conductive lead layer; 34. Auxiliary fixing part; 35. Third flexible insulating layer; 36. Fourth flexible insulating layer; 4. Traction piece; 41. Traction part; 5. Stimulator. DETAILED DESCRIPTION

[0033] In order to enable those skilled in the art to better understand the technical solution of the present application, the present application is described in detail below in conjunction with the accompanying drawings and specific implementation examples. The embodiments of the present application are further described in detail below in conjunction with the accompanying drawings and specific implementation examples, but are not intended to limit the present application.

[0034] The words "first", "second" and similar words used in this application do not indicate any order, quantity or importance, but are only used to distinguish different parts. The words "include" or "comprise" and similar words mean that the elements before the word include the elements listed after the word, and do not exclude the possibility of including other elements. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0035] In the present application, when a specific device is described as being located between a first device and a second device, there may or may not be an intermediate device between the specific device and the first device or the second device. When a specific device is described as being connected to other devices, the specific device may be directly connected to the other device without an intermediate device, or may not be directly connected to the other device but have an intermediate device.

[0036] All terms (including technical terms or scientific terms) used in this application have the same meaning as those understood by ordinary technicians in the field to which this application belongs, unless otherwise specifically defined. It should also be understood that terms defined in general dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and should not be interpreted in an idealized or extremely formal sense, unless explicitly defined herein.

[0037] Technologies, methods, and equipment known to ordinary technicians in the relevant art may not be discussed in detail, but where appropriate, the technologies, methods, and equipment should be considered as part of the specification.

[0038] An embodiment of the present invention provides a percutaneous minimally invasive flexible electrode, which can be used in the medical field, etc. A percutaneous minimally invasive flexible electrode according to an embodiment of the present invention will be described in detail below in conjunction with the accompanying drawings.

[0039] like Figure 1 , Figure 2 and Figure 3 As shown, the percutaneous minimally invasive flexible electrode includes an internal component 1, an external component 2 and a transcutaneous connection portion 3. The internal component 1 is made of a flexible material, and the internal component 1 includes at least one stimulation electrode site 11 for applying electrical stimulation to the target tissue. The distal end of the internal component 1 is provided with an auxiliary implantation portion 13, and the auxiliary implantation portion 13 is used to implant the internal component 1 toward the target target area corresponding to the target tissue. The external component 2 includes a contact 21 corresponding to the stimulation electrode site 11 of the internal component 1, and the external component 2 is used to be electrically connected to an external device. One end of the transcutaneous connection portion 3 is connected to the proximal end of the internal component 1, and the other end is connected to the distal end of the external component 2, and is used to electrically connect the stimulation electrode site 11 of the internal component 1 to the contact 21 of the external component 2. The transcutaneous connection portion 3 includes a first flexible insulating layer 31, a conductive lead layer 33 and a second flexible insulating layer 32, which are stacked in sequence, and the thickness of the transcutaneous connection portion 3 along the stacking direction is not more than 0.2 mm.

[0040] The internal component 1 can be made of a flexible material, specifically a material with good electrical conductivity and biocompatibility, which can ensure that the internal component 1 can work stably for a long time, and also has a certain flexibility, so that the internal component 1 can be deformed with the movement of the human body component after being implanted into the human body component. Of course, the internal component 1 can be made of a metal material, or a non-metallic material, or a combination of a non-metallic material and a metal material. This application does not specifically limit the material used for the internal component 1.

[0041] Part or all of the above-mentioned transcutaneous connection part 3 can be made of flexible material, and at least the part implanted in the target tissue can be made of flexible material to adapt to the complex target tissue structure. The flexible material used in the above-mentioned transcutaneous connection part 3 can be the same as or different from the flexible material used in the internal component 1, and this application does not make specific restrictions on this.

[0042] The above-mentioned external component 2 can be made of flexible material or non-flexible material. The present application does not impose any limitation on this. It only needs to achieve a stable connection between the external component 2 and the transcutaneous connection part 3.

[0043] The width of the distal end of the intracorporeal component 1 is in the range of 100 μm to 10 mm, and the thickness is in the range of no more than 0.2 mm, which ensures the flexibility and mechanical stability of the intracorporeal component 1, enables it to adapt to the structure of different implantation areas, and reduces damage to the target tissue.

[0044] Optionally, the width from the percutaneous connection part 3 to the auxiliary implant part 13 can be gradually narrowed, or the width from the external component 2 to the auxiliary implant part 13 can be gradually narrowed. This can help the percutaneous minimally invasive flexible electrode better adapt to different areas of the neural tissue, reduce damage to the neural tissue, and better adapt to the complex neural tissue structure.

