CN117883699A

CN117883699A - Cannula, assembly bundle and device for implantable flexible neural electrode

Info

Publication number: CN117883699A
Application number: CN202410296203.3A
Authority: CN
Inventors: 王大为; 田慧慧; 王晋芬; 杨贵强
Original assignee: Beijing Zhiran Medical Technology Co ltd
Current assignee: Beijing Zhiran Medical Technology Co ltd
Priority date: 2024-03-15
Filing date: 2024-03-15
Publication date: 2024-04-16

Abstract

The application provides a cannula, a component bundle and a device for an implantable flexible nerve electrode. The flexible nerve electrode comprises a distal electrode site layout part, a lead part and a proximal part, the sleeve for the implantable flexible nerve electrode comprises a tube body and an end limiting mechanism, the tube body is provided with a cavity extending longitudinally to accommodate a target section of the lead part to be subjected to bending deformation and can be elastically stretched to a limiting length in the longitudinal direction, the limiting length is within the range of the safe extension length of the target section of the lead part, and the end limiting mechanism is configured to limit and lock the target section of the lead part in the longitudinal direction at two ends of the tube body so as to achieve the purpose of improving the use comfort of a patient and the internal activity degree of the flexible nerve electrode while guaranteeing the stable, safe and long-term use of the flexible nerve electrode in an implanted body.

Description

Cannula, assembly bundle and device for implantable flexible neural electrode

Technical Field

The application belongs to the technical field of flexible nerve electrode implantation, and particularly relates to a sleeve, a component bundle and a device for an implantable flexible nerve electrode.

Background

The nerve electrode has wide application in the fields of biomedical engineering, neuroscience, clinical treatment and the like, particularly in the fields of nerve recording, nerve regulation and control and the like, including Deep Brain Stimulation (DBS), spinal cord stimulation, peripheral nerve stimulation and the like. The lead portion of existing nerve electrodes typically needs to be extended in the body to allow interconnection with an implanted adapter (e.g., a pulse generator). This arrangement often results in a significant foreign body sensation and reduced comfort after surgery. One of the reasons is that the hardness of the nerve electrode lead is not coordinated with the tissue in the body; more importantly, the existing nerve electrode leads have poor deformation performance such as stretching, and cannot generate enough deformation to bear the stretching caused by the movement of a patient (such as the movement of the neck), so that the amplitude and the range of the free movement of the neck of the patient can be limited, and the nerve electrode leads can be damaged mechanically to fail.

The flexible neural electrode has good bending deformation ability. In order to improve the stability of the flexible neural electrode in a stretched state, the prior art has focused on directly applying or wrapping a flexible neural electrode lead having a curved shape (e.g., serpentine shape) to a malleable material. However, this approach only allows for basic mechanical protection, and ignores the interaction and dynamic matching issues between the support or encapsulation material and the flexible neural electrode lead. For example, when the whole is longitudinally stretched, the flexible nerve electrode lead may still be mechanically damaged due to the different mechanical response characteristics of the support or wrapping material and the flexible nerve electrode lead. Thus, there remains a technical challenge in ensuring the mechanical stability and safety of the flexible neural electrode lead in the body. And, the curvilinear shape generally greatly increases the size of the flexible neural electrode lead. There is a need for a solution that protects the flexible nerve electrode lead from mechanical damage and allows it to deform somewhat during the patient's free movement. In particular, there is no ideal solution to the problem of how to ensure that the flexible nerve electrode lead is not damaged in long-term use after implantation, and at the same time, to adapt to various mechanical stresses caused by in vivo activities.

In addition, in the multi-electrode application scenario, a plurality of flexible neural electrode leads are required to be arranged in parallel or in a crossed manner. This adds complexity to the design of its protection device, as not only is protection of a single flexible neural electrode lead required to be considered, but also the spatial distribution and interaction issues between multiple leads need to be addressed to ensure stability and reliability of the overall system.

Disclosure of Invention

The present application has been made to solve the above-mentioned problems occurring in the prior art.

The object of the present application is to provide a cannula, a module bundle and a device for an implantable flexible neural electrode, which can ensure that the lead part of the flexible neural electrode is protected from mechanical damage during in vivo activities and allows the lead part to freely undergo a bending deformation including bending, twisting, stretching and loosening, especially considering the interaction of the flexible neural electrode lead with in vivo tissues, especially when the patient moves or the body posture changes, and can ensure the use comfort of the patient while ensuring that the lead part of the flexible neural electrode remains stable, safe and undamaged during long-term use in the body of the implanted person.

According to a first aspect of the present application, a cannula for an implantable flexible nerve electrode is provided. The flexible nerve electrode comprises a distal electrode site layout part, a lead part and a proximal part, and the sleeve comprises a tube body and an end limiting mechanism. The tube body has a longitudinally extending cavity to receive a target segment of the lead portion to be subjected to a deployment deformation and is elastically stretchable in a longitudinal direction to a defined length within a safe extension length of the target segment of the lead portion. The end position limiting mechanism is configured to limit-lock the target segment of the lead portion in the longitudinal direction at both ends of the tube body.

According to a second aspect of the present application, an assembly for an implantable flexible neural electrode is provided. The assembly includes a cannula for an implantable flexible neural electrode and a flexible neural electrode according to various embodiments of the present application. The flexible nerve electrode comprises a distal electrode site layout part, a lead part and a proximal end part, wherein at least one part of the lead part extends in the longitudinal direction inside the sleeve and penetrates out from two ends of the sleeve. One end of the lead part is connected with the distal electrode site layout part and is communicated with the electrode site of the distal electrode site layout part, and the other end of the lead part is connected with the adapter and is electrically communicated with the adapter.

According to a third aspect of the present application, there is provided an assembly bundle for an implantable flexible neural electrode. The assembly bundle includes a plurality of assemblies for implantable flexible neural electrodes according to some embodiments of the present application, the cannulas of the plurality of assemblies being distributed in parallel or overlapping fashion with each other and extending in a longitudinal direction.

