US20030208160A1 - Needle assembly - Google Patents

Needle assembly Download PDF

Info

Publication number
US20030208160A1
US20030208160A1 US10/173,928 US17392802A US2003208160A1 US 20030208160 A1 US20030208160 A1 US 20030208160A1 US 17392802 A US17392802 A US 17392802A US 2003208160 A1 US2003208160 A1 US 2003208160A1
Authority
US
United States
Prior art keywords
assembly
patient
blunting member
blood collection
hub assembly
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
US10/173,928
Inventor
Jamieson Crawford
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
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 Becton Dickinson and Co filed Critical Becton Dickinson and Co
Priority to US10/173,928 priority Critical patent/US20030208160A1/en
Assigned to BECTON, DICKINSON AND COMPANY reassignment BECTON, DICKINSON AND COMPANY ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CRAWFORD, JAMIESON WILLIAM MACLEAN
Publication of US20030208160A1 publication Critical patent/US20030208160A1/en
Priority to US11/170,130 priority patent/US7678076B2/en
Priority to US12/694,568 priority patent/US7972309B2/en
Abandoned legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154Devices using pre-evacuated means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150503Single-ended needles
    • A61B5/150519Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150572Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150633Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
    • A61B5/150641Protective 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694Procedure for removing protection means at the time of piercing
    • A61B5/150717Procedure for removing protection means at the time of piercing manually removed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150732Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/15074Needle sets comprising wings, e.g. butterfly type, for ease of handling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150801Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
    • A61B5/150809Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by audible feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150801Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
    • A61B5/150816Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by tactile feedback, e.g. vibration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150885Preventing re-use
    • A61B5/150916Preventing re-use by blocking components, e.g. piston, driving device or fluid passageway
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M2005/3212Blunting means for the sharp end of the needle

