Implantable neuromuscular stimulation electrode and implantable neuromuscular stimulation system

Abstract

The utility model belongs to the field of medical instruments, and particularly discloses an implantable neuromuscular stimulation electrode and an implantable neuromuscular stimulation system. The stimulating electrode comprises a lengthwise insulating base body, and the insulating base body is sequentially provided with a stimulating section, a transition section and a lead section in the lengthwise extending direction. Wherein the stimulation section is arranged to be in a flat shape, the lead section is arranged to be in a cylindrical shape, the transition section is smoothly connected with the stimulation section and the lead section, and the stimulation section, the transition section and the lead section are respectively provided with a first cross section, a second cross section and a third cross section which are perpendicular to the lengthwise extension direction. The second cross-section has a cross-sectional area determined based on cross-sectional areas of the first cross-section and the third cross-section. According to the utility model, the problem of stress concentration is solved by optimizing the structural design of the stimulating electrode, and the tensile property of the stimulating electrode can be remarkably improved, so that the long-term effectiveness of the stimulating electrode is ensured, and the service life of the stimulating electrode is prolonged.

Description

TECHNICAL FIELD

[0001] The utility model belongs to the field of medical devices, concretely relates to an implantable neuromuscular stimulation electrode and implantable neuromuscular stimulation system. BACKGROUND

[0002] Nystagmus is an involuntary, rhythmic and reciprocating eye swing or jump, and its clinical manifestations are complex, often accompanied by binocular visual impairment. According to the primary disease of nystagmus, nystagmus is divided into ocular nystagmus, vestibular nystagmus, central nystagmus and nystagmus of unknown cause. Among them, ocular nystagmus is closely related to ophthalmology, and is mainly congenital nystagmus (CN), which often occurs at birth or within 4 months after birth. According to statistics, the prevalence rate in children is 1 / 1000-1 / 1500, and there are about millions of patients worldwide. Extraocular muscle neuromuscular electrical stimulation can inhibit congenital nystagmus. The electrical stimulation is generated by an implanted stimulator and acts on the extraocular muscles through the stimulating electrode. Compared with traditional extraocular muscle shortening surgery, extraocular muscle neuromuscular electrical stimulation does not cause irreversible damage to the extraocular muscles, and has no effect on the movement range of the eyeball after surgery.

[0003] Compared with other neuromuscular stimulation electrodes such as deep brain stimulation, spinal cord stimulation and cochlear implant, the extraocular muscle neuromuscular electrical stimulation electrode has higher requirements for its flexibility. The space in the human eye socket is limited, and the eyeball is very flexible. With the movement of the eyeball, the stimulating electrode will stretch, compress, bend and twist. This puts different requirements on the size and structure design of the stimulating electrode compared with traditional neural stimulation electrodes.

[0004] In view of this, it is desirable to provide a stimulating electrode structure design and implementation method for extraocular muscle neuromuscular electrical stimulation to ensure the long-term effectiveness of the electrode. UTILITY MODEL CONTENT

[0005] The utility model aims at providing an implantable neuromuscular stimulation electrode and implantable neuromuscular stimulation system which can be implanted for a long time.

[0006] To achieve the above-mentioned purpose, the utility model adopts the following technical scheme:

[0007] According to the first aspect of the utility model, provide a kind of implantable nerve muscle stimulation electrode, it includes long insulating matrix, the insulating matrix is sequentially provided with stimulation section, transition section and lead section along longitudinal extension direction, wherein, the stimulation section is set to flat shape, the lead section is set to cylindrical shape, the transition section is smoothly connected the stimulation section with the lead section, and the stimulation section, the transition section, the lead section respectively have first cross section, second cross section and third cross section perpendicular to the longitudinal extension direction, the second cross section has cross section area determined based on the cross section area of the first cross section and the third cross section.

[0008] According to an embodiment of the utility model, in the case where the cross-sectional areas of the first cross section and the third cross section are equal, the cross-sectional area of the second cross section floats within ±10% of the cross-sectional areas of the first cross section and the third cross section.

[0009] According to an embodiment of the utility model, in the case where the cross-sectional areas of the first cross section and the third cross section are equal, the cross-sectional area of the second cross section is equal to the cross-sectional areas of the first cross section and the third cross section.