[0045] The proximal end may be represented as the end close to the user, and conversely, the distal end may be represented as the end away from the user. The external component 2 and the internal component 1 may be connected via a transcutaneous connection portion 3, and the transcutaneous connection portion 3 may have at least one conductive lead layer 33, which is used to electrically connect the contact 21 of the external component 2 with the stimulation electrode site 11 of the internal component 1. The electric pulse generated by the external device may be transmitted to the stimulation electrode site 11 of the internal component 1 through the contact 21 of the external component 2 and the transcutaneous connection portion 3 in sequence, and the stimulation electrode site 11 is in contact with the target tissue, so that the target tissue can be acted on by the electric pulse.

[0046] The number of stimulation electrode sites 11 may range from 1 to 100 to meet different clinical needs. The size of a single stimulation electrode site 11 may range from no less than 100 micrometers to ensure sufficient electrical stimulation coverage.

[0047] The auxiliary implantation part 13 may be disposed on a side of the external component 2 away from the user, and the auxiliary implantation part 13 may enable the percutaneous minimally invasive flexible electrode to accurately reach the target tissue position.

[0048] The first flexible insulating layer 31 and the second flexible insulating layer 32 play a role in protecting the conductive lead layer 33, isolating the conductive lead layer 33 from the surrounding target tissue, thereby ensuring that the electric pulses can be accurately transmitted to the stimulation electrode site 11, avoiding the loss of electric pulses during the transmission process, and effectively improving the reliability of the percutaneous minimally invasive flexible electrode.

[0049] The internal component 1 made of flexible material of the present application has good flexibility, can reduce the damage to the surrounding tissues during the implantation process, and can be more adaptable to the surrounding target tissue structure, so that the internal component 1 is not easy to shift after implantation, which can significantly improve the treatment effect, and the electric pulses released by the external device can be transmitted to the internal component 1 via the external component 2 and the percutaneous connection part 3 in sequence, and the stimulation electrode site 11 located on the internal component 1 is used to apply electrical stimulation to the target tissue, which effectively enhances the functionality and reliability of the percutaneous minimally invasive flexibility, and the first in the percutaneous connection part 3 The flexible insulating layer 31 and the second flexible insulating layer 32 can protect the conductive lead layer 33, effectively ensure the conductive efficiency of the transcutaneous connection part 3, and reduce the loss of electric pulses. By limiting the thickness of the transcutaneous connection part 3 along the stacking direction, that is, the thickness of the transcutaneous connection part 3 along the stacking direction is not more than 0.2 mm, the percutaneous wound during the implantation process can be effectively reduced, ensuring the flexibility and stability of the percutaneous minimally invasive flexible electrode when entering the target tissue, reducing damage to surrounding tissues, alleviating patient trauma and pain, and reducing the risk of infection during the implantation process.

[0050] In some embodiments, Figure 1 , Figure 3 and Figure 4 As shown, an auxiliary fixing portion 34 is provided on the transdermal connection portion 3, and the auxiliary fixing portion 34 has a thorn-like structure and / or a hollow structure. The thorn-like structure extends from the auxiliary fixing portion 34 in a direction away from the transdermal connection portion 3, and the hollow structure is located on the side of the transdermal connection portion 3 and / or on the transdermal connection portion 3.

[0051] In the above embodiment, the auxiliary fixing portion 34 provided on the percutaneous connection portion 3 can increase the contact area between the percutaneous minimally invasive flexible electrode and the target tissue, so that the percutaneous minimally invasive flexible electrode can maintain stable contact with the target tissue after implantation, so that the percutaneous minimally invasive flexible electrode can be firmly fixed at the target position, providing more accurate electrical stimulation, avoiding the situation where the stimulation effect is poor and the patient may be injured due to its movement, and effectively improving the reliability and use effect of the percutaneous minimally invasive flexible electrode, as well as the treatment effect and comfort of the patient. In addition, the auxiliary fixing portion 34 with different structures can have different contact areas with the target tissue, and the user can use the percutaneous minimally invasive flexible electrode with different auxiliary fixing portions 34 according to the use requirements or actual conditions, so as to achieve a better fixation effect and improve the flexibility and adaptability of the percutaneous minimally invasive flexible electrode.

[0052] A portion of the percutaneous connection portion 3 may be disposed inside the patient's body, and another portion may be disposed outside the patient's body. At least the percutaneous connection portion 3 disposed inside the patient's body may be provided with an auxiliary fixing portion 34 .

[0053] The auxiliary fixing part 34 can be understood as a component that can ensure that the percutaneous minimally invasive flexible electrode stays at a specific position or avoids drifting during the process of implanting the percutaneous minimally invasive flexible electrode into the target tissue. The auxiliary fixing part 34 can be arranged on one side or both sides of the transcutaneous connecting part 3. The auxiliary fixing part 34 can increase the contact area between the percutaneous minimally invasive flexible electrode and the human body component, thereby effectively fixing the position of the percutaneous minimally invasive flexible electrode to prevent it from moving or falling off.

[0054] The number of the auxiliary fixing parts 34 may be 1 to 100, and the size of the auxiliary fixing parts 34 may range from 0.1 mm to 10 mm. The user may determine the size based on actual use requirements, and the present application does not make any specific limitation on this.

[0055] The auxiliary fixing portion 34 may have a thorn-like structure, or may have a hollow structure, or may have a thorn-like structure and a hollow structure. The thorn-like structure may be understood as a spike-like structure formed by protruding outward from the side of the percutaneous connecting portion 3. The auxiliary fixing portion 34 having a thorn-like structure may not only fix the percutaneous minimally invasive flexible electrode, but also prevent the percutaneous minimally invasive flexible electrode from shifting after implantation. The auxiliary fixing portion 34 having a hollow structure allows the target tissue to be embedded in the hollow structure of the auxiliary fixing portion 34 after implantation, so that the percutaneous minimally invasive flexible electrode and the target tissue can maintain a stable relative position relationship, provide better mechanical stability and reduce tissue intrusion, so as to provide a stronger anchoring effect.

[0056] For example, Figure 3 As shown, Figure 3 The auxiliary fixing part 34 shown in the figure has a thorn-like structure and a hollow structure. The thorn-like structure and the hollow structure can be arranged in combination, that is, the hollow structure can be arranged on the thorn-like structure, and the combination of the two can achieve a better anchoring effect. Of course, the above-mentioned thorn-like structure and the hollow structure can also be arranged independently, such as the hollow structure is directly arranged on the surface of the transcutaneous connection part 3, and the thorn-like structure is arranged on the side of the transcutaneous connection part 3. The present application does not specifically limit the arrangement relationship between the thorn-like structure and the hollow structure, and it is sufficient to achieve stable fixation of the percutaneous minimally invasive flexible electrode.

[0057] The above-mentioned thorn-like structure and hollow structure can be made of flexible materials. The auxiliary fixing part 34 made of flexible material can be deformed by external force when the percutaneous minimally invasive flexible electrode is pulled out, so as to facilitate the separation of the percutaneous minimally invasive flexible electrode from the target tissue. Specifically, the thorn-like structure made of flexible material can bend or shrink due to external force during the extraction process, thereby reducing the friction between it and the target tissue. The hollow structure made of flexible material can make it adaptively deform during the extraction process, reducing the pulling on the surrounding target tissue. In this way, the auxiliary fixing part 34 can pass through the target tissue more smoothly during the extraction process, thereby reducing damage to the target tissue, minimizing the trauma to the patient, and improving the safety of the extraction process and the comfort of the patient.

[0058] In some other embodiments, the above-mentioned percutaneous connection part 3 may not have the auxiliary fixing part 34, and the percutaneous connection part 3 may be constructed as a solid structure, and the percutaneous connection part 3 of the solid structure may have a smooth surface.

[0059] In some embodiments, Figure 1 , Figure 3 and Figure 4 As shown, the auxiliary fixing portion 34 has a thorn-like structure, and the thorn-like structure is arranged obliquely relative to the transcutaneous connecting portion 3 toward the direction where the external component 2 is located.

[0060] In the above embodiment, the auxiliary fixing portion 34 with a thorn-like structure can firmly fix the percutaneous minimally invasive flexible electrode to the target tissue position, effectively avoiding the percutaneous minimally invasive flexible electrode from falling off and moving, and further improving the reliability of the percutaneous minimally invasive flexible electrode.

[0061] The thorn-like structure extends from the percutaneous connection part 3 to a direction away from the percutaneous connection part 3. In other words, the inclination direction of the thorn-like structure can be opposite to the implantation direction of the percutaneous minimally invasive flexible electrode, that is, the thorn-like structure of the auxiliary fixing part 34 is barbed, and the barbed thorn-like structure can effectively increase the contact area and friction with the target tissue. In addition, such a design can also help reduce resistance during implantation, so that the percutaneous minimally invasive flexible electrode can be firmly fixed at the target tissue position, so that the percutaneous minimally invasive flexible electrode can smoothly and conveniently reach the target tissue.

