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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/15003—Source of blood for venous or arterial blood
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150473—Double-ended needles, e.g. used with pre-evacuated sampling tubes
  • A61B5/150496—Details of construction of hub, i.e. element used to attach the double-ended needle to a piercing device or sampling device
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/15058—Joining techniques used for protective means
  • A61B5/150618—Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/150633—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
  • A61B5/150641—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position
  • A61B5/150656—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position semi-automatically triggered, i.e. in which the triggering of the protective sleeve requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/150694—Procedure for removing protection means at the time of piercing
  • A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150732—Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
  • A61B5/154—Devices using pre-evacuated means
• • 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
  • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
• • 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
  • A61M5/3257—Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• • 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

Definitions

• This invention relates to the field of protective devices used in health care, and, more particularly, to a needle protective assembly for needlea used for collecting blood from, or dispensing medication to, a patient.
• the assembly includes a protective cover for covering the tip of a needle used with the assembly, after usage, to avoid accidental needlesticks .
• the assembly includes a slidable sheath which moves along a hypodermic needle to lockingly cover the tip, and thereby prevent accidental needlesticks.
• the patented device is useful, but not in every application which involves the use of needles for piercing the human body.
• one area which has been underserved by the prior art is the field of multi-draw needles used for drawing several vials of blood from a patient with only one- neediestick.
• a blood collection tube holder is fitted with a needle for drawing blood.
• a vial for holding blood drawn from the patient is placed in the blood collection tube holder.
• the top of the vial includes a self-sealing rubber top which is pierced by the end of the needle opposite the end which is inserted into the patient.
• the needle conducts blood from the patient into the vial. If more than one vial of blood is required, the first vial may be removed, and replaced by a second vial, without removing the needle from the patient's vein, thereby reducing the amount of trauma suffered by repeated needlesticks, and avoiding scarring .
• the medical professional drawing blood in this fashion has the same imperative to avoid an accidental needlestick and prevent infection as the user of the mentioned devices, but the prior devices may not be suitable for all applications.
• Neither invention is targeted to the particular problems encountered in the field of multi- draw blood collection assemblies, in which the smaller overall profile is desired, with the ability to connect to a larger blood collection tube.
• the prior devices suffer from the drawback that they require assembly before use, and it would be useful to provide a simple unitary device capable of being used without the need to attach a needle to another device, so that it may be manufactured more easily and less expensively.
• the invention is directed to a needle protective assembly in which a slidable sheath is mounted over a barrel which, in turn, encircles a needle.
• the sheath may be spring-loaded to slide along the barrel, and cover the needle after use, protecting against accidental needlesticks .
• the inner barrel is integrally formed with a hub in which the needle is mounted, and which may be used to attach the inventive protective assembly to a blood collection vial holder, or a hypodermic syringe, depending upon the application.
• the protective assembly may also be formed integrally with either the blood collection vial holder, or the hypodermic syringe.
• Figure 1 is a cross-sectional view of the inventive needle protective assembly, before use.
• Figure 2 is a detail of the view of Fig. 1, in which the locking assembly is shown in greater detail.
• Figure 3 is a detail of the hub section of the inventive assembly, showing its integral connection to the barrel of the assembly.
• Figure 4 is an end view of the assembly of Fig.
• Figure 5 is a further detail of the sheath of the assembly shown in Fig. 1, from a rear perspective, to illustrate the features thereof.
• Figure 6 is a cross-section of the assembly of Fig. 1, in which the movable sheath has been locked in place covering the tip of the needle after use, and also showing the connection of the inventive assembly to a blood collection vial.
• Figure 7 is a detail of a second embodiment of the invention, in which the inventive assembly is formed integrally with a syringe assembly, and the needle is omitted for clarity.
• Figure 8 is a cross-section of a third embodiment of the invention, in which the entire inventive assembly is encapsulated with a two-piece protective cap.
• Figure 9 is a cross-sectional view of a fourth embodiment of the inventive needle protective assembly, before use.
• Figure 10 is a further detail of the sheath of the assembly shown in Fig. 9, from a rear perspective, to illustrate the features thereof.
