Abstract:
A transfer needle safety apparatus including a guide port adapted to fit a variety of body fluid receptacle sizes. A sleeve substantially fills the cavity inside a needle shield. The sleeve includes a robust external lead-in structure for aligning/assembling and centering the sleeve in the shield and a robust internal lead-in structure for aligning and centering a narrow body receptacle onto a needle. The sleeve engages a long section of the outer surface of a receptacle thereby preventing rocking or lateral motion of a receptacle septum relative to a needle tip. Streamlined gripping features allow removal of the sleeve from the shield.

Description:
BACKGROUND  
         [0001]    1. Technical Field  
           [0002]    The present disclosure relates to the field of medical fluid transfer devices, and more particularly, to methods and apparatus for safely transferring bodily fluids to a receptacle.  
           [0003]    2. Description of the Related Art  
           [0004]    In the medical field, specimens of blood or other bodily fluids are commonly obtained from a subject using a syringe and hypodermic needle or a hypodermic needle connected to a fluid collection system. Health care workers who handle fluid samples and collection apparatus are routinely exposed to dangers from inadvertent contact with contaminated needles or exposure to contaminated bodily fluids. Rigorous safety precautions must be exercised to prevent exposure to fluid samples or contaminated needles.  
           [0005]    It is often desirable to transfer blood or other bodily fluids collected from a patient to one or more receptacles, for example, to be stored or taken to a lab for testing. Various sized receptacles such as specimen culture bottles and vials are commonly used to receive bodily fluid specimens. It is well known to cover the entry portion of a receptacle with a piercable rubber septum which seals the entry portion and to facilitate fluid transfer to and from the receptacle. The septum is pierced by the needle or cannula of a fluid transfer device such as a medical syringe containing the fluid to be transferred. Fluid can then be safely transferred from the fluid transfer device to the receptacle. When the needle or cannula is withdrawn from the pierceable septum, the septum substantially reseals itself thereby preventing fluid from escaping the receptacle and preventing contaminants from entering the receptacle.  
           [0006]    Fluid transfer devices such as blood collection devices are commonly adapted for transferring samples to more than one receptacle. At least one type of multiple sample adapter for a fluid transfer device provides a needle covered by a piercable rubber sheath. Like the piercable septum, the piercable sheath is capable of resealing itself after a needle is withdrawn. Upon use, the needle of a multiple sample adapter pierces the rubber sheath and the septum of a receptacle. The septum allows the needle to pass into a receptacle but blocks entry of the sheath. The sheath is thus compacted along the needle shaft as the needle advances further through the sheath and the septum. As the needle is withdrawn from the receptacle, the sheath resiliently springs back along the needle shaft. When the needle tip clears the septum, the sheath takes its original shape thereby covering and sealing the needle.  
           [0007]    A serious risk is encountered by health care workers when a needle is uncovered. The rubber sheath of a multiple collection device does not protect health care workers from accidental needle stick injuries. An accidental needle stick can be caused, for example, by slipping or improperly aiming a needle while attempting to puncture the septum of a receptacle.  
           [0008]    Various methods and apparatus are known for reducing the risk of inadvertent contact with contaminated needles while transferring blood to a receptacle. U.S. Pat. No. 5,360,423 to McCormick (hereinafter “McCormick &#39;423) describes a safety system for transfer and collection of body fluids. McCormick &#39;423 describes a cup shaped guide port adaptable over a fluid transfer needle wherein the needle is recessed rearward from an open end of the guide port. An open end of the cup shaped guide port guides a fluid receiver into contact with the needle to reduce the likelihood of a needle-stick injury to a health care worker. A plurality of sized guide ports are described to guide a transfer needle into contact with a variety of fluid receivers.  
           [0009]    McCormick &#39;423 also describes a cap adaptable to the open end of the guide port. The cap substantially covers the open end of the guide port to reduce exposure risk to health care workers. The cap also includes a centered aperture for guiding a smaller receptacle such as a vial into contact with the needle.  
