Apparatus and methods for accessing the lymphatic system

• US 9,642,991 B2
• Filed: 05/03/2013
• Issued: 05/09/2017
• Est. Priority Date: 05/03/2011
• Status: Active Grant

• Current Assignee: LXS, LLC
• Original Assignee: LXS, LLC
• Inventors: Eversull, Christian S., Leeflang, Stephen A., Callaghan, Matthew J.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): DARB, HAMZA A.
• Application Number:
  US13/887,277
• Publication Number:
  US 20130245607A1
• Time in Patent Office: 1,467 Days
• Field of Search: 604 401, 604 9601, 60410101, 60410105, 604500, 604508, 604509, 604510
• 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 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
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

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 method for performing a medical procedure within a patient'"'"'s body, the body comprising a thoracic duct including a terminal valve and an ostium communicating with a patient'"'"'s venous system of the patient'"'"'s body, comprising:

introducing a distal portion of a tubular member through the patient'"'"'s venous system into a body lumen adjacent the terminal valve and ostium of the thoracic duct, the distal portion biased to a curvilinear configuration;

manipulating the tubular member until a distal tip of the distal portion enters the ostium of the thoracic duct;

further manipulating the tubular member to direct the distal portion into the thoracic duct until an expandable member on the distal portion passes through the terminal valve;

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

performing a medical procedure via the thoracic duct,

wherein the expandable member comprises a first balloon, the method further comprising expanding a second balloon on the distal portion adjacent the first balloon.

2. The method of claim 1, wherein the medical procedure comprises removing lymphatic fluid from the thoracic duct through a lumen of the tubular member.

3. The method of claim 1, wherein the medical procedure comprises introducing one or more agents into the thoracic duct through a lumen of the tubular member.

4. The method of claim 1, wherein the expandable member is expanded within a region of the thoracic duct between two valves.

5. The method of claim 4, wherein the expandable member substantially fills the region between the two valves when expanded.

6. The method of claim 1, wherein the first and second balloons are expanded such that either the terminal valve or a next valve adjacent to the terminal valve in the thoracic duct is captured between the first and second balloons.

7. The method of claim 1, further comprising moving one of the first and second balloons relative to the other.

8. The method of claim 7, wherein one of the first and second balloons is moved relative to the other to capture either the terminal valve or a next valve adjacent to the terminal valve between the first and second balloons.

9. The method of claim 1, wherein the first balloon is expanded within the thoracic duct adjacent the terminal valve and wherein the second balloon is expanded to engage the ostium outside the terminal valve.

10. The method of claim 1, wherein the first balloon is expanded within the thoracic duct between the terminal valve and a next valve adjacent to the terminal valve and wherein the second balloon is expanded beyond the next valve.

11. The method of claim 1, wherein the distal portion is supported by a stylet positioned through a proximal portion of the tubular member into the distal portion when the distal portion is introduced into the body lumen.

12. The method of claim 11, further comprising:

removing the stylet to release the distal portion within the body lumen,

wherein the distal portion returns towards the curvilinear configuration before the tubular member is manipulated to direct the distal tip into the ostium of the thoracic duct.

13. The method of claim 11, further comprising positioning the stylet into the distal portion before introducing the distal portion into the body lumen such that the stylet directs the distal portion from its curvilinear configuration to a less curved or substantially straight configuration.

14. The method of claim 11, further comprising replacing the stylet with one or more shaped stylets before further manipulating the tubular member to direct the distal portion into the thoracic duct.

15. The method of claim 1, wherein expanding the expandable member comprises expanding the first balloon on the distal portion within the thoracic duct between the terminal valve and a next valve within the thoracic duct.

16. The method of claim 15, further comprising expanding the second balloon on the distal portion within the thoracic duct distally beyond the next valve.

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

introducing a distal portion of a tubular member through the patient'"'"'s venous system into a body lumen adjacent the terminal valve and ostium of the thoracic duct, the distal portion biased to a curvilinear configuration;

manipulating the tubular member until a distal tip of the distal portion enters the ostium of the thoracic duct;

further manipulating the tubular member to direct the distal portion into the thoracic duct until an expandable member on the distal portion passes through the terminal valve;

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

performing a medical procedure via the thoracic duct,

wherein the distal portion of the tubular member has a curvilinear shape in a relaxed state and terminates in the distal tip, and wherein a proximal portion of the tubular member comprises a distal end including a transition that tapers such that the distal portion has a smaller outer diameter along its length than the proximal portion;

wherein introducing the distal portion of the tubular member comprises;

introducing the distal portion of the tubular member into a patient'"'"'s vasculature via a percutaneous access site in the patient'"'"'s left internal jugular vein;

advancing the tubular member until the distal portion is disposed near a junction of the left internal jugular vein and the patient'"'"'s left subclavian vein and the proximal portion is disposed through the access site and in the left internal jugular vein; and

manipulating the tubular member to orient the distal tip towards the thoracic duct;

wherein further manipulating the tubular member comprises retracting the tubular member to direct the distal tip and the expandable member into the thoracic duct beyond a terminal valve of the thoracic duct; and

wherein expanding the expandable member comprises;

expanding a first balloon on the distal portion within the thoracic duct between the terminal valve and a next valve within the thoracic duct; and

expanding a second balloon on the distal portion within the thoracic duct distally beyond the next valve.

18. The method of claim 17, wherein the distal portion is at least partially straightened or otherwise supported while the tubular member is introduced into the patient'"'"'s vasculature and the tubular member is advanced until the distal portion is disposed within the junction of the left internal jugular vein and the left subclavian vein.

19. The method of claim 17, wherein the first and second balloons engage opposite sides of the next valve when expanded to enhance sealing the thoracic duct.