CN111840748A - Peripherally passed central venous catheter and preparation method thereof - Google Patents
Peripherally passed central venous catheter and preparation method thereof Download PDFInfo
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- 238000002360 preparation method Methods 0.000 title description 9
- 230000002093 peripheral effect Effects 0.000 claims abstract description 49
- 238000001802 infusion Methods 0.000 claims abstract description 11
- 239000000463 material Substances 0.000 claims description 7
- 238000000034 method Methods 0.000 claims description 5
- 230000005489 elastic deformation Effects 0.000 claims description 3
- 239000004814 polyurethane Substances 0.000 claims description 3
- 229920003225 polyurethane elastomer Polymers 0.000 claims description 3
- 229920002379 silicone rubber Polymers 0.000 claims description 3
- 239000004945 silicone rubber Substances 0.000 claims description 3
- 238000001125 extrusion Methods 0.000 claims description 2
- 230000007774 longterm Effects 0.000 abstract description 2
- 239000008280 blood Substances 0.000 description 5
- 210000004369 blood Anatomy 0.000 description 5
- 230000000740 bleeding effect Effects 0.000 description 4
- 238000010586 diagram Methods 0.000 description 4
- 239000013013 elastic material Substances 0.000 description 4
- 210000003462 vein Anatomy 0.000 description 4
- 230000032683 aging Effects 0.000 description 3
- 229940044683 chemotherapy drug Drugs 0.000 description 2
- 238000010992 reflux Methods 0.000 description 2
- 206010001526 Air embolism Diseases 0.000 description 1
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- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
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Abstract
本发明提供一种经外周中心静脉导管,所述导管的近管头端处侧壁设置有输入开口和回抽开口;正压输液时,所述输入开口打开,所述回抽开口关闭;负压回抽时,所述回抽开口打开,所述输入开口关闭;平衡时,所述输入开口和所述回抽开口均处于关闭状态。本发明的经外周中心静脉导管,输入开口和回抽开口分别采用单向开口,增加了使用的安全性和有效性,避免长期使用过程中出现回抽不良和瓣膜关闭不良。
The invention provides a peripheral central venous catheter. The side wall near the head end of the catheter is provided with an input opening and a withdrawal opening; during positive pressure infusion, the input opening is opened and the withdrawal opening is closed; When pressing and withdrawing, the withdrawing opening is opened and the input opening is closed; when balancing, both the input opening and the withdrawing opening are in a closed state. In the peripheral central venous catheter of the present invention, the input opening and the withdrawal opening are respectively unidirectional openings, which increases the safety and effectiveness of use, and avoids poor withdrawal and poor valve closure during long-term use.
Description
技术领域technical field
本发明属于医疗器械领域,具体涉及一种经外周中心静脉导管及其制备方法。The invention belongs to the field of medical devices, in particular to a peripheral central venous catheter and a preparation method thereof.
背景技术Background technique
经外周中心静脉导管(PICC),是利用导管从外周手臂的静脉进行穿刺,导管直达靠近心脏的大静脉,避免化疗药物与手臂静脉的直接接触,加上大静脉的血流速度很快,可以迅速冲稀化疗药物,防止药物对血管的刺激,近年来逐渐在术后临床得到广泛应用。Peripheral central venous catheter (PICC) uses a catheter to puncture a vein in the peripheral arm. The catheter goes directly to the large vein close to the heart, avoiding direct contact between chemotherapy drugs and the vein in the arm. In addition, the blood flow of the large vein is very fast. The rapid dilution of chemotherapy drugs to prevent the stimulation of drugs to blood vessels has gradually been widely used in postoperative clinics in recent years.
目前,经外周中心静脉导管,为了输液和回抽,常用的方式是采取三向瓣膜的方式,负压时阀门向内打开,可抽血,正压时阀门向外打开,可输液,平衡是阀门关闭,避免了空气栓塞、血液反流或凝固风险。美国专利US4671769公开了一种静脉导管,导管壁上沿中心轴线切缝,导管切缝的两边完全对称,所述切缝起阀门作用,抽血时,导管内腔形成负压,导管切缝的两边同时内凹,输液时,导管内腔形成正压,切缝向外凸导,在平衡时,处于自然封闭状态。At present, through the peripheral central venous catheter, for infusion and withdrawal, the commonly used method is to adopt the three-way valve method. When the negative pressure is used, the valve opens inwards, and blood can be drawn. When the positive pressure is used, the valve opens outwards for infusion. The valve is closed, avoiding the risk of air embolism, blood reflux or coagulation. US Patent US4671769 discloses a venous catheter, the catheter wall is cut along the central axis, the two sides of the catheter slit are completely symmetrical, the slit acts as a valve, when blood is drawn, the catheter lumen forms a negative pressure, and the catheter slit Both sides are concave at the same time. During infusion, the lumen of the catheter forms a positive pressure, and the incision protrudes outward. When it is balanced, it is in a natural closed state.
所述方法的经外周中心静脉导管的输液和回抽都采用的同一开口,长期不同方向的反复作用,很容易造成老化,导致回抽不良或关闭不严而造成渗血等问题。The method uses the same opening for infusion and withdrawal through the peripheral central venous catheter. Repeated action in different directions for a long time can easily cause aging, resulting in poor withdrawal or lax closure, causing problems such as bleeding.
发明内容SUMMARY OF THE INVENTION
为了克服背景技术所提到的经外周中心静脉导管的输液和回抽都采用的同一开口,长期不同方向的反复作用,很容易造成老化,导致回抽不良或关闭不严而造成渗血等问题,本发明提供一种如下方案的经外周中心静脉导管及其制备方法:In order to overcome the same opening used for infusion and withdrawal through the peripheral central venous catheter mentioned in the background art, repeated actions in different directions for a long time can easily cause aging, resulting in poor withdrawal or lax closure, resulting in problems such as bleeding and other problems. , the present invention provides a peripheral central venous catheter and a preparation method thereof according to the following scheme:
一种经外周中心静脉导管,所述导管的近管头端处侧壁设置有输入开口和回抽开口;正压输液时,所述输入开口打开,所述回抽开口关闭;负压回抽时,所述回抽开口打开,所述输入开口关闭;平衡时,所述输入开口和所述回抽开口均处于关闭状态。A peripheral central venous catheter, the side wall near the head end of the catheter is provided with an input opening and a withdrawal opening; during positive pressure infusion, the input opening is opened, and the withdrawal opening is closed; negative pressure withdrawal At the time of balance, both the input opening and the withdrawing opening are in the closed state.
可选的,开口方向线与管轴线形成小于90度的角度,所述开口两侧分别为弹性端和固定端,所述弹性端比所述固定端易于发生弹性形变,沿管内方向,所述输入开口的弹性端覆盖固定端,所述回抽开口的固定端覆盖弹性端。Optionally, the opening direction line and the tube axis form an angle of less than 90 degrees, the two sides of the opening are respectively an elastic end and a fixed end, the elastic end is easier to elastically deform than the fixed end, and along the inner direction of the tube, the The elastic end of the input opening covers the fixed end, and the fixed end of the retraction opening covers the elastic end.
可选的,所述角度为45~75度。Optionally, the angle is 45-75 degrees.
可选的,所述弹性端材料的邵尔硬度为30~60度,所述固定端的邵尔硬度为弹性端的邵尔硬度的1.5倍以上。Optionally, the Shore hardness of the elastic end material is 30-60 degrees, and the Shore hardness of the fixed end is more than 1.5 times the Shore hardness of the elastic end.
可选的,所述导管的厚度为0.2~0.4mm,管外径为0.6~1.5mm。Optionally, the thickness of the conduit is 0.2-0.4 mm, and the outer diameter of the tube is 0.6-1.5 mm.
可选的,所述开口为沿管圆周方向。Optionally, the opening is along the circumferential direction of the pipe.
可选的,所述开口沿圆周方向的长度为圆周长度的1/4~1/3。Optionally, the length of the opening in the circumferential direction is 1/4 to 1/3 of the circumferential length.
可选的,所述开口与管头端的距离为4-6mm。Optionally, the distance between the opening and the pipe head end is 4-6 mm.
可选的,所述导管材料为医用聚氨酯或硅橡胶。Optionally, the catheter material is medical polyurethane or silicone rubber.
上述所述的经外周中心静脉导管的制备方法,包括以下步骤:通过交替供料挤出的方式,在经外周中心静脉导管模具内形成经外周中心静脉导管的管体,在所述管体的近管头端依次形成硬段、软段和硬段,在硬段和软段连接处切口形成所述输入开口和回抽开口。The above-mentioned preparation method of the peripheral central venous catheter, comprising the following steps: by the mode of alternate feeding extrusion, in the peripheral central venous catheter mold, the tube body through the peripheral central venous catheter is formed, and the tube body is formed in the peripheral central venous catheter mold. A hard segment, a soft segment and a hard segment are formed in sequence near the head end of the tube, and the input opening and the withdrawal opening are formed by incisions at the connection of the hard segment and the soft segment.
与现有技术相比,本发明的方案具有如下优点:输入开口和回抽开口分别采用单向开口,增加了使用的安全性和有效性,避免长期使用过程中出现回抽不良和瓣膜关闭不良。Compared with the prior art, the solution of the present invention has the following advantages: the input opening and the retraction opening are respectively unidirectional openings, which increases the safety and effectiveness of use, and avoids poor retraction and poor valve closure during long-term use. .
附图说明Description of drawings
图1现有经外周中心静脉导管示意图;1 is a schematic diagram of an existing peripheral central venous catheter;
图2本发明一具体实施方式外周中心静脉导管示意图;2 is a schematic diagram of a peripheral central venous catheter according to a specific embodiment of the present invention;
图3本发明另一具体实施方式外周中心静脉导管示意图;3 is a schematic diagram of a peripheral central venous catheter according to another specific embodiment of the present invention;
具体实施方式Detailed ways
为使本发明的特征和优点能够更加明显易懂,下面结合附图对本发明的具体实施方式做详细的说明。In order to make the features and advantages of the present invention more clearly understood, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
参考图1,现有经外周中心静脉导管示意图,现有的经外周中心静脉导管包括导管管体11,在管体11近管头端的侧壁具有一个沿中心轴线的开口12,所述经外周中心静脉导管通过所述开口12进行输液和回抽,这样同一开口长期不同方向的反复作用,很容易造成老化,导致回抽不良或关闭不严而造成渗血等问题。1, a schematic diagram of an existing peripheral central venous catheter, the existing peripheral central venous catheter includes a
为解决上述问题,本发明的具体实施方式提供一种经外周中心静脉导管,如图2,所述经外周中心静脉导管包括管体21,所述导管管体21的近管头端处侧壁设置有输入开口22和回抽开口23;正压输液时,所述输入开口22打开,所述回抽开口23关闭;负压回抽时,所述回抽开口23打开,所述输入开口22关闭;平衡时,所述输入开口22和所述回抽开口23均处于关闭状态。In order to solve the above problems, a specific embodiment of the present invention provides a peripheral central venous catheter, as shown in FIG. 2 , the peripheral central venous catheter includes a
本发明的具体实施方式的经外周中心静脉导管,导管内负压低于-7mmHg时,回抽开口23向内开放,输入开口22关闭,可以抽取血样;导管内压力大于80mmHg,此时输入开口22打开,输入开口向外开放,回抽开口23关闭,允许药液进入人体;当压力范围在-7mm~80mm之间时,即导管不被使用时,回抽开口23和输入开口22均关闭,防止血液反流,在临床使用过程中可以防止凝血堵塞导管。Through the peripheral central venous catheter according to the specific embodiment of the present invention, when the negative pressure in the catheter is lower than -7 mmHg, the withdrawal opening 23 is opened inward, the
本发明的具体实施方式的经外周中心静脉导管,进一步,如图3,所述经外周中心静脉导管包括管体31,所述导管管体31的近管头端处侧壁设置有输入开口32和回抽开口33;所述开口方向线39,40,即输入开口32的开口方向线39和回抽开口33的开口方向线40与管轴线38形成小于90度的角度,所述开口两侧分别为弹性端34,36和固定端35,37,所述弹性端34,36比所述固定端35,37易于发生弹性形变,沿管内方向,所述输入开口的弹性端覆盖固定端,所述回抽开口的固定端35,37覆盖弹性端34,36。通过以上设计,当正压输液时,可以保证所述输入开口32打开,所述回抽开口33关闭;当负压回抽时,所述回抽开口33打开,所述输入开口32关闭;平衡时,所述输入开口32和所述回抽开口33均处于关闭状态。The peripheral central venous catheter according to the specific embodiment of the present invention, further, as shown in FIG. 3 , the peripheral central venous catheter includes a
本发明的具体实施方式的经外周中心静脉导管,如图3,所述输入开口32和回抽开口33为沿管圆周方向,这样可以有利于输入开口32和回抽开口33单向控制开口的制备,所述沿管圆周方向并非严格的沿圆周方向,允许有一定偏差,通常偏差以不超过30度为宜,最好不超过10度。所述输入开口32和回抽开口33可以在同一圆周上,也可以不在同一圆周上,通常以不在同一圆周上为好,这样可以防止如果输入开口32和回抽开口33均在同一圆周上,容易造成开口的集中导致导管更容易受损。所述输入开口32和回抽开口33可以在同一侧,也可以在不同侧,可以根据具体的实际需求进行设定,通常所述开口32,33与管头端的距离为4-6mm。In the peripheral central venous catheter according to the specific embodiment of the present invention, as shown in FIG. 3 , the input opening 32 and the withdrawal opening 33 are along the circumferential direction of the tube, which can facilitate the unidirectional control of the opening of the
本发明的具体实施方式的经外周中心静脉导管,如图3,所述开口方向线39,40是指形成所述开口32,33的切口方向所在的线,所述输入开口32的开口方向线39与管轴线38形成的角度,和回抽开口33的开口方向线40与管轴线38形成的角度,可以相同,也可以不相同。为了更好保证所述输入开口32和回抽开口33的单向开闭作用,所述开口方向线39,40与管轴线38形成角度为45~75度。In the peripheral central venous catheter according to the specific embodiment of the present invention, as shown in FIG. 3 , the
本发明的具体实施方式的经外周中心静脉导管,所述开口沿圆周方向的长度为圆周长度的1/4~1/3,所述圆周是指所述导管的外圆圆周,过长或过短都不利于输入开口32和回抽开口33单向开闭的控制,并且过长容易使导管受损。In the peripheral central venous catheter according to the specific embodiment of the present invention, the length of the opening in the circumferential direction is 1/4 to 1/3 of the circumference of the circumference, and the circumference refers to the outer circumference of the catheter, which is too long or too long. A short one is not conducive to the control of one-way opening and closing of the
本发明的具体实施方式的经外周中心静脉导管,如图3,所述弹性端34,36的材料为弹性材料,其材料的邵尔硬度为30~60度,一方面作为经外周中心静脉导管,另一方面为防止开口32,33关闭状态下渗血,所述固定端35,37同样为弹性材料,但所述固定端35,37的材料的邵尔硬度为弹性端34,36的材料的邵尔硬度的1.5倍以上,优选为2~4倍,输液或回抽时,可由弹性端34,36的弹性形变控制开口32,33的开变。In the peripheral central venous catheter according to the specific embodiment of the present invention, as shown in FIG. 3 , the
本发明的具体实施方式的经外周中心静脉导管,所述弹性材料通常为医用高分子弹性材料,具体的优选为聚氨酯或硅橡胶。In the peripheral central venous catheter according to a specific embodiment of the present invention, the elastic material is usually a medical polymer elastic material, specifically, preferably polyurethane or silicone rubber.
本发明的具体实施方式的经外周中心静脉导管,所述导管的厚度为0.2~0.4mm,管外径为0.6~1.5mm。According to the peripheral central venous catheter according to the specific embodiment of the present invention, the thickness of the catheter is 0.2-0.4 mm, and the outer diameter of the tube is 0.6-1.5 mm.
本发明的具体实施方式的经外周中心静脉导管,所述输入开口32和回抽开口33分别可以有1个或多个,可以根据需要进行多个设置,通常分别设置为各1个。In the peripheral central venous catheter according to the specific embodiment of the present invention, there may be one or
本发明的还提供一种上述经外周中心静脉导管的制备方法的具体实施方式,继续参考图3,所述制备方法,包括以下步骤:通过交替供料挤出的方式,在经外周中心静脉导管模具内形成经外周中心静脉导管的管体31,在所述管体31的近管头端依次形成硬段41、软段42和硬段43,在硬段41,43和软段42连接处按开口方向线39,40方向进行切口,在硬段41,43形成固定端35,37,在软段42形成弹性端34,36,从而形成所述输入开口32和回抽开口33。The present invention also provides a specific embodiment of the above-mentioned preparation method of the peripheral central venous catheter. Continuing to refer to FIG. 3 , the preparation method includes the following steps: by alternately feeding and extruding, in the peripheral central venous catheter
本发明具体实施方式的经外周中心静脉导管的制备方法,通过专用工装进行所述切口操作,具体地,将所述经外周中心静脉导管管体放到专用工装的切刀位置,按图纸设计通过计算机控制工装进行切口。In the preparation method of the peripheral central venous catheter according to the specific embodiment of the present invention, the incision operation is performed through a special tooling. A computer-controlled tool makes the incision.
本发明具体实施方式的经外周中心静脉导管的制备方法,所述输入开口的弹性端与所述回抽开口的弹性端可以在同一软段上形成,也可以在不同软段上形成。According to the preparation method of the peripheral central venous catheter according to the specific embodiment of the present invention, the elastic end of the input opening and the elastic end of the withdrawal opening can be formed on the same soft segment, or can be formed on different soft segments.
虽然本发明披露如上,但本发明并非限定于此。任何本领域技术人员,在不脱离本发明的精神和范围内,均可作各种更动与修改,因此本发明的保护范围应当以权利要求所限定的范围为准。Although the present invention is disclosed above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention should be based on the scope defined by the claims.
Claims (10)
Priority Applications (1)
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WO2023022944A1 (en) * | 2021-08-19 | 2023-02-23 | Luther Needlesafe Products, Llc | System and method for assembly of a low profile passive protector for an i.v. catheter |
CN116262155A (en) * | 2021-12-13 | 2023-06-16 | 众之峰(苏州)医疗科技有限公司 | Peripheral central venous catheter and preparation method thereof |
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WO2023022944A1 (en) * | 2021-08-19 | 2023-02-23 | Luther Needlesafe Products, Llc | System and method for assembly of a low profile passive protector for an i.v. catheter |
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