INTEGRATED VASCULAR DELIVERY SYSTEM

• US 20110040281A1
• Filed: 08/12/2010
• Published: 02/17/2011
• Est. Priority Date: 08/14/2009
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Original Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Inventors: Sami, Merrell, Kemmerer, Elyse, White, Steven B., Harris, Adrienne
• Granted Patent: US 8,323,249 B2
• Time in Patent Office: Days
• US Class Current: 604/513
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• 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 25/0693 Flashback chambers
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

An integrated vascular delivery system having a frame configured to receive a catheter insertable in a patient to deliver fluid at an insertion site. The frame includes a first hub, a second hub, and a pair of flexible lateral members extending between the hubs and including a tubular lateral member. The system also includes a fluidic channel that fluidically communicates with the catheter, wherein the fluidic channel passes through the tubular lateral member and at least one of the hubs, and includes a fixed turnabout portion in which fluid flows in a direction different from that within the catheter. The first and second hubs provide anchoring points on the patient distributed around the insertion site and on opposite ends of the catheter, thereby anchoring the frame to the patient and stabilizing the catheter. A method is provided for using an integrated vascular delivery system.

Claims

1. An integrated vascular delivery system adapted to be placed about an insertion site on a patient, comprising:

a frame configured to receive a catheter insertable in the patient to transfer a fluid at the insertion site, wherein the frame includes;

a first hub that provides a first anchoring point on the patient;

a second hub that provides a second anchoring point on the patient; and

a pair of flexible lateral members, including a tubular lateral member, extending between the hubs and configured to be spaced apart from the catheter;

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

a fluidic channel that fluidically communicates with the catheter, wherein the fluidic channel passes through the tubular lateral member and at least one of the hubs, and includes a fixed turnabout portion in which fluid flows in a direction different from that within the catheter.

2. The system of claim 1, wherein the system further comprises a catheter, wherein a proximal portion of the catheter is embedded in a portion of the frame, relative to the catheter.

3. The system of claim 2, wherein the proximal portion of the catheter is embedded in the first or second hub.

4. The system of claim 1, wherein the first anchoring point is distal to the insertion site and the second anchoring point is proximal to the insertion site, relative to the patient.

5. The system of claim 1, wherein the lateral members are reversibly bendable to fold one of the first and second hubs over the other hub.

6. The system of claim 5, wherein the lateral members are substantially parallel, such that the frame forms an approximately rectangular perimeter around the insertion site.

7. The system of claim 1, wherein the turnabout portion of the fluidic channel is fixed within one of the hubs.

8. The system of claim 7, wherein the turnabout portion of the fluidic channel directs fluid flow in a direction opposite of fluid flow within the catheter.

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

10. The system of claim 1, wherein the pair of lateral members includes a solid lateral member.

11. The system of claim 1, wherein the lateral members include a second tubular member, wherein the system further comprises a second fluidic channel that fluidically communicates with the catheter and passes through the second tubular member and at least one of the hubs.

12. The system of claim 11, wherein the second fluidic channel receives a second fluid.

13. The system of claim 12, wherein the second fluid is different from the first fluid.

14. The system of claim 12, wherein the system comprises a first extension tube that delivers a first fluid to the first fluidic channel, and a second extension tube coupled to the second fluidic channel that delivers a second fluid to the second fluidic channel.

15. The system of claim 1, further comprising a flow control system that selectively restricts flow of the fluid through the catheter.

16. The system of claim 15, wherein the flow control system includes at least one valve.

17. The system of claim 11, wherein the catheter is a dual lumen catheter including a first lumen coupled to the first fluidic channel and a second lumen coupled to the second fluidic channel.

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

a catheter having a proximal end that receives fluid and a distal end that delivers the fluid to the patient at an insertion site;

a frame that provides an approximately rectangular perimeter surrounding the insertion site, including;

a first hub that provides a first anchoring point on the patient;

a second hub that provides a second anchoring point on the patient;

a pair of flexible lateral members, including a tubular lateral member, extending between the hubs and spaced apart from the catheter on opposite sides of the catheter;

wherein the first and second anchoring points are on opposite sides of the insertion site to anchor the frame to the patient, thereby stabilizing the catheter;

wherein the lateral members are reversibly bendable to fold one of the first and second hubs over the other hub; and

a fluidic channel that fluidically communicates with the catheter, wherein the fluidic channel passes through the tubular lateral member and at least one of the hubs, and includes a fixed turnabout portion in which fluid flows in a direction opposite from that within the catheter.

19. The system of claim 18, wherein the pair of lateral members includes a solid lateral member.

20. The system of claim 18, wherein the lateral members include a second tubular member, wherein the system further comprises a second fluidic channel that fluidically communicates with the catheter and passes through the second tubular member and at least one of the hubs.

21. A method of using an integrated vascular delivery system, comprising the steps of:

supplying a frame forming a perimeter, wherein the frame includes a catheter having a distal end contained within the perimeter, a first hub and a second hub, and a fluidic channel;

folding the frame to modify the perimeter of the frame, thereby freeing the distal end of the catheter from the perimeter of the frame;

inserting the catheter into the patient at an insertion site;

unfolding the frame to restore the perimeter of the frame around the distal end of the catheter and insertion site;

securing the frame to the patient at a plurality of anchoring points distributed around the insertion site, thereby stabilizing the catheter relative to the insertion site; and

allowing fluid to flow between the catheter and the patient.

22. The method of claim 21, wherein the step of folding the frame includes bending the lateral members to pass the first hub over the second hub.

23. The method of claim 22, wherein the step of inserting the catheter includes passing a needle over the first hub and through the catheter.

24. The method of claim 22, wherein the step of inserting the catheter includes passing a needle under the first hub and through the catheter.

25. The method of claim 21, wherein the step of securing the frame includes securing the first hub at a first anchoring point distal to the insertion site and securing the second hub at a second anchoring point proximal to the insertion site.