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WO2006032064A1 - Dispositif ameliore de protection d'aiguille - Google Patents

Dispositif ameliore de protection d'aiguille Download PDF

Info

Publication number
WO2006032064A1
WO2006032064A1 PCT/ZA2005/000139 ZA2005000139W WO2006032064A1 WO 2006032064 A1 WO2006032064 A1 WO 2006032064A1 ZA 2005000139 W ZA2005000139 W ZA 2005000139W WO 2006032064 A1 WO2006032064 A1 WO 2006032064A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
tubular member
end cap
hypodermic
hypodermic needle
Prior art date
Application number
PCT/ZA2005/000139
Other languages
English (en)
Inventor
Ricardo Sheath Oxford Steyn
Original Assignee
Ratio Investments Close Corporation
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 Ratio Investments Close Corporation filed Critical Ratio Investments Close Corporation
Publication of WO2006032064A1 publication Critical patent/WO2006032064A1/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
    • 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of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle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
    • A61M5/178—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
    • 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
    • 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

  • This invention relates to a needle protective device. More particularly, this invention relates to a protective device for a needle of a hypodermic syringe, catheter or the like device for use on humans or animals.
  • Hypodermic needles are widely used all over the world for medical (human and veterinary) use, including, but not limited to the administration of injections, the drawing of blood, intravenous feeding etc. People who handle these needles on a daily basis, such as medical professionals and cleaning personnel are at risk of accidental needle stick injuries, i.e. the accidental piercing of the body with the point of the needle. This is obviously dangerous as the needle may be contaminated by dangerous pathogens. Even more obvious today are the dangers presented to medical and cleaning personnel who handle hypodermic needles and apparatus including hypodermic needles, in the form of Acquired Immune Deficiency Syndrome or AIDS, which can easily be transmitted to such personnel as a result of needle stick injuries.
  • a hypodermic needle protective device which includes a slightly curved elongate tubular member having disposed about its circumference at least one elongate axial cut-out in a wall thereof extending over a greater portion of its length, manufactured of a resiliently flexible material, the tubular member having, at its one end, attachment means for attachment to a hub of a hypodermic needle and having, at its opposite end, an end cap manufactured of a hard material, the end cap having a blocking surface in which is formed an opening through which a point of the needle can pass, in use, and a guide formation for guiding the needle towards the opening in the blocking surface, in use.
  • the end cap may be manufactured of a hard plastics material.
  • the end cap is manufactured of a transparent, hard plastics material.
  • the tubular member is approximately the same length as a hypodermic needle to which it is attached. Once attached, the slightly curved tubular member circumscribes the needle, which extends the length of the tubular member and the point of the needle is displaced from the center or longitudinal axis of the tubular member near its free end due to the curvature of the tubular member.
  • the terms “slightly curved” or “curved” in relation to the tubular member means curved to the extent that a straight line of substantially the same length as the tubular member, extending from the center of one end of the tubular member, terminates at a position which is off-set from the center of the tubular member at its opposite end.
  • the end cap encloses the point of the needle, which needle point is displaced from the center of the end cap due to the curvature of the tubular member.
  • the end cap includes an opening through which the needle point extends during use and this opening is located at a side of the end cap which is opposite to the side to which the needle point is displaced.
  • the needle point and the end cap opening are not aligned and a positive alignment action by the user is required to align the needle point and the end cap opening. This misalignment of the needle point and the end cap opening serves to prevent or minimise accidental needle stick injuries.
  • the tubular member includes two axial cut-outs, preferably diametrically opposed to each other.
  • the cut-outs may be in the form of slots or splits in the wall of the tubular member. In a preferred form of the invention, the cut-outs terminate in rounded holes.
  • the end cap may, in one form of the invention, include a chamber which is open at one end which is attached to one end of the tubular member, the blocking surface being sloped and located at an opposite end of the chamber.
  • the end cap may be provided internally with one or more guide formations for guiding a point of the needle to a mouth of the opening when the needle is displaced sideways within the end cap.
  • the guide formations may be in the form of ridges or slots defined in the wall of the end cap.
  • the end cap preferably defines an open spigot formation having an outwardly extending collar, the one end of the tubular member locating over the spigot formation and bearing against the collar, in use.
  • the collar may include one or more cut-outs to accommodate gripper elements during an assembly process to stretch the tubular member over the spigot formation.
  • the tubular member may be made from a silicone rubber material having a Shore hardness of between 30 and 80.
  • the tubular member may be moulded or extruded. Preferably, the tubular member is extruded.