           [0010]    Guide ports and other heretofore known safety apparatus for fluid transfer needles suffer from various drawbacks. For example, the cap described in McCormick &#39;423 must be manually aligned and pushed onto the open end of the guide port. The finger of a health care can accidentally slip inside the guide as the health care worker attempts to install the cap onto the guide. Therefore, although the guide cap of McCormick &#39;423 is intended to protect the health care worker, it requires an installation step that can endanger the health care worker.  
           [0011]    The guide port described in McCormick &#39;423 also does not provide a lead-in structure to guide a vial through the opening in the cap and into the guide port. Rather, the cap described in McCormick &#39;423 includes a flange or outwardly directed edge around the smaller opening. The flange or outwardly directed edge can impede the installation of a vial through the opening.  
           [0012]    The cap described in McCormick &#39;423 contacts a vial only around a narrow circumference at a proximal position on the vial. Therefore, the center axis of the vial is not robustly aligned and located relative to the center axis of a needle. The vial&#39;s freedom of movement can allow lateral movement of the vial&#39;s septum relative to the needle tip. Lateral movement of the septum relative to the needle can tear the septum which can prevent the septum from resealing properly after use. Such tears can allow dangerous fluids to escape from the receptacle or allow contamination into a receptacle. Lateral movement of a vial or receptacle relative to the needle can similarly tear a needle sheath and allow dangerous fluid to escape from a fluid transfer device.  
           [0013]    Various guide ports heretofore known must be provided in a plurality of sizes to accommodate a variety of receptacle sizes. Heretofore known guide ports are also typically designed for use with a single fluid transfer device. The single fluid transfer device typically includes a needle permanently mounted inside of the guide port and permanently attached to tubing or a syringe mounted outside of the guide port. The needle is connected to the tubing or syringe via at a neck portion of the guide port.  
           [0014]    Therefore, it would be desirable to overcome the disadvantages and drawbacks of the prior art with a guide port including a sleeve that substantially fills the cavity inside the guide port preventing a user who is holding the sleeve on the outside rim from having his finger slip between the sleeve and the needle. It would be desirable if such a guide included a sleeve having a robust external lead-in structure for aligning/assembling and centering the sleeve in the guide and a robust internal lead-in structure for aligning and centering a vial onto a needle. It would be desirable to provide a guide that engages long section of the outer surface of a vial thereby preventing rocking of a receptacle or lateral motion of the septum relative to the needle tip. It would also be desirable to provide a guide adapted to fit a variety of sized receptacles. It would also be desirable to guide port adapted for use with multiple fluid transfer devices.  
         SUMMARY  
         [0015]    Accordingly, a transfer needle safety apparatus is provided that is adapted to fit a variety of fluid receptacles. The transfer needle safety apparatus includes a shield for use with wide body receptacles and a removable sleeve which adapts the shield for use with narrow body receptacles. The sleeve includes a robust external lead-in structure for aligning and centering the sleeve in a shield and a robust internal lead-in structure for aligning and centering a vial onto a needle. The sleeve engages an extended area along the outer surface of a vial thereby aligning the vial and preventing rocking or lateral motion of the vial&#39;s septum relative to a needle tip. The sleeve substantially fills the cavity of a shield thereby preventing a user&#39;s finger from slipping between the sleeve and the shield.  
           [0016]    Internal stepped shoulders are provided in the shield to guide and center a variety of sized receptacles. A tubular extension protruding distally from the shield includes features for attachment and removal of multiple fluid transfer devices to and from a single shield. Snap features provide audible and/or tactile indications of full insertion of a sleeve to a shield. Gripping features are provided for removal of the sleeve from the shield. Streamlined gripping features prevent accidental disengagement of the sleeve from the shield.  
           [0017]    In one particular embodiment, a needle shield for safe transfer of body fluids to a container is provided. The needle shield comprises an outer cylinder having a wide diameter side-wall defining a large substantially full diameter proximal end opening and a narrower diameter distal end wall having an open tubular extension extending distally therefrom. The outer cylinder has an inside diameter adapted to receive a wide body collection vessel. The tubular extension is adapted to retain a transfer needle and mate with a fluid transfer device. For example, the tubular extension can include threads or other mating features for removable attachment to a male luer of a fluid transfer syringe. The outer cylinder has a depth sufficient to extend beyond a transfer needle tip when a transfer needle is installed in the tubular extension.  
           [0018]    The needle shield includes a removable sleeve comprising an inner cylinder defining a proximal open end and having an inside diameter adapted for receiving a narrow body collection vessel. A plurality of ribs extends radially from an outside surface of the inner cylinder to the inside diameter of the outer cylinder. The inside cylinder has an open distal end.  
           [0019]    In at least one embodiment, the proximal opening of the inner cylinder has an annular flange extending from the inner cylinder to a diameter equal or greater than the large opening in the outer cylinder. In an alternative embodiment, the proximal opening includes a shoulder having at least one finger protruding radially therefrom. A slot can be provided in the outer cylinder side wall adjacent the outer cylinder&#39;s proximal end opening to accept a finger protruding radially from the sleeve when the sleeve is installed in a needle shield.  
           [0020]    A radial protrusion such as a flange or finger extending from a sleeve may be accidentally pushed or bumped in a proximal direction thereby accidentally disengaging the sleeve from the needle shield. Accordingly, still another embodiment is provided wherein the inner cylinder&#39;s proximal opening is defined by a cylindrical proximal extension. The cylindrical proximal extension allows a user to grip the sleeve. The proximal extension thereby provides for removal of a sleeve from a needle shield without having a radial protrusion such as a flange or finger extending from the sleeve. In still another embodiment, at least one slot is provided in the outer cylinder side wall adjacent the outer cylinder&#39;s proximal end opening to allow gripping and removal of the sleeve without requiring a radial protrusion or proximal extension from the sleeve.  
           [0021]    In an illustrative embodiment, a snap feature provides audible and/or tactile feedback to the user to indicate that a sleeve is fully installed to the needle shield. Such feedback can prevent a user from applying excessive or insufficient force when installing the sleeve to a needle shield. A snap feature such as an undercut or annular ring can be formed in the inside diameter of the needle shield to provide a snap-fit with a cooperating feature in the sleeve. For example, a step can be provided in the proximal end of at least one rib to accept an annular ring in the shield. Such snap features also provide retention of the sleeve within the needle shield. An annular ring or other snap feature that extends around the full diameter of the shield provides a 360 degree snap fit without requiring rotational orientation of the sleeve to the shield  
           [0022]    Each of the ribs includes an inclined alignment surface that engages the rim of the outer cylinder when the sleeve is installed to the removable shield. The ribs cause the sleeve to become aligned coaxially with the shield during installation thereto. Coaxial alignment of the sleeve within the shield is completed before the distal end of the inner cylinder of the sleeve reaches the needle tip. This early centering of the sleeve prevents interference between a needle tip and the removable shield which could damage the needle or a needle sheath.  
           [0023]    In a particular embodiment, at least one of the ribs includes a rib extension extending distally from the rib&#39;s inclined alignment surface. Clearance windows are provided in the shield and disposed to allow protrusion of the rib extensions there-through when the sleeve is assembled to the shield. Protrusion of the rib extensions through the clearance windows facilitates removal of the sleeve from the needle shield by applying force in a proximal direction on the rib extensions while holding the needle shield.  
           [0024]    In at least one embodiment, the shield includes a pre-installed needle to form a transfer needle safety apparatus. The needle is non-removably installed in the distal end opening of the needle shield and extends proximally into the cavity of the needle shield. A resilient needle sheath is optionally installed around the needle and attached to form a seal at its distal end against an inside wall of the needle shield.  
           [0025]    In another illustrative embodiment, a method is provided for safely transferring body fluids to a vessel comprising fitting fluid transfer needle assembly to an adapter protruding from the closed distal end of a wide mouthed needle shield. Then a receptacle having a puncturable septum is fitted into the wide open end of the wide mouthed needle shield so that the septum is punctured with the needle. Next fluid is transferred from the said needle into the receptacle. The receptacle is then removed from the shield and a sleeve is installed to the shield to adapt the shield for receiving a tube. A tube having a puncturable septum can then be fitted into the sleeve so that the septum is punctured with the needle. Fluid can then be transferred safely to the tube. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0026]    The foregoing and other features and advantages of the present invention will be more fully understood from the following detailed description of illustrative embodiments, taken in conjunction with the accompanying drawings in which:  
         [0027]    [0027]FIG. 1 is a diagrammatic representation of a removable sleeve aligned with a needle shield according to the disclosure;  
         [0028]    [0028]FIG. 2 is a cross sectional view of a transfer needle safety apparatus aligned with a wide body collection vessel according to the disclosure;  
         [0029]    [0029]FIG. 3 is a cross sectional view of a transfer needle safety apparatus and a partially installed removable sleeve according to the disclosure;  
         [0030]    [0030]FIG. 4 is a cross sectional view of a transfer needle safety apparatus and a fully installed removable sleeve according to the disclosure;  
         [0031]    [0031]FIG. 5 is a diagrammatic representation of a removable sleeve having a radially protruding finger aligned with a shield having a slot according to an alternative embodiment;  
         [0032]    [0032]FIG. 6 is a cross sectional view of a transfer needle safety apparatus and a fully installed removable sleeve according to an alternative embodiment;  
         [0033]    [0033]FIG. 7 is a diagrammatic representation of a removable sleeve having rib extensions aligned with a shield having clearance windows to accept the rib extensions according to an alternative embodiment;  
         [0034]    [0034]FIG. 8 is a diagrammatic representation of a removable sleeve having a cylindrical proximal extension aligned with a shield according to an alternative embodiment;  
         [0035]    [0035]FIG. 9 is a diagrammatic representation of a removable sleeve aligned with a shield having a plurality of slots according to an alternative embodiment;  
         [0036]    [0036]FIG. 10 is a cross sectional view of a transfer needle safety apparatus and a fully installed removable sleeve aligned with a narrow body collection vessel according to the disclosure; and  
         [0037]    [0037]FIG. 11 is a cross sectional view of a transfer needle safety apparatus and a fully installed removable sleeve with a fully installed narrow body collection vessel according to the disclosure. 
     
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS  
       [0038]    The present invention will be described in detail with respect to blood collection applications with the understanding that embodiments of the present invention are directed to various other fluid transfer applications as well.  
         [0039]    In the discussion that follows, the term “proximal” will refer to the portion of a structure that is closer to a practitioner, while the term “distal” will refer to the portion that is further from the practitioner. As used herein, the term “subject” refers to a human patient or other animal. According to the present disclosure, the term “practitioner” refers to a doctor, nurse or other care provider and may include support personnel.  
         [0040]    Referring to FIGS. 1-4, a transfer needle safety apparatus includes a shield  10  having a wide diameter proximal end side-wall  22  defining cavity  44 . The cavity  44  has a rim  46  defining a substantially full diameter proximal opening  26 . The cavity  44  also has a narrower diameter distal end wall  18  with an open tubular extension  20  extending distally therefrom. The inner contour  54  of the shield  10  is adapted to receive a wide body collection vessel  50 .  
         [0041]    The transfer needle safety apparatus also includes a removable sleeve  30  adapted to fit into the cavity  44  of the shield  10  and self align coaxially therewith. The removable sleeve  30  has an inner cylinder  32  defining a proximal opening  34  and a distal opening  48  and an inside diameter  33  adapted for receiving a narrow body collection vessel  52  (FIGS. 10, 11). In an illustrative embodiment, the proximal opening  34  of the inner cylinder  32  includes an annular flange  38  extending radially beyond the rim  46  of proximal opening  26 . In at least one illustrative embodiment the flange  38  includes a rounded shoulder  31  blending into the proximal opening  34  of the inner cylinder  32 .  
         [0042]    In an illustrative embodiment, the transfer apparatus includes a plurality of ribs  40  extending radially from the outer surface  35  of the inner cylinder  32  to a diameter corresponding to the inner contour  54  and cooperatively engages with the shield side-wall  22  to provide coaxial alignment of the sleeve  30  with the shield  10 .  
         [0043]    In at least one embodiment, the transfer apparatus includes a transfer needle  56  non-removably installed with the shield  10 . The transfer needle  56  extends proximally into the cavity  44  from the distal end wall  18 , and distally into the tubular extension opening  27 . The sidewall  22  extends beyond the tip  57  of the transfer needle  56 . Optionally, a re-sealable needle sheath  58  is non-removably installed over the transfer needle  56  and sealed against the distal end wall  18 .  
         [0044]    In an illustrative embodiment, a tubular extension  20  is adapted for mounting to a luer  29  of a fluid transfer syringe. The tubular extension  20  can includes threads adapted for attachment to a threaded luer  29  of a fluid transfer syringe. Alternatively, the tubular extension  20  opening can include a distal end inside diameter adapted for receiving a male luer  29  of a fluid transfer syringe. In still another embodiment, the tubular extension  20  can include a luer-lock fitting (not shown) for removable attachment to a cooperating luer lock fitting (not shown) of a fluid transfer syringe.  
         [0045]    In at least one illustrative embodiment, side wall  22  of shield  10  includes an internal undercut (not shown) adjacent to the rim  46 . At least one of the ribs  40  includes an inwardly formed step  41  which engages the undercut when the sleeve  30  is installed in the needle shield  10  for removable retention of the sleeve  30  in the cavity  44 . In another illustrative embodiment, the inside diameter  43  of shield  10  provides an interference fit with the ribs  40  for removable retention of the sleeve  30  in the cavity  44 .  
         [0046]    In still another embodiment, each of the ribs  40  include an inclined distal end alignment surface  42  for aligning the sleeve  30  with the shield  10  when the alignment surface  42  engages the rim  46  during installation of the sleeve  30  to the shield  10 .  
         [0047]    In at least one embodiment, each of the ribs  40  extend far enough distally to engage the side-wall  22  and ensure alignment of the sleeve  30  within the shield  10  before the distal end of the inner cylinder  32  reaches the transfer needle tip  57  during installation of the sleeve  30  to the shield  10 .  
         [0048]    Referring now to FIGS. 5 and 6, another illustrative embodiment of a transfer needle safety apparatus is shown including a shield  10  having a side-wall  22  defining a cavity  44  with a substantially full diameter proximal opening  26  and having a narrower diameter distal end wall  18  with an open tubular extension  20  extending distally therefrom. The shield  10  includes an inner contour  54  adapted to receive a wide body collection vessel  50  (FIG. 2). A removable sleeve  30  is adapted to fit into the cavity  44  and self align coaxially therewith. The removable sleeve  30  comprises an inner cylinder  32  defining a proximal opening  34  and an distal opening  48  and having an inside diameter  33  adapted for receiving a narrow body collection vessel  52  (FIGS. 10, 11). A finger  60  extends from the proximal opening  34  of the inner cylinder  32 . The finger  60  extends to a diameter equal or greater than the proximal opening  26  of the shield  10 . The side-wall  22  of the shield  10  includes a slot  62  disposed therein configured to receive the finger  60  of the removable sleeve  30 . In at least one embodiment, the inner cylinder  32  includes a rounded shoulder  61  flaring outwardly to a diameter corresponding to the cavity inside diameter.  
