Tibial nerve stimulator

Abstract

A tibial nerve stimulator comprises a stimulating chip, a ceramic substrate composed of several ceramic pieces, a metal ring, a metal cover and several stimulating electrodes; the stimulating electrodes are located under the ceramic substrate, the ceramic substrate is connected with the metal cover through the metal ring; the stimulating chip is in a sealed cavity surrounded by the ceramic substrate, the metal ring and the metal cover, and is electrically connected with the metal cover; each ceramic piece is provided with the same number of through holes as the number of electrodes, and the through holes on different ceramic pieces do not overlap in projection; the stimulating electrodes are electrically connected with the stimulating chip through the through holes. Through the projection non-overlapping through holes, the liquid in the implant environment is prevented from penetrating into the sealed cavity surrounded by the ceramic substrate, the metal ring and the metal cover to cause damage to the electronic devices.

Description

Technical Field

[0001] This patent belongs to the field of medical devices, specifically relating to an implantable tibial nerve stimulation package. Background Technology

[0002] Overactive bladder (OAB) is a chronic disease with a prevalence of approximately 17% between men and women, showing no significant difference in incidence. Its prevalence increases with age and is associated with multiple chronic diseases, severely impacting patients' quality of life, work efficiency, and mental and physical health, while also increasing the socioeconomic burden. Treatment for OAB typically employs a three-line approach (behavioral therapy, drug therapy, and surgical treatment), with neuromodulation surgery being particularly suitable for patients with severe OAB. Implantable tibial nerve stimulators (TNS), primarily composed of an implant and an external control system, offer less invasiveness and lower maintenance costs compared to sacral nerve stimulation (SNS) for OAB treatment. Previously, due to the lack of implantable tibial nerve stimulators, patients could only be treated with sacral nerve stimulators. Sacral nerve stimulator treatment often resulted in numerous complications and a high rate of secondary surgeries. Furthermore, the complexity, invasiveness, and cost of sacral nerve stimulation therapy (such as the usual need for general anesthesia after a trial period and ongoing patient and device management) deterred many patients from undergoing the procedure. Currently, there are research reports on leadless implantable tibial nerve stimulators. Patent CN117101000 discloses a leadless tibial nerve stimulator that uses a metal ring feedthrough welded to a base metal, with the metal ring feedthrough composed of insulating material and metal. However, in active implantation practice, medical device electronic packaging substrates often develop cracks at the feedthrough edges where dissimilar materials meet, leading to failure and leakage, and posing a risk to the reliability of the shell seal. This patent aims to provide a novel, highly reliable ceramic-metal packaging structure, employing multi-layer lamination technology to prepare the electrode feedthrough channels, isolating moisture, and using semiconductor processing to form electrode materials capable of withstanding injected charge density, providing flexible and selectable stimulation channels and multi-directional selectable electric field therapy pathways to meet clinical treatment needs. Patent Content: This patent aims to provide a highly sealed tibial nerve stimulator that simultaneously achieves flexible and selectable stimulation channels and multi-directional selectable electric field therapy pathways. Utility Model Content

[0003] To achieve the above effects, the technical solution adopted in this patent is as follows: a tibial nerve stimulator, including a stimulation chip, a ceramic substrate composed of several ceramic sheets, a metal ring, a metal cap, and several stimulation electrodes; the stimulation electrodes are located below the ceramic substrate, and the ceramic substrate is connected to the metal cap through the metal ring; the stimulation chip is located within a sealed cavity formed by the ceramic substrate, the metal ring, and the metal cap, and is electrically connected to the metal cap; each ceramic sheet has the same number of through holes as the number of electrodes, and the through holes on different ceramic sheets do not overlap in projection; the stimulation electrodes are electrically connected to the stimulation chip through the through holes. The non-overlapping through holes prevent liquid from the implantation environment from seeping into the sealed cavity formed by the ceramic substrate, the metal ring, and the metal cap, thus avoiding damage to the electronic device.

[0004] Preferably, each through-hole is filled with a filling slurry, and a laminated slurry is provided between the ceramic sheets; the filling slurries on different ceramic sheets are electrically connected to the filling slurries on other ceramic sheets through the laminated slurry; the stimulation electrode is electrically connected to the stimulation chip through the filling slurry and the laminated slurry. The laminated slurry diffuses on the ceramic sheets, and after being laminated and sintered together between the ceramic sheets, it does not affect the sealing performance and achieves conductivity.

[0005] Preferably, the filling slurry and laminating slurry are made of platinum. Platinum possesses both biocompatibility and electrical conductivity. Preferably, the metal cap and several stimulation electrodes form a circuit loop; the metal cap serves as one pole of the circuit loop, and the stimulation electrodes together serve as the other pole. Using the metal cap as one pole of the circuit simplifies the circuit device structure and reduces fabrication difficulty.

[0006] Preferably, the metal ring and metal cap can be made of medical-grade metal materials such as titanium and stainless steel. Titanium and stainless steel possess both biocompatibility and electrical conductivity.

[0007] Preferably, the surfaces of the metal ring and the metal cap are coated with a platinum, iridium oxide, or a composite coating of platinum and iridium oxide. The composite coating serves as a surface modification to increase charge capacity.

