Subcutaneous sensor inserter and method

• US 10,194,843 B2
• Filed: 09/02/2015
• Issued: 02/05/2019
• 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): Natnithithadha, Navin
• Application Number:
  US14/843,725
• Publication Number:
  US 20160058474A1
• Time in Patent Office: 1,252 Days
• Field of Search: 600309, 600345-366
• 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, a sensor bore and a lumen tube sealingly fixed to the sensor deployment assembly and extending concentric with a deployment axis through the needle bore to a lower lumen end, the lumen tube defining a lumen side opening in communication with the sensor bore that extends transversely from the lumen tube, wherein the needle is disposed within the lumen tube and extends through the lumen tube when the deployment mechanism is in the ready position and in the insertion position;

a sensor with an electrical contact portion, the sensor partially disposed within the needle and extending through the lumen side opening and sensor bore with the electrical contact portion extending 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 and the lumen tube 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 sensor 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 defining the sensor bore and having a board-receiving face on a top sensor carrier surface and extending transversely to the deployment axis; and

a sensor board with a plurality of electronic coupling pads electrically coupled to the electrical contact portion of the sensor, wherein the sensor board mates with the board-receiving face with the plurality of electronic coupling pads positioned for electrical coupling to measuring electronics;

wherein the sensor extends from the lumen through the sensor bore and along the sensor board.

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 lumen tube is a single lumen tube sized to receive the needle and the sensor therein, wherein an electrode system on the sensor extends from the lower lumen end of the single lumen tube.

6. The apparatus of claim 5, wherein a working electrode of the electrode system is spaced from the lower lumen end of the single lumen tube by about 4 mm to about 7 mm.

7. The apparatus of claim 5, wherein a working electrode of the electrode system is spaced from the lower lumen end of the single lumen tube by about 2 mm to about 10 mm.

8. The apparatus of claim 1, wherein the lumen tube is a dual lumen defining a first lumen tube for receiving the needle therethrough and a second lumen tube for receiving the sensor therethrough.

9. The apparatus of claim 8, wherein the second lumen tube defines a lumen side opening adjacent the lower lumen end wherein an electrode system on the sensor is disposed.

10. The apparatus of claim 8, wherein the second lumen tube defines one or more second lumen electrode openings adjacent the lower lumen end exposing an electrode system on the sensor to a sample to be measured.

11. The apparatus of claim 1 further comprising a cover assembly releasably attachable to a top of the sensor deployment assembly, the cover assembly comprising:

a plurality of resilient sensor housing engagement tabs on a medication delivery housing each with a tab catch configured to be received within a corresponding engagement tab receiver in the sensor housing to lock the cover assembly to the sensor housing;

a sealing member on a bottom surface of the cover assembly that aligns with and seals into the needle bore; and

an electrical component housing configured to receive and transmit electrical signals generated by the electrode system on the sensor.

12. The apparatus of claim 11, wherein the cover assembly defines a delivery bore with a first bore end and a second bore end at a delivery bore opening in a bottom surface of the sealing cover.

13. The apparatus of claim 12 further comprising a flexible medication delivery tube connected to the first bore end of the delivery bore.

14. 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.

15. 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 in moved to the second locked position.

16. 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.