According to a fourth aspect of the present application, there is provided an apparatus for an implantable flexible neural electrode. The device includes an electrode assembly portion and a positioning implant portion. The electrode assembly portion includes an assembly for an implantable flexible neural electrode according to some embodiments of the present application, or an assembly bundle for an implantable flexible neural electrode according to some embodiments of the present application. The positioning implantation part obtains current position information of the distal electrode site layout part of the component or the component bundle at each moment, and guides the distal electrode site layout part to reach the target position based on a position comparison result of comparing the current position information with target implantation position information of the component or the component bundle.

The sleeve, the assembly bundle and the device for the implanted flexible nerve electrode are sleeved outside the target end of the lead part of the flexible nerve electrode in a limiting mode in the longitudinal direction by utilizing the sleeve which can be elastically stretched in the longitudinal direction, so that the sleeve and the lead part of the flexible nerve electrode can be flexibly adjusted to avoid damage under the dynamic condition of being implanted into a body, the lead part of the flexible nerve electrode can be protected from damage, the use comfort of a patient is ensured, and the use comfort and the in-vivo activity freedom of the flexible nerve electrode of the patient are improved while the stability, the safety and the long-term use of the flexible nerve electrode in the body of an implanted person are ensured.

Drawings

In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. The same reference numerals with letter suffixes or different letter suffixes may represent different instances of similar components. The accompanying drawings illustrate various embodiments by way of example in general and not by way of limitation, and together with the description and claims serve to explain the disclosed embodiments. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive of the present apparatus or method.

FIG. 1 illustrates a cannula for an implantable flexible neural electrode and a block diagram of the flexible neural electrode according to an embodiment of the present application;

fig. 2 shows a schematic structural view of an extended state of an assembly for an implantable flexible neural electrode according to example 1 of an embodiment of the present application;

FIG. 3 illustrates a structural schematic of a retracted state of an assembly for an implantable flexible neural electrode according to example 1 of an embodiment of the present application;

FIG. 4 illustrates a schematic diagram of the structure of an extended state and a retracted state of an assembly for an implantable flexible neural electrode according to example 2 of an embodiment of the present application;

FIG. 5 illustrates a block diagram of an assembly for an implantable flexible neural electrode according to example 3 of an embodiment of the present application;

FIG. 6 is an enlarged view showing a sectional structure of an area A of the flexible neural electrode according to the embodiment of the present application;

FIG. 7 illustrates a schematic diagram of an assembly bundle for an implantable flexible neural electrode, in accordance with an embodiment of the present application; and

Fig. 8 shows a configuration diagram of an apparatus for an assembly of implantable flexible neural electrodes according to an embodiment of the present application.

Detailed Description

In order to better understand the technical solutions of the present disclosure, the following detailed description of the present disclosure is provided with reference to the accompanying drawings and the specific embodiments. Embodiments of the present disclosure will be described in further detail below with reference to the drawings and specific embodiments, but not by way of limitation of the present disclosure.

The terms "first," "second," and the like, as used herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The expressions "first", "second" are merely numerical for convenience of description and are not intended to imply that "first component" and "second component" must have different physical properties. In practice, the "first component" and the "second component" may have the same or different structures, and are not limited herein, as long as the "first component" and the "second component" are separate components. Further, where the context indicates that the "first component" and "second component" may not even be separate components, may be integrated as the same component, or may be replaced with each other.

In the present application, when it is described that a specific device is located between a first device and a second device, an intervening device may or may not be present between the specific device and the first device or the second device. When it is described that a particular device is connected to other devices, the particular device may be directly connected to the other devices without intervening devices, or may be directly connected to the other devices without intervening devices.

The word "comprising" or "comprises" and the like means that elements preceding the word encompass the elements recited after the word, and not exclude the possibility of also encompassing other elements. "upper", "lower", "left", "right", etc. are used merely to indicate relative positional relationships, which may also be changed when the absolute position of the object to be described is changed.

In the present application, the term "proximal" is intended to mean the side close to the operator (e.g., doctor) performing the implantation operation, while the term "distal" is intended to mean the side close to the target location of the flexible neural electrode to be implanted.

In some embodiments of the present application, a cannula 10 for an implantable flexible nerve electrode is provided. The sleeve 10 includes a body 101 and an end stop 102. The flexible neural electrode may be the flexible neural electrode 20 of the structure shown in fig. 1 to 5, or may be other structures. In the embodiment of the present application, the flexible neural electrode 20 is described as an example of the flexible neural electrode.

As shown in fig. 1, the flexible neural electrode 20 includes a distal electrode site layout part 201, a lead part 202, and a proximal part 203. The tube body 101 has a longitudinally extending cavity to accommodate a target section of the lead portion 202 to be subjected to the stretching deformation, and the tube body 101 is elastically stretchable to a defined length in the longitudinal direction. The defined length is within a safe extension length of the target segment of the lead portion 202. The end stop mechanism 102 is configured to limit lock the target segment of the lead portion 202 in the longitudinal direction at both ends of the tube body 101.

In particular, the inner diameter of the sleeve 10 is preferably 0.05-10mm, and the wall thickness is preferably 0.005-5mm, so that it has both good mechanical strength and sufficient ductility. The cannula 10 is designed to be somewhat flexible and may be coated on its interior surface with a biocompatible lubricant (e.g., silicone) to further reduce friction between the body 101 and the lead portion 202 of the flexible nerve electrode 20. To ensure smooth movement of the lead portion 202 in the sleeve 10, the inner surface of the tube body 101 may be specially treated to have a slight longitudinal texture. These textures can reduce friction between the tube 101 and the lead portion 202 of the flexible nerve electrode 20, while promoting distribution of lubricant, ensuring uniform coverage throughout the interior of the tube 101.

Further, end limit mechanisms 102 are provided at both ends in the longitudinal direction of the tube body 101 and/or at the inner position of the tube body 101 for fixing the lead portions 202 of the flexible nerve electrodes 20 to ensure synchronous movement with the tube body 101 when the lead portions 202 are subjected to the bending deformation in the longitudinal direction. The end stop 102 may be constructed of a tiny rubber ring or other flexible material that ensures that the mobility of the lead portion 202 of the flexible nerve electrode 20 is not affected.

Moreover, the longitudinal length, i.e., the defined length, of the tube body 101 of the cannula 10 in the expanded state is designed to be smaller than the longitudinal length, i.e., the safe extension length, of the target segment of the lead portion 202 of the flexible nerve electrode 20 in the expanded state. Through the design, when the lead part 202 of the flexible nerve electrode 20 is subjected to the stretching deformation, the tube body 101 of the sleeve 10 can provide enough operation space for the flexible nerve electrode 20, so that the mechanical stress born by the lead part 202 of the flexible nerve electrode 20 during the stretching deformation is reduced, and the service life and the stability of the sleeve 10 are further optimized.

The sleeve 10 for the implanted flexible neural electrode can be dynamically matched with the flexible neural electrode 20 by synchronously performing stretching deformation with the lead part 202 of the flexible neural electrode 20, so that the configuration of the flexible neural electrode 20 in the implanted body is more natural, the problem of unmatched hardness between the electrode lead and the tissue in the body is effectively solved, the foreign body sensation of the implanted body is greatly reduced, the interaction problem between the wrapping material and the electrode lead is solved, and the dynamic response of the sleeve 10 and the flexible neural electrode 20 in the body is more harmonious, and the use comfort of the flexible neural electrode 20 is improved.

Moreover, the cannula 10 for an implantable flexible neural electrode of the present application enables the lead portion 202 of the flexible neural electrode 20 to be freely deformed in a body of an implanted subject, thereby not limiting the movement of the patient and providing the patient with a greater freedom of movement. Furthermore, the cannula 10 for an implantable flexible nerve electrode of the present application provides additional protection to the lead portion 202 of the flexible nerve electrode 20, ensuring that it is not mechanically damaged even when subjected to longitudinal stretching, thereby effectively reducing the risk of damage to the flexible nerve electrode.

In some embodiments, at least a portion of the tube 101 is made of an elastic material. The elastic material is rubber or polyurethane, for example. The highly elastic nature of the material imparts significant longitudinal stretch and retractive capabilities to the tube body 101. Specifically, the tube body 101 can be stretched and deformed when the sleeve 10 is subjected to external stretching force, and can automatically return to the original length after the stretching force is removed.

In some embodiments, the wall of the tube body 101 is configured in a pleated structure or a telescopic structure, and the tube body 101 is elastically deformable in the longitudinal direction.

Illustratively, the body 101 of the sleeve 10 is constructed in whole or in part with a well-defined pleated structure, such as a bellows. This design provides the sleeve 10 with longitudinal scalability. Specifically, the tube body 101 expands the pleats to elongate when the cannula 10 is subjected to an external stretching force, and after the stretching force is removed, an external squeezing force is required to urge the pleats to reclose, thereby effecting retraction of the cannula 10. In addition, the sleeve 10 may be of telescopic joint construction. This structure comprises a series of annular segments, each of which may vary slightly in diameter, length, shape. The ring segments can telescope into one another to form a telescoping tube in the longitudinal direction. When an external pulling or pressing force is applied to the sleeve 10, a series of ring segments in the body 101 can slide relative to each other in the longitudinal direction of the sleeve 10, thereby achieving telescoping of the sleeve 10.

In some embodiments, at least a portion of the tube body 101 is made of an elastic material and the wall of the tube body 101 is constructed in a mesh structure or a lattice structure, and the tube body 101 is elastically deformable in the longitudinal direction.

The body 101 of the sleeve 10 may also take the form of a structure that combines an elastomeric material with a specific physical structure in whole or in part. For example, the tubular body 101 may be at least partially formed of an elastomeric material and exhibit a honeycomb or mesh-like structure, and the combination of such material and the particular structure provides elasticity while also enhancing the deformability of the sleeve 10, thereby providing the tubular body 101 of the sleeve 10 with superior stretch characteristics in the longitudinal direction.

In some embodiments, the tube 101 is elastically stretchable in the longitudinal direction to a limit length that is greater than or equal to 110% of the defined length of the tube 101.

The tensile properties of the body 101 of the sleeve 10 and its ability to deform at limit are particularly critical, as they directly affect the protection and operating range of the lead portion 202. The material and structure of the sleeve 10 of the present application are selected so that the tubular body 101 is capable of achieving a ultimate tensile deformation of at least 10% in the longitudinal direction. This property is derived not only from the nature of the material chosen, but also from the optimisation and design of the internal structure of the material. The bushing 10 of the application realizes the high tensile property of the pipe body 101 under a certain threshold value through the combination of the regulation and control of the microstructure and the macroscopic material, thereby meeting the deformation requirement of the target section of the lead part 202 in the operation process and ensuring that the target section of the lead part 202 is not mechanically damaged in the pipe body 101.

In some embodiments, the difference between the defined length of the tube 101 and the safe extension length of the target segment of the lead portion 202 is greater than or equal to a first threshold.

Specifically, the defined length of the tube body 101 is smaller than the safe extension length of the lead portion 202, and the difference therebetween is set to a first threshold value. The first threshold is preferably 1-50cm to ensure that the lead portion 202 of the flexible nerve electrode 20 is not mechanically damaged during dynamic changes. Also, the safe extension length of the target segment of the lead portion 202 of the flexible neural electrode 20 may be adjusted according to actual needs. For example, and when used for deep brain stimulation, the safe extension length may be 1.5-250cm; at the same time, the limited length of the sleeve 10 also needs to be adjusted according to the safe extension length of the target segment of the lead portion 202 of the flexible neural electrode 20, for example, the limited length of the tube body 101 can be adjusted to be 0.5-100cm.

In some embodiments, the first threshold is the difference between the limit length and the defined length of the tube 101.

In some embodiments, the tube 101 is configured to have an inner diameter that is greater than or equal to a second threshold value when stretched in the longitudinal direction.

Specifically, the second threshold is used to define the inner diameter of the body 101 of the cannula 10 to ensure that the lead portion 202 of the flexible nerve electrode 20 has sufficient deformation space within the cannula 10. The second threshold is preferably 0.05-10mm.

In some embodiments, the tube 101 is configured to have a radial cross-section of at least any one of circular, elliptical, or square when stretched in the longitudinal direction. By maintaining the above specific shape, it is ensured that the internal passage of the tube body 101 remains clear during the stretching process, thereby allowing the lead portion 202 to freely move in the longitudinal direction within the tube body 101, and further avoiding the lead portion 202 being clamped due to the closing of the internal passage of the tube body 101 during the stretching, thereby affecting the normal deformation thereof. Moreover, since the circular, oval, and square shapes are typical shapes that may occur when the pipe body 101 is stretched under a force, the radial cross-sectional configuration of the pipe body 101 in the case of stretching in the longitudinal direction is three of the above-described shapes, further enhancing the adaptability and practicality of the pipe body 101.

In some embodiments, to further reduce the impact on biological tissue, the outside of the tube wall of the tube 101 has micro-nano scale textures. Such special structures or surface treatments may help reduce adhesion of surrounding tissue.

In some embodiments, the outside of the tube wall of the tube body 101 is constructed with micro-thorns or hooks to allow the cannula 10 to be more easily and stably fixed when being implanted into the target tissue, reducing positional deviations due to in vivo movement or external shock.

In some embodiments, an antioxidant and corrosion inhibitor, such as zinc oxide, selenium, or other natural or synthetic compounds, may also be added to the materials of construction of the lead portion 202 of the flexible nerve electrode 20 and the cannula 10 to enhance the antioxidant and corrosion resistance of the lead portion 202 of the flexible nerve electrode 20 and the cannula 10, in view of the need for long term implantation.

In practicing the design of the cannula 10, one key aspect is to consider how the lead portion 202 of the flexible nerve electrode 20 accommodates longitudinal length variations of the cannula 10.

Specifically, as shown in fig. 2 and 3, the "effective longitudinal length" of the target segment is relatively intuitive for the lead portion 202 that remains substantially in a straight-line configuration as shown in example 1. The effective longitudinal length of the target segment of the lead portion 202 is its actual or physical length, i.e., the direct distance from one end point of the flexible neural electrode 20 to the other end point. Meanwhile, as shown in fig. 4, with respect to the lead portion 202 which exhibits a nonlinear form in its configuration as shown in example 2, for example, a spiral or curve-shaped lead portion 202, the "effective longitudinal length" of its target section is defined as the linear distance of the lead portion 202 in the horizontal direction from one end point to the other end point, that is, even if the lead portion 202 is arranged along a curved or spiral path, the effective longitudinal length thereof refers to the linear horizontal distance between the two end points.

The lead portion 202 may undergo a variety of deformations including twisting, torsion, splaying, and bending to accommodate longitudinal length variations of the sleeve 10. When the lead portion 202 within the sleeve 10 is subjected to a stretching deformation, its "effective longitudinal length" will change accordingly.

As shown in fig. 2 and the lower part of fig. 4, when the sleeve 10 is subjected to a tensile force in the longitudinal direction, it will generate a corresponding longitudinal tensile deformation, and at the same time, the target section of the lead portion 202 inside the tube body 101 will generate a longitudinal stretching deformation to increase its "effective longitudinal length" so as to adapt to the increase of the longitudinal length of the sleeve 10.

As shown in fig. 3 and the upper half of fig. 4, when the sleeve 10 is pressed in the longitudinal direction, it will be correspondingly retracted longitudinally or deformed longitudinally, and at the same time, the target section of the lead portion 202 inside the tube body 101 will be deformed longitudinally and bent longitudinally, so as to reduce the effective longitudinal length thereof, so as to adapt to the reduction of the longitudinal length of the sleeve 10.

When the sleeve 10 is subjected to bending shear forces, it will undergo corresponding torsional or bending deformation, while the target section of the lead portion 202 inside the body 101 will undergo torsional or bending deformation to increase its "effective longitudinal length" to accommodate the deformation of the sleeve 10.

When the sleeve 10 is subjected to torsional shear forces, it will undergo corresponding torsional deformation, while the target section of the lead portion 202 inside the tube body 101 will undergo torsional or bending deformation to increase its "effective longitudinal length" to accommodate the deformation of the sleeve 10.

Within the longitudinal length limits of the cannula 10, the structural integrity of the tube body 101 and the lead portion 202 of the flexible nerve electrode 20 is not affected in any way over a long period of time, and the long-term range of variation in the electrical characteristics of the lead portion 202 of the flexible nerve electrode 20 is not exceeded by its performance index.

The sleeve 10 is configured such that, when implanted in a target site, its length varies over a range of lengths in the longitudinal direction that satisfies the deformation requirements of the sleeve 10 due to forces generated by movement of the target implantation site.

In particular, when designing the sleeve 10, the core principle is to ensure that it is able to adapt to the normal range of motion and the maximum forces that can be generated in a particular application environment (e.g. the human neck), while maintaining its structural and functional integrity. By applying the mechanics principle and performing detailed computer simulations, it is possible to predict and test the behavior of the sleeve under extreme conditions, for example in case the target implantation position is the neck region, simulating the stress distribution and possible deformation of the sleeve at the maximum range of motion of the neck of the person being implanted. Based on a detailed understanding of the target site, the range of motion of the cannula 10 and the flexible neural electrode 20 is considered and the forces that may be exerted on the cannula 10 are predicted, and the defined or limiting length of the body 101 of the cannula 10 is set such that its range of variation in length in the longitudinal direction can meet the deformation requirements of the cannula 10 for the forces generated by the motion of the target implantation site, to achieve an assurance that the cannula 10 is able to accommodate the natural motion of the human body without restricting or altering the normal motion of the site in the vicinity of the target implantation site.

In some embodiments, the tube body 101 has exchange holes formed in the wall thereof, through which substances inside and outside the tube wall are exchanged.

In some embodiments, the walls of the tube body 101 are constructed in a closed structure, and substances inside and outside the walls are isolated by the walls.

In some embodiments, the interior of the tube 101 further includes a filler protector, and the lead portion 202 is movable relative to the filler within the interior of the tube 101.

In particular, in order to optimize the performance of the flexible neural electrode 20 in the body, the interior of the body 101 of the cannula 10 is filled with a particular protective substance, which is composed of gel or other highly flexible biological material. Such a protective substance not only provides additional protection to the lead portion 202, but also provides a "sliding" effect to the lead portion 202 so that it moves more smoothly inside the tube body 101 and, in the event of deformation of the sleeve 10, also reduces friction between the inside of the tube wall of the tube body 101 and the lead portion 202.

In addition, the exterior of the cannula 10 may be coated with an anti-biofilm material to prevent the attachment of bacteria and other microorganisms for further optimizing its stability and safety in vivo.

In some embodiments, the end stop mechanism 102 is further configured to limit lock the target segment of the lead portion 202 in the longitudinal direction at any one of the longitudinal directions of the tube body 101.

In some embodiments, the end stop 102 is configured to connect with the lead portion 202 by way of an adhesive or physical connection to limit lock the target segment of the lead portion 202 in the longitudinal direction.

Illustratively, the end stop 102 is coupled to the lead portion 202 using a biomedical adhesive, a tiny rubber ring, or other reliable mechanical structure.

In some embodiments, as shown in fig. 5, at least one fixing connection 103 is provided on the tube body 101, which is connected with at least one sleeve fixing portion (not shown) located at a target position to fix the tube body 101 at the target position.

Illustratively, the cannula fixation portion is a connection mechanism located at the skull or subcutaneous tissue of the implanted person, such as the adapter 40 shown in fig. 1-4, or the like. The pipe body 101 is fixed to a target position by connection of the fixed connection 103 and the sleeve fixing portion so as to limit the sleeve in the longitudinal direction.

Illustratively, a set of fixed connection 103 and sleeve fixation are provided at each end of the tube body 101. At the distal end of the tube 101 is provided an artificial skull designed to snap over the cranium window, thereby providing a stable fixation point. And a catch is provided at the proximal end of the tube 101 to which the pulse generator is attached, so that the tube is connected to the pulse generator at this end to form another attachment point. The combination of the fixing connection 103 and the sleeve fixing portion not only fixes the position of the tube body 101 but also limits the moving range thereof in the longitudinal direction. This means that, although various forces may be generated by the patient's daily activities, this fixation ensures that the body 101 does not move or slip due to these forces to non-target areas that do not include the target location.

In some embodiments, the fixed connection 103 is disposed at any of the two ends of the tube body 101, the proximal end, the middle section, or the distal end of the tube wall of the tube body 101.

The fixed connection 103 may be located at either end of the tube body 101 or at various locations along the tube wall, including at the proximal, mid-section or distal ends. In order to achieve longitudinal restraint of the cannula 10, a specific securement mechanism may be employed to ensure that the cannula is stable and evenly distributed at the target site.

In some embodiments, the fixed connection 103 is attached to the cannula mount by adhesive or physical attachment.

Illustratively, an artificial skull is formed at the middle section of the tube wall of the tube body 101, which can be snapped onto the cranium window, or a latch is formed at the distal end of the tube body 101, which can be secured to the pulse generator, the securing of the cannula 10 at the target location being formed by the snap-fit of the artificial skull onto the cranium window or the securing of the latch to the pulse generator. With this configuration, the position of the sleeve 10 in the longitudinal direction is limited to a stable and reasonable range, ensuring both functionality and improved comfort and safety.

Also, in order to prevent non-uniform stretching of the cannula 10 in the subcutaneous tissue, additional sets of fixation connections 103 and cannula fixation may be provided at the midsection of the tube wall of the tube body 101. The plurality of sets of fixed connection 103 and sleeve fixation at the mid-section of the tube wall can further enhance the stability of the overall structure of sleeve 10, ensuring that sleeve 10 remains in proper tension and position for long periods of use.

In some embodiments of the present application, an assembly 1 for an implantable flexible neural electrode 20 is provided. As shown in fig. 2-4, the assembly 1 includes a cannula 10 for an implantable flexible nerve electrode 20 and a flexible nerve electrode 20 according to various embodiments of the present application. The flexible nerve electrode 20 includes a distal electrode site layout part 201, a lead part 202, and a proximal part 203, at least a part of the lead part 202 extending in the longitudinal direction inside the cannula 10 and penetrating out from both ends of the cannula 10. Wherein one end of the lead portion 202 is connected to the distal electrode site layout portion 201 and is in electrical communication with the electrode site of the distal electrode site layout portion 201, and the other end of the lead portion 202 is connected to the adapter 40 and is in electrical communication with the adapter 40.

Specifically, fig. 2 shows a schematic structural view of an extended state of an assembly for an implantable flexible neural electrode according to example 1 of an embodiment of the present application, fig. 3 shows a schematic structural view of a retracted state of an assembly for an implantable flexible neural electrode according to example 1 of an embodiment of the present application, and fig. 4 shows a schematic structural view of an extended state and a retracted state of an assembly for an implantable flexible neural electrode according to example 2 of an embodiment of the present application. As shown in fig. 2 to 4, the lead portion 202 of the flexible neural electrode 20 can be deformed in a stretching manner inside the tube body 101 of the cannula 10 to accommodate the movement and deformation of the flexible neural electrode 20 in the body of the implanted person without being easily broken or failed. The width of the lead portion 202 is designed to be 0.01-5mm and the thickness is designed to be 0.001-1 mm to ensure the protection capability of the lead portion 202 against conductive lines inside thereof and to ensure sufficient flexibility. In addition, the surface of the lead portion 202 may be designed with a minute texture for reducing friction with the inside of the wall of the tube body 101 while increasing mobility of the lead portion 202 in the body.

