CN117101000A - Implantable stimulation device and tibial nerve stimulation system - Google Patents
Implantable stimulation device and tibial nerve stimulation system Download PDFInfo
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- CN117101000A CN117101000A CN202210626479.4A CN202210626479A CN117101000A CN 117101000 A CN117101000 A CN 117101000A CN 202210626479 A CN202210626479 A CN 202210626479A CN 117101000 A CN117101000 A CN 117101000A
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- 230000007383 nerve stimulation Effects 0.000 title claims abstract description 26
- 210000002972 tibial nerve Anatomy 0.000 title claims abstract description 25
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- 206010020853 Hypertonic bladder Diseases 0.000 description 9
- 208000009722 Overactive Urinary Bladder Diseases 0.000 description 9
- 208000020629 overactive bladder Diseases 0.000 description 9
- 238000003466 welding Methods 0.000 description 8
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- 230000001537 neural effect Effects 0.000 description 5
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 3
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- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
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- 206010059866 Drug resistance Diseases 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36064—Epilepsy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36125—Details of circuitry or electric components
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
Abstract
The invention relates to an implantable stimulation device and a tibial nerve stimulation system. The implantable stimulation device comprises a shell, a battery, an electric component and a feed-through structure, wherein the battery, the electric component and the feed-through structure are sequentially arranged in a cavity of the shell, the feed-through structure is fixed in a through hole on the first surface of the shell, a first conductive end of the feed-through structure is positioned in the cavity of the shell and is electrically connected with the electric component, a second conductive end of the feed-through structure is electrically connected with an electrode slice which is arranged in an insulating mode of the shell, a first discharge end of a circuit formed by the battery and the electric component is connected to the shell, and a second discharge end of the circuit formed by the battery and the electric component is connected to the electrode slice through the feed-through structure. The tibial nerve stimulation system comprises a program control instrument and the implantable stimulation device.
Description
Technical Field
The invention relates to the field of medical equipment, in particular to an implantable stimulation device and a tibial nerve stimulation system.
Background
In recent years, as China enters an aging society and diabetes mellitus and nervous system injury diseases grow, the occurrence rate of secondary related diseases such as overactive bladder (Overactive bladder, OAB) also rises year by year. Overactive bladder is a syndrome characterized by symptoms of urgency, often accompanied by frequent urination and nocturia, with or without urge incontinence; urodynamics may manifest as detrusor overactivity, but also other forms of urethral-bladder dysfunction, with overactivity of the bladder having no clear etiology, excluding symptoms caused by acute urinary tract infections or other forms of local lesions of the bladder urethra. Overactive bladder, which significantly affects the daily life and social activities of patients, has become a major disorder afflicting people. The currently preferred treatment methods are behavioral therapy and drug therapy, and the non-obstructive urinary retention and overactive bladder with drug resistance and tolerance are mainly treated by two-wire nerve stimulation.
Implantable stimulation devices are used to apply electrical stimulation to target neural tissue (e.g., tibial nerve) by generating an electric field after implantation into the human body. The existing in-vivo power supply type implantable stimulation device has the problems of complex assembly process and insufficient reliability.
Disclosure of Invention
The invention provides an implantable stimulation device which is convenient to assemble and has higher reliability. The present invention additionally provides a tibial nerve stimulation system.
In one aspect, the present invention provides an implantable stimulation device comprising:
a housing having a cavity and first and second surfaces opposite to each other, the housing having a through hole at the first surface;
the battery, the electricity utilization component and the feed-through structure are sequentially arranged in the cavity, the feed-through structure is fixed in the through hole, and the first conductive end of the feed-through structure is positioned in the cavity and is electrically connected with the electricity utilization component; the method comprises the steps of,
an electrode plate, which is arranged in an insulating way with the shell and is electrically connected with the second conductive end of the feed-through structure;
the circuit formed by the battery and the power utilization assembly is provided with a first discharge end and a second discharge end which are opposite in polarity, the first discharge end is connected to the shell, and the second discharge end is connected to the electrode plate through the feed-through structure.
