WO2014107800A1 - Système d'aiguille et procédé l'utilisant - Google Patents

Système d'aiguille et procédé l'utilisant Download PDF

Info

Publication number
WO2014107800A1
WO2014107800A1 PCT/CA2014/000015 CA2014000015W WO2014107800A1 WO 2014107800 A1 WO2014107800 A1 WO 2014107800A1 CA 2014000015 W CA2014000015 W CA 2014000015W WO 2014107800 A1 WO2014107800 A1 WO 2014107800A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
cap body
tip segment
cap
outer end
Prior art date
Application number
PCT/CA2014/000015
Other languages
English (en)
Inventor
Joseph KERR
Michael FERNANDO
Original Assignee
Fernando Kerr Design Inc.
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 Fernando Kerr Design Inc. filed Critical Fernando Kerr Design Inc.
Publication of WO2014107800A1 publication Critical patent/WO2014107800A1/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
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • 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
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • 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
    • A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering 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
    • A61M2005/325—Means obstructing the needle passage at distal end of a needle protection sleeve

Definitions

  • the needle subassembly 14 typically includes a needle base 22 securely engaged with the barrel 16 and a hollow needle 24 securely mounted in the needle base 22.
  • the needle 24 includes a bore therein (not shown in Figs. 1A and IB) that is substantially aligned with the central axis 18 when the needle subassembly 14 is secured to the barrel 16.
  • an embedded portion (not shown in Figs. 1A and IB) of the needle 24 is secured to the needle base 22, and an outer portion 26 of the needle 24 projects from the needle base 22.
  • an end part 28 of the outer portion 26 is inserted into the patient (not shown in Figs. 1A, IB). It will be understood that the extent of the outer portion 26 that is inserted into the patient varies, depending on a number of factors well known in the art.
  • Examples of applications in which needle assemblies are used include, but are not limited to, blood sampling and intra-muscular injection. In blood sampling, in particular, there is a need for the healthcare professional to carefully insert the end part of the outer portion of the needle into a vein or artery in close proximity to the healthcare professional's fingers, which are used to stabilize the patient and sometimes to feel a pulse during the procedure.
  • Arterial blood sampling is a particular type of blood sampling with increased risk to the healthcare professional, due to the delicate nature of the procedure and the proximity of the professional's fingers to the exposed part of the needle during the procedure.
  • First an artery is located by the physician by digital manipulation of the patient's arm, wrist, or other anatomical structure in the case of animals.
  • the end part of the outer portion of the needle is inserted at an angle of approximately 45° into an artery so that at least some of the needle end travels along the artery with the end part directed upstream into the blood flow through the artery.
  • the depth of insertion is typically from three to five millimeters through the patient's skin.
  • the invention provides a needle system including a needle assembly and a cap assembly.
  • the needle assembly includes a syringe having a barrel extending between first and second ends thereof, and a needle subassembly having a needle base extending between a syringe end and a nose end thereof, the syringe end being secured to the first end of the barrel.
  • the needle subassembly also includes an elongate needle including an embedded portion secured to the nose end of the needle base and an outer portion projecting from the nose end.
  • the cap assembly includes a cap body extending between inner and outer ends thereof. The cap body is connected with the needle assembly to permit relative movement between the needle and the cap body.
  • the cap body is movable in a first axial direction relative to the needle in which the outer end of the cap body is moved toward the nose end of the needle base, and the cap body is movable in a second axial direction in which the outer end of the cap body is moved away from the nose end of the needle base.
