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CN115192892A - A body-surface interface system combined with intravascular fistula - Google Patents

A body-surface interface system combined with intravascular fistula Download PDF

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Publication number
CN115192892A
CN115192892A CN202210996809.9A CN202210996809A CN115192892A CN 115192892 A CN115192892 A CN 115192892A CN 202210996809 A CN202210996809 A CN 202210996809A CN 115192892 A CN115192892 A CN 115192892A
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flat
blood vessel
needle tube
interface system
artificial blood
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栗喆
陈志法
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Puduobang Xingda Tianjin Medical Technology Co ltd
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Puduobang Xingda Tianjin Medical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/105Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/062Apparatus for the production of blood vessels made from natural tissue or with layers of living cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/24Check- or non-return valves

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Prostheses (AREA)

Abstract

The invention provides a body surface interface system combined with intravascular fistula, which comprises: the artificial blood vessel is embedded in human tissue, one end of the artificial blood vessel is an artery port and is connected with the autologous artery of the patient, and the other end of the artificial blood vessel is a vein port and is connected with the autologous vein of the patient; 2 flat-mouth needle tube connectors which are respectively and integrally connected to the artificial blood vessel and form 2 side branch structures with the artificial blood vessel, and the ports of the 2 flat-mouth needle tube connectors are exposed on the surface of the skin and are parallel and level to the surface of the skin to form a channel outside the human blood vessel connector; the flat-mouth puncture outfit comprises a flat-mouth needle tube which can be inserted into the flat-mouth needle tube connector and a needle seat for installing the flat-mouth needle tube, and the flat-mouth puncture outfit is used for connecting an extracorporeal blood pipeline. This structure combines artificial blood vessel fistula, flat mouthful of puncture ware and flat mouthful of needle tubing connector, and the internal fistula of being convenient for is maintained, reduces the internal fistula pathological change, practices thrift the blood vessel resource that the patient can make the fistula, prolongs internal fistula and patient's life-span.

Description

一种结合血管内瘘的体表接口系统A body-surface interface system combined with intravascular fistula

技术领域technical field

本发明涉及医疗器械领域,尤其是涉及一种结合血管内瘘的体表接口系统。The invention relates to the field of medical devices, in particular to a body surface interface system combined with an intravascular fistula.

背景技术Background technique

血液透析是急慢性肾功能衰竭患者肾脏替代治疗方式之一。它通过将体内血液引流至体外,经由中空纤维组成的透析器,血液与透析液通过中空纤维,利用弥散、超滤、吸附和对流原理进行物质交换,清除体内的代谢废物、维持电解质和酸碱平衡;同时清除体内过多的水分,并将经过净化的血液回输的整个过程称为血液透析。患者需要建立用于血液透析治疗的血液通路,即血管内瘘,这可以提高血液流速,并且使静脉血管壁厚加厚,利于穿刺,这种手术称为造瘘。Hemodialysis is one of the ways of renal replacement therapy for patients with acute and chronic renal failure. It drains the blood from the body to the outside of the body, through a dialyzer composed of hollow fibers, the blood and dialysate pass through the hollow fibers, and use the principles of dispersion, ultrafiltration, adsorption and convection to exchange substances, remove metabolic wastes in the body, maintain electrolytes and acid-base. Balance; at the same time removing excess water from the body and returning the purified blood to the whole process is called hemodialysis. The patient needs to establish a blood access for hemodialysis treatment, that is, an intravascular fistula, which can increase the blood flow rate and thicken the wall of the venous blood vessel to facilitate puncture. This operation is called a fistula.

目前造瘘优先选择患者上肢的自体动静脉瘘,依次为人工血管瘘、下肢的血管瘘、中心静脉插管等。自体动静脉瘘较人工血管瘘发生狭窄、感染等病变的机率小,存活时间长。中心静脉是人体关键部位,插管处容易病变,会危及患者生命,不轻易采用,中心静脉插管也造成患者行动极其不便。长期透析治疗,即使是自体动静脉瘘也会出现病变,修复困难,最终废弃需要更换新的内瘘位置。人体能够建立自体动静脉瘘的血管资源是有限的,人工血管瘘也需要连接自体血管,所以这些血管是稀缺资源;如果消耗殆尽,最终导致患者无法透析治疗、威胁生命。At present, the autologous arteriovenous fistula of the upper extremity is the preferred choice for ostomy, followed by artificial vascular fistula, vascular fistula of the lower extremity, and central venous cannulation. Compared with artificial vascular fistula, autogenous arteriovenous fistula is less prone to stenosis, infection and other diseases, and has a longer survival time. The central vein is a key part of the human body. The intubation site is prone to lesions, which will endanger the patient's life. It is not easy to use. After long-term dialysis treatment, even the autologous arteriovenous fistula will have lesions, and it is difficult to repair, and eventually it needs to be replaced with a new internal fistula. The human body has limited vascular resources to establish autologous arteriovenous fistulas, and artificial vascular fistulas also need to be connected to autologous blood vessels, so these blood vessels are scarce resources; if they are exhausted, patients will eventually be unable to receive dialysis treatment, which is life-threatening.

