CN112138280B - Therapeutic apparatus with infinite electric stimulation function for resisting gastroesophageal reflux disease - Google Patents
Therapeutic apparatus with infinite electric stimulation function for resisting gastroesophageal reflux disease 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
- A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
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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
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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
- A61N1/37211—Means for communicating with stimulators
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Abstract
Description
技术领域technical field
本发明涉及生物工程技术领域,具体涉及一种具有无限电刺激功能的抗胃食管反流病的治疗仪。The invention relates to the technical field of bioengineering, in particular to a therapeutic instrument for resisting gastroesophageal reflux disease with infinite electric stimulation function.
背景技术Background technique
胃食管反流病(gastroesophageal reflux disease,GERD),是指食管腔因过度接触(或暴露)于上消化道内容物而引起的胃食管反流和食管黏膜损伤疾病的总称;是指胃、十二指肠内容物反流入食管甚至口腔引起临床症状及(或)食管炎症的一种疾病。反流物主要是胃酸、胃蛋白酶,尚可有十二指肠液、胆酸、胰液等,此疾病临床上多见,胃大部切除术后、胃肠吻合术后、食管肠吻合术后患者更易发生。胃食管反流及其并发症的发生是多因素的,其中包括食管本身抗反流机制的缺陷,如食管下括约肌功能障碍和食管体部运动异常等;也有食管外诸多机械因素的功能紊乱等。Gastroesophageal reflux disease (GERD) refers to the general term for gastroesophageal reflux and esophageal mucosal injury diseases caused by excessive contact (or exposure) of the esophageal lumen to the contents of the upper gastrointestinal tract; A disease in which duodenal contents reflux into the esophagus or even the oral cavity, causing clinical symptoms and/or esophageal inflammation. Reflux is mainly gastric acid, pepsin, duodenal juice, bile acid, pancreatic juice, etc. This disease is more common in clinical practice. Patients after subtotal gastrectomy, gastrointestinal anastomosis, and esophagoenterostomy more likely to happen. The occurrence of gastroesophageal reflux and its complications is multifactorial, including defects in the anti-reflux mechanism of the esophagus itself, such as dysfunction of the lower esophageal sphincter and abnormal movement of the esophageal body; there are also dysfunctions of many mechanical factors outside the esophagus, etc. .
GERD在西方国家十分常见,人群中约7%-15%有胃食管反流症状,发病率随年龄增加而增加,40-60岁为高峰发病年龄,男女发病无差异,多数报道认为,胃食管反流病患者中,男性患者显著多于女性。调查显示其男女发病率之比为2.4:1。近年来,亚太地区GERD呈明显上升趋势。GERD可严重影响患者生活质量,GERD患者常表现为反酸、烧心、咽喉部及胸骨后不适;也可出现食管外的相关症状,如胸痛、咳嗽、声音嘶哑和吸入性肺炎等肺部吸入综合征,甚至窒息死亡。GERD is very common in western countries. About 7%-15% of the population has gastroesophageal reflux symptoms. The incidence increases with age. The peak age of onset is 40-60 years old. Among patients with reflux disease, male patients are significantly more than female patients. The survey showed that the ratio of male to female incidence was 2.4:1. In recent years, GERD has shown a clear upward trend in the Asia-Pacific region. GERD can seriously affect the quality of life of patients. Patients with GERD often present with acid reflux, heartburn, throat and retrosternal discomfort; related symptoms outside the esophagus may also occur, such as chest pain, cough, hoarseness, and aspiration pneumonia. symptoms, and even death by suffocation.
约半数GERD患者内镜下见食管粘膜糜烂、溃疡等炎症病变,称反流性食管炎;但相当部分胃食管反流病患者内镜下面可无反流性食管炎表现,这类胃食管反流病称为内镜阴性的胃食管反流病。About half of GERD patients see esophageal mucosal erosions, ulcers and other inflammatory lesions under the endoscope, which is called reflux esophagitis; The epidemic is called endoscopy-negative gastroesophageal reflux disease.
