Intraosseous-needle stabilizer and methods

• US 9,839,740 B2
• Filed: 02/02/2011
• Issued: 12/12/2017
• Est. Priority Date: 02/02/2010
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences II LLC
• Original Assignee: Teleflex Medical Devices S. R.L (Teleflex Incorporated)
• Inventors: Beamer, Cynthia L., Kilcoin, Chris
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Swanson, Leah
• Application Number:
  US13/576,943
• Publication Number:
  US 20130096508A1
• Time in Patent Office: 2,505 Days
• Field of Search: 604174, 604177, 604179, 604180
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2210/02 Bones
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

Stabilizers for intraosseous devices, such as, for example, stabilizers that may be coupled to an intraosseous device (e.g., a device including an intraosseous needle) while a portion of the device extends into a patient'"'"'s bone and/or while the device is coupled to a fluid source (e.g., FV bag, syringe, etc.).

Claims

1. An apparatus comprising:

two members configured to be coupled together such that the two members cooperate to encircle an intraosseous device to resist movement of the intraosseous device relative to the members, where the two members when coupled together cooperate to define an opening for the intraosseous device, where the two members define opposite sides of the opening; and

one or more flexible tabs each coupled to at least one of the members and comprising an adhesive layer configured to be coupled to skin of a patient,

where the members each have a proximal surface configured to face the skin of the patient, where a longitudinal axis of the opening is disposed at a non-zero angle relative to a plane of the proximal surface,

where the members each have a coupling surface, each coupling surface defining a first groove configured to receive a portion of the intraosseous device when the intraosseous device is in a first position in the opening relative to the proximal surface of at least one of the two members and a second groove configured to receive the portion of the intraosseous device when the intraosseous device is in a second position in the opening relative to the proximal surface of at least one of the two members, the first position closer to the proximal surface of at least one of the two members than the second position.

2. The apparatus of claim 1, where the two members are substantially identical.

3. The apparatus of claim 1, where the two members each comprise two connection portions.

4. The apparatus of claim 3, where the two connection portions comprise a male connection portion and a female connection portion.

5. The apparatus of claim 4, where the male connection portion comprises a resilient barb, and the female connection portion comprises a ledge configured such that if the members are coupled together, the resilient barb of each member contacts the ledge of the other member to resist separation of the members.

6. The apparatus of claim 1, where the coupling surface of each member is configured such that when the two members are coupled together, the coupling surfaces cooperate to define the opening.

7. The apparatus of claim 6, where the first and second grooves are configured to receive a flange of the intraosseous device.

8. The apparatus of claim 1, where the longitudinal axis of the device opening is substantially perpendicular to a plane of the proximal surface.

9. The apparatus of claim 1, where the first and second grooves in the coupling surface are each shaped to correspond to the portion of the intraosseous device.

10. The apparatus of claim 1, where each member comprises a lower sidewall, and one of the one or more flexible tabs is coupled to the lower sidewall.

11. The apparatus of claim 10, where the one or more flexible tabs each comprises:

a double-sided tape layer having an upper side coupled to a lower surface of the lower sidewall; and

a single-sided tape layer having an adhesive side coupled to an upper surface of the lower sidewall and to a portion of the upper side of the double-sided tape layer that is not coupled to the lower surface of the lower sidewall.

12. The apparatus of claim 11, where the one or more flexible tabs each comprises:

a liner layer coupled to a lower side of the double-sided tape layer;

where the liner layer is configured to be removable from the lower side of the doublesided tape layer such that the lower side of the double-sided tape layer can be coupled to skin of a patient.

13. The apparatus of claim 12, where the liner layer extends beyond at least one peripheral edge of the double-sided tape layer.

14. The apparatus of claim 1, where the apparatus is non-sterile.

15. The apparatus of claim 1, where the two members are configured to be coupled together to encircle the intraosseous device after the intraosseous device is inserted into a bone.

16. The apparatus of claim 1, where the first groove comprises a shape identical to a shape of the second groove.

17. The apparatus of claim 16, where the first and second grooves each comprise a tapered surface.

18. A kit comprising:

three or more members each configured to be coupled to any of the other plurality of members such that the coupled members cooperate to encircle an intraosseous device to resist movement of the intraosseous device relative to the members, where the coupled members cooperate to define an opening for the intraosseous device, where the coupled members define opposite sides of the opening; and

a plurality of flexible tabs each coupled to at least one of the members and comprising an adhesive layer configured to be coupled to skin of a patient,

where the three or more members each have a proximal surface configured to face the skin of the patient, where a longitudinal axis of the opening is disposed at a non-zero angle relative to a plane of the proximal surface,

where the three or more members each have a coupling surface, each coupling surface defining a first groove configured to receive a portion of the intraosseous device when the intraosseous device is in a first position in the opening relative to the proximal surface of at least one of the three or more members and a second groove configured to receive the portion of the intraosseous device when the intraosseous device is in a second position in the opening relative to the proximal surface of at least one of the three or more members, the first position closer to the proximal surface of at least one of the three or more members than the second position.

19. The kit of claim 18, where each member comprises two connection portions.

20. The kit of claim 18, where the three or more members are configured to be coupled to any of the other plurality of members to encircle the intraosseous device after the intraosseous device is inserted into a bone.

21. A component comprising:

a member; and

a flexible tab coupled to the member and comprising an adhesive layer configured to be coupled to skin of a patient;

where the member is configured to be coupled to a substantially identical member such that the coupled members cooperate to encircle an intraosseous device to resist movement of the intraosseous device relative to the members,

where the coupled members cooperate to define an opening for the intraosseous device, where the coupled members define opposite sides of the opening,

where the member and the substantially identical member each have a proximal surface configured to face the skin of the patient, where a longitudinal axis of the opening is disposed at a non-zero angle relative to a plane of the proximal surface,

where the member and the substantially identical member each have a coupling surface, each coupling surface defining a first groove configured to receive a portion of the intraosseous device when the intraosseous device is in a first position in the opening relative to the proximal surface of at least one of the member and the substantially identical member and a second groove configured to receive the portion of the intraosseous device when the intraosseous device is in a second position in the opening relative to the proximal surface of at least one of the member and the substantially identical member, the first position closer to the proximal surface of at least one of the member and the substantially identical member than the second position.

22. The component of claim 21, where the member comprises a male connection portion.