COMPACT MEDICAL DEVICE INSERTERS AND RELATED SYSTEMS AND METHODS

• US 20160331284A1
• Filed: 05/13/2016
• Published: 11/17/2016
• Est. Priority Date: 05/14/2015
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Pace, Louis G.
• Granted Patent: US 10,674,944 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• 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 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Compact medical device inserters, systems incorporating the same, and related methods of use are described. The inserters can include a housing, a sharp support, a sharp body, and a shroud, and can apply a sensor control device to a recipient with a sensor implanted in the recipient'"'"'s body. The shroud can extend from the sensor control device in a position that covers or protects the sensor and a sharp, and can be retracted by pressure placed upon the inserter against the recipient'"'"'s body to cause the sharp and sensor to penetrate the body, after which the sharp can be automatically withdrawn with the aid of a biasing element.

Claims

1. A method for inserting an analyte sensor into a human body with an inserter, the inserter comprising a posterior housing, a sensor control device coupled with the housing, the analyte sensor, a sharp, and a shroud, the method comprising:

placing an anterior surface of the shroud against a recipient'"'"'s skin, wherein the shroud, the sensor, and the sharp are extended with respect to an anterior surface of the sensor control device, and wherein the shroud covers the sensor and the sharp;

advancing the sensor control device towards the recipient'"'"'s skin such that the shroud retracts with respect to the sensor control device and the sharp and sensor are inserted into the recipient'"'"'s body; and

withdrawing the sharp while leaving the sensor within the recipient'"'"'s body.

2. The method of claim 1, wherein the sharp and sensor are inserted into the recipient'"'"'s body through an aperture in the shroud.

3. The method of claim 1, wherein the shroud is held extended with respect to the anterior surface of the sensor control device by a first lock mechanism comprising a structure on the shroud that locks with a structure on the sensor control device.

4. The method of claim 3, wherein the structure on the shroud is a detent and the structure on the sensor control device is a recess.

5. The method of claim 1, wherein the shroud is held extended with respect to the anterior surface of the sensor control device by a biasing element.

6. The method of claim 1, wherein the inserter comprises a biasing element, the method further comprising automatically withdrawing the sharp from the recipient'"'"'s body with a force applied by the biasing element.

7. The method of claim 6, wherein the sharp is coupled with a posterior mount, the method comprising automatically withdrawing the sharp from the recipient'"'"'s body with the force applied by the biasing element against the posterior mount.

8. The method of claim 7, wherein the biasing element contacts a base of the shroud and a surface on the posterior mount, and is adapted to apply the force therebetween.

9. The method of claim 7, wherein the biasing element is in a relatively uncompressed state when the shroud is extended, the method further comprising advancing the sensor control device towards the recipient'"'"'s skin such that the shroud retracts with respect to the sensor control device and the biasing element transitions from the relatively uncompressed state to a relatively compressed state.

10. The method of claim 9, further comprising releasing a second lock mechanism wherein, upon release, the biasing element decompresses from the relatively compressed state and causes withdrawal of the sharp from the recipient'"'"'s body.

11. The method of claim 10, wherein the second lock mechanism comprises an elastic arm coupled with the housing and adapted to releasably hold the posterior mount in position with respect to the sensor control device.

12. The method of claim 11, wherein retraction of the shroud causes a release surface of the shroud to deflect the elastic arm and thereby release the second lock mechanism.

13. The method of claim 9, wherein the inserter comprises two elastic arms coupled with the housing and adapted to releasably hold the posterior mount in position with respect to the sensor control device.

14. The method of claim 13, wherein upon placement of the anterior surface of the shroud against the recipient'"'"'s skin, the two elastic arms are holding the posterior mount in position with respect to the sensor control device and, wherein retraction of the shroud causes a release surface of the shroud to deflect the two elastic arms and thereby release the posterior mount from the elastic arms.

15. The method of claim 14, wherein after release of the posterior mount from the elastic arms, the biasing element decompresses from the relatively compressed state and causes withdrawal of the sharp from the recipient'"'"'s body.

16. The method of claim 1, further comprising adhesively coupling an anterior surface of the sensor control device to the recipient'"'"'s skin.

17. The method of claim 16, further comprising withdrawing the inserter such that the sensor control device is separated from the inserter and the sensor control device remains adhesively coupled to the recipient'"'"'s skin with the sensor at least partially implanted within the recipient'"'"'s body.

18. The method of claim 17, wherein, after withdrawal of the inserter, an electrode on the sensor is in contact with a fluid of the recipient and capable of measuring a level of an analyte in the fluid, wherein the fluid is only interstitial fluid or only dermal fluid.

19. The method of claim 18, wherein the analyte is glucose.

20. The method of claim 1, wherein the sensor control device is coupled with the housing of the inserter and advancing the sensor control device towards the recipient'"'"'s skin comprises grasping the housing of the inserter and advancing the housing towards the recipient'"'"'s skin.

21-40. -40. (canceled)