Optionally, the feed-through structure includes the shell, set up in insulating part and feed-through seal wire in the shell, feed-through seal wire wears to locate in the insulating part and both ends expose, feed-through seal wire's both ends constitute first conductive end with the second conductive end.
Optionally, the electrode plate is annular, and the electrode plate is welded with the feed-through guide wire.
Optionally, a groove is formed on a side, close to the electrode plate, of the feed-through structure, the electrode plate is located in the groove, and the feed-through guide wire extends into the groove to be connected with the electrode plate.
Optionally, the thicknesses of the electrode plates of the depths of the grooves are equal.
Optionally, the housing of the feed-through structure has a mounting shoulder.
Optionally, the shell further comprises an insulating coating, wherein the insulating coating is coated on the outer surface of the shell and exposes part of the outer surface positioned on the first surface and/or the second surface; the outer surface of the part is a positive electrode, and the electrode plate is a negative electrode.
Optionally, the positive electrode is circumferentially arranged on the first surface and/or the second surface, and the electrode sheet is disposed corresponding to a middle region of the first surface; alternatively, the positive electrode includes a plurality of positive electrodes distributed on the first surface and/or the second surface, and adjacent positive electrodes on the same surface are separated by an insulating coating.
Optionally, a minimum distance between the positive electrode and the electrode sheet in the radial direction of the case is greater than or equal to 6mm.
In one aspect, the present invention provides a tibial nerve stimulation system, which comprises a programmable controller and the above-mentioned implantable stimulation device, wherein the programmable controller is in wireless connection with the implantable stimulation device.
According to the implantable stimulation device, the battery, the electricity consumption component and the feed-through structure are sequentially arranged in the cavity of the shell, the electricity consumption component in the cavity is electrically connected with the electrode plate by utilizing the feed-through structure, the implantable stimulation device is convenient to assemble, the first discharge end of a circuit formed by the battery and the electricity consumption component is connected to the shell, the second discharge end of the circuit formed by the battery and the electricity consumption component is connected to the electrode plate by utilizing the feed-through structure, nerve stimulation can be performed according to set parameters in an implanted state, and the implantable stimulation device is high in reliability.
The tibial nerve stimulation system provided by the invention comprises the program control instrument and the implanted stimulation device, wherein the program control instrument is in wireless connection with the implanted stimulation device, parameters of the implanted stimulation device can be set through the program control instrument, and the automatic tibial nerve stimulation treatment is realized, so that the system is convenient to use and high in reliability.
Drawings
FIG. 1 is a schematic diagram of tibial nerve stimulation using an implantable stimulation device according to one embodiment of the present invention;
FIG. 2 is a schematic cross-sectional view of an implantable stimulation device according to an embodiment of the present invention;
FIG. 3 is an exploded view of an implantable stimulation device according to one embodiment of the present invention;
FIG. 4 is a schematic cross-sectional view of a feed-through structure according to an embodiment of the present invention;
FIG. 5 is a schematic top view of a feed-through structure and an electric device according to an embodiment of the present invention;
fig. 6A to 6D are schematic views showing the distribution of the positive electrode and the electrode sheet in the embodiment of the present invention;
fig. 7 is a schematic diagram of neural stimulation using a tibial neural stimulation system in accordance with an embodiment of the present invention.
Reference numerals illustrate:
100-an implantable stimulation device; 10-skin; 20-tibial nerve; 101-positive electrode; 102-a negative electrode; 103-electric field lines; 110-a housing; 111-a first surface; 111 a-a through hole; 112-a second surface; 113-side surfaces; 120-cell; 130-an electrical component; 140-a feed-through structure; 140 a-a first conductive terminal; 140 b-a second conductive terminal; 141-a housing; 141 a-mounting a shoulder; 142-insulating part; 142 a-grooves; 143-a feed-through guidewire; 150-insulating coating.
Detailed Description
The implantable stimulation device and the tibial nerve stimulation system of the present invention are described in further detail below with reference to the drawings and the detailed description. The advantages and features of the present invention will become more apparent from the following description. It should be understood that the drawings in the specification are in a very simplified form and are all to a non-precise scale, simply to facilitate a clear and thorough description of the embodiments of the invention.