• a needle protective assembly 10 in accordance with the invention is shown in Fig. 1.
• Assembly 10 includes a hollow needle 12.
• Needle 12 defines a longitudinal axis of assembly 10 and includes a first end 14 which is extremely pointed and is the end which is inserted into the patient for dispensing medication or removing blood and a second, opposed, end 16.
• First end 14 is also the end which must be covered after usage to avoid accidental needlesticks.
• First end 14 is connected to second end 16 by a hollow lumen 18 which extends along the longitudinal axis of assembly 10.
• a barrel 20 is securely mounted to needle 12 by a hub portion 22 thereof, disposed at the rear of barrel 20.
• Hub portion 22 is preferably integrally formed as part of barrel 20. Needle 12 extends into hub portion 22, but need not extend to the other side thereof, depending upon the application.
• second end 16 of needle 12 may be disposed within or at the end of hub portion 22, or, as shown in Fig. 1, it may extend past the end of hub portion 22.
• Barrel 20 further includes at least one angled shoulder or pawl 24 on one side thereof. In the preferred embodiment, barrel 20 would include two angled shoulders 24 on opposite sides of barrel 20, as shown in Figs. 1 and 6.
• Shoulder 24 includes a generally flat front side 26 extending axially from barrel 20, a flat top 28, and a sloped rear side 30.
• Rear side 30 need not be sloped, and may instead be generally parallel to front side 26, as a matter of design choice.
• the configuration of shoulder 24 may best be seen in Fig. 2 which is a detailed view of a portion of Fig. 1.
• Hub portion 22 may include a threaded neck 32, depending upon the application, as will be described presently. As best shown in Fig. 3, threaded neck 32, hub portion 22 and barrel 20 are formed integrally as a single piece, permitting barrel 20 to be formed with a reduced diameter (profile) . This reduced profile renders the device less expensive to manufacture, since it uses less material, and, more importantly, renders assembly 10 safer.
• the reduced diameter of barrel 20 makes it less possible for people with small fingers to stick themselves accidentally with needle 12 after usage, and allows for less movement of barrel 20 once locked in place, as described below.
• protective cap 34 is attached to barrel 20 at a frangible line 36.
• Protective cap 34 covers first end 14 of needle 12, and protects against accidental needlesticks prior to use of assembly 10.
• a sheath 38 is slidably mounted about barrel 20.
• Sheath 38 includes a slot 40, in which shoulder 24 is positioned. If assembly 10 includes two shoulders 24, then sheath 38 includes two respective slots 40.
• Slot 40 extends generally parallel to the longitudinal axis of needle 12, and constrains the sliding movement of sheath 38 along barrel 20 to be generally linear, i.e. with no twisting of sheath 38 as it travels the length of barrel 20. The positioning of shoulders 24 in slots 40 may also be seen in Fig. 4.
• Sheath 38 further includes an annular flange 42, which may be used to slide sheath 38 along barrel 20.
• a locking tab 44 projects downwardly and rearwardly from flange 42, into slot 40.
• the bottom of tab 44 is disposed at a height below that of top 28 of shoulder 24.
• a stop 46 is disposed at the rear of sheath 38, and at a height below top 28 of shoulder 24. Stop 46 is positioned a distance from tab 44, so that a gap 48 is formed therebetween.
• Gap 48 is sized to be at least as large as top 28 of shoulder 24, and preferably only slightly larger than top 28
• a rear cap 50 is attached to hub portion 22 before usage, and a sleeve 52 may be placed about second end 16 of needle 12, for additional protection against accidental needlesticks before usage.
• Rear cap 50 may be removably affixed to hub portion 22 in any desired fashion, such as, for example, by frictional seal, and sterile tape (not shown) .
• assembly 10 may simply and effectively protect against accidental needlesticks after usage.
• assembly 10 may be used with a blood collection vial holder 54. After, the user removes rear cap 50 and sleeve 52 (Shown in Fig.
• a threaded portion 56 of blood collection vial holder 54 is threaded onto threaded neck 32 of hub portion 22, so that blood collection vial holder 54 is securely mounted to barrel 20.
• the user will then place a blood collection vial 58 onto second end 16 of needle 12, by piercing a self-sealing rubber cap 60 at the head of blood collection vial 58, in known fashion.
• protective cap 34 is broken off at frangible line 36 (Shown in Fig. 1) exposing first end 14 of needle 12.
• First end 14 is then inserted into the patient for collecting blood, and blood travels through lumen 18, out second end 16 and into blood collection vial 58.
• the user may stop the flow of blood into needle 12 by pressing on the patient's vein, and changing vials. This process is repeated as necessary, until a sufficient amount of blood is drawn.
• needle 12 is removed from the patient, exposing the user to the danger of accidental needlesticks with the contaminated first end 14 of needle 12.
• the user protects himself by pushing on flange 42 in a forward direction, causing sheath 38 to slide along barrel 20.
• sheath 38 is linear, since the movement of sheath 38 is constrained by the co-operation of shoulder 24 in slot 40, until top 28 of shoulder of shoulder 24 contacts the bottom of tab 44. At this point, sheath 38 is still capable of returning to its original position, exposing (the now) contaminated first end 14 of needle 12. To render assembly 10 safe, it is necessary for the user to continue pressing on flange 42, causing rear side 30 of shoulder 24 to contact the bottom of tab 44, and thereby deflect tab 44 upwards, sliding along top 28 of shoulder 24, until shoulder 24 reaches the position illustrated in dashed line as 24' in Fig. 2, wherein shoulder 24 will rest in gap 48 between tab 44 and stop 46.
