CN115006724A - Sealing Devices and Implantable Medical Systems - Google Patents
Sealing Devices and Implantable Medical Systems Download PDFInfo
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- CN115006724A CN115006724A CN202110246711.7A CN202110246711A CN115006724A CN 115006724 A CN115006724 A CN 115006724A CN 202110246711 A CN202110246711 A CN 202110246711A CN 115006724 A CN115006724 A CN 115006724A
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- 238000007789 sealing Methods 0.000 title claims abstract description 150
- 238000003780 insertion Methods 0.000 claims abstract description 47
- 230000037431 insertion Effects 0.000 claims abstract description 47
- 230000005489 elastic deformation Effects 0.000 claims abstract description 7
- 239000000945 filler Substances 0.000 claims description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 8
- 238000000034 method Methods 0.000 abstract description 4
- 230000008569 process Effects 0.000 abstract description 3
- 230000000638 stimulation Effects 0.000 description 7
- 210000004556 brain Anatomy 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 238000001356 surgical procedure Methods 0.000 description 4
- 238000013461 design Methods 0.000 description 3
- 238000001727 in vivo Methods 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 238000010586 diagram Methods 0.000 description 2
- 230000007383 nerve stimulation Effects 0.000 description 2
- 230000000149 penetrating effect Effects 0.000 description 2
- 229920001296 polysiloxane Polymers 0.000 description 2
- 208000018737 Parkinson disease Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 210000005013 brain tissue Anatomy 0.000 description 1
- 210000003169 central nervous system Anatomy 0.000 description 1
- 210000003710 cerebral cortex Anatomy 0.000 description 1
- 230000007012 clinical effect Effects 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 238000005336 cracking Methods 0.000 description 1
- 230000001066 destructive effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000003822 epoxy resin Substances 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 229920000647 polyepoxide Polymers 0.000 description 1
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- 229920002635 polyurethane Polymers 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 210000000278 spinal cord Anatomy 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
- 210000001186 vagus nerve Anatomy 0.000 description 1
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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
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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
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
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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
- A61N1/36125—Details of circuitry or electric components
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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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
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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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/3758—Packaging of the components within the casing
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Abstract
Description
技术领域technical field
本发明涉及医疗器械技术领域,特别涉及一种密封装置及植入式医疗系统。The invention relates to the technical field of medical devices, in particular to a sealing device and an implantable medical system.
背景技术Background technique
随着介入医疗手术和神经电子科学技术的发展,植入式神经刺激系统被广泛地应用于临床。根据神经刺激系统被植入的部位和所治疗的疾病科分为:脑深部电刺激(DBS)、脑皮层电刺激(CNS)、脊髓电刺激(SCS)、骶神经电刺激(SNS)、迷走神经电刺激(VNS)等。With the development of interventional medical surgery and neuroelectronic science and technology, implantable neurostimulation systems are widely used in clinical practice. According to the site where the neurostimulation system is implanted and the diseases to be treated, it is divided into: deep brain stimulation (DBS), cerebral cortex stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), vagus nerve stimulation Electrical stimulation (VNS), etc.
其中,脑深部电刺激(DBS)凭借其优于损毁手术的临床效果,不破坏脑组织的神经介入手术过程以及治疗方案的可逆,成为世界范围内晚期帕金森病的首选治疗手段。现有的脑深部电刺激系统主要由植入体内的脉冲发生器(IPG),刺激电极(Lead),体内延长导线(Extension),体外程控设备(Programer&Remoter)以及相关手术工具(Surgical tool)等部分组成。Among them, deep brain stimulation (DBS) has become the preferred treatment for advanced Parkinson's disease worldwide due to its clinical effect superior to destructive surgery, neuro-interventional surgery that does not destroy brain tissue, and reversibility of treatment options. The existing deep brain stimulation system mainly consists of implanted pulse generator (IPG), stimulating electrode (Lead), in vivo extension lead (Extension), external program control equipment (Programer&Remoter) and related surgical tools (Surgical tool) and other parts. composition.
在DBS系统中,体内电极延长线和脉冲发生器IPG的连接头通过紧固件固定。手术时,医生使用操作工具(如扭力扳手)穿入防水密封件后插入至紧固件上进行锁紧或拧松操作,如果操作不当或操作时间过长,可能会造成防水密封件脱落和撕裂,从而增加防水密封件漏水的风险。In the DBS system, the connector of the in-vivo electrode extension wire and the pulse generator IPG is fixed by fasteners. During surgery, the doctor uses an operating tool (such as a torque wrench) to penetrate the waterproof seal and then insert it into the fastener for locking or loosening operations. cracking, thereby increasing the risk of leaking water from the waterproof seal.
发明内容SUMMARY OF THE INVENTION
本发明的目的在于提供一种密封装置及植入式医疗系统,以解决现有防水密封件容易脱落和撕裂,从而增加漏水风险的问题。The purpose of the present invention is to provide a sealing device and an implantable medical system to solve the problem that the existing waterproof seal is easy to fall off and tear, thereby increasing the risk of water leakage.
