CN118512712A - Implantable electrical stimulator with electromagnetic shielding function - Google Patents
Implantable electrical stimulator with electromagnetic shielding function Download PDFInfo
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- 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
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- A—HUMAN NECESSITIES
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- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
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- 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
- A61N1/36042—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of grafted tissue, e.g. skeletal muscle
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- 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
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- 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
- A61N1/36146—Control systems specified by the stimulation parameters
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- 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
- A61N1/372—Arrangements in connection with the implantation of stimulators
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- A—HUMAN NECESSITIES
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- 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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/378—Electrical supply
- A61N1/3787—Electrical supply from an external energy source
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Abstract
本公开提供一种具有电磁屏蔽功能的植入式电刺激器。该植入式电刺激器包括第一壳体部分、第二壳体部分、控制装置以及至少一个交互装置。第一壳体部分收纳控制装置,第二壳体部分收纳至少一个交互装置。至少一个交互装置与控制装置电连接。第一壳体部分构造为至少部分地形成控制装置相对于外部环境的电磁屏蔽。第二壳体部分构造为允许至少一个交互装置与体外设备无线地交互。这样,在确保交互装置能够与体外设备可靠交互的基础上,外界电磁干扰对控制装置的影响以及控制装置自身产生的电磁辐射对周围的电子设备的影响都能得到有效抑制。
The present disclosure provides an implantable electrical stimulator with an electromagnetic shielding function. The implantable electrical stimulator includes a first shell portion, a second shell portion, a control device and at least one interactive device. The first shell portion accommodates the control device, and the second shell portion accommodates the at least one interactive device. The at least one interactive device is electrically connected to the control device. The first shell portion is configured to at least partially form an electromagnetic shielding of the control device relative to the external environment. The second shell portion is configured to allow at least one interactive device to wirelessly interact with an external device. In this way, on the basis of ensuring that the interactive device can reliably interact with the external device, the influence of external electromagnetic interference on the control device and the influence of the electromagnetic radiation generated by the control device itself on the surrounding electronic equipment can be effectively suppressed.
Description
技术领域Technical Field
本公开涉及医疗器械领域,特别地,涉及一种植入式电刺激器。The present disclosure relates to the field of medical devices, and in particular, to an implantable electrical stimulator.
背景技术Background Art
植入式电刺激器包括控制装置,控制装置用于生成刺激脉冲。相关技术提供的植入式电刺激器难以应对外界电磁干扰对控制装置的影响。外界电磁干扰可能会导致刺激参数不稳定,影响治疗效果,甚至可能错误触发刺激等风险。此外,控制装置自身产生的电磁辐射若未妥善抑制,可能干扰植入式电刺激器周围的电子设备如交互装置等。The implantable electrical stimulator includes a control device, which is used to generate stimulation pulses. The implantable electrical stimulator provided by the related art is difficult to cope with the influence of external electromagnetic interference on the control device. External electromagnetic interference may cause the stimulation parameters to be unstable, affect the treatment effect, and may even trigger the stimulation by mistake. In addition, if the electromagnetic radiation generated by the control device itself is not properly suppressed, it may interfere with electronic equipment around the implantable electrical stimulator, such as interactive devices.
发明内容Summary of the invention
有鉴于此,本公开对植入式电刺激器进行了改进,旨在改善相关技术提供的植入式电刺激器难以有效应对电磁干扰的问题。In view of this, the present disclosure improves the implantable electrical stimulator, aiming to improve the problem that the implantable electrical stimulator provided by the related art is difficult to effectively cope with electromagnetic interference.
本公开提供一种具有电磁屏蔽功能的植入式电刺激器。该植入式电刺激器包括第一壳体部分、第二壳体部分、控制装置以及至少一个交互装置。第一壳体部分收纳控制装置,第二壳体部分收纳至少一个交互装置。至少一个交互装置与控制装置电连接。第一壳体部分构造为至少部分地形成控制装置相对于外部环境的电磁屏蔽。第二壳体部分构造为允许至少一个交互装置与体外设备无线地交互。The present disclosure provides an implantable electrical stimulator with an electromagnetic shielding function. The implantable electrical stimulator includes a first shell portion, a second shell portion, a control device, and at least one interactive device. The first shell portion accommodates the control device, and the second shell portion accommodates the at least one interactive device. The at least one interactive device is electrically connected to the control device. The first shell portion is configured to at least partially form an electromagnetic shielding of the control device relative to the external environment. The second shell portion is configured to allow the at least one interactive device to wirelessly interact with an external device.
根据本公开提供具有电磁屏蔽功能的植入式电刺激器,易受电磁干扰和易产生电磁信号的控制装置被收纳在具有电磁屏蔽效果的第一壳体部分内,需要与外部无线交互的至少一个交互装置收纳在不产生电磁屏蔽的第二壳体部分内。这样,在确保交互装置能够与体外设备可靠交互的基础上,外界电磁干扰对控制装置的影响以及控制装置自身产生的电磁辐射对周围的电子设备的影响都能得到有效抑制。According to the present disclosure, an implantable electrical stimulator with an electromagnetic shielding function is provided, wherein a control device susceptible to electromagnetic interference and prone to generating electromagnetic signals is housed in a first housing portion having an electromagnetic shielding effect, and at least one interaction device that needs to wirelessly interact with the outside is housed in a second housing portion that does not generate electromagnetic shielding. In this way, while ensuring that the interaction device can reliably interact with an external device, the influence of external electromagnetic interference on the control device and the influence of electromagnetic radiation generated by the control device itself on surrounding electronic equipment can be effectively suppressed.