[0010] According to an embodiment of the utility model, in the case where the cross-sectional areas of the first cross section and the third cross section are not equal, the cross-sectional area of the second cross section is determined based on the linear interpolation result of the cross-sectional areas of the first cross section and the third cross section.

[0011] According to an embodiment of the utility model, in the case where the cross-sectional areas of the first cross section and the third cross section are not equal, the cross-sectional area of the second cross section floats within ±10% of the linear interpolation result of the cross-sectional areas of the first cross section and the third cross section.

[0012] According to an embodiment of the utility model, the stimulation section, the transition section and the lead section of the insulating matrix are integrally formed.

[0013] According to an embodiment of the utility model, the first cross section is flat circular or square, the third cross section is circular or nearly circular, and the second cross section gradually changes from circular or nearly circular to flat circular or square.

[0014] According to an embodiment of the utility model, the diameter of the lead section is between 0.5 mm and 2.0 mm.

[0015] According to an embodiment of the utility model, the thickness of the stimulation section is between 0.1 mm and 0.7 mm, the length is less than 10 mm, and the width is less than 10 mm.

[0016] According to an embodiment of the utility model, the length of the transition section is between 1 mm and 10 mm.

[0017] According to one embodiment of the present application, the stimulation section has a flat upper surface and a lower surface, the transition section has a top surface and a bottom surface adjacent to a part of the stimulation section, the top surface is arranged as a plane or a curved surface extending obliquely towards the upper surface, and the bottom surface is arranged as a plane or a curved surface extending obliquely towards the lower surface.

[0018] According to one embodiment of the present application, the insulating base body comprises at least one fixing part for fixing the stimulation electrode, the at least one fixing part comprises at least one first fixing part arranged in the stimulation section and at least one second fixing part arranged in the transition section, and the second fixing part is in a semicircular shape or an inverted triangular shape.

[0019] According to one embodiment of the present application, the distance between the second fixing part and the nearest first fixing part is 6-12mm.

[0020] According to the second aspect of the present application, an implantable neuromuscular stimulation system is provided, comprising: a stimulator; and the implantable neuromuscular stimulation electrode according to the first aspect of the present application, wherein the lead section of the implantable neuromuscular stimulation electrode is connected to the stimulator.

[0021] By adopting the above technical scheme, the present application has at least the following beneficial effects:

[0022] The implantable neuromuscular stimulation electrode and the implantable neuromuscular stimulation system provided by the present application solve the problem of stress concentration by optimizing the structure design of the stimulation electrode, can significantly improve the tensile property of the stimulation electrode, thereby ensuring the long-term effectiveness of the stimulation electrode, prolonging the service life of the stimulation electrode, and being suitable for long-term implantation and use. BRIEF DESCRIPTION OF DRAWINGS

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required by the embodiments will be briefly introduced as follows. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor on the basis of these drawings.

[0024] Figure 1 Schematic diagram of an extraocular muscle nerve stimulation electrode and its fixed position;

[0025] Figure 2 Schematic diagram of the implantable neuromuscular stimulation electrode provided by one embodiment of the present application from the top;

[0026] Figure 3The utility model provides a three -dimensional schematic view of implantable nerve muscle stimulation electrode for one embodiment of the utility model;

[0027] Figure 4 The utility model provides a three -dimensional schematic view of implantable nerve muscle stimulation electrode for another embodiment of the utility model;

[0028] Figure 5 It is three -dimensional schematic view of traditional stimulation electrode;

[0029] Figures 6A-6C The utility model provides a transition section cross -section area design scheme schematic drawing of implantable nerve muscle stimulation electrode;

[0030] Figure 7 The utility model provides a top view schematic view of implantable nerve muscle stimulation electrode for another embodiment of the utility model;

[0031] Figure 8 The utility model provides a three -dimensional schematic view of implantable nerve muscle stimulation electrode for another embodiment of the utility model;

[0032] Figure 9 It is displacement and load relation curve diagram measured during tensile test for material as insulating matrix;

[0033] Figure 10 It is fixed and load mode schematic drawing of electrode structure during tensile test;

[0034] Figure 11 It is Figure 3 Stress simulation result of stimulation electrode structure design scheme shown in the figure;

[0035] Figure 12 It is Figure 4 Stress simulation result of stimulation electrode structure design scheme shown in the figure;

[0036] Figure 13 It is Figure 5 Stress simulation result of stimulation electrode structure design scheme shown in the figure;

[0037] Figure 14 It is Figures 3-5 Stress-position curve diagram of three stimulation electrode structure design schemes shown in the figure.

