WO2015027427A1 - 一种用于穿刺肝素帽的设备及血管通路*** - Google Patents

一种用于穿刺肝素帽的设备及血管通路*** Download PDF

Info

Publication number
WO2015027427A1
WO2015027427A1 PCT/CN2013/082549 CN2013082549W WO2015027427A1 WO 2015027427 A1 WO2015027427 A1 WO 2015027427A1 CN 2013082549 W CN2013082549 W CN 2013082549W WO 2015027427 A1 WO2015027427 A1 WO 2015027427A1
Authority
WO
WIPO (PCT)
Prior art keywords
heparin cap
puncturing
vascular access
guiding
heparin
Prior art date
Application number
PCT/CN2013/082549
Other languages
English (en)
French (fr)
Inventor
胡成平
雷鸣
Original Assignee
阳普医疗（湖南）有限公司
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
Application filed by 阳普医疗（湖南）有限公司 filed Critical 阳普医疗（湖南）有限公司
Priority to DE112013007370.6T priority Critical patent/DE112013007370T5/de
Priority to RU2016101676A priority patent/RU2651076C2/ru
Priority to CN201380068611.3A priority patent/CN105492065A/zh
Priority to KR1020167001595A priority patent/KR20160022368A/ko
Priority to US14/902,295 priority patent/US20160235959A1/en
Priority to PCT/CN2013/082549 priority patent/WO2015027427A1/zh
Publication of WO2015027427A1 publication Critical patent/WO2015027427A1/zh

Links

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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/344—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
    • A61M5/345—Adaptors positioned between needle hub and syringe nozzle
    • 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
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61M2039/0205—Access sites for injecting media
    • 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
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0258—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
    • 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
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/027—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body having a particular valve, seal or septum
    • 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
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0288—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body protectors, caps or covers therefor
    • 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
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1072—Tube connectors; Tube couplings with a septum present in the connector
    • 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
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1077—Adapters, e.g. couplings adapting a connector to one or several other connectors

Definitions

  • the present disclosure relates generally to the field of vascular access, and more particularly, to an infusion device for puncturing a heparin cap in a vascular access.
  • the composition of the heparin cap generally comprises two components as shown in Figure 1 : a seal 110 and a housing 120.
  • the seal is usually made of rubber (such as silica gel) or other elastic material.
  • the housing is typically made of a transparent thermoplastic material with a fluid passageway 130 at the inside and a standard 6% (Ruhr) conical locking joint 121 at one end that prevents accidental attachment during long-term use. To maintain the reliability of the connection.
  • the sealing rubber is firmly fitted to the inner wall 122 of the plastic housing at one end away from the locking joint by physical extrusion or chemical bonding, and is sealed to form a complete heparin cap 100.
  • the sealing rubber 110 of the heparin cap allows the insertion and withdrawal of a pointed needle bar.
  • the inserted needle bar and the device can be in fluid communication through the fluid passage 130 inside the heparin cap. Once the needle bar is withdrawn, the sealing rubber instantly seals itself, blocking Disconnect the device from the outside world. Heparin caps can be punctured multiple times and repeatedly.
  • Heparin caps are often used in conjunction with long-term use of vascular access devices, and their use can be used to infuse a drug solution from the outside into the blood vessel.
  • Vascular access devices such as peripheral short, medium length catheters (such as indwelling needles (PVC)), medium cardiovascular access devices (such as central venous catheters (CVC), peripherally punctured central venous catheters (PICC), etc.), and arterial catheters.
  • PVC indwelling needles
  • CVC central venous catheters
  • PICC peripherally punctured central venous catheters
  • the particular type of vascular access device should not pose any limitation to the embodiments described below and the scope of protection of the present application.
  • vascular access device When the vascular access device is in a non-infusion state, an appropriate amount of physiological saline and/or heparin solution can be injected through the heparin cap to flush or close the vascular access device, thereby preventing The residual drug solution and blood flow in the vascular access device form blood clotting.
  • vascular access device such as PVC, CVC, PICC or the like that requires a heparin cap to inject a drug solution into a blood vessel for a therapeutic task
  • FIG. 2 shows the connection of these devices when used together: First, the outer cone (lock) joint 211 of the medical solution supply device such as the syringe 200 is connected to the inner conical joint 311 of the intravenous infusion needle 300; then the intravenous infusion needle The needle tip 341 is inserted into the heparin cap 410 of the vascular access device, such as the indwelling needle 400, connected to the blood vessel of the human body; finally, the drug solution in the drug supply device is infused into the human body through a fluid passage communicating between the three. Intravascular.
  • the operator When using an IV needle, the operator (such as a nurse) needs to remove the protective sleeve 350 of the needle bar 340. At this time, the sharp tip 341 of the dew may cause accidental injury to the medical staff and/or the patient, and the risk of accidental injury is Subsequent operations will continue to increase.
  • a steel needle ie, a needle bar
  • the medical staff usually holds the heparin cap with the thumb and forefinger of one hand, and the thumb and index finger of the other hand holds the needle handle 330 of the infusion needle, and then be careful Complete the puncture action. If the medical staff's skills are not skilled enough, the spirit is not concentrated enough, or the operation method is not appropriate, the following procedures may occur during the puncture process:
  • the medical staff or patient is stabbed by the needle tip. Since the shape of the heparin cap is generally small, and the heparin cap is usually fixed to the surface of the patient's skin, the tip of the needle is easily stabbed. The medical staff holds the finger of the heparin cap and/or the skin of the patient.
  • the needle tip penetrates the plastic inner wall surface of the heparin cap to produce plastic chips, which enter the human body with the liquid in the subsequent infusion process; or the needle tip is inserted in the wrong direction or deep enough, so that the needle tip penetrates into the inner wall of the plastic and Buried in the plastic body, resulting in a fluid path between the steel needle and the heparin cap, the subsequent infusion can not be carried out; both of these conditions may cause medical accidents or introduce potential health risks. Only the tip of the needle selects the heparin cap seal rubber The position of the part and the vertical insertion can effectively avoid the above phenomenon.
  • a complete set of intravenous infusion needles has a complex structure and is not manufactured. If the connection between the needle bar 340, the needle handle 330, the hose 320, and the needle hub (inner conical joint) 310 in the assembly is improper, the internal fluid passage of the entire infusion needle may not be smooth, blocked or leaked. Subsequent medical use brings a variety of accidents. Since the hose 320 is long (generally not less than 250 mm), the infusion needle also wastes a certain amount of liquid during use.
  • the vascular access device is a long-term medical device, and it is left in the human body for a long time.
  • a vascular access device is used from the beginning to the end, the intravenous infusion needle is used many times, and the heparin cap is repeatedly punctured repeatedly. The risks mentioned above will increase and the amount of waste will increase.
  • the present application relates to an apparatus, method, and vascular access system for puncturing a heparin cap.
  • an apparatus for piercing a heparin cap comprising: a connection device adapted to be coupled in fluid communication to the medical fluid supply device; a guide device adapted to receive at least a portion of the heparin cap; and a lancing device for piercing the heparin cap configured to be in fluid communication with the connection device and at least partially Located at a predetermined location in the guide.
  • the predetermined position is configured such that: during entry of at least a portion of the heparin cap into the guide, the puncture device inserts the sealing rubber of the heparin cap at a suitable relative angle of the heparin cap and ultimately penetrates the sealing rubber.
  • the suitable relative angle comprises the piercing means being perpendicular to the sealing rubber and the suitable position comprising the middle portion of the sealing rubber.
  • the guiding device further includes a limiting member for restricting the heparin cap from entering the final depth of the guiding device.
  • the limiting member comprises at least one of the following: a shape in which the projection or guiding means inside the guiding device tapers in a direction from the heparin cap to the guiding means. Further, the final depth ensures that the puncture device is inserted into the heparin cap at a final position near the sealing rubber.
  • the connecting device, the guiding device, and the lancing device are integrally formed.
  • the connecting device, the guiding device, and the lancing device are integrally formed.
  • the connecting device, the guiding device, and the puncturing device are all made of a plastic material.
  • the connecting device, the guiding device, and the lancing device are separately fabricated, and the separately manufactured devices are assembled together in a detachable manner.
  • the connecting device, the guiding device, and the lancing device are separately manufactured, and the outer surface of the lancing device is bonded to the inner surface of the connecting device, and the connecting device is engaged in the guiding device.
  • the connecting device and the guiding device are made of a transparent thermoplastic material, and the piercing device is made of stainless steel.
  • the coupling between the connecting device and the medical solution supply device is detachable.
  • the puncturing device is a needle having a fluid passage therein.
  • the puncturing device is a hollow needle.
  • a method for piercing a heparin cap comprising: separately holding a device for piercing a heparin cap according to the first aspect (possibly including the above various One or more of the preferred and further features) and the heparin cap; and bringing the device into proximity with the heparin cap such that the at least one portion of the heparin cap enters the guide device, the puncture device being in the proper position of the heparin cap Insert the sealing rubber of the heparin cap at a suitable relative angle and finally penetrate the sealing rubber.
  • a vascular access system comprising: a vascular access device; a heparin cap coupled to the vascular access device; and a device for puncturing a heparin cap according to the first aspect (which may include each One or more of the preferred and further features; and a medical fluid supply device in fluid communication with the device for use in a medical fluid supply.
  • the vascular access device comprises at least one of: an indwelling needle, a central venous catheter, a peripherally punctured central venous catheter, and an arterial catheter.
  • the present application provides a single, safe, easy-to-manufacture infusion needle (ie, a device for piercing a heparin cap) that allows medical personnel to do not require very skilled skills and does not require very careful handling, but The puncture of the heparin cap can be completed safely, easily, quickly and efficiently.
  • the infusion needle can greatly reduce or eliminate the unnecessary waste of the liquid in the subsequent infusion process, and also help the medical staff to thoroughly rinse the residual liquid inside the heparin cap.
  • FIG. 1 is a cutaway side view of a typical heparin cap in accordance with the prior art.
  • Fig. 2 is an exploded side elevational view, partly in section, of a syringe, an intravenous infusion needle, and an indwelling needle according to the prior art.
  • Figure 3 is a cut-away perspective view of a heparin cap puncture infusion needle in accordance with one embodiment of the present application.
  • Figure 4 is a cutaway side view of the heparin cap puncture infusion needle of Figure 3.
  • Figure 5 is a syringe, the heparin cap puncture infusion needle of Figure 3, and the indwelling needle when used together Cutaway side view.
  • Figure 6 is a cross-sectional side view of the heparin cap puncture infusion needle puncture heparin cap of Figure 3.
  • FIG. 7 and 8 are (partial) cutaway perspective views of a heparin cap puncture infusion needle in accordance with two alternative embodiments of the present application.
  • Figures 9 and 10 are cutaway side views of a heparin cap puncture infusion needle in accordance with two alternative embodiments of the present application. detailed description
  • an infusion needle 500 according to an embodiment, the assembly comprising a hub 510 and a needle bar 520.
  • the hub is preferably made of a thermoplastic material suitable for injection molding, especially a transparent thermoplastic material such as polycarbonate, polypropylene or the like.
