WO2000016832A1 - Ensemble capuchon de securite avec gaine pour pointe d'aiguille - Google Patents

Ensemble capuchon de securite avec gaine pour pointe d'aiguille Download PDF

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Publication number
WO2000016832A1
WO2000016832A1 PCT/US1998/020176 US9820176W WO0016832A1 WO 2000016832 A1 WO2000016832 A1 WO 2000016832A1 US 9820176 W US9820176 W US 9820176W WO 0016832 A1 WO0016832 A1 WO 0016832A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
needle point
cover
safety cap
cap assembly
Prior art date
Application number
PCT/US1998/020176
Other languages
English (en)
Inventor
Lawrence R. Koh
Edward E. Elson
Original Assignee
Koh Lawrence R
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 Koh Lawrence R filed Critical Koh Lawrence R
Priority to CNB988142503A priority Critical patent/CN1193804C/zh
Priority to AU97775/98A priority patent/AU9777598A/en
Priority to PCT/US1998/020176 priority patent/WO2000016832A1/fr
Publication of WO2000016832A1 publication Critical patent/WO2000016832A1/fr

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
    • 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
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3275—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands
    • 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
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • 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
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A61M2005/3249—Means to disalign the needle tip and the distal needle passage of a needle protection sleeve
    • 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
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps

Definitions

  • the present invention relates to the field of hypodermic needles. More specifically the present invention relates to the Covering of a hypodermic needle point after use to prevent accidental sticks when disposing of the hypodermic needle.
  • hypodermic needles are an integral part of health care.
  • Typical hypodermic needles include a replaceable plastic sheath which must be removed prior to use and subsequently replaced prior to disposal.
  • the act of replacing the needle cap exposes the user, typically hospital or medical personnel, to accidental needle sticks.
  • An accidental needle stick can transmit diseases through the body's first line of defense — the skin. Because some diseases such as HIV are presently incurable and can ultimately lead to death, the exposed point of a used needle and every needle sheath replacement is potentially life threatening.
  • prior devices have addressed this problem, until now an effective and economical device has not been found.
  • a needle point cover assembly that securely covers and protects the needle point after a syringe has been used.
  • the assembly preferably includes a cover in the form of an elongated hollow member that is open at one end for receiving the needle therein, and at its other end is mostly enclosed by an end wall having a hole through which the needle can pass.
  • a lid typically encloses the otherwise open end of the cover member. The lid has a hole through which the needle may pass so that the needle may extend through both the lid hole and the hole in the lid wall.
  • An extensible frame that is manually actuable can be attached to the cover member for moving the cover member along the needle when the syringe is being readied for disposal. After an injection has been made and the syringe is ready for disposal, the cover is then slid to where its end wall is beyond the extremity of the needle point. The cover member can then be supported by the hole in the lid and rotated about the lid hole until the needle point passes inside the enclosed end wall of the cover member into a protected position where it cannot pass through the cover member hole.
  • the needle point cover assembly incorporates several elements to provide tactile and aural feedback to the user to indicate that the needle cover has been successfully deployed.
  • a latch arm member which serves to retain the frame prior to use "snaps" through a slot in the frame; upon full deployment of frame, tabs on the frame "snap" around the needle shaft.
  • the tactile and aural feedback serves to provide reassurance to the user that the needle has been rendered safe without requiring visual inspection of the needle.
  • the latch arm and slot in addition to providing the user with tactile feedback, insure that once deployment of the needle shield has been initiated, sufficient momentum is present in the finger of the user to complete deployment.
  • the preferred embodiment of the needle shield incorporates an annular slot which engages a corresponding annular ring on the hypodermic. In some situations it is also important that cannula opening at the tip of the hypodermic be properly oriented.
  • the preferred embodiment may also incorporate a longitudinal slot to engage a corresponding rib on the hypodermic. In such situations, the needle shield provides an added indication of the cannula orientation.
  • the preferred embodiment is integrally formed of a resilient plastic, making it economical to manufacture.
  • Fig. 1 is a perspective view of one side of the presently preferred embodiment of the needle point guard safety cap assembly.
  • Fig. 2 is a perspective view of the flip-side of the embodiment shown in Fig 1.
  • Fig. 3 is a cross-section at 3-3 of Fig. 1.
  • Fig. 4 is a cross-section at 3-3 of Fig. 1 when the needle point guard safety cap assembly is prepared for attachment to a syringe.
  • Fig. 5 is a cross-section of the presently preferred embodiment of Fig. 1 illustrating the needle point guard safety cap assembly attached to a syringe.
  • Fig. 6 is a cross-section of the presently preferred embodiment of Fig.
  • FIG. 1 illustrating the needle point guard safety cap assembly attached to a syringe with a needle sheath covering the needle.
  • FIG. 7 is a cross-section of the presently preferred embodiment of Fig. 1 illustrating the needle point guard safety cap assembly attached to a syringe with the needle sheath removed so that the syringe is ready for use.
  • Fig. 8 is a cross-section of the presently preferred embodiment of Fig. 1 illustrating the needle point guard safety cap assembly attached to a syringe showing how the user actuates the assembly to cover the needle point.
  • Fig. 9 is a cross-section of the presently preferred embodiment of Fig.
  • Fig. 10 is a cross-section at 10-10 of Fig. 9 illustrating the clips which secure the needle guard safety cap to the needle when the guard is deployed.
  • Fig. 11 is a perspective view of one side of an alternate embodiment of the needle point guard safety cap assembly.
  • Fig. 12 is a perspective view of the flip-side of the embodiment shown in Fig 11.
  • Fig. 13 is a cross-section at 13-13 of Fig. 11.
  • Fig. 14 is a cross-section at 13-13 of Fig. 11 when the alternate embodiment of the needle point guard safety cap assembly is prepared for attachment to a syringe.
  • Fig. 10 is a cross-section at 10-10 of Fig. 9 illustrating the clips which secure the needle guard safety cap to the needle when the guard is deployed.
  • Fig. 11 is a perspective view of one side of an alternate embodiment of the needle point guard safety cap assembly.
  • Fig. 12 is a perspective view of the flip-side of the embodiment shown in Fig 11.
  • Fig. 13 is a
  • FIG. 15 is a cross-section of the alternate embodiment of Fig. 11 illustrating the needle point guard safety cap assembly attached to a syringe.
  • Fig. 16 is a cross-section of the alternate embodiment of Fig. 11 illustrating the needle point guard safety cap assembly attached to a syringe with a needle sheath covering the needle.
  • the present invention utilizes a cover or cap or cup-shaped member to cover or contain the point of the needle in a protected position after use.
  • the needle point cover has a hole so that it can be slid along, the needle to a stowed position distal from the point prior to injection and then slid back along the needle to cover the point after injection. Once the point of the needle is within the cover after injection, the cover is rotated or skewed so that the needle point can not re-emerge through the hole in the cover.
  • a well chamber formed in the end of the cover serves to capture the end of the needle an prevent it from re-emerging through the hole in the end wall.
  • the needle point cover is typically adapted to receive a typical needle sheath.
  • the needle point guard safety cap assembly typically can be installed prior to sheath installation and needle distribution. Needles can therefore be distributed with the needle point cover stowed distal the point and with the sheath covering the needle in the normal fashion.
  • the needle sheath is removed and the syringe is then used in the normal fashion to administer the injection.
  • the needle point cover can be slid the length of the needle and rotated to prevent re-emergence of the needle point.
