Apparatus and methods for accessing the lymphatic system

• US 10,111,997 B2
• Filed: 01/21/2014
• Issued: 10/30/2018
• Est. Priority Date: 05/03/2011
• Status: Active Grant

• Current Assignee: LXS, LLC
• Original Assignee: LXS, LLC
• Inventors: Callaghan, Matthew J., Leeflang, Stephen A., Eversull, Christian S.
• Primary Examiner(s): Osinski, Bradley J
• Assistant Examiner(s): Darb, Hamza
• Application Number:
  US14/160,547
• Publication Number:
  US 20140243790A1
• Time in Patent Office: 1,743 Days
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2202/0405 Lymph
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2230/207 hematocrit
• CPC Class Codes: A61M 2230/208 pH-value

Abstract

Systems and methods are provided for performing a medical procedure within a patient'"'"'s body that involves a thoracic duct including an ostium communicating with the patient'"'"'s venous system. An apparatus is provided that includes a catheter including proximal and distal ends and a lumen extending therebetween. An expandable sealing member is carried beyond the distal end that is expandable from a delivery condition to a deployed condition in which the sealing member defines a concave contact surface shaped for engaging a vessel wall surrounding the outlet of the thoracic duct. The sealing member includes an aspiration port in the contact surface communicating with the catheter lumen for removing fluid from the thoracic duct.

Claims

1. An apparatus for accessing a thoracic duct of a patient'"'"'s body, the thoracic duct including an outlet adjacent a confluence of an internal jugular vein and subclavian vein of the patient'"'"'s body, comprising:

a tubular member comprising a proximal end, a distal end sized for introduction into a patient'"'"'s vasculature, and an aspiration lumen extending between the proximal and distal ends; and

an expandable sealing member comprising;

a frame comprising a first arm and a second arm movable between a collapsed configuration and an expanded configuration;

a fluid-tight membrane comprising a first end coupled to the first arm and a second end coupled to the second arm such that the membrane is suspended between the first arm and the second arm free of additional supports, the membrane is expandable from a delivery condition sized for introduction into a patient'"'"'s vasculature to a deployed condition in which the membrane defines a flexible concave outer contact surface extending between the first arm and the second arm and oriented away from the distal end, the outer contact surface configured to conform to a shape of a vessel wall surrounding the outlet of the thoracic duct for engaging a vessel wall surrounding the outlet of the thoracic duct to provide a fluid-tight seal isolating the thoracic duct from the internal jugular vein and the subclavian vein; and

an aspiration port in the outer contact surface communicating with the aspiration lumen for removing fluid from the thoracic duct through the aspiration port into the aspiration lumen.

2. The apparatus of claim 1, wherein the membrane comprises opposing longitudinal edges extending between the first end and the second end of the membrane and defining a width of the membrane between the longitudinal edges, the membrane having a curved cross-section across the width in the deployed condition.

3. The apparatus of claim 2, wherein the membrane has a uniform width between the longitudinal edges along a length of the membrane between the first end and the second end.

4. The apparatus of claim 2, wherein an intermediate region of the membrane between the first end and the second end has an intermediate region width that extends between the longitudinal edges that is greater than an end width at the first end or the second end that extends between the longitudinal edges.

5. The apparatus of claim 1, wherein each of the first arm and the second arm includes first fixed ends coupled to the distal end of the tubular member and second free ends, and wherein the ends of the membrane are attached to the arms between the first fixed ends and the second free ends.

6. The apparatus of claim 1, wherein the first arm has an “

L”

or curved shape in the expanded configuration.

7. The apparatus of claim 6, wherein the second arm is substantially straight in the expanded configuration.

8. The apparatus of claim 1, wherein the first arm and the second arm are spaced asymmetrically relative to the distal end of the tubular member in the expanded configuration.

9. The apparatus of claim 1, further comprising a lumen extension extending between the membrane and the distal end of the tubular member and providing a fluid path between the aspiration port and the aspiration lumen.

10. The apparatus of claim 9, further comprising an expandable member on the lumen extension adjacent an inner surface of the membrane, the expandable member configured to expand and apply a distal force against the inner surface to press the outer contact surface against the vessel wall surrounding the outlet.

11. The apparatus of claim 1, wherein the membrane is oriented transversely relative to a longitudinal axis of the tubular member in the deployed condition.

12. An apparatus for accessing a thoracic duct of a patient'"'"'s body, the thoracic duct including an outlet adjacent a confluence of an internal jugular vein and subclavian vein of the patient'"'"'s body, comprising:

a tubular member comprising a proximal end, a distal end sized for introduction into a patient'"'"'s vasculature, a longitudinal axis extending between the proximal end and the distal end, and an aspiration lumen extending between the proximal and distal ends;

a frame comprising first and second arms including first fixed ends coupled to the distal end of the tubular member and second free ends disposed distally beyond the distal end of the tubular member, the free ends movable away from one another to an expanded configuration in which the arms extend away from one another such that the free ends are spaced apart from one another and movable towards one another to a collapsed configuration; and

a flexible sealing member comprising a flexible membrane including first and second ends attached to the first and second arms, respectively, such that the membrane is suspended between the first and second arms and defines an outer contact surface, the membrane movable between a delivery condition when the arms are in the collapsed configuration for introduction into a patient'"'"'s vasculature and a deployed condition when the arms are in the expanded configuration in which the outer contact surface is oriented transversely relative to the longitudinal axis of the tubular member and shaped for engaging a vessel wall surrounding the outlet of the thoracic duct, the sealing member comprising an aspiration port in the outer contact surface communicating with the aspiration lumen for removing fluid from the thoracic duct through the aspiration port into the aspiration lumen.

13. The apparatus of claim 12, further comprising a flexible lumen extension extending between the aspiration port and the aspiration lumen.

14. The apparatus of claim 13, further comprising an expandable member on the lumen extension adjacent an inner surface of the membrane, the expandable member configured to expand and apply a distal force against the inner surface to press the outer contact surface against the vessel wall surrounding the outlet.

15. The apparatus of claim 12, wherein the first and second arms are spaced asymmetrically relative to a central longitudinal axis extending from the distal end of the tubular member in the expanded configuration.

16. The apparatus of claim 12, wherein the first arm has an “

L”

or curved shape in the expanded configuration.

17. The apparatus of claim 16, wherein the second arm is straight in the expanded configuration.

18. The apparatus of claim 12, wherein the arms are biased to the expanded configuration.

19. The apparatus of claim 12, wherein the membrane is attached to the frame only at the free ends of the first and second arms.

20. A method for accessing a thoracic duct of a patient'"'"'s body, comprising:

introducing a distal end of a tubular member into a patient'"'"'s vasculature with a sealing member extending distally from the distal end in a delivery condition;

advancing the tubular member until the distal end is disposed adjacent a junction of the patient'"'"'s left internal jugular vein and the patient'"'"'s left subclavian vein;

deploying the sealing member adjacent the junction such that arms of a frame of the sealing member expand and a membrane suspended between the arms is expanded by the frame to extend transversely relative to a longitudinal axis of the tubular member and define a concave outer contact surface oriented away from the tubular member distal end;

manipulating the tubular member to press the outer contact surface against a vessel wall surrounding an outlet of the thoracic duct, the outer contact surface conforming to a shape of the vessel wall to provide a fluid-tight seal isolating the thoracic duct from the left internal jugular vein and left subclavian vein; and

removing fluid from the thoracic duct through an aspiration port in the outer contact surface communicating with an aspiration lumen within the tubular member.