Definitions

  • the present invention relates to needle assemblies having a blunting element for safe and convenient handling. More particularly, the present invention relates to a non-patient needle assembly which includes a blunting element for the non-patient needle for use in connection with a blood collection set.
  • Disposable medical devices having piercing elements are typically used for administering a medication or withdrawing a fluid, such as blood collecting needles, fluid handling needles and assemblies thereof.
  • a fluid such as blood collecting needles, fluid handling needles and assemblies thereof.
  • Current medical practice requires that the fluid containers and needle assemblies used in such systems be inexpensive and readily disposable. Consequently, existing blood collection systems, for example, typically employ some form of durable, reusable holder on which detachable and disposable needles and fluid collection tubes may be mounted.
  • a blood collection system of this nature can be assembled prior to use and then disassembled after usage.
  • these blood collection systems allow repeated use of the relatively expensive holder upon replacement of the relatively inexpensive needle and/or fluid collection tube.
  • these blood collection systems also help minimize the production of hazardous medical waste.
  • a particularly useful intravenous tubing set for such application is the VACUTAINER® Brand Safety-LokTM Blood Collection Set, available from Becton Dickinson and Company of Franklin Lakes, N.J.
  • a Blood Collection Set includes an intravenous needle assembly attached to one end of a tube, with the other end of the tube connected to a blood collection needle assembly including a stopper puncture needle, or a “non-patient” puncture needle.
  • the intravenous needle assembly is inserted into the vein of a patient, and a tube holder is attached to the blood collection needle assembly.
  • An evacuated tube is inserted into the tube holder, and the stopper puncture needle or non-patient puncture needle punctures the stopper of the tube, allowing blood to flow into the tube.
  • WO 98/42393 discloses a parenteral fluid transfer apparatus useful as a blood collection assembly, which includes an intravenous needle assembly having a rod or probe-like blunting member which is extendable beyond the tip of the intravenous needle tip to prevent accidental needle-stick wounds from occurring after use of the device. Such a device, however, does not provide protection for the second end of the needle at the non-patient end of the assembly.
  • the present invention is directed to a non-patient safety needle assembly for mounting with a conventional intravenous blood collection set.
  • the non-patient needle assembly includes a hub assembly having opposing first and second ends, with the first end being adapted for mounting with a blood collection set.
  • An internal blunting member is in fixed engagement with the hub assembly.
  • the internal blunting member includes a first end which is concentric with the hub assembly, a second end having a blunted tip, and an internal lumen which extends through the internal blunting member from the first end to the blunted tip.
  • the needle assembly also includes an external cannula concentric with the internal blunting member and axially displaceable with respect to the hub assembly.
  • the external cannula includes a non-patient puncture tip at one end thereof adjacent the blunted tip of the internal blunting member.
  • the external cannula is adapted for axial displacement with respect to the hub assembly between a first retracted position, in which the non-patient puncture tip extends beyond the blunted tip, and a second activated position in which the blunted tip extends beyond the non-patient puncture tip.
  • the non-patient needle assembly preferably includes a carriage assembly which is integral with the external cannula and concentric with the internal blunting member, and which is in slidable engagement with the hub assembly. Also, a sleeve preferably extends about the non-patient puncture tip.
  • the needle assembly also includes a fitting, such as a luer fitting, for engagement with a blood collection set. Additionally, the needle assembly includes means for attaching the needle assembly to a holder capable of holding blood collection tubes, such as threads extending circumferentially about the hub assembly.
  • the external cannula is axially displaceable between the first retracted position and the second activated position in a single axial direction.
  • the needle assembly may also include a locking mechanism for preventing axial displacement of the external cannula from the second activated position to the first retracted position.
  • the present invention is also directed to a blood collection set which includes such a non-patient needle assembly in fluid communication with a tubing, which tubing is in fluid communication with an intravenous needle assembly including a needle having an intravenous puncture tip.
  • the non-patient needle assembly includes a hub assembly which is removably attached to the tubing, such as through a luer fitting.
  • FIG. 1 is a perspective view of a blood collection set in accordance with the present invention, including a non-patient safety needle assembly attached to an intravenous needle assembly through tubing.
  • FIG. 2 is a perspective view of a non-patient safety needle assembly in accordance with the present invention shown in a retracted position.
  • FIG. 3 is a side cross-sectional view of the non-patient safety needle assembly of FIG. 2 shown in a retracted position.
  • FIG. 4 is a perspective view of the non-patient safety needle assembly of FIG. 2 shown in an activated blunted position.
  • FIG. 5 is a side cross-sectional view of the non-patient safety needle assembly of FIG. 4 in an activated blunted position.
  • FIG. 1 illustrates a blood collection set in accordance with the present invention and the related features.
  • the present invention is generally described in terms of a blood collection set, and encompasses such a blood collection set as well as a non-patient safety needle assembly for use in such a blood collection set.
  • Blood collection set 10 is depicted generally including non-patient needle assembly 12 in engagement with a conventional intravenous blood collection assembly.
  • Non-patient needle assembly 12 and the intravenous blood collection assembly include interrelating elements to provide for engagement therebetween.
  • non-patient needle assembly 12 is interconnected with intravenous needle assembly 90 through tubing 84 .
  • Such interconnection may be provided through any method as is known in the art, such as through a luer fitting.
  • Intravenous needle assembly 90 includes an intravenous cannula 92 having an intravenous puncture tip 94 , for insertion into the vein of a patient, for example, during a blood collection procedure.
  • Intravenous needle assembly 90 further includes a butterfly-type wing assembly 96 , for use in connection with positioning and placement of intravenous needle assembly 90 during a blood collection procedure, as is known in the art.
  • intravenous needle assembly 90 is interconnected through tubing 84 to non-patient needle assembly 12 .
  • non-patient needle assembly 12 may be provided with means for attachment to a separate holder (not shown) for use in connection with blood collection tubes, such as a snap fit attachment, or, more desirably, attachment threads 14 which engage a threaded section of the holder.
  • Non-patient needle assembly 12 of the present invention is shown more particularly at FIGS. 2 - 5 .
  • Non-patient needle assembly 12 includes hub assembly 20 having first end 22 and second end 24 , with an internal opening 26 extending therethrough from first end 22 to second end 24 .
  • First end 22 of hub assembly 20 is adapted for mounting with tubing 84 of blood collection set 10 .
  • hub assembly 20 may further include ferrule 30 extending from first end 22 .
  • Ferrule 30 may be integrally formed with hub assembly 20 , or may be a separate member attached to hub assembly 20 .
  • hub assembly 20 includes shoulder 34 at an internal opening within first end 22 for engagement with ferrule 30 such that ferrule 30 interfits within first end 22 and rests against shoulder 34 of hub assembly 20 .
  • Ferrule 30 includes an internal opening 36 extending therethrough, which is in fluid communication with internal opening 26 of hub assembly 20 .
  • Non-patient needle assembly 12 further includes internal blunting member 40 in fixed engagement with hub assembly 20 .
  • Internal blunting member 40 is a generally tubular hollow structure which includes first end 42 and second end 44 with a central bore or internal lumen 48 extending through the length thereof. Internal lumen 48 allows fluid flow through needle assembly 12 during use. Second end 44 is blunted to form blunt tip 46 as an end portion, such that, under ordinary hand pressure, blunt tip 46 will not easily puncture human skin or other biological tissue.
  • Internal blunting member 40 is provided in concentric relation with hub assembly 20 . More particularly, first end 42 of internal blunting member 40 is positioned concentrically within internal opening 26 of hub assembly 20 , while second end 44 of internal blunting member 40 extends axially from second end 22 of hub assembly 20 . Internal lumen 48 is in fluid communication with internal opening 26 of hub assembly 20 and, in turn, internal opening 36 of ferrule 30 . Internal blunting member 40 may be integrally formed with hub assembly 20 , but is more desirably a separate member which is fixedly attached to hub assembly 20 . In particular, as depicted in FIG.
  • first end 42 of internal blunting member 40 is provided within internal opening 26 of hub assembly 20 and abuts lip 38 of ferrule 30 , which extends within first end 22 of hub assembly 20 . In this manner, hub assembly 20 , ferrule 30 and internal blunting member 40 form a single unitary structure.
  • Non-patient needle assembly 12 further includes external cannula 50 extending concentrically about internal blunting member 40 .
  • External cannula 50 is adapted for axial movement with respect to hub assembly 20 , as will be described in more detail herein.
  • External cannula 50 includes a first end 52 and a second end 54 , with a central bore or internal lumen 58 extending through the length thereof.
  • Second end 54 includes non-patient puncture tip 56 , which is provided in the form of a needle tip for puncturing a stopper such as is used in an evacuated tube, for example, during a blood collection procedure.
  • External cannula 50 is further provided with an elastomeric sleeve 80 extending about second end 44 and covering non-patient puncture tip 56 , as is generally known in the art.
  • second end 54 of external cannula 50 is adjacent second end 44 of internal blunting member 40 .
  • External cannula 50 is axially slidable along second end 44 of internal blunting member 40 within the internal lumen 58 of external cannula 50 .
  • external cannula 50 is axially displaceable with respect to hub assembly 20 , since internal blunting member 40 is in fixed engagement with hub assembly 20 .
  • the inner diameter of external cannula 50 is substantially the same as the outer diameter of second end 44 of internal blunting member 40 .
