Abstract:
A self-contained universal front-end automatic blood collection device is disclosed herein. The device collects a few micro-liters blood sample that is used for a broad range of blood analyzers. The design of the front-end closely mimics current phlebotomist practice and provides a number of unique features that ensure patient safety and sterility, improve collection efficacy, and prevent sample contamination and user cross contamination.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    Not Applicable 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable 
       BACKGROUND OF THE INVENTION 
       [0003]    1. Field of the Invention 
         [0004]    The present invention generally relates to blood collection. More specifically, the present invention relates to automatic blood collection. 
         [0005]    2. Description of the Related Art 
         [0006]    The prior art discusses various devices to collect blood from a patient. 
         [0007]    Currently when collection of blood with a capillary tube is required for finger-stick testing the procedure involves a six step process that typically requires a phlebotomist (a person skilled in the process of making an incision in a vein with a needle). This process is 1—cleaning the finger 2—pricking the finger with a commercially available lancet that contains a clean needle, 3—wiping off of the first droplet of blood, 4—using a capillary tube to collect the quantity of blood needed for testing, 5 transport the blood into a blood analyzer device, 6 Applying a bandage around finger at the puncture location, and 7 dispose all the contaminated materials in a safe waste. 
       BRIEF SUMMARY OF THE INVENTION 
       [0008]    The present invention provides a solution to blood collection. 
         [0009]    One aspect of the present invention is a self-contained universal front-end automatic blood collection device that collects a few micro-liters blood sample that is used for a broad range of blood analyzers. The design of the front-end closely mimics current phlebotomist practice and provides a number of unique features that ensure patient safety and sterility, improve collection efficacy, prevent sample contamination and user cross contamination. All the features are integrated into a compact, low-cost package. 
         [0010]    Another aspect of the present invention is an apparatus for automatic blood collection from a patient. The apparatus comprises a housing having an insertion port, a lancet comprising a needle, a dispenser positioned within the housing, a mechanism for removing an initial droplet of blood, a capillary tube for collecting a predetermined amount of blood, and a dressing dispenser. The lancet is positioned within the housing and in communication with the insertion port. The dispenser comprises a sanitizing agent. The mechanism removing an initial droplet of blood is positioned within the housing. The dressing dispenser is located at an opening of the insertion port. The dressing dispenser comprises a bandage. The capillary tube is positioned within the housing and in communication with the insertion port. The dispenser is adapted to dispense the sanitizing agent on a portion of a finger of a patient placed within the insertion port. The needle is adapted to pierce the sanitized finger. The mechanism is adapted to remove the initial droplet of blood from the pierced finger. The capillary is adapted to collect the predetermined amount of blood from the patient. The dressing dispenser is adapted to wrap the bandage around the pierced finger of the patient. 
         [0011]    Yet another aspect of the present invention is a method for automatic blood collection from a patient. The method includes inserting a finger of a patient into a port of an automatic blood collection apparatus. The method also includes sanitizing a portion of the finger of the patient within the automatic blood collection apparatus. The method also includes piercing the sanitized portion of the finger with a needle of a lancet. The method also includes removing a first droplet of blood from the pierced finger. The method also includes collecting a predetermined amount of blood from the pierced finger in a capillary tube. The method also includes transporting the predetermined amount of blood to a blood analyzer device. The method also includes bandaging the pierced finger of the patient with a wrap within the automatic blood collection apparatus. The method also includes disposing of a plurality of contaminated materials from the automatic blood collection apparatus. 
         [0012]    Yet another aspect of the present invention is an apparatus for dressing a punctured finger of a patient subsequent to automatic blood collection from a patient. The apparatus comprises a housing having an insertion port, and a dressing dispenser located at an opening of the insertion port. The dressing dispenser comprises a dressing. The dressing dispenser is adapted to automatically wrap the dressing around a pierced finger of the patient as the pierced finger is removed from the insertion port. The dressing protects and avoids cross contamination of the finger. 
         [0013]    Having briefly described the present invention, the above and further objects, features and advantages thereof will be recognized by those skilled in the pertinent art from the following detailed description of the invention when taken in conjunction with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0014]      FIG. 1  is a block diagram of automatic blood collection. 
           [0015]      FIG. 2  is an illustration of the disposable components and the control components for automatic blood collection. 
           [0016]      FIG. 2A  is an exploded view of an automatic blood collection apparatus. 
           [0017]      FIG. 3  is an illustration of an automatic blood collection apparatus within an opened sterile package. 
           [0018]      FIG. 4  is an illustration of a patient inserting a finger into an automatic blood collection apparatus. 
           [0019]      FIG. 5A  is a side view of an automatic blood collection apparatus. 
           [0020]      FIG. 5B  is a front view of an automatic blood collection apparatus. 
           [0021]      FIG. 5C  is an opposing side view of an automatic blood collection apparatus. 
           [0022]      FIG. 5D  is a rear view of an automatic blood collection apparatus. 
           [0023]      FIG. 6  is a cross-sectional view of an automatic blood collection apparatus. 
           [0024]      FIG. 6A  is cross-sectional view of an automatic blood collection apparatus with a patient&#39;s finger inserted therein. 
           [0025]      FIG. 7  is an illustration of a patient finger entering an automatic blood collection apparatus and a cross sectional view of the blood collection receptacle of  FIG. 6A . 
           [0026]      FIG. 7A  is an illustration of sanitizing a patient finger and a cross sectional view of the blood collection receptacle of  FIG. 6A . 
           [0027]      FIG. 7B  is an illustration of piercing a patient finger and a cross sectional view of the blood collection receptacle of  FIG. 6A . 
           [0028]      FIG. 7C  is an illustration of blood collection from a patient finger and a cross sectional view of the blood collection receptacle of  FIG. 6A . 
           [0029]      FIG. 8  is a flow chart a method for automatic blood collection from a patient. 
           [0030]      FIG. 9  is an illustration of a patient at a kiosk for automatic blood collection. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0031]    As shown in  FIG. 1 , the automatic blood collection apparatus  20  is interfaced on one side with a patient&#39;s finger  10 , and on the other side with a broad range of blood related components  30 , such as blood analyzers  31  or blood test strips  32 . 
         [0032]    As illustrated in  FIG. 2 , the automatic blood collection apparatus  20  is utilized with disposable components  200  and controller components  250 . The disposable components  200  preferably comprise a finger sterilization component, a finger prick component, a blood collection component and a finger-dressing component. The controller component  250  preferably comprises blood draw control components, blood transport and ejection components, user identification components and disposal components. 
         [0033]    As shown in  FIG. 2A , the automatic blood collection apparatus  200  preferably comprises a main body/housing  257  of the apparatus, an insertion port  260  for receiving a finger of a patient, a lancet having a puncturing needle, an actuator  254  which biases the patient&#39;s finger towards a puncturing needle, a vacuum port  256  to aid in blood withdrawal, a strip  259  for removing a first drop of blood, a capillary tube for collecting a predetermined amount of blood, a blood collection receptacle for receiving the blood from the capillary tube, a dressing mechanism  251  comprising a bandage  252  for bandaging a punctured finger, and a disposable container  261  for containing a needle and blood collection components. The automatic blood collection apparatus  200  may also include massaging mechanism  263  having nubs for messaging a patient finger in order to increase the flow of blood, and other optional components as shown in  FIGS. 7-7C . 
         [0034]    The housing  257  preferably composed of a sterile material such as a polycarbonate plastic material, an ABS material, a stainless steel material, or the like. 
         [0035]    The insertion port  260  preferably has a length ranging from 2 centimeters to 10 centimeters, more preferably from 4 centimeters to 8 centimeters, and most preferably 6 centimeters. A diameter of the insertion port preferably ranges from 1 centimeter to 3 centimeters, and is most preferably 2 centimeters. The biasing member/actuator  254  aligns a patient&#39;s finger in an optimal position within the insertion port  262  with the puncturing needle for blood collection. 
         [0036]    The lancet is preferably positioned near the internal end of the insertion port  262 . The puncturing needle is preferably the type typically utilized by a phlebotomist such as a 21 g (green top) needle, a 22 g (black top) needle, a 21 g (green label) butterfly needle, a 23 g (blue label) butterfly needle, and a 25 g (orange label) butterfly needle. 
         [0037]    In a preferred embodiment, a transport mechanism transports the blood collection receptacle containing blood to a blood analyzer. The blood collection receptacle is preferably a vacuum tube such as a VACUTAINER tube available from Becton, Dickinson &amp; Company, or a similar generic model. Preferably, the blood collection receptacle contains up to ten milliliters of blood, and alternatively contains from 1 milliliter to 10 milliliters of blood from the patient. 
         [0038]    In a preferred embodiment, the apparatus  200  further comprises a heater adapted to warm the finger within the automatic blood collection apparatus  200  to enhance a blood flow of the patient. 
         [0039]    In a preferred embodiment, the apparatus  200  further comprises a massage mechanism adapted to massage the patient&#39;s finger within the automatic blood collection apparatus  200  to enhance a blood flow of the patient. 
         [0040]    In a preferred embodiment, the apparatus  200  further comprises a vacuum mechanism to withdraw air from the insertion port of the automatic blood collection apparatus  200  to enhance a blood flow of the patient. The vacuum pressure ranges from 0 to negative 600 mmHg. Negative pressure signifies pressure less than standard atmospheric pressure (14.7 phi or 760 mm Hg at sea level). A vacuum pump is placed in flow communication with the insertion port in order to create the vacuum or partial vacuum in the insertion port for assistance in the flow of blood from the patient. 
         [0041]    In a preferred embodiment, the apparatus  200  further comprises a sensor for measuring the amount of blood drawn from the patient. The sensor is positioned within the housing  257 . 
         [0042]    In a preferred embodiment, the apparatus  200  further comprises an ejection mechanism for ejecting the blood collection receptacle from the housing  257 . 
         [0043]    As illustrated in  FIG. 3 , the disposable apparatus  200  is preferably enclosed in a sterile package  50  prior to initial use. In this manner, a patient is provided with greater certainty that the apparatus  200  is safe for use in collecting blood from the patient. 
         [0044]      FIG. 4  shows the placement of a user&#39;s finger  10  within the automatic blood collection apparatus  200  after removing the apparatus  200  from the sterile packaging  50 . 
         [0045]      FIGS. 5A-5D  illustrate another embodiment of the disposable apparatus  200  from different perspective views showing the different components of the apparatus  200 .  FIG. 5A  is a side view showing a main body of the apparatus  257 , a capillary tube  255 , a disposable container  261 , a vacuum port with tubing  256 , and a strip  259  for removing the first drop of blood.  FIG. 5B  is a front view showing a main body of the apparatus  257  with the insertion port  260 , a capillary tube  255  extending from a disposable container  261 , and an actuator  254 .  FIG. 5C  is an opposing side view showing an actuator  254 , a strip  259  for removing the first drop of blood, a vacuum port with tubing  256 , and a main body of the apparatus  257 .  FIG. 5D  is a rear view showing a main body of the apparatus  257 , a capillary tube  255 , a disposable container  261 , a vacuum port with tubing  256 , a strip  259  for removing the first drop of blood, and an actuator  254 . 
         [0046]      FIGS. 6-6A  are sectional views of the disposable apparatus  200 .  FIG. 6A  illustrates the placement of a user&#39;s finger  10  within the apparatus  200 . As the actuator  254  is pushed downward, towards the finger  10 , the needle contained within the disposable container  261  pricks the finger  10  and the strip  259  is pulled outwards to remove the first drop of blood. 
         [0047]      FIG. 7  illustrates the automatic blood collection apparatus  20  utilized by a patient  15 . The disposable apparatus  200  is inserted into the controller apparatus  250 . The controller apparatus  250  comprises one or more of the following elements: a control display screen  246 ; a bay  245 , including a mechanical lock (not shown), wherein the disposable apparatus  200  is locked into place; biometric identification components, such as a camera  249 , a fingerprint reader  248 , or an identification card reader  247 ; and an area  244  within the apparatus  250  to contain the disposed parts. 
         [0048]      FIGS. 7-7C  show the components of the blood collection receptacle  261  in cross sectional views.  FIG. 7  shows the blood collection receptacle  261  of  FIG. 6A . The receptacle  261  comprises the lancet  267  comprising a needle  268 , a blood collection container, such as a capillary tube  255 , a sanitizing agent  266  within a dispenser  265 , a heater  264 , a sensor  269 , and a circuit  270  that controls the components. 
         [0049]    In  FIG. 7A , the finger  10  is placed on the receptacle  261  and a dispenser  265 , adapted to dispense a sanitizing agent  266  on a portion of a finger  10  of a patient placed within the insertion port, sprays a sanitizing agent  266  onto the finger  10 . In  FIG. 7B  a cross-sectional view of the finger  10  is pierced by the needle  268  of the lancet  267 . The next step, wiping the first drop of blood is not shown within  FIGS. 7-7C  as the mechanism  259  may be a separate component, and not be a component of the receptacle  261 .  FIG. 7C  shows the blood collection into a capillary tube  255 , for collecting a predetermined amount of blood. A heater  264 , adapted to warm the finger within the automatic blood collection apparatus, can be utilized to enhance a blood flow of the patient. Also, as shown in  FIG. 2A , a massaging mechanism  263  may be used to massage the finger within the automatic blood collection apparatus  200  to enhance a blood flow of the patient. A sensor  269  measures the amount of blood drawn from the patient. 
         [0050]    A flow chart of a method  300  for automatic blood collection from a patient is illustrated in  FIG. 8 . At block  301 , a finger of a patient is inserted into a port of an automatic blood collection apparatus. At block  302 , a portion of the finger of the patient is sanitized within the automatic blood collection apparatus. At block  303 , the sanitized portion of the finger is pierced with a needle of a lancet. At block  304 , a first droplet of blood is removed from the pierced finger. At block  305 , a predetermined amount of blood is collected from the pierced finger in a capillary tube. At block  306 , the predetermined amount of blood is transported to a blood analyzer device. At block  307 , the pierced finger of the patient is bandaged with a wrap within the automatic blood collection apparatus. At block  308 , contaminated materials from the automatic blood collection apparatus are disposed of in an appropriate manner. 
         [0051]      FIG. 9  illustrates the automatic blood collection apparatus being utilized by a user  15 . The disposable apparatus  200  is inserted into the controller apparatus  250 . The controller apparatus  250  comprises one or more of the following elements: a control display screen  246 ; a bay  245 , including a mechanical lock (not shown), wherein the disposable apparatus  200  is locked into place; biometric identification components, such as a camera  249 , a fingerprint reader  248 , or an identification card reader  247 ; and an area  244  within the apparatus  250  to contain the disposable components. 
         [0052]    From the foregoing it is believed that those skilled in the pertinent art will recognize the meritorious advancement of this invention and will readily understand that while the present invention has been described in association with a preferred embodiment thereof, and other embodiments illustrated in the accompanying drawings, numerous changes modification and substitutions of equivalents may be made therein without departing from the spirit and scope of this invention which is intended to be unlimited by the foregoing except as may appear in the following appended claim. Therefore, the embodiments of the invention in which an exclusive property or privilege is claimed are defined in the following appended claims.