Devices and methods for reduced-pain blood sampling

Abstract

Systems, methods and devices are provided for invasive reduced-pain blood sampling and testing, the devices including, a horizontally-disposed finger support element configured to support the finger thereupon, a finger holding element adapted, in a closed position, to radially grip the finger on said support element near to a tip thereof and configured to force blood into said tip, a lancet housing element disposed vertically underneath the finger support element for piercing the finger tip with a lancet while said finger tip is gripped by said finger holding element and supported by said finger support element; and a test strip conveying element adapted to be received by the finger support element after retraction of the lancet housing element thereby bringing a test strip into direct contact with a predetermined volume of blood from said finger support element thereby effecting a blood test.

1 . A medical device for a blood test, the device comprising:
 (i) a housing defining a finger site for supporting a user's finger or a portion thereof within said finger site during the device operation;   (ii) piercing, sampling and testing assemblies sequentially actuatable to successively initiate piercing, sampling and testing operational modes of the device;   (iii) a carriage at least partially accommodated within said housing and being adapted for movement with respect to said finger site between its first position corresponding to the piercing mode of the device and a second position corresponding to the sampling and testing modes of the device, the device being thereby capable of operating in the piercing, sampling and testing modes while at a static position of the user's finger.   
     
     
         2 . A device according to  claim 1 , wherein the piercing assembly is accommodated inside said housing with respect to the finger site such that an operation of the piercing assembly in the piercing mode of the device is hidden from the user. 
     
     
         3 . A device according to  claim 1 , comprising a finger holder element configured to be fit on the finger such as to apply pressure to the finger in a manner assisting in withdrawal of blood during the piercing and sampling modes and reducing pain associated with the blood test. 
     
     
         4 . A device according to  claim 3 , wherein said finger holder comprises a band operable to be shifted from its open inoperative position to a closed-loop operative position in which it fits the finger, said band when in the operative position thereof applies the pressure to the finger while preventing over-pressing of the finger, thereby reducing pain involved in the blood test procedures. 
     
     
         5 . A device according to  claim 1 , comprising a finger holder element configured to be fit on the finger such as to apply pressure to a certain location on the finger, said certain location being selected to be spaced a predetermined distance from at least one of the finger tip and a piercing orifice provided in said finger site. 
     
     
         6 . A device according to  claim 5 , wherein said housing comprises a groove located within said finger site and being configured for immobilizingly receiving a portion of the finger holder element therein, thereby fixing a position of the finger with respect to said finger site, during the device operation, said groove being located at a predetermined distance from the piercing orifice, thereby ensuring the application of pressure to the finger by said finger holder element a certain predetermined distance from a location on the finger being pierced. 
     
     
         7 . A device according to  claim 1 , wherein said housing comprises a protrusion defining a distal end of the finger site to be abutted by a finger tip during the device operation. 
     
     
         8 . A device according to  claim 7 , comprising a finger holder element configured to be fit on the finger such as to apply pressure to a certain location on the finger, said certain location being selected to be spaced a predetermined distance from the protrusion, which is located a predetermined distance from a piercing orifice provided in said finger site. 
     
     
         9 . A device according to  claim 1 , wherein the piercing assembly comprises a piercing element movable along a first axis towards and away from the finger site and accessing the finger via an orifice in said finger site to perform piercing. 
     
     
         10 . A device according to  claim 9 , wherein said piercing assembly being movable by said carriage along a second, intersecting axis, with respect to the finger site, between its first inoperative position in which the piercing element is not aligned with the orifice along the first axis and a second operative position in which the piercing elements is aligned with said orifice along the first axis. 
     
     
         11 . A device according to  claim 1 , wherein the sampling assembly comprises a blood holding element for collecting a predetermined volume of a liquid-phase blood sample flowing from the finger as a result of piercing. 
     
     
         12 . A device according to  claim 11 , wherein the blood holding element is configured such that, when in the sampling mode of the device, the blood holding element has a top portion formed with a projecting sloped member for flowing a portion of collected blood volume above said predetermined volume out of a liquid reservoir towards an indication window, appearance of blood in the indication window being indicative of that the blood holding element contains the predetermined volume of blood. 
     
     
         13 . A device according to  claim 11 , wherein the blood holding element comprises a hollow liquid reservoir of the predetermined volume for collecting the blood sample freely flowing from the orifice, said liquid reservoir comprising a bottom plate movable between its first position, in which it is aligned with side walls of the reservoir, corresponding to a closed state of the reservoir keeping collected blood in the reservoir, and a second position, in which it is misaligned with the side walls corresponding to an open state of the reservoir allowing blood flow from the reservoir onto a test strip of the testing assembly. 
     
     
         14 . A device according to  claim 12 , wherein the blood holding element is a two-part element, the first part being in the form of a hollow liquid reservoir of the predetermined volume for collecting the blood sample freely flowing from the orifice, and the second part being selectively movable to be brought into an assembled position with said reservoir thereabove, thereby forming the top portion of said blood holding element having said projecting sloped member and displaced into a dissembled position, said displacement removing excess blood from the reservoir. 
     
     
         15 . A device according to  claim 13 , wherein the test strip is insertable into a slot made in said housing in a manner enabling sliding movement of the test strip towards and away from a location of alignment with the piercing orifice. 
     
     
         16 . A device according to  claim 1 , wherein the testing assembly comprises a test strip selectively insertable into a position in which a portion thereof is aligned with a piercing orifice to receive a blood sample from the finger after piercing. 
     
     
         17 . A device according to  claim 16 , wherein the test strip being insertable into a slot made in said housing in a manner enabling sliding movement of the test strip towards and away from a location of alignment with the piercing orifice. 
     
     
         18 . A device according to  claim 17 , wherein the sampling assembly comprises a blood holding element for collecting a predetermined volume of a liquid-phase blood sample flowing from the finger as a result of piercing, the blood holding element comprising a hollow liquid reservoir of the predetermined volume for collecting the blood sample freely flowing from the orifice, said liquid reservoir comprising a bottom plate movable between its first position, in which it is aligned with side walls of the reservoir, corresponding to a closed state of the reservoir keeping collected blood in the reservoir, and a second position, in which it is misaligned with the side walls corresponding to an open state of the reservoir allowing blood flow from the reservoir onto said test strip. 
     
     
         19 . A device according to  claim 1 , wherein said carriage incorporates or is connected to elements of the piercing, sampling and testing assemblies such that the movement of the carriage with respect to the finger site successively brings said elements into an operative position in which the element of the respective assembly is aligned with the finger site corresponding to said first and second positions of the carriage. 
     
     
         20 . A device according to  claim 1 , comprising a reagent holding unit mounted to be selectively brought into alignment position with respect to an element of the testing assembly, when in the testing mode of the device. 
     
     
         21 . A medical device for a blood test, the device comprising: a housing defining a finger site for supporting a user's finger or a portion thereof within said finger site during the device operation, and piercing, sampling and testing assemblies at least partially accommodated in said housing, wherein
 the piercing assembly comprises a piercing element movable towards and away from the finger site accessing the finger via an orifice in said finger site to perform piercing;   the sampling assembly comprises a blood holding element, which comprises a hollow liquid reservoir for collecting blood freely flowing from the orifice, said liquid reservoir comprising a bottom plate movable between its first position, in which it is aligned with side walls of the reservoir, corresponding to a closed state of the reservoir keeping collected blood in the reservoir, and a second position, in which it is misaligned with the side walls corresponding to an open state of the reservoir allowing blood flow from the reservoir onto a test strip of the testing assembly.   
     
     
         22 . A device for use in a blood test, the device comprising a finger holding element configured to be fit on the finger such as to apply certain pressure to the finger, said finger holder comprising a band operable to be shifted from its open inoperative position to a closed-loop operative position in which it fits the finger, said band when in the operative position thereof applies the pressure to the finger while preventing over-pressing of the finger, thereby reducing pain associated with the blood test. 
     
     
         23 . A device according to  claim 22 , comprising a cap-like element configured to accommodate at least a portion of the finger and defining a distal end comprising a contact surface and a proximal end being connected to a portion of said band. 
     
     
         24 . A system:
 (i) the blood test device according to  claim 1 ; and   (ii) a measurement device for non-invasively measuring one or more body parameters.   
     
     
         25 . A system according to  claim 24 , wherein measurement device is configured and operable for non-invasive measurement of a blood glucose. 
     
     
         26 . A system according to  claim 24 , wherein said measurement device is adapted to perform at least one of the following measurements: an optical measurement, an impedance-type measurement, a photo-acoustic measurement and an ultrasound tagging-based measurement. 
     
     
         27 . A system according to  claim 25 , wherein the measurement device comprises a ring-shaped sensor. 
     
     
         28 . A system according to  claim 27 , wherein the ring-shaped sensor is adapted to be placed on the finger in addition to a finger holding element for use in the blood test. 
     
     
         29 . A system according to  claim 28 , wherein the measurement device comprises a finger encompassing element for applying pressure to the finger.