为解决上述技术问题,本发明提供一种密封装置,用于供操作工具穿行以对紧固件进行操作,包括:密封主体,所述密封主体包括至少两个弹性结构和位于相邻两个弹性结构之间的空腔结构,所有所述弹性结构沿所述操作工具的插入方向依次设置,所述弹性结构用于在所述操作工具穿行时通过弹性形变对所述操作工具形成密封。In order to solve the above-mentioned technical problem, the present invention provides a sealing device for an operating tool to pass through to operate a fastener, comprising: a sealing main body, the sealing main body includes at least two elastic structures and two elastic structures located adjacent to each other. In the cavity structure between the structures, all the elastic structures are arranged in sequence along the insertion direction of the operating tool, and the elastic structures are used to seal the operating tool through elastic deformation when the operating tool passes through.
可选的,在所述的密封装置中,所述弹性结构为弹性体,所述弹性体具有沿所述操作工具的插入方向设置的穿行通道,用于供所述操作工具穿行,所述穿行通道在所述操作工具插入之前闭合,以及在所述操作工具插入之后最小宽度与所述操作工具的插入部分的宽度相适应。Optionally, in the sealing device, the elastic structure is an elastic body, and the elastic body has a passageway provided along the insertion direction of the operating tool for the operating tool to pass through, and the passing through The channel is closed before the insertion of the operation tool, and the minimum width is adapted to the width of the insertion portion of the operation tool after the insertion of the operation tool.
可选的,在所述的密封装置中,所述穿行通道为直型通道,所述操作工具在插入所述穿行通道之后,插入部分沿自身周向与所述弹性体呈面型贴合;或者,所述穿行通道为沙漏型通道,所述操作工具在插入所述穿行通道之后,插入部分沿自身周向与所述弹性体呈线型贴合。Optionally, in the sealing device, the passing channel is a straight channel, and after the operating tool is inserted into the passing channel, the insertion part is in a surface fit with the elastic body along its own circumferential direction; Alternatively, the passageway is an hourglass-shaped passageway, and after the operating tool is inserted into the passageway, the insertion portion is in line fit with the elastic body along its own circumferential direction.
可选的,在所述的密封装置中,所述密封装置还包括:防撕裂环,所述防撕裂环设于所述密封主体的靠近所述操作工具插入的一端,且围绕所述穿行通道设置。Optionally, in the sealing device, the sealing device further comprises: a tear-proof ring, the tear-proof ring is provided at the end of the sealing body close to the insertion of the operating tool, and surrounds the Walkthrough settings.
可选的,在所述的密封装置中,所述防撕裂环的纵向剖面呈半圆形。Optionally, in the sealing device, the longitudinal section of the tear-proof ring is semicircular.
可选的,在所述的密封装置中,所述弹性结构包括弹性管和弹性环,所述弹性管沿所述操作工具的插入方向设置,用于供所述操作工具穿行,所述弹性环套设在所述弹性管上,用于使得在所述操作工具插入之前所述弹性管处于密闭状态,以及使得在所述操作工具插入之后,所述弹性管的最小内径与所述操作工具的插入部分的宽度相适应。Optionally, in the sealing device, the elastic structure includes an elastic tube and an elastic ring, the elastic tube is arranged along the insertion direction of the operating tool, and is used for the operating tool to pass through, and the elastic ring The elastic tube is sleeved on the elastic tube, so that the elastic tube is in a closed state before the operation tool is inserted, and after the operation tool is inserted, the minimum inner diameter of the elastic tube is the same as the operation tool. Fits the width of the insert.
可选的,在所述的密封装置中,所述密封主体沿轴向还具有孔结构,所述孔结构设于密封主体的远离所述操作工具插入的一端,供所述操作工具穿出,所述孔结构的内径不小于所述操作工具的外径。Optionally, in the sealing device, the sealing body further has a hole structure along the axial direction, and the hole structure is provided at an end of the sealing body away from the insertion of the operating tool, for the operating tool to pass through, The inner diameter of the hole structure is not smaller than the outer diameter of the operating tool.
可选的,在所述的密封装置中,所述孔结构为沉孔,所述沉孔包括沿所述操作工具的插入方向依次布置的第一部分和第二部分,所述第一部分的内径配置为小于所述紧固件的外径,所述第二部分的内径配置为不小于所述紧固件的外径。Optionally, in the sealing device, the hole structure is a counterbore, the counterbore includes a first part and a second part arranged in sequence along the insertion direction of the operating tool, and the inner diameter of the first part is configured To be smaller than the outer diameter of the fastener, the inner diameter of the second portion is configured to be not smaller than the outer diameter of the fastener.
可选的,在所述的密封装置中,所述第一部分的内径配置为大于所述操作工具的外径。Optionally, in the sealing device, the inner diameter of the first portion is configured to be larger than the outer diameter of the operating tool.
