APPARATUS AND METHODS FOR ACCESSING THE LYMPHATIC SYSTEM

• US 20140303461A1
• Filed: 03/15/2014
• Published: 10/09/2014
• 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.
• Granted Patent: US 10,052,059 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 5/41 Detecting, measuring or recording for evaluating the immune or lymphatic systems
• 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 1/3659 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 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

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 member 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 treating a patient via a thoracic duct of the patient'"'"'s body, comprising:

a tubular member comprising a proximal end, a distal end sized for introduction into the patient'"'"'s body into a thoracic duct, a lumen extending between the proximal and distal ends for removing fluid from a thoracic duct, and an expandable member on the distal end;

an ex-vivo treatment device for treating the removed lymphatic fluid removed from the thoracic duct; and

an infusion device for reintroducing the treated lymphatic fluid back into the patient'"'"'s body.

2. The system of claim 1, wherein the ex-vivo treatment device is configured for one or more of:

a) performing leukofiltration of the removed lymphatic fluid before returning the lymphatic fluid to the patient'"'"'s body to decrease immune response by the patient'"'"'s body;

b) filtering at least one of antibodies, interleukin, and non-cellular mediators before returning the lymphatic fluid to the patient'"'"'s body to decrease t-cell activation by the patient'"'"'s body;

or

c) performing dialysis on the removed lymphatic fluid to remove at least one of toxins and non-cellular mediators before returning the lymphatic fluid to the patient'"'"'s body.

3. A method for treating a patient via a thoracic duct of the patient'"'"'s body, comprising:

providing a tubular member comprising a proximal end, a distal end sized for introduction into the patient'"'"'s body, and an expandable member on the distal end;

introducing the distal end of the tubular member into the patient'"'"'s vasculature via a percutaneous access site with the expandable member in a contracted condition;

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

manipulating the tubular member to direct the distal end into the thoracic duct;

expanding an expandable member on the distal portion adjacent the distal tip to substantially isolate the thoracic duct from the left internal jugular vein and left subclavian vein;

removing lymphatic fluid from the thoracic duct through the tubular member to a location exterior to the patient'"'"'s body;

treating the removed lymphatic fluid; and

returning at least a portion of the lymphatic fluid back into the patient'"'"'s body.

4. The method of claim 3, wherein the at least a portion of the lymphatic fluid is returned into the thoracic duct through the tubular member.

5. The method of claim 3, wherein the at least a portion of the lymphatic fluid is returned to treat sepsis within the patient'"'"'s body, and wherein treating the removed lymphatic fluid comprises one of:

a) performing leukofiltration of the removed lymphatic fluid before returning the lymphatic fluid to the patient'"'"'s body to decrease immune response by the patient'"'"'s body;

b) filtering at least one of antibodies, interleukin, and non-cellular mediators before returning the lymphatic fluid to the patient'"'"'s body to decrease t-cell activation by the patient'"'"'s body;

or

c) performing dialysis on the removed lymphatic fluid to remove at least one of toxins and non-cellular mediators before returning the lymphatic fluid to the patient'"'"'s body.

6. The method of claim 3, wherein the at least a portion of the lymphatic fluid is returned to treat HIV or other viral infection within the patient'"'"'s body, and wherein treating the removed lymphatic fluid comprises at least one of:

a) separating t-cells from the fluid and wherein the at least a portion of the lymphatic fluid returned to the patient'"'"'s body comprises the separated t-cells; and

a) separating protein from the fluid and wherein the at least a portion of the lymphatic fluid returned to the patient'"'"'s body comprises the separated protein.

7. The method of claim 3, wherein the at least a portion of the lymphatic fluid is returned to treat HIV or other viral infection within the patient'"'"'s body, and wherein treating the removed lymphatic fluid comprises:

analyzing the removed lymphatic fluid to detect latently infected cell populations of the patient.

8. The method of claim 7, wherein the removed lymphatic fluid is returned to the patient'"'"'s body to push the patient towards a virus-free equilibrium or restore natural immune function after suppression.

9. The method of claim 3, wherein the at least a portion of the lymphatic fluid is returned to treat HIV or other viral infection within the patient'"'"'s body, wherein treating the removed lymphatic fluid to the patient'"'"'s body comprises adding one or more compounds to the removed lymphatic fluid returning at least a portion of the lymphatic fluid back into the patient'"'"'s body, and wherein returning the lymphatic fluid to the patient'"'"'s body comprises infusing the removed lymphatic fluid with the one or more added compounds to push the patient towards a virus-free equilibrium or restore natural immune function after suppression.

