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CN115105196A - A transapical mitral valve tethered chordae tendineae identification and release device - Google Patents

A transapical mitral valve tethered chordae tendineae identification and release device
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CN115105196A
CN115105196ACN202210777173.9ACN202210777173ACN115105196ACN 115105196 ACN115105196 ACN 115105196ACN 202210777173 ACN202210777173 ACN 202210777173ACN 115105196 ACN115105196 ACN 115105196A
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hook
chordae
chordae tendineae
push rod
rod
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陈金淼
魏来
王春生
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Zhongshan Hospital Fudan University
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Zhongshan Hospital Fudan University
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Abstract

Translated fromChinese

本发明涉及一种经心尖的二尖瓣拴系腱索识别和松解装置,属于医疗器械技术领域。介入鞘管中穿设有腱索识别和松解装置;包括腱索钩和拦截推杆;腱索钩远离操作者的末端设有用于钩住腱索的钩体,钩体上设有用于切断腱索的切割部;与腱索钩相邻设有活动的用于防止腱索脱离钩体并配合切割部切断腱索的拦截推杆。通过本发明可以松解部分拴系瓣叶的腱索,使瓣叶活动度增加,达到减少二尖瓣返流或为后续介入二尖瓣夹合术创造解剖条件。本发明结构简单,手术创伤小且无植入物。

Figure 202210777173

The invention relates to a transapical mitral valve tethered chordae tendineae identification and release device, belonging to the technical field of medical devices. A chord identification and release device is provided in the interventional sheath; it includes a chordal hook and an intercepting push rod; the end of the chordal hook away from the operator is provided with a hook body for hooking the tendon chord, and the hook body is provided with a hook for cutting the tendon chord. The cutting part of the chordae; adjacent to the chordae hook, there is a movable intercepting push rod used to prevent the chordae from being separated from the hook body and cooperate with the cutting part to cut the chordae. The present invention can release part of the chordae tendineae tethering the valve leaflets to increase the activity of the valve leaflets, thereby reducing mitral valve regurgitation or creating anatomical conditions for subsequent intervention in mitral valve clipping. The invention has simple structure, small surgical trauma and no implants.

Figure 202210777173

Description

Translated fromChinese
一种经心尖的二尖瓣拴系腱索识别和松解装置A transapical mitral valve tethered chordae tendineae identification and release device

技术领域technical field

本发明涉及一种经心尖的二尖瓣拴系腱索识别和松解装置,属于医疗器械技术领域。The invention relates to a transapical mitral valve tethered chordae tendineae identification and release device, belonging to the technical field of medical devices.

背景技术Background technique

重度室性二尖瓣返流,往往是由于心室重构导致腱索乳头肌移位,使得瓣叶被腱索拴系,从而出现功能性二尖瓣返流。此类患者心功能较差,传统外科手术治疗往往创伤较大,死亡率高;且无论外科置换还是修复效果均较差。现有技术中经导管介入二尖瓣缘对缘手术即介入二尖瓣夹合术,虽然大大降低了手术创伤,但是该技术并不适用于瓣叶明显拴系的患者。此类患者瓣叶活动度差,如果强行把二尖瓣前叶和后叶夹合,存在瓣叶撕裂的风险。因此,对于这类瓣叶明显拴系的患者是目前临床治疗的难点,急需新的治疗方案。如果通过松解导致二尖瓣瓣叶拴系的“目标栓系腱索”,解除对二尖瓣瓣叶的拴拽,从而可以增加二尖瓣瓣叶对合面积,部分减轻二尖瓣返流,或者可为后续介入二尖瓣夹合术创造解剖条件,从而达到减轻心衰的目的。若要实现这一技术方案,本技术领域亟需获得一种经心尖二尖瓣拴系腱索识别和松解装置。Severe ventricular mitral regurgitation is often due to ventricular remodeling that leads to the displacement of the papillary chordae muscles, so that the valve leaflets are tethered by the chordae tendineae, resulting in functional mitral regurgitation. Such patients have poor cardiac function, traditional surgical treatment is often more traumatic and has a high mortality rate; and both surgical replacement and repair are less effective. In the prior art, the edge-to-edge transcatheter interventional mitral valve edge-to-edge operation, namely the interventional mitral valve clipping operation, greatly reduces the surgical trauma, but this technology is not suitable for patients with obvious tethered valve leaflets. Such patients have poor leaflet mobility, and if the anterior and posterior mitral valve leaflets are forcibly clamped, there is a risk of leaflet tearing. Therefore, it is a difficult clinical treatment for such patients with obvious tethered valve leaflets, and new treatment options are urgently needed. If the "target tethered chordae tendineae" that tethers the mitral valve leaflets is released, the tethering of the mitral valve leaflets can be released, thereby increasing the coaptation area of the mitral valve leaflets and partially reducing the mitral valve recurrence. Flow, or create anatomical conditions for subsequent interventional mitral valve clipping, so as to achieve the purpose of reducing heart failure. To realize this technical solution, there is an urgent need in the art to obtain a transapical mitral valve tethered chordae tendineae identification and release device.