可选的,在所述的密封装置中,所述密封装置还包括:倒扣结构,所述倒扣结构凸出于所述密封主体的外侧壁。Optionally, in the sealing device, the sealing device further comprises: an undercut structure, and the undercut structure protrudes from the outer side wall of the sealing body.
本发明还提供一种植入式医疗系统,包括如上所述的密封装置。The present invention also provides an implantable medical system comprising the sealing device as described above.
可选的,在所述的植入式医疗系统中,还包括:紧固件、定位件、连接头和电极延长线,所述紧固件和所述定位件配合使用,用于将所述电极延长线与所述连接头固定连接,所述密封装置设于所述连接头内,用于供操作工具穿行对所述紧固件进行操作。Optionally, the implantable medical system further includes: a fastener, a positioning member, a connector and an electrode extension wire, and the fastener and the positioning member are used in cooperation to connect the The electrode extension wire is fixedly connected with the connecting head, and the sealing device is arranged in the connecting head, and is used for operating tools to pass through to operate the fastener.
可选的,在所述的植入式医疗系统中,所述植入式医疗系统还包括:密封填充件,所述密封填充件填充在所述密封装置的外侧壁与所述连接头之间。Optionally, in the implantable medical system, the implantable medical system further comprises: a sealing filler, the sealing filler is filled between the outer side wall of the sealing device and the connecting head .
综上所述,本发明提供的用于供操作工具穿行进行以对紧固件进行操作的密封装置以及包括所述密封装置的植入式医疗系统,包括:密封主体,所述密封主体包括至少两个弹性结构和位于相邻两个弹性结构之间的空腔结构,所有所述弹性结构沿所述操作工具的插入方向依次设置,所述弹性结构用于在所述操作工具穿行时通过弹性形变对所述操作工具形成密封。即,本发明提供的所述密封装置中,至少两个所述弹性结构的依次布置,使得所述密封装置具有多层防水功能,当操作工具刚插入时,即使最上层的所述弹性结构的防水密封功能失效,下层的弹性结构依旧可以起到防水密封的作用;随着所述操作工具的插入,即使下层的所述弹性结构的防水密封功能失效,最上层的所述弹性结构已通过弹性形变与所述操作工具紧密均匀贴合,而恢复防水密封功能,因此,可以降低手术过程中的漏水风险。In summary, the present invention provides a sealing device for an operating tool to pass through to operate a fastener, and an implantable medical system including the sealing device, including: a sealing body, the sealing body including at least Two elastic structures and a cavity structure located between two adjacent elastic structures, all the elastic structures are arranged in sequence along the insertion direction of the operating tool, and the elastic structures are used to pass the elasticity when the operating tool passes through The deformation creates a seal on the working tool. That is, in the sealing device provided by the present invention, at least two elastic structures are arranged in sequence, so that the sealing device has a multi-layer waterproof function. When the operating tool is just inserted, even if the uppermost elastic structure is If the waterproof sealing function fails, the elastic structure of the lower layer can still play the role of waterproof sealing; with the insertion of the operating tool, even if the waterproof sealing function of the elastic structure of the lower layer fails, the elastic structure of the uppermost layer has passed the elastic The deformation is closely and evenly fitted with the operating tool, and the waterproof sealing function is restored, therefore, the risk of water leakage during the operation can be reduced.
进一步的,所述密封主体设置的所述孔结构,使得所述操作工具在插入密封主体的行程末端,其端部不受到所述密封主体的挤压力作用,从而可以减小所述操作工具在插入所述密封装体时所需的插入力。Further, the hole structure provided on the sealing body makes the end of the operating tool not subjected to the pressing force of the sealing body at the end of the stroke of inserting the sealing body, so that the operating tool can be reduced in size Insertion force required when inserting the sealing body.
进一步的,所述孔结构为沉孔,所述沉孔包括第一部分和第二部分,所述第一部分与所述第二切缝连接,所述第一部分的内径配置为小于所述紧固件的外径,所述第二部分的内径配置为不小于所述紧固件的外径,如此设计,一方面可通过所述第二部分给所述紧固件拧松提供行程,另一方面可通过所述第一部分限定所述紧固件的行程,避免所述紧固件脱离出定位件。Further, the hole structure is a counterbore, the counterbore includes a first part and a second part, the first part is connected with the second slit, and the inner diameter of the first part is configured to be smaller than the fastener The outer diameter of the second part is configured to be not less than the outer diameter of the fastener, so designed, on the one hand, the second part can provide travel for the fastener to loosen, and on the other hand The travel of the fastener can be limited by the first portion to prevent the fastener from disengaging from the positioning member.
进一步的,所述密封装置外侧壁的倒扣和其与脉冲发生器的连接头之间的密封填充件使所述密封装置难以脱落。Further, the inversion of the outer side wall of the sealing device and the sealing filler between it and the connection head of the pulse generator make it difficult for the sealing device to fall off.
进一步的,所述密封装置上的防撕裂环,很大程度地保护了所述密封装置不被撕裂。Further, the tear-proof ring on the sealing device protects the sealing device from being torn to a great extent.
