High-flow port and infusion needle systems

• US 10,166,321 B2
• Filed: 01/09/2015
• Issued: 01/01/2019
• Est. Priority Date: 01/09/2014
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Casiello, Damon, LeBlanc, Kenneth, Kewley, Marissa, Girard, Mark
• Primary Examiner(s): Lee, Brandy S
• Application Number:
  US14/593,502
• Publication Number:
  US 20160199560A1
• Time in Patent Office: 1,453 Days
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2039/0054 Multiple layers
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration

Abstract

The present invention relates to a multi-reservoir port, catheter and non-coring needle systems that support high-flow applications such as hemodialysis and apheresis. In particular, the present invention relates to improvements to each of these systems to provide optimal flow rates and septum life with minimal intraluminal pressure; both individually and in combination.

Claims

1. A multi-reservoir port system, comprising:

a vascular access port, including;

a housing defining first and second reservoirs,

a first septum mounted within the housing sealing the first reservoir, the first septum comprising an elastomeric material having a first septum first layer having a first durometer and a first septum second layer having a second durometer, the first septum second layer being encapsulated on all sides by the first septum first layer,

a second septum mounted within the housing sealing the second reservoir, the second septum comprising an elastomeric material having a second septum first layer having a first durometer and a second septum second layer having a second durometer, the second septum second layer being encapsulated on all sides by the second septum first layer,

an inlet stem having an inlet lumen in fluid communication with the first reservoir, and

an outlet stem having an outlet lumen in fluid communication with the second reservoir; and

a dual-lumen catheter having a proximal end, a distal end, and first and second lumens extending therebetween;

wherein the inlet stem is dimensioned to receive the first lumen at the proximal end of the catheter; and

wherein the outlet stem is dimensioned to receive the second lumen at the proximal end of the catheter.

2. The assembly of claim 1, wherein the durometer of the first septum first layer and second septum first layer are less than the durometer of the first septum second layer and the second septum second layer.

3. The assembly of claim 1, wherein the thickness of the first septum second layer and second septum second layer is greater than the thickness of the first septum first layer and second septum first layer.

4. A multi-reservoir port and needle system, comprising:

a vascular access port, including;

a housing defining first and second reservoirs,

a first septum mounted within the housing sealing the first reservoir, the first septum comprising an elastomeric material having a first septum first layer having a first durometer and a first septum second layer having a second durometer, the first septum second layer being encapsulated on all sides by the first septum first layer,

a second septum mounted within the housing sealing the second reservoir, the second septum comprising an elastomeric material having a second septum first layer having a first durometer and a second septum second layer having a second durometer, the second septum second layer being encapsulated on all sides by the second septum first layer,

an inlet stem having an inlet lumen in fluid communication with the first reservoir, and

an outlet stem having an outlet lumen in fluid communication with the second reservoir; and

a needle assembly, including;

at least one infusion needle; and

at least two aspiration needles wherein the at least two aspiration needles are attached to each other so as to be parallel of one another;

wherein the infusion needle is configured to penetrate the second septum of the vascular access port, and the at least two aspiration needles are configured to penetrate the first septum of the vascular access port.

5. The assembly of claim 4, wherein the at least one infusion needle and at least two aspiration needles are non-coring.

6. The assembly of claim 4, wherein the at least one infusion needle and at least two aspiration needles are at least 19 gauge.

7. The assembly of claim 4, wherein each of the at least two aspiration needles include openings that face in opposite directions.

8. The assembly of claim 4, wherein the at least two aspiration needles are attached to each other.

9. The assembly of claim 4, wherein the at least two aspiration needles are in fluid communication with the aspiration reservoir.

10. The assembly of claim 4, wherein the infusion needle is in fluid communication with the infusion reservoir.

11. The assembly of claim 4, wherein the at least one infusion needle and at least two aspiration needles are in fluid communication with a blood circulation apparatus.

12. The assembly of claim 11, wherein the blood circulation apparatus includes a dialysis machine or an apheresis machine.

13. A method of performing apheresis, comprising:

implanting a multi-reservoir vascular access port, the multi-reservoir vascular access port comprising;

a housing defining an aspiration reservoir and an infusion reservoirs,

a first septum mounted within the housing sealing the aspiration reservoir, the first septum comprises an elastomeric material having a first septum first layer having a first durometer and a first septum second layer having a second durometer, the first septum second layer being encapsulated on all sides by the first septum first layer,

a second septum mounted within the housing sealing the infusion reservoir, the second septum comprises an elastomeric material having a second septum first layer having a first durometer and a second septum second layer having a second durometer, the second septum second layer being encapsulated on all sides by the second septum first layer;

accessing the aspiration reservoir of the multi-reservoir vascular access port with an aspiration needle assembly;

accessing the infusion reservoir of the multi-reservoir vascular access port with an infusion needle assembly;

flowing fluid from the aspiration reservoir through the aspiration needle assembly to an apheresis machine; and

flowing fluid from the apheresis machine to the infusion reservoir through the infusion needle assembly.

14. The method of claim 13, wherein the needles of the aspiration needle assembly and infusion needle assembly are non-coring 19 gauge needles.