The embodiment of the invention relates to an implantable stimulation device, which can form an electric field in a target nerve tissue area and stimulate the target nerve tissue after being implanted into a human body. According to the treatment requirement, the implantable stimulation device can be implanted at different positions in a human body, and related diseases (such as epilepsy, overactive bladder or other applicable diseases) are treated by the control of an in-vitro program-controlled instrument. The following examples mainly illustrate implantable stimulation devices for tibial nerve stimulation.
Fig. 1 is a schematic view of tibial nerve stimulation using an implantable stimulation device according to one embodiment of the present invention. Referring to fig. 1, the implantable stimulation device is used, for example, to treat overactive bladder (OAB) or other applicable conditions of tibial nerve stimulation, in which the implantable stimulation device 100 is implanted over the tibial nerve 20 under the skin 10 at the ankle location, and the positive electrode 101 and the negative electrode 102 of the implantable stimulation device 100 form a current loop through human tissue, and the tibial nerve can be stimulated (or neuromodulated) by pulse discharge. In operation, an electric field is formed between the positive electrode 101 and the negative electrode 102, as shown by electric field lines 103 in FIG. 1. The tibial nerve 20 is stimulated by the electric field.
Fig. 2 is a schematic cross-sectional view of an implantable stimulation device according to an embodiment of the present invention. Fig. 3 is an exploded view of an implantable stimulation device according to one embodiment of the present invention. Referring to fig. 2 and 3, an implantable stimulation device 100 of an embodiment of the present invention includes a housing 110, the housing 110 having a cavity and first and second surfaces 111, 112 opposite each other. The first surface 111 and the second surface 112 are, for example, both circular. The housing 110 is, for example, a flat cylindrical structure, which may have side surfaces 113.
The implantable stimulation device 100 further comprises a battery 120, an electrical component 130 and a feed-through structure 140, which are arranged in the cavity in sequence, and further comprises an electrode sheet arranged insulated from the housing 110, in this embodiment, the housing 110 is used to form the positive electrode 101, and the electrode sheet is used as the negative electrode 102, so the electrode sheet in fig. 2 adopts the same reference sign as the negative electrode 102.
Specifically, the housing 110 has a through hole 111a in the first surface 111. The feed-through structure 140 is fixed within the through hole 111a. The feed-through structure 140 has a first conductive end 140a and a second conductive end 140b, the first conductive end 140a being located within the cavity and electrically connected to the powered component 130, the second conductive end 140b being electrically connected to the electrode sheet (in this embodiment as the negative electrode 102). The battery 120 and the electrical circuit formed with the electrical assembly 130 have first and second discharge ends of opposite polarity, the first discharge end being connected to the housing 110 and the second discharge end being connected to the electrode pad through a feed-through structure 140.
The housing 110 is, for example, cylindrical or other shape, and for convenience of assembly, the housing 110 is, for example, formed by welding upper and lower cylindrical shells, which may be respectively formed by a stamping process using biocompatible conductive materials (e.g., platinum or titanium), and the housing 110 may be formed by welding, the housing 110 enclosing a cavity. The housing 110 may also be provided in other arrangements, such as in another embodiment, the housing 110 is formed by welding a cylindrical shell and a dome over the cylindrical shell.
It should be noted that the present embodiment illustrates the relative positions of components in implantable stimulation device 100 in the orientation shown in fig. 2, it being understood that the spatially relative terms are intended to encompass different orientations in use or operation in addition to the orientation of the device depicted in fig. 2. For example, if the structure in the figures is inverted or otherwise oriented (e.g., rotated), the exemplary term "above … …" may also include "below … …" and other orientations.
The battery 120 and the power consumption component 130 are sequentially arranged in a cavity surrounded by the casing 110, and the battery 120 is used for supplying power to the power consumption component 130. In this embodiment, for ease of assembly, the battery 120 and the power consuming assembly 130 are stacked within the cavity. But is not limited thereto, for example, in another embodiment, the power consuming assembly 130 may also be disposed around the battery 120 to reduce the thickness of the housing 110.