[0038] Mark explanation

[0039] 1 extraocular muscle nerve stimulation electrode; 2 extraocular muscle; 3 surgical suture; 4 eyeball; 10 insulating base; 11 stimulation segment; 111 upper surface; 112 lower surface; 12 transition segment; 121 top surface; 122 bottom surface; 13 lead segment; 14 first fixing portion; 15 second fixing portion; 151 triangular upper surface; 152 triangular lower surface; 153 inclined surface; 154 right-angled surface; A longitudinal extension direction; L distance of the second fixing portion from the nearest first fixing portion. DETAILED DESCRIPTION

[0040] In order to make the purpose, technical scheme and advantages of the present application clearer, the following will be further described in detail with specific embodiments and with reference to the drawings.

[0041] It should be noted that in the description of the present application, the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", "longitudinal" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0042] In the description of the present application, the terms "include", "contain", "have" and the like indicate non-exclusive inclusion, and the terms "first", "second" and the like are used to distinguish different objects, but are not used to describe a particular order. The meaning of "a plurality of" is two or more, unless otherwise specifically limited.

[0043] In the description of the present application, when an element is referred to as "fixed to" or "mounted to" or "provided on" or "connected to" another element, it can be directly or indirectly on the other element. For example, when an element is referred to as "connected to" another element, it can be directly or indirectly connected to the other element.

[0044] It should be noted that the specific structure, features and advantages of the present application will be specifically described below by way of example, however all the descriptions are only for illustration and should not be understood as limiting the present application. In addition, any single technical feature described or implied in the embodiments mentioned in the present text, or any single technical feature shown or implied in the drawings, can still be combined or deleted between these technical features (or their equivalents), so as to obtain more other embodiments of the present application which can not be directly mentioned in the present text.

[0045] As mentioned in the background section, extraocular muscle neuromuscular electrical stimulation can suppress congenital nystagmus, the electrical stimulation being generated by an implanted stimulator and acting on the extraocular muscle via a stimulation electrode. As shown in Figure 1 When performing the surgery, the extraocular muscle nerve stimulation electrode 1 will be placed on the medial side of the extraocular muscle 2 and fixed to the extraocular muscle by surgical sutures 3. After the surgery, the stimulation electrode 1 can move with the eyeball 4 and stimulate the extraocular muscle and the nerve that controls the movement of the extraocular muscle through the electrode contact. Compared with the traditional extraocular muscle shortening surgery, the extraocular muscle neuromuscular electrical stimulation does not cause irreversible damage to the extraocular muscle 2 and has no effect on the movement range of the eyeball 4 after the surgery.

[0046] Compared with other neuromuscular stimulation electrodes, such as deep brain electrical stimulation, spinal cord electrical stimulation, cochlear implant, etc., the extraocular muscle neuromuscular electrical stimulation electrode has higher requirements for its flexibility. The space in the human eye socket is limited, and the eyeball is very flexible. With the movement of the eyeball, the electrode will stretch, compress, bend, twist, etc. This puts different requirements on the size and structure design of the electrode compared with traditional neural stimulation electrodes. For example, the extraocular muscle neuromuscular electrical stimulation electrode needs to have excellent tensile resistance so that it can be implanted in the eye for a long time to treat congenital nystagmus. Traditional neural stimulation electrodes are prone to stress concentration and have relatively poor tensile resistance, which cannot meet the long-term implantation requirements.

[0047] Therefore, the utility model aims at providing an implantable neuromuscular stimulation electrode and an implantable neuromuscular stimulation system which can be implanted for a long time. Although the implantable neuromuscular stimulation electrode and the implantable neuromuscular stimulation system are described in the application in the context of application to extraocular muscle neuromuscular electrical stimulation, those skilled in the art can understand that the implantable neuromuscular stimulation electrode and the implantable neuromuscular stimulation system provided in the application are not limited to application to this, but can also be applied to other similar scenarios.