• This assembly permits the safe and efficient drawing of the patient's blood, and protects against accidental needlesticks after use.
• the reduced open diameter of sheath 38 compared to prior available protective devices renders assembly 10 less prone to accidental needlesticks, as well as cheaper to manufacture.
• inventive assembly 10 with a standard hypodermic syringe, by merely changing threaded neck 22 to a standard luer lock, thereby enabling the connection of assembly 10 to a hypodermic syringe. It would also be possible to reverse the relative positions of shoulder 24 and gap 48, placing a pawl on sheath 38 and a notch in barrel 20 without departing from the scope of the invention described herein, so long as sheath 38 and barrel 20 may be locked in place, with sheath 38 extended past end 14 of needle 12, after use.
• a second end 16' of a needle 12' not extend -into a blood collection tube as shown in the embodiment of the invention shown in Fig. 7.
• a sheath (not shown) may then be positioned identically to sheath 38 of the embodiment shown in Figs. 1-6 on barrel portion 102.
• reducing the overall diameter of the protective device is advantageous for many reasons. While the above-described device reduces the overall diameter of the protective sheath significantly, it may be possible to reduce it further.
• the provision of protective cap 34 within sheath 38 requires a certain amount of clearance between the two elements, to allow for lateral movement of protective cap 34 in the process of breaking it off barrel 20.
• a third embodiment of the invention shown in Fig. 8 the use of a protective cap at the end of barrel 20 is eliminated, permitting an even smaller diameter barrel, and thus an even smaller diameter assembly overall.
• needle protective assembly 200 needle 202 is held within a barrel 204 having an integral hub 206.
• Hub 206 has a threaded portion for mating with a suitable blood collection device (not shown) , or may have a luer lock (also not shown) for mating with a standard syringe. Otherwise barrel 204 is similar in shape and operation to barrel 20 of assembly 10, and co-operates with a sheath 208 which is, in turn, similar in shape and operation to sheath 38 of assembly 10. However, since assembly 200 lacks protective cap 34, the diameter of barrel 204 and sheath 208 may be significantly smaller than those of their counterparts.
• Assembly 200 nonetheless requires some mechanism for protecting against accidental needlesticks before usage, as well as preserving the sterile nature of needle 202. Accordingly, a pair of mating encapsulating caps 210, 212 may be provided. Caps 210, 212 are configured to mate securely and maintain the integrity and safety of assembly 200, as shown.
• Still another embodiment of the invention is shown generally as 300 in Fig. 9, which is generally similar to Fig. 1, and like elements are denoted with a double prime (") .
• a spring 302 is mounted between annular flange 42" and rear cap 50", and co-axially with needle 12".
• Spring 302 is biased to urge sneath 38" is the direction of first end 14" of needle 12" (to the left in Fig. 9) , rendering it easier to move sheath 38" along barrel 20" .
• sheath 38" may be formed shorter that the distance between stop 46" and shoulders 24" . In this instance, slot 40" will not engage shoulder 24" and permit movement of sheath 38" unless they are aligned.
• sheath 38" may be rotated so that slot 40" is out of engagement with shoulder 24" .
• Spring 302 will urge sheath 38" towards its first position nonetheless, but the non-alignment of slots 40" and shoulders 24" will prevent movement of sheath 38" .
• sheath 38" is rotated to permit slot 40" to engage shoulder 24" , and enable the linear movement of sheath 38" along barrel 20".
• sheath 38" reaches the end of its length of travel, it may be locked as described above .
• a projection 304 may be added to annular flange 42" (see Fig. 10), so that the user may have a convenient surface for gripping sheath 38" for rotation thereof, and subsequently enabling the movement of sheath 38" along barrel 20" .
• a notch could be cut in annular flange 42" to add a surface on which pressure may be more easily exerted to effect rotation of sheath 38" . In this fashion, the movement of sheath 38" into its desired position covering first end 14" is facilitated.
• spring 302 may be any type of device for urging sheath 38" into its desired position.
• it could take the form of a resilient element (such as, for example, a foam or compressed fluid) which, when compressed, tends to expand, and thereby urge sheath 38" as indicated.
• spring 302 could comprise a set of resilient fingers biased to urge sheath 38" into its first position, or any other device capable of imparting movement to sheath 38" .

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

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Citations (3)

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• 2002
  • 2002-01-24 WO PCT/US2002/002250 patent/WO2003095002A1/en not_active Application Discontinuation
  • 2002-01-24 AU AU2002320357A patent/AU2002320357A1/en not_active Abandoned
  • 2002-01-24 WO PCT/US2002/021639 patent/WO2002092137A2/en not_active Application Discontinuation
  • 2002-01-24 EP EP02749870A patent/EP1399208A4/de not_active Withdrawn
  • 2002-01-24 AU AU2002332384A patent/AU2002332384A1/en not_active Abandoned

Patent Citations (3)

Non-Patent Citations (1)

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