INTEGRATED VASCULAR DELIVERY SYSTEM

• US 20140296829A1
• Filed: 05/01/2014
• Published: 10/02/2014
• Est. Priority Date: 05/19/2010
• Status: Active Grant

• Current Assignee: Tangent Medical Technologies, Inc (ICU Medical Incorporated)
• Original Assignee: Tangent Medical Technologies, LLC
• Inventors: White, Steven B., White, Elyse, Farrell, Nathan, Brown, Henry J. H., Harris, Adrienne Rose, Duis, Ronald Dean
• Granted Patent: US 9,827,398 B2
• Time in Patent Office: Days
• US Class Current: 604/508
• 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• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle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. A method for stabilizing a catheter at a patient, comprising:

providing a frame, wherein the frame includes a catheter hub configured to couple to the catheter, a stabilization hub, a flexible lateral member defining a lumen and extending between the catheter hub and the stabilization hub, and a fluidic channel that fluidically communicates with the catheter and passes through the lumen of the flexible lateral member;

operating in a folded configuration by way of the flexible lateral member, wherein the stabilization hub is retained in an angularly displaced position relative to the catheter hub;

following insertion of a part of the catheter into the patient at the insertion site, operating in an unfolded configuration, wherein the stabilization hub is at least partially reverted from the angularly displaced position relative to the catheter hub; and

operating in a secured configuration that secures the frame to the patient at a set of anchoring points distributed about the insertion site, thereby stabilizing the catheter at the patient.

6. The method of claim 1, wherein operating in the unfolded configuration occurs substantially after insertion of a majority of the catheter into the patient.

7. The method of claim 1, further including receiving a needle in the catheter by way of the catheter hub prior to insertion of the part of the catheter into the patient, and delivering the needle from the catheter and out of the catheter hub following insertion of the part of the catheter into the patient.

8. The method of claim 7, further including providing a needle shield coupled to at least one of the catheter hub and the stabilization hub that engages at least a distal portion of the needle upon delivery of the needle from the catheter.

9. The method of claim 1, wherein operating in the secured configuration includes operating in the secured configuration wherein the catheter hub is secured at a first anchoring point proximal the insertion site and the stabilization hub is secured at a second anchoring point distal the insertion site, wherein the first and the second anchoring points are distributed about the insertion site.

10. The method of claim 9, wherein operating in the secured configuration further comprises operating in the secured configuration wherein the frame is secured at a third anchoring point such that the first, the second, and the third anchoring points are distributed about the insertion site.

11. The method of claim 1, further comprising providing a septum at a proximal portion of the catheter hub, wherein the septum is configured to guide insertion of a needle into the catheter hub and through the catheter, and to prevent fluid leakage upon penetration of the septum.

2. The method of claim 2, wherein operating in the folded configuration comprises facilitating coupling of the catheter hub to the stabilization hub.

3. The method of claim 2, wherein facilitating coupling of the catheter hub to the stabilization hub includes providing an extension at one of the catheter hub and the stabilization hub that is complementary to a recess at the other of the catheter hub and the stabilization hub.

4. The method claim 3, further including receiving a needle in the catheter by way of the catheter hub and passing the needle through the extension, thereby coupling the catheter hub to the stabilization hub.

5. The method of claim 4, further comprising enabling retraction of the extension into a body of at least one of the catheter hub and the stabilization hub.

12. 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, having a proximal side and a distal side, providing a first anchoring point on the patient, the catheter hub configured to receive the catheter at the proximal side;

a stabilization hub coupled to the catheter hub by way of a flexible lateral member and providing a second anchoring point on the patient, wherein the frame operates in a folded configuration, by way of the flexible lateral member, that retains the stabilization hub in an angularly displaced position relative to the catheter hub;

a fluidic channel configured to pass through the catheter hub, comprising a fixed turnabout portion defined within the catheter hub, wherein the fluidic channel is configured to receive fluid flow from the proximal side of the catheter hub, to direct fluid flow into the fixed turnabout portion, and to direct fluid flow out of the fixed turnabout portion and out of the proximal side of the catheter hub and into the catheter; and

a septum, coupled to the distal side of the catheter hub, configured to receive a needle and to direct the needle into a portion of the fixed turnabout portion and into the catheter to facilitate insertion of the catheter at the insertion site.

13. The system of claim 12 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 the first and second anchoring points are distributed about the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.

14. The system of claim 13, 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.

15. The system of claim 14, 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.

16. The system of claim 12, further comprising a needle shield, coupled to at least one of the catheter hub and stabilization hub, that allows the needle to penetrate the catheter, through the needle shield, in an inactive configuration, and that covers a distal end of the needle in an active configuration, in withdrawing of the needle from the catheter.

17. The system of claim 16, 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.

18. The system of claim 12, wherein the septum includes:

a rigid core having a core wall defining an elongated aperture;

two members extending approximately perpendicularly from the core wall, wherein the two members are separated and approximately parallel; and

a cylindrical elastomeric plug circumferentially surrounding the two members and having a distal face opposing the wall of the rigid core and a proximal face occluding the aperture of the core wall;

wherein a diameter of the elastomeric plug is smaller than a diameter of the core wall, such that the core wall forms a flange;

wherein the distal face of the elastomeric plug defines a primary seal and the proximal face of the elastomeric plug provides a secondary seal; and

wherein the two members, the primary seal, and the secondary seal cooperatively define a cavity.

19. The system of claim 12, wherein the fluidic channel is disposed within the flexible lateral member, and wherein the frame further comprises a solid lateral opposite the flexible lateral member in relation to the catheter hub, that couples the catheter hub to the stabilization hub.

20. The system of claim 12, wherein the needle has a lumen.