Insertion device and method

Abstract

The present invention provides an insertion device and method for implanting a biosensor into a patient subject. In one embodiment, a biosensor is stored in the instrument's hydration chamber which enables the biosensor to maintain proper hydration and sterilization prior to insertion. The instrument further includes a plunger that travels along a channel within the support device. After the biosensor is placed into the channel, the user pushes the plunger causing the biosensor to move through the channel and a hollow tube and into the patient subject. The present invention also provides for packaging and storing a biosensor and insertion device so that the biosensor is hydrated and sterile prior to insertion.

1 . An instrument for inserting a biosensor into a subject, said instrument comprising: 
 a support device, wherein said support device contains at least one channel;    a plunger, wherein said plunger is slidable within said channel;    a compartment, said compartment having a top end and a bottom end and wherein said compartment stores at least one of said biosensors;    a plug, wherein said plug is insertable into the top end of the compartment;    a hollow tube, wherein said hollow tube is attached to and extends from one end of said support device, and wherein said channel, plunger and hollow tube are configured such that said biosensor can be expelled through said channel and hollow tube by said plunger and into said subject.    
     
     
         2 . The instrument of  claim 1 , wherein said compartment is a hydration compartment which is configured to contain hydration fluid for hydrating said biosensor.  
     
     
         3 . The instrument of  claim 2 , wherein said hydration fluid is at least one selected from the group consisting of: saline solution, inorganic salts, buffer salts, preservatives, antimicrobial agents, antibiotics, anti-inflammatory drugs, pharmacological compounds, ionic surfactants, nonionic surfactants, thickening agents, antioxidants, vitamins, and saccharides.  
     
     
         4 . The instrument of  claim 1 , wherein said compartment contains a breakable floor.  
     
     
         5 . The instrument of  claim 1 , wherein said plug includes a slot through which hydration fluid enters the compartment.  
     
     
         6 . The instrument of  claim 1 , wherein said plug is made of a porous material allowing fluid to enter said compartment.  
     
     
         7 . The instrument of  claim 1 , wherein said plug is made of solid material and creates a fluid-tight friction fit within the walls of said compartment.  
     
     
         8 . The instrument of  claim 1 , wherein said plug contains a hollow chamber for containing hydrating fluid.  
     
     
         9 . The instrument of  claim 8 , wherein said plug contains a breakable bottom, wherein said breakable bottom breaks upon the application of pressure by the user and releases said hydrating fluid into the compartment.  
     
     
         10 . The instrument of  claim 1 , wherein said support device is made of a porous material allowing fluid to enter said compartment.  
     
     
         11 . The instrument of  claim 1 , wherein said support device further comprises a first element that identifies the backward most position of the plunger within the channel.  
     
     
         12 . The instrument of  claim 1 , wherein said support device further comprises a second element identified when the plunger and biosensor are positioned within the channel such that biosensor is positioned at the distal end of the hollow tube.  
     
     
         13 . The instrument of  claim 1 , wherein said support device further comprises a third element that identifies the forward most position of the plunger within the channel.  
     
     
         14 . The instrument of  claim 11 , wherein said first element is a ramp that is configured to engage an extension arm extending from said plunger.  
     
     
         15 . The instrument of  claim 12 , wherein said second element is a ramp that is configured to engage an extension arm extending from said plunger.  
     
     
         16 . The instrument of  claim 13 , wherein said third element is a ramp that is configured to engage an extension arm extending from said plunger.  
     
     
         17 . The instrument of  claim 1 , wherein said plunger contains at least one extension arm.  
     
     
         18 . The instrument of  claim 1 , wherein a hydration compartment can be located opposite the extension arm.  
     
     
         19 . The instrument of  claim 1 , wherein said plug is substantially t-shaped and is configured to slidably engage the walls of said compartment.  
     
     
         20 . The instrument of  claim 1 , wherein said plug is shaped to cradle said biosensor.  
     
     
         21 . The instrument of  claim 1 , wherein said support device contains ridges to allow for ergonomic gripping of said instrument.  
     
     
         22 . The instrument of  claim 1 , wherein said support device contains at least one slot allowing an extension arm extending from said plunger to be moved back and forth along said support device.  
     
     
         23 . The instrument of  claim 1 , wherein said plunger is made of a guide wire.  
     
     
         24 . The instrument of  claim 1 , wherein said plunger is made of plastic.  
     
     
         25 . The instrument of  claim 1 , wherein said hollow tube is a needle.  
     
     
         26 . The instrument of  claim 1 , wherein the distal end of said hollow tube is beveled.  
     
     
         27 . The instrument of  claim 1 , wherein said plunger is a stylet.  
     
     
         28 . The instrument of  claim 1 , wherein said plunger has a beveled distal end matching a beveled end of said tube.  
     
     
         29 . The instrument of  claim 1 , wherein said channel further comprises a first breakable barrier and second breakable barrier.  
     
     
         30 . The instrument of  claim 29 , wherein said first and second breakable barriers form part of the compartment for containing said biosensor and said hydration fluid.  
     
     
         31 . The instrument of  claim 30 , wherein the compartment is sealed by a plug.  
     
     
         32 . The instrument of  claim 30 , wherein said plug is configured to secure said biosensor in said compartment.  
     
     
         33 . A method for inserting a biosensor into a subject comprising the steps of: 
 providing an instrument for inserting a biosensor into a subject comprising a support device containing at least one channel, a plunger slidable within said channel, a compartment that stores at least one biosensor, a plug configured to secure said biosensor in said compartment, and a hollow tube which is attached to and extends from a distal end of said support device;    moving said plunger to a first position of said support device to allow a biosensor to enter said channel of said support device;    pushing said plug into said compartment contained in said support device to secure said biosensor within said channel of said support device;    moving said plunger toward a second position of said support device to indicate to the user that said biosensor has traveled through said hollow tube and is about to enter said subject;    moving said plunger to a third position of said support device to indicate to the user that said biosensor has exited said hollow tube and entered said subject.    
     
     
         34 . The method of  claim 33 , wherein said biosensor is initially located within said compartment.  
     
     
         35 . The method of  claim 33 , wherein said biosensor enters said channel by gravity.  
     
     
         36 . The method of  claim 33 , wherein ramps lock said plunger at said positions.  
     
     
         37 . A method for loading a biosensor into an insertion device comprising the steps of: 
 providing an instrument for inserting a biosensor into a subject comprising a support device containing at least one channel, a plunger slidable within said channel, a compartment that stores at least one biosensor, a plug configured to secure said biosensor in said compartment, and a hollow tube which is attached to and extends from a distal end of said support device;    moving said plunger to a first position of said support device to allow room for said biosensor to be placed in the distal end of the hollow tube of said support device;    placing said biosensor inside said distal end of said hollow tube;    moving said plunger through said channel to a second position of said support device to allow said biosensor to travel through said channel and enter said compartment;    moving said plunger to a third position of said support device to allow said biosensor to be secured between said plug and said plunger.    
     
     
         38 . The method of  claim 37 , wherein said biosensor rests against a distal end of said plunger when said plunger moves to said second position.  
     
     
         39 . The method of  claim 37 , wherein said biosensor enters said compartment by gravity.  
     
     
         40 . A package assembly for storing a biosensor and apparatus for inserting a biosensor into a subject comprising: 
 a package body shaped to contain at least one insertion instrument within a cavity of said package body;    a sterile barrier sealed to said package body, wherein said sterile barrier contains at least one septum which allows said cavity to be filled with fluid, and wherein said barrier is sealed to said body so as to prevent fluid from leaking from said cavity.    
     
     
         41 . The package assembly of  claim 40 , wherein said package body is composed of plastic.  
     
     
         42 . The package assembly of  claim 40 , wherein said sterile barrier is at least one selected from the group consisting of: plastic, paper or aluminum foil.  
     
     
         43 . The package assembly of  claim 40 , wherein said septum prevents fluid from leaking out of said cavity.  
     
     
         44 . The package assembly of  claim 40 , wherein said package body is shaped to secure said instrument.  
     
     
         45 . The package assembly of  claim 40 , wherein said instrument is secured to said package body by friction fitting.  
     
     
         46 . The package assembly of  claim 40 , wherein said septum is configured to be pierced by a syringe.  
     
     
         47 . The package assembly of  claim 40 , wherein said package assembly further comprises side walls extending form a front portion of said package body.  
     
     
         48 . The package assembly of  claim 47 , wherein said side walls further comprise flap portions that can be engaged together.  
     
     
         49 . The package assembly of  claim 48 , wherein said package assembly wherein said side walls and flap portions enable the package assembly to stand vertically.  
     
     
         50 . The package assembly of  claim 48 , wherein said flap portions further comprise slotted clasps.