附图说明Description of drawings
图1为本发明实施例一提供的密封装置的截面图;1 is a cross-sectional view of a sealing device provided in
图2a和2b为本发明实施一中直型穿行通道的示意图;2a and 2b are schematic diagrams of a straight-through passage in the implementation of the present invention;
图3a和3b为本发明实施一中沙漏型穿行通道的示意图;Figures 3a and 3b are schematic views of an hourglass-shaped passageway in a first embodiment of the present invention;
图4为本发明实施例一提供的密封装置的剖视图;4 is a cross-sectional view of the sealing device provided in
图5为本发明实施例一提供的植入式医疗系统的立体图;5 is a perspective view of the implantable medical system provided in
图6为本发明实施例一提供的植入式医疗系统的俯视图;6 is a top view of the implantable medical system provided in
图7为本发明实施例一提供的植入式医疗系统的剖视图;7 is a cross-sectional view of an implantable medical system provided in
图8为本发明实施例二中弹性结构的结构示意图;8 is a schematic structural diagram of an elastic structure in
其中,各附图标记说明如下:Wherein, each reference sign is described as follows:
1-操作工具;1- Operating tools;
2-密封装置;21-防撕裂环;22-密封主体;23-倒扣结构;24-空腔结构;2-sealing device; 21-tear-proof ring; 22-sealing body; 23-inverted structure; 24-cavity structure;
22a、22b-弹性结构;22a, 22b - elastic structure;
25a、25b-穿行通道;25a, 25b - walk through channel;
26-孔结构;26a-第一部分;26b26b-第二部分;26-hole structure; 26a-first part; 26b26b-second part;
3-连接头;4-电极延长线;31-紧固件;32-定位件;33-密封填充件;3-connector; 4-electrode extension wire; 31-fastener; 32-positioning piece; 33-sealing filler;
201-弹性管;202-弹性环。201 - elastic tube; 202 - elastic ring.
具体实施方式Detailed ways
以下结合附图和具体实施例对本发明提出的密封装置及植入式医疗系统作进一步详细说明。需说明的是,附图均采用非常简化的形式且均使用非精准的比例,仅用以方便、明晰地辅助说明本发明实施例的目的。此外,附图所展示的结构往往是实际结构的一部分。特别的,各附图需要展示的侧重点不同,有时会采用不同的比例。还应当理解的是,除非特别说明或者指出,否则说明书中的术语“第一”、“第二”、“第三”等描述仅仅用于区分说明书中的各个组件、元素、步骤等,而不是用于表示各个组件、元素、步骤之间的逻辑关系或者顺序关系等。此外,术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或成一体;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系。The sealing device and the implantable medical system proposed by the present invention will be described in further detail below with reference to the accompanying drawings and specific embodiments. It should be noted that, the accompanying drawings are all in a very simplified form and in inaccurate scales, and are only used to facilitate and clearly assist the purpose of explaining the embodiments of the present invention. Furthermore, the structures shown in the drawings are often part of the actual structure. In particular, each drawing needs to show different emphases, and sometimes different scales are used. It should also be understood that unless otherwise specified or indicated, the terms "first", "second", "third" and other descriptions in the specification are only used to distinguish various components, elements, steps, etc. in the specification, rather than It is used to represent the logical relationship or sequence relationship among various components, elements, steps, etc. In addition, the terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it may be a fixed connection, a detachable connection, or an integrated body; it may be directly connected or indirectly connected through an intermediate medium, It can be a communication within the two elements or an interaction relationship between the two elements.
【实施例一】[Example 1]
本实施例提供一种密封装置2,用于供操作工具穿行进行以对紧固件进行操作。This embodiment provides a
本实施例所涉及之所述操作工具,为能穿过所述密封装置2对紧固件进行拧动的工具,包括扭力扳手、螺丝刀等。The operating tool involved in this embodiment is a tool that can pass through the
本实施例所涉及之所述紧固件,为能够与设置于连接头的定位件配套使用,以对电极延长线与所述连接头进行固定的部件,例如,当所述定位件为定位螺母时,所述紧固件为紧固螺钉,利用所述操作工具进行所述紧固螺钉在所述定位螺母上的锁紧或拧松操作,又例如,所述定位件具有限位槽,所述紧固件具有与所述限位槽相卡合的限位齿,利用所述操作工具旋转所述紧固件实现所述限位齿在所述限位槽内的卡合或解除所述限位齿在所述限位槽内的卡合,本实施例对紧固件的具体实现方式不做限制。The fastener involved in this embodiment is a component that can be used in conjunction with a positioning member disposed on the connecting head to fix the electrode extension wire and the connecting head. For example, when the positioning member is a positioning nut When the fastener is a fastening screw, the operating tool is used to perform the locking or loosening operation of the fastening screw on the positioning nut. For another example, the positioning member has a limit groove, so The fastener has limit teeth that engage with the limit groove, and the operating tool is used to rotate the fastener to realize the engagement of the limit teeth in the limit groove or release the The engagement of the limiting teeth in the limiting grooves does not limit the specific implementation of the fastener in this embodiment.
