WO2008049331A1 - Safety transfusion catheter - Google Patents

Safety transfusion catheter Download PDF

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Publication number
WO2008049331A1
WO2008049331A1 PCT/CN2007/003007 CN2007003007W WO2008049331A1 WO 2008049331 A1 WO2008049331 A1 WO 2008049331A1 CN 2007003007 W CN2007003007 W CN 2007003007W WO 2008049331 A1 WO2008049331 A1 WO 2008049331A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
tube
indwelling
infusion
soft
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2007/003007
Other languages
English (en)
French (fr)
Inventor
Luyi Shen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SUN MEDICAL-SCIENTIFIC (SHANGHAI) Co Ltd
Original Assignee
SUN MEDICAL-SCIENTIFIC (SHANGHAI) Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN 200620047022 external-priority patent/CN200973880Y/zh
Priority claimed from CN 200620047024 external-priority patent/CN200973906Y/zh
Priority claimed from CN 200610117448 external-priority patent/CN1986014A/zh
Application filed by SUN MEDICAL-SCIENTIFIC (SHANGHAI) Co Ltd filed Critical SUN MEDICAL-SCIENTIFIC (SHANGHAI) Co Ltd
Priority to CA002667404A priority Critical patent/CA2667404A1/en
Priority to US12/446,755 priority patent/US8167851B2/en
Priority to EP07816620.4A priority patent/EP2077131A4/en
Priority to AU2007308578A priority patent/AU2007308578B2/en
Publication of WO2008049331A1 publication Critical patent/WO2008049331A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1587—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body suitable for being connected to an infusion line after insertion into a patient
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Definitions

  • the invention belongs to the field of medical devices, and in particular relates to an instrument for inputting a liquid medium into a human body. Background technique
  • Intravenous infusion is one of the main means of clinical rescue and treatment of patients. Especially when salvaging critically ill patients, it is a key link to quickly establish an intravenous infusion channel for the rescue.
  • the speed of establishing an intravenous infusion channel depends mainly on the accuracy of the patient's venous needle and the thickness and depth of the patient's venous tube.
  • the rigid needle stays in the venous blood vessels for a long time, and it is easy to cause the needle tip to smash or withdraw from the blood vessel due to the movement or sway of the rigid needle, so that the injection/therapeutic fluid no longer flows into the blood vessel and is injected into the blood vessel.
  • the physiological tissue gap, causing tissue edema, is also a very painful thing.
  • the announcement date is May 4, 1994, the Chinese patent "Disposable Infusion Needle" with the announcement number CN 2163653Y, and a softer needle sleeve is placed on a solid core rigid needle to form an infusion needle.
  • the needle core and the needle sleeve are pierced into the vein, and the needle core is pulled out during the infusion to keep the needle sleeve in the vein, and the infusion tube can be connected to the infusion. Because it uses a soft material (non-toxic plastic) as an infusion needle, it avoids the need for multiple needle sticks during multiple infusions in a short period of time.
  • the end of the front end of the soft needle sleeve is a plane at an angle of 90° with the longitudinal axis of the hose or the longitudinal wall of the tube (refer to the disclosure of Chinese Patent Application Publication No. CN 1468637A.
  • the resistance during the vascular puncture is large, which makes the operation difficult. It takes two or more punctures to meet the unsuccessful puncture.
  • the front end of the needle sleeve will form a flared (opening) "bell" shape.
  • the front end of the needle sleeve may even crack, which may cause the puncture operation to continue, and a new kit must be replaced to re-run.
  • the cross-section of the needle body of the prior infusion needle has a circular or curved curved surface, which poses certain difficulties in fixing the needle to the patient.
  • the announcement date is January 21, 2004, the Chinese patent for the CN 1135122C "multi-purpose safety automatic infusion intravenous indwelling needle", including three-fork joint, indwelling soft needle, steel needle and infusion tube; three-fork joint first
  • the second joint end is axially aligned, the second joint end is nested with a rubber cap sleeve;
  • the indwelling soft needle is sleeved on the first joint end of the trigeminal joint;
  • the steel needle is sleeved in the sleeve, and the sleeve is nested in the trigeminal
  • the second joint end of the pipe joint, the needle body is axially placed in the indwelling soft needle;
  • the infusion pipe is connected in series with the third joint end of the trigeminal pipe joint.
  • the needle body is pulled back from the rear side of the sleeve, so that the needle body is buckled in the sleeve, which solves the shortcomings of the foregoing technical solutions, and can avoid the needle body being exposed. Stabbing other people and accidents that cause illness.
  • the infusion operator is required to manually pull the steel needle back into the sleeve.
  • the steel needle has a long moving stroke, so the process of retracting the entire steel needle is inconvenient for the operator;
  • Trigeminal joints are difficult to handle with fingers, especially for patients who are difficult to find for obese patients, excessive blood loss, and dehydration of patients. It is difficult for medical staff to quickly and accurately pin the needle into the patient's vein. This will not only delay the treatment time, but also bring unnecessary suffering to the patient.