         [0049]    Referring now to FIG. 7, an alternative embodiment of the sleeve  30  and shield  10  according to the disclosure includes at least one rib extension  70  protruding distally from the inclined surface  42  of at least one rib  40 . At least one corresponding clearance window  66  is provided in shield  10  to accept the rib extension  70  when the sleeve  30  is installed in the shield  10 . No radial protrusion from the sleeve such as a finger  60  (FIGS. 5, 6) or flange  38  (FIGS. 1-4) is required because removal of the sleeve  30  from the shield  10  can be effected by pushing on the rib extensions  70  while holding the shield  10 .  
         [0050]    Referring to FIG. 8, an alternative embodiment of the sleeve  30  according to the disclosure includes a cylindrical proximal extension  68  surrounding the proximal opening  34  of the sleeve  30 . No radial protrusion from the sleeve  30  is required because removal of the sleeve  30  from the shield  10  can be effected by gripping the proximal extension  68  to pull the sleeve  30  proximally while holding the shield  10 .  
         [0051]    Referring to FIG. 9, an alternative embodiment of the sleeve  30  and shield  10  according to the disclosure includes at least one slot  72  in the side wall  22  of shield  10  adjacent the shield&#39;s proximal opening  26  to allow gripping and removal of the sleeve  30  without requiring a radial protrusion or proximal extension  68  (FIG. 8) from the sleeve  30 .  
         [0052]    The present disclosure also provides a method for safely transferring body fluids to a vessel. Referring now to FIGS. 10 and 11, the method includes providing a shield  10  having a side-wall  22  defining a cavity  44  with a rim  46  defining a substantially full diameter proximal opening  26 . The shield  10  has a narrower diameter distal end wall  18  with an open tubular extension  20  extending distally therefrom. The shield  10  also includes an inner contour  54  adapted to receive a wide body collection vessel  50  (FIG. 2). A fluid transfer needle  56  is permanently installed with the shield  10  and extends from the proximal end of the tubular extension  20  into the cavity  44 .  
         [0053]    A removable sleeve is  30  adapted to fit into the cavity  44  and self align coaxially therewith. The removable sleeve  30  comprises an inner cylinder  32  defining a proximal opening  34  and a distal opening  48  and having an inside diameter adapted for receiving a narrow body collection vessel  52 .  
         [0054]    According to the method of an illustrative embodiment, a luer  29  of fluid transfer device such as a syringe is fitted to the distal end of the tubular extension  20 . In one illustrative embodiment, the luer of a transfer syringe is fitted to the tubular extension  20  by engaging threads disposed on the luer  29  with cooperating threads disposed on the tubular extension  20 . A narrow body fluid collection vessel  52  having a penetrable septum  53  is inserted into the sleeve  30  so that the septum  53  is penetrated by the transfer needle tip  57 . Fluid from the fluid transfer syringe is transferred into the narrow body receptacle  52 . The narrow body receptacle  52  is then removed from the sleeve  30 .  
         [0055]    In an illustrative embodiment of method according to the present disclosure, the sleeve  30  is then removed from the shield  10 . Referring again to FIG. 2, a wide body fluid receptacle  50  having a penetrable septum  51  is inserted into the shield  10  and so that the septum  51  is penetrated by the transfer needle tip  57 . Fluid is transferred from the fluid transfer device into the wide body receptacle  50 . The wide body receptacle  50  is then removed from the shield  10 .  
         [0056]    Although the invention is described in terms of transferring fluid to a receptacle from a fluid collection device, persons skilled in the art should appreciate that fluid can be transferred to a receptacle using the method and apparatus of the present disclosure from any number of fluid container or transfer apparatus having a needle or cannula such as, for example, a transfer apparatus connected to a transfusion tube.  
         [0057]    It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.