In this embodiment, the power module 130 includes, for example, a PCB board and electronic components mounted on the PCB board, so that the connection terminals of the power module 130 can be disposed on the PCB board. The electrodes of the battery 120 may be connected to corresponding terminals on the PCB board by soldering. The circuit formed by the battery 120 and the electrical component 130 is used for generating a discharge signal for nerve stimulation, wherein a first discharge end is connected to the housing 110, a second discharge end is connected to the electrode pad, a discharge electric field can be formed between the positive electrode 101 and the negative electrode 102 by applying a suitable signal between the first discharge end and the second discharge end, and the implantable stimulation device 100 has a simple structure, is convenient to assemble, and can realize a reliable discharge electric field.
In this embodiment, the electrode pad connected to the second discharge end is a negative electrode 102, which is disposed on a first surface 111 of the housing 110 of the implantable stimulation device 100, the first surface 111 faces the tibial nerve 20 during treatment, and the housing 110 connected to the first discharge end is used to form the positive electrode 101. In one embodiment, the positive and negative electrodes of the battery 120 are soldered to the corresponding terminals on the PCB, and the electrode terminals on the PCB are bonded or soldered to the case 110 by conductive adhesive. In another embodiment, the positive electrode of the battery 120 is soldered to a corresponding terminal on the PCB board, and the negative electrode of the battery 120 is bonded or soldered to the housing 110 by conductive adhesive.
The feed-through structure 140 is fixedly disposed within the through hole 111a of the first surface 111, and further, an end of the feed-through structure 140 remote from the battery 120 is disposed within the through hole 111a. Feedthrough structure 140 and housing 110 may enclose battery 120 and powered assembly 130 within a cavity defined by housing 110. Electrical connection between the electrical components 130 within the cavity and the electrode pads outside the cavity may be achieved by a feed-through structure 140. In this embodiment, the power consuming component 130 is located in the cavity near the first surface 111, and the feedthrough structure 140 draws the second discharge end of the circuit formed by the battery 120 and the power consuming component 130 out of the cavity. The feed-through structure 140 may be inserted in the through hole 111a along a vertical direction of the first surface 111.
FIG. 4 is a schematic cross-sectional view of a feed-through structure according to an embodiment of the present invention. Fig. 5 is a schematic top view of a feed-through structure and an electric device according to an embodiment of the invention. Referring to fig. 4 and 5, in the present embodiment, the feed-through structure 140 includes a housing 141, an insulating portion 142 disposed in the housing 141, and a feed-through wire 143, wherein the feed-through wire 143 is disposed in the insulating portion 142 and has two ends exposed, and two ends of the feed-through wire 143 respectively form a first conductive end 140a and a second conductive end 140b of the feed-through structure 140. The first conductive end 140a is located in the cavity and is connected with the power utilization component 130; the second conductive end 140b is connected to the electrode pad through the through hole 111a, and the feedthrough structure 140 is simple and compact, which contributes to miniaturizing the implantable stimulation device.
In this embodiment, the casing 141 of the feed-through structure 140 is, for example, a ring structure, which is in contact with the housing 110 and welded. The housing 141 has a mounting shoulder 141a. In mounting the feedthrough 140, for example, the feedthrough 140 is first passed through the through-hole 111a from a cylindrical case located below that constitutes the case 110, the mounting shoulder 141a is made to adhere to the surface of the case 110 around the through-hole 111a, and then the case 141 of the feedthrough 140 is welded to the case 110 by laser welding.
The electrode pads may be connected to the second conductive end 140b of the feed-through structure 140 in different ways. The electrode pad is, for example, circular, oval, square, or other shape, which is in contact with and fixedly connected to the exposed second conductive end 140b of the feed-through structure 140. After the feedthrough structure 140 is mounted to the through hole 111a, an insulating coating may be formed on the outer surface of the case 110 and the outer surface of the feedthrough structure 140, and then the electrode sheet 150 may be welded to the second conductive end 140 of the feedthrough structure 140, so that the electrode sheet may be prevented from being shorted to the case 141. Optionally, the electrode pad and the feed-through structure 140 are both located in a middle region of the first surface 111, that is, the through hole 111a is opened in a middle region of the first surface 111.