作为一种可能的实现方式,该具有电磁屏蔽功能的植入式电刺激器还包括电磁屏蔽件,第一壳体部分设有穿通通道,电磁屏蔽件封堵穿通通道。至少一个交互装置分别通过至少一个连接线与控制装置电连接。每个连接线一端与控制装置电连接,且其另一端经过电磁屏蔽件与对应的交互装置电连接。As a possible implementation, the implantable electrical stimulator with electromagnetic shielding function also includes an electromagnetic shielding component, the first shell portion is provided with a through-channel, and the electromagnetic shielding component blocks the through-channel. At least one interactive device is electrically connected to the control device through at least one connecting wire. One end of each connecting wire is electrically connected to the control device, and the other end thereof is electrically connected to the corresponding interactive device through the electromagnetic shielding component.
连接交互装置与控制装置的连接线需要穿过穿通通道,以在两个壳体部分之间延伸。由于电磁屏蔽件的存在,外界电磁干扰将难以通过穿通通道进入第一壳体部分内部影响控制装置,同时,控制装置产生的电磁辐射也将难以逃出第一壳体部分。这样,可以进一步提高植入式电刺激器应对电磁干扰的能力。The connection line connecting the interactive device and the control device needs to pass through the through-channel to extend between the two shell parts. Due to the presence of the electromagnetic shielding member, it will be difficult for external electromagnetic interference to enter the first shell part through the through-channel to affect the control device. At the same time, the electromagnetic radiation generated by the control device will also be difficult to escape from the first shell part. In this way, the ability of the implantable electrical stimulator to cope with electromagnetic interference can be further improved.
作为一种可能的实现方式,电磁屏蔽件包括导电结构和支撑导电结构的基体。As a possible implementation manner, the electromagnetic shielding component includes a conductive structure and a substrate supporting the conductive structure.
基体能够对导电结构进行有效支撑,导电结构能够起到电磁屏蔽的作用。The substrate can effectively support the conductive structure, and the conductive structure can play a role in electromagnetic shielding.
在一个示例中,导电结构为与基体层叠布置的导电层。In one example, the conductive structure is a conductive layer arranged in stacked relationship with the substrate.
在另一个示例中,导电结构为分布在基体中的导电网格或导电颗粒。In another example, the conductive structure is a conductive grid or conductive particles distributed in the matrix.
根据这种构造,导电结构将能够为连接线的置于电磁屏蔽件中的部分提供电磁屏蔽。这确保了信号传输路径上的电磁兼容性,减少了信号衰减和干扰,维持了介于控制装置和交互装置之间的数据交换的高保真度和低延迟性。According to this configuration, the conductive structure will be able to provide electromagnetic shielding for the portion of the connection line placed in the electromagnetic shielding member. This ensures electromagnetic compatibility on the signal transmission path, reduces signal attenuation and interference, and maintains high fidelity and low latency of data exchange between the control device and the interactive device.
作为一种可能的实现方式,基体以至少一个连接线为嵌件注塑而成。As a possible implementation manner, the base body is formed by injection molding with at least one connecting line as an insert.
通过注塑工艺直接将连接线包覆于基体内部,基体将对连接线进行支撑和固定,这样的集成方式减少了连接点,提升了整个系统的机械稳定性。另外,这种方式集成了连接线的固定与基体成型于一体,简化了组装步骤,减少了制造成本。另外,集成在一起的连接线和电磁屏蔽件在后续的工序中将作为整体被组装,这有助于进一步降低制造难度,减小制造成本。The connecting wires are directly wrapped inside the matrix through the injection molding process, and the matrix will support and fix the connecting wires. This integration method reduces the connection points and improves the mechanical stability of the entire system. In addition, this method integrates the fixation of the connecting wires with the molding of the matrix, simplifies the assembly steps, and reduces manufacturing costs. In addition, the integrated connecting wires and electromagnetic shielding parts will be assembled as a whole in the subsequent process, which helps to further reduce the manufacturing difficulty and reduce the manufacturing cost.
作为一种可能的实现方式,导电结构与至少一个连接线绝缘且与第一壳体部分电连接。As a possible implementation manner, the conductive structure is insulated from the at least one connecting line and is electrically connected to the first housing portion.
导电结构与第一壳体部分电连接,形成了一个闭合的屏蔽回路,能够更有效地阻挡外部电磁干扰,同时减少内部电子组件产生的电磁辐射对外界的影响。导电结构与至少一个连接线绝缘,避免了导电结构对信号传输的影响。The conductive structure is electrically connected to the first housing portion to form a closed shielding loop, which can more effectively block external electromagnetic interference and reduce the impact of electromagnetic radiation generated by internal electronic components on the outside world. The conductive structure is insulated from at least one connecting line to avoid the influence of the conductive structure on signal transmission.
作为一种可能的实现方式,电磁屏蔽件包括连接部,连接部包括周壁部和凸缘部,周壁部围绕基体,凸缘部从周壁部的外表面向外凸出。As a possible implementation manner, the electromagnetic shielding component includes a connecting portion, the connecting portion includes a peripheral wall portion and a flange portion, the peripheral wall portion surrounds the base body, and the flange portion protrudes outward from an outer surface of the peripheral wall portion.
周壁部能够接收电磁屏蔽件的基体,确保其被可靠定位。凸缘部的外凸结构提供了额外的机械支撑,增强了电磁屏蔽件与壳体部分间的连接强度,能够更好地抵御体内外各种力学应力,如挤压、扭曲等,从而提高了植入装置的稳定性和耐用性。The peripheral wall portion can receive the base of the electromagnetic shielding component to ensure that it is reliably positioned. The convex structure of the flange portion provides additional mechanical support, enhances the connection strength between the electromagnetic shielding component and the shell portion, and can better resist various mechanical stresses inside and outside the body, such as extrusion, twisting, etc., thereby improving the stability and durability of the implant device.