[0048] According to a first aspect of the utility model, an implantable neuromuscular stimulation electrode is provided, as shown in Figures 2-4 The stimulation electrode includes a longitudinal insulating base body 10, and the insulating base body 10 is sequentially provided with a stimulation section 11, a transition section 12 and a lead section 13 along a longitudinal extension direction A, wherein the stimulation section 11 is arranged in a flat shape, the lead section 13 is arranged in a cylindrical shape, the transition section 12 smoothly connects the stimulation section 11 and the lead section 13, and the stimulation section 11, the transition section 12 and the lead section 13 respectively have a first cross section, a second cross section and a third cross section perpendicular to the longitudinal extension direction A, and the second cross section has a cross-sectional area determined based on the cross-sectional areas of the first cross section and the third cross section.

[0049] Although not shown in the figures, it should be understood that the stimulating electrode provided by the present application also includes, as a conventional stimulating electrode, an electrode contact provided on the stimulating section 11 of the insulating base 10 and at least partially exposed outside the insulating base 10 for applying electrical stimulation to the stimulation site; and an internal conductor connecting the electrode contact to the stimulator and extending at least partially inside the insulating base in the longitudinal extension direction A, specifically, extending through the stimulating section 11, the transition section 12 and the lead section 13 to connect with the stimulator.

[0050] In the present application, the insulating base 10 is longitudinal or strip-shaped, which means that the size of the insulating base 10 in one direction (i.e. the longitudinal extension direction A) is greater than that in the other directions. The insulating base 10 is elastic to be able to change the length in the longitudinal extension direction A, thereby making the insulating base 10 able to change its respective length together with the internal conductor to enable the electrode contact to be more stably positioned at a specific location. The insulating base 10 is made of an elastomer with biocompatibility, such as silicone rubber, etc.

[0051] Due to the limitations of human anatomy and implantation position, the part of the stimulating electrode in contact with the stimulation site (i.e. the stimulating section 11) is provided in a flat shape, while the part connecting the stimulating electrode with the stimulator (i.e. the lead section 13) is provided in a cylindrical shape. The flat-shaped stimulating section 11 can be more stably fitted and placed at the stimulation site, and the cylindrical-shaped lead section 13 can be more conveniently processed and facilitate the placement of the internal conductor.

[0052] In the present application, "the transition section 12 smoothly connects the stimulating section 11 with the lead section 13" means that there is a smooth transition from the stimulating section 11 to the lead section 13, without obvious step-like structures. This arrangement is beneficial to reduce stress concentration, thereby improving the tensile performance and service life of the electrode. In particular, the transition section 12 bears most of the deformation caused by the eyeball movement and is the weak point of the mechanical strength of the entire electrode, playing a key role in extending the service life of the stimulating electrode.

[0053] In some embodiments, as shown in FIG. 2, the stimulating section 11 is provided with a plurality of stimulating electrodes 20, and the transition section 12 is provided with a plurality of transition electrodes 21. The stimulating electrodes 20 and the transition electrodes 21 are electrically connected to each other through the internal conductor. Figure 3As shown, the transition segment 12 is configured to transition from the stimulation segment 11 to the lead segment 13 via a straight line (hereinafter also referred to as the straight line scheme), in other words, the transition from the stimulation segment 11 to the lead segment 13 is via an inclined plane. Specifically, the stimulation segment 11 has a flat upper surface 111 and a lower surface 112, and the portion of the transition segment 12 adjacent to the stimulation segment 11 has a top surface 121 and a bottom surface 122. The top surface 121 is configured as a plane extending inclined toward the upper surface 111, and the bottom surface 122 is configured as a plane extending inclined toward the lower surface 112. Since the top surface 121 and the bottom surface 122 are straight in a cross-sectional view along the longitudinal extension direction A, they are simply referred to here as a straight line transition. In addition to the top surface 121 and the bottom surface 122, the portion of the transition segment 12 adjacent to the stimulation segment 11 also includes two side surfaces, which are arcuate surfaces, meaning that this portion of the transition segment 12 transitions with the stimulation segment 11 via arcuate surfaces. The top surface 121 and the side surface, as well as the bottom surface 122 and the side surface, are connected by an arc.