基于上述描述可知,本实施例中所涉及之具体所述操作工具以及具体所述紧固件不构成对于本申请之密封装置2的限制。Based on the above description, it can be seen that the specific operating tools and the specific fasteners involved in this embodiment do not constitute limitations on the
请参考图1,所述密封装置2包括:密封主体22,所述密封主体22包括至少两个弹性结构和位于相邻两个弹性结构之间的空腔结构24,所有所述弹性结构沿所述操作工具1的插入方向依次设置,所述弹性结构用于在所述操作工具1穿行时通过弹性形变对所述操作工具1形成密封。Referring to FIG. 1, the
图1所示是以所述密封主体22包括两个弹性结构22a和22b,在另外一些实施例中,所述弹性结构的数量还可为3、4等,本申请对此不作限制,但在实际应用时,考虑到需尽可能缩小所述密封装置2的尺寸,可优先选择采用2个所述弹性结构,在满足防水功能的同时,也可避免因尺寸过大,而不便于设置,或者导致DBS系统整体尺寸过大,在植入后引起被植入者的不适。As shown in FIG. 1, the sealing body 22 includes two
如前所述,脑深部电刺激(DBS)系统中,体内电极延长线和脉冲发生器IPG的连接头通过紧固件固定,在实现体内电极延长线和连接头的固定时,为避免漏水,通常会采用防水密封件,通过将操作工具1(如扭力扳手)穿入防水密封件后插入至紧固件上进行锁紧或拧松操作,而当操作工具1穿入防水密封件的瞬间,其密封功能容易失效,从而会增加漏水的风险。As mentioned above, in the deep brain stimulation (DBS) system, the connector between the in-vivo electrode extension cable and the pulse generator IPG is fixed by fasteners. Usually, a waterproof seal is used, by inserting the operating tool 1 (such as a torque wrench) into the waterproof seal and then inserting it into the fastener to perform locking or loosening operations. When the
而本实施例提供的所述密封装置2中,至少两个所述弹性结构的依次布置,使得所述密封装置2具有多层防水功能,当操作工具1刚插入时,即使最上层的所述弹性结构22a的防水密封功能失效,下层的弹性结构22b依旧可以起到防水密封的作用;随着所述操作工具1的插入,即使下层的所述弹性结构22b的防水密封功能失效,最上层的所述弹性结构22a已通过弹性形变与所述操作工具1紧密均匀贴合,而恢复防水密封功能,因此,可以降低手术过程中的漏水风险。However, in the
本实施例中,所述弹性结构为弹性体,所述弹性体具有沿所述操作工具1的插入方向设置的穿行通道,用于供所述操作工具1穿行,所述穿行通道在所述操作工具1插入之前闭合,以及在所述操作工具1插入之后最小宽度与所述操作工具1的插入部分的宽度相适应。具体的,如图1中所示,弹性结构22a具有穿行通道25a,弹性结构22b具有穿行通道25b。为描述方便起见,在下文的描述,均以弹性结构22a和弹性结构22b,分别具有穿行通道25a和25b来对本实施例中所述密封主体22进行示例性说明,但应理解,本申请不以此为限。In this embodiment, the elastic structure is an elastic body, and the elastic body has a passageway provided along the insertion direction of the
进一步的,本实施例中,所述穿行通道25a和25b可为直型通道,所述操作工具1在插入所述穿行通道25a和25b之后,插入部分沿自身周向与所述弹性体呈面型贴合,所述穿行通道25a、25b,例如可采用沿所述弹性体的轴向贯穿的切缝构成,该切缝在所述操作工具在插入之前,因应力的作用处于闭合状态,在所述操作工具1插入之后,发生弹性形变而张开,且该切缝数量可为一个或者多个。请参考图2a,当切缝的数量为一个时,其自身即构成所述操作工具1的穿行通道,且较佳的,其宽度大于所述操作工具1的插入部分的宽度,以使得在所述操作工具1插入之后,所述弹性体能够沿所述操作工具1的周向对所述操作工具1进行包裹,起到较佳的防水密封效果;请参考图2b,当切缝的数量为多个时,多个所述切缝可沿所述弹性体的周向依次布置,且一端在所述弹性体的轴线上相接,相接处构成所述穿行通道25a、25b。Further, in this embodiment, the passing
请参考图3a和图3b所示,本实施例中,所述弹性体还可具有朝向轴线凸出的曲面,从而使得所述穿行通道25a、25b为沙漏型通道,即,所述穿行通道25a、25b的径向尺寸先逐渐减小而后逐渐变大,在所述操作工具1插入之前,所述穿行通道25a、25b的径向尺寸最小处呈闭合状态,在所述操作工具1在插入所述穿行通道25a、25b之后,插入部分在所述穿行通道25a、25b的径向尺寸最小处沿自身周向与相应所述弹性体呈线型贴合。当穿行通道为沙漏型通道时,由于所述操作工具1的插入部分与所述弹性体呈线型贴合,相较于面型贴合,其防水密封效果虽会有所下降,但如图3b所示,由于两个所述弹性体之间可以彼此相邻,两者之间的空间即可构成所述空腔结构,可满足所述密封装置2的较小轴向尺寸的设计需求。Referring to FIG. 3a and FIG. 3b, in this embodiment, the elastic body may further have a curved surface protruding toward the axis, so that the passing
在另外一些实施例中,所述穿行通道25a、25b还可采用其它设计,例如,所述穿行通道25a、25b采用无限缩小的孔设计,或者采用切缝和小孔的交替排布结构,本申请对此不作限制,只需使得在所述操作工具1插入之前,能够呈现闭合状态,而在所述操作工具1在插入之后,所述操作工具1能够至少一部分沿周向与所述弹性体紧密贴合即可。In other embodiments, the passing