10. The method of claim 9, wherein the one or more compounds comprise at least one of osmotically active fluid, osmotically neutral fluid, and one or more drugs to activate a virus causing the viral infection.

11. A method for treating a patient via a thoracic duct of the patient'"'"'s body, comprising:

providing a tubular member comprising a proximal end, a distal end sized for introduction into the patient'"'"'s body, and an expandable member on the distal end;

introducing the distal end of the tubular member into the patient'"'"'s vasculature via a percutaneous access site with the expandable member in a contracted condition;

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

manipulating the tubular member to direct the distal end into the thoracic duct;

expanding an expandable member on the distal portion adjacent the distal tip to substantially isolate the thoracic duct from the left internal jugular vein and left subclavian vein; and

removing lymphatic fluid from the thoracic duct through the tubular member to a location exterior to the patient'"'"'s body.

12. The method of claim 11, wherein the lymphatic fluid is removed to reduce volume of interstitial fluid within the patient'"'"'s body.

13. The method of claim 12, wherein the lymphatic fluid is removed to reduce portal pressure within the patient'"'"'s portal vein.

14. The method of claim 13, wherein the lymphatic fluid is removed to reduce portal pressure to treat esophageal varicies.

15. The method of claim 13, wherein the lymphatic fluid is removed to reduce portal pressure to treat ascites.

16. The method of claim 11, wherein the lymphatic fluid is removed to manage hepatorenal syndrome.

17. The method of claim 11, further comprising:

treating the removed lymphatic fluid; and

returning at least a portion of the lymphatic fluid back into the patient'"'"'s body.

18. The method of claim 11, wherein removing lymphatic fluid from the thoracic duct comprises periodically or intermittently drain lymphatic fluid from the thoracic duct to titrate the fluid to a desired level or amount.

19. The method of claim 18, wherein the fluid is titrated to achieve a desired lymph parameter selected from one or more of flow rate within the thoracic duct, pressure within the thoracic duct, volume removed, and color of fluid within the thoracic duct.

20. The method of claim 18, wherein the fluid is titrated to maintain a desired systemic parameter of the patient selected from one or more of the patient'"'"'s body weight, central venous pressure (CVP), oxygen saturation, and dyspnea of the patient.

21. The method of claim 11, further comprising performing a surgical procedure on the patient, and wherein lymphatic fluid is removed from the thoracic duct for fluid management of the patient during the procedure.

22. The method of claim 21, wherein the surgical procedure includes a bypass procedure.

23. The method of claim 21, wherein the lymphatic fluid is removed for fluid management of the patient'"'"'s anuria during the procedure.

24. The method of claim 21, further comprising measuring pressure within the thoracic duct using the tubular member to monitor at least one of ventilation of the patient and fluid status of the patient, and wherein lymphatic fluid is removed from the thoracic duct based at least in part on the measured pressure.

25. A system for treating a patient via a thoracic duct of the patient'"'"'s body, comprising:

a tubular member comprising a proximal end, a distal end sized for introduction into the patient'"'"'s body into a thoracic duct, a lumen extending between the proximal and distal ends for removing fluid from a thoracic duct, and an expandable member on the distal end; and

an ex-vivo analyzer for analyzing the removed lymphatic fluid to monitor one or more parameters of the patient.

26. The system of claim 25, wherein the ex-vivo analyzer is configured for one or more of:

a) generating a composite assay of the removed lymphatic fluid to provide a snapshot of the immune system of the patient;

b) comparing one or more parameters of the removed lymphatic fluid with other parameters of the patient to diagnose a medical condition;

c) assaying at least one oft-cell population and status in the fluid to monitor changes indicating function or rejection of an implant within the patient'"'"'s body;

d) monitoring the one or more parameters to identify antagonistic t-cells to indicate that treatment of an autoimmune condition is needed;

e) analyzing the removed lymphatic fluid to monitor a cancer status of the patient or to monitor one or more indicators of cancer metastasis of the patient;

f) identifying at least one of type oft-cells and number oft-cells in the fluid to diagnose remission or recurrence of cancer within the patient'"'"'s body;

g) analyzing the removed lymphatic fluid to monitor the patient'"'"'s cancer status based on detecting or quantifying circulating t-cell surface markers or substances found in circulating lymph that have been released by tumor cells.

