Implantable nerve stimulation electrode and implantable hypoglossal nerve stimulation system

Abstract

The embodiment of the invention discloses an implantable nerve stimulation electrode and an implantable hypoglossal nerve stimulation system. The implantable nerve stimulation electrode comprises a base, a first rolling arm, a second rolling arm and a skeleton. A stimulation contact is arranged on the inner side of the base, the first rolling arm is curled and extends from one end of the base and is matched with the base to form a sleeve hole, the second rolling arm is curled and extends from the other end of the base and wraps the outer side of the first rolling arm, and the framework comprises a first framework arranged in the first rolling arm and a second framework arranged in the second rolling arm. The rigidity of the first framework is larger than that of the first rolling arm. The rigidity of the second framework is larger than that of the second rolling arm. Therefore, through the arrangement of the skeleton, the whole structure of the implantable nerve stimulation electrode is rigid inside and soft outside, the thickness, the implant size and foreign body sensation can be reduced under the condition of maintaining the function and performance requirements, and meanwhile, the implantable nerve stimulation electrode is also beneficial to improving the restoring force and enhancing the coating and fixing effects on a target nerve.

Description

Technical Field

[0001] The present invention relates to the technical field of implantable medical devices, and in particular to an implantable nerve stimulation electrode and an implantable hypoglossal nerve stimulation system. Background Art

[0002] Implantable medical devices collect human physiological information and deliver stimulating electrical pulses to monitor the body's condition, treat, and improve symptoms of related diseases. In order to obtain the best stimulation effect, it is necessary to ensure that the stimulating electrode is in reliable contact with the target nerve. The sleeve electrode is an electrode that can be placed on the target nerve and achieve nerve stimulation or signal perception through contacts arranged inside the sleeve. The sleeve electrode is limited by the use environment of the implant in the body, and has certain requirements for material stability and biocompatibility, and the range of material selection is small. The existing sleeves are overall changeable and have low restoring force. The clamping force formed on the nerve is small, and it is easy to shift, resulting in a poor stimulation effect. Summary of the invention

[0003] In view of this, the purpose of the present invention is to provide an implantable nerve stimulation electrode and an implantable hypoglossal nerve stimulation system, which can realize an overall structure that is rigid inside and flexible outside by setting a skeleton, and can reduce the thickness of the cuff, reduce the size of the implant, and reduce the foreign body sensation while maintaining the requirements of function and performance.

[0004] In a first aspect, an embodiment of the present invention provides an implantable neural stimulation electrode, comprising:

[0005] A base, wherein a stimulation contact is provided on an inner side of the base;

[0006] A first rolling arm, which is curled and extended from one end of the base and cooperates with the base to form a sleeve hole;

[0007] a second rolling arm, the second rolling arm curlingly extending from the other end of the base and covering the outer side of the first rolling arm; and

[0008] The skeleton comprises a first skeleton arranged in the first winding arm and / or a second skeleton arranged in the second winding arm, the rigidity of the first skeleton is greater than that of the first winding arm, and the rigidity of the second skeleton is greater than that of the second winding arm.

[0009] In some embodiments, the first frame is located at a middle position in the first reel arm or at a side of the first reel arm away from the sleeve hole;

[0010] The second frame is located at a middle position in the second rolling arm or at a side of the second rolling arm away from the sleeve hole.

[0011] In some embodiments, the skeleton further comprises:

[0012] A third frame is disposed in the base and connected to the first frame and the second frame.

[0013] In some embodiments, the backbone comprises:

[0014] Borders; and

[0015] A grid frame is arranged in the area surrounded by the frame, the thickness of the grid frame is between 0.2 mm and 0.5 mm, and the opening rate is between 20% and 80%.

[0016] In some embodiments, the base, the first rolling arm, and the second rolling arm are made of elastic material, and the frame is made of elastic material or shape memory material.

[0017] In some embodiments, the implantable neural stimulation electrode further comprises:

[0018] A wire, a first end of which is provided with the base;

[0019] A connector is disposed at the second end of the wire.

[0020] In some embodiments, at least one first fixing member is further included, which is slidably disposed on the wire, and a center hole is provided on the first fixing member to form a cylindrical structure. The first fixing member is sleeved on the wire through the center hole, and an annular groove is provided on the outer wall of the first fixing member along the circumferential direction, and a gap connecting to the center hole is provided on the outer wall of the first fixing member along the axial direction.