发明内容SUMMARY OF THE INVENTION

本发明的目的是为解决如何获得一种经心尖的二尖瓣拴系腱索识别和松解装置的技术问题。The purpose of the present invention is to solve the technical problem of how to obtain a transapical mitral valve tethered chordae tendineae identification and release device.

为达到解决上述问题的目的,本发明所采取的技术方案是提供一种经心尖的二尖瓣拴系腱索识别和松解装置,介入鞘管中穿设有腱索识别和松解装置;腱索识别和松解装置包括腱索钩和拦截推杆;腱索钩远离操作者的末端设有用于钩住腱索的钩体,钩体上设有用于切断腱索的切割部;与腱索钩相邻设有活动的用于防止腱索脱离钩体并配合切割部切断腱索的拦截推杆。In order to achieve the purpose of solving the above problems, the technical solution adopted by the present invention is to provide a transapical mitral valve tethered chord identification and release device, and the intervention sheath is provided with a chord identification and release device; The chord identification and release device includes a chord hook and an intercepting push rod; the end of the chordal hook away from the operator is provided with a hook body for hooking the chord, and the hook body is provided with a cutting part for cutting the chord; The cable hook is provided with a movable intercepting push rod adjacent to the cable hook, which is used to prevent the tendon cable from being separated from the hook body and cooperate with the cutting part to cut the tendon cable.

优选地,所述腱索钩包括杆体一和杆体一末端的钩体;所述钩体设为半包围的环状体,钩体设有用于腱索进入半包围的环状体内部的缺口。Preferably, the chord hook comprises a rod body and a hook body at one end of the rod body; the hook body is set as a semi-enclosed annular body, and the hook body is provided with a notch for the tendon cable to enter the interior of the semi-enclosed annular body.

优选地,所述钩体半包围的环状体与所述缺口设于同一虚拟平面上。Preferably, the annular body half surrounded by the hook body and the gap are arranged on the same virtual plane.

优选地,所述拦截推杆包括杆体二和推杆头部;所述杆体二的末端设有与所述缺口相对应的推杆头部,推杆头部设于远离操作者的一端;推杆头部与所述缺口设于同一虚拟平面上。Preferably, the intercepting push rod includes a rod body two and a push rod head; the end of the rod body two is provided with a push rod head corresponding to the gap, and the push rod head is provided at one end away from the operator; The rod head and the notch are arranged on the same virtual plane.

优选地,所述推杆头部的长度小于所述缺口的宽度。Preferably, the length of the push rod head is smaller than the width of the notch.

优选地,所述杆体一中沿杆体长度方向设有一卡槽,卡槽中卡设有活动的杆体二。Preferably, therod body 1 is provided with a clamping groove along the length direction of the rod body, and themovable rod body 2 is clamped in the clamping groove.

优选地,所述推杆头部设于杆体一的外侧,与杆体二连接。Preferably, the push rod head is arranged on the outer side of the first rod body and is connected with the second rod body.

优选地,所述钩体半包围环状体的内侧设有切割部。Preferably, a cut portion is provided on the inner side of the hook body half surrounding the ring body.

优选地,所述切割部为电切割部;杆体一中穿设有导线,导线与切割部连接;切割部周边钩体设为绝缘体。Preferably, the cutting part is an electric cutting part; a wire is passed through the first rod body, and the wire is connected with the cutting part; the hook body around the cutting part is set as an insulator.

相比现有技术,本发明具有如下有益效果:Compared with the prior art, the present invention has the following beneficial effects:

本发明结构简单,手术创伤小且无植入物。通过本发明可以松解部分拴系瓣叶的腱索,使瓣叶活动度增加,达到减少二尖瓣返流的目的,或为后续介入二尖瓣夹合术创造解剖条件。The invention has simple structure, small surgical trauma and no implants. The invention can release part of the chordae tendineae tethering the valve leaflets, increase the activity of the valve leaflets, achieve the purpose of reducing mitral valve regurgitation, or create anatomical conditions for subsequent intervention in mitral valve clamping.

附图说明Description of drawings

图1为本发明立体结构示意图。FIG. 1 is a schematic diagram of the three-dimensional structure of the present invention.

图2为本发明钩住腱索时结构示意图。FIG. 2 is a schematic structural diagram of the present invention when the tendon is hooked.

图3为本发明切断腱索时结构示意图。FIG. 3 is a schematic structural diagram of the present invention when the chordae tendineae are cut.

图4为本发明杆体一剖面结构示意图。FIG. 4 is a schematic diagram of a cross-sectional structure of the rod body of the present invention.

附图标记:1.腱索钩;2.杆体一;3.钩体;4.切割部;5.卡槽;6.拦截推杆; 7.杆体二;8.推杆头部;9.导线;10.腱索;11.缺口。Reference signs: 1. Tendon hook; 2. Rod body one; 3. Hook body; 4. Cutting part; Wire; 10. chordae tendineae; 11. Notch.

具体实施方式Detailed ways

为使本发明更明显易懂,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 invention more obvious and easy to understand, preferred embodiments are hereby described in detail with the accompanying drawings as follows:

如图1-4所示,本发明所采取的技术方案是提供一种经心尖的二尖瓣拴系腱索识别和松解装置,介入鞘管中穿设有腱索识别和松解装置;腱索识别和松解装置包括腱索钩1和拦截推杆6;腱索钩1远离操作者的末端设有用于钩住腱索10 的钩体3,钩体3上设有用于切断腱索10的切割部4;与腱索钩1相邻设有活动的用于防止腱索10脱离钩体3并配合切割部4切断腱索10的拦截推杆6。腱索钩1包括杆体一2和杆体一2末端的钩体3;钩体3设为半包围的环状体,钩体3设有用于腱索10进入半包围的环状体内部的缺口11。钩体3半包围的环状体与缺口11设于同一虚拟平面上。拦截推杆6包括杆体二7和推杆头部8;杆体二7的末端设有与缺口11相对应的推杆头部8,推杆头部8设于远离操作者的一端;推杆头部8与缺口11设于同一虚拟平面上。推杆头部8的长度小于缺口 11的宽度。杆体一2中沿杆体长度方向设有一卡槽5,卡槽5中卡设有活动的杆体二7。推杆头部8设于杆体一2的外侧,与杆体二7连接。钩体3半包围环状体的内侧设有切割部4。切割部4为电切割部;杆体一2中穿设有导线9,导线 9与切割部4连接;切割部4周边钩体3设为绝缘体。As shown in Figures 1-4, the technical solution adopted by the present invention is to provide a transapical mitral valve tethered chord identification and release device, and the interventional sheath is provided with a chord identification and release device; The chord identification and release device includes achord hook 1 and anintercepting push rod 6; the end of thechord hook 1 away from the operator is provided with ahook body 3 for hooking thetendon chord 10, and thehook body 3 is provided with a chord for cutting the tendon chord. The cutting part 4 of 10; adjacent to thechordae hook 1, there is a movableintercepting push rod 6 for preventing thechordae 10 from leaving thehook body 3 and cooperating with the cutting part 4 to cut thechordae 10. Thetendon hook 1 includes arod body 2 and ahook body 3 at the end of therod body 2; thehook body 3 is set as a semi-enclosed annular body, and thehook body 3 is provided with agap 11 for thetendon chord 10 to enter the interior of the semi-enclosed annular body . The annular body half surrounded by thehook body 3 and thenotch 11 are arranged on the same virtual plane. The interceptingpush rod 6 includes a rod body two 7 and apush rod head 8; the end of the rod body two 7 is provided with apush rod head 8 corresponding to thenotch 11, and thepush rod head 8 is located at one end away from the operator; the push rod head Theportion 8 and thenotch 11 are arranged on the same virtual plane. The length of thepush rod head 8 is smaller than the width of thenotch 11. Therod body 1 2 is provided with aclamping groove 5 along the length direction of the rod body, and themovable rod body 2 7 is clamped in theclamping groove 5 . Thepush rod head 8 is arranged on the outer side of therod body 1 2 and is connected with therod body 2 7 . The inner side of thehook body 3 half surrounding the annular body is provided with a cutting part 4 . The cutting part 4 is an electric cutting part; awire 9 is passed through therod body 2, and thewire 9 is connected with the cutting part 4; theperipheral hook body 3 of the cutting part 4 is set as an insulator.

严重的室性二尖瓣关闭不全往往是由于左心室重构,造成乳头肌移位,从而导致二尖瓣瓣叶被腱索拴系,使得瓣叶在关闭的时候不能回到瓣环正常位置,造成关闭不全。因此基于这个发病机制,本发明提供一款经心尖的二尖瓣拴系腱索的识别和松解装置,通过松解导致二尖瓣瓣叶拴系的“目标栓系腱索”,解除对二尖瓣瓣叶的拴拽,从而增加二尖瓣瓣叶对合面积,部分减轻二尖瓣返流,或为后续介入二尖瓣夹合术创造解剖条件,从而达到减轻心衰的作用。Severe ventricular mitral regurgitation is often due to left ventricular remodeling, resulting in displacement of the papillary muscle, which causes the mitral valve leaflets to be tethered by the chordae tendineae, making the valve leaflets unable to return to the normal position of the valve annulus when closed. , resulting in incomplete shutdown. Therefore, based on this pathogenesis, the present invention provides a device for identifying and releasing the chordae tendineae tethered to the mitral valve through the apex. The tethering of the mitral valve leaflets, thereby increasing the coaptation area of the mitral valve leaflets, partially reducing mitral valve regurgitation, or creating anatomical conditions for subsequent intervention in mitral valve clipping, thereby reducing heart failure.

实施例Example

如图1-4所示,本发明提供一种经心尖的二尖瓣拴系腱索识别和松解装置,腱索识别和松解装置通过介入鞘管到达二尖瓣拴系瓣叶附近;As shown in Figures 1-4, the present invention provides a transapical mitral valve tethered chord identification and release device, and the chord identification and release device reaches the vicinity of the mitral valve tethered leaflet through an intervention sheath;

腱索识别和松解装置包括腱索钩1和拦截推杆6;腱索钩1远离操作者的末端设置有可露出介入鞘管用于钩住腱索10的钩体3,钩体3上设置有用于切断腱索10的切割部4;The chord identification and release device includes achord hook 1 and an interceptingpush rod 6; the end of thechord hook 1 away from the operator is provided with ahook body 3 that can expose an intervention sheath for hooking thetendon chord 10, and thehook body 3 is provided with There is a cutting portion 4 for severing thechordae tendineae 10;

腱索钩1包括杆体一2和杆体一2末端的钩体3;钩体3设置为半包围的环状体,并设有便于腱索10进入半包围的环状体内部的缺口11。半包围的环状体为近似于U字形的钩状结构,钩状结构的末端经过180度回转与杆体一2的杆体平行;U字形的开口处即为缺口11;Thechordae hook 1 includes arod body 1 2 and ahook body 3 at the end of therod body 2; The semi-enclosed annular body is a hook-shaped structure similar to a U-shape, and the end of the hook-shaped structure is rotated 180 degrees to be parallel to the rod body of therod body 1 2; the opening of the U shape is thegap 11;