  • Fig. 2A is a cross-section of an embodiment of a cap assembly of the invention and a needle subassembly, drawn at a larger scale;
  • Fig. 2C is a partial cross-section of the needle system of Fig. 2B with a cap body of the cap assembly thereof in an extended condition, drawn at a larger scale;
  • Fig. 3A is a cross-section of another embodiment of the cap assembly of the invention including a blocking element in an open position thereof, and the needle subassembly, drawn at a larger scale;
  • Fig. 3D is a partial cross-section of the needle system of Fig. 3C in which the blocking element is in the open position and the cap body is in the retracted condition thereof;
  • Fig. 3E is a partial cross-section of the needle system of Figs. 3C and 3D in which the blocking element is in the blocking position and the cap body is in the extended condition thereof;
  • Fig. 4A is a partial cross-section of another embodiment of the needle system of the invention including an alternative embodiment of the cap assembly of the invention in which the blocking element is shown in the open position and the cap body is in an initial extended condition;
  • Fig. 4B is a cross-section of the cap assembly and the needle subassembly of
  • FIG. 4A drawn at a larger scale
  • Fig. 4C is a cross-section of the cap assembly and the needle subassembly of
  • Fig. 4B in which the blocking element is in the open position and the cap body is in the retracted condition
  • Fig. 4D is a cross-section of the cap assembly and the needle subassembly of
  • Fig. 4B in which the blocking element is shown in the blocking position and the cap body is in a final extended condition
  • Fig. 4E is a cross-section of an exploded view of the cap assembly and the needle subassembly of Figs. 4A-4D, drawn at a smaller scale;
  • Fig. 5A is a side view of an alternative embodiment of the needle system of the invention including another embodiment of the cap assembly of the invention in which the cap body is shown in the extended condition thereof, drawn at a smaller scale;
  • Fig, 5B is a side view of the needle system of Fig. 5A in which the cap body is shown in the retracted condition;
  • Fig. 5C is a side view of the needle system of Figs. 5A and 5B in which the cap body is shown in a secured condition;
  • Fig. 6C is a partial cross-section of an embodiment of the needle system of the invention including the cap assembly of Figs. 6A and 6B, drawn at a smaller scale;
  • Fig. 7 is a side view of an embodiment of the needle system of the invention in which an end part of a tip segment of the needle is shown inserted into a patient, drawn at a smaller scale;
  • Fig. 8 is a side view of another embodiment of the needle system of the invention.
  • Figs. 2A-2E describe an embodiment of a needle system in accordance with the invention indicated generally by the numeral 130.
  • the needle system 130 preferably includes a needle assembly 110.
  • the needle assembly 1 10 preferably includes a syringe 112, a barrel 116 extending between first and second ends 132, 134 thereof, and a needle subassembly 114 having a needle base 122 extending between a syringe end 136 and a nose end 138 thereof, secured to the first end 132 of the barrel 116.
  • the needle subassembly 1 14 also includes an elongate needle 124 with an embedded portion 140 secured to the nose end 138 of the needle base 122 and an outer portion 126 projecting from the nose end 138.
  • the needle system 130 includes a cap assembly 144 having a cap body 146 extending between inner and outer ends 148, 150 thereof.
  • the cap body 146 preferably is connected with the needle assembly 1 10 to permit relative movement between the needle 124 and the cap body 146. It is also preferred that the cap body 146 defines an inner chamber 152 between the outer end 150 and the nose end 138 of the needle base 122.
  • the outer end 150 of the cap body 146 preferably includes an aperture 154 through which a tip segment 156 of the outer portion 126 of the needle 124 is movable, to locate the tip segment 156 beyond the outer end 150, and to permit the tip segment 156 to be withdrawn through the aperture 154, to locate the tip segment 156 of the outer portion 126 in the inner chamber 152.
  • the cap body 146 is movable in a first axial direction (indicated by arrow "A” in Fig. 2C) relative to the needle 124 in which the outer end 150 of the cap body 146 is moved toward the nose end 138 of the needle base 122, and the cap body 146 is movable in a second axial direction (indicated by arrow "B” in Fig. 2D) in which the outer end 150 of the cap body 146 is moved away from the nose end 138 of the needle base 122.
  • the first and second axial directions are substantially parallel to an axis 118 of the needle assembly 110 (Figs. 2C, 2D).
  • the cap body 146 is in the extended condition (Fig. 2C).
  • the cap body 146 is then moved by the healthcare professional to the retracted condition (Fig. 2D).
  • the tip segment 156 is ready for use.
  • the tip segment 156 i.e., including the end part 128, preferably is returned to the inner chamber 152 promptly, to minimize the risk of an inadvertent needle stick of the healthcare professional or another by the then-contaminated end part 128.
  • the tip segment 156 is positioned in the inner chamber 152 as described above, i.e., by movement of the cap body 146 from the retracted condition to the extended condition.
  • the needle system 130 may then be discarded in accordance with standard protocols.
  • the tip segment 156 preferably is maintained in the inner chamber 152 (i.e., as illustrated in Figs. 2A and 2C) until the needle system 130 is to be used, e.g., to take blood from the patient. (It will also be understood that the syringe 112 is omitted from Fig. 2A for clarity of illustration.) For the purposes hereof, it will be understood that the extended condition of the cap body before the needle system has been used is sometimes referred to as an "initial extended condition".
  • the needle system 130 preferably is packaged in a blister pack or otherwise suitably packaged (such packaging not shown) upon its manufacture to protect the needle system 130 from contamination prior to use.
  • a suitable means for temporarily securing the cap body relative to the needle is applied or engage to the needle system, before the needle system is package.
  • such means may be suitable adhesive tape, securing the inner end 148 of the cap body 146 to the syringe barrel 1 16 until the packaging is removed from the needle system 130.
  • the securing means i.e., the adhesive tape
  • the adhesive tape is removed, to permit the cap body thereafter to be moved to the retracted condition.
  • the tip segment 156 is exposed for use when the healthcare professional moves the cap body 146 to the retracted condition.
  • the healthcare professional does not move the cap body 146 to the retracted condition until shortly before the healthcare professional is ready to insert the end part 128 into the patient.
  • the cap body 146 After the end part 128 of the tip segment 156 is inserted into the patient and then withdrawn therefrom (i.e., after the needle system has been used), the cap body 146 preferably is moved to the extended condition thereof, so that the tip segment 156 (and the contaminated end part 128) are located in the inner chamber 1 2.
  • the extended condition of the cap body after the needle system has been used is sometimes referred to as a "final extended condition”.
  • the cap body 146 and the needle assembly 110 may be connected in any suitable manner.
  • any such manner of connection permits movement of the cap body 146 relative to the needle 124 between the extended and retracted conditions, as described above.
  • the cap assembly 144 preferably includes a connector 158 for connecting the needle assembly 1 10 and the cap body 146. It is also preferred that the cap body 146 is slidably engaged with the connector 158.
  • the connector 158 may be mounted on the needle assembly 110 in any suitable manner.
  • the connector 158 is positioned between the needle base 122 and the syringe 1 12 and is substantially stationary relative to the needle base 122.
  • the connector 158 preferably includes one or more engagement elements 160 (Fig. 2E) formed and positioned for sliding engagement with edges 162 that define one or more slots 164 along sides 166 of the cap body 146 (Fig. 2B).
  • the connector 158 preferably has any suitable shape.
  • the connector 158 preferably is formed to locate the engagement element(s) 160 for sliding engagement with the edges 162 of the slots 164.
  • the cap body 146 preferably includes two opposed slots 164, and the connector 158 preferably includes two engagement elements 160, one of which is slidably engaged with the edges 162 defining each of the slots 164 respectively.
  • the engagement elements 160 extend into the slots 164, as can be seen in Fig. 2E.
  • the components of the needle system 130 may be assembled in any suitable manner.
  • the syringe 1 12 in order to assemble the needle system 130, the syringe 1 12 preferably is first inverted, i.e., the syringe 1 12 is positioned substantially vertical, with the first end 132 of the barrel 116 located above the second end 134 thereof. It will be understood that, while the syringe 1 12 is held inverted, the other components are also assembled in inverted positions.
  • the barrel 1 16 includes a barrel body 170 and a relatively narrow barrel tip 172 extending from the barrel body 170 at the first end 132 of the barrel 1 16.
  • the connector 158 preferably is positioned on the barrel tip 172, by sliding the connector 158 thereon in the direction indicated by arrow "C" in Fig. 2B, while the syringe 1 12 is inverted.
  • the syringe end 136 of the needle base 122 is positioned on the barrel tip 172, by sliding the needle base 122 onto the barrel tip 172 in the direction indicated by arrow "C” in Fig. 2B, while the syringe 112 is inverted.
  • the connector 158 and the needle base 122 preferably are secured to the barrel tip 172.
  • the connector 158 and the needle base 122 may be secured to the barrel tip 172 in any suitable manner.
  • the connector 158 and the syringe end 136 of the needle base 122 are formed to fit securely onto the barrel tip 172, with the connector 158 preferably secured between the syringe end 136 of the needle base 122 and the barrel body 170.
  • the connector 158 and the syringe end 136 of the needle base 122 define bores 174, 176 therein respectively that are each formed so that the connector 158 and the needle base 122 are secured the barrel tip 172 in any suitable manner.
  • the barrel body 170 includes a substantially planar surface 178 to which the barrel tip 172 is secured, and the connector 158 includes a mating surface 180 that conforms to the surface 178 when the connector 158 is mounted on the barrel tip 172.
  • the needle base 122 preferably is secured to the barrel tip 172 using conventional means, except that the connector 158 is positioned between the needle base 122 and the barrel body 170 after the connector 158 and the needle base 122 are secured to the barrel tip 172.
  • the needle assembly is generally conventional, except that the connector 158 is located between the needle base 122 and the barrel body 170.
  • the cap assembly of the invention preferably is made of any suitable material. Those skilled in the art would be aware of suitable medical grade plastics, e.g., various types of polycarbonate resin. It is preferred that the material of the cap assembly is substantially clear (i.e., transparent) or translucent, to enable the user to observe the position of the tip segment in the inner chamber.
  • FIG. 3C-3E Another embodiment of the needle system 230 of the invention, including another embodiment of the cap assembly 244 of the invention, is illustrated in Figs. 3C-3E.
  • the needle system 230 preferably also includes the needle assembly 110, described above.
  • Figs. 3 A and 3B are cross-sections of the cap assembly 244, and the needle subassembly 114. (It will also be understood that the syringe 1 12 is omitted from Figs. 3A and 3B for clarity of illustration.)
  • the cap assembly 244 includes a cap body 246 having an internal wall 282 spaced apart from an outer end 250 of the cap body 246 (Figs. 3A, 3B).
  • the internal wall 282 includes an opening 284 therein that is substantially aligned with an aperture 254 in the outer end 250, through which the tip segment 156 of the needle 124 is movable.
  • the cap body 246 additionally includes an end wall 286 at the outer end 250, the end wall 286 including the aperture 254.
  • the end wall 286 at least partially defines an end chamber 288 of the cap assembly 244 between the end wall 286 and the internal wall 282. (It will be understood that the end chamber 288 is included in the inner chamber 252.)
  • the cap assembly 244 additionally includes a blocking element 290 at least partially located in the end chamber 288 and movable between an open position (Figs. 3A, 3C), in which movement of the tip segment 156 of the needle 124 through the blocking element 290 is permitted, and a blocking position (Figs. 3B, 3D), in which movement of the tip segment 156 through the blocking element 290 is prevented.
  • the blocking element 290 preferably is held between the internal wall 282 and the end wall 286. Preferably, the blocking element 290 is held therein sufficiently loosely to permit its movement from the open position to the blocking position. In one embodiment, and as will be described, the blocking element 290 preferably is biased to the blocking position.
  • the blocking element 290 includes a channel 292 therethrough, as can be seen in Figs. A and 3B. It is preferred that the channel 292 is substantially straight, and is large enough that part of the tip segment 156 may pass therethrough.
  • the blocking element 290 is movable between the open position (Fig. 3A), in which the channel 292 is substantially aligned with the aperture 254 to permit the tip segment 156 of the needle 124 to be at least partially positioned in the channel 292, and the blocking position (Fig. 3B), in which the channel 292 is non-aligned with the aperture 254, and the blocking element 290 prevents movement of the tip segment 156 into the channel 292.
  • the needle system 230 when ready for use, preferably includes the blocking element 290 in the open position.
  • the tip segment 156 preferably is partially inserted into the channel 292. Specifically, it is preferred that only a part 294 of the tip segment 156 is positioned in the channel 292 when the needle system 230 is manufactured, to hold the blocking element 290 in the open position prior to the needle system's use.
  • the needle system 230 illustrated in Fig. 3C is ready for use.
  • the part 294 of the tip segment 156 functions as a brake or a stop, holding the blocking element 290 in the open position until the needle system 230 has been used.
  • the cap body 246 when the needle system 230 is ready for use as described above, the cap body 246 preferably is in the initial extended condition.
  • the tip segment 156 When the cap body 246 is in the initial extended condition, the tip segment 156 is in an inner chamber 252 located between the outer end 250 and the nose end 138 of the needle base 122.
  • the inner chamber 252 is partially defined by the cap body 246 between the outer end 250 and the nose end 138 of the needle base 122 (Fig. 3B).
  • the cap body 246 when the cap body 246 is in the initial extended condition, only the part 294 of the tip segment 156 is positioned in the channel 292, and the tip segment 156 does not extend beyond the outer end 250.
  • the cap body 246 is moved in the first axial direction relative to the needle 124, to the retracted condition (Fig. 3D).
  • the first axial direction is indicated by arrow "A
  • the blocking element 290 is also moved in the first axial direction, so that the blocking element 290 is moved past part of the tip segment 156, to locate a covered part "Q" of the tip segment 1 6 in the channel 292 when the cap body 246 is in the retracted condition (Fig. 3D).
  • the movement of the blocking element 290 past part of the tip segment 156 as the cap body is moved in the first axial direction is permitted by the alignment of the tip segment 256 with the channel 292 when the blocking element 290 is in the open position.
  • the healthcare professional preferably uses the tip segment 156 for a selected procedure, e.g., taking blood.
  • a selected procedure e.g., taking blood.
  • the cap body 246 is moved in the second axial direction (indicated by arrow "Bi" in Fig. 3D) to a final extended condition (Fig. 3E).
  • the blocking element 290 is held in the open position by the part 294 of the tip segment 156, which is inserted in the channel 292 (Fig. 3A). However, and as can be seen in Fig. 3E, when the cap body 246 is in the final extended condition, no part of the tip segment 156 remains in the channel 292. Because no part of the tip segment 156 remains in the channel 292 at this point, and because the blocking element 290 is biased to the blocking position, the blocking element 290 is allowed to move to the blocking position when the cap body 246 is in the final extended condition.
  • the needle system 230 provides a mechanism for preventing inadvertent movement of the cap body 246 to the retracted condition after the cap body 246 is moved to the final extended condition, thereby significantly reducing the risk of an accidental needle stick with a contaminated needle.
  • the surface 396 is configured in this way to urge the blocking member 390 to move from the open position thereof to the blocking position.
  • the surface 396 is configured to obstruct the blocking element, once in the blocking position, from returning to the open position.
  • the blocking element 290 preferably has any suitable shape so that it is biased, at least partially due to the influence of gravity, to the blocking position.
  • the blocking member 390 is formed in a general diamond shape (e.g., a tetrahedron, or a bisphenoid), so that when in the open position, its ends "E" and "F” (Fig.
  • the blocking element 390 engages the part of the convex region 397 around an opening 384 in the internal wall, and the part of an end wall 386 around an aperture 354 therein.
  • the blocking element 390 is not held securely between the internal wall 382 and the end wall 386. Because the blocking element 390 has a general diamond shape and is positioned on its ends when in the open position, the blocking element 390 is unstable in this position. In particular, because the end "E" is engaged with a rounded part of the convex region 397, the blocking element 390 is unstable.
  • the tip segment 156 includes a part 394 that is positioned in a portion of a channel 392 through the blocking element 390.
  • the part 394 of the needle 124 serves to hold the blocking element 390 in the open position prior to use.
  • the cap body 346 is moved relative to the needle in a first axial direction, indicated by arrow "A 2 " in Fig. 4B, to the retracted condition (Fig. 4C). In this condition, part of the tip segment 156 extends beyond the outer end 350, ready for use in a selected procedure.
  • the cap body 346 preferably is moved by the user in the second axial direction, indicated by arrow "B 2 " in Fig. 4C, to the final extended condition (Fig. 4D).
  • the blocking element 390 rotates or otherwise moves to the blocking position, in which the channel 392 is non- aligned with the opening 384 and the aperture 354.
  • the advantage of the blocking element 390 being biased to the blocking position is that the tip segment 156 cannot again be extended beyond the outer end 350 after the cap body 346 has been moved to the final extended condition.
  • the needle system 430 includes an embodiment of a cap assembly 444 of the invention. It will be understood that the needle system 430 preferably also includes the needle assembly 110, described above.
  • the cap assembly 444 preferably has a cap body 446 that includes one or more lock elements 401. As will be described, each of the lock elements 401 is activated upon the cap body 446 being positioned relative to the needle subassembly 114 of the needle system 430 in a secured condition, in which a tip segment 156 of the needle 124 is located in an inner chamber 452.
  • a connector 458 preferably engages the lock element 401 to secure the needle subassembly 114 and the cap body 446 together when the lock element 401 is activated.
  • the cap body 446 extends between an inner end 448 and an outer end 450.
  • the cap body 446 preferably defines the inner chamber 452 between the outer end 450 and the nose end 138 of the needle base 122 (Fig. 5C). [0075] In one embodiment, the cap body 446 is configured to lock the tip segment
  • the cap body 446 is movable relative to the needle subassembly 114 in the second axial direction past the initial extended condition to the secured condition.
  • the lock element 401 mounted on the cap body 446 is thereby moved in the second axial direction to position the lock element(s) 401 against the connector 458, thereby preventing subsequent movement of the cap body 446 in the first axial direction relative to the needle 124.
  • the needle system 430 enables the user to move the cap body 446 to the secured condition after use, thereby locking the contaminated tip segment 156 in a covered location to minimize the risk of an inadvertent needle stick.
  • cap assembly 544 of the invention preferably is included in another embodiment of the needle system 530 of the invention.
  • the needle system 530 also includes the needle assembly 1 10.
  • the cap assembly preferably includes one or more stop elements 503 for locating a predetermined length "L" of the tip segment 156 outside an outer end 550 of a cap body 546 when the cap body 546 is in the retracted condition. (It will be understood that the syringe 1 12 is omitted from Figs. 6A and 6B for clarity of illustration.)
  • the cap body 546 extends between an inner end 548 and an outer end 550.
  • the cap body 546 defines an inner chamber 552 between the outer end 550 and the nose end 138 of the needle base 122 (Fig. 6A).
  • the cap body 546 is movable between an extended condition and a retracted condition, similar to the embodiments described above.
  • the cap assembly 544 and the needle subassembly 114 are shown in Fig. 6A with the cap body 546 in the extended condition.
  • the tip segment 156 is located in the inner chamber 552.
  • the tip segment 156 extends beyond the outer end 550.
  • the stop element 503 preferably is configured for engagement with the needle base 122 to provide the predetermined length "L" of the tip segment 156 positioned beyond the outer end 550 when the cap body 546 is in the retracted condition.
  • the stop element 503 may be supported for engagement with the nose end 138 in various ways.
  • the stop element 503 preferably is mounted on an internal wall 582 of the cap assembly 544 that is located inside the cap body 546 and spaced apart from the outer end 550.
  • the stop element 503 includes a bore 504 therethrough to permit the stop element 503 to be moved past the tip element 156 as the cap body 546 is moved from the extended condition (Fig. 6A) to the retracted condition (Fig. 6B).
  • an embodiment of a method of the invention preferably includes moving the cap body of the cap assembly of the needle system relative to the needle to locate the tip segment of the outer portion of the needle beyond the outer end of the cap assembly.
  • the patient's skin is pierced at a preselected position thereon with the end part of the tip segment.
  • the end part is removed from the patient.
  • the cap body preferably is moved relative to the needle to position the tip segment in an inner chamber at least partially defined by the cap body between the needle base and the outer end.
  • a cap assembly 744 preferably includes a resilient element 711 that biases a cap body 746 of the cap assembly to an extended condition thereof. (It will be understood that the cap body 746 as illustrated in Fig. 8 is between extended and retracted conditions thereof.)
  • the advantage of the needle system 730 is that the cap body 746 tends to move, relative to the needle 124, to the extended condition, unless the cap body 746 is prevented from doing so.
  • the user may allow the cap body 746 to move to the extended condition, so that the risk of an accidental needle stick with the contaminated tip segment 156 is thereby automatically minimized. In circumstances where the healthcare professional may have only one hand free after the needle has been used, this feature would be useful.
  • FIG. 8 Another alternative embodiment of the needle system 830 is illustrated in Fig.
  • the embodiment of the cap assembly 844 preferably includes a sleeve element 813 formed to assist the healthcare professional positioning the tip segment relative to the patient's skin surface (not shown in Fig. 9).
  • sleeve 813 as illustrated in Fig. 9 includes a contact surface for contacting the patient's skin surface, at an angle relative to the central axis (i.e., relative to the needle 124) identified as a relative to a substantially planar portion of the patient's skin surface.
  • the contact surface 815 preferably is substantially planar.
  • the sleeve 813 preferably is positioned on the cap body 846 when the cap body 846 is in the initial extended condition. However, the sleeve 813 is used when the cap body 846 is in the retracted condition thereof (not shown in Fig. 9). When the cap body 813 is in the retracted condition, the sleeve 813 preferably is positioned on the end region 817 of the cap body 846, to assist the healthcare professional in maintaining a preselected insertion angle as the needle is inserted into the patient.
  • the stop element 503 may be included in the cap assembly that includes the blocking element, and also such cap assembly may include the internal wall that has the convex region formed thereon (illustrated in Figs. 4A-4E).
  • the lock elements 401 may be included in embodiments of the cap assembly that include other elements, e.g., the stop element 503 and the blocking element.

Abstract

La présente invention concerne un système d'aiguille comprenant un ensemble aiguille et un ensemble capuchon. L'ensemble capuchon comprend un corps de capuchon s'étendant d'une extrémité intérieure à une extrémité extérieure de celui-ci. Le corps de capuchon est raccordé à l'ensemble aiguille pour permettre le mouvement relatif entre une aiguille de l'ensemble aiguille et le corps de capuchon. Le corps de capuchon définit une chambre intérieure entre l'extrémité extérieure et une extrémité avant d'une base d'aiguille de l'ensemble aiguille dans lequel l'aiguille est fixée. L'extrémité extérieure du corps de capuchon comprend une ouverture à travers laquelle un segment de pointe de l'aiguille est amovible, pour positionner le segment de pointe au-delà de l'extrémité extérieure, et pour permettre que le segment de pointe soit rétracté à travers l'ouverture, afin de positionner le segment de pointe de la partie extérieure dans la chambre intérieure.
PCT/CA2014/000015 2013-01-11 2014-01-13 Système d'aiguille et procédé l'utilisant WO2014107800A1 (fr)

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US201361751258P 2013-01-11 2013-01-11
US61/751,258 2013-01-11

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4927417A (en) * 1988-07-07 1990-05-22 Schneider Medical Technologies, Inc. Safety sleeve adapter
US4966592A (en) * 1989-05-05 1990-10-30 Burns Cameron A Protective sleeve for hypodermic needle
US4994045A (en) * 1990-04-20 1991-02-19 Sherwood Medical Company Split sleeve safety syringe
US5267977A (en) * 1992-10-29 1993-12-07 Feeney Jr Richard J No-stick syringe
US5342310A (en) * 1992-10-31 1994-08-30 Nihon Chemical Research Co., Ltd. Syringe with needle-hangaring mechanism
US5368577A (en) * 1993-05-24 1994-11-29 Biocon International Corporation Needle stick prevention device
US6190361B1 (en) * 2000-04-18 2001-02-20 Gettig Technologies, Inc. Selectively lockable needle guard
US8128594B1 (en) * 2010-11-03 2012-03-06 Chang li-feng Safety syringe

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4927417A (en) * 1988-07-07 1990-05-22 Schneider Medical Technologies, Inc. Safety sleeve adapter
US4966592A (en) * 1989-05-05 1990-10-30 Burns Cameron A Protective sleeve for hypodermic needle
US4994045A (en) * 1990-04-20 1991-02-19 Sherwood Medical Company Split sleeve safety syringe
US5267977A (en) * 1992-10-29 1993-12-07 Feeney Jr Richard J No-stick syringe
US5342310A (en) * 1992-10-31 1994-08-30 Nihon Chemical Research Co., Ltd. Syringe with needle-hangaring mechanism
US5368577A (en) * 1993-05-24 1994-11-29 Biocon International Corporation Needle stick prevention device
US6190361B1 (en) * 2000-04-18 2001-02-20 Gettig Technologies, Inc. Selectively lockable needle guard
US8128594B1 (en) * 2010-11-03 2012-03-06 Chang li-feng Safety syringe

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