[0021] In some embodiments, at least one second fixing member is further included, and the second fixing member is slidably disposed on the wire, and the second fixing member includes:

[0022] A main body, wherein the main body is provided with a through hole for sleeved on the wire;

[0023] a first flange extending outwardly from the main body; and

[0024] A second flange extends outward from the main body and has a gap between the second flange and the first flange.

[0025] In some embodiments, the wire comprises a stranded conductor;

[0026] The skeleton is made of a shape memory alloy material, and the skeleton is connected to the wire conductor so as to be connected to an implantable neural stimulator through the wire conductor.

[0027] In a second aspect, an embodiment of the present invention provides an implantable neural stimulation system, the implantable neural stimulation system comprising:

[0028] Implantable neurostimulators; and

[0029] The above-mentioned implantable neural stimulation electrode is connected to the implantable neural stimulator via a connector;

[0030] The implantable neural stimulator is provided with an inertial sensor and / or is externally connected with a breathing detection element, and the breathing detection element is connected to the implantable neural stimulator.

[0031] The embodiment of the present invention provides an implantable nerve stimulation electrode and an implantable hypoglossal nerve stimulation system, including a base, a first roll arm, a second roll arm and a frame. Among them, a stimulation contact is arranged on the inner side of the base, the first roll arm is curled and extended from one end of the base and cooperates with the base to form a sleeve hole, part of the stimulation contact is located in the sleeve hole, the second roll arm is curled and extended from the other end of the base and wrapped around the outer side of the first roll arm, and the frame includes a first frame arranged in the first roll arm and a second frame arranged in the second roll arm, the first frame has a greater rigidity than the first roll arm, and the second frame has a greater rigidity than the second roll arm. Thus, the electrode is provided with a frame so that the overall structure is rigid inside and soft outside, and the thickness can be reduced, the implant size can be reduced, and the foreign body sensation can be reduced while maintaining the requirements of function and performance. At the same time, it is also beneficial to improve the restoring force and enhance the covering and fixing effect on the target nerve. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The above and other objects, features and advantages of the present invention will become more apparent through the following description of the embodiments of the present invention with reference to the accompanying drawings, in which:

[0033] Figure 1 is a partial structural schematic diagram of an implantable neural stimulation electrode provided by an embodiment of the present invention;

[0034] Figure 2 is a partial longitudinal cross-sectional schematic diagram of an implantable neural stimulation electrode provided by an embodiment of the present invention;

[0035] Figure 3 is a partial cross-sectional schematic diagram of an implantable neural stimulation electrode provided by an embodiment of the present invention;

[0036] Figure 4 is a schematic diagram of a partial internal structure of an implantable neural stimulation electrode provided by an embodiment of the present invention;

[0037] Figure 5 is a schematic diagram of an expanded structure of a skeleton provided by an embodiment of the present invention;

[0038] Figure 6is a partial cross-sectional schematic diagram of another implantable neural stimulation electrode provided by an embodiment of the present invention;

[0039] Figure 7 is a schematic diagram of the structure of another skeleton provided by an embodiment of the present invention;

[0040] Figure 8 is a schematic diagram of an arrangement of stimulation contacts provided by an embodiment of the present invention;

[0041] Fig. 9 is a schematic diagram of another arrangement of stimulation contacts provided by an embodiment of the present invention;

[0042] Fig.10 is a schematic diagram of another arrangement of stimulation contacts provided by an embodiment of the present invention;

[0043] Fig.11 is a schematic structural diagram of an implantable neural stimulation electrode provided by an embodiment of the present invention;

[0044] Fig.12 is a schematic structural diagram of a first fixing member provided in an embodiment of the present invention;

[0045] Fig.13 is a schematic structural diagram of another implantable neural stimulation electrode provided by an embodiment of the present invention;

[0046] Fig.14 is a schematic structural diagram of a second fixing member provided in an embodiment of the present invention;

[0047] Fig.15 is a schematic diagram of a use state of an implantable neural stimulation system provided by an embodiment of the present invention;

[0048] Fig.16 It is a schematic diagram of the usage status of another implantable neural stimulation system provided by an embodiment of the present invention.

[0049] Description of reference numerals:

[0050] 1-stimulation part; 11-base; 111-stimulation contact; 112-first joint part; 113-second joint part; 12-first roll arm; 13-hole; 14-second roll arm; 15-skeleton; 151-first skeleton; 152-second skeleton; 153-third skeleton; 154-frame; 155-grid frame; 2-wire; 3-connector; 4-first fixing member; 4'-second fixing member; 41-center hole; 42-annular groove; 43-gap; 44-main body; 441-through hole; 45-first flange; 46-second flange; 47-gap; A-implantable neural stimulation electrode; B-implantable neural stimulator; C-respiration detection element; N-target nerve. DETAILED DESCRIPTION

[0051] The present application is described below based on embodiments, but the present application is not limited to these embodiments. In the detailed description of the present application below, some specific details are described in detail. It is possible for those skilled in the art to fully understand the present application without the description of these details. In order to avoid confusing the essence of the present application, known methods, processes, flows, components and circuits are not described in detail.

[0052] In addition, persons of ordinary skill in the art will appreciate that the drawings provided herein are for illustration purposes and are not necessarily drawn to scale.

[0053] Unless otherwise clearly defined and specified, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0054] For ease of explanation, spatially relative terms such as "inside", "outside", "below", "below", "lower", "above", "upper", etc. are used herein to describe the relationship of one element or feature illustrated in the figures to another element or feature. It will be understood that spatially relative terms may be intended to include different orientations of the device in use or operation other than the orientation depicted in the figures. For example, if the device in the figure is turned over, an element described as being "below" or "below" other elements or features will then be positioned as being "above" the other elements or features. Thus, the example term "below" can include both the orientations of above and below. The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially relative descriptors used herein should be interpreted accordingly.

[0055] Unless the context clearly requires otherwise, the words "include", "comprising" and similar words throughout the application should be interpreted as including rather than exclusive or exhaustive; that is, the meaning is "including but not limited to".

[0056] In the description of this application, it should be understood that the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. In addition, in the description of this application, unless otherwise specified, the meaning of "plurality" is two or more.

[0057] Figure 1 is a schematic diagram of the structure of an implantable neural stimulation electrode provided by an embodiment of the present invention, such as Figure 1 As shown, the implantable neural stimulation electrode includes a stimulation part 1, which includes a base 11, a first roll arm 12, a second roll arm 14 and a frame 15. In the figure, part of the roll arm is made transparent to show part of the internal frame 15. Further, Figure 2 It is a partial longitudinal cross-sectional schematic diagram of an implantable neural stimulation electrode provided by an embodiment of the present invention. Figure 3 It is a partial transverse cross-sectional schematic diagram of an implantable neural stimulation electrode provided by an embodiment of the present invention. Figure 4 It is a schematic diagram of a portion of the internal structure of an implantable neural stimulation electrode provided in an embodiment of the present invention.

[0058] Combination Figures 1 to 4 As shown, a stimulation contact 111 is provided inside the base 11, a first roll arm 12 is curled and extended from one end of the base 11 and cooperates with the base 11 to form a sleeve hole 13, and a second roll arm 14 is curled and extended from the other end of the base 11 and covers the outside of the first roll arm 12. Furthermore, the frame 15 includes a first frame 151 and a second frame 152, the first frame 151 is arranged in the first roll arm 12 and has the same curling degree as the first roll arm 12, and the second frame 152 is arranged in the second roll arm 14 and has the same curling degree as the second roll arm 14. Figure 4 As shown, the first skeleton 151 passes through the first joint 112 between the base 11 and the first roll arm 12 from one end of the base 11, and the second skeleton 152 passes through the second joint 113 between the base 11 and the second roll arm 14 from the other end of the base 11. The material rigidity of the skeleton 15 is greater than that of the base 11, the first roll arm 12, and the second roll arm 14, ensuring that the rigidity of the first skeleton 151 is greater than that of the first roll arm 12, and the rigidity of the second skeleton 152 is greater than that of the second roll arm 14. Thus, the implantable neural stimulation electrode is provided with the skeleton 15 so that the overall structure is rigid inside and flexible outside. While maintaining the requirements of function and performance, the thickness of the roll arm can be reduced, the size of the implant can be reduced, and the foreign body sensation can be reduced. At the same time, it is also beneficial to improve the restoring force and enhance the covering and fixing effect on the target nerve N. In some other embodiments, only the first skeleton 151 or the second skeleton 152 can also be provided, which can also enhance the covering and fixing effect on the target nerve N.

[0059] Figure 5 is a schematic diagram of the unfolded structure of a skeleton provided by an embodiment of the present invention, such as Figure 5As shown, in one embodiment, the skeleton 15 includes a frame 154 and a grid frame 155. It should be noted that, corresponding to the split structure of the first skeleton 151 and the second skeleton 152, the first skeleton 151 and the second skeleton 152 are respectively composed of a frame 154 and a grid frame 155, and the difference between the first skeleton 151 and the second skeleton 152 is the length. The specific length can be set according to the roll arm. Specifically, the frame 154 is set as a rectangular outer frame structure, and the grid frame 155 is set in the area surrounded by the frame 154. Furthermore, the grid frame 155 is composed of a plurality of regular hexagonal cells arranged in a honeycomb structure, thereby improving the structural stability of the skeleton 15. On the other hand, the skeleton 15 can achieve the maximum coverage area while using the same amount of material by setting the grid frame 155. It should be further noted that the mesh shape and density of the grid frame 155 can be adjusted according to the material and stiffness requirements of the skeleton 15. In the present invention, the thickness of the grid frame 155 is between 0.2mm and 1mm. If the grid frame 155 is too thin, the curling shape of the coiled arm will be poorly maintained, and the coating and fixation effect on the target nerve N will be weak. If it is too thick, the thickness of the coiled arm will increase, which is not conducive to the miniaturization of the electrode, and the foreign body sensation will be obvious after implantation into the human body. The mesh is a regular hexagon, which has six axes of symmetry and can maintain its shape after bending, thereby providing structural stability. The opening rate of the grid frame 155 is between 20% and 80%. When the thickness of the grid frame 155 is between 0.2mm and 0.5mm, the opening rate is preferably between 20% and 60%. When the hypoglossal nerve is stimulated, coated and fixed, the stress distribution of the skeleton 15 is more uniform, the overall bearing capacity is strong, it is not easy to deform, and it is closely attached to the nerve, avoiding tissue aggregation between the nerve and the electrode, thereby ensuring the effectiveness of the stimulation.

[0060] Figure 6 is a partial cross-sectional schematic diagram of another implantable neural stimulation electrode provided by an embodiment of the present invention, combined with Figure 6 and Figure 7 As shown, in one embodiment, the frame 15 further includes a third frame 153, and the third frame 153 is disposed in the base 11. Further, the third frame 153 is integrally formed with the first frame 151 and the second frame 152. It should be noted that, corresponding to the integrated structure of the frame 15, the frame 15 as a whole is composed of a frame 154 and a grid frame 155. Figure 6 , 7 The skeleton shown is relative to Figure 1-5 The length of the frame shown is increased so that the frame passes through the base 11, and the first frame 151 and the second frame 152 are connected by a third frame.

[0061] It should be noted that, in one embodiment, the base 11, the first roll arm 12, and the second roll arm 14 are made of elastic material. For example, the base 11, the first roll arm 12, and the second roll arm 14 are made of materials such as silicone rubber or polyurethane rubber. Further, the material rigidity of the skeleton 15 is greater than that of the base 11, the first roll arm 12, and the second roll arm 14. For example, the skeleton 15 is made of materials such as polyetheretherketone, polyurethane fiber, polyethylene terephthalate, or polyimide.

[0062] It should be noted that the skeleton 15 is made of an elastic material or a shape memory material. In one embodiment, the skeleton 15 is made of a shape memory material by injection molding or weaving. Optionally, the skeleton 15 is made of a shape memory alloy or a shape memory polymer material, so that the curling and retraction can be maintained at human body temperature. The strength of the material of the skeleton 15 is greater than the strength of the coil arm material. A thinner skeleton 15 can obtain sufficient rigidity, so that the implantable neural stimulation electrode covers and fixes the target nerve N, thereby improving the fixation effect on the target nerve N.

[0063] It should be noted that, in one embodiment, the first skeleton 151 is located at the middle position of the first coiled arm 12 or at the side of the first coiled arm 12 away from the ferrule 13, and the second skeleton 152 is located at the middle position of the second coiled arm 14 or at the side of the second coiled arm 14 away from the ferrule 13. As a result, the wall thickness of the elastic material on the side of the first coiled arm 12 and the second coiled arm 14 close to the target nerve N is relatively thicker. Optionally, the third skeleton 153 is located at the middle position of the base 11 or at the side of the base 11 away from the ferrule 13. As a result, the wall thickness of the elastic material on the side of the base 11 close to the target nerve N is relatively thicker.

[0064] It should be noted that the implantable neural stimulation electrode provided in the embodiment of the present invention forms a composite structure by providing a skeleton 15. Compared with the existing sleeve electrode without the skeleton 15, the first roll arm 12 and the second roll arm 14 only need a thinner thickness to ensure the overall rigidity and dimensional stability, while also obtaining good restoring force. Therefore, it helps to reduce the external dimensions of the implantable neural stimulation electrode and reduce the foreign body sensation, while helping to enhance the clamping and fixing effect of the implantable neural stimulation electrode, thereby achieving the improvement and maintenance of therapeutic effect.

[0065] Figure 8 is a schematic diagram of an arrangement of stimulation contacts provided by an embodiment of the present invention, such as Figure 8 As shown, in one embodiment, a plurality of stimulation contacts 111 are disposed on the base 11 and arranged in a straight line. Specifically, the plurality of stimulation contacts 111 are configured into three groups, each group having one stimulation contact 111 and arranged at intervals along a straight line.

[0066] Fig. 9FIG. 1 is a schematic diagram of another arrangement of stimulation contacts provided by an embodiment of the present invention. Fig. 9 As shown, in one embodiment, a plurality of stimulation contacts 111 are arranged in a cross shape. Specifically, the plurality of stimulation contacts 111 are configured into three groups, and the number of stimulation contacts 111 in the three groups is set to one, three and one, respectively, and arranged alternately to form a cross shape. Three stimulation contacts 111 are arranged as a group of middle contacts on the base 11, and the other two stimulation contacts 111 are respectively arranged on the first roll arm 12 and the second roll arm 14 as the side wall of the sleeve hole 13. It can be understood that in this example, the first roll arm 12 is not completely enclosed with the base 11.

[0067] Fig.10 FIG. 1 is another schematic diagram of the arrangement of stimulation contacts provided by an embodiment of the present invention. Fig.10 As shown, in one embodiment, a plurality of stimulation contacts 111 are arranged in a rectangular arrangement. Specifically, the plurality of stimulation contacts 111 are configured into three groups, each group having three stimulation contacts 111 arranged alternately to form a rectangle. The middle stimulation contact of each group is arranged on the base 11, and the other two stimulation contacts 111 in each group are respectively arranged on the first roll arm 12 and the second roll arm 14 as the side wall of the sleeve hole 13.

[0068] Fig.11 is a schematic diagram of the structure of an implantable neural stimulation electrode provided by an embodiment of the present invention, such as Fig.11 As shown, the implantable neural stimulation electrode A includes a stimulation part 1, a wire 2, a connector 3 and at least one first fixing part 4. Among them, the specific structure of the stimulation part 1 is as described above and will not be repeated here. Furthermore, the stimulation part 1 is arranged at the first end of the wire 2, the connector 3 is arranged at the second end of the wire 2, and the stimulation contact 111 on the stimulation part is connected to the connector 3 through the wire. Furthermore, the first fixing part 4 is slidably arranged on the wire 2, and the number of the first fixing parts 4 can be set as needed. It should be noted that the stimulation part 1 is sleeved on the target nerve N, and the stimulation contact 111 can contact the target nerve N to apply electrical stimulation or detect neural electrical signals. On the other hand, the first fixing part 4 is used to fix and sew the implantable neural stimulation electrode A to the tissue.

[0069] Fig.12 is a schematic structural diagram of a first fixing member provided in an embodiment of the present invention, such as Fig.12As shown, in one embodiment, the first fixing member 4 is configured as a cylindrical structure, that is, a center hole 41 is provided on the first fixing member 4. Optionally, the two ends of the first fixing member 4 are configured as a truncated cone structure. It is easy to understand that the first fixing member 4 is sleeved on the wire 2 through the center hole 41, so that it can slide along the wire 2. Further, an annular groove 42 is circumferentially provided on the outer wall of the first fixing member 4. Optionally, there are two annular grooves 42 and they are spaced apart from each other. Thus, the doctor can adjust the relative position of the first fixing member 4 according to the anatomical characteristics of the patient during the operation, and use sutures to fix and sew the implantable neural stimulation electrode A to the tissue at the annular groove 42. Furthermore, a gap 43 connecting the center hole 41 is axially provided on the outer wall of the first fixing member 4 so as to be sleeved on the wire 2.

[0070] Fig.13 is a schematic structural diagram of another implantable neural stimulation electrode provided by an embodiment of the present invention, Fig.14 is a schematic diagram of the structure of the second fixing member provided in an embodiment of the present invention, Fig.13 and Fig.14 As shown, in one embodiment, the second fixing member 4' includes a main body 44, a first flange 45 and a second flange 46. Specifically, the main body 44 is provided with a through hole 441 with an opening on the circumference so as to be sleeved on the wire 2, and the second fixing member 4' can slide along the wire 2. Further, the first flange 45 extends outward from one side of the main body 44, and the second flange 46 extends outward from the other side of the main body 44 and has a gap 47 between the first flange 45. Optionally, the first flange 45 and the second flange 46 are integrally configured as a triangular prism structure and the tip is rounded. Thus, the doctor can adjust the second fixing member 4' to a suitable position during the operation, and then use a suture needle and suture thread to partially sew the first flange 45 and the second flange 46 to the tissue to achieve the fixation of the implantable neural stimulation electrode A, and at the same time, the two opposite sides of the first flange 45 and the second flange 46 are fitted together to close the opening to ensure the connection reliability.

[0071] Furthermore, a mesh metal shielding layer (not shown) is provided on the outer peripheral side of the wire 2 of the present invention, and the mesh metal shielding layer weakens the induced current generated by the wire being excited by the radio frequency magnetic field in MRI, thereby suppressing the heat generation at the stimulation contact 111.

[0072] Fig.15 It is a schematic diagram of the use status of an implantable neural stimulation system provided by an embodiment of the present invention. The implantable neural stimulation system includes an implantable neural stimulation electrode A and an implantable neural stimulator B. Optionally, the implantable neural stimulator B is configured as a pulse generator. It should be noted that the specific structure of the implantable neural stimulation electrode A is as described above and will not be repeated here. Furthermore, the implantable neural stimulation electrode A is connected to the implantable neural stimulator B via a connector 3.

[0073] like Fig.15 As shown, the stimulation system of the present invention is an implantable hypoglossal nerve stimulation system, the implantable nerve stimulation electrode A is fixed on the hypoglossal nerve, and the stimulation signal generated by the implantable nerve stimulator B can be transmitted to the stimulation contact 111 via the implantable nerve stimulation electrode A to achieve stimulation of the hypoglossal nerve, thereby achieving the purpose of treating obstructive sleep apnea. Optionally, the stimulation signal is generated at the beginning of inspiration and ends at the beginning of exhalation, that is, synchronized with the inspiration phase.

[0074] It should be noted that, in one embodiment, an inertial sensor is provided in the implantable neurostimulator B. Specifically, an acceleration sensor and / or a gyroscope is provided in the implantable neurostimulator B, and the judgment of the inhalation phase can be realized by judging the sensing signals of the acceleration sensor and the gyroscope separately or in combination, so as to achieve the treatment purpose of the implantable neurostimulation system.

[0075] Fig.16 FIG. 1 is a schematic diagram of another implantable neural stimulation system in use according to an embodiment of the present invention. Fig.16 As shown, the stimulation system of the present invention is an implantable hypoglossal nerve stimulation system, including a breathing detection element C. Specifically, the breathing detection element C is a breathing detection electrode, which is connected to an implantable neurostimulator B and is used to detect the breathing state. The implantable neurostimulator B generates a stimulation signal in the inhalation phase according to the detection signal of the breathing detection element C and transmits it to the stimulation contact 111, thereby achieving the purpose of treatment.

[0076] It should be noted that, in one embodiment, the breathing detection element C includes a pressure sensor or a bioimpedance sensor. It is easy to understand that the pressure sensor can detect the fluctuation of the chest or abdomen of the human body during breathing to determine the breathing state, and the bioimpedance sensor can detect the breathing state according to the impedance change of the human body during breathing.

[0077] The embodiment of the present invention provides an implantable nerve stimulation electrode and an implantable hypoglossal nerve stimulation system, including a base, a first roll arm, a second roll arm and a frame. Among them, stimulation contacts can be set on the inner sides of the base, the first roll arm and the second roll arm, the first roll arm is curled and extended from one end of the base and cooperates with the base to form a sleeve hole, and part of the stimulation contact is located in the sleeve hole, the second roll arm is curled and extended from the other end of the base and covered on the outer side of the first roll arm, and the frame includes a first frame arranged in the first roll arm and a second frame arranged in the second roll arm, and the material rigidity of the frame is greater than that of the base, the first roll arm and the second roll arm. Therefore, the implantable nerve stimulation electrode is provided with a frame so that the overall structure is rigid inside and soft outside, and the thickness can be reduced, the implant size can be reduced, and the foreign body sensation can be reduced while maintaining the requirements of function and performance. At the same time, it is also beneficial to improve the restoring force and enhance the covering and fixing effect on the hypoglossal nerve.

[0078] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. An implantable neural stimulation electrode, characterized in that: include: A base (11), wherein a stimulation contact (111) is provided on the inner side of the base (11); A first rolling arm (12), the first rolling arm (12) is curled and extended from one end of the base (11), and cooperates with the base (11) to form a sleeve hole (13); A second rolling arm (14), the second rolling arm (14) is curled and extended from the other end of the base (11) and wrapped around the outer side of the first rolling arm (12); and A skeleton (15), wherein the skeleton (15) comprises a first skeleton (151) arranged in the first reel (12) and / or a second skeleton (152) arranged in the second reel (14), wherein the rigidity of the first skeleton (151) is greater than that of the first reel (12), and the rigidity of the second skeleton (152) is greater than that of the second reel (14).

2. The implantable neural stimulation electrode according to claim 1, characterized in that: The first frame (151) is located at a middle position in the first rolling arm (12) or at a side of the first rolling arm (12) away from the sleeve hole (13); The second frame (152) is located at a middle position in the second rolling arm (14) or at a side of the second rolling arm (14) away from the sleeve hole (13).

3. The implantable neural stimulation electrode according to claim 1, characterized in that: The skeleton (15) further comprises: A third frame (153), wherein the third frame (153) is disposed in the base (11) and is connected to the first frame (151) and the second frame (152).

4. The implantable neural stimulation electrode according to claim 1, characterized in that: The skeleton (15) comprises: a border (154); and A grid frame (155), wherein the grid frame (155) is arranged in the area surrounded by the frame (154), the thickness of the grid frame (155) is between 0.2 mm and 0.5 mm, and the opening rate is between 20% and 80%.

5. The implantable neural stimulation electrode according to claim 1, characterized in that: The base (11), the first rolling arm (12) and the second rolling arm (14) are made of elastic material, and the frame (15) is made of elastic material or shape memory material.

6. The implantable neural stimulation electrode according to claim 1, characterized in that: Also includes: A wire (2), wherein the base (11) is disposed at a first end of the wire (2); A connector (3), the connector (3) being arranged at the second end of the wire (2).

7. The implantable neural stimulation electrode according to claim 6, characterized in that: It also comprises at least one first fixing member (4), wherein the first fixing member (4) is slidably arranged on the wire (2); The first fixing member (4) is provided with a center hole (41) to form a cylindrical structure. The first fixing member (4) is sleeved on the wire (2) through the center hole (41). An annular groove (42) is provided on the outer wall of the first fixing member (4) along the circumferential direction. A gap (43) communicating with the center hole (41) is provided on the outer wall of the first fixing member (4) along the axial direction.

8. The implantable neural stimulation electrode according to claim 6, characterized in that: It also comprises at least one second fixing member (4'), wherein the second fixing member (4') is slidably arranged on the wire (2); The second fixing member (4') comprises: A main body (44), wherein the main body (44) is provided with a through hole (441) for sleeve-mounting on the wire (2); a first flange (45), the first flange (45) extending outward from the main body (44); and A second flange (46), the second flange (46) extends outward from the main body (44) and has a gap (47) between the second flange (46) and the first flange (45).

9. The implantable neural stimulation electrode according to claim 6, characterized in that: The wire (2) comprises a plurality of strands of conductors; The skeleton (15) is made of a shape memory alloy material, and the skeleton (15) is connected to the wire conductor so as to be connected to an implantable neural stimulator through the wire conductor.

10. An implantable neural stimulation system, characterized in that: The implantable neural stimulation system comprises: Implantable neurostimulators (B); and The implantable neural stimulation electrode (A) according to any one of claims 1 to 9, wherein the implantable neural stimulation electrode (A) is connected to the implantable neural stimulator (B) via a connector (3); The implantable neural stimulator (B) is provided with an inertial sensor and / or is externally connected with a breathing detection element (C), and the breathing detection element (C) is connected to the implantable neural stimulator (B).

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