Phlebotomy needle assembly and frangible cover

• US 8,870,828 B2
• Filed: 12/04/2012
• Issued: 10/28/2014
• Est. Priority Date: 01/14/2008
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: West, Richard L., Lynn, Daniel R., Jones, Mark B., Bischof, Daniel F.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US13/693,189
• Publication Number:
  US 20130096462A1
• Time in Patent Office: 693 Days
• Field of Search: 604/110, 604/111, 604/192, 604/198, 604/263
• US Class Current: 604/192
• CPC Class Codes: A61B 5/1405 Devices for taking blood samples devices for taking samples of other body liquids A61B10/0045
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150366 Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag collection bags as such A61J1/05, A61M1/0209
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150541 Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
• CPC Class Codes: A61B 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150587 by friction fit
• CPC Class Codes: A61B 5/150595 by snap-lock (i.e. based on axial displacement)
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61M 2005/312 comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
• 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

Abstract

Medical needle assemblies incorporating a needle cover are provided. According to one aspect, the needle cover is integrally formed from a material that: (1) is sufficiently rigid to prevent bending of an underlying cannula, (2) is suitable for allowing a frangible portion thereof to be broken under pre-selected conditions, and/or (3) has a moisture vapor transmission rate sufficient for steam sterilization of a needle tip enclosed by the needle cover. According to another aspect, at least part of a cap portion and a hub portion of the needle cover are translucent. According to yet another aspect, the needle cover is provided with a wing having an enlarged rib suitable for gripping during separation of a cap portion from the remainder of the needle cover.

Claims

1. A medical needle assembly, comprising:

a cannula;

a base secured to a proximal end of the cannula and including at least one base retention member; and

a needle cover comprising

a proximal hub portion including an inner bore with at least one hub retention member which mates with said base retention member to secure the hub portion to the base;

a distal cap portion substantially enclosing at least a distal end of the cannula; and

a frangible portion proximal the cap portion and adapted to be broken to separate the cap portion, allowing removal thereof to expose the distal end of the cannula,

characterized in that

the base includes separate, substantially co-planar flat portions positioned adjacent to the base retention member, with the base including only one flat portion positioned proximally of the base retention member and only one flat portion positioned distally of the base retention member,

the distal end of the cannula includes a heel aligned with said flat portions of the base, and

at least part of one of said flat portions extends outside of the inner bore of the hub portion and is indicative of the orientation of the heel.

2. The medical needle assembly of claim 1, wherein the base includes a substantially tubular proximal end positioned proximally to said flat portions.

3. The medical needle assembly of claim 1, wherein the base is overmolded onto the proximal end of the cannula.

4. The medical needle assembly of claim 1, wherein the base is adhered to the proximal end of the cannula.

5. The medical needle assembly of claim 1, wherein the base is press-fit onto the proximal end of the cannula.

6. The medical needle assembly of claim 1, wherein the flat portions of the base are substantially aligned with each other.

7. The medical needle assembly of claim 1, wherein the inner bore of the hub portion includes a flat portion aligned with the heel of the cannula and with said flat portions of the base and positioned in facing relation to at least one of the flat portions of the base.

8. The medical needle assembly of claim 1, wherein the hub portion includes an external indicia aligned with the heel of the cannula and with said flat portions of the base.

9. The medical needle assembly of claim 1, wherein the inner bore of the hub portion includes a flat portion aligned with the heel of the cannula and with said flat portions of the base and positioned in facing relation to at least one of the flat portions of the base and wherein the hub portion includes an external indicia aligned with the heel of the cannula and with said flat portions of the base.

10. The medical needle assembly of claim 1, wherein each flat portion is present in a plane that is non-orthogonal to a central axis of the cannula.

11. The medical needle assembly of claim 1, wherein the base retention member is generally frusto-conical.

12. A medical needle assembly, comprising:

a cannula;

a base secured to a proximal end of the cannula and including at least one base retention member; and

a needle cover comprising

a proximal hub portion including an inner bore with at least one hub retention member which mates with said base retention member to secure the hub portion to the base;

a distal cap portion substantially enclosing at least a distal end of the cannula; and

a frangible portion proximal the cap portion and adapted to be broken to separate the cap portion, allowing removal thereof to expose the distal end of the cannula,

characterized in that

the base includes separate flat portions positioned adjacent to the base retention member, wherein

the base includes only one flat portion positioned proximally of the base retention member and only one flat portion positioned distally of the base retention member and each flat portion is present in a plane that is non-orthogonal to a central axis of the cannula,

the distal end of the cannula includes a heel aligned with said flat portions of the base, and

at least part of one of said flat portions extends outside of the inner bore of the hub portion and is indicative of the orientation of the heel.

13. The medical needle assembly of claim 12, wherein the base retention member is generally frusto-conical.

14. The medical needle assembly of claim 12, wherein the base includes a substantially tubular proximal end positioned proximally to said flat portions.

15. The medical needle assembly of claim 12, wherein the flat portions of the base are substantially aligned with each other.

16. A medical needle assembly, comprising:

a cannula;

a base secured to a proximal end of the cannula and including at least one base retention member; and

a needle cover comprising

a proximal hub portion including an inner bore with at least one hub retention member which mates with said base retention member to secure the hub portion to the base;

a distal cap portion substantially enclosing at least a distal end of the cannula; and

a frangible portion proximal the cap portion and adapted to be broken to separate the cap portion, allowing removal thereof to expose the distal end of the cannula,

characterized in that

the base includes flat portions positioned adjacent to the base retention member, wherein

the base includes only one flat portion positioned proximally of the base retention member and only one flat portion positioned distally of the base retention member and the base retention member is generally frusto-conical and separates the flat portions,

the distal end of the cannula includes a heel aligned with said flat portions of the base,

at least part of one of said flat portions extends outside of the inner bore of the hub portion and is indicative of the orientation of the heel, and

the flat portions are substantially co-planar and/or are each present in a plane that is non-orthogonal to a central axis of the cannula.

17. The medical needle assembly of claim 16, wherein the base includes a substantially tubular proximal end positioned proximally to said flat portions.

18. The medical needle assembly of claim 16, wherein the flat portions of the base are substantially aligned with each other.