[0054] In other embodiments, such as Figure 4 As shown, the transition segment 12 is configured to transition from the stimulation segment 11 to the lead segment 13 via a curve (hereinafter also referred to as a curve scheme), in other words, the transition from the stimulation segment 11 to the lead segment 13 is via a curved surface. Specifically, the stimulation segment 11 has a flat upper surface 111 and a lower surface 112, and the portion of the transition segment 12 adjacent to the stimulation segment 11 has a top surface 121 and a bottom surface 122. The top surface 121 is configured as a curved surface extending obliquely toward the upper surface 111, and the bottom surface 122 is configured as a curved surface extending obliquely toward the lower surface 112. Since the top surface 121 and the bottom surface 122 are curved in the cross-sectional view along the longitudinal extension direction A, they are simply referred to here as a curved transition. In addition to the top surface 121 and the bottom surface 122, the portion of the transition segment 12 adjacent to the stimulation segment 11 also includes two side surfaces, which are arcuate curved surfaces, that is, this portion of the transition segment 12 transitions to the stimulation segment 11 via arcuate curved surfaces. The top surface 121 and the side surface, as well as the bottom surface 122 and the side surface, are connected by an arc.

[0055] Figure 5 A conventional stimulation electrode scheme, different from the scheme of this application, is shown. In this conventional scheme, the insulating substrate 20 is provided with a stimulation section 21, a transition section 22 and a lead section 23 in sequence along the longitudinal extension direction. The transition section 22 forms a distinct stepped structure (hereinafter also referred to as the stepped scheme). This arrangement is prone to stress concentration, which is detrimental to the tensile strength of the stimulation electrode.

[0056] In the present application, the cross-sectional area of the second section is determined based on the cross-sectional areas of the first section and the third section for the purpose of reducing stress concentration. In some embodiments, the cross-sectional area of the second section can be set equal to the cross-sectional areas of the first section and the third section. In other embodiments, the cross-sectional area of the second section can be determined based on a linear interpolation of the cross-sectional areas of the first section and the third section.

[0057] Specifically, in the present application, the cross-sectional area of the transition section 12 perpendicular to the longitudinal extension direction A is determined based on the cross-sectional areas of the stimulation section 11 and the lead section 13 perpendicular to the longitudinal extension direction A for the purpose of reducing stress concentration. In the case where the cross-sectional area of the stimulation section 11 is equal to the cross-sectional area of the lead section 13, the cross-sectional area of the transition section 12 at each position along the longitudinal extension direction A is set to be substantially equal to the cross-sectional areas of the stimulation section 11 and the lead section 13, for example, the cross-sectional area of the transition section 12 is allowed to fluctuate within a range of ±10% relative to the cross-sectional areas of the stimulation section 11 and the lead section 13, so as to reduce stress concentration as much as possible. Preferably, the cross-sectional area of the transition section 12 is equal to the cross-sectional areas of the stimulation section 11 and the lead section 13. During the electrode implantation process, the electrode is inevitably stretched. The lead section 13 is a uniform cylinder, and there is no position where stress concentration occurs, and damage is unlikely to occur. The transition section 12 transitions from a circular or near-circular cross-section to a rectangular cross-section, and improper handling can easily cause stress concentration points. In the present application, it is proposed that the cross-sectional area of the transition section is always equal to the cross-sectional areas of the stimulation section 11 and the lead section 13, which can ensure that the average stress in each cross-section is equal, thereby avoiding the occurrence of stress concentration points as much as possible.

[0058] In the case where the cross-sectional area of the stimulation section 11 is not equal to the cross-sectional area of the lead section 13, the cross-sectional area of the transition section 12 at each position along the longitudinal extension direction A is determined based on a linear interpolation of the cross-sectional area of the stimulation section 11 and the cross-sectional area of the lead section 13. For example, the cross-sectional area of the transition section 12 at each position along the longitudinal extension direction A is allowed to fluctuate within a range of ±10% relative to the linear interpolation of the cross-sectional area of the stimulation section 11 and the cross-sectional area of the lead section 13, so as to reduce stress concentration as much as possible. Preferably, the cross-sectional area of the transition section 12 at each position along the longitudinal extension direction A is set to be the linear interpolation of the cross-sectional area of the stimulation section 11 and the cross-sectional area of the lead section 13. Here, the "cross-sectional area of the stimulation section 11" refers to the cross-sectional area of the end of the stimulation section 11 closest to the transition section 12.