目前GERD主要有三种治疗方式:(1)药物治疗为GERD的主要治疗方法,但它难以维持长期疗效;(2)胃底折叠术为创伤性手术,部分患者术后并发明显吞咽困难或腹胀;(3)食管下端括约肌射频治疗为内镜下微创治疗,目前临床应用的这种射频消融电极针采用气囊将电极针插入被射频消融治疗的组织,在治疗的同时会把食道阻塞,并且采用冲水的方式冷却,食道中的冷却水可能会向咽部流出,有被患者吸入气管的风险。At present, there are three main treatment methods for GERD: (1) Drug therapy is the main treatment for GERD, but it is difficult to maintain long-term efficacy; (2) Fundoplication is a traumatic operation, and some patients have obvious dysphagia or abdominal distension after operation; (3) The radiofrequency treatment of the lower esophageal sphincter is a minimally invasive treatment under the endoscope. The radiofrequency ablation electrode needle currently used clinically uses a balloon to insert the electrode needle into the tissue to be treated by radiofrequency ablation, which will block the esophagus during treatment, and use Cooled by flushing water, the cooling water in the esophagus may flow out to the pharynx, and there is a risk of being inhaled by the patient into the trachea.
发明内容Contents of the invention
针对上述治疗中存在的技术问题,本发明提供了一种具有无限电刺激功能的抗胃食管反流病的治疗仪,该装置通过外部遥控控制内部装置进行操作,内部装置可长期安全存于体内,具有适时辅助食道收缩,防止胃食管反流的功能。Aiming at the technical problems in the above-mentioned treatment, the present invention provides an anti-gastroesophageal reflux disease treatment instrument with unlimited electrical stimulation function. The device is operated by controlling the internal device through an external remote control, and the internal device can be safely stored in the body for a long time , has the function of timely assisting esophageal contraction and preventing gastroesophageal reflux.
本发明采用的技术方案:The technical scheme adopted in the present invention:
一种具有无限电刺激功能的抗胃食管反流病的治疗仪,包括收缩装置、体内控制装置、操作装置以及体外控制装置,所述收缩装置位于食管下段括约肌外侧与食道外壁贴合且靠近贲门的位置,所述收缩装置包括具有开放端的管状壳体、对称布置于管状壳体内壁的柔性内衬、集成在柔性内衬内表面的多个电元件,所述管状壳体内表面与柔性内衬内表面之间形成内腔且对内腔上下端进行封装形成封闭腔室,所述体内控制单元响应于体外控制装置发出的控制指令而控制操作装置改变柔性内衬对食道壁进行收缩。A therapeutic instrument for anti-gastroesophageal reflux disease with infinite electrical stimulation function, comprising a contraction device, an internal control device, an operating device and an external control device, the contraction device is located on the outside of the lower esophageal sphincter and is attached to the outer wall of the esophagus and close to the cardia position, the shrinking device includes a tubular housing with an open end, a flexible lining symmetrically arranged on the inner wall of the tubular housing, a plurality of electrical components integrated on the inner surface of the flexible lining, the inner surface of the tubular housing and the flexible lining An inner cavity is formed between the inner surfaces and the upper and lower ends of the inner cavity are sealed to form a closed chamber. The in vivo control unit controls the operating device to change the flexible inner lining to shrink the esophagus wall in response to the control command issued by the external control device.
优选的,所述操作装置以液压方式操作收缩装置,所述操作装置包括双向泵和流体储器,所述流体储器与双向泵相连,体内控制装置控制双向泵将液压流体从可扩张储器内泵送至管状壳体内的两个内腔中以使两个柔性内衬移动抵靠食道壁。Preferably, the operating device hydraulically operates the constriction device, the operating device includes a bidirectional pump and a fluid reservoir, the fluid reservoir is connected to the bidirectional pump, and the control device in the body controls the bidirectional pump to transfer hydraulic fluid from the expandable reservoir Inner pumping into the two lumens within the tubular housing moves the two flexible linings against the esophageal wall.
优选的,所述管状壳体采用聚四氯乙烯材料,在管状壳体的侧壁上设置有开口且所述开口贯穿管状壳体的纵向侧壁,所述开口两侧以锁扣方式连接,方便套设至食道上。Preferably, the tubular housing is made of polytetrachlorethylene material, an opening is provided on the side wall of the tubular housing and the opening runs through the longitudinal side wall of the tubular housing, and the two sides of the opening are connected in a locking manner, Easy to set on the esophagus.
优选的,所述柔性内衬则采用聚四氟乙烯薄膜,所述柔性内衬的宽度为管状壳体直径的2/3。Preferably, the flexible lining is made of polytetrafluoroethylene film, and the width of the flexible lining is 2/3 of the diameter of the tubular shell.
优选的,所述电元件沿着柔性内衬内表面横向排列形成至少4列的电元件路径,每个电元件路径包括沿着内衬内表面纵向排列的至少4个电元件。Preferably, the electrical elements are arranged laterally along the inner surface of the flexible lining to form at least 4 rows of electrical element paths, and each electrical element path includes at least 4 electrical elements arranged longitudinally along the inner surface of the inner lining.
优选的,所述柔性内衬的内表面上还设置于贴合于食道壁上的压力传感器。Preferably, a pressure sensor attached to the wall of the esophagus is also arranged on the inner surface of the flexible lining.
本发明与现有技术相比,其有益效果是:The present invention compares with prior art, and its beneficial effect is:
本发明通过腹腔镜植入具有无限电刺激功能的抗反流食管炎的收缩装置适时压缩食道壁以收缩而使内腔中的流动停止时,内部控制装置适合控制电元件同时地和循环地刺激被压缩壁部分,同时控制装置可响应于传感到患者生理参数或设备功能参数即食道壁的压力参数而控制电元件改变对食道壁的刺激。有效防止胃食管反流,明显改善生活质量,避免了药物治疗的长疗程、依从性差及外科手术带来的各种并发症,同时通过体外控制装置,不改变胃食管结合部的生理结构,极大的提升了治疗时的安全性和灵活性。When the present invention implants a constriction device for anti-reflux esophagitis with unlimited electrical stimulation function through laparoscopy to compress the esophagus wall to contract and stop the flow in the lumen, the internal control device is suitable for controlling the electrical components to stimulate simultaneously and cyclically The wall part is compressed, and the control device can control the electric element to change the stimulation to the esophagus wall in response to the sensed physiological parameter of the patient or the function parameter of the device, ie, the pressure parameter of the esophagus wall. It can effectively prevent gastroesophageal reflux, significantly improve the quality of life, avoid the long course of drug treatment, poor compliance and various complications caused by surgery. It greatly improves the safety and flexibility of treatment.
附图说明Description of drawings
为了更清楚地说明本发明实施例的技术方案,下面将对实施例中所需要使用的附图作简单地介绍,应当理解,以下附图仅示出了本发明的某些实施例,因此不应被看作是对范围的限定,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他相关的附图。In order to illustrate the technical solutions of the embodiments of the present invention more clearly, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention, and thus It should be regarded as a limitation on the scope, and those skilled in the art can also obtain other related drawings based on these drawings without creative work.
图1为本发明的治疗仪植入病人体内的结构示意图;Fig. 1 is the structural representation of the therapeutic apparatus of the present invention implanted in the patient's body;
图2-4为本发明中收缩装置的纵截面;Fig. 2-4 is the longitudinal section of shrinking device among the present invention;
图5为压缩装置的液压操作原理的结构图。Fig. 5 is a block diagram of the hydraulic operation principle of the compression device.
其中,1-收缩装置;101-管状壳体;102-柔性内衬;103-内腔;104-电元件;2-操作装置;201-可扩充储器;202-双向泵;3-体内控制装置;4-体外控制装置。Among them, 1-constriction device; 101-tubular shell; 102-flexible inner lining; 103-inner cavity; 104-electrical components; 2-operating device; 201-expandable reservoir; 202-bidirectional pump; 3-body control device; 4 - in vitro control device.