  • the needle bar is preferably made of a stainless steel material.
  • the hub 510 can further include an open butt end 511 and an open end 515, wherein the open end 511 is adapted to receive at least a portion of the heparin cap 410, such as shown in FIG. 2, and the open end 515 is adapted It is coupled in fluid communication to, for example, the upper portion of the medical solution supply device 200 shown in Fig. 2 (more specifically, the mating relationship is schematically shown in Fig. 5).
  • the open end 511 and the open end 515 will now be described in greater detail with reference to Figures 3-4.
  • the open thick end 511 has a substantially cylindrical side wall 512 and an inner wall 513, and the side wall 512 is preferably a cylindrical or square polygonal prism having a number of not less than six, and the inner wall 513 is preferably cylindrical or round.
  • the cone shape has a mouth diameter indicated by A, and preferably A is more than 8.5 mm.
  • the open end 515 includes an inner wall 516 conforming to ISO 594-2:1998 and GB/T 1962.2-2001 and a side wall 517 having a lug 518.
  • the open end 515 is a 6% (Ruhr) inner conical locking joint that conforms to medical industry standards to properly engage the outer conical locking joint 211 of the medical fluid supply such as the syringe 200.
  • open end 511 and the open end 515 are schematic. Those skilled in the art will vary depending on the actual needs and the components associated therewith (eg, different heparin cap shapes and sizes, different syringe standard fittings, etc.) Various modifications and improvements are readily made, including setting different shapes, sizes, and relative positional relationships for them, without departing from the teachings and scope of the present application.
  • the open end of the opening is usually used to receive and guide the heparin cap 410, and the open end is usually used for connecting/fluid communication with the liquid chemical supply device, in the context, the open end is sometimes referred to as a "guide", and the opening is opened.
  • the thin end is called the "connecting device”.
  • the open end 511 and the open end 515 are joined at a central portion of the hub 510 and have a common bottom layer 531 having a central portion having a boss 541 extending toward the opening of the thick end.
  • a stepped cylindrical aperture 534 extending through the bottom layer 531 and the boss 541 communicates with the open end and the open end.
  • the stepped cylindrical aperture 534 has the same axial center as the inner wall 513 of the thick end 511.
  • the bottom layer 531, the boss 541 and the inner wall 513 include at least one shoulder 551 having a plane 552 parallel to the thick end surface 519.
  • the diameter of the circumference of the plane 552 and the inner wall 513 is represented by B, and is thick.
  • the distance between the end faces 519 is indicated by C, preferably B is greater than 8 mm, preferably C is less than 12 mm.
  • Needle bar 520 includes a proximal end 521, a distal end 523, and a lumen 522 therethrough.
  • the proximal end 521 is preferably secured within the stepped cylindrical aperture 534 by adhesive means, and the distal end 523 can include a blunt tip or a pointed tip 524 as shown, the top of the tip 524 and the top plane 552 of the shoulder 551
  • the distance is indicated by D, and the distance between the cusp of the tip 524 and the end face 519 is indicated by E, preferably D is greater than 5 mm, preferably E is greater than 2 mm.
  • the open and open ends can be communicated through the lumen 522 of the needle shaft 520.
  • the needle bar 520 has the same axis as the inner wall 513 of the butt end 511.
  • the needle bar 520 is typically used to puncture the heparin cap 410, the needle bar is sometimes referred to as a "puncture device" in the context. Similar to the explanation above, the terms of the needle bar and the piercing device are not substantially different in substance.
  • the heparin cap punctures the three portions of the infusion needle 500, the open thin end 515, the open thick end 511, and the needle bar 520 - respectively, to perform the following operations to achieve the technical purpose of the present application:
  • the end 515 is connected to a corresponding joint of the medical solution supply device using a known method (for example, a 6% (Ruhr) outer conical locking joint 211 of the syringe 200 in the drawing); the inner wall 513 of the open end 511 is nested (ie, accommodated)
  • the heparin cap of the vascular access device or the three-way valve device for example, the heparin cap 410 for the indwelling needle 400 in Fig.
  • the needle bar 520 can be inserted (under the guidance of the inner wall 513) into the heparin in the open end of the opening
  • the inside of the cap 410 has a piercing process as shown in the sequence of Figs. 6(i), (ii), (iii).
  • the diameter of the inner wall 513 of the open, thick end 511 of the heparin cap puncture needle 500 is slightly larger than the outer diameter of the sealing rubber end 110 of the heparin cap 100.
  • the piercing process can be roughly divided into the following three stages:
  • the tip end 524 of the needle bar 520 is in contact with the sealing rubber end 110, and is inserted substantially vertically from the central portion of the heparin cap sealing rubber 110 (see Fig. 6 (ii)).
  • a series of adverse consequences may result from the generation of plastic chips and the burying of the needle tip in the plastic body. This problem is effectively addressed herein by properly positioning and orienting the tip 524 and sealing the rubber end 110.
  • the needle bar 520 can be inserted into the sealing rubber at other relative positions, or in other relative orientations, as desired. End 110.
  • the system assembled in accordance with the above procedure may be referred to as a vascular access system which is coupled to the joint 211 of the syringe 200 at the thin end 515 of the heparin cap puncture infusion needle 500 and causes the needle shaft 520 to penetrate the heparin cap 410 of the indwelling needle 400.
  • the vascular access system ensures that a suitable fluid path is established between the syringe 200 and a human blood vessel (not shown) that connects the indwelling needle bar 420, and that the inside of the syringe can be moved by a medical person pushing the push rod 220 of the syringe.
  • the liquid is infused into the blood vessels of the human body for the purpose of medical treatment.
  • Figure 7 shows a heparin cap puncture infusion needle 600 in accordance with another embodiment of the present application.
  • the assembly of the heparin cap puncture infusion needle 600 is integrally formed, which in turn can be subdivided into an open thick end portion 611, an open thin end portion 621 and a 4"H dry portion 631, three of which are
  • the same plastic material is preferably injection molded by injection molding.
  • the integrally formed infusion needle 600 may further reduce manufacturing costs and labor costs, and can be used directly without the user having to install it.
  • FIG. 8 shows a heparin cap puncture infusion needle 700 in accordance with yet another embodiment of the present application.
  • the heparin cap puncture infusion needle 700 is divided into three separate components: an open thick end assembly 710, an open thin end assembly 720, and a 4"H dry assembly 730.
  • the open thick end assembly 710 and the open thin end assembly 720 It is preferably made of a thermoplastic material suitable for injection molding, especially a transparent thermoplastic material such as polycarbonate, polypropylene, etc.
  • the needle bar 730 is preferably made of a stainless steel material.
  • the needle bar 730 and the opening The thin ends 720 are fixed together by bonding, and the open end 710 and the open thin end 720 are connected by physical connection (such as the buckles 711, 721 in this embodiment).
  • the open and thin end assembly 710 and the open thin end assembly 720 are mechanically coupled (eg, with a barbed snap) and are not detachably or extremely easily detachably coupled to ensure a one-time use of the medical device. Ensure the medical safety of the entire drug supply process.
  • FIG. 9 shows a heparin cap puncture infusion needle 800 in accordance with yet another embodiment of the present application.
  • the heparin cap puncture infusion needle 800 is still divided into three separate components: an open butt end assembly 810, an open thin end assembly 820, and a needle bar assembly 830.
  • the open end assembly 810 and the open end assembly 820 are not directly connected by a machine-like manner, but are "stringed” together by the needle bar assembly 830.
  • inter-engaging positioning members 811 and 821 may be provided on opposite sides of the open stub assembly 810 and the open thin end assembly 820 to assist in the connection between the open stub assembly 810 and the open thin end assembly 820. .
  • the three component open end assembly 810, the open end assembly 820 and the 4"H dry assembly 830 of Figure 9 are detachable from each other.
  • Figure 10 shows a heparin cap puncture of yet another embodiment of the present application.
  • Infusion needle 900 In this embodiment, the heparin cap puncture needle 900 is divided into five separate components: an open thick end assembly 910, an inner conical joint assembly 920, a needle bar assembly 930, a needle hub assembly 940, and a catheter assembly 950.
  • the inner conical joint 920 and the catheter 950, the catheter 950 and the needle hub assembly 940, the needle hub 940 and the needle bar 930 are fixed by adhesion, and the needle hub 940 and the open thick end 910 are connected by detachable threads.
  • the embodiment shown in Figure 9 differs in that the open stub assembly 910 and the open stub assembly 920 are physically separated and fluidly fluidized only by the needle bar assembly 930 and the catheter 950, the hub assembly 940, and the like. Coupled together.
  • the liquid from the open thin end assembly 920 eg, from the syringe
  • the fluid passage catheter 950 - needle hub assembly 940 - needle bar assembly 930
  • End component 910 thereby requiring Time to ensure normal delivery of liquid.
  • the heparin cap puncture infusion needles 600, 700, 800, and 900 can be heparin with the syringe 200 and the indwelling needle 400 in a manner similar to that described above in connection with Figures 5-6.
  • the caps 410 are respectively connected and establish a fluid path between the syringe and the patient's blood vessel by piercing the puncture needle of the heparin cap.
  • the relative positions of the connecting device, the guiding device, and the lancing device may be different from those in the embodiment (eg, the connecting device, the guiding device, and the lancing device are not necessarily in a straight line when in use)
  • the lines are substantially coaxial, they can be arranged arbitrarily according to actual needs, but this still falls within the scope of protection of the present application.
  • to reduce the overall size of the device for piercing the heparin cap only a portion of the lancing device may be located in the guide rather than all of it.
  • two of the connecting device, the guiding device, and the lancing device can be integrally fabricated as one large component, and the other component can be detachably or non-detachably and/or fluidly connected to the large component. Connected together, or another component is only in fluid communication (ie, physically separated).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

一种用于穿刺肝素帽的设备及血管通路***。所述用于穿刺肝素帽的设备包括适于流体连通地耦接药液供给装置的连接装置（515、621、720、820、920），适于容纳肝素帽的至少一部分的导向装置（511、611、710、810、910），以及用于穿刺肝素帽的穿刺装置（520、631、730、830、930），所述穿刺装置配置成与连接装置流体连通并至少部分地位于导向装置中的预定位置处。该预定位置配置成使得在肝素帽的至少一部分进入到导向装置的过程中，穿刺装置在肝素帽的合适位置以合适的相对角度***肝素帽的密封橡胶并最终穿透密封橡胶。所述设备可使医护人员安全、轻松、快速、有效地完成肝素帽的穿刺，极大减少或消除后续输液过程中药液浪费，并且有助于医护人员更加彻底地冲洗肝素帽内部的残留药液。

Description

一种用于穿刺肝素帽的设备及血管通路***
技术领域
本公开一般涉及血管通路领域， 更具体地，本公开涉及一种用于 穿刺血管通路中的肝素帽的输液设备。 背景技术
肝素帽的组成一般包括如图 1所示的两个部件：密封件 110和壳体 120。 密封件通常由橡胶（如硅胶）或其他弹性材料制成。 壳体一般 由透明的热塑性材料制成， 内部具有流体通道 130, 且一端为标准的 6% (鲁尔） 圓锥锁定接头 121 , 该接头能够防止其在长时间的使用中 连接不当发生意外脱落以保持连接的可靠性。密封橡胶通过物理挤压 嵌入或化学粘接贴合的方式，牢固地装配在塑料壳体远离锁定接头的 一端的内壁 122上， 两者之间形成密闭， 组成一个完整的肝素帽 100。
肝素帽的密封橡胶 110允许***和抽出尖的针杆。 当肝素帽另一 端的锁定接头 121上连接有其他装置时， ***的针杆与该装置之间可 通过肝素帽内部的流体通道 130建立流体连通， 一旦针杆抽出， 密封 橡胶瞬间密封自己， 阻断该装置与外界的连通。 肝素帽可多次、反复 穿刺。
肝素帽常与长期使用的血管通路装置配合使用，通过它们的配合 使用可以从外部向血管内输注药液。血管通路装置例如外周短、 中等 长度导管（如留置针（PVC ) ) 、 中心血管通路装置（如中心静脉导 管 （CVC ) 、 经外周穿刺中心静脉导管 （PICC )等)、 以及动脉导管 等。 应该意识到， 其它类型的血管通路装置也是可能的， 包括已有的 或将来开发的任何血管通路装置， 只要它们能够结合肝素帽一起使 用。血管通路装置的具体类型不应对下文所描述的实施例及本申请的 保护范围构成任何限制。
当血管通路装置处于非输液状态时，可通过肝素帽向里注射适量 的生理盐水和 /或肝素溶液， 以沖洗或封闭血管通路装置， 从而防止 血管通路装置内残留药液及血液回流形成凝血。
使用 PVC、 CVC、 PICC等需肝素帽封头的血管通路装置向人体 血管内输注药液进行治疗任务时，配套使用的装置除了药液供给装置
(如注射器、 输液器）夕卜， 通常还包括静脉输液针。 图 2示出了这些 装置配套使用时的连接方式： 首先诸如注射器 200的药液供给装置的 外圓锥（锁定）接头 211与静脉输液针 300的内圓锥接头 311相连； 然 后静脉输液针的针杆针尖 341***到与人体血管相连的、 诸如留置针 400的血管通路装置的肝素帽 410内； 最终，通过三者之间连通的流体 通道将药液供给装置内的药液输注到人体血管内。 当药液输注完成 后， 为防止血管通路装置内残留药液及血液回流形成凝血，通常需继 续输入适量的肝素溶液进行封管， 然后从肝素帽拔出静脉输液针。 下 次输液之前，通常需先用适量的生理盐水进行沖管清洗， 然后进行药 液的输注操作。
使用静脉输液针时， 操作人员 （如护士） 需先取下针杆 340的保 护套 350, 这时棵露的锋利针尖 341就可能对医护人员和 /或患者造成 意外伤害，且意外伤害的风险在后续的操作中还会继续增加。在钢针 (即， 针杆）穿刺肝素帽时， 医护人员通常是一只手的拇指和食指握 持肝素帽， 另一只手的拇指和食指握持输液针的针柄 330, 然后小心 谨慎地完成穿刺动作。如果医护人员的技巧不够熟练、精神不够集中 或操作方法不当， 穿刺过程^艮可能出现以下情况：
( 1 ) 医护人员或患者被针尖刺伤。 由于肝素帽的外形一般较为 小巧， 而且肝素帽通常是固定在患者的皮肤表面，所以针尖容易刺伤 医护人员握持肝素帽的手指和 /或患者的皮肤。
( 2 )针尖刺到肝素帽的塑料内壁表面， 产生塑屑， 塑屑在后续 的输液过程中随药液进入人体； 或针尖刺入的方向不合适或足够深， 以致针尖刺入塑料内壁并埋没在塑料本体中，从而造成钢针与肝素帽 之间不能建立流体通道，后续输液无法进行； 此两种情况都可能造成 医疗事故或引入潜在的健康风险。只有针尖选择肝素帽密封橡胶的中 部位置并垂直地***才能有效避免上述现象。
( 3 ) 沖管时肝素帽内清洗不够彻底。 通常情况下， 输液针的针 杆较长， 而肝素帽较短， 如果不加控制或控制不当，很容易造成针杆 ***肝素帽的深度较大，这样在使用生理盐水进行沖管清洗时， 靠近 密封橡胶端的肝素帽内壁处将不易被沖洗到，沖管结束后此处也容易 残留药液。如果即将输注的药液与残留的药液存在配伍禁忌，就 4艮可 能造成医疗事故。 此外， 血液制品、 营养液等残留后可为生物的被膜 生长提供营养， 所以应该将其沖洗出导管腔内。
一支完整的静脉输液针组件较多， 结构复杂， 制造也不筒单。 如 果组件中的针杆 340、 针柄 330、 软管 320、 针座（内圓锥接头） 310 之间的连接不当，则可能导致整支输液针的内部流体通道不通畅、堵 塞或泄漏， 为后续的医疗使用带来各种事故。 由于软管 320较长（一 般不小于 250mm ) , 输液针在使用过程中也会浪费一定量的药液。
血管通路装置为长期使用的医疗装置， 留置在人体的时间较长， 一支血管通路装置从开始使用到结束使用， 会多次用到静脉输液针， 肝素帽也被多次、 反复穿刺， 于是， 上面提到的各种风险都会增加， 药液浪费量也会增加。
因此， 本领域中需要一种筒单、 安全、 易于制造的输液针， 其使 得医护人员 （其操作和维护 PVC、 CVC、 PICC、 三通阀门等需肝素 帽封头的装置或端口）不需要非常熟练的技巧，也不需要非常小心谨 慎的操作， 却能够安全、 轻松、 快速、 有效地完成肝素帽的穿刺。 同 时， 该针还能够极大地减少或消除后续输液过程中药液的不必要浪 费， 也有助于医护人员更加彻底地沖洗肝素帽内部的残留药液。
发明内容
本申请涉及一种用于穿刺肝素帽的设备、方法及包含用于穿刺肝 素帽的血管通路***。
根据第一方面，提供了一种用于穿刺肝素帽的设备，该设备包括： 适于流体连通地耦接到药液供给装置的连接装置；适于容纳肝素帽的 至少一部分的导向装置； 以及用于穿刺肝素帽的穿刺装置，其配置成 与连接装置流体连通并至少部分地位于导向装置中的预定位置处。其 中，该预定位置配置成使得： 在肝素帽的至少一部分进入到导向装置 的过程中， 穿刺装置在肝素帽的合适位置、以合适的相对角度***肝 素帽的密封橡胶并最终穿透密封橡胶。
优选地，该合适的相对角度包括穿刺装置与密封橡胶垂直，并且 该合适位置包括密封橡胶的中部。
优选地，该导向装置还包括限位部件，用于限制肝素帽进入到导 向装置的最终深度。 进一步地， 该限位部件包括以下至少之一： 导向 装置内部的凸起或导向装置在从肝素帽到导向装置的方向上逐渐变 窄的形状。进一步地，该最终深度保证穿刺装置***到肝素帽中的最 终位置靠近密封橡胶。
优选地， 该连接装置、导向装置、 和穿刺装置中的至少其中两者 是整体成形制造的。 进一步地， 该连接装置、 导向装置、 和穿刺装置 都是整体成形制造的。 更进一步地， 该连接装置、 导向装置、 和穿刺 装置都由塑料材料制成。
优选地， 该连接装置、导向装置、 和穿刺装置中的至少其中两者 是分别制造的， 并且所分别制造的装置通过可拆卸的方式组装在一 起。进一步地，该连接装置、导向装置、和穿刺装置都是分别制造的， 并且穿刺装置的外表面粘合到连接装置的内表面，连接装置卡合在导 向装置中。更进一步地，该连接装置和导向装置由透明的热塑性塑料 材料制成， 并且穿刺装置由不锈钢制成。
优选地， 该连接装置和药液供给装置之间的耦接是可拆卸的。 优选地， 该穿刺装置是内部具有流体通道的针状物。 进一步地， 该穿刺装置是中空的针状物。
根据第二方面，提供了一种用于穿刺肝素帽的方法，该方法包括： 分别握持根据第一方面的用于穿刺肝素帽的设备（可能包括上述各种 优选的和进一步的特征中的一个或多个）和肝素帽； 以及使得该设备 与肝素帽相互靠近，从而在肝素帽的至少一部分进入到导向装置的过 程中， 穿刺装置在肝素帽的合适位置、 以合适的相对角度***肝素帽 的密封橡胶并最终穿透密封橡胶。
根据第三方面，提供了一种血管通路***，该血管通路***包括： 血管通路装置； 与血管通路装置耦接的肝素帽；根据第一方面的用于 穿刺肝素帽的设备（可能包括上述各种优选的和进一步的特征中的一 个或多个）； 以及与所述设备流体连通的药液供给装置， 其用于药液 供给。 优选地， 该血管通路装置包括以下至少之一： 留置针、 中心静 脉导管、 经外周穿刺中心静脉导管、 动脉导管。
本申请提供了一种筒单、 安全、 易于制造的输液针（即， 用于穿 刺肝素帽的装置）， 其可以使得医护人员不需要非常熟练的技巧， 也 不需要非常小心谨慎的操作， 却能够安全、 轻松、 快速、 有效地完成 肝素帽的穿刺。 同时，该输液针还能够极大地减少或消除后续输液过 程中药液的不必要浪费，也有助于医护人员更加彻底地沖洗肝素帽内 部的残留药液。 附图说明
当参考附图阅读下面的详细描述时，将更好地理解本申请的这些 和其他特征、方面和优点，在所有附图中，相似的符号表示相似部件， 在附图中：
图 1是根据现有技术的典型肝素帽的剖切侧视图。
图 2是根据现有技术的注射器、 静脉输液针、 留置针配套使用时 局部剖切的分解侧视图。
图 3是根据本申请的一个实施例的肝素帽穿刺输液针的剖切透视 图。
图 4是图 3的肝素帽穿刺输液针的剖切侧视图。
图 5是注射器、 图 3的肝素帽穿刺输液针、 留置针配套使用时局部 剖切的分解侧视图。
图 6是图 3的肝素帽穿刺输液针穿刺肝素帽的剖切侧视图。
图 7和图 8是根据本申请的两个可选实施例的肝素帽穿刺输液针 的 （局部） 剖切透视图。
图 9和图 10是根据本申请的另两个可选实施例的肝素帽穿刺输液 针的剖切侧视图。 具体实施方式
如图 3和图 4所示， 其中图示了根据实施例的的输液针 500, 其组 件包括针座 510和针杆 520。针座优选地由适合于注塑成型的热塑性材 料制成， 尤其是透明的热塑性塑料材料， 例如聚碳酸酯、 聚丙烯等。 针杆优选为不锈钢材料制成。
如图所示，针座 510又可进一步包括开口粗端 511和开口细端 515 , 其中开口粗端 511适于容纳例如图 2中所示的肝素帽 410的至少一部 分，并且开口细端 515适于流体连通地耦接到例如图 2中所示的药液供 给装置 200的上部（更具体的配合关系示意性地示于图 5中 )。 在整体 描述针座与针杆的连接、 配合之前， 现结合图 3-4来较为详细地介绍 开口粗端 511和开口细端 515的优选实施例。
( 1 )开口粗端 511具有大体圓筒形侧壁 512和内壁 513 ,并且侧壁 512优选为圓筒形或边数不少于六的正多边柱形，内壁 513优选为圓筒 形或圓锥筒形， 其口部直径用 A表示， 优选 A大于 8.5mm。
( 2 )开口细端 515包括符合 ISO 594-2: 1998和 GB/T 1962.2-2001 标准的内壁 516和具有凸耳 518的侧壁 517。开口细端 515是一个符合医 疗行业标准的 6% (鲁尔） 内圓锥锁定接头， 以合适地与诸如注射器 200的药液供给装置的外圓锥锁定接头 211接合。
能够理解的是，上述关于开口粗端 511、开口细端 515的具体限定 都是示意性的。根据实际需要和与之相关的组件的不同（例如， 不同 的肝素帽形状和尺寸、 不同的注射器标准接头等）， 本领域技术人员 容易地做出各种修改和改进， 包括对它们设置不同的形状、尺寸和相 对位置关系， 这些都没有超出本申请的教导和范围。
由于开口粗端通常用于容纳并导向肝素帽 410, 并且开口细端通 常用于连接 /流体连通药液供给装置， 因此在上下文中有时又将开口 粗端称之为 "导向装置" 、 将开口细端称之为 "连接装置" 。 可以意 识到的是，由于上述不同称谓只是分别从形状和功能两方面对同一部 件进行的不同人为命名， 因此开口粗端和导向装置、以及开口细端和 连接装置在实质意义上并没有区别。
现在回到图 3-4 ,开口粗端 511和开口细端 515在针座 510的中部位 置结合， 并具有共同的底层 531 , 该底层的中部位置具有向粗端开口 方向延伸的凸台 541 ,贯穿底层 531和凸台 541的阶梯圓柱小孔 534连通 开口粗端和开口细端。优选地，阶梯圓柱小孔 534与粗端 511的内壁 513 具有相同的轴心。 底层 531、 凸台 541和内壁 513之间包括至少一个凸 肩 551 ,该凸肩顶部具有平行于粗端端面 519的平面 552,平面 552与内 壁 513结合处的圓周直径大小用 B表示， 与粗端端面 519之间的距离用 C表示， 优选 B大于 8mm, 优选 C小于 12mm。
针杆 520包括近端 521、 远端 523和穿过其的管腔 522。 近端 521优 选地通过粘接方式固定在在阶梯圓柱小孔 534内，远端 523可以包括钝 的尖端或如图所示尖的尖端 524, 尖端 524的粗部与凸肩 551的顶部平 面 552的距离用 D表示， 尖端 524的尖点与粗端端面 519的距离用 E表 示， 优选 D大于 5mm, 优选 E大于 2mm。 开口粗端和开口细端可通过 针杆 520的管腔 522建立连通。 在优选实施例中， 针杆 520与粗端 511 的内壁 513具有相同的轴心。
由于针杆 520通常用于穿刺肝素帽 410,因此在上下文中有时又将 针杆称之为 "穿刺装置" 。 与上文所解释的类似， 针杆和穿刺装置的 称谓在实质意义上并没有区别。
下面结合肝素帽和药液供给装置，描述如何使用根据本申请实施 例的输液针 500。 如图 5所示，在操作中肝素帽穿刺输液针 500的三个部分一开口细 端 515、 开口粗端 511、 以及针杆 520—分别进行下述操作以实现本申 请的技术目的： 开口细端 515使用公知方法连接到药液供给装置的对 应接头（例如图中的注射器 200的 6% (鲁尔）外圓锥锁定接头 211 )； 开口粗端 511的内壁 513套住（即， 容纳）血管通路装置或三通阀门装 置的肝素帽 （例如， 图 4中用于留置针 400的肝素帽 410 ) ； 针杆 520 可以刺入（在内壁 513的引导下）进入到开口粗端中的肝素帽 410的内 部， 其刺入过程如图 6 ( i ) 、 ( ii ) 、 ( iii )顺序示出的那样。
如图 6所示并根据本申请的优选实施例， 肝素帽穿刺输液针 500 的开口粗端 511的内壁 513的直径较肝素帽 100的密封橡胶端 110的外 径尺寸稍大。 刺入过程大致可划分为以下三个阶段：
( 1 )首先，在肝素帽 100的密封橡胶端 110沿内壁 513向里***时， 针杆 520与密封橡胶端 110相互靠近（见图 6 ( i ) ) 。 由于针体在靠近 密封橡胶端的过程中始终位于开口粗端 511以内， 因此医护人员或患 者被刺伤的风险极大减少。
( 2 )然后， 针杆 520的尖端 524与密封橡胶端 110接触， 并大体上 从肝素帽密封橡胶 110的中部位置垂直地***肝素帽内部 （见图 6 ( ii ) ) 。 如上文在背景技术中解释的那样， 如果针杆刺入位置和 / 或刺入方向不正确，可能造成塑屑产生、针尖埋没在塑料本体中等一 系列不利后果。 本文通过适当地相对定位和定向尖端 524与密封橡胶 端 110, 有效地解决了上述问题。 另外， 如本领域技术人员能够理解 的，通过适当布置开口粗端 511和针杆 520之间的相对定位，可以按照 特定需要在其它相对位置、 或以其它相对朝向将针杆 520刺入密封橡 胶端 110。
( 3 )最后， 当肝素帽端面 111碰到内壁 513底部的凸肩 551顶部的 平面 552不能继续前进时（即， 肝素帽被限位时） ， 针杆的穿刺尖端 524停留在肝素帽 100内部靠近密封橡胶 110的附近（见图 6 ( iii ) ) 。 如上文在背景技术中解释的那样，这种最终定位方式有助于医护人员 在沖管时更加彻底地沖洗肝素帽内部的残留药液，有效避免因药液配 伍禁忌可能导致的医疗事故。
按照上述过程组装好的***可以称之为血管通路***，该***在 肝素帽穿刺输液针 500的细端 515连接注射器 200的接头 211 ,并使得针 杆 520刺入留置针 400的肝素帽 410。 根据本申请的血管通路***保证 了在注射器 200和连接留置针针杆 420的人体血管（未示出）之间建立 合适的流体通路， 并且通过医疗人员推动注射器的推杆 220便可将注 射器内部的药液输注到人体血管中， 以达到相应的医疗目的。
图 7显示了根据本申请另一实施例的肝素帽穿刺输液针 600。在该 实施例中， 肝素帽穿刺输液针 600的组件是整体成形制造的， 该整体 结构又可细分为开口粗端部分 611、开口细端部分 621和 4"H干部分 631 , 三者为同种塑料材料，优选通过注塑成型的方法一次注塑制造。整体 成形的输液针 600可能进一步降低制造成本和人工成本， 并无需用户 进行安装就可直接使用。
图 8显示了本申请再一实施例的肝素帽穿刺输液针 700。在该实施 例中，肝素帽穿刺输液针 700分为三个单独的组件：开口粗端组件 710、 开口细端组件 720和 4"H干组件 730。 开口粗端组件 710和开口细端组件 720优选地由适合于注塑成型的热塑性材料制成， 尤其是透明的热塑 性塑料材料， 例如聚碳酸酯、 聚丙烯等。 针杆 730优选为不锈钢材料 制成。 如图所示， 针杆 730与开口细端 720通过粘接固定在一起， 开口 粗端 710与开口细端 720通过物理连接方式（如本实施例中的卡扣 711、 721 )连接在一起。 优选地， 在图 8的实施例中， 开口粗端组件 710与 开口细端组件 720通过机械的方式（例如， 带有倒钩的卡扣） 而不可 拆卸地或极不容易拆卸连接在一起， 以保证医疗器械的一次性使用， 从而确保整个药液供给过程的医疗安全性。
图 9显示了本申请又一实施例的肝素帽穿刺输液针 800。在该实施 例中， 肝素帽穿刺输液针 800仍然分为三个单独的组件： 开口粗端组 件 810、开口细端组件 820和针杆组件 830。与图 8所示的实施例不同在 于，开口粗端组件 810和开口细端组件 820之间并没有通过机戈方式直 接连接， 而是通过针杆组件 830将它们两者 "串" 在一起。 另外， 如 图所示，在开口粗端组件 810和开口细端组件 820的相对侧可以设置相 互配合的定位部件 811和 821 , 以辅助开口粗端组件 810和开口细端组 件 820之间的连接。 优选地， 图 9中的三个组件开口粗端组件 810、 开 口细端组件 820和 4"H干组件 830互相之间是可拆卸的。图 10显示了本申 请又一实施例的肝素帽穿刺输液针 900。 在该实施例中， 肝素帽穿刺 输液针 900分为五个单独的组件： 开口粗端组件 910、 内圓锥接头组件 920、 针杆组件 930、 针座组件 940、 导管组件 950。 内圓锥接头 920与 导管 950、 导管 950与针座组件 940、 针座 940与针杆 930之间通过粘接 固定，针座 940与开口粗端 910通过可拆卸螺纹连接。与图 8和图 9所示 的实施例不同在于，开口粗端组件 910和开口细端组件 920之间是物理 上分离的， 并且仅通过针杆组件 930和导管 950、 针座组件 940等将它 们两者流体耦合在一起。换句话说，来自开口细端组件 920的药液（比 如， 来自注射器）可以经由如图所示的流体通路（导管 950-针座组 件 940-针杆组件 930 )而到达开口粗端组件 910, 从而在需要的时候保 证药液的正常传递。
将开口粗端组件 910和开口细端组件 920分离虽然增加了若干中 间部件、 从而提高了成本， 但可分离肝素帽穿刺输液针 900无疑增加 了灵活性， 保证了治疗过程更加有效的进行。
尽管未具体示出， 但应该意识到， 可以类似于上文结合图 5-图 6 所描述的方式， 将该肝素帽穿刺输液针 600、 700、 800和 900与注射器 200和留置针 400的肝素帽 410分别连接， 并通过刺入肝素帽的穿刺输 液针而在注射器和患者血管之间建立流体通路。
虽然上文示意性给出了本申请的多种替换实施例，但通过阅读上 面的公开， 技术人员容易想到其它的变形、 替换或改变。 例如， 连接 装置、导向装置、和穿刺装置的相对位置可能与实施例中的有所不同 (比如， 连接装置、 导向装置、 和穿刺装置在使用时不一定在一条直 线上并基本同轴， 它们可以根据实际需要任意的布置） , 但这仍然落 入本申请的保护范围。又例如， 为了减小穿刺肝素帽的设备的整体大 小， 穿刺装置可能只有一部分位于导向装置中而不是全部位于其中。 又例如， 连接装置、 导向装置、 和穿刺装置中的某两个组件可以整体 上制造为一个大的组件， 而另一个组件通过可拆卸或不可拆卸和 /或 流体连通的方式与该大的组件连接在一起，或者另一个组件仅与之流 体连通（即， 物理上分离） 。
另外，在不发生沖突的情况下，各实施例中的限定也可相互组合。 例如，某一实施例中提到的某个组件的组成材料或制造方式， 完全可 能部分或全部地适用于其它实施例中的该组件， 这也是容易想到的， 因此并未超出本公开的教导和范围。
总之，本书面描述使用示例来公开包括最佳模式的本发明，并还 使本领域技术人员能实践本发明，包括制作和使用任何装置或***及 执行任何结合的方法。然而，本发明可取得专利的范围由权利要求定 义， 且可包括本领域技术人员想到的其它示例。

Claims

1. 一种用于穿刺肝素帽（410 ) 的设备， 其特征在于， 所述设备 包括：
连接装置 （515、 621、 720、 820、 920 ) , 其适于流体连通地耦 接到药液供给装置（200 ) ；
导向装置 （511、 611、 710、 810、 910 ) , 其适于容纳所述肝素 帽的至少一部分； 以及
用于穿刺所述肝素帽的穿刺装置 （520、 631、 730、 830、 930 ) , 其配置成与所述连接装置流体连通并至少部分地位于所述导向装置 中的预定位置处，
其中， 所述预定位置配置成使得： 在所述肝素帽的所述至少一部 分进入到所述导向装置的过程中， 所述穿刺装置在所述肝素帽的合适 位置、 以合适的相对角度***所述肝素帽的密封橡胶并最终穿透所述 密封橡胶。
2. 根据权利要求 1所述的设备， 其特征在于， 所述合适的相对角 度包括所述穿刺装置与所述密封橡胶垂直， 并且所述合适位置包括所 述密封橡胶的中部。
3. 根据权利要求 1或 2所述的设备， 其特征在于， 所述导向装置 还包括限位部件， 用于限制所述肝素帽进入到所述导向装置的最终深 度。
4. 根据权利要求 3所述的设备， 其特征在于， 所述限位部件包括 以下至少之一： 所述导向装置内部的凸起或所述导向装置在从所述肝 素帽到所述导向装置的方向上逐渐变窄的形状。
5. 根据权利要求 1或 2所述的设备，其特征在于，所述连接装置、 所述导向装置、 和所述穿刺装置中的至少其中两者是整体成形制造 的。
6. 根据权利要求 5所述的设备， 其特征在于， 所述连接装置、 所 述导向装置、 和所述穿刺装置都是整体成形制造的。
7. 根据权利要求 1或 2所述的设备，其特征在于，所述连接装置、 所述导向装置、 和所述穿刺装置中的至少其中两者是分别制造的， 并 且所分别制造的装置通过可拆卸的方式组装在一起。
8. 根据权利要求 7所述的设备， 其特征在于， 所述连接装置、 所 述导向装置、 和所述穿刺装置都是分别制造的， 并且所述穿刺装置的 外表面粘合到所述连接装置的内表面， 所述连接装置卡合在所述导向 装置中。
9. 一种血管通路***， 其特征在于， 所述血管通路***包括： 血管通路装置，
与血管通路装置耦接的肝素帽；
根据权利要求 1-8中的任一项所述的设备， 所述设备用于对所述 肝素帽进行穿刺； 以及
与所述设备流体连通的药液供给装置， 用于药液供给。
10. 根据权利要求 9所述的血管通路***， 其特征在于， 所述血 管通路装置包括以下至少之一： 留置针、 中心静脉导管、 经外周穿刺 中心静脉导管、 以及动脉导管。
PCT/CN2013/082549 2013-08-29 2013-08-29 一种用于穿刺肝素帽的设备及血管通路*** WO2015027427A1 (zh)

Priority Applications (6)

Application Number Priority Date Filing Date Title
DE112013007370.6T DE112013007370T5 (de) 2013-08-29 2013-08-29 Vorrichtung zum Durchstechen eines Heparin-Verschlusses und Gefässzugangssystem
RU2016101676A RU2651076C2 (ru) 2013-08-29 2013-08-29 Устройство для прокалывания гепаринового колпачка и система сосудистого доступа
CN201380068611.3A CN105492065A (zh) 2013-08-29 2013-08-29 一种用于穿刺肝素帽的设备及血管通路***
KR1020167001595A KR20160022368A (ko) 2013-08-29 2013-08-29 헤파린캡의 천공을 위한 장치 및 혈관 접근 시스템
US14/902,295 US20160235959A1 (en) 2013-08-29 2013-08-29 Device for puncturing heparin cap and vascular access system
PCT/CN2013/082549 WO2015027427A1 (zh) 2013-08-29 2013-08-29 一种用于穿刺肝素帽的设备及血管通路***

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2013/082549 WO2015027427A1 (zh) 2013-08-29 2013-08-29 一种用于穿刺肝素帽的设备及血管通路***

Publications (1)

Publication Number Publication Date
WO2015027427A1 true WO2015027427A1 (zh) 2015-03-05

Family

ID=52585404

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2013/082549 WO2015027427A1 (zh) 2013-08-29 2013-08-29 一种用于穿刺肝素帽的设备及血管通路***

Country Status (6)

Country Link
US (1) US20160235959A1 (zh)
KR (1) KR20160022368A (zh)
CN (1) CN105492065A (zh)
DE (1) DE112013007370T5 (zh)
RU (1) RU2651076C2 (zh)
WO (1) WO2015027427A1 (zh)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3103105A1 (en) * 2018-07-31 2020-02-06 Amgen Inc. Fluid path assembly for a drug delivery device
CN109876235A (zh) * 2019-03-20 2019-06-14 嘉兴市第一医院 可拆解输液管连接头
CN110448311A (zh) * 2019-06-12 2019-11-15 广州医科大学附属第一医院（广州呼吸中心） 一种留置针采血接头
CN115006713B (zh) * 2022-05-31 2023-09-29 苏州市第九人民医院 一种心包置管与引流袋之间的快速连接交换器

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6446470A (en) * 1988-01-26 1989-02-20 Haruo Yoshida Syringe equipped with needle cover and lid of container equipped with rubber cap
US5961493A (en) * 1998-06-03 1999-10-05 Liu; Wen-Neng Automatic safety infusion catheter needle
CN201516072U (zh) * 2009-09-02 2010-06-30 邹胜伟 一种改进的颅内血肿穿刺粉碎针和带顶孔的盖
CN201768251U (zh) * 2010-01-13 2011-03-23 忽新刚 急救用快速引导深静脉穿刺套件
CN201855476U (zh) * 2010-06-07 2011-06-08 陈维勇 输液针护套
CN202682524U (zh) * 2012-03-02 2013-01-23 碧迪控股有限公司 导管和引入针组件
CN103007385A (zh) * 2013-01-05 2013-04-03 广州阳普医疗科技股份有限公司 一种安全型留置针以及屏蔽帽
CN203043329U (zh) * 2013-01-28 2013-07-10 山东威高集团医用高分子制品股份有限公司 一种静脉留置针与静脉输液针快速连接装置

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2625810B1 (fr) * 1988-01-08 1990-12-21 Allflex Europ Sa Dispositif de prelevement de liquides a usage unique
CA1330412C (en) * 1988-07-08 1994-06-28 Steven C. Jepson Pre-slit injection site and tapered cannula
CA2001732A1 (en) * 1988-10-31 1990-04-30 Lawrence A. Lynn Intravenous line coupling device
SE467442B (sv) * 1990-09-17 1992-07-20 Anders Trell C O Apoteket Engaangshylsa foer venoes provtagning enligt vakuumroersmetodiken
US6245056B1 (en) * 1999-02-12 2001-06-12 Jack M. Walker Safe intravenous infusion port injectors
EP1266618B1 (en) * 2001-06-11 2005-12-14 Long-Hsiung Chen Safety vacuum syringe for blood sampling conformed to ergonomics

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6446470A (en) * 1988-01-26 1989-02-20 Haruo Yoshida Syringe equipped with needle cover and lid of container equipped with rubber cap
US5961493A (en) * 1998-06-03 1999-10-05 Liu; Wen-Neng Automatic safety infusion catheter needle
CN201516072U (zh) * 2009-09-02 2010-06-30 邹胜伟 一种改进的颅内血肿穿刺粉碎针和带顶孔的盖
CN201768251U (zh) * 2010-01-13 2011-03-23 忽新刚 急救用快速引导深静脉穿刺套件
CN201855476U (zh) * 2010-06-07 2011-06-08 陈维勇 输液针护套
CN202682524U (zh) * 2012-03-02 2013-01-23 碧迪控股有限公司 导管和引入针组件
CN103007385A (zh) * 2013-01-05 2013-04-03 广州阳普医疗科技股份有限公司 一种安全型留置针以及屏蔽帽
CN203043329U (zh) * 2013-01-28 2013-07-10 山东威高集团医用高分子制品股份有限公司 一种静脉留置针与静脉输液针快速连接装置

Also Published As

Publication number Publication date
CN105492065A (zh) 2016-04-13
KR20160022368A (ko) 2016-02-29
US20160235959A1 (en) 2016-08-18
RU2651076C2 (ru) 2018-04-18
DE112013007370T5 (de) 2016-05-12
RU2016101676A (ru) 2017-07-26

Similar Documents

Publication Publication Date Title
US11969247B2 (en) Extension housing a probe or intravenous catheter
EP3222310B1 (en) Syringe for sequential expression of different liquids
US8657788B2 (en) Infusion set
US7309326B2 (en) Infusion set
WO2015027427A1 (zh) 一种用于穿刺肝素帽的设备及血管通路***
JP4013248B2 (ja) 混注具
CN207856028U (zh) 一种穿刺针防护装置和套管针
CN204170209U (zh) 密闭式留置针
JP2005027991A (ja) 留置輸液器具
EP1315530B1 (en) An infusion and infusion/sampling device for blood circuits outside the body
JPH08206230A (ja) 輸液用ニードルレス混注管
TWM559182U (zh) 安全留置針
US20130090589A1 (en) Transfusion tube and transfusion tube set
KR20230135460A (ko) 정맥 카테터
JP2023530656A (ja) カテーテルベントアセンブリおよび関連するシステムおよび方法
JP4847647B2 (ja) コネクタおよび留置針組立体
TWM531287U (zh) 留置針之改良(二)

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: 201380068611.3

Country of ref document: CN

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 13892323

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 14902295

Country of ref document: US

ENP Entry into the national phase

Ref document number: 20167001595

Country of ref document: KR

Kind code of ref document: A

Ref document number: 2016101676

Country of ref document: RU

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 112013007370

Country of ref document: DE

Ref document number: 1120130073706

Country of ref document: DE

122 Ep: pct application non-entry in european phase

Ref document number: 13892323

Country of ref document: EP

Kind code of ref document: A1