Fluid delivery device, transcutaneous access tool and insertion mechanism for use therewith

• US 10,569,011 B2
• Filed: 11/19/2018
• Issued: 02/25/2020
• Est. Priority Date: 03/30/2012
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Dilanni, Steven, McLaughlin, Ian, O'Connor, Jason Brian, Campbell, Robert, Schmid, Kevin
• Primary Examiner(s): Hayman, Imani N
• Assistant Examiner(s): Legette, Tiffany
• Application Number:
  US16/194,873
• Publication Number:
  US 20190255251A1
• Time in Patent Office: 463 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• 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
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: F04B 9/02 the means being mechanical
• CPC Class Codes: F04C 2270/041 Controlled or regulated

Abstract

A fluid delivery device comprising a fluid reservoir; a transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool including a needle or a trocar; and a transcutaneous access tool insertion mechanism for deploying the transcutaneous access tool, wherein the insertion mechanism is configured to insert and retract the needle/trocar in a single, uninterrupted motion.

Claims

1. A fluid delivery device comprising:

a fluid reservoir;

a transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool including a needle or a trocar; and

a transcutaneous access tool insertion and retraction mechanism, wherein the insertion and retraction mechanism comprises;

a spring defining a longitudinal axis;

a first linkage and a second linkage coupled between the spring and a first sliding member;

the first sliding member coupled with the needle/trocar, wherein the first and second linkages configured to move the first sliding member in an insertion direction and a retraction direction in response to a force from the spring, wherein the first linkage includes a first end adjacent the spring and a second end directly coupled to the second linkage, wherein the first linkage rotates about the longitudinal axis of the spring and the second linkage rotates relative to the second end of the first linkage.

2. The fluid delivery device of claim 1 wherein the insertion and retraction mechanism is configured to increase an insertion force as the needle/trocar moves in an insertion direction.

3. The fluid delivery device of claim 1 wherein the transcutaneous access tool includes a cannula, and wherein the needle/trocar is located within the cannula such that the cannula remains inserted when the needle/trocar is retracted.

4. The fluid delivery device of claim 3 wherein the insertion and retraction mechanism comprises:

a first sliding member configured to move the needle/trocar in an insertion direction and in a retraction direction;

a second sliding member configured to move the cannula in the insertion direction;

a torsion spring; and

linkages coupled between the torsion spring and the first sliding member such that energy stored in the torsion spring causes the linkages to move the first sliding member in the insertion direction and the retraction direction.

5. The fluid delivery device of claim 4 wherein the insertion and retraction mechanism further comprises:

a frame slidably receiving the sliding members and configured to lock the sliding members in a pre-deployment position and to lock the second sliding member in a post-deployment position.

6. The fluid delivery device of claim 5 wherein the frame includes a cam finger configured to lock the sliding members in the pre-deployment position.

7. The fluid delivery device of claim 6 wherein the cam finger is configured to lock the second sliding member in the post-deployment position.

8. The fluid delivery device of claim 6 wherein the insertion and retraction mechanism further comprises:

a release bar configured to hold the cam finger when the cam finger locks the sliding members in the pre-deployment position and configured to release the cam finger to allow the sliding members to move in the insertion direction.

9. The fluid delivery device of claim 8 further comprising a drive mechanism for driving fluid from the reservoir, wherein the drive mechanism engages the release bar and triggers movement of the release bar to release the cam finger.

10. A fluid delivery device comprising:

a fluid reservoir;

a transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool including a cannula, and a needle or a trocar located inside the cannula;

a transcutaneous access tool insertion and retraction mechanism configured to deploy the transcutaneous access tool, comprising

a first sliding member coupled with the needle/trocar and operable to move the needle/trocar in an insertion direction and in a retraction direction;

a second sliding member coupled with the cannula and operable to move the cannula in the insertion direction;

a torsion spring;

linkages coupled between the torsion spring and the first sliding member such that energy stored in the torsion spring causes the linkages to move the first sliding member in the insertion direction and the retraction direction; and

wherein the torsion spring has a longitudinal axis and the linkages rotate around the longitudinal axis of the torsion spring.

11. The fluid delivery device of claim 10 wherein the transcutaneous access tool insertion and retraction mechanism is configured to insert the needle/trocar with an increasing insertion force as the needle/trocar moves in an insertion direction;

and

wherein the torsion spring operates to increase the insertion force as the needle/trocar moves in the insertion direction.

12. The fluid delivery device of claim 10 wherein the needle/trocar is located within the cannula such that the cannula remains inserted when the needle/trocar is retracted.

13. The fluid delivery device of claim 10 wherein the insertion and retraction mechanism further comprises:

a frame slidably receiving the sliding members and configured to lock the sliding members in a pre-deployment position and to lock the second sliding member in a post-deployment position.

14. The fluid delivery device of claim 13 wherein the frame includes a cam finger configured to lock the sliding members in the pre-deployment position.

15. The fluid delivery device of claim 14 wherein the cam finger is configured to lock the second sliding member in the post-deployment position.

16. The fluid delivery device of claim 14 wherein the insertion and retraction mechanism further comprises:

a release bar configured to hold the cam finger when the cam finger locks the sliding members in the pre-deployment position and configured to release the cam finger to allow the sliding members to move in the insertion direction.

17. The fluid delivery device of claim 16 further comprising a drive mechanism for driving fluid from the reservoir, wherein the drive mechanism engages the release bar and triggers movement of the release bar to release the cam finger.

18. A transcutaneous access tool insertion and retraction mechanism configured to deploy a transcutaneous access tool including a cannula, and a needle or a trocar located inside of the cannula, the insertion and retraction mechanism comprising:

a first sliding member coupled with the needle/trocar and operable to move the needle/trocar in an insertion direction and in a retraction direction;

a second sliding member coupled with the cannula and operable to move the cannula in the insertion direction;

a torsion spring having a longitudinal axis;

first and second linkages coupled between the torsion spring and the first sliding member such that, upon deployment, energy stored in the torsion spring causes the first and second linkages to cooperate to move the first sliding member in the insertion direction and the retraction direction; and

wherein, upon deployment, the first linkage is arranged to rotate about the longitudinal axis of the torsion spring, and the first linkage and second linkage are arranged to rotate relative to each other about a moving pivot to move the first sliding member in the insertion direction and the retraction direction.

19. The transcutaneous access tool insertion and retraction mechanism of claim 18 further comprising:

a frame slidably receiving the sliding members and configured to lock the sliding members in a pre-deployment position and to lock the second sliding member in a post-deployment position.

20. The transcutaneous access tool insertion and retraction mechanism of claim 19 wherein the frame includes a cam finger configured to lock the sliding members in the pre-deployment position.

21. The transcutaneous access tool insertion and retraction mechanism of claim 20 wherein the cam finger is configured to lock the sliding members in the post-deployment position.

22. The transcutaneous access tool insertion and retraction mechanism of claim 20 further comprising:

a release bar configured to hold the cam finger when the cam finger locks the sliding members in the pre-deployment position and configured to release the cam finger to allow the sliding members to move in the insertion direction.