In some embodiments, as shown in fig. 6, the flexible neural electrode 20 includes a first insulating layer 211, a circuit layout part 212, and a second insulating layer 213. Wherein the circuit layout section 212 is located above the first insulating layer 211 and includes a plurality of metal layers 214, and the second insulating layer 213 is located above the circuit layout section 212. Wherein at least one of the first insulating layer 211 and the second insulating layer 213 exposes a portion of the metal layer 214 attached thereto from among the plurality of metal layers 214 to form an electrode site of the distal electrode site layout part 201.

Specifically, between the first insulating layer 211 and the second insulating layer 213, a circuit layout section 212 including a plurality of metal layers 214 is provided. The circuit layout part 212 composed of a plurality of metal layers 214 can realize a complex circuit layout with various functional requirements such as signal transmission, power distribution and the like so as to meet the multifunctional requirements of the flexible neural electrode 20. Each metal layer 214 may be used to meet different circuit requirements, for example, some metal layers 214 may be used for signal transmission, while other metal layers 214 may be used for power supply or ground.

The thickness of the metal layer 214 is preferably between 10nm and 20000nm and is made of any one or a combination of at least two of highly conductive materials such as gold, platinum or iridium to ensure high-speed, high-quality transmission of signals. The thickness of the first insulating layer 211 and the second insulating layer 213 is preferably between 0.1 μm and 20 μm, and is made of any one or a combination of at least two of flexible materials having insulating properties, such as polyimide, parylene, SU-8 photoresist, parylene, fluororesin (e.g., CYTOP (r)), etc., to ensure that the signal of the flexible neural electrode 20 does not interfere with or short-circuit with the external environment. The stacked combination of the first insulating layer 211, the metal layer 214 and the second insulating layer 213 ensures that the metal layer 214 is sufficiently protected and allows flexible movement of the metal layer 214 within the sleeve 10, thereby ensuring physical protection and functional stability of the metal layer 214 in dynamic applications.

In some embodiments, the circuit layout part 212 includes a plurality of third insulating layers 215, and each third insulating layer 215 is disposed between two adjacent metal layers 214 of the plurality of metal layers 214, respectively.

Specifically, as shown in fig. 6, the third insulating layer 215 is provided between two metal layers 214 adjacent to each other in the upper and lower and/or left and right directions. Providing a plurality of metal layers 214 between the upper side of the first insulating layer 211 and the lower side of the second insulating layer 213 with a spacing through the third insulating layer 215 enables the flexible neural electrode 20 to have more flexibility of application while maintaining basic functions. Furthermore, the addition of additional insulating layers between the multiple metal layers 214 ensures electrical isolation between the different metal layers 214, for example, preventing shorting and signal interference when the assembly 1 is used with high density circuitry.

In some embodiments, as shown in fig. 6, a via 216 is provided on the third insulating layer 215, which shorts the metal layers 214 on both sides of the third insulating layer 215.

Specifically, on the multi-layer metal layer 214 and the third insulating layer 215 between the first insulating layer 211 and the second insulating layer 213, through hole processing of setting the through hole 216 is performed on the third insulating layer 215 between any two or more layers of metal layers 214, so that short circuit is realized in a bridging manner, and thus the practical application requirement of realizing short circuit between different electrode lines in a multi-layer structure can be met.

In some embodiments, the circuit layout section 212 is a spiral structure or a twisted pair structure. These structures are capable of satisfying the mechanical property requirements of the flexible neural electrode 20, such as flexibility or stability, and contribute to the durability and adaptability of the assembly 1.

In some embodiments, the assembly 1 has a plurality of flexible nerve electrodes 20. Inside the cannula 10, the lead portions 202 of the plurality of flexible nerve electrodes 20 are distributed in parallel or overlapping relation to each other and extend in the longitudinal direction of the cannula 10.

In some embodiments, as shown in fig. 5, an auxiliary implant device 30 is also included in the assembly 1 of example 3. The distal side of the auxiliary implant device 30 is formed with a traction portion 301 and is configured to form a physical connection mechanism with the flexible neural electrode 20 so as to guide the flexible neural electrode 20 to perform implantation toward a target position. The distal electrode site layout part 201 includes an auxiliary implant part 210. The auxiliary implant portion 210 forms a physical connection mechanism with the traction portion 301 of the auxiliary implant device 30 so that the flexible neural electrode 20 is implanted to a target position under the guidance of the auxiliary implant device 30 to improve the efficiency and accuracy of the flexible neural electrode implantation.

In some embodiments, the auxiliary implant 210 is formed with a hole-like structure or a groove structure, and the traction portion 301 is formed at a distal end thereof with a sharp-tipped structure or a retractable blunt-tipped structure to insert the auxiliary implant 210, thereby forming a physical connection mechanism.

Specifically, the auxiliary implant device 30 is formed as a member extending in the longitudinal direction, and a distal end side thereof is formed with a traction portion 301. The traction portion 301 is combined with an auxiliary implantation portion 210 of the flexible neural electrode 20, which will be described later, to form a physical connection mechanism for guiding the implantation of the flexible neural electrode 20. To ensure the stability of the connection, the distal end of the traction portion 301 is designed as a sharp tip or a retractable blunt tip so that it can be inserted into the hole-like structure or the groove structure of the auxiliary implant portion 210 of the flexible nerve electrode 20 to ensure the stability of the physical connection mechanism.