钩体3的U字形的钩状结构与缺口11设于同一虚拟平面上。拦截推杆6包括杆体二7和推杆头部8;杆体二7的末端设有与缺口11相对应的推杆头部8,推杆头部8设于远离操作者的一端;推杆头部8与杆体二7和杆体一2几乎垂直;The U-shaped hook structure of thehook body 3 and thenotch 11 are arranged on the same virtual plane. The interceptingpush rod 6 includes a rod body two 7 and apush rod head 8; the end of the rod body two 7 is provided with apush rod head 8 corresponding to thegap 11, and thepush rod head 8 is located at the end away from the operator; the push rod head Thepart 8 is almost perpendicular to the rod body two 7 and the rod body one 2;

且推杆头部8与缺口11设于同一虚拟平面上。推杆头部8的长度小于或等于缺口11的宽度。And thepush rod head 8 and thenotch 11 are arranged on the same virtual plane. The length of thepush rod head 8 is less than or equal to the width of thenotch 11 .

杆体一2中沿杆体长度方向设有一卡槽5,卡槽5的一端延伸至接近钩体3 的U字形钩状结构的底部;Therod body 2 is provided with aclamping groove 5 along the length direction of the rod body, and one end of theclamping groove 5 extends to the bottom of the U-shaped hook structure close to thehook body 3;

卡槽5在杆体一2的外表面设置有开口;卡槽5中卡设有活动的杆体二7。推杆头部8设于杆体一2杆体的外侧,与杆体二7连接。卡槽5的横截面设置为梯形,梯形卡槽5中较短的上底设置于杆体一2的外表面,较长的下底设置于杆体一2的内部;Theclamping slot 5 is provided with an opening on the outer surface of therod body 1 2 ; themovable rod body 2 7 is clamped in theclamping slot 5 . Thepush rod head 8 is arranged on the outer side of therod body 1 2 and is connected with therod body 2 7 . The cross section of theclamping slot 5 is set as a trapezoid, the shorter upper bottom of thetrapezoidal clamping slot 5 is set on the outer surface of therod body 1 2, and the longer lower bottom is set on the inside of therod body 1 2;

杆体二7杆体的横截面设置为与卡槽5横截面相匹配的梯形结构;杆体二7 可由杆体一2靠近操作者一端的卡槽5开口处穿入,并可一直沿杆体一2杆体的长度方向推送;推送过程中,卡槽5卡住杆体二7使其不会脱落;推送杆体二7 直至杆体二7末端的推杆头部8到达钩体3的U字形钩状结构的缺口11处;由于推杆头部8的长度略小于缺口11的宽度,则推杆头部8可用于封堵住已经钩住的腱索10,避免腱索10由缺口11逃逸;继续推送杆体二7,推杆头部8抵住钩住的腱索10,并进一步挤压腱索10,直至紧贴U字形钩状结构内侧壁设置的切割部4;Rod body 27 The cross section of the rod body is set to a trapezoidal structure matching the cross section of theclamping slot 5; Pushing in the length direction; during the pushing process, theslot 5 jams the rod body two 7 so that it will not fall off; push the rod body two 7 until thepush rod head 8 at the end of the rod body two 7 reaches thegap 11 of the U-shaped hook structure of thehook body 3 Since the length of thepush rod head 8 is slightly smaller than the width of thegap 11, thepush rod head 8 can be used to block thechordae 10 that have been hooked to prevent thechordae 10 from escaping from thegap 11; continue to push the rod body 27 , thepush rod head 8 is against the hookedtendon chord 10, and further squeezes thetendon chord 10 until it is close to the cutting portion 4 provided on the inner wall of the U-shaped hook structure;

钩体3的U字形钩状结构底部的内侧壁上设置有与缺口11相对应的切割部 4;切割部4设置有用于电切割的电极;杆体一2中穿设有导线9,导线9与切割部4的电极连接;切割部4电极的周边钩体3设置为绝缘体;除电极外的钩体 3涂布有绝缘层。电极通电后可用于切割腱索10。The inner side wall of the bottom of the U-shaped hook structure of thehook body 3 is provided with a cutting part 4 corresponding to thenotch 11; the cutting part 4 is provided with an electrode for electric cutting; The electrodes of the cutting part 4 are connected; theperipheral hook bodies 3 of the electrodes of the cutting part 4 are set as insulators; thehook bodies 3 except the electrodes are coated with an insulating layer. The electrodes can be used to cut thechordae tendineae 10 when energized.

