CN115192251A - Ectopic artificial bladder device - Google Patents
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- CN115192251A CN115192251ACN202210897379.5ACN202210897379ACN115192251ACN 115192251 ACN115192251 ACN 115192251ACN 202210897379 ACN202210897379 ACN 202210897379ACN 115192251 ACN115192251 ACN 115192251A
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract
Translated fromChinese
Description
Translated fromChinese技术领域technical field
本申请涉及一种异位人工膀胱装置，属于医疗器械技术领域。The application relates to an ectopic artificial bladder device, which belongs to the technical field of medical devices.
背景技术Background technique
根治性膀胱切除术后的尿流改道或重建与术后并发症、患者生活质量密切相关。常用的输尿管皮肤造口、回肠导管术(Bricker术)通过腹部皮肤造口实现排尿，具有恢复快，住院时间短等优势，但患者无法通过尿道自行排尿，需终生佩戴造口袋，对生活质量影响较大。原位新膀胱术利用肠道裁制成储尿袋作为新膀胱置于盆腔原来的位置(即原位)，连接输尿管和尿道，可实现自主排尿，患者在社会心理学方面具有显著的优势。然而，该手术过程较为复杂，术后并发症多，住院时间显著延长。Urinary diversion or reconstruction after radical cystectomy is closely related to postoperative complications and patient quality of life. The commonly used ureterostomy and ileal catheterization (Bricker procedure) achieve urination through abdominal skin stoma, which has the advantages of quick recovery and short hospital stay, but patients cannot urinate through the urethra on their own and need to wear an ostomy bag for life, which affects the quality of life. larger. In situ neobladder surgery utilizes the bowel to make a urine storage bag as a neobladder placed in the original position of the pelvis (ie in situ), connecting the ureter and the urethra to achieve spontaneous urination, and the patient has significant advantages in social psychology. However, the surgical procedure is complicated, with many postoperative complications and significantly prolonged hospital stay.
原位新膀胱的短期和长期发症包括感染、电解质紊乱、导尿管堵塞、吻合口瘘、吻合口狭窄、肠梗阻、肠代膀胱坏死、膀胱排空不全、尿失禁、反复肾盂肾炎、结石形成、肾功能进行性损害、短肠综合征等。分析其中的危险因素，可以发现①使用较多的肠攀、②新膀胱无感觉功能、③无收缩功能以及④肠粘膜分泌和吸收功能旺盛是导致上述并发症最重要的原因之四。由于无感觉和收缩功能，患者排尿主要借助腹压及膀胱过度充盈后的压力，膀胱不易完全排空，患者残余尿增加，易出现尿潴留、尿液反流、肾盂压力增高等。在术后早期，这些因素加上肠粘膜本身的特征会导致患者感染、电解质紊乱、吻合口瘘等风险显著增加。随着时间的推移，长时间的排空不全导致新膀胱容积逐渐扩大，此时残余尿更多，患者可出现反复肾盂肾炎、结石形成、肾功能进行性下降等情况。为了尽可能排空膀胱，减少并发症，部分患者需长期间歇性导尿，该情况在女性中更为常见。Short-term and long-term complications of orthotopic neobladder include infection, electrolyte disturbances, catheter obstruction, anastomotic leakage, anastomotic stricture, intestinal obstruction, intestinal necrosis, incomplete bladder emptying, urinary incontinence, recurrent pyelonephritis, calculi formation, progressive impairment of renal function, short bowel syndrome, etc. Analyzing the risk factors, it can be found that ① the use of more bowel movements, ② no sensory function of the neobladder, ③ no contractile function, and ④ strong secretion and absorption of the intestinal mucosa are the four most important reasons for the above-mentioned complications. Due to the lack of sensation and contraction, patients urinating mainly rely on abdominal pressure and pressure after bladder overfilling. It is not easy to completely empty the bladder, the residual urine of patients increases, and it is prone to urinary retention, urinary regurgitation, and increased renal pelvis pressure. In the early postoperative period, these factors, combined with the characteristics of the intestinal mucosa itself, can lead to a significantly increased risk of infection, electrolyte disturbances, and anastomotic leakage in patients. With the passage of time, long-term incomplete emptying leads to the gradual expansion of the new bladder volume, and more residual urine is present at this time, and the patient may experience repeated pyelonephritis, stone formation, and progressive decline in renal function. In order to empty the bladder as much as possible and reduce complications, some patients require long-term intermittent catheterization, which is more common in women.
