Anchoring an intravenous cannula

• US 10,532,188 B2
• Filed: 09/07/2017
• Issued: 01/14/2020
• Est. Priority Date: 02/17/2012
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S., Christianson, Mark R.
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US15/698,074
• Publication Number:
  US 20170368312A1
• Time in Patent Office: 859 Days
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• 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 2025/0286 anchored in the skin by suture or other skin penetrating devices
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• 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

Some embodiments of a medical system include a subcutaneous anchor device that extends outwardly from side wall of an intravenous cannula so as to secure the intravenous cannula in a position relative to a skin penetration point.

Claims

1. A medical system for anchoring an intravenous cannula device under a skin layer, comprising:

an intravenous cannula device including a flexible catheter having a distal opening configured to provide fluid communication into a targeted vessel, a proximal connector hub, and a tissue anchor device, the tissue anchor device being positioned along the flexible catheter between the distal tip opening of the flexible catheter and the proximal connector hub, the flexible catheter including a lumen and extending distally of the proximal connector hub to the distal opening, and the proximal connector hub including a thread pattern configured to releasably connect with an external fluid line; and

an inserter tool removably coupled to the intravenous cannula device so as to insert the flexible catheter of the intravenous cannula device through a skin penetration point and into the targeted vessel, the inserter tool including a handle and an insertion needle extending distally from the handle, the insertion needle being slidably engaged with the lumen of the flexible catheter of the intravenous cannula device, wherein the inserter tool is removable from the intravenous cannula device when the insertion needle is proximally withdrawn from the lumen of the flexible catheter,

wherein the tissue anchor device is configured to anchor the outer wall under the skin layer when the flexible catheter of the intravenous cannula device is inserted through the skin penetration point and into the targeted vessel.

2. The system of claim 1, wherein the tissue anchor device comprises one or more flexible circumferential rings integrally formed as a unitary structure with the outer wall of the flexible catheter.

3. The system of claim 2, wherein each of the one or more flexible circumferential rings are configured to prolapse and extend toward a distal end of the flexible catheter during removal through the skin penetration point.

4. The system of claim 1, wherein the tissue anchor device comprises one or more pairs of recessed tabs integrally formed as a unitary structure with the outer wall of the flexible catheter, wherein each respective recessed tab includes a corresponding cavity to receive the recessed tab during insertion through the skin penetration point.

5. The system of claim 4, wherein each of the one or more pairs of recessed tabs are configured to prolapse such that free ends of the recessed tabs extend toward a distal end of the flexible catheter during removal through the skin penetration point.

6. The system of claim 1, wherein the tissue anchor device comprises one or more slotted circumferential rings integrally formed as a unitary structure with the outer wall of the flexible catheter.

7. The system of claim 6, wherein each of the one or more slotted circumferential rings are configured to prolapse and extend toward a distal end of the flexible catheter during removal through the skin penetration point.

8. The system of claim 1, wherein the tissue anchor device comprises one or more anchor flaps integrally formed as a unitary structure with the outer wall of the flexible catheter, wherein each of the one or more anchor flaps comprises a generally straight body that extends transversely to a longitudinal axis of the flexible catheter.

9. The system of claim 1, wherein the tissue anchor device comprises one or more tapered circumferential rings integrally formed as a unitary structure with the outer wall of the flexible catheter, wherein each of the tapered circumferential rings have an asymmetric shape in which a proximal face is steeper than a distal tapered face.

10. The system of claim 1, wherein the tissue anchor device comprises a set of textured cutouts integrally formed as a unitary structure with the outer wall of the flexible catheter, wherein each of the textured cutouts are defined by cavity walls formed in the outer wall of the flexible catheter.

11. The system of claim 1, wherein the tissue anchor device comprises a threaded anchor integrally formed as a unitary structure with the outer wall of the flexible catheter, wherein the threaded anchor comprises a raised thread pattern helically extending around the outer wall of the flexible catheter.

12. The system of claim 1, wherein the tissue anchor device comprises a wedge anchor integrally formed as a unitary structure with the outer wall of the flexible catheter, wherein the wedge anchor comprises an asymmetric shape having a proximal face and a distal face, the proximal face defines an incline relative to the outer wall of the flexible catheter that is greater than an incline defined by the distal face.

13. The system of claim 1, wherein the proximal connector hub is fixedly attached to a proximal end of the flexible catheter.

14. The system of claim 1, wherein the proximal connector hub has a longitudinal length extending from a proximal end of the proximal connector hub to a distal end of the proximal connector hub, wherein the longitudinal length of the proximal connector hub is greater than a maximum outer diameter of the proximal connector hub.

15. The system of claim 14, wherein the tissue anchor device has a maximum lateral width that is less than a minimum outer diameter of the proximal connector hub.

16. The system of claim 1, wherein the tissue anchor device includes at least one surface to engage tissue in a subcutaneous region along an underside of a skin layer when the flexible catheter of the intravenous device is inserted through the skin penetration point and into a targeted vessel.

17. The system of claim 1, wherein the tissue anchor device includes at least one surface to engage an underside of the skin layer when the flexible catheter of the intravenous cannula device is inserted through the skin penetration point and into a targeted vessel.

18. A method of using an intravenous cannula device, comprising:

inserting a needle portion of an inserter tool through a skin penetration point and into a targeted vessel, wherein an intravenous cannula device is removably coupled to the inserter tool such that a flexible catheter of the intravenous cannula device is advanced through the skin penetration point and into the targeted vessel while a tissue anchor device integrally formed as a unitary structure with an outer wall of the flexible catheter is positioned under a skin layer;

removing the inserter tool from the intravenous cannula device such that the needle portion of the inserter tool is slidably withdrawn from a lumen of the flexible catheter while a distal opening of the flexible catheter remains in the targeted vessel to provide fluid communication with a targeted vessel and the tissue anchor device remains under the skin layer;

threadably engaging an external fluid line to a proximal connector hub of the intravenous cannula device while the flexible catheter remains in the targeted vessel and the tissue anchor device remains under the skin layer, wherein the tissue anchor device is positioned between a distal tip of the flexible catheter and the proximal connector hub; and

infusing a fluid from the proximal connector hub through the lumen of the flexible catheter and into the targeted vessel.

19. The method of claim 18, wherein the tissue anchor device includes at least one surface to engage tissue in the subcutaneous region proximate to the skin penetration point.

20. The method claim 19, further comprising applying a withdrawal force to the proximal connector hub of the intravenous cannula device so as to withdrawal the tissue anchor device through the skin penetration point.