作为一种可能的实现方式,导电结构通过连接部与第一壳体部分电连接。As a possible implementation manner, the conductive structure is electrically connected to the first shell portion via a connecting portion.
这样一来,这种构造确保了导电结构与第一壳体部分之间形成一个连续且低阻抗的电连接路径,有助于形成一个完整的电磁屏蔽回路,更有效地屏蔽外部电磁干扰,同时减少内部产生的电磁辐射泄漏,提升了整个电刺激系统的电磁兼容性和治疗的可靠性。连接部既具有支撑、定位屏蔽件的作用,由具有导通屏蔽件与第一壳体部分的电连接的作用。同一构件具有多个作用,这有助于降低结构的复杂程度和制造成本。In this way, this structure ensures that a continuous and low-impedance electrical connection path is formed between the conductive structure and the first shell part, which helps to form a complete electromagnetic shielding loop, more effectively shielding external electromagnetic interference, while reducing the leakage of electromagnetic radiation generated internally, and improving the electromagnetic compatibility and treatment reliability of the entire electrical stimulation system. The connecting part has the function of supporting and positioning the shielding member, and has the function of conducting the electrical connection between the shielding member and the first shell part. The same component has multiple functions, which helps to reduce the complexity of the structure and the manufacturing cost.
作为一种可能的实现方式,基体以至少一个连接线和连接部为嵌件注塑而成。As a possible implementation manner, the base body is formed by insert injection molding with at least one connecting line and a connecting portion.
这种方式集成了连接线的固定、连接部的固定以及基体成型于一体,简化了组装步骤,减少了制造成本。另外,集成在一起的连接线、连接部以及电磁屏蔽件在后续的工序中将作为整体被组装,这有助于进一步降低制造难度,减小制造成本。周壁部界定了物料的流动范围,有助于控制注塑过程中的物料分布。This method integrates the fixing of the connecting wire, the fixing of the connecting part and the molding of the base, simplifies the assembly steps and reduces the manufacturing cost. In addition, the integrated connecting wire, connecting part and electromagnetic shielding part will be assembled as a whole in the subsequent process, which helps to further reduce the manufacturing difficulty and reduce the manufacturing cost. The peripheral wall defines the flow range of the material, which helps to control the material distribution during the injection molding process.
作为一种可能的实现方式,控制装置包括沿第一壳体部分的厚度方向层叠且间隔布置的第一电路板和第二电路板。第一电路板在厚度方向上具有相对的有电子器件面和无电子器件面,有电子器件面与第二电路板面相对,无电子器件面与第一壳体部分的内表面抵触。As a possible implementation, the control device includes a first circuit board and a second circuit board stacked and spaced apart in the thickness direction of the first housing portion. The first circuit board has an electronic device surface and an electronic device-free surface opposite to each other in the thickness direction, the electronic device surface is opposite to the second circuit board surface, and the electronic device-free surface is in contact with the inner surface of the first housing portion.
在厚度方向上叠置的两层电路板,充分利用了厚度方向的空间,避免植入式电刺激器面积过大。通过无电子器件面与第一壳体部分的内表面直接抵触,且将电子器件集中在两个电路板之间,提高了第一壳体部分内部空间在厚度方向上的利用率,使得在集成更多的电子元件,满足复杂功能需求的前提下,不增加装置整体大小。The two layers of circuit boards stacked in the thickness direction make full use of the space in the thickness direction to avoid the implantable electrical stimulator being too large. The surface without electronic components directly contacts the inner surface of the first shell part, and the electronic components are concentrated between the two circuit boards, which improves the utilization rate of the internal space of the first shell part in the thickness direction, so that more electronic components can be integrated to meet complex functional requirements without increasing the overall size of the device.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
应当理解,以下附图仅示出了本公开的某些实施例,不应看作是对范围的限制。It should be understood that the following drawings only illustrate certain embodiments of the present disclosure and should not be viewed as limiting the scope.
应当理解,在附图中使用相同或相似的附图标记来表示相同或相似的要素。It should be understood that the same or similar reference numerals are used in the drawings to indicate the same or similar elements.
应当理解,附图仅是示意性的,附图中的要素的尺寸和比例不一定精确。It should be understood that the drawings are merely schematic and that the sizes and proportions of elements in the drawings are not necessarily accurate.
图1示出了根据本公开一实施例的脊髓刺激系统的示意图。FIG. 1 shows a schematic diagram of a spinal cord stimulation system according to an embodiment of the present disclosure.
图2是图1的植入式电刺激器的结构示意图。FIG. 2 is a schematic structural diagram of the implantable electrical stimulator of FIG. 1 .
图3是图1中的植入式电刺激器的内部结构示意图。FIG. 3 is a schematic diagram of the internal structure of the implantable electrical stimulator in FIG. 1 .
图4是图1中的植入式电刺激器的一部分构件的分解示意图。FIG. 4 is an exploded schematic diagram of a portion of components of the implantable electrical stimulator in FIG. 1 .
图5是图1中的植入式电刺激器的一部分构件的结构示意图。FIG. 5 is a schematic structural diagram of a portion of components of the implantable electrical stimulator in FIG. 1 .
图6是图4中的电磁屏蔽件的结构示意图。FIG. 6 is a schematic structural diagram of the electromagnetic shielding component in FIG. 4 .
图7是图3中的电路板、第一壳体部分以及电池的结构示意图。FIG. 7 is a schematic structural diagram of the circuit board, the first housing portion, and the battery in FIG. 3 .
图8是根据本公开一变形例的电磁屏蔽件的结构示意图。FIG. 8 is a schematic structural diagram of an electromagnetic shielding component according to a modified example of the present disclosure.
图9是根据本公开另一变形例的电磁屏蔽件的结构示意图。FIG. 9 is a schematic structural diagram of an electromagnetic shielding component according to another variation of the present disclosure.
