Abstract:
A blood collection device includes a syringe assembly containing a slidable needle assembly within the cavity of a syringe body. The syringe body has a syringe top for receiving a seal assembly wherein the seal assembly is reversibly locked to the top of the syringe top. Within the insertable tube of the seal assembly is an occluding seal secured within the insertable cylinder with retaining rings. The occluding seal allows blood to flow from on end of a double pointed needle into a fully inserted collection tube. When the collection tube is removed the occluding seal keeps blood from flowing into the cavity of the insertable cylinder.

Description:
PRIORITY APPLICATION  
       [0001]    This application is related to U.S. Provisional Application Serial No. 60/299,498 filed on Jun. 20, 2001, entitled “BLOOD COLLECTION SAFETY DEVICE” and assigned to all the above named inventors, and incorporated by reference herein, with priority claimed for all commonly disclosed subject matter. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    The present invention relates to a device for collecting blood having a needle containment safety apparatus and method for protecting medical personnel and others from the risk of accidental percutaneous needlestick injuries.  
           [0004]    2. BACKGROUND OF THE INVENTION  
           [0005]    Because there are risks associated with accidental needle sticks to a medical person collecting blood, a variety of safety blood collection syringes have been developed. Most of these syringes have a safety shield that slides over an extended needle after the blood is collected. The safety shield may be held in place by a spring, friction, locking tabs or other means. However many of these safety devices require the person to manually place or move the protective shield over the needle thereby providing an opportunity, though slight, for an accidental needle stick.  
           [0006]    A safety blood collection and transfer device of McCallister, U.S. Pat. No. 6,360,011 is designed to accept a vacuum type blood tube (vacutainer) for collecting blood. McCallister&#39;s invention requires two double pointed needles coupled to each end of a plunger with a hollow core. In addition, a cylindrical syringe and a blood tube holder are required. However the user is required to remove and replace a needle cover providing a slight chance of a stick.  
           [0007]    The hypodermic safety device of Lockwood, U.S. Pat. No. 5,403,286 is an example of a device having an extendable cover for user protection. Lockwood&#39;s invention has an extension apparatus attached to a standard hypodermic needle that places or disposes a protective cover over an extended needle when a compressed spring is manually released. Lockwood&#39;s patent, in a prior art review, discusses much of the prior art related to protective covers and then describes the improvements provided by his invention.  
           [0008]    There is a need to new approach for a blood collection device. The present invention does not use an extendable cover, but retracts the needle within a disposable syringe body. A novel device for blood collection, described herein, is less complex than existing and convention devices, is easy to use, and should cost less than most existing devices.  
         SUMMARY OF THE INVENTION  
         [0009]    A blood collection device, that is adapted for use with conventional blood collection tubes (“vacutainer”) and does not have the complexity of prior art blood collection syringes, has been invented. The blood collection device is easy to operate and is an improvement over prior art devices.  
           [0010]    A blood collection device for use with a conventional collection tube is comprised of a syringe assembly and a sealing assembly. The syringe assembly comprises a syringe body having a tapered distal end and adapted for holding a slidable needle assembly wherein the needle assembly comprises a needle carrier and a double pointed needle, the syringe assembly further has a syringe top, securely attached to the proximal end of the syringe body, for containing the needle assembly within the syringe body. The sealing assembly has an occluding seal inside a cavity of an insertable cylinder that is adapted for pushing the needle assembly towards the distal end of the syringe body or for pulling the needle assembly towards the proximal end of the syringe body. When the occluding seal and seal of the collection tube are punctured by the proximal point of the needle (the distal point of the needle is used to puncture a vein), as the collection tube is pushed into place for blood collection, blood flows into the collection tube. When the collection tube is removed from the insertable cylinder the occluding seal blocks (occludes) blood from contaminating the proximal end of the blood collection device. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]    The invention can be better understood with reference to the following drawings. The elements of the drawings are not necessarily to scale relative to each other, emphasis instead being placed upon clearly illustrating the principles of the invention. Furthermore, like reference numerals designate corresponding parts throughout several views.  
         [0012]    [0012]FIG. 1 illustrates an assembly arrangement for the essential elements of the blood collection device in accordance with the present invention;  
         [0013]    [0013]FIG. 2 shows a partially assembled collection device having the elements shown in FIG. 1;  
         [0014]    [0014]FIG. 3 illustrates the assembled stage of the blood collection device, stage one;  
         [0015]    [0015]FIG. 4 illustrates the pre-collection stage of the blood collection device, stage two;  
         [0016]    [0016]FIG. 5 illustrates the collecting stage of the blood collection device, stage three;  
         [0017]    [0017]FIG. 6 illustrates the removal stage of the blood collection device, stage four;  
         [0018]    [0018]FIG. 7 illustrates the safety stage of the blood collection device, stage five;  
         [0019]    [0019]FIG. 8 illustrates details of the syringe assembly of FIG. 1;  
         [0020]    [0020]FIG. 9 illustrates details of the syringe body of FIG. 1;  
         [0021]    [0021]FIG. 10 illustrates details of the needle assembly of FIG. 1;  
         [0022]    [0022]FIG. 11 illustrates details of the syringe top of FIG. 1;  
         [0023]    [0023]FIG. 12 illustrates details of the flat seal of FIG. 1;  
         [0024]    [0024]FIG. 13 illustrates details of the spring of FIG. 1;  
         [0025]    [0025]FIG. 14 illustrates details of the conical seal of FIG. 1;  
         [0026]    [0026]FIG. 15 illustrates details of the insertable cylinder of FIG. 1; and  
         [0027]    [0027]FIG. 16 illustrates details of the blood container of FIG. 1. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0028]    Although those skilled in the art may apply variations to the present invention as characterized in the detailed description, such variations would fall within the scope of the present invention.  