  • the needle point guard safety cap assembly may also have a collapsible extension or extendible frame coupled to the needle point cover.
  • the extension or frame can in turn be coupled to an attachment member which is adapted to attach to the needle hub in a non-releasable fashion.
  • the needle hub in turn may be pre-assembled to a syringe or a syringe may be attached to the needle hub prior to use in injecting or withdrawing fluids from a patient.
  • the preferred embodiment incorporates an annular groove which mates with a annular ring on the needle hub.
  • the frame in co-operation with the attachment member, retains the needle point cover in its stowed position distal the needle point.
  • a protrusion on the attachment member engages a slot on the frame; the enlarged end of the protrusion "snaps" through the slot when the needle shield is actuated.
  • the frame can be manually actuated or urged so that the needle point cover is released to slide toward and eventually cover the point. After the point is contained within the cover, rotation can be made to occur in response to urging of the frame. Once the point of the needle is within the cover, further urging of the frame causes the cover to rotate.
  • the rotated cover prevents the needle point from re-emerging through the hole in the cover by retaining the needle point in a well chamber formed in the cover end wall.
  • the frame typically can be locked or secured to the needle shaft. Securing the frame also prevents the frame from collapsing and allowing the cover to slide back up the needle shaft which further ensures that the needle point can not be re-exposed.
  • the needle point guard safety cap assembly 100 of the present invention can be manufactured of a unitary molded plastic piece to increase reliability and to reduce manufacturing and installation cost.
  • the presently preferred embodiment of the present invention is of a unitary molded plastic piece.
  • the present invention is designed to be installed prior to needle use. It typically would be installed on the needle or syringe prior to distribution. The steps necessary to install the presently preferred embodiment are shown by the arrows in Figs. 1 - 5.
  • the syringe. attachment member and the needle point cover must be rotated into position to receive the needle.
  • the syringe attachment member and frame are flexibly coupled.
  • the syringe attachment member or base cup 150 is therefore rotated approximately 90 degrees with respect to the frame 130 so that the needle can extend through the syringe attachment member 150 approximately parallel to the extended frame 130.
  • a lid or enclosing member 118 which is flexibly coupled to the needle point cover 110, is rotated to plug or enclose the cover 110.
  • an annular ring 182 on the lid engages an annular slot 184 on the cover member; the ring and slot may have tapered cross sections to allow them to engage easily, but which make them difficult to separate.
  • the enclosed cover 110 which is flexibly coupled to the frame 130, is then rotated so that the needle can pass through both the hole in it and a hole in the syringe attachment member 150.
  • the frame or segmented extension 130 begins to collapse or fold at a flexible portion between the segments.
  • the cover 110 is then slid along the needle shaft away from the needle point.
  • a needle sheath 300 can be placed over the cover 110 in order to more easily manipulate the cover 110.
  • the frame or collapsible extension 130 continues to fold.
  • the frame 130 in co-operation with the syringe attachment member 150, releasably retains the cover.
  • a protrusion 192 with an enlarged head on the syringe attachment member passes through a slot 194 on the frame.
  • the enlarged head of the protrusion is sized such that when appropriate force is applied to the frame the head "snaps" through the slot.
  • the sheath 300 By using the sheath 300 to slide the cover 110 down the needle shaft, it too is installed in preparation for distribution.
  • the preferred embodiment incorporates an annular slot 186 on the inside of the attachment member which engages a corresponding annular ring 206 on the needle hub.
  • the ring and slot may have tapered cross sections to allow them to engage easily, but which make them difficult to separate. Sheath 300 removal prior to an injection does not disturb the retained cover 110, however, the frame can be released by the user to actuate the cover.
  • Figs. 1 - 10 illustrate one embodiment of the needle point guard safety cap assembly 100 of the present invention. It is presently preferred to form the needle point guard safety cap assembly of a unitary plastic piece. As such, Figs. 1 & 2 depict alternate sides of the presently preferred needle point guard safety cap assembly as it appears after it is removed from a mold. Figs. 3 - 10 depict the presently preferred embodiment as it is being prepared for use and in actual use with a syringe.
  • the needle point guard assembly or needle point cover 100 comprises the needle point cap or cup- shaped member or needle point covering means 110 for covering the point of the needle.
  • the needle point cap or cover 110 is shaped in the form of an elongated member having a circumferential wall 112. One end of the elongated member 112 is open while the other is mostly enclosed by a bottom or end wall 116.
  • the hole or bore 114 in the bottom wall 116 of the needle point cap 110 allows the needle to pass through.
  • the hole 114 is off-centered in the bottom wall, with the a well chamber 126 occupying most of the remaining wall area.
  • a lever arm or rotating means 120 attached to the needle point cap when urged, causes the needle point cap 110 to rotate about the needle point to prevent the needle point from passing through the hole 114.
  • FIG. 1 & 2 show the enclosing member or top wall or lid 118 that is rotated about the needle point cap-to- enclosing member attachment so as to enclose the needle point cap 110.
  • the enclosing member or enclosing means 118 has a bore or hole 122 to allow the needle to pass through.
  • the enclosing member or needle shaft engaging means 118 acts as a fulcrum which engages the needle.
  • the fulcrum or needle shaft engaging means 118 engages the needle and provides a pivot point used for rotating the needle point cap when the needle is passing through enclosing member hole 122 but not through bottom wall hole 114.
  • the needle point guard safety cap assembly 100 is adapted to be attached to the needle hub or syringe.
  • the needle point cap 110 is coupled to the collapsible extension or collapsible member or collapsible segmented extension 130 which in turn is coupled to the syringe attachment member or base cup 150.
  • the syringe attachment member 150 is used to connect the needle point guard assembly to the needle hub or syringe.
  • the needle point cap 110 to collapsible member 130 coupling means is by direct coupling.
  • the base cup 150 has a circumferential wall 152 and a bottom wall 154.
  • the bottom wall 154 has the hole 156 to allow the needle to pass through.
  • slats 158 which define channels in the inside of the circumferential wall 152 near the bottom wall 154, are included to allow for easy attachment of the base cup 150 to the needle hub.
