WO2016206624A1 - 用于留置针的安全机构以及带有该安全机构的留置针 - Google Patents

用于留置针的安全机构以及带有该安全机构的留置针 Download PDF

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Publication number
WO2016206624A1
WO2016206624A1 PCT/CN2016/087002 CN2016087002W WO2016206624A1 WO 2016206624 A1 WO2016206624 A1 WO 2016206624A1 CN 2016087002 W CN2016087002 W CN 2016087002W WO 2016206624 A1 WO2016206624 A1 WO 2016206624A1
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WO
WIPO (PCT)
Prior art keywords
arm
button
handle
indwelling needle
hub
Prior art date
Application number
PCT/CN2016/087002
Other languages
English (en)
French (fr)
Inventor
林作钱
Original Assignee
千禧光医疗有限公司
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 千禧光医疗有限公司 filed Critical 千禧光医疗有限公司
Priority to EP16813740.4A priority Critical patent/EP3315152A4/en
Priority to JP2017564368A priority patent/JP6789249B2/ja
Priority to US15/580,461 priority patent/US10773018B2/en
Publication of WO2016206624A1 publication Critical patent/WO2016206624A1/zh

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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
    • 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
    • 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
    • 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
    • A61M2005/1585—Needle inserters
    • 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
    • A61M2005/1586—Holding accessories for holding infusion needles on the body
    • 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A61M2005/3241—Needle retraction energy is accumulated inside of a hollow plunger rod
    • A61M2005/3242—Needle retraction by vacuum
    • 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
    • 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

Definitions

  • the utility model relates to a safety mechanism for an indwelling needle and an indwelling needle with the safety mechanism.
  • venous indwelling needles also known as venous trocars
  • existing indwelling needles typically include a puncture needle and a catheter that can be placed in the blood vessel. During use, the catheter is inserted into the blood vessel along with the puncture needle. When the catheter is fully inserted into the blood vessel, the puncture needle is retracted, and only the catheter is placed in the blood vessel for subsequent treatment.
  • the positioning of the indwelling needle is very important during use. After the puncture needle penetrates the patient's blood vessel, the patient's blood pressure will cause a small amount of blood to flow into the hollow puncture needle. When the user observes a small amount of blood at the back of the puncture needle, it can be determined that the indwelling needle is positioned and the puncture needle can be retracted. . But a bloody needle can pose a lot of risks to health care workers and other people who may be exposed to medical waste, such as infectious diseases.
  • the utility model provides a safety mechanism for an indwelling needle and an indwelling needle with the safety mechanism, which can safely retract the puncture needle after the catheter and the puncture needle of the indwelling needle are properly penetrated into the blood vessel. Avoid user contact with used puncture again
  • the needle has high safety, simple structure and cost-effectiveness.
  • a safety mechanism for an indwelling needle comprising a hollow handle and a needle hub at least partially located within the handle for receiving a puncture needle
  • the safety mechanism comprising: a card holder on the inner side of the hollow handle; at least one elastic arm disposed radially outwardly on the needle seat, the end portion of the elastic arm having a radially outwardly protruding engaging portion, the engaging portion being used for Engaging with the card; a button disposed on the distal portion of the handle, the button pressing the resilient arm in a radially inward direction when the button is depressed, such that the engaging portion of the resilient arm disengages from the card
  • the needle seat and the puncture needle extending outside the handle are retracted into the hollow handle.
  • the card table is disposed on an inner wall of the distal portion of the hollow handle, the resilient arms being flared radially outwardly and extending from a proximal side of the hub to a distal direction.
  • the button includes a pressing portion and at least one pressing arm extending radially from the pressing portion, the end of the pressing arm having a thickened portion, which is pressed when the button is not pressed
  • the arm extends into the gap between the main body of the needle seat and the elastic arm that is radially outwardly opened from the main body, and the elastic arm is pressed against the card table by the thickened portion, and the pressing arm is increased after the button is pressed down.
  • the thick portion extends beyond the gap and no longer presses the resilient arm radially outward.
  • the button further includes at least one driving arm extending radially from the pressing portion, the driving arm having an inclined end and disposed outside the pressing arm when the button is not pressed
  • the drive arm is located outside but not in contact with the end of the resilient arm.
  • the width of the end of the resilient arm is less than the width of the body portion of the resilient arm.
  • the button has at least one drive arm extending in a radial direction, the drive arm having an inclined end and disposed on an outer side of the resilient arm, the tilt of the drive arm after the button is depressed The inclined side of the end gradually squeezes the ball radially inward Sexual arm.
  • the resilient arms are two and the drive arms are one or two.
  • the card table is disposed on an inner wall of a distal portion of the hollow handle, the resilient arms being flared radially outwardly and extending from a distal side of the hub to a proximal direction.
  • the button has at least one drive arm extending in a radial direction, the drive arm having an inclined end and disposed on an outer side of the resilient arm, the tilt of the drive arm after the button is depressed The inclined side of the end gradually presses the resilient arm radially inward.
  • the drive arms are two.
  • the hollow handle includes a cylindrical ferrule disposed therein, an edge of the ferrule extending to a distal portion of the handle and an edge formed as the card table, the resilient arm radial Open outward and extend from the distal side of the hub to the proximal direction.
  • the button is formed by a sidewall of the distal portion of the handle that pushes the engagement portion of the resilient arm away from the edge of the ferrule when the lower button is depressed.
  • the distal portion of the hollow handle and the hub are made of a transparent material.
  • an indwelling needle comprising:
  • a hub that is at least partially located within the handle
  • the security mechanism comprising:
  • a card table disposed on the handle; at least one elastic arm disposed on the needle seat and extending radially outwardly, the end portion of the elastic arm having a radially outwardly protruding engaging portion, the engaging portion For engaging with the card; a button is disposed on the distal portion of the handle, and when the button is pressed, the button will push the elastic arm in a radially inward direction, such that the engaging portion and the card of the elastic arm Disengaged while relying on the true inside the hollow handle The suction force causes the puncture needle extending out of the handle to retract into the hollow handle.
  • a vacuum sealing plug is disposed between the base of the hub and the interior of the hollow handle to create a vacuum within the handle.
  • a vacuum sealing plug is disposed between the base of the hub and the inner cavity of the ferrule of the hollow handle to create a vacuum within the ferrule of the handle.
  • the concept is ingenious and the safety is high.
  • the indwelling needle with the safety mechanism according to the present invention is not only safe, but also simple and convenient to operate, and can effectively prevent the indwelling needle from causing damage to the user or any contact person during use and after use.
  • 1A and 1B are perspective views of unused indwelling needles viewed from different directions in accordance with a first embodiment of the present invention.
  • 1C to 1G illustrate a use process of an indwelling needle according to a first embodiment of the present invention.
  • FIGS. 1A and 1B are longitudinal cross-sectional views of the indwelling needle of the first embodiment shown in Figs. 1A and 1B along different cross sections.
  • 3A and 3B are a perspective view and a longitudinal cross-sectional view, respectively, of the protective cover of the indwelling needle of the first embodiment shown in Figs. 1A and 1B.
  • FIGS. 4A, 4B, 4C, and 4D are a perspective view of a needle holder of the indwelling needle of the first embodiment shown in Figs. 1A and 1B, respectively, and a longitudinal cross-sectional view taken from a different cross section.
  • FIGS. 5A and 5B are perspective views, respectively, of different directions of the distal portion of the handle of the indwelling needle of the first embodiment shown in Figs. 1A and 1B.
  • 6A, 6B, and 6C are a perspective view and a plan view, respectively, of the button of the indwelling needle of the first embodiment shown in Figs. 1A and 1B.
  • Figure 7 is a cross-sectional view of the vacuum sealing plug of the indwelling needle of the first embodiment shown in Figures 1A and 1B.
  • 8A, 8B, 8C, 8D, and 8E are the different directions of the catheter and catheter hub assembly of the indwelling needle of the first embodiment shown in Figs. 1A and 1B, respectively.
  • 9A, 9B, and 9C are the buttons of the first embodiment of the first embodiment shown in FIGS. 1A and 1B, respectively, after the catheter is inserted into the blood vessel after use, and the button of the safety mechanism has not been pressed after pushing the catheter and the catheter hub assembly distally.
  • 10A, 10B, 10C, 10D, 10E, 10F, 10G, and 10H are the indwelling needles of the first embodiment shown in Figs. 1A and 1B, respectively, which are inserted into the blood vessel and are distally inserted during use.
  • 11A and 11B are perspective views of unused indwelling needles viewed from different directions in accordance with a second embodiment of the present invention.
  • FIGS. 12A and 12B are longitudinal cross-sectional views of the indwelling needle of the second embodiment shown in Figs. 11A and 11B taken along different cross sections.
  • FIGS. 11A and 11B are a perspective view and a cross-sectional view, respectively, of the protective cover of the indwelling needle of the second embodiment shown in Figs. 11A and 11B.
  • 14A, 14B, 14C, and 14D are a perspective view of a needle holder of the indwelling needle of the second embodiment shown in Figs. 11A and 11B, respectively, and a longitudinal cross-sectional view taken from a different cross section.
  • 15A, 15B, 15C, 15D, and 15E are a perspective view of the base of the indwelling needle of the second embodiment shown in Figs. 11A and 11B, respectively, and a cross-sectional view taken from a different direction.
  • FIG. 17A and 17B are perspective views of the distal portion of the handle of the indwelling needle of the second embodiment shown in Figs. 11A and 11B, respectively.
  • FIGS. 18A, 18B, 18C, 18D, 18E and 18F are diagrams showing a state of use of the indwelling needle of the second embodiment shown in Figs. 11A and 11B, wherein Fig. 18A shows that the protective sleeve has not been removed.
  • the indwelling needle, Fig. 18B is the indwelling needle from which the protective sheath has been removed
  • Fig. 18C is the indwelling needle that pushes the catheter and the catheter hub assembly distally
  • Fig. 18D is the indwelling needle that presses the button of the lower safety mechanism
  • Figs. 18E and 18F are respectively Puncture needle
  • the indwelling needle is retracting and retracting.
  • FIGS. 19A and 19B are views showing the interaction between the driving arm of the button and the elastic arm of the needle holder when the button of the indwelling needle of the second embodiment shown in Figs. 11A and 11B is pressed.
  • FIG. 20 is a perspective view of an indwelling needle that has not been used but has been removed from the protective cover in accordance with a third embodiment of the present invention.
  • 21A and 21B are longitudinal cross-sectional views of unused indwelling needles cut from different cross-sections in accordance with a third embodiment of the present invention.
  • 22A, 22B, and 22C are respectively a perspective view of a needle holder of the indwelling needle of the third embodiment shown in Fig. 20, and a longitudinal cross-sectional view taken from a different side.
  • 23A and 23B are perspective views of the distal portion of the handle of the indwelling needle of the third embodiment shown in Fig. 20, respectively.
  • Fig. 24 is a cross-sectional view showing the hub base of the indwelling needle of the third embodiment shown in Fig. 20;
  • Figure 25 is a partial enlarged view of Figure 21A showing the mating relationship between the button, the resilient arm of the hub and the ferrule when the safety mechanism is not activated.
  • Fig. 26 is a cross-sectional view showing the puncture needle of the indwelling needle of the third embodiment shown in Fig. 20 retracted into the handle after pressing the button.
  • 27A, 27B, and 27C are cross-sectional views, a needle base, and an O-ring seal, respectively, of a fourth embodiment of the indwelling needle, in accordance with a fourth embodiment of the present invention.
  • proximal refers to the side of the medical device that is close to the operator
  • distal refers to the side of the medical device that is remote from the operator
  • upper,Bottom, “left”, and “right” are relative to the longitudinal axis of the instrument, as indicated with respect to the drawings. Further, the same components are denoted by the same reference numerals.
  • FIGS. 1A and 1B are perspective views of an unused indwelling needle 10 viewed obliquely from above and obliquely downward, in accordance with a first embodiment of the present invention.
  • 2A and 2B are longitudinal cross-sectional views of the indwelling needle 10 of the first embodiment shown in Figs. 1A and 1B, taken along different cross sections.
  • the indwelling needle 10 has a longitudinal axis X-X (as shown in Figures 2A and 2B).
  • the indwelling needle 10 includes: a hollow handle 20; a needle and hub assembly 30 at least partially within the handle 20; a catheter and catheter hub assembly 80 located distally of the handle 20 and surrounding a portion of the needle and hub assembly 30; Safety agency 100.
  • the indwelling needle 10 further includes a protective sheath 11 at the distal end of the indwelling needle for preventing the unused indwelling needle from stabbing the contact.
  • FIG. 1C-1G illustrate the use of the indwelling needle 10 in accordance with the present invention.
  • the protective cover 11 is first removed from the indwelling needle 10, and the puncture needle of the indwelling needle 10 is inserted into the blood vessel (see Figs. 1C and 1D).
  • the catheter and catheter hub assembly 80 is advanced distally (as shown in Figure 1E). After the catheter is in place, the catheter and the tabs of the catheter hub assembly 80 are held with one hand and the other hand is pressed against the safety mechanism 100 (see Figure 1F).
  • the button of the safety mechanism 100 disengages the needle and hub assembly 30 from the catheter and catheter hub assembly 80, and the puncture needle is retracted into the lumen of the handle 20 by the vacuum within the hollow handle 20, thereby preventing the user from The puncture needle used is stabbed to improve safety.
  • the specific structure and joining manner and the manner of use of the components of the indwelling needle 10 will be described in detail below.
  • the hollow handle 20 has a lumen 21, a proximal portion 22 and a distal portion 23.
  • the proximal portion 22 of the handle 20 is generally cylindrical, with the proximal end of the barrel closed and the distal end open for engagement with the distal portion 23 of the handle 20.
  • 5A and 5B are perspective views of the distal portion 23 of the handle 20 of the indwelling needle of the first embodiment shown in Figs. 1A and 1B, respectively, as seen from different directions.
  • the distal portion 23 of the handle 20 has an open proximal end 24 for engaging the open distal end of the proximal portion 22.
  • the distal end 25 of the distal portion 23 is closed and the distal end 25 has a flower aperture 26.
  • the so-called flower The hole is formed with a plurality of notches 26a on the circumference of a common circular hole.
  • the shape of the flower hole 26 is not limited thereto as long as it is fitted with a corresponding portion of the needle holder (which will be described in detail later).
  • the side wall of the distal portion 23 has a button aperture 27 for receiving a button 110 of the safety mechanism 100.
  • the inner wall of the distal portion 23 has an inwardly projecting card table 28 (see Figs. 9B and 10C) for engaging the resilient arms of the hub, as will be described in detail later.
  • an end surface of the distal end 25 of the distal portion 23 of the handle 20 (i.e., on the end surface on which the flower aperture 26 is formed) is also formed with a distally extending projection 29 (see figure). 5A, FIG. 9A, FIG. 9B, FIG. 10B, and FIG. 10C).
  • the needle and hub assembly 30 includes a puncture needle 31 and a needle hub 32.
  • the puncture needle 31 is hollow and has a sharp distal end for puncturing the patient's skin.
  • the proximal end of the puncture needle 31 is fixed to the distal end of the needle hub 32.
  • 4A, 4B, 4C, and 4D are a perspective view of a needle holder of the indwelling needle of the first embodiment shown in Figs. 1A and 1B, respectively, and a longitudinal cross-sectional view taken from a different cross section.
  • the hub 32 is a hub body of a generally hollow cylinder having a base 38 on the proximal side of the hub body, a reduced diameter portion 33 on the distal side of the hub body, and a hub
  • the body also has a resilient arm 35 that flares radially outward.
  • Two resilient arms 35 are shown, but those skilled in the art will appreciate that the number of resilient arms 35 can also be one or more than two, as long as it can be mated with a corresponding portion of the handle 20, and the hub 32
  • the cylinder of the hub body is preferably a cylinder, but may be other prisms.
  • a plurality of ribs or ribs 33a are provided around the reduced diameter portion 33 of the hub 32, and the number of ribs or ribs 33a corresponds to the number of the notches 26a of the flower hole 26 or less than the number of the notches 26a. .
  • the reduced diameter portion 33 is formed with a shoulder 34 with respect to other portions of the hub body.
  • the base 38 of the hub 32 is two flanges 39 and 40 that extend radially from the body of the hub.
  • the flanges 39 and 40 are sized to fit within the handle 20, and while Figures 4A and 4B show that the diameter of the flange 39 is greater than the diameter of the flange 40, those skilled in the art will appreciate that for two projections
  • the relative diameter relationship of the rims 39, 40 is not limited, and the diameter of the flange 39 may be smaller than the diameter of the flange 40.
  • the flange 40 may form a slope 40a on the bottom side to facilitate assembly of the vacuum sealing plug 120 (See Figures 2A, 2B, and 7).
  • the resilient arms 35 of the hub 32 are flared radially outward from the hub body and leave sufficient clearance 50 between the resilient arms 35 and the hub body.
  • the formation of the void 50 may be because the wall thickness of the hub body is thinned here to form a large gap 50 with the elastic arm (as shown in FIGS. 4B and 4C). This is because the elastic arms 35 are flared outwardly to a sufficient size. As shown in Figures 4A and 4B, the resilient arms 35 are radially outwardly flared from the hub body and extend from the proximal to the distal direction, having a radially outwardly convex shape on the distal side of the resilient arms.
  • the engaging portion 36 has a tip 37 at the end.
  • the tip 37 shown in the figure is a rounded small protrusion.
  • the tip 37 can also be trapezoidal or the like.
  • the width of the tip 37 is smaller than the width of the arm body of the resilient arm 35. As will be described later, this facilitates the faster passage of the squeeze arms of the buttons of the security mechanism 100 through the gaps 50.
  • the hub 32 is hollow with a lumen therethrough.
  • 4C and 4D show that the lumen of the hub 32 is divided into segments, wherein the distal segment lumen 45 at the reduced diameter portion 33 of the hub 32 is used to receive and secure the puncture needle 31, whereby the hollow needle
  • the lumen of 31 is in communication with the midsection lumen 46 and the proximal section lumen 47 of the hub 32 such that blood can flow into the midsection lumen 46 and the proximal section lumen 47 of the hub 32 after the needle 31 has penetrated into the vessel.
  • the proximal end of the hub 32 i.e., the side of the base 38, is blocked by a plug 48 (see Figures 2A and 2B) to prevent blood from flowing out.
  • the reduced diameter portion 33 of the hub 32 passes through the flower hole 26 in the distal end 25 of the distal portion 23 of the handle, the rib of the reduced diameter portion 33 or The ribs 33a extend into the corresponding notches 26a of the flower holes 26, thereby preventing the needle holder 32 from rotating.
  • the needle holder 32 can be caught at the flower hole 26, preventing the needle holder 32 from excessively protruding to Outside the handle 20.
  • the base 38 of the hub 32 engages the vacuum sealing plug 120.
  • the vacuum sealing plug 120 is a conventional sealing plug.
  • the vacuum sealing plug 120 For assembly with the base 38, as shown in FIG. 7, the vacuum sealing plug 120 has a substantially bowl shape, and its outer diameter is interference-fitted with the inner diameter of the inner cavity 21 of the handle 20 (see FIG. 9B). And FIG. 10C) to create a vacuum within the interior 21 of the handle 20.
  • the vacuum sealing plug 120 has a lumen 121 And a protrusion 122 projecting inwardly from the bowl-shaped inner bowl portion for snapping onto the flange 40.
  • a slope 123 may be formed on the upper side of the protrusion 122.
  • the catheter and catheter hub assembly 80 includes a catheter 81 and a catheter hub 82.
  • the catheter 81 includes a catheter body 81a, a tapered portion 81b at the distal end of the catheter body 81a, and a catheter lumen 81c therethrough.
  • the catheter hub 82 includes a cylindrical catheter hub body 83. At the distal end of the cylindrical catheter hub body 83 there is a radially reduced cylindrical catheter receiving portion 84 extending distally for receiving the proximal portion of the catheter 81.
  • a projection 86 is provided on one side or upper side of the catheter hub body 83 or away from the patient's skin side during use so that the user can push the catheter and catheter hub assembly 80 distally during use.
  • a flap 85 is provided on the opposite side of the projection 86 or on the skin side of the patient in use, and when the catheter and catheter hub assembly 80 are in place, the user can press the flap 85 with one hand to hold the catheter and catheter hub assembly Position 80, while pressing the safety mechanism 100 with the other hand to retract the puncture needle 31; furthermore, after the indwelling needle has been placed, the flap 85 can be passed through the medical tape (thereby making the catheter and catheter hub assembly) Adhere to the patient's skin.
  • the catheter and catheter hub assembly 80 is assembled with the handle 20 and the needle and hub assembly 30, the proximal end face of the catheter hub body 83 mates with the end face of the distal end 25 of the distal portion 23 of the handle 20, the hub 32 The reduced diameter portion 33 extends through the flower aperture 26 in the distal end 25 of the distal portion 23 of the handle and extends into the lumen 89 of the cylindrical catheter hub body 83.
  • the diameter of the needle 31 is reduced from the diameter of the needle hub 32.
  • the portion 33 extends out into the catheter hub 82 and through the catheter lumen 81c of the catheter 81, and the sharp end of the puncture needle 31 projects from the tapered end 81b of the catheter 81 while the position of the notch 88 is aligned with the distal end of the handle 20.
  • the projection 29 on the end face of the distal end 25 of the side portion 23 thereby prevents rotation of the catheter and catheter hub assembly 80 relative to the handle 20 by the engagement of the notch 88 and the projection 29, while determining the relative position between the portions.
  • notch 88 is a notch occupying a quarter of a circumference, it will be understood by those skilled in the art that the size of the notch 88 is not limited thereto as long as it can be end face with the distal end 25 of the distal portion 23 of the handle 20. On The protrusions cooperate to prevent the catheter and catheter hub assembly 80 from rotating.
  • the assembled connection relationship between the distal portion 23 of the handle 20 and the catheter and catheter hub assembly 80 is not limited thereto.
  • An additional aperture may be formed in the distal end 25 of the distal portion 23 of the handle 20, and a proximal end surface of the catheter hub body 83 is formed with a protrusion, the distal portion 23 of the handle 20 being conduitd through the engagement of the aperture and the projection Connected to the catheter hub assembly 80, it is not rotatable but can be moved relative to each other in the longitudinal direction by pushing the projections 86 on the catheter hub 82.
  • 3A and 3B show the protective cover 11 of the indwelling needle 10 of the present invention.
  • the shape of the protective sheath 11 generally conforms to the shape of the distal portion of the indwelling needle 10 (or the distal portion of the handle 20 and the catheter and catheter hub assembly).
  • the protective sheath 11 is shown to include a small cylindrical portion 12, a large cylindrical portion 14 and a tapered transition portion 13 therebetween. There may be a pattern 12a on the outer side surface of the small cylindrical portion 12 to facilitate gripping when the protective cover 11 is removed.
  • the large cylindrical portion 14 and the tapered transition portion 13 remove a portion of the underside for ease of nesting to the distal portion of the indwelling needle while leaving a slit 15 at the tapered transition portion 13 for snapping into the catheter and catheter hub assembly 80 on the flap 85. It is also conceivable by those skilled in the art to configure the protective cover in other ways as long as the puncture needle of the unused indwelling needle can be prevented from stabbing the contact person.
  • the safety mechanism 100 includes a card table 28 disposed on an inner side wall of the distal portion 23 of the hollow handle 20; at least one elastic portion radially outwardly disposed on the needle seat 32
  • the arm 35, the end portion of the resilient arm has a convex engaging portion 36 for engaging with the card table 28; the button 110 is disposed on the distal portion 23 of the handle 20 when the button 110 is depressed The button 110 will urge the resilient arm 35 in a radially inward direction such that the latching portion 36 of the resilient arm 35 disengages from the card post 28.
  • FIGS. 6A-6C are a perspective view and a plan view, respectively, of the button 110 of the indwelling needle 10 of the first embodiment shown in Figs. 1A and 1B.
  • the button 110 according to the present invention includes a pressing portion 111 and at least one pressing arm 112 extending from the pressing portion 111 in the radial direction (ie, the radial direction of the handle 20).
  • the number of the pressing arms 112 is the same as the number of the elastic arms 35 of the needle holder 32 so as to cooperate with each other to enhance safety.
  • the button 110 includes two squeeze arms 112. The end of each of the squeeze arms 112 has a thickened portion 113.
  • the button 110 also includes at least one drive arm 114 that extends radially from the pressing portion 111 (ie, the radial direction of the handle 20).
  • the number of the driving arms 114 is at least one, and may be less than or equal to the number of the elastic arms 35 of the needle holder 32 so as to cooperate with each other.
  • the button 110 includes two drive arms 114, and the drive arm 114 is located outside of the squeeze arm 112.
  • the drive arm 114 has an angled end 115. When the button 110 is depressed, the drive arm 114 will urge the resilient arm 35 in a radially inward direction to disengage the resilient arm 35 from engagement with the card 28.
  • the drive arm 114 disengages the resilient arm 35 from engagement with the card 28 and the squeeze arm 112 is used to press the resilient arm 35 further against the card 28, Therefore, in some embodiments, the button may be provided with no pressing arm, but only the driving arm, and the elastic arm is pressed against the card by its own elastic force.
  • 9A, 9B, and 9C show the cooperative relationship between the button and other members in the case where the safety mechanism of the indwelling needle of the first embodiment is not depressed.
  • 10A to 10H show the cooperative relationship between the button and other members in the case where the safety mechanism of the indwelling needle of the first embodiment is just pressed.
  • FIG. 9B is an enlarged view of a portion inside the two-dot chain line frame of FIG. 9A
  • FIG. 9C is a cross-sectional view taken along line 9AA-9AA of FIG. 9B.
  • the thickened portion 113 at the end pushes the resilient arm 35 radially outward, thereby causing the radially outwardly projecting engagement portion 36 of the resilient arm 35 to snap onto the inner wall of the distal portion 23 of the handle 20.
  • the card is at 28.
  • the driving arm 114 is located outside the elastic arm 35 (see FIGS. 9B and 9C) and has not been in contact with the elastic arm 35. Due to the pushing of the thickened portion 113 of the end of the pressing arm 112 and the elasticity of the elastic arm 35 itself, the elastic arm 35 firmly abuts against the card table 28, thereby the needle and the needle The seat assembly 30 remains in this position and the puncture needle 31 extends beyond the catheter 81.
  • FIGS. 10C, 10D, 10E, and 10F show in detail the relationship between the resilient arm 35, the distal portion 23 of the handle 20, and the button 110 just after the button 110 has been depressed. Where only a portion of the button 110 is shown in FIG.
  • a portion of the drive arm 114 is removed to show the rearwardly squeezed arm 112, and a portion of the upper portion of the squeeze arm 112 is removed for clear display and the end of the resilient arm 35. 37 relationship.
  • Fig. 10F is the same as that shown in Fig. 10E except that it is viewed from the other side. As shown in FIGS. 10C to 10F, after the button 110 is pressed, the pressing arm 112 of the button 110 moves forward, and the thickened portion 113 that previously abuts against the elastic arm 35 moves through the gap 50 to the end of the elastic arm 35.
  • the thickness of the end 37 of the resilient arm 35 is smaller than the width of the body portion of the resilient arm 35 to facilitate the thickening of the portion 113 through the gap 50
  • the elastic arm 35 is no longer pressed radially outward to the card table 28, and the elastic arm 35 is inwardly elasticized due to its own elasticity. Back, off the deck 28.
  • both the pressing arm 112 and the driving arm 114 are moved forward, and the inclined end portion 115 of the driving arm 114 is brought close to the elastic arm.
  • the end 37 of the 35, the inclined side of the inclined end 115 gradually urges the resilient arm 35 to move radially inwardly, thereby assisting the engagement portion 36 of the resilient arm 35 from disengaging from the card 28. Since the resilient arm 35 is disengaged from the distal portion 23 of the handle 20 and the interior of the handle 20 is vacuumed, the needle and hub assembly 30 is retracted into the lumen 21 of the handle 20, as shown in Figure 10G and 10H is shown.
  • 11A and 11B are perspective views of an unused indwelling needle 10' viewed from different directions in accordance with a second embodiment of the present invention.
  • 12A and 12B are longitudinal cross-sectional views of the indwelling needle of the second embodiment shown in Figs. 11A and 11B taken along different cross sections.
  • the structure and configuration of the proximal portion of the handle 20', the catheter and catheter hub assembly 80', etc. are the same as those of the first embodiment of the present invention, and the same portion will not Let me repeat. Only different features are described.
  • 13A, 13B, and 13C are a perspective view and a cross-sectional view, respectively, of the protective cover 11' of the indwelling needle 10' of the second embodiment shown in Figs. 11A and 11B.
  • the shape of the protective sheath 11' is also substantially the same as the shape of the distal portion of the indwelling needle 10' (or the distal portion of the handle 20' and the catheter and catheter hub assembly), and the underside of the protective sheath 11' has A portion is removed to fit over the distal portion of the indwelling needle 10' and a slit 15' is left over the protective sheath 11' for snapping onto the tab 85' of the catheter and catheter hub assembly 80'.
  • the distal portion of the handle of the indwelling needle of the second embodiment, the needle hub, and the button of the safety mechanism are specifically described below.
  • 14A, 14B, 14C, and 14D are a perspective view of the needle hub 32' of the indwelling needle 10' of the second embodiment shown in Figs. 11A and 11B, respectively, and a longitudinal cross-sectional view taken from a different direction.
  • the hub 32' also has a hub body having a generally hollow cylinder having a reduced diameter portion 33' on the distal side of the hub body, and the hub body also has a resilient arm that flares radially outwardly. 35'.
  • the number of resilient arms 35' may also be one or more than two, as long as it can be mated with a corresponding portion of the handle 20', and
  • the cylinder of the hub body of the hub 32' is preferably a cylinder, but may be other prisms.
  • a plurality of ribs or ribs 33a' are provided around the reduced diameter portion 33' of the hub 32', and the number of ribs or ribs 33a' corresponds to the notch 26a' of the flower hole 26' or Less than the number of notches 26a'.
  • the reduced diameter portion 33' is formed with a shoulder 34' with respect to the hub body.
  • the resilient arms 35' of the hub 32' are flared radially outward from the hub body and leave sufficient clearance 50' between the resilient arms 35' and the hub body. It will be understood by those skilled in the art that the formation of the void may be because the elastic arm 35' is flared outwardly, as shown in FIGS.
  • the thinning is made to form a large gap with the elastic arm.
  • the resilient arm 35' is radially outwardly flared from the hub body and extends from the distal to the proximal direction, having a latching portion 36' on the distal side of the resilient arm, the latching portion 36' having a radially outward direction Protrusion 37'. Further, at the proximal end of the hub 32', there is an engaging piece 47' on one side of the hub body.
  • the hub 32' is hollow with a lumen therethrough.
  • the penetrating lumen is divided into two segments, wherein the distal segment lumen 45' at the reduced diameter portion 33' of the hub 32' is adapted to receive and secure the puncture needle 31', whereby the hollow needle 31'
  • the lumen communicates with the proximal section lumen 46' of the hub 32' such that blood can flow into the proximal section lumen 46' of the hub 32' after the needle 31' has been punctured into the vessel, prompting the user .
  • 15A, 15B, 15C, 15D, and 15E are perspective views of the base 38' of the hub 32' of the indwelling needle 10' of the second embodiment shown in Figs. 11A and 11B, respectively, and from different cross sections. Cut longitudinal section view.
  • the base 38' includes an upper disc 39', a lower disc 40', and a cylindrical section 41' connecting the upper disc 39' and the lower disc 40'.
  • a plunger 43' is eccentrically disposed on the upper surface of the upper disc 39', and at least one engaging piece 42' is also provided, and two engaging pieces 42' are shown.
  • the lower disc 40' may be provided with an inclined portion 40a' to facilitate assembly with a vacuum sealing plug.
  • a reinforcing rib or rib 44' may be provided on the lower surface of the upper disc 39'.
  • the plunger 43' blocks the proximal end of the lumen of the hub 32', preventing flow into the hub. Blood leaks within the proximal segment lumen 46' of 32'.
  • the engaging piece 47' of the hub body of the hub 32' and the engaging piece 42' of the upper disc 39' of the base 38' are engaged with each other, preventing the hub body of the hub 32' from being opposite to the base 38' motion.
  • the safety mechanism 100' includes a card table 28' disposed on the inner side wall of the distal portion 23' of the hollow handle 20'; at least one elastically disposed radially outwardly of the needle seat 32'
  • the arm 35', the end portion of the resilient arm has a convex engaging portion 36' for engaging the card table 28';
  • the button 110' is disposed at the distal portion 23' of the handle 20' Above, when the button 110' is depressed, the button 110' will push the resilient arm 35' radially inwardly such that the engaging portion 36' of the resilient arm 35' disengages from the card post 28'.
  • buttons 16A and 16B are perspective views of the button 110' of the indwelling needle 10' of the second embodiment shown in Figs. 11A and 11B, respectively.
  • the button 110' according to the present invention includes a curved sheet-like pressing portion 111' and at least one driving arm 114' extending from a lower portion of the pressing portion 111'.
  • the number of the driving arms 114' and the number of the elastic arms 35 of the hub 32 are Consistent so that they work together.
  • button 110' includes two drive arms 114' and drive arm 114' has an angled end 115'.
  • the pressing portion 111' of the button 110' also has an engaging portion 112' for engaging with the receiving portion 25a' of the distal portion 23' of the handle 20'.
  • Two joint portions 112' are shown in the drawing, and one of the joint portions 112' has a positioning protrusion 112a'.
  • the joint can be at least one and can be other shapes as long as the button 110' is engaged to the receiving portion of the distal portion 23' of the handle 20'.
  • FIG. 17A and 17B are perspective views of the distal portion 23' of the handle 20' of the indwelling needle 10' of the second embodiment shown in Figs. 11A and 11B, respectively.
  • the distal portion 23' has an open proximal end 24' for engaging the open distal end of the proximal portion 22'.
  • the distal end 25' of the distal portion 23' has a flower hole 26' formed therein, as shown in Figs. 17A and 17B, a plurality of notches 26a' are formed in the flower hole 26'.
  • the shape of the flower hole 26' is not limited thereto as long as it is engaged with a corresponding portion of the needle holder.
  • the side wall of the distal portion 23' has a button hole 27' for receiving the button 110' of the safety mechanism 100'.
  • the inner wall of the distal portion 23' has an inwardly projecting card post 28' (see Fig. 17A) for engaging the resilient arm 35' of the hub 32'.
  • the distal end of the distal end portion 25' of the distal portion 23' of the handle 20' i.e., the end surface on which the flower aperture 26' is formed
  • a projection 29' is also formed to extend distally.
  • the catheter and catheter hub assembly 80' When the catheter and catheter hub assembly 80' is assembled with the handle 20' and the needle and hub assembly 30', the proximal end face of the catheter hub body 83' and the distal end 25' of the distal portion 23' of the handle 20' The end face fits, the reduced diameter portion 33' of the hub 32' extends through the flower hole 26' in the distal end 25' of the distal portion 23' of the handle and extends into the lumen of the cylindrical catheter hub body 83'.
  • the puncture needle 31' projects from the reduced diameter portion 33' of the hub 32', enters the catheter hub 82' and passes through the catheter lumen 81c' of the catheter 81', and the sharp end of the puncture needle 31' is from the catheter 81.
  • the tapered end 81b' extends while the notch 88' is aligned with the projection 29' on the end face of the distal end 25' of the distal portion 23' of the handle 20', the button 110' being placed distal to the handle 20' In the side portion 23', wherein the pressing portion 111' of the button 110' is fitted into the button hole 27' of the distal portion 23', and the surface of the pressing portion 111' is not pressed when not pressed The two side edges of the distal portion 23' are flush.
  • the engaging portion 36' of the resilient arm 35' of the hub 32' abuts against the card 28' on the inner wall of the distal portion 23'.
  • FIGS. 11A and 11B are diagrams showing a state of use of the indwelling needle of the second embodiment shown in Figs. 11A and 11B, wherein Fig. 18A shows the indwelling needle 10' from which the protective sheath 11' has not been removed, and Fig. 18B has been removed.
  • 18C is the indwelling needle 10' which pushes the catheter and the catheter hub assembly 80' distally
  • Fig. 18D is the indwelling needle 10' which presses the button 110' of the lower safety mechanism 100'.
  • 18E and 18F are the indwelling needles 10' in which the puncture needle 31' is in the retracted state and has been retracted, respectively.
  • 19A and 19B are views showing the interaction between the driving arm of the button and the elastic arm of the needle holder when the button of the indwelling needle of the second embodiment shown in Figs. 11A and 11B is pressed.
  • Figure 20 is a perspective view of an indwelling needle 10" that has not been used but has been removed, in accordance with a third embodiment of the present invention.
  • Figures 21A and 21B are cut from different cross-sections in accordance with a third embodiment of the present invention.
  • the structure and configuration of the proximal portion of the handle 20", the catheter and catheter hub assembly 80", and the like are the same as those of the first and second embodiments of the present invention, and the same portions will not be described again. Only different features are described.
  • the distal portion of the handle of the indwelling needle of the third embodiment, the ferrule of the handle, the needle hub, and the button of the safety mechanism are specifically described below.
  • 22A, 22B, and 22C are a perspective view of the needle hub 32" of the indwelling needle 10" of the third embodiment shown in Fig. 20, respectively, and a longitudinal cross-sectional view taken from a different side.
  • the hub 32" also has a generally hollow cylindrical body for the body of the hub.
  • the distal side has a reduced diameter portion 33"
  • the hub body also has a resilient arm 35" that flares radially outward.
  • the figure shows a resilient arm 35", but those skilled in the art will appreciate that the number of resilient arms 35" may also be one or more than two, as long as it can be mated with a corresponding portion of the handle 20" and the needle
  • the cylinder of the hub body of the seat 32" is preferably a cylinder, but may be other prisms.
  • the diametrically reduced portion 33" of the hub 32" is provided with a plurality of ribs or ribs 33a", the number of ribs or ribs 33a” and the distal end face of the distal portion 23" of the handle 20"
  • the notch 26a" of the upper flower hole 26" corresponds to or is smaller than the number of the notches 26a".
  • the reduced diameter portion 33" is formed with a shoulder 34" with respect to the hub body.
  • the resilient arm 35" of the hub 32" is self-contained The hub body flares radially outwardly and leaves sufficient clearance 50" between the resilient arms 35" and the hub body.
  • the voids may be formed either because the resilient arms 35" are outwardly
  • the opening is large, as shown in Fig. 23A. It may also be because the wall thickness of the hub body is thinned here to form a large gap with the elastic arm.
  • the resilient arm 35" is radially outwardly flared from the hub body and extends from the distal to the proximal direction, having a latching portion 36" on the distal side of the resilient arm, the latching portion 36" having a radially outward direction
  • the raised card table 36a" and the wedge portion 37" extending from the card table 36a" in the longitudinal direction.
  • Figure 24 is a cross-sectional view of the hub base 38" of the indwelling needle 10" of the third embodiment shown in Figure 20 .
  • the base 38" includes an upper disc 39", a lower disc 40", and a cylindrical section 41" connecting the upper disc 39" and the lower disc 40".
  • the upper surface of the upper disc 39" is concentrically provided with a plunger 43".
  • the lower disc 40" may be provided with a sloped portion 40a" to facilitate assembly with a vacuum sealing plug.
  • the plunger 43" blocks the proximal end of the lumen of the hub 32", preventing the flow into the hub. Blood leaks within the 32" proximal segment lumen 46".
  • the handle 20" further includes a ferrule 20a" for engaging the engagement portion 36" of the resilient arm 35".
  • the ferrule 20a” shown in Figure 21A is of cylindrical configuration, placed within the handle 20", the bottom of the barrel being placed at the proximal end of the handle 20" and the open end facing the hub 32" for receiving the hub 32", A vacuum is formed in the ferrule 20a" by the vacuum sealing plug 120". The edge 20a1" of the ferrule 20a" is engaged with the card 36a" (see figure). 25).
  • the form of the ferrule 20a" is not limited thereto, and it may also be, for example, a cylinder that is open at both ends in the proximal portion of the handle 20", still forming a vacuum by the lumen 21" of the handle 20".
  • FIG. 23A and 23B are perspective views of the distal portion 23" of the indwelling needle 10" of the third embodiment shown in Fig. 20, respectively.
  • the distal portion 23" of the handle 20" is similar to that of the first embodiment, but the button 110" is formed by a portion of the side wall of the distal portion 23" that can be accessed by the distal end face and the side wall of the distal portion 23"
  • the interposed hinge portion 111a" is pressed radially inwardly to urge the engaging portion 36" of the resilient arm 35" inwardly away from the ferrule 20a".
  • Figure 25 is a partial enlarged view of Figure 21A showing the mating relationship between the button 110", the resilient arm 35" of the hub 32" and the ferrule 20a” when the safety mechanism is not activated.
  • the reduced diameter portion 33" of the hub 32" disposed within the handle 20" extends from the flower opening 26" on the distal end face of the distal portion 23" of the handle 20"
  • the elastic arm 35" of the needle seat 32" is opened radially outward, and is engaged at the edge 20a1" of the ferrule 20a” through the card table 36a
  • the base of the needle seat 32" 38” is engaged with the vacuum sealing plug 120", and a vacuum is formed in the ferrule 20a”.
  • the safety mechanism 100" is activated, that is, the button 110" (see Fig. 25) is pressed to retract the puncture needle 31".
  • the button 110" is rotated inwardly about the hinge portion 111a
  • the elastic arm is 35" is urged radially inwardly, thereby causing 35" to move radially inwardly, and the card table 36a" is disengaged from the edge 20a1" of the ferrule 20a", and the needle holder 32" and the puncture needle 31" are retracted by vacuum.
  • Fig. 26 is a cross-sectional view showing the puncture needle of the indwelling needle of the third embodiment shown in Fig. 20 retracted into the handle after pressing the button.
  • 27A, 27B, and 27C illustrate cross-sectional views of the indwelling needle 10"" of the fourth embodiment, the hub base 38"", and the O-ring, respectively, in accordance with a fourth embodiment of the present invention. Cutaway view.
  • the fourth embodiment according to the present invention is substantially identical in structure to the third embodiment except that the structure of the base 38'' of the hub is different.
  • the hub 32'' The base 38"" is a cylinder, and a small cylinder 39"" protrudes from the upper surface of the cylinder for blocking the proximal end of the hub 32'".
  • a plurality of cylinders are formed on the circumference of the cylinder.
  • the groove 40''' is for accommodating the O-ring 41''.
  • the working principle of the fourth embodiment is identical to that of the third embodiment.
  • the indwelling needle according to the present invention as previously described can be made of any suitable material, and the distal portion of the handle and the needle hub are transparent so as to be viewable by the user after the blood has entered the indwelling needle.

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Abstract

一种用于留置针（10）的安全机构（100）以及带有该安全机构（100）的留置针（10），所述留置针（10）包括中空手柄（20）和至少部分地位于手柄（20）内用于接收穿刺针（31）的针座（32），所述安全机构（100）包括：设置于中空手柄（20）的内侧的卡台（28）；设置于针座（32）上的径向向外张开的至少一个弹性臂（35），弹性臂（35）的末端部分具有径向向外凸出的卡合部（36），所述卡合部（36）用于与卡台（28）接合；按钮（110），设置在手柄（20）的远侧部分上，当按下按钮（110），按钮（110）将沿径向向内方向推压所述弹性臂（35），使得所述弹性臂（35）的卡合部（36）与卡台（28）脱离接合，同时借助中空手柄（20）内的真空，使得针座（32）以及伸出在手柄（20）外的穿刺针（31）缩回到中空手柄（20）内。

Description

用于留置针的安全机构以及带有该安全机构的留置针 技术领域
本实用新型涉及一种用于留置针的安全机构及带有该安全机构的留置针。
背景技术
随着现代医学的发展，研究人员致力于减少由于医疗所带来的痛苦。静脉留置针(又称静脉套管针)的使用能减少患者因反复静脉穿刺而造成的痛苦，减轻医护人员的工作量，目前已经得到广泛应用。现有留置针通常包括穿刺针以及可以留置在血管内的导管。在使用过程中，导管随着穿刺针一起刺入血管内，当导管全部进入血管后，缩回穿刺针，仅将导管留置在血管内，以备后续治疗。
在使用过程中，留置针的定位非常重要。在穿刺针刺入患者血管后，患者的血压会使得少量血液流入中空的穿刺针内，当使用者观察到穿刺针后部的少量血液后，就能够确定留置针定位完成，可以缩回穿刺针。但是带血的穿刺针会给医护人员以及其他可能接触医疗垃圾的人员带来很多风险，诸如感染疾病等。
目前市场上虽然已经有防刺伤留置针销售，但是大多结构复杂，制造成本高，因而价格昂贵，并且操作不方便。
因此仍然需要一种安全性高、结构简单、成本经济、易于操作的留置针以及适用于留置针的确保其安全性的安全机构。
实用新型内容
本实用新型提供了一种用于留置针的安全机构以及带有该安全机构的留置针，该安全机构允许在留置针的导管和穿刺针被正确刺入血管后更安全地缩回穿刺针，避免使用者再次接触使用过的穿刺 针，其安全性高、结构简单、成本经济。
根据本实用新型的一个方面，提供一种用于留置针的安全机构，所述留置针包括中空手柄和至少部分地位于手柄内用于接收穿刺针的针座，所述安全机构包括：设置于中空手柄的内侧的卡台；设置于针座上的径向向外张开的至少一个弹性臂，弹性臂的末端部分具有径向向外凸出的卡合部，所述卡合部用于与卡台接合；按钮，设置在手柄的远侧部分上，当按下按钮，按钮将沿径向向内方向推压所述弹性臂，使得所述弹性臂的卡合部与卡台脱离接合同时借助中空手柄内的真空吸力，使得针座以及伸出在手柄外的穿刺针缩回到中空手柄内。
在一种实施方式中，所述卡台设置在中空手柄的远侧部分的内壁上，所述弹性臂径向向外张开并从针座的近侧向远侧方向延伸。
在一种实施方式中，所述按钮包括按压部以及从按压部沿径向延伸的至少一个挤压臂，所述挤压臂的末端具有增厚部分，在按钮未被按压下时，挤压臂伸入针座的主体和从主体径向向外张开的弹性臂之间的空隙，利用增厚部分将弹性臂压靠到卡台上，当按钮被按压下之后，挤压臂的增厚部分伸出所述空隙之外，不再径向向外挤压弹性臂。
在一种实施方式中，所述按钮还包括从按压部沿径向延伸的至少一个驱动臂，所述驱动臂具有倾斜的端部并且布置在挤压臂的外侧，在按钮未被按压下时，驱动臂位于弹性臂的端头外侧但并未与之接触，当按钮被按压下之后，随着挤压臂的增厚部分伸出所述空隙之外不再径向向外挤压弹性臂，位于外侧的驱动臂的倾斜的端部的倾斜侧逐渐径向向内挤压弹性臂。
在一种实施方式中，所述弹性臂的端头的宽度小于弹性臂的主体部分的宽度。
在一种实施方式中，所述按钮具有沿径向延伸的至少一个驱动臂，所述驱动臂具有倾斜的端部并且布置在弹性臂的外侧，当按钮被按压下之后，驱动臂的倾斜的端部的倾斜侧逐渐径向向内挤压弹 性臂。
在一种实施方式中，所述弹性臂为两个，所述驱动臂为一个或两个。
在一种实施方式中，所述卡台设置在中空手柄的远侧部分的内壁上，所述弹性臂径向向外张开并从针座的远侧向近侧方向延伸。
在一种实施方式中，所述按钮具有沿径向延伸的至少一个驱动臂，所述驱动臂具有倾斜的端部并且布置在弹性臂的外侧，当按钮被按压下之后，驱动臂的倾斜的端部的倾斜侧逐渐径向向内挤压弹性臂。
在一种实施方式中，所述驱动臂为两个。
在一种实施方式中，所述中空手柄包括设置在其内部的筒形的卡套，卡套的边缘延伸到手柄的远侧部分处并且边缘形成为所述卡台，所述弹性臂径向向外张开并从针座的远侧向近侧方向延伸。
在一种实施方式中，所述按钮由手柄的远侧部分的侧壁形成，当按压下按钮时，按钮将弹性臂的卡合部推离卡套的边缘。
在一种实施方式中，所述中空手柄的远侧部分和针座是透明材料制成的。
根据本实用新型的另一个方面，提供一种留置针，所述留置针包括：
中空的手柄；
至少部分地位于手柄内的针座；
固定于所述针座的远端的穿刺针；
设置在穿刺针外部的导管和导管毂；
安全机构，所述安全机构包括：
设置于所述手柄上的卡台；设置于针座上的径向向外张开的至少一个弹性臂，弹性臂的末端部分具有径向向外凸出的卡合部，所述卡合部用于与卡台接合；按钮，设置在手柄的远侧部分上，当按下按钮，按钮将沿径向向内方向推压所述弹性臂，使得所述弹性臂的卡合部与卡台脱离接合，同时借助中空手柄内的真 空吸力，使得伸出在手柄外的穿刺针缩回到中空手柄内。
在一种实施方式中，所述针座的基座和中空手柄的内腔之间设置有真空密封塞，以便在手柄内形成真空。
在一种实施方式中，所述针座的基座和中空手柄的卡套的内腔之间设置有真空密封塞，以便在手柄的卡套内形成真空。
根据本实用新型的用于留置针的安全机构，构思巧妙，安全性高。根据本实用新型的带有所述安全机构的留置针不仅安全性高，而且操作简单方便，能够有效地防止留置针在使用过程中以及使用后造成使用者或者任何接触者的损伤。
附图说明
图1A和图1B是根据本实用新型第一种实施方式的从不同方向观察的尚未使用的留置针的立体图。图1C至图1G示出了根据本实用新型第一种实施方式的留置针的使用过程。
图2A和图2B是图1A和图1B所示第一种实施方式的留置针沿着不同剖面的纵向剖视图。
图3A和图3B分别是图1A和图1B所示第一种实施方式的留置针的保护套的立体图和纵向剖视图。
图4A、图4B、图4C和图4D分别是图1A和图1B所示第一种实施方式的留置针的针座的立体图以及从不同剖面剖切的纵向剖视图。
图5A和图5B分别是图1A和图1B所示第一种实施方式的留置针的手柄远侧部分的不同方向观察的立体图。
图6A、图6B和图6C分别是图1A和图1B所示第一种实施方式的留置针的按钮的立体图和俯视图。
图7是图1A和图1B所示第一种实施方式的留置针的真空密封塞的剖视图。
图8A、图8B、图8C、图8D和图8E分别是图1A和图1B所示第一种实施方式的留置针的导管和导管毂组件的从不同方向看的立 体图以及纵向剖视图。
图9A、图9B和图9C分别是图1A和图1B所示第一种实施方式的留置针在使用时刺入血管后向远侧推动导管和导管毂组件之后尚未按压下安全机构的按钮的状态的不同剖面的剖视图。
图10A、图10B、图10C、图10D、图10E、图10F、图10G和图10H分别是图1A和图1B所示第一种实施方式的留置针在使用时刺入血管后向远侧推动导管和导管毂组件之后刚刚按压下安全机构的按钮的状态的不同方向的剖视图。
图11A和图11B是根据本实用新型第二种实施方式的从不同方向观察的尚未使用的留置针的立体图。
图12A和图12B是图11A和图11B所示第二种实施方式的留置针从不同剖面剖切的纵向剖视图。
图13A、图13B和图13C分别是图11A和图11B所示第二种实施方式的留置针的保护套的立体图和剖视图。
图14A、图14B、图14C和图14D分别是图11A和图11B所示第二种实施方式的留置针的针座的立体图以及从不同剖面剖切的纵向剖视图。
图15A、图15B、图15C、图15D和图15E分别是图11A和图11B所示第二种实施方式的留置针的基座的立体图以及从不同方向剖切的剖视图。
图16A和图16B分别是图11A和图11B所示第二种实施方式的留置针的按钮的立体图。
图17A和图17B分别是图11A和图11B所示第二种实施方式的留置针的手柄远侧部分的立体图。
图18A、图18B、图18C、图18D、图18E和图18F是图11A和图11B所示第二种实施方式的留置针的使用过程状态图，其中图18A显示的是尚未去除保护套的留置针，图18B是已经去除保护套的留置针，图18C是向远侧推动导管和导管毂组件的留置针，图18D是按压下安全机构的按钮的留置针，图18E和图18F分别是穿刺针 正在缩回状态和已经缩回状态的留置针。
图19A和图19B是图11A和图11B所示第二种实施方式的留置针的按钮被按压下时按钮的驱动臂和针座的弹性臂之间相互作用的视图。
图20是根据本实用新型第三种实施方式的尚未使用但已去除保护套的留置针的立体图。
图21A和图21B是根据本实用新型第三种实施方式的从不同剖面剖切的尚未使用的留置针的纵向剖视图。
图22A、图22B和图22C分别是图20所示第三种实施方式的留置针的针座的立体图以及从不同侧面剖切的纵向剖视图。
图23A和图23B分别是图20所示第三种实施方式的留置针的手柄远侧部分的立体图。
图24是图20所示第三种实施方式的留置针的针座基座的剖视图。
图25是图21A的局部放大图，示出了未启动安全机构时按钮、针座的弹性臂和卡套之间的配合关系。
图26是图20所示第三种实施方式的留置针的穿刺针在按压按钮后缩回到手柄内的剖视图。
图27A、图27B和图27C示出了根据本实用新型的第四种实施方式，分别为第四种实施方式的留置针的剖视图、针座基座以及O型密封圈的纵向剖视图。
具体实施方式
根据本实用新型的设计思想，存在多种实施方式实现实用新型目的，下面将参照附图所示的优选实施方式来解释本实用新型的留置针的结构、配置和工作原理。本领域技术人员参照所示的优选实施方式，可以想到能够实现本实用新型目的的其他实施方式。
在本说明书中，术语“近侧”指的是医疗器械的靠近操作者的一侧，术语“远侧”指的是医疗器械的远离操作者的一侧，术语“上”、 “下”、“左”、“右”是相对于附图图面所示而言，术语“纵向”、“径向”是相对于器械的纵向轴线而言。此外，相同的部件采用相同的附图标记来表示。
图1A和图1B是根据本实用新型第一种实施方式的从斜上方和斜下方观察的尚未使用的留置针10的立体图。图2A和图2B是图1A和图1B所示第一种实施方式的留置针10沿着不同剖面的纵向剖视图。留置针10具有纵向轴线X-X(如图2A和图2B所示)。留置针10包括：中空的手柄20；至少部分地位于手柄20内的针和针座组件30；位于手柄20的远侧并围绕针和针座组件30的一部分的导管和导管毂组件80；以及安全机构100。优选地，留置针10还包括位于留置针的远端、用于防止未使用的留置针刺伤接触者的保护套11。
图1C至图1G示出了根据本实用新型的留置针10的使用过程。在准备使用时，首先将保护套11从留置针10上去除，并将留置针10的穿刺针刺入血管(参见图1C和图1D)。在看到血液进入穿刺针和/或针座内后，向远侧推进导管和导管毂组件80(如图1E所示)。在导管就位后，用一只手按住导管和导管毂组件80的翼片，另一只手按下安全机构100(参见图1F)。安全机构100的按钮使得针和针座组件30与导管和导管毂组件80脱离接合，穿刺针借助中空的手柄20内的真空与针座一起缩回到手柄20的内腔内，从而防止使用者被使用过的穿刺针刺伤，提高安全性。下面将详细描述留置针10的各部件的具体结构和接合方式以及使用方式。
如图2A和图2B所示，中空的手柄20具有内腔21、近侧部分22和远侧部分23。手柄20的近侧部分22为大致筒形，筒形的近端封闭，远端开放，用于与手柄20的远侧部分23接合。图5A和图5B分别是图1A和图1B所示第一种实施方式的留置针的手柄20的远侧部分23的从不同方向观察的立体图。手柄20的远侧部分23具有用于与近侧部分22的开放远端接合的开放近端24。并且远侧部分23的远端25封闭，远端25上具有花孔26。如图5A所示，所谓花 孔，是在普通的圆形孔的圆周上形成有数个缺口26a。当然，花孔26的形状不限于此，只要其与针座的相应部分(将在后面详细描述)配合即可。此外，远侧部分23的侧壁上具有用于接收安全机构100的按钮110的按钮孔27。远侧部分23的内壁上具有向内凸的卡台28(参见图9B和图10C)，所述卡台28用于与针座的弹性臂接合，这将在后面进行详细描述。此外，为了与导管和导管毂组件80接合，手柄20的远侧部分23的远端25的端面上(即形成有花孔26的端面上)还形成有向远侧延伸的突起29(参见图5A、图9A、图9B、图10B和图10C)。
仍然参照图2A和图2B，针和针座组件30包括穿刺针31和针座32。穿刺针31是空心的并且具有锋利的远端，用于穿刺患者皮肤。穿刺针31的近端固定到针座32的远端。图4A、图4B、图4C和图4D分别是图1A和图1B所示第一种实施方式的留置针的针座的立体图以及从不同剖面剖切的纵向剖视图。如图4A至图4D所示针座32为大致空心柱体的针座主体，在针座主体的近侧具有基座38，在针座主体的远侧具有直径减小部分33，并且针座主体上还具有沿径向向外张开的弹性臂35。图中所示为两个弹性臂35，但是本领域技术人员可以理解，弹性臂35的数量还可以是一个或多于两个，只要能够与手柄20的相应部分配合即可，并且针座32的针座主体的柱体优选为圆柱体，但是也可以是其他棱柱体。
如图4A和图4B清楚显示，针座32的直径减小部分33的周围设置有多条肋或筋33a，肋或筋33a的数量与花孔26的缺口26a对应或少于缺口26a的数量。而且，直径减小部分33相对于针座主体的其他部分形成有台肩34。针座32的基座38为从针座主体沿径向伸出的两个凸缘39和40。凸缘39和40的直径大小只要能够装配在手柄20内即可，而且虽然图4A和图4B显示凸缘39的直径大于凸缘40的直径，但是本领域技术人员可以理解，对于两个凸缘39、40的直径相对大小关系并无限制，凸缘39的直径可以小于凸缘40的直径。凸缘40可以在底侧形成斜面40a，以便于装配真空密封塞120 (参见图2A、图2B和图7)。针座32的弹性臂35自针座主体沿着径向向外张开并且在弹性臂35与针座主体之间留有足够空隙50。本领域技术人员可以理解，空隙50的形成既可以是因为针座主体的壁厚在此处减薄从而与弹性臂之间形成较大空隙50(如图4B和图4C所示)，也可以是因为弹性臂35向外张开得尺寸足够大。如图4A和图4B所示，弹性臂35是从针座主体沿着径向向外张开并且从近侧向远侧方向延伸，在弹性臂的远侧具有径向向外的凸台状的卡合部36，并且在末端具有端头37。图中所示端头37为圆化的小突起。本领域技术人员可以理解，端头37也可以是梯形等形状。与弹性臂35的臂主体的宽度相比，端头37的宽度较小。如后续将会描述的，这样便于安全机构100的按钮的挤压臂更快地通过空隙50。
此外，如图4C和图4D最清楚显示的，针座32为中空的，具有贯穿的内腔。图4C和图4D中显示针座32的内腔分为数段，其中针座32的直径减小部分33处的远侧段内腔45用于接收和固定穿刺针31，由此空心的穿刺针31的内腔与针座32的中段内腔46和近侧段内腔47连通，从而在穿刺针31刺入血管中之后血液能够流入针座32的中段内腔46和近侧段内腔47内，给使用者以提示。针座32的近端、即基座38一侧通过堵头48封堵(参见图2A和图2B)，以防止血液流出。
在将针和针座组件30与手柄20装配到一起时，针座32的直径减小部分33穿过手柄远侧部分23的远端25上的花孔26，直径减小部分33的肋或筋33a伸入花孔26的对应的缺口26a内，由此可防止针座32转动。同时，由于直径减小部分33相对于针座主体所形成的台肩34的尺寸比花孔26的尺寸大，因而使得针座32能够卡在花孔26处，防止针座32过度伸出到手柄20之外。针座32的基座38与真空密封塞120接合。真空密封塞120为常用密封塞，为了与基座38装配，如图7所示，真空密封塞120为大致碗形，其外径与手柄20的内腔21的内径过盈配合(参见图9B和图10C)，以在手柄20的内腔21内形成真空。为此，真空密封塞120具有内腔121 以及从碗形的内碗口部分向内突出的突起122，以便扣合到凸缘40上。为了接合方便，还可以在突起122的上侧形成有斜面123。
图8A至图8E分别是图1A和图1B所示第一种实施方式的留置针10的导管和导管毂组件80的从不同方向看的立体图以及纵向剖视图。导管和导管毂组件80包括导管81和导管毂82。所述导管81包括导管主体81a、位于导管主体81a远端的锥形部分81b以及贯穿的导管腔81c。导管毂82包括圆筒形的导管毂主体83。在圆筒形的导管毂主体83的远端具有向远侧延伸的直径减小的圆筒形导管接收部84，用于接收导管81的近端部分。在导管毂主体83的一侧或说上侧或在使用时背向患者皮肤侧具有突出部86，以便使用者在使用过程中向远侧推动导管和导管毂组件80。在突出部86的相对一侧或在使用时患者皮肤侧设置有翼片85，当导管和导管毂组件80就位时，使用者可以用一只手压住翼片85保持导管和导管毂组件80的位置，同时用另一只手按压安全机构100，以便缩回穿刺针31；此外，在已经布置好留置针后，可以通过医用胶布将翼片85(由此使得导管和导管毂组件)粘附到患者皮肤上。在导管毂主体83的近端具有周向凸缘87，在凸缘87上形成有缺口88，缺口88具有两个侧壁88a和88b。当导管和导管毂组件80与手柄20以及针和针座组件30组装在一起时，导管毂主体83的近端的端面与手柄20的远侧部分23的远端25的端面配合，针座32的直径减小部分33穿过手柄远侧部分23的远端25上的花孔26，一直伸入圆筒形导管毂主体83的内腔89内，穿刺针31从针座32的直径减小部分33伸出，进入导管毂82并穿过导管81的导管腔81c，并且穿刺针31的锋利的末端从导管81的锥形末端81b伸出，同时缺口88的位置对准手柄20的远侧部分23的远端25的端面上的突起29，由此通过缺口88和突起29的配合来阻止导管和导管毂组件80相对于手柄20的转动，同时确定了各部分之间的相对位置。虽然图8D所示的缺口88为占据四分之一圆周的缺口，但是本领域技术人员可以理解，缺口88的大小不限于此，只要能够与手柄20的远侧部分23的远端25的端面上 的突起配合而阻止导管和导管毂组件80转动即可。
此外，本领域技术人员还可以理解，手柄20的远侧部分23与导管和导管毂组件80之间的组装连接关系不限于此。手柄20的远侧部分23的远端25上可以形成有额外的孔，而导管毂主体83的近端面上形成有突起，通过孔和突起的配合而将手柄20的远侧部分23与导管和导管毂组件80之间连接到一起，不能转动但是能够通过推动导管毂82上的突出部86而使得二者在纵向方向上相对移动。
图3A和图3B示出了本实用新型的留置针10的保护套11。保护套11的形状与留置针10的远侧部分(或说手柄20的远侧部分以及导管和导管毂组件)的形状大致一致。所示的保护套11包括小圆筒部分12、大圆柱部分14和二者之间的锥形过渡部分13。在小圆筒部分12的外侧表面上可以具有花纹12a，以便于移除保护套11时抓持。大圆柱部分14和锥形过渡部分13为了便于套到留置针的远侧部分，去除了下侧的一部分，同时在锥形过渡部分13处还留有切口15，以便卡到导管和导管毂组件80的翼片85上。本领域技术人员还可以想到其他方式配置保护套，只要能够防止未使用的留置针的穿刺针刺伤接触者即可。
根据本实用新型第一种实施方式的安全机构100包括设置于中空手柄20的远侧部分23的内侧壁上的卡台28；设置于针座32上的径向向外张开的至少一个弹性臂35，弹性臂的末端部分具有凸出的卡合部36，所述卡合部36用于与卡台28接合；按钮110，设置在手柄20的远侧部分23上，当按下按钮110，按钮110将沿着径向向内方向推压所述弹性臂35，使得所述弹性臂35的卡合部36与卡台28脱离接合。
图6A、图6B和图6C分别是图1A和图1B所示第一种实施方式的留置针10的按钮110的立体图以及俯视图。根据本实用新型的按钮110包括按压部111以及从按压部111沿着径向延伸(即手柄20的径向)的至少一个挤压臂112。其中挤压臂112的数量与针座32的弹性臂35的数量是一致的，以便互相配合动作，增强安全性。 在图6A至图6C所示的例子中，按钮110包括两个挤压臂112。每个挤压臂112的末端具有增厚部分113。按钮110还包括从按压部111沿着径向延伸(即手柄20的径向)的至少一个驱动臂114。其中驱动臂114的数量为至少一个，可以小于等于针座32的弹性臂35的数量，以便互相配合动作。在图6A和图6C所示的例子中，按钮110包括两个驱动臂114，并且驱动臂114位于挤压臂112的外侧。驱动臂114具有倾斜的端部115。在按下按钮110时，驱动臂114将沿着径向向内的方向推压弹性臂35，使弹性臂35脱离与卡台28的接合。如后面将会详细描述的，本领域技术人员可以理解，驱动臂114使得弹性臂35脱离与卡台28的接合，而挤压臂112用于将弹性臂35进一步压靠到卡台28上，因此在一些实施方式中，按钮可以不设置挤压臂，而仅仅设置驱动臂，弹性臂依靠自身的弹力压靠到卡台上。
图9A、图9B和图9C示出了第一种实施方式的留置针的安全机构未被压下的情况下按钮和其他部件之间的配合关系。图10A至图10H示出了第一种实施方式的留置针的安全机构刚被压下的情况下按钮和其他部件之间的配合关系。
图9B为图9A的双点划线框内的部分的放大图，图9C为沿着图9B中线9AA-9AA剖切的剖视图。组装后，按钮110置于图5A所示的手柄20的远侧部分23内，按钮110的按压部111置于按钮孔27内，在未被按下时，按压部111的表面与远侧部分23的表面大致平齐。如图9B和图9C所示，在未被按下时，按钮110的挤压臂112伸入到针座32的弹性臂35与针座主体之间的空隙50内，并且挤压臂112的末端的增厚部分113将弹性臂35沿径向向外推压，由此使得弹性臂35的径向向外的凸台状的卡合部36卡到手柄20的远侧部分23的内壁上的卡台28处。而在按钮未被按压下时，驱动臂114位于弹性臂35的外侧(参见图9B和图9C)，尚未与弹性臂35接触。由于挤压臂112的末端的增厚部分113的推压以及弹性臂35自身的弹性，弹性臂35牢牢地抵靠到卡台28上，由此将针和针 座组件30保持在该位置，穿刺针31伸出到导管81之外。
当定位好穿刺针31和导管81、推进导管和导管毂组件80之后，需要缩回穿刺针31时，则启动安全机构100，即以力F按下按钮110(见图10A)，以便缩回穿刺针31。更具体地，图10C、图10D、图10E和图10F详细示出了在按钮110刚刚被按压下后弹性臂35、手柄20的远侧部分23和按钮110之间的关系。其中图10E中仅仅显示了按钮110的一部分，部分驱动臂114被去除以显示其后边的挤压臂112，并且挤压臂112的上部的一部分被去除，以清楚显示和弹性臂35的端头37的关系。图10F与图10E所示内容相同，只是从另一侧观察。如图10C至图10F所示，在按下按钮110后，按钮110的挤压臂112向前移动，之前抵住弹性臂35的增厚部分113移动通过空隙50，运动到弹性臂35的端头37之外(如图10D、图10E和图10F清楚显示)(弹性臂35的端头37的厚度比弹性臂35的主体部分的宽度小有助于增厚部分113快速通过空隙50)，由于挤压臂112的除了增厚部分113之外的部分的厚度较小，因而不再将弹性臂35径向向外挤压到卡台28处，弹性臂35由于自身的弹性而向内弹回，脱离卡台28。另一方面，由于驱动臂114是位于弹性臂35的外侧，随着按钮110被按下，挤压臂112和驱动臂114都向前移动，驱动臂114的倾斜端部115随之靠近弹性臂35的端头37，倾斜端部115的倾斜侧逐渐推动弹性臂35径向向内运动，从而辅助弹性臂35的卡合部36脱离与卡台28的接合。由于弹性臂35与手柄20的远侧部分23脱离接合，而手柄20的内腔21内为真空，于是针和针座组件30被缩回到手柄20的内腔21内，如图10G和图10H所示。
图11A和图11B是根据本实用新型第二种实施方式的从不同方向观察的尚未使用的留置针10′的立体图。图12A和图12B是图11A和图11B所示第二种实施方式的留置针从不同剖面剖切的纵向剖视图。其中手柄20′的近侧部分、导管和导管毂组件80′等的结构和配置与本实用新型第一种实施方式的相同，在此对于相同的部分将不 再赘述。仅仅描述不同的特征。
图13A、图13B和图13C分别是图11A和图11B所示第二种实施方式的留置针10′的保护套11′的立体图和剖视图。类似地，保护套11′的形状也是与留置针10′的远侧部分(或说手柄20′的远侧部分以及导管和导管毂组件)的形状大致一致，并且保护套11′的下侧有一部分被去除以便套到留置针10′的远侧部分上，并且在保护套11′上还留有切口15′，以便卡到导管和导管毂组件80′的翼片85′上。
下面具体描述第二种实施方式的留置针的手柄的远侧部分、针座以及安全机构的按钮。
图14A、图14B、图14C和图14D分别是图11A和图11B所示第二种实施方式的留置针10′的针座32′的立体图以及从不同方向剖切的纵向剖视图。类似地，针座32′同样具有大致空心柱体的针座主体，在针座主体的远侧具有直径减小部分33′，并且针座主体上还具有沿径向向外张开的弹性臂35′。图中所示为两个弹性臂35′，但是本领域技术人员可以理解，弹性臂35′的数量还可以是一个或多于两个，只要能够与手柄20′的相应部分配合即可，并且针座32′的针座主体的柱体优选为圆柱体，但是也可以是其他棱柱体。
如图14A和图14B清楚显示，针座32′的直径减小部分33′的周围设置有多条肋或筋33a′，肋或筋33a′的数量与花孔26′的缺口26a′对应或少于缺口26a′的数量。而且，直径减小部分33′相对于针座主体形成有台肩34′。针座32′的弹性臂35′自针座主体沿着径向向外张开并且在弹性臂35′与针座主体之间留有足够空隙50′。本领域技术人员可以理解，空隙的形成既可以是因为弹性臂35′向外张开得尺寸大，如图14A、图14B和图14D所示，也可以是因为针座主体的壁厚在此处减薄从而与弹性臂之间形成较大空隙。弹性臂35′是从针座主体沿着径向向外张开并且从远侧向近侧方向延伸，在弹性臂的远侧具有卡合部36′，卡合部36′具有径向向外的突起37′。此外，在针座32′的近端在针座主体的一侧具有卡合片47′。
此外，如图14C和14D最清楚显示，针座32′为中空的，具有贯穿的内腔。该贯穿的内腔分为两段，其中针座32′的直径减小部分33′处的远侧段内腔45′用于接收和固定穿刺针31′，由此空心的穿刺针31′的内腔与针座32′的近侧段内腔46′连通，从而在穿刺针31′刺出血管中之后血液能够流入针座32′的近侧段内腔46′内，给使用者以提示。
图15A、图15B、图15C、图15D和图15E分别是图11A和图11B所示第二种实施方式的留置针10′的针座32′的基座38′的立体图以及从不同剖面剖切的纵向剖视图。基座38′包括上圆盘39′、下圆盘40′以及连接上圆盘39′和下圆盘40′的圆柱段41′。上圆盘39′的上表面上偏心地设置有柱塞43′，并且还设置有至少一个卡合片42′，图中所示为两个卡合片42′。下圆盘40′可以设置有倾斜部40a′，以便于与真空密封塞装配。此外，在上圆盘39′的下表面还可设置有加强筋或肋44′。如图12A和图12B所示，当针座32′的针座主体和基座38′组装到一起时，柱塞43′封堵住针座32′的内腔的近端，阻止流入针座32′的近侧段内腔46′内的血液泄露。针座32′的针座主体的卡合片47′与基座38′的上圆盘39′的卡合片42′互相卡合，防止针座32′的针座主体相对于基座38′运动。
根据本实用新型的安全机构100′包括设置于中空手柄20′的远侧部分23′的内侧壁上的卡台28′；设置于针座32′上的径向向外张开的至少一个弹性臂35′，弹性臂的末端部分具有凸出的卡合部36′，所述卡合部36′用于与卡台28′接合；按钮110′，设置在手柄20′的远侧部分23′上，当按下按钮110′，按钮110′将沿径向向内推压所述弹性臂35′，使得所述弹性臂35′的卡合部36′与卡台28′脱离接合。
图16A和图16B分别是图11A和图11B所示第二种实施方式的留置针10′的按钮110′的立体图。根据本实用新型的按钮110′包括弧形片状的按压部111′以及从按压部111′的下部延伸的至少一个驱动臂114′。其中驱动臂114′的数量与针座32的弹性臂35的数量是 一致的，以便互相配合动作。在图16A和图16B所示的例子中，按钮110′包括两个驱动臂114′，并且驱动臂114′具有倾斜端部115′。此外，按钮110′的按压部111′还具有接合部112′，用于与手柄20′的远侧部分23′的接收部25a′接合。图中所示为两个接合部112′，并且其中一个接合部112′上具有定位突起112a′。但是本领域技术人员可以理解，接合部可为至少一个，并且可以是其他形状，只要将按钮110′接合到手柄20′的远侧部分23′的接收部即可。
图17A和图17B分别是图11A和图11B所示第二种实施方式的留置针10′的手柄20′的远侧部分23′的立体图。类似地，该远侧部分23′具有用于与近侧部分22′的开放远端接合的开放近端24′。并且远侧部分23′的远端25′上具有花孔26′，如图17A和图17B所示，花孔26′上形成有数个缺口26a′。当然，如前所述，花孔26′的形状不限于此，只要其与针座的相应部分配合即可。此外，远侧部分23′的侧壁上具有用于接收安全机构100′的按钮110′的按钮孔27′。远侧部分23′的内壁上具有向内凸的卡台28′(参见图17A)，所述卡台28′用于与针座32′的弹性臂35′接合。此外，为了与导管和导管毂组件80′接合，手柄20′的远侧部分23′的远端25′的端面上(即形成有花孔26′的端面上)还形成有向远侧延伸的突起29′(参见图17A和图17B)。
当导管和导管毂组件80′与手柄20′以及针和针座组件30′组装在一起时，导管毂主体83′的近端的端面与手柄20′的远侧部分23′的远端25′的端面配合，针座32′的直径减小部分33′穿过手柄远侧部分23′的远端25′上的花孔26′，一直伸入圆筒形导管毂主体83′的内腔内，穿刺针31′从针座32′的直径减小部分33′伸出，进入导管毂82′并穿过导管81′的导管腔81c′，并且穿刺针31′的锋利的末端从导管81′的锥形末端81b′伸出，同时缺口88′的位置对准手柄20′的远侧部分23′的远端25′的端面上的突起29′，按钮110′置于手柄20′的远侧部分23′内，其中按钮110′的按压部111′配合到远侧部分23′的按钮孔27′中，并且在未被按压时按压部111′的表面与 远侧部分23′的两个侧边缘齐平。针座32′的弹性臂35′的卡合部36′与远侧部分23′的内壁上的卡台28′抵靠。
当定位好穿刺针31′和导管81′、推进导管和导管毂组件80′之后，需要缩回穿刺针时，则启动安全机构100′，即按下按钮110′，以便缩回穿刺针31。图18A至图18F是图11A和图11B所示第二种实施方式的留置针的使用过程状态图，其中图18A显示的是尚未去除保护套11′的留置针10′，图18B是已经去除保护套11′的留置针10′，图18C是向远侧推动导管和导管毂组件80′的留置针10′，图18D是按压下安全机构100′的按钮110′的留置针10′，图18E和图18F分别是穿刺针31′正在缩回状态和已经缩回状态的留置针10′。图19A和图19B是图11A和图11B所示第二种实施方式的留置针的按钮被按压下时按钮的驱动臂和针座的弹性臂之间相互作用的视图。当按压下按钮110′，借助倾斜端部115′，位于弹性臂35′的外侧的按钮110′的驱动臂114′将与远侧部分23′的内壁上的卡台28′抵靠的弹性臂35′径向向内挤压并推离开卡台28′(如图19A和图19B所示)。此后，弹性臂35′已经脱离卡台28′，并受到驱动臂114′的向内挤压，借助手柄20′的内腔21′的真空作用，针座32′被缩回到手柄20′内。
图20是根据本实用新型第三种实施方式的尚未使用但已去除保护套的留置针10″的立体图。图21A和图21B是根据本实用新型第三种实施方式的从不同剖面剖切的尚未使用的留置针10″的纵向剖视图。其中手柄20″的近侧部分、导管和导管毂组件80″等的结构和配置与本实用新型第一种和第二种实施方式的相同，在此对于相同的部分将不再赘述。仅仅描述不同的特征。
下面具体描述第三种实施方式的留置针的手柄的远侧部分、手柄的卡套、针座以及安全机构的按钮。
图22A、图22B和图22C分别是图20所示第三种实施方式的留置针10″的针座32″的立体图以及从不同侧面剖切的纵向剖视图。类似地，针座32″同样具有大致空心柱体的针座主体，在针座主体 的远侧具有直径减小部分33″，并且针座主体上还具有沿径向向外张开的弹性臂35″。图中所示为一个弹性臂35″，但是本领域技术人员可以理解，弹性臂35″的数量还可以是一个或多于两个，只要能够与手柄20″的相应部分配合即可，并且针座32″的针座主体的柱体优选为圆柱体，但是也可以是其他棱柱体。
如图23A清楚显示，针座32″的直径减小部分33″的周围设置有多条肋或筋33a″，肋或筋33a″的数量与手柄20″的远侧部分23″的远端面上的花孔26″的缺口26a″对应或少于缺口26a″的数量。而且，直径减小部分33″相对于针座主体形成有台肩34″。针座32″的弹性臂35″自针座主体沿着径向向外张开并且在弹性臂35″与针座主体之间留有足够空隙50″。本领域技术人员可以理解，空隙的形成既可以是因为弹性臂35″向外张开得尺寸大，如图23A所示。也可以是因为针座主体的壁厚在此处减薄从而与弹性臂之间形成较大空隙。弹性臂35″是从针座主体沿着径向向外张开并且从远侧向近侧方向延伸，在弹性臂的远侧具有卡合部36″，卡合部36″具有径向向外凸出的卡台36a″和从卡台36a″开始沿着纵向延伸的楔形部37″。
图24是图20所示第三种实施方式的留置针10″的针座基座38″的剖视图。基座38″包括上圆盘39″、下圆盘40″以及连接上圆盘39″和下圆盘40″的圆柱段41″。上圆盘39″的上表面同心设置有柱塞43″。下圆盘40″可以设置有倾斜部40a″，以便于与真空密封塞装配。如图21A和图21B所示，当针座32″的针座主体和基座38″组装到一起时，柱塞43″封堵住针座32″的内腔的近端，阻止流入针座32″的近侧段内腔46″内的血液泄露。
如图21A和图21B所示，手柄20″还包括卡套20a″，用于与弹性臂35″的卡合部36″卡合。图21A中示出的卡套20a″为筒形结构，置于手柄20″内，筒底置于手柄20″的近端，开放端朝着针座32″，用于接收针座32″，由真空密封塞120″在卡套20a″内形成真空。并且卡套20a″的边缘20a1″与卡台36a″卡合(参见图 25)。当然，卡套20a″的形式不限于此，其也可以是例如置于手柄20″的近侧部分内的一段两端开放的圆筒，仍然由手柄20″的内腔21″形成真空。
图23A和图23B分别是图20所示第三种实施方式的留置针10″的手柄远侧部分23″的立体图。手柄20″的远侧部分23″与第一种实施方式的类似，但是按钮110″由远侧部分23″的一部分侧壁形成，能够借助在远侧部分23″的远端面和侧壁之间形成的铰接部111a″径向向内按压，从而将弹性臂35″的卡合部36″向内推压脱离卡套20a″。
图25是图21A的局部放大图，示出了未启动安全机构时按钮110″、针座32″的弹性臂35″和卡套20a″之间的配合关系。当未按压下安全机构100″时，置于手柄20″内的针座32″的直径减小部分33″从手柄20″的远侧部分23″的远侧端面上的花孔26″伸出并且卡在台肩34″处，针座32″的弹性臂35″径向向外张开，通过卡台36a″卡合在卡套20a″的边缘20a1″处，针座32″的基座38″与真空密封塞120″接合，在卡套20a″内形成有真空。当定位好穿刺针31″和导管81″、推进导管和导管毂组件80″之后，需要缩回穿刺针时，则启动安全机构100″，即按下按钮110″(见图25)，以便缩回穿刺针31″。当按压下按钮110″时，按钮110″绕着铰接部111a″向内转动，将弹性臂35″径向向内推压，由此使得35″径向向内运动，卡台36a″脱离卡套20a″的边缘20a1″，借助真空，将针座32″和穿刺针31″缩回到卡套20a″内，如图26所示。
图26是图20所示第三种实施方式的留置针的穿刺针在按压按钮后缩回到手柄内的剖视图。
图27A、图27B和图27C示出了根据本实用新型的第四种实施方式，分别为第四种实施方式的留置针10″′的剖视图、针座基座38″′以及O型密封圈的剖视图。
根据本实用新型的第四种实施方式与第三种实施方式的结构基本相同，只是针座的基座38″′的结构不同。如图27B所示，针座32″′ 的基座38″′为一圆柱体，并且在圆柱体的上表面伸出一段小圆柱39″′，用于封堵针座32″′的近端。在圆柱体的圆周上形成有多个沟槽40″′，用于容纳O形圈41″′。第四种实施方式的工作原理与第三种实施方式的工作原理完全相同。
如前所述的根据本实用新型的留置针可由任何适当的材料制成，并且手柄的远侧部分和针座是透明的，以便在血液进入留置针后能够被使用者观察。
上面参照附图所示的具体实施方式描述了本实用新型的具体结构，但是，本领域技术人员应该理解，上面的具体描述是举例性质的，本领域技术人员根据上面的描述，能够作出各种变型和改进，而不会脱离本实用新型的范围。

Claims (28)

  1. 一种用于留置针的安全机构，所述留置针包括中空手柄和至少部分地位于手柄内用于接收穿刺针的针座，其特征在于所述安全机构包括：
    设置于中空手柄的内侧的卡台；
    设置于针座上的径向向外张开的至少一个弹性臂，弹性臂的末端部分具有径向向外凸出的卡合部，所述卡合部用于与卡台接合；
    按钮，设置在手柄的远侧部分上，当按下按钮，按钮将沿径向向内方向推压所述弹性臂，使得所述弹性臂的卡合部与卡台脱离接合，同时借助中空手柄内的真空，使得针座以及伸出在手柄外的穿刺针缩回到中空手柄内。
  2. 如权利要求1所述的用于留置针的安全机构，其中，所述卡台设置在中空手柄的远侧部分的内壁上，所述弹性臂径向向外张开并从针座的近侧向远侧方向延伸。
  3. 如权利要求2所述的用于留置针的安全机构，其中，所述按钮包括按压部以及从按压部沿径向延伸的至少一个挤压臂，所述挤压臂的末端具有增厚部分，在按钮未被按压下时，挤压臂伸入针座的主体和从主体径向向外张开的弹性臂之间的空隙，利用增厚部分将弹性臂压靠到卡台上，当按钮被按压下之后，挤压臂的增厚部分伸出所述空隙之外，不再径向向外挤压弹性臂。
  4. 如权利要求3所述的用于留置针的安全机构，其中，所述按钮还包括从按压部沿径向延伸的至少一个驱动臂，所述驱动臂具有倾斜的端部并且布置在挤压臂的外侧，在按钮未被按压下时，驱动臂位于弹性臂的端头外侧但并未与之接触，当按钮被按压下之后，随着挤压臂的增厚部分伸出所述空隙之外不再径向向外挤压弹性臂，位于外侧的驱动臂的倾斜的端部的倾斜侧逐渐径向向内挤压弹性臂。
  5. 如权利要求3或4所述的用于留置针的安全机构，其中，所 述弹性臂的端头的宽度小于弹性臂的主体部分的宽度。
  6. 如权利要求2所述的用于留置针的安全机构，其中，所述按钮具有沿径向延伸的至少一个驱动臂，所述驱动臂具有倾斜的端部并且布置在弹性臂的外侧，当按钮被按压下之后，驱动臂的倾斜的端部的倾斜侧逐渐径向向内挤压弹性臂。
  7. 如权利要求3或4所述的用于留置针的安全机构，其中，所述弹性臂为两个，所述驱动臂为一个或两个。
  8. 如权利要求1所述的用于留置针的安全机构，其中，所述卡台设置在中空手柄的远侧部分的内壁上，所述弹性臂径向向外张开并从针座的远侧向近侧方向延伸。
  9. 如权利要求8所述的用于留置针的安全机构，其中，所述按钮具有沿径向延伸的至少一个驱动臂，所述驱动臂具有倾斜的端部并且布置在弹性臂的外侧，当按钮被按压下之后，驱动臂的倾斜的端部的倾斜侧逐渐径向向内挤压弹性臂。
  10. 如权利要求9所述的用于留置针的安全机构，其中，所述驱动臂为两个。
  11. 如权利要求1所述的用于留置针的安全机构，其中，所述中空手柄包括设置在其内部的筒形的卡套，卡套的边缘延伸到手柄的远侧部分处并且边缘形成为所述卡台，所述弹性臂径向向外张开并从针座的远侧向近侧方向延伸。
  12. 如权利要求11所述的用于留置针的安全机构，其中，所述按钮由手柄的远侧部分的侧壁形成，当按压下按钮时，按钮将弹性臂的卡合部推离卡套的边缘。
  13. 如权利要求1所述的用于留置针的安全机构，其中，所述中空手柄的远侧部分和针座是透明材料制成的。
  14. 一种留置针，所述留置针包括：
    中空的手柄；
    至少部分地位于手柄内的针座；
    固定于所述针座的远端的穿刺针；
    设置在穿刺针外部的导管和导管毂；
    安全机构，所述安全机构包括：
    设置于所述手柄的内侧的卡台；设置于针座上的径向向外张开的至少一个弹性臂，弹性臂的末端部分具有径向向外凸出的卡合部，所述卡合部用于与卡台接合；按钮，设置在手柄的远侧部分上，当按下按钮，按钮将沿径向向内方向推压所述弹性臂，使得所述弹性臂的卡合部与卡台脱离接合，同时借助中空手柄内的真空，使得伸出在手柄外的穿刺针缩回到中空手柄内。
  15. 如权利要求14所述的留置针，其中，所述卡台设置在中空手柄的远侧部分的内壁上，所述弹性臂径向向外张开并从针座的近侧向远侧方向延伸。
  16. 如权利要求15所述的留置针，其中，所述按钮包括按压部以及从按压部沿径向延伸的至少一个挤压臂，所述挤压臂的末端具有增厚部分，在按钮未被按压下时，挤压臂伸入针座的主体和从主体径向向外张开的弹性臂之间的空隙，利用增厚部分将弹性臂压靠到卡台上，当按钮被按压下之后，挤压臂的增厚部分伸出所述空隙之外，不再径向向外挤压弹性臂。
  17. 如权利要求16所述的留置针，其中，所述按钮还包括从按压部沿径向延伸的至少一个驱动臂，所述驱动臂具有倾斜的端部并且布置在挤压臂的外侧，在按钮未被按压下时，驱动臂位于弹性臂的端头外侧但并未与之接触，当按钮被按压下之后，随着挤压臂的增厚部分伸出所述空隙之外不再径向向外挤压弹性臂，位于外侧的驱动臂的倾斜的端部的倾斜侧逐渐径向向内挤压弹性臂。
  18. 如权利要求16或17所述的留置针，其中，所述弹性臂的端头的宽度小于弹性臂的主体部分的宽度。
  19. 如权利要求15所述的留置针，其中，所述按钮具有沿径向延伸的至少一个驱动臂，所述驱动臂具有倾斜的端部并且布置在弹性臂的外侧，当按钮被按压下之后，驱动臂的倾斜的端部的倾斜侧逐渐径向向内挤压弹性臂。
  20. 如权利要求16或17所述的留置针，其中，所述弹性臂为两个，所述驱动臂为一个或两个。
  21. 如权利要求14所述的留置针，其中，所述卡台设置在中空手柄的远侧部分的内壁上，所述弹性臂径向向外张开并从针座的远侧向近侧方向延伸。
  22. 如权利要求21所述的留置针，其中，所述按钮具有至少一个驱动臂，所述驱动臂具有倾斜的端部并且布置在弹性臂的外侧，当按钮被按压下之后，驱动臂的倾斜的端部的倾斜侧逐渐径向向内挤压弹性臂。
  23. 如权利要求22所述的留置针，其中，所述驱动臂为两个。
  24. 如权利要求14所述的留置针，其中，所述中空手柄包括设置在其内部的筒形的卡套，卡套的边缘延伸到手柄的远侧部分处并且边缘形成为所述卡台，所述弹性臂径向向外张开并从针座的远侧向近侧方向延伸。
  25. 如权利要求24所述的留置针，其中，所述按钮由手柄的远侧部分的侧壁形成，当按压下按钮时，按钮将弹性臂的卡合部推离卡套的边缘。
  26. 如权利要求14所述的留置针，其中，所述中空手柄的远侧部分和针座是透明材料制成的。
  27. 如权利要求14所述的留置针，其中，所述针座的基座和中空手柄的内腔之间设置有真空密封塞，以便在手柄内形成真空。
  28. 如权利要求24所述的留置针，其中，所述针座的基座和中空手柄的卡套的内腔之间设置有真空密封塞，以便在手柄的卡套内形成真空。
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CN205041892U (zh) 2015-06-25 2016-02-24 千禧光医疗有限公司 用于留置针的安全机构以及带有该安全机构的留置针
CN106310446B (zh) * 2015-06-25 2021-01-01 千禧光医疗有限公司 用于留置针的安全机构以及带有该安全机构的留置针
CN106362263A (zh) * 2016-08-30 2017-02-01 苏州鱼跃医疗科技有限公司 用于导管组件的引入针保护装置、导管组件及留置针
EP3603706A4 (en) 2017-03-24 2020-10-07 Sol-Millennium Medical HK Limited SAFE INJECTION DEVICE AND SECURITY MECHANISM APPLIED TO IT

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TWI661848B (zh) 2019-06-11
TW201700121A (zh) 2017-01-01
EP3315152A1 (en) 2018-05-02
JP6789249B2 (ja) 2020-11-25
CN205041892U (zh) 2016-02-24
US20180318500A1 (en) 2018-11-08
JP2018518275A (ja) 2018-07-12
EP3315152A4 (en) 2019-03-27
AR105123A1 (es) 2017-09-06
US10773018B2 (en) 2020-09-15

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