In some embodiments, the physical attachment mechanism is configured to disengage upon application of a proximally directed force to the traction portion 301, such that when the distal electrode site deployment portion 201 is implanted at the target location, the auxiliary implant device 30 is able to independently and proximally withdraw from the target site at which the target location is located.

In some embodiments of the present application, an assembly bundle 11 for an implantable flexible neural electrode 20 is provided. As shown in fig. 7, the assembly bundle 11 includes a plurality of assemblies 1 for implantable flexible nerve electrodes 20 according to some embodiments of the present application, and the cannulas 10 of the plurality of assemblies 1 are distributed in parallel or overlapping fashion with each other and extend in a longitudinal direction.

In some embodiments, as shown in fig. 7, the assembly bundle 11 further includes at least one inter-tube fixation 110. Each inter-tube fixing portion 110 is located between adjacent two of the plurality of the sleeves 10 and fixes the adjacent two of the sleeves 10 to each other to limit-lock the adjacent two of the sleeves 10 in the lateral direction.

Specifically, for a multi-electrode lead application scenario, this may be achieved by arranging lead portions 202 of a plurality of flexible neural electrodes 20 in parallel or in a cross manner. To ensure stability and reliability of the overall system, taking into account the spatial distribution and interaction between the individual lead portions 202, the overall structure may be further optimized by fixing the bushings 10 of multiple adjacent assemblies 1 to each other to reduce the distribution area of the assemblies 1 in cross section, while providing a unified protection and arrangement scheme for the lead portions 202 of multiple flexible neural electrodes 20, so that the application of the multi-electrode leads becomes simpler, more stable and reliable, reducing the arrangement complexity.

In some embodiments, at least one stationary connection 103 is provided on the body 101 of at least one sleeve 10 of the plurality of sleeves 10. The fixing connection portion 103 is connected with at least one ferrule fixing portion (not shown) located at the target position to fix the assembly bundle 11 at the target position.

Illustratively, two adjacent bushings 10 in the assembly bundle 11 may be fixed to each other by the inter-pipe fixing portion 110, and may also be fixed to each other by connecting the fixing connection portions 103 of the two bushings.

In some embodiments of the present application, a device for an implantable flexible neural electrode 20 is provided. The device may be the flexible neural electrode implant device 2 of the construction shown in fig. 8, or may be other constructions. In the embodiments of the present application, the flexible nerve electrode implantation device 2 is described as an example of a device.

As shown in fig. 8, the flexible neural electrode implant device 2 includes an electrode assembly portion 3 and a positioning implant portion 4. The electrode assembly portion 3 comprises an assembly 1 for an implantable flexible neural electrode 20 according to some embodiments of the present application, or an assembly bundle 11 for an implantable flexible neural electrode 20 according to some embodiments of the present application. The positioning implantation section 4 acquires current position information of the distal electrode site layout section 201 of the component 1 or the component bundle 11 at each timing, and guides the distal electrode site layout section 201 to the target position based on a position comparison result of comparing the current position information with target implantation position information of the component 1 or the component bundle 11.

In particular, the positioning implant 4 is used to fix and control the position and orientation of the auxiliary implant device 30 in three dimensions, the auxiliary implant device 30 being responsible for performing the implantation operation, while the positioning implant 4 is responsible for ensuring its precise navigation and positioning, both of which cooperate closely during the implantation process. The positioning implant part 4 precisely positions the distal electrode site layout part 201 in real time and compares it with a medical image or a medical map. In this way, it can effectively guide the auxiliary implant device 30, ensuring that the distal electrode site placement portion 201 accurately reaches the target position.

Also, positioning the implant 4 may be accomplished in a variety of ways, including but not limited to, manual operator control, stereotactic, or high precision robotic arms, to provide a stable and reliable platform for precisely controlling the implantation process of the assembly 1. By the cooperation of the positioning implant in the device and the auxiliary implant device 30, the accuracy and safety of the assembly 1 during implantation can be improved.

Furthermore, although exemplary embodiments have been described herein, the scope thereof includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of the various embodiments across schemes), adaptations or alterations based on the present disclosure. The elements in the claims are to be construed broadly based on the language employed in the claims and are not limited to examples described in the present specification or during the practice of the application, which examples are to be construed as non-exclusive. It is intended, therefore, that the specification and examples be considered as exemplary only, with a true scope and spirit being indicated by the following claims and their full scope of equivalents.

The above description is intended to be illustrative and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. For example, other embodiments may be used by those of ordinary skill in the art upon reading the above description. In addition, in the above detailed description, various features may be grouped together to streamline the disclosure. This is not to be interpreted as an intention that the disclosed features not being claimed are essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the detailed description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that these embodiments may be combined with one another in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

1. A cannula for an implantable flexible nerve electrode, the flexible nerve electrode comprising a distal electrode site layout, a lead and a proximal end, the cannula comprising a body and an end stop mechanism,

The tube body has a longitudinally extending cavity to accommodate a target segment of the lead portion to be subjected to a deployment deformation and is elastically stretchable in a longitudinal direction to a defined length within a safe extension length of the target segment of the lead portion;

the end position limiting mechanism is configured to limit-lock the target segment of the lead portion in the longitudinal direction at both ends of the tube body.

2. The cannula of claim 1, wherein at least a portion of the tube body is made of an elastomeric material.

3. A cannula according to claim 1, wherein the wall of the tube is configured as a pleated structure or a telescopic structure, and the tube is telescopically deformable in a longitudinal direction.

4. A cannula according to claim 1, wherein at least a portion of the tube body is made of an elastic material and a wall of the tube body is constructed in a mesh structure or a lattice structure, and the tube body is elastically deformable in a longitudinal direction.

5. A sleeve according to any one of claims 1 to 4, wherein the tubular body is elastically stretchable in the longitudinal direction to a limit length, the limit length being 110% or more of the defined length.

6. The cannula according to claim 5, wherein a difference between the defined length and a safe extension length of the target segment of the lead portion is greater than or equal to a first threshold.