  • the technical problem to be solved by the present invention is to provide a safe infusion indwelling needle for inputting a liquid into a blood vessel, which can meet the needs of long-time intravenous indwelling and can meet the needs of multiple punctures, and is convenient for venipuncture.
  • the operation is beneficial to fix it on the surface of the human body, and the damage to the blood vessel can be minimized, so that the whole puncture operation process is simple and easy to carry out, and also helps to reduce unnecessary pain of the patient.
  • the technical solution of the present invention is: providing a full infusion indwelling needle comprising a soft indwelling tube sleeved on a metal guiding needle having a wedge-shaped tip portion, the soft indwelling tube being provided with a needle handle body connected thereto,
  • the characteristic is that: the angle between the end of the soft indwelling tube and the longitudinal axis or the longitudinal tube wall is less than 90°; the outer contour line of the transverse cross section of the needle handle body is a curve intersecting with the straight line The closed curve formed.
  • the end of the soft indwelling tube is parallel to the wedge-shaped tip end of the metal guiding needle; the chamfering structure is arranged on the front end wall of the soft indwelling tube; the end of the soft indwelling tube and the outer wall thereof
  • the joint uses a smooth transition joint structure.
  • the above curve is a circular arc curve, an elliptical arc curve, a drop shape curve or a combination of the above curves.
  • the outer contour line of the transverse cross section of the needle handle body is semicircular, semi-elliptical, semi-droplet shaped, approximately semi-circular, approximately semi-elliptical, approximately half-drop shaped or a combination of the above figures.
  • the needle handle body is a slidable hinge-shaped member, and the fastening buckle is respectively disposed on the opening sides of the two hinge-shaped members, and the opposite faces of the two hinge-shaped members of the needle handle body Upper, a groove is provided, and the soft indwelling tube is detachably disposed between the two hinge members of the needle body.
  • the present invention also provides a safe infusion indwelling needle comprising a soft indwelling tube that is placed over the metal guiding needle, an infusion connecting tube that communicates with the soft indwelling tube, and a rubber plug that is located at the end of the soft indwelling tube.
  • the rear end of the metal guiding needle is slidably sleeved with a hollow sleeve, and the infusion connecting tube and the soft indwelling tube form a T-shaped or oblique Y-shaped structure, and the feature is: at the front end of the hollow sleeve, a length shorter than a safety sheath for the metal guiding needle; a spring is arranged between the end of the metal guiding needle and the front end of the hollow sleeve; in the hollow sleeve, a seesaw stop is arranged; in the rocker type stop A reset button is provided on the hollow sleeve at one end of the block.
  • the metal guiding needle is slidably disposed in the safety sheath; the spring is set on the metal guiding needle; and the rocker type stopper is disposed when the metal guiding needle can completely extend out of the hollow sleeve.
  • the rear end of the needle seat is located; the safety sheath and the metal guide pin therein are disposed through the rubber plug.
  • a wing-shaped or butterfly-shaped auxiliary handle body is provided, one side surface of the auxiliary handle body is a plane, and a surface of at least one side surface of the auxiliary handle body , set the embossed anti-slip pattern.
  • the auxiliary handle body is a snap-fit hinge member which is detachably disposed at the joint portion of the infusion connection tube and the soft retention tube.
  • Figure 1 is a schematic view showing the end structure of the soft indwelling tube of the present invention.
  • Figure 2 is a schematic structural view of the embodiment of Figure 1;
  • Figure 3 is a schematic structural view of another embodiment of Figure 1;
  • Figure 4 is a schematic view showing the structure of the needle body portion of the present invention.
  • Figure 5 is a cross-sectional view of Figure 4.
  • Figure 6 is a schematic view showing another structure of the needle body portion of the present invention.
  • Figure 7 is a C-direction view of Figure ;
  • Figure 8 is a schematic structural view of a metal guide pin assembly of the present invention
  • Figure 9 is a schematic structural view of the auxiliary handle body
  • Figure 10 is a cross-sectional structural view taken along line A-A' of Figure 9;
  • FIG. 11 is a schematic structural view of still another embodiment of a metal guide pin assembly
  • Figure 12 is a schematic view showing the structure of a plug-in connecting pipe.
  • the technical solution comprises a soft indwelling tube 2 which is placed on a metal guiding needle 1 having a wedge-shaped tip portion 1-1.
  • the key point is the end portion 3 of the indwelling tube and its longitudinal axis or longitudinal wall. The angle ⁇ between them is less than 90°.
  • end portion 3 of the soft indwelling tube is parallel to the wedge-shaped tip end portion 1-1 of the metal guiding needle.
  • the longitudinal section of the end of the soft indwelling tube has a non-planar wedge-shaped configuration that helps to reduce the penetration and travel resistance of the soft retention tube or catheter.
  • a chamfered structure 4 is provided on the wall of the soft end tube or the end of the tube 3 to further reduce the penetration resistance.
  • the soft indwelling tube or the end portion 3' of the conduit is joined to the joints 5 and 6 of the outer wall in a smooth transition.