[0062] In some embodiments, Figure 3 As shown, the auxiliary fixing portion 34 is formed on the first flexible insulating layer 31 and / or the second flexible insulating layer 32 .

[0063] In the above embodiment, the auxiliary fixing part 34 can be arranged on the first flexible insulating layer 31 and / or the second flexible insulating layer 32 according to actual usage conditions, so as to avoid contact between the auxiliary fixing part 34 and the conductive lead layer 33, thereby ensuring the reliability of the percutaneous minimally invasive flexible electrode.

[0064] In some embodiments, the first flexible insulating layer 31 and the second flexible insulating layer 32 are made of one or a combination of the following materials: SU-8 photoresist, polyparaxylene, fluorinated polymer and polyimide; and / or the conductive lead layer 33 is made of a metal material.

[0065] Thus, the first flexible insulating layer 31 and the second flexible insulating layer 32 are made of the above insulating material to ensure the flexibility and biocompatibility of the percutaneous minimally invasive flexible electrode, and the conductive lead layer 33 is made of metal material to ensure effective signal conduction.

[0066] The conductive lead layer 33 may be made of a metal material having good conductivity and biocompatibility so that the electric pulses released by the external device can reach the stimulation electrode site 11. The conductive lead layer 33 may be made of metal materials such as gold, platinum, iridium, etc. to ensure effective transmission of electrical signals.

[0067] The first flexible insulating layer 31 and the second flexible insulating layer 32 can be made of SU-8 photoresist, polyparaxylene, fluorinated polymer and polyimide. The above materials have good chemical stability and can ensure flexibility while also having strong mechanical strength.

[0068] In some embodiments, Figure 3 As shown, the conductive lead layer 33 includes a first conductive lead layer 331 arranged in contact with the first flexible insulating layer 31 and a second conductive lead layer 332 arranged in contact with the second flexible insulating layer 32. The through-skin connection part 3 also has a third flexible insulating layer 35 along its thickness direction. The third flexible insulating layer 35 is placed between the first conductive lead layer 331 and the second conductive lead layer 332.

[0069] In the above embodiments, the functionality and applicability of the percutaneous minimally invasive flexible electrode can be further enhanced by configuring the first flexible insulating layer 31, the second flexible insulating layer 32, the first conductive lead layer 331, the second conductive lead layer 332 and the third flexible insulating layer 35. Among them, by providing the conductive lead layer 33 with the first conductive lead layer 331 and the second conductive lead layer 332, the conductive efficiency and conductive strength of the transcutaneous connection part 3 can be effectively increased to meet the different usage requirements of users.

[0070] The third flexible insulating layer 35 may be made of one or a combination of the following materials: SU-8 photoresist, polyparaxylene, fluorinated polymer and polyimide.

[0071] In some embodiments, Figure 3 As shown, there are multiple first conductive lead layers 331, the multiple first conductive lead layers 331 are arranged in parallel, and a fourth flexible insulating layer 36 is arranged between adjacent first conductive lead layers 331; and / or, there are multiple second conductive lead layers 332, the multiple second conductive lead layers 332 are arranged in parallel, and a fourth flexible insulating layer 36 is arranged between adjacent second conductive lead layers 332.

[0072] In the above embodiment, by providing multiple first conductive lead layers 331 and / or multiple second conductive lead layers 332, the conductive efficiency and conductive strength of the transcutaneous connection part 3 can be further improved, thereby improving the flexibility and effect of the treatment, and by providing a fourth flexible insulating layer 36, the adjacent first conductive lead layers 331 and / or the adjacent second conductive lead layers 332 can be protected.

[0073] For example, Figure 3 The first conductive lead layer 331 and the second conductive lead layer 332 shown in the figure are both two, and the two adjacent first conductive lead layers 331 are provided with a fourth flexible insulating layer 36, and the two adjacent second conductive lead layers 332 are provided with a fourth flexible insulating layer 36. Of course, the number of the first conductive lead layer 331 and the second conductive lead layer 332 can also be three, four, etc., and this application does not make a specific limitation on this.

[0074] In some embodiments, Figure 3 As shown, the outer contour edge of the thorn-like structure is in the shape of a straight line or an arc.

[0075] In the above embodiment, the thorn-like structure with different shapes of outer contour edges can adapt to different implantation requirements, and can also make the anchoring between the auxiliary fixing part 34 and the target tissue more firmly, effectively ensuring the tightness of the anchoring between the percutaneous minimally invasive flexible electrode and the target tissue.

