Apparatus and method for lymphatic anastomosis

Abstract

The preferred embodiment relates to an apparatus and method for performing a lymphatic venous bypass procedure, in which a first ring is secured to tissue connected to at least one lymphatic flow channel of a patient and a second ring is attached to a vein of the patient, an end of the lymphatic flow channel extending through the first ring is inserted into an open end of the vein, and the rings are connected together to establish fluid flow from the lymphatic flow channel to the vein.

Description

Background Art

[0001] This application is a continuation of U.S. application Ser. No. 17 / 133,277, filed Dec. 23, 2020, which claims priority to U.S. Provisional Application No. 62 / 864,862, filed Jun. 21, 2019, the entire contents of each of the above applications are hereby incorporated by reference in their entirety. This application also relates to U.S. Patent Application No. 17 / 132,946, filed Dec. 23, 2020, the entire contents of which are hereby incorporated by reference.

[0002] The lymphatic system is a complex system of tissues, vessels, and organs that works to carry excess fluid to the bloodstream and provides an important function to the body's immune system by removing pathogens from the circulatory system. The lymphatic system includes small organs or lymph nodes, of which there are approximately 500 to 600 in the human body. Lymphatic capillaries and vessels typically transport interstitial fluid to the circulatory system through the lymphatic trunks. Interstitial fluid (lymph) in the lymphatic system can accumulate due to disease or injury. Excessive accumulation of this fluid is known as lymphedema.

[0003] Breast cancer-related lymphedema (BCRL) is one of the most significant survivorship issues in breast cancer management. Currently, there is no cure for BCRL. Of the 2.8 million breast cancer survivors in the United States, one in five is estimated to have BCRL. Patients with BCRL often complain of a sense of compression, heaviness, fatigue, and ill-fitting clothing following the swelling commonly experienced in this condition. In selected cases, patients repeatedly develop cellulitis that spreads rapidly to the affected limb, which can be life-threatening if not treated promptly. The signs and symptoms of BCRL are associated with a tendency towards anxiety, depression, and an overall decline in quality of life. The most common risk factors for the development of BCRL are axillary lymph node dissection, regional lymph node radiation (RLNR), and / or an elevated BMI (>30).

[0004] Standard treatment for chronic lymphedema (BCRL) includes manual lymphatic drainage, compression, topical skin treatment, exercise, and pneumatic physiotherapy. Surgical management of chronic lymphedema may include lymphovenous bypass and lymph node grafting, but these do not provide a definitive cure. The single greatest risk factor for developing BCRL is axillary lymph node dissection (ALND). Lymphatic microsurgical prophylactic treatment approaches (LYMPHA) are surgical procedures to reduce the risk of lymphedema in patients undergoing ALND. LYMPHA has been used in patients undergoing ALND who have developed lymphedema.

[0005] It should be noted that ALND is a significant risk factor for the development of lymphatic hydrops. In one study, 1 in 67 patients who underwent sentinel lymph node biopsy developed lymphatic hydrops (1.5%). On the other hand, 4 in 10 patients who underwent ALND alone developed lymphatic hydrops (40%). However, when LYMPHA was performed along with ALND, only 1 in 8 patients developed lymphatic hydrops (12.5%). For example, in this study, providing LYMPHA along with ALND reduced the in-house incidence of lymphatic hydrops from 40% to 12.5%.

[0006] In LYMPHA procedures, during axillary lymph node dissection, lymphatic vessels flowing through the arm are identified and bypassed to axillary venous branches. This technique has demonstrated, for example, a 5% incidence of lymphatic hydrops after axillary lymph node dissection (ALND) and LYMPHA over a four-year period. While the historical incidence of lymphatic hydrops after ALND is highly variable, it is often shown to be between 20% and 40%, and has been reported to be as high as 77%.

[0007] One challenge of the LYMPHA procedure is visualizing healthy, severed lymphatic vessels from the lateral side of the level 1 lymph nodes after ALND. A technique for identifying these lymphatic vessels can be used to visualize their location by injecting a blue dye into the ipsilateral proximal upper arm. While most LYMPHA procedures are performed in the axillary bed, it should be noted that other lymph node dissection sites, including the neck, chest, abdomen, and groin, carry a risk of developing lymphedema, and bypasses can reduce the risk of developing lymphedema in these areas and associated limbs. Despite improvements in the treatment of lymphedema using the procedures referenced above, further improvements are needed in this procedure to improve the management of this condition. [Overview of the Initiative]

[0008] The present invention relates to a device for connecting one or more lymphatic channels to a vascular system. It is important to note that in all other lymphatic and vascular anastomosis devices described previously, vessels of similar diameter need to be connected end to end, or end to side in the case of size mismatch. Preferred embodiments described herein allow, for example, one or more lymphatic channels of significantly different sizes to intussusception into a single vein. Consequently, these preferred embodiments of the connecting device can facilitate LYMPHA procedures by improving the speed of the procedure, improve the stability of the resulting anastomosis, and function to connect one or more lymphatic channels to a single vascular channel, such as a vein or artery.

[0009] The procedure may utilize adipose tissue associated with the grouping of one, two, or more lymphatic pathways to help connect the lymphatic pathways to the first connecting element of the device. Before commencing the procedure, the lymphatic system in the area of ​​interest may be assessed by visualization techniques. Dyes are injected for microscopic imaging and lymph mapping, and specific areas of interest that function to drain fluid from the affected area, such as the patient's arm, may be identified. The surgeon commences the procedure by accessing the site by incision to expose the lymphatic pathways and one or more veins that may be used, and by identifying one or more lymphatic pathways to be connected to the selected veins. implants The visualization of the device can be improved using a fluorescence fluoroscopy marker attached to, embedded in, or positioned on one or more areas of the device. Connectors can be used to connect lymphatic pathways to veins, or to connect to one or more branches of veins. implants Visualization of lymphatic flow after this procedure can be used to monitor the viability of lymphatic flow after surgical wound closure.

[0010] Specific coupling devices may be selected based on the number and size of the lymphatic channels and veins in which they are located. The devices may be manufactured using standard molding and assembly techniques, for example, using biocompatible materials such as synthetic polymers or silicone. These are, implants Depending on the specific site for which it is used, it may have different sizes and shapes. For example, a vein may be attached to a second connecting element which may include an aperture or opening with a diameter of 1.0 mm to 3.0 mm. The first and second connecting elements may be in the shape of rings, with the lymphatic pathway connected so as to extend through the central opening of the first ring, the vein connected to the second ring, and the first ring attached to the second ring, and one or more lymphatic pathways extending into a single vein, i.e., the lymphatic pathways overlapping within the vein.

[0011] In further embodiments, a connector device may be used to align and connect a first ring to a second ring. The connector device may include, for example, one or more conical elements having connector channels through which lymphatic channels can extend into a vein through a second ring opening, i.e., the lymphatic channels are superimposed or fitted into a vein. The conical element may include a shaped surface or surface that extends from a larger diameter portion to a smaller diameter portion that extends around an opening of a cavity through which lymphatic vessels slide into a vein. The cavity may include a tubular channel into which the vein is inserted, and the wall of the vein is engaged by pins or tissue anchors. Lymphatic vessels and capillaries are generally embedded within supporting tissue surrounding the lymphatic vessels. When a lymph node is removed to treat a patient's condition, the lymphatic vessels that were connected to that lymph node are severed, and typically lymphatic fluid is released through the severed ends. To surrounding organizationsIt should be noted that passage is allowed. The surgeon may expose the end of the severed lymphatic vessel, where the end extends a certain distance from a portion of supporting tissue attached to a pin or tissue anchor that is sized and shaped to grasp supporting tissue. Supporting tissue may include, for example, fibrous connective tissue that the surgeon can grasp by hand using forceps or tweezers. These may include grasping instruments with small tip sizes for grasping lymphatic vessels, which may have diameters ranging from 0.1 mm to 1.0 mm or larger, and they are positioned in or near the exposed end of the vein from which lymphatic fluid is supplied. There are often three or four lymphatic vessels in the area around the removed lymph node, and these lymphatic vessels can be grasped using the surrounding fatty tissue that supports them. The lymphatic vessels are spaced apart, and the surgeon often selects groups of lymphatic vessels that are spaced close enough to fit within the diameter of the vein for anastomosis. Lymph nodes can vary in size depending on the patient's age and condition, but often range in size from 4 mm to 2 cm along the long axis of the lymph node. The size of the device can vary depending on the size of the vein to which it is attached, but can also be in diameter from 4 mm to 2 cm. By attaching the supporting tissue to the pin or anchor, this attachment movement causes the cut end of the lymphatic vessel to extend further from the surrounding tissue, thereby easily positioning it within the exposed end of the vein, where the end of the vein is attached to the pin or anchor. The open end of the vein may be slightly enlarged. Since the length of the lymphatic vessel extending from the supporting tissue can vary, it may be positioned within the vein at different insertion lengths, or there may be ends of lymphatic vessels located outside the end of the vein that continue to supply lymph fluid into the vein. Some lymphatic vessels have a higher flow rate, so the device implants Furthermore, even if located outside the vein after closure of a surgical wound, the vein must be close enough to maintain flow. Tissue flow extending into the vein from the end of a high-flow lymphatic vessel. of A channel may be formed.

[0012] The first connecting element may have tissue-grasping elements such as pins, projections, or tissue anchors that grasp the adipose tissue surrounding the lymphatic pathway. Thus, the lymphatic pathway extends into the pathway-supporting tissue that can be attached to the first connecting element without impairing the lymphatic pathway function, thereby enabling the transport of lymph into the veins to reduce swelling. The pins, posts, projections, or tissue anchors may extend through the adipose tissue and engage with a receiving mechanism on the second connecting element. In embodiments utilizing a connector element between the first and second rings, for example, the pins, projections, or tissue anchors may engage with the tissue and also engage with the connector element.

[0013] Surgical instruments may be used to grasp the tissue and position it against a pin, projection, or tissue anchor, thereby attaching the tissue to the anastomosis device. If necessary, clamping devices may be used to temporarily hold the connecting elements of the device in place, facilitating the attachment of tissue to each element, alignment of the connecting elements, and connection of components to each other.

[0014] A healthcare professional may perform the procedures described herein by first assessing the patient's condition in which swelling has occurred or is likely to occur. The visualization techniques described herein involve visualizing those areas of the lymphatic system using one or more devices described herein. implants It can be used to map to one or more selected areas to reduce or eliminate swelling. Preferably, at least two, three, four, five or more lymphatic pathways can be fluidly connected to a single vein so that a significant amount of lymph can be removed into a single vein using a single device. After mapping and selection, one or more devices described herein implants It will be done.

[0015] Further embodiments employ devices in which lymphatic pathways are grasped individually or collectively and positioned within a vein at a selected depth. This can be performed manually or by using a robotic device. For example, loops of forceps and / or suture material may be used to grasp one or more pathways and position them within a vein attached to a tube or ring. The suture material may be temporarily attached to the tube after wound closure and before biodegradation, over the period of healing of the pathway and venous tissues, to permanently connect the pathway to the vein. For example, biocompatible adhesives may also be used to attach tissue to the tube. The tube may have surface elements or grooves that allow it to be held by a surgeon for attachment of a vein inserted on one side and connected to a pin or projection, as described herein, and a pathway inserted into a vein at the opposite end of the tube. In robotic surgery, multiple control arms with manipulative elements may be used to isolate and grasp a vein and attach its exposed end to a first connecting element. The control arms may also operate to attach tissue, such as visceral adipose tissue containing lymphatic vessels, to a second connecting element, as described herein. The robotic arm can then be controlled by the surgeon to grasp, align, and attach the first and second elements together so as to fluidly connect the lymphatic pathway into the vein. The device can then be placed inside the wound opening, and the wound is sutured to close it.

[0016] In further embodiments, one or more lymphatic vessels may be fluidly connected to a vein by attaching the vein and lymphatic vessel to a single integral connecting element. The integral connecting element may generally include a cylindrical body to which the vein is connected at a first end and the lymphatic vessel at a second end. Embodiments may further include more rounded or elliptical shapes. The external surface may be more easily handled by the user manually or with surgical grasping instruments such as forceps or tweezers. implantsIt may have slots or grooves that allow the device to be grasped. The integral connecting element has a first opening at the first end for receiving a vein, with a first group of pins or anchors located around the inner portion of the first opening, and the open end of the vein is fixed within the implant. The second end may have a wider opening than the vein insertion opening for providing insertion of supporting tissue, and typically has a larger diameter than the vein, as it needs to accommodate all spaced lymphatic vessels that are inserted into the vein. Extending around the outer edge of the second opening implants The side walls of the device may have side wall openings or windows. Through these, a surgeon may insert surgical grasping instruments, such as forceps, to grasp different areas of supporting tissue for placement on a second group of pins or anchors, which generally extend in the opposite direction to a first group of pins or anchors that secure the open end of a vein. The pins or anchors may, for example, provide a more secure attachment. implants The elements may extend along the longitudinal axis of the device, or radially, or at some angle between 1 and 45 degrees with respect to the longitudinal axis. [Brief explanation of the drawing]

[0017] [Figure 1] An embodiment of a coupling device that uses a pair of rings to align and connect lymphatic pathways to veins or arteries is illustrated. [Figure 2A] The illustration shows an embodiment that includes a connector element that attaches together a pair of rings, connecting one or more lymphatic channels to a vein. [Figure 2B] Embodiments including a central tube connected to a ring are further illustrated, and an external sheath may be attached to surround the connecting element. [Figure 2C] A further mechanism for connecting the first connecting element to the second connecting element is illustrated. [Figure 2D] A perspective view of the first end of an implant for lymphatic vein bypass surgery is shown. [Figure 2E] A perspective view of the second end of the implant shown in Figure 2D is further illustrated. [Figure 3]Illustrate the axillary dissection area after clearance of level 1 and 2 lymph nodes where lymphatic channels emit light from FITC injection and bypass described hereinafter. [Figure 4] Schematically illustrate the steps of a surgical procedure for performing a bypass surgical procedure according to an embodiment of the invention. [Figure 5] Schematically illustrate the lymphatic channel system of the human body where bypass procedures according to the present invention can be performed at different locations to reduce lymphedema. [Figure 6] Illustrate a flowchart of a lymphedema protocol used in conjunction with the surgical procedures described herein. [Figure 7] Illustrate a robotic control system with computer control of an arm having a manipulator so that a surgeon can perform a procedure according to a preferred embodiment. [Figure 8] Illustrate a process flow diagram for performing a robotic control surgical process according to a preferred embodiment. [Figure 9] Illustrate a sensor mounted on a connector device for measuring the flow of lymphatic fluid into a vein. [Figure 10] Illustrate a valve device for controlling the liquid pressure at the junction in a vein where lymphatic fluid enters the vein. [Figure 11] Illustrate further embodiments of a connecting device and a fixing element according to a specific embodiment. [Figure 12] Illustrate a front view of the connecting device of FIG. 11. [Figure 13] Illustrate a left side cross-sectional view of the connecting device taken along the line shown in FIG. 12. [Figure 14] Illustrate a rear view of the connecting device of FIG. 11. [Figure 15] Illustrate a front view of the connecting device of FIG. 11. [Figure 16] Illustrate a side view of a further embodiment of a first connecting element according to a specific embodiment described herein. [Figure 17] Illustrate a top view of the first connecting element of FIG. 16. [Figure 18]A side perspective view of the first connecting element in Figure 16a is shown. [Figure 19] A side view of the first connecting element is shown. [Figure 20] A top view of the first connecting element is shown. [Figure 21] Embodiments of pins compatible with the first and second connecting elements described herein are illustrated. [Figure 22A] A perspective view of an embodiment of the second connecting element including a pin is shown. [Figure 22B] Perspective views of the internal volume of the coupling device of several embodiments described herein are shown. [Figure 23] A rear perspective view of a further embodiment of the first connecting element including a pin is shown. [Figure 24A] A front perspective view of a further embodiment of the coupling device is shown. [Figure 24B] An upper perspective view of a further embodiment of the coupling device is shown. [Figure 24C] A bottom view of a further embodiment of the coupling device is shown. [Modes for carrying out the invention]

[0018] A preferred embodiment of the invention utilizes a device for connecting one or more lymphatic channels to the veins of a patient's circulatory system. Figure 1 shows An embodiment of the coupling device is shown. , In the connecting device, the first connecting element 100 constitutes a ring having a central opening 109. Adipose tissue 104 surrounding lymphatic channels 106 and 108 It is pulled through the central opening 109 to cover the pin, projection, or tissue anchor 102. The pin, projection, or tissue anchor 102 faces toward the second connecting element 120 and is directed inward from the inner circumferential surface of the ring. The ends of the two blood vessels between departments Unlike vascular anastomosis couplers used to connect, the present invention provides one or more lymphatic channels, one Inserting into the open end of a blood vessel or vein (i.e., intrusion: intussusception ) makes this possible. Because, One lymphatic channel is significantly smaller than the size of the vein into which it is inserted. typical Na size No consistency Ide Yes. Therefore, 1, 2, or more lymphatic vessels having a channel for carrying lymph fluid can be inserted into a single vein 128 depending on their size. Coagulation can lead to failure of the anastomosis, so blood vessels AlliesNote that they cannot be inserted into each other. On the other hand, lymph fluid does not coagulate. Insertion into the blood vessels of lymphatic pathway tissue does not induce such coagulation, and the lymph does not become obstructed. blood This allows it to flow through the pipe.

[0019] The components in Figure 1 include pins, projections, or tissue anchors configured to penetrate and grasp tissue. tree, Generally smooth surface Special Having the characteristic of rigid or semi-rigid flexible It may include elastic biocompatible materials. In selected embodiments, the component provides a sutureless tissue connector, but in some embodiments, the device implants Sutures may be used to help with this.

[0020] The device components include silicone, polyurethane, polytetrafluoroethylene (PTFE), polyester, polyethylene, polyamide, polyetheretherketone (PEEK), polypropylene, Mylar, and Kevlar (registered trademark). TM ), they may be made using biocompatible materials such as polyisoprene, polyolefin, or combinations thereof.

[0021] The first connecting element may comprise a ring with a larger opening to accommodate the thickness of adipose tissue such as visceral adipose tissue (including lymphatic vessels having channels extending through lymphatic vessels for transporting lymph fluid). Adipose tissue is in the opening Through tt It extends and surrounds the lymphatic tissue, which consequently does not come into contact with the connector surface. Note that the ring element may have other shapes, such as an elliptical cross-section, or any other shape suitable for the specific anatomical arrangement in the patient. The outer surface is adjacent to the surrounding tissue. ScratchTo avoid this, smoothness is preferable. Lymphatic vessels are thin-walled, tubular tissue structures containing smooth muscle, lined with endothelial cells and connected to surrounding tissue with an outer membrane. Lymphatic capillaries are smaller, lack muscle and outer membrane, and have a diameter ranging from 15 to 75 microns. Larger lymphatic vessels have valves spaced apart along their length, and fluid movement is provided by peristalsis, with fluid pressure moving the lymph fluid within the vessel. Lymphatic collecting ducts have a diameter ranging from 100 to 800 microns or larger. Veins of the vascular system are 1 mm or 1mm Each selected vein may have a larger diameter. each , 2 or 2 Receiving more lymphatic pathways Entry They can be selected as such. Generally, veins have a diameter in the range of 2-4 mm. Veins are connected to lymphatic vessels that have supporting tissue, and the supporting tissue is, The diameter of the aperture that holds the vein is greater than too Large device of Inside the aperture Settling The connecting element may have a diameter in the range of 1 to 15 mm, and in an embodiment including two connecting elements, the connecting element may have a diameter in the range of 1 to 15 mm. teeth , may have matching diameters. The apparatus and method also allows one or more smaller veins to flow into a larger vein. flow It can be used to connect to a vein. The inner surface of the central opening in the inner ring allows the vein to pass through the central opening so that the exposed end of the vein can be attached to the second connector. can sufficient Na Large That's fine. Therefore, the second connector 120 is Pi It has an inner ring 124 with a projection or tissue anchor 125. The pin, projection, or tissue anchor 125 engages with the vein tissue 129 that folds over the pin 125. The outer ring 122 engages, for example, with at least the tissue. can It protrudes above the ring surface to a sufficient height. 、 The end of pin 102 Entry , Pin 102 Engaging pin receiver Entry It has a region 126. The region 126 may be configured to snap into place with at least a portion of a protruding element from the surface of the ring 100 or a pin 102 to provide a snap-fit ​​connector. A latching mechanism or other connector may be connected to the connecting element Allies These can be used for fixing. These features are illustrated in one or more of the figures described herein.