  • external cannula 50 and internal blunting member 40 are dimensioned and configured for a close fit so that blunt tip 46 of internal blunting member 40 lies flat against the internal surface of second end 54 of external cannula 50 within internal lumen 58 when non-patient needle assembly 12 is in a retracted position, as shown in FIGS. 2 and 3, and so that non-patient puncture tip 56 lies flat against the external surface of second end 44 of internal blunting member 40 when non-patient needle assembly 12 is in an activated position, as shown in FIGS. 4 and 5.
  • external cannula 50 is adapted for axial movement with respect to hub assembly 20 .
  • external cannula 50 may be axially slidable within internal opening 26 of hub assembly 20 between a first retracted position in which non-patient puncture tip 56 extends beyond blunt tip 46 , and a second activated position in which blunt tip 46 extends beyond non-patient puncture tip 56 .
  • axial movement of external cannula 50 within internal opening 26 of hub assembly 20 in a direction of arrow 100 causes external cannula 50 to axially displace with respect to hub assembly 20 .
  • Carriage assembly 60 is concentric with external cannula 50 , and is provided for slidable engagement within internal opening 26 of hub assembly 20 .
  • Carriage assembly 60 may be integral with external cannula 50 , or may be a separate member which is fixedly adhered to external cannula 50 such as through the use of an adhesive.
  • Carriage assembly 60 is defined by a generally tubular body, although other shapes or configurations may be apparent to those skilled in the art.
  • Carriage assembly 60 includes a central nub portion 62 , a forward portion 64 and a rear portion 66 . As shown in FIGS. 2 and 3, forward portion 64 of carriage assembly 60 is positioned within internal opening 26 of hub assembly 20 when non-patient needle assembly 12 is assembled and in the retracted position. Forward portion 64 of carriage assembly 60 includes a surface 70 for interference engagement with shoulder 28 of hub assembly 20 . Such interference engagement prevents carriage assembly 60 , and therefore external cannula 50 which is attached thereto, from being easily removed or disassembled from hub assembly 20 after assembly thereof.
  • Central nub portion 62 includes a tapered surface 68 extending circumferentially thereabout. Tapered surface 68 provides an interference engagement with face 32 at second end 24 of hub assembly 20 , preventing axial displacement of carriage assembly 60 with respect to hub assembly 20 without a force exerted thereon, as will be described in more detail herein.
  • Carriage assembly 60 further includes rear face 72 which is adapted for engagement with the top surface of a blood collection tube during use. As will be discussed with respect to the use and operation of non-patient needle assembly 12 , rear face 72 provides a mechanism for activating non-patient needle assembly 12 , thereby axially displacing external cannula 50 with respect to hub assembly 20 between a first retracted position and a second activated position.
  • External cannula 50 and hub assembly 20 may be reversibly axially displaceable with respect to each other, such that external cannula 50 may displace with respect to hub assembly 20 from either the first retracted position to the second activated position or from the second activated position to the first retracted position.
  • external cannula 50 is axially displaceable with respect to hub assembly 20 in only a single direction from the first retracted position to the second activated position.
  • non-patient needle assembly 12 may be provided with means for preventing axial displacement of external cannula 50 from the second activated position to the first retracted position once it has been activated, such as a locking mechanism.
  • central nub portion 62 may further include a surface 76 which extends circumferentially about central nub portion 62 for interference engagement with shoulder 28 of hub assembly 20 after activation of non-patient needle assembly 12 from the first retracted position to the second activated position.
  • Such interference engagement prevents axial movement of carriage assembly 60 with respect to hub assembly 20 in a direction opposite arrow 100 after movement from the first retracted position to the second activated position.
  • Non-patient needle assembly 12 may be provided with means for indicating movement of external cannula 50 with respect to hub assembly 20 between the first retracted position and the second activated position.
  • Such means may be a visible, audible and/or tactile indicator, identifying movement between the first retracted position and the second extended position.
  • a tactile indication is accomplished through the interference engagement of tapered surface 68 with face 32 of hub assembly 20 , as well as the interference engagement of front face 74 of carriage assembly 60 with face 32 of hub assembly 20 .
  • carriage assembly 60 when carriage assembly 60 is axially displaced in a direction of arrow 100 , the user will detect an audible and/or tactile detection through the forcing of tapered surface 68 of carriage assembly 60 past face 32 of hub assembly 20 .
  • carriage assembly 60 When carriage assembly 60 is completely displaced to the second activated position, a further audible and/or tactile detection will be detected by front face 74 of carriage assembly 60 abutting with face 32 of hub assembly 20 .
  • Non-patient needle assembly 12 may be provided with a needle cover (not shown) for covering non-patient puncture tip 56 of external cannula 50 prior to assembling of non-patient needle assembly 12 with a needle holder.
  • a needle cover may be constructed of rigid polymeric material.
  • This needle cover may be attached to non-patient needle holder 12 , for example, by threaded engagement with external threads 14 extending about hub assembly 20 . In this manner, this needle cover can be removed from non-patient needle assembly 12 prior to assembly with a needle holder by unthreading the needle cover from external threads 14 , and then threading external threads 14 into an internal thread of such a needle holder, as is known in the art.
  • blood collection set 10 is provided including intravenous needle assembly 90 and non-patient needle assembly 12 attached through tubing 84 .
  • non-patient needle assembly 12 may be provided as separate from a blood collection assembly including intravenous needle assembly 90 and tubing 84 interconnected.
  • non-patient needle assembly 12 is first attached to tubing 84 , for example through connector 86 which is desirably a luer fitting for connection with ferrule 30 .
  • Non-patient needle assembly 12 is provided including a needle cover (not shown) extending over external cannula 50 .
  • a needle cover (not shown) extending over external cannula 50 .
  • the needle cover is removed from external cannula 50 , and non-patient needle assembly 12 is then attached to a needle holder, such as by threading external threads 14 with internal threads provided on a standard needle holder.
  • a further needle cover may extend over intravenous cannula 92 encompassing intravenous puncture tip 94 .
  • This needle cover is also removed.
  • Venipuncture is then conducted in known manner, whereby intravenous puncture tip 94 is inserted into a vein of a patient, and an evacuated tube having a pierceable closure is inserted into the needle holder, such that the pierceable closure of the evacuated tube contacts sleeve 80 extending about external cannula 50 .
  • the piercable closure contacting sleeve 80 causes sleeve 80 to displace, thereby causing non-patient puncture tip 56 to puncture sleeve 80 and, in turn, the piercable closure of the evacuated tube.
  • the interior of the evacuated tube and internal lumen 58 of external cannula 50 are in fluid communication.
  • intravenous needle assembly 90 may include a blunting member for blunting of the intravenous needle, which blunting operation is separate from blunting of the non-patient needle.
  • Blunting of the non-patient needle assembly 12 is accomplished by exerting pressure in a direction of arrow 100 on rear face 72 of carriage assembly 60 .
  • the top surface of the pierceable closure of the evacuated tube contacts rear face 72 of carriage assembly 60 within the holder.
  • rear face 72 is forced in the direction of arrow 100 .
  • Such force causes interference engagement between tapered surface 68 of central nub portion 62 of carriage assembly 60 against face 32 of hub assembly 20 .
  • central nub portion 62 of carriage 60 is forced within internal opening 26 of hub assembly 20 due to the configuration of tapered surface 82 , thereby causing axial movement of carriage assembly 60 with respect to hub assembly 20 .
  • carriage assembly 60 is attached to external cannula 50 , axial displacement of carriage assembly 60 with respect to hub assembly 20 causes axial displacement of external cannula 50 with respect to hub assembly 20 .
  • internal blunting member 40 is attached to hub assembly 20 , axial displacement of external cannula 50 with respect to hub assembly 20 causes second end 54 of external cannula 50 to axially displace with respect to second end 44 of internal blunting member 40 .
  • blunted tip 44 is positioned short of non-patient puncture tip 56 such that non-patient puncture tip 56 extends beyond blunted tip 44
  • axial displacement of second end 54 of external cannula 50 with respect to second end 44 of internal blunting member 40 causes relative axial displacement of non-patient puncture tip 56 with respect to blunted tip 46 .
  • non-patient puncture tip 56 slides about internal blunting member 40 such that blunted tip 46 is exposed and extends beyond non-patient puncture tip 56 , as depicted in FIGS. 4 and 5.
  • Non-patient needle assembly 12 can then be appropriately discarded.
  • the needle assembly of the present invention may be used in conjunction with a standard needle holder known for use in blood collection. It is also contemplated that the needle assembly of the present invention may be used with a needle holder which includes a mechanism for causing axial displacement of carriage assembly 60 with respect to hub assembly 20 to effect blunting of non-patient puncture tip 56 . For example, as opposed to exerting pressure on an evacuated tube extending within the needle holder, a mechanism on or within the needle holder may be activated which causes carriage assembly 60 to axially displace.
  • the needle assembly of the present invention may be comprised of moldable e parts which can be mass produced from a variety of materials including, for example, polyethylene, polyvinyl chloride, polystyrene or the like. Materials will be selected which will provide the proper support for the structure of the invention in its use, but which will also provide a degree of resiliency for the purpose or providing the cooperative relative movement.
  • needle assembly of the present invention has been described in terms of one embodiment for use in connection with a blood collection system, it is further contemplated that the needle assembly could be used with other medical procedures, such as in conjunction with a conventional intravenous infusion set, as which are well known in the art for use with conventional needle assemblies.