[0059] Figures 6A-6C The design scheme of the cross-sectional area of the transition section at each position along the longitudinal extension direction is shown, wherein, Figure 6A The case where the cross-sectional area of the transition section at each position along the longitudinal extension direction is equal is shown, Figure 6B The case where the cross-sectional area of the transition section at each position along the longitudinal extension direction linearly increases is shown, Figure 6CThe linearly decreasing case of the cross-sectional area of the transition section at various positions along the longitudinal extension direction is shown. In the three graphs, the ordinate represents the cross-sectional area of the transition section, and the abscissa represents the position of the transition section along the longitudinal extension direction, wherein the positions "0" and "1" respectively represent the junction of the transition section with the lead section or the junction of the transition section with the stimulation section.

[0060] Preferably, in order to further reduce stress concentration and improve overall strength, the stimulation section 11, the transition section 12 and the lead section 13 of the insulating base 10 are integrally formed.

[0061] In the context of application to extraocular muscle neuromuscular electrical stimulation, during the operation, the lead section 13 passes subcutaneously from behind the ear to the lateral canthus, and part of it runs in the conjunctival fornix. The cross-section of the lead section 13 is circular or nearly circular, with a diameter of between 0.5 mm and 2.0 mm. The stimulation section 11 stimulates the neuromuscular junction on the medial side of the extraocular muscle, and its shape is flat circular or square, covering the intramuscular nerve dense area of the extraocular muscle. The thickness of the stimulation section 11 is between 0.1 mm and 0.7 mm, the length should be less than 10 mm, and the width should be less than 10 mm. The length of the transition section 12 is between 1 mm and 10 mm, and its cross-section gradually changes from circular or nearly circular to flat circular or square.

[0062] In some embodiments, the insulating base 10 can further include at least one fixing portion for fixing the stimulation electrode, which is provided with a fixing hole for passing a surgical suture to fix the stimulation electrode to the stimulation site. The size of the fixing hole can be determined according to the size of the surgical suture. In some examples, the diameter of the fixing hole is in the range of 0.1-0.2 mm. The fixing portion is advantageous to ensure that the position of the stimulation electrode, especially the stimulation section of the stimulation electrode, remains unchanged.

[0063] The at least one fixing portion can include a first fixing portion 14 and a second fixing portion 15. The first fixing portion 14 can be provided in the stimulation section 11. The first fixing portion 14 can be multiple, which are respectively provided on both sides of the electrode contact along the longitudinal extension direction A and located at the edges of the stimulation section 11. The second fixing portion 15 can be provided in the transition section 12. The second fixing portion 15 can be two, which are tabs protruding from both sides of the insulating base 10, respectively. For example, the tabs can be provided in a semicircular shape (as shown in Figures 2-4 or an inverted triangular shape (as shown in Figures 7-8 The second fixing portion 15 can achieve the following effects: ensuring that the electrode stimulation section stays under the conjunctiva without falling out, playing a fixed role; as a landmark point, informing the doctor how much length should be left after the electrode enters the orbit, so that the implanted electrode does not interfere with the normal rotation of the eyeball; as a surgical tool clamping point, preventing the electrode from being damaged by clamping other positions. Due to the provision of the first fixing portion 14 and the second fixing portion 15, the stimulation electrode is placed more stably.

[0064] As shown in Figures 7-8 , the second fixing part 15 in the shape of an inverted triangle comprises a flat triangular upper surface 151 and a triangular lower surface 152, the planes of which are parallel to the planes of the upper surface 111 and the lower surface 112 of the stimulating section. The second fixing part 15 in the shape of an inverted triangle further comprises an inclined surface 153 arranged obliquely towards the stimulating section and a right-angled surface 154 arranged perpendicularly to the longitudinal extension direction A. Compared with a semicircle, the inclined surface 153 in the shape of an inverted triangle can more easily enter the conjunctiva during the implantation surgery, and the right-angled surface 154 in the shape of an inverted triangle can anchor in the conjunctiva once the electrode is pulled outwards during the surgery, effectively preventing the stimulating section from slipping out of the conjunctiva and into the subcutaneous tunnel, and causing traction or even damage to the extraocular muscle.

[0065] Preferably, the distance L between the second fixing part 15 and the nearest first fixing part 14 can be set to 6-12 mm, for example, in one embodiment, the distance L is 9 mm. If the distance L is too long, it can interfere with the operation during the surgery, and can be coiled, knotted and accumulated under the conjunctiva after the surgery, affecting the normal movement of the eyeball. If the distance L is too short, it can limit the normal movement of the eyeball during the movement of the eyeball.

[0066] In order to verify the effect of the scheme of the present application relative to the traditional scheme, the applicant has evaluated the tensile resistance of the stimulating electrode through theoretical calculation combined with simulation.

[0067] Firstly, the basic properties of the material as the insulating matrix were measured, and the displacement-load relationship curve measured by the tensile test is shown in Figure 9 , the initial length of the tensile test is 5.5 mm, and the diameter is 1.35 mm. In the Mooney-Rivlin two-parameter model, for uniaxial tension, the stress and the tensile rate have the following relationship:

[0068]

[0069]

[0070] .

[0071] wherein, P is the stress, F is the applied tension, d is the cross-sectional area, is the tensile rate, L is the length after stretching, L 0 is the initial length of stretching, C 10and C 01 is fitted. The fitting result is The insulating base of different flexible materials is also applicable to the calculation formula, but the corresponding part parameters are different, and the calculation result is also different.

[0072] In the simulation software, the stretching of the three stimulation electrode structures shown in Figures 3-5 is simulated, and the fixing and load mode is as shown in Figure 10 The total length of the simulation sample is 21mm, and the 6 holes of the stimulation section are used as fixing points, and a fixed displacement of 3mm is applied to the lead section.

[0073] The simulation results of the three stimulation electrode structures are as shown in Figures 11-13 , wherein Figure 11 corresponds to the simulation result of the stimulation electrode structure provided by the application shown in Figure 3 , wherein Figure 12 corresponds to the simulation result of the stimulation electrode structure provided by the application shown in Figure 4 , wherein Figure 13 corresponds to the simulation result of the traditional stimulation electrode structure shown in Figure 5 . It can be more obviously seen from Figures 11-13 that under the same displacement load, the traditional stimulation electrode structure has obvious stress concentration at the electrode neck (i.e. the transition section), which is not conducive to the tensile resistance of the electrode; and the stimulation electrode structure provided by the application does not have stress concentration at the electrode neck (i.e. the transition section), which is conducive to the tensile resistance of the electrode.

[0074] The average stress of the simulation result cross section is extracted, taking the stretching place as the origin, and the average stress of different positions is as shown in Figure 14 The traditional stimulation electrode structure can be seen to have obvious stress increasing points, while the two stimulation electrode structures provided by the application have similar results, and the transition of the curve scheme is smoother. Specifically, the maximum stress of the curve scheme is reduced by 45% compared with the stepped scheme and by 10% compared with the straight line scheme. Considering the simulation results and the feasibility of processing, the curve scheme can better improve its tensile resistance without greatly changing the appearance and meeting the implant size requirements.

[0075] According to the second aspect of the application, an implantable neuromuscular stimulation system is provided, which comprises: a stimulator; and the implantable neuromuscular stimulation electrode of the first aspect of the application, the lead section of the implantable neuromuscular stimulation electrode is connected to the stimulator, specifically, the internal conductor passing out from the lead section is connected to the stimulator.

[0076] In summary, the utility model discloses the problem of stress concentration is solved through optimizing electrode structure design, can significantly improve the tensile property of electrode, thereby guarantee the long-term effectiveness of electrode, prolong the service life of electrode, can satisfy long-term implantation demand.

[0077] The above is the exemplary embodiment disclosed by the utility model, and the sequence of the utility model embodiment disclosed above is only for description, not representing the advantages and disadvantages of the embodiment. However, it should be noted that the discussion of the above any embodiment is only exemplary, and is not intended to imply that the scope (including claims) of the utility model embodiment disclosed is limited to these examples, and various changes and modifications can be made without departing from the scope defined by the claims. In addition, although the elements of the utility model embodiment disclosed can be described or claimed in individual form, they can also be understood as plural unless explicitly limited to singular.

