WO2022178523A1 - Lymphatic access, drainage, and shunting - Google Patents

Lymphatic access, drainage, and shunting Download PDF

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Publication number
WO2022178523A1
WO2022178523A1 PCT/US2022/070709 US2022070709W WO2022178523A1 WO 2022178523 A1 WO2022178523 A1 WO 2022178523A1 US 2022070709 W US2022070709 W US 2022070709W WO 2022178523 A1 WO2022178523 A1 WO 2022178523A1
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WO
WIPO (PCT)
Prior art keywords
catheter
needle
drainage
lymphatic
fluid
Prior art date
Application number
PCT/US2022/070709
Other languages
French (fr)
Inventor
Jeremy Koehler
Glen Rabito
Joseph Passman
Elliot HOWARD
Alexander Siegel
Robert C. Taft
Original Assignee
Nxt Biomedical, Llc
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Publication date
Priority claimed from US202163151519P external-priority
Application filed by Nxt Biomedical, Llc filed Critical Nxt Biomedical, Llc
Publication of WO2022178523A1 publication Critical patent/WO2022178523A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B17/3439Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3415Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters

Abstract

Several embodiments and methods are described for draining a lymphatic system for therapeutic purposes. The lymphatic draining can be performed by removal of fluid from the lymphatic system via a needle, a catheter, an access port, a reservoir, or a combination of these devices. The drainage devices can be configured for use during only a single procedure or for reoccurring procedures.

Description

LYMPHATIC ACCESS, DRAINAGE, AND SHUNTING
RELATED APPLICATIONS
[0001] This application claims benefit of and priority to U.S. Provisional Application Serial No. 63/151 ,519 filed February 19, 2021 entitled Lymphatic Access, Drainage, And Shunting·, U.S. Provisional Application Serial No. 63/211 ,993 filed June 17, 2021 entitled Lymphatic Drainage; U. S. Provisional Application Serial No. 63/223,912 filed July 20, 2021 entitled Lymphatic Access, Drainage, And Shunting; and U.S. Provisional Application Serial No. 63/264,771 filed December 1 , 2021 entitled Lymphatic Drainage; all of which are hereby incorporated herein by reference in their entireties.
BACKGROUND OF THE INVENTION
[0002] Chronic and acute congestive heart failure (CHF) generally occurs when the heart is incapable of circulating an adequate blood supply to the body. This is typically due to inadequate cardiac output, which has many causes. In CHF decompensation fluids back up in a retrograde direction through the lungs and venous/lymphatic systems throughout the body, causing discomfort and organ dysfunction. Many diseases can impair the pumping efficiency of the heart to cause congestive heart failure, such as coronary artery disease, high blood pressure, and heart valve disorders.
[0003] In addition to fatigue, one of the prominent features of congestive heart failure is the retention of fluids within the body. Commonly, gravity causes the retained fluid to accumulate to the lower body, including the abdominal cavity, liver, and other organs, resulting in numerous related complications. Fluid restriction and a decrease in salt intake can be helpful to manage the fluid retention, but diuretic medications are the principal therapeutic option, including furosemide, bumetanide, and hydrochlorothiazide. Additionally, vasodilators and inotropes may also be used for treatment.
[0004] While diuretics can be helpful, they are also frequently toxic to the kidneys and if not used carefully can result in acute and/or chronic renal failure. This mandates careful medical management while in a hospital, consuming large amounts of time and resources. Hence, the ability to treat fluid retention from congestive heart failure without the need for toxic doses of diuretics would likely result in better patient outcomes at substantially less cost.
[0005] Fluid retention is not limited only to CHF. Conditions such as organ failure, cirrhosis, hepatitis, cancer, ascites, and infections can cause fluid buildup within the body.
[0006] In this regard, what is needed is an improved treatment option for fluid buildup in the body, whether that buildup is caused by CHF, cirrhosis, organ failure, cancer, infections, or other underlying diseases.
SUMMARY OF THE INVENTION
[0007] The present invention is generally directed to different embodiments and methods of accessing, draining, and/or shunting a lymphatic system for therapeutic purposes.
[0008] Some embodiments include a catheter having one or more of the following features: anchoring features (e.g., radially enlarged shapes, one or more inflatable balloons, one or more expandable structures, or one or more hooks), curved or shaped distal ends, radially expandable distal ends, one or more magnets, one or more sensors, attached access ports, one or more valves, an attached reservoir, an attached fluid supply, an attached pump, a stylet, a snare, sensor to sense connection of catheter segments, multiple distal guidewire openings, a balloon within a drainage lumen, a valve within a drainage lumen, a vibration element, a vibrating guidewire, a pressurized fluid supply, a disruption lumen, a deflectable member, and/or a perfusion passage.
[0009] Some embodiments include an implantable marker device that may include a marker wire configured to be grasped by a snare.
[0010] Some embodiments include a needle or cannula that includes one or more of the following: and expandable diameter, an outer sheath, a pressure source connected to an outer sheath, a biased outer sheath, a patch with a needle guide, a needle with expandable elements to anchor or limit forward movement, a balloon, an inner wire having a secondary shape when unrestrained, a plurality of holes, an outer sheath with a plurality of holes, a stylus, and/or a stylus with a plurality of holes.
[0011] Some embodiments include a method of access including one or more of the following: direct lymphatic system access, lymphatic system access via a venous vessel, lymphatic access via needle, lymphatic access via catheter, lymphatic access via an access port, lymphatic access via a reservoir, lymphatic drainage during a single procedure, lymphatic drainage during several different procedures, and/or lymphatic pumping.
[0012] Some embodiments include a system for accessing, re-accessing, and draining lymphatic fluid including one or more of the following elements: one or more catheters, one or more needles, one or more ports, one or more sensors, one or more reservoirs, one of more markers, one or more filters, one or more valves, one or more stylets, and/or a suction source.
[0013] Some embodiments include a needle system having one or more of the following elements: stylet, sheath, wire, wire assembly, balloon, cannula, port, vibration element, cryotherapy element, and a pressure source.
[0014] Some embodiments include a drainage system having one or more of the following elements: drainage catheter with one or more lumens, wire, sheath, valve, fluid source, reservoir, fluid restrictor, stylet, clamp, balloon, sensor, fluid fittings, port, access device.
[0015] Some embodiments include a method of removing fluid including one or more of the following: identifying a lymphatic vessel, draining fluid from the lymphatic vessel, and compressing a body region to facilitate removal fluid from the body.
[0016] Some embodiments include a method of removing fluid including one or more of the following: identifying a lymphatic vessel, draining fluid from the lymphatic vessel, and compressing a body region to facilitate removal fluid from the body. BRIEF DESCRIPTION OF THE DRAWINGS
[0017] These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which:
[0018] Fig. 1 is a view of anatomy in and around a thoracic duct.
[0019] Fig. 2 is a view of a needle entry location to a lymphatic structure.
[0020] Fig. 3 is a view of a needle entry location to a thoracic duct.
[0021] Fig. 4 is a view of a catheter within a thoracic duct.
[0022] Fig. 5 is a view of a catheter within a thoracic duct.
[0023] Fig. 6 is a view of a catheter within a cisterna chyli.
[0024] Fig. 7 is a view of a needle.
[0025] Fig. 8 is a view of a needle within a thoracic duct.
[0026] Fig. 9 is a view of a catheter within a patient.
[0027] Fig. 10 is a view of a guidewire within a patient.
[0028] Fig. 11 is a view of an implanted catheter.
[0029] Fig. 12 is a view of an implanted guidewire.
[0030] Fig. 13 is a view of a first and second catheters in a patient.
[0031] Fig. 14 is a view of an implanted catheter.
[0032] Fig. 15 is a view of a catheter within a patient.
[0033] Fig. 16 is a view of a catheter within a patient.
[0034] Fig. 17 is a view of a catheter within a patient.
[0035] Fig. 18 is a view of an implanted marker. [0036] Fig. 19 is a view of an implanted marker.
[0037] Fig. 20 is a view of a catheter within a patient.
[0038] Fig. 21 is a view of a marker.
[0039] Fig. 22 is a view of a marker within a patient.
[0040] Fig. 23 is a view of a snare catheter.
[0041] Fig. 24 is a view of an implanted catheter.
[0042] Fig. 25 is a view of an implanted catheter.
[0043] Fig. 26 is a view of a catheter with magnetic connector.
[0044] Fig. 27 is a view of a catheter with a magnetic connector.
[0045] Fig. 28 is a view of two catheters with magnetic connectors.
[0046] Fig. 29 is a view of two catheters with an electrical circuit.
[0047] Fig. 30 is a view of a catheter in a patient.
[0048] Fig. 31 is a view of a catheter in a patient.
[0049] Fig. 32 is a view of a catheter in a patient.
[0050] Fig. 33 is a view of a catheter.
[0051] Fig. 34 is a view of a catheter.
[0052] Fig. 35 is a view of a catheter.
[0053] Fig. 36 is a view of a catheter.
[0054] Fig. 37 is a view of a catheter.
[0055] Fig. 38 is a view of an infusion catheter in a patient.
[0056] Fig. 39 is a view of a needle system with a stylet. [0057] Fig. 40 is a view of a needle system with a stylet.
[0058] Fig. 41 is a view of a needle system with a stylet.
[0059] Fig. 42 is a view of a needle system with a sheath.
[0060] Fig. 43 is a view of a needle system with a sheath.
[0061] Fig. 44 is a view of a needle system with a sheath and suction source.
[0062] Fig. 45 is a view of a needle system with a spring-loaded sheath.
[0063] Fig. 46 is a view of a patch device for needle guidance.
[0064] Fig. 47 is a view of a patch device for needle guidance with adjustable interface feature.
[0065] Fig. 48 is a view of a needle system with securing features.
[0066] Fig. 49 is a view of a needle system within a thoracic duct.
[0067] Fig. 50 is a view of a needle system within a thoracic duct.
[0068] Fig. 51 is a view of a needle device with a balloon anchor with securing features.
[0069] Fig. 52 is a view of a needle device with a balloon anchor.
[0070] Fig. 53 is a view of a needle device with a balloon anchor.
[0071] Fig. 54 is a view of a needle device with two balloon anchors.
[0072] Fig. 55 is a view of a needle system within a thoracic duct.
[0073] Fig. 56 is a view of a needle system with a sheath and balloon anchor.
[0074] Fig. 57 is a view of a needle device in a patient.
[0075] Fig. 58 is a view of a needle.
[0076] Fig. 59 is a view of a shaped wire. [0077] Fig. 60 is a view of a needle and shaped wire.
[0078] Fig. 61 is a view of a needle and shaped wire.
[0079] Fig. 62 is a view of a needle and shaped wire in a patient.
[0080] Fig. 63 is a view of a shaped wire.
[0081] Fig. 64 is a view of a shaped wire.
[0082] Fig. 65 is a view of a shaped wire.
[0083] Fig. 66 is a view of a shaped wire.
[0084] Fig. 67 is a view of a shaped wire.
[0085] Fig. 68 is a view of a shaped wire.
[0086] Fig. 69 is a view of a shaped wire.
[0087] Fig. 70 is a view of a shaped wire.
[0088] Fig. 71 is a view of a shaped wire.
[0089] Fig. 71 is a view of a shaped wire.
[0090] Fig. 72A is an end view of a shaped wire.
[0091] Fig. 72B is a side view of a shaped wire from Fig. 72A. [0092] Fig. 73A is an end view of a shaped wire.
[0093] Fig. 73B is a side view of a shaped wire from Fig. 73A. [0094] Fig. 74 is a view of a needle with a cryotherapy element.
[0095] Fig. 75 is a view of a stylet and shaped cannula system.
[0096] Fig. 76 is a view of a stylet and shaped cannula system.
[0097] Fig. 77 is a view of a shaped cannula. [0098] Fig. 78 is a view of a shaped cannula.
[0099] Fig. 79 is a view of a shaped cannula.
[00100] Fig. 80 is a view of a needle/cannula.
[00101] Fig. 81 is a view of a hollow stylet.
[00102] Fig. 82 is a view of a needle assembly within the thoracic duct of a patient.
[00103] Fig. 83 is a view of a hollow stylet.
[00104] Fig. 84 is a view of a needle system within the thoracic duct of a patient.
[00105] Fig. 85 is a view of a catheter with multiple lumens.
[00106] Fig. 86 is a view of a catheter with multiple lumens.
[00107] Fig. 87 is a view of a catheter with a valve.
[00108] Fig. 88 is a view of a catheter with a drainage tube and clamp.
[00109] Fig. 89 is a view of a catheter with a drainage lumen and vibrating element.
[00110] Fig. 90 is a view of a catheter system with a guidewire and vibration element.
[00111] Fig. 91 is a view of stylet with a spiral cutout.
[00112] Fig. 92 is a view of a catheter system with a valve and pressurized fluid source.
[00113] Fig. 93 is a view of a catheter with multiple lumens and a pressurized fluid source.
[00114] Fig. 94 is a view of a catheter with multiple lumens and a pressurized fluid source.
[00115] Fig. 95 is a view of a catheter with multiple lumens, a valve, a pressurized fluid source. [00116] Fig. 96 is a view of a catheter with a pressure sensor.
[00117] Fig. 97 is a view of a catheter with a flow sensor.
[00118] Fig. 98 is a view of catheter with two pressure sensors.
[00119] Fig. 99A is an end view of a catheter with two lumens.
[00120] Fig. 99B is a side view of the catheter from Fig. 99A.
[00121] Fig. 100A is an end view of a catheter with two lumens.
[00122] Fig. 100B is a side view of the catheter of Fig. 100A.
[00123] Fig. 101 A is an end view of a catheter system with a catheter with two lumens and a stylet.
[00124] Fig. 101 B is a side view of the catheter system of Fig. 101 A.
[00125] Fig. 102A is a view of a drainage catheter system within the thoracic duct of a patient.
[00126] Fig. 102B is a view of a drainage catheter system within the thoracic duct of a patient.
[00127] Fig. 102C is a view of a drainage catheter system within the thoracic duct of a patient.
[00128] Fig. 103A is a view of a drainage catheter system within the thoracic duct of a patient.
[00129] Fig. 103B is a view of a drainage catheter system within the thoracic duct of a patient.
[00130] Fig. 103C is a view of a drainage catheter system within the thoracic duct of a patient.
[00131] Fig. 104A is a view of a drainage catheter system within the thoracic duct of a patient. [00132] Fig. 104B is a view of a drainage catheter system within the thoracic duct of a patient.
[00133] Fig. 105A is a view of a drainage catheter system within the thoracic duct of a patient.
[00134] Fig. 105B is a view of a drainage catheter system within the thoracic duct of a patient.
[00135] Fig. 105C is a view of a drainage catheter system within the thoracic duct of a patient.
[00136] Fig. 105D is a view of a drainage catheter system within the thoracic duct of a patient.
[00137] Fig. 105E is a view of a drainage catheter system within the thoracic duct of a patient.
[00138] Fig. 105F is a view of a drainage catheter system within the thoracic duct of a patient.
[00139] Fig. 106A is a view of a drainage catheter with deflection member.
[00140] Fig. 106B is a view of a drainage catheter with deflection member.
[00141] Fig. 107 illustrates a flow chart for a method of identifying and draining a thoracic duct.
[00142] Fig. 108 illustrates a flow chart for a method of draining a lymphatic structure aided by compression.
DESCRIPTION OF EMBODIMENTS
[00143] Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.
[00144] The present specification is directed to several different embodiments and methods related to drainage of the lymphatic system. While aspects of each embodiment and method are presented individually for clarity, the intent of the specification is that any embodiments, elements of the different embodiments, and methods can be combined and used interchangeably with each other without limitation, unless specified otherwise. Hence, while embodiments with specific combinations of steps or features may not be described, such combinations are contemplated and intended to be encompassed by the present specification.
[00145] This specification is directed to several different treatment devices and methods of use. Some of these devices and methods may be performed via direct access to a lymphatic structure (e.g., any part of the lymphatic system, such as portion of the thoracic duct, right thoracic duct, cisterna chyli, lymph node, lymphatic vessel, or collecting lymphatic structure). Any methods and embodiments described elsewhere in this specification can be used with these treatment techniques unless specifically indicated otherwise. Also, additional explanation and embodiments that can be used with and according to the those in the present specification can be found in U. S. Pub. No. 2020/0054867 entitled System And Method For Treatment Via Bodily Drainage Or Injection, and in PCT Pub. No. WO 2021/146589 entitled Lymphatic Access, Drainage, and Shunting, the contents of which are hereby incorporated by reference.
[00146] Fig. 1 illustrates several locations within the body that may be of particular relevance when performing the direct access techniques that follow. As seen in Fig. 1 , the thoracic duct 20 has an opening into the left subclavian vein 10, near the left internal jugular 14 and right brachiocephalic vein 12. While the thoracic duct is shown with an opening into the left subclavian vein in Fig. 1 , in some patients it may have an opening into the left internal jugular vein, an opening into the junction between the left subclavian vein, external jugular vein, vertebral vein, and the internal jugular vein, or a plurality of branches at its distal end that may terminate into one or more of the aforementioned veins or confluences thereof. The thoracic duct 20 includes a plurality of internal valves 24, as well as a terminal valve 22 at the interface or annulus with the left subclavian vein 10. The thoracic duct 20 includes an upper cervical portion 20A and a lower thoracic portion 20B that is connected to the cisterna chyli 26.
[00147] In one example method, an access device such as a needle 110 is advanced through the skin and directly into a lymphatic structure of a patient in order to remove lymphatic fluid from the structure. For example, the needle 110 may be advanced through the skin of a patient and directly into a lymph node, a thoracic duct, a right thoracic duct, a renal lymphatic vessel, and/or the cisterna chyli. The thoracic duct may be accessed in its cervical portion (e.g., above the brachiocephalic vein) or in its thoracic potion (e.g., below the brachiocephalic vein and above the diaphragm). For simplicity, the thoracic duct 20 will be used as an example of a lymphatic structure; however, any lymphatic structure may be used without deviating from the present invention. Fig. 2 illustrates three such example access sites in which the needle 110 is advanced into the upper cervical portion 20A (also shown in Fig. 3), the lower thoracic portion 20B, or the cisterna chyli 26 (or even combinations thereof).
[00148] In order to confirm the thoracic duct 20 is successfully accessed, suction is applied to the needle 110 to withdraw fluid from the target structure into the needle 110. The fluid may then be identified by one or more properties including but not limited to color, pH, viscosity, impedance, salinity, and presence or absence of constituents such as red blood cells. Additionally, the fluid may be identified by analysis for the concentration of one or more constituents such as lipids, triglycerides, lymphocytes, or leukocytes.
[00149] In another example method, a needle 110 with a sensor 124 at its distal tip is advanced into a thoracic duct 20 in order to confirm that the thoracic duct 20 was successfully accessed. The sensor 124 may directly measure one or more physical properties of the fluid including but not limited to color, pH, viscosity, impedance, and salinity, or one or more properties of the thoracic duct 20 including but not limited to pressure, orientation, compliance, presence of valves, contractile motion, and size.
[00150] In one example method, a needle 110 is advanced into a thoracic duct and, in order to confirm the thoracic duct was successfully accessed, a contrast agent such as Lipiodol (Guerbet) or IsoView (Bracco Diagnostics) is injected through the needle and into the target structure. X-Ray or fluoroscopy is then used to directly visualize the internal anatomy of the structure and determine whether the correct structure was successfully accessed.
[00151] In another example method, a contrast agent such as Lipiodol may be injected into a lymph node and allowed to spread throughout the lymphatic network. The lymphatic network may then be visualized using X-ray or fluoroscopy to determine a suitable location to access the desired lymphatic structure. For example, if a thoracic duct 20 contains numerous small branches in the cervical portion 20A (plexiform anatomy), an access device may be inserted into the thoracic portion 20B or into the cisterna chyli 26. Alternatively, instead of X-ray or fluoroscopy, ultrasound may alternatively be used to identify the anatomy of the lymphatic network to identify a desired access location.
[00152] After confirmation that the thoracic duct has been accessed, a guidewire may be advanced through the needle 110 and into the thoracic duct 20. The needle 110 may be removed and a catheter 116 with one or more lumens may be advanced over the guidewire. Once the catheter 116 is in place, lymphatic fluid may be drained through the one or more lumens within the catheter’s body. Depending on the access site and direction, a distal end of the catheter 116 may be advanced in an antegrade or retrograde direction to a location within the upper cervical portion 20A as seen in Fig. 4 (e.g., between the final two, three, or four valves 24), in the lower thoracic portion 20B of the thoracic duct 20 as seen in Fig. 5, or in the cisterna chyli 26 as seen in Fig. 6. The catheter 116 may, for example, be a length within a range inclusive of about 5 centimeters (cm) and 150 cm (5cm, 10cm, 15cm, 20cm, 25cm, 30cm, 35cm, 40cm, 45cm, 50cm, 55cm, 60cm, 65cm, 70cm, 75cm, 80cm, 85cm, 90cm, 95cm, 100cm, 105cm, 110cm, 115cm, 120cm, 125cm, 130cm, 135cm, 140cm, 145cm, or 150cm).
[00153] In order to guide an access device to its intended location, imaging techniques such as ultrasound, CT, or MRI may be used with or without the aid of contrast agents. For example, the target structure may be identified using an ultrasound probe based on relevant anatomical landmarks such as a vein or confluence of veins or physiologic features such as flow patterns of fluid inside the structure, motion of the structure, or presence of one or more valves within the structure. In one example, a needle device 118 includes an elongated needle portion 120 and a passage therethrough (Fig. 7), which may be advanced through the skin and into the field of view of an ultrasound probe (Fig. 8). The needle 118 includes echogenic properties (e.g., composed of echogenic material or that includes an echogenic member on the tip of the needle, a band, coating, sleeve, layer, etc.) so that it can be visualized during the procedure. Optionally, the tip of the needle may also include a sensor 124, as previously described (e.g., for color, pH, viscosity, impedance, and salinity). The tip of the needle portion 120 may be tracked in real time as the operator advances into the target structure.
[00154] In one example method and system shown in Figs. 9-12, fluid may be removed from a lymphatic system by initially passing a guidewire 117 and/or first catheter 119 from a lymphatic structure and then out a patient’s skin where additional components, catheters, and/or access devices can be connected for use with drainage.
[00155] For example, a first catheter 116 and guidewire 117 may be inserted into a vein of a patient and advanced into the desired lymphatic structure as described elsewhere in this application and incorporated references. In the present example of Fig. 9, both components are advanced into the thoracic duct 20, though any lymphatic structure may be used.
[00156] The guidewire 117 may then be advanced through the wall of the lymphatic structure (e.g., thoracic duct 20) and into the surrounding tissue. Additionally or alternatively, the catheter 116 may be comprised of a lumen for accepting the guidewire 117 and directing the guidewire 117 away from the body of the catheter and into the surrounding space (e.g., through a tissue vessel wall or into adjacent space within a vessel). The distal end of the lumen may be at least partially comprised of a ramp or curve with an outlet angled away from the axis of the catheter 116.
[00157] Alternatively, the first catheter 116 may be used to pierce or assist in piercing the lymphatic structure or enlarging any opening created by the guidewire 117. [00158] Next, an incision may be made in the skin 11 , and the guidewire 117 may then be identified and captured. Optionally, the first catheter 116 may be removed and the position of the guidewire 117 may be adjusted, depending on the procedure, or left in to provide a secondary drainage passage. Alternatively, the first catheter 116 may be used to insert a second guidewire 117 from the skin/incision area into the lymphatic structure so that the first guidewire 117 and first catheter 116 can be removed.
[00159] As seen in Fig. 10, a second drainage catheter 119 may then be advanced over the guidewire 117 and into the lymphatic structure (e.g., thoracic duct 20), and lymphatic fluid may be drained by the second drainage catheter 119, the first catheter 166 if left in the patient, or both catheters 116, 119.
[00160] If desirable, a re-access device 244 may be implanted or connected for repeat access and drainage to the lymphatic structure. The re-access device 244 may be an internal or external needle or catheter access port with its own tubular components or may be attached to the proximal end of the catheter 119. For example, Fig. 11 illustrates a re-access device 244 implanted underneath the skin 11 of the patient and accessed using a needle.
[00161] Additionally or alternatively as shown in Fig. 12, following draining lymphatic fluid, the catheter 119 may be removed, and the guidewire 117 may be left in the subcutaneous tissue. When additional lymphatic fluid is desired to be removed, a small incision may be made in the skin 11 to capture the guidewire 117, and a drainage catheter 119 may be advanced over the wire 117 and into the lymphatic structure to drain lymphatic fluid. If the guidewire 117 is entrapped in tissue, laser excimer or mechanical boring catheters may be used to free the guidewire 117 and re-establish a desirable working length. If additional guidewire length is needed, an additional guidewire may be attached to the implanted guidewire by means such as crimping or attachment with a connector (e.g., Tuohy Borst connector, metal or plastic collar).
[00162] Additionally or alternatively, second catheter 119 may be comprised of means of sealing the hole left in the thoracic duct after removal, such as metal flanges (e.g., nitinol, steel, stainless steel), coated metal flanges, metal clips (e.g., nitinol, steel, stainless steel), coated metal clips, or other closure device as discussed elsewhere in this application and the incorporated references.
[00163] In one example, a re-access device 244 may be connected to an endocardial lead for pacing. Re-access device 244 may be connected to an in dwelling venous catheter portion for therapeutic delivery of therapeutic agents (e.g., chemotherapy agents, stem cell agents, blood constituents, diuretic agents, etc.) or hemodialysis therapy. Re-access device 244 may have an in-dwelling pressure monitor antenna with a capacitive or piezoelectric pressure transducer and may be located in the lymphatic or venous space.
[00164] In another method, a first catheter can be introduced first into a lymphatic structure (e.g., thoracic duct 20) and may facilitate or direct a second catheter with a shorter access path (i.e. , enters closer) to the desired target location in the lymphatic structure.
[00165] A first catheter 116A and guidewire 117A may be inserted into the vein of a patient at a traditional catheter entry point (e.g., in the arm) and advanced into the desired lymphatic structure (e.g., through the left subclavian vein 10, through the terminal valve 22, and into the thoracic duct 20) as described elsewhere in this specification. A second catheter 116B and guidewire 117B may be inserted into the same or different vein of a patient at a location much closer to the entry into the lymphatic structure and then advanced into the lymphatic structure.
[00166] The presence of the first catheter/guidewire may serve as a guide to facilitate navigation of the second catheter/guidewire. For example, the presence of a first catheter 116A alone may help deflect or guide the second catheter 116B into the lymphatic structure. However, the first catheter 116A may also have features that assist in this deflection, such as a longitudinal groove on its outer body surface, an expandable barrier that expands in width, or similar features.
[00167] Lymphatic fluid may be drained through either catheter 116A, 116B. A re access device 244 (e.g., an internal or external port) may be attached to the proximal end of the second catheter 116B for repeat access and drainage. In the example of Fig. 14, the re-access device 244 is implanted underneath the skin 11 of the patient and accessed using a needle. The venous access location for the second catheter 116B and guidewire 117B may be determined based on a suitable location for implanting a re-access device (e.g., neck, back, chest, arm).
[00168] A marker device may also be used according to any of the methods of this specification. For example, the marker device can be placed within the patient, in or near a lymphatic structure to allow its location to be repeatably identified to re-access. The marker may be identified using any visualization means known to one skilled in the art, including but not limited to ultrasound, fluoroscopy, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or X-Ray. The marker may be comprised of one or more materials suitable for visualization using one or more imaging modalities including but not limited to steel, stainless steel, aluminum, chromium, barium, iodine, gadolinium, alloys or composite materials containing one or more of these materials, plastics, plastics with one or more radiopaque or fluorogenic additives such as barium, or plastics with one or more MRI contrast agents such as gadolinium.
[00169] In one example, at least part of the marker may comprise an anchor shape, such as a clip, staple, t-tag, or barbed anchor. The marker may also comprise a tubular stent shape (e.g., mesh or laser cut tube), a partial tubular structure (e.g., a cross sectional “C” shape), or a tubular frame formed from a plurality of struts/rings creating the outline of a cylinder.
[00170] Alternatively, the marker may also be an adhesive patch or ink-based injection. The marker may further be partially or fully comprised of a magnetic material to help with both visualization and detection of its magnetic fields via a sensor.
[00171] The previously described markers may further comprise a section of marker wire attached to it to help with visualization. For example, a wire attached to and extending away from a tubular stent shape, a wire attached to and extending away from a barb anchor, and/or a wire attached to and extending away from an Ί” shaped anchor. The wire of these embodiments may be partially or fully comprised of a magnetic material or other visualization materials previously discussed.
[00172] In another example, the marker may contain a sensor to measure one or more physiologic parameters including but not limited to pressure, flow rate, temperature, pH, salinity, and water content. The sensor may be battery-powered or inductively-powered by placing a coil above the marker. The sensor data may be transmitted wirelessly to a receiver exterior to the body to record and display the data.
[00173] Fig. 15 illustrates the use of one such marker 130 having a marker wire 132 which allows it to be later retrieved and/or engaged so that a drainage catheter can be advanced to its location. The marker 130 (or marker anchor structure) may take the form of any of the previously described markers but is depicted in Fig. 15 as a generally tubular, stent-like framework (e.g., a plurality of laser cut or braided wires/struts). Further, a marker wire 132 may be attached to the marker 130.
[00174] Initially, the marker 130 may be delivered into the lymphatic system (e.g., thoracic duct 20) at a desired location, optionally as part of an initial lymphatic fluid drainage procedure. The wire 132 may be long enough to extend out from the lymphatic system and into a vessel. In Fig. 15, the wire 132 is positioned such that it extends out of the terminal valve 22 and into the left subclavian vein 10.
[00175] When a drainage procedure is to be performed, a snare catheter 127 (e.g., with an end loops 127A) may be used to capture or snare the end of the wire 132 and pull it into an overlying drainage catheter 116. As seen in Fig. 16, the drainage catheter may be advanced over the wire 132 and therefore relatively easily into the lymphatic system (in this case the thoracic duct 20) until its distal end reaches a desired drainage location. This location may be judged by visualization of the marker 130, if helpful to the physician. At that time, drainage of lymph fluid may commence.
[00176] Additionally or alternatively, the drainage catheter 116 may be comprised of two or more lumens to accommodate the snare catheter 127 and a guidewire 117 simultaneously. Following introduction of the drainage catheter 116 into the lymphatic structure along the snare catheter 127, the guidewire 117 may be advanced through the drainage catheter 116 and into the thoracic duct 20 and further into the desired lymphatic structure (e.g., upper cervical portion 20A). The snare catheter 127 may release the wire 132 and be removed. The drainage catheter 116 may then be further advanced over the guidewire 117 and advanced past the marker 130 into the desired lymphatic vessel and drain lymphatic fluid as shown in Fig. 17. [00177] Additionally or alternatively, a lumen of catheter 116 may be comprised of a ramp to direct a guidewire 117 toward the outlet of the thoracic duct. The ramp may be comprised of nitinol, and the angle of the ramp may be adjustable, for example by heating the wire above its transition temperature.
[00178] The wire 132 may alternatively be placed in locations of tissue outside of a patient’s vessels. For example, Fig. 18 illustrates a similar example marker 130 and attached wire 132 as previously discussed in Figs. 16 and 17. Flowever, the wire 132 attached may traverse the terminal valve 22 of the thoracic duct 20, into the left subclavian vein 10, and then passing through the sidewall of the left subclavian vein 10. The distal end of the wire 132 may be positioned within the subcutaneous tissue near the skin 11 of a patient. When drainage is required, an incision may be made in the skin 11 and the distal end of the wire 132 may be externalized. A drainage catheter 116 may be advanced over the wire 132 and advanced toward the marker 130 and into the desired lymphatic structure.
[00179] While Figs. 15-17 disclose the use of a snare 127, other techniques of capturing the marker wire 132 are also possible. For example, at least a proximal end of the marker wire 132 and a distal end of a guidewire 117 may include materials configured to magnetically attract each other (e.g., both include magnetic material or one includes magnetic material while the other includes metal attracted to magnets, such as ferromagnetic metal).
[00180] A specific use of this technique can be seen in Figs. 19 and 20 in which the marker 130 is placed within the lymphatic structure (e.g., thoracic duct 20) and the marker wire 132 extends into a vessel (e.g., into the left subclavian vein 10). As seen in Fig. 19, the guidewire 117 is advanced toward the position of the marker wire 132. As seen in Fig. 20, the ends contact, causing the magnetic attraction to physically join the marker wire 132 and the guidewire 117. A catheter 116 may then be advanced over both and into the lymphatic structure (e.g., thoracic duct 20) where it can drain lymph fluid.
[00181] While the marker/wire arrangements have been discussed as having one marker 130 and one marker wire 132, other variations are possible. For example, one embodiment may include one marker 130 and a plurality of connected markers wires 132 extending from it, which may make it easier to snare at least one of the wires 132.
[00182] In another example, two markers 130 may be connected to one or more marker wires 132, as seen in Fig. 21. In use, the shapes may be placed in the same vessel such as the thoracic duct 20 or subclavian vein 10, or in different vessels, such as the thoracic duct 20 and the subclavian vein 10, as shown in FIG 22. This arrangement may prevent a free end of the marker wire 132 from becoming embedded or otherwise difficult to capture, especially due to blood flow. Flence, a snare catheter 127 may be configured to engage the marker wire 132, travel into the lymphatic structure (e.g., thoracic duct 20), and then allow a drainage catheter 116 to advance over the snare catheter 127 and into the lymphatic structure.
[00183] Fig. 23 illustrates an embodiment of a snare device that can be used with some of the previously described marker wires 132. The snare device may include a catheter 116 that may have two or more lumens 116F, 116G; one of which having a snare wire or snare catheter 127. The snare 127 may be comprised of a wire with one or more loops 127A at the distal end and a user interface on the proximal end (e.g., a handle). Optionally, the wire and/or loops 127A may be at least partially magnetic which may allow it to better capture an intended target.
[00184] The catheter 116 may be placed in a venous vessel in proximity to a wire (e.g., marker wire 132) exiting a lymphatic vessel with its distal end in the venous vessel. For example, the marker wire 132 may have been placed through a lymphatic vessel and into a venous vessel by direct needle access and passing the marker wire 132 through the needle and antegrade into the venous vessel as described elsewhere in this application and incorporated references or may be attached to a marker 130 placed in a lymphatic vessel as described elsewhere in this application and incorporated references. The snare 127 may capture the distal end of the marker wire 132 by being retracted into the lumen of the catheter 116 via the user interface portion and collapse the wire loops 127A to entrap the distal end of the wire (e.g., 132). The catheter 116 may then be advanced along the snare 127 and captured wire (e.g., 132) and into the lymphatic vessel. The second lumen 116G of the catheter 116 may then be used to pass a guidewire 117 through and into the lymphatic vessel. The guidewire 117 may be advanced to place its distal end in a desired location within a lymphatic structure and the snared wire (e.g., 132) may then be released so that the catheter 116 may be advanced past the proximal end of marker wire 132 within the lymphatic vessel.
[00185] In one embodiment and in combination with other disclosed embodiments, an access device such as a guidewire 117 or catheter 116 may contain echogenic or fluorogenic features such as marker bands or contain materials such as steel or barium to enhance visualization during navigation of the device or to confirm correct positioning following the placement of the device.
[00186] Fig. 31 in PCT application PCT/US21/13684, herein incorporated by reference in its entirety, illustrates an embodiment in which a catheter 116 (or similar access device) includes a distal end 116E with one or more simple or compound curves to align the tip of the catheter 116 more easily with the terminal valve 22 of the thoracic duct 20. The distal end 116E may be positioned within the subclavian vein 10 such that its distal opening is pointing at the terminal valve 117A. A flexible guidewire may be advanced through the lumen of the shaped catheter 116 to cross the terminal valve 22 and access the thoracic duct 20. After successfully accessing the thoracic duct, the distal end 116E of the catheter could be stiffened to maintain a desired shape to allow the passage of larger guidewires along the same trajectory.
[00187] The catheter may have a chamber filled with a material that could rapidly harden and maintain its current shape. This material may be a two-part epoxy that initially has a membrane separating the two parts. When the catheter is in the correct orientation, the membrane could be removed by a pull-wire integrated into the catheter and allow the two parts to mix and harden. Alternatively, the material may be a supersaturated mixture with a high concentration of a solute such that when initiation event occurs, the solute comes out of the solution and stiffens the remaining solution. Additionally or alternatively, the distal end 116E has a simple curve that curves only in a single direction, however, more complex curves with multiple different degrees and angles are also anticipated, such as the example of Fig. 32 in PCT application PCT/US21/13684 in which the distal end 116E curves in a first direction and then in an opposite direction. Three or more curves and/or angles are anticipated to achieve the desired orientation of the distal tip 116E of the catheter 116. [00188] In some embodiments, an indwelling catheter may be implanted within a location within the lymphatic system. This indwelling catheter may have an anchor (e.g., a stent-like anchor, balloon anchor, or similar device) that maintains its position within the lymphatic system. As previously discussed, the distal end of the indwelling catheter may be attached to a port that allows needle and/or catheter access via the skin of the patient. However, in some circumstances it may be desirable for the distal end of the catheter to remain in the vessel of a patient or even in the lymphatic system itself.
[00189] For example, Figs. 24 and 25 illustrate a re-access and drainage system comprised of an indwelling access catheter 116 and a removable/replaceable drainage catheter 119 that is configured to be advanced through venous vessels. The indwelling drainage catheter 116 may have a distal end positioned in a lymphatic vessel (e.g., thoracic duct 20) and a proximal end in a venous vessel (e.g., left subclavian vein 10) or in the tissue around the lymphatic vessel.
[00190] The indwelling drainage catheter 116 may be anchored in the lymphatic vessel using attachment mechanism described elsewhere in this application and one or more valves to prevent flow from the lymphatic vessel when drainage is not desired. The proximal end of the indwelling drainage catheter 116 may be located by tactile or visualization means such as ultrasound via ultrasound transducer 126. The re-access drainage catheter 119 may be advanced through the skin 11 and/or vessel and the distal end may be advanced to the proximal end of the indwelling drainage catheter 116. Once the two ends are in contact (Fig. 25), lymphatic fluid may be drained through both catheters to remove lymphatic fluid from the patient.
[00191] The two contact ends of the catheters 116, 119 may be configured to easily align and connect to each other. In the example of Figs. 26-28, the ends of the catheters 116, 119 may include magnetic portions 116K, 119K that are configured to attract each other to cause the ends to align and come together. The two contact ends may further include flanges 116J and 119 J that are disposed around the outer circumferences of the catheters and that help provide greater contact areas to connect together and optionally provide a location for the magnets 116K, 119K. The distal end of the re-access drainage catheter 119 may also be configured to open a valve 133, such as a duckbill valve, in the indwelling drainage catheter 116 when the two ends are in contact to permit flow. Alternatively or additionally, the two contact ends may be threaded to aid with intra-procedural alignment. Additionally, the contact ends may be partially or fully comprised of radiopaque materials to provide intraoperative confirmation of successful contact.
[00192] Additionally or alternatively, as shown in Fig. 29, the catheters 116 and 119 may include a sensor system 125 configured to signal, indicate, or otherwise provide data when the ends of the catheters 116 and 119 connect together. For example, catheter ends (e.g., flanges 116J and 119J) may include electrical contacts 125A and 125B that, when in contact with each other, complete a circuit of the sensor system 125. For example, the contacts 125B may take the form of a continuous conductive ring while the contacts 125A may include at least two discrete electrical contacts positioned to align with the circular contact 125B. The electrical circuit may extend through the body of the catheter 119 and may either further include an integrated power supply and indicator mechanism (e.g., and LED light) or the catheter 119 may itself have proximal contacts that connected to a handle or other external device that includes the power supply and indicator. Hence, when the contacts 125A and 125B align and contact, they complete the circuit and cause the indicator to indicate the contact to a user.
[00193] Guidewire placement as used in connection with many of the embodiments of this specification can also be guided by using a catheter to withdraw fluids along a guidewire access path within a catheter. Lymphatic fluid tends to be white or milky color as opposed to the red of blood, and therefore if lymph fluid is withdrawn, the physician can determine that the end of the guidewire opening is at or within the opening of the lymphatic system (e.g., the opening of the thoracic duct 20).
[00194] One specific example of a catheter 116 that may achieve this fluid sampling can be seen in Figs. 30-32. The catheter 116 generally includes a balloon 136 at its distal end that has inflation ports connecting to an inflation lumen 116M within the catheter body to allow inflation of the balloon 136. A first passage 116E and a second passage 116F extend through the balloon, opening on an outer surface of the balloon 136 and extending proximally back through the catheter body to a proximal end of the catheter 116. [00195] The balloon 136 can be positioned near the opening of the lymphatic structure (e.g., the thoracic duct 20). This will hopefully seal off the lymphatic structure opening, depending on its position, but may also seal off other blood vessels, such as the left internal jugular 14, as seen in Fig. 30. Suction (e.g., syringes) can be used to withdraw fluid from both passages 116E and 116F, and if lymph fluid is drawn out from one of the passages, such as passage 116E, the physician may determine that the distal opening of the passage 116E is directed against the opening of the lymphatic structure. As seen in Fig. 32, a guidewire 117 may be advanced through the passage 116E and into the lymphatic structure. Finally, the balloon 136 may then be deflated and the catheter 116 removed, leaving only the guidewire 117, onto which a drainage catheter can be advance over for removing fluid.
[00196] Alternatively, only one passage 116E may be needed. Flowever, this may require the physician to reposition the balloon more than with an embodiment with multiple passages. Alternatively, three or more passages may be possible.
[00197] Alternatively, the catheter of Figs. 30-32 may be also used to perform initial drainage on the lymphatic structure and the guidewire 117 may be used to delivery a marker, indwelling catheter, port, or other element discussed in this specification for additional drainage procedures at later times.
[00198] Additionally or alternatively as shown in Fig. 33, the balloon 136 may include one or a plurality of protrusions 136C (e.g., flexible fingers). In one example, the plurality of protrusions are positioned near the opening of the fluid path(s) 116E, 116F to help secure the position of the openings. Additionally or alternatively, the opening of the fluid path(s) 116E, 116F may be located at or near the tips of one or more protrusions. Upon inflation of the balloon 136, the protrusions 136C may extend into any branching vessel and allow fluid to be withdrawn from at least partially within the branching vessel via the fluid path or to inject fluid (e.g., contrast) to assess the anatomy of the branching vessel. Additionally or alternatively, the balloon 136 may be inflated with a fluid that contains a contrast agent to allow the shape and orientation of the balloon 136 to be visualized under fluoroscopy and identify the potential location of branching vessels. [00199] The previously described protrusions or fingers can also be used for visualization purposes on a catheter 116 in connection with any of the embodiments of this specification. The marker fingers 137 may be partially or fully composed of a radiopaque material, may contain a radiopaque additive, or a marker band to visualize the location and orientation of the fingers under fluoroscopic guidance.
[00200] The marker fingers 137 may be flexible such that they may deflect or move into a branching vessel when the distal tip of the finger 137 passes across the opening of the branching vessel. Hence, the physician may monitor the position of the marker fingers 137 to note when they move from being at least partially restrained to extending radially further, which may indicate the location of the opening of a branching vessel, such as a lymphatic structure. The fingers 137 can be generally perpendicular to the axis of the catheter 116, angled or curved proximally as seen in Fig. 34, or angled or curved distally as seen in Fig. 35. The marker fingers 137 may also contain a strain gauge or angle sensor to detect if a marker finger 137 deflects into a branching vessel.
[00201] In use, the catheter 116 may be placed in a venous vessel and may be advanced past the anatomical area of interest such as the confluence of the internal jugular vein, subclavian vein, and innominate vein. The catheter 116 may then be retracted proximal to allow the marker fingers 137 to engage and penetrate any branching vessels. The catheter 116 may then be visualized using fluoroscopy to identify the presence, location, and orientation of branching vessels. The catheter 116 may then be advanced and retracted to explore different anatomical areas to identify a lymphatic structure.
[00202] Additionally or alternatively, the marker fingers 137 may be further composed of a fluid lumen to allow the injection of contrast through the fingers and into a branching vessel to enhance the ability to visualize the branching vessel. Additionally or alternatively, the distal end of the catheter may be vibrated to encourage the fingers to enter branching vessels or could be comprised of a vibrating motor.
[00203] Returning to the embodiment of Figs. 30-32 which allows a user to remove fluid from a distal opening to determine if one of the openings is aligned with a desired access location (e.g., a lymphatic structure such as the thoracic duct 20), other catheter embodiments may also be possible to achieve a similar method.
[00204] For example, Fig. 36 illustrates another embodiment of a catheter 116 that is generally similar in structure and use to that of Figs. 30-32 but instead of having a single balloon 136 with passages 116E, 116F passing through, the passages 116E, 116F open at the sidewall of the catheter body, in between multiple, individual balloons (e.g., one balloon 136 proximal and one balloon 136 distal of each passage opening). In this manner, the balloons can be inflated so as to isolate each opening of each passage 116E, 116F, allowing fluid to be drawn from each opening to determine if the desired lymphatic structure alignment has been achieved. If so, injection of fluid (e.g., contrast, saline), initial drainage, and/or placement of a guidewire 117 through the passage 116E, 116F may be performed.
[00205] The balloons 136 may be disposed around the circumference of the catheter body and may share a common inflation lumen 116M so as to inflate and deflate the balloons 136 at about the same time. Inflating the balloons 136 in a substantially cylindrical body vessel may substantially occlude the vessel and isolate a space between the balloons 136. Again, two passages 116E, 116F are shown, but alternatives may include only 1 , 3, 4, 5, or more passages and openings (as well as corresponding balloons).
[00206] In one example use, the catheter 116 may be placed into a venous vessel and advanced into a region of interest such as the suspected outlet of the thoracic duct 20. The balloons 136 may be inflated to isolate various regions of the anatomy. The one or more access lumens 116E, 116F may be used to aspirate the fluid from the space between the balloons, and the fluid may be removed to determine whether it contains lymphatic fluid (e.g., visual appearance, conductance, salinity, etc.). If the fluid does not contain lymphatic fluid, a different access lumen may be accessed in the same manner or the balloons may be at least partially deflated and the catheter repositioned in a different anatomical region. This process may be repeated until lymphatic fluid is identified. Once lymphatic fluid is identified, contrast may be injected into the space and into the suspected thoracic duct 20. The injection may be performed using a pump to generate a driving pressure capable of inducing retrograde flow into the thoracic duct. The anatomy of the vessel may be visualized using fluoroscopy to determine whether the vessel is the thoracic duct 20. If confirmed, a guidewire 117 may be passed through the access lumen and into the thoracic duct. The catheter 116 may then be retracted to leave the guidewire 117 in the thoracic duct 20 and a drainage catheter may be advanced over the guidewire 117 to drain lymphatic fluid.
[00207] In another example, Fig. 37 illustrates a catheter that is generally similar to that of Fig. 36 in structure and its method of use. Flowever, the catheter comprises an inner catheter member 141 with a passage 141 A that can be longitudinally moved and aligned with ports 139A or 139B in an outer catheter member 139 in which the inner catheter member 141 is located. Since it can often be beneficial to limit the number of passages within a catheter generally to keep a smaller radial size, the present catheter allows only a single passage 141 A to connect to either of the ports 139A, 139B, instead of the two passages 116E, 116F of the Fig. 36 embodiment.
[00208] The inner catheter member 141 may be comprised of at least a central lumen for use with a guidewire 117 and the passage/lumen 141 A that opens on a side of the inner catheter member 141 . The outer catheter member 139 may be comprised of one or more ports 139A, 139B, a plurality of balloons 136 that are located on the proximal and distal sides of the ports 139A, 139B, one or more inflation lumens 139C extending from the proximal end of the catheter and into the balloons 136, and an inner central access lumen through which the inner catheter member 141 may be moved.
[00209] The inflation lumens 139C may be used to inflate the one or more of the balloons 136. The ports 139A, 139B may be used in conjunction with the inner catheter member 141 to access the space between the balloons 136 via passage 141 A to aspirate fluid, inject fluid, or pass a guidewire 117, as discussed with prior embodiments. The outlet of the passage 141 A may be longitudinally and radially aligned with one of the ports 139A, 139B in the outer catheter member 139 to perform the aforementioned functions.
[00210] In use, the inner catheter member 141 and outer catheter member 139 may be advanced together through a venous vessel to an area of anatomical interest. The balloons 136 may be inflated to isolate a specific area, such as the suspected region of the terminal valve of the thoracic duct 20. The opening of the passage 141 A may be aligned with one of the ports 139A, 139B in the isolated region to sample fluid, injection contrast, or deliver a guidewire 117. If another anatomical area is desired to be evaluated, the inner catheter member 141 may be rotated and/or translated to align with another port 139A, 139B in a different region of the outer catheter member 139. That region may then be evaluated by sampling fluid, injecting contrast, or delivering a guidewire 117. If a still different anatomical region is desired to be evaluated and no further ports are available, both the inner and outer catheter members may be re positioned within the patient and the process may be repeated as necessary to identify the desired anatomical area.
[00211] In some embodiments and methods of this specification, it may be helpful to inject contrast or other fluids near an opening of a lymphatic structure, and particularly the opening into the thoracic duct 20 to help determine the location, orientation, and other aspects of the opening, among other visualized data.
[00212] In that respect, Fig. 38 illustrates one embodiment of an infusion catheter 143 with three inflatable balloons 136 that are each arranged to occlude three different branching vessels so that an infusion fluid (e.g., contrast) may be infused between them.
[00213] The infusion catheter 143 may comprise a main catheter portion 143A that branches into a Ύ” shape with two branching portions 143B and 143C. Each portion 143A, 143B, and 143C has a connected balloon 136 that are each fed by the same or different inflation lumens within the catheter 143. A proximally accessible infusion lumen opens distally at port 143D to allow fluids to be infused. When inflated within vessels with a Ύ” shape, such as within the left subclavian vein 10, the left internal jugular 14, and right brachiocephalic vein 12, an isolated area of the vessels is created, allowing fluid, such as contrast, to be injected into the area. In the present examples, the balloons 136 are positioned on the catheter 143 at locations so as to isolate the opening of the thoracic duct 20. Hence, when contrast is released from the fluid port 143D with enough pressure, it will enter into the opening of the thoracic duct 20.
[00214] In use, the catheter 143 may be advanced in a venous vessel to an anatomic region of interest such as the confluence of the left subclavian vein 10, the left internal jugular 14, and right brachiocephalic vein 12. The balloons 136 may be inflated in each of the three branches to substantially occlude the venous branch in which the balloon 136 resides and isolate the anatomic region of interest. The infusion lumen may then be used to deliver contrast into the isolated region via the infusion port 143D. The infusion may be performed using a pump to generate a driving pressure capable of inducing retrograde flow into the thoracic duct 20. The thoracic duct 20 may then be visualized using fluoroscopy.
[00215] Additionally or alternatively, the catheter may have two rails: one rail with two balloons and one rail with a third balloon. The first rail may be advanced into the innominate and subclavian veins and the second rail may be advanced into the internal jugular. In other words, the catheter with two balloons, for example, can be placed first, and then the catheter with a single balloon can be slid along the first catheter and into a desired position. The second rail may be advanced/retracted independent of the first rail to optimize the positioning of the balloons within the veins. In one embodiments, this arrangement can be performed with two separate catheters, where one of the catheters has clip or aperture configured to connect around the body of the other catheter, allowing it to slide. This arrangement might be similar to “over-the- wire” or “monorail” catheter systems currently in use.
[00216] As discussed elsewhere in this specification, needles may be used, in whole or in part, for accessing a lymphatic structure. In one embodiment shown in Figs. 39, 40, and 41 , a needle device is selectively expandable in diameter to enhance the fluid removal rate from a patient’s lymphatic system.
[00217] The needle 147 may have a tubular shape and be composed of a plastically deformable material, such as polyethylene that allows for circumferential stretching and/or unfolding (e.g., corrugated walls that unfold) to increase the diameter of the needle 147. In its initial state (Fig. 39), the needle 147 has a first diameter, D1 , which is inserted into the patient’s skin and eventually into the lymphatic structure. When more lymphatic fluid flow is desired, a rigid stylet 149 may be inserted into the inner passage of the needle 147 (Fig. 40). The stylet 147 has an elongated body and a larger diameter, D2, than the needle 147 and therefore causes the circumference of the needle 147 to stretch or otherwise unfold, increasing the overall diameter of the needle 147 and its inner passage to D2 (Fig. 41 ). [00218] The stylet 149 may be solid and only temporarily moved into the needle 147, or the stylet 149 may have its own passage therethrough between its ends for draining lymphatic fluid. The stylet 149 may be advanced by manual hand pressure on its end or may include threads that mates with threads on the needle 147 which allow the stylet 149 to advance when rotated. Additionally, the stylet 149 is one of many shapes including, but not limited to, cylindrical, tapered, conical, frustoconical, stepped, etc. and includes chamfers and radii to break sharp edges.
[00219] Figs. 42 and 43 illustrate another embodiment of a needle assembly having an elongated needle 110 and a generally tubular outer sheath 151 that is configured to be advanced partially or fully over (i.e. , around) the needle 110 and its distal tip, allowing a user to expose some or none of the tip of the needle 110. It may be advantageous to expose only a small length or amount of the sharpened tip of the needle 110 to reduce the likelihood of passing through both sides of the thoracic duct 20 or through another lymphatic structure. In this respect, the sheath 151 contacts the outside of the lymphatic structure and prevents the needle assembly from passing any further into the structure. In one example, the outer sheath 151 is retracted and secured at a distance less than the diameter of the thoracic duct 20, as may be measured by ultrasound imaging, CT, or MRI. The outer sheath may have a mechanism to lock the position of the sheath 151 relative to the needle 110, such as a set screw, a clamp, threading, or other means known to one skilled in the art. The needle may also have markings to delineate gradation of distance to aid in the setup of the device. The position of the sheath 151 may be such that the exposed portion of the needle 110 is less than the diameter of a lymphatic structure such as the thoracic duct, such as a length that is within an inclusive range of 1mm to 10mm, 4mm to 8mm, or more preferably 5mm to 6mm. Note that these lengths are applicable to any embodiment of this specification where the needle tip is limited from passing through the lymphatic structure.
[00220] In another embodiment shown in Fig 44, suction is applied to the space between the sheath 151 and the needle device 110 once the needle device 110 enters the thoracic duct 10. In that respect, the sheath 151 may include a side port that communicates with the internal lumen of the sheath 151 and connects to the suction source (e.g., threads, a fitting, etc.). Additionally, the sheath 151 may include a sealing member 151 A at its proximal end configured to engage and seal around the needle 110. The suction may help maintain the position of the tip of the sheath 151 against the outer wall of the thoracic duct 20.
[00221] The needle 110 may also be spring loaded relative to the sheath 151 , as seen in Fig. 45, such that the tip of the needle 110 is biased to a fully retracted position within the sheath 151. The stiffness of the spring 155 is determined such that the needle tip is exposed as the device is passed through solid tissue (e.g., fat, skin, muscle, etc.) when the physician is holding only the needle 110 due to the friction of the solid tissue on the sheath. The needle 110 is able to extend beyond the distal tip of the sheath 151 and retract fully within the sheath 151 .
[00222] In an exemplary method of use, the physician advances the needle assembly into the tissue by holding only the needle 110 and not the outer sheath 151 . When the physician applies force to the needle 110, it advances beyond the sheath 151 as the sheath 151 contacts the tissue and penetrates the tissue. As the physician continues to apply force, the needle 110 bottoms out against the proximal end of the sheath 151 and the entire needle assembly advances within the tissue, which provides the physician with tactile feedback. When the physician releases the force, the needle 110 retracts into the sheath 151 to protect the tissue from the sharp tip. The physician is then able to evaluate the position or change the trajectory of the device without the sharp tip of the needle 110 being exposed. Once the desired trajectory is determined, the physician is able to apply force to advance the needle assembly to continue as desired. Once the desired structure, such as the thoracic duct, is reached, the physician releases the needle assembly to allow the sharp tip of the needle 110 to retract to avoid puncturing another wall of the thoracic duct 20 or similar structure. Fluid is then aspirated through the needle 110 to confirm appropriate placement of the device.
[00223] In one embodiment shown in Fig 46, a patch device 157 comprising a patch body is used in conjunction with a needle 110. The patch device 157 is secured to the patient by an adhesive such as a pressure-sensitive adhesive (PSA) and contains a needle interface feature 157A such as a passage or hole with threads, bosses, ridges, or other solid features to align the needle and/or control longitudinal movement of the needle 110 so that it is not advanced too far into the patient. The needle 110 is then coupled to the needle interface feature 157 A and advanced into the tissue by rotational coupling with threads or by translation along guiding features.
[00224] In one embodiment, the needle interface feature 157A or passage is rigidly integrated into the body of the patch device 157 such that the needle 110 is guided along a fixed trajectory. In another embodiment as shown in Fig. 47, the orientation of the needle interface feature 157A is adjustable relative to the patch 157 to alter the trajectory of the needle 110 as it enters the skin. The angular adjustment mechanism may include a pin interface, a ball-in-socket joint, a press-fit joint, a snap-fit joint, a deformable joint, or other joint known to one skilled in the art to allow adjustment in one, two, or more degrees of freedom to enable fine adjustment of the trajectory of the needle 110.
[00225] Several embodiments in this specification may include one or more enlargement features on the outside of a needle or cannula near its distal tip to prevent it from passing too far into a lymphatic structure. Generally, such enlargement features can be arms, tangs, ridges, balloons, expandable mesh, or similar structures. The enlargement features may be such that the needle is stopped from advancing past the diameter of a lymphatic structure, such as the thoracic duct, such as a length that is within an inclusive range of 1mm to 10mm, 4mm to 8mm, or more preferably 5mm to 6mm.
[00226] For example, Figs. 48-50 illustrate another embodiment of a needle assembly with a mechanism to limit its travel so that it does not completely pass through a desired target vessel (e.g., thoracic duct 20) or is accidentally pulled out of the target vessel. The needle assembly comprises a tubular cannula 163 with one or a plurality of externally movable flared arm or tang members 161 and wire ring support 159. Prior to advancement into the tissue, the tang members 161 and ring support 159 of the needle assembly are retracted into the cannula 163 via one or more deployment mechanism, such as pull wires 159A, 161A extending to a proximal end of the cannula 163, so the needle assembly is able to advance into the tissue easily. In order to enable collapsing within the needle assembly and then returning to their desired shape upon deployment, the tangs 161 and ring support 159 may be comprised of a flexible material, such as a metal, nitinol, spring steel, stainless steel, or plastic and are bent, elastically deformed, or shape-set to their desired shape. Once the needle assembly is advanced into the target structure, such as thoracic duct 20, the tang members 161 are deployed to maintain the position of the needle within the tissue (e.g., prevent it from being pulled out) and the ring support 159 is deployed within the target structure to prevent the tip of the cannula 163 from puncturing through the opposite wall of the target vessel, as shown in Fig 50.
[00227] Note, the terms “needle” and “cannula” are used throughout this specification and may be used interchangeably. Both are generally defined as relatively small diameter tubular structures used to drain off and/or infuse fluid to a target structure. While traditionally, a needle typically includes a sharpened tip while a cannula includes a blunt tip, for the purposes of this specification, either the needle or the cannula may have a sharp or blunt tip.
[00228] Any of the needle devices/assemblies of this specification may contain a radio-frequency element at the distal tip, such as the R-F Needles by Epimed. In one method, the needle is advanced through the tissue by using RF energy to vaporize the tissue rather than pierce the tissue as with a standard needle. Once the needle is advanced into the thoracic duct 20, the RF energy is discontinued to prevent passing through the opposite wall of the thoracic duct 20. This may be advantageous to allow manipulation of the needle within the thoracic duct without risk of inadvertently piercing the opposite wall of the thoracic duct.
[00229] It is also possible to anchor or restrict movement of a needle within a vessel (e.g., lymphatic) of a patient with balloon anchors positioned on the outer wall of a needle and that are selectively inflatable.
[00230] For example, Figs. 51 and 52 illustrate a needle assembly with a single inflatable balloon 165 located near a distal end of a tubular cannula 163. The balloon 165 may have a symmetric, circumferential orientation and may be inflated and deflated via an inflation lumen 165A within the cannula 163 of the needle that proximally terminates with an inflation connector outside the cannula 163 such as a Luer Connector, barbed connector, Tuohy Borst connector, or other appropriate connector known to one skilled in the art. [00231] In use, the needle assembly is advanced into the target vessel, such as a thoracic duct 20, and the balloon 165 is inflated to maintain the position of the cannula 163 within the thoracic duct 20. The balloon 165 may be inflated internal to the thoracic duct 20 or external to the thoracic duct 20 within the soft tissues or another body vessel such as a blood vein.
[00232] While the balloon 165 may be symmetrically positioned entirely around the cannula 163 of the needle assembly, it may also be asymmetrically positioned on only one side, as seen in Fig. 53.
[00233] While the needle assembly may include only one balloon 165, it may also include a plurality of balloons, such as two circumferential balloons 165 shown in Fig. 54. One balloon 165 may be deployed internal to the target vessel (e.g., thoracic duct 20) and the second may be deployed external to the target vessel. In that respect, it may be desirable to position the balloons 165 at a distance sufficient to engage a tissue wall (e.g., 0.5mm to 5mm).
[00234] A needle assembly may also have a balloon that is inflated within a nearby vessel. For example, in Fig. 55 a cannula 163 is advanced through a vein 7 and then into the thoracic duct 20. The balloon 165 is then inflated within the vein 7. In such uses, the balloon 165 is preferably positioned at a distance from the distal end of the cannula 163 that would allow the vein inflation while maintaining the distal end within the thoracic duct 20.
[00235] While the balloons 165 of the previously described embodiments have been shown on the cannula 163 or needle 110, the balloons 165 may alternatively be located on an outer sheath 151 disposed over a needle 110. Again, these balloons 165 may be in any of the previously described configurations (single, double, circumferential, asymmetrical, etc.).
[00236] Any of the needles of this specification, alone or in combination with other features may also have a “step” or size difference. For example, Fig. 57 illustrates a stepped needle 167 having a needle body with a larger diameter proximal region 167A (D1 ) and a smaller diameter distal region 167B (D2), where the proximal region 167B is smaller than the distal region 167A (Di < D2). The distal region 167B of the needle 167 is advanced into the thoracic duct 20 until the proximal region 167A contacts the outer wall of the thoracic duct 20. The larger diameter of the proximal region 167A may prevent the ingress of the proximal region 167A into the thoracic duct and, therefore, limits the penetration depth of the needle 167 into the thoracic duct 20. The length of the distal region 167B may be less than the diameter of the thoracic duct 20. For example, the length is between 1 mm and 10mm, 4mm and 8mm, or more preferably 5mm-6mm.
[00237] In another embodiment, a needle 110 may be anchored in place by wire 169 that can be extended out a distal end of the needle 110, as seen in Figs. 58-62. The wire 169 may have a secondary shape such that when unconstrained, it bends or curves in one or more directions away from the axis of the needle 110. This may help prevent the needle from passing through a target structure (e.g., a thoracic duct 20) and prevent the needle 110 from being accidentally pulled out of the target structure. The wire 169 may be shaped by any means known to one skilled in the art including, but not limited to, heat-setting, plastic deformation, annealing, and similar techniques. In its unconstrained shape, the wire 169 may form a variety of different shapes including a “U” shape, a “C” shape, a curl, a circle, a coil, a spiral, or similar shapes.
[00238] In use, the wire 169 is straightened and placed within the needle 110 with its shaped distal end fully contained within the needle 110 as seen in Fig. 60. The needle 110 is advanced to the target structure (e.g., thoracic duct 20). The wire 169 is then advanced through the wall of the target structure and into its lumen (e.g., the lumen of the thoracic duct 20). The distal tip of the wire 169 then returns to its U- shape to prevent puncturing the opposite wall of the target structure as it is advanced a desired amount. The wire 169 may be advanced out of the needle 110 and through the target vessel wall prior to the needle 110 entering the target vessel or after.
[00239] As previously discussed, the unrestrained shape of the wire 169 may have a variety of different forms. Some further examples include the spiral shape 169A of Fig. 63, the hook or “C” shape 169B of Fig. 64, the angled and straight segment shapes 169C of Fig. 65, the open perpendicular oval shape 169D of Fig. 66, the planar spiral shape 169E of Fig. 67, The perpendicular loop shape 169F of Fig. 68, the plurality of small loops forming a larger loop shapes 169G of Fig. 69, the plurality of radially oriented loops shape 169H of Fig. 70, and the planar perpendicular spiral shape 169I of Fig. 71 . Further, the unrestrained shape of the wire 169 may form more complicated, three-dimensional shapes, such as the spherical shape 169J of Figs. 72A and 72B, or the perpendicular circular array of smaller coils 169K of Figs. 73A and 73B. Any of these shapes may be formed from a single wire or a plurality of wires or wire segments attached to each other.
[00240] Any of the needle embodiments of this specification that include a wire may further include a mechanism to cause the wire to vibrate. The vibrating wire may be coupled to a vibration source at its proximal end to transmit vibrations along the length to its distal end. In use, the needle device is advanced into the tissue and the vibrating wire is advanced beyond the distal tip of the needle. The vibration is activated, and the distal tip of the wire can be visualized within the tissue by ultrasound visualization. As the needle passes through solid tissue, the vibrating wire will be hindered from vibrating freely. Once the needle and vibrating wire pass into the lumen of the thoracic duct, the wire will be freer to vibrate within the lymphatic fluid compared to solid tissue, and its visual appearance will change.
[00241] Any of the needle embodiments of this specification may also include a cryotherapy element 171 , as seen in the example of Fig. 74, to help anchor its position within a patient. The cryotherapy element may be located proximal to the tip of the needle 110 such that it is in contact with the soft tissues surrounding the thoracic duct 20 or other target structure when the tip of the needle 110 is in the thoracic duct 20. The cryotherapy element 171 may be cooled by electrical current (e.g., Peltier Junction) or phase transition of a liquid to a gas (e.g., refrigerant evaporation). The needle 110 may be advanced into the thoracic duct 20 and the cryotherapy element 171 is activated to adhere a portion of the needle 110 to the surrounding tissue to maintain the position of the needle 110 relative to the thoracic duct 20. In another embodiment, the cryotherapy element 171 is located at the distal tip of the needle 110. After the needle is advanced into the thoracic duct 20, the cryotherapy element 171 is activated to create a protective ice ball around the distal tip of the needle 110 to prevent puncturing the opposite wall of the thoracic duct 20.
[00242] Any of the needle or needle assemblies of this specification may also include a plurality of holes or apertures through a sidewall of the needle/cannula to improve drainage when inserted into a lymphatic system target location such as a thoracic duct 20. Additionally, any of the needles/cannulas of this specification may also be biased to form a secondary shape, such as a curved or bent shape when unrestrained. This may allow a user to penetrate a target structure with the needle/cannula and then remove the restraints on the needle/cannula.
[00243] Figs. 75 and 76 illustrates one example of a needle assembly comprised of a sharp, straight, rigid stylet 149 and a shape-set, flexible cannula 173 having a plurality of apertures 173A through its sidewall. The cannula 173 may be shape-set into a “U” shape, “C” shape, spiral shape, a 90-degree bent shape (Fig. 79), or other curved shape such that when the stylet 149 is removed from the cannula 173, the cannula 173 will take on its set shape.
[00244] The one or more holes 178A may be created by one or more of drilling, skiving, punching, melting or other process known to one skilled in the art. Additionally, the one or more holes may be created at different patterns, locations, angles or orientations relative to each other and the axis of the cannula 173 including a linear pattern seen in Fig. 75, a helical spiral pattern seen in Fig. 77, or an alternating pattern seen in Fig. 78.
[00245] In use, the stylet 149 is advanced through the cannula 173 to straighten the cannula 173 and then the needle assembly is advanced through the tissue of the patient and into the target structure, such as thoracic duct 20. The stylet 149 is then partially or fully retracted to allow the cannula 173 to return to its set shape and maintain its position within the thoracic duct 20. The stylet 149 is then fully retracted to allow fluid to be removed through the cannula 173. It may be appreciated by one skilled in the art that the cannula 173 may be shape-set into at least one or more of the following shapes including, but not limited to, a planar spiral shape, a three- dimensional spiral shape, an “L” shape, a circular shape, a conical shape, or similar shapes.
[00246] Another similar example embodiment seen in Figs. 80-82, a cannula or needle 173 can be used with a stylet 149 such that fluid is drained through the apertures 173A of the cannula/needle 173 and into a hollow passage of the stylet 149. The internal diameter of the cannula/needle 173 and the outer diameter of the hollow stylet 149 are closely matched to minimize free space between the two. The stylet 149 may also have a plurality of holes or apertures 149A within its sidewalls and extending into its internal lumen. The stylet 149 may optionally include a closed tip so that when the tip is located proximal to the apertures 173A of the cannula/needle 173, fluid flow is blocked through the cannula/needle 173 and through the inner lumen of the stylet 149. However, when the distal tip of the stylet 149 is advanced distally beyond at least some of the apertures 173A, fluid is able to pass through both apertures 173A and 149A into the lumen of the stylet 149 where is can be proximally drained.
[00247] Referring to Fig. 82, the cannula/needle 173 may be advanced through the target structure, such as thoracic duct 20, such that one or more side holes 173A are located within the lumen of the thoracic duct 20. The hollow stylet 149 is then advanced at least partially within the cannula/needle 173 to initially block fluid passing into one or more of the apertures 149A to prevent fluid from entering/exiting in an undesired location such as a vein or the soft tissues surrounding the thoracic duct. Fluid is then drained through the one or more side holes in the needle and through the hollow stylet.
[00248] While the stylet 149 may have a plurality of small apertures 149A, it may alternately or additional have one or more larger “windows” 149B that can overlap and encompass multiple of the apertures 173A of the cannula/needle 173. The windows 149B may have a variety of shapes including a longitudinally elongated or oval shape and may be located near the distal end of the stylet 149. By including one or more windows 149B, especially in only one area of the stylet 149 (e.g., a distal portion), the user can selectively open and block certain apertures 173A of the cannula/needle 173. This may be helpful, for example, if the cannula/needle 173 has passed entirely through a target structure, such as a thoracic duct 20 seen in Fig. 84. The window 149B can be aligned by the user to open only apertures 173A within the thoracic duct 20, while blocking those outside of the thoracic duct 20. Additionally, the closed distal end of the stylet 173 may block any unwanted fluid from the distal opening and apertures 173A of the cannula/needle 173. Hence, only fluid from locations aligned with the window 149B can be drained through the lumen of the stylet 149.
[00249] The one or more windows 149A may be created by one or more of the following processes including laser cutting, milling, skiving, or other process known to one skilled in the art. A coupling mechanism may also be included to fix the relative position of the cannula/needle 173 to the stylet 149. The coupling may be accomplished by any means known to one skilled in the art including, but not limited to, threads, clamps, adhesive, or other locking features.
[00250] In one embodiment, a needle device assembly is comprised of a first needle, a guidewire, a flexible cannula with a magnetic tip, and a second needle with a magnetic tip. The first needle is advanced into the thoracic duct and the guidewire is advanced through the lumen of the needle and into the thoracic duct. The first needle is then removed, and the flexible cannula is advanced over the guidewire and into the thoracic duct. The second needle with a magnetic tip is then advanced into the tissue near the thoracic duct near a desirable location to place the distal end of the flexible cannula. The flexible cannula is then advanced into the thoracic duct and toward the second needle tip using the magnetic attraction to the desired location. In another embodiment, the second needle with a magnetic tip is advanced into the thoracic duct in a desired location. The flexible cannula is then advanced toward and coupled to the second needle by the magnetic attraction to maintain a desired location within the thoracic duct. In another embodiment, a catheter with a magnetic tip is placed in a vein near a desirable location and the cannula with a magnetic tip in the thoracic duct is advanced toward and maintained in a desirable location based on the magnetic attraction between the magnetic tips.
[00251] In one embodiment, a needle assembly is comprised of a needle and a pressure sensor. The pressure sensor is integrated into the distal portion of the needle to provide real-time pressure measurements as the needle passes through tissue and body structures. In use, as the needle is advanced through tissue and the pressure is monitored to determine if the needle is in the thoracic duct. Once the needle enters the thoracic duct, the pressure signal can be observed to confirm the correct location based on the wave form and value relative to the values as the needle was passing through the tissue.
[00252] In one method, a needle is advanced through tissue toward the thoracic duct. Saline is infused through the needle to create saline bubbles that can be tracked as the needle advances through the tissue. Once the needle enters the thoracic duct, the saline will mix with the lymphatic fluid to confirm proper location of the distal tip of the needle. Alternatively, a gas such as CO2 may be injected through the needle to determine the location of the distal tip of the needle.
[00253] Any of the preceding devices, systems, and methods for accessing the thoracic duct may be further comprised of a drainage catheter to remove fluid from a lymphatic vessel in a patient, such as the thoracic duct. Any of the aforementioned methods may further be comprised of a step of advancing a guidewire through a needle in the thoracic duct, removing the needle, and advancing a drainage catheter over the guidewire placed in the thoracic duct and removing fluid through the drainage catheter. Further, the guidewire may be removed from the drainage catheter to enhance the flow rate of the fluid removal.
[00254] In some instances, it is helpful to leave an implanted catheter within the patient for future lymph drainage sessions. In that respect, it may be helpful to include a valve mechanism to block off the drainage lumen of the catheter when not in use.
[00255] For example, a balloon 136 may be positioned within the drainage lumen 116G of a body of a catheter 116 and is configured to maintain the drainage lumen 116G in an open state when deflated (Fig. 85) and to close off the drainage lumen 116G when in its inflated, expanded state (Fig. 86). An inflation lumen 116F may be connected to an inflation source at the proximal end of the catheter 116 and to the balloon 136 near the distal end of the catheter 116 (or wherever the balloon 136 is located).
[00256] The drainage catheter 116 is placed into the thoracic duct 20 of a patient and fluid is drained. When the drainage therapy is complete, the drainage catheter 116 is flushed with saline, heparinized saline, or similar fluid to remove the lymphatic fluid from the lumen 116G. The balloon 136 is then inflated to substantially prevent the ingress of lymphatic fluid into the drainage lumen 116G. When another drainage therapy is desired, the balloon 136 is deflated and fluid drainage can resume. The balloon 136 may be located substantially within the drainage lumen 116G and anywhere along the length of the lumen 116G (e.g., near the distal end, in the middle, or near the proximal end) or may extend beyond the tip of the inflation lumen and into the thoracic duct 20. [00257] In another example, the catheter 116 may include a valve 175 that can be used to temporarily close off a drainage lumen 116G, as seen in Fig. 87. The valve 175 may be one of any valves known to one skilled in the art including a stopcock, needle valve, gate valve, or umbrella valve. The drainage catheter 116 is placed into the target structure, such as the thoracic duct 20 of a patient, and fluid is drained. When the drainage therapy is complete, the drainage catheter may be flushed with saline, heparinized saline, or similar fluid to remove the lymphatic fluid from the lumen. The valve 175 is then actuated to substantially eliminate flow (e.g., rotating a lever on a stopcock). When another drainage therapy is desired, the valve 175 is opened and fluid drainage can resume. The valve 175 may be located near the proximal end for ease of use.
[00258] In another example, the valve 175 may be a magnetically-actuated valve which may allow a valve to be located at any location along the catheter 116, including the distal end. The drainage catheter 116 may be placed into the thoracic duct 20 of a patient and fluid is drained. When the drainage therapy is complete, the drainage catheter 116 is flushed with saline, heparinized saline, or similar fluid to remove the lymphatic fluid from the lumen. The valve 175 is then actuated to substantially prevent the ingress of lymphatic fluid into the drainage lumen 116G. The valve 175 is actuated by an external magnetic source such as a magnet placed exterior to the patient (e.g., on the skin) or a magnetic catheter placed in a vein in proximity to the drainage catheter. When another drainage therapy is desired, the opposite pole of the same or different magnet is used to open the valve 175 and fluid drainage can resume. The valve may be located substantially within the drainage lumen anywhere along the length of the lumen (e.g., near the distal end, in the middle, or near the proximal end) or may extend beyond the tip of the inflation lumen 116G and into the thoracic duct 20.
[00259] Another closure mechanism example can be seen in Fig 88, in which a tube 177B is attached to the proximal end of the drainage catheter 116 to collect the drained fluid and a clamp 177A such as a roller clamp or tubing clamp is placed on the tubing 177B. The flow through the drainage catheter is controlled by actuating or releasing the clamp on the tubing. [00260] Any of the embodiments of a drainage catheter described in this specification may include an ultraviolet element within the drainage lumen 116G. The drainage catheter 116 is placed into the thoracic duct of a patient and fluid is drained. While the fluid is being drained, the ultraviolet element is activated to destroy, denature, or otherwise disrupt the constituents of the drained fluid to prevent the formation of biofilm or clot within the drainage lumen 116G.
[00261] Any of the embodiments of a drainage catheter described in this specification may include a vibration element 179 that may help disrupt formation of a clot or clog. The drainage catheter 116 is placed into a target structure such as the thoracic duct 20 of a patient and fluid is drained. While the fluid is being drained, the vibration element 179 is activated to cause at least a portion of the drainage lumen 116G to vibrate to disrupt the potential formation of a clot or clog within the drainage lumen 116G. The vibration element 179 may be placed anywhere along the length of the drainage lumen 116G including near the distal end, in the middle, or near the proximal end. Alternately, the vibration element may be integrated into the proximal hub of the drainage catheter. Alternately, the vibration element 179 is coupled with a guidewire 117 that is placed within the drainage lumen 116G and vibrated as desired to disrupt the potential formation of a clot or clog within the drainage lumen as seen in Fig. 90.
[00262] In another example technique for disrupting clot and clogs of the drainage catheter 116 alone or in combination with other techniques, a guidewire is placed within the drainage lumen 116G and rotated.
[00263] Fig. 91 illustrates another example technique for disrupting clot and clogs of the drainage catheter 116 alone or in combination with other techniques, with a stylet 149 with having a spiral recess 149C along its length (e.g., an auger). The drainage catheter 116 is placed into the target structure such as a thoracic duct 20 of a patient and fluid is drained. While the fluid is being drained, the stylet 149 is introduced into the drainage lumen 116G and rotated. The rotation aids in removing the fluid and preventing fluid stagnating as well as removing a clots or clogs that form within the drainage lumen 116G. [00264] In another example technique for disrupting clot and clogs of the drainage catheter 116 alone or in combination with other techniques, pressurized fluid can be injected into a drainage catheter 116 to disrupt clogs or clots.
[00265] For example, Fig. 92 illustrates, a drainage catheter system that is comprised of a catheter 116 with at least one drainage lumen 116G, a valve 175, and a pressurized fluid source 171 coupled to the valve and drainage lumen. The drainage catheter 116 is placed into a target structure such as the thoracic duct 20 of a patient and fluid is drained. While the fluid is being drained, the valve 175 is intermittently cycled (i.e., opened and closed) to allow fluid from the fluid source 171 to flow through and flush the drainage lumen 116G to push any clot or clogging materials back into the thoracic duct 20. The frequency and duration of the flushes is optimized for a given patient and could include a 10-second flush every hour, every 30 minutes, or every 15 minutes or a 5-second flush every 30 minutes, every 15 minutes, or every 10 minutes.
[00266] Another example drainage and infusion system can be seen in Fig. 93 in which an infusion lumen 116F within a body of a catheter 116 opens into a drainage lumen 116G to help flush and unclog any material buildup within the drainage lumen 116G. A pressurized fluid source 171 is connected via fitting 189 (including a sealing member to prevent leaks) to the infusion lumen 116F to supply the infusion fluid while a drainage reservoir 204 is connected to the drainage lumen 116G to capture the lymphatic fluid and infusion fluid. The infusion lumen 116G is blocked off at its distal end from directly opening outside the catheter 116 and instead opens via opening 116L into the drainage lumen 116G.
[00267] Optionally, the drainage lumen 116G may have a one-way valve 175 located near a distal end of the catheter 116. This valve 175 allows lymphatic fluid to enter the drainage lumen 116G during drainage but prevents fluid from distally exiting the drainage lumen into the lymphatic structure, especially when pressurized infusion fluid is infused into the drainage lumen 116G. Without this valve, the infusion fluid may generally exit the distal end of the drainage lumen 116G during infusion. In such embodiments without the valve 175, it may be desirable to position the opening 116L near the proximal end of the drainage lumen 116G so that the infusion fluid may be forced down nearly the entire length of the drainage lumen 116G. Flowever, if the valve 175 is present, it may be desirable to locate the opening 116L near a distal end of the drainage lumen 116G for similar reasons. Nevertheless, the opening 116L can be positioned at any location along the length of the drainage lumen 116G (e.g. , distal, middle, proximal location).
[00268] Optionally, the catheter 116 may also have a dedicated guidewire lumen 116R for use with a guidewire 117. Alternatively, the drainage lumen 116G may be used with a guidewire 117.
[00269] The fluid source 171 of this or any other embodiments may include one or more of a syringe, a fluid bag, a syringe injector, or other fluid source known to one skilled in the art. Due to the fluid fitting 189, more than one type of fluid source may be used throughout a therapy session. The fluid restrictor 191 coupled to the drainage tubing of the reservoir 204 is adjustable and is used to selectively restrict the flow of fluid or allow the free flow of fluid through the drainage lumen and into the reservoir 204. The fluid restrictor 191 may be comprised of a butterfly valve, stopcock, roller clamp, slide clamp, or other fluid control means known to one skilled in the art.
[00270] The reservoir 204 is further comprised of one or more of the following including but not limited to a fluid bag, a syringe, a fluid collection system such as a Pluer-evac system by Teleflex. The reservoir 204 may be further connected to a suction source to enhance the flow rate of fluid through the drainage lumen and into the reservoir 204. In one embodiment, the tube fitting connecting to the reservoir 204 has multiple attachment points to allow a suction source to be attached in conjunction with the drainage tubing and the reservoir 204. The reservoir fitting is also benefical to allow a reservoir 204 to be disconnected and replaced with an empty reservoir 204 as needed.
[00271] In use, initially, one or more guidewires are advanced through the lumen 116R (if present) or 116G and into the thoracic duct 20. As discussed elsewhere in this application, the guidewires 117 may include different unrestrained shape (e.g., curved) at their distal ends. The guidewires 117 are advanced through the lumen 116R until the non-linear portion of the guidewires 117 (e.g., the distal end) is substantially in the thoracic duct 20 to push the tissue away from the distal tip of the drainage lumen 116G. The one or more guidewires 117 may also be secured to the drainage catheter 116 to aid in maintaining the position of the drainage catheter within the lymphatic vessel.
[00272] Additionally, one or more side holes may be drilled through the drainage lumen 116G distal to the valve 175 in a manner consistent with holes and hole patterns described elsewhere in this specification and referenced applications (e.g., for cannula/needle embodiments). The one or more side holes may provide additional routes for fluid drainage in the presence of a clog or if one or more holes are contacting tissue and are blocked from drainage.
[00273] The catheter 116 is inserted into a patient and advanced into a thoraicic duct 20 or other desired lymphatic vessel as described in this specification and the referenced applications until the tip of the catheter is in fluid communication with lymphatic fluid. Lymphatic fluid is then drained through the valve 175, through the drainage lumen tubing and into the reservoir 204. As needed during the therapy (e.g., to remove a clog), a fluid source 171 is connected to the infusion lumen fitting 189 to influse fluid. The fluid passes through the infusion lumen 116F, through the opening 116L, into the drainage lumen 116G, and into the reservoir 204. The fluid source 171 is then removed and lymphatic drainage is re-established. If the flow rate of the lypmhatic draingage is higher than desired, the fluid restrictor 191 is actuated to reduce the flow rate.
[00274] Initially, one or more guidewires are advanced through the lumen and into the thoracic duct. As discussed elsewhere in this application, the guidewires are shaped into a planar or three-dimensional shape. The guidewires are advanced through the lumen until the non-linear portion of the guidewires is substantially in the thoracic duct to push the tissue away from the distal tip of the drainage lumen. The guidewires may also be secured to the drainage catheter to aid in maintaining the position of the drainage catheter within the lymphatic vessel. Additionally, one or more side holes may be drilled through the drainage lumen distal to the valve in a manner consistent with holes and hole patterns described elsewhere in this and referenced applications. The one or more side holes may provide additional routes for fluid drainage in the presence of a clog or one or more holes contacting tissue and be blocked from drainage. [00275] In another embodiment extending the embodiments described above, one or more pressure sensors are integrated into the drainage lumen to indicate if a clog is forming with a pressure sensor in the distal portion of the drainage lumen and another in the proximal portion of the lumen. In another embodiment extending the embodiments described above, the drainage system is further comprised of external securement means to maintain the location of the distal tip of the drainage catheter within the thoracic duct. The securement means is placed on the skin or external surface of the patient and includes, but is not limited to, an adhesive patch such as Tegaderm by 3M, medical tape such as Transpore Medical Tape by 3M, a suture placed through the skin and around the drainage catheter, or other means know to one skilled in the art. Additionally or alternatively, the drainage catheter may be further comprised of anchoring means located within the patient (i.e. , within a vein or lymphatic vessel) to maintain the location of the distal tip of the drainage catheter within the throacic duct.
[00276] In one illustrative method of removing a clog or suspected clog in the embodiment shown in Fig. 93, a syringe full of fluid is coupled to the infusion lumen fitting and an empty syringe is coupled to the reservoir fitting. The infusion syringe is then actuated to force fluid into the infusion lumen and increase the pressure within the infusion lumen and distal portion of the drainage lumen. At substantially the same time or after a delay without displacement of a clog or observing flow, the drainage syringe may be actuated to pull a vacuum and reduce the pressure in the proximal end of the drainage lumen; effectively increasing the pressure gradient driving a clog from the distal portion of the drainage lumen toward the proximal portion of the drainage lumen and into the syringe and/or reservoir.
[00277] When performing lymphatic fluid draining, it can sometimes be helpful to inject or infuse fluid (e.g., saline, isotonic saline, dialyzed/filtered lymphatic fluid that was removed) into the lymphatic structure or venous structure, depending on the procedure. In that respect, some of the drainage systems of this specification may include mechanisms for improving such infusions/injections so that the fluid is not immediately drained by a drainage catheter that may be in place.
[00278] For example, Fig. 94 illustrates a drainage catheter system that is comprised of a drainage lumen 116G, an infusion lumen 116F, and a pressurized fluid source 171 coupled to the infusion lumen 116F. The drainage catheter 116 is placed into a target location such as the thoracic duct 20 of a patient and fluid is drained. While the fluid is being drained, the pressurized fluid source 171 coupled to the infusion lumen 116F continuously infuses fluid into the thoracic duct, thereby altering the properties of the fluid in the region of the distal tip of the drainage lumen 116. The infused fluid may be saline and may contain heparin (e.g., heparinized saline) to dilute the clotting factors and prevent the formation of clots or clogs within the drainage lumen.
[00279] In another example, Fig. 95 illustrates an embodiment of a drainage system that can temporarily close off a distal/forward fluid path during fluid infusion so that when the drainage is again activated, it will not immediately drain off the infused fluid. As described in further detail below, this may be achieved with a distal sealing member 116Q and at least one a valve 175A.
[00280] The drainage catheter 116 includes a drainage lumen 116G that is connected to a two-way valve switch 175B, which allows the catheter 116 to be switch from a connection to a reservoir 204 into which fluid is drained or a fluid source 171 that may be pressurized. In a normal draining state, the valve switch 175B is switched to a connection into the reservoir 204. Fluid enters the distal end of the drainage lumen 116G of the catheter and then passes into the reservoir 204. A one-way valve 175A within the drainage lumen 175A allows fluid flow in a proximal direction while blocking fluid flow in a distal direction. In the draining state, fluid is generally blocked from entering the drainage lumen 116G through the one or more apertures 116P in the wall of the catheter 116. In some circumstances, it may not be desirable to allow fluid through these one or more apertures 116P since the location of the apertures 116P might be located within the venous system. Preventing such fluid flow may be achieved in several different ways. For example, each aperture 116P may have its own one-way valve or, as seen in Fig. 95, the main drainage lumen one-way valve 175A may have leaflets that, when open, cover the apertures 116P to prevent fluid flow.
[00281] When infusion is needed, the valve switch 175B is adjusted to connect to the fluid source 171. Fluid passes distally through the drainage lumen 116G but is prevented from passing the one-way valve 175A. Instead, the fluid is directed out apertures 116P. As discussed above, the apertures 116P either have their own one way valves that allow fluid to pass outside of the drainage lumen 116G or the leaflets of the one-way valve 175A uncover the apertures 116P. Once outside of the catheter 116, the fluid is further prevented from moving distally by one or more enlarged sealing members 116Q that extend circumferentially around the outside of the catheter 116.
[00282] The one or more sealing members 116Q are preferably sized such that they seal or block off the space between the catheter and the vessel in which it is located in (e.g., a lymphatic vessel such as the thoracic duct 20). Hence the fluid moves proximally outside of the catheter 116, away from the distal end of the catheter 116. The one or more sealing members 116Q may be generally maintained in its enlarged configuration against the walls of the lymphatic structure or can be selectively increased in size during infusion and decreased in size during drainage. For example, the one or more sealing members 116Q may be one or more balloons that are connected to an inflation lumen extending to a proximal end of the catheter 116.
[00283] In use, the drainage catheter 116 is advanced into a venous vessel under ultrasound or fluoroscopic guidance. The tip of the drainage catheter 116 is advanced into the thoracic duct 20. The sealing member is positioned in the thoracic duct 20 or venous vessel. In order to drain lymphatic fluid, the valve switch 175B is actuated to allow flow from the thoracic duct 20 through the lumen 116G of the catheter 116 and into the reservoir. The sealing member 116Q, which is optional, is deflated at this time. When infusion of fluid (e.g., saline, isotonic saline, dialyzed/filtered lymphatic fluid that was removed) is desired, the valve switch 175B is actuated to allow flow from the fluid source 171 through the catheter, out of the openings 116P and into the distal thoracic duct 20 or venous vessel. Additionally, if the sealing member 116Q is included in the system, it is inflated to block off the vessel distally. The inflated sealing member 116Q prevents the infused fluid from exiting the catheter opening and passing retrograde down the thoracic duct 20. In another embodiment, the drainage catheter does not have a sealing member.
[00284] In one embodiment shown in Fig 96, a drainage catheter is comprised of a drainage lumen 116G and a pressure sensor 183 on the outer surface of the catheter 116 and which is configured to sense pressure outside of the catheter 116. The drainage catheter 116 is placed in a target structure such as the thoracic duct 20 and fluid is drained. During the drainage therapy, the pressure sensor 183 measures the interstitial fluid pressure in the soft tissue surrounding the catheter 116. If the interstitial fluid pressure increases, this may signify that the drainage lumen 116G is partially or fully blocked.
[00285] Additionally or alternately, pressure sensors can be located within the drainage lumen 116G. For example, in Fig 98, two pressure sensors 183 are located within the drainage lumen 116G, with one near the distal portion of the catheter 116 and one near the proximal portion of the catheter 116. If the distal sensor 183 detects significantly higher pressure than the proximal sensor 183, this may signify that the drainage lumen is partially or fully blocked. A computerized control mechanism receiving the data may analyze it and create an alert (e.g., a message, lights, etc.) indicating a clog.
[00286] In another embodiment shown in Fig 97, a sensor 185 is located within or coupled to the drainage lumen 116G to detect the flow of fluid and/or measure the flow rate of fluid. If the flow rate of fluid is substantially reduced/stopped or the flow rate approaches zero, this may signify that the drainage lumen is partially or fully blocked.
[00287] Figs. 99A (end view), 99B (side view), 100A (end view), and 100B (side view) illustrate another embodiment with a mechanism for breaking up clogs or clots within the drainage lumen 116G of a catheter 116. The drainage catheter 116 includes a disruption balloon or lumen 187. The disruption lumen 187 may be at least partially comprised of a flexible sealed wall that allows the lumen to be inflated and thereby expand to compress the contents within the drainage lumen 116G. The drainage catheter 116 may be placed in a target structure such as the thoracic duct and fluid is removed. If a clog is suspected, the disruption lumen 187 is inflated and collapsed to disrupt the accumulation of contents within the drainage lumen 116G and thereby force the contents out of the drainage lumen 116G. The disruption lumen may be inflated with a gas, such as CO2 or air, or a liquid, such as saline. The disruption lumen may be present along the full length of the drainage lumen 116G or limited to one region of the drainage lumen 116G (e.g., a distal or proximal region). Alternately, a stylet 149 may be used to increase the size of the disruption lumen 187 as seen in Figs. 101 A (end view) and Fig. 101 B (side view). The stylet 149 may be advanced distally into the disruption lumen 187 to increase its size and disrupt any clots within the drainage lumen 116G.
[00288] As previously discussed, drainage ports 244 allow for multiple drainage sessions with a patient. One drainage system embodiment can be seen in Figs. 102A, 102B, and 102C, and includes a drainage catheter 116, a fluid fitting 189, and an indwelling port 244. The drainage catheter 116 is placed in the thoracic duct 20 and fluid is drained, as seen in Fig. 102A. In order to convert to an indwelling drainage system, the proximal end of the catheter 116 is cut off and a fluid fitting 189, such as a barbed fitting, Luer lock fitting, Tuohy-Borst fitting, is placed on the cut end. The indwelling port 244 is then attached to the opposite side of the fitting it to establish a fluid path through the lumen of the drainage catheter 116 to the port 244, as seen in Fig. 102B. An incision is then made in the skin 11 , and the indwelling port 244 is placed within the subcutaneous tissue of the patient and then closed as seen in Fig. 102C. Additionally, the incision may be made prior to attaching the fluid fitting 189 or port 244 to the drainage catheter 116, and the drainage catheter 116 may be tunneled within the subcutaneous tissue to exit from the patient at the incision location. The fluid fittingl 89 and port 244 may then be attached and implanted.
[00289] In another embodiment as shown in Figs. 103A, 103B, and 103C, the port 244 may be attached as describe above and left external to the patient. The port 244 may be adhered to the patient with an adhesive, sutures, or other securement means.
[00290] While the catheter 116 is described above as being cut, it may alternately have two catheter segments connected together by a coupling device such as, but not limited to, threads, luer-lock connector, adhesive, quick-connect, or barb. In this respect, the drainage catheter 116 is placed in the thoracic duct 20 and fluid is drained. In order to convert to an indwelling drainage system, the proximal portion of the drainage catheter 116 is uncoupled or separated from the distal portion of the drainage catheter by, for example, twisting the distal portion to disengage the threads. The indwelling port 244 is then coupled to the proximal end of the distal portion of the drainage catheter 116. The indwelling port 244 is then implanted within the patient as describe elsewhere in this application. Alternatively, the port 244 may be placed external to the patient as describe elsewhere in this application. [00291] In one embodiment shown in Figs. 104A and 104B, a drainage system is comprised of a drainage catheter 116 with two drainage lumens and an indwelling port 244. The drainage catheter 116 has a bifurcation partway along its length and the two drainage lumens are present in the two bifurcations 116M and 116N. One drainage lumen of segment 116M is configured for placement external to the patient for fluid drainage and the other drainage lumen of segment 116N is configured for placement internal to the patient and attachment to an indwelling port 244. The drainage catheter 116 is placed in the thoracic duct 20 and fluid is drained through the first drainage lumen of segment 116M as seen in Fig. 104A. In order to convert to an indwelling system, an incision is made in a desirable location and the second drainage lumen of segment 116N is tucked within the incision as seen in Fig. 104B. The second drainage lumen in segment 116N is then coupled to the indwelling port to establish a fluid path and both are implanted. The first drainage lumen in the first segment 116M is then occluded with glue or a plug and implanted within the patient.
[00292] In one embodiment shown in Figs. 105A-105F, a drainage system is comprised of a drainage catheter 116, guidewire 117, and indwelling port 244 with integrated drainage tube 119. The drainage catheter 116 is placed in the thoracic duct 20 and fluid is drained, as seen in Fig. 105A. In order to convert into an indwelling system, the guidewire 117 is advanced through the lumen of the drainage catheter 116 until it is advanced beyond the distal end of the drainage catheter 116 and is in the thoracic duct 20, as seen in Fig. 105B. The drainage catheter 116 is then removed while leaving the guidewire 117 in place, as seen in Fig. 105C. The indwelling port 244 with integrated drainage tube 119 is then advanced over the guidewire 117 and into the thoracic duct 20 as seen in Fig. 105D and the guidewire 117 is removed either before the incision or after as seen in Fig. 105E. The indwelling system is then implanted as seen in Fig. 105F. The indwelling system is then accessed to remove fluid.
[00293] In the previously described embodiment of Figs. 105A-105F, the indwelling port 244 and is described as being integrated with the drainage tube/catheter 119. Alternately, the same procedure can be performed with a separate port 244 and drainage tube/catheter 119. First the drainage tube/catheter 119 may be advanced over the guidewire 117 and then the indwelling port 244 may be advanced over the guidewire 117, at which point the two may be physically coupled together to form a continuous drainage passage. The port 244 and/or tube/catheter 119 may include a variety of different connectors to connect to two components, such as a barbed connector, screw fitting, or similar mechanism.
[00294] Another drainage system embodiment is similar to the previous embodiments except that a tee-junction or “T” connection can be used to connect to the catheter 116. Specifically, the drainage system is comprised of a drainage catheter 116, fluid fitting 189, and indwelling port 244. The drainage catheter 116 is placed in the thoracic duct 20 and fluid is drained. In order to convert to an indwelling system, a fluid fitting 189, such as a tee-junction, is advanced along the length of the drainage catheter 116. The fluid fitting 189 is then secured to the drainage catheter 116 using adhesive, crimping, suture, or other securement means. The open side of the fluid fitting 189 is then accessed to pierce the drainage catheter 116 and establish a fluid path through the fluid fitting. The fluid fitting 189 may be crimped and pierced as a part of the same process. An incision is then made and the indwelling port 244 is placed in the incision. The distal end of the port 24 is tunneled to the fluid fitting and coupled using adhesive, crimping, suture, a barbed connection, or other securement means. The port 244 is then implanted. The proximal end of the drainage catheter 116 is occluded to prevent flow and also implanted within the patient.
[00295] As previously discussed with regard to other embodiments in this specification, it can be helpful to lock a position of the drainage catheter within a lymphatic vessel and/or temporarily occlude a lymphatic vessel while infusing certain fluids. Figs. 106A and 106B illustrate one example embodiment of a drainage catheter 116 with a selectively enlargeable portion at its distal end.
[00296] Specifically, the distal end of the catheter 116 may include one or more deflectable members 195 that partially or fully surround the catheter 116 and that can radially bend outwards when longitudinally compressed to the shape seen in Fig. 106B. These one or more deflectable members 195 can be longitudinally compressed by a variety of different mechanisms. For example, the catheter 116 may have an overlying tube or sheath 193 that may move longitudinally relative to the catheter 116, pressing its distal end against the proximal end of the one or more deflectable members 195. The catheter 116 may also have a ridge or lip 116S at its distal end that presses against or retains the distal ends of the one or more deflectable members 195. The sheath 193 may have a mechanism to control its movement, such as threading 193A that mates with threading on the outer surface of the catheter 116 such that when the sheath 193 rotates, it moves either proximally or distally relative to the catheter 116. Alternatively, the sheath 193 may include a clamp mechanism, gear mechanism, or similar controlled movement mechanism. Alternatively, the sheath 193 may have no locking or movement mechanism, relying solely on the hands of a physician for adjustment.
[00297] The one or more deflection members 195 may be comprised of a circular tube comprised of a rigid or semi-rigid material, such as a metal or polymer. Its proximal and distal ends may be fixed to the distal end of the sheath 193 and the ridge 116S so that the one or more deflection members 195 can be pushed or pulled as needed. The one or more deflection members 195 may also be further comprised of a shape that is pre-disposed to deflect outward to reduce the stress in the deflection member 195 (e.g., shape memory material).
[00298] Additionally or alternately, the one or more deflection members 195 may be further comprised of a porous material such as a foam or hydrogel matrix, or may contain one or more holes to allow native flow through the deflection member 195 while still maintaining the position of the drainage catheter 116 within the thoracic duct 20.
[00299] In use, the drainage catheter 116 is advanced into the thoracic duct 20 of a patient as described elsewhere in this and the referenced applications. Once the drainage catheter 116 is in a desired position, the compression sheath 193 is actuated to compress the one or more deflection members 195 until the outer diameter of the deflection member is increased and the drainage catheter is secured within a lymphatic structure. Alternatively, if the deflection members 195 are being used to occlude a lymphatic structure, such as elements 116Q in Fig. 95, the deflection members 195 are only temporarily increased in diameter while infusion is performed.
[00300] While this specification has described various devices and methods of use, it should be appreciated that additional methods of use are possible. The following discusses various aspects of methods of use and treatment that can be used with any of the devices and other techniques/methods also discussed in this specification and/or the references incorporated into this specification. [00301] Several of the embodiments of this specification are related to accessing a lymphatic structure, such as the thoracic duct. Any of the embodiments of devices, systems, and methods may employ the use of ultrasound imaging for identifying structures with the body, guiding the advancement of devices such as needle devices to desired body structures, providing feedback of device location, and providing feedback on the movement of fluid with a body structure and/or into a drainage device.
[00302] Fig. 107 discloses a flow chart for one general method of draining lymphatic fluid, comprising identifying a thoracic duct, identifying one or more anatomical features of the thoracic duct, determining potential approaches for placing a drainage catheter, needle, or cannula in the thoracic duct, placing the drainage catheter, needle, or cannula in the thoracic duct, and draining lymphatic fluid from the thoracic duct. Each of these will be discussed further below.
[00303] Identifying a Thoracic Duct
[00304] As previously discussed, one initial step to performing a lymphatic drainage procedure may be identifying the location and position of the thoracic duct within a patient. This step can be important so that the catheter and/or needle used to enter the thoracic duct can be properly directed.
[00305] In that respect, the step of identifying a thoracic duct may further include using one or more of the following imaging modalities or techniques. In one embodiment, transcutaneous ultrasound techniques are used to non-invasively identify a thoracic duct including, but not limited to planar, bi-plane, 3D, 4D, and contrast-enhanced techniques.
[00306] In another embodiment, intravascular ultrasound techniques (IVUS) are used to identify a thoracic duct by, for example, advancing an IVUS catheter such as the Eagle Eye Platinum catheter manufactured by Philips into a vein and imaging the tissue surrounding the vein to identify a thoracic duct.
[00307] In another embodiment, optical coherence tomography (OCT) technology is used to identify a thoracic duct by, for example, advancing an OCT catheter such as the Dragonfly Optis Imaging Catheter by Abbott into a vein and imaging the tissue surrounding the vein to identify a thoracic duct. [00308] In another embodiment, lymphangiography techniques are used to identify a thoracic duct by injecting contrast into the patient’s body (e.g., into a lymph node) and using fluoroscopy or X-Ray techniques to identify the thoracic duct. In another embodiment, lymphoscintigraphy techniques are used to identify the thoracic duct by injection or ingestion of a radioisotope such as technium-99m albumin that is then used to visualize the thoracic duct.
[00309] In another embodiment, magnetic-resonance imaging (MRI) is used to image a thoracic duct using contrast (e.g., contrast-enhanced MR lymphangiography) or using a pre-specified imaging algorithm such as a heavily-T2 weighted imaging algorithm. In another embodiment, computer tomography (CT) is used to image a thoracic duct using contrast (e.g., contrast-enhanced CT lymphangiography) or using a pre-specified imaging algorithm.
[00310] In conjunction with any of the above embodiments or group of above embodiments, a contrast agent such as Lipiodol, Isovue, or other suitable contrast agent known to one skilled in the art or radioactive agent such as technium-99m albumin or other agent known to one skilled in the art may be introduced into the patient by injection, ingestion, inhalation, diffusion, electroporation, or other means known to one skilled in the art via any suitable anatomical route such as transdermal, transoral, transrectal, transbronchial, transesophageal, transintestinal, transcolonic, transabdominal, or other route known to one skilled in the art in order to enhance the ability to visualize the thoracic duct via one or more visualization embodiments described above.
[00311] Identifying One or More Anatomical Features of the Thoracic Duct
[00312] The step of identifying the anatomy of the thoracic duct may further be comprised of identifying one or more of the anatomical features of the thoracic duct including, but not limited to, the diameter of the thoracic duct as measured at any point along its length (e.g., abdominal portion, thoracic portion, cervical portion, and/or terminal end), the anatomical course of the vessel relative to other structures (e.g., aorta, esophagus, vena cava, internal jugular vein, subclavian vein, brachiocephalic vein, external jugular vein, carotid artery, vertebral vein, spinal column, and vertebrae), the presence or absence of a termination location of the thoracic duct on the left or right side of the patient, the presence of a branching structure of the thoracic duct along its length, the location of any branches in the thoracic duct, the size of the branches in the thoracic duct, the number of branches of the thoracic duct along its length, the number of terminal branches of the thoracic duct at its termination into the venous system, the location of the one or more terminations of the thoracic duct into the venous system (e.g., internal jugular vein, subclavian vein, brachiocephalic vein, external jugular vein, and vertebral vein), the presence of lymphovenous junctions outside of the left or right neck, the presence of an ampullary configuration in the cervical portion of the thoracic duct, the presence of a dilation or dilatation of the thoracic duct at any point along the length of the thoracic duct, the thickness of the thoracic duct vessel wall at any point along its length, the presence of a lymphatic leak at any point along its length, the presence of absence of a terminal valve, the presence or absence of reflux of fluid into the thoracic duct.
[00313] Determining Potential Approaches for Placing a Drainage Catheter
[00314] The step of determining the potential approach(es) for placing a drainage catheter in the thoracic duct may further be comprised of considering one or more of the anatomical features identified in the previous steps in relation to one or more procedural approaches including, but not limited to, a transvenous approach wherein a catheter is advanced into a venous vessel and then introduced into the thoracic duct, a direct cervical approach wherein a needle, guidewire, and/or catheter is advanced through the skin in the neck and directly into the thoracic duct, or an abdominal approach wherein a needle, guidewire, and/or catheter is advanced through the skin in the abdomen and directly into the thoracic duct. These approaches and associated techniques are discussed in detail in the referenced applications. The consideration may include comparison of the risks and challenges associated with each procedural approach relative to the anatomical features of a patient.
[00315] One or more of the following anatomical features may be evaluated as described below to guide or help guide the choice of one or more procedural approaches. If the thoracic duct is identified to have a branching structure at the termination with the venous system with small branches (less than 4mm, 3mm, 2mm, or 1mm), the transvenous approach may present an increased challenge in cannulating and traversing small branches from the vein. If the thoracic duct is identified to have a branching structure in the cervical portion of the thoracic duct with small branches (less than 4mm, 3mm, 2mm, or 1mm), the direct cervical approach may present an increased challenge in accessing and traversing small branches in a direct manner. If the thoracic duct is identified to have a branching structure in the abdominal or thoracic portion of the thoracic duct with small branches (less than 4mm, 3mm, 2mm, or 1 mm) or tortuous anatomy, the direct abdominal approach may present an increased challenge in accessing and traversing small branches and tortuous anatomy in a direct manner. If the thoracic duct is identified to have reflux from the vein, the challenge associated with a transvenous approach may be reduced due to lack of a competent valve at the venous interface. If the thoracic duct is dilated in the cervical portion, the challenge associated with a direct cervical approach may be reduced due to the large target for needle access provided by the dilated anatomy. If the thoracic duct is observed to be close to the aorta or carotid artery in the abdomen or neck, a direct access approach may present an increased risk due to the potential to puncture one of those structures. If the thoracic duct has a narrow region with a diameter less than 5mm, 4mm, 3mm, 2mm, or any diameter substantially less than the diameter of the drainage catheter, advancing a drainage catheter past that region in an antegrade or retrograde manner may lead to an increased risk of dissection of the vessel when advancing the drainage catheter and impact the suitability of any procedural approach.
[00316] Placing a Drainage Catheter, Needle, or Cannula in the Thoracic Duct
[00317] The step of placing a drainage catheter, needle, and/or cannula in the thoracic duct may be further comprised of one or more of the approaches and techniques discussed in detail in the present specification and the references incorporated by reference.
[00318] Draining Lymphatic Fluid from the Thoracic Duct
[00319] The step of draining lymphatic fluid from the thoracic duct may be further comprised of one or more of the approaches and techniques discussed in detail in the present specification and the references incorporated by reference.
[00320] Several specific exemplary embodiments are discussed further below. [00321] In one embodiment, the terminal portion of the thoracic duct is visualized using non-invasive surface ultrasound. The thoracic duct is determined to have multiple small terminal branches that terminate into the internal jugular vein. Proximal to the bifurcation of the branches, the thoracic duct is observed to be dilated in the cervical region and have a diameter of 5mm. Based on this anatomical assessment, a direct cervical approach is recommended with the access location in the thoracic duct in the dilated cervical portion proximal to the bifurcation. An abdominal approach is also identified as a potential approach as well. The thoracic duct is then accessed in the neck with a needle using surface ultrasound to guide the needle into the thoracic duct. A guidewire is advanced through the needle and into the thoracic duct. A drainage catheter is then exchanged for the needle to drain lymphatic fluid. Lymphatic fluid is drained from the thoracic duct.
[00322] In one embodiment, the thoracic duct is visualized using lymphangiography and the entire duct is visualized with fluoroscopy. A branching structure is identified in the thoracic portion of the thoracic duct, but re-combines into a single terminal branch in the left neck approximately 4cm proximal to the termination into the subclavian vein. The single terminal branch measures 6mm in diameter. A terminal valve is observed to limit outflow from the thoracic duct, but reflux is observed. Based on the anatomical assessment, a transvenous approach is recommended. The thoracic duct is then accessed with a catheter through a vein in the leg (e.g., femoral vein) or arm (e.g., brachial vein, basilic vein) and advanced into the thoracic duct up to the bifurcation. Lymphatic fluid is drained from the thoracic duct.
[00323] In one embodiment, the thoracic duct is visualized using an MRI sequence with a heavily T2-weighted algorithm. The thoracic duct is identified to follow a tortuous path through the thoracic portion and have a branching termination into the external jugular and subclavian veins in the left neck. Based on the anatomical assessment, a transabdominal approach is recommended. The thoracic duct is then accessed with a needle using lymphangiography and fluoroscopy to guide the needle into the thoracic duct. A guidewire is advanced through the needle and into the thoracic duct. A drainage catheter is then exchanged for the needle to drain lymphatic fluid. Lymphatic fluid is drained from the thoracic duct. [00324] In one embodiment, the thoracic duct is visualized using a combination of IVUS and fluoroscopy. An IVUS catheter is advanced into the subclavian vein and the termination of the thoracic duct is identified by exploring the various structures identified to enter the vein. A guidewire and catheter are introduced into the thoracic duct and contrast is injected in a retrograde manner to visualize a greater portion of the thoracic duct. The contrast is injected and reaches into the thoracic portion of the thoracic duct as visualized using fluoroscopy. The terminal thoracic duct is identified to have a single terminal branch and measured 4mm. Based on the anatomical assessment, a transvenous approach is recommended. A drainage catheter is exchanged for the catheter in the thoracic duct, and lymphatic fluid is drained from the thoracic duct.
[00325] In one embodiment, the thoracic duct is visualized using a combination of imaging approaches. An IVUS catheter is advanced into the subclavian vein and the termination of the thoracic duct is identified as a structure entering the vein. A guidewire and catheter are introduced into the thoracic duct and contrast is injected in a retrograde manner to visualize a greater portion of the thoracic duct. The contrast reaches into the thoracic portion of the thoracic duct as visualized using fluoroscopy. The terminal thoracic duct is identified to have multiple terminal branches proximal to the catheter tip with no visualization of the proximal bifurcation of the branching portion. A lymphangiogram with fluoroscopy is then performed to visualize the abdominal portion of the thoracic duct and un-opacified thoracic portion of the thoracic duct. A linear course of the thoracic duct is identified through the abdomen and the branching structure is identified to begin in the proximal end of the thoracic portion of the thoracic duct. Based on this anatomical assessment, an abdominal approach is recommended.
[00326] In one example, a system and method for accessing the lymphatic system of a patient may include a needle with a forward-looking ultrasound transducer, a guidewire, and a drainage catheter. The needle may be advanced partially into the tissue, and the ultrasound image may be used to visualize the tissue in front of the needle. The trajectory of the needle may be adjusted to ensure the desired structure is entered by the needle.
[00327] In one example, a system and method for accessing the lymphatic system in a patient may include a balloon, a needle, and an endoscope. The balloon may be deflated and advanced through the skin and toward a lymphatic structure. When in the desired location, the balloon may be inflated with gas (e.g., air, CO2) or fluid (e.g., saline, water), and the scope may be advanced through the balloon to directly visualize the adjacent tissue. The needle may then be advanced through the tissue to probe the tissue under direct visualization to identify the desired lymphatic vessel. Additionally or alternatively, the system and method may include injecting a fluorescent agent such as indocyanine green (ICG) into a lymphatic structure (e.g., lymph node, cisterna chyli, collecting lymphatic duct, or thoracic duct) prior to the procedure. During the direct visualization portion of the procedure, light with at least a component between 750nm and 950nm (more specifically, 800nm or 810nm or 830nm) may be directed toward the surgical field to identify the lymphatic structure.
[00328] In one example, a system and method for accessing the lymphatic system in a patient may include a needle and contrast media. A needle may be advanced through the skin and into proximity of a desired lymphatic structure. The contrast media may then be injected through the needle and into the tissue. Due to the wall of the lymphatic vessel, the contrast may spread throughout the interstitial space surrounding the vessel without entering the lymphatic vessel. The region may then be imaged using visualization means such as fluoroscopy to identify the volume of tissue surrounding the lymphatic vessel. Based on the space that does not contain contrast, the location of the lymphatic vessel may be identified.
[00329] In one example, a system and method for accessing the lymphatic system may include an orally ingested agent. The agent may include a fatty substance known to enter the lymphatic system via the digestive tract. The agent may also be partially comprised of a radioactive tracer or fluorogenic tracer that could be identified via an appropriate visualization means. With the lymphatic system visualized with the aid of the ingested agent, the lymphatic system may be accessed using one or more systems and methods or combinations of systems and methods described elsewhere in this application and incorporated references.
[00330] Generally, compression of the different areas of the patient, such as the patient’s limbs, can be performed during a drainage procedure to improve the drainage results (e.g., drain faster or drain a greater amount of lymphatic fluid). As seen in the flow chart of Fig. 108, this method generally includes identifying a lymphatic structure, accessing the lymphatic structure, draining the lymphatic structure, and applying compression to areas of the patient during at least some of the draining process. Examples of a drainage procedure with this use of compression are discussed further below.
[00331] In one embodiment, a method for draining the lymphatic system includes the following steps: Identifying a lymphatic vessel, accessing a lymphatic vessel, placing a drainage catheter within the lymphatic vessel, beginning to drain lymphatic fluid, applying a compression device to a body region, compressing the body region, and ending drainage of the lymphatic fluid. Each step is further described in the subsequent paragraphs.
[00332] The step of identifying a lymphatic vessel may further be comprised of using transcutaneous ultrasound to non-invasively identify a lymphatic vessel or injecting contrast into a patient’s body and imaging using fluoroscopy or X-ray.
[00333] The step of accessing the lymphatic vessel may further be comprised of advancing a needle into the lymphatic vessel under ultrasound or fluoroscopic guidance or advancing a guidewire and catheter through a blood vessel and into the lymphatic vessel under fluoroscopic guidance.
[00334] The step of placing a drainage catheter within the drainage vessel may further be comprised of advancing a guidewire through a needle within the lymphatic vessel, retracting the needle, and advancing the drainage catheter over the guidewire such that its distal tip is within the lymphatic vessel. Alternatively, if a guidewire and catheter have been advanced through a blood vessel and into the lymphatic vessel, the catheter may be retracted and the drainage catheter advanced over the guidewire such that its distal tip is within the lymphatic vessel.
[00335] The step of draining lymphatic fluid may further be comprised of attaching a collection reservoir to the drainage catheter and opening a valve to allow fluid to flow through the drainage catheter. Additionally, the draining may be augmented by the application of suction to the distal end of the catheter to further promote flow through the drainage catheter. [00336] The step of applying a compression device to a body region may be further comprised of placing an active compression device, such as a sequential compression device (SCD) such as the Leg Compression System offered by Vive Health as well as other active compression devices as known to those skilled in the art. The compression device may be applied to one or more of the following body regions: leg, arm, torso, abdomen, foot, ankle, or chest.
[00337] The step of applying compression to the body area may further be comprised of activating the compression device in an intermittent or continuous fashion. Further, the compression device, such as a sequential compression device (SCD), may have two or more separate regions that are independently activated to allow greater control of the compression therapy. As an illustrative example, the compression starts with the distal-most regions first and moves proximal to encourage movement of the lymphatic fluid toward the center of the body by activating the regions in that order in a sequential fashion. As an additional illustrative example, the compression therapy starts with intermittent compression toward the center of the body as aforementioned and then ends with a continuous compression to minimize the ability of fluid to accumulate in those tissues.
[00338] In another embodiment, a method for draining the lymphatic system includes the following steps: Identifying a lymphatic vessel, accessing a lymphatic vessel, placing a drainage catheter within the lymphatic vessel, beginning to drain lymphatic fluid, applying a compression device to a body region, and ending drainage of the lymphatic fluid. Each step is further described in the subsequent paragraphs.
[00339] The step of identifying a lymphatic vessel may further be comprised of using transcutaneous ultrasound to non-invasively identify a lymphatic vessel or injecting contrast into a patient’s body and imaging using fluoroscopy or X-ray.
[00340] The step of accessing the lymphatic vessel may further be comprised of advancing a needle into the lymphatic vessel under ultrasound or fluoroscopic guidance or advancing a guidewire and catheter through a blood vessel and into the lymphatic vessel under fluoroscopic guidance. [00341] The step of placing a drainage catheter within the drainage vessel may further be comprised of advancing a guidewire through a needle within the lymphatic vessel, retracting the needle, and advancing the drainage catheter over the guidewire such that its distal tip is within the lymphatic vessel. Alternatively, if a guidewire and catheter have been advanced through a blood vessel and into the lymphatic vessel, the catheter may be retracted and the drainage catheter advanced over the guidewire such that its distal tip is within the lymphatic vessel.
[00342] The step of draining lymphatic fluid may further be comprised of attaching a collection reservoir to the drainage catheter and opening a valve to allow fluid to flow through the drainage catheter. Additionally, the draining may be augmented by the application of suction to the distal end of the catheter to further promote flow through the drainage catheter.
[00343] The step of applying a compression device to a body region may be further comprised of placing a passive compression device, such as a compression sock, sleeve, band or other garment designed for application onto a desired body region as known to those skilled in the art. One example of such a compression device is the Jobst Relief compression stocking. Another example is the LympheDIVAs Arm Sleeve. The compression device may be applied to one or more of the following body regions: leg, arm, torso, abdomen, foot, ankle, or chest. As would be appreciated by one skilled in the art, the step of applying the compression device in this method could be performed at any point within the method including at the beginning, middle, or at the end.
[00344] In another embodiment, a method for draining the lymphatic system includes the following steps: Identifying a lymphatic vessel, accessing a lymphatic vessel, placing a drainage catheter within the lymphatic vessel, beginning to drain lymphatic fluid, applying manual compression to a body region, and ending drainage of the lymphatic fluid. Each step is further described in the subsequent paragraphs.
[00345] The step of identifying a lymphatic vessel may further be comprised of using transcutaneous ultrasound to non-invasively identify a lymphatic vessel or injecting contrast into a patient’s body and imaging using fluoroscopy or X-ray. [00346] The step of accessing the lymphatic vessel may further be comprised of advancing a needle into the lymphatic vessel under ultrasound or fluoroscopic guidance or advancing a guidewire and catheter through a blood vessel and into the lymphatic vessel under fluoroscopic guidance.
[00347] The step of placing a drainage catheter within the drainage vessel may further be comprised of advancing a guidewire through a needle within the lymphatic vessel, retracting the needle, and advancing the drainage catheter over the guidewire such that its distal tip is within the lymphatic vessel. Alternatively, if a guidewire and catheter have been advanced through a blood vessel and into the lymphatic vessel, the catheter may be retracted and the drainage catheter advanced over the guidewire such that its distal tip is within the lymphatic vessel.
[00348] The step of draining lymphatic fluid may further be comprised of attaching a collection reservoir to the drainage catheter and opening a valve to allow fluid to flow through the drainage catheter. Additionally, the draining may be augmented by the application of suction to the distal end of the catheter to further promote flow through the drainage catheter.
[00349] The step of applying manual compression a body region may be further comprised of performing manual lymphatic drainage or massage. The compression therapy may be applied to one or more of the following body regions: leg, arm, torso, abdomen, foot, ankle, or chest. The compression therapy may be performed once or more than once during the drainage period as needed.
[00350] Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.

Claims

What is claimed is:
1. An expandable needle assembly comprising: a needle having a tubular shape and an inner passage extending therethrough; the inner passage of the needle being configured to expand from a first diameter to a second diameter; and, a stylet having an elongated body sized to increase the inner passage of the needle from the first diameter to the second diameter when the stylet is placed within the inner passage.
2. The expandable needle assembly of claim 1 , wherein the needle is composed of plastically deformable material that allows for stretching and/or unfolding.
3. The expandable needle assembly of claim 1, wherein the stylet is solid or comprises a stylet passage extending between its ends.
4. A method of draining lymphatic fluid, comprising: inserting a needle into a lymphatic structure; increasing a diameter of an inner passage of the needle; and, draining lymphatic fluid.
5. The method of draining lymphatic fluid of claim 4, wherein increasing a diameter of the inner passage includes inserting a stylet into the inner passage.
6. A needle assembly, comprising: an elongated need with a sharpened tip; a tubular sheath disposed over the needle.
7. The needle of claim 6, further comprising a locking mechanism configured to lock the longitudinal position of the sheath relative to the needle.
8. The needle of claim 7, wherein the locking mechanism is configured to lock needle such that it is exposed from an end of the sheath by 4mm to 8mm.
9. The needle of claim 6, further comprising a spring connected to the needle and to the sheath so as to bias the needle to a fully retracted position within the sheath.
10. A method of draining lymphatic fluid, comprising: adjusting a position of a sheath over a needle; engaging a locking mechanism to lock the position of the sheath relative to the needle; inserting a needle into a lymphatic structure; contacting an outside of the lymphatic structure so as to prevent the sheath from passing into an interior of the lymphatic structure; and, draining lymphatic fluid.
11. A patch for providing guidance to a needle, comprising: a patch body; and, a needle passage sized and configured for allowing passage of a needle.
12. The patch of claim 11 , wherein the needle passage comprises threads, bosses, ridges, or other solid features.
13. The patch of claim 11 , wherein the needle passage is fixed relative to patch body or wherein the needle passage is connected to an angular adjustment mechanism to allow adjustment of the angle of the needle relative to the patch body.
14. A needle assembly for draining lymphatic fluid, comprising: a needle; and, an enlargement feature located on the outside of the needle near a distal tip configured to prevent a distal tip of the needle from extending beyond a predetermined length into a lymphatic vessel.
15. The needle assembly of claim 14, wherein the enlargement feature is one or a plurality of arm members configured to move from within a passage of the needle to a position at least partially outside of the needle.
16. The needle assembly of claim 14, wherein the enlargement feature is an inflatable balloon.
17. The needle assembly of claim 14, wherein the enlargement feature is a first inflatable balloon and a second inflatable balloon.
18. A method of draining lymphatic fluid, comprising: increasing a size of an enlargement feature located on the outside of a needle near a distal tip of the needle; and, advancing the distal tip of the needle into a lymphatic structure.
19. A needle assembly, comprising: a needle; a sheath configured for placement over the needle; and, an enlargement feature located on the outside of the sheath near a distal tip configured to prevent a distal tip of the needle from extending beyond a predetermined length into a lymphatic vessel.
20. A needle assembly, comprising: a needle body; and, a distal region have a smaller diameter than a proximal region so as to form a step between the distal region and the proximal region; wherein the distal region has a length smaller than a diameter of a lymphatic structure.
21 . A needle assembly, comprising: a needle; and, a wire configured to be advanced through the needle and out a distal tip of the needle; the wire forming a secondary shape when unrestrained.
22. The needle assembly of claim 21 , wherein the secondary shape is a “U” shape, a “C” shape, a curl, a circle, a coil, or a spiral.
23. The needle assembly of claim 21, further comprising a vibration source connected to the wire.
24. A method of draining lymphatic fluid, comprising: advancing a needle into a lymphatic structure of a patient; extending a wire out a distal end of the needle: and, allowing a distal end of the wire to form a secondary shape.
25. A cannula assembly for draining lymphatic fluid, comprising: a cannula having a flexible shape and forming a secondary shape when unrestrained; and, a stylet configured for placement within the cannula and having a length configured to straighten a distal region of the cannula.
26. The cannula assembly of claim 25, further comprising a plurality of holes in the distal region of the cannula.
27. The cannula assembly of claim 25, further comprising a plurality of holes in the stylet connecting to a stylet drainage passage.
28. A method of draining lymphatic fluid, comprising: advancing a cannula with a stylet within a drainage passage of the cannula into a lymphatic structure of a patient; at least partially withdrawing the stylet from the cannula; and, allowing a distal end of the cannula to form a secondary shape.
29. A catheter for draining lymphatic fluid, comprising: a catheter body; a drainage lumen between a proximal and distal end of the catheter body; and, a valve member located within the drainage lumen.
30. The catheter of claim 29, wherein the valve member is a balloon that is inflatable via an inflation lumen within the catheter body.
31. The catheter of claim 29, wherein the valve member is a stopcock, needle valve, gate valve, or umbrella valve.
32. A method of cleaning out a drainage catheter, comprising: draining lymphatic fluid via a catheter within a patient; actuating a valve to connected to a pressurized fluid source; and, allowing pressurized fluid to flow into the catheter.
33. A catheter for draining lymphatic fluid, comprising: a catheter body, a drainage lumen extending between a proximal and distal end of the catheter body; and, an infusion lumen extending from a proximal end of the catheter body and opening into a distal region of the drainage lumen.
34. The catheter of claim 33, further comprising a one-way valve positioned near the distal region of the drainage lumen.
35. A catheter for draining lymphatic fluid, comprising: a catheter body, a drainage lumen extending between a proximal and distal end of the catheter body; a plurality of apertures opening into the drainage lumen; a one-way valve located in the drainage lumen and configured to close the drainage lumen distally of the plurality of apertures.
36. The catheter of claim 35, wherein the one-way valve is configured to close off the drainage lumen in one position and close off the plurality of apertures in another position.
37. The catheter of claim 35, further comprising a sealing member disposed around an outside of the catheter body and having a size configure to block off a lymphatic vessel.
38. A method of cleaning out a drainage catheter, comprising: draining lymphatic fluid via a catheter within a patient; supplying pressurized fluid to a drainage lumen of the catheter from a pressurized fluid source; and, directing the pressurized fluid out one or more apertures in a sidewall of the drainage lumen.
39. A method of draining lymphatic fluid, comprising: draining lymphatic fluid through a drainage lumen in a drainage catheter; monitoring a first pressure value from a distal pressure sensor in the drainage lumen; monitoring a second pressure value from a proximal pressure sensor in the drainage lumen; and, monitoring for a pressure differential between the first pressure value and the second pressure value to indicate a clog in the drainage lumen.
40. A catheter for draining lymphatic fluid, comprising: a catheter body, a drainage lumen extending between a proximal and distal end of the catheter body; a disruption balloon positioned in the drainage lumen and configured to inflate against the inner surface of the drainage lumen to disrupt any accumulated material.
41. A method of draining lymphatic fluid, comprising: placing a distal end of a drainage catheter within a lymphatic vessel; draining lymphatic fluid; removing a proximal portion of the drainage catheter; placing a fluid fitting on an end of the drainage catheter; connecting the fluid fitting to a port.
42. A method of draining a lymphatic fluid, comprising: draining lymphatic fluid from a first drainage catheter placed within a lymphatic structure of a patient; advancing a guidewire through a lumen of the catheter and into the lymphatic structure; removing the first drainage catheter; advancing a second drainage catheter at least partially into the lymphatic structure and over the guidewire; and, also advancing a port over the guidewire.
43. A drainage catheter for lymphatic fluid, comprising: a catheter body having a drainage lumen; a sleeve longitudinally moveable over the catheter body; and, a deflectable member that is configured to deflect outward as the sleeve is moved distally and longitudinally.
44. A method of draining a lymphatic fluid, comprising: implanting a marker assembly within a lymphatic structure; the marker assembly comprising a marker anchor structure connected to a marker wire; capturing the marker wire with a snare catheter; and, delivering a drainage catheter into the lymphatic structure.
45. A method of connecting an indwelling catheter to a drainage catheter, comprising: advancing a distal end of the drainage catheter near a proximal end of an indwelling catheter positioned at least partially within a lymphatic structure; magnetically attracting the distal end of the drainage to the proximal end of the indwelling catheter.
46. A method of connecting an indwelling catheter to a drainage catheter, comprising: advancing a distal end of the drainage catheter near a proximal end of an indwelling catheter positioned at least partially within a lymphatic structure; sensing a connection between the distal end of the drainage catheter and the proximal end of the indwelling catheter.
47. A drainage catheter for lymphatic fluid, comprising: a catheter body; a first lumen opening at a distal region of a sidewall of the catheter body; a second lumen opening at the distal region of the sidewall of the catheter body; and one or more balloons disposed near the distal region and configured to isolate each lumen to different vessel areas when inflated.
48. A method of draining a lymphatic fluid, comprising: advancing a catheter within a venous vessel; inflating one or more balloons at a distal region of the catheter; sampling fluid from a first isolated area; sampling fluid from a second isolated area; and, determining is lymphatic fluid taken from one of the two isolated areas; and, performing drainage on one of the two isolated areas in which lymphatic fluid was taken.
49. A method of draining a lymphatic fluid, comprising: identifying a thoracic duct; identifying one or more features of the thoracic duct; determine an approach to placing a needle, drainage catheter, or cannula in the thoracic duct; and, draining lymphatic fluid from the thoracic duct.
0. A method of draining a lymphatic fluid, comprising: identifying a lymphatic structure; accessing the lymphatic structure with a drainage catheter or needle; draining lymphatic fluid from the lymphatic structure; and, applying compression to areas of the patient.
PCT/US2022/070709 2021-02-19 2022-02-17 Lymphatic access, drainage, and shunting WO2022178523A1 (en)

Applications Claiming Priority (8)

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US202163151519P 2021-02-19 2021-02-19
US63/151,519 2021-02-19
US202163211993P 2021-06-17 2021-06-17
US63/211,993 2021-06-17
US202163223912P 2021-07-20 2021-07-20
US63/223,912 2021-07-20
US202163264771P 2021-12-01 2021-12-01
US63/264,771 2021-12-01

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Citations (6)

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US4716901A (en) * 1984-09-27 1988-01-05 Pratt Burnerd International Limited Surgical appliance for forming an opening through the skin
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US20120029466A1 (en) * 2009-01-12 2012-02-02 The Board Of Trustees Of The Leland Stanford Junior University Drainage devices and methods for use
US20180042588A1 (en) * 2015-03-26 2018-02-15 SPIRATION, INC., d/b/a OLYMPUS RESPIRATORY AMERICA Device for creating a local vacuum at a distal end of a sampling device
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Publication number Priority date Publication date Assignee Title
US3993079A (en) * 1974-12-14 1976-11-23 Henriques De Gatztanondo Carlo Device for percutaneous paracentesis, injection, drainage and catheterization
US4716901A (en) * 1984-09-27 1988-01-05 Pratt Burnerd International Limited Surgical appliance for forming an opening through the skin
US4957484A (en) * 1988-07-26 1990-09-18 Automedix Sciences, Inc. Lymph access catheters and methods of administration
US20120029466A1 (en) * 2009-01-12 2012-02-02 The Board Of Trustees Of The Leland Stanford Junior University Drainage devices and methods for use
US20180042588A1 (en) * 2015-03-26 2018-02-15 SPIRATION, INC., d/b/a OLYMPUS RESPIRATORY AMERICA Device for creating a local vacuum at a distal end of a sampling device
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