Systems for isolation of a needle-based infusion set

• US 10,143,799 B2
• Filed: 02/01/2016
• Issued: 12/04/2018
• Est. Priority Date: 09/10/2010
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Barron, William R., Powers, Kelly B.
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US15/012,800
• Publication Number:
  US 20160144107A1
• Time in Patent Office: 1,037 Days
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/325 Means obstructing the needle passage at distal end of a needle protection sleeve
• CPC Class Codes: A61M 2005/3256 having folding ring sections
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• 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 5/1626 Needle protectors therefor in combination with syringes A61M5/3202; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3245 Constructional features thereof, e.g. to improve manipulation or functioning
• CPC Class Codes: A61M 5/3275 being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands

Abstract

A safety needle assembly of an infusion set for infusing fluids into a subcutaneously implanted access port is disclosed. The needle assembly is configured to prevent fluid/vapor escape therefrom so as to reduce or prevent fluid exposure to a clinician using the needle assembly. In one embodiment, the needle assembly comprises a handle portion including a needle extending therefrom, the needle defining a lumen for passage of a fluid therethrough. The needle assembly also includes a safety assembly defining a needle hole through which the needle initially extends. The safety assembly is selectively and axially slidable along the needle in order to shield a distal tip of the needle and prevent user contact therewith. A fluid isolation component is included in the safety assembly for isolating fluid escape from the needle to prevent exposure to a clinician.

Claims

1. A needle assembly, comprising:

a handle portion including a needle defining a lumen for passage of a fluid therethrough;

a safety assembly selectively and axially slidable along the needle to shield a distal tip of the needle and prevent user contact therewith, the safety assembly including;

a base including a needle hole; and

a spring-based obstruction component biased to obstruct the needle hole after retraction of the needle distal tip into the base, the spring-based obstruction component including at least one shutter having a distal end designed to obstruct the needle hole, a proximal end coupled to the base, and a spring arm connecting the proximal end of the distal end; and

a fluid isolation component designed to isolate fluid escape from the needle, the fluid isolation component including an absorbent pad disposed on the at least one shutter, the distal tip of the needle resting against the absorbent pad after retraction of the needle distal tip into the base, the absorbent pad isolating fluid leaked from the needle so as to prevent fluid escape from the safety assembly.

2. The needle assembly according to claim 1, further comprising an extensible hollow shroud extending between the handle portion and the safety assembly so as to enclose a substantial portion of the needle after retraction of the needle distal tip into the base.

3. The needle assembly according to claim 2, wherein the extensible hollow shroud is conically shaped and defines a plurality of interengaging elements.

4. The needle assembly according to claim 3, wherein the plurality of interengaging elements include a plurality of predetermined, repeating surface features.

5. The needle assembly according to claim 4, wherein the extensible hollow shroud includes plastic and wherein the repeating surface features include a plurality of corrugations defined by a surface of the extensible hollow shroud.

6. The needle assembly according to claim 3, wherein the interengaging elements include a plurality of telescoping segments that are interlocked in series with one another.

7. The needle assembly according to claim 3, wherein at least the extensible hollow shroud interconnects the handle portion and the safety assembly when the distal tip of the needle is shielded by the safety assembly.

8. The needle assembly according to claim 1, wherein the at least one shutter comprises a first shutter defining a first shutter hole, and a second shutter defining a second shutter hole, the needle extending through the first shutter hole, the second shutter hole, and the needle hole prior to retraction of the needle distal tip into the base.

9. The needle assembly according to claim 8, wherein the fluid isolation component includes an oil film interposed between the first shutter and the second shutter to prevent escape of fluid from between the shutters.

10. The needle assembly according to claim 9, wherein the fluid isolation component further includes an absorbent pad disposed on each of the first shutter and the second shutter.

11. The needle assembly according to claim 1, wherein the fluid isolation component includes a shield attached to the obstruction component to prevent fluid escape from the safety assembly via the needle hole.

12. The needle assembly according to claim 11, wherein the shield includes an absorbent component for absorbing fluid leaked from the needle.

13. The needle assembly according to claim 1, wherein the fluid isolation component includes an absorption disk positioned to prevent fluid leakage from the needle through the needle hole in the safety assembly.

14. The needle assembly according to claim 13, wherein the absorption disk includes activated charcoal.

15. The needle assembly according to claim 1, wherein the fluid isolation component includes an O-ring disposed in the base to wipe an outer surface of the needle as the safety assembly is axially slid along the needle.

16. The needle assembly according to claim 15, wherein the O-ring includes an absorbent material.

17. The needle assembly according to claim 1, wherein the handle portion is pivotally attached to the safety assembly at a pivot point.

18. The needle assembly according to claim 17, further comprising an extensible hollow shroud extending between the handle portion and the safety assembly so as to enclose a substantial portion of the needle after retraction of the needle distal tip into the base.

19. A needle assembly, comprising:

a handle portion including a needle defining a lumen for passage of a fluid therethrough;

a safety assembly selectively and axially slidable along the needle to shield a distal tip of the needle and prevent user contact therewith, the safety assembly including;

a base including a needle hole; and

a spring-based obstruction component biased to obstruct the needle hole after retraction of the needle distal tip into the base, the spring-based obstruction component including at least one shutter having a distal end designed to obstruct the needle hole, a proximal end coupled to the base, and a spring arm connecting the proximal end of the distal end, the at least one shutter comprising a first shutter defining a first shutter hole, and a second shutter defining a second shutter hole, the needle extending through the first shutter hole, the second shutter hole, and the needle hole prior to retraction of the needle distal tip into the base; and

a fluid isolation component designed to isolate fluid escape from the needle, the fluid isolation component including an oil film interposed between the first shutter and the second shutter to prevent escape of fluid from between the shutters.