本发明的使用过程:The use process of the present invention:

第一步:将超声探头放置在心脏表面,明确被腱索拴系的瓣叶位置和可能的“目标栓系腱索”,然后通过食道超声的引导,将本发明装置递送至二尖瓣拴系瓣叶附近;先将钩体3从鞘管中释放出来,捕获腱索10,并进行拉动,同时通过食道超声,确认该腱索是否为“目标栓系腱索”。Step 1: Place the ultrasound probe on the surface of the heart, identify the leaflets tethered by the chordae tendineae and possible "target tethered chordae tendineae", and then deliver the device of the present invention to the mitral valve tether via esophageal ultrasound guidance Near the leaflets of the tethered valve; first release thehook body 3 from the sheath, capture thechordae tendineae 10, and pull them, while ultrasound through the esophagus is performed to confirm whether the chordae tendineae is the "target tethered chordae tendineae".

第二步:确认钩住的腱索是“目标栓系腱索”后,将拦截推杆6从鞘管中推出,拦截推杆6末端的推杆头部8封堵挤压住腱索10,继续推进拦截推杆6,通过推杆头部8和钩体3上的切割部4配合,切断捕获的腱索10,再用食道超声实时观察瓣叶活动度及瓣膜返流是否减轻。Step 2: After confirming that the hooked chordae is the "target tethered chordae", push the interceptingpush rod 6 out of the sheath, and thepush rod head 8 at the end of the interceptingpush rod 6 blocks and squeezes thechordae 10. , Continue to advance the interceptingpush rod 6, cut the capturedchordae tendineae 10 through the cooperation of thepush rod head 8 and the cutting part 4 on thehook body 3, and then use esophageal ultrasound to observe the valve leaflet mobility and whether the valve regurgitation is alleviated in real time.

第三步:根据实际情况,重复以上两步,直至被拴系的瓣叶活动度恢复或瓣膜返流明显减轻,手术结束。Step 3: According to the actual situation, repeat the above two steps until the mobility of the tethered valve leaflets is restored or the valve regurgitation is significantly reduced, and the operation is over.

以上所述,仅为本发明的较佳实施例,并非对本发明任何形式上和实质上的限制,应当指出,对于本技术领域的普通技术人员,在不脱离本发明的前提下,还将可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。凡熟悉本专业的技术人员,在不脱离本发明的精神和范围的情况下,当可利用以上所揭示的技术内容而做出的些许更动、修饰与演变的等同变化,均为本发明的等效实施例;同时,凡依据本发明的实质技术对上述实施例所作的任何等同变化的更动、修饰与演变,均仍属于本发明的技术方案的范围内。The above are only preferred embodiments of the present invention, and are not intended to limit the present invention in any form or substance. It should be pointed out that those of ordinary skill in the art can also Several improvements and additions have been made, and these improvements and additions should also be regarded as the protection scope of the present invention. All those skilled in the art, without departing from the spirit and scope of the present invention, can utilize the above-disclosed technical content to make some changes, modifications and equivalent changes of evolution, all belong to the present invention. Equivalent embodiments; at the same time, any modification, modification and evolution of any equivalent changes made to the above embodiments according to the essential technology of the present invention still fall within the scope of the technical solutions of the present invention.

Claims (9)

1. A transapical mitral valve tethered chordae tendineae identification and release device is characterized in that the chordae tendineae identification and release device is arranged in an interventional sheath in a penetrating way; the chordae identification and release device comprises a chordae hook and an interception push rod; the tail end of the chordae tendineae hook, which is far away from an operator, is provided with a hook body for hooking chordae tendineae, and the hook body is provided with a cutting part for cutting off the chordae tendineae; and an intercepting push rod which is movable and used for preventing the chordae tendineae from being separated from the hook body and cutting the chordae tendineae by matching with the cutting part is arranged adjacent to the chordae tendineae hook.
CN202210777173.9A2022-07-042022-07-04 A transapical mitral valve tethered chordae tendineae identification and release devicePendingCN115105196A (en)

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