[0076] In some embodiments, Figure 3 As shown, the shape of the hollow structure is polygonal and / or curved.

[0077] In the above embodiment, the auxiliary fixing part 34 with a hollow structure of different shapes can form more contact relationships between the hollow structure and the target tissue, so that the auxiliary fixing part 34 and the target tissue are more closely connected.

[0078] In some embodiments, Figure 1 , Figure 4 and Figure 5 As shown, the auxiliary implantation part 13 is configured as an auxiliary implantation hole or a groove.

[0079] In the above embodiment, the auxiliary implantation part 13 can ensure accurate positioning during the implantation process and reduce damage to the target tissue, thereby greatly facilitating the implantation operation of the percutaneous minimally invasive flexible electrode.

[0080] The user can use the auxiliary tool and drive the auxiliary implant part 13 to transport the stimulation electrode site 11 on the internal component 1 to the target tissue position. The width of the auxiliary implant part 13 and the diameter of the auxiliary implant part 13 range from 0.002 mm to 2 mm. For example, the auxiliary tool can be the traction member 4 described below, which will not be described in detail here.

[0081] In some embodiments, Figure 1 , Figure 4 and Figure 5 As shown, the in-vivo component 1 further includes at least one recording electrode site 12, and the recording electrode site 12 is used to record a first potential signal of the target tissue.

[0082] In the above embodiment, the recording electrode site 12 can record highly detailed and accurate electrical activity data, which greatly facilitates the user's analysis and evaluation of the treatment effect and effectively improves the practicality of the percutaneous minimally invasive flexible electrode.

[0083] like Figure 5 As shown, a stimulation electrode site 11 and a recording electrode site 12 may be respectively provided on the in-body component 1 , and the recording electrode site 12 is provided at the distal end of the stimulation electrode site 11 .

[0084] Optionally, the stimulation electrode sites 11 of the in vivo structure 1 can be used simultaneously to record highly detailed and accurate electrical activity data.

[0085] The number of recording electrode sites 12 on the in-vivo component 1 may range from 1 to 1000, and the size of a single recording electrode site 12 may range from no greater than 100 microns. The recording electrode sites 12 may be used to record action potentials at the single-cell level, so that the user can accurately observe and analyze the electrical activity patterns of single cells.

[0086] In some embodiments, the shape of the stimulation electrode site 11 is a combination of one or more of the following: circle, ellipse and polygon; and / or the shape of the recording electrode site 12 is a combination of one or more of the following: circle, ellipse and polygon.

[0087] In the above embodiments, the shapes of the stimulation electrode sites 11 and / or the recording electrode sites 12 can be determined according to actual use requirements, thereby effectively increasing their adaptability in different neuroscience research and clinical applications.

[0088] In some embodiments, the auxiliary fixation portion 34 is located inside and / or outside the target tissue.

[0089] In this way, the tissue is allowed to pass through the auxiliary fixing part 34, especially the hollow structure of the auxiliary fixing part 34, during the recovery process, thereby forming a stable electrode and target tissue interface, achieving better mechanical stability and less tissue invasion.

[0090] The present application also provides a percutaneous minimally invasive flexible electrode assembly, such as Figure 4 and Figure 5 As shown, the percutaneous minimally invasive flexible electrode assembly includes a traction member 4 and the percutaneous minimally invasive flexible electrode as described above, the distal end of the traction member 4 forms a traction portion 41, and the traction portion 41 acts on the auxiliary implantation portion 13 of the percutaneous minimally invasive flexible electrode to implant the percutaneous minimally invasive flexible electrode toward the target area via the auxiliary implantation portion 13.

[0091] The traction member 4 can form a physical connection with the auxiliary implantation portion 13 of the percutaneous minimally invasive flexible electrode, so that the in-vivo component 1 of the percutaneous minimally invasive flexible electrode is implanted toward the target area, effectively improving the convenience of the percutaneous minimally invasive flexible electrode.

[0092] The traction member 4 can implant the percutaneous minimally invasive flexible electrode into the target area without completely opening the skin and exposing the target tissue. Optionally, when the traction member 4 is not strong enough to pierce the skin, the traction member 4 and the percutaneous minimally invasive flexible electrode can be pierced through the skin together with a puncture tool until the target area is reached.

[0093] The traction portion 41 is formed at the distal end of the traction member 4 . The shape of the traction portion 41 may be a pointed tip, or other shapes that can be stably connected to the auxiliary implant portion 13 . The present application does not impose any limitation on this.

[0094] The traction member 4 can be constructed in a cylindrical shape, and its diameter can range from 0.001 mm to 2 mm, and the distal end of the traction member 4 has a smaller diameter than its proximal end. This can ensure that the traction portion 41 at the distal end of the traction member 4 can smoothly penetrate the auxiliary implant portion 13 and can form a certain force on the auxiliary implant portion 13 to pull the internal component 1 to the target area.

[0095] The internal component 1 of the percutaneous minimally invasive flexible electrode assembly using the above-mentioned percutaneous minimally invasive flexible electrode is made of flexible material, has good flexibility, can reduce the damage to the surrounding tissues during the implantation process, and can be more adaptable to the surrounding target tissue structure, so that the internal component 1 is not easy to shift after implantation, which can significantly improve the treatment effect, and the electric pulses released by the external device can be transmitted to the internal component 1 via the external component 2 and the percutaneous connection part 3 in sequence, and the stimulation electrode site 11 located on the internal component 1 is used to apply electrical stimulation to the target tissue, which effectively enhances the functionality and reliability of the percutaneous minimally invasive flexible electrode. Moreover, the first flexible insulating layer 31 and the second flexible insulating layer 32 in the transcutaneous connection part 3 can protect the conductive lead layer 33, effectively ensure the conductive efficiency of the transcutaneous connection part 3, and reduce the loss of electric pulses. Furthermore, by limiting the thickness of the transcutaneous connection part 3 along the stacking direction, that is, the thickness of the transcutaneous connection part 3 along the stacking direction is not more than 0.2 mm, the percutaneous wound during the implantation process can be effectively reduced, ensuring the flexibility and stability of the percutaneous minimally invasive flexible electrode when entering the target tissue, reducing damage to surrounding tissues, alleviating patient trauma and pain, and reducing the risk of infection during the implantation process.

[0096] In some embodiments, Figure 4 , Figure 5 and Figure 6 As shown, the traction member 4 is used to drive the traction portion 41 to separate from the auxiliary implantation portion 13 of the percutaneous minimally invasive flexible electrode when subjected to a force acting toward the proximal end.

[0097] In the above embodiment, after the percutaneous minimally invasive flexible electrode is implanted toward the target area using the traction member 4, the traction portion 41 is separated from the percutaneous minimally invasive flexible electrode by applying a force toward the proximal end. This can simplify the implantation operation process and reduce damage to surrounding target tissues, thereby effectively improving the experience of using the percutaneous minimally invasive flexible electrode.

[0098] When the auxiliary implant part 13 is driven by the traction member 4 to make the internal component 1 reach the target tissue position, the user can apply a force toward the proximal end to separate the traction part 41 from the auxiliary implant part 13, thereby completing the percutaneous minimally invasive flexible electrode implantation operation process.

[0099] The present application also provides a percutaneous minimally invasive flexible electrode system, such as Figure 1 As shown, the percutaneous minimally invasive flexible electrode system includes a stimulator 5 and the percutaneous minimally invasive flexible electrode as described above, the stimulator 5 includes at least one stimulation unit, and the stimulation unit is used to deliver pulse signals to at least two stimulation electrode sites 11 in the percutaneous minimally invasive flexible electrode after being electrically connected to the percutaneous minimally invasive flexible electrode.

[0100] A pulse loop can be formed between the at least two stimulation electrode sites 11, so that a path is formed between the stimulator 5 and the stimulation electrode sites 11. In addition, each stimulation electrode site 11 is insulated from each other to avoid crosstalk or loss of pulse signals.

[0101] After the above-mentioned stimulator 5 is connected to the percutaneous minimally invasive flexible electrode through the stimulation unit, it can deliver electrical pulses to the stimulation electrode site 11 on the internal component 1, and finally the stimulation electrode site 11 applies electrical stimulation to the target tissue, thereby effectively relieving the patient's pain and improving the treatment effect.

[0102] The in-vivo component 1 of the percutaneous minimally invasive flexible electrode system using the above-mentioned percutaneous minimally invasive flexible electrode assembly is made of flexible material, has good flexibility, can reduce the damage to the surrounding tissues during the implantation process, and can be more adaptable to the surrounding target tissue structure, so that the in-vivo component 1 is not easy to shift after implantation, which can significantly improve the treatment effect, and the electric pulses released by the external device can be transmitted to the in-vivo component 1 via the external component 2 and the percutaneous connection part 3 in sequence, and the stimulation electrode site 11 located on the in-vivo component 1 is used to apply electrical stimulation to the target tissue, which effectively enhances the functionality and reliability of the percutaneous minimally invasive flexibility. In addition, the first flexible insulating layer 31 and the second flexible insulating layer 32 in the transcutaneous connection part 3 can protect the conductive lead layer 33, effectively ensure the conductive efficiency of the transcutaneous connection part 3, and reduce the loss of electric pulses. By limiting the thickness of the transcutaneous connection part 3 along the stacking direction, that is, the thickness of the transcutaneous connection part 3 along the stacking direction is not more than 0.2 mm, the percutaneous wound during the implantation process can be effectively reduced, ensuring the flexibility and stability of the percutaneous minimally invasive flexible electrode when entering the target tissue, reducing damage to surrounding tissues, alleviating patient trauma and pain, and reducing the risk of infection during the implantation process.

