Handheld Device for Drawing, Collecting, and Analyzing Bodily Fluid

Abstract

A handheld device for drawing, collecting, and analyzing bodily fluid includes a body having a lumen defined therein, a plunger configured to be user-actuated, and a base. Multiple needles are fixed to the plunger, and at least one of the needles is configured to pass through the apertures of the base and penetrate a subject's skin to release bodily fluid when the plunger is actuated. After the plunger is actuated, a mechanism retracts the plunger from the subject's skin and creates a vacuum within the lumen. A network of passages on the base is configured to collect at least some of the bodily fluid and communicate the bodily fluid to one or more sensing areas for analysis.

What is claimed is: 
     
         1 . A device comprising:
 a. a body comprising a proximal end, a distal end, an outer surface, and a lumen defined within the body;   b. a base attached to the distal end of the body, the base comprising an outer face, an inner face, a plurality of apertures, at least one sensing area, and a network of passages in communication with the plurality of apertures and the at least one sensing area;   c. a plunger comprising:
 i. a proximal end; and 
 ii. a distal end comprising a face; 
 iii. wherein the distal end of the plunger is configured to be disposed within the lumen at the proximal end of the body and the plunger is configured to be user-actuated within the lumen from the proximal end of the body to the distal end of the body; and 
   d. a plurality of needles fixed to the face of the plunger, wherein at least a portion of each of the plurality of needles is configured to extend through the plurality of apertures of the base and beyond the outer face of the base when the plunger is actuated to the distal end of the body;   e. wherein:
 i. at least one of the plurality of needles is configured to pass through the plurality of apertures of the base and penetrate a subject's skin to release bodily fluid; and 
 ii. the network of passages of the base is configured to collect at least some of the bodily fluid and communicate the bodily fluid to the at least one sensing area. 
   
     
     
         2 . The device of  claim 1 , further comprising a mechanism configured to retract the face of the plunger within the lumen from the distal end of the body to the proximal end of the body and create a vacuum within the lumen. 
     
     
         3 . The device of  claim 2  wherein the mechanism further comprises a spring. 
     
     
         4 . The device of  claim 2  wherein the mechanism further comprises an elastic membrane. 
     
     
         5 . The device of  claim 2 , wherein the vacuum created by the mechanism is from greater than 0 Pa to 75,000 Pa. 
     
     
         6 . The device of  claim 1 , further comprising at least one pre-loaded spring, wherein the preloaded spring is activated by the actuation of the plunger so as to return the plunger to its original location following actuation. 
     
     
         7 . The device of  claim 1 , further comprising a one-way valve. 
     
     
         8 . The device of  claim 1 , wherein the outer face of the base comprises an adhesive configured to releaseably adhere the device to the subject's skin. 
     
     
         9 . The device of  claim 1 , wherein the plurality of apertures comprises from two to 100 apertures. 
     
     
         10 . The device of  claim 1 , wherein the plurality of needles comprises a plurality of microneedles. 
     
     
         11 . The device of  claim 1 , wherein each of the needles has a gauge from 29 gauge to 40 gauge. 
     
     
         12 . The device of  claim 1 , wherein the network of passages comprises tubes, microfluidic channels, or paper channels. 
     
     
         13 . The device of  claims 1 , wherein the at least one sensing area further comprises a sensing apparatus, said sensing apparatus selected from a group consisting of: an electrical sensing apparatus, an audial sensing apparatus, and a visual sensing area. 
     
     
         14 . The device of  claim 1 , wherein the bodily fluid is blood or interstitial fluid. 
     
     
         15 . A method comprising:
 a. providing a handheld device for drawing, collecting, and analyzing bodily fluid, the device comprising:
 i. a body comprising a proximal end, a distal end, an outer surface, and a lumen defined within the body; 
 ii. a base attached to the distal end of the body, the base comprising an outer face, an inner face, a plurality of apertures, at least one sensing area, and a network of passages in communication with the plurality of apertures and the at least one sensing area; 
 iii. a plunger comprising:
 1. a proximal end; and 
 2. a distal end comprising a face; 
 3. wherein the distal end of the plunger is configured to be disposed within the lumen of the body and the plunger is configured to move between the proximal end of the body and the distal end of the body; and 
 
 iv. a plurality of needles fixed to the face of the plunger, wherein at least a portion of each of the plurality of needles is configured to extend through the plurality of apertures of the base and beyond the outer face of the base when the plunger is actuated to the distal end of the body; 
 v. wherein:
 1. at least one of the plurality of needles is configured to pass through the plurality of apertures of the base and penetrate a subject's skin to release bodily fluid; and 
 2. the network of passages of the base is configured to collect at least some of the bodily fluid and communicate the bodily fluid to the at least one sensing area; 
 
   b. placing the outer face of the base on a subject's skin;   c. manually actuating the plunger within the lumen toward the distal end of the body to cause the plurality of needles to pass through the plurality of apertures of the base and at least one of the plurality of needles to penetrate the subject's skin;   d. retracting the plunger from the distal end of the body to the proximal end of the body, thereby causing a vacuum to form in the lumen and drawing bodily fluid from the subject's skin into the network of passages of the base; and   e. directing the bodily fluid through the network of passages of the base to the at least one sensing area for analysis.   
     
     
         16 . The method of  claim 12 , further comprising providing a mechanism configured to retract the face of the plunger from the distal end of the body to the proximal end of the body and create a vacuum within the lumen; 
     
     
         17 . The method of  claim 16 , wherein the mechanism comprises a spring or an elastic membrane. 
     
     
         18 . The method of  claim 16 , wherein the bodily fluid is blood or interstitial fluid. 
     
     
         19 . The method of  claim 16 , wherein the retracting comprises removal of the manual activation force from the plunger. 
     
     
         20 . The method of  claim 16 , wherein the retracting comprises activation of an internal mechanism triggered when the user-provided force imparted on the plunger pushes the plunger past a trigger point. 
     
     
         21 . The method of  claim 20 , wherein the internal mechanism is a preloaded spring. 
     
     
         22 . The method of  claim 15 , wherein the vacuum is from greater than 0 Pa to 75,000 Pa. 
     
     
         23 . The method of  claim 15  further comprising: providing a readout from the at least one sensing area that is electrical, visual, or auditory. 
     
     
         24 . The device of  claim 16 , further comprising providing a one-way valve, wherein the one-way valve creates the vacuum.