图10是根据本公开另一变形例的植入式电刺激器的结构示意图。FIG. 10 is a schematic diagram of the structure of an implantable electrical stimulator according to another variation of the present disclosure.
具体实施方式DETAILED DESCRIPTION
下面结合附图,对本公开的实施例进行示例性地描述。应当理解,本公开的实现方式可以有多种,不应被解释为局限于这里阐述的实施例,这里阐述的实施例仅是为了更加透彻和清楚地理解本公开。The following is an exemplary description of the embodiments of the present disclosure in conjunction with the accompanying drawings. It should be understood that the present disclosure can be implemented in a variety of ways and should not be construed as being limited to the embodiments described herein, which are only for a more thorough and clear understanding of the present disclosure.
为了便于理解,下面参考图1,先对本公开提供的植入式电刺激器100所使用的电刺激系统进行举例说明。可以理解的是,在不存在矛盾的前提下,植入式电刺激器100可以适用于其它电刺激系统。For ease of understanding, the electrical stimulation system used by the implantable electrical stimulator 100 provided by the present disclosure is first illustrated with reference to Fig. 1. It is understandable that the implantable electrical stimulator 100 can be applied to other electrical stimulation systems under the premise that there is no contradiction.
参见图1,电刺激系统可以包括植入式电刺激器100、体外程控设备50和体外充电装置60。体外程控设备50和体外充电装置60也可以被称为体外设备。如图1所示,植入式电刺激器100可以被全部或部分地植入到患者的体内。需要说明的是,在图1中,附图标记SC用于指示患者的脊髓,附图标记SK用于指示患者的皮肤。Referring to FIG1 , the electrical stimulation system may include an implantable electrical stimulator 100, an external programming device 50, and an external charging device 60. The external programming device 50 and the external charging device 60 may also be referred to as external devices. As shown in FIG1 , the implantable electrical stimulator 100 may be implanted in whole or in part into the patient's body. It should be noted that in FIG1 , the reference numeral SC is used to indicate the patient's spinal cord, and the reference numeral SK is used to indicate the patient's skin.
植入式电刺激器100可以包括电极引线30。仅以示例的方式,电极引线30的至少部分可以被植入到患者的脊髓硬膜外腔中。当然,在其它示例中,电极引线30也可以被植入到其它外周神经处。电极引线30包括多个电极触点40。示例性地,电极触点40的个数可以为2个、4个、6个或8个。当然,在其它示例中,电极触点40的个数也可以为其它数量,本公开对于电极触点40的数量不做具体限定。例如,在某些实施例中,电极触点40的数量也可以为奇数。The implantable electrical stimulator 100 may include an electrode lead 30. By way of example only, at least a portion of the electrode lead 30 may be implanted into the patient's spinal epidural space. Of course, in other examples, the electrode lead 30 may also be implanted into other peripheral nerves. The electrode lead 30 includes a plurality of electrode contacts 40. Exemplarily, the number of electrode contacts 40 may be 2, 4, 6, or 8. Of course, in other examples, the number of electrode contacts 40 may also be other numbers, and the present disclosure does not specifically limit the number of electrode contacts 40. For example, in some embodiments, the number of electrode contacts 40 may also be an odd number.
植入式电刺激器100被配置为生成电脉冲。需要说明的是,在本公开中,电脉冲可以是指电流脉冲或电压脉冲。电脉冲经由电极引线30传递至电极触点40,并最终经电极触点40被递送至患者的目标神经,以达到缓解疼痛等治疗目的。The implantable electrical stimulator 100 is configured to generate electrical pulses. It should be noted that in the present disclosure, electrical pulses may refer to current pulses or voltage pulses. The electrical pulses are transmitted to the electrode contacts 40 via the electrode leads 30, and are ultimately delivered to the target nerves of the patient via the electrode contacts 40 to achieve therapeutic purposes such as pain relief.
根据本公开提供的植入式电刺激器100被置于患者的体内,并且可以通过例如体外充电装置60为植入式电刺激器100补充电能。同时,植入式电刺激器100也可以被构造为通过体外程控设备50来交换数据。若采用本公开提供的植入式电刺激器100,可以方便的通过体外设备实现例如无线充电,脉冲控制指令更改,数据交换等功能。The implantable electrical stimulator 100 provided by the present disclosure is placed in the patient's body, and the implantable electrical stimulator 100 can be supplemented with electrical energy through, for example, an external charging device 60. At the same time, the implantable electrical stimulator 100 can also be configured to exchange data through an external programming device 50. If the implantable electrical stimulator 100 provided by the present disclosure is used, functions such as wireless charging, pulse control instruction changes, data exchange, etc. can be conveniently realized through external devices.
为了方便理解,下面对植入式电刺激器100的构造进行举例说明。应当理解,植入式电刺激器100的构造不应局限于下面的描述。例如,下面引出的某一个或某几个要素可以被省略或替换,它们之间的布局关系可以被替换。For ease of understanding, the structure of the implantable electrical stimulator 100 is illustrated below. It should be understood that the structure of the implantable electrical stimulator 100 should not be limited to the following description. For example, one or more of the elements cited below can be omitted or replaced, and the layout relationship between them can be replaced.
