Subcutaneous sensor inserter and method

• US 10,335,066 B2
• Filed: 09/02/2015
• Issued: 07/02/2019
• 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.
• Primary Examiner(s): Messersmith, Eric J
• Application Number:
  US14/843,623
• Publication Number:
  US 20160058344A1
• Time in Patent Office: 1,399 Days
• 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. A continuous analyte monitoring inserter apparatus for subcutaneous placement of a sensor into a patient, the apparatus comprising:

an inserter assembly comprising;

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

a deployment button partially disposed and slidable within the housing body through the first body end, the deployment button being movable into the housing body from a first position to 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; and

a sensor deployment assembly having a sensor deployment body with a resilient deployment body catch thereon, the sensor deployment assembly disposed within the housing body and removably mated with the deployment mechanism, the sensor deployment assembly having a sensor partially disposed within the needle of the deployment mechanism wherein the deployment button, the deployment mechanism and the sensor deployment assembly are adapted to all move linearly together; and

a sensor housing having a base catch surface for receiving and retaining the resilient deployment body catch of the sensor deployment body when the deployment button is moved from the first position to the second locked position, the sensor housing being partially disposed within and removably retained in the second body end of the housing body;

wherein the inserter assembly is adapted to substantially simultaneously;

implant the sensor subcutaneously into the patient, retract the needle, fix the sensor deployment assembly within the sensor housing, engage a release surface of the deployment button with a locking mechanism on the housing body of the inserter assembly, and thereby release the inserter assembly from the sensor housing with a single activation of the deployment button caused by moving the deployment button from the first position to the second position.

2. The apparatus of claim 1 wherein the single activation has an auditory indication that the sensor is implanted in the patient and the inserter assembly is released from the sensor housing.

3. The apparatus of claim 1 wherein the single activation has a sensory indication through the inserter assembly that the sensor is implanted in the patient and the inserter assembly is released from the sensor housing.

4. The apparatus of claim 1 wherein the needle is oriented substantially perpendicular with a bottom of the sensor housing.

5. The apparatus of claim 1 wherein the housing body has a body recess for receiving and retaining a button catch when the deployment button is oriented in the second position.

6. The apparatus of claim 1 wherein the housing body has a body catch retaining the sensor housing partially within the housing body, which body catch is released from the sensor housing by the deployment button when the deployment button is oriented in the second position.

7. The apparatus of claim 1 wherein the inserter assembly further includes a lumen disposed on the needle and wherein the inserter assembly substantially simultaneously implants the lumen with the sensor subcutaneously into the patient.

8. A single action inserter assembly for subcutaneous placement of a sensor into a patient using a single action comprising:

a housing body;

a deployment button partially disposed and slidable within the housing body, the deployment button being movable into the housing body from a first position to a second locked position;

a deployment mechanism having a needle slidably disposed within the deployment button and movable between a tensioned orientation, and a released position;

a sensor deployment assembly having a sensor deployment body with a resilient deployment catch thereon, the sensor deployment assembly disposed within the housing body and removably mated with the deployment mechanism, the sensor deployment assembly having a sensor partially disposed within the needle of the deployment mechanism wherein the deployment button, the deployment mechanism and the sensor deployment assembly are adapted to all move linearly together; and

a sensor housing having a base catch surface for receiving and retaining the resilient deployment catch of the sensor deployment body when the deployment button is moved from the first position to the second locked position, the sensor housing being partially disposed within and removably retained in the housing body,

wherein a single action of the deployment button moving to the second locked position is configured to insert the sensor and the needle subcutaneously into the patient while substantially simultaneously causing the sensor deployment body to be retained within the sensor housing, the deployment mechanism to be released from the tensioned orientation retracting the needle into the deployment button, and the housing body to be released from the sensor housing.

9. The assembly of claim 8 wherein the single action emits an auditory indication that the sensor is implanted in the patient and the inserter assembly is released from the sensor housing.

10. The assembly of claim 8 wherein the single action emits a sensory indication through the inserter assembly that the sensor is implanted in the patient and the inserter assembly is released from the sensor housing.

11. The assembly of claim 8 further includes implanting a lumen along with the sensor subcutaneously in the patient.

12. A single action inserter assembly for subcutaneous placement of a sensor into a patient comprising:

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

a deployment button partially disposed and slidable within the housing body through the first body end, the deployment button being movable into the housing body from a first position to a second locked position;

a deployment mechanism having a needle carrier and a needle slidably disposed within the deployment button and movable between a tensioned orientation, and a released position;

a sensor deployment assembly having a sensor carrier and a sensor deployment body with a resilient deployment catch thereon, the sensor deployment assembly disposed within the housing body and removably mated with the deployment mechanism, the sensor deployment assembly having a sensor partially disposed within the needle of the deployment mechanism wherein the deployment button, the deployment mechanism and the sensor deployment assembly are adapted to all move linearly together; and

a sensor housing having a base catch surface for receiving and retaining the resilient deployment catch of the sensor deployment body when the deployment button is moved between the first position to the second locked position, the sensor housing being partially disposed within and removably retained in the second body end of the housing body,

wherein a single action of the deployment moving to the second locked position is configured to insert the sensor and the needle subcutaneously into the patient while substantially simultaneously causing the sensor deployment body to be retained within the sensor housing by the resilient deployment catch engaging the base catch surface of the sensor housing, the deployment mechanism to be released from the tensioned orientation causing the needle to retract into the deployment button, and the housing body to be released from the sensor housing.

13. The assembly of claim 12 wherein the single action emits an auditory indication that the sensor is implanted in the patient and the inserter assembly is released from the sensor housing.

14. The assembly of claim 12 wherein the single action emits a sensory indication through the inserter assembly that the sensor is implanted in the patient and the inserter assembly is released from the sensor housing.

15. The assembly of claim 12 further includes implanting a lumen along with the sensor subcutaneously in the patient.