Subcutaneous sensor inserter and method

• US 20160058473A1
• Filed: 09/02/2015
• Published: 03/03/2016
• Est. Priority Date: 09/03/2014
• Status: Active Grant

• Current Assignee: Sanvita Medical Corporation
• Original Assignee: Nova Biomedical Corporation (Nova Chemicals)
• Inventors: Peterson, Thomas H., Cionek, Scott P., Florindi, Anthony, Hart, Julian I.
• Granted Patent: US 10,376,187 B2
• Time in Patent Office: Days
• 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 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 2562/04 Arrangements of multiple sensors of the same type
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

An inserter assembly for continuous glucose monitoring with medication delivery capability where the assembly has a deployment button containing a needle deployment mechanism having a sharp held in a pre-release position, a housing body in which the deployment button is movably received within a top end of the housing body, the housing body having a sensor deployment assembly containing a lumen and a sensor disposed within the lumen and extending out of the lumen to a circuit board that is part of the sensor deployment assembly, the sensor deployment assembly matingly connected to the sharp where the sharp extends beyond the sensor deployment assembly and contains the sensor not fixedly attached to the sharp, and a sensor housing releasably received within a lower end of the housing body, the sharp extending into a sensor deployment assembly recess within the sensor housing and directly above a sensor opening in a bottom of the sensor housing.

Claims

1. An inserter assembly for implanting a sensor subcutaneously into a patient, the assembly comprising:

a housing body having a first body end and a second body end;

a deployment button at least partially disposed in and slidable within the housing body through the first body end, the deployment button being movable between a first position and a second locked position;

a deployment mechanism slidably disposed within the deployment button and movable between a ready position, an insertion position, and a retracted position, the deployment mechanism having a needle;

a sensor deployment assembly disposed within the housing body and removably mated with the deployment mechanism, the sensor deployment assembly having a needle bore in which the needle is disposed when the deployment mechanism is in the ready position, and a sensor partially disposed within the needle bore, wherein the deployment mechanism, the needle, and the sensor define a deployment axis, the sensor having an electrical contact portion wherein the electrical contact portion extends transversely away from the deployment axis; and

a sensor housing disposed at and removably retained by the second body end of the housing body, the sensor housing having a bottom surface and defining a sensor opening therethrough that is aligned with the deployment axis,

wherein movement of the deployment button from the first position to the second locked position causes the sensor to be implanted subcutaneously into the patient along the deployment axis, the needle of the deployment mechanism to retract to the retracted position, the sensor deployment assembly to be fixed within the sensor housing, and the housing body, the deployment button and the deployment mechanism to release from the sensor housing.

2. The apparatus of claim 1, wherein the sensor deployment assembly comprises:

a sensor deployment body with a sensor deployment locking mechanism configured to engage the sensor housing when the button is moved to the second locked position, thereby locking the sensor deployment assembly with the sensor housing;

a sensor deployment guide attached to the sensor deployment body and positioned to abut the sensor housing to stop travel of the deployment assembly when the deployment button is moved to the second locked position;

a sensor carrier attached to the sensor deployment guide and securing the sensor, the sensor carrier having a board-receiving face on a top sensor carrier surface and extending transversely to the deployment axis; and

a sensor board mated with the board-receiving face and having a plurality of electronic coupling pads positioned for being electrically coupled to measuring electronics, wherein the sensor extends through the sensor bore and along the sensor board with the electrical contact portion of the sensor electrically coupled to the plurality of electronic coupling pads.

3. The apparatus of claim 1, wherein the deployment axis is substantially perpendicular to the bottom surface of the sensor housing.

4. The apparatus of claim 1, wherein the bottom surface of the sensor housing is configured to contact the patient during implantation of the sensor.

5. The apparatus of claim 1, wherein the sensor implanted subcutaneously in the patient has a working electrode of an electrode system on the sensor extending into the patient by about 4 mm to about 7 mm.

6. The apparatus of claim 1, wherein the sensor implanted subcutaneously in the patient has a working electrode of an electrode system on the sensor extending into the patient by about 2 mm to about 10 mm.

7. The apparatus of claim 2, wherein the sensor deployment locking mechanism comprises one or more resilient deployment catch on the sensor deployment assembly biased to engage a deployment catch surface on the sensor housing.

8. The apparatus of claim 1 further comprising:

a resilient button catch on one of the housing body or the sensor housing, the button catch biased to engage a button catch surface on the other of the housing body or the sensor housing when the deployment button is in the second locked position;

a resilient needle-carrier catch on one of the deployment button or the needle carrier, the needle-carrier catch biased to disengage a second catch surface on the other of the deployment button or the needle carrier when the deployment button is moved to the second locked position; and

a resilient housing catch on one of the housing body or the sensor housing, the housing catch biased to disengage a housing catch surface on the other of the housing body or the sensor housing when the button is moved to the second locked position.

9. The apparatus of claim 1, wherein the movement of the deployment button from the first position to the second locked position is a single movement causing substantially at the same time the sensor to be implanted subcutaneously into the patient along the deployment axis, the needle of the deployment mechanism to retract to the retracted position, the sensor deployment assembly to be fixed within the sensor housing, and the housing body, the deployment button and the deployment mechanism to release from the sensor housing.