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CN1342443A - Setting-up tool for internal netted supporter in human cavity and its setting-up method - Google Patents

Setting-up tool for internal netted supporter in human cavity and its setting-up method
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Publication number
CN1342443A
CN1342443ACN 01132086CN01132086ACN1342443ACN 1342443 ACN1342443 ACN 1342443ACN 01132086CN01132086CN 01132086CN 01132086 ACN01132086 ACN 01132086ACN 1342443 ACN1342443 ACN 1342443A
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body cavity
human body
tube
stent
mesh
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蔡玉华
毛立民
邬蕴杰
王文祖
陈南梁
张佩华
杨盛
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Donghua University
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Donghua University
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Abstract

Translated fromChinese

本发明是一种新型人体腔网状内支架置入器,它包括内管、内管手柄、中管、中管夹头、外鞘管、外鞘管手柄,其特征是还包括阶梯轴孔圆锥形导向头,它固结在内管头端外径上。阶梯轴孔网锥形导向头与内管形成一个圆槽,活套在内管上的人体腔网状内支架轴向两端分别由圆槽和中管的端面定位,并压缩在阶梯轴孔圆锥形导向头的圆槽和外鞘管内。本发明采用不同于现有人体腔网状内支架置入器的置入方法,人体腔网状内支架的释放按中段、后段、前端的顺序扩张,它避免了操作过程中对人体腔管壁的损伤,可将人体腔网状内支架收回外鞘管内重新放置,提高了人体腔网状内支架置入操作的安全性、可靠性和定位准确性。

The present invention is a new human body cavity net-shaped internal stent inserter, which includes an inner tube, an inner tube handle, a middle tube, a middle tube chuck, an outer sheath tube, and an outer sheath tube handle, and is characterized in that it also includes a stepped shaft hole Conical guide head, which is fixed on the outside diameter of the head end of the inner tube. The tapered guide head of the stepped shaft hole network and the inner tube form a circular groove, and the axial ends of the body cavity mesh inner bracket on the inner tube are respectively positioned by the circular groove and the end surface of the middle tube, and compressed in the stepped shaft hole. In the circular groove of the conical guide head and in the outer sheath. The present invention adopts an insertion method different from the existing human body cavity mesh stent inserter. The release of the human body cavity mesh stent expands in the order of the middle section, the back section, and the front end, which avoids damage to the body cavity wall during operation. In case of injury, the mesh inner stent in the human body cavity can be retracted into the outer sheath tube and placed again, which improves the safety, reliability and positioning accuracy of the implantation operation of the mesh inner stent in the human body cavity.

Description

Translated fromChinese
新型人体腔网状内支架置入器及其置入方法New human body cavity mesh stent inserter and its inserting method

技术领域:Technical field:

本发明属于医用器材,尤其是一种新型人体腔网状内支架置入器及其置入方法。The invention belongs to medical equipment, in particular to a novel human body cavity net-like stent inserter and an inserting method thereof.

背景技术:Background technique:

人体腔网状内支架置入器是一种将人体腔网状内支架放置在人体腔内病变部位的器械,人体腔网状内支架由形状记忆合金材料制成。如图1所示,现有的一种人体腔网状内支架头端扩张式置入器,圆锥形导向头7开有一个轴孔固结在内管2头端外径上,内管2尾端固结在内管手柄2上,活套在内管2上的人体腔网状内支架3轴向两端分别由圆锥形导向头7和中管4的端面定位,中管4尾端固结在中管夹头上,整根人体腔网状内支架3被压缩在外鞘管5内,外鞘管5的尾端固结在外鞘管手柄5上。置入方法如图2所示,先将人体腔网状内支架头端扩张式置入器伸入人体腔内病变处(图2a);然后将外鞘管5慢慢抽出,人体腔网状内支架3的头端依靠自身弹性力自然扩张成喇叭状(图2b);随着外鞘管5的逐步抽出,人体腔网状内支架3的中段随之扩张成圆筒状(图2c);直至外鞘管5对人体腔网状内支架3的约束消除,整根人体腔网状内支架3支撑在人体腔管壁6内(图2d);最后将置入器抽出体外,完成人体腔网状内支架3的置入操作。这种现有的人体腔网状内支架头端扩张式置入器存在如下缺点:1.置入过程中人体腔网状内支架的头端先扩张成喇叭状支撑在人体腔管壁内,置入过程的推送和操作抖动,容易引起人体腔网状内支架的头端喇叭状刃口刮伤人体腔管壁。The human body cavity mesh stent implanter is a device for placing the body cavity mesh inner stent on the diseased part of the human body cavity. The body cavity mesh inner stent is made of a shape memory alloy material. As shown in Fig. 1, in an existing human body cavity reticular internal stent head end expansion implanter, theconical guide head 7 has a shaft hole and is consolidated on the outer diameter of the head end of theinner tube 2, and theinner tube 2 The tail end is fixed on thehandle 2 of the inner tube, and the axial ends of the meshinner support 3 of the human body cavity on theinner tube 2 are respectively positioned by theconical guide head 7 and the end face of themiddle tube 4, and the tail end of themiddle tube 4 Consolidated on the chuck of the middle tube, the whole body cavity meshinternal support 3 is compressed in theouter sheath tube 5 , and the tail end of theouter sheath tube 5 is fixed on thehandle 5 of the outer sheath tube. The insertion method is shown in Figure 2. Firstly, the head-end expandable inserter of the reticular internal stent in the human cavity is inserted into the lesion in the human cavity (Figure 2a); The head end of theinternal stent 3 naturally expands into a trumpet shape relying on its own elastic force (Fig. 2b); as theouter sheath tube 5 is gradually withdrawn, the middle section of the mesh-likeinternal stent 3 in the human body cavity expands into a cylindrical shape (Fig. 2c) ; until theouter sheath tube 5 eliminates the restriction of the body cavity meshinner bracket 3, the whole body cavity meshinner bracket 3 is supported in the body cavity wall 6 (Fig. 2d); finally, the inserter is pulled out of the body to complete the human body cavity. Insertion operation of the bodycavity mesh stent 3 . There are following disadvantages in this existing human body cavity reticular internal stent tip expansion type inserter: 1. During the insertion process, the head end of the human cavity reticular internal stent first expands into a trumpet shape and is supported in the human cavity wall, The push and operation vibration during the insertion process may easily cause the trumpet-shaped cutting edge at the head end of the mesh inner stent in the human body cavity to scratch the wall of the human body cavity.

2.置入过程中人体腔网状内支架的头端先扩张成喇叭状支撑在人体腔管壁内定位,由于人体腔网状内支架的直径扩张,人体腔网状内支架轴向尾端会向前缩短,影响人体腔网状内支架在人体腔管壁的定位准确性,甚至由于误抽动外鞘管而引人体腔网状内支架头端意外扩张,导致手术失败的情况出现。2. During the insertion process, the head end of the mesh inner stent in the human body cavity first expands into a trumpet-shaped support for positioning in the wall of the human body cavity. Due to the expansion of the diameter of the mesh inner stent in the human body cavity, the axial tail end It will be shortened forward, which will affect the positioning accuracy of the body cavity mesh stent on the body cavity wall, and even lead to the accidental expansion of the head end of the body cavity mesh mesh stent due to erroneous twitching of the outer sheath, resulting in surgical failure.

3.现有的人体腔网状内支架头端扩张式置入器一般都不具有将人体腔网状内支架收回外鞘管重新放置的功能。3. The existing human body cavity mesh stent head-end expandable inserter generally does not have the function of retracting the body cavity mesh stent and repositioning the outer sheath tube.

发明内容:Invention content:

本发明在于避免上述技术的缺点,而提供一种新型人体腔网状内支架置入器及其置入方法。The present invention avoids the disadvantages of the above-mentioned technologies, and provides a novel human body cavity mesh inner stent inserter and its inserting method.

本发明解决技术问题的技术方案如下:The technical scheme that the present invention solves technical problem is as follows:

一种新型人体腔网状内支架置入器,它包括内管2、内管手柄2、中管4、中管夹头4、外鞘管5、外鞘管手柄5,其特征是还包括阶梯轴孔圆锥形导向头1,它固结在内管2头端外径上。阶梯轴孔圆锥形导向头1与内管2形成一个圆槽1,活套在内管2上的人体腔网状内支架3轴向两端分别由阶梯轴孔圆锥形导向头1的圆槽1和中管4的端面定位,并压缩在圆槽1和外鞘管5内。A new human body cavity reticular internal stent inserter, which includes aninner tube 2, aninner tube handle 2, amiddle tube 4, amiddle tube chuck 4, anouter sheath tube 5, and an outersheath tube handle 5, and is characterized in that it also includes Aconical guide head 1 with a stepped shaft hole is fixed on the outer diameter of the head end of theinner tube 2. The stepped shaft holeconical guide head 1 and theinner tube 2 form acircular groove 1, and the body cavity meshinner support 3 looped on theinner tube 2 is respectively formed by the circular groove of the stepped shaft holeconical guide head 1 at both axial ends. 1 and the end face of themiddle tube 4 are positioned and compressed in thecircular groove 1 and theouter sheath tube 5.

本发明的人体腔网状内支架置入器置入方法特征是:The method for inserting the stent implanter in the human cavity of the present invention is characterized by:

(1)先将人体腔网状内支架置入器伸入到人体腔内病变处;(1) Firstly insert the human body cavity mesh stent inserter into the lesion in the human body cavity;

(2)将外鞘管5慢慢抽出到一定距离时,人体腔网状内支架3中段依靠自身弹性力自然扩张成鼓状支撑在人体腔壁6内;(2) When theouter sheath tube 5 is slowly drawn out to a certain distance, the middle section of the meshinner bracket 3 of the human body cavity naturally expands into a drum shape and is supported in thebody cavity wall 6 by virtue of its own elastic force;

(3)外鞘管5仍慢慢抽出,直至对人体腔网状内支架3尾端的约束消除,人体腔网状内支架3后段扩张支撑在人体腔壁6内;(3) Theouter sheath tube 5 is still slowly drawn out until the restriction on the tail end of the reticularinternal stent 3 of the human body cavity is eliminated, and the rear section of the reticularinternal stent 3 of the human body cavity is expanded and supported in thewall 6 of the human cavity;

(4)将置入器或内管2向前推送稍许,使人体腔网状内支架3头端脱离圆槽1的约束,人体腔网状内支架3即随之扩张支撑在人体腔壁6内;(4) Push the inserter or theinner tube 2 forward a little, so that the head end of the meshinner stent 3 of the human body cavity is separated from the constraint of thecircular groove 1, and the meshinner stent 3 of the human body cavity is expanded and supported on thewall 6 of the human body cavity Inside;

(5)最后将置入器收回人体外完成置入操作。(5) Finally, the inserter is withdrawn from the body to complete the inserting operation.

与现有技术相比,本发明的优点是:Compared with prior art, the advantage of the present invention is:

1.人体腔网状内支架置入过程中,人体腔网状内支架的中段先支撑定位于人体腔管壁,人体腔网状内支架与人体腔管壁的接触面积大,不易走动,人体腔网状内支架扩张后两端向中间收缩,定位准确。1. During the implantation process of the mesh inner stent in the human body cavity, the middle section of the mesh inner stent in the human body cavity is first supported and positioned on the wall of the human body cavity. The two ends of the stent in the body cavity shrink toward the middle after being expanded, and the positioning is accurate.

2.人体腔网状内支架置入过程中,人体腔网状内支架光滑平整的中段先扩张成鼓状支撑于人体腔管壁,不会损伤人体腔管壁。2. During the implantation of the human cavity mesh stent, the smooth and flat middle section of the human cavity mesh internal stent first expands into a drum shape to support the human cavity wall without damaging the human cavity wall.

3.人体腔网状内支架置入过程中,外鞘管抽出到一定距离时,若出现定位不妥仍可将人体腔网状内支架收回外鞘管内重新放置。3. During the insertion of the human cavity mesh stent, when the outer sheath tube is drawn out to a certain distance, if the positioning is improper, the human body cavity mesh inner stent can still be retracted into the outer sheath tube and placed again.

附图说明:Description of drawings:

图1现有的人体腔网状内支架头端扩张式置入器示意图2——内管,2——内管手柄,3——人体腔网状内支架,4——中管,4——中管夹头,5——外鞘管,5——外鞘管手柄,7——圆锥形导向头;Fig. 1 Schematic diagram of the existing human body cavity mesh internal stent head-end expansion type inserter 2 - inner tube, 2 - inner tube handle, 3 - human body cavity mesh internal stent, 4 - middle tube, 4 - —middle tube chuck, 5—outer sheath tube, 5—outer sheath tube handle, 7—conical guide head;

图2现有的人体腔网状内支架头端扩张式置入器置入方法示意图2——内管,3——人体腔网状内支架,4——中管,5——外鞘管,6——人体腔管壁,7——圆锥形导向头;Fig. 2 Schematic diagram of the method of inserting the head-end expansion type implanter of the existing human body cavityreticular stent 2—inner tube, 3—reticular internal stent in the human cavity, 4—middle tube, 5—outer sheath , 6—body cavity wall, 7—conical guide head;

图3新型人体腔网状内支架置入器示意图1——阶梯轴孔圆锥形导向头,1——圆槽,2——内管,2——内管手柄,3——人体腔网状内支架,4——中管,4——中管夹头,5——外鞘管,5——外鞘管手柄;Figure 3 Schematic diagram of the new human body cavity meshinner stent inserter 1—conical guide head with stepped shaft hole, 1—circular groove, 2—inner tube, 2—inner tube handle, 3—human cavity mesh Inner bracket, 4—middle tube, 4—middle tube clamp, 5—outer sheath, 5—outer sheath handle;

图4新型人体腔网状内支架置入器置入方法示意图1——阶梯轴孔圆锥形导向头,1——圆槽,2——内管,3——人体腔网状内支架,4——中管,5——外鞘管,6——人体腔管壁。Fig. 4 Schematic diagram of the insertion method of the new human body cavitymesh stent inserter 1—conical guide head with stepped shaft hole, 1—round groove, 2—inner tube, 3—body cavity mesh inner stent, 4 - middle tube, 5 - outer sheath tube, 6 - body cavity wall.

具体实施方式:Detailed ways:

请参阅图3和图4,本发明的一种新型人体腔网状内支架置入器,它包括内管2、内管手柄2、中管4、中管夹头4、外鞘管5、外鞘管手柄5,其特征是还包括阶梯轴孔圆锥形导向头1,它固结在内管2头端外径上。阶梯轴孔圆锥形导向头1与外鞘管5的外径相同,阶梯轴孔圆锥形导向头1的小轴孔与内管2头端固结,其尾端轴孔大于内管2外径,与内管2形成一个圆槽1。活套在内管2上的人体腔网状内支架3轴向两端分别由圆槽1和中管4的端面定位,头端一小段压缩在阶梯轴孔圆锥形导向头1的圆槽1内,其余压缩在外鞘管5内。置入方法如图4所示,先将人体腔网状内支架置入器伸入到人体腔内病变处(图4a);然后将外鞘管5慢慢抽出,此时人体腔网状内支架3头端仍压缩在圆槽1内,外鞘管5抽出到一定距离时,人体腔网状内支架3依靠自身弹性力先自中段自然扩张成鼓状支撑在人体腔管壁6内(图4b);直至外鞘管5对人体腔网状内支架3尾端的约束消除,人体腔网状内支架3后段扩张支撑在人体腔管壁6内(图4c);此后将置入器或内管2向前推送稍许,使人体腔网状内支架3头端脱离圆槽1的约束,人体腔网状内支架3的头端即随之扩张,由此整根人体腔网状内支架3完全支撑在人体腔管壁6内(图4d);最后将置入器收回人体外,即完成人体腔网状内支架3的置入操作。本发明置入方法采用人体腔网状内支架3的释放按中段—后段—前端的顺序扩张。置入过程中,外鞘管5抽出到一定距离时,若人体腔网状内支架3定位不妥,仍可将外鞘管5回退,把人体腔网状内支架3收拢在外鞘管5内重新放置。可回退最大距离取决于人体腔网状内支架3的刚性,一般为人体腔网状内支架3长度的三分之二。Please refer to Fig. 3 and Fig. 4, a kind of novel human body cavity inner stent inserter of the present invention, it comprisesinner tube 2,inner tube handle 2,middle tube 4,middle tube chuck 4,outer sheath tube 5, The outersheath tube handle 5 is characterized in that it also includes atapered guide head 1 with a stepped shaft hole, which is fixed on the outer diameter of the head end of theinner tube 2 . The outer diameter of theconical guide head 1 with stepped shaft hole is the same as that of theouter sheath tube 5, the small shaft hole of theconical guide head 1 with stepped shaft hole is fixed with the head end of theinner tube 2, and the shaft hole at the tail end is larger than the outer diameter of theinner tube 2 , forming acircular groove 1 with theinner tube 2 . The two axial ends of the body cavity meshinner bracket 3 on the looperinner tube 2 are respectively positioned by thecircular groove 1 and the end face of themiddle tube 4, and a short section of the head end is compressed in thecircular groove 1 of theconical guide head 1 in the stepped shaft hole. Inside, the rest are compressed in theouter sheath tube 5. The insertion method is shown in Figure 4. First, the human body cavity reticular stent inserter is inserted into the lesion in the human cavity (Figure 4a); The head end of thebracket 3 is still compressed in thecircular groove 1, and when theouter sheath tube 5 is pulled out to a certain distance, the net-shapedinner bracket 3 of the human body cavity first naturally expands from the middle section into a drum-like support by its own elastic force and is supported in thetube wall 6 of the human body cavity ( Fig. 4b); until the restriction of theouter sheath tube 5 to the tail end of the bodycavity reticulate stent 3 is eliminated, the rear section of the human bodycavity reticulate stent 3 is expanded and supported in the body cavity wall 6 (Fig. 4c); after that, the inserter Or theinner tube 2 is pushed forward a little, so that the head end of the meshinner stent 3 of the human body cavity is separated from the constraint of thecircular groove 1, and the head end of the meshinner stent 3 of the human body cavity expands accordingly, so that the whole body cavity mesh inner Thestent 3 is completely supported in the body cavity wall 6 ( FIG. 4 d ); finally, the inserter is withdrawn from the body, and the insertion operation of thestent 3 in the body cavity network is completed. The insertion method of the present invention adopts the release of the reticularinternal stent 3 in the human body cavity and expands in the order of middle section-rear section-front end. During the insertion process, when theouter sheath tube 5 is pulled out to a certain distance, if the positioning of the meshinner stent 3 of the human body cavity is not properly positioned, theouter sheath tube 5 can still be retracted, and the meshinner stent 3 of the human body cavity can be folded into theouter sheath tube 5 reposition within. The maximum retractable distance depends on the rigidity of the meshinner bracket 3 in the human body cavity, and is generally two-thirds of the length of the meshinner bracket 3 in the human body cavity.

由图4可知,在本发明新型人体腔网状内支架置入器置入过程中,人体腔网状内支架3的头端一直压缩在阶梯轴孔圆锥形导向头1的圆槽1内,这种释放方法能有效地避免操作过程中对人体腔壁的损伤,可避免操作过程中人体腔网状内支架3的意外扩张,可将人体腔网状内支架3收回外鞘管内重新放置,提高了人体腔网状内支架3置入操作的安全性、可靠性和定位准确性。It can be seen from Fig. 4 that during the insertion process of the novel human body cavity mesh internal stent implanter, the head end of the human body cavity meshinternal frame 3 is always compressed in thecircular groove 1 of theconical guide head 1 of the stepped shaft hole, This release method can effectively avoid damage to the body cavity wall during the operation, and can avoid accidental expansion of the meshinner stent 3 of the body cavity during the operation. The safety, reliability and positioning accuracy of the implantation operation of the meshinner stent 3 in the human cavity are improved.

Claims (2)

CN 011320862001-11-012001-11-01Setting-up tool for internal netted supporter in human cavity and its setting-up methodPendingCN1342443A (en)

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US12121461B2 (en)2015-03-202024-10-22Jenavalve Technology, Inc.Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath
US12171658B2 (en)2022-11-092024-12-24Jenavalve Technology, Inc.Catheter system for sequential deployment of an expandable implant
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US11154398B2 (en)2008-02-262021-10-26JenaValve Technology. Inc.Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
US11564794B2 (en)2008-02-262023-01-31Jenavalve Technology, Inc.Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
US12232957B2 (en)2008-02-262025-02-25Jenavalve Technology, Inc.Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
CN102596111B (en)*2009-08-242015-04-01阔利迈德股份有限公司 Implantable device with handle and method of use thereof
CN102596111A (en)*2009-08-242012-07-18阔利迈德股份有限公司 Implantable device with handle and method of use thereof
US12414854B2 (en)2010-05-202025-09-16Jenavalve Technology, Inc.Catheter system for introducing an expandable stent into the body of a patient
US11589981B2 (en)2010-05-252023-02-28Jenavalve Technology, Inc.Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent
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US12121461B2 (en)2015-03-202024-10-22Jenavalve Technology, Inc.Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath
US11337800B2 (en)2015-05-012022-05-24Jenavalve Technology, Inc.Device and method with reduced pacemaker rate in heart valve replacement
US12343255B2 (en)2015-05-012025-07-01Jenavalve Technology, Inc.Device and method with reduced pacemaker rate in heart valve replacement
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CN106345043A (en)*2016-10-142017-01-25南京鼓楼医院Transurethral filtering screen expansion device for ejaculatory duct obstruction
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US12433745B2 (en)2017-01-272025-10-07Jenavalve Technology, Inc.Heart valve mimicry
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