  • the smooth transition structure of the joint portion also reduces the penetration and travel resistance of the soft indwelling tube or catheter, prolongs its service life, increases the number of successful punctures, and minimizes damage to the blood vessels.
  • the end portion 3 of the indwelling hose front end can also adopt a non-planar arc surface structure, and the specific structure thereof can be fully understood and understood by those skilled in the art. Then describe. '
  • the technical solution comprises a needle 21 and a needle handle body 22 connected thereto.
  • a convex and concave anti-slip pattern 24 is arranged, and in the second half of the needle handle body, an infusion hose is arranged. Connection port 23.
  • the outer contour of the transverse section of the needle body 22 is a closed curve formed by a curve 25 intersecting the straight line 26.
  • the above curve may be a circular arc curve, an elliptical arc curve, a drop shape curve or a combination of the above curves.
  • the outer contour of the transverse section of the needle handle body is semicircular, semi-elliptical, semi-droplet shaped, nearly semi-circular, approximately semi-elliptical, approximately half-drop shaped or a combination of the above figures.
  • the outer contour of the transverse section of the needle handle body shown in the drawing is a closed line formed by the intersection of a circular arc line 5 and a straight line 6. ' Since one side of the needle handle is flat, it helps to fix the infusion needle to the patient's body surface. The rest is the same as Figure 4.
  • the prior art needle handle body 22' is detachably provided with an auxiliary needle handle body
  • the auxiliary needle handle body is a snap-fit hinge member, in which two pieces are combined
  • the opening sides of the page members 27-1, 27-2 are respectively provided with snap fastening hooks 28-1 and 28-2; the opposite faces of the two hinge members of the auxiliary needle handle body are provided with the needle handles
  • the groove with the body shape matching, the needle handle body is detachably disposed between the two hinge structures of the auxiliary needle handle body.
  • the outer contour of the overall transverse section of the auxiliary needle handle body is the same as or similar to the figure shown in Figure 5, and will not be described in detail.
  • a convex and concave anti-slip pattern 24' is also provided.
  • the needle handle 'body 22' of the existing commercially available infusion product is placed into the open two-piece hinge member as shown in FIG. 2-7, 27-2 in the groove matching the shape of the needle handle body, the two hinge members are closed to form a closed needle handle body 27 in the closed state, in the snap button 28 (open state)
  • the two hinge members and the needle body 22' sandwiched therein are integrated, and have the same outer shape structure as the foregoing.
  • a safety sheath 33 having a length shorter than the metal guide needle 32 is provided; between the end needle holder 34 of the metal guide needle and the front end of the hollow sleeve, a spring is disposed. 35; In the hollow sleeve, a rocker type stop block 36 is disposed, and a reset button 37 is disposed on the hollow sleeve at one end of the rocker type stop block.
  • the metal guiding needle is slidable: 1 ⁇ is disposed in the safety sheath and the hollow sleeve.
  • the spring is placed on the metal guide pin.
  • the seesaw stop is placed behind the position of the end of the needle when the metal guide pin can fully extend out of the hollow sleeve.
  • the entire metal guide needle can be safely protected by moving the distance between the needle tip position and the front end position of the safety sheath when it is fully extended, and the metal guide needle and the end needle are provided.
  • the moving distance of the seat is greatly shortened, and the longitudinal dimension of the entire hollow sleeve can also be shortened.
  • a wing-like or butterfly-shaped auxiliary handle body 40 is provided at the joint portion of the infusion connection tube 38 and the soft indwelling tube 39, and a concave-convex anti-slip pattern 41 is provided on the surface of at least one side surface of the auxiliary handle body.
  • auxiliary handle body is a splicable hinge member, which is detachably disposed at the infusion connection
  • the length dimension of the entire hollow sleeve 31 is reduced, and on the other hand, since it increases the contact area with the rubber plug 42, the cutting action of the metal guide against the rubber plug is eliminated, and the reduction is eliminated.
  • the probability of the rubber plug being opened and reamed ensures the integrity and sealing effect of the rubber plug.
  • one side surface 40-1 of the auxiliary handle body 40 is a flat surface, and a concave-convex non-slip pattern 41 is provided on the surface of the other side surface 40-2 of the auxiliary handle body.
  • a embossed anti-slip pattern is provided, which is more advantageous for the operator to handle and use.
  • the soft indwelling tube is configured as a structure with a rear seat tube, and an anti-seepage rubber plug is disposed at the end of the rear seat tube; the metal guiding needle assembly with the safety sheath is detachably disposed in the soft indwelling tube In the rear seat tube, a needle that can be inserted into the rubber plug is placed at the front end of the infusion tube.
  • a needle that can be inserted into the rubber plug is placed at the front end of the infusion tube.
  • FIG. 1 to FIG. 10 are also applicable, but are not shown for the sake of simplicity of the drawing, but this is not meant to limit the technical solution of the present invention.
  • Figure 11 is a combination of an indwelling hose, a hose holder, a rubber stopper and a sheath, and the indwelling hose 511, the hose holder 512, the rubber stopper 513 and the sheath 514 constitute an anti-seepage hose needle. 51.
  • the front end of the indwelling hose is provided with a conical contraction section, and the rear end is connected with the small hole at the front end of the hose holder.
  • the cylindrical inner bore of the rear end of the hose seat communicates with the inner hole of the indwelling hose through a frustum-shaped hole, and the rubber plug is fixed in the middle of the cylindrical inner hole.
  • the metal guide pin assembly 53 is composed of a safety front cover 511, a safety back cover 532, a spring '533, a retraction key 534, and a lock key 535.
  • the puncture needle is passed through the small hole at the front end of the safety front cover.
  • the safety front cover is provided with a lateral slot and an axial sliding slot on one side.
  • the positioning piece of the retracting key is inserted into the slot and is caught in the slot of the needle hub, so that the puncture needle is fixed before safety before use.
  • the front end of the sleeve and the spring are under compression.
  • the locking button is installed in the sliding slot, and the locking piece is clamped to the bottom of the retracting button before use to prevent false triggering, and the safety rear sleeve is integrated with the safety front sleeve through the inverted buckle.
  • the plug-in connecting tube shown in the figure can be used, which is composed of a needle tube 69, a needle holder 70, a catheter 71, and a narrow tube.
  • the shaped connector 72 is formed by a lock cap 74.
  • the front end of the insertion needle tube is provided with a tapered tapered needle tip, and the rear end is connected with the front end hole of the needle tube seat.
  • the rear end of the needle hub is connected to one end of the catheter and communicates with the inner hole of the insertion needle, and the other end of the catheter is connected with the small hole at the front end of the Y-shaped connector.
  • the other ends of the connector are provided with an inner conical Luer lock connector, which can be closed with a lock cap before use or when suspended.
  • the slit-type cut-off plate is placed around the outer circumference of the catheter, and if necessary, the catheter can be snapped into the slit to block the flow of the liquid.
  • the sheath that shields the tip is placed at the outer edge of the hose holder's front end and the indwelling hose connection.
  • the metal guide needle assembly needs to be inserted into the sheath and the rubber plug on the blood-proof hose needle with the indwelling hose. After the puncture is successful, the metal guide is unplugged.
  • the needle assembly insert the plug-in connection tube with the infusion tube into the sheath and rubber stopper on the blood-proof hose needle for normal infusion.
  • the end of the soft indwelling tube or the end of the catheter adopts a non-planar wedge structure, it helps to reduce the puncture and travel resistance of the soft indwelling tube or catheter, and one side of the needle handle is flat, which helps The infusion needle is fixed on the patient's body surface, and by setting the 3 ⁇ 41 plate stop block, reset button and spring, the metal guide needle can be quickly retracted, simplifying the operation process and facilitating the operation of the medical staff, avoiding the existing Many defects and shortcomings of the technology have reached the goal of satisfying the need of long-term intravenous indwelling, adapting to multiple punctures, facilitating venipuncture operations, and minimizing damage to blood vessels.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Engineering & Computer Science (AREA)
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Description

安全输液留置针
技术领域
本发明属于医疗器械领域， 尤其涉及一种用于将液体介质输入至人体内的器械。 背景技术
静脉输液 （俗称输液） 是目前临床抢救、 治疗病人的主要手段之一， 特别是抢救 危重病人时， 为抢救争取时间， 迅速建立静脉输液通道是十分关键的一个环节。
建立静脉输液通道的速度， 主要取决于医护人员对病人静脉扎针的准确度和病人 静脉管的粗细、 深浅程度。
' 目前最常用的输液方法是将刚性 （金属） 针头穿入静'脉进行注射， 注射完毕后再 将针头拔出。 这对于一天需要输液数次的患者而言， 每注射一次， 即要忍受至少一次 的针刺痛苦， 这无疑给患者添加了精神上的负担和肉体上的痛苦。
同时， 随着医疗手段的进步和药物作用机理的研究， 出于治疗的需要， 对于某些 特殊疾病的患者， 已经出现了低剂量、长时间的注射供药 /治疗方式。'对于这类患者， 刚性针头长时间地滞留在静脉血管中， 极容易因刚性针头发生移动或窜动而导致针尖 划破或退出血管， 使得注射 /治疗液体不再流入血管而被注入血管周围的生理组织间 隙， 引起组织生理水肿， 此亦是一件十分痛苦的事。 ， 公告日为 1994年 5月 4日，公告号为 CN 2163653Y的中国专利"一次性输液针头"， 釆用一种比较柔软的针套， 套在一个实芯的刚性针芯上， 构成输液针头， 血管穿刺时 针芯、 针套一并被刺入静脉血管， 输液时拔出针芯使针套留在静脉血管内， 接上输液 管即可进行输液。 由于其采用了柔软的材料 （无毒塑料） 作为输液针管使用， 避免了 短时间内多次输液时需要多次针刺之状况的发生。
在实际使用过程中发现， 由于软质针套前端之端部为一个与软管纵向轴线或纵向 管壁成 90°夹角的平面 (具体可参见公开号为 CN 1468637A的中国专利发明专利申请公 开文本中附图 3所示)， 且由于构成针套的材质之刚生较小， 在血管穿刺过程中阻力较 大， 给操作带来困难， 遇到一次穿刺不成功需要二次或多次穿刺的情况时， 针套前端 会形成向外扩张 （涨开） 的"喇叭口"形状， 严重时针套前端甚至会产生开裂现象， 导 致穿刺操作无法继续进行， 必须更换新的套件才能重新进行。 此外， 现有输液针头的针柄体横截面之外轮廓均为圆形或弧形曲面， 给将针头固 定在患者身上带来一定的困难。 '
公告日为 2004年 1 月 21 日， 公告号为 CN 1135122C的中国专利"多用途安全自 动输液静脉留置针"，包括三叉管接头、留置软针、钢针及输液管；三叉管接头其第一、 第二接头端轴向对正， 第二接头端嵌套橡胶帽套； 留置软针錄套于三叉管接头第一接 头端； · 钢针滑套于套筒中， 套筒嵌套于三叉管接头第二接头端， 针体轴向穿置留置软 针中； 输液管串接三叉管接头第三接头端。 在将留置软针连同针体刺入患者静脉后， 从套筒后侧拉退针体， 使针体内縮卡扣于套筒内， 其解决了前述技术方案之不足， 可 避免针体外露造成刺伤其他人员及感染疾病的意外。
但是该方案存在以下不足：
1. 一是需要输液操作人员手动将钢针拉回套筒中， 二是钢针移动行程较长， 故而 整个钢针缩回的操 #过程对于操作者而言较为不便；
2. 三叉管接头用手指拿捏操作 较困难， 特别是对于一些对于肥胖病人、 失血过 多者、 病人脱水等静脉难找的病人， 医护人员很难快速、 准确地将针扎入患者的静脉 中， 这样不但会延误治疗时间， 也给病人带来不必要的痛苦。
3. 三叉管接头、 留置管的横截面之外轮廓均为圆形曲面， 给将输液针头固定在患 者身上带来一定的困难， 同时， 留置管易于发生转动的情况， 亦会给患者带来不必要 的痛苦。 发明内容
本发明所要解决的技术问题是提供一种用于将液体输入血管的安全输液留置针， 其既能满足长时间静脉注射留置的需要， 又能适应多次穿刺的需要， 既便于静脉穿刺 过程中的操作，又有利于将其固定在人体表面，且可将对血管的损伤程度减少到最小， 使得整个穿刺操作过程简洁、 易于进行， 亦有助于减少患者不必要的痛苦。
本发明的技术方案是： 提供一种 全输液留置针， 包括套在具有楔状尖端部之金 属导引针上的软质留置管， 其软质留置管设置有与之相连的针柄体， 其特征在于： 所 述软质留置管的端部与其纵向轴线或纵向管壁之间的夹角小于 90°; 所述针柄体之横 向截面的外轮廓线， 为一个由一曲线与一直线相交所构成的封闭曲线。
具体的， 所述的软质留置管的端部与金属导引针的楔状尖端部平行； 在软质留置 管端部的前端管壁设置倒角结构； 在软质留置管之端部与其外壁的接合部采用圆滑过 渡结合结构。 ' 上述的曲线为圆弧曲线、 椭圆弧曲线、 水滴形曲线或上述曲线的组合。 进一步地， 上述针柄体之横向截面的外轮廓线为半圆形、 半椭圆形、 半水滴形、 近似半圆形、 近似半椭圆形、 近似半水滴形或上述图形的组合。
上述的针柄体为一可扣合的合页状构件， 在其两片合页状构件的开口侧分别对应 设置扣合搭扣， 所述针柄体之两片合页状构件之相对面上， 设置有沟槽， 软质留置管 可分离地贯穿设置在针柄体两片合页状构件之间。
进一步地， 在所述针柄体的外表面， 设置有凸凹式防滑纹。 ' 本发明还提供了一种安全输液留置针， 包括套在金属导引针上的软质留置管、 与 软质留置管相通的输液连接管和位于软质留置管末端的橡胶堵头， 其金属导引针的后 端与一个中空套筒滑动套接， 输液连接管与软质留置管构成 T字形或斜 Y字形结构， 其特征是:.在中空套筒的前端， 设置一个长度短于金属导引针的安全护套； 在金属导 引针的末端针座与中空套筒的前端之间， 设置一弹簧； 在中空套筒内， 设置一翘板式 止挡块； 在翘板式止挡块一端的中空套筒上， 设置一复位按钮。
具体的， 其金属导引针可滑动地贯穿设置在安全护套中； 其弹簧套装在金属导引 针上； 其翘板式止挡块设置在金属导引针能够完全伸出中空套筒时其末端针座所在位 置的后方； 其安全护套和其中的金属导引针贯穿橡胶堵头设置。
进一步地， 在所述输液连接管与软质留置管连通的接合部， 设置翼状或蝶形状辅 助柄体， 其辅助柄体的一个侧面为平面， 在所述辅助柄体的至少一个侧面的表面， 设 置凹凸式防滑纹。
其辅助柄体为一个可扣合的合页状构件， 其可分离地设置在输液连接管和软质留 置管的接合部位。 附图概述
图 1是本发明软质留置管的端部结构示意图；
图 2是图 1实施例的结构示意图；
图 3是图 1另一实施例的结构示意图；
图 4是本发明针柄体部分的结构示意图；
图 5是图 4的 向剖面图；
图 6是本发明针柄体部分的另一结构示意图；
图 7是图 ό的 C向视图；
图 8是本发明金属导引针组件的结构示意图； ― 图 9是辅助柄体的结构示意图；
图 10是图 9之 A-A'向剖面结构示意图；
图 11是金属导引针组件又一实施例的结构示意图；
图 12是插入式连接管的结构示意图。 具体实施方式 图 1中， 本技术方案包括套在具有楔状尖端部 1-1之金属导引针 1上的软质留置 管 2， 关键点是留置管的端部 3与其纵向轴线或纵向管壁之间的夹角 α小于 90°。
进一步的， 软质留置管.的端部 3与金属导引针的楔状尖端部 1-1平行。
软质留置管前端之端部的纵向剖面采用非平面的楔形状结构， 有助于减少软质留 置管或导管的穿刺和行进阻力。 ' - 图 2中， 在软质留置管或导管端部 3的煎端管壁设置倒角结构 4， 以进一步减小 其穿剌阻力。
其余同前。
图 3中， 软质留置管或导管端部 3'与其外壁的接合部 5和 6圆滑过渡结合。 接合部分釆用圆滑过渡结构， 亦可减少软质留置管或导管的穿剌和行进阻力， 延 长了其使用寿命， 增加了可成功穿刺的次数， 还可将对血管的损伤程度减少到最小。
其余同前。
考虑到加工工艺的简化， 作为一种简化结构， 留置软管前端之端部 3亦可采用非 平面的圆弧面结构， 其具体结构对本领域技术人员而言完全可以领会和明白， 在此不 再叙述。 '
图 4中， 本技术方案包括针头 21和与之相连的针柄体 22， 在针柄体之外表面， 设置有凸凹式防滑紋 24， 在针柄体的后半部份， 设置输液软管连接口 23。
图 5中，针柄体 22之横向截面的外轮廓线， 为一个由一曲线 25与一直线 26相交 所构成的封闭曲线。
上述曲线可以为圆弧曲线、 椭圆弧曲线、 水滴形曲线或上述曲线的组合。
进一步地， 其针柄体之横向截面的外轮廓线为半圆形、 半椭圆形、 半水滴形、 近 似半圆形、 近似半椭圆形、 近似半水滴形或上述图形的组合。
图中所示针柄体之横向截面的外轮廓线为一个由一圆弧线 5与一直线 6相交所构 成的封闭线。 ' 由于针柄体的一个侧面为平面， 有助于将输液针头固定在患者的体表。 其余同图 4。 ' 图 6中，本技术方案在现有针柄体 22'上， 可分离地设置了一辅助针柄体，其辅助 针柄体为一可扣合的合页状构件， 在其两片合页状构件 27-1、 27-2的开口侧分别对应 设置了扣合褡扣 28-1和 28-2;辅助针柄体之两片合页状构件的相对面上，设置了与针 柄体外形相匹配的沟槽，针柄体可分离地贯穿设置在辅助针柄体两片合页状构^ ^之间。
其辅助针柄体之整体横向截面的外轮廓线， 与图 5所示之图形相同或相似， 不再 详述
在辅助针柄体之外表面， 同样设置有凸凹式防滑紋 24'。
图 7中， 由于辅助针柄体为一可扣合的合页状构件， 将现有市售输液产品的针柄' 体 22'放入打开的如图 6所示之两片合页状构件 27-1、 27-2上的与针柄体外形相匹配 的沟槽中， 闭合两片合页状构件， 形成一个闭合状态下的辅助针柄体 27， 在扣合褡扣 28 (打开状态下为图 6中的 28-1、 28-2) 的作用下， 两合页状构件和夹嵌于其中的针 柄体 22'成为一个整体， 成为与前述方案具有相同外形结构的构件。
其余同图 6。
图 8中，在中空套筒 31的前端，设置一个长度短于金属导引针 32的安全护套 33 ; 在金属导引针的末端针座 34与中空套筒的前端之间， 设置一弹簧 35 ; 在中空套筒内， 设置一翘板式止挡块 36， 在翘板式止挡块一端的中空套筒上， 设置一复位按钮 37。
其中， 金属导引针可滑动: 1ψ贯穿设置在安全护套和中空套筒中。
弹簧套装在金属导引针上。 ，
翘板式止挡块， 设置在金属导引针能够完全伸出中空套筒时其末端针座所在位置 '的后方。 '
当按下复位按钮后， 翘板式止挡块与末端针座脱离接触， 末端针座在弹簧的作用 下后退（图中是向右运动）， 带动金属导引针快速缩回， 实现了 "单手操作、快速简洁" 的发明目的。
由于设置了安全护套， 整个金属导引针只需移动其完全伸出时针尖位置到安全护 套之前端位置之间的距离， 即可达到安全防护的目的， 其金属导引针及末端针座的移 动距离大大缩短， 同时亦可缩短整个中空套筒之纵向尺寸。 ' 图 9中， 在输液连接管 38与软质留置管 39的接合部， '设置翼状或蝶形状辅助柄 体 40， 在辅助柄体的至少一个侧面的表面， 设置凹凸式防滑紋 41。
进一步的， 其辅助柄体为一个可扣合的合页状构件， 其可分离地设置在输液连接 管和软质留置管的接合部位， 由于合页状构件对本领域技术人员而言完全可以理解和 实现， 故在此不再给出其详细的结构示意图。 .
通过设置安全护套，一方面减少了整个中空套筒 31的长度尺寸， 另一方面由于其 增大了与橡胶堵头 42的接触面积，杜绝了金属导引针对橡胶堵头的切割作用，减少了 橡胶堵头被豁开和扩孔的机率， 保证了橡胶堵头的完好和密封效果。
图 10中， 其辅助柄体 40的一个侧面 40-1为平面， 在辅助柄体的另一个侧面 40-2 的表面， 设置有凹凸式防滑纹 41。
在柄体之外表面， 设置凹凸式防滑紋， 更有利于操作者的拿捏和使用。
' 作为一种示范和扩展， 下面再列举一种可分离式的实施方式：
将软质留置管设置成带有后座管的结构， 其后座管的末端设置一防渗胶塞； 将带 有安全护套的金属导引针组件可分离地设置在软质留置管的后座管中， 再在输液管的 前端设置一可插入 fe渗胶塞的针头。 首先用金属导引针将软质留置管送入血管， 然后 拔出金属导引针， 再将前端带有针头的输液管插入软质留置管的后座 t^'中， 即可完成 整个操作， 亦可达到同样的发明目的和实施效果。
其示意性结构如图 11和图 12所示。
在该实施例中，图 1至图 10的技术特征同样可以继续采用，只是为了图面的简洁， 未再绘出， 但这并不表示是对本发明技术方案的限制。
图 11是将留置软管、 软管座、 胶塞和护套与图 8'结合而得到， 其留置软管 511、 软管座 512、 胶塞 513和护套 514构成防渗血软管针 51。
其中留置软管前端设有圆锥形收缩段， 后端与软管座前端小孔相连。 软管座的后 端圆柱形内孔通过锥台形孔与留置软管内孔相通， 胶塞被固定于圆柱形内孔的中部。
金属导引针组件 53由安全前套 511、 安全后套 532、 弹簧' 533、 回缩键 534和锁 定键 535构成。 穿刺针从安全前套的前端小孔穿出。 安全前套'单侧设有横向插槽和轴 向滑槽， 回缩键的定位片插入插槽中并卡于穿刺针针座的卡槽内， 使得穿刺针在使用 前被固定于安全前套的前端和弹簧处于压紧状态。 锁定键装于滑槽内， 其锁定片在使 用前卡于回缩键按钮的底部， 以防止误触发，安全后套通过倒扣与安全前套连成一体。
当拉开锁定键并按下回缩键时， 可使穿刺针整体退出留置软管并完全自动缩进安 全套筒内。 ' ' 其余同图 8 。
图 12中， 为了便于防渗血软管针和输液管连接， 在采用图 11的结构时， 可采用 本图所示的插入式连接管， 其由针管 69、 针管座 70、 导管 71、 狭缝式截止板 73、 Y 形连接座 72 ^锁帽 74构成。
其中插入针管的前端设有斜锥形针尖， 后端与针管座前端孔相连。 针管座后端孔 与导管一端相连并与插入针管内孔相通， 导管的另一端与 Y形连接座前端小孔相连。
连接座的另两端设有内圆锥鲁尔锁合接头， 使用前或暂停使用时可用锁帽封闭。 狭缝式截止板套于导管外周， 必要时可将导管卡入狭缝以阻断液体流通。 可遮蔽针尖 的护套被装于软管座前端与留置软管连接处的外缘。
当将图 11和图 12结合应用时， 则需要先将金属导引针组件插入带有留置软管的 防渗血软管针上的护套和胶塞中， 穿刺成功后拔下金属导引针组件， 再将带有输液管 的插入式连接管插入防渗血软管针上的护套和胶塞中， 进行正常输液即可。
以上的各实施例仅仅是用来解释和说明本发明的， 而并非用作对本发明技术方案 的限定； 本领域的普通技术人员应当认识到， 只要在本发明的实质精神范围内， 对以 上实施例的变化、 变形， 都将落在本发明权利要求所要求的保护范围内。 工业应用性
由于软质留置管或导管前端之端部采用了非平面的楔形结构特征， 有助于减少软 质留置管或导管的穿刺和行进阻力， 且针柄体的一个侧面为平面， 有助于将输液针头 固定在患者的体表， 加上通过设置 ¾1板式止挡块、 复位按钮和弹簧等结构， 使得金属 导引针可快速回缩， 简化了操作过程， 便于医护人员操作， 避免了现有技术的诸多缺 陷和不足， 达到了既能满足长时间静脉注射留置的需要， 又能适应多次穿刺的需要， 易于进行静脉穿刺操作， 且将对血管的损伤程度减少到最小的发明目的。

Claims

权利要求书
1.一种安全输液留置针， 包括套在具有楔状尖端部之金属导引针上的软质留置 管， 其软质留置管设置有与之相连的针柄体， 其特征在于：
所述软质留置管的端部与其纵向轴线或纵向管壁之间的夹角小于 90°;
所述针柄体之横向截面的外轮廓线， 为一个由一曲线与一直线相交所构成的封 闭曲线。
2. 如权利要求 1所述的安全输液留置针， 其特征是所述软质留置管的端部与金属 导引针的楔状尖端部平行； 在软质留置管端部的前端管壁设置倒角结构； 在软质留置 管之端部与其外壁的接合部采用圆滑过渡结合结构。
3. 如权利要求 1所述的安全输液留置针， 其特征是其所述的曲线为圆弧曲线、 椭 圆弧曲线、 水滴形曲线或上述曲线的组合。
4. 如权利要求 1所述的安全输液留置针， 其特征是所述的针柄体之横向截面的外 轮廓线为半圆形、 半椭圆形、 半水滴形、 近似半圆形、 近似半椭圆形、 近似半水滴形 或上述图形的组合。 ，
5. 如权利要求 1所述的安全输液留置针， 其特征是所述的针柄体为一可扣合的合 页状构件， 在其两片合页状构件的开口侧分别对应设置扣合搭扣， 所述针柄体之两片 合页状构件之相对面上， 设置有沟槽， 软质留置管可分离地贯穿设置在针柄体两片合 页状构件之间。 ，
6. 如权利要求 1所述的安全输液留置针， 其特征是在所述针柄体的外表面， 设置 有凸凹式防滑紋。 '
7.一种安全输液留置针， 包括套在金属导引针上的软质留置管、 与软质留置管相 通的输液连接管和位于软质留置管末端的橡胶堵头， 其金属导引针的后端与一个中空 套筒滑动套接， 输液连接管与软质留置管构成 T字形或斜 Y字形结构， 其特征是： 在中空套筒的前端， 设置一个长度短于金属导引针的安全护套；
在金属导引针的末端针座与中空套筒的前端之间， 设置一弹簧；
在中空套筒内， 设置一翘板式止挡块；
在翘板式止挡块一端的中空套筒上， 设置一复位按钮。
8. 如权利要求 7所述的安全输液留置针， 其特征是所述的金属导引针可滑动地贯 穿设置在安全护套中； 其弹簧套装在金属导引针上； 其翘板式止挡块设置在金属导引 针能够完全伸出中空套筒时其末端针座所在位置的后方； 其安全护套和其中的金属导 引针贯穿橡胶堵头设置。
^ 9.如权利要求 7所述的安全输液留置针，其特征是在所述输液连接管与软质留置 管连通的接合部，. 设置翼状或蝶形状辅助柄体， 其辅助柄体的一个侧面为平面， 在所 述辅助柄体的至少一个侧面的表面， 设置凹凸式防滑紋。
10.如权利要求 7所述的安全输液留置针， 其特征是所述的辅助柄体为一个可扣 合的合页状构件， 其可分离地设置在输液连接管和软质留置管的接合部位。
PCT/CN2007/003007 2006-10-23 2007-10-22 Safety transfusion catheter Ceased WO2008049331A1 (en)

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CA002667404A CA2667404A1 (en) 2006-10-23 2007-10-22 Safety transfusion catheter
US12/446,755 US8167851B2 (en) 2006-10-23 2007-10-22 Safety transfusion catheter
EP07816620.4A EP2077131A4 (en) 2006-10-23 2007-10-22 SAFETY TRANSFUSION CATHETER
AU2007308578A AU2007308578B2 (en) 2006-10-23 2007-10-22 Safety transfusion catheter

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Application Number Priority Date Filing Date Title
CN 200620047022 CN200973880Y (zh) 2006-10-23 2006-10-23 输液用针
CN200610117448.7 2006-10-23
CN200620047022.4 2006-10-23
CN 200620047024 CN200973906Y (zh) 2006-10-23 2006-10-23 一种用于将液体输入血管的输液留置管或导管
CN 200610117448 CN1986014A (zh) 2006-10-23 2006-10-23 一种用于将液体输入血管的输液留置管或导管
CN200620047024.3 2006-10-23

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AU2007308578A1 (en) 2008-05-02
EP2077131A1 (en) 2009-07-08

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