本发明的目的是提供一种异位人工膀胱装置，实现全膀胱切除术后的自主、可控式排尿，并大幅度降低手术并发症。The purpose of the present invention is to provide an ectopic artificial bladder device, which can realize autonomous and controllable urination after total cystectomy, and greatly reduce surgical complications.
发明内容SUMMARY OF THE INVENTION
本申请的目的是提供一种可以用于膀胱全切术后尿流重建的异位人工膀胱，相比于原位新膀胱，本申请可实现自主、可控式排尿，并大幅度降低手术并发症。The purpose of the present application is to provide an ectopic artificial bladder that can be used for urinary flow reconstruction after total cystectomy. Compared with the orthotopic neo-bladder, the present application can realize autonomous and controllable urination, and greatly reduce the complications of surgery. disease.
为了达到上述目的，本申请的技术方案是提供一种异位人工膀胱装置，包括位于患者腹部皮下脂肪层的本体，所述本体为弹性储尿袋，所述本体设有用于连接输尿管或肠导管(如由回肠导管)的流入道，靠下位置设有用于连接尿道的流出道。In order to achieve the above purpose, the technical solution of the present application is to provide an ectopic artificial bladder device, including a body located in the subcutaneous fat layer of a patient's abdomen, the body is an elastic urine storage bag, and the body is provided with a ureter or intestinal catheter for connecting The inflow tract (eg, from the ileal catheter), with an outflow tract connecting the urethra in the lower position.
优选的，所述本体、流入道、流出道由坚韧、组织相容性好的材料构成。本体另具有一定的弹性。当尿液聚集时，本体充盈并有一定程度的膨胀；当尿液排空后，本体则随之空虚并有一定程度的皱缩。优选的，所述流入道内设有防逆流的瓣膜。Preferably, the body, the inflow channel, and the outflow channel are made of tough, tissue-compatible materials. The body also has a certain elasticity. When the urine gathers, the body is filled with a certain degree of expansion; when the urine is emptied, the body is empty and shrunken to a certain degree. Preferably, a valve for preventing backflow is provided in the inflow channel.
优选的，所述流出道上设有控尿组件；所述控尿组件包括尿控体、连接管和尿控开关，尿控体套设在流出道上，连接管一端连通尿控体，另一端连通位于腹盆部局部皮下的尿控开关，尿控开关用于控制尿控体闭合或开放流出道。尿控开关外覆盖设有密封袋。Preferably, the outflow tract is provided with a urine control assembly; the urine control assembly includes a urine control body, a connecting pipe and a urine control switch, the urine control body is sleeved on the outflow tract, one end of the connecting pipe is connected to the urine control body, and the other end is connected to the urine control body. The urinary control switch located under the skin of the abdomen and pelvis is used to control the urinary control body to close or open the outflow tract. The urine control switch is covered with a sealing bag.
优选的，所述尿控体设为环形水囊、外圈硬于内圈，尿控体充液后内圈向内膨胀。Preferably, the urinary control body is set as an annular water bladder, the outer ring is harder than the inner ring, and the inner ring expands inward after the urine control body is filled with fluid.
优选的，所述尿控开关包括基础件和按压件，所述基础件侧壁设有供按压件插入的凹槽，按压件与基础件围成的空间内设有回弹水囊，所述连接管连通回弹水囊和尿控体；所述基础件和按压件之间设有压缩弹簧，压缩弹簧一端抵靠基础件的凹槽槽底、另一端抵靠按压件伸入凹槽的端部；按压件伸入凹槽的端部铰接有连接杆，连接杆另一端设有移动桩，基础件内开设有心形滑槽，移动桩位于心形滑槽内，心形滑槽的心形底部尖端处设为第一停留位、心形顶部凹陷处设为第二停留位，第一停留位靠近按压件、第二停留位远离按压件，心形滑槽的一半滑槽为导引移动桩从第一停留位移动至第二停留位的进位滑槽、另一半滑槽为导引移动桩从第二停留位移动至第一停留位的回位滑槽。Preferably, the urine control switch includes a base member and a pressing member, the side wall of the base member is provided with a groove for inserting the pressing member, and a rebound water bladder is provided in the space enclosed by the pressing member and the base member, and the The connecting pipe communicates the resilient water bladder and the urine control body; a compression spring is arranged between the base piece and the pressing piece, one end of the compression spring abuts against the groove bottom of the base piece, and the other end abuts against the pressing piece extending into the groove The end; the end of the pressing piece extending into the groove is hinged with a connecting rod, the other end of the connecting rod is provided with a moving pile, the base piece is provided with a heart-shaped chute, the moving pile is located in the heart-shaped chute, and the center of the heart-shaped chute is provided. The tip of the bottom of the shape is set as the first stop position, and the depression at the top of the heart shape is set as the second stop position. The first stop position is close to the pressing piece, and the second stopping position is far away from the pressing piece. The moving pile moves from the first stop position to the carry chute for the second stop position, and the other half of the chute is a return chute for guiding the moving pile to move from the second stop position to the first stop position.
本申请优点在于，本申请提供的异位人工膀胱装置在实现自主、可控式排尿的同时，可以解决大部分原位新膀胱所面临的现实问题。本申请提供的人工膀胱装置，位于患者腹部皮下脂肪层，腹部皮肤可随着本体的充盈而有一定程度的隆起，从而提醒患者需要排尿；患者可通过按压实现膀胱的完全排空；由于膀胱本身无需有收缩和感觉功能，本装置的设计和使用方法降大幅度低了组织工程膀胱的难度；与原位新膀胱相比，本装置可大幅度降低手术难度及术后并发症；本装置可避免尿失禁；本装置具有抗反流作用，降低了返流所致的感染和肾功能损害风险。The advantage of the present application is that the ectopic artificial bladder device provided by the present application can solve the practical problems faced by most of the orthotopic neo-bladders while realizing autonomous and controllable urination. The artificial bladder device provided in this application is located in the subcutaneous fat layer of the patient's abdomen, and the abdominal skin can bulge to a certain extent with the filling of the body, thereby reminding the patient that urination is required; the patient can completely empty the bladder by pressing; There is no need for contraction and sensory functions, and the design and use of the device greatly reduces the difficulty of tissue-engineered bladders; Avoid urinary incontinence; the device is anti-reflux, reducing the risk of infection and kidney damage from reflux.
附图说明Description of drawings
图1为实施例中提供的异位人工膀胱装置结构示意图；Fig. 1 is the structural representation of the ectopic artificial bladder device provided in the embodiment;
图2-1为实施例中提供的异位人工膀胱装置植入人体内侧视示意图，其中a表示皮肤、b表示腹壁肌层、a和b之间为皮下脂肪层、c表示耻骨联合、d表示尿道、e表示子宫、f表示直肠；Figure 2-1 is a schematic view of the implantation of the ectopic artificial bladder device provided in the embodiment inside the human body, wherein a represents the skin, b represents the abdominal wall muscle layer, between a and b is the subcutaneous fat layer, c represents the pubic symphysis, d represents urethra, e for uterus, f for rectum;
图2-2为流入道和输尿管连接方式Ⅰ局部放大图：流入道在腹腔内与输尿管直接吻合；Figure 2-2 is a partial enlarged view of the connection between the inflow tract and the ureter I: the inflow tract is directly anastomosed with the ureter in the abdominal cavity;
图2-3为流入道和输尿管连接方式Ⅱ局部放大图：流入道在腹壁肌层外与肠导管吻合；Figure 2-3 is a partial enlarged view of the connection between the inflow tract and the ureter II: the inflow tract is anastomosed with the intestinal catheter outside the abdominal wall muscle layer;
图3为实施例中提供的异位人工膀胱装置植入人体内正视示意图；3 is a schematic front view of the implantation of the ectopic artificial bladder device provided in the embodiment;
图4为实施例中提供的控尿组件的结构示意图；Fig. 4 is the structural representation of the urinary control assembly provided in the embodiment;
图5为实施例中提供的尿控开关结构及开关动作示意图；5 is a schematic diagram of the structure of the urine control switch and the switch action provided in the embodiment;
附图标记：本体1、流入道2、瓣膜21、流出道3、尿控体41、连接管42、尿控开关43、基础件43-1、按压件43-2、回弹水囊43-3、压缩弹簧43-4、连接杆43-5、移动桩43-6。Reference numerals:
具体实施方式Detailed ways
为使本申请更明显易懂，兹以优选实施例，并配合附图作详细说明如下。In order to make the present application more obvious and easy to understand, preferred embodiments are hereby described in detail as follows in conjunction with the accompanying drawings.
实施例Example
本实施例提供的是一种异位人工膀胱装置，参见图1、图2-1，包括位于患者腹部皮下的本体1、流入道2和流出道3。This embodiment provides an ectopic artificial bladder device, see Fig. 1 and Fig. 2-1 , including a
本体、流入道、流出道由高分子材料构成，其上可附细胞及细胞因子，植入后有新生血管长入。本体1另具有一定的弹性，为弹性储尿袋，其特点是坚韧、组织相容性好、不易生菌、长期使用不会导致细菌定植或结石形成等。The body, the inflow channel and the outflow channel are composed of polymer materials, on which cells and cytokines can be attached, and new blood vessels grow in after implantation. The
本体1用于存储尿液。本体1植入患者腹部皮下脂肪层，如肥胖患者可置于浅筋膜的深层和浅层之间，瘦削患者可置于肌膜与浅筋膜之间，使其充盈时既可使皮肤局部轻度隆起，又不至于因过度膨隆而影响美观。局部皮肤的隆起可提醒患者需及时进行排尿。The
流入道2连通本体1，流入道2和输尿管的连接方式有两种。第一种是流入道2穿过腹壁肌层，在腹腔内与输尿管直接吻合(吻合口在腹腔内)，参见图2-2。此时，尿液经过输尿管、本装置流入道后进入本体。第二种是在输尿管和流入道之间增加一段肠导管作过渡，即由一小段肠道制成的导管(如回肠导管)一端与输尿管吻合，另一端穿过腹壁肌层(并与之固定)后在皮下脂肪层与流入道通过手术吻合(吻合口在皮下脂肪层)(图2-1和图2-3显示的即为第二种方法)。此时，尿液经输尿管、肠导管、本装置流入道进入本体1。第一种方法简单直接，不使用肠道，但对人工膀胱的材料要求更高。第二种方法与目前Bricker术有共通之处，优点是对人工膀胱材料的要求较低，潜在的吻合口狭窄风险较低。因此，使用哪种方法取决于人工膀胱材料的改进和患者自身情况。流入道2内设置有防逆流的瓣膜21，从而减少反流、减少逆行感染、保护肾功能。The
流出道3为长管状，穿过腹壁肌层后与尿道连接。流出道3上设有控尿组件，位于腹壁肌层外，参见图4，包括尿控体41、连接管42和尿控开关43。尿控体41套设在流出道3上，连接管42一端连通尿控体41，另一端连通位于流出道3外的尿控开关43。尿控开关43位于皮下较浅位置，如一侧髂嵴内侧(图3)，既方便患者按压，又不影响穿着(如腰带)，避免误触。患者可通过控制尿控开关43控制尿控体41。按压尿控开关43，尿控体41充液膨胀后挤压流出道3从而使之闭合；再次按压尿控开关43，尿控体41内液体回流，流出道3开放。若患者存在尿失禁，在不需排尿时可持续保持流出道3闭合状态，从而避免尿失禁。The
具体的，尿控开关43的结构如图5所示，尿控开关43包括基础件43-1和按压件43-2，基础件43-1和按压件43-2均为中空柱型结构，基础件43-1侧壁开设有供按压件43-2插入的凹槽，按压件43-2插入基础件43-1、二者围成的空间用于放置回弹水囊43-3，回弹水囊43-3具有自膨胀性、在无基础件43-1和按压件43-2的约束时有膨胀至最大容积的趋势，回弹水囊43-3连通连接管42，尿控体41为一环形水囊、外圈较硬、内圈向内膨胀，连接管42将回弹水囊43-3和尿控体41连通；基础件43-1和按压件43-2之间设置有压缩弹簧43-4，压缩弹簧43-4一端抵靠基础件43-1的凹槽槽底、另一端抵靠按压件43-2伸入凹槽的端部；按压件43-2伸入凹槽的端部铰接有连接杆43-5，连接杆43-5另一端设有移动桩43-6，基础件43-1内开设有心形滑槽，移动桩43-6位于心形滑槽内，心形滑槽的心形底部尖端处为第一停留位、心形顶部凹陷处为第二停留位，第一停留位靠近按压件43-2、第二停留位远离按压件43-2，心形滑槽的一半滑槽为导引移动桩43-6从第一停留位移动至第二停留位的进位滑槽、另一半滑槽为导引移动桩43-6从第二停留位移动至第一停留位的回位滑槽。Specifically, the structure of the
具体的，尿控开关43外覆盖设置一层弹性高分子材料的密封袋，密封袋完全包裹尿控开关43，防止尿控开关43内机械结构直接与身体组织接触。Specifically, the
初始时，移动桩43-6位于第一停留位，此时基础件43-1和按压件43-2围成的空间为最大空间，回弹水囊43-3保持最大体积，尿控体41内缺少液体未膨胀，流出道3保持导通，按压按压件43-2，推动移动桩43-6进入第二停留位，基础件43-1和按压件43-2围成的空间缩小，挤压回弹水囊43-3，回弹水囊43-3将液体挤压至尿控体41中，尿控体41向内膨胀封闭流出道3；再次按压按压件43-2，移动桩43-6在弹簧作用下回到第一停留位，基础件43-1和按压件43-2围成的空间恢复最大空间，回弹水囊43-3在自身恢复力下降尿控体41内液体吸回，流出道3导通。Initially, the moving pile 43-6 is located at the first stop position. At this time, the space enclosed by the base member 43-1 and the pressing member 43-2 is the maximum space, the rebound water bladder 43-3 maintains the maximum volume, and the
使用本装置时，患者尿控由本装置的尿控组件及患者自身尿控机制(由尿道外括约肌、盆底结构等组成的生理控尿机制)控制。因盆底结构的破坏，患者术后早期多有不同程度的尿失禁，此时可利用本装置的尿控组件控制排尿，防止尿失禁。随着时间的推移，多数患者自身尿控机制恢复，可自行控尿，此时本装置的尿控组件可长期处于打开状态。少部分患者存在长期尿失禁，这些患者可继续利用本装置的尿控组件控制排尿。因此，利用本装置可避免尿失禁的发生。When using the device, the patient's urinary continence is controlled by the urinary continence component of the device and the patient's own urinary continence mechanism (a physiological urinary continence mechanism composed of external urethral sphincter, pelvic floor structure, etc.). Due to the destruction of the pelvic floor structure, many patients have different degrees of urinary incontinence in the early postoperative period. At this time, the urinary continence component of the device can be used to control urination and prevent urinary incontinence. With the passage of time, most patients recover their own urinary continence mechanism and can control their own urine. At this time, the urinary continence component of the device can be opened for a long time. A small number of patients have long-term urinary incontinence, and these patients can continue to use the urinary continence component of the device to control urination. Therefore, the occurrence of urinary incontinence can be avoided by using the device.
如前所述，使用本装置的患者可通过皮肤表面改变知晓是否需要排尿，并可通过按压达到完全排空膀胱的目的，因此本装置涉及的人工膀胱的组织工程学要求大幅度降低。目前在实验室条件中已可构造出与生理膀胱类似的人工膀胱，然而仍无法实现感觉和收缩功能，有限的临床试验也多以失败告终，人工膀胱并未显示出较肠代膀胱更为明显的优势。如前述，本装置涉及的人工膀胱对组织工程学要求明显降低，无需实现感觉和收缩功能即可应用于临床，因而潜在应用价值巨大。As mentioned above, the patient using the device can know whether to urinate through changes in the skin surface, and can completely empty the bladder by pressing, so the tissue engineering requirements of the artificial bladder involved in the device are greatly reduced. At present, artificial bladders similar to physiological bladders have been constructed in laboratory conditions, but they still cannot achieve sensory and contractile functions. Limited clinical trials have also ended in failure. Artificial bladders have not been shown to be more obvious than intestinal bladders. The advantages. As mentioned above, the artificial bladder involved in the device has significantly lower requirements on tissue engineering, and can be applied in clinic without realizing the functions of sensation and contraction, so the potential application value is huge.
与原位新膀胱相比，本申请装置降低了手术难度和并发症。由于无需裁剪大段的肠道，手术难度明显降低。本装置可在I期膀胱全切手术的同时安装，也可经一段时间的皮下扩张后(如2-3月后)II期手术植入本装置。本装置既适用于新的膀胱癌患者，也适用于已行Bricker手术，但希望实现自主、可控式排尿的患者人群。与此同时，由于本装置相关手术不使用或仅使用少量肠段、通过皮肤表面的改变“感知”是否需要排尿、通过按压实现完全排尿、避免肠粘膜的分泌和吸收功能，并通过瓣膜抗反流、通过尿控装置避免尿失禁，在实现经尿道自主排尿的同时，手术并发症可大幅度降低。Compared with the orthotopic neobladder, the device of the present application reduces the difficulty and complications of surgery. Since there is no need to cut a large section of the intestine, the difficulty of the operation is significantly reduced. The device can be installed at the same time of the I-stage cystectomy, or can be implanted in the II-stage operation after a period of subcutaneous expansion (eg, after 2-3 months). The device is suitable for both new bladder cancer patients and patients who have undergone Bricker surgery but wish to achieve autonomous and controlled urination. At the same time, because the operation related to this device does not use or only uses a small amount of intestinal segments, it "senses" whether it is necessary to urinate through changes in the skin surface, achieves complete urination by pressing, avoids the secretion and absorption functions of the intestinal mucosa, and resists the reaction through the valve. Urinary incontinence can be avoided through the urinary continence device, and the surgical complications can be greatly reduced while realizing the spontaneous urination through the urethra.
Claims (6)
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