7. The cannula of claim 6, wherein the first threshold is a difference between the limit length and the defined length.

8. The cannula of claim 1, wherein the tube body is configured to have an inner diameter greater than or equal to a second threshold value when stretched in a longitudinal direction.

9. The cannula of claim 1, wherein the tube body is configured to have a radial cross-section of at least any one of a circular shape, an oval shape, or a square shape when stretched in a longitudinal direction.

10. The cannula according to claim 1, wherein the outside of the tube wall of the tube body has micro-nano scale texture.

11. The cannula according to claim 1, wherein the wall of the tube is configured with a micropunch or hook configuration.

12. The sleeve of claim 1 wherein said lead portion and said sleeve are formed of materials having oxidation and corrosion resistance.

13. A cannula according to claim 1, wherein exchange holes are formed in the wall of the tube body, and substances on the inner and outer sides of the tube wall are exchanged through the exchange holes.

14. A cannula according to claim 1, wherein the wall of the tube body is constructed as a closed structure, and wherein substances inside and outside the wall are isolated by the wall.

15. The cannula of claim 1, wherein the interior of the tube body further comprises a fill protector, the lead portion being relatively movable within the interior of the tube body with respect to the fill protector.

16. The cannula according to claim 1, wherein the end stop mechanism is further configured to limit lock a target segment of the lead portion in a longitudinal direction at any one of the longitudinal directions of the tube body.

17. The cannula according to claim 16, wherein the end stop mechanism is configured to connect with the lead portion by way of an adhesive or physical connection to positively lock the target segment of the lead portion in a longitudinal direction.

18. A cannula according to claim 1, wherein the tube body is provided with at least one fixed connection which connects with at least one cannula fixation at a target location to fix the tube body at the target location.

19. The cannula of claim 18, wherein the fixed connection is disposed at any one of two ends of the tube body, a proximal end, a middle section, or a distal end of a wall of the tube body.

20. The cannula according to claim 18, wherein the fixed connection is attached to the cannula fixation portion by means of an adhesive or physical connection.

21. An assembly for an implantable flexible neural electrode, comprising:

a cannula for an implantable flexible nerve electrode according to any one of claims 1-20;

the flexible nerve electrode comprises a distal electrode site layout part, a lead part and a proximal end part, wherein at least one part of the lead part extends in the longitudinal direction inside the sleeve and penetrates out of two ends of the sleeve, one end of the lead part is connected with the distal electrode site layout part and is communicated with an electrode site of the distal electrode site layout part, and the other end of the lead part is connected with an adapter and is electrically communicated with the adapter.

22. The assembly of claim 21, wherein the flexible neural electrode comprises:

A first insulating layer;

a circuit layout part which is positioned above the first insulating layer and comprises a plurality of metal layers;

A second insulating layer above the circuit layout part,

Wherein at least one of the first insulating layer and the second insulating layer exposes a portion of the metal layer attached thereto from among the plurality of metal layers to form an electrode site of the distal electrode site layout part.

23. The assembly of claim 22, wherein the circuit layout section includes a plurality of third insulating layers, each third insulating layer being disposed between two adjacent metal layers of the plurality of metal layers, respectively.

24. The assembly of claim 23, wherein the third insulating layer is provided with vias that short the metal layers on both sides of the third insulating layer.

25. The assembly of any one of claims 22-24, wherein the circuit layout portion is in a spiral or twisted pair configuration.

26. The assembly of claim 21, wherein the assembly has a plurality of the flexible nerve electrodes, the lead portions of the plurality of the flexible nerve electrodes being distributed in parallel or overlapping relation to each other inside the cannula and extending in a longitudinal direction of the cannula.

27. The assembly of claim 21, further comprising an auxiliary implant device having a traction portion formed on a distal side thereof and configured to form a physical connection mechanism with the flexible neural electrode so as to guide the flexible neural electrode to perform implantation toward a target site,

The distal electrode site layout portion includes an auxiliary implantation portion forming a physical connection mechanism with a traction portion of the auxiliary implantation device so that the flexible neural electrode is implanted to a target position under the guidance of the auxiliary implantation device.

28. The assembly of claim 27, wherein the auxiliary implant portion is formed with a hole-like structure or a groove structure, and the traction portion is formed at a distal end thereof with a sharp-tipped structure or a retractable blunt-tipped structure to be inserted into the auxiliary implant portion, thereby forming the physical connection mechanism.

29. The assembly of claim 27 or claim 28, wherein the physical connection mechanism is configured to disengage upon application of a proximally directed force to the traction portion, such that the auxiliary implant device is independently able to be withdrawn proximally from a target site where the target site is located after the distal electrode site deployment portion is implanted at the target site.

30. A bundle of components for an implantable flexible neural electrode, characterized by comprising a plurality of components for an implantable flexible neural electrode according to any one of claims 1 to 29, the cannulas of the plurality of components being distributed in parallel or overlapping manner with each other and extending in a longitudinal direction.

31. The assembly bundle for an implantable flexible nerve electrode according to claim 30, further comprising at least one inter-tube fixation portion, each inter-tube fixation portion being located between and securing adjacent two of the plurality of cannulas to each other to limit lock the adjacent two cannulas in a lateral direction.

32. The assembly bundle for an implantable flexible nerve electrode according to claim 31, wherein at least one fixed connection is provided on a tube body of at least one of the plurality of cannulas, which is connected with at least one cannula fixation at the target site to fix the assembly bundle at the target site.

33. A device for an implantable flexible neural electrode, comprising:

An electrode assembly portion comprising the assembly for an implantable flexible neural electrode according to any one of claims 21 to 29, or the assembly bundle for an implantable flexible neural electrode according to any one of claims 30 to 32;

And a positioning implantation part which acquires current position information of the distal electrode site layout part of the component or the component bundle at each moment and guides the distal electrode site layout part to the target position based on a position comparison result of comparing the current position information with target implantation position information of the component or the component bundle.