[0022] The ring element 124 is 1 or a few millimeters from the surface of the ring 122. minutes high It's getting better. Please take note of this. Therefore, The surrounding wall 121 may have a height of at least 1 mm. This allows, for example, the lymphatic channel 106 to be at least 1 mm deep within the vein 128. of Insertion This will result in Therefore, the relative dimensions of the connecting elements can define the depth of insertion.

[0023] Figure 2A shows the reception of vein 220 as previously described. Entry The coupler 200 has a first ring 208 for mooring, First Ring teeth, small To the opening of the 205mm diameter pipe and A first cone-shaped element 202 having an open end whose diameter gradually narrows towards the first end, engagement death, multiple The lymphatic channel 224 is narrowed from the second cone 204 toward the second end of the tube 205. Pipe 205 Receiving keirera Cone of wide edge 206 teeth The size and shape are for attachment to the inward-facing surface of the second ring 240. , The second ring, 240, The ring 240 has pins, projections, or tissue anchors 242 that engage and fix adipose tissue containing lymphatic vessels 224 to the ring 240. death The tissue 260 surrounding the lymph is folded over, for example, onto the anchor 242 on the surface 250. In this way the lymphatic vessel is folded over the open end of the cone. 206 Enter and go through the narrow opening tt pipe 205 And then vein to It passes through. The embodiment in Figure 1 is, A single cone may be used, and this single cone is From the open end of the cone through the narrow opening of the cone tt into the vein and Inserting lymphatic vessels guide Then, the junction where lymphatic fluid enters the vein is defined. child Please note the following. Returning to Figure 2A, the1 The ring 208 may include a first fluoroscopic marker 270, the cone 206 may include a second fluoroscopic marker 272, and the second ring 240 may include a third fluoroscopic marker 274, for example illustrating the use of markers in various embodiments described herein. Figure 2B shows a further embodiment in which the first ring 277 may be connected to the second ring 278. The tube 275 is connected to the ring 278 by a plurality of arms or connecting elements 279. The tube 275 is into which a vein is inserted, as described herein, and the tube to It has an internal cavity into which it is mounted. In a preferred embodiment, the first ring The second ring and the second ring are connected together. ru At that time, they can be aligned on a common axis. The pins or anchors are on a common longitudinal axis. Centered They can be arranged symmetrically. Pins or anchors for veins may protrude in a first direction parallel to the common axis, but support join The pins or anchors for the organization are parallel to the common axis. However , it may extend in the opposite, second direction.

[0024] The embodiments described herein are The rings When connected together, they are aligned along a common axis. these It may be contained within an outer sheath 276 extending around the ring. The first connecting element or ring may be connected to the second connecting element using one or more connector elements. Connector elements such as pins, posts or projections may be used as described herein. As shown in Figure 2C, a plurality of projections 271, 273 may extend from the first ring to the second ring. Inside Laterally facing projections or protrusions grip the outer edge of the second ring. The outer sheath or surface of the device provides a smooth outer surface. Certain elements of the device may be flexible to move with the surrounding tissue of the patient. One or more elements of the device may contain bioabsorbable material. Selected surfaces may be porous to accommodate internal growth and adhesion to tissue adjacent to the device in order to stabilize the device within the tissue matrix. The length of tube 275 (or tube 205) is such that the lymphatic pathway anastomoses thingIt may be used to indicate to the user that the length of the lymphatic pathway extending into the vein is sufficiently long to prevent it from coming loose. Preferably, the joining area is located within the device housing. joining area Lymphatic vessels then supply lymph fluid into the veins. Optionally, the first and second connecting elements are connected on one side, and the user simply rotates these two components relative to each other around a pivot axis, and the lymphatic system With the fluid channel inserted into the vein, 1st connection element and the second connected element Align and connect death Please note that obtaining the outer sheath 276 The outer sheath 276 can be attached to the device. Extending around the device death The sheath 276 may also include portions extending periphery from each ring that are connected together by the sheath connector.

[0025] In a further embodiment, the coupling device receives a vein through the first end Entry It may be manufactured as a single, integrated piece having a tubular portion for which the vein wall can be grasped by a pin or anchor on the second end of the tubular portion. The second end of the device is inserted into the vein. ru Supporting tissues including lymphatic vessels Entry and may have a larger opening. As shown in the front view of Figure 2D and the rear view of Figure 2E, the coupling device 300 according to some embodiments described herein may be manufactured as a single, integrated unit using standard molding techniques or by using three-dimensional (3D) printing methods. component It may have a body formed from. In this embodiment, the coupling device 300 is defined by a cylindrical wall 302 that at least partially encloses different parts of the coupling device 300. In some embodiments, the cylindrical wall 302 may have side wall openings 306, 308, 310 adjacent to the outer ring side wall 312. The side wall openings 306, 308, 310 are used by the user to first access the side wall openings. Our Through one, and then through the ring opening. tt This allows forceps or other instruments to pass over the bottom ring surface 304. Yo size Settings The forceps grasp the tissue (such as adipose tissue surrounding the lymphatic pathway) at each of the openings 306, 308, and 310. organization ring opening Let it pass through , pins, anchors and other tissue gripping elements 324 to pull put on It can be used for the following purposes. The pin can be inserted, for example, into a pin fixing area, or it can be formed integrally with the coupling device 300. In some embodiments, the coupling device 300 is Connecting element 300 From the inner bottom surface 314 above It may have a central aperture 316 extending to the surface 320. The vein is above From surface 320 Through the central aperture 316 It can be attached to a tissue gripping element 315 such as a pin, which may extend, be inserted into a pin fixing area, or be formed integrally with the coupling device 300. The tissue gripping element 315 is below the ring element. direction At a depth of 318 Place It may protrude from the inner bottom surface 314. In some embodiments, adipose tissue is on the pin 324. Pulling postponed good , This within adipose tissue of Lymphatic vessels It extends As a result, the lymphatic vessel is preferably fixed at pin 315. Ta intravenous to Nobu Shin The bottom ring surface opening is fluid-connected to the vein. should Includes lymphatic channels Larger volume supporting organization of Since insertion needs to be accommodated, the central aperture 316 Yo the law of nature too It has a large size or diameter.

[0026] On the upper surface 320, the surface around the central aperture 316 may be a conical surface 322. The conical surface 322 guides the tissue into the central aperture 316 when a force is applied to the tissue, thereby promoting tissue insertion. Direction This can help. In addition, since the conical surface 322 has no sharp corners or edges, it can reduce abrasion of the inserted tissue (e.g., a vein).

[0027] Figure 3 shows the pair of lymphatic vessels 287 and 289. EntryA magnified view 284 shows the location 280 in the axilla, which contains a vein 285 and a lymph node 282. lymph Unlike conventional procedures that use sutures 286 to fix the flow path to the vein 285, the present invention lymph Channels 287, 289 Entering the vein A coupler 290 is used at the joint.

[0028] Schematically shown in Figure 4 is a method 400 for performing a surgical procedure, for example, in which a surgeon may perform an incision in the skin to access tissue containing one or more lymphatic channels (402). A coupling device is placed in the patient (404), with a first coupling element attached to one or more lymphatic channels (406) and a second coupling element attached to a vein (408). The first coupling element is connected to the second coupling element (410), and one or more lymphatic channels are positioned within the exposed venous opening at a depth such that lymph from the lymphatic channels can flow into the vein. The surgeon then places the coupling device in the patient implants The surgical opening is closed in such manner (412). Alternatively, the connecting device may include a single tube or ring having a pin or tissue anchor on one side for connecting to a vein inserted into one open end of the tube. The wall tissue of the vein is positioned on the pin or tissue anchor element that penetrates the wall tissue to hold the vein in place relative to the device. The lymphatic pathway may be inserted through the tube opening at the opposite end into a vein that is at least partially located inside the tube. The tube is, one end of a vein The tube may have internal features that allow insertion but prevent removal of the vein. Thus, the inner wall of the tube may have friction surfaces with unidirectional teeth, pins, or other features to prevent movement of the vein within the tube. lymph It may have external features that allow a loop of material for gripping the flow path to be attached to the pipe.

[0029] Dyes can be used to aid in the visualization and mapping of the lymphatic system. For example, fluorescein isothiocyanate (FITC), which is excited in the visible spectrum, is routinely used in the operating room. Neurosurgeons inject this dye intravenously and use a microscope equipped with filtering technology to visualize tumors while maintaining the vivid color of surrounding tissues, allowing for simultaneous magnification and tissue dissection. This is important for lymph surgeons. Therefore, FITC can be used in the operating room for lymph mapping. It should be further noted that FITC has been used to perform lymphovenous bypass (LVB) in the surface tissue of the arm in patients with chronic lymphedema. FITC is a safe and highly effective dye for lymph mapping and dissection in surgical fields such as LYMPHA procedures.

[0030] The lymphatic hydrops repository data for all breast cancer patients who underwent LYMPHA treatment included demographic information (age, body mass index (BMI)) and perioperative data (number of lymphatic pathways visualized and bypassed, distance of pathways from the axillary vein, name of target vein, and adverse events).

[0031] In an exemplary procedure (see Spiguel et al. "Fluorescein Isothiocynate: A Novel Application for Lymphatic Surgery", Annals of Plastic Surgery, Volume 78 (2017), the entire content of which is incorporated herein by reference), for example, 2 cc of a modified 2% fluorescein solution is intradermally injected along the ipsilateral upper arm fascia prior to ALND. The solution may be modified from stock AK-FLUOR 10% (Akorn Inc., Lake Forest, IL) solution by diluting 2 cc with 7.5 cc of saline and 0.5 cc of AlbuRx5 (CSL Behring Inc., King of Prussia, PA). ALND is performed carefully to protect the superficial accessory venous tributaries traversing the level I lymph nodes longitudinally. Upward Dissection is typically performed using the identification of accessory venous branches located anterior to the thoracodorsal neurovascular bundle. The veins are then dissected from the Level I axillary contents and clipped distally to provide maximum length. Subsequently, completion of Level I and II ALND is performed.

[0032] After the completion of axillary lymph node dissection, for example, a Pentero 900D Microscope (Carl Zeiss Inc., Germany) equipped with a YELLOW 560 package may be used to identify and map the divided lymphatic pathways flowing through the arm. The harvested vein is prepared for standard microsurgical techniques. The surgeon utilizes existing techniques to place a "U" stitch using 9-0 nylon sutures on the anterior wall of the vein. Capture , Ba Selected lymphatic pathways for Ipas of parachute Insert into the formula Subsequently, 10-0 nylon can be used to suture the vein wall to the perilymphatic tissue. The pathway that is not bypassed is clipped. Filling inside Lymphatic flow after anastomosis 1 time inIt can be visualized using activated filters.

[0033] However, according to the selected embodiment, instead of suturing, the surgeon attaches the perilymphatic tissue to a first connecting element, attaches the vein to a second connecting element, inserts the exposed end of the lymphatic pathway into the opening in the vein, and connects these components to perform an anastomosis or lymphatic pathway to the vein. inset Complete it safely.

[0034] As shown in the study by Spiguel, et al., 13 patients underwent LYMPHA with intraoperative FITC lymphatic imaging between March and September 2015. The mean age of the patients was 50 years, and the mean BMI was 28. On average, 3.4 segmented lymphatic channels (range 1–8) were identified over an average distance of 2.72 cm (range 0.25–5 cm) caudal to the axillary vein. 1.7 per patient (0~4) The flow path was bypassed. 。 Anastomosis was performed on the accessory or collateral branches of the axillary vein. In these cases, LYMPHA added an average of 67 minutes (45–120 minutes) to the oncological procedure.

[0035] Therefore, FITC is a safe and effective dye for LYMPHA techniques. Compared to ICG and blue dyes, FITC has many advantages. Unlike ICG and blue dyes, FITC does not permanently stain surrounding tissue, thus facilitating the dissection of lymphatic pathways. The main advantage of FITC over ICG in lymphatic surgery is that, for example, FITC is excited in the visible spectrum and is a dye used in the field of invasive surgery, thus enabling simultaneous visualization and dissection of lymphatic pathways.

[0036] Patients diagnosed with breast cancer may undergo a preoperative assessment for lymphatic hydrops. Each preoperative and postoperative assessment may include three elements: (1) assessment by a certified lymphatic hydrops therapist for signs and symptoms of BCRL, (2) circumferential measurements, and (3) bioelectrical impedance spectroscopy. Lymphatic hydrops may be defined as having signs / symptoms of BCRL and one objective positive indicator, and may be transient or prolonged beyond, for example, six months. Demographics (age, BMI, past radiation or chemotherapy), cancer treatment characteristics (type of chemotherapy, radiation therapy, and surgical management), and physiotherapy assessments (circumferential measurements, bioelectrical impedance spectroscopy data, follow-up) may be included in the analysis.

[0037] The ALND procedure involves excision of axillary nodes I and II. Patients undergoing ALND can have the fragmented lymphatic vessels identified using FITC, and then their pathways can be rerouted to protected axillary venous branches.

[0038] Demographic and potential risk factors for the development of lymphedema, including age, body mass index, clinical stage, radiation therapy, and chemotherapy, were examined. Similarly, patients who received the LYMPHA technique were compared to those who received ALND alone. All p-values ​​were calculated using Fisher's exact test or two-tailed test, as appropriate. Calculations were performed using statistical computing, version 3.3.2 of the R language.

[0039] For example, power analysis can be performed using Fisher's exact test and SAS. This is based on our facility's data. The proportion of the control group Set to 0.40 death As previously shown, the incidence of lymphedema after simultaneous lymphovenous bypass was 0.04. In evaluating this procedure, the statistical power can be conservatively set at 0.8.

[0040] In a study conducted by Hahamoff et al (the full content of which is incorporated herein by reference, "A Lymphatic Surveillance Program for Breast Cancer Patients Reveals the Promise of Surgical Prevention", Journal of Surgical Research, 2017, 10.008), 177 patients were presented for preoperative lymphatic hydrops evaluation, and 87 patients (49%) participated in the program during the period. 45% (67 / 145) of patients who underwent sentinel lymph node (SLN) biopsy and 64% (18 / 28) of patients who participated in the program and received ALND had a mean age of 60 (ranging from 32 to 83) and a BMI of 30 (ranging from 17 to 46). 40% underwent mastectomy, 21% received ALND, 18% received neoadjuvant chemotherapy, and 24% received RLNR. The majority of patients in this case were: Re 62% did not undergo construction work.

[0041] The single most significant risk factor for the development of lymphatic hydrops was ALND (p<0.001). Mastectomy (p=0.02), adjuvant chemotherapy (p=0.03), and RLNR (p=0.05) were also associated with the development of lymphatic hydrops. A tendency toward the development of lymphatic hydrops and clinical stage III disease (p=0.10) was also observed.

[0042] Table 1. Advantages and disadvantages of two fluorophores (blue dye and ICG) most commonly used in lymphatic surgery, compared to FITC. [Table 1] All patients who developed lymphatic hydrops were first diagnosed during treatment or within 6 months of the completion of cancer treatment. Therefore, all patients InitiallyTransient lymphatic hydrops was diagnosed. The mean time to diagnosis after surgical intervention was 4.7 months. In the SLN biopsy group, one patient developed transient lymphatic hydrops and subsequently developed persistent lymphatic hydrops (1 / 67 or 1.5%). Of the five patients who developed transient lymphatic hydrops after receiving ALND without LYMPHA treatment, one patient's symptoms and objective indicators completely resolved, and four patients' symptoms persisted and lymphatic hydrops developed (4 / 10 or 40%). Of these four patients, three were diagnosed with lymphatic hydrops based on symptomatic changes accompanied by relevant changes in ambient measurements and bioelectrical impedance spectroscopy. The fourth patient was diagnosed based on symptomatic changes and ambient measurements alone. Of the 17 patients who received LYMPHA treatment during the period, only eight were involved in our monitoring program. One patient in the ALND+LYMPHA group developed persistent transient lymphatic hydrops, but this occurred within 6 months of completion of adjuvant radiotherapy (1 / 8 or 12.5%). This patient's diagnosis was based on changes in symptoms and bioelectrical impedance, with no changes in ambient measurements. The only significant difference between the two groups receiving ALND with or without LYMPHA was the follow-up period, which was 15 months and 20 months, respectively (p<0.03).

[0043] In a comparison of patients who received ALND with or without LYMPHA and those who were lost to follow-up, to identify any potential confounding factors or biases, the only difference between the groups shown was that participants who received LYMPHA were 10 years older than those who were lost to follow-up (59 vs. 49, p=0.04).

[0044] Since there is currently no treatment for BCRL, recognition of high-risk patients and prophylactic treatment are important considerations. The rate of lymphedema after ALND can be reduced from 40% to 12.5% ​​after the introduction of the LYMPHA approach in this case. Similarly, lymphedema in patients undergoing ALND is preferably identified within 5 months of the procedure. ALND, mastectomy, adjuvant chemotherapy, and RLNR are associated with the development of lymphedema.

[0045] A notable finding in the study by Hahamoff et al. was that the incidence of lymphatic hydrops was reduced from 40% to 12.5% ​​in patients who underwent ALND after the introduction of the LYMPHA technique.

[0046] It should be noted that patients who developed lymphatic hydrops first showed signs and symptoms during treatment or within six months of completing cancer treatment. Of these patients, one patient's condition completely resolved. To date, no patients have shown lymphatic hydrops more than six months after completing cancer treatment. This finding supports the value of monitoring to detect early lymphatic hydrops. This is especially important for high-risk patients, as rapid detection and treatment can potentially slow disease progression.

[0047] ALND and RLNR are important risk factors for the development of lymphatic hydrops. In patients who have undergone mastectomy, the incidence of lymphatic hydrops may be increased, and this is due to ALND. Adaptation This can be explained by the following: Specifically, patients who have undergone mastectomy with limited lymph node metastasis do not require ALND, while patients who have undergone mastectomy with a similar degree of lymph node metastasis do. Therefore, patients who have undergone mastectomy undergo more invasive axillary management than patients who have undergone mastectomy. In patients who have received adjuvant chemotherapy, the incidence of lymphedema may be increased, and bias may occur again because patients who received chemotherapy are more likely to have initially presented with more advanced disease. However, studies have shown that certain chemotherapy regimens are associated with the development of lymphedema. Finally, since patients presented for ALND have more advanced disease, it is not surprising that the incidence of lymphedema has been shown to be increased in patients with clinical stage 3 disease.

[0048] While surgical prevention can help improve the quality of life for breast cancer survivors, developing this program has presented challenges. When SLNs were sent for permanent sections and patients later returned to the operating room for ALND, combined procedure scheduling between breast and plastic surgeons proved effective. However, scheduling could be more irregular, especially considering recent trials that challenge the need for ALND when SLNs are sent for frozen sections, as a larger proportion of patients do not progress to ALND.

[0049] This device and method for treating lymphatic hydrops may change the treatment of axillary metastatic disease. Given the significant mortality associated with ALND (also known as ALND), ALND is clearly avoided compared to RLNR (also known as ALND) in early-stage breast cancer. However, improvements in LYMPHA procedures and the expected decrease in the incidence of lymphatic hydrops may enhance the role of ALND in providing improved methods for localized control.

[0050] A significant finding is that the average time to diagnosis of lymphatic hydrops is 4.7 months after surgical intervention, indicating a remarkable decrease in the incidence of lymphatic hydrops after the introduction of LYMPHA. In this case, ALND group The total follow-up time in the ALND+LYMPHA group was 20 months and 15 months, respectively.

[0051] Providing LYMPHA along with ALND reduced the incidence of lymphatic hydrops from 40% to 12.5%. Similarly, postoperative monitoring may provide early diagnosis and intervention through physiotherapy. Significant risk factors for the development of lymphatic hydrops include ALND, RLNR, adjuvant chemotherapy, and mastectomy.

[0052] It should be noted that thymic surgeons often prefer the use of a dual tracer method that includes both blue dye and technetium sulfur colloid for sentinel lymph node (SLN) identification. This is especially important when neoadjuvant chemotherapy has been prescribed previously. Therefore, different dyes were sought for lymph mapping of the arm to distinguish staining from lymphatic vessels in the arm and chest. Thus, a combination of visualization procedures may be used. Figure 5 shows regions of the body that contain parts of the lymphatic system. Each of these regions can be imaged to map lymphatic flow as needed for a particular medical condition.

[0053] The most common method currently used for lymphatic mapping is indocyanine green (ICG). However, a challenge with ICG is that the dye is near-infrared and therefore excited in the invisible spectrum. This limits the usefulness of ICG for visualization and simultaneous dissection, because the dye appears as a white signal against a black background and cannot be visualized simultaneously through both eyes of a microscope.

[0054] Figure 6 illustrates a flowchart 600 showing the steps involved in treating lymphedema in cancer patients. The process begins at 602, where the patient may be sent to one of three different protocols 604, 606, or 608. In the first protocol 604, no axillary surgery is performed, and follow-up shows that no lymphedema is observed. The second protocol 606 employs sentinel lymph node biopsy in a specific population that develops lymphedema requiring treatment. The third protocol 608 involves the performance of an ALND procedure with or without the LYMPHA procedure described herein (612 or 610).

[0055] Figures 7 and 8 illustrate the provisions described herein. Ren Connecting device implantsThis is a system and method for performing robotic lymphovenous bypass surgical procedures. Robotic systems, such as the Da Vinci system available from Intuitive Surgical Inc., Sunnyvale CA, have been used to perform LVA microsurgical procedures illustrated in connection with Figure 3. See van Mulken et al, "First-in-human robotic supermicrosurgery using a dedicated microsurgical robot for treating breast cancer-related lymphedema: a randomized pilot trial", Nature Communications, 11:757, February 20, 2020, the full content of which is incorporated herein by reference. Further details relating to robotic surgery are described in U.S. Patent Application No. 9,138,297, the full content of which is incorporated herein by reference. The system 700 may employ robotic arms 702, 704 attached to grasping elements 706, 708 such as forceps-like manipulators. A surgeon can use the system 700 to grasp and control microsurgical instruments in the surgical field. The computerized system 710 in system 700 is programmed with software to perform, for example, scaling operations and tremor filtering. As shown in the process flow diagram in Figure 8, process 800 is driven to perform the action. 2 or 2 more multiple Control arms 702, 704 are used. Here, a vein having a diameter suitable for connection to a first (or second) connecting element as described herein is selected (802). The robotic arm may further grasp an area of ​​adipose tissue having one or more lymphatic vessels. fat The Facilitator organization is described herein. The The robotic arm is attached to the 2 (or 1) connecting element (804). The robotic arm is attached to the 1 (or 1) connecting element as shown in Figure 7. Connecting element 100 and second connecting element ofThe lymphatic vessels can be grasped, and typically, visualization with a surgical microscope shows that the lymphatic vessels are inserted into the veins, with two... Link Align elements Let (806). Robotic gripping devices 706 and 708 are, It can enable a stable and secure grip. The two connecting elements are held by an outer peripheral surface which may be made to have notches or slots. do The two connecting elements are connected to each other (808), and the device is positioned within the wound opening for wound closure (810).

[0056] As shown in Figure 9, one or more sensors 265 or imaging devices may be used to measure the flow of lymph fluid into the vein at the junction within the device. Sensor 265 may be an optical sensor, and a light source such as a light-emitting diode (LED) or laser diode may be positioned relative to a photodetector array in a sensor module 266 that contacts the outer surface of the vein. As described herein, a fluorescent dye may be used so that the optical sensor can measure the flow rate by detecting the movement of the dye. but It can be supplied into the lymphatic vessel before, during, or after the procedure. Alternatively, the sensor 265 is introduced into the lymphatic vessel together with a fluorescent dye. reflector To detect this, the device may include an ultrasonic transducer 266 capable of sending an acoustic signal into a vein. A cable or wire 268 may extend through a percutaneous port 267 that extends onto the tissue surface after wound closure. The cable is connected to a computer-controlled data processing and display device for displaying the measured data on a display and for storing the data in memory. This data may be sent to an electronic medical record for each patient. In a particular embodiment, The sensor detects wound closure after Easily Insertion and removal So that , Po So that it is inserted through the Size settings and Constituted profitAs previously described, sensors and / or fluoroscopic imaging may optionally be used during and / or after the procedure to confirm the proper arrangement of lymphatic vessels and lymphatic flow. The device may also optionally be coated with one or more therapeutic agents that inhibit coagulation formation in the vein near the junction. Further shown in Figure 10 is an embodiment in which a flexible valve ring 281 may be attached to a connecting element 277 having a membrane 283. The inner surface of the valve element 281 is in contact with the outer surface of the vein to which a pin shown on the inner surface of element 277 is attached. The valve element may be sized to constrict the vein in order to limit the venous pressure on the junction in the device and reduce the back pressure from the venous fluid on the junction region. At the junction, this reduced pressure may help establish a lymphatic fluid flow that tends to increase over time. The valve element may have and be configured to have a shape, size, and so as to correspond to slowing the increase in lymphatic fluid pressure at the junction, thereby reducing the amount of compression over time. The valve element may include a biodegradable material that reduces venous restriction over time due to the rate of material degradation. The valve may also be activated by a pressurized bladder, which can release a pressurized liquid such as saline solution over time. Alternatively, a flexible flap can also provide sufficient pressure over the vein using an elastic material that expands at a selected rate.

[0057] Figure 11 further shows an embodiment in which the coupling device 900 may comprise a first coupling element 902 having a first ring outer surface 920, and a second coupling element 904. The first coupling element 902 may be attached to adipose tissue 906 including a lymphatic vessel 905, while the second coupling element 904 may be attached to a vein 908. When the first coupling element 902 and the second coupling element 906 are combined to form the coupling device 900, lymphatic fluid from the lymphatic vessel 905 flows into the vein 908.

[0058] Figure 12 shows a bottom view of the connecting device 900. The first connecting element may be in the form of a ring element having a first ring outer surface 920 and a connecting element projection 922. The second connecting element 904 first engages with a vein connected to a pin so that one or more lymphatic vessels 905 can be inserted into the vein, and also receives fat or adipose tissue 906 in a conical volume. Entry The resulting conical elements may include adipose tissue 906 and embedded lymphatic vessels 905 through the ring opening 901 of the connecting device 900. tt The lymphatic vessel 905 may extend through the opening in the second connecting element 904 into the vein 908. In some embodiments, the first connecting element 902 is connected to the connecting element 922 by It can be connected to the second connecting element 904. The connecting element 922 of the first connecting element 902 is connected to the receiving element on the second connecting element 904. Entry Engage with element By doing The first connecting element 902 can be connected to the second connecting element 904. In some embodiments, the second connecting element 904 may have a tissue gripping element 918 which can be positioned to grasp the end of the vein 908. In some embodiments, the tissue gripping element 918 may be a pin. The pin 918 may be formed integrally with the second connecting element or may be inserted into an opening 916 in the second connecting element. The tissue gripping element 918 of the second connecting element 904 may, during surgery, grasp the vein 908 place To be fixed in place. The first connecting element 902 and the second connecting element 904 have generally smooth surfaces, except for pins, projections, or tissue anchors configured to penetrate and grip tissue. Special Having the characteristic of rigid or semi-rigid flexible It may include elastic biocompatible materials. In some embodiments, the first connecting element 902 and the second connecting element 904 are these Two components but Both surfaces may have a snap-fit ​​design that allows for easier formation of the connecting device 900.

[0059] As shown in Figure 12, the first connecting element 902 may have a connecting element projection 922 configured to connect the first connecting element 902 to the second connecting element 904 to form a connecting device 900. In some embodiments, the first connecting element 902 is connected when a user uses an instrument. 1st connection It may have a ring wall channel 911 that can provide a surface area that allows gripping of the element and operating the connecting element or device 900. The first connected element and the second connected element When connected together, the surface 915 of the second ring outer ring wall channel 911 of the second connecting element 904 abuts against the ends of each ring wall element in the first connecting element 902.

[0060] Figure 13 illustrates a cross-sectional view of the coupling device 900 acquired along the line shown in Figure 12. As shown in Figure 13, the lymphatic vessel wall 905 extends into the interior 908 of the vein. By doing This allows lymphatic fluid to flow from the lymphatic vessels into the veins. According to various embodiments, the second connecting element 904 grasps the vein. The vein may have a diameter 914 in the range of, for example, 1 to 3 mm. In some embodiments, the first connecting element 902 may have a tissue contact surface 903 that can provide support for contact between the first connecting element 902 and the adipose tissue 906. In some embodiments, the diameter of the opening 936 in the first inner ring may be in the range of 5 mm to 12 mm. In other embodiments, the opening 936 may have a diameter less than 7.2 mm or greater than 10 mm. In some embodiments, the first connecting element 902 may have a length 910 in the range of 5 to 10 mm, preferably about 7 mm. The diameter of the opening 936 is The opening to Allows for comfortable passage of micro-forceps (typically, with a tip width of 0.5 mm for each arm of the micro-forceps). set Grasp the fabric and open the 936 Go through Enough to draw out the organization Na Large That's fine. In conventional devices for vein-vein anastomosis teeth , Making it possible to pass through veins small diameter of The opening is on both elements to be established Such devices openingThese are bundles of adipose tissue and lymphatic channels that are too small for microforceps to pass through. Let it pass through the opening Too small to pull out Sometimes The systems and methods described herein may employ a larger diameter opening 936 to facilitate tissue manipulation and ensure that one or more lymphatic vessels are positioned relative to the veins to allow lymphatic fluid to flow into the veins.

[0061] In some embodiments, the first connecting element 902 may be attached to adipose tissue 906 containing one, two, or more lymphatic vessels. A single lymphatic vessel is illustrated in Figures 11 to 15. The lymphatic vessel wall 905 is inside the lymphatic vessel wall 905. to It may have a channel 907. In some embodiments, the channel 907 within the lymphatic vessel wall 905 may have a diameter 912 in the range of about 15 to 4000 microns (0.015 to 4 mm), or more preferably 0.1 to 0.8 mm. Using the apparatus of the present disclosure, multiple Lymphatic trunks one In applications connected to veins, the diameter 912 of the lymphatic vessel may be in the range of 2 to 4 mm. The first inner ring 901 may contact the adipose tissue 906 between the first connecting element 902 and the second connecting element 904. In some embodiments, through the first inner ring 901 ru There may be an open channel 917. In some embodiments, the second connecting element 904 may have a pin fixing region 918 for a pin 916. The pin fixing region 918 may include holes, each connecting to a portion of the pin 916 to be fixed. In some embodiments, the pin fixing region 918 may include a screw hole. The pin 916 fixes the vein to the second connecting element 904. The pin 916 is described in more detail below with reference to Figure 21.

[0062] In a preferred embodiment, the flow path 907 within the lymphatic vessel may extend a certain distance within the vein 908 when the coupling device 900 is assembled. In other words, the lymphatic vessel extends within the vein. insetIt is possible. In some embodiments, the channel 907 may extend only a distance of 0.5 mm, 1 mm, 1.5 mm, or more. By extending the channel 907 only as far as it is within the vein, the lymph fluid leaving the channel can be directly connected to and flow into the vein 908. In other embodiments, the channel 907 does not extend into the vein when the coupling device 900 is assembled. Rather, it extends into the lymphatic vessel and the end of the vein. Allies teeth, Inside the coupling device 900 Lined up, Seal It can be stopped. After assembly, lymphatic fluid may continue to leak from the lymphatic vessels and come into contact with the adipose tissue 906. Adipose tissue The internal space within the coupling device 900 can be filled. After contact with lymph, the adipose tissue 906 can transform into a natural lining material, such as that which forms in the celluloma cavity. This lining material is relatively impermeable to further lymph penetration. The formation of this lining material on the surface in contact with the lymph creates a seal within the coupling device 900. The sealing is, Lymphatic fluid in veins 908 Except for passing through, all flow Out of To prevent.

[0063] Figures 14 and 15 show the front of the coupling device 900, respectively. Perspective view And a rear perspective view is shown. As shown above, the first connecting element 902 may have a ring-wall channel 911 that can provide structural support and operability to the connecting device 900. In some embodiments, the ring-wall channel 911 can help to fix the first connecting element 902 to the second connecting element 904. In some embodiments, the second connecting element 904 may include an internal cylindrical-wall channel 909. The internal cylindrical-wall channel 909 is for the connecting device 900 to , it can provide flexibility while maintaining a lighter overall weight. In some embodiments, Internal cylinder The wall channel 909 is implants It can be engaged by a device to allow the second connecting element 904 to be held and operated inside. In some embodiments, the connecting device 900 may have a surface 915 of the outer ring wall channel 911 of the second ring. In some embodiments, the connecting device 900 passes through the ring hole 901 ruIt may have an open channel 917. The open channel 917 is of the coupling device 900 implants At times, this can allow for internal growth of the tissue, providing additional stability to the device over time.

[0064] As shown in Figure 16, the first connecting element 902 may have a first ring outer surface 920. In some embodiments, the first ring outer surface 920 extends to a connecting element projection 922. In some embodiments, the connecting element projection 922 may have an upper surface 924. In some embodiments, the upper surface 924 of the connecting element projection 922 may be rigid and textured. In some embodiments, the connecting element 922 may enable a snap-fit ​​connection between the first connecting element 902 and the second connecting element 904, forming a connecting device 900. In some embodiments, the first connecting element 902 may have a height 925 of about 7 mm. In some embodiments, a hook also is latch element 928 The bottom and ring and The distance 930 between them may be about 4 mm. In some embodiments, the connecting element 922 may have a width 926 of about 1 mm.

[0065] As shown in Figure 17, the opening 936 in the first connecting element 902 may have a diameter in the range of 5 mm to 15 mm. In some embodiments, the first connecting element 902 may have a ring wall channel 911 having a diameter 934 of about 1 mm. In some embodiments, the first connecting element 902 at the base of the ring Opposing It may have a diameter of 938 between the notches.

[0066] As shown in Figure 18, the connecting element 922 may include a hook or latch element 928. In some embodiments, the first connecting element 902 may include a pin fixing area 933. The pin fixing area 933 may receive and fix a pin 946 (for example, shown in Figure 23). The pin 946 may be similar to the pin 918 associated with the first connecting element 902. The pin 946 in the pin fixing area 933 may connect to or grasp adipose tissue 906 containing lymphatic vessels. For example, the adipose tissue 906 may be connected to the opening 936 of the first connecting element 902 Pass through Transported to one or more of the 946 pins pull It can be extended.

[0067] As shown in Figure 19, the first connecting element 902 may have a latching element 928 on a connecting element projection 922 having an upper surface 924. In some embodiments, Opposing Between the inner surfaces of the connecting element 922, Distance 939 Yes. In some embodiments, the latch element 928 may extend a distance 927 from the inner surface of the connecting element 922. In some embodiments, the angle 947 of the upper surface of the hook or latch element 928 may be, for example, about 40 to 65 degrees.

[0068] As shown in Figure 20, the first connecting element 902 may have an angular distance 929 between adjacent connecting element projections 922 of about 60 degrees. In some embodiments, the width 925 of each latch 928 may be, for example, about 1 to 2 mm. In some embodiments, the width 961 of each projection is larger than the corresponding latch.

[0069] As shown in Figure 21, in some embodiments, the pin 918 may have a fastener 913 at its base. In some embodiments, the fastener 913 may be a thread that engages with the pin fixing area 916. In some embodiments, the end of each pin 918 may taper towards the tip 921. In some embodiments, the tip 921 may be pointed. In some embodiments, the tip 921 of the pin 916 may be adipose tissue 906 or a venous wall. of retention deathobtain.

[0070] As shown in Figure 22A, the second connecting element 904 may have a ring channel 942. The central portion of the second connecting element 904 may include a conical surface 940. The diameter of the conical surface 940 may increase from the narrowest diameter at the bottom of the second connecting element 904 to the maximum diameter at the top surface of the raised ring. In some embodiments, the conical surface 940 receives adipose tissue 906. Entry In some embodiments, the pin 916 may be located in a pin fixing region 918. The pin fixing region 918 may be located on the conical surface 940 such that the pin 916 extends from the conical surface 940. In some embodiments, the second connecting element 904 may have a second ring outer surface 945. In some embodiments, the conical surface 940 is one or several millimeters from the surface of the second connecting element 904. minutes high It's fine to be treated that way. This allows, for example, the insertion of a lymphatic channel 907 into a vein 908 to a depth of at least 1 mm. It can bring about Therefore, the relative dimensions of the connecting elements can define the depth of insertion.

[0071] An exemplary perspective view of the coupling device 900 is shown in Figure 22B. When the first coupling element and the second coupling element are connected... 、 An internal volume is created within the coupling device. The internal volume is the ring aperture. inside General That It was drawn out, some It can be filled with adipose tissue under tension. The adipose tissue acts to seal the ring aperture, preventing lymphatic fluid from entering the internal volume. flow Out vinegar This can prevent that from happening.

[0072] As shown in Figure 23, the first connecting element 902 is a connecting element that can connect to the second connecting element 904 to form a connecting device 900. ofIt may have a projection 922. In some embodiments, the first connecting element 902 may have a first ring outer surface 920 of the first inner ring 901. The first connecting element 902 may include a pin 946 for connecting to and gripping the adipose tissue 906.

[0073] As shown in Figures 24A to 24C, the coupling device 900 in some embodiments may be defined by a cylindrical wall 950 surrounding the components. As shown above, in some embodiments, the coupling device 900 may be formed by connecting a first coupling element and a second coupling element. The first coupling element and the second coupling element are separate component It could be, or the connecting sheath, hinge, or , These The elements may be connected using other connecting devices that allow them to move relative to one another. Alternatively, the connecting device 900 may be formed as a single, integrated object. In some embodiments, the connecting device 900 may have a first conical surface 952 and a second conical surface 940. The first conical surface 952 may help position the vein within the device and avoid tissue abrasion. The second conical surface 940 may help position the vein of The diameter is different from the normal diameter, above the second cone surface 940. edge It can provide support when it extends to the expanded diameter. The tissue gripping element extends from the second cone surface and can fix tissue such as veins.

[0074] Those skilled in the art will understand that modifications and variations of the apparatus and methods described above can be made without departing from the inventive spirit disclosed herein. Therefore, the disclosure should not be considered limited except by the scope and spirit of the appended claims.

[0075] [Item 1] A device for lymphatic vein bypass surgery, A first connecting element having a first tissue-grasping element connected to at least one lymphatic channel; and A second connecting element connectable to the first connecting element, wherein the second connecting element has a second tissue grasping element configured to fix a vein to the second connecting element. The first and second connecting elements are configured to provide lymphatic fluid from the lymphatic pathway to the vein of the patient, and the first and second connecting elements are configured to provide lymphatic fluid from the lymphatic pathway to the vein, Device. [Item 2] The apparatus according to item 1, wherein the second connecting element has a conical surface, and the second tissue gripping element protrudes from the conical surface. [Item 3] The apparatus according to item 2, wherein the conical surface has a first diameter in the range of 1 to 3 mm and a second diameter in the range of 7 to 12 mm. [Item 4] The apparatus according to item 3, wherein the second diameter of the conical surface is aligned with the ring aperture of the first connecting element along a common axis. [Item 5] The apparatus according to item 1, wherein the first tissue gripping element includes one or more pins. [Item 6] The apparatus according to item 1, wherein the second tissue gripping element includes one or more pins. [Item 7] The apparatus according to item 1, wherein the first connecting element includes a ring aperture into which tissue containing at least one lymphatic channel is inserted for connection with the first tissue grasping element. [Item 8] The apparatus according to item 1, wherein at least one of the first connecting element and the second connecting element comprises a biocompatible polymer material. [Item 9] The apparatus according to item 1, wherein the first connecting element includes a plurality of connecting elements that each engage with a recess in the second connecting element to fix the first connecting element and the second connecting element together. [Item 10] Each connecting element includes a hook or latch element, as described in item 9. [Item 11] The apparatus according to any one of items 1 to 10, wherein the first connecting element has a circular shape with a diameter in the range of 1 mm to 15 mm. [Item 12] The second connecting element has a circular shape with a diameter in the range of 1 mm to 15 mm, and the first connecting element and the second connecting element are connected. implants An apparatus according to any one of items 1 to 11, which forms a possible tubular body. [Item 13] The apparatus according to item 2, wherein the conical surface has a wider diameter at its upper surface compared to the narrower diameter to which the conical surface is connected to the tube through which the vein extends. [Item 14] The apparatus according to item 2, wherein the conical surface has a plurality of recesses into which a pin can be inserted. [Item 15] The apparatus according to item 14, wherein the pins are inserted into at least six recesses. [Item 16] The apparatus according to item 1, wherein the first tissue gripping element includes at least six pins spaced apart around the outer edge of the first connecting element. [Item 17] The apparatus according to item 16, wherein the pin on the first connecting element is arranged in a single plane extending through the pin on the second connecting element. [Item 18] The apparatus according to item 1, wherein the first and second connecting elements are connected together along a common longitudinal axis, and the pins attached to the tissue extend parallel to the longitudinal axis. [Item 19] The apparatus according to item 1, wherein connector elements extending from the first connecting element are spaced apart around a circumferential ring of the first connecting element, each connector element has a latch that connects to a portion of the second connecting element, the apparatus includes a cylindrical body, the cylindrical body has slots that allow the cylindrical body to be gripped by a user. [Item 20] A method for performing lymphatic vein bypass surgery using a connecting device, The step of attaching the first connecting element to tissue containing at least one lymphatic pathway in the patient; The step of attaching a second connecting element to the patient's vein, wherein the second connecting element includes a cone; and, The first connecting element and the second connecting element are connected, thereby connecting the at least one lymphatic pathway to the vein, wherein the lymphatic pathway extends through the cone. A method for providing this. [Item 21] The first and second connecting elements are connected to form a connector device that connects a plurality of lymphatic pathways into the open end of the patient's vein, and the connector device is provided to the patient implants The method according to item 20, including a tubular body. [Item 22] The method according to item 20, wherein attaching the first connecting element to tissue includes inserting the tissue into the ring aperture of the first connecting element; and fixing the tissue on the first tissue gripping element. [Item 23] The method according to item 20, wherein the vein is superimposed on the at least one lymphatic pathway by connecting the at least one lymphatic pathway to the vein and extending it within the vein for a certain distance. [Item 24] The method according to item 23, wherein one or more of the multiple lymphatic channels extend to a depth of at least 1 mm inside the vein. [Item 25] Attaching the second connecting element to the vein means Inserting the vein through the second connecting element, starting from the first end of the conical surface of the second connecting element; and The vein is fixed to the second end of the conical surface using the second tissue grasping element. The method described in item 20, including the method described in item 20. [Item 26] The method of item 25, wherein fixing the vein includes increasing the diameter of the open end of the vein at the second end of the conical surface. [Item 27] Connecting the first connecting element to the second connecting element is The plurality of connecting elements of the first connecting element are slid on the surface of the second connecting element, thereby fixing both the first and second connecting elements together. The method described in item 20, including the method described in item 20. [Item 28] The method according to item 27, wherein connecting the first connecting element to the second connecting element further includes engaging the hook or latch element of each of the plurality of connecting elements with the respective recess of the second connecting element. [Item 29] A first connecting element to be attached to tissue containing at least one lymphatic channel; A second connecting element connectable to the first connecting element, wherein the second connecting element has a conical surface configured to receive a vein. The first and second connecting elements are configured to position the at least one lymphatic pathway relative to the vein of the patient in order to supply lymph fluid from the at least one lymphatic pathway into the vein. A device used for lymphatic vein bypass surgery. [Item 30] The apparatus according to item 29, further comprising a first tissue gripping element on the surface of the first connecting element, and a second tissue gripping element protruding from the conical surface. [Item 31] The apparatus according to item 29, wherein the conical surface has a first diameter in the range of 1 to 3 mm and a second diameter in the range of 7 to 12 mm. [Item 32] The apparatus according to item 31, wherein the second diameter of the conical surface is aligned with the ring aperture of the first connecting element along a common axis. [Item 33] The apparatus according to item 29, wherein each first tissue grasping element connected to the tissue containing at least one lymphatic pathway and the second tissue grasping element connected to the vein each include one or more pins, projections, sutures, or adhesives. [Item 34] The apparatus according to item 29, wherein the first connecting element includes a ring aperture into which the tissue containing the at least one lymphatic channel is inserted for connection to the first tissue grasping element. [Item 35] The apparatus according to item 29, wherein the first and second connecting elements are connected together along a common longitudinal axis, and the apparatus further includes pins for attachment to the tissue extending parallel to the longitudinal axis, and at least one of the first and second connecting elements comprises a biocompatible polymer material. [Item 36] The apparatus according to item 29, wherein the first connecting element includes a plurality of connecting elements that each engage with a recess in the second connecting element to secure the first connecting element and the second connecting element together. [Item 37] Each connecting element includes a hook or latch element, as described in item 36. [Item 38] The apparatus according to item 29, wherein the first connecting element and the second connecting element each have a circular shape with a diameter in the range of 1 mm to 15 mm. [Item 39] The apparatus according to item 29, wherein the conical surface has a wider diameter at its upper surface compared to the narrower diameter to which the conical surface is connected to the tube through which the vein extends. [Item 40] The apparatus according to item 29, wherein the conical surface has a plurality of at least six recesses into which a pin can be inserted. [Item 41] The apparatus according to item 30, wherein the first tissue gripping element includes at least six pins spaced apart around the outer edge of the first connecting element, and the pins on the first connecting element are arranged in a single plane extending through the pins on the second connecting element. [Item 42] The apparatus according to item 29, wherein connector elements extending from the first connecting element are spaced apart around a circumferential ring of the first connecting element, each connector element has a latch that connects to a portion of the second connecting element, the apparatus includes a cylindrical body, the cylindrical body has slots that allow the cylindrical body to be gripped by a user. [Item 43] A first connecting element configured to connect to tissue containing at least one lymphatic pathway in the patient; A second connecting element configured to connect to the patient's vein, wherein the second connecting element includes a cone having an opening for receiving the vein. Equipped with, The first connecting element is connectable to the second connecting element, thereby connecting the at least one lymphatic pathway into the vein, the lymphatic pathway extending through the cone into the open end of the vein. A device for performing lymphatic venous bypass surgery. [Item 44] The apparatus according to item 43, wherein a plurality of lymphatic pathways are connected into the veins of the patient by connecting the first connecting element and the second connecting element. [Item 45] The apparatus according to item 43, wherein the first connecting element connects to the tissue by inserting the tissue through the ring aperture of the first connecting element and fixing the tissue on the first tissue grasping element; and overlaps the at least one lymphatic channel with the vein by connecting the at least one lymphatic channel to the vein and extending it into the vein by a distance of at least 1 mm. [Item 46] The apparatus according to item 43, wherein the second connecting element is connected to the vein by inserting the vein into the second connecting element, starting at the first end of the conical surface of the second connecting element, and fixing the vein to the second end of the conical surface using the second tissue gripping element, the diameter of the vein being enlarged at the second end of the conical surface. [Item 47] The apparatus according to item 43, wherein the first connecting element and the second connecting element are connected using a plurality of connecting elements of the first connecting element that slide on the surface of the second connecting element, thereby fixing the first connecting element and the second connecting element together. [Item 48] The apparatus according to item 47, wherein the first connecting element and the second connecting element are connected using hook or latch elements of each of the plurality of connecting elements that engage with the respective recesses of the second connecting element. [Item 49] The apparatus according to item 43, wherein the first connecting element is connected to tissue using at least one of sutures, adhesives, pins, projections, posts, and tissue anchors. [Item 50] The apparatus according to item 43, wherein the second connecting element is connected to a vein using at least one of sutures, adhesives, pins, projections, posts, and tissue anchors. [Item 51] The apparatus according to any one of items 1 to 19 and 29 to 50, wherein the first opening in the first connecting element receiving the at least one lymphatic channel is larger than the second opening in the second connecting element receiving the vein. [Item 52] The apparatus according to any one of items 1 to 19 and 29 to 51, wherein the at least one lymphatic channel has an outer diameter smaller than the inner diameter of the vein. [Item 53] The apparatus according to any one of items 1 to 19 and 29 to 52, wherein multiple lymphatic channels are inserted into the vein. [Item 54] The apparatus according to any one of items 1 to 19 and 29 to 53, wherein the robotic apparatus connects the first connecting element to the second connecting element. [Item 55] The apparatus according to any one of items 1 to 19 and 29 to 53, wherein the robotic device connects the at least one lymphatic channel to the first connecting element. [Item 56] The robotic device according to any one of items 1 to 19 and 29 to 53, wherein the robotic device connects the vein to the second connecting element. [Item 57] The robotic device, as described in any one of items 54 to 56, includes a first arm and a second arm, each arm having a gripping device. [Item 58] The robotic device is the device according to any one of items 54 to 57, which includes a computer-controlled system programmed to perform a lymphatic-vein bypass procedure. [Item 59] The apparatus according to any one of items 54 to 58, wherein at least one of the first or second connecting element includes one or more surrounding slots for gripping by the robotic device. [Item 60] The first connecting element having a first opening for receiving at least one lymphatic channel connected to the first connecting element; A second connecting element connectable to the first connecting element, wherein the second connecting element has a second opening for receiving a vein connected to the second connecting element; The first and second connecting elements are configured to position the at least one lymphatic pathway relative to the patient's vein in order to supply lymph fluid from the lymphatic pathway to the vein. A device used for lymphatic vein bypass surgery. [Item 61] The apparatus according to item 60, wherein the first connecting element has a first tissue gripping element, and the second connecting element has a conical surface having a second tissue gripping element. [Item 62] The apparatus according to item 60, wherein the second connecting element comprises a conical surface having a first diameter in the range of 1 to 3 mm and a second diameter in the range of 7 to 12 mm. [Item 63] The apparatus according to item 62, wherein the second diameter of the conical surface is aligned with the ring aperture of the first connecting element along a common axis. [Item 64] The apparatus according to item 61, wherein the first tissue grasping element includes one or more pins, projections, sutures, or adhesives. [Item 65] The apparatus according to item 61, wherein the second tissue grasping element includes one or more pins, projections, sutures, or adhesives. [Item 66] The apparatus according to item 60, wherein the first connecting element includes a ring aperture into which tissue containing at least one lymphatic channel is inserted for connection to the first tissue grasping element. [Item 67] The apparatus according to item 60, wherein at least one of the first or second connecting element comprises a biocompatible polymer material. [Item 68] The apparatus according to any one of items 60 to 67, wherein the first connecting element includes a plurality of connecting elements, each engaging with a recess in the second connecting element to secure the first connecting element and the second connecting element together. [Item 69] Each connecting element includes a hook or latch element, as described in item 68. [Item 70] The apparatus according to item 60, wherein the first connecting element has a circular shape with a diameter in the range of 1 mm to 15 mm. [Item 71] The apparatus according to item 60, wherein the second connecting element has a circular shape with a diameter in the range of 1 mm to 15 mm. [Item 72] The first connecting element and the second connecting element are connectable, implants Apparatus according to any one of items 60 to 71, which forms a possible tubular body. [Item 73] The apparatus according to item 60, wherein the second connecting element has a conical surface having a wider diameter on its upper surface compared to a narrower diameter, to which the conical surface is connected to the tube through which the vein extends. [Item 74] The apparatus according to item 73, wherein the conical surface has a plurality of recesses into which a pin can be inserted. [Item 75] The apparatus according to item 74, wherein the pin is inserted into at least six recesses. [Item 76] The apparatus according to item 61, wherein the first tissue gripping element includes at least six pins spaced apart around the outer edge of the first connecting element. [Item 77] The apparatus according to item 76, wherein the pin on the first connecting element is located in a single plane extending through the pin on the second connecting element. [Item 78] The apparatus according to item 60, wherein the first and second connecting elements are connected together along a common longitudinal axis, and the apparatus further includes a pin attached to tissue extending parallel to the longitudinal axis. [Item 79] The apparatus according to item 68, wherein the plurality of connecting elements extend from the first connecting element and are spaced apart around a ring surrounding the first connecting element, each connector element has a latch that connects to a portion of the second connecting element, the apparatus includes a cylindrical body, the cylindrical body has slots that allow the cylindrical body to be grasped by a user. [Item 80] The apparatus according to item 60, wherein the first connecting element has a first central opening for receiving tissue containing a plurality of lymphatic channels, and the second connecting element has a second central opening for receiving the veins, and the first central opening is larger than the second central opening. [Item 81] The apparatus according to any one of items 60 to 80, wherein the plurality of lymphatic channels connected to the first connecting element extend into the vein. [Item 82] The apparatus according to any one of items 60 to 81, further comprising a robotic device configured to perform a lymphovenous bypass procedure so that lymphatic fluid is supplied to the vein. [Item 83] The apparatus according to any one of items 60 to 82, wherein the first and second connecting elements include a molded polymer material. [Item 84] The apparatus according to any one of items 60 to 83, wherein the first connecting element is snap-fitted together with the second connecting element. [Item 85] A lymphovenous bypass device comprising an integrated body having a first end for receiving a patient's vein and a second end for connecting to one or more lymphatic channels, wherein the integrated body has an opening on one side, the vein extends into the opening, and the second end receives the one or more lymphatic channels extending into the vein. [Item 86] The lymphovenous bypass device according to item 85, further comprising: a first plurality of tissue gripping elements for attachment to the vein; and a second plurality of tissue gripping elements for attachment to tissue containing the one or more lymphatic channels. [Item 87] The integrated body has one or more side wall openings, as described in item 85 or 86, for the lymphatic vein bypass device. [Item 88] The lymphovenous bypass device according to any one of items 85 to 87, wherein the veins extend within the integrated body toward a conical surface aligned to receive the one or more lymphatic channels.

Claims

1. A lymphovenous bypass device comprising an integrated body having a first end that receives a patient's vein through a first opening on the upper surface and a second end that receives a plurality of lymphatic channels through a second opening on the bottom surface, wherein the vein is connected to a first plurality of tissue gripping elements on the integrated body, adipose tissue surrounding the plurality of lymphatic channels is gripped by a second plurality of tissue gripping elements on the integrated body, the vein extends into the first opening on the upper surface, the second end receives the plurality of lymphatic channels, and the plurality of lymphatic channels extend into the vein. Lymphatic venous bypass device.

2. The lymphatic vein bypass device according to claim 1, wherein the veins are attached to a plurality of first tissue gripping elements including pins around a second opening in the bottom surface, and the plurality of second tissue gripping elements include pins around a ring element extending from the bottom surface and gripping the adipose tissue including the plurality of lymphatic channels.

3. The lymphatic vein bypass device according to claim 1 or 2, wherein the integrated body has one or more side wall openings.

4. The lymphatic vein bypass device according to any one of claims 1 to 3, wherein the vein extends within the integrated body toward a conical surface in the upper surface which is adjusted to receive the plurality of lymphatic channels.

5. The lymphatic vein bypass device according to any one of claims 1 to 4, wherein the integrated body has a tubular portion at a first end for receiving the vein and a tubular portion at a second end for receiving the adipose tissue containing the plurality of lymphatic channels.

6. The lymphatic vein bypass device according to claim 1, wherein the second plurality of tissue gripping elements extend in the opposite direction to the first plurality of tissue gripping elements.

7. The lymphatic vein bypass device according to any one of claims 1 to 6, wherein the plurality of lymphatic channels extend through a first opening on the upper surface of the first end and a second opening on the bottom surface of the second end which is aligned along the axis.

8. The lymphatic vein bypass device according to claim 2, wherein the surface opening of the ring element is larger than the second opening of the bottom surface.

9. The lymphovenous bypass device according to any one of claims 1 to 8, wherein the plurality of lymphatic channels are connected to the vein at a certain depth in the vein, forming an implant for insertion into the body for delivering lymph fluid from the plurality of lymphatic channels to the vein, and the implant comprises a biocompatible material.

10. The lymphatic vein bypass device according to any one of claims 1 to 9, wherein the integrated body includes a cylindrical wall.

11. The lymphatic vein bypass device according to claim 2, wherein the first plurality of tissue gripping elements extend in the opposite direction to the second plurality of tissue gripping elements positioned around the ring element at the second end.

12. The lymphatic vein bypass device according to any one of claims 1 to 11, wherein the adipose tissue extends into the second opening of the bottom surface.

13. The lymphatic vein bypass device according to any one of claims 1 to 12, wherein the first opening on the upper surface of the first end constitutes a central aperture extending to a conical surface.

14. The lymphatic vein bypass device according to claim 13, wherein the central aperture extends from the first opening on the upper surface to the second opening on the bottom surface.

15. The lymph-vein bypass device according to any one of claims 1 to 14, wherein the plurality of lymphatic pathways extend at least 1 mm into the vein.

16. The lymphatic vein bypass device according to claim 2, wherein the first plurality of tissue gripping elements and the second plurality of tissue gripping elements extend in opposite directions along the axis of the integrated body.

17. The lymphovenous bypass device according to claim 9, wherein the adipose tissue includes a plurality of lymphatic channels having a cut end superimposed at a certain depth within the vein.

18. The lymphovenous bypass device according to any one of claims 1 to 17, wherein the plurality of lymphatic pathways are installed in the vein and the lymphovenous bypass device is implanted in the patient's arm or leg.

19. The lymphovenous bypass device according to any one of claims 1 to 18, wherein the integrated body is implanted in the patient so that lymphatic fluid from one or more of the plurality of lymphatic channels flows into the vein.

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