Integrated vascular delivery system

• US 8,771,230 B2
• Filed: 05/19/2011
• Issued: 07/08/2014
• 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., Harris, Adrienne Rose, Kemmerer, Elyse, Farrell, Nathan, Duis, Ronald Dean, Brown, Henry J. H.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US13/111,693
• Publication Number:
  US 20110301541A1
• Time in Patent Office: 1,146 Days
• Field of Search: 604/48, 60416402-16404, 604/167.02, 604174-177, 604/179, 604/180, 604/506, 604/513, 604/905
• US Class Current: 604/174
• 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• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle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 be placed on a patient, comprising:

a frame including;

a catheter hub providing a first anchoring point on the patient, wherein the catheter hub is configured to receive a catheter insertable in a patient to transfer a fluid at an insertion site;

a stabilization hub coupled to the catheter hub and providing a second anchoring point on the patient;

wherein the frame operates in a folded configuration wherein the catheter hub is configured to reversibly couple to the stabilization hub, and an unfolded configuration wherein the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter;

a fluidic channel extending between the catheter hub and the stabilization hub, that fluidically communicates with the catheter; and

a needle shield, coupled to at least one of the catheter hub and stabilization hub, that allows a 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, wherein the needle is configured to facilitate insertion of the catheter into the patient.

2. The system of claim 1, wherein one of the catheter hub and stabilization hub includes an extension, wherein in the folded configuration of the frame, the extension is inserted in the other one of the catheter and stabilization hubs.

3. The system of claim 1, wherein in the unfolded configuration of the frame, one of the first and second anchoring points is proximal to the insertion site and the other one of the first and second anchoring points is distal to the insertion site, relative to the patient.

4. The system of claim 3, wherein in the unfolded configuration of the frame, the first anchoring point is substantially opposite the second anchoring point.

5. The system of claim 1, wherein the fluidic channel is at least partially housed within a lateral member extending between the catheter hub and the stabilization hub.

6. The system of claim 5, further comprising a second lateral member extending between the catheter hub and the stabilization hub.

7. The system of claim 6, wherein the first and second lateral members are substantially nonparallel.

8. The system of claim 1, wherein the fluidic channel includes a turnabout portion in which fluid flows in a direction different from that within the catheter.

9. The system of claim 8, wherein the turnabout portion of the fluidic channel is configured to direct fluid flow in a direction substantially opposite from that within the catheter.

10. The system of claim 8, wherein the turnabout portion of the fluidic channel is fixed within at least one of the catheter hub and stabilization hub.

11. The system of claim 1, 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.

12. The system of claim 11, wherein the needle shield is removably coupled to an internal portion of the catheter hub.

13. The system of claim 1, wherein the needle shield is removably coupled to the stabilization hub.

14. The system of claim 1, wherein the needle shield includes a spring clip that engages a distal portion of the needle upon withdrawal of the needle from the catheter in the active configuration of the needle shield.

15. The system of claim 1, further comprising a catheter that is coupled to the catheter hub.

16. The system of claim 1, further comprising a septum coupled to the catheter hub.

17. The system of claim 16, wherein the septum includes a primary seal and a secondary seal.

18. The system of claim 16, wherein the septum includes a rigid core.

19. The system of claim 18, wherein the septum further includes an elastomeric plug surrounding at least a portion of the core.

20. The system of claim 19, wherein the rigid core includes a wall defining an aperture, and a plurality of members extending from the wall.

21. The system of claim 20, wherein the elastomeric plug surrounds the plurality of members to define a septum cavity between the members.

22. The system of claim 17, wherein the septum includes a hollow, rigid septum housing and a tapered elastomeric plug disposed within the rigid septum housing.

23. The system of claim 17, wherein the septum includes a cavity and a spring clip disposed inside the cavity.

24. The system of claim 1, wherein at least one of hubs includes a sensor that measures a biometric or fluid parameter.

53. The system of claim 2, wherein the extension defines a through hole configured to allow passage of the needle into the catheter, and wherein passage of the needle into the through hole reversibly locks the frame in the folded configuration.