例如,植入式电刺激器100可以主要由壳体部分、控制装置、交互装置及引线和电极触点组成。壳体部分的主要作用是为植入式电刺激器100的内部组件如可充电电池103、控制装置等提供一个坚固的保护层。这有助于防止外部环境的物理冲击、化学物质侵蚀和生物体的自然反应如排异反应对内部组件造成损害,确保电刺激器的稳定和安全运行。控制装置是电刺激器的核心部分,这个模块会产生一定频率、波形、脉宽、强度的电刺激脉冲。这些脉冲参数可以根据治疗需要进行调整。交互装置通常包括通信装置202和无线充电装置203等,通信装置202负责接收体外控制器的指令,将指令传输给控制装置,控制装置根据预设的参数生成刺激脉冲控制信号。有的通信装置202还提供系统启闭控制接口、刺激信号发生模块接口和程序写入接口,以确保整个系统的正常运作。通过通信装置202,医生或患者可以例如根据需要远程调整电刺激器的刺激参数,如频率、脉宽、刺激强度等。这有助于实现个性化的治疗方案,并根据治疗效果进行实时调整。有的通信装置202还可以通过发送信息,使得医务人员能够记录电刺激器的使用数据、治疗效果等信息,并将其存储在相关的设备或云端服务器上。引线及刺激生理电极是电刺激器与神经或肌肉直接接触的部分,负责将电刺激脉冲传导至目标神经或肌肉组织,从而实现对神经或肌肉的电刺激治疗。For example, the implantable electrical stimulator 100 may be mainly composed of a shell part, a control device, an interactive device, and leads and electrode contacts. The main function of the shell part is to provide a solid protective layer for the internal components of the implantable electrical stimulator 100, such as the rechargeable battery 103, the control device, etc. This helps to prevent the physical impact of the external environment, the erosion of chemical substances, and the natural reaction of the organism, such as rejection, from damaging the internal components, and ensure the stable and safe operation of the electrical stimulator. The control device is the core part of the electrical stimulator. This module can generate electrical stimulation pulses with a certain frequency, waveform, pulse width, and intensity. These pulse parameters can be adjusted according to treatment needs. The interactive device usually includes a communication device 202 and a wireless charging device 203, etc. The communication device 202 is responsible for receiving instructions from the external controller and transmitting the instructions to the control device, and the control device generates a stimulation pulse control signal according to preset parameters. Some communication devices 202 also provide a system start-up and shutdown control interface, a stimulation signal generation module interface, and a program writing interface to ensure the normal operation of the entire system. Through the communication device 202, doctors or patients can, for example, remotely adjust the stimulation parameters of the electrical stimulator, such as frequency, pulse width, stimulation intensity, etc., as needed. This helps to implement personalized treatment plans and make real-time adjustments based on the treatment effect. Some communication devices 202 can also send information so that medical staff can record the use data, treatment effects and other information of the electrical stimulator, and store them on related equipment or cloud servers. The leads and stimulating physiological electrodes are the parts of the electrical stimulator that are in direct contact with the nerves or muscles, and are responsible for transmitting electrical stimulation pulses to the target nerves or muscle tissues, thereby achieving electrical stimulation treatment of the nerves or muscles.
参考图2和图3,一个实施例中,壳体部分将植入体内的刺激器分成两部分,第一壳体部分10、第二壳体部分20。第一壳体部分10收纳控制装置及电池103,控制装置包括例如沿第一壳体部分10的厚度方向层叠且间隔布置的第一电路板101和第二电路板102,以及例如在第一电路板101和第二电路板102旁侧布置的电池103,电池103与第二电路板102相连接,用以对控制装置提供电能。第二壳体部分20位于第一壳体部分10背离电池103方向,容纳交互装置,交互装置包括例如通信装置202和无线充电装置203。通信装置202例如为螺旋缠绕的天线,通过连接线205与控制装置相连接,无线充电装置203例如为感应线圈,通过连接线205可以连接至控制装置,感应线圈例如可贴临第二壳体部分20的内表面。Referring to FIG. 2 and FIG. 3 , in one embodiment, the housing portion divides the implanted stimulator into two parts, a first housing portion 10 and a second housing portion 20. The first housing portion 10 accommodates a control device and a battery 103. The control device includes, for example, a first circuit board 101 and a second circuit board 102 stacked and arranged at intervals along the thickness direction of the first housing portion 10, and, for example, a battery 103 arranged beside the first circuit board 101 and the second circuit board 102. The battery 103 is connected to the second circuit board 102 to provide power to the control device. The second housing portion 20 is located in the first housing portion 10 away from the battery 103 and accommodates an interactive device. The interactive device includes, for example, a communication device 202 and a wireless charging device 203. The communication device 202 is, for example, a spirally wound antenna connected to the control device via a connecting line 205. The wireless charging device 203 is, for example, an induction coil that can be connected to the control device via a connecting line 205. The induction coil can, for example, be attached to the inner surface of the second housing portion 20.
作为一个实施例,其中第一壳体部分10构造为至少部分地形成控制装置相对于外部环境的电磁屏蔽,第二壳体部分20构造为允许至少一个交互装置与体外设备无线地交互。As an embodiment, the first housing portion 10 is configured to at least partially form an electromagnetic shielding of the control device relative to the external environment, and the second housing portion 20 is configured to allow at least one interaction device to wirelessly interact with the external device.
第一壳体部分10可以是金属制成,例如钛合金。作为电磁屏蔽层,第一壳体部分10主要目的是保护内部的电子组件如脉冲发生器等电子元件不受外部电磁干扰EMI。这在无线通信设备日益增多、电磁环境复杂的现代社会尤为重要,能够确保设备稳定运行,避免误操作或功能失效。The first housing portion 10 may be made of metal, such as titanium alloy. As an electromagnetic shielding layer, the first housing portion 10 is mainly used to protect internal electronic components such as pulse generators from external electromagnetic interference EMI. This is particularly important in the modern society where wireless communication devices are increasing and the electromagnetic environment is complex, and can ensure stable operation of the device and avoid misoperation or functional failure.
进一步的,如图3,植入式电刺激器100还包括电磁屏蔽件204,第一壳体部分10设有穿通通道1001(图中未示出),电磁屏蔽件204封堵穿通通道1001,至少一个交互装置分别通过至少一个连接线205与控制装置电连接;每个连接线205一端与控制装置电连接,且其另一端经过电磁屏蔽件204与对应的交互装置电连接。Furthermore, as shown in FIG3 , the implantable electrical stimulator 100 also includes an electromagnetic shielding component 204 , the first shell portion 10 is provided with a through channel 1001 (not shown in the figure), the electromagnetic shielding component 204 blocks the through channel 1001 , and at least one interactive device is electrically connected to the control device via at least one connecting wire 205 ; one end of each connecting wire 205 is electrically connected to the control device, and the other end thereof is electrically connected to the corresponding interactive device via the electromagnetic shielding component 204 .
将电磁屏蔽件204与穿通通道1001的封堵一体化构造,展现了高集成度和空间利用效率,有利于缩小植入设备的体积,减少对患者的生理和心理负担。The integrated structure of the electromagnetic shielding component 204 and the plugging of the through channel 1001 demonstrates high integration and space utilization efficiency, which is conducive to reducing the size of the implanted device and reducing the physiological and psychological burden on the patient.
更进一步的,电磁屏蔽件包括导电结构和支撑导电结构的基体2042。Furthermore, the electromagnetic shielding component includes a conductive structure and a substrate 2042 supporting the conductive structure.
导电结构作为屏蔽的核心部分,导电结构能够反射或吸收外部的电磁波,形成一道屏障,有效阻挡干扰信号穿透至内部电路或导线。良好的导电性能确保了电磁屏蔽的高效性。这种组合构造允许根据实际需求灵活调整屏蔽件的形状、尺寸和布局,使之能够紧密贴合植入式电极的具体结构,同时集成到整个设备中,不影响电极的其他功能和操作。As the core part of the shield, the conductive structure can reflect or absorb external electromagnetic waves to form a barrier, effectively blocking interference signals from penetrating into internal circuits or wires. Good conductivity ensures the high efficiency of electromagnetic shielding. This combined structure allows the shape, size and layout of the shield to be flexibly adjusted according to actual needs, so that it can fit the specific structure of the implantable electrode closely and be integrated into the entire device without affecting other functions and operations of the electrode.
进一步的,导电结构为分布在基体2042中的导电网格(如图6)。Furthermore, the conductive structure is a conductive grid distributed in the substrate 2042 (as shown in FIG. 6 ).
在一个植入式电极构造中,导电结构采用了分布在基体2042中的导电网格,导电网格由细小的导电线条构成,这些线条可能是由银、铜或其他高导电性金属的微细丝编织,形成规则或不规则的网格图案。网格构造旨在最大化表面积,以更有效地反射或吸收外部电磁波。当外部电磁辐射遇到导电网格时,由于网格的高导电性,电磁波会在网格表面产生感应电流,这些电流会产生反向的电磁场,与原入射波相互抵消,从而实现对外部电磁干扰的有效屏蔽。此外,网格结构还允许一定程度的灵活性和延展性,使得整个植入式电极能够适应身体的动态变化,而不会影响其屏蔽效能。In an implantable electrode structure, the conductive structure uses a conductive grid distributed in the matrix 2042. The conductive grid is composed of fine conductive lines, which may be woven from fine filaments of silver, copper or other highly conductive metals to form a regular or irregular grid pattern. The grid structure is designed to maximize the surface area to more effectively reflect or absorb external electromagnetic waves. When external electromagnetic radiation encounters the conductive grid, due to the high conductivity of the grid, the electromagnetic waves will generate induced currents on the surface of the grid. These currents will generate reverse electromagnetic fields, which will cancel each other out with the original incident waves, thereby achieving effective shielding of external electromagnetic interference. In addition, the grid structure also allows a certain degree of flexibility and ductility, so that the entire implantable electrode can adapt to the dynamic changes of the body without affecting its shielding effectiveness.
更进一步的,基体2042以至少一个连接线205为嵌件注塑而成。Furthermore, the base body 2042 is formed by injection molding with at least one connecting line 205 as an insert.
嵌件注塑是一种高效的一体化成型技术,能够将多个组件基体2042材料和连接线205一次性整合成型,相比传统组装方式大大简化了生产流程,降低了制造成本,同时提高了生产效率和产品一致性。嵌件注塑允许高度定制化构造,可以根据植入电极的具体结构和功能需求,精确地定位和形状构造连接线205的路径和分布,优化电极的结构紧凑性和功能性。Insert molding is an efficient integrated molding technology that can integrate multiple component substrates 2042 materials and connecting wires 205 into a one-time molding process. Compared with traditional assembly methods, it greatly simplifies the production process, reduces manufacturing costs, and improves production efficiency and product consistency. Insert molding allows for highly customized construction, and can accurately locate and shape the path and distribution of the connecting wires 205 according to the specific structure and functional requirements of the implanted electrode, thereby optimizing the structural compactness and functionality of the electrode.
更进一步的,导电结构与连接线205绝缘且与第一壳体部分10电连接。Furthermore, the conductive structure is insulated from the connecting wire 205 and is electrically connected to the first housing portion 10 .
