INFUSION DEVICE WITH RELEASABLE FLUID CONNECTOR

• US 20140350485A1
• Filed: 12/07/2012
• Published: 11/27/2014
• Est. Priority Date: 12/07/2011
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Sonderegger, Ralph, Marsh, Ronald, Hwang, Charles, Richards, Stephen, Politis, Victor, Glace, Benjamin, Sullivan, James, Ben, Eric, Horvath, Joshua, Lambert, Ryan, Venditto, Gregory
• Granted Patent: US 9,795,777 B2
• Time in Patent Office: Days
• US Class Current: 604/244
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2039/0036 characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/1055 Rotating or swivel joints in general F16L27/00
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3213 Caps placed axially onto the needle, e.g. equipped with finger protection guards axially-extensible protective sleeves A61M5/3243
• CPC Class Codes: B29C 45/14 incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles B29C45/1671 takes precedence
• CPC Class Codes: B29C 45/14344 Moulding in or through a hole in the article, e.g. outsert moulding
• CPC Class Codes: B29C 45/16 Making multilayered or multicoloured articles B29C45/0062 takes precedence; feeding colouring materials into the injection unit B29C45/1816
• CPC Class Codes: B29C 45/1615 The materials being injected at different moulding stations
• CPC Class Codes: B29C 45/1657 using means for adhering or bonding the layers or parts to each other mechanical anchoring B29C37/0082

Abstract

An infusion set system, including a base and a fluid connector removably coupleable thereto is disclosed. The fluid connector includes a fluid path portion and at least one connector latch displaceably connected to the fluid path portion and displaceable to a latching position in which at least a portion of the connector latch extends into the fluid path portion, which includes a cannula extending from a top interior surface thereof, and a plurality of internal sidewalls corresponding to at least two of a plurality of flat side surfaces of at least one of a base section and a base latch, thereby facilitating connection between the base and the fluid connector in a plurality of discrete rotational connecting positions. When the fluid connector is locked to the base, the at least one connector latch engages a base latching portion of the base and restricts proximal displacement of the fluid connector.

Claims

1. An infusion set system comprising;

a base attachable on a distal side thereof to a patient at an infusion site, the base comprising;

a base section extending proximally from a surface of the base;

a latching portion extending proximally from the base section; and

a base latch extending proximally from the latching portion;

wherein the latching portion has a smaller lateral width than the base latch, and at least one of the base section and the base latch has a plurality of substantially flat side surfaces; and

a fluid connector removably coupleable to the base, the fluid connector comprising;

a fluid path portion, comprising;

a cannula extending from a top interior surface of the fluid path portion; and

a plurality of internal sidewalls corresponding to at least two of the plurality of the flat side surfaces of the at least one of the base section and the base latch, thereby facilitating connection between the base and the fluid connector in a plurality of discrete rotational connecting positions; and

at least one connector latch displaceably connected to the fluid path portion and displaceable to a latching position in which at least a portion of the connector latch extends into the fluid path portion;

wherein when the fluid connector is locked to the base, the at least one connector latch engages the latching portion of the base and restricts proximal displacement of the fluid connector relative to the base.

2. The system according to claim 1, wherein:

the base section has a first plurality of substantially flat side surfaces; and

the base latch has a second plurality of flat side surfaces.

3. The system according to claim 1, wherein:

the base latch has eight substantially flat side surfaces; and

the base section has eight substantially flat side surfaces corresponding to the side surfaces of the base latch, the flat side surfaces of the base latch and the base section facilitating eight discrete rotational connecting positions between the base and the fluid connector.

4. The system according to claim 1, wherein:

the latching portion of the base has a longitudinal axis, and

the at least one connector latch has a pair of angled side surfaces that are substantially parallel to the longitudinal axis of the latching portion when the fluid connector is locked to the base.

5. The system according to claim 4, wherein:

the latching portion of the base is substantially cylindrical; and

when the fluid connector is locked to the base, the pair of angled side surfaces of the at least one connector latch contacts the latching portion at two distinct locations.

6. The system according to claim 1, wherein flat side surfaces of the base latch are substantially coplanar with flat side surfaces of the base section.

7. The system according to claim 1, wherein:

the fluid connector further comprises at least one activation lever, integral with and corresponding to the at least one connector latch; and

the activation lever and the connector latch pivot about a common axis.

8. The system according to claim 1, wherein a proximal surface of the base latch is at least one of one of faceted, convex, and sloped in a distal direction, enabling the at least one connector latch to be incrementally displaced outward by contacting the proximal surface of the base latch during initial engagement of the fluid connector with the base.

9. The system according to claim 8, wherein the at least one connector latch has a beveled distal surface that engages the proximal surface of the base latch during initial engagement of the fluid connector with the base.

10. The system according to claim 1, wherein:

the fluid path portion of the fluid connector further comprises a tubing connector portion for connecting to tubing connected to a pump, the tubing connector portion being in fluid communication with the fluid connector cannula; and

a longitudinal axis of the tube connector portion is substantially perpendicular to a longitudinal axis of the cannula.

11. The system according to claim 7, wherein:

the fluid connector further comprises a stop portion; and

when the fluid connector is locked to the base, pivoting the at least one activation lever to contact the rigid stop portion releases the at least one connector latch from engagement with the latch portion of the base, to permit free proximal displacement of the fluid connector relative to the base.

12. The system according to claim 11, wherein the stop portion is located between a pair of opposing activation levers.

13. The system according to claim 1, further comprising a septum secured within the base;

wherein the cannula pierces the septum when the fluid connector is locked to the base.

14. The system according to claim 13, wherein the septum is secured within the base via at least one of a friction fit, swaging, and an adhesive.

15. The system according to claim 1, wherein the at least one connector latch is resiliently biased toward the latching position.

16. A two-piece fluid connector comprising:

a fluid path portion, comprising a cannula integral with and extending from a proximal interior surface of the fluid path portion; and

a latching portion secured to the fluid path portion and having at least one displaceable arm, the arm comprising;

a connector latch disposed at a first end of the arm; and

an activation lever disposed at an opposite end of the arm;

wherein the connector latch is displaceable to a latching position in which at least a portion of the connector latch extends into an interior of the fluid path portion through side walls of the fluid path portion.

17. The system according to claim 16, wherein the at least one arm is pivotably connected to the latching portion via a living hinge.

18. The connector according to claim 16, wherein the fluid path portion has a dome-shaped exterior surface to reduce its profile and aid in preventing unintentional disconnection of the fluid connector.

19. The connector according to claim 16, wherein the fluid path portion and the latching portion are made of the same material.

20. The connector according to claim 16, wherein the latching portion is secured to the fluid path portion via a snap-fit engagement.

21. The system according to claim 16, wherein the connector latch has a pair of angled side surfaces substantially parallel to a longitudinal axis of the cannula.

22. The system according to claim 16, wherein the connector latch has a beveled distal surface.

23. The system according to claim 21, wherein the connector latch has a beveled distal surface.

24. The system according to claim 16, wherein the connector latch is resiliently biased toward the latching position.

25. A septum, comprising:

a peripheral portion having a substantially straight external side and a peripheral thickness along a first axis substantially parallel to the external side; and

a web portion surrounded by the peripheral portion, the web portion having a central portion surrounded by a connecting portion connecting the central portion with the peripheral portion;

wherein the central portion has a maximum central thickness along the first axis that is substantially less than the peripheral thickness and greater than a minimum thickness of the connecting portion along the first axis.

26. The septum according to claim 25, wherein the peripheral portion is substantially annular.

27. The septum according to claim 25, wherein the septum is a slit septum.

28. The septum according to claim 25, wherein the web has first and second opposing ends that are substantially symmetrical about the first axis and a second axis substantially perpendicular to the first axis.

29. The septum according to claim 25, wherein the septum is substantially symmetrical about the first axis.

30. The septum according to claim 25, wherein:

the peripheral portion has first and second opposing ends; and

the web portion is connected to the peripheral portion substantially closer to the first end than to a midpoint between the first and second ends of the peripheral portion.

31. The septum according to claim 30, wherein:

the web portion has first and second opposing ends corresponding to the first and second ends of the peripheral portion; and

an internal face of the peripheral portion bordering a cavity adjacent to the second end of the web portion is sloped to connect with the connecting portion.

32. The septum according to claim 25, wherein:

the septum has first and second opposing ends; and

the septum further comprises at least one nub disposed on at least one of the first end and the second end of the septum.

33. The septum according to claim 32, wherein the number of nubs disposed on the first end of the septum is different than the number of nubs disposed on the second end of the septum.

34. A needle guard for guarding a sharp cannula of an infusion device, the needle guard comprising:

a proximal portion for connecting to the base of the infusion device; and

a distal portion for user interaction;

wherein the proximal and distal portions each include at least one axial cutout that divides the needle guard into first and second lateral sides; and

wherein a fulcrum web is disposed between the proximal and distal axial cutouts to join the first and second lateral sides of the needle guard and provide a fulcrum for relative rotation of the first and second lateral sides of the needle guard.

35. The needle guard according to claim 34, wherein the needle guard is integrally formed as a unitary structure;

36. The needle guard according to claim 34, wherein:

the proximal portion includes a pair of axial cutouts;

the distal portion includes a pair of axial cutouts;

the proximal axial cutouts are substantially aligned with the distal axial cutouts, forming pairs of aligned cutouts; and

the needle guard further comprises a pair of fulcrum webs respectively disposed between the pairs of aligned cutouts.

37. The needle guard according to claim 34, wherein the distal portion includes a pair of concave sculpted portions for interaction with the user'"'"'s fingers.

38. The needle guard according to claim 34, wherein the distal portion includes a plurality of support ribs to increase the structural rigidity of the distal portion.

39. The needle guard according to claim 34, wherein the proximal portion includes a pair of opposing, inward-cantilevered gripping portions for connecting with the infusion device.

40. A combination, comprising:

the needle guard according to claim 39; and

a base of the infusion set, wherein the base includes distally-extending column from which a cannula protrudes distally;

the column having an undercut middle portion, thereby forming a lip at its distal end;

wherein the gripping portions of the needle guard engage the lip to selectively retain the needle guard on the base.

41. The combination according to claim 40, wherein when connected with the base, a proximal portion of the needle guard contacts the proximal ceiling of an annular space surrounding the column.

42. The combination according to claim 41, wherein the column extends distally beyond a substantially planar distal surface of the base.