Apparatus and methods for accessing the lymphatic system

• US 9,421,316 B2
• Filed: 05/03/2011
• Issued: 08/23/2016
• Est. Priority Date: 05/04/2010
• Status: Active Grant

• Current Assignee: LXS, LLC
• Original Assignee: Christian S. Eversull, Matthew J. Callaghan, Stephen A. Leeflang
• Inventors: Leeflang, Stephen A., Eversull, Christian S., Callaghan, Matthew J.
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US13/100,297
• Publication Number:
  US 20110276023A1
• Time in Patent Office: 1,939 Days
• Field of Search: 604/500, 604/319
• US Class Current: 1/1
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• 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

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. A distal end of a catheter is introduced through the patient'"'"'s venous system into a body lumen adjacent the ostium of the thoracic duct. An expandable member on the distal end of the tubular may be expanded adjacent the ostium, e.g., within the body lumen or the thoracic duct itself, and used to isolate the thoracic duct from the body lumen, whereupon a medical procedure may be performed via the thoracic duct. For example, lymphatic fluid may be removed from the thoracic duct through a lumen of the tubular member and/or one or more agents may be introduced into the thoracic duct through the tubular member.

Claims

1. A system for performing a medical procedure via a thoracic duct of a patient'"'"'s body, comprising:

a tubular member comprising a proximal end, a distal end sized for introduction into a body lumen, an aspiration lumen extending from the proximal end to a port in the distal end, an expandable member on the distal end sized for substantially isolating the thoracic duct when expanded within the thoracic duct, and an actuator on the proximal end of the tubular member to selectively expand and collapse the expandable member when the proximal end is external to the patient'"'"'s body;

one or more external devices configured to be located external to the patient'"'"'s body for removing fluid within the thoracic duct from the patient'"'"'s body, comprising;

a detector for analyzing the fluid removed from the thoracic duct via the aspiration lumen to identify whether blood is present in the removed fluid;

a container coupled to the proximal end of the tubular member for collecting fluid removed from the thoracic duct via the aspiration lumen; and

a controller coupled to the detector for opening a fluid path between the aspiration lumen and the container when the detector confirms that the fluid removed via the aspiration lumen does not include whole blood.

2. The system of claim 1, wherein the one or more external devices comprises a separator coupled to the proximal end of the tubular member for separating the lymphatic fluid or components of the lymphatic fluid from other fluid in the fluid removed from the thoracic duct, and wherein the separator comprises a valve comprising an inlet that receives fluid from the tubular member, a first outlet for directing the lymphatic fluid or components of the lymphatic fluid to the container, and a second outlet for directing other fluids to a waste container, the valve being selectively operable between the first and second outlets.

3. The system of claim 2, wherein the separator comprises at least one of a mechanical filtration system, an osmotic gradient system, a concentration gradient system, and a centrifuge.

4. The system of claim 1, wherein the detector comprises one or more sensors that comprise at least one of an optical sensor that detects the presence of red blood cells by light transmission or reflection characteristics, a chemical sensor that detects one or more of pH, oxygen concentration, lactate, and leukocyte esterase, a sensor that measures hematocrit, an electrical sensor that measures impedance, a mechanical sensor that detects pressure waves that differ between the venous system and the thoracic duct, and a Doppler ultrasound sensor.

5. The system of claim 1, wherein the expandable member comprises a balloon, wherein the actuator comprises a source of inflation media, and wherein the tubular member comprises an inflation lumen for delivering inflation media from the source of inflation media into and out of the balloon for selectively expanding and collapsing the balloon.

6. The system of claim 5, wherein the tubular member terminates in a flexible distal tip beyond the balloon.

7. The system of claim 1, further comprising a source of vacuum coupled to the proximal end of the tubular member and communicating with the aspiration lumen for removing fluid within the thoracic duct via the port and aspiration lumen, wherein the controller is coupled to the source of vacuum to activate the source of vacuum when the detector confirms that the fluid removed via the aspiration lumen does not include whole blood.

8. The system of claim 7, wherein the controller is configured to deactivate the source of vacuum when the detector indicates that the fluid removed from the thoracic duct includes whole blood to stop fluid flow from the tubular member.

9. The system of claim 7, wherein the controller is configured to deactivate the source of vacuum when the detector indicates a sudden change in pressure in the fluid being removed via the aspiration lumen to stop fluid flow from the tubular member.

10. The system of claim 1, further comprising an infusion device comprising a proximal end communicating with the container and a distal end sized for delivering one or more components of the lymphatic fluid back into the patient'"'"'s body.

11. The system of claim 1, further comprising a valve associated with the detector, wherein the controller is coupled to the valve to open the valve when the detector confirms that the fluid removed via the aspiration lumen does not include whole blood, thereby opening the fluid path between the aspiration lumen and the container.

12. A method for performing a medical procedure within a patient'"'"'s body, the body comprising a thoracic duct including an ostium communicating with the patient'"'"'s venous system, comprising:

introducing a distal end of a tubular member through the patient'"'"'s venous system into a body lumen adjacent the ostium of the thoracic duct such that a proximal end of the tubular member remains external to the patient'"'"'s body;

inserting the distal end into the thoracic duct such that an expandable member on the distal end of the tubular member is positioned beyond a valve of the thoracic duct;

expanding the expandable member within the thoracic duct beyond the valve to substantially isolate the thoracic duct from the body lumen; and

performing a medical procedure via the thoracic duct,

wherein performing a medical procedure comprises;

activating a source of vacuum to remove fluid within the thoracic duct via the tubular member;

analyzing the removed fluid to determine whether the removed fluid contains whole blood;

if the removed fluid includes whole blood, deactivating the source of vacuum to stop fluid flow from the thoracic duct; and

if the removed fluid does not include whole blood, directing the removed fluid to a container external to the patient'"'"'s body.

13. The method of claim 12, wherein the medical procedure comprises removing lymphatic fluid from the thoracic duct through a lumen of the tubular member to a location external to the patient'"'"'s body.

14. The method of claim 13, further comprising infusing one or more components of the removed lymphatic fluid back into the patient'"'"'s body.

15. The method of claim 13, wherein one or more components of the removed lymphatic fluid are infused back into the patient'"'"'s body via an infusion device introduced into the patient'"'"'s body.

16. The method of claim 12, wherein the percutaneous access site is one of a left or right internal or external jugular, subclavian, axillary, anterior cubital, or femoral vein of the patient'"'"'s body.

17. The method of claim 12, wherein performing a medical procedure comprises:

activating a source of vacuum to remove fluid within the thoracic duct via the tubular member; and

deactivating the source of vacuum when a sudden change in pressure in the fluid being removed is detected to stop fluid flow from the tubular member.

18. The method of claim 12, wherein performing a medical procedure comprises:

activating a source of vacuum to remove fluid within the thoracic duct via the tubular member; and

emitting a warning when a sudden change in pressure in the fluid being removed is detected to stop fluid flow from the tubular member.

19. The method of claim 12, wherein the medical procedure comprises introducing one or more agents into the thoracic duct through a lumen of the tubular member.

20. The method of claim 12, wherein the body lumen comprises a brachiocephalic vein.

21. The method of claim 12, further comprising separating components of the lymphatic fluid from other components of the fluid external to the patient'"'"'s body.

22. The method of claim 21, wherein the medical procedure further comprises directing the separated components of the lymphatic fluid to a storage container.

23. The method of claim 21, wherein the medical procedure further comprises infusing the separated components of the lymphatic fluid into the patient'"'"'s body.

24. The method of claim 12, wherein the distal end of the tubular member is introduced into the patient'"'"'s venous system from a percutaneous access site.

25. The method of claim 24, further comprising removing the tubular member from the patient'"'"'s body via the percutaneous access site after performing the medical procedure.

26. The method of claim 12, further comprising using external ultrasound imaging during navigation of the distal end of the tubular member through the patient'"'"'s venous system.

27. The method of claim 26, wherein the distal end of the tubular member comprises one or more echogenic features to facilitate navigation of the distal end while using the ultrasound imaging.