除了造瘘位置的局限,每次透析需要用瘘针穿刺内瘘,一般是两支瘘针分别穿刺。瘘针针管较粗直径多为1.5-1.6mm,患者每周普遍需要两次以上的透析。瘘针穿刺对患者内瘘部位的皮肤组织损伤严重,每刺穿刺疼感很大,对患者身体和心理都有极大的伤害。而且目前临床多采用带有锐角的金属针管穿刺皮肤,容易误伤患者和护士,造成意外感染。In addition to the limitation of the location of the fistula, each dialysis needs to puncture the internal fistula with a fistula needle, usually two fistula needles are punctured separately. The thicker diameter of the fistula needle is 1.5-1.6mm, and patients generally need more than twice a week of dialysis. Fistula needle puncture seriously damages the skin tissue of the patient's internal fistula, and each puncture is very painful, which has great harm to the patient's body and mind. Moreover, at present, metal needles with sharp angles are often used in clinical practice to puncture the skin, which is easy to accidentally injure patients and nurses and cause accidental infection.

发明内容SUMMARY OF THE INVENTION

有鉴于此,本发明旨在提出一种结合血管内瘘的体表接口系统,结合人工血管瘘和平口针管连接器,便于内瘘维护,减少内瘘病变,节约患者瘘的血管资源,延长内瘘和患者寿命。In view of this, the present invention aims to propose a body surface interface system combined with vascular fistula, combined with artificial vascular fistula and flat needle tube connector, which is convenient for internal fistula maintenance, reduces internal fistula lesions, saves vascular resources of patient's fistula, and prolongs internal fistula. Fistula and patient longevity.

为达到上述目的,本发明的技术方案是这样实现的:In order to achieve the above object, the technical scheme of the present invention is achieved in this way:

一种结合血管内瘘的体表接口系统,包括:A body-surface interface system incorporating an endovascular fistula, comprising:

人工血管,埋于人体组织内,人工血管一端为动脉端口,并与患者自体动脉连接,人工血管另一端为静脉端口,并与患者自体静脉连接;The artificial blood vessel is buried in the human tissue. One end of the artificial blood vessel is an arterial port, which is connected to the patient's own artery, and the other end of the artificial blood vessel is a venous port, which is connected to the patient's own vein;

2个平口针管连接器,分别一体连接在人工血管上,并与人工血管形成2个侧枝结构,2个平口针管连接器的端口裸露在皮肤表面,并与皮肤表面平齐,成为人体血管连接体外的通道;平口针管连接器的大小可根据患者皮下组织的厚度确定;Two flat-mouth needle tube connectors are integrally connected to the artificial blood vessel, and form two side branch structures with the artificial blood vessel. The ports of the two flat-mouth needle tube connectors are exposed on the surface of the skin and are flush with the surface of the skin, becoming the connection of human blood vessels to the body. channel; the size of the flat needle tube connector can be determined according to the thickness of the patient's subcutaneous tissue;

平口穿刺器,包括可插设在平口针管连接器上的平口针管和安装平口针管的针座,平口穿刺器用于连接体外血液管路,平口针管由医用级高分子材料制成。The flat-mouth trocar includes a flat-mouthed needle tube that can be inserted into a flat-mouthed needle tube connector and a needle seat for installing the flat-mouthed needle tube. The flat-mouthed trocar is used to connect an extracorporeal blood pipeline.

进一步,平口针管连接器包括外壳、固定环、单向阀和护帽;外壳的一端插入人工血管内部,并与人工血管一体成型,外壳内设有若干个叠放的单向阀,单向阀的上方设有起固定作用的固定环,固定环的中心设有用于插设平口穿刺器的插孔,固定环的上方设有起密封作用的护帽。Further, the flat needle tube connector includes a casing, a fixing ring, a one-way valve and a protective cap; one end of the casing is inserted into the artificial blood vessel, and is integrally formed with the artificial blood vessel, and the casing is provided with several stacked one-way valves. The upper part of the fixing ring is provided with a fixing ring for fixing, the center of the fixing ring is provided with an insertion hole for inserting the flat trocar, and the upper part of the fixing ring is provided with a protective cap for sealing.

进一步,外壳包括一体成型的外壳本体和外壳尾部,外壳本体的直径大于外壳尾部的直径,外壳尾部插在人工血管的内部,外壳本体与外壳尾部的连接处形成用于支撑单向阀的台阶。Further, the shell includes an integrally formed shell body and a shell tail, the diameter of the shell body is larger than that of the shell tail, the shell tail is inserted inside the artificial blood vessel, and the connection between the shell body and the shell tail forms a step for supporting the one-way valve.

进一步,外壳本体的端口和外壳尾部的端口均为斜切面。Further, both the port of the housing body and the port of the rear of the housing are chamfered surfaces.

进一步,外壳本体的内部自斜切面的最低端至台阶之间的距离等于或略大于固定环与若干个单向阀的厚度之和。Further, the distance from the innermost end of the chamfered surface to the step inside the housing body is equal to or slightly larger than the sum of the thicknesses of the fixing ring and the plurality of one-way valves.

进一步,外壳本体的外侧壁上设有定位环,定位环埋在皮肤里,用于防止接口受力移动,对人体造成损伤。Further, a positioning ring is provided on the outer side wall of the housing body, and the positioning ring is embedded in the skin to prevent the interface from moving under force and causing damage to the human body.

进一步,护帽上设有连接鼻,连接鼻上设有通孔。Further, the protective cap is provided with a connecting nose, and the connecting nose is provided with a through hole.

护帽的内部还设有凹槽,透析后,护帽底部的凹槽放入浸有消毒液的药棉,然后盖在平口针管连接器的端口,阻止液体、异物进入内部,防止感染。There is also a groove inside the protective cap. After dialysis, the groove at the bottom of the protective cap is put into cotton wool soaked with disinfectant, and then covered with the port of the flat needle tube connector to prevent liquid and foreign objects from entering the interior and prevent infection.

进一步,平口针管的外侧壁上设有凸起的限位台,固定环上设有供限位台穿过的缺口。Further, the outer side wall of the flat-mouthed needle tube is provided with a convex limit table, and the fixing ring is provided with a gap for the limit table to pass through.

进一步,固定环与外壳螺纹连接。Further, the fixing ring is threadedly connected with the housing.

进一步,还包括球囊导管,球囊导管的球囊端穿过单向阀伸入外壳内,且球囊端充气后可用于堵塞血管,单向阀可沿球囊导管滑动。Further, it also includes a balloon catheter, the balloon end of the balloon catheter extends into the housing through the one-way valve, and the balloon end can be used to block the blood vessel after inflation, and the one-way valve can slide along the balloon catheter.

相对于现有技术,本发明所述的结合血管内瘘的体表接口系统具有以下优势:Compared with the prior art, the body surface interface system combined with vascular fistula described in the present invention has the following advantages:

(1)本发明所述的结合血管内瘘的体表接口系统可预先埋在人体组织内,仅将平口针管连接器的端口漏在皮肤表面成为人体血管连接体外的通道,该结构可以免刺穿皮肤,减少透析患者每次穿刺的疼痛的感;避免带穿刺斜角的金属针管对血管的损伤,保护血管资源,节省患者的血管资源,保证人工血管的正常使用,延长使用寿命。(1) The body surface interface system combined with the vascular fistula of the present invention can be embedded in human tissue in advance, and only the port of the flat needle tube connector is leaked on the skin surface to become a channel for human blood vessels to connect to the outside of the body. This structure can avoid puncture. Perforating the skin, reducing the pain of each puncture for dialysis patients; avoiding the damage to blood vessels caused by metal needles with puncture bevels, protecting vascular resources, saving patients' vascular resources, ensuring the normal use of artificial blood vessels, and prolonging the service life.