  • the tubular member is extruded with an uneven side wall thickness.
  • the uneven side wall thickness of the tubular member causes it to be extruded in a curved shape, the diameter of the curve being relative to the difference in the thickness of the side wall of the tubular member. I.e., the greater the difference in the wall thickness of the tubular member, the smaller the curvature diameter.
  • the tubular member may be mounted to the needle hub in a skewed manner so as to deform the tubular member slightly into a curved shape relative to the needle.
  • the tubular member may further include laterally extending fins.
  • the fins may terminate in rounded bead formations.
  • the bead formations allow the gripper elements to be attached to the fins in order to stretch the tubular member over the hub of the needle and over the spigot formation of the end cap during an automated assembly process of the device.
  • the end cap is preferably made from a transparent material so that at least the point of the needle is visible.
  • the end cap is preferably made by way of an injection moulding process, from a hard plastics material.
  • the needle includes a bevel which, in use, is orientated opposite to the slope of the blocking surface. In this way, when the needle point is directed towards the opening in the blocking surface and touches the side wall of the end cap, the point does not snag against the side wall.
  • the needle once the protective device has been attached thereto, may be bent slightly to remain out of alignment with the opening in the end cap. In this way, a skewed fitting of the device to the needle is obviated.
  • hypodermic needle having attached thereto a protective device as defined above.
  • the hypodermic needle may be in the form of catheter or the like.
  • the invention further extends to a method of assembly of a hypodermic needle including a hypodermic needle protective device as defined above and to method of assembly of a hypodermic catheter device including a hypodermic needle protective device.
  • Figure 1 is a partly sectioned side view of a hypodermic needle fitted with a needle protective device according to the invention
  • Figure 2 is a side view of the needle and device of Figure 1 , viewed from a direction 90 degrees rotated from the direction shown in Figure 1;
  • Figure 3 is a top view of the needle and device of Figures 1 and 2;
  • Figure 4 is a sectioned view of the needle and device of Figures 1 and 2 along line III - Ill, showing the positions of feeder rollers during the manufacturing stage of the tubular member;
  • Figure 5 is a side view of the device of Figures 1 and 2 with the needle exposed and ready for use;
  • Figure 6 is a partly sectioned, schematic side views of a catheter arrangement fitted with a needle protective device according to the invention.
  • Figure 7 is a schematic side view of the arrangement of Figure 1 with the needle of the catheter extended into the cannula.
  • a needle protective device 10 according to the invention is shown to be fitted to a hypodermic needle 12.
  • the device 10 includes attachment means 13, a tubular member 14 and an end cap 16 which protects the point 15 of the needle 12 during handling.
  • the tubular member 14 is made from medical grade silicon rubber with a Shore hardness of between 30 and 80 in an extrusion process. As is evident from Figure 1 , the member 14 is slightly curved. The curvature may be attained in various ways, but in this embodiment, an extrusion die (not shown) is used which gives the one side wall of the tubular member a slightly greater thickness than the opposite side. A slight curvature can also be attained by providing a slight bend in the extrusion die (not shown) or by way of special post curing processes or by a combination of the above.
  • the silicone rubber is transparent but may be colour coded to indicate needle dimensions.
  • An advantage of using a resiliently flexible member include the fact that the member can be twisted axially and still resume its shape after release.
  • the overall design of the device furthermore lends itself to use by a left- or right handed user.
  • the curvature may also be obtained by a "skewed" fitting of the member 14 to the hub 22 of the needle 12 (or to the end cap 16, for that matter). This would be accomplished by, instead of locating the end of the member 14 flush against the collar 30 as shown in Figure 1 , only a portion, or one side of the end of member 14 (the right hand side in Figure 1 for purposes of this illustration) bears up flush against the collar 30 and the other side (the left hand side) extends only to position A indicated on Figure 1.
  • the curvature can also be obtained during a process of "curing" after extrusion when the tubular member raw material lies rolled up for a period of time - typically ten days or so.
  • the tubular member 14 can be moulded from a mouldable plastics material, and the mould defining the required slight curve.
  • the tubular member 14 is in the form of a slightly curved cylinder having axially extending slots 18 therein.
  • the slots 18 terminate in rounded holes 19 to prevent the slots 18 from tearing.
  • the tubular member 14 further includes laterally extending fins 17 which terminate in bead formations 20.
  • the bead formations 20 provide purchase to grippers (not shown) which grip and stretch the fins 17 over a hub 22 of the needle 12 and a spigot formation 24 on the end cap 16 during assembly.
  • the member 14 is located between two feeder rollers 21.
  • the feeder rollers 21 extend the member 14 from a roll of raw material (not shown) to a die (not shown) which cuts the slots 18.
  • the feeder rollers 21 grip the member 14 between fins 17 as shown, and have knurled contact surfaces where the rollers 21 make contact with the member 14.
  • the end cap 16 also includes a collar 26 against which the tubular member 14 bears once attached to the end cap 16.
