INFUSION SET

• US 20120150123A1
• Filed: 01/21/2010
• Published: 06/14/2012
• Est. Priority Date: 01/21/2009
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Lawrence, Tyson, McGee, James, Taylor, Todd, Colonna, Rob, Lu, Zenas, Banik, Robert, Skutnik, Peter, Sugalski, Eric, Barmore, Chris K.
• Granted Patent: US 10,933,191 B2
• Time in Patent Office: Days
• US Class Current: 604/180
• 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 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2205/586 Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
• CPC Class Codes: A61M 2209/088 on the body
• CPC Class Codes: A61M 39/08 Tubes; Storage means specially adapted therefor
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• 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 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Abstract

A single package infusion set is provided, including one or more of the following inserters: pushbutton-type, squeeze-type, contact-type, skin pinching-type, folding retraction-type, or multistage-type inserter having at least one reusable stage. The infusion set further includes adhesion means with user-selectable degrees of adhesion strength, self-sealing tube connection means, a lens feature to view, a site beneath the set, exemplary tube management and connection elements, insulin supply, adhesion concealment means, finger loops on the inserter and site preparation wipes or sprays, optionally provided as part of the inserter. The system further includes a package which may hold a number of easily released sets, retrievable by an inserter, an exemplary insertion needle handle and shroud, an exemplary squeeze-type latch between an upper portion and a lower portion of the set, and/or a tool removable upper portion of the set.

Claims

1. A packaged infusion set, comprising at least three of the following:

a sealable tray configured to receive and contain elements of an infusion set;

an inserter, configured to secure a set for placement at an insertion site;

a set, comprising at least one of a skin contacting surface and a catheter extending therefrom;

a tube and tube management device, comprising at least one length of tubing configured to communicate a medicament from a medicament supply to said set;

a medicament supply, configured to provide a medicament to said set;

a placement assistance element, configured to guide said inserter and set to an insertion site; and

site preparation elements, configured to prepare an insertion site to receive said set.

2. The packaged infusion set of claim 1, wherein said sealable tray comprises:

a plurality of recessed openings configured to orient and secure at least one said inserter, set, tube and tube management devices, medicament supply, placement assistant elements and/or site preparation elements;

a set package comprising a plurality of recessed openings configured to orient and secure at least one set, wherein said set package is covered with a pierceable cover configured to release said set when pierced by said inserter; and

at least one of a clear cover and a labeled cover configured to identify at least one of said contents of said tray.

3. The packaged infusion set of claim 1, wherein said inserter comprises:

a main housing;

an inserter rod, slidably disposed within said main housing; and

a push-button, slidably extending from a first end of said main housing and configured to release said inserter rod to slide toward a second end of said main housing;

said main housing comprising a substantially open second end configured to slidably receive said set, and to release said set at an insertion site as directed by said inserter rod.

4. The packaged infusion set of claim 1, wherein said inserter comprises:

a main housing;

an inserter rod, slidably disposed within said main housing; and

a push-button, rotatably disposed at a side of said main housing and configured to release said inserter rod to slide toward an end of said main housing;

said main housing comprising a substantially open end configured to slidably receive said set, and to release said set at an insertion site as directed by said inserter rod.

5. The packaged infusion set of claim 1, wherein said inserter comprises:

a main housing, comprising at least one user-deflectable body portion; and

an inserter rod, slidably disposed within said main housing, wherein said user-deflectable body portion is configured to release said inserter rod to slide toward an end of said main housing;

said main housing comprising a substantially open end configured to slidably receive said set, and to release said set at an insertion site as directed by said inserter rod.

6. The packaged infusion set of claim 1, wherein said inserter comprises:

a main housing;

an inserter rod, slidably disposed within said main housing; and

a lower housing, slidably disposed within an open end of said main housing and configured to contact a skin surface at an insertion site, and further configured to release said inserter rod to slide toward an end of said lower housing when said lower housing contacts said skin surface;

said lower housing comprising a substantially open end configured to slidably receive said set, and to release said set at an insertion site as directed by said inserter rod.

7. The packaged infusion set of claim 1, wherein said inserter comprises:

a main housing, comprising a first and second opposite leg configured to pivot about a midpoint, wherein at a first position, said first and second opposite legs are configured to secure an inserter rod within said main housing, and at a second position, said first and second opposite legs are configured to release said inserter rod within said main housing; and

an inserter rod, slidably disposed within said main housing;

said main housing comprising a substantially open end configured to slidably receive said set, and to release said set at an insertion site as directed by said inserter rod.

8. The packaged infusion set of claim 7, wherein at said second position, said first and second opposite legs are configured to manipulate said insertion site within said substantially open end of said main housing.

9. The packaged infusion set of claim 1, wherein said inserter comprises:

a main housing, comprising at least one pushbutton extending therefrom; and

an inserter rod, slidably disposed within said main housing, wherein said inserter rod is captured in an extended position by said pushbutton of said main housing, and is configured to slidably retract within said housing upon activation of said pushbutton;

wherein said main housing is rotatably secured to said set and is configured to rotate from a first position to a second position upon retraction of said inserter rod.

10. The packaged infusion set of claim 1, wherein said inserter comprises:

a main housing, comprising at least one pushbutton extending therefrom, wherein said main housing is substantially open at a first end for slidably receiving said set; and

wherein said pushbutton is biased toward a first position to secure said set within said main housing and is configured to rotate to a second position to release said set from within said main housing.

11. The packaged infusion set of claim 1, wherein said set comprises:

a plurality of concentric adhesive areas, wherein a first concentric adhesive area is configured to provide a first degree of adhesion, and a second concentric adhesive area is configured to provide a second degree of adhesion, wherein said first degree of adhesion is greater that said second degree of adhesion; and

a plurality of covers for said plurality of concentric adhesive areas, respectively.

12. The packaged infusion set of claim 1, wherein said set comprises at least one construction material configured to permit visibility between an upper surface and a lower surface of said set at or near an insertion site.

13. The packaged infusion set of claim 1, wherein said set comprises at least one cover for an upper surface of said set configured to substantially conceal said set or decorate said set.

14. The packaged infusion set of claim 1, wherein said a tube and tube management devices comprise at least one of:

a tube reel configured to store tubing in a substantially circular manner;

at least a first and a second clip configured to store tubing in a substantially circular manner;

an elastic binding configured to store tubing in a substantially accordion manner;

a wrapping binding configured to store tubing in a substantially bundled manner; and

a flexible cup-shaped element configured to store tubing;

wherein said tubing can be provided having a targeted length to minimize excess tubing for storage.

15. The packaged infusion set of claim 1, wherein said a tube and tube management devices comprises:

a flexible ring, configured to expand to a first diameter to allow placement over said set, and contract to a second diameter to securely circumscribe an outer diameter of said set;

a tubing length secured to said flexible ring; and

a fitting, disposed at an end of said tubing length and extending into said flexible ring, said fitting configured to sealably mate with an opening of said set to permit communication of a medicament therebetween.

16. The packaged infusion set of claim 15, wherein said set comprises:

a hub, constructed of a viscoelastic material, wherein said fitting comprises a cannula configured to sealably pierce said hub.

17. The packaged infusion set of claim 15, wherein said viscoelastic material comprises at least one of a thermoplastic elastomer (TPE), thermoplastic urethane (TPU), silicone, or similar material.

18. The packaged infusion set of claim 1, wherein said tube and tube management device comprises at least one tubing connection having at least one of a tapered tubing end, a tubing end having one or more detents, and a magnetically attractable tubing end.

19. The packaged infusion set of claim 1, wherein said tubing connection is configured to generate an audible indication when disconnected.

20. The packaged infusion set of claim 1, wherein said medicament supply comprises at least one medicament container, tubing segment and tubing connection, wherein said medicament container is configured to indicate a content quantity therein.

21. The packaged infusion set of claim 1, wherein said catheter comprises a splined lumen wherein said spline comprises one of a linear axis and a helical axis.

22. The packaged infusion set of claim 1, wherein said catheter comprises at least one hole or opening along a body length.

23. The packaged infusion set of claim 1, wherein said catheter is made of a body temperature softening polyurethane or similar material.

24. The packaged infusion set of claim 1, wherein said a placement assistance element comprises:

a placement ring, configured to adhere to an insertion site such that said insertion site is centered within an opening of said placement ring, said insertion ring comprising at least one detent configured to receive a detent of an inserter; and

said inserter, configured to removably mate with said placement ring and place said set at said insertion site.

25. The packaged infusion set of claim 1, wherein said placement assistance element comprises at least one finger loop disposed on said inserter.

26. The packaged infusion set of claim 1, wherein said placement assistance element comprises:

a connection tool, comprising a body and at least one pin extending therefrom, wherein said pin is configured to engage a rotatable latch of a tube connection and in response, release said tube connection from said set.

27. The packaged infusion set of claim 1, wherein said inserter further comprises at least one hinged member adjacent to an insertion needle, wherein said hinged member is configured to rotate between a first position configured to allow insertion of said set, and a second position to substantially cover said insertion needle after insertion of said set.

28. The packaged infusion set of claim 1, wherein said site preparation elements comprise at least one of a spray and applicator for applying a disinfectant, anesthetic or similar material.

29. A packaged infusion set, or elements thereof, comprising:

a sealable tray configured to receive and contain elements of an infusion set;

an inserter, configured to secure a set for placement at an insertions site;

a set, comprising at least one of a skin contacting surface and a catheter extending therefrom;

a tube and tube management device, comprising at least one length of tubing configured to communicate a medicament from a medicament supply to said set;

a placement assistance element, configured to guide said inserter and set to an insertion site; and

site preparation elements, configured to prepare an insertion site to receive said set.

30. The packaged infusion set of claim 29, further comprising a medicament supply, configured to provide a medicament to said set.

31. A packaged infusion set, comprising:

a sealable tray configured to receive and contain a set; and

a set, comprising at least one of a skin contacting surface and a catheter extending therefrom.

32. The packaged infusion set of claim 31, wherein said sealable tray comprises:

a set package comprising a plurality of recessed openings configured to orient and secure at least one set, wherein said set package is covered with a pierceable cover configured to release said set when pierced by an inserter; and

at least one of a clear cover and a labeled cover configured to identify contents of said tray.

33. An infusion set, comprising:

a set, comprising at least one of a skin contacting surface and a catheter extending therefrom;

said skin contacting surface comprising a plurality of concentric adhesive areas, wherein a first concentric adhesive area is configured to provide a first degree of adhesion, and a second concentric adhesive area is configured to provide a second degree of adhesion, wherein said first degree of adhesion is greater that said second degree of adhesion; and

a plurality of covers for said plurality of concentric adhesive areas, respectively.

34. The infusion set of claim 33, wherein said set comprises at least one construction material configured to permit visibility between an upper surface and a lower surface of said set at or near an insertion site.

35. The infusion set of claim 33, wherein said set comprises at least one cover for an upper surface of said set configured to substantially conceal said set or decorate said set.

36. An infusion set, comprising:

a set, comprising at least one of a skin contacting surface and a catheter extending therefrom; and

a flexible ring, configured to expand to a first diameter to allow placement over said set, and contract to a second diameter to securely circumscribe an outer diameter of said set.

37. The infusion set of claim 36, further comprising:

a tubing length secured to said flexible ring; and

a fitting, disposed at an end of said tubing length and extending into said flexible ring, said fitting configured to sealably mate with an opening of said set to permit communication of a medicament therebetween.

38. The infusion set of claim 37, wherein said set comprises:

a hub, constructed of a viscoelastic material, wherein said fitting comprises a cannula configured to sealably pierce said hub.

39. The infusion set of claim 38, wherein said viscoelastic material comprises at least one of a thermoplastic elastomer (TPE), thermoplastic urethane (TPU), silicone, or similar material.

40. The infusion set of claim 37, further comprising at least one tubing connection, comprising at least one of a tapered tubing end, a tubing end having one or more detents, and a magnetically attractable tubing end.

41. The infusion set of claim 40, wherein said tubing connection is configured to generate an audible indication when disconnected.

42. The infusion set of claim 36, further comprising a medicament supply, comprising at least one medicament container, tubing segment and tubing connection, wherein said medicament container is configured to indicate a content quantity therein.

43. The infusion set of claim 36, wherein said catheter comprises a splined lumen wherein said spline comprises one of a linear axis and a helical axis.

44. The infusion set of claim 36, wherein said catheter comprises at least one hole or opening along a body length.

45. The infusion set of claim 36, wherein said catheter is constructed of a body temperature softening polyurethane or similar material.

46. The infusion set of claim 36, wherein said set is configured to receive a connection tool, comprising a body and at least one pin extending therefrom, and wherein said set comprises a rotatable latch configured to engage said pin of said connection tool and in response, to release a tube connection from said set.

47. The infusion set of claim 36, wherein said set comprises at least one push button element, wherein operation of said push button element is configured to release a tube connection from said set.