[0103] In some embodiments, the stimulator 5 also includes at least one sensing unit, and the in vivo component 1 of the percutaneous minimally invasive flexible electrode also includes at least one recording electrode site 12. The stimulation unit is used to record the first potential signal collected by the above-mentioned recording electrode site 12 after being electrically connected to the percutaneous minimally invasive flexible electrode.

[0104] In the above embodiment, the sensing unit can record relevant data information in a timely manner so as to provide data basis for the treatment effect of the percutaneous minimally invasive flexible electrode system in the later stage, thereby effectively ensuring the reliability of the percutaneous minimally invasive flexible electrode system.

[0105] In some embodiments, the stimulator 5 also includes a switching module, which is used to switch the stimulation unit between a first working state and a second working state; wherein the stimulation unit in the first working state is used to deliver a pulse signal to the stimulation electrode site 11, and the stimulation unit in the second working state is used to record a second potential signal of the target tissue through the stimulation electrode site 11.

[0106] In the above embodiment, the user can use the switching module to timely switch the different usage states of the stimulation unit to meet different usage requirements, which can effectively improve the practicality and treatment effect of the stimulator 5.

[0107] The first working state may be represented by the working state when the stimulation unit applies electrical stimulation to the target tissue through the stimulation electrode site 11. The second working state may be represented by the working state when the stimulation unit records the situation after applying electrical stimulation to the target tissue through the recording electrode site 12.

[0108] In addition, although exemplary embodiments have been described herein, the scope includes any and all embodiments based on the present application with equivalent elements, modifications, omissions, combinations (e.g., schemes that cross various embodiments), adaptations or changes. The elements in the claims will be interpreted broadly based on the language used in the claims, and are not limited to the examples described in this specification or during the practice of the present application, and the examples will be interpreted as non-exclusive.

[0109] The above description is intended to be illustrative rather than restrictive. For example, the above examples (or one or more schemes thereof) may be used in combination with each other. For example, a person of ordinary skill in the art may use other embodiments when reading the above description. In addition, in the above-mentioned specific embodiments, various features may be grouped together to simplify the present application. This should not be interpreted as an intention that a disclosed feature that is not required to be protected is necessary for any claim. On the contrary, the subject matter of the present application may be less than all the features of a particular disclosed embodiment. Thus, the claims are incorporated herein as examples or embodiments in the specific embodiments, wherein each claim is independently a separate embodiment, and it is considered that these embodiments may be combined with each other in various combinations or arrangements. The scope of the present application should be determined with reference to the attached claims and the full scope of equivalent forms granted by these claims.

[0110] The above embodiments are only exemplary embodiments of the present application and are not intended to limit the present application. The protection scope of the present application is defined by the claims. Those skilled in the art may make various modifications or equivalent substitutions to the present application within the essence and protection scope of the present application, and such modifications or equivalent substitutions shall also be deemed to fall within the protection scope of the present application.

Claims

1. A percutaneous minimally invasive flexible electrode, characterized in that: include: An in-vivo component, which is made of a flexible material, comprises at least one stimulation electrode site for applying electrical stimulation to a target tissue, and an auxiliary implantation portion is provided at a distal end of the in-vivo component, wherein the auxiliary implantation portion is used to implant the in-vivo component toward a target area corresponding to the target tissue; an external component, comprising contacts corresponding to stimulation electrode sites of the internal component, the external component being used for electrical connection with an external device; The transcutaneous connection portion is provided with an auxiliary fixing portion, one end of which is connected to the proximal end of the internal component and the other end is connected to the distal end of the external component, and is used to electrically connect the stimulation electrode site of the internal component with the contact of the external component. The transcutaneous connection portion includes a first flexible insulating layer, a conductive lead layer and a second flexible insulating layer which are stacked in sequence, and the thickness of the transcutaneous connection portion along the stacking direction is not more than 0.2 mm. The auxiliary fixing portion is formed on the first flexible insulating layer and / or the second flexible insulating layer, and has a thorn-like structure and a hollow structure. The thorn-like structure is in the shape of a barb, and the thorn-like structure extends from the auxiliary fixing portion in a direction away from the transcutaneous connection portion. The thorn-like structure is inclined relative to the transcutaneous connection portion toward the direction of the external component, and the hollow structure is located on the side of the transcutaneous connection portion and / or on the transcutaneous connection portion.