通过将导电结构与第一壳体部分10电连接,形成了一个闭合的屏蔽体。这意味着整个植入式电极的第一壳体部分10变成了一个大型的法拉第笼,有效阻止外部电磁波的穿透,保护内部电路和连接线205免受干扰。这种构造确保了屏蔽的连续性和完整性,提高了屏蔽效率。电连接提供了低阻抗的接地路径,有助于快速引导和耗散任何因屏蔽作用而产生的感应电流,减少在系统内部形成闭合回路的可能性,进而避免了因接地回路引起的干扰问题。连接线205通常用于传输信号,保持其与导电结构的绝缘可以有效防止外部电磁场通过导电结构耦合到连接线205上,干扰原本传输的信号,这对于数据采集等的精确性至关重要。By electrically connecting the conductive structure to the first shell portion 10, a closed shielding body is formed. This means that the first shell portion 10 of the entire implantable electrode becomes a large Faraday cage, which effectively prevents the penetration of external electromagnetic waves and protects the internal circuit and the connecting wire 205 from interference. This structure ensures the continuity and integrity of the shielding and improves the shielding efficiency. The electrical connection provides a low-impedance grounding path, which helps to quickly guide and dissipate any induced current generated by the shielding effect, reduce the possibility of forming a closed loop within the system, and thus avoid interference problems caused by the grounding loop. The connecting wire 205 is usually used to transmit signals, and keeping it insulated from the conductive structure can effectively prevent the external electromagnetic field from coupling to the connecting wire 205 through the conductive structure and interfering with the originally transmitted signal, which is crucial for the accuracy of data acquisition, etc.
更进一步的,电磁屏蔽件包括连接部2041,连接部2041包括周壁部2041a和凸缘部2041b,周壁部2041a围绕基体2042,凸缘部2041b从周壁部的外表面向外凸出。Furthermore, the electromagnetic shielding member includes a connecting portion 2041 , and the connecting portion 2041 includes a peripheral wall portion 2041 a and a flange portion 2041 b . The peripheral wall portion 2041 a surrounds the base 2042 , and the flange portion 2041 b protrudes outward from an outer surface of the peripheral wall portion.
电磁屏蔽件的构造中,连接部2041的结构包括周壁部2041a和凸缘部2041b,凸缘部2041b具体作用在于提供一种高效且可靠的连接方式,以覆盖并保护植入式电极第一壳体部分10所设的穿通通道1001,同时增强整体的电磁屏蔽效能。周壁部2041a形成凹槽结构,使得在一体注塑过程中,液态基体2042材料能够充分流入并填充这些凹槽,冷却固化后,形成牢固的机械互锁结构。这种构造显著增强了电磁屏蔽件与基体2042材料之间的结合强度,确保了长期植入的稳固性和耐用性。凹槽构造简化了一体注塑成型的工艺流程,通过自然流动填充,减少了额外的组装步骤和粘合剂的使用,提高了生产效率,同时也降低了制造成本。通过精心构造的凹槽结构,可以适应交互装置经过基体2042时可能的复杂多变的几何形状,即便是细微或不规则的区域也能得到有效覆盖和保护,增加了构造的灵活性,使得交互装置能够更加贴合电极的具体需求。In the structure of the electromagnetic shielding component, the structure of the connecting portion 2041 includes a peripheral wall portion 2041a and a flange portion 2041b. The flange portion 2041b specifically functions to provide an efficient and reliable connection method to cover and protect the through-channel 1001 provided in the first shell portion 10 of the implantable electrode, while enhancing the overall electromagnetic shielding effectiveness. The peripheral wall portion 2041a forms a groove structure, so that during the one-piece injection molding process, the liquid matrix 2042 material can fully flow into and fill these grooves, and after cooling and solidification, a strong mechanical interlocking structure is formed. This structure significantly enhances the bonding strength between the electromagnetic shielding component and the matrix 2042 material, ensuring the stability and durability of long-term implantation. The groove structure simplifies the process flow of one-piece injection molding, reduces additional assembly steps and the use of adhesives through natural flow filling, improves production efficiency, and also reduces manufacturing costs. Through the carefully constructed groove structure, the possible complex and changeable geometric shapes of the interactive device when passing through the substrate 2042 can be adapted, and even tiny or irregular areas can be effectively covered and protected, which increases the flexibility of the structure and enables the interactive device to better fit the specific needs of the electrode.
图3、图4及图5展示了交互装置与连接部2041,基体2042,穿通通道1001、信号线2010之间的相互位置关系。3 , 4 and 5 show the relative positional relationship between the interactive device and the connecting portion 2041 , the base 2042 , the through channel 1001 and the signal line 2010 .
另一方面,如图7,控制装置包括沿第一壳体部分10的厚度方向层叠且间隔布置的第一电路板101和第二电路板102,第一电路板101在厚度方向上具有相对的有电子器件面和无电子器件面,有电子器件面与第二电路板102面相对,无电子器件面与第一壳体部分10的内表面抵触。On the other hand, as shown in Figure 7, the control device includes a first circuit board 101 and a second circuit board 102 stacked and spaced apart in the thickness direction of the first shell portion 10. The first circuit board 101 has a relative surface with electronic components and a surface without electronic components in the thickness direction. The surface with electronic components is opposite to the surface of the second circuit board 102, and the surface without electronic components is in contact with the inner surface of the first shell portion 10.
第一电路板101的无电子器件面直接与第一壳体部分10的内表面抵触,如图7所示图中仅表示部分壳体部分,意味着电路板背面没有额外的组件或突起,并且沿厚度方向堆叠电路板,而不是传统的平行放置,极大程度上节省了植入式电极内部的空间。这种构造使得设备可以更加紧凑,减小了植入体积,从而减轻了对患者身体的负担,同时也便于在狭小的体内环境中植入。The non-electronic device surface of the first circuit board 101 directly contacts the inner surface of the first housing portion 10. As shown in FIG. 7, only part of the housing portion is shown in the figure, which means that there are no additional components or protrusions on the back of the circuit board, and the circuit boards are stacked in the thickness direction instead of the traditional parallel placement, which greatly saves the space inside the implantable electrode. This structure makes the device more compact, reduces the implant volume, thereby reducing the burden on the patient's body, and is also convenient for implantation in a narrow in vivo environment.
可选择的,至少一个交互装置包括通信装置202和/或无线充电装置203。Optionally, the at least one interaction device includes a communication device 202 and/or a wireless charging device 203 .
接下来介绍其他可能的变形实施例。Other possible variant embodiments are introduced next.
如图8所示,在一个变形例中,导电结构为分布在基体2042中的导电颗粒。As shown in FIG. 8 , in a variation, the conductive structure is conductive particles distributed in the matrix 2042 .
另一个植入式电极构造中,导电结构采用了分布在基体2042中的导电颗粒。这一构造通过将微小的导电颗粒均匀掺杂在基体2042中,形成了一种导电复合材料,既保留了基体2042材料的机械性能,又赋予了整体结构电磁屏蔽的能力。导电颗粒通常为金属粉末如银、铜、镍粉或者碳基材料如石墨烯、碳纳米管,这些材料具有优异的导电性能。颗粒大小一般在微米或纳米级别,以便更好地分散在基体2042中,同时减小对材料整体柔韧性的影响。In another implantable electrode structure, the conductive structure uses conductive particles distributed in the matrix 2042. This structure forms a conductive composite material by uniformly doping tiny conductive particles in the matrix 2042, which not only retains the mechanical properties of the matrix 2042 material, but also gives the overall structure the ability of electromagnetic shielding. The conductive particles are usually metal powders such as silver, copper, nickel powder or carbon-based materials such as graphene and carbon nanotubes, which have excellent conductive properties. The particle size is generally at the micrometer or nanometer level, so that it can be better dispersed in the matrix 2042 while reducing the impact on the overall flexibility of the material.
如图9所示,在另一个变形例中,导电结构为与基体2042层叠布置的导电层2043。As shown in FIG. 9 , in another variation, the conductive structure is a conductive layer 2043 stacked with a substrate 2042 .
导电层2043通常由薄层的金属箔如铜箔、铝箔或是涂布有导电材料如银浆、碳墨的薄膜构成,具有高导电性和良好的电磁波反射能力。The conductive layer 2043 is usually composed of a thin layer of metal foil such as copper foil, aluminum foil, or a film coated with a conductive material such as silver paste or carbon ink, and has high conductivity and good electromagnetic wave reflection capability.
如图10所示,在另一个变形例中,无线充电装置203与基体2042中的导电部分共同连接至转换电路105,同时转换电路105与电池103、第一电路板101、第一壳体部分10电连接。特殊构造的转换电路105发挥了至关重要的作用,使得无线充电装置203在工作模式下也能提供部分屏蔽功能。充电模式下,植入式刺激器处于无线充电状态。一旦充电完成,转换电路105接收到充电完成信号或根据预设时间/电量阈值,并同时开启无线充电装置203与第一壳体部分10的电连接,使得无线充电装置203作为电磁屏蔽的部分。这一构成进一步完善信号屏蔽过程,使得引线连接装置201被进一步电磁屏蔽的同时,屏蔽不会干扰交互装置。As shown in FIG. 10 , in another variation, the wireless charging device 203 and the conductive part in the substrate 2042 are connected to the conversion circuit 105, and the conversion circuit 105 is electrically connected to the battery 103, the first circuit board 101, and the first shell part 10. The specially constructed conversion circuit 105 plays a crucial role, so that the wireless charging device 203 can also provide a partial shielding function in the working mode. In the charging mode, the implantable stimulator is in a wireless charging state. Once the charging is completed, the conversion circuit 105 receives a charging completion signal or according to a preset time/power threshold, and simultaneously opens the electrical connection between the wireless charging device 203 and the first shell part 10, so that the wireless charging device 203 serves as part of the electromagnetic shielding. This structure further improves the signal shielding process, so that the lead connection device 201 is further electromagnetically shielded, and the shielding does not interfere with the interactive device.
以上结合具体实施例描述了本公开的基本原理,但是,需要指出的是,在本公开中提及的优点、优势、效果等仅是示例而非限制,不能认为这些优点、优势、效果等是本公开的各个实施例必须具备的。另外,上述公开的具体细节仅是为了示例的作用和便于理解的作用,而非限制,上述细节并不限制本公开为必须采用上述具体的细节来实现。The basic principles of the present disclosure are described above in conjunction with specific embodiments. However, it should be noted that the advantages, strengths, effects, etc. mentioned in the present disclosure are only examples and not limitations, and it cannot be considered that these advantages, strengths, effects, etc. must be possessed by each embodiment of the present disclosure. In addition, the specific details disclosed above are only for the purpose of illustration and ease of understanding, rather than limitation, and the above details do not limit the present disclosure to the necessity of adopting the above specific details to be implemented.
为了例示和描述的目的已经给出了以上描述。此外,此描述不意图将本公开的实施例限制到在此公开的形式。尽管以上已经讨论了多个示例方面和实施例,但是本领域技术人员将认识到其某些变型、修改、改变、添加和子组合。The above description has been given for the purpose of illustration and description. In addition, this description is not intended to limit the embodiments of the present disclosure to the forms disclosed herein. Although multiple example aspects and embodiments have been discussed above, those skilled in the art will recognize certain variations, modifications, changes, additions and sub-combinations thereof.
本公开中涉及的部件、装置仅作为例示性的例子并且不意图要求或暗示必须按照附图示出的方式进行连接、布置、配置。如本领域技术人员将认识到的,可以按任意方式连接、布置、配置这些部件、装置。The components and devices involved in this disclosure are only illustrative examples and are not intended to require or imply that they must be connected, arranged, or configured in the manner shown in the drawings. As will be appreciated by those skilled in the art, these components and devices may be connected, arranged, or configured in any manner.
以上,仅为本公开的具体实施方式,但本公开的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本公开揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本公开的保护范围之内。因此,本公开的保护范围应以权利要求的保护范围。The above are only specific embodiments of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any technician familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed in the present disclosure, which should be included in the protection scope of the present disclosure. Therefore, the protection scope of the present disclosure should be based on the protection scope of the claims.
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