Bodily fluid collection devices and related methods

Abstract

Devices and methods for withdrawing bodily fluid from a patient are disclosed herein. A handheld device configured in accordance with the present technology can include a housing having an opening, a skin-piercing assembly located at least partially within the housing, and an actuator movable relative to the housing along a deployment direction. The skin-piercing assembly can include a skin-piercing feature and a biasing member. The biasing member can be coupled to the skin-piercing feature to bias the skin-piercing feature along the deployment direction. Movement of the actuator along the deployment direction to a predetermined position can increase a load on the biasing member to at least a partially loaded state. Movement of the actuator along the deployment direction beyond the predetermined position can release the load on the biasing member so that the biasing member actively drives the skin-piercing feature along the deployment direction.

I/We claim: 
     
         1 . A handheld device for withdrawing bodily fluid from a subject, the device comprising:
 a housing having an opening;   a skin-piercing assembly positioned at least partially within the housing and having a skin-piercing feature configured to pierce the skin of the subject;   an actuator coupled to the skin-piercing assembly, wherein the actuator is movable relative to the housing, and wherein movement of the actuator toward the opening drives the skin-piercing feature toward the opening;   a biasing member coupled to the skin-piercing assembly, wherein the biasing member is configured to drive the skin-piercing assembly away from the opening, and wherein movement of the skin-piercing assembly away from the opening draws a vacuum within at least a portion of the housing; and   a flexible membrane coupled to the housing and covering at least a portion of the opening, wherein the membrane is configured to be drawn at least partially through the opening when the vacuum is drawn.   
     
     
         2 . The device of  claim 1  wherein the membrane is configured to assume a curved shape when the vacuum is drawn. 
     
     
         3 . The device of  claim 1  wherein the membrane entirely covers the opening, and wherein the skin-piercing feature is configured to puncture the membrane to allow the bodily fluid to flow through the opening. 
     
     
         4 . The device of  claim 1  wherein the membrane includes an aperture, and wherein the movement of the actuator toward the opening drives the skin-piercing feature through the aperture. 
     
     
         5 . The device of  claim 1  wherein the membrane includes a microfluidic pattern configured to direct the bodily fluid into the housing. 
     
     
         6 . The device of  claim 1  wherein the membrane includes at least one of a hydrophobic, hydrophilic, or amphiphilic coating. 
     
     
         7 . The device of  claim 1  wherein the membrane includes an anticoagulant. 
     
     
         8 . The device of  claim 1  wherein the membrane has a first thickness at a central portion of the membrane, and wherein the membrane has a second thickness at an outer portion of the membrane that is smaller than the first thickness. 
     
     
         9 . The device of  claim 1 , further comprising a flexible sealing member coupled to the skin-piercing assembly within the housing, wherein the sealing member surrounds the opening to define a lumen within the housing, wherein the movement of the skin-piercing assembly toward the opening reduces the volume of the lumen, and wherein the movement of the skin-piercing assembly away from the opening increases the volume of the lumen to draw the vacuum within the lumen. 
     
     
         10 . A method for withdrawing bodily fluid from a subject, the method comprising:
 positioning a handheld device against the skin of the subject such that a flexible membrane of the handheld device contacts the skin of the patient, wherein the handheld device includes a housing having an opening, and wherein the membrane covers at least a portion of the opening;   actuating the handheld device to deploy a skin-piercing feature of the handheld device through the opening and through the membrane to puncture the skin of the patient and withdraw the bodily fluid; and   transferring the bodily fluid across the membrane into the housing of the handheld device.   
     
     
         11 . The method of  claim 10  wherein the method further comprises drawing a vacuum within the handheld device to pull the flexible membrane and the skin at least partially through the opening. 
     
     
         12 . The method of  claim 11  wherein drawing the vacuum includes dynamically generating the vacuum. 
     
     
         13 . The method of  claim 11  wherein the method further comprises:
 after puncturing the skin of the patient, driving the skin-piercing feature away from the skin of the patient back through the membrane and through the opening; and 
 dynamically generating the vacuum while driving the skin-piercing feature away from the skin of the patient. 
 
     
     
         14 . The method of  claim 10  wherein deploying the skin-piercing feature through the membrane includes puncturing the membrane. 
     
     
         15 . The method of  claim 10  wherein deploying the skin-piercing feature through the membrane includes deploying the skin-piercing feature through an aperture in the membrane. 
     
     
         16 . The method of  claim 10  wherein transferring the bodily fluid across the membrane into the housing includes directing the bodily fluid across the membrane via a microfluidic pattern on the membrane. 
     
     
         17 . The method of  claim 10  wherein transferring the bodily fluid across the membrane into the housing includes directing the bodily fluid across the membrane via a hydrophobic coating on the membrane. 
     
     
         18 . A handheld device for withdrawing bodily fluid from a subject, the device comprising:
 a housing having an opening;   a skin-piercing assembly positioned at least partially within the housing,
 wherein the skin-piercing assembly includes a skin-piercing feature and a first biasing member, and 
 wherein the first biasing member is coupled to the skin-piercing feature to bias the skin-piercing feature toward the opening in a deployment direction; 
   an actuator movable relative to the housing in the deployment direction,
 wherein movement of the actuator in the deployment direction to a predetermined position increases a load on the first biasing member, and 
 wherein movement of the actuator in the deployment direction beyond the predetermined position releases the load on the first biasing member such that the first biasing member drives the skin-piercing feature in the deployment direction; and 
   a second biasing member coupled to the skin-piercing assembly,
 wherein the second biasing member is configured to drive the skin-piercing feature in a retraction direction after the skin-piercing feature has been deployed in the deployment direction, and 
 wherein the handheld device is configured to generate a vacuum within the housing when the skin-piercing feature moves in the retraction direction. 
   
     
     
         19 . The device of  claim 18  wherein—
 the housing includes an arm positioned proximate to the opening, 
 the first biasing member is coupled to the skin-piercing feature via a base, 
 the movement of the actuator to the predetermined position engages the arm with the base to increase the load on the first biasing member, and 
 the movement of the actuator beyond the predetermined position disengages the arm from the base to release the load on the first biasing member. 
 
     
     
         20 . The device of  claim 19 , further comprising a plunger coupled to the skin-piercing assembly and including a projection, wherein the projection is shaped to disengage the arm from the base when the actuator is moved beyond the predetermined position.