  • the collar 26 includes a plurality of cut-outs 28 to provide space for the grippers (not shown) during an automated assembly process.
  • the needle 12 is conventional and includes a hub 22 with an end collar 30 and an elongate hollow steel shaft 32 extending from the hub 22.
  • the end cap 16 is made from medical grade clear polystyrene and defines an inner chamber 34, a sloped blocking surface 36 and an opening 38 in the blocking surface 36.
  • On the inner chamber is provided a guide formation 39 (see Figures 1 and 2).
  • the guide formation 39 defines a pair of parallel ridges 41 (see Figure 2) which extend towards the mouth of the opening 38 as shown in Figure 2.
  • the guide formation 39 aids a user in finding the opening 38 easily and quickly when the needle point 15 is required to be advanced through the opening 38.
  • end cap 16 can be made from any suitable hard plastics material, including polypropylene or polycarbonate.
  • the attachment means13 is defined by the lower end of the tubular member 14 and is attached to the hub 22 by way of a friction fit method, adhesive or a combination thereof.
  • the sloped blocking surface 36 is so shaped to facilitate the administration of an intravenous injection where the needle 12 is required to enter the patient at an angle.
  • the shaft 32 may be bent slightly further to facilitate this type of procedure.
  • notches 50 are provided along the edges of the axial slots 18 in the tubular member 14. These notches 50 ensure that when the tubular member 14 is axially compressed it will be disposed to bow outwardly as shown in Figure 5, enabling the end cap 16 to be retracted over the shaft 32 of the needle 12 until it encounters the needle hub 22.
  • the notches 50 require a notch shaped cutting tool during the manufacturing process and the shape of such a tool provides for a more stable cutting operation than a straight tool.
  • the invention allows the needle 12 to remain sterile through an entire injection procedure as it is not at any stage, before, during and after the procedure, necessary to touch the needle 12.
  • the end cap 16 can be used to bear against the needle 12 for purposes of bending the shaft 32 as described above. Again, this procedure allows bending the shaft 32 without the user having to touch it.
  • syringes can be pre filled with medication and used as and when required, without having to cap the needles after filling.
  • the device is shown to include a lever 25 (shown in broken lines).
  • This lever 25 is useful in certain applications where a user may want to administer repeated injections without the end cap 16 automatically covering the needle point 15.
  • the needle shaft 32 is "jammed” in opening 38 and the cap is held back by means of friction between the needle shaft 32 and the opening 1 38. This works particularly well when the opening 38 is made very small, i.e. only just big enough for the needle to pass through straight.
  • the lever 25 is flicker forward to release the needle 32 from the opening and the end cap 16 moves over the needle point 15.
  • a needle protective device 110 is shown to be fitted to a hypodermic needle 112.
  • the device 110 includes an attachment means 113, a tubular member 114 and an end cap 116 which protects the point 115 of the needle 112 during handling.
  • the arrangement further includes a cannula 117 which locates over a spigot formation 118 on the end cap 116.
  • the end cap 116 includes a flange 116.1 which is orientated at an angle "a" relative to a line perpendicular to the longitudinal axis L of the end cap 116 as shown in Figure 6.
  • the tubular member 114 is attached to the end cap 116 so that the end of the tubular member 114 bears flush against the flange 116.1 and this causes the tubular member 114 to be curved slightly out of axial alignment with the longitudinal axis L.
  • the arrangement thus causes the tip 115 of the needle 112 to be off-set within the end cap 116 as shown in Figure 1.
  • the tubular member 114 is made from medical grade silicon rubber with a Shore hardness of between 30 and 80 in an extrusion process.
  • the needle 112 is conventional and includes a hub 122 with an end collar 130 and an elongate hollow steel shaft 132 extending from the hub 122.
  • the end cap 116 is made from medical grade clear polystyrene and defines an inner chamber 134, a sloped blocking surface 136 and an opening 138 in the blocking surface 136.
  • the attachment means 113 is defined by the lower end of the tubular member 114 and is attached to the hub 122 by way of a friction fit method, adhesive or a combination thereof.
  • the needle shaft 132 and the cannula 117 are inserted into a vein (not shown) of a patient.
  • the friction between the undersized cannula 117 and the needle shaft 132 retain the arrangement 110 in position as shown in Figure 7.
  • the needle shaft 132 may be slightly bent to provide the necessary friction between itself and the cannula 117.
  • the invention allows the needle 112 to remain sterile through the procedure as it is not at any stage, before, during and after the procedure, necessary to touch the needle 112.
  • the tubular member 114 once bowed outwardly as shown in Figure 7 and the end cap 116 having extended over the shaft 132, is held firm to expose the needle 132 and the cannula 117. Once the procedure is completed, the user releases the held down tubular member 114 and its resiliently flexible nature causes to resume its shape so that the end cap 116 again covers the needle point 115. Thus, no re ⁇ capping of the needle 126 is necessary after use.
  • One of the main advantages of the invention is that it requires no positive intervention from the user to make the device safe after use.
  • the tubular member is simply released which causes the end cap to cover the tip of the needle.
  • the user needs to pull or push the plunger of the device until he or she hears or feels a positive "click" which is not necessary with the current invention.