(2)本发明所述的平口针管连接器包括外壳、固定环、单向阀和护帽,使用时,拔下护帽,将平口针管依次穿过固定环和单向阀插入外壳内实现管路的连接,操作简单方便。完成透析后,再盖上护帽,对平口针管连接器起保护作用。(2) The flat needle tube connector of the present invention includes a housing, a fixing ring, a one-way valve and a protective cap. When in use, the protective cap is removed, and the flat needle tube is inserted into the housing through the fixing ring and the one-way valve in turn to realize the tube. The connection of the road is simple and convenient to operate. After dialysis is complete, put the protective cap back on to protect the flush needle connector.

(3)本发明所述的结合血管内瘘的体表接口系统还可以用球囊导管更换、维修平口针管连接器,延长器械使用寿命。还可打开平口针管连接器,病变血管进行疏通、治疗,延长内瘘的寿命,无需再造新的内瘘。(3) The body surface interface system combined with the vascular fistula of the present invention can also be used to replace and repair the flat needle tube connector with a balloon catheter, so as to prolong the service life of the device. The flat-mouth needle connector can also be opened, and the diseased blood vessels can be dredged and treated, so as to prolong the life of the internal fistula, and there is no need to create a new internal fistula.

附图说明Description of drawings

构成本发明的一部分的附图用来提供对本发明的进一步理解,本发明的示意性实施例及其说明用于解释本发明,并不构成对本发明的不当限定。在附图中:The accompanying drawings constituting a part of the present invention are used to provide further understanding of the present invention, and the exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the attached image:

图1为本发明实施例所述的结合血管内瘘的体表接口系统的示意图;1 is a schematic diagram of a body surface interface system combined with an intravascular fistula according to an embodiment of the present invention;

图2为本发明实施例所述的平口针管连接器的结构示意图;2 is a schematic structural diagram of the flush needle tube connector according to the embodiment of the present invention;

图3为本发明实施例所述的平口针管连接器的剖视图;3 is a cross-sectional view of the flush needle tube connector according to the embodiment of the present invention;

图4为本发明实施例所述的固定环的结构示意图;4 is a schematic structural diagram of a fixing ring according to an embodiment of the present invention;

图5为本发明实施例所述的平口针管连接器的安装结构图;Fig. 5 is the installation structure diagram of the flush needle tube connector according to the embodiment of the present invention;

图6为本发明实施例所述的平口穿刺器的结构示意图;6 is a schematic structural diagram of a flat-mouth trocar according to an embodiment of the present invention;

图7为本发明实施例所述的平口穿刺器的剖视图;7 is a cross-sectional view of the flat-mouth trocar according to an embodiment of the present invention;

图8为本发明实施例所述的结合血管内瘘的体表接口系统的使用状态图;8 is a state diagram of the use of the body surface interface system combined with the vascular fistula according to the embodiment of the present invention;

图9为更换单向阀的操作示意图;Fig. 9 is the operation schematic diagram of replacing the one-way valve;

图10为该结构的维护操作结构图。FIG. 10 is a structural diagram of a maintenance operation of this structure.

附图标记说明:Description of reference numbers:

1-人工血管;11-动脉端口;12-静脉端口;2-平口针管连接器;21-外壳;211-外壳本体;212-外壳尾部;213-台阶;22-固定环;221-插孔;222-缺口;23-单向阀;24-护帽;25-定位环;26-连接鼻;261-通孔;3-平口穿刺器;31-平口针管;32-针座;33-限位台;4-接头;5-体外动脉侧血液管路;6-体外静脉侧血液管路;7-患者自体动脉;8-患者自体静脉;9-球囊导管。1-arterial blood vessel; 11-arterial port; 12-venous port; 2-flush needle connector; 21-housing; 211-housing body; 212-housing tail; 213-step; 22-fixing ring; 222-notch; 23-check valve; 24-protecting cap; 25-locating ring; 26-connecting nose; 261-through hole; 3-flat trocar; 31-flat needle; 32-needle seat; 4-joint; 5-extracorporeal artery side blood pipeline; 6-extracorporeal venous side blood pipeline; 7-patient's own artery; 8-patient's own vein; 9-balloon catheter.

具体实施方式Detailed ways

需要说明的是,在不冲突的情况下,本发明中的实施例及实施例中的特征可以相互组合。It should be noted that the embodiments of the present invention and the features of the embodiments may be combined with each other under the condition of no conflict.

在本发明的描述中,需要理解的是,术语“中心”、“纵向”、“横向”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。此外,术语“第一”、“第二”等仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”等的特征可以明示或者隐含地包括一个或者更多个该特征。在本发明的描述中,除非另有说明,“多个”的含义是两个或两个以上。In the description of the present invention, it should be understood that the terms "center", "portrait", "horizontal", "top", "bottom", "front", "rear", "left", "right", " The orientation or positional relationship indicated by vertical, horizontal, top, bottom, inner, outer, etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and The description is simplified rather than indicating or implying that the device or element referred to must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as limiting the invention. In addition, the terms "first", "second", etc. are used for descriptive purposes only, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature defined as "first", "second", etc., may expressly or implicitly include one or more of that feature. In the description of the present invention, unless otherwise specified, "plurality" means two or more.

在本发明的描述中,需要说明的是,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以通过具体情况理解上述术语在本发明中的具体含义。In the description of the present invention, it should be noted that the terms "installed", "connected" and "connected" should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood through specific situations.

下面将参考附图并结合实施例来详细说明本发明。The present invention will be described in detail below with reference to the accompanying drawings and in conjunction with the embodiments.

一种结合血管内瘘的体表接口系统,包括:A body-surface interface system incorporating an endovascular fistula, comprising:

人工血管1,埋置于人体组织内,人工血管一端为动脉端口11,并与患者自体动脉7连接,人工血管另一端为静脉端口12,并与患者自体静脉8连接;The artificial blood vessel 1 is embedded in human tissue, one end of the artificial blood vessel is an arterial port 11, and is connected with the patient's autologous artery 7, and the other end of the artificial blood vessel is a venous port 12, and is connected with the patient's autologous vein 8;

2个平口针管连接器2,分别一体连接在人工血管上,并与人工血管形成2个侧枝结构,2个平口针管连接器的端口裸露在皮肤表面,并与皮肤表面平齐,成为人体血管连接体外的通道;Two flat-mouthed needle tube connectors 2 are integrally connected to the artificial blood vessel, and form two side branch structures with the artificial blood vessel. The ports of the two flat-mouthed needle tube connectors are exposed on the skin surface and are flush with the skin surface to become human blood vessel connections. extracorporeal channels;

平口针管连接器的材料采用与生物相容性优良的材料制造,减少排异反应,延长使用寿命,可由3D打印技术制造,自体细胞组织,使用接口与人体自然结合。The material of the flat needle tube connector is made of materials with excellent biocompatibility, which reduces rejection reaction and prolongs the service life.

具体的,平口针管连接器包括外壳21、固定环22、单向阀23和护帽24;外壳的一端插入人工血管内部,并与人工血管一体成型,外壳内设有若干个叠放的单向阀,单向阀的上方设有起固定作用的固定环,固定环的中心设有用于插设平口穿刺器的插孔221,固定环的上方设有起密封作用的护帽。更具体的,单向阀可以为2个,单向阀可采用软质弹性材料,安装时直接卡在外壳内即可,便于拆卸和更换。Specifically, the flat needle tube connector includes a casing 21, a fixing ring 22, a one-way valve 23 and a protective cap 24; one end of the casing is inserted into the artificial blood vessel, and is integrally formed with the artificial blood vessel, and the casing is provided with several stacked one-way valves. The upper part of the one-way valve is provided with a fixing ring for fixing, the center of the fixing ring is provided with an insertion hole 221 for inserting a flush trocar, and a protective cap for sealing is arranged above the fixing ring. More specifically, the number of one-way valves can be two, and the one-way valve can be made of soft elastic material, which can be directly clamped in the casing during installation, which is convenient for disassembly and replacement.

该结构还包括球囊导管9,球囊导管的球囊端穿过单向阀伸入外壳内,且球囊端充气后可用于堵塞血管,单向阀可沿球囊导管滑动移出外壳。The structure also includes a balloon catheter 9, the balloon end of the balloon catheter extends into the housing through the one-way valve, and the balloon end can be used to block blood vessels after inflation, and the one-way valve can slide out of the housing along the balloon catheter.

单向阀多次使用后,如果发生渗血现象需要更换时,如图9所示,新单向阀先套在球囊导管上,在使用球囊导管穿过透析接口单向阀,使用球囊充气堵塞血管,沿导管取出旧单向阀,剪下旧单向阀,将导管上的新单向阀置入透析接口内,完成更换。After the one-way valve is used for many times, if bleeding occurs and needs to be replaced, as shown in Figure 9, the new one-way valve is first set on the balloon catheter. The balloon is inflated to block the blood vessel, the old one-way valve is taken out along the catheter, the old one-way valve is cut off, and the new one-way valve on the catheter is placed in the dialysis port to complete the replacement.

如果诊断内瘘附近血管有堵塞、狭窄、感染等病变,如图10所示,可拆除固定环,必要时拆除单向阀,使用现有介入治疗技术,从平口针管连接器插入导管,对病变血管进行疏通、治疗,从而延长内瘘的寿命。这种开放性的通道,便于内瘘的维护。If it is diagnosed that the blood vessels near the internal fistula have blockage, stenosis, infection and other diseases, as shown in Figure 10, the fixing ring can be removed, and the one-way valve can be removed if necessary. The blood vessels are dredged and treated, thereby prolonging the life of the internal fistula. This open channel facilitates the maintenance of the internal fistula.

更具体的,外壳包括一体成型的外壳本体211和外壳尾部212,外壳本体的直径大于外壳尾部的直径,外壳尾部插在人工血管的内部,外壳本体与外壳尾部的连接处形成用于支撑单向阀的台阶213。More specifically, the shell includes an integrally formed shell body 211 and a shell tail 212, the diameter of the shell body is larger than the diameter of the shell tail, the shell tail is inserted inside the artificial blood vessel, and the connection between the shell body and the shell tail is formed to support one-way Step 213 of the valve.

外壳本体的端口和外壳尾部的端口均为斜切面,外壳本体的端口的斜切面便于与皮肤保持齐平,外壳尾部的端口的斜切面便于人工血管内血液的流动。The port of the shell body and the port at the tail of the shell are both chamfered surfaces, the chamfered surface of the port of the shell body is convenient to keep flush with the skin, and the chamfered surface of the port at the tail of the shell is convenient for blood flow in the artificial blood vessel.

外壳本体的内部自斜切面的最低端至台阶之间的距离等于或略小于固定环与若干个单向阀的厚度之和,可便于固定环、单向阀的安装。The distance from the lowest end of the chamfered surface to the step inside the housing body is equal to or slightly smaller than the sum of the thicknesses of the fixing ring and several one-way valves, which can facilitate the installation of the fixing ring and the one-way valve.

固定环可直接塞在外壳内,或者,优选的,固定环与外壳螺纹连接。The retaining ring can be plugged directly into the housing, or, preferably, the retaining ring is screwed to the housing.

外壳本体的外侧壁上设有定位环25,定位环埋在皮肤里,用于防止接口受力移动,对人体造成损伤。A positioning ring 25 is arranged on the outer side wall of the housing body, and the positioning ring is embedded in the skin to prevent the interface from moving under force and causing damage to the human body.

护帽上设有连接鼻26,连接鼻上设有通孔261。如果发生护帽与平口针管连接器粘连,不易取下,可用金属丝穿过通孔261,取下护帽。The protective cap is provided with a connecting nose 26, and the connecting nose is provided with a through hole 261. If the protective cap adheres to the flat needle tube connector and is not easy to remove, a metal wire can be passed through the through hole 261 to remove the protective cap.

护帽的内部还设有凹槽,透析后,护帽底部的凹槽放入浸有消毒液的药棉,然后盖在平口针管连接器的端口,阻止液体、异物进入内部,防止感染。平口针管的外侧壁上设有凸起的限位台33,固定环上设有供限位台穿过的缺口222。插入平口针使,使限位台对准缺口,当限位台完全插入之后,转动平口针管,使限位台与缺口错开,防止透析治疗期间平口穿刺器脱落。There is also a groove inside the protective cap. After dialysis, the groove at the bottom of the protective cap is put into cotton wool soaked with disinfectant, and then covered with the port of the flat needle tube connector to prevent liquid and foreign objects from entering the interior and prevent infection. The outer side wall of the flat needle tube is provided with a raised limiting platform 33, and the fixing ring is provided with a notch 222 for the limiting platform to pass through. Insert the flat-mouthed needle so that the limiter is aligned with the notch. When the limiter is fully inserted, rotate the flat-mouthed needle tube to stagger the limiter and the notch to prevent the flat-mouth trocar from falling off during dialysis treatment.

平口穿刺器3,包括可插设在平口针管连接器上的平口针管31和安装平口针管的针座32,平口穿刺器用于连接体外血液管路,如分别连接体外动脉侧血液管路5和体外静脉侧血液管路6。The flat-mouth trocar 3 includes a flat-mouthed needle tube 31 that can be inserted into the flat-mouthed needle tube connector and a needle holder 32 for installing the flat-mouthed needle tube. The flat-mouthed trocar is used to connect the extracorporeal blood pipeline, such as connecting the extracorporeal artery side blood pipeline 5 and the extracorporeal needle respectively. Venous side blood line 6.

动脉端口用于引出动脉血液,使其经动脉体外血液管路、透析器、静脉体外血液管路、静脉端口,经过透析后的血液流回人体静脉。The arterial port is used to draw out the arterial blood, so that the blood after dialysis flows back to the human vein through the arterial extracorporeal blood pipeline, the dialyzer, the venous extracorporeal blood pipeline, and the venous port.

具体使用原理:Specific use principle:

通过手术将人工血管1两端与患者自体动脉和静脉血管连接,这种手术是目前成熟技术。人工血管1及平口针管连接器提前一周埋置于人体组织内,两个平口针管连接器端口与皮肤表面平齐,成为人体血管连接体外的通道。外壳上的定位环25卡在皮肤里,用于防止接口受力移动,对人体造成损伤。The two ends of the artificial blood vessel 1 are connected to the patient's own arterial and venous blood vessels through surgery, which is a mature technology at present. The artificial blood vessel 1 and the flat-mouthed needle tube connector are embedded in the human tissue one week in advance, and the two flat-mouthed needle tube connector ports are flush with the surface of the skin, which become the channels for the human blood vessels to connect to the outside of the body. The positioning ring 25 on the shell is stuck in the skin to prevent the interface from moving under force and causing damage to the human body.

手术后3-4周,可以开始试用内瘘进行血液透析。3-4 weeks after surgery, a trial of internal fistula for hemodialysis can be started.

一个平口针管连接器用于从动脉引出血液,输入透析管路。另一个平口针管连接器用于从透析管中引入血液,输入人体静脉血管。A flush needle connector is used to draw blood from the artery into the dialysis line. Another flush needle connector is used to introduce blood from a dialysis tube into a human vein.

该结合血管内瘘的体表接口系统可预先埋在人体组织内,仅将平口针管连接器的端口漏在皮肤表面成为人体血管连接体外的通道,该结构可以免刺穿皮肤,减少透析患者每次穿刺的疼痛的感;同时保护血管资源,节省患者的血管资源,保证人工血管内瘘的正常使用,延长使用寿命。The body surface interface system combined with vascular fistula can be pre-buried in human tissue, and only the port of the flat needle tube connector is leaked on the skin surface to become a channel for human blood vessels to connect to the body. At the same time, it protects the vascular resources, saves the patient's vascular resources, ensures the normal use of the artificial vascular fistula, and prolongs the service life.

本发明也可以应用于与血液透析相近的连续性肾脏替代治疗(CRRT)、血液灌流或血浆置换等体外循环血液净化治。The present invention can also be applied to continuous renal replacement therapy (CRRT) similar to hemodialysis, blood perfusion or plasma exchange and other extracorporeal blood purification treatments.

以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included in the scope of the present invention. within the scope of protection.

Claims (10)