27. A method for diagnosing, monitoring, or treating a patient via a thoracic duct of the patient'"'"'s body, comprising:

providing a tubular member comprising a proximal end, a distal end sized for introduction into the patient'"'"'s body, and an expandable member on the distal end;

introducing the distal end of the tubular member into the patient'"'"'s vasculature via a percutaneous access site with the expandable member in a contracted condition;

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

manipulating the tubular member to direct the distal end into the thoracic duct;

expanding an expandable member on the distal portion adjacent the distal tip to substantially isolate the thoracic duct from the left internal jugular vein and left subclavian vein;

removing lymphatic fluid from the thoracic duct through the tubular member to a location exterior to the patient'"'"'s body; and

analyzing the removed lymphatic fluid to monitor one or more parameters of the patient.

28. The method of claim 27, wherein analyzing the removed lymphatic fluid comprises generating a composite assay of the removed lymphatic fluid to provide a snapshot of the immune system of the patient.

29. The method of claim 27, wherein analyzing the removed lymphatic fluid comprises comparing one or more parameters of the removed lymphatic fluid with other parameters of the patient to diagnose a medical condition.

30. The method of claim 27, wherein analyzing the removed lymphatic fluid comprises assaying at least one oft-cell population and status in the fluid to monitor changes indicating function or rejection of an implant.

31. The method of claim 27, wherein analyzing the removed lymphatic fluid comprises monitoring the one or more parameters to identify antagonistic t-cells to indicate that treatment of an autoimmune condition is needed.

32. The method of claim 27, wherein the removed lymphatic fluid is analyzed to monitor a cancer status of the patient.

33. The method of claim 32, wherein the removed lymphatic fluid is analyzed to monitor one or more indicators of cancer metastasis of the patient.

34. The method of claim 32, analyzing the removed lymphatic fluid comprises identifying at least one of type oft-cells and number oft-cells in the fluid to diagnose remission or recurrence of cancer within the patient'"'"'s body.

35. The method of claim 32, wherein the removed lymphatic fluid is analyzed to quantify tumor antigens or mediators in the fluid to determine the cancer status of the patient.

36. The method of claim 32, wherein the removed lymphatic fluid is analyzed to monitor cancer status based on detecting or quantifying circulating t-cell surface markers or substances found in circulating lymph that have been released by tumor cells.

37. The method of claim 27, further comprising infusing one or more medications or biologics into the thoracic duct through the tubular member to stimulate growth to treat lymphedema within the patient'"'"'s lymphatic system.

38. A method for diagnosing, monitoring, or treating a patient via a thoracic duct of the patient'"'"'s body, comprising:

providing a tubular member comprising a proximal end, a distal end sized for introduction into the patient'"'"'s body, and an expandable member on the distal end;

introducing the distal end of the tubular member into the patient'"'"'s vasculature via a percutaneous access site with the expandable member in a contracted condition;

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

manipulating the tubular member to direct the distal end into the thoracic duct;

expanding an expandable member on the distal portion adjacent the distal tip to substantially isolate the thoracic duct from the left internal jugular vein and left subclavian vein; and

infusing one or more fluids into the thoracic duct through the tubular member.

39. The method of claim 38, wherein infusing one or more fluids comprises infusing one or more medications or biologics into the thoracic duct through the tubular member to stimulate growth to treat lymphedema within the patient'"'"'s lymphatic system.

40. The method of claim 38, wherein infusing one or more fluids comprises:

infusing contrast through the tubular member into the thoracic duct; and

imaging the patient'"'"'s lymphatic system to diagnose chylothorax.

41. The method of claim 40, wherein the imaging identifies a target site having a breach within the patient'"'"'s lymphatic system, the method further comprising introducing a repair device into the thoracic duct to repair the breach at the target site.

42. The method of claim 41, wherein the repair device comprises a prosthesis introduced into the target site over a wire.

43. The method of claim 41, wherein the repair device comprises a sealing material introduced into the target site.

44. 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 the patient'"'"'s body into a thoracic duct, a lumen extending between the proximal and distal ends for removing fluid from a thoracic duct, and an expandable member on the distal end; and

an ex-vivo analyzer coupled to the proximal end of the tubular member and communicating with the lumen for analyzing lymphatic fluid removed from the thoracic duct.

45. The system of claim 44, wherein analyzer is configured to analyze lymphatic fluid according to any preceding method.