具体实施方式Detailed ways
为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。通常在此处附图中描述和示出的本发明实施例的组件可以以各种不同的配置来布置和设计。In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments It is a part of embodiments of the present invention, but not all embodiments. The components of the embodiments of the invention generally described and illustrated in the figures herein may be arranged and designed in a variety of different configurations.
因此,以下对在附图中提供的本发明的实施例的详细描述并非旨在限制要求保护本发明的范围,而是仅仅表示本发明的选定实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。Accordingly, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.
如图1所示的一种具有无限电刺激功能的抗胃食管反流病的治疗仪,包括收缩装置1、体内控制装置3、操作装置2以及体外控制装置4。As shown in FIG. 1 , an anti-gastroesophageal reflux disease therapeutic instrument with infinite electrical stimulation function includes a
具体的,体内控制装置3由聚四氟乙烯贴片贴合并缝线固定于膈肌上,体内控制装置3的壳体上设置有外部接口,其内设置有集成于同一控制主板上的体内无线收发模块、体内控制模块、刺激信号发生模块、供能模块和压力信号处理模块。其中,供能模块包括能量收集单元、电源管理单元和储能单元,体内无线收发模块与体内控制模块相连,用于体外控制装置与体内控制装置之间双向无线通信,将接收到体外控制装置发送的刺激信号参数及各种控制指令传送给体内控制模块,同时将体内控制模块输出的食道壁压力参数发送至体外控制装置接收保存,此外,体内无线收发模块还与能量收集模块相连,从由信号接收装置所接收到的高频电磁波信号中提取能量,这一部分能量通过电源管理模块处理为适合充电使用的稳定直流电,并暂时存储于储能模块(如柔性电池),储能模块以稳定的能源供给体内控制模块进行相关操作。Specifically, the
体内控制模块还与操作装置2相连接,操作装置2以液压方式操作收缩装置1,所述操作装置2包括双向泵202和流体储器201,所述流体储器201与双向泵202相连,体内控制模块将接收到体外控制装置发送的控制指令进而控制双向泵202将流体储器201内的液压流体泵送至收缩装置,将食道壁轻柔地压缩于压缩状态(如图5所示)。The control module in the body is also connected with the operating device 2. The operating device 2 hydraulically operates the
其中,所述收缩装置1位于食管下段括约肌外侧与食道外壁贴合且靠近贲门的位置,所述收缩装置1包括具有开放端的管状壳体101、对称布置于管状壳体101内壁的柔性内衬102、集成在柔性内衬102内表面的多个电元件104,所述管状壳体101内表面与柔性内衬102内表面之间形成内腔103且对内腔上下端进行封装形成封闭腔室。柔性内衬102则采用聚四氟乙烯薄膜,将柔性内衬102的宽度设置为管状壳体101直径的2/3,方便柔性内衬膨胀时挤压食道壁形成收缩状态。双向泵202通过软管与两个内腔103连通,将液压流体泵送至内腔103中,增大内腔103的体积,进而迫使柔性内衬102挤压食道壁,缩小食道内腔的距离,并通过设置于柔性内衬102内表面上的压力传感器测得当前食道壁的压力参数反馈至压力信号处理模块,用于放大压力传感器输出的原始信号并将其转换为数字信号提供给体内控制模块,由体内控制模块控制输出参数可调的电脉冲信号经刺激信号发生模块输出控制电元件104刺激食道壁进而实现收缩,其过程如图2-4所示。Wherein, the
在本发明中,电元件104沿着柔性内衬内表面横向排列形成至少4列的电元件路径,每个电元件路径包括沿着内衬内表面纵向排列的至少4个电元件。当治疗仪处于其刺激状态下,重要的是,以一定方式刺激食道壁不同部位而使其随时间推移基本上保持其自然生理性能以防止所述区域受伤,因此,内部控制单元控制脉冲信号发生模块以双向电脉冲(即正负脉冲组合)对电元件功能,通过改变不同脉冲参数实现所希望的刺激效果,脉冲电流应在1至30mA,脉冲重复频率适合地约为10Hz。为了随时保持刺激效果,内部控制单元控制脉冲发生模块沿与患者食道内腔中的流动方向相反的方向对成系列的每个电元件路径连续供能。使得当前不被刺激的每个电元件路径在其被再次刺激之前恢复至基本正常的血液循环。In the present invention, the
为了方便将收缩装置1固定到食道壁上,在管状壳体101的侧壁上有设置有开口且所述开口贯穿管状壳体101的纵向侧壁,所述开口两侧以锁扣方式连接,所述管状壳体101采用聚四氯乙烯材料。In order to facilitate fixing the
本发明中体外控制装置4可采用手持式无线远程控制器,所述控制器能够由患者方便地操作以导通和截止所述收缩装置,无线远程控制器也可被设计为如手表那样施加于患者身体上。这样的手表类型的远程控制器可发出控制信号,所述控制信号使患者身体遵从被植入的设备的信号响应装备。In the present invention, the
以上所述,仅是本发明的较佳实施例,并非对本发明作任何限制。凡是根据发明技术实质对以上实施例所作的任何简单修改、变更以及等效变化,均仍属于本发明技术方案的保护范围内。The above descriptions are only preferred embodiments of the present invention, and do not limit the present invention in any way. All simple modifications, changes and equivalent changes made to the above embodiments according to the technical essence of the invention still belong to the protection scope of the technical solution of the invention.
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| US6463935B1 (en) * | 2000-02-10 | 2002-10-15 | Obtech Medical Ag | Controlled heartburn and reflux disease treatment |
| US6470892B1 (en) * | 2000-02-10 | 2002-10-29 | Obtech Medical Ag | Mechanical heartburn and reflux treatment |
| US6432040B1 (en) * | 2000-09-14 | 2002-08-13 | Nizam N. Meah | Implantable esophageal sphincter apparatus for gastroesophageal reflux disease and method |
| US9668690B1 (en) * | 2001-05-01 | 2017-06-06 | Intrapace, Inc. | Submucosal gastric implant device and method |
| ITMI20012046A1 (en) * | 2001-10-03 | 2003-04-03 | Sintesi S R L | ANTI-REFLUX GASTRO-ESOPHAGEAL VALVE PROSTHESIS |
| US20050228505A1 (en) * | 2004-03-29 | 2005-10-13 | Cornet Douglas A | Device and method for treating gastroesophageal reflux disease |
| EP1779821A1 (en) * | 2005-10-26 | 2007-05-02 | Etervind AB | Adjustable gastric band |
| WO2007127209A2 (en) * | 2006-04-25 | 2007-11-08 | Valentx, Inc. | Methods and devices for gastrointestinal stimulation |
| US20090012546A1 (en) * | 2007-07-03 | 2009-01-08 | Synecor, Llc | Devices for treating gastroesophageal reflux disease and hiatal hernia, and methods of treating gastroesophageal reflux disease and hiatal hernia using same |
| SI2211768T1 (en) * | 2007-10-11 | 2021-11-30 | Implantica Patent Ltd. | Device for controlling the flow in the body organ |
| US8992629B2 (en) * | 2008-01-29 | 2015-03-31 | Peter Forsell | Methods and instruments for treating GERD and hiatal hernia |
| CN105213066B (en) * | 2014-06-25 | 2017-04-19 | 中国人民解放军第二军医大学 | Synthesized patch with wireless stimulation function and used for resisting reflux esophagitis |
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| CN110860038A (en) * | 2019-12-30 | 2020-03-06 | 南京智映博康医疗器械有限公司 | An in vivo passive electrical stimulation device for the treatment of gastroesophageal reflux disease |
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