Abstract

A non-patient safety needle assembly for mounting with a conventional intravenous blood collection set is provided. The non-patient needle assembly includes a hub assembly adapted for mounting with a blood collection set, and an internal blunting member including a blunted tip. The non-patient needle assembly further includes an external cannula concentric with the internal blunting member and including a non-patient puncture tip adjacent the blunted tip. The external cannula is axially displaceable with respect to the hub assembly between a first retracted position in which the non-patient puncture tip extends beyond the blunted tip and a second activated position in which blunted tip extends beyond the non-patient puncture tip. A blood collection set including such a non-patient needle assembly interconnected with an intravenous needle assembly through tubing is also provided.

Description

    RELATED APPLICATION
  • This application is a non-provisional of Appl. No. 60/377,399 filed on May 2, 2002. [0001]
  • BACKGROUND OF THE INVENTION
  • 1. Field of the Invention [0002]
  • The present invention relates to needle assemblies having a blunting element for safe and convenient handling. More particularly, the present invention relates to a non-patient needle assembly which includes a blunting element for the non-patient needle for use in connection with a blood collection set. [0003]
  • 2. Description of Related Art [0004]
  • Disposable medical devices having piercing elements are typically used for administering a medication or withdrawing a fluid, such as blood collecting needles, fluid handling needles and assemblies thereof. Current medical practice requires that the fluid containers and needle assemblies used in such systems be inexpensive and readily disposable. Consequently, existing blood collection systems, for example, typically employ some form of durable, reusable holder on which detachable and disposable needles and fluid collection tubes may be mounted. A blood collection system of this nature can be assembled prior to use and then disassembled after usage. Thus, these blood collection systems allow repeated use of the relatively expensive holder upon replacement of the relatively inexpensive needle and/or fluid collection tube. In addition to reducing the cost of collecting blood specimens, these blood collection systems also help minimize the production of hazardous medical waste. [0005]
  • Conventional intravenous tubing sets are commonly employed for use in connection with blood collection. A particularly useful intravenous tubing set for such application is the VACUTAINER® Brand Safety-Lok™ Blood Collection Set, available from Becton Dickinson and Company of Franklin Lakes, N.J. Such a Blood Collection Set includes an intravenous needle assembly attached to one end of a tube, with the other end of the tube connected to a blood collection needle assembly including a stopper puncture needle, or a “non-patient” puncture needle. In use, the intravenous needle assembly is inserted into the vein of a patient, and a tube holder is attached to the blood collection needle assembly. An evacuated tube is inserted into the tube holder, and the stopper puncture needle or non-patient puncture needle punctures the stopper of the tube, allowing blood to flow into the tube. [0006]
  • In order to reduce the risk of incurring an accidental needle-stick wound, protection of used needle tips becomes important. With concern about infection and transmission of diseases, methods and devices to enclose the used disposable needle have become very important and in great demand. Many arrangements have been designed for protecting used needle tips. For example, U.S. Pat. No. 5,120,320 to Fayngold and U.S. Pat. No. 5,192,275 to Burns disclose safety shields for use in connection with the intravenous needle assembly of such blood collection assemblies. The safety shield covers and protects the intravenous needle assembly after use. Also, PCT International Publication No. WO 98/42393 discloses a parenteral fluid transfer apparatus useful as a blood collection assembly, which includes an intravenous needle assembly having a rod or probe-like blunting member which is extendable beyond the tip of the intravenous needle tip to prevent accidental needle-stick wounds from occurring after use of the device. Such a device, however, does not provide protection for the second end of the needle at the non-patient end of the assembly. [0007]
  • Accordingly, a need exists for a blood collection set with a non-patient needle assembly which provides for safety blunting of the non-patient needle tip and which is simple to manufacture and easy to operate. [0008]
  • SUMMARY OF THE INVENTION
  • The present invention is directed to a non-patient safety needle assembly for mounting with a conventional intravenous blood collection set. The non-patient needle assembly includes a hub assembly having opposing first and second ends, with the first end being adapted for mounting with a blood collection set. An internal blunting member is in fixed engagement with the hub assembly. The internal blunting member includes a first end which is concentric with the hub assembly, a second end having a blunted tip, and an internal lumen which extends through the internal blunting member from the first end to the blunted tip. The needle assembly also includes an external cannula concentric with the internal blunting member and axially displaceable with respect to the hub assembly. The external cannula includes a non-patient puncture tip at one end thereof adjacent the blunted tip of the internal blunting member. The external cannula is adapted for axial displacement with respect to the hub assembly between a first retracted position, in which the non-patient puncture tip extends beyond the blunted tip, and a second activated position in which the blunted tip extends beyond the non-patient puncture tip. [0009]
  • The non-patient needle assembly preferably includes a carriage assembly which is integral with the external cannula and concentric with the internal blunting member, and which is in slidable engagement with the hub assembly. Also, a sleeve preferably extends about the non-patient puncture tip. [0010]
  • The needle assembly also includes a fitting, such as a luer fitting, for engagement with a blood collection set. Additionally, the needle assembly includes means for attaching the needle assembly to a holder capable of holding blood collection tubes, such as threads extending circumferentially about the hub assembly. [0011]
  • Preferably, the external cannula is axially displaceable between the first retracted position and the second activated position in a single axial direction. The needle assembly may also include a locking mechanism for preventing axial displacement of the external cannula from the second activated position to the first retracted position. [0012]
  • The present invention is also directed to a blood collection set which includes such a non-patient needle assembly in fluid communication with a tubing, which tubing is in fluid communication with an intravenous needle assembly including a needle having an intravenous puncture tip. Preferably, the non-patient needle assembly includes a hub assembly which is removably attached to the tubing, such as through a luer fitting.[0013]
  • DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a perspective view of a blood collection set in accordance with the present invention, including a non-patient safety needle assembly attached to an intravenous needle assembly through tubing. [0014]
  • FIG. 2 is a perspective view of a non-patient safety needle assembly in accordance with the present invention shown in a retracted position. [0015]
  • FIG. 3 is a side cross-sectional view of the non-patient safety needle assembly of FIG. 2 shown in a retracted position. [0016]
  • FIG. 4 is a perspective view of the non-patient safety needle assembly of FIG. 2 shown in an activated blunted position. [0017]
  • FIG. 5 is a side cross-sectional view of the non-patient safety needle assembly of FIG. 4 in an activated blunted position. [0018]
  • DETAILED DESCRIPTION
  • While the present invention is satisfied by embodiments in many different forms, there is shown in the drawings and will herein be described in detail, the preferred embodiments of the invention, with the understanding that the present disclosure is to be considered as examplary of the principles of the invention and is not intended to limit the invention to the embodiments illustrated. Various other embodiments will be apparent to and readily made by those skilled in the art without departing from the scope and spirit of the invention. The scope of the invention will be measured by the appended claims and their equivalents. [0019]
  • Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof, FIG. 1 illustrates a blood collection set in accordance with the present invention and the related features. The present invention is generally described in terms of a blood collection set, and encompasses such a blood collection set as well as a non-patient safety needle assembly for use in such a blood collection set. [0020]
  • [0021] Blood collection set 10 is depicted generally including non-patient needle assembly 12 in engagement with a conventional intravenous blood collection assembly. Non-patient needle assembly 12 and the intravenous blood collection assembly include interrelating elements to provide for engagement therebetween. In particular, non-patient needle assembly 12 is interconnected with intravenous needle assembly 90 through tubing 84. Such interconnection may be provided through any method as is known in the art, such as through a luer fitting.
  • [0022] Intravenous needle assembly 90 includes an intravenous cannula 92 having an intravenous puncture tip 94, for insertion into the vein of a patient, for example, during a blood collection procedure. Intravenous needle assembly 90 further includes a butterfly-type wing assembly 96, for use in connection with positioning and placement of intravenous needle assembly 90 during a blood collection procedure, as is known in the art.
  • As noted, [0023] intravenous needle assembly 90 is interconnected through tubing 84 to non-patient needle assembly 12. In addition, non-patient needle assembly 12 may be provided with means for attachment to a separate holder (not shown) for use in connection with blood collection tubes, such as a snap fit attachment, or, more desirably, attachment threads 14 which engage a threaded section of the holder.
  • [0024] Non-patient needle assembly 12 of the present invention is shown more particularly at FIGS. 2-5. Non-patient needle assembly 12 includes hub assembly 20 having first end 22 and second end 24, with an internal opening 26 extending therethrough from first end 22 to second end 24. First end 22 of hub assembly 20 is adapted for mounting with tubing 84 of blood collection set 10. For example, hub assembly 20 may further include ferrule 30 extending from first end 22. Ferrule 30 may be integrally formed with hub assembly 20, or may be a separate member attached to hub assembly 20. Desirably, hub assembly 20 includes shoulder 34 at an internal opening within first end 22 for engagement with ferrule 30 such that ferrule 30 interfits within first end 22 and rests against shoulder 34 of hub assembly 20. Ferrule 30 includes an internal opening 36 extending therethrough, which is in fluid communication with internal opening 26 of hub assembly 20.
  • [0025] Non-patient needle assembly 12 further includes internal blunting member 40 in fixed engagement with hub assembly 20. Internal blunting member 40 is a generally tubular hollow structure which includes first end 42 and second end 44 with a central bore or internal lumen 48 extending through the length thereof. Internal lumen 48 allows fluid flow through needle assembly 12 during use. Second end 44 is blunted to form blunt tip 46 as an end portion, such that, under ordinary hand pressure, blunt tip 46 will not easily puncture human skin or other biological tissue.
  • [0026] Internal blunting member 40 is provided in concentric relation with hub assembly 20. More particularly, first end 42 of internal blunting member 40 is positioned concentrically within internal opening 26 of hub assembly 20, while second end 44 of internal blunting member 40 extends axially from second end 22 of hub assembly 20. Internal lumen 48 is in fluid communication with internal opening 26 of hub assembly 20 and, in turn, internal opening 36 of ferrule 30. Internal blunting member 40 may be integrally formed with hub assembly 20, but is more desirably a separate member which is fixedly attached to hub assembly 20. In particular, as depicted in FIG. 3, first end 42 of internal blunting member 40 is provided within internal opening 26 of hub assembly 20 and abuts lip 38 of ferrule 30, which extends within first end 22 of hub assembly 20. In this manner, hub assembly 20, ferrule 30 and internal blunting member 40 form a single unitary structure.
  • [0027] Non-patient needle assembly 12 further includes external cannula 50 extending concentrically about internal blunting member 40. External cannula 50 is adapted for axial movement with respect to hub assembly 20, as will be described in more detail herein. External cannula 50 includes a first end 52 and a second end 54, with a central bore or internal lumen 58 extending through the length thereof. Second end 54 includes non-patient puncture tip 56, which is provided in the form of a needle tip for puncturing a stopper such as is used in an evacuated tube, for example, during a blood collection procedure. External cannula 50 is further provided with an elastomeric sleeve 80 extending about second end 44 and covering non-patient puncture tip 56, as is generally known in the art.
  • As best depicted in FIGS. 2 and 3, [0028] second end 54 of external cannula 50 is adjacent second end 44 of internal blunting member 40. External cannula 50 is axially slidable along second end 44 of internal blunting member 40 within the internal lumen 58 of external cannula 50. As such, external cannula 50 is axially displaceable with respect to hub assembly 20, since internal blunting member 40 is in fixed engagement with hub assembly 20. The inner diameter of external cannula 50 is substantially the same as the outer diameter of second end 44 of internal blunting member 40. As such, external cannula 50 and internal blunting member 40 are dimensioned and configured for a close fit so that blunt tip 46 of internal blunting member 40 lies flat against the internal surface of second end 54 of external cannula 50 within internal lumen 58 when non-patient needle assembly 12 is in a retracted position, as shown in FIGS. 2 and 3, and so that non-patient puncture tip 56 lies flat against the external surface of second end 44 of internal blunting member 40 when non-patient needle assembly 12 is in an activated position, as shown in FIGS. 4 and 5.
  • It may be desirable to lubricate the mating surfaces of [0029] external cannula 50 and internal blunting member 40, as well as to provide a seal between them to prevent the unwanted flow of air bubbles. Accordingly, a drop of viscous sealant-lubricant, such as petroleum jelly, may be provided about the mating surfaces thereof.
  • As noted, [0030] external cannula 50 is adapted for axial movement with respect to hub assembly 20. For example, external cannula 50 may be axially slidable within internal opening 26 of hub assembly 20 between a first retracted position in which non-patient puncture tip 56 extends beyond blunt tip 46, and a second activated position in which blunt tip 46 extends beyond non-patient puncture tip 56. More particularly, axial movement of external cannula 50 within internal opening 26 of hub assembly 20 in a direction of arrow 100 causes external cannula 50 to axially displace with respect to hub assembly 20. Since internal blunting member 40 is fixedly attached to hub assembly 20, such axial displacement causes external cannula 50 to axially slide along second end 44 of internal blunting member 40. Since second end 54 of external cannula 50 is adjacent second end 44 of internal blunting member 40 and non-patient puncture tip 56 extends beyond blunt tip 46, such axial movement causes second end 54 of external cannula 50 to axially displace with respect to second end 44 of internal blunting member 40, which causes non-patient puncture tip 56 to slide about internal blunting member 40 such that blunt tip 46 extends beyond non-patient puncture tip 56, as depicted in FIGS. 4 and 5. As such, non-patient puncture tip 56 is blunted.
  • Slidable engagement of [0031] external cannula 50 and hub assembly 20 may be effected through carriage assembly 60. Carriage assembly 60 is concentric with external cannula 50, and is provided for slidable engagement within internal opening 26 of hub assembly 20. Carriage assembly 60 may be integral with external cannula 50, or may be a separate member which is fixedly adhered to external cannula 50 such as through the use of an adhesive. Carriage assembly 60 is defined by a generally tubular body, although other shapes or configurations may be apparent to those skilled in the art.
  • [0032] Carriage assembly 60 includes a central nub portion 62, a forward portion 64 and a rear portion 66. As shown in FIGS. 2 and 3, forward portion 64 of carriage assembly 60 is positioned within internal opening 26 of hub assembly 20 when non-patient needle assembly 12 is assembled and in the retracted position. Forward portion 64 of carriage assembly 60 includes a surface 70 for interference engagement with shoulder 28 of hub assembly 20. Such interference engagement prevents carriage assembly 60, and therefore external cannula 50 which is attached thereto, from being easily removed or disassembled from hub assembly 20 after assembly thereof.
  • [0033] Central nub portion 62 includes a tapered surface 68 extending circumferentially thereabout. Tapered surface 68 provides an interference engagement with face 32 at second end 24 of hub assembly 20, preventing axial displacement of carriage assembly 60 with respect to hub assembly 20 without a force exerted thereon, as will be described in more detail herein.
  • [0034] Carriage assembly 60 further includes rear face 72 which is adapted for engagement with the top surface of a blood collection tube during use. As will be discussed with respect to the use and operation of non-patient needle assembly 12, rear face 72 provides a mechanism for activating non-patient needle assembly 12, thereby axially displacing external cannula 50 with respect to hub assembly 20 between a first retracted position and a second activated position.
  • [0035] External cannula 50 and hub assembly 20 may be reversibly axially displaceable with respect to each other, such that external cannula 50 may displace with respect to hub assembly 20 from either the first retracted position to the second activated position or from the second activated position to the first retracted position. In preferred embodiments, external cannula 50 is axially displaceable with respect to hub assembly 20 in only a single direction from the first retracted position to the second activated position. As such, non-patient needle assembly 12 may be provided with means for preventing axial displacement of external cannula 50 from the second activated position to the first retracted position once it has been activated, such as a locking mechanism. For example, central nub portion 62 may further include a surface 76 which extends circumferentially about central nub portion 62 for interference engagement with shoulder 28 of hub assembly 20 after activation of non-patient needle assembly 12 from the first retracted position to the second activated position. Such interference engagement prevents axial movement of carriage assembly 60 with respect to hub assembly 20 in a direction opposite arrow 100 after movement from the first retracted position to the second activated position.
  • [0036] Non-patient needle assembly 12 may be provided with means for indicating movement of external cannula 50 with respect to hub assembly 20 between the first retracted position and the second activated position. Such means may be a visible, audible and/or tactile indicator, identifying movement between the first retracted position and the second extended position. For example, in one particular embodiment, a tactile indication is accomplished through the interference engagement of tapered surface 68 with face 32 of hub assembly 20, as well as the interference engagement of front face 74 of carriage assembly 60 with face 32 of hub assembly 20. For example, when carriage assembly 60 is axially displaced in a direction of arrow 100, the user will detect an audible and/or tactile detection through the forcing of tapered surface 68 of carriage assembly 60 past face 32 of hub assembly 20. When carriage assembly 60 is completely displaced to the second activated position, a further audible and/or tactile detection will be detected by front face 74 of carriage assembly 60 abutting with face 32 of hub assembly 20.
  • [0037] Non-patient needle assembly 12 may be provided with a needle cover (not shown) for covering non-patient puncture tip 56 of external cannula 50 prior to assembling of non-patient needle assembly 12 with a needle holder. Such a needle cover may be constructed of rigid polymeric material. This needle cover may be attached to non-patient needle holder 12, for example, by threaded engagement with external threads 14 extending about hub assembly 20. In this manner, this needle cover can be removed from non-patient needle assembly 12 prior to assembly with a needle holder by unthreading the needle cover from external threads 14, and then threading external threads 14 into an internal thread of such a needle holder, as is known in the art.
  • Operation and use of the blood collection set including the non-patient needle assembly will now be described with reference to FIGS. [0038] 1-5. In use, blood collection set 10 is provided including intravenous needle assembly 90 and non-patient needle assembly 12 attached through tubing 84. Alternatively, non-patient needle assembly 12 may be provided as separate from a blood collection assembly including intravenous needle assembly 90 and tubing 84 interconnected. In such a case, non-patient needle assembly 12 is first attached to tubing 84, for example through connector 86 which is desirably a luer fitting for connection with ferrule 30.
  • [0039] Non-patient needle assembly 12 is provided including a needle cover (not shown) extending over external cannula 50. When preparing the blood collection set for use in a sampling procedure, the needle cover is removed from external cannula 50, and non-patient needle assembly 12 is then attached to a needle holder, such as by threading external threads 14 with internal threads provided on a standard needle holder.
  • Moreover, a further needle cover (not shown) may extend over [0040] intravenous cannula 92 encompassing intravenous puncture tip 94. This needle cover is also removed. Venipuncture is then conducted in known manner, whereby intravenous puncture tip 94 is inserted into a vein of a patient, and an evacuated tube having a pierceable closure is inserted into the needle holder, such that the pierceable closure of the evacuated tube contacts sleeve 80 extending about external cannula 50. When slight pressure is exerted on the evacuated tube, the piercable closure contacting sleeve 80 causes sleeve 80 to displace, thereby causing non-patient puncture tip 56 to puncture sleeve 80 and, in turn, the piercable closure of the evacuated tube. At such time, the interior of the evacuated tube and internal lumen 58 of external cannula 50 are in fluid communication. Since the interior of the evacuated tube is at a negative pressure, blood is drawn from the vein of the patient, through intravenous needle assembly 90, through tubing 84 and connector 86, through internal opening 36 of ferrule 30, through internal lumen 48 of internal blunting member 40, through internal lumen 58 of external cannula 50, and into the evacuated tube.
  • When all desired samples have been drawn, activation of the non-patient needle assembly is accomplished. Activation of the non-patient needle assembly is desirably accomplished while venipuncture is maintained, that is while [0041] intravenous puncture tip 94 of intravenous needle assembly 90 is maintained within the vein of the patient. It is noted that intravenous needle assembly 90 may include a blunting member for blunting of the intravenous needle, which blunting operation is separate from blunting of the non-patient needle.
  • Blunting of the [0042] non-patient needle assembly 12 is accomplished by exerting pressure in a direction of arrow 100 on rear face 72 of carriage assembly 60. In particular, during sampling, the top surface of the pierceable closure of the evacuated tube contacts rear face 72 of carriage assembly 60 within the holder. When additional force is exerted against the evacuated tube in a direction of arrow 100, rear face 72 is forced in the direction of arrow 100. Such force causes interference engagement between tapered surface 68 of central nub portion 62 of carriage assembly 60 against face 32 of hub assembly 20. As such, central nub portion 62 of carriage 60 is forced within internal opening 26 of hub assembly 20 due to the configuration of tapered surface 82, thereby causing axial movement of carriage assembly 60 with respect to hub assembly 20.
  • Since [0043] carriage assembly 60 is attached to external cannula 50, axial displacement of carriage assembly 60 with respect to hub assembly 20 causes axial displacement of external cannula 50 with respect to hub assembly 20. Moreover, since internal blunting member 40 is attached to hub assembly 20, axial displacement of external cannula 50 with respect to hub assembly 20 causes second end 54 of external cannula 50 to axially displace with respect to second end 44 of internal blunting member 40. Since blunted tip 44 is positioned short of non-patient puncture tip 56 such that non-patient puncture tip 56 extends beyond blunted tip 44, axial displacement of second end 54 of external cannula 50 with respect to second end 44 of internal blunting member 40 causes relative axial displacement of non-patient puncture tip 56 with respect to blunted tip 46. More particularly, when external cannula 50 is axially displaced in the direction of arrow 100, non-patient puncture tip 56 slides about internal blunting member 40 such that blunted tip 46 is exposed and extends beyond non-patient puncture tip 56, as depicted in FIGS. 4 and 5. As such, non-patient puncture tip 56 is effectively blunted. Non-patient needle assembly 12 can then be appropriately discarded.
  • As noted, the needle assembly of the present invention may be used in conjunction with a standard needle holder known for use in blood collection. It is also contemplated that the needle assembly of the present invention may be used with a needle holder which includes a mechanism for causing axial displacement of [0044] carriage assembly 60 with respect to hub assembly 20 to effect blunting of non-patient puncture tip 56. For example, as opposed to exerting pressure on an evacuated tube extending within the needle holder, a mechanism on or within the needle holder may be activated which causes carriage assembly 60 to axially displace.
  • The needle assembly of the present invention may be comprised of moldable e parts which can be mass produced from a variety of materials including, for example, polyethylene, polyvinyl chloride, polystyrene or the like. Materials will be selected which will provide the proper support for the structure of the invention in its use, but which will also provide a degree of resiliency for the purpose or providing the cooperative relative movement. [0045]
  • While the needle assembly of the present invention has been described in terms of one embodiment for use in connection with a blood collection system, it is further contemplated that the needle assembly could be used with other medical procedures, such as in conjunction with a conventional intravenous infusion set, as which are well known in the art for use with conventional needle assemblies. [0046]

Claims (19)

What is claimed:
1. A non-patient safety needle assembly for mounting with a conventional intravenous blood collection set comprising:
a hub assembly having opposing first and second ends, said first end adapted for mounting with a blood collection set;
an internal blunting member in fixed engagement with said hub assembly, said internal blunting member having a first end concentric with said hub assembly, a second end having a blunted tip and an internal lumen extending through said internal blunting member from said first end to said blunted tip; and
an external cannula concentric with said internal blunting member and axially displaceable with respect to said hub assembly, said external cannula including a non-patient puncture tip adjacent said blunted tip of said internal blunting member, said external cannula adapted for axial displacement with respect to said hub assembly between a first retracted position in which said non-patient puncture tip extends beyond said blunted tip of said internal blunting member and a second activated position in which said blunted tip of said internal blunting member extends beyond said non-patient puncture tip of said external cannula.
2. A safety needle assembly as in claim 1, further comprising a carriage assembly integral with said external cannula and concentric with said internal blunting member, said carriage assembly provided for slidable engagement with said hub assembly.
3. A safety needle assembly as in claim 1, further comprising a sleeve extending about said non-patient puncture tip.
4. A safety needle assembly as in claim 1, further comprising a fitting for engagement with a blood collection set.
5. A safety needle assembly as in claim 4, wherein said fitting comprises a luer fitting.
6. A safety needle assembly as in claim 1, further comprising means for attaching said needle assembly to a holder capable of holding blood collection tubes.
7. A safety needle assembly as in claim 6, wherein said attaching means comprises threads extending circumferentially about said hub assembly.
8. A safety needle assembly as in claim 1, wherein said external cannula is axially displaceable between said first retracted position and said second activated position in a single axial direction.
9. A safety needle assembly as in claim 8, further comprising a locking mechanism for preventing axial displacement of said external cannula from said second activated position to said first retracted position.
10. A blood collection set comprising:
a) in intravenous needle assembly including a needle having an intravenous puncture tip;
b) a tubing in fluid communication with said intravenous needle assembly; and
c) a non-patient needle assembly in fluid communication with said tubing, said non-patient needle assembly comprising:
i) a hub assembly having opposing first and second ends, said first end in engagement with said tubing,
ii) an internal blunting member in fixed engagement with said hub assembly, said internal blunting member having a first end concentric with said hub assembly, a second end having a blunted tip and an internal lumen extending through said internal blunting member from said first end to said blunted tip, and
iii) an external cannula concentric with said internal blunting member and axially displaceable with respect to said hub assembly, said external cannula including a non-patient puncture tip adjacent said blunted tip of said internal blunting member, said external cannula adapted for axial displacement with respect to said hub assembly between a first retracted position in which said non-patient puncture tip extends beyond said blunted tip of said internal blunting member and a second activated position in which said blunted tip of said internal blunting member extends beyond said non-patient puncture tip of said external cannula.
11. A blood collection set as in claim 10, further comprising a carriage assembly integral with said external cannula and concentric with said internal blunting member, said carriage assembly provided for slidable engagement with said hub assembly.
12. A blood collection set as in claim 10, further comprising a sleeve extending about said non-patient puncture tip.
13. A blood collection set as in claim 10, wherein said hub assembly is removably attached to said tubing.
14. A blood collection set as in claim 13, further comprising a luer fitting between said tubing and said hub assembly.
15. A blood collection set as in claim 10, wherein said non-patient needle assembly further comprises means for attaching said blood collection set to a holder capable of holding blood collection tubes.
16. A blood collection set as in claim 15, wherein said attaching means comprises threads extending circumferentially about said hub assembly.
17. A blood collection set as in claim 10, wherein said external cannula is axially displaceable between said first retracted position and said second activated position in a single axial direction.
18. A blood collection set as in claim 17, further comprising a locking mechanism for preventing axial displacement of said external cannula from said second activated position to said first retracted position.
19. A blood collection set comprising:
a) in intravenous needle assembly including a needle having an intravenous puncture tip;
b) a tubing in fluid communication with said intravenous needle assembly; and
c) a non-patient needle assembly in fluid communication with said tubing, said non-patient needle assembly comprising:
i) a hub assembly having a first end, an opposing second end, and a central opening extending through said hub assembly from said first end to said second end, said first end in engagement with said tubing,
ii) an internal blunting member having a first end, an opposing second end, and an internal lumen extending through said internal blunting member from said first end to said second end, said first end positioned concentrically within said central opening of said hub assembly, said second end having a blunted tip,
iii) a carriage assembly having a first end and an opposed second end, said first end of said carriage assembly extending through said second end of said hub assembly into said central opening of said hub assembly and in sliding engagement with said hub assembly, and
iv) an external cannula extending from said second end of said carriage assembly and concentric with said internal blunting member, said external cannula including a non-patient puncture tip adjacent said blunted tip of said internal blunting member,
wherein sliding of said carriage assembly within said hub assembly causes axial movement of said external cannula about said internal blunting member between a first retracted position in which said non-patient puncture tip extends beyond said blunted tip of said internal blunting member and a second activated position in which said blunted tip of said internal blunting member extends beyond said non-patient puncture tip of said external cannula.
US10/173,928 2002-05-02 2002-06-17 Needle assembly Abandoned US20030208160A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US10/173,928 US20030208160A1 (en) 2002-05-02 2002-06-17 Needle assembly
US11/170,130 US7678076B2 (en) 2002-05-02 2005-06-29 Needle assembly
US12/694,568 US7972309B2 (en) 2002-05-02 2010-01-27 Needle assembly

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US37739902P 2002-05-02 2002-05-02
US10/173,928 US20030208160A1 (en) 2002-05-02 2002-06-17 Needle assembly

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US11/170,130 Division US7678076B2 (en) 2002-05-02 2005-06-29 Needle assembly

Publications (1)

Publication Number Publication Date
US20030208160A1 true US20030208160A1 (en) 2003-11-06

Family

ID=29215910

Family Applications (3)

Application Number Title Priority Date Filing Date
US10/173,928 Abandoned US20030208160A1 (en) 2002-05-02 2002-06-17 Needle assembly
US11/170,130 Expired - Lifetime US7678076B2 (en) 2002-05-02 2005-06-29 Needle assembly
US12/694,568 Expired - Fee Related US7972309B2 (en) 2002-05-02 2010-01-27 Needle assembly

Family Applications After (2)

Application Number Title Priority Date Filing Date
US11/170,130 Expired - Lifetime US7678076B2 (en) 2002-05-02 2005-06-29 Needle assembly
US12/694,568 Expired - Fee Related US7972309B2 (en) 2002-05-02 2010-01-27 Needle assembly

Country Status (5)

Country Link
US (3) US20030208160A1 (en)
EP (1) EP1358898A1 (en)
JP (1) JP2004000576A (en)
AU (1) AU2003200194B2 (en)
CA (1) CA2417375C (en)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030208139A1 (en) * 2002-05-02 2003-11-06 Becton, Dickinson And Company Needle holder for use with safety needle assembly
US20030208161A1 (en) * 2002-05-02 2003-11-06 Becton, Dickinson And Company Needle holder for use with safety needle assembly
US20040147880A1 (en) * 2003-01-24 2004-07-29 Niall Duffy Device for protecting a distal portion of a catheter system during shipment and storage
US20050240161A1 (en) * 2002-05-02 2005-10-27 Becton, Dickinson And Company Needle assembly
US20060129064A1 (en) * 2004-11-29 2006-06-15 Becton, Dickinson And Company Blood collection set with an expanded internal volume
WO2007127619A1 (en) 2006-04-25 2007-11-08 Medtronic Ps Medical, Inc. Cerebrospinal fluid shunt having long term anti-occlusion agent delivery
US8512295B2 (en) 2010-08-19 2013-08-20 West Pharmaceutical Services, Inc. Rigid needle shield
USD740410S1 (en) * 2013-03-29 2015-10-06 Teleflex Medical Incorporated Catheter insertion device
US20170014062A1 (en) * 2014-04-11 2017-01-19 Shanghai Jinta Medical Co., Ltd. Safety Blood-Collection Needle
US10350366B2 (en) 2013-02-01 2019-07-16 Nxstage Medical, Inc. Safe cannulation devices, methods, and systems
US11439333B2 (en) * 2019-01-18 2022-09-13 Becton, Dickinson And Company Blood collection system including a baffle

Families Citing this family (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060258957A1 (en) * 2005-05-10 2006-11-16 Deleon Luis Blood drawing system
US8197420B2 (en) 2006-12-18 2012-06-12 Magnolia Medical Technologies, Inc. Systems and methods for parenterally procuring bodily-fluid samples with reduced contamination
WO2009140529A2 (en) * 2008-05-14 2009-11-19 John Stephens Needle protective device
US8864684B2 (en) 2011-10-13 2014-10-21 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US8535241B2 (en) 2011-10-13 2013-09-17 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US9060724B2 (en) 2012-05-30 2015-06-23 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US9022950B2 (en) 2012-05-30 2015-05-05 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
WO2014022275A1 (en) 2012-08-01 2014-02-06 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
EP3906952A1 (en) 2012-10-11 2021-11-10 Magnolia Medical Technologies, Inc. Systems and methods for delivering a fluid to a patient with reduced contamination
US9155495B2 (en) 2012-11-30 2015-10-13 Magnolia Medical Technologies, Inc. Syringe-based fluid diversion mechanism for bodily fluid sampling
EP2928375B1 (en) 2012-12-04 2018-01-31 Magnolia Medical Technologies, Inc. Sterile bodily-fluid collection device
US10772548B2 (en) 2012-12-04 2020-09-15 Magnolia Medical Technologies, Inc. Sterile bodily-fluid collection device and methods
WO2014164263A1 (en) 2013-03-12 2014-10-09 Bullington Gregory J Methods and apparatus for selectively occluding the lumen of a needle
US9456775B2 (en) 2013-09-06 2016-10-04 Millaghi Medical, Inc. Passive safety I.V. blood collection catheter
US10123783B2 (en) 2014-03-03 2018-11-13 Magnolia Medical Technologies, Inc. Apparatus and methods for disinfection of a specimen container
WO2016201406A1 (en) 2015-06-12 2016-12-15 Bullington Gregory J Devices and methods for syringe-based fluid transfer for bodily-fluid sampling
US10010282B2 (en) * 2015-07-24 2018-07-03 Kurin, Inc. Blood sample optimization system and blood contaminant sequestration device and method
WO2017041087A1 (en) 2015-09-03 2017-03-09 Bullington Gregory J Apparatus and methods for maintaining sterility of a specimen container
AU2017220022B2 (en) 2016-02-18 2021-06-10 Smiths Medical Asd, Inc. Closed system catheter
DE102016108870A1 (en) * 2016-05-13 2017-11-16 Gerresheimer Regensburg Gmbh Stinging agent protection device for a syringe
USD808013S1 (en) * 2016-10-27 2018-01-16 Smiths Medical Asd, Inc. Catheter
US10569069B2 (en) 2016-12-14 2020-02-25 Combat Comb, Llc Applicator for treatments applied to animal skin
USD828653S1 (en) 2016-12-14 2018-09-11 Brandon Penland Treatment applicator
EP4091544A1 (en) 2016-12-27 2022-11-23 Kurin, Inc. Blood sample optimization system and blood contaminant sequestration device and method
US11617525B2 (en) * 2017-02-10 2023-04-04 Kurin, Inc. Blood contaminant sequestration device with passive fluid control junction
US10827964B2 (en) * 2017-02-10 2020-11-10 Kurin, Inc. Blood contaminant sequestration device with one-way air valve and air-permeable blood barrier with closure mechanism
AU2018334138A1 (en) 2017-09-12 2020-03-12 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
CN115553822A (en) 2017-12-07 2023-01-03 木兰医药技术股份有限公司 Fluid control device and method of use
WO2020163744A1 (en) 2019-02-08 2020-08-13 Magnolia Medical Technologies, Inc. Devices and methods for bodily fluid collection and distribution
CN113784793B (en) 2019-03-11 2023-09-19 木兰医药技术股份有限公司 Fluid control device and method of using the same
CN112972829B (en) * 2021-02-24 2022-07-08 鄂东医疗集团市中心医院 Medical clinical syringe is with using syringe needle

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5009642A (en) * 1987-09-28 1991-04-23 Bio-Plexus, Inc. Self-blunting needle assembly for use with a catheter, and catheter assembly using the same
US5951520A (en) * 1996-12-19 1999-09-14 Bio-Plexus, Inc. Self-blunting needle medical devices and methods of manufacture thereof
US6264619B1 (en) * 1999-09-01 2001-07-24 Becton, Dickinson And Company Kit for drawing a blood sample
US20020147428A1 (en) * 1998-12-23 2002-10-10 Chang Joseph Jawshin Solid blunt for a needle assembly
US6629956B1 (en) * 1997-03-26 2003-10-07 John M. Polidoro Parenteral fluid transfer apparatus
US20040030291A1 (en) * 1998-10-16 2004-02-12 Holdaway Richard G. Needle member with off-set flash chamber and/or display member

Family Cites Families (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2564726B1 (en) 1984-05-22 1988-12-16 Biggio Alain DEVICE FOR PERFORMING A BLOOD SAMPLING
US4828547A (en) * 1987-09-28 1989-05-09 Bio-Plexus, Inc. Self-blunting needle assembly and device including the same
US4887998A (en) * 1987-12-14 1989-12-19 Martin Catherine L Hypodermic needle guard
US5356392A (en) * 1990-05-09 1994-10-18 Safety Syringes, Inc. Shielded blood collection tube holder
US5084019A (en) * 1990-11-30 1992-01-28 Owen J. Meegan Hypodermic syringe with means to destroy and safely store the cannula
US5120320A (en) 1991-02-13 1992-06-09 Becton, Dickinson And Company I.V. infusion or blood collection assembly with automatic safety feature
US5192275A (en) 1991-09-18 1993-03-09 Becton, Dickinson And Company IV infusion or blood collection guard assembly
US5472430A (en) * 1993-08-18 1995-12-05 Vlv Associates Protected needle assembly
CA2241631C (en) * 1995-12-28 2002-10-15 Bio-Plexus, Inc. Needle holder for fluid collection and/or injection system
US5605544A (en) * 1996-02-12 1997-02-25 Tsao; Chien-Hua Safety injector with returnable needle
AUPN941296A0 (en) * 1996-04-22 1996-05-16 Pisaniello, Luigi Luke A safety hypodermic needle
US5893845A (en) * 1996-06-21 1999-04-13 Becton Dickinson & Company Telescoping needle shield
DE29620187U1 (en) * 1996-11-20 1997-01-09 Kabe Labortechnik Gmbh Blood collection device
US5800395A (en) * 1996-12-05 1998-09-01 Mdc Investment Holdings, Inc. Medical device with retractable needle
US5810775A (en) * 1997-05-23 1998-09-22 Shaw; Thomas J. Cap operated retractable medical device
US6077244A (en) * 1998-04-30 2000-06-20 Mdc Investment Holdings, Inc. Catheter insertion device with retractable needle
CA2346640C (en) 1998-10-06 2008-01-29 Maxwell Edmund Whisson A needle apparatus
US6544239B2 (en) * 1998-10-16 2003-04-08 Bio-Plexus Delaware, Inc. Releasable locking needle assembly with optional release accessory therefor
US6146337A (en) * 1998-11-25 2000-11-14 Bio-Plexus, Inc. Holder for blood collection needle with blunting mechanism
US6224576B1 (en) * 1999-11-04 2001-05-01 Specialized Health Products, Inc. Safety device for a needle having two sharpened ends
US6077253A (en) * 1999-11-15 2000-06-20 Cosme; Edgar Z. Safety needle assembly
US6475189B1 (en) * 1999-12-21 2002-11-05 Ethicon, Inc. Apparatus and method for a self-blunting safety catheter
US6616637B2 (en) * 2000-06-21 2003-09-09 Gary E. Alexander Fluid collection safety syringe
US20030055381A1 (en) * 2001-09-17 2003-03-20 Wilkinson Bradley M. Medical devices
US6855128B2 (en) * 2001-09-25 2005-02-15 Becton, Dickinson And Company Dual blunting needle assembly
US20030208160A1 (en) * 2002-05-02 2003-11-06 Becton, Dickinson And Company Needle assembly
US6761704B2 (en) * 2002-05-02 2004-07-13 Becton, Dickinson And Company Safety blood collection needle assembly
US6755804B2 (en) * 2002-05-02 2004-06-29 Becton, Dickinson And Company Needle holder for use with safety needle assembly

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5009642A (en) * 1987-09-28 1991-04-23 Bio-Plexus, Inc. Self-blunting needle assembly for use with a catheter, and catheter assembly using the same
US5951520A (en) * 1996-12-19 1999-09-14 Bio-Plexus, Inc. Self-blunting needle medical devices and methods of manufacture thereof
US6254574B1 (en) * 1996-12-19 2001-07-03 Bio-Plexus, Inc. Self-blunting needle medical devices and methods of manufacture thereof
US6629956B1 (en) * 1997-03-26 2003-10-07 John M. Polidoro Parenteral fluid transfer apparatus
US20040030291A1 (en) * 1998-10-16 2004-02-12 Holdaway Richard G. Needle member with off-set flash chamber and/or display member
US20020147428A1 (en) * 1998-12-23 2002-10-10 Chang Joseph Jawshin Solid blunt for a needle assembly
US6264619B1 (en) * 1999-09-01 2001-07-24 Becton, Dickinson And Company Kit for drawing a blood sample

Cited By (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7678076B2 (en) 2002-05-02 2010-03-16 Becton, Dickinson And Company Needle assembly
US20030208162A1 (en) * 2002-05-02 2003-11-06 Becton, Dickinson And Company Safety blood collection needle assembly
US20100168614A1 (en) * 2002-05-02 2010-07-01 Becton, Dickinson And Company Needle Assembly
US7972309B2 (en) 2002-05-02 2011-07-05 Becton, Dickinson And Company Needle assembly
US6761704B2 (en) * 2002-05-02 2004-07-13 Becton, Dickinson And Company Safety blood collection needle assembly
US20030208139A1 (en) * 2002-05-02 2003-11-06 Becton, Dickinson And Company Needle holder for use with safety needle assembly
US6837872B2 (en) * 2002-05-02 2005-01-04 Becton, Dickinson And Company Needle holder for use with safety needle assembly
US20050240161A1 (en) * 2002-05-02 2005-10-27 Becton, Dickinson And Company Needle assembly
US6755804B2 (en) * 2002-05-02 2004-06-29 Becton, Dickinson And Company Needle holder for use with safety needle assembly
US20030208161A1 (en) * 2002-05-02 2003-11-06 Becton, Dickinson And Company Needle holder for use with safety needle assembly
AU2003200200B2 (en) * 2002-05-02 2008-06-26 Becton, Dickinson And Company Safety blood collection needle assembly
US20040147880A1 (en) * 2003-01-24 2004-07-29 Niall Duffy Device for protecting a distal portion of a catheter system during shipment and storage
US7108682B2 (en) * 2003-01-24 2006-09-19 Medtronic Vascular, Inc. Device for protecting a distal portion of a catheter system during shipment and storage
US20060129064A1 (en) * 2004-11-29 2006-06-15 Becton, Dickinson And Company Blood collection set with an expanded internal volume
WO2007127619A1 (en) 2006-04-25 2007-11-08 Medtronic Ps Medical, Inc. Cerebrospinal fluid shunt having long term anti-occlusion agent delivery
US9084854B2 (en) 2010-08-19 2015-07-21 West Pharmaceutical Services, Inc. Rigid needle shield
US8512295B2 (en) 2010-08-19 2013-08-20 West Pharmaceutical Services, Inc. Rigid needle shield
US10350366B2 (en) 2013-02-01 2019-07-16 Nxstage Medical, Inc. Safe cannulation devices, methods, and systems
US11419988B2 (en) 2013-02-01 2022-08-23 Nxstage Medical, Inc. Safe cannulation devices, methods, and systems
US11865320B2 (en) 2013-02-01 2024-01-09 Nxstage Medical, Inc. Safe cannulation devices, methods, and systems
USD740410S1 (en) * 2013-03-29 2015-10-06 Teleflex Medical Incorporated Catheter insertion device
US20170014062A1 (en) * 2014-04-11 2017-01-19 Shanghai Jinta Medical Co., Ltd. Safety Blood-Collection Needle
US9943258B2 (en) * 2014-04-11 2018-04-17 Shanghai Jinta Medical Co., Ltd. Safety blood-collection needle
US11439333B2 (en) * 2019-01-18 2022-09-13 Becton, Dickinson And Company Blood collection system including a baffle
US20220369969A1 (en) * 2019-01-18 2022-11-24 Becton, Dickinson And Company Blood collection system including a baffle
US11850047B2 (en) * 2019-01-18 2023-12-26 Becton, Dickinson And Company Blood collection system including a baffle

Also Published As

Publication number Publication date
AU2003200194B2 (en) 2009-04-23
US20050240161A1 (en) 2005-10-27
US20100168614A1 (en) 2010-07-01
JP2004000576A (en) 2004-01-08
US7678076B2 (en) 2010-03-16
US7972309B2 (en) 2011-07-05
EP1358898A1 (en) 2003-11-05
CA2417375A1 (en) 2003-11-02
AU2003200194A1 (en) 2003-11-20
CA2417375C (en) 2006-06-06

Similar Documents

Publication Publication Date Title
US7678076B2 (en) Needle assembly
US6837872B2 (en) Needle holder for use with safety needle assembly
US6855128B2 (en) Dual blunting needle assembly
US7063673B2 (en) Coupling device for blood collection assembly
AU692245B2 (en) Needle assembly having single-handedly activatable needle barrier
US7422573B2 (en) Forward blunting wingset with leaf spring driven shield
US7399292B2 (en) Activation of dual blunting needle assembly
US6755804B2 (en) Needle holder for use with safety needle assembly

Legal Events

Date Code Title Description
AS Assignment

Owner name: BECTON, DICKINSON AND COMPANY, NEW JERSEY

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:CRAWFORD, JAMIESON WILLIAM MACLEAN;REEL/FRAME:013023/0549

Effective date: 20010905

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION