Blood sampling system and method

Abstract

This disclosure relates to a system and method for drawing blood from a user by skin puncture instead of venous puncture and storing it for analysis. The system includes a receptacle configured to engage an area of skin of the user at a blood draw location and store blood drawn from the user; a lancet device disposed within the receptacle configured to puncture the skin of the user at the blood draw location; a vacuum device configured to reduce a pressure within the receptacle such that the skin at the blood draw location is drawn into the receptacle before the lancet device punctures the skin, and to enhance blood flow while blood is drawn from the user; and a housing configured to house the receptacle, the lancet device, and the vacuum device. The receptacle, the lancet device, and the vacuum device may be modular and removably coupled with the housing.

1 . A blood sampling system configured to draw and store blood from a user for analysis, the system comprising:
 a receptacle configured to engage an area of skin of the user at a blood draw location and store blood drawn from the user;   a lancet device disposed within and movable within the receptacle and configured to puncture the skin of the user at the blood draw location;   the receptacle further including a blood storage substrate configured to absorb blood from the punctured skin;   a vacuum device configured to reduce a pressure within the receptacle (1) such that the skin at the blood draw location is drawn into the receptacle before the lancet device punctures the skin, and (2) to enhance blood flow while blood is drawn from the user; and   a housing, wherein the receptacle together with the lancet device and the vacuum device are each modular and removably coupled with the housing,   the housing having an opening for removably receiving the receptacle with the lancet device therein, wherein a first end of the receptacle comprises an opening that is configured to engage the area of the skin and a second end of the receptacle is configured to be sealed to support reduced pressure in the receptacle, and   wherein the vacuum device is separately removable from the housing relative to the receptacle.   
     
     
         2 .- 5 . (canceled) 
     
     
         6 . The system of  claim 1 , wherein the substrate is toroidal shaped and positioned around the lancet device such that the lancet device punctures the skin of the user within an opening in the middle of the toroidal shape. 
     
     
         7 . The system of  claim 1 , further comprising a cap that removably couples with the receptacle to prevent blood from escaping from the receptacle when blood is stored in the receptacle. 
     
     
         8 . (canceled) 
     
     
         9 . The system of  claim 1 , wherein the lancet device comprises multiple lancets configured to puncture the skin at the blood draw location. 
     
     
         10 . The system of  claim 1 , wherein at least a portion of the lancet device is coated with an anticoagulant coating. 
     
     
         11 .- 12 . (canceled) 
     
     
         13 . The system of  claim 1 , further comprising an analog indicator and/or an electronic sensor configured to convey information of a quantity of blood in the receptacle. 
     
     
         14 . The system of  claim 1 , further comprising a button configured to initiate action of the vacuum device to reduce pressure in the receptacle. 
     
     
         15 . The system of  claim 13 , further comprising an LED indicator device coupled with the housing, the LED indicator device configured to indicate the quantity of blood in the receptacle. 
     
     
         16 . The system of  claim 1 , further comprising a pressure sensor configured to generate output signals that convey information related to a pressure within the receptacle, the pressure sensor being disposed within the receptacle; and a controller configured to, responsive to the pressure in the receptacle breaching a threshold level, cause the lancet device to puncture the skin of the user. 
     
     
         17 . The system of  claim 1 , further comprising a comfort pad coupled with a first surface of the housing, the first surface of the housing facing the skin of the user while blood is drawn from the user. 
     
     
         18 . (canceled) 
     
     
         19 . A method for drawing and storing blood from a user for analysis with a system comprising a receptacle, a lancet device, a vacuum device, and a housing, the method comprising:
 engaging, with the receptacle, an area of skin of the user at a blood draw location;   puncturing, with the lancet device, the skin of the user at the blood draw location, the lancet device being disposed within and movable within the receptacle;   absorbing, with a blood storage substrate, blood from the punctured skin, wherein the blood storage substrate is disposed within the receptacle;   reducing, with the vacuum device, a pressure within the receptacle (1) such that the skin at the blood draw location is drawn into the receptacle before the lancet device punctures the skin, and (2) to enhance blood flow while blood is drawn from the user; and   storing, with the receptacle, blood drawn from the user,   wherein the receptacle together with the lancet device and the vacuum device are each modular and removably coupled with the housing,   the housing having an opening for removably receiving the receptacle with the lancet device therein, wherein a first end of the receptacle comprises an opening that is configured to engage the area of the skin and a second end of the receptacle is configured to be sealed to support reduced pressure in the receptacle, and   wherein the vacuum device is separately removable from the housing relative to the receptacle.   
     
     
         20 .- 24 . (canceled) 
     
     
         25 . The method of  claim 19 , further comprising indicating, with an LED indicator, a quantity of blood in the receptacle responsive to output signals generated by an electronic sensor. 
     
     
         26 .- 27 . (canceled) 
     
     
         28 . The method of  claim 19 , further comprising causing, by a controller, the lancet device to puncture the skin of the user responsive to the pressure in the receptacle breaching a threshold level. 
     
     
         29 .- 30 . (canceled) 
     
     
         31 . A receptacle comprising:
 a first end and a second end, the second end being opposite the first end and being sealed to support reduced pressure in the receptacle, the first end of the receptacle being configured to engage an area of skin of a user at a blood draw location and store blood drawn from the user;   a lancet device disposed within and movable therein between the first end and the second end thereof and configured to puncture the skin of the user at the blood draw location;   a blood storage substrate in the receptacle and disposed at or near the first end thereof, the blood storage substrate being configured to absorb blood from the punctured skin, the blood storage substrate comprising a solid, liquid, or gel stabilization matrix,   wherein the receptacle and the lancet device are modular and the lancet device being removable together with the receptacle.   
     
     
         32 . The receptacle according to  claim 31 , wherein the receptacle has a cylindrical shape. 
     
     
         33 . The receptacle according to  claim 31 , wherein the blood storage substrate is toroidal shaped and positioned around lancet device such that lancet device is configured to puncture the skin of the user within an opening in a middle of the toroidal shape. 
     
     
         34 . The receptacle according to  claim 31 , further comprising an analog indicator configured to indicate of a quantity of blood in the receptacle. 
     
     
         35 . The receptacle according to  claim 31 , further comprising a cap that is removably couplable with the first end of the receptacle to prevent blood from escaping from the receptacle when blood is stored therein. 
     
     
         36 . The receptacle according to  claim 31 , wherein the receptacle has a volume of at least 0.5 mL. 
     
     
         37 . The receptacle according to  claim 31 , wherein the lancet device includes a 17 gauge or an 18 gauge lancet. 
     
     
         38 . The receptacle according to  claim 31 , wherein the lancet device comprises multiple lancets configured to puncture the skin at the blood draw location. 
     
     
         39 . The receptacle according to  claim 31 , wherein at least a portion of the lancet device is coated with an anticoagulant coating. 
     
     
         40 . The receptacle according to  claim 31 , wherein the stabilization matrix stabilizes nucleic acids present in a blood sample.