  • attachment arms 160 extending from the base cup 150 near the bottom wall 154.
  • the attachment arms 160 are used to couple the base cup 150 to the collapsible member 130.
  • the attachment arms 160 are flexibly connected to the collapsible member 130.
  • the base cup 150 of the preferred embodiment has an annular slot 186 to engage a corresponding annular ring 206 on the needle hub.
  • the ring and slot are tapered in cross-section, making them easy to engage but difficult to separate.
  • the preferred embodiment further includes a longitudinal slot 188 which engages a corresponding longitudinal slot 208 on the needle hub to allow the needle shield to be fixedly rotationally alligned with the cannula opening 220 of the needle.
  • the collapsible member or extensible frame 130 has many uses. It is used for connecting the syringe attachment member 150 to needle point cover 110 and for releasably securing the needle point cap 110 distal from the needle point. It is also used for sliding the needle point cover 110 down the needle shaft and facilitates rotation of the needle point cap 110 about the needle point. Additionally, it assists in maintaining the rotated position of the needle point cover 110.
  • the collapsible segmented extension 130 as shown in Figs.
  • the wishbone segment 132 can be comprised of a wishbone segment 132 and a lower segment 140.
  • the wishbone segment 132 has two arms 134 and a base 136.
  • the wishbone arms 134 are flexibly connected to the base cup attachment arms 160.
  • the lower segment 140 has an upper end 142 and a lower end 144.
  • the wishbone segment base 136 is flexibly connected to the upper end 142 of the lower segment 140.
  • a lower end 144 of the lower segment is flexibly connected to the needle point cap 110.
  • Mounted to the lower segment 140 are two clips 148.
  • the wishbone segment 132 forms an opening or means through which the clips 148 can extend when the collapsible segment 130 is folded.
  • Fig. 2 shows a pressure platform 146 that ultimately contacts the lever arm 120 and causes rotation of the needle point cap 110. Rotation of the needle point cap 110 about the needle point is best shown in Figs. 8 & 9 and will be more thoroughly discussed later.
  • Fig. 2 also shows a pair of protruding clips 148 that extend from the lower segment 140 to provide a protective position locking means. The clips 148 provide a means to secure the collapsible segmented extension 130 to the needle shaft after needle use.
  • Fig. 9 shows one of the clips 148 engaging the needle shaft and securing the collapsible segmented extension 130 to the needle shaft.
  • Fig. 10 is a cross- section through the clip, indicating how they engage the needle shaft.
  • Fig. 3 shows how base cup 150 is rotated in preparation for needle passage through the base cup 150 and attachment to the syringe.
  • the Slats 158 provide a means to orient and prevent rotation of the needle within the base cup when a syringe is attached to or separated from a needle seated in the base cup.
  • the base cup or syringe attachment member 150 also has a protrusion 192 with an enlarged head. The protrusion releasably engages the slot 194 in the lower segment 140 to provide a locking means when the collapsible extension 130 is collapsed as shown in Figs. 6 & 7.
  • Fig. 3 also shows how the enclosing member 118 is rotated to enclose the needle point cap 110 to form a chamber 128 shown in Fig. 4.
  • the hole or bore 122 in the enclosing member 118 has partially beveled edges 124.
  • the partially beveled edges 124 allow the needle point cap 110 to more easily rotate about the needle point as is evident in Fig. 9.
  • the needle point cap 110 has a well chamber 126 located adjacent to the hole or bore 114. It helps prevent the accidental re-emergence of the needle point through the hole 114 by capturing the needle point after the needle point cap 110 has been rotated about the needle point.
  • Fig. 4 depicts the base cup 150 after rotation and shows the direction of needle insertion in preparation for attachment of the needle point guard safety cap assembly 100 to the syringe.
  • Fig. 4 also depicts the enclosed point cap 110 having the chamber 128.
  • the chamber not only covers the point of the needle but also serves to capture fluid that might exude from the needle point.
  • the arrow adjacent the enclosed needle point cap 110 in Fig. 4 indicates the direction the enclosed needle point cap 110 is rotated in preparation for attachment of the needle point guard safety cap assembly 100 to the syringe. Rotation of the base cup 150 and the enclosed needle point cap 110 allows the needle to pass through both of them in preparation for attachment of the needle point guard safety cap assembly 100 to the syringe.
  • Fig. 5 depicts the needle point guard safety cap assembly 100 attached to the syringe 190 in preparation for receiving a needle sheath 300.
  • the collapsible extension 130 is beginning to collapse as the needle point guard safety cap assembly is installed in preparation for application of needle sheath 300.
  • Fig. 5 also shows how one of the clips 148 will ultimately extend between the arms 134 of the wishbone segment 132 when the collapsible extension 130 is collapsed.
  • Fig. 6 shows the extension 130 collapsed or folded with one of the clips 148 extending between the arms 134 of the wishbone segment 132. Both of the clips 148, as is evident from Fig. 6 will extend between the arms 134 of the wishbone segment 132 when the collapsible extension 130 is folded.
  • Fig. 5 also depicts the base cup 150 protrusion 192 and the slot 194 in the collapsible extension prior to needle sheath 300 application.
  • the arms of the wishbone segment 13? allow the protrusion 192 to engage the slot 194.
  • the needle point cap 110 is adapted to receive the needle sheath 300 to protect the needle from contaminants prior to use.
  • the enclosing member or top wall 118 abuts the bottom wall 154 of the base cup 150 to prevent needle contamination.
  • the syringe with the needle point guard safety cap assembly 100 and the needle sheath 300 installed as depicted in Fig. 6, is as the user would receive it prior to use.
  • the user simply removes the needle sheath and proceeds to use the syringe in the normal manner depicted by Fig. 7.
  • the protrusion 192 on the attachment member and slot 194 in the collapsible extension keep the needle point cap 110 from sliding down the needle shaft while the needle sheath 300 is being removed. Subsequent to use, the user simply urges the folded collapsible extension 130 with his finger to dislodge the enlarged head of protrusion 192 from the slot 194.
  • the passage of the enlarged head of the protrusion through the slot provides tactile feedback to the user that the needle shield has actuated; also, in applying sufficient pressure to force the head through the slot, it is assured that the user's finger has sufficient momentum to fully actuate the needle shield.
  • the user then continues to urge the collapsible extension 130 to cause the needle point cap 110 to slide the length of the needle as shown in Fig. 8.
  • the pressure platform 146 nears and ultimately contacts the lever arm 120.
  • further urging of the collapsible extension 130 causes a force to be applied to the lever arm 120.
  • the needle point clears the hole 114 and becomes located within the chamber 128.