         [0029]    The blood collection safety device as described in the figures is fabricated of materials typically used for medical devices of the same type, such as syringes for injecting medication, traditional blood collecting devices and the like. All elements of the device and the assembled device would meet the requirements of corresponding government and medical agencies provided for protection of those practicing and receiving medical services. As new materials are developed that meet the needs for each and every part of the safety device, the device fabricated with the new materials would fall within the scope of the present invention (and claims when a utility application is completed).  
         [0030]    Referring now to FIG. 1 there is shown a drawing illustrating essential elements of the present invention. A syringe body  11  is cylinder with a tapered end, the distal end, and a proximal end, no tapering. The proximal end is adapted to receive a needle assembly  13  comprising a needle carrier  14  and a needle  12 . After the needle assembly is inserted in and contained within the syringe body  11  a syringe top  16  is bonded via an insertable edge  15  to the inside of the proximal end of the syringe body  11 . Note that the syringe top  16  has a lock channel  17  on the proximal end of the syringe top for receiving a tab which will be described below. A syringe assembly  10  as shown in FIG. 2 is provided when all elements  11 ,  13  and  16  are assembled.  
         [0031]    Still referring to FIG. 1 there is a seal assembly  20  comprised of an insertable cylinder  28  with a twist tab  29 , where the insertable assembly encloses or contains an occluding seal  21 . The occluding seal is comprised of a flat seal  22 , a spring  24  and a conical seal  26  in an arrangement as shown in FIG. 1. The occluding seal fits inside the seal assembly  20  as shown in FIG. 2. The twist tab  29  of the seal assembly  20  engages the lock channel  17  of the syringe assembly  10  in a twisting motion and may be referred to as a bayonet connection. FIG. 3 illustrates the assembled invention comprising the seal assembly  20  inserted in the syringe assembly  10 . Other locking methods may also be used and fall within the scope of the present invention.  
         [0032]    [0032]FIG. 3 represents a first stage, an assembled stage  42 , of five stages (FIGS.  3 - 7 ) that illustrate the operation of the blood collection safety device in accordance with the present invention. The assembled stage, stage  1 , is accomplished just before blood is to be collected. To reach the assembled stage  42  the needle  12 , which has been advanced by pushing the seal assembly  20  in the distal direction such that the needle is extending outward from the distal end of the syringe assembly  10 , is inserted in a blood vessel using the appropriate medical procedure. When blood is observed flowing from the proximal lumen of the needle  12  into the cavity between the punctured flat seal  22  and conical seal  26 , the seal assembly  20  is further advanced until the proximal lumen is embedded in the distal surface of the conical seal  26  thereby stopping blood flow, concomitantly the lock tab  27  snaps into lock groove  18  providing an irreversible connection. After the twist tab  29  is rotated, for a reversible lock, into the lock channel  17  (a bayonet type coupling) the assembled stage is complete.  
         [0033]    Next, for stage  2  or a pre-collection stage  44 , the vacutainer  30  (collection tube) is positioned within the seal assembly  20  as shown in FIG. 4. Note that the distal end of the vacutainer seal  32  rests against the proximal end of the conical seal  26  and there is no blood flow.  
         [0034]    Next for stage  3 , a collecting stage  46 , the vacutainer is pushed or urged towards the occluding seal  21 . When sufficient force is applied to the vacutainer, the proximal point of the needle  12  punctures both the conical seal  26  and the vacutainer seal  32 . The proximal point of the needle  12 , as shown, goes through the center of the spring  24  and the spring is compressed as long as a force is applied to the vacutainer. When the vacutainer  30  is filled with blood and the force is removed, the spring  24  goes from a compressed position to an extended or normal position and the vacutainer is withdrawn or removed from the seal assembly  20  as shown in FIG. 6 stage  4 , a removal stage  48 . The spring goes from a compressed mode to an uncompressed mode (the original mode) causing the conical seal  26  to stop blood flow from entering the open section of the seal assembly. Other sealing methods may also be used and fall within the scope of the present invention. The process comprising stages  2 - 4  is repeated if more than one vacutainer of blood is needed. When all the required blood has been collected the needle is removed from the blood vessel as described in FIG. 7.  
         [0035]    [0035]FIG. 7 illustrated a stage  5 , a safety stage  49 , for the collection device. In order to reach the safety stage the bayonet connection is released and the seal assembly is pulled in a proximal direction as shown in FIG. 7. The lock tab  27 , being irreversibly engaged in the lock groove  18  pulls the needle from the vein supplying blood and pulls the needle assembly  14  inside the syringe body, where the needle assembly (and hence the needle) is locked and held in a safe position within the syringe assembly and seal assembly. When the needle assembly is contained within the syringe assembly, medical and other persons are protected from the possibility of a needle stick. When in the safety stage  49 , the needle now contaminated cannot stick or cause injury to medical or other persons.  
         [0036]    The remaining figures, FIGS.  8 - 16 , provide more details of the elements shown in FIG. 1 and further assist a person skilled in the art with the necessary details to build the blood collection safety device of the present invention. The inventor has provided an embodiment that would allow a person skilled in the art to build, fabricate or make the blood collection safety device. However the inventor believes those making some variation in the invention, such as for example, having different locking arrangements, changing shapes of seals, using different materials and making other non-substantial changes would be practicing the invention.  
       Operational Instructions for the Blood Collection Device  
       [0037]    Operational instructions for the blood collection device are provided to illustrate how each of the elements work together to collect blood in a blood container such as a vacutainer. The operation is described in distinct steps or stages that are illustrated in FIGS.  3 - 7 . It may also be helpful to refer to FIGS. 1 and 2 for viewing the details of each of the elements.  
         [0038]    For the description of the operation of the blood collection device consider first the elements:  
         [0039]    syringe assembly  10 ;  
         [0040]    needle assembly  13 ;  
         [0041]    seal assembly  20 ;  
         [0042]    blood container  30  (vacutainer); and  
         [0043]    occluding seal  21  with compressible mechanism  
         [0044]    First the distal end of seal assembly  20  is inserted into the proximal opening of syringe assembly  10 , step  1 . The user then pushes or urges the seal assembly  20  in the distal direction.  
         [0045]    As the seal assembly  20  goes forward the lock tab  27  of seal assembly pushes the needle assembly  13  down the barrel (the cavity) of the syringe body  11  until the distal end of the needle  12  is fully extruded from the opening at the distal tapered end of the syringe body. During this operation, step  2 , the proximal end of the needle  12  penetrates the flat seal  22  placing the proximal end of the needle in the space between the flat seal  22  and the conical seal  26 .  
         [0046]    Next, step  3 , the distal end of the needle  12  is inserted into a vein and when a positive blood flow is detected at the proximal lumen of needle  12  the seal assembly  20  is moved farther distally until there is an irreversible engagement with the lock groove  18  of the needle carrier  14  and the lock tab  27  of the seal assembly  20 . At this stage the proximal lumen of needle  12  partially penetrates the conical seal  26  and causing (by blocking) blood flow to cease. The distal locking twist tab  29  is reversibly engaged (bayonet type locking mechanism) with proximal lock channel  17  of the syringe top  16 .  
         [0047]    For step  4 , the distal end of a standard vacutainer  34  (collection tube) is then inserted into the proximal opening of seal assembly  20  and moved in a distal direction until the distal seal of the vacutainer contacts the proximal aspect of the conical seal  26  of the occluding seal  21 . Additional distal pressure on the vacutainer  34  compresses the conical seal  26  exposing the proximal end of the needle  12  and causing the proximal end of needle  12  to penetrate the distal end of vacutainer seal  32  of the vacutainer. Blood flow now resumes (it was earlier blocked) at this point and blood collects within the cavity of the vacutainer  34 .  
         [0048]    When sufficient (the desired amount) blood has been collected in the vacutainer  34 , the filled vacutainer is removed, step  5 , from the combined seal assembly  20  and syringe assembly  10 . Concomitantly, the conical seal  26  decompresses (spring  24  expands) and moves proximally to again occlude blood flow from the lumen of the proximal end of the needle  12 .  
         [0049]    If more blood is needed, step  6  (optional), additional vacutainers are used by repeating steps  4  through  5 .  
         [0050]    When the blood collection procedure has been completed, and while the needle remains in the vein, the seal assembly  20  is disengaged (it was earlier reversibly engaged) from the syringe assembly  10  by rotating the bayonet type locking mechanism and withdrawing the seal assembly  20  in a proximal direction, step  7 . The needle assembly  13 , being irreversibly locked with the locking tabs  27  of the seal assembly  20 , is concomitantly and safely withdrawn into the cavity of syringe body  11 . This action removes the needle from the target tissue without the contaminated needle being exposed to the health care provider. The distal insertable edge  15  of the syringe top  16 , prevents the needle carrier  14  from being withdrawn from the syringe assembly  10  thereby further enhancing the safety of this blood collection device.  
         [0051]    All such modifications and variations of the embodiments of the blood collection device are intended to be included herein and are within the scope of this disclosure that is protected by the following claims: