# US 11,298,449 B2 · Systems and methods for performing medical procedures involving accessing the lymphatic system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,298,449 B2 - Document ID: US11298449B2 - Status: Granted - Kind: B2 - Application number: 14/300,179 - Filed: 2014-06-09 - Published: 2014-12-11 - Granted: 2022-04-12 - Earliest claimed: 2013-06-08 - Assignees: Lxs, LLC - Applicants: Matthew J. Callaghan; Christian S. Eversull; Stephen A. Leeflang - Inventors: Matthew J. Callaghan; Christian S. Eversull; Stephen A. Leeflang - Web page: https://patentgrep.com/patent/US11298449B2 ## CPC - A61M 1/3653: {Interfaces between patient blood circulation and extra-corporal blood circuit} - A61M 25/0023: {by the form of the lumen, e.g. cross-section, variable diameter} - A61B 10/0045: {Devices for taking samples of body liquids} - A61M 1/3496: {Plasmapheresis; Leucopheresis; Lymphopheresis (A61M1/3472 takes precedence)} - A61M 1/3609: {Physical characteristics of the blood, e.g. haematocrit, urea} - A61M 1/3615: {Cleaning blood contaminated by local chemotherapy of a body part temporarily isolated from the blood circuit} - A61M 1/3659: {Cannulae pertaining to extracorporeal circulation} - A61M 1/367: {Circuit parts not covered by the preceding subgroups of group A61M1/3621} - A61B 5/6852: {Catheters} - A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)} - A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)} - A61M 25/0053: {having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid} - A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure} - A61M 25/0082: {Catheter tip comprising a tool} - A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod} - A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)} - 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}) - A61M 2025/0042: {Microcatheters, cannula or the like having outside diameters around 1 mm or less} - A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector} - A61M 2025/1079: {having radio-opaque markers in the region of the balloon} - A61M 2202/0405: Lymph - A61M 2205/3306: Optical measuring means - A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means - A61M 2230/207: hematocrit - A61M 2230/208: pH-value - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract System and methods are provided for treating a patient that include a delivery device sized for introduction into a target site within a patient's body, a source of one or more therapeutic and/or diagnostic agents coupled to the delivery device, and a tubular member sized for introduction into the patient's vasculature to isolate the thoracic duct. Once the thoracic duct is isolated, fluid may be removed from the thoracic duct, e.g., to prevent the agents that transit from the target site into the thoracic duct from entering the patient's vasculature, and/or to modulate flow through the thoracic duct to modulate concentration and/or resident time of the agents at the target site. The one or more agents may include particles sized for preferential transit into the lymphatic system. ## Claims ### Claim 1 A method for treating a patient having a body including vasculature and a lymphatic system including a thoracic duct, comprising: injecting one or more therapeutic agents directly into a target treatment site outside the lymphatic system within the patient's body, the one or more therapeutic agents comprising particles sized for preferential transit into the lymphatic system; introducing a distal end of a tubular member into the vasculature via a percutaneous access site; advancing the tubular member until the distal end of the tubular member is disposed within a junction of a left internal jugular vein and left subclavian vein and adjacent the thoracic duct; sealing the thoracic duct using the distal end of the tubular member to isolate the thoracic duct from the junction; and removing fluid from the thoracic duct through the tubular member to a location exterior to the patient's body, thereby removing particles from the one or more therapeutic agents that have transited into the thoracic duct. ### Claim 2 (depends on 1) The method of claim 1, wherein the particles have an outer cross-section larger than thirty nanometers (30 nm). ### Claim 3 (depends on 2) The method of claim 2, wherein the particles have an outer cross-section smaller than one hundred nanometers (100 nm). ### Claim 4 (depends on 1) The method of claim 1, wherein the one or more therapeutic agents comprise a chemotherapy agent encapsulated within a lipid membrane. ### Claim 5 (depends on 1) The method of claim 1, further comprising: removing the particles from the removed fluid via one or more external components exterior to the patient's body; and returning at least a portion of the removed fluid from the one or more external components into the thoracic duct through the tubular member after removing the particles. ### Claim 6 (depends on 1) The method of claim 1, wherein sealing the thoracic duct comprises: manipulating the tubular member to direct the distal end into the thoracic duct; and expanding an expandable member on the distal end to isolate the thoracic duct from the patient's vasculature. ### Claim 7 (depends on 1) The method of claim 1, further comprising analyzing the removed fluid to detect whether the one or more therapeutic agents are present in the removed fluid, thereby identifying when the one or more therapeutic agents have transited into the thoracic duct. ### Claim 8 (depends on 7) The method of claim 7, wherein the removed fluid is analyzed to determine a concentration of the one or more therapeutic agents in the removed fluid. ### Claim 9 (depends on 8) The method of claim 8, further comprising returning the removed fluid into the patient's body before the one or more therapeutic agents have been detected in the removed fluid. ### Claim 10 (depends on 1) The method of claim 1, further comprising controlling a flow rate of fluid removed from the thoracic duct to control a resident time of the one or more therapeutic agents at the target treatment site. ### Claim 11 (depends on 1) The method of claim 1, wherein the target treatment site comprises a tumor. ### Claim 12 (depends on 1) The method of claim 1, wherein injecting the one or more therapeutic agents comprises injecting one or more chemotherapy agents into the target treatment site to treat cancer at the target treatment site. ### Claim 13 A method for treating a patient having a body including a lymphatic system including a thoracic duct, comprising: injecting a therapeutic agent into interstitial tissue adjacent a target site within a patient's body outside the thoracic duct, the therapeutic agent sized for preferential transit into the lymphatic system; and subsequently modulating flow from the thoracic duct to modulate one or both of resident time and concentration of the therapeutic agent within the tissue at the target site. ### Claim 14 (depends on 13) The method of claim 13, wherein the therapeutic agent moves into, remains within, or transits within the lymphatic system from the target site. ### Claim 15 (depends on 13) The method of claim 13, wherein modulating flow from the patient's thoracic duct comprises collecting lymph from the thoracic duct, the method further comprising: monitoring agent concentration within the collected lymph; and discontinuing collecting lymph when the agent concentration reaches a predetermined threshold. ### Claim 16 (depends on 15) The method of claim 15, wherein collecting lymph comprises: introducing a tubular member into vasculature within the patient's body; using the tubular member to isolate the thoracic duct from the vasculature; and collecting the lymph from the thoracic duct using the tubular member. ### Claim 17 A method for treating a patient having a body including a lymphatic system including a thoracic duct, comprising: injecting one or more therapeutic agents into interstitial tissue within the patient's body outside the thoracic duct, the one or more therapeutic agents sized for preferential transit into the lymphatic system; and modulating lymph output from the thoracic duct to manipulate delivery of the one or more therapeutic agents within the patient's body. ### Claim 18 (depends on 17) The method of claim 17, wherein modulating lymph output comprises at least one of modulating flow and volume of lymph from the thoracic duct. ### Claim 19 (depends on 17) The method of claim 17, wherein modulating lymph output comprises modifying or eliminating a natural return path of lymph into a venous system of the patient's body. ### Claim 20 (depends on 17) The method of claim 17, wherein modulating lymph output comprises: introducing a tubular member into vasculature within the patient's body; using the tubular member to isolate the thoracic duct from the vasculature; and selectively removing lymph from the thoracic duct using the tubular member. ### Claim 21 (depends on 17) The method of claim 17, wherein the interstitial tissue is located in or around a tumor. ### Claim 22 (depends on 21) The method of claim 21, wherein the tumor is located in one of the patient's breast, ovary, lung, and gastrointestinal (GI) tract.