The second conductive end 140b may be fixedly connected to the electrode tab by laser welding. In this embodiment, the electrode plate is, for example, an annular plate having a hollow region, and the electrode plate can be sleeved on the exposed end (i.e., the second conductive end 140 b) of the feed-through wire 143, and then welded together. Optionally, feedthrough structure 140 employs a countersink structure to facilitate placement of the electrode pads in depressions of the countersink structure, with the components of implantable stimulation device 100 being stacked better throughout, thereby reducing the overall thickness of implantable stimulation device 100.
Specifically, referring to fig. 4, a side of the feed-through structure 140 adjacent to the electrode sheet may have a recess 142a. The groove 142a may be formed in a surface of the insulating part 142 adjacent to the electrode sheet (in this case, a sidewall of the groove 142a is the insulating part 142), or the groove 142a may be surrounded by a surface of the insulating part 142 adjacent to the electrode sheet and the case 141 (in this case, a sidewall of the groove 142a is the case 141). The electrode tab is located within the recess 142a, and a feed-through wire 143 extends into the recess 143 and connects with the electrode tab. The second conductive end 140b is, for example, located in a middle region of the recess 142a and is exposed at a bottom surface of the recess 142a. When the electrode sheet is mounted, the electrode sheet may be placed in the groove 142a and sleeved on the second conductive end 140b in the groove 142a, and then the electrode sheet and the second conductive end 140b may be welded and fixed. The electrode pad and the second conductive end 140b are disposed in the recess 142a, so as to avoid increasing the thickness of the implantable stimulation device 100. Optionally, the depth of the groove 142a is equal to the thickness of the electrode sheet, so that the surface of the implantable stimulation device 100 on which the electrode sheet is mounted can be kept planar, and the stacked structure makes the structure more compact.
The implantable stimulation device 100 of the present embodiment may further include an insulating coating applied to the outer surface of the housing 110, which may be used to define the extent of the positive electrode 101, and may be used to insulate the electrode sheet from the housing 110. In this embodiment, the insulating coating is applied on the first surface 111, the second surface 112 and the side surface 113, and exposes a portion of the outer surface of the first surface 111 and/or the second surface 112, which is the positive electrode 101 when the implantable stimulation device 100 performs nerve stimulation, and the electrode sheet is the negative electrode 102 (see fig. 1). In this embodiment, the positive electrode 101 is disposed on the second surface 112 and/or the first surface 111 of the implantable stimulation device 100, and since the second surface 112 and the first surface 111 have a larger area and are flat than the side surface 113, the shape and position of the positive electrode 101 can be adjusted as required, and the shape and position of the positive electrode 101 can be directly defined by an insulating coating, which is convenient for manufacturing. The insulating coating may be of biocompatible material.
Fig. 6A to 6D are schematic views showing the distribution of the positive electrode and the electrode sheet in the embodiment of the present invention. Referring to fig. 6A to 6D, after the insulating coating 150 is applied, the positive electrode 101 composed of the exposed first surface 111 and/or second surface 112 is circumferentially arranged on the corresponding first surface 111 and/or second surface 112 (i.e., double-sided arrangement or single-sided arrangement), and the negative electrode 102 composed of the electrode sheet is arranged corresponding to the middle region of the first surface 111. Upon application of a nerve stimulating signal, an electric field is formed between the positive electrode 101 at the first surface 111 and/or the second surface 112 and the electrode pad at the first surface 111, and a tibial nerve within the electric field may be stimulated.
The shape and position of the positive electrode 101 may be set as desired. For example, the positive electrode 101 may be a closed loop disposed on the first surface 111 or the second surface 112, or the positive electrode 101 may include a plurality of positive electrodes distributed on the first surface 111 and/or the second surface 112, adjacent positive electrodes located on the same surface (the first surface 111 or the second surface 112) being separated by an insulating coating 150. As shown in fig. 6A, in an embodiment, the positive electrode 101 is located on the first surface 111 and/or the second surface 112, and the positive electrode 101 located on the same surface (the first surface 111 or the second surface 112) is annular. As shown in fig. 6B to 6D, in other embodiments, two, three, or four blocks may be exposed in the circumferential direction of the first surface 111 or the second surface 112, and the outer surface of the housing 110 corresponding to each block serves as one of the positive sub-electrodes. Two or more of the positive sub-electrodes on the same surface may be uniformly disposed along the circumference of the corresponding first surface 111 or second surface 112, for example, uniformly disposed on the circumference of the first surface 111 or second surface 112, to form a uniform electric field in the tibial nerve range when nerve stimulation is performed. In other embodiments, the positive electrode formed on the first surface 111 or the second surface 112 may be five or more. When the positive electrodes are provided on both sides of the first surface 111 and the second surface 112, the number and/or positions of the positive electrodes formed on the upper and lower surfaces may be the same or different. Referring to fig. 6A, alternatively, the positive electrode 101 (or the positive electrode therein) and the electrode sheet are arranged in the radial direction of the case 110, and the minimum distance (pitch d) between the positive electrode 101 (or the positive electrode therein) and the electrode sheet in the radial direction of the case 110 may be set to be greater than or equal to 6mm to form an electric field suitable for charge density in a corresponding nerve range when nerve stimulation is performed.
As an example, a method of assembling the implantable stimulation device 100 of the present invention is described, the method comprising the steps of: first, two cylindrical housings (e.g., titanium housings) that match each other are obtained, and a feed-through structure 140; then, the feed-through structure 140 penetrates out of the lower cylindrical shell from inside and is connected with the lower cylindrical shell in a sealing way by laser welding; then, one end of the feed-through guide wire 143 is connected with the electricity consumption component 130, the electricity consumption component 130 is connected with the anode of the battery in a soldering way, and the cathode of the battery is communicated with the upper cylindrical shell or the lower cylindrical shell through epoxy conductive adhesive; then, the lower cylindrical housing and the upper cylindrical housing are connected by laser welding to form a housing 110; next, an insulating coating (for example, parylene) having biocompatibility is applied to the outer surface of the case 110 except for the areas where the first surface 111 and the second surface 112 are required to be exposed as the positive electrode 101; finally, a circular electrode sheet (such as a titanium sheet) is connected with the end of the feed-through wire 143 outside the housing 110 by laser welding to form the negative electrode 102 required for nerve stimulation.
The embodiment of the invention also relates to a tibial nerve stimulation system. Fig. 7 is a schematic diagram of neural stimulation using a tibial neural stimulation system in accordance with an embodiment of the present invention. Referring to fig. 7, the tibial nerve stimulation system includes a programmable controller 200 and the implantable stimulation device 100 described in the above embodiment of the present invention, and the programmable controller 200 is wirelessly connected with the implantable stimulation device 100. In operation, the implantable stimulation device 100 is implanted in a corresponding location under the human skin 10, and the programmer 200 is located outside the body, and the programmer 200 can control the implantable stimulation device 100 by sending wireless signals, and a physician can set relevant operating parameters of the implantable stimulation device 100 via the programmer 200. The implanted stimulation device 100 can perform long-time autonomic nerve stimulation treatment according to the built-in parameters, and because the stimulation signals are directly from the implanted stimulation device 100 in the body, patients do not need to wear other equipment, the use is convenient, the safety is good, and the convenience and the reliability of the tibial nerve stimulation system are both higher.
The foregoing description is only illustrative of the preferred embodiments of the present invention, and is not intended to limit the scope of the claims, and any person skilled in the art may make any possible variations and modifications to the technical solution of the present invention using the method and technical content disclosed above without departing from the spirit and scope of the invention, so any simple modification, equivalent variation and modification made to the above embodiments according to the technical matter of the present invention fall within the scope of the technical solution of the present invention.
Claims (10)
1. An implantable stimulation device, comprising:
a housing having a cavity and first and second surfaces opposite to each other, the housing having a through hole at the first surface;
the battery, the electricity utilization component and the feed-through structure are sequentially arranged in the cavity, the feed-through structure is fixed in the through hole, and the first conductive end of the feed-through structure is positioned in the cavity and is electrically connected with the electricity utilization component; the method comprises the steps of,
an electrode plate, which is arranged in an insulating way with the shell and is electrically connected with the second conductive end of the feed-through structure;
the circuit formed by the battery and the power utilization assembly is provided with a first discharge end and a second discharge end which are opposite in polarity, the first discharge end is connected to the shell, and the second discharge end is connected to the electrode plate through the feed-through structure.
