Integrated vascular delivery system

• US 10,569,057 B2
• Filed: 11/22/2017
• Issued: 02/25/2020
• Est. Priority Date: 05/19/2010
• Status: Active Grant

• Current Assignee: Tangent Medical Technologies, Inc (ICU Medical Incorporated)
• Original Assignee: Tangent Medical Technologies, Inc (ICU Medical Incorporated)
• Inventors: White, Steven B., Harris, Adrienne Rose, White, Elyse, Farrell, Nathan, Duis, Ronald Dean, Brown, Henry J. H.
• Primary Examiner(s): Shah, Nilay J
• Application Number:
  US15/821,680
• Publication Number:
  US 20180154119A1
• Time in Patent Office: 825 Days
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• CPC Class Codes: A61M 2025/0253 where the catheter is attached by straps, bands or the like secured by adhesives
• CPC Class Codes: A61M 2025/0266 using pads, patches, tapes or the like
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2039/0036 characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0618 having means for protecting only the distal tip of the needle, e.g. a needle guard
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 25/0637 Butterfly or winged devices, e.g. for facilitating handling or for attachment to the skin
• 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

An integrated vascular delivery system and method of use, the system including: a frame having a catheter hub that provides a first anchoring point on the patient and receives a catheter insertable in the patient to transfer fluid at an insertion site, a stabilization hub that provides a second anchoring point on the patient, at least one lateral member extending between the catheter and stabilization hubs, and a fluidic channel. The frame operates in a folded configuration in which the hubs are coupleable and an unfolded configuration in which the anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter. In some embodiments, the system further includes a septum that helps prevent fluid leakage from the catheter hub, or a needle shield that covers the distal end of a needle used during catheter insertion.

Claims

1. An integrated vascular delivery system adapted to facilitate insertion of a catheter into a patient at an insertion site, comprising:

a frame including;

a catheter hub coupled to the catheter,

a stabilization hub,

one or more sensors configured to couple to the catheter hub and/or the stabilization hub,

a first flexible lateral member defining a lumen and extending from a distal region of the catheter hub to a proximal region of the stabilization hub,

a fluidic channel configured to pass through the catheter hub, wherein the fluidic channel comprises a fixed turnabout portion defined within the catheter hub, wherein the fixed turnabout portion is configured to direct fluid flow toward the distal region of the catheter hub, and

a septum coupled to the catheter hub, wherein the septum is configured to receive a needle to facilitate insertion of the catheter at the insertion site; and

a needle shield configured to capture at least a portion of the needle as the needle is withdrawn from the catheter hub.

2. The system of claim 1, wherein the needle shield is coupled to the proximal region of the catheter hub.

3. The system of claim 1, further comprising a second flexible lateral member.

4. The system of claim 3, wherein the frame is configured to operate in a folded configuration by way of the first and second flexible lateral members.

5. The system of claim 4, wherein in the folded configuration of the frame, the catheter hub is configured to reversibly couple to the stabilization hub, and wherein the frame further operates in an unfolded configuration wherein first and second anchoring points are distributed about the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.

6. The system of claim 4, wherein one of the catheter hub and stabilization hub includes an extension, wherein in the folded configuration of the frame, the extension is received by the other one of the catheter hub and the stabilization hub.

7. The system of claim 4, wherein the stabilization hub includes an extension with a through hole configured to receive the needle, and the catheter hub includes a recess configured to receive the extension, such that the frame is locked in the folded configuration when the needle passes through the septum and into the through hole of the extension.

8. The system of claim 1, wherein the one or more sensors is configured to measure at least one parameter of the patient.

9. The system of claim 8, wherein the at least one parameter comprises temperature, blood pressure, pulse rate, pH, and/or flow rate.

10. The system of claim 1, wherein the stabilization hub is retained in an angularly displaced position relative to the catheter hub.

11. The system of claim 1, wherein the fluidic channel is configured to direct fluid flow into the fixed turnabout portion.

12. The system of claim 1, wherein the catheter hub provides a first anchoring point on the patient.

13. The system of claim 12, wherein the stabilization hub provides a second anchoring point on the patient.

14. The system of claim 1, wherein the needle shield allows the needle to penetrate the catheter, through the needle shield, in an inactive configuration, and wherein the needle shield covers a distal end of the needle in an active configuration, after the needle is withdrawn from the catheter.

15. The system of claim 14, wherein the needle shield is removably coupled to the catheter hub, and configured to engage a needle catch, upon withdrawal of the needle from the catheter hub, that transitions the needle shield from the inactive configuration to the active configuration.

16. The system of claim 1, wherein the needle shield includes a spring clip.

17. The system of claim 16, wherein at least a portion of the spring clip is positioned proximal of the catheter hub, and wherein the spring clip is configured to capture at least a tip of the needle.

18. The system of claim 16, wherein the spring clip is configured to be coupled to an outer region of the catheter hub.

19. The system of claim 16, wherein the catheter hub further comprises a receiving feature, and wherein the spring clip is configured to be coupled to the receiving feature.

20. The system of claim 1, wherein the septum is configured to direct the needle into a portion of the fixed turnabout portion and into the catheter.

21. The system of claim 1, wherein the fixed turnabout portion is configured to direct the fluid flow to a direction opposite of that within the catheter.

22. The system of claim 21, wherein the fixed turnabout portion is configured to direct the fluid flow in an approximately 180-degree turn.

23. An integrated vascular delivery system adapted to facilitate insertion of a catheter into a patient at an insertion site, comprising:

a frame including;

a catheter hub configured to couple to the catheter,

a stabilization hub,

one or more sensors configured to couple to the catheter hub and/or the stabilization hub,

a first flexible lateral member defining a lumen and extending from a distal region of the catheter hub to a proximal region of the stabilization hub,

a fluidic channel configured to pass through the catheter hub, wherein the fluidic channel comprises a fixed turnabout portion defined within the catheter hub, and

a septum coupled to the catheter hub, wherein the septum is configured to receive a needle to facilitate insertion of the catheter at the insertion site; and

a needle shield configured to capture at least a portion of the needle as the needle is withdrawn from the catheter hub;

wherein the fluidic channel is disposed within the first flexible lateral member, and wherein the frame further comprises a second flexible lateral member that couples the catheter hub to the stabilization hub, wherein the first flexible lateral member is disposed on a first side of a longitudinal axis of the frame and the second flexible lateral member is disposed on a second side of the longitudinal axis opposite the first side.

24. The system of claim 23, wherein the fixed turnabout portion is configured to direct fluid flow toward the distal region of the catheter hub.

25. The system of claim 23, wherein the frame is configured to operate in a folded configuration by way of the first and second flexible lateral members.

26. The system of claim 25, wherein in the folded configuration of the frame, the catheter hub is configured to reversibly couple to the stabilization hub, and wherein the frame further operates in an unfolded configuration wherein first and second anchoring points are distributed about the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.

27. The system of claim 23, wherein the one or more sensors is configured to measure at least one parameter of the patient.

28. The system of claim 27, wherein the at least one parameter comprises temperature, blood pressure, pulse rate, pH, and/or flow rate.

29. The system of claim 23, wherein the septum is configured to direct the needle into a portion of the fixed turnabout portion and into the catheter.

30. The system of claim 23, wherein the fixed turnabout portion is configured to direct fluid flow to a direction opposite of that within the catheter.

31. The system of claim 30, wherein the fixed turnabout portion is configured to direct the fluid flow in an approximately 180-degree turn.