2. The percutaneous minimally invasive flexible electrode according to claim 1, characterized in that: The first flexible insulating layer and the second flexible insulating layer are made of one or a combination of the following materials: SU-8 photoresist, polyparaxylene, fluorinated polymer and polyimide; and / or, The conductive lead layer is made of metal material.

3. The percutaneous minimally invasive flexible electrode according to claim 1, characterized in that: The conductive lead layer includes a first conductive lead layer arranged in contact with the first flexible insulating layer and a second conductive lead layer arranged in contact with the second flexible insulating layer. The through-skin connection part also has a third flexible insulating layer along its thickness direction, and the third flexible insulating layer is placed between the first conductive lead layer and the second conductive lead layer.

4. The percutaneous minimally invasive flexible electrode according to claim 3, characterized in that: There are a plurality of first conductive lead layers, the plurality of first conductive lead layers are arranged in parallel, and a fourth flexible insulating layer is arranged between adjacent first conductive lead layers; and / or, There are a plurality of the second conductive lead layers, and the plurality of the second conductive lead layers are arranged in parallel, and a fourth flexible insulating layer is arranged between adjacent second conductive lead layers.

5. The percutaneous minimally invasive flexible electrode according to claim 1, characterized in that: The outer contour edge of the thorn-like structure is in a straight line or an arc shape.

6. The percutaneous minimally invasive flexible electrode according to claim 1, characterized in that: The hollow structure has a polygonal and / or curved shape.

7. The percutaneous minimally invasive flexible electrode according to claim 1, characterized in that: The auxiliary implantation portion is configured as an auxiliary implantation hole or a groove.

8. The percutaneous minimally invasive flexible electrode according to claim 1, characterized in that: The in-vivo component further comprises at least one recording electrode site, wherein the recording electrode site is used to record a first potential signal of a target tissue.

9. The percutaneous minimally invasive flexible electrode according to claim 8, characterized in that: The shape of the stimulation electrode site is a combination of one or more of the following: circular, elliptical and polygonal; and / or, The shape of the recording electrode site is a combination of one or more of the following: circular, elliptical and polygonal.

10. The percutaneous minimally invasive flexible electrode according to claim 1, characterized in that: The auxiliary fixing portion is located inside and / or outside the target tissue.

11. A percutaneous minimally invasive flexible electrode assembly, characterized in that: It comprises a traction member and a percutaneous minimally invasive flexible electrode as described in any one of claims 1 to 10, wherein the distal end of the traction member forms a traction portion, and the traction portion acts on an auxiliary implantation portion of the percutaneous minimally invasive flexible electrode to implant the percutaneous minimally invasive flexible electrode toward a target area via the auxiliary implantation portion.

12. The percutaneous minimally invasive flexible electrode assembly according to claim 11, characterized in that: The traction member is used to drive the traction part to separate from the auxiliary implantation part of the percutaneous minimally invasive flexible electrode when subjected to a force acting toward the proximal end.

13. A percutaneous minimally invasive flexible electrode system, characterized in that: It comprises a stimulator and a percutaneous minimally invasive flexible electrode as described in any one of claims 1 to 10, wherein the stimulator comprises at least one stimulation unit, and the stimulation unit is used to deliver pulse signals to at least two stimulation electrode sites in the percutaneous minimally invasive flexible electrode after being electrically connected to the percutaneous minimally invasive flexible electrode.

14. The percutaneous minimally invasive flexible electrode system according to claim 13, characterized in that: The stimulator also includes at least one sensing unit, and the in vivo component of the percutaneous minimally invasive flexible electrode also includes at least one recording electrode site. The stimulation unit is used to record the first potential signal collected by the recording electrode site after being electrically connected to the percutaneous minimally invasive flexible electrode.

15. The percutaneous minimally invasive flexible electrode system according to claim 13, characterized in that: The stimulator also includes a switching module, which is used to switch the stimulation unit between a first working state and a second working state; wherein the stimulation unit in the first working state is used to deliver a pulse signal to the stimulation electrode site, and the stimulation unit in the second working state is used to record a second potential signal of the target tissue through the stimulation electrode site.

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