2. The implantable stimulation device of claim 1, wherein the feed-through structure comprises a housing, an insulating portion disposed within the housing, and a feed-through wire that is threaded into the insulating portion and has both ends exposed, the two ends of the feed-through wire constituting the first conductive end and the second conductive end.
3. The implantable stimulation device of claim 2, wherein the electrode pad is annular and the electrode pad is welded to the feed-through guidewire.
4. The implantable stimulation device of claim 2, wherein a side of the feed-through structure adjacent to the electrode pad has a recess, the electrode pad is located within the recess, and the feed-through guidewire extends into the recess to connect with the electrode pad.
5. The implantable stimulation device of claim 4, wherein the depth of the groove is equal to the thickness of the electrode pad.
6. The implantable stimulation device of claim 2, wherein the housing of the feed-through structure has a mounting shoulder.
7. The implantable stimulation device of claim 1, further comprising an insulating coating applied to an outer surface of the housing and exposing a portion of the outer surface at the first surface and/or the second surface; the outer surface of the part is a positive electrode, and the electrode plate is a negative electrode.
8. The implantable stimulation device of claim 7, wherein the positive electrode is circumferentially disposed on the first surface and/or the second surface, the electrode pad being disposed corresponding to a middle region of the first surface; alternatively, the positive electrode includes a plurality of positive electrodes distributed on the first surface and/or the second surface, and adjacent positive electrodes on the same surface are separated by an insulating coating.
9. The implantable stimulation device of claim 7, wherein a minimum distance between the positive electrode and the electrode pad in the radial direction of the housing is greater than or equal to 6mm.
10. A tibial nerve stimulation system comprising a programmable controller and an implantable stimulation device according to any one of claims 1 to 9, wherein the programmable controller is wirelessly connected to the implantable stimulation device.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210626479.4A CN117101000A (en) | 2022-06-02 | 2022-06-02 | Implantable stimulation device and tibial nerve stimulation system |
| PCT/CN2023/092192 WO2023231690A1 (en) | 2022-06-02 | 2023-05-05 | Implantable stimulation device and tibial nerve stimulation system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210626479.4A CN117101000A (en) | 2022-06-02 | 2022-06-02 | Implantable stimulation device and tibial nerve stimulation system |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117101000A true CN117101000A (en) | 2023-11-24 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210626479.4A Pending CN117101000A (en) | 2022-06-02 | 2022-06-02 | Implantable stimulation device and tibial nerve stimulation system |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN117101000A (en) |
| WO (1) | WO2023231690A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117771545A (en) * | 2024-02-26 | 2024-03-29 | 苏州新云医疗设备有限公司 | Implantable electric stimulator and electric stimulation system |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9802054B2 (en) * | 2012-08-01 | 2017-10-31 | Pacesetter, Inc. | Biostimulator circuit with flying cell |
| US10004907B2 (en) * | 2014-02-21 | 2018-06-26 | Pacesetter, Inc. | Automatic capture verification within leadless implantable medical devices |
| CN109803720B (en) * | 2016-09-21 | 2023-08-15 | 心脏起搏器股份公司 | Leadless stimulation device having a housing containing its internal components and functioning as a terminal for a battery case and an internal battery |
| CN113599698A (en) * | 2021-09-03 | 2021-11-05 | 苏州景昱医疗器械有限公司 | Channel module and implanted nerve stimulator |
-
2022
- 2022-06-02 CN CN202210626479.4A patent/CN117101000A/en active Pending
-
2023
- 2023-05-05 WO PCT/CN2023/092192 patent/WO2023231690A1/en unknown
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117771545A (en) * | 2024-02-26 | 2024-03-29 | 苏州新云医疗设备有限公司 | Implantable electric stimulator and electric stimulation system |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2023231690A1 (en) | 2023-12-07 |
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