1.一种结合血管内瘘的体表接口系统,其特征在于:包括:1. a body surface interface system in conjunction with vascular fistula, is characterized in that: comprise: 人工血管,埋置于人体组织内,人工血管一端为动脉端口,并与患者自体动脉连接,人工血管另一端为静脉端口,并与患者自体静脉连接;The artificial blood vessel is embedded in human tissue, one end of the artificial blood vessel is an arterial port, and is connected to the patient's own artery, and the other end of the artificial blood vessel is a venous port, and is connected to the patient's own vein; 2个平口针管连接器,分别一体连接在人工血管上,并与人工血管形成2个侧枝结构,2个平口针管连接器的端口裸露在皮肤表面,并与皮肤表面平齐,成为人体血管连接体外的通道;Two flat-mouth needle tube connectors are integrally connected to the artificial blood vessel, and form two side branch structures with the artificial blood vessel. The ports of the two flat-mouth needle tube connectors are exposed on the surface of the skin and are flush with the surface of the skin, becoming the connection of human blood vessels to the body. channel; 平口穿刺器,包括可插设在平口针管连接器上的平口针管和安装平口针管的针座,平口穿刺器用于连接体外血液管路。The flat-mouth trocar includes a flat-mouthed needle tube that can be inserted into the flat-mouthed needle tube connector and a needle seat for installing the flat-mouthed needle tube. The flat-mouthed trocar is used to connect an extracorporeal blood pipeline. 2.根据权利要求1所述的结合血管内瘘的体表接口系统,其特征在于:平口针管连接器包括外壳、固定环、单向阀和护帽;外壳的一端伸入人工血管内部与人工血管连通,并与人工血管一体成型,外壳内设有若干个叠放的单向阀,单向阀的上方设有起固定作用的固定环,固定环的中心设有用于插设平口穿刺器的插孔,固定环的上方设有起密封作用的护帽。2. The body surface interface system combined with intravascular fistula according to claim 1, characterized in that: the flat needle tube connector comprises a casing, a fixing ring, a one-way valve and a protective cap; The blood vessel is connected and formed integrally with the artificial blood vessel. Several stacked one-way valves are arranged in the shell. The upper part of the one-way valve is provided with a fixing ring for fixing. There is a protective cap on the top of the fixing ring, which plays a sealing role. 3.根据权利要求2所述的结合血管内瘘的体表接口系统,其特征在于:外壳包括一体成型的外壳本体和外壳尾部,外壳本体的直径大于外壳尾部的直径,外壳尾部连接在人工血管的内部,外壳本体与外壳尾部的连接处形成用于支撑单向阀的台阶。3. The body surface interface system combined with vascular fistula according to claim 2, characterized in that: the shell comprises an integrally formed shell body and a shell tail, the diameter of the shell body is greater than the diameter of the shell tail, and the shell tail is connected to the artificial blood vessel Inside, the connection between the housing body and the rear of the housing forms a step for supporting the one-way valve. 4.根据权利要求3所述的结合血管内瘘的体表接口系统,其特征在于:外壳本体的端口和外壳尾部的端口均为斜切面。4 . The body surface interface system combined with vascular fistula according to claim 3 , wherein the port of the shell body and the port of the tail of the shell are both chamfered surfaces. 5 . 5.根据权利要求4所述的结合血管内瘘的体表接口系统,其特征在于:外壳本体的内部自斜切面的最低端至台阶之间的距离等于或略大于固定环与若干个单向阀的厚度之和。5. The body surface interface system combined with vascular fistula according to claim 4, characterized in that: the distance between the inner part of the housing body from the lowest end of the chamfered surface to the step is equal to or slightly larger than the fixed ring and several one-way The sum of the valve thicknesses. 6.根据权利要求3所述的结合血管内瘘的体表接口系统,其特征在于:外壳本体的外侧壁上设有定位环,定位环埋在皮肤里,用于防止接口受力移动,对人体造成损伤。6. The body surface interface system combined with vascular fistula according to claim 3, characterized in that: a positioning ring is provided on the outer side wall of the shell body, and the positioning ring is embedded in the skin to prevent the interface from being forced damage to the human body. 7.根据权利要求2所述的结合血管内瘘的体表接口系统,其特征在于:护帽上设有连接鼻,连接鼻上设有通孔。7 . The body surface interface system combined with vascular fistula according to claim 2 , wherein the protective cap is provided with a connecting nose, and the connecting nose is provided with a through hole. 8 . 8.根据权利要求2所述的结合血管内瘘的体表接口系统,其特征在于:平口针管的外侧壁上设有凸起的限位台,固定环上设有供限位台穿过的缺口。8 . The body surface interface system combined with vascular fistula according to claim 2 , wherein the outer side wall of the flat-mouthed needle tube is provided with a raised limiting platform, and the fixing ring is provided with a stop for the limiting platform to pass through. 9 . gap. 9.根据权利要求2所述的结合血管内瘘的体表接口系统,其特征在于:固定环与外壳螺纹连接。9 . The body surface interface system combined with vascular fistula according to claim 2 , wherein the fixing ring is threadedly connected to the housing. 10 . 10.根据权利要求2所述的结合血管内瘘的体表接口系统,其特征在于:还包括球囊导管,球囊导管的球囊端穿过单向阀伸入外壳内,且球囊端充气后可用于堵塞血管,单向阀可沿球囊导管滑动。10. The body surface interface system combined with an endovascular fistula according to claim 2, further comprising a balloon catheter, the balloon end of the balloon catheter extends into the housing through the one-way valve, and the balloon end After inflation, it can be used to block blood vessels, and the one-way valve can slide along the balloon catheter.
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US6086553A (en) * 1999-07-01 2000-07-11 Akbik; Mohamad J. Arteriovenous shunt
JP2005074112A (en) * 2003-09-02 2005-03-24 Nippon Sherwood Medical Industries Ltd Indwelling needle
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