需说明的是,本实施例对所述密封主体22除所述弹性结构以外的部分不作限制,在本实施例中,可如图1所示,所述密封主体22全部采用弹性体的设计,而在另外一些实施例中,所述密封主体22除所述弹性结构以外的部分也可采用刚性设计。It should be noted that this embodiment does not limit the parts of the sealing body 22 other than the elastic structure. In this embodiment, as shown in FIG. 1 , the sealing body 22 is all designed as an elastic body. In other embodiments, the parts of the sealing body 22 other than the elastic structure can also be rigidly designed.
较佳的,请参考图4,本实施例提供的所述密封装置2还包括:防撕裂环21,所述防撕裂环21设于所述密封主体22的靠近所述操作工具1插入的一端(以下简称插入端),且围绕所述穿行通道设置。Preferably, please refer to FIG. 4 , the
对于所述密封主体22而言,其插入端更易发生撕裂,故当所述防撕裂环21围绕插入端的所述穿行通道25a设置时,能起到较佳的防撕裂效果,从而可以减小漏水风险。其中,本实施例中,所述防撕裂环21的纵向剖面可呈半圆形,当所述防撕裂环21的纵向剖面呈半圆形时,受张力的影响,其防撕裂效果最佳,在另外一些实施例中,所述防撕裂环21的纵向剖面还可呈方形,三角形等。For the sealing body 22, the insertion end is more prone to tearing, so when the tear-
另外,较佳的,请继续参考图4并结合图1,所述密封装置2还包括:倒扣结构23,所述倒扣结构23凸出于所述密封主体22的外侧壁。所述倒扣结构23可以防止所述密封主体22在设置于脉冲发生器的连接头内后,脱出于所述连接头。如图4所示,所述倒扣结构23可为沿所述密封主体22的周向设置的凸出环,但本申请不以此为限,所述倒扣结构23还可为沿所述密封主体22的周向依次分布的多个凸出块。本实施例中,所述倒扣结构23可与所述密封主体22一体成型,而在另外一些实施例中,所述倒扣结构23也可固定在所述密封主体22上。In addition, preferably, please continue to refer to FIG. 4 in conjunction with FIG. 1 , the
需说明的是,图4所示是以所述密封装置2包括两个并列的所述密封主体22做示例,以对连接头具有两个连接槽的脉冲发生器进行密封。在实际应用时,所述密封装置2也可仅包括一所述密封主体22,或多个并列的所述密封主体22,本申请对此不作限制。另由于本发明实施例提供的密封装置2为植入性密封装置2,故较佳的,所述密封主体22采用硅胶材料制成,当然也可采用其他具有弹性的生物相容性材料。It should be noted that, as shown in FIG. 4 , the
优选的,请参考图1,所述密封主体22沿轴向还设有孔结构26,所述孔结构26设于所述密封主体22的远离操作工插入的一端(以下简称穿出端),供所述操作工具1穿出,所述孔结构26的内径不小于所述操作工具1的外径。在所述密封主体22的穿出端设置所述孔结构26,使得所述操作工具1在插入密封主体22的行程末端,其端部不再受到所述密封主体22的挤压力的作用,从而可以减小所述操作工具1在插入所述密封主体22时所需的插入力。Preferably, please refer to FIG. 1 , the sealing body 22 is further provided with a
进一步优选的,所述孔结构26为沉孔,所述沉孔包括沿所述操作工具1的插入方向依次布置的第一部分26a和第二部分26b,所述第一部分26a的内径配置为小于所述紧固件的外径,所述第二部分26b的内径配置为不小于所述紧固件的外径。如此设计,一方面,通过所述第二部分26b给所述紧固件拧松提供行程,另一方面,通过所述第一部分26a限定所述紧固件的行程,避免所述紧固件脱离定位件。Further preferably, the
如图5~7所示,本发明实施例还提供一种植入式医疗系统,所述植入式医疗系统包括:如本实施例所述的密封装置2。As shown in FIGS. 5 to 7 , an embodiment of the present invention further provides an implantable medical system, and the implantable medical system includes: the sealing
此外,所述植入式医疗系统还包括:紧固件31、定位件32、连接头3(脉冲发生器的连接头)和电极延长线4,所述紧固件31和所述定位件32配合使用,用于将所述电极延长线4与所述连接头3固定连接,所述密封装置2设于所述连接头3内,用于供操作工具1穿行对所述紧固件31进行操作。In addition, the implantable medical system further includes: a
优选的,所述植入式医疗系统还包括:密封填充件33,所述密封填充件33填充在所述密封装置2的外侧壁与所述连接头3之间。且较佳的,所述密封填充件33为可植入填充物,例如为环氧树脂填充物、硅胶填充物、聚氨酯填充物等。Preferably, the implantable medical system further comprises: a sealing
本实施例中,所述紧固件31为紧固螺钉,所述定位件32为定位螺母。相应的,所述操作工具1为扭力板手。通过所述扭力板手进行所述紧固螺钉在所述定位螺母上的锁紧或拧松操作从而相应实现所述电极延长线4与所述脉冲发生器的连接头3的连接和解除连接。In this embodiment, the
所述紧固螺钉的顶部设有内六角孔,所述扭力板手的端部插入所述内六角孔,来实现对所述紧固螺钉的锁紧或拧松操作。The top of the fastening screw is provided with an inner hexagonal hole, and the end of the torque wrench is inserted into the inner hexagonal hole to realize the locking or loosening operation of the fastening screw.
当所述紧固件31为螺钉,所述定位件32为定位螺母时,所述植入式医疗系统的使用过程如下:When the
利用所述定位件32实现所述电极延长线4和所述脉冲发生器的连接头3的初步连接;Use the positioning
将扭力板手插入所述密封装置2,当所述扭力板手插入弹性结构22a时,弹性结构22b起到防水密封的功能,当所述扭力板入插入弹性结构22b时,弹性结构22a已恢复密封功能;Insert the torsion wrench into the
当扭力板手插入紧固螺钉顶部的内六角孔时,通过沿第一方向旋转来将所述紧固螺钉锁紧在所述定位螺母内,以实现所述电极延长线4和所述脉冲发生器的连接头3的固定连接;When the torque wrench is inserted into the hexagonal hole on the top of the fastening screw, the fastening screw is locked in the positioning nut by rotating in the first direction, so as to realize the
当需要拧松所述紧固螺钉时,通过沿与所述第一方向相反的第二方向旋转所述扭力板手来将所述紧固螺钉拧松,由于所述沉孔的第二部分26b的内径不小于所述紧固螺钉的外径,所述沉孔的第一部分26a的内径小于所述紧固螺钉的外径,故所述沉孔的第二部分26b给所述紧固螺钉提供了在所述定位螺母之外的行程空间,而所述沉孔的第一部分26a限定所述紧固螺钉的行程终点,以避免所述紧固螺钉完全脱离于所述定位螺母。When the tightening screw needs to be loosened, the tightening screw is loosened by rotating the torque wrench in a second direction opposite to the first direction, due to the
在另外一些实施例中,所述定位件32具有限位槽,所述紧固件31具有与所述限位槽相卡合的限位齿,当所述限位齿卡合于所述限位槽时,实现所述电极延长线4和所述脉冲发生器的连接头3的固定连接。所述紧固件31的顶部也可设置内六角孔,当扭力板手插入紧固螺钉顶部的内六角孔时,所述扭力板手旋转带动所述紧固件31在所述定位件32内的旋转,从而以实现所述限位槽对所述限位齿的卡合或解除卡合。In other embodiments, the positioning
当所述定位件32具有限位槽,所述紧固件31具有与所述限位槽相卡合的限位齿,所述植入式医疗系统的使用过程如下:When the positioning
利用所述定位件32实现所述电极延长线4和所述脉冲发生器的连接头3的初步连接;Use the positioning
将扭力板手插入所述密封装置2,当所述扭力板手插入弹性结构22a时,弹性结构22b起到防水密封的功能,当所述扭力板手插入弹性结构22b时,弹性结构22a已恢复密封功能;Insert the torsion wrench into the
当扭力板手插入紧固件31的内六角孔时,通过沿第一方向旋转来将所述紧固件31的限位齿卡合在所述限位槽内,以实现所述电极延长线4和所述脉冲发生器的连接头3的固定连接;When the torque wrench is inserted into the hexagonal hole of the
当需要将电极延长线4拆离于脉冲发生器时,通过沿与所述第一方向相反的第二方向旋转所述扭力板手来带动所述紧固件31沿第二向旋转,以解除对所述限位齿的卡合。When the
【实施例二】[Example 2]
请参考图8,与实施例一不同的是,本实施例中,所述弹性结构包括弹性管201和弹性环202,所述弹性管201沿所述操作工具1的插入方向设置,用于供所述操作工具1穿行,所述弹性环202套设在所述弹性管201上,用于使得在所述操作工具1插入之前所述弹性管201处于密闭状态,以及使得在所述操作工具1插入之后,所述弹性管201的最小内径与所述操作工具1的插入部分的宽度相适应,从而使得所述操作工具1与所述弹性管201的内壁相贴合,进而对所述操作工具1进行密封。Referring to FIG. 8 , the difference from the first embodiment is that in this embodiment, the elastic structure includes an
综上所述,本发明提供的用于供操作工具穿行进行以对紧固件进行操作的密封装置以及包括所述密封装置的植入式医疗系统,包括:密封主体,所述密封主体包括至少两个弹性结构和位于相邻两个弹性结构之间的空腔结构,所有所述弹性结构沿所述操作工具的插入方向依次设置,所述弹性结构用于在所述操作工具穿行时通过弹性形变对所述操作工具形成密封。即,本发明提供的所述密封装置中,至少两个所述弹性结构的依次布置,使得所述密封装置具有多层防水功能,当操作工具刚插入时,即使最上层的所述弹性结构的防水密封功能失效,下层的弹性结构依旧可以起到防水密封的作用;随着所述操作工具的插入,即使下层的所述弹性结构的防水密封功能失效,最上层的所述弹性结构已通过弹性形变与所述操作工具紧密均匀贴合,而恢复防水密封功能,因此,可以降低手术过程中的漏水风险。In summary, the present invention provides a sealing device for an operating tool to pass through to operate a fastener, and an implantable medical system including the sealing device, including: a sealing body, the sealing body including at least Two elastic structures and a cavity structure located between two adjacent elastic structures, all the elastic structures are arranged in sequence along the insertion direction of the operating tool, and the elastic structures are used to pass the elasticity when the operating tool passes through The deformation creates a seal on the working tool. That is, in the sealing device provided by the present invention, at least two elastic structures are arranged in sequence, so that the sealing device has a multi-layer waterproof function. When the operating tool is just inserted, even if the uppermost