IP Library › Granted Patent US 12,357,751
Granted Patent B2
US 12,357,751 · App. 17/289,009 · Granted Jul 15, 2025

Linear insertion device with rotational drive

Inventors: Justin Coker (Laguna Niguel, CA); Mark A. DeStefano (Collegeville, PA); Kenneth C. Hsu (Tustin, CA); Amber Stansberry (Irvine, CA); Paul Strasma (Irvine, CA); David Gillett (San Diego, CA); Mark Estes (Malibu, CA); Amrith Karunaratne (Irvine, CA)
Assignee: Tandem Diabetes Care, Inc.
A61M5/158A61M5/14248A61M25/0113A61M25/0606A61M2005/14252A61M2005/1585A61M2025/0246
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Quick Facts
Patent No.
US 12,357,751
App. No.
17/289,009
Granted
Jul 15, 2025
Kind
B2
Abstract

A system for delivering fluid to a user transcutaneously includes a torsion spring, a drive wheel, a linear slide having a stylet attached thereto, and a cannula. The torsion spring, when actuated, is configured to rotate the drive wheel to cause the linear slide to move axially to drive the stylet and cannula into a user-s skin.

Claims (42)

1. A system for delivering fluid to a user transcutaneously, the system comprising:

a drive wheel;

a torsion spring disposed within the drive wheel;

a linear slide engaged within the drive wheel and having a stylet attached thereto;

a cannula; and

an infusion set base configured to removably couple to an inserter housing and to attach to a user's skin;

wherein the torsion spring is energized such that, when actuated, the torsion spring delivers a spring force on the drive wheel to rotate the drive wheel, and wherein rotation of the drive wheel causes the linear slide engaged with the drive wheel to move axially to drive the stylet and cannula into a user's skin, and

wherein the infusion set base is configured to engage with the cannula as the cannula is driven into the user's skin so as to hold the cannula in the user's skin as the stylet is retracted and the system includes an automatic release mechanism configured to automatically decouple the inserter housing from the infusion set base following insertion of the cannula.

2. The system of claim 1 , wherein the drive wheel is configured to rotate a first amount to axially drive the infusion cannula into the user's skin with a stylet, and wherein the drive wheel is configured to rotate a second additional amount to retract the stylet from the user's skin.

3. The system of claim 2 , wherein the first amount is approximately 180 degrees, and wherein the second additional amount is approximately 180 degrees.

4. The system of claim 2 , wherein the torsion spring is configured to supply all energy required to both drive the infusion cannula and retract the stylet.

5. The system of claim 2 , wherein the torsion spring, drive wheel, linear slide, and cannula are all configured to be housed within an inserter housing prior to insertion of the stylet and cannula into the user's skin, and wherein the stylet and cannula extend out of the housing for insertion into the user's skin.

6. The system of claim 1 , wherein the infusion set base includes an adhesive on at least one surface thereof configured to attach the infusion set base to the user's skin.

7. The system of claim 1 , wherein the automatic release mechanism comprises a post configured to engage with the linear slide as the linear slide moves axially, the infusion set base configured to decouple from the inserter as the linear slide moves the post.

8. The system of claim 1 , wherein the automatic release mechanism comprises a plurality of arms configured to engage with the infusion set base to hold the infusion set base to the inserter prior to activation of the automatic release mechanism.

9. The system of claim 1 , wherein the cannula is flexible.

10. The system of claim 1 , further comprising a housing configured to house the torsion spring, drive wheel, linear slide, and cannula, wherein the housing comprises an angled surface therein upon which the drive wheel is rotational mounted so as to enable angled delivery of the stylet and cannula into the user's skin.

11. The system of claim 1 , wherein the cannula further comprises a septum at the proximal end thereof, the septum configured to seal upon removal of the stylet from the cannula.

12. The system of claim 11 , further comprising a fluid connection assembly configured to fluidically connect the cannula to a source of delivery fluid through the septum.

13. A system for delivering fluid to a user transcutaneously, the system comprising:

a torsion spring;

a drive wheel;

a linear slide having a stylet attached thereto; and

a cannula;

wherein the torsion spring, when actuated, is configured to rotate the drive wheel to cause the linear slide to move axially to drive the stylet and cannula into a user's skin,

the drive wheel comprises a pin and the linear slide comprises a framework having an elongate slot therein, the elongate slot configured to be positioned around the pin to transfer rotational movement of the drive wheel to axial movement of the linear slide.

14. The system of claim 13 , wherein the framework comprises a curved portion extending radially outwards therefrom, the stylet attaching to the curved portion, further wherein rotation of the pin through the curved portion creates a dwell in movement of the linear slide.

15. A system for delivering fluid to a user transcutaneously, the system comprising:

a cannula comprising a barrel and an elongate flexible member, wherein the barrel further includes a septum therein, the septum configured to allow passage of a stylet through the cannula and to self-seal as the stylet is removed from the cannula; and

an infusion set base comprising a central port through which the elongate flexible member is configured to extend, the infusion set base configured to lock the barrel thereto.

16. The system of claim 15 , further comprising an inserter configured to removably couple with the infusion set base, the inserter further configured to insert the cannula into the infusion set base.

17. The system of claim 16 , wherein the inserter is further configured to retract the stylet from the cannula.

18. The system of claim 15 , wherein the infusion set base further comprises one or more clips configured to open radially to allow the elongate flexible member to pass therethrough and to close radially around the barrel to lock the barrel thereto.

19. The system of claim 15 , further comprising an inserter comprising a drive wheel and a linear slide, the drive wheel configured to rotate to cause the linear slide to move axially to drive the cannula into a user's skin.

20. The system of claim 19 , wherein the drive wheel comprises a pin and the linear slide comprises a framework having an elongate slot therein, the elongate slot configured to be positioned around the pin to transfer rotational movement of the drive wheel to axial movement of the linear slide.

21. The system of claim 20 , wherein the framework comprises a curved portion extending radially outwards therefrom, the stylet attaching to the curved portion, further wherein rotation of the pin through the curved portion creates a dwell in movement of the linear slide so as to allow time for the infusion set base to lock to the barrel.

22. The system of claim 15 , further comprising an infusion set cap configured to interlock with the infusion set base, the infusion set cap comprising a needle configured to pierce the septum as the infusion set cap and infusion set base are mated.

23. The system of claim 22 , wherein the needle is configured to pierce the septum at a different angle than the stylet.

24. The system of claim 23 , wherein the needle is configured to pierce the septum at approximately a 10-65° degree angle relative to the stylet.

25. The system of claim 15 , wherein the septum comprises an elastomer.

26. The system of claim 15 , wherein the barrel compresses the septum radially and axially.

27. The system of claim 15 , wherein the septum comprises a cylindrical outer wall and an H-shaped longitudinal cross-section.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2022
From: CAPILLARY BIOMEDICAL, INC.
To: TANDEM DIABETES CARE, INC.
Reel/Frame 060849/0752 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 7, 2021
From: COKER, JUSTIN; DESTEFANO, MARK A.; HSU, KENNETH C.; STANSBERRY, AMBER; STRASMA, PAUL; GILLETT, DAVID; ESTES, MARK; KARUNARATNE, AMRITH
To: CAPILLARY BIOMEDICAL, INC.
Reel/Frame 056171/0451 →
Continuity (2)
Provisional Application 62757684 · Nov 8, 2018
Related Publication 20210402084A1 · Dec 30, 2021
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