Landscapes

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

Abstract

L'invention concerne un dispositif de protection d'aiguille hypodermique, comprenant un élément tubulaire allongé (14), légèrement incurvé, comportant au moins une découpe axiale allongée (18) dans sa paroi, sur une grande partie de sa longueur. Cet élément tubulaire est fabriqué à partir d'un matériau flexible et comprend, à une extrémité, un moyen de fixation destiné à être relié à un raccord (22) d'aiguille hypodermique, et à son extrémité opposée, un capuchon d'extrémité (16) fabriqué à partir d'un matériau rigide. Ce capuchon d'extrémité comporte une surface de blocage (36) dans laquelle est formée une ouverture (38) par laquelle la pointe (15) de l'aiguille peut passer, lorsqu'elle est utilisée, et un canal de guidage (39) permettant de guider l'aiguille vers l'ouverture, dans la surface de blocage, lorsque l'aiguille est utilisée.
PCT/ZA2005/000139 2004-09-15 2005-09-13 Dispositif ameliore de protection d'aiguille WO2006032064A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
ZA200407387 2004-09-15
ZA200407388 2004-09-15
ZA2004/7388 2004-09-15
ZA2004/7387 2004-09-15

Publications (1)

Publication Number Publication Date
WO2006032064A1 true WO2006032064A1 (fr) 2006-03-23

Family

ID=35355501

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ZA2005/000139 WO2006032064A1 (fr) 2004-09-15 2005-09-13 Dispositif ameliore de protection d'aiguille

Country Status (1)

Country Link
WO (1) WO2006032064A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007141603A2 (fr) * 2006-03-14 2007-12-13 Ricardo Sheath Oxford Steyn dispositif de protection pour assemblage à aiguille
WO2009140529A2 (fr) 2008-05-14 2009-11-19 John Stephens Dispositif de protection d'aiguille
US8821453B2 (en) 2011-07-25 2014-09-02 Safety Syringes, Inc. Folding panel needle guard
CN105288800A (zh) * 2015-12-01 2016-02-03 辛莉 安全注射器

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4911706A (en) * 1988-10-14 1990-03-27 Regents Of The University Of Minnesota Automatic needle cover
US4978344A (en) * 1988-08-11 1990-12-18 Dombrowski Mitchell P Needle and catheter assembly
DE4201228A1 (de) * 1991-01-22 1992-07-23 Ricardo Sheath Oxford Steyn Schutzeinrichtung fuer die nadel einer spritze
EP0752252A2 (fr) * 1995-06-07 1997-01-08 JOHNSON & JOHNSON MEDICAL, INC. Dispositif de protection de pointe
US5746718A (en) * 1994-07-05 1998-05-05 Steyn; Ricardo Sheath Oxford Needle protective device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4978344A (en) * 1988-08-11 1990-12-18 Dombrowski Mitchell P Needle and catheter assembly
US4911706A (en) * 1988-10-14 1990-03-27 Regents Of The University Of Minnesota Automatic needle cover
DE4201228A1 (de) * 1991-01-22 1992-07-23 Ricardo Sheath Oxford Steyn Schutzeinrichtung fuer die nadel einer spritze
US5746718A (en) * 1994-07-05 1998-05-05 Steyn; Ricardo Sheath Oxford Needle protective device
EP0752252A2 (fr) * 1995-06-07 1997-01-08 JOHNSON & JOHNSON MEDICAL, INC. Dispositif de protection de pointe

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007141603A2 (fr) * 2006-03-14 2007-12-13 Ricardo Sheath Oxford Steyn dispositif de protection pour assemblage à aiguille
WO2007141603A3 (fr) * 2006-03-14 2008-03-06 Ricardo Sheath Oxford Steyn dispositif de protection pour assemblage à aiguille
US8460246B2 (en) 2006-03-14 2013-06-11 Ricardo Sheath Oxford Steyn Protective device for a needle assembly
WO2009140529A2 (fr) 2008-05-14 2009-11-19 John Stephens Dispositif de protection d'aiguille
EP2296735A2 (fr) * 2008-05-14 2011-03-23 John Stephens Dispositif de protection d'aiguille
EP2296735A4 (fr) * 2008-05-14 2013-05-29 John Stephens Dispositif de protection d'aiguille
US8821453B2 (en) 2011-07-25 2014-09-02 Safety Syringes, Inc. Folding panel needle guard
US9925341B2 (en) 2011-07-25 2018-03-27 Safety Syringes, Inc. Folding panel needle guard
CN105288800A (zh) * 2015-12-01 2016-02-03 辛莉 安全注射器

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