  • Fig. 9 shows the rotated needle point cap 110.
  • the clips 148 engage or surround the needle so that the collapsible extension 130 is clipped in place as shown in Fig. 9. This provides a means to maintain or secure the rotated position of the needle point cap 110 with respect to the needle point by maintaining engagement of the pressure platform 146 with the lever arm 120 so as to prevent the needle point from re-emerging through the hole 114.
  • the clips 148 provide a means for securing the needle point cover 110 in the needle-protective position.
  • the clips also provide additional tactile feedback to the user as they engage the needle shaft.
  • the well chamber 126 serves to capture the needle point and prevent it from re-emerging through the hole 114.
  • the well chamber also helps to capture fluid that might exude from the needle point so that it can not easily escape from the needle point cap.
  • needle sheath 300 can be placed over the needle point cap 110 for convenience and to ensure the capture of any excess fluid which might leak from the hole 114 in the bottom wall 116 of the needle point cap 110.
  • the needle point guard safety cap assembly 400 of the alternate embodiment is also manufactured of a unitary molded plastic piece to increase reliability and to reduce manufacturing and installation cost.
  • the syringe attachment member and the needle point cover must be rotated into position to receive the needle.
  • the syringe attachment member and frame are flexibly coupled.
  • the syringe attachment member or base cup 450 is therefore rotated approximately 90 degrees with respect to the frame 430 so that the needle can extend through the syringe attachment member 450 approximately parallel to the extended frame 430.
  • a lid or enclosing member 418 which is flexibly coupled to the needle point cover 410, is rotated to plug or enclose the cover 410.
  • the enclosed cover which is flexibly coupled to the frame 430, is then rotated so that the needle can pass through both the hole in it and a hole in the syringe attachment member 450.
  • the frame or segmented extension 430 begins to collapse or fold at a flexible portion between the segments.
  • the cover 410 is then slid along the needle shaft away from the needle point.
  • the needle sheath 480 can be placed over the cover 410 in order to more easily manipulate the cover 410.
  • the frame or collapsible extension 430 continues to fold.
  • the frame 430 in co-operation with the syringe attachment member 150, releasably retains the cover
  • sheath 480 to slide the cover 410 down the needle shaft, it too is installed in preparation for distribution.
  • Sheath 480 removal prior to 1] injection does not disturb the retained cover 410, however, the frame can be released by the user to actuate the cover.
  • Figs. 11 & 12 depict alternate sides of the alternate embodiment as it appears after it is removed from a mold.
  • Figs. 13 - 16 depict the presently preferred embodiment as it is being prepared for use with a syringe. Turning to Figs.
  • the needle point guard assembly or needle point cover 400 comprises the needle point cap or cup-shaped member or needle point covering means 410 for covering the point of the needle.
  • the needle point cap or cover 410 is shaped in the form of an elongated member having a circumferential wall 412. One end of the elongated member 412 is open while the other is mostly enclosed by a bottom or end wall 416.
  • the hole or bore 414 in the bottom wall 416 of the needle point cap 410 allows the needle to pass through.
  • a lever arm or rotating means 420 attached to the needle point cap when urged, causes the needle point cap 410 to rotate about the needle point to prevent the needle point from passing through the hole 414.
  • the enclosing member or top wall or lid 118 that is rotated about the needle point cap-to- enclosing member attachment so as to enclose the needle point cap 410.
  • the enclosing member or enclosing means 418 has a bore or hole 422 to allow the needle to pass through.
  • the enclosing member or needle shaft engaging means 418 acts as a fulcrum which engages the needle.
  • the fulcrum or needle shaft engaging means 418 engages the needle and provides a pivot point used for rotating the needle point cap when the needle is passing through enclosing member hole 422 but not through bottom wall hole 414.
  • the needle point cap 410 is coupled to the collapsible extension or collapsible member or collapsible segmented extension 430 which in turn is coupled to the syringe attachment member or base cup 450.
  • the syringe attachment member 450 is used to connect the needle point guard assembly to the needle hub or syringe.
  • the needle point cap 410 to collapsible member 430 coupling means is by direct coupling.
  • the base cup 450 has a circumferential wall 452 and a bottom wall 454.
  • the bottom wall 454 has the hole 456 to allow the needle to pass through.
  • slats 458, which define channels in the inside of the circumferential wall 452 near the bottom wall 454, are included to allow for easy attachment of the base cup 450 to the needle hub.
  • attachment arms 460 extending from the base cup 450 near the bottom wall 454.
  • the attachment arms 460 are used to couple the base cup 450 to the collapsible member 430.
  • the attachment arms 460 are flexibly connected to the collapsible member 430.
  • the collapsible member or extensible frame 430 has many uses. It is used for connecting the syringe attachment member 450 to needle point cover 410 and for releasably securing the needle point cap 410 distal from the needle point.
  • the collapsible segmented extension 430 can be comprised of a wishbone segment 432 and a lower segment 440.
  • the wishbone segment 432 has two arms 434 and a base 436.
  • the wishbone arms 434 are flexibly connected to the base cup attachment arms 460.
  • the lower segment 440 has an upper end 442 and a lower end 444.
  • the wishbone segment base 436 is flexibly connected to the upper end 442 of the lower segment 440.
  • a lower end 444 of the lower segment is flexibly connected to the needle point cap 410.
  • Mounted to the lower segment 440 are two clips 448.
  • the wishbone segment 432 forms an opening or means through which the clips 448 can extend when the collapsible segment 430 is folded.
  • Fig. 12 shows a pressure platform 446 that ultimately contacts the lever arm 420 and causes rotation of the needle point cap 410.
  • Pressure platform 446 is adjacent locking surface or locking ledge 449.
  • the locking surface 449 is used to secure the collapsible extension 430 to the base cup 450 when the extension is collapsed. The locking surface 449 will be discussed in more detail ' later.
  • FIG. 12 also shows a pair of protruding clips 448 that extend from the lower segment 440 to provide a protective position locking means.
  • the clips 448 provide a means to secure the collapsible segmented extension 430 to the needle shaft after needle use. Securing the collapsible segmented extension 430 to the needle shaft ensures that the needle point cap 410 maintains its rotated or skewed position and also maintains the protective position of the needle point cap 410 so that it can not slide back up the needle shaft and expose the needle point.