elastic structure is If the waterproof sealing function fails, the elastic structure of the lower layer can still play the role of waterproof sealing; with the insertion of the operating tool, even if the waterproof sealing function of the elastic structure of the lower layer fails, the elastic structure of the uppermost layer has passed the elastic The deformation is closely and evenly fitted with the operating tool, and the waterproof sealing function is restored, therefore, the risk of water leakage during the operation can be reduced.
需要说明的是,本说明书中各个实施例采用递进的方式描述,每个实施例重点说明的都是与其他实施例的不同之处,各个实施例之间相同相似部分互相参见即可,此外,各个实施例之间不同的部分也可互相组合使用,本发明对此不作限定。It should be noted that the various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments, and the same and similar parts between the various embodiments can be referred to each other. , the different parts of each embodiment can also be used in combination with each other, which is not limited in the present invention.
此外还应该认识到,虽然本发明已以较佳实施例披露如上,然而上述实施例并非用以限定本发明。对于任何熟悉本领域的技术人员而言,在不脱离本发明技术方案范围情况下,都可利用上述揭示的技术内容对本发明技术方案做出许多可能的变动和修饰,或修改为等同变化的等效实施例。因此,凡是未脱离本发明技术方案的内容,依据本发明的技术实质对以上实施例所做的任何简单修改、等同变化及修饰,均仍属于本发明技术方案保护的范围。In addition, it should be appreciated that although the present invention has been disclosed above in terms of preferred embodiments, the above-mentioned embodiments are not intended to limit the present invention. For any person skilled in the art, without departing from the scope of the technical solution of the present invention, many possible changes and modifications can be made to the technical solution of the present invention by using the technical content disclosed above, or modified to equivalent changes, etc. effective example. Therefore, any simple modifications, equivalent changes and modifications made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solutions of the present invention still fall within the protection scope of the technical solutions of the present invention.
Claims (13)
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JPH05293111A (en) * | 1992-04-15 | 1993-11-09 | Olympus Optical Co Ltd | Tracheal |
CN102300781A (en) * | 2009-02-02 | 2011-12-28 | 万通集团公司 | Dual sealing system for use with a probe |
CN105107091A (en) * | 2015-08-21 | 2015-12-02 | 北京品驰医疗设备有限公司 | Sealing plug and implantable medical device using same |
CN215195018U (en) * | 2021-03-05 | 2021-12-17 | 上海神奕医疗科技有限公司 | Sealing device and implantable medical system |
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JPH05293111A (en) * | 1992-04-15 | 1993-11-09 | Olympus Optical Co Ltd | Tracheal |
CN102300781A (en) * | 2009-02-02 | 2011-12-28 | 万通集团公司 | Dual sealing system for use with a probe |
CN105107091A (en) * | 2015-08-21 | 2015-12-02 | 北京品驰医疗设备有限公司 | Sealing plug and implantable medical device using same |
CN215195018U (en) * | 2021-03-05 | 2021-12-17 | 上海神奕医疗科技有限公司 | Sealing device and implantable medical system |
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