25. An integrated vascular delivery system adapted to be placed on a patient, comprising:

a frame including;

a catheter hub providing a first anchoring point on the patient, wherein the catheter hub is configured to receive a catheter insertable in a patient to transfer a fluid at an insertion site; and

a stabilization hub coupled to the catheter hub and providing a second anchoring point on the patient;

a fluidic channel extending between the catheter and the stabilization hub, that fluidically communicates with the catheter;

a needle shield, coupled to at least one of the catheter hub and stabilization hub, that allows a needle to penetrate the catheter, through the needle shield, in an inactive configuration and covers a distal end of the needle in an active configuration, in withdrawing of the needle from the catheter;

wherein the frame operates in;

a folded configuration wherein the catheter and stabilization hubs are coupleable; and

an unfolded configuration wherein the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.

26. The system of claim 25, wherein one of the catheter and stabilization hubs includes an extension, wherein in the folded configuration of the frame, the extension is inserted in the other one of the catheter and stabilization hubs.

27. The system of claim 26, wherein the stabilization hub includes an extension with a through hole that receives a needle when the frame is in the folded configuration.

28. The system of claim 27, wherein the extension is retractable.

31. The system of claim 25, further comprising a first flexible lateral member configured to house at least a portion of the fluidic channel and a second flexible lateral member.

32. The system of claim 31, wherein the first and second flexible lateral member are substantially non-parallel.

33. The system of claim 25, wherein the fluidic channel includes a turnabout portion in which fluid flows in a direction different from that within the catheter.

34. The system of claim 33, wherein the turnabout portion of the fluidic channel directions fluid flow in a direction substantially opposite from that within the catheter.

35. The system of claim 33, wherein the turnabout portion of the fluidic channel is fixed within at least one of the catheter and stabilization hubs.

36. The system of claim 25, wherein the needle shield is removably coupled to the catheter hub.

37. The system of claim 36, wherein the needle shield includes a spring clip that engages a distal portion of the needle.

38. The system of claim 25, further comprising a catheter that is coupled to the catheter hub.

39. The system of claim 25, further comprising a septum coupled to the catheter hub.

40. The system of claim 39, wherein the septum includes an elastomeric plug.

41. The system of claim 39, wherein the septum includes a primary seal and a secondary seal.

42. The system of claim 41, wherein the septum further includes a rigid core.

43. The system of claim 42, wherein the septum further includes an elastomeric plug surrounding at least a portion of the core.

44. The system of claim 43, wherein the rigid core includes a wall defining an aperture, and a plurality of members extending from the wall.

45. The system of claim 44, wherein the elastomeric plug surrounds the plurality of members to define a septum cavity between the members.

46. The system of claim 39, wherein the septum includes a hollow, rigid septum housing and a tapered elastomeric plug disposed within the rigid septum housing.

47. The system of claim 39, wherein the septum includes a cavity and a spring clip disposed inside the cavity.

48. The system of claim 25, wherein at least one of hubs includes a sensor that measures a biometric or fluid parameter.

51. The system of claim 27, wherein the needle has a lumen.

29. The system of 27, wherein in the unfolded configuration of the frame, one of the first and second anchoring points is proximal to the insertion site and the other one of the first and second anchoring points is distal to the insertion site, relative to the patient.

52. The system of claim 29, wherein the needle has a lumen.

30. The system of 29, wherein in the unfolded configuration of the frame, the first anchoring point is substantially opposite the second anchoring point across the insertion site.

49. An integrated vascular delivery system adapted to be placed on a patient, comprising:

a frame including;

a catheter hub providing a first anchoring point on the patient, wherein the catheter hub is configured to receive a catheter insertable in the patient to transfer a fluid at an insertion site; and

a stabilization hub providing a second anchoring point on the patient;

wherein the frame operates in;

a folded configuration wherein the catheter and stabilization hubs are coupleable; and

an unfolded configuration wherein the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.

50. An integrated vascular delivery system adapted to be placed on a patient, comprising:

a frame including;

a catheter hub providing a first anchoring point on the patient, wherein the catheter hub is configured to receive a catheter insertable in the patient to transfer a fluid at an insertion site; and

a stabilization hub providing a second anchoring point on the patient; and

a septum disposed in the catheter hub and including;

a rigid core having a core wall defining an aperture and a plurality of members extending from the core; and

an elastomeric plug circumferentially surrounding at least a portion of the plurality of members and defining a septum cavity;

wherein the frame operates in;

a folded configuration wherein the catheter and stabilization hubs are coupleable; and

an unfolded configuration wherein the first and second anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter.