Subcutaneous sensor inserter and method

• US 10,456,064 B2
• Filed: 09/02/2015
• Issued: 10/29/2019
• 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:
  US14/843,663
• Publication Number:
  US 20160058470A1
• Time in Patent Office: 1,518 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 skin of a patient that minimizes pain to a patient, the apparatus comprising:

a single action inserter assembly having a housing body with 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 between a first position and a second position, and a sensor housing partially disposed within and removably retained in the second body end;

a needle having a cross-sectional shape that minimizes a peak force of insertion into the skin of the patient, the needle having an insertion angle that further minimizes the peak force of insertion into the skin of the patient, wherein the needle is movably disposed within the single action inserter assembly, the implantable sensor having sidewalls which frictionally engage an inside surface portion of the needle;

a deployment mechanism that contains a sensor deployment assembly and the needle wherein the deployment mechanism is contained within the deployment button; and

an implantable sensor partially disposed within the needle and the sensor deployment assembly, wherein the implantable sensor comprises a loop configured to secure the implantable sensor in the sensor deployment assembly;

wherein the inserter assembly is adapted to substantially simultaneously implant the sensor subcutaneously into the patient, retract the needle, fix the sensor and the sensor deployment assembly within the sensor housing and 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 while minimizing pain to the patient.

2. The apparatus of claim 1 wherein a longitudinal portion of the needle has a skive cut along a length of the needle from a sharp end of the needle to a predefined location.

3. The apparatus of claim 1 wherein the insertion angle of the needle is such that the needle is oriented substantially perpendicular to a surface of the single action inserter, the surface being a portion of the sensor housing and intended for placement against the skin of the patient.

4. The apparatus of claim 1 wherein the needle has a cross-sectional shape that is selected from the group consisting of oval, elliptical, egg-shaped, and oblong.

5. The apparatus of claim 2 wherein the longitudinal portion of the needle has a cross-sectional shape that is selected from the group consisting of oval, elliptical, egg-shaped, and oblong.

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

a needle having a cross-sectional shape, an insertion angle, and a sharpness that minimizes a peak force of insertion, and thereby, that minimizes pain to the patient;

a deployment mechanism that contains a sensor deployment assembly and the needle;

a deployment button that is partially disposed and slidable within the housing body, the deployment button contains the deployment mechanism, wherein the deployment button, the deployment mechanism and the needle are adapted to all move linearly together; and

a sensor that is partially disposed within the needle and the sensor deployment assembly, wherein the sensor comprises a loop configured to secure the sensor in the deployment assembly;

wherein the inserter assembly is adapted to substantially simultaneously using a single action cause the inserter assembly (1) to implant the sensor subcutaneously into the patient, (2) to fixedly seat the sensor deployment assembly that includes the sensor within a sensor housing adhesively attached to the patient, (3) retracting the needle used to implant the sensor, and (4) releasing the inserter assembly from the sensor housing.

7. The assembly of claim 6 wherein a longitudinal portion of the needle has a skive cut along a length of the needle from a sharp end of the needle to a predefined location.

8. The assembly of claim 6 wherein the insertion angle of the needle is such that the needle is oriented substantially perpendicular to a surface of the single action inserter, the surface being a portion of the sensor housing and intended for placement against the skin of the patient.

9. The assembly of claim 6 wherein the needle has a cross-sectional shape that is selected from the group consisting of oval, elliptical, egg-shaped, and oblong.

10. The assembly of claim 7 wherein the longitudinal portion of the needle has a cross-sectional shape that is selected from the group consisting of oval, elliptical, egg-shaped, and oblong.

11. The assembly of claim 6 wherein the single operation of the inserter assembly is performed by an inserter assembly user other than the patient.

12. The assembly of claim 11 wherein a longitudinal portion of the needle has a skive cut along a length of the needle from a sharp end of the needle to a predefined location, and the insertion angle of the needle is such that peak force of insertion is less than 0.25 lbs.

13. The assembly of claim 11 wherein the insertion angle of the needle is such that the needle is oriented substantially perpendicular to a surface of the single action inserter, the surface being a portion of the sensor housing and intended for placement against the skin of the patient;

whereby the peak force of insertion is less than 0.3 lbs.

14. The assembly of claim 11 wherein the needle has a cross-sectional shape that is selected from the group consisting of oval, elliptical, egg-shaped, and oblong;

and a distance of insertion is between 2.5 mm and 7.6 mm.

15. The assembly of claim 12 wherein the longitudinal portion of the needle has a cross-sectional shape that is selected from the group consisting of oval, elliptical, egg-shaped, and oblong;

whereby a work energy of insertion of the needle is less than 0.04 in-lb.

16. A method of minimizing pain when inserting an in-vivo analyte sensor subcutaneously for continuous analyte monitoring of a patient, the method comprising:

providing a single action inserter assembly having a needle with a cross-sectional shape and an insertion angle that minimizes a peak force of insertion into the skin of the patient, an implantable sensor, a deployment button for implanting the implantable sensor using the needle and for retracting the needle, a deployment mechanism that contains a sensor deployment assembly and the needle and is disposed within the deployment button, a sensor partially disposed within the needle and the sensor deployment assembly, wherein the sensor comprises a loop configured to secure the sensor in the deployment assembly, and a sensor housing for retaining the implanted sensor in an implanted orientation once deployed by the deployment button, wherein the deployment button and the needle are adapted to move linearly together when the single action inserter assembly is activated; and

using a single action to activate the deployment button of the single action inserter assembly that causes the following actions to substantially simultaneously occur;

(1) implanting the sensor subcutaneously into the patient, (2) fixedly seating the sensor within the sensor housing attached to the patient, (3) retracting the needle used to implant the sensor into the inserter assembly, and (4) releasing the inserter assembly from the sensor housing,

wherein the needle and the single action minimizes pain when inserting the sensor subcutaneously.

17. The method of claim 16 wherein the providing step includes providing the needle with a skive cut along a longitudinal portion of the needle from a sharp end of the needle to a predefined location.

18. The method of claim 16 wherein the providing step includes providing the needle with the insertion angle that is oriented substantially perpendicular to a surface of the single action inserter, the surface being a portion of the sensor housing and intended for placement against the skin of the patient.

19. The method of claim 16 wherein the providing step includes providing the needle with a cross-sectional shape that is selected from the group consisting of oval, elliptical, egg-shaped, and oblong.

20. The method of claim 17 wherein the providing step includes providing the needle with the longitudinal portion having a cross-sectional shape that is selected from the group consisting of oval, elliptical, egg-shaped, and oblong.