[0078] Those skilled in the art should understand that the discussion of any embodiment above is only exemplary, and is not intended to imply that the scope (including claims) of the utility model embodiment disclosed is limited to these examples; under the idea of the utility model embodiment, the technical features in the above embodiment or different embodiments can also be combined, and there are many other changes of different aspects of the utility model embodiment as described above. In order to be brief, they are not provided in details. Therefore, any omission, modification, equivalent replacement, improvement, etc. made within the spirit and principle of the utility model embodiment should be included in the protection scope of the utility model embodiment.

Claims

1. An implantable neuromuscular stimulation electrode, characterized by, The stimulation electrode comprises a longitudinally extending insulation base body, the insulation base body is sequentially provided with a stimulation section, a transition section and a lead section along a longitudinal extension direction, wherein the stimulation section is provided in a flat shape, the lead section is provided in a cylindrical shape, the transition section smoothly connects the stimulation section and the lead section, and the stimulation section, the transition section and the lead section respectively have a first cross section, a second cross section and a third cross section perpendicular to the longitudinal extension direction, and the second cross section has a cross-sectional area determined based on cross-sectional areas of the first cross section and the third cross section.

2. The implantable neuromuscular stimulation electrode of claim 1, wherein, In the case that the cross-sectional areas of the first cross section and the third cross section are equal, the cross-sectional area of the second cross section floats within a range of ±10% of the cross-sectional areas of the first cross section and the third cross section.

3. The implantable neuromuscular stimulation electrode of claim 2, wherein, In the case that the cross-sectional areas of the first cross section and the third cross section are equal, the cross-sectional area of the second cross section is equal to the cross-sectional areas of the first cross section and the third cross section.

4. The implantable neuromuscular stimulation electrode of claim 1, wherein, In the case that the cross-sectional areas of the first cross section and the third cross section are not equal, the cross-sectional area of the second cross section is determined based on a linear interpolation result of the cross-sectional areas of the first cross section and the third cross section.

5. The implantable neuromuscular stimulation electrode of claim 4, wherein, In the case that the cross-sectional areas of the first cross section and the third cross section are not equal, the cross-sectional area of the second cross section floats within a range of ±10% of the linear interpolation result of the cross-sectional areas of the first cross section and the third cross section.

6. The implantable neuromuscular stimulation electrode according to any one of claims 1-5, wherein, The stimulation section, the transition section and the lead section of the insulation base body are integrally formed.

7. The implantable neuromuscular stimulation electrode according to any one of claims 1-5, wherein, One or more of the following are included: The first cross section is a flat circle or a square, the third cross section is a circle or a near circle, and the second cross section gradually changes from a circle or a near circle to a flat circle or a square; The thickness of the stimulation section is between 0.1 mm and 0.7 mm, the length is less than 10 mm, and the width is less than 10 mm; The diameter of the lead section is between 0.5 mm and 2.0 mm; The length of the transition section is between 1 mm and 10 mm; The stimulation section has a flat upper surface and a lower surface, the part of the transition section adjacent to the stimulation section has a top surface and a bottom surface, the top surface is provided as a plane or a curved surface extending obliquely towards the upper surface, and the bottom surface is provided as a plane or a curved surface extending obliquely towards the lower surface.

8. The implantable neuromuscular stimulation electrode of claim 1, wherein, The insulation base body comprises at least one fixing portion for fixing the stimulation electrode, at least one fixing portion comprises at least one first fixing portion provided in the stimulation section and at least one second fixing portion provided in the transition section, and the second fixing portion is in a semicircular shape or an inverted triangular shape.

9. The implantable neuromuscular stimulation electrode of claim 8, wherein, The distance between the second fixing portion and the nearest first fixing portion is 6-12 mm.

10. An implantable neuromuscular stimulation system, characterized by It comprises: a stimulator; and The implantable neuromuscular stimulation electrode of any one of claims 1-9, the lead section of the implantable neuromuscular stimulation electrode is connected to the stimulator. ​

Images