Insertion device and method

• US 9,241,660 B2
• Filed: 12/05/2012
• Issued: 01/26/2016
• Est. Priority Date: 06/08/2005
• Status: Active Grant

• Current Assignee: Senseonics, Incorporated (Senseonics Holdings, Inc.)
• Original Assignee: Senseonics, Incorporated (Senseonics Holdings, Inc.)
• Inventors: Walters, Steven J., O'Connor, Casey J.
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US13/705,816
• Publication Number:
  US 20130313133A1
• Time in Patent Office: 1,147 Days
• Field of Search: 600562-572, 600/309, 600/414, 600/420, 600426-427, 600/431, 482 79- 80, 601/23, 601 27- 28, 606/142, 606/151, 606/153, 606/185, 606/219
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

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.

Claims

1. A method for inserting a biosensor into a subject comprising the steps of:

positioning at least one biosensor in a hydration compartment of a biosensor insertion instrument, the instrument comprising a support device having a continuous structure with a first end and a second end, said support device containing at least one channel enclosed within said continuous structure such as said at least one channel opens only at said first end, a plunger slidable within said at least one channel, a plug configured to secure said at least one biosensor within said hydration compartment while said at least one biosensor is bathed in hydration fluid, and a hollow tube attached to and extending from said first end of said support device, wherein the plunger serves as a floor for the compartment;

trapping said at least one biosensor in said hydration compartment between the plunger and the plug, wherein said hydration compartment is capable of containing hydration fluid for hydrating said at least one biosensor;

moving said plunger to a first position of said support device such that the plunger no longer serves as a floor for the compartment and a biosensor is allowed to enter said channel of said support device;

pushing said plug into said compartment to secure said biosensor within said at least one channel of said support device;

moving said plunger toward a second position of said support device such that said biosensor travels through said hollow tube and is about to enter said subject;

moving said plunger to a third position of said support device such that said biosensor exits said hollow tube and enters said subject.

2. The method of claim 1, wherein said biosensor is initially located within said compartment.

3. The method of claim 1, wherein said biosensor enters said channel by gravity.

4. The method of claim 1, wherein ramps lock said plunger at said positions.