[0008] Preferably, the metal ring and metal cap are further coated with an inorganic insulating layer on a portion of their surface or the surface of a portion of the composite coating. This inorganic insulating layer is at least one of silicon oxide, silicon nitride, aluminum oxide, and silicon carbide. Alternatively, the metal ring and metal cap are further coated with an organic insulating layer on a portion of their surface or the surface of a portion of the composite coating. This organic insulating layer includes at least one of polyimide, pyrene, and polytetrafluoroethylene. Or, a composite structure is formed where the metal ring and metal cap are further coated with both inorganic and organic insulating layers on a portion of their surface or the surface of a portion of the composite coating. By covering the surface of the metal cap, which serves as the electrode, with insulating material, the shape and area of ​​the electrode are adjusted, thereby obtaining an ideal charge flow direction and distribution. Attached Figure Description

[0009] Figure 1 is a schematic diagram of one structure of the metal cover of this patent; Figure 2 is a schematic diagram of one structure of the metal ring of this patent; Figure 3 is a schematic diagram of a structure of the sealed cavity side of the ceramic substrate of this patent; Figure 4 is a schematic diagram of a structure of the ceramic substrate stimulation side of this patent; Figure 5 is a schematic diagram of a structure of the sealed cavity side of the ceramic substrate of this patent; Figure 6 is a schematic diagram of one structure of the ceramic substrate stimulation side of this patent; Figure 7 is a schematic diagram of the three-layer ceramic sheet laminate structure of the ceramic substrate of this patent; Figure 8 is an exploded structural diagram of the metal cap, metal ring, and ceramic substrate of this patent. In the figure, 1-ceramic substrate, 11-ceramic sheet, 12-through hole, 13-hole filling paste; 14-laminated paste; 15-stimulation electrode, 2-metal cap, 3-metal ring, 4-solder joint. Detailed Implementation

[0010] The present patent will be further described below with reference to the accompanying drawings. Example 1, referring to Figures 1-4 and Figures 7 and 8, describes a tibial nerve stimulator, comprising a sealed cavity formed by a ceramic substrate 1, a metal ring 3, and a metal cap 2. The ceramic substrate 1 has five through holes 12 and two solder joints 4 on one side within the sealed cavity. The solder joints 4 are used for electrical connection between the stimulation chip and the metal cap 2. The ceramic substrate 1 is formed by laminating and sintering three layers of ceramic sheets 11. Each ceramic sheet 11 has five through holes 12, and the projections of the through holes 12 of adjacent ceramic sheets 11 do not overlap. A portion of the surface of the ceramic sheets 11 is diffused with platinum as a lamination paste 14, and the through holes 12 of adjacent ceramic sheets 11 are electrically connected through the lamination paste 14. The inner wall of each through hole is wet-printed with platinum and filled with platinum as a filling paste 13. The lower surface of the bottom ceramic sheet 11 (i.e. the side that contacts the human body to perform electrical stimulation) is provided with five stimulation electrodes 15. Each stimulation electrode 15 is electrically connected to the stimulation chip in the sealed cavity through the lamination paste 14 and the pore-filling paste 13.

[0011] When performing electrical stimulation, the metal cover 2 can be used as one pole of the circuit loop, and the five stimulation electrodes 15 can be used together as the other pole of the circuit loop. Alternatively, depending on the stimulation site or other needs, some of the metal cover 2 and the five stimulation electrodes 15 can be selected as one pole of the circuit loop, and the remaining ones can be selected as the other pole of the circuit loop.

[0012] Example 2, referring to Figures 5 and 6. The difference from Example 1 is that the ceramic substrate 1 is provided with three stimulation electrodes 15. Generally speaking, increasing the number of stimulation electrodes 15 increases the processing difficulty, but at the same time, it also enables more stimulation strategies.

[0013] The above description of the disclosed embodiments enables those skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of this application. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A tibial nerve stimulator, comprising: The device includes a ceramic substrate composed of several ceramic sheets, a stimulation chip, a metal ring, a metal cap, and several stimulation electrodes. The stimulation electrodes are located below the ceramic substrate, and the ceramic substrate is connected to the metal cap via the metal ring. The stimulation chip is located within a sealed cavity formed by the ceramic substrate, the metal ring, and the metal cap, and is electrically connected to the metal cap. Each ceramic sheet has the same number of through holes as the number of electrodes, and the through holes on different ceramic sheets do not overlap in projection. The stimulation electrodes are electrically connected to the stimulation chip via the through holes.

2. A tibial nerve stimulator according to claim 1, wherein, Each through hole is filled with a filling paste, and a laminating paste is provided between the ceramic sheets; the filling pastes on different ceramic sheets are electrically connected to the filling pastes on other ceramic sheets through the laminating paste; the stimulation electrode is electrically connected to the stimulation chip through the filling paste and the laminating paste.

3. A tibial nerve stimulator according to claim 2, wherein, The materials used for filling slurry and laminating slurry are platinum.

4. A tibial nerve stimulator according to claim 3, wherein, The metal cap and several stimulation electrodes form a circuit loop; the metal cap serves as one pole of the circuit loop, and the several stimulation electrodes together serve as the other pole of the circuit loop.

5. A tibial nerve stimulator according to claim 4, wherein, The metal ring and metal cap are medical-grade metal materials such as titanium or stainless steel.

6. A tibial nerve stimulator according to claim 5, wherein, The surfaces of the metal ring and metal cap are coated with platinum, iridium oxide, or a composite coating of platinum and iridium oxide.

7. A tibial nerve stimulator according to claim 6, wherein, The metal ring and metal cap are further coated with an inorganic insulating layer on a portion of their surface or the surface of a portion of the composite coating. The inorganic insulating layer is at least one of silicon oxide, silicon nitride, aluminum oxide, and silicon carbide. Alternatively, the metal ring and metal cap are further coated with an organic insulating layer on a portion of their surface or the surface of a portion of the composite coating. The organic insulating layer includes at least one of polyimide, pyrene, and polytetrafluoroethylene. Or, the metal ring and metal cap are further coated with a composite structure of the inorganic insulating layer and the organic insulating layer on a portion of their surface or the surface of a portion of the composite coating.

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