  • Fig. 13 shows how base cup 450 is rotated in preparation for needle passage through the base cup 450 and attachment to the syringe.
  • the Slats 458 provide a means to orient and prevent rotation of the needle within the base cup when a syringe is attached to or separated from a needle seated in the base cup.
  • the base cup or syringe attachment member 450 also has a protrusion or locking nub 462.
  • the protrusion or locking nub 462 releasably engages the locking surface or locking ledge 449 to provide a locking means when the collapsible extension 430 is collapsed as shown in Figure 16.
  • Fig. 13 also shows how the enclosing member 418 is rotated to enclose the needle point cap 410 to form a chamber 428 shown in Fig. 14.
  • the hole or bore 422 in the enclosing member 418 has partially beveled edges 424.
  • the partially beveled edges 424 allow the needle point cap 410 to more easily rotate about the needle point as is evident in Fig. 9.
  • the needle point cap 410 has an annular channel 426 located around the hole or bore 414. It helps prevent the accidental re-emergence of the needle point through the hole 414 by capturing the needle point after the needle point cap 410 has been rotated about the needle point.
  • Fig. 14 depicts the base cup 450 after rotation and shows the direction of needle insertion in preparation for attachment of the needle point guard safety cap assembly 400 to the syringe.
  • Fig. 14 also depicts the enclosed point cap 410 having the chamber 428.
  • the chamber not only covers the point of the needle but also serves to capture fluid that might exude from the needle point.
  • the arrow adjacent the enclosed needle point cap 410 in Fig. 14 indicates the direction the enclosed needle point cap 410 is rotated in preparation for attachment of the needle point guard safety cap assembly 400 to the syringe. Rotation of the base cup 450 and the enclosed needle point cap 410 allows the needle to pass through both of them in preparation for attachment of the needle point guard safety cap assembly 400 to the syringe.
  • Fig. 15 depicts the needle point guard safety cap assembly 400 attached to the syringe 490 in preparation for receiving a needle sheath 480.
  • the collapsible extension 430 is beginning to collapse as the needle point guard safety cap assembly 400 is installed in preparation for application of needle sheath 480.
  • Fig. 15 also shows how one of the clips 448 will ultimately extend between the arms 434 of the wishbone segment 432 when the collapsible extension 430 is collapsed.
  • Fig. 16 shows the extension 430 collapsed or folded with one of the clips 448 extending between the arms 434 of the wishbone segment 432. Both of the clips 448, as is evident from Fig.
  • Fig. 16 will extend between the arms 434 of the wishbone segment 432 when the collapsible extension 430 is folded.
  • Fig. 15 also depicts the base cup 450 locking nub or protrusion 462 and the locking surface or locking ledge 449 prior to needle sheath 480 application.
  • the locking nub or protrusion 462 on the base cup 450 provides a surface to which the locking ledge or locking surface 449 on the collapsible extension 430 can contact to provide the means for releasable locking.
  • the arms of the wishbone segment 434 allow the locking nub 462 contact the locking surface 449.
  • Fig. 16 depicts the locking surface 449 engaging the locking nub 462 when the sheath is covering the needle. As is evident from Fig.
  • the needle point cap 410 is adapted to receive the needle sheath 480 to protect the needle from contaminants prior to use.
  • the enclosing member or top wall 418 abuts the bottom wall 454 of the base cup 450 to prevent needle contamination.
  • the syringe with the needle point guard safety cap assembly 400 and the needle sheath 480 installed as depicted in Fig. 16, is as the user would receive it prior to use. To use the syringe, the user simply removes the needle sheath and proceeds to use the syringe in the normal manner.
  • the engaged locking nub 462 and locking surface 449 keep the needle point cap 410 from sliding down the needle shaft while the needle sheath 480 is being removed.
  • the user simply urges the folded collapsible extension 430 with his finger to dislodge the locking surface 449 from the locking nub 462.
  • the pressure platform 446 nears and ultimately contacts the lever arm 420.
  • further urging of the collapsible extension 430 causes a force to be applied to the lever arm 420.
  • the needle point clears the hole 414 and becomes located within the chamber 428.
  • the needle point cap 410 rotates about hole 422, and hence about the needle point in response to urging of the lever arm 420.
  • the clips 448 engage or surround the needle so that the collapsible extension 430 is clipped in place.
  • This provides a means to maintain or secure the rotated position of the needle point cap 410 with respect to the needle point by maintaining engagement of the pressure platform 446 with the lever arm 420 so as to prevent the needle point from re-emerging through the hole 414. It also serves provides a means to keep the collapsible extension 430 from folding and allowing the needle point cap 410 to slide back up the needle shaft thereby exposing the needle point. Therefore, the clips 448 provide a means for securing the needle point cover 410 in the needle- protective position.
  • Annular channel 426 serves to capture the needle point and prevent it from re-emerging through the hole 414.
  • the channel also helps to capture fluid that might exude from the needle point so that it can not easily escape from the needle point cap. It is also preferred to have the hole 422 closely surround the needle shaft so that fluid captured in the chamber, can not leak out through the hole 422.
  • needle sheath 480 can be placed over the needle point cap 410 for convenience and to ensure the capture of any excess fluid which might leak from the hole 414 in the bottom wall 416 of the needle point cap 410.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Environmental & Geological Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne différentes forme d'exécution d'un ensemble capuchon de sécurité avec gaine pour pointe d'aiguille. Ces ensembles comprennent une protection (110) de pointe d'aiguille reliée à une structure (130) extensible, elle-même reliée à un élément (150) pouvant être monté sur l'embout de l'aiguille. Avant l'utilisation, la tige de l'aiguille traverse complètement la protection (110) de pointe d'aiguille. Après l'utilisation, l'utilisateur pousse la structure (130) extensible, de manière à faire glisser la protection (110) le long de la tige de l'aiguille jusqu'à ce que la pointe de l'aiguille soit retenue dans la protection (110). Cet ensemble (100) capuchon de sécurité avec gaine pour pointe d'aiguille peut être fabriqué d'une seule pièce dans un matériau plastique souple.
PCT/US1998/020176 1998-09-23 1998-09-23 Ensemble capuchon de securite avec gaine pour pointe d'aiguille WO2000016832A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CNB988142503A CN1193804C (zh) 1998-09-23 1998-09-23 针尖防护安全帽组件
AU97775/98A AU9777598A (en) 1998-09-23 1998-09-23 Needle point guard safety cap assembly
PCT/US1998/020176 WO2000016832A1 (fr) 1998-09-23 1998-09-23 Ensemble capuchon de securite avec gaine pour pointe d'aiguille

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1998/020176 WO2000016832A1 (fr) 1998-09-23 1998-09-23 Ensemble capuchon de securite avec gaine pour pointe d'aiguille

Publications (1)

Publication Number Publication Date
WO2000016832A1 true WO2000016832A1 (fr) 2000-03-30

Family

ID=22267941

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/020176 WO2000016832A1 (fr) 1998-09-23 1998-09-23 Ensemble capuchon de securite avec gaine pour pointe d'aiguille

Country Status (3)

Country Link
CN (1) CN1193804C (fr)
AU (1) AU9777598A (fr)
WO (1) WO2000016832A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
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WO2002072181A2 (fr) * 2001-03-14 2002-09-19 Tyco Healthcare Group Lp Protecteur d'aiguille medicale
EP1346738A1 (fr) * 2002-03-21 2003-09-24 Becton, Dickinson and Company Dispositif de sécurité d'aiguille avec un aileron
EP1350538A1 (fr) * 2002-03-19 2003-10-08 Becton Dickinson and Company Assemblage d'aiguille
WO2007127345A2 (fr) 2006-04-26 2007-11-08 Tyco Healthcare Group Lp appareil de blindage de sécurité et structure de montage pour utilisation avec dispositifs à aiguille médicale
WO2009046560A2 (fr) * 2007-10-12 2009-04-16 Otto Hess Dispositif de sécurité pour la canule d'un instrument invasif
CN102139130A (zh) * 2010-01-29 2011-08-03 林铭田 安全针头套
US8043300B2 (en) 2005-07-05 2011-10-25 Alcon, Inc. Handpiece tip assembly
US11191316B2 (en) 2017-04-26 2021-12-07 Fend Corp. Collapsible helmet
US11471325B2 (en) 2016-09-27 2022-10-18 Sanoculis Ltd. Apparatus for tissue removal
US11583442B2 (en) 2017-04-09 2023-02-21 Sanoculis Ltd. Device and method for creating a channel in soft tissue

Families Citing this family (4)

* Cited by examiner, † Cited by third party
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NZ555327A (en) * 2007-05-21 2009-09-25 Simcro Tech Ltd An applicator which has a two stage interlock that protects from æneedle stickÆ injuries by covering the needle with a shield which also needs to be retracted before a dose can be administered
CN110869072B (zh) 2017-05-30 2021-12-10 西部制药服务有限公司(以色列) 用于穿戴式注射器的模块化驱动机构
CN115634342A (zh) * 2017-05-30 2023-01-24 西医药服务以色列有限公司 用于注射针回缩的针罩
US11266792B2 (en) * 2019-10-28 2022-03-08 FGC Holdings Limited Single use safety needle guard

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EP0344606A2 (fr) * 1988-05-31 1989-12-06 Habley Medical Technology Corporation Fourreau d'aiguille apte à se collaber
US4892521A (en) * 1988-08-03 1990-01-09 Lincoln Mills, Inc. Protective cover for hypodermic needle
US5250031A (en) * 1992-12-14 1993-10-05 The George Washington University Locking needle cover
GB2283429A (en) * 1993-11-04 1995-05-10 David Howell Jenkins A protector for a syringe needle or scalpel
US5549570A (en) * 1993-01-27 1996-08-27 Rogalsky; Alena Medical needle unit
US5735827A (en) * 1996-09-26 1998-04-07 Becton, Dickinson And Company Needle assembly having locking enclosure
US5814018A (en) * 1997-06-20 1998-09-29 Lawrence R. Koh Needle point guard safety cap assembly

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EP0344606A2 (fr) * 1988-05-31 1989-12-06 Habley Medical Technology Corporation Fourreau d'aiguille apte à se collaber
US4892521A (en) * 1988-08-03 1990-01-09 Lincoln Mills, Inc. Protective cover for hypodermic needle
US5250031A (en) * 1992-12-14 1993-10-05 The George Washington University Locking needle cover
US5549570A (en) * 1993-01-27 1996-08-27 Rogalsky; Alena Medical needle unit
GB2283429A (en) * 1993-11-04 1995-05-10 David Howell Jenkins A protector for a syringe needle or scalpel
US5735827A (en) * 1996-09-26 1998-04-07 Becton, Dickinson And Company Needle assembly having locking enclosure
US5814018A (en) * 1997-06-20 1998-09-29 Lawrence R. Koh Needle point guard safety cap assembly

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8226617B2 (en) 1999-11-04 2012-07-24 Tyco Healthcare Group Lp Safety shield apparatus and mounting structure for use with medical needle devices
US8172809B2 (en) 1999-11-04 2012-05-08 Tyco Healthcare Group Lp Safety shield apparatus and mounting structure for use with medical needle devices
WO2002072181A3 (fr) * 2001-03-14 2003-04-10 Tyco Healthcare Protecteur d'aiguille medicale
WO2002072181A2 (fr) * 2001-03-14 2002-09-19 Tyco Healthcare Group Lp Protecteur d'aiguille medicale
EP1350538A1 (fr) * 2002-03-19 2003-10-08 Becton Dickinson and Company Assemblage d'aiguille
EP1346738A1 (fr) * 2002-03-21 2003-09-24 Becton, Dickinson and Company Dispositif de sécurité d'aiguille avec un aileron
US6918891B2 (en) 2002-03-21 2005-07-19 Becton Dickinson Co Safety device
US8043300B2 (en) 2005-07-05 2011-10-25 Alcon, Inc. Handpiece tip assembly
WO2007127345A2 (fr) 2006-04-26 2007-11-08 Tyco Healthcare Group Lp appareil de blindage de sécurité et structure de montage pour utilisation avec dispositifs à aiguille médicale
EP2010257A2 (fr) * 2006-04-26 2009-01-07 Tyco Healthcare Group LP Appareil de blindage de securite et structure de montage pour utilisation avec dispositifs a aiguille medicale
EP2010257A4 (fr) * 2006-04-26 2013-08-07 Covidien Lp Appareil de blindage de securite et structure de montage pour utilisation avec dispositifs a aiguille medicale
WO2009046560A3 (fr) * 2007-10-12 2009-11-05 Otto Hess Dispositif de sécurité pour la canule d'un instrument invasif
WO2009046560A2 (fr) * 2007-10-12 2009-04-16 Otto Hess Dispositif de sécurité pour la canule d'un instrument invasif
CN102139130A (zh) * 2010-01-29 2011-08-03 林铭田 安全针头套
US11471325B2 (en) 2016-09-27 2022-10-18 Sanoculis Ltd. Apparatus for tissue removal
US20230146263A1 (en) * 2016-09-27 2023-05-11 Sanoculis Ltd. Apparatus for tissue removal
US11583442B2 (en) 2017-04-09 2023-02-21 Sanoculis Ltd. Device and method for creating a channel in soft tissue
US11701257B2 (en) 2017-04-09 2023-07-18 Sanoculis Ltd. Device and method for creating a channel in soft tissue
US11974947B2 (en) 2017-04-09 2024-05-07 Sanoculis Ltd. Device and method for creating a channel in soft tissue
US11191316B2 (en) 2017-04-26 2021-12-07 Fend Corp. Collapsible helmet
US11589634B2 (en) 2017-04-26 2023-02-28 Fend Corp. Collapsible helmet

Also Published As

Publication number Publication date
CN1193804C (zh) 2005-03-23
CN1355716A (zh) 2002-06-26
AU9777598A (en) 2000-04-10

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