Apparatus and method of lymphatic vessel anastomosis

Abstract

A preferred embodiment relates to an apparatus and method for performing a lymphovenous bypass procedure. A connecting element is fixed to tissue connected to at least one lymphatic pathway in the patient and to the patient's vein or artery. To supply lymph from the lymphatic pathway into the vein or artery, the end of the lymphatic pathway extending through the connecting element is inserted into the open end of the vein or artery.

Description

[Background technology]

[0001] [Cross-reference of related applications] This application claims priority to U.S. Provisional Application No. 63 / 522,710 filed on 22 June 2023, is a continuation in part of International Application No. PCT / US2021 / 065126 filed on 23 December 2021, and is a continuation in part of U.S. Non-Provisional Application No. 17 / 133,277 filed on 23 December 2020, which relates to International Application No. PCT / US2020 / 033806 filed on 19 June 2020, which claims priority to U.S. Provisional Application No. 62 / 864,862 filed on 21 June 2019, and the entire contents of each of the above applications are incorporated herein by reference. This application is also a continuation of part of U.S. Patent Application No. 17 / 132,946 filed on 23 December 2020 and a continuation of part of U.S. Patent Application No. 17 / 621,566 filed on 21 December 2021, the entire contents of those applications are incorporated herein by reference. The lymphatic system is a complex system of cells, tissues, blood vessels, and organs that work to transport excess fluid into the bloodstream, playing a vital role in the body's immune system by removing pathogens from the circulatory system. The system includes approximately 500 to 600 organelles, or lymph nodes, in the human body. Lymphatic capillaries and lymphatic vessels typically transport interstitial fluid into the circulatory system through the lymphatic trunk. Interstitial fluid ("lymph") in the lymphatic system can accumulate due to disease or injury. This excessive accumulation of fluid is known as lymphedema.

[0002] Breast Cancer-Related Lymphedema (BCRL) is one of the most significant survivorship issues in breast cancer management. Currently, there is no cure for BCRL. Among the 2.8 million breast cancer survivors in the United States, an estimated one in five suffers from BCRL. Patients with BCRL often complain of a sense of compression, heaviness, fatigue, and ill-fitting clothing following the swelling commonly experienced with this condition. In selected cases, patients repeatedly present with cellulitis that rapidly spreads to the affected limb, which can be life-threatening if not treated promptly. The signs and symptoms of BCRL have been 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).

[0003] The standard treatment for BCRL is manual lymphatic drainage, compression, topical skin treatment, exercise, and physical therapy using pneumatic devices. Surgical management of chronic lymphedema may include lymphovenous bypass and lymph node transplantation, but these do not offer definitive treatment. The single greatest risk factor for developing BCRL is axillary lymph node dissection (ALND). The Lymphatic Microsurgical Preventative Healing Approach (LYMPHA) is a surgical procedure to reduce the risk of lymphedema in patients undergoing ALND. LYMPHA has been used in patients who have developed lymphedema following ALND.

[0004] 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 in conjunction 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%.

[0005] In LYMPHA procedures, during axillary lymph node dissection, lymphatic vessels that drain into the arm are identified and bypassed into 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. The incidence of lymphatic hydrops after ALND is highly variable, but is often shown to be between 20% and 40%, and has been reported to be as high as 77%.

[0006] One challenge in LYMPHA procedures is visualizing healthy, severed lymph nodes 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 may reduce the risk of 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 project]

[0007] 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 other lymphatic and vascular anastomosis devices described previously, vessels of similar diameters need to be connected in an end-to-end manner, or in an end-to-lateral manner if there is a size mismatch. Preferred embodiments described herein allow, for example, one or more lymphatic channels of significantly different sizes to be intussusception into a single vein. As a result, 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 into a single vascular channel such as a vein or artery.

[0008] The procedure may utilize adipose tissue associated with the grouping of one, two, or more lymphatic pathways to assist in connecting the lymphatic pathways to the first connecting element of the device. Prior to the start of the procedure, the lymphatic system within the region of interest may be assessed by visualization techniques. Dyes may be injected for microscopic imaging and lymph mapping to identify specific regions of interest that function to drain fluid from the affected area, such as the patient's arm. The surgeon begins the procedure by accessing the site by incision to expose the lymphatic pathways and one or more veins that can be used, and by identifying one or more lymphatic pathways to be connected into the selected veins. Visualization of the implanted device may be enhanced using fluorescent fluoroscopy markers attached to, embedded in, or positioned on one or more regions of the device. Visualization of lymphatic flow after connector implantation may be used to monitor the viability of lymphatic flow after surgical wound closure in order to connect lymphatic pathways into veins or to one or more branches of veins.

[0009] A preferred embodiment of the coupling device may include a coupling element having an aperture extending through the coupling device to receive a vein or artery, which is attached to one or more first tissue gripping elements on one side to provide the exposed open end of the vein or artery. The open end of the artery is sized to receive one or more lymphatic channels inserted to a depth within the vein or artery. The lymphatic channels may be stabilized within the vein or artery by attaching the tissue adhering to the lymphatic channel to one or more second tissue gripping elements on the second side of the device. In a preferred embodiment, the device may have a rounded outer surface to prevent abrasion of surrounding tissue during or after the procedure in which the device is implanted in the body to provide a lymphovenous bypass for the treatment of lymphedema. This embodiment provides inserting the lymphatic channel into the open end of the artery after insertion of the vein or artery into the aperture and coupling of the vein or artery to the first side of the device, and then moving the tissue in which the lymphatic tissue is positioned onto the outer surface of the device and coupling the tissue to the second side of the device. This embodiment thus provides an integrated device for grasping both veins or arteries, and for connecting them to lymphatic pathways to stabilize them within veins or arteries, and for implanting the connection device into a patient as generally described herein. For embodiments of tissue grasping elements on one or both sides of the device, where further covering of the tissue grasping element is necessary, one or more caps may be used to surround any exposed features of the tissue grasping element to prevent further abrasion of surrounding tissue after implantation.

[0010] Specific connecting devices may be selected based on the number and size of the lymphatic channels and veins to which they are to be positioned. The devices may be fabricated by standard molding and assembly techniques using biocompatible materials such as synthetic polymers or silicone. They may have different sizes and shapes depending on the specific site for implantation. 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 ring-shaped, with the lymphatic channels connected so as to extend through the central opening of the first ring, and the veins connected to the second ring, and the first ring attached to the second ring, so that one or more lymphatic channels extend within a single vein, i.e., the lymphatic channels overlap 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 via a second ring opening, i.e., the lymphatic channels are superimposed or fitted into the vein. The conical element may include one or more molded surfaces extending from a larger diameter portion to a smaller diameter portion extending around an opening of a cavity through which the lymphatic vessels slide into the 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 blood vessels. It should be noted that when a lymph node is removed to treat a patient's condition, the lymphatic vessels that were connected to that lymph node are severed, typically allowing lymphatic fluid to continue to pass through the severed ends into the surrounding tissue. 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 of a size and shape suitable for grasping supporting tissue. Supporting tissue may include, for example, fibrous connective tissue that the surgeon can grasp manually 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 are positioned within or near the exposed end of the vein from which lymphatic fluid is to be supplied. In the area surrounding the removed lymph node, there are often three or four lymphatic vessels, which can be grasped using the surrounding lipid tissue supporting these lymphatic vessels. The lymphatic vessels are separated, and the surgeon often selects groups of lymphatic vessels separated close enough to fit within the diameter of the vein for anastomosis. Lymph nodes may vary in size depending on the patient's age and condition, but are often in the range of 4 mm to 2 cm along the long axis of the lymph node. The size of this device may vary depending on the size of the vein to which it is attached, and its diameter can be within the range of 4 mm to 2 cm.By attaching the supporting tissue to a pin or anchor, the movement of this attachment causes the severed end of the lymphatic vessel to extend further from the surrounding tissue, thereby easily locating 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. The lymphatic vessel has a variable length extending from the supporting tissue, and therefore may be placed within the vein at different insertion lengths, or there may be ends of lymphatic vessels that are outside the end of the vein, yet continue to supply lymph fluid into the vein. Some lymphatic vessels have a higher flow rate, which ensures that even those that are outside the vein after implantation of the device and closure of the surgical wound are close enough for the vein to maintain flow. Tissue flow channels may be formed extending into the vein from the ends of high-flow lymphatic vessels.

[0012] The first connecting element may have tissue-grasping elements such as pins, projections, or tissue anchors that grasp the fatty 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 lymphatic pathway function, thereby enabling the transport of lymph into the veins in a way that reduces swelling. The pins, posts, projections, or tissue anchors may extend through the fatty 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 / or with the connector element.

[0013] Surgical instruments may be used to grasp tissue, position it relative to pins, projections, or tissue anchors, and thereby attach the tissue to the anastomosis device. If necessary, clamping devices may be used to temporarily hold the connecting elements of the device in place and to facilitate the attachment of tissue to each element, the alignment of the connecting elements, and the connection of the components.

[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 may be used to map those areas of the lymphatic system to one or more selected areas to reduce or eliminate swelling by implanting one or more of the devices described herein. Preferably, at least two, three, four, five or more lymphatic pathways can be fluidly connected into a single vein so that a significant amount of lymph can be removed into a single vein using a single device. Following mapping and selection, one or more of the devices described herein are implanted.

[0015] Further embodiments employ devices in which lymphatic pathways are grasped individually or collectively and placed in a vein at a selected depth. This can be performed manually or by using a robotic device. For example, a loop of forceps and / or suture material may be used to grasp one or more pathways and to position them in 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, so as 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 insertion on one side and connection to a vein with a pin or projection, and for attachment of the pathway inserted into the vein at the opposite end of the tube, as described herein. In robotic surgery, multiple control arms having manipulative elements may be used to isolate and grasp the vein and attach the exposed end to a first connecting element. The control arm may also operate to attach tissue, such as visceral adipose tissue, that houses lymphatic vessels to the second connecting element, as described herein. The robotic arm may then be controlled by the surgeon to grasp, align, and attach the first and second elements together to fluidly connect the lymphatic pathway into the vein. The device may then be positioned within the wound opening, and the wound is sutured to close the wound.

[0016] In further embodiments, one or more lymphatic vessels may be fluidly coupled to a vein by attaching the vein and blood vessel to a single integral coupling element. The integral coupling element may comprise a generally cylindrical body to which the vein is coupled at a first end of the cylindrical body and the lymphatic vessel at a second end of the cylindrical body. Embodiments may further include more rounded or elliptical shapes. The external surface may have slots or grooves that allow the user to more easily grasp the implantation device manually or with grasping surgical instruments such as forceps or tweezers. The integral coupling element has a first opening for receiving a vein at a first end, using a first group of pins or anchors positioned around the inner portion of the first opening to secure the open end of the vein within the implant. The second end may have a wider opening than the vein insertion opening for providing insertion of supporting tissue, which typically has a larger diameter than the vein, as it must incorporate all separated lymphatic vessels that are inserted into the vein. The side walls of the implantation device extending around the outer edge of the second opening may have side wall openings or windows through which the surgeon can insert surgical grasping instruments, such as forceps for grasping different areas of supporting tissue, to be placed on a second group of pins or anchors that extend generally in the opposite direction to a first group of pins or anchors that fix the open end of a vein. The pins or anchors may extend along the longitudinal axis of the implantation device to provide a more secure attachment, for example, or they may extend radially or at some angle between 1 and 45 degrees with respect to the longitudinal axis.

[0017] It should be noted that an integrated tissue coupling device generally refers to a coupling device having a first tissue gripping element on a first side and a second tissue gripping element on a second side, and which does not require assembly during surgical implantation. Therefore, for example, an implementation of a coupler device having at least two coupler components, each having a tissue gripping element, which must be assembled during use to provide a fluid flow channel connection, does not constitute an integrated tissue coupling device. [Brief explanation of the drawing]

[0018] [Figure 1] Illustrate an embodiment of a connecting device that aligns and connects lymphatic channels to a vein or artery using a pair of rings.

[0019] [Figure 2A] Illustrate an embodiment including a connector element that attaches a pair of rings together to connect one or more lymphatic channels to a vein.

[0020] [Figure 2B] Illustrate a further embodiment including a central tube connected to the ring, and an external sheath that can be attached to surround the connecting element.

[0021] [Figure 2C] Illustrate a further mechanism for connecting a first connecting element to a second connecting element.

[0022] [Figure 2D] Illustrate a perspective view of the first end of an implant for lymphaticovenous bypass treatment.

[0023] [Figure 2E] Illustrate a further perspective view of the second end of the implant shown in FIG. 2D.

[0024] [Figure 3] Illustrate the axillary dissection area after level 1 and 2 lymph node dissection where the lymphatic channels emit light from the FITC injection described hereinafter and the bypass treatment has been performed.

[0025] [Figure 4] Schematically illustrate the steps of a surgical procedure for performing a bypass surgical procedure according to an embodiment of the present invention.

[0026] [Figure 5] Schematically illustrate the lymphatic channel system of the human body where bypass treatments according to the present invention can be performed at different locations to reduce lymphedema.

[0027] [Figure 6] A flowchart illustrating the lymphatic hydrops protocol used in conjunction with the surgical procedures described herein is shown.

[0028] [Figure 7] A robotic control system having computer control of an arm having a manipulator is illustrated so that a surgeon can perform a procedure according to a preferred embodiment of this specification.

[0029] [Figure 8] A process flow diagram illustrating a robot-controlled surgical process according to a preferred embodiment is shown.

[0030] [Figure 9] A sensor attached to a connector device for measuring the flow of lymphatic fluid into a vein is shown in the diagram.

[0031] [Figure 10] A valve device for controlling the fluid pressure at the junction within a vein where lymphatic fluid enters the vein is illustrated.

[0032] [Figure 11] Further embodiments of the coupling device and fixing element according to a specific embodiment are illustrated.

[0033] [Figure 12] Figure 11 shows a front view of the coupling device.

[0034] [Figure 13] Figure 12 shows a left-side cross-sectional view of the coupling device, taken along the line indicated.

[0035] [Figure 14] A rearward perspective view of the coupling device shown in Figure 11 is provided.

[0036] [Figure 15] Figure 11 shows a front perspective view of the coupling device.

[0037] [Figure 16] A side view of a further embodiment of the first connecting element according to a specific embodiment described herein is shown.

[0038] [Figure 17] Figure 16 shows a top view of the first connecting element.

[0039] [Figure 18] A side perspective view of the first connecting element is shown in Figure 16.

[0040] [Figure 19] A side view of the first connecting element is shown.

[0041] [Figure 20] A top view of the first connecting element is shown.

[0042] [Figure 21] An embodiment of a pin compatible with the first and second connecting elements described herein is illustrated.

[0043] [Figure 22A] A perspective view of one embodiment of a second connecting element including a pin is shown.

[0044] [Figure 22B] Perspective views of the internal volume of the coupling device in several embodiments described herein are shown.

[0045] [Figure 23] A rear perspective view of a further embodiment of the first connecting element including a pin is shown.

[0046] [Figure 24A] A front perspective view of a further embodiment of the coupling device is shown.

[0047] [Figure 24B] An upper perspective view of a further embodiment of the coupling device is shown.

[0048] [Figure 24C] A bottom view of a further embodiment of the coupling device is shown.

[0049] [Figure 25A] A bottom view of the first connecting element of a further embodiment of a connecting device according to a specific embodiment is shown.

[0050] [Figure 25B] Figure 25A shows a top view of the first connecting element.

[0051] [Figure 25C] Figure 25A shows an upward perspective view of the first connecting element.

[0052] [Figure 25D] Figure 25A shows a front perspective view of the first connecting element.

[0053] [Figure 25E] Figure 25A shows a side perspective view of the first connecting element.

[0054] [Figure 25F] Figure 25A shows a side view of the first connecting element.

[0055] [Figure 25G] Perspective views of a first connecting element with a breakable handle, according to several embodiments, are shown.

[0056] [Figure 25H] Perspective views of a first connecting element without a handle, according to several embodiments, are shown.

[0057] [Figure 25I]Perspective views of a first connecting element including a recess for forceps, according to several embodiments, are shown.

[0058] [Figure 26A] Figure 25A shows perspective views of the first and second connecting elements.

[0059] [Figure 26B] Figure 25A shows a side view of the first connecting element, and Figure 26A shows a side view of the second connecting element.

[0060] [Figure 27A] Figure 25A shows perspective views of the first and second connecting elements.

[0061] [Figure 27B] Figure 25A shows side views of the first and second connecting elements.

[0062] [Figure 28A] Figure 25A shows a perspective view of the holder for attaching the first and second connecting elements to the first connecting element.

[0063] [Figure 28B] Figure 25A shows a side view of the first connecting element and holder.

[0064] [Figure 29A] Figure 25A shows a perspective view of the first connecting element attached to the second connecting element by the holder in Figure 28A.

[0065] [Figure 29B] Figure 25A shows a side view of the first connecting element attached to the second connecting element by the holder in Figure 28A.

[0066] [Figure 30] This illustrates an exemplary method for performing lymphatic venous bypass surgery.

[0067] [Figure 31A] An illustrative perspective view of a grasping instrument inserted through a coupler element to grasp the lymphatic pathway during lymphatic bypass surgery is shown, along with a magnified view of the distal grasping element of the grasping instrument. [Figure 31B] An illustrative perspective view of a grasping instrument inserted through a coupler element to grasp the lymphatic pathway during lymphatic bypass surgery is shown, along with a magnified view of the distal grasping element of the grasping instrument.

[0068] [Figure 32A] This is a process flow diagram for performing lymphatic bypass surgery using the integrated coupler described herein. [Figure 32B] This is a process flow diagram for performing lymphatic bypass surgery using the integrated coupler described herein.

[0069] [Detailed Description of the Drawings] A preferred embodiment of the present invention utilizes a device for connecting one or more lymphatic channels to a vein in a patient's circulatory system. Figure 1 shows one embodiment of the coupling device, in which a first coupling element 100 includes a ring through its central opening 109, through which fatty tissue 104 surrounding lymphatic channels 106, 108 is drawn out onto a pin, projection, or tissue anchor 102 that faces inward from the inner ring surface toward a second coupling element 120. Unlike vascular anastomosis couplers used to connect the ends of two blood vessels, the present invention allows one or more lymphatic channels to be inserted into the open end of a blood vessel or vein (i.e., intussusception) because typically there is a size mismatch, and one lymphatic channel is considerably smaller than the size of the vein into which it is inserted. Thus, one, two, or more lymphatic vessels having channels for lymphatic fluid flow can be inserted into a single vein 128, depending on their size. It should be noted that blood vessels cannot be inserted into each other, as coagulation can lead to anastomosis failure. On the other hand, lymph fluid does not coagulate. Insertion of lymphatic pathway tissue into blood vessels does not induce such coagulation, allowing lymph to flow into the blood vessels without obstruction.

[0070] The component in Figure 1 may include a rigid or semi-rigid flexible, elastic biocompatible material having a generally smooth surface feature, excluding pins, projections, or tissue anchors configured to penetrate and grasp tissue. In selected embodiments, the component provides a suture-free tissue connector, although in some embodiments, sutures may be used to assist in implanting the device.

[0071] The components of the apparatus may be made using biocompatible materials such as silicone, polyurethane, polytetrafluoroethylene (PTFE), polyester, polyethylene, polyamide, polyetheretherketone (PEEK), polypropylene, Mylar, Kevlar®, polyisoprene, polyolefin, or combinations thereof.

[0072] The first connecting element may comprise a ring with a larger opening to accommodate the thickness of fatty tissue such as visceral adipose tissue (which houses lymphatic vessels having channels that extend through blood vessels to transport lymph), through which the lymphatic tissue extends and surrounds, so that they do not come into contact with the connector surface. It should be noted that the ring element may have other shapes, such as an elliptical cross-section, or any other shape that is suitable for a particular anatomical arrangement in the patient. The outer surface is preferably smooth to avoid abrasion of adjacent tissue. Lymphatic vessels are thin-walled, tubular tissue structures containing smooth muscle, lined with endothelial cells and connected to surrounding tissue with an adventitia. Lymphatic capillaries are smaller, lack muscle and adventitia, and have a diameter ranging from 15 to 75 microns. Larger lymphatic vessels have valves separated along their length, and fluid movement is provided by peristalsis, moving lymph through blood vessels under fluid pressure. Lymphatic collecting ducts have a diameter ranging from 100 to 800 microns or larger. The veins of the vascular system may have a diameter of 1 mm or more and may be selected to receive two or more lymphatic pathways for each selected vein. Generally, the veins will be connected to lymphatic vessels with supporting tissue that fit within a device aperture having a diameter in the range of 2 to 4 mm and larger than the diameter of the aperture holding the vein. The connecting elements may have a diameter in the range of 1 to 15 mm and, in embodiments including two connecting elements, may have matching diameters. The device and method may also be used to connect one or more smaller branch veins to be delivered into a larger vein. The inner surface of the central opening within the inner ring may be large enough to allow the vein to pass through the central opening so that the exposed end of the vein can be attached to the second connector. Thus, the second connector 120 may have an inner ring 124 having a pin, projection, or tissue anchor 125 that engages with the tissue of the vein 129 which folds over the pin 125. The outer ring 122 has a pin receiving region 126 that receives, for example, the end of a pin 102 that protrudes above the ring surface to a height sufficient to engage with the tissue.Region 126 may be configured to snap-fit ​​with at least a portion of the protruding elements from the surface of the ring 100 or the pins 102 to provide a snap-fit ​​connector. A latching mechanism or other connector may be used to secure the connecting elements together. These features are illustrated in one or more of the figures described herein.

[0073] It should be noted that the ring element 124 may be 1 or a few millimeters higher than the surface of the ring 122. Therefore, the peripheral wall 121 may have a height of at least 1 mm. This may allow for the insertion of the lymphatic channel 106 to a depth of at least 1 mm into the vein 128, for example. Thus, the relative dimensions of the connecting elements may define the depth of insertion.

[0074] Figure 2A shows a coupler 200 having a first ring 208 for receiving and anchoring a vein 220, as previously described, which engages with a first cone-shaped element 202 having an open end that gradually narrows in diameter toward a first end toward an opening of a smaller diameter tube 205, where the lymphatic channel 224 is received from a second cone 204 that narrows toward a second end of the tube 205. The broad end of the cone 206 is sized and shaped to attach to the inward-facing surface of the first ring 240, which has a pin, projection, or tissue anchor 242 for engaging and securing the lipid tissue containing the lymphatic vessel 224 to the ring 240, where the tissue surrounding the lymph 260 folds over the anchor 242, for example, on the surface 250. In this way the lymphatic vessel enters the open end of the cone 206 and passes through the narrow opening into the tube 205 and into the vein. It should be noted that the embodiment in Figure 1 may employ a single cone that defines the junction where lymphatic fluid enters the vein by guiding the lymphatic vessel to enter the vein from the open end of the cone through the narrow opening of the cone. Returning to Figure 2A, for example, to illustrate the use of markers in various embodiments described herein, the second ring 208 may include the first fluoroscopic marker 270, the cone 206 may include the second fluoroscopic marker 272, and the second ring 240 may include the third fluoroscopic marker 274. Shown in Figure 2B is 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 has an internal cavity into which a vein can be inserted and attached to the tube, as described herein. In a preferred embodiment, the first and second rings may be aligned on a common axis when they are connected together. The pins or anchors may be arranged symmetrically around a common longitudinal axis. Pins or anchors for veins may protrude in a first direction parallel to the common axis, while pins or anchors for connective tissue may extend in a second, opposite direction parallel to the common axis.

[0075] Embodiments described herein may be enclosed within an outer sheath 276 extending around a ring that, when connected together, aligns along a common axis. 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, where inwardly facing projections or ridges 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 patient's surrounding tissue. One or more elements of the device may include bioabsorbable material. The selected surface 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) may be used to indicate to the user that the length of the lymphatic pathway extending into the vein is sufficiently long to prevent the lymphatic pathway from disengaging from the anastomosis. Preferably, a joining region exists within the device housing where the lymphatic vessel supplies lymph fluid into the vein. It should be noted that the first and second connecting elements may be optionally connected on one side so that the user can simply rotate the two components relative to each other around a pivot axis in order to align and connect the elements with the pathway inserted into the vein. In a further embodiment, an outer sheath 276 may be attached to the device extending around the periphery of the device, thereby enclosing the device. The sheath 276 may also include portions extending peripherically from each ring connected together by a sheath connector.

[0076] In further embodiments, the coupling device may be fabricated as a single, integral part having a tubular portion for receiving a vein through a first end, thereby allowing the vein wall to be gripped by a pin or anchor on a second end of the tubular portion. The second end of the device may have a larger opening for receiving supporting tissue that accommodates a lymphatic vessel inserted into the vein. As shown in the front view in Figure 2D and the rear view in Figure 2E, coupling devices 300 according to some embodiments described herein may have a body formed from a single, integral part that can be fabricated using standard molding techniques or by using three-dimensional (3D) printing methods. 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 an outer ring side wall 312. The side wall openings 306, 308, and 310 are sized to allow a user to pass a forceps or other instrument through one of the side wall openings, and then through the ring opening, over the bottom ring surface 304. Forceps can be used at each opening 306, 308, and 310 to grasp tissue (such as lipid tissue surrounding a lymphatic pathway) and pull it through the ring opening onto a tissue grasping element 324, such as a pin or anchor. The pin may be inserted, for example, within a pin fixing area, or may be formed integrally with the coupling device 300. In some embodiments, the coupling device 300 may have a central aperture 316 extending from the inner bottom surface 314 to the upper surface 320 of the coupling element 300. A vein may extend from the upper surface 320 through the central aperture 316 and be attached to a tissue grasping element 315, such as a pin, which may be inserted within a pin fixing area, or may be formed integrally with the coupling device 300. The tissue gripping element 315 may protrude from the inner bottom surface 314, which is set at a depth 318 below the ring element. In some embodiments, lipid tissue may be extended onto the pin 324, which may cause the extension of lymphatic vessels within the lipid tissue, thereby extending into veins which are preferably fixed at the pin 315.The bottom ring surface opening has a larger size or diameter than the central aperture 316, as it must accommodate the insertion of a larger volume of supporting tissue that will house the lymphatic pathway to which the vein will be fluidly connected.

[0077] On the upper surface 320, the surface around the central aperture 316 may be a conical surface 322. The conical surface 322 can assist in the direct insertion of tissue by guiding the tissue into the central aperture 316 when force is applied to the tissue. In addition, the conical surface 322 can reduce abrasion on the inserted tissue (e.g., a vein) because it does not have sharp corners or edges.

[0078] Figure 3 shows a magnified view 284 of the axillary location 280, including a lymph node 282 and a vein 285 that receive a pair of lymphatic vessels 287 and 289. Unlike previous procedures that used sutures 286 to fix the flow path to the vein 285, the present invention uses a coupler 290 at the junction of the flow paths 287 and 289 entering the vein.

[0079] Schematically shown in Figure 4 is a method 400 for performing a surgical procedure, where, for example, a surgeon may perform an incision through the skin to access tissue containing one or more lymphatic channels 402. The grafting device is positioned within the patient 404, with a first grafting element attached to one or more lymphatic channels 406, and a second grafting element attached to a vein 408. The first grafting element is connected to the second grafting element 410 so that one or more lymphatic channels are positioned within the exposed venous opening to a depth such that lymph from the lymphatic channels can flow into the vein. The surgeon then closes the surgical opening 412 so that the grafting device is implanted in the patient. Alternatively, the grafting device may comprise a single tube or ring having a pin or tissue anchor on one end for connecting to a vein inserted into one open end of the tube. The vein wall tissue is placed on the pin or tissue anchor element penetrating the wall tissue to hold the vein in place relative to the device. A lymphatic pathway may be inserted into a vein at least partially positioned within the pathway through a duct opening at the opposite end. The pathway may have internal features that allow insertion into one end but prevent removal of the vein. In this way, the inner wall of the pathway may have friction surfaces with teeth, pins, or other features oriented in one direction to prevent movement of the vein within the pathway. The pathway may have external features that allow a loop of material for gripping the pathway to be attached to the pathway.

[0080] Dyestics 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 vibrant 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 the field of open surgery, such as LYMPHA procedures.

[0081] 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 were obtained (number of visualized and bypassed lymphatic pathways, distance of pathways from the axillary vein, name of target vein, and adverse events).

[0082] 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 superficial accessory venous branches traversing the level I lymph nodes longitudinally. Superior dissection of level I axillary contents along the axillary vein is typically performed using identification of accessory venous branches located anterior to the thoracodorsal neurovascular bundle. The vein is then dissected from the Level I axillary contents and clipped distally to provide maximum length. The completion of Level I and II ALND is then performed.

[0083] After the completion of axillary lymph node dissection, a Pentero900D Microscope (Carl Zeiss Inc., Germany) equipped with a YELLOW560 package, for example, may be used to identify and map the divided lymphatic channels draining into the arm. The harvested vein is prepared according to standard microsurgical techniques. The surgeon utilizes existing techniques to place a "U" stitch using 9-0 nylon sutures to capture the anterior wall of the vein and the parachutes within the lymphatic channels selected for bypass. 10-0 nylon may then be used to suture the vein wall to the perilymphatic tissue. Channels not bypassed are clipped. The lymphatic flow filling the vein may be visualized using a filter activated for 1 hour after anastomosis.

[0084] 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 of the vein, and connects these components to safely complete the anastomosis or the transposition of the lymphatic pathway into the vein.

[0085] As shown in the study by Spiguel, et al., thirteen 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 channels per patient were bypassed (0–4). Anastomosis was performed on 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.

[0086] Therefore, FITC is a safe and effective dye for the LYMPHA technique. 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. A major advantage of FITC over ICG in lymphatic surgery is that, for example, FITC is excited in the visible spectrum, making it the dye used in the surgical field, thus enabling simultaneous visualization and dissection of lymphatic pathways.

[0087] Patients diagnosed with breast cancer may undergo a preoperative assessment for lymphedema. Each preoperative and postoperative assessment may include three components: (1) assessment by a certified lymphedema therapist for signs and symptoms of BCRL, (2) circumferential measurements, and (3) bioelectrical impedance spectroscopy. Lymphedema 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.

[0088] The ALND procedure involves excision of axillary nodes I and II. Patients undergoing ALND may have their divided lymphatic vessels identified using FITC, and then their pathways diverted into protected axillary venous branches.

[0089] 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 underwent the LYMPHA technique were compared to those who had ALND only. 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.

[0090] For example, a power analysis can be performed using Fisher's exact test with SAS. Based on our institution's data, a set control percentage of 0.40 was used. As previously shown, the incidence of lymphedema after concurrent lymphovenous bypass was 0.04. In evaluating this procedure, the power can be conservatively set to 0.8.

[0091] 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 over the period. 45% (67 / 145) of patients who underwent sentinel lymph node (SLN) biopsy and 64% (18 / 28) of patients who underwent ALND participated in the program, with an average age of 60 (ranging from 32 to 83) and a BMI of 30 (ranging from 17 to 46). 40% underwent mastectomy, and 21% underwent ALND. 18% received neoadjuvant chemotherapy, and 24% received RLNR. In this example, the majority of patients (62%) did not undergo any reconstructive surgery.

[0092] 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.

[0093] Table 1. The advantages and disadvantages of two fluorophores (blue dye and ICG) most commonly used in lymph node surgery, compared to FITC. [Table 1] All patients who developed lymphatic hydrops were first diagnosed either during treatment or within six months of the completion of their cancer treatment. Therefore, all patients were initially diagnosed with transient lymphatic hydrops. The mean time to diagnosis after surgical intervention was 4.7 months. One patient in the SLN biopsy group developed transient lymphatic hydrops and then persistent lymphatic hydrops (1 / 67 or 1.5%). Of the five patients who developed transient lymphatic hydrops after ALND without LYMPHA treatment, the symptoms and objective indicators of one patient completely resolved, and the symptoms of four patients persisted, and they developed lymphatic hydrops (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 underwent LYMPHA treatment during the study period, only 8 participated in our monitoring program. One patient in the ALND+LYMPHA group developed transient lymphatic hydrops, which was persistent but still 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, without changes in ambient measurements. The only significant difference between the two groups—those who underwent ALND with or without LYMPHA—was the follow-up period, which was 15 months and 20 months, respectively (p<0.03).

[0094] To identify any potential confounding factors or biases, in a comparison between patients who underwent ALND with or without LYMPHA and those who were lost to follow-up, the only difference between the groups shown was that participants who underwent LYMPHA were 10 years older than those who were lost to follow-up (59 vs. 49, p=0.04).

[0095] Since there is currently no treatment for BCRL, recognition of high-risk patients and prophylactic treatment are important considerations. The incidence 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 those procedures. ALND, mastectomy, adjuvant chemotherapy, and RLNR were associated with the development of lymphedema.

[0096] A notable finding in the study by Hahamoff et al. was that the incidence of lymphedema decreased from 40% to 12.5% ​​in patients who underwent ALND after the introduction of the LYMPHA technique.

[0097] It should be noted that patients who developed lymphatic hydrops first presented signs and symptoms either during treatment or within six months of the completion of their cancer treatment. Of these patients, one patient's condition completely resolved. To date, no patients have presented with lymphatic hydrops more than six months after the completion of cancer treatment. This finding supports the value of surveillance that can detect early lymphatic hydrops, and this is especially important for high-risk patients, as rapid detection and treatment can potentially slow disease progression.

[0098] ALND and RLNR are important risk factors for the development of lymphatic hydrops. The incidence of lymphatic hydrops may be increased in patients who have undergone mastectomy, which can be explained by the indication for ALND. Specifically, patients who have undergone mammary tumor removal with limited lymph node metastasis do not require ALND, while those 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 those who have undergone mammary tumor removal. The incidence of lymphatic hydrops may be increased in patients who have undergone adjuvant chemotherapy, and here again, there may be a bias because those who have undergone chemotherapy are more likely to have presented with more advanced disease initially. However, studies have shown that certain chemotherapy regimens are linked to the development of lymphatic hydrops. Finally, since patients presented for ALND have more advanced disease, it is not surprising that the incidence of lymphatic hydrops has been shown to be increased in those with clinical stage 3 disease.

[0099] While surgical prevention can help improve quality of life in breast cancer survivors, the development of this program has presented challenges. When SLNs were sent for permanent sections and the patient later returned to the operating room for ALND, the scheduling of combined procedures between breast and plastic surgeons was effective. However, when SLNs were sent for frozen sections, scheduling may be more irregular, especially considering recent trials that challenge the need for ALND, as a larger percentage of patients do not progress to ALND.

[0100] This device and method for the treatment of lymphatic hydrops may change how metastatic disease to the axilla is treated. Given the significant mortality associated with ALND, i.e., lymphatic hydrops, ALND is clearly avoided in early-stage breast cancer, with RLNR instead. However, improvements in LYMPHA treatment and the prospect of a lower incidence of lymphatic hydrops may enhance the role of ALND in providing an improved method of localized control.

[0101] A significant finding is that the average time to diagnosis of lymphatic hydrops was 4.7 months after surgical intervention, indicating a remarkable decrease in the incidence of lymphatic hydrops after the introduction of LYMPHA. In this case, the total follow-up time in the ALND vs. ALND+LYMPHA group was 20 months and 15 months, respectively.

[0102] The combination of LYMPHA 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 included ALND, RLNR, adjuvant chemotherapy, and mastectomy.

[0103] 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 prior to the procedure. Therefore, different dyes were needed 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 the 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 specific pathological conditions.

[0104] 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.

[0105] 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 routed to one of three distinct protocols 604, 606, and 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 performing an ALND procedure either with or without the LYMPHA procedure 612 as described herein.

[0106] Illustrated in relation to Figures 7 and 8 are systems and methods for performing robotic lymphovenous bypass surgery for implanting the linkage devices described herein. Robotic systems such as the Da Vinci system, available from Intuitive Surgical Inc., Sunnyvale CA, have been used to perform the LVA microsurgical procedure illustrated in relation to 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, which is incorporated herein by reference in its entirety. Further details relating to robotic surgery are described in U.S. Patent No. 9,138,297, which is incorporated herein by reference in its entirety. The system 700 may employ robotic arms 702, 704 attached to gripping elements 706, 708, such as forceps-like manipulators. A surgeon can use system 700 to grasp and control microsurgical instruments within the surgical field. A computerized system 710 within system 700 is software-programmed to perform, for example, scaling movements and tremor filtering. As shown in the process flow diagram of Figure 8, process 800 uses a plurality of two or more control arms 702, 704 that are operated to perform a procedure, where a vein having a diameter suitable for connecting to a first (or second) connecting element as described herein is selected 802. The robotic arm can further grasp an area of ​​lipid tissue having one or more lymphatic vessels, where the lipid tissue is attached to a second (or first) connecting element as described herein 804. The robotic arm can grasp the first and second connecting elements 100, 120 as seen in Figure 7, and align the two elements so that the lymphatic vessel is inserted into the vein, typically by visualization under a surgical microscope 806.The robotic gripping devices 706, 708 may hold two connecting elements by an outer peripheral surface which may be fabricated to have notches or slots, enabling a stable and secure grip. The two connecting elements are connected to each other, and the device is positioned within the wound opening for wound closure 810.

[0107] As shown in Figure 9, one or more sensors 265 or imaging devices may be used to measure the flow of lymph fluid into a vein at a junction within the device. The sensor 265 may be an optical sensor, where, for example, 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 supplied into the lymphatic vessel before, during, or after the procedure so that the optical sensor can measure the flow rate by detecting the movement of the dye. Alternatively, the sensor 265 may include an ultrasonic transducer 266 capable of transmitting an acoustic signal into the vein to detect a reflector introduced into the lymphatic vessel along with the fluorescent dye. A cable or wire 268 may extend through a percutaneous port 267 extending 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 transferred to an electronic medical record for each patient. The sensor may be sized and configured such that it is inserted through a port in certain embodiments to allow for easy insertion and removal after wound closure. As previously described, the sensor and / or fluoroscopic imaging may optionally be used during and / or after the procedure to confirm proper positioning of the lymphatic vessel and lymphatic flow. The device may also optionally be coated with one or more therapeutic agents to inhibit coagulation formation in the vein near the junction. Shown in Figure 10 is a further embodiment in which a flexible valve ring 281 may be attached to a connecting element 277 together with 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 the element 277 is attached. The valve element may be sized to constrict the vein to limit the venous pressure on the junction in the device, thereby reducing the back pressure from the venous fluid on the junction region. This reduced pressure at the junction may help establish a lymphatic flow that tends to increase over time.The valve element may be shaped and sized to slow the increase in lymphatic fluid pressure at the joint, and may be configured in such a way that it can reduce the amount of compression over time. The valve element may include a biodegradable material that reduces the constraints on the vein over time due to the rate of material decomposition. The valve may also be active, such as by a pressurized bladder, which can release a pressurized fluid such as saline over time. Alternatively, a flexible flap may also provide sufficient pressure on the vein using an elastic material that expands at a selected rate.

[0108] Further shown in Figure 11 is a further 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 lipid tissue 906 including lymphatic vessels 905, while the second coupling element 904 may be attached to veins 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 vessels 905 is discharged into the veins 908.

[0109] Figure 12 shows a bottom view of the coupling device 900. The first coupling 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 coupling element 904 may include a conical element that engages with a vein, which is first connected to a pin, so that one or more lymphatic vessels 905 can be inserted into the vein, and which can receive lipid or adipose tissue 906 within its conical volume. The lipid tissue 906 and embedded lymphatic vessels 905 may extend through the ring opening 901 of the coupling device 900. The lymphatic vessels 905 may be inserted into a vein 908 which may extend through an opening in the second coupling element 904. In some embodiments, the first coupling element 902 may be connected to the second coupling element 904 via a connecting element 922. The connecting element 922 of the first connecting element 902 engages with a receiving element on the second connecting element 904, thereby connecting the first connecting element 902 to the second connecting element 904. In some embodiments, the second connecting element 904 may have a tissue gripping element 918 that 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 within the second connecting element. The tissue gripping element 918 of the second connecting element 904 fixes the vein 908 in place during surgery. The first connecting element 902 and the second connecting element 904 may include a rigid or semi-rigid flexible or elastic biocompatible material having a generally smooth surface feature except for pins, projections, or tissue anchors configured to penetrate and grasp tissue. In some embodiments, the first connecting element 902 and the second connecting element 904 may have surfaces that allow the two components to be snap-fitted together to more easily form the connecting device 900.

[0110] 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 may have a ring wall channel 911, which may provide a surface area that allows a user to grasp the element using a tool and manipulate the connecting element or device 900. When coupled together, the surface 915 of the second ring outer ring wall channel 911 of the second connecting element 904 abuts against the end of each ring wall element in the first connecting element 902.

[0111] Figure 13 illustrates a cross-sectional view through a coupling device 900 taken along the lining illustrated in Figure 12. As shown in Figure 13, the lymphatic vessel wall 905 may extend into the interior 908 of the vein, thus allowing lymphatic fluid to drain from the lymphatic vessel into the vein. According to various embodiments, a second coupling element 904 grasps the vein. The vein may have a diameter 914 in the range of 1 to 3 mm, for example. In some embodiments, the first coupling element 902 may have a tissue contact surface 903 that can provide support for contact between the first coupling element 902 and lipid tissue 906. In some embodiments, the diameter of the opening 936 in the first inner ring may be in the range of 5 mm and 12 mm. In other embodiments, the opening 936 may have a diameter smaller than 7.2 mm or larger than 10 mm. In some embodiments, the first coupling 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 may be large enough to comfortably pass a microforceps (typically with a tip width of 0.5 mm for each arm of the microforceps) through the opening, grasp the tissue, and pull the tissue through the opening 936. In conventional devices for vein-vein anastomosis, a small-diameter opening is provided on both elements to allow the vein to pass through. Such devices may have an opening that is too small for a microforceps to pass through and too small to pull bundled lipid tissue and lymphatic channels through it. 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 vein to drain lymph fluid into the vein.

[0112] In some embodiments, the first connecting element 902 may attach to lipid tissue 906 containing one, two, or more lymphatic vessels. A single lymphatic vessel is illustrated in Figures 11–15. The lymphatic vessel wall 905 may have a channel 907 within the lymphatic vessel wall 905. In some embodiments, the channel 907 within the lymphatic vessel wall 905 may have a diameter 912 in the range of about 15–4000 microns (0.015–4 mm), or more preferably 0.1–0.8 mm. In applications where a lymphatic trunk is connected to a vein using the apparatus of the present disclosure, the diameter 912 of the lymphatic vessel may be in the range of 2–4 mm. The first inner ring 901 may contact the lipid tissue 906 between the first connecting element 902 and the second connecting element 904. In some embodiments, an open channel 917 may exist through the first inner ring 901. In some embodiments, the second connecting element 904 may have a pin fixing area 918 for the pin 916. The pin fixing area 918 may include holes, each connecting to a portion of the pin 916 to be fixed. In some embodiments, the pin fixing area 918 may include screw holes. The pin 916 fixes the vein to the second connecting element 904. The pin 916 is described in more detail below with respect to Figure 21.

[0113] In a preferred embodiment, the channel 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 may overlap the vein. In some embodiments, the channel 907 may extend a distance of 0.5 mm, 1 mm, 1.5 mm, or greater. By extending the channel 907 for a distance within the vein, the lymphatic fluid exiting the channel can be directly connected to and discharged into the vein 908. In other embodiments, the channel 907 does not extend into the vein when the coupling device 900 is assembled. Rather, the ends of the lymphatic vessel and vein can be aligned and sealed within the coupling device 900. After assembly, lymphatic fluid may continue to leak from the lymphatic vessel and come into contact with lipid tissue 906, filling the internal space within the coupling device 900. After contact with lymphatic fluid, the lipid tissue 906 may transform into a natural lining material, such as that which occurs in the ceromatal cavity. This lining material is relatively impermeable to further lymphatic fluid penetration. The formation of this lining material on the surface in contact with the lymphatic fluid creates a seal within the coupling device 900, preventing the lymphatic fluid from escaping by any means other than through the veins 908.

[0114] Figures 14 and 15 show front and rear perspective views of the coupling device 900, respectively. As shown above, the first coupling element 902 may have a ring wall channel 911 that can provide structural support and operability to the coupling device 900. In some embodiments, the ring wall channel 911 can assist in fixing the first coupling element 902 to the second coupling element 904. In some embodiments, the second coupling element 904 may include an internal cylindrical wall channel 909. The internal cylindrical wall channel 909 can provide flexure for the coupling device 900 while maintaining an overall lighter weight. In some embodiments, the wall channel 909 can be engaged by a tool to allow holding and operation of the second coupling element 904 during planting. In some embodiments, the coupling device 900 may have a surface 915 of the second ring outer ring wall channel 911. In some embodiments, the coupling device 900 may have an open channel 917 through the ring hole 901. The open channel 917 may allow for internal tissue growth, providing additional stability to the device over time when the connecting device 900 is implanted.

[0115] 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 is rigid and may be 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 to form a connecting device 900. In some embodiments, the first connecting element 902 may have a height 925 of about 7 mm. In some embodiments, the distance 930 between the bottom of the hook or latch element 928 and the ring may be about 4 mm. In some embodiments, the connecting element 922 may have a width 926 of about 1 mm.

[0116] 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 may have a diameter 938 between opposite notches in the ring base.

[0117] 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 region 933. The pin fixing region 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 region 933 may connect to or grasp lipid tissue 906 that houses lymphatic vessels. For example, the lipid tissue 906 may be carried through the opening 936 of the first connecting element 902 and extended over one or more of the pins 946.

[0118] As shown in Figure 19, the first connecting element 902 may have a latch element 928 on a connecting element projection 922 having an upper surface 924. In some embodiments, the distance 939 is between the inner surfaces of the opposite connecting elements 922. 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.

[0119] 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 greater than the corresponding latch.

[0120] 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 ends of each pin 918 may taper towards a tip 921. In some embodiments, the tip 921 may be pointed. In some embodiments, the tip 921 of the pin 918 may be held on fatty tissue 906 or a vein wall.

[0121] 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 largest diameter at the top surface of the raised ring. In some embodiments, the conical surface 940 may receive fatty tissue 906. In some embodiments, a pin 918 may be positioned within a pin fixing region 916. The pin fixing region 916 may be located on the conical surface 940 such that the pin 918 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 may be 1 or a few millimeters higher than the surface of the second connecting element 904. This may, for example, allow for the insertion of a lymphatic channel 907 into a vein 908 to a depth of at least 1 mm. Thus, the relative dimensions of the connecting elements may define the depth of insertion.

[0122] An exemplary perspective view of a 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 may be filled with lipid tissue under some tension, which is drawn out through the ring aperture. The lipid tissue may act to seal the ring aperture to prevent lymphatic fluid from leaking out of the internal volume.

[0123] As shown in Figure 23, the first connecting element 902 may have a connecting element projection 922 that can connect to the second connecting element 904 to form a connecting device 900. 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 lipid tissue 906.

[0124] As shown in Figures 24A–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 may be separate parts or may be joined using a coupling sheath, hinge, or other coupling device that allows the elements to move relative to each other. Alternatively, the coupling device 900 may be formed as a single, integrated object. In some embodiments, the coupling 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 provide support when the vein diameter widens from its normal diameter to an expanded diameter at the apical edge of the second conical surface 940. The tissue gripping element extends from the second cone surface and can fix tissues such as veins.

[0125] Figures 25A to 25I show a further embodiment in which the coupling device 1000 may have a first coupling element 1002. In this embodiment, a first tissue gripping element 1018 for gripping lymphatic channels and a second tissue gripping element 1020 for gripping veins or arteries are positioned on a single element referred to herein as the first coupling element. The first coupling element 1002 may have an aperture 1008 extending through a plane having a first side and a second opposing side of the first coupling element 1002. The plane is parallel to a first ring surface on which the first tissue gripping element is fixed, and may extend from the first ring surface onto one side of the plane. The first coupling element 1002 may include a first tissue gripping element 1018 that extends from the first side of the plane in a first direction and is configured to attach to tissue. For example, the first tissue gripping element 1018 may be attached to lymphatic tissue such as lymphatic channels, and / or fatty tissue surrounding the lymphatic channels. The first connecting element 1002 may include a second tissue gripping element 1020 extending from a second opposing side or a second ring surface in a second direction. The second tissue gripping element 1020 may be configured to be attached to a vein or artery. In some embodiments, the gripping elements 1018 and 1020 may be pins or projections as previously described herein, which are structures configured to facilitate attachment to tissue.

[0126] In some embodiments, the first connecting element 1002 has a conical surface 1005. In further embodiments, the conical surface 1005 extends around the aperture 1008 of the first connecting element 1002 along a central axis 1006 perpendicular to a plane. In one embodiment, the plane extends through the center of the ring midway between the first ring surface and the second ring surface. Smaller conical surfaces may also be used on the opposing sides of the first connecting element, as in other embodiments described herein.

[0127] The aperture 1008 of the ring may have a radius of 1012. The first tissue gripping element 1018 may extend circumferentially around the aperture 1008 and axis 1006 with a radius of 1007. The outer peripheral wall of the ring may have a radius of 1017 such that the ring has a diameter within the range of embodiments described earlier herein. The second tissue gripping element 1020 may also extend circumferentially around the aperture with a radius of 1011. Note that the radius 1011 of the second tissue gripping element is mainly smaller than the radius 1007 of the first tissue gripping element. The tissue gripping elements extend orthogonally from each ring surface, but other embodiments may include tissue gripping elements at different oblique angles to one or both ring surfaces to better stabilize the tissue for healing. The tissue gripping elements may have different lengths and diameters, as described earlier herein.

[0128] In some embodiments, the first connecting element 1002 includes a circle 1009A having a first radius that defines the positions of first tissue gripping elements 1018 that are equally spaced around a first circumference defined by a first radius. In further embodiments, the first connecting element 1002 includes a smaller circle 1009B having a second radius that defines the positions of second tissue gripping elements 1020 that are equally spaced around a second circumference defined by a second radius. In some embodiments, the circular outlines 1009A and 1009B may not be physical components of the first connecting element 1002, but instead may refer to the positioning of tissue gripping elements 1018 and 1020 that may be formed by molding one or more polymer materials to form an integral component. In some embodiments, the circle 1009B is sized, shaped, and positioned such that it lies outside the widest part of the conical surface 1005.

[0129] The components of the coupling device 1000 may be made of biocompatible materials, such as biocompatible polymer materials or silicone, as discussed above in this specification.

[0130] The first connecting element 1002 may be connected to the handle 1010. In some embodiments, such as the embodiment depicted in Figure 25G, the handle 1010 may be detachably attached to the first connecting element 1002. For example, a surgeon may break off the handle 1010 after attaching a vein or artery to the first connecting element 1002, after attaching a lymphatic channel to the first connecting element 1002, or after securing one or more cap elements to the first connecting element 1002. Figure 25H depicts the first connecting element 1002 after the handle 1010 has been removed.

[0131] In some embodiments, such as the embodiment depicted in Figure 25I, the first connecting element 1002 does not include a handle. Instead, the first connecting element 1002 may include one or more recesses 1022 configured to be grasped by a surgical instrument, such as forceps. The recesses 1022 may be located on or within the outer surface of the first connecting element 1002. In some embodiments, the first connecting element 1002 includes two recesses 1022. In a further embodiment, the two recesses 1022 are positioned 180 degrees apart from each other.

[0132] Figures 26A-26B illustrate perspective views of a first connecting element 1002 and a second connecting element 1004 in the form of a connecting cap 1012. The second connecting element 1004 may be configured to connect to the first connecting element 1002. Either end of the second connecting element 1004 may include at least one opening 1007A or 1007B configured to receive a vein or artery.

[0133] The first connecting element 1002 and the second connecting element 1004 are configured to position one or more lymphatic channels within the open end of a patient's vein or artery in order to supply lymphatic fluid from the lymphatic channels into a vein or artery. The advantages associated with supplying lymphatic fluid from the lymphatic channels into a vein or artery are described above herein.

[0134] Figures 27A-27B illustrate perspective views of a second connecting element 1004, which takes the form of two separate cap elements. In some embodiments, the second connecting element 1004 may include a first cap element 1004A having a first opening 1007A and a second cap element 1004B having a second opening 1007B. In some embodiments, the first opening 1007A has a smaller diameter than the second opening 1007B. In some embodiments, the first cap element 1004A and the second cap element 1004B have similar diameters.

[0135] In some embodiments, the first cap element 1004A surrounds the first tissue gripping element 1018, and the second cap element 1004B surrounds the second tissue gripping element 1020. Thus, each cap element may include a plurality of bores 1019A and 1019B configured to receive the first tissue gripping element 1018 and the second tissue gripping element 1020, respectively. The cap elements may alternatively be snapped into place using raised elements on the connecting elements or elements that flex to engage with the edges.

[0136] Figures 28A-29B illustrate a holder 1022 for connecting a cap element 1024 to a first connecting element 1002. The surgeon may connect the cap element 1024 to the holder 1022 during the surgical procedure, or the holder 1022 may be attached to the cap element 1024 before the procedure. The holder 1022 may be sized to be inserted into the aperture 1008 of the first connecting element 1002. For example, the end of the holder 1022 opposite to the cap element 1024 may be inserted into the aperture 1016 such that the cap element 1024 is adjacent to the side of the first connecting element 1002 that houses the first tissue gripping element 1018. The holder 1022 may then be pulled out through the aperture 1008, leaving the cap element 1024 fixed to the first connecting element 1002.

[0137] Figure 30 illustrates an exemplary method 3000 for performing a lymphatic vein bypass surgical procedure. The method begins in S3002 when a vein or artery is inserted through the conical aperture of the second cap element and the first connecting element. The vein or artery is inserted from the first side of the first connecting element where the conical aperture is widest. In S3004, the vein or artery is secured to a gripping element on the second side of the first connecting element. The vein or artery may be secured so that it is widened to allow insertion of a lymphatic channel. In S3006, the second cap element is secured to the second side of the first connecting element. In some embodiments, the second cap element is secured to a gripping element on the second side.

[0138] In S3008, lymphatic tissue, such as lymphatic pathways and associated fatty tissue, is inserted through the second cap element, a fixed vein or artery, and the aperture of the first connecting element. In S3010, the lymphatic tissue is fixed to the gripping element on the first side of the first connecting element. Then, in S3012, the first cap element is fixed to the first side of the first connecting element. In some embodiments, the first cap element is fixed to the gripping element on the first side.

[0139] It should be noted that in certain embodiments, the cap for the first connecting element may include a first cap element flexibly connected to a second cap element so as to align each cap element with its respective tissue grasping element, in order to simplify the process. In this embodiment, the cap engages with one or more of the tissue grasping elements on each side. In other embodiments, the cap may be connected to a feature portion on a ring, or the cap elements may be connected to one another so as to surround the tissue grasping elements. The cap may also include side wall openings to avoid the need to pass a vein or artery through one cap element, and / or to provide insertion into place for attachment of lymphatic channels and / or fatty tissue, which are positioned within the second cap element, to the first connecting element. Miniature forceps devices, such as the SpyBite® biopsy forceps manufactured by Boston Scientific Corporation, Marlborough, MA, may be used to grasp tissue in the procedures described herein. A further improved forceps design better suited to this procedure has a working length of less than 12 cm, with a cable diameter in the range of 1–1.5 mm or less, and a jaw outer diameter in the range of 1–1.5 mm or less. The forceps are operated in a scissor-like manner to simplify tissue grasping and manipulation, as described herein, for operation in narrow surgical spaces and for grasping and manipulating objects during the procedure.

[0140] Further exemplary embodiments are shown in Figure 31A, which depicts a gripping instrument 2000 having dimensions oriented through a conical opening 1008 on the first side of a coupling device 1000. The instrument 2000 has a handle 2002 connected to the proximal end of a tubular body 2008 having one or more movable instrument elements 2010 at the distal end of the tubular body, suitable for gripping one or more lymphatic channels. The distal instrument elements 2012, 2014 pivot relative to a hinge to open and close (see Figure 31B) in response to manual movement of a handle actuator configured to be operated by a user. The instrument elements may include a flexible material on the tissue contact surface that compresses under the gripping pressure applied by the user to prevent damage to the lymphatic channels by excessive manual pressure. The outer surface of the distal instrument element is a rounded smooth surface for sliding through isolated sections of a vein or artery or graft 2009 during entry and removal. The outer diameter of the tube and instrument element in the closed position is preferably between 0.5 and 1.5 mm. The length of the tubular portion of the device with the instrument element in the closed position is preferably between 10 and 25 cm, but lengths up to 40 cm may be used depending on the length of the isolated arterial section as described herein. The handle actuator may have a pistol grip with one or more movable handle elements 2004, 2006 such that the user's hands can grasp the handle elements facing each other and move the gripping element from the open position toward each other. The handle elements may have a textured surface 2011 made of a flexible material to provide tactile feedback to the user in order to avoid applying too much pressure and thereby avoid the risk of damaging the gripped tissue. The actuator may be spring-biased to open the distal instrument element unless it is locked in the closed position or by manual operation using the handle actuator.The handle actuator operates using a cable 2005 extending through a tube 2008 to the distal end to rotate elements 2012, 2014, and may also include handle elements 2004, 2006 having a textured surface 2007 with a flexible surface element to detect the level of pressure applied to the tissue grasped by the instrument by the user's hand, thereby preventing damage to fragile lymphatic flow tissue. A vascular coupler 2020 may be used to connect the proximal open end of the graft 2009 to a healthy vein or artery 2022, thereby restoring the flow that now includes lymph flowing through the coupler device, the graft 2009, and into the vein or artery 2022. Note that a cap 2015 may be applied to cover the end of the tissue grasping element that holds the end of the vein or artery in place. Supporting tissue 2017, which partially contains the lymphatic pathway drawn into the graft 2009, is then drawn at least partially around the outer circumference of the coupler to engage with the tissue gripping element 1018.

[0141] A preferred method 2050 for inserting a lymphatic pathway into a vein or artery is illustrated in Figures 32A and 32B. The vein or artery is cut 2052, and the end of the vein or artery is inserted through a coupler opening and attached to a tissue gripping element on the second side of an integral coupler 2054. Alternatively, the graft may be cut at both ends, and a gripping device may be inserted through the graft to assist in holding the graft in place, while it is inserted through an opening in a coupling device and attached to one side with a tissue gripping element. As seen in Figures 32A and 32B, the attached portion of the vein or artery provides a graft or a separated section of a vein or artery, which will then be cut proximal after coupling to the coupler device and subsequently reattached to the same end from the healthy vein from which it was cut. The isolated section of the vein or artery has a proximal opening through which the distal end of the grasping device is inserted and extends to a position where it completely passes through the opening of the integral coupler, as shown in Figure 31A. The distal elements of the grasping device, 2012, 2014 are actuated to grasp the exposed lymphatic pathway, which are then drawn out to a selected depth within the distal end of the isolated portion of the vein or artery, referred herein as a graft, in the grasping device. The exposed end of the tissue grasping element on the first side of the integral coupler may be optionally covered by the first cap element, as described herein. The tissue on which the portion of the lymphatic pathway is placed is then drawn out onto the outer circumference of the integral coupler and attached to the tissue grasping element on the second side of the integral coupler. It should be noted that the gripping device has been removed from the coupler opening and the separated portion of the vein or artery, so that the proximal opening of the vein or artery can then be reattached with the vascular coupler. First, the second cap element can be optionally attached to the exposed end of the tissue gripping element on the second side of the integral coupler.2064 This step involves inserting the proximal end of the separated portion of the vein or artery through the opening of the second cap element.

[0142] Next, the exposed end of a healthy vein or artery is attached (or reattached) to the separated section of the vein or artery in order to re-establish blood flow within the previously separated section of the vein or artery, which has now come to receive lymph fluid through a lymphatic channel inserted within the previously separated section of the vein or artery 2066. It should be noted that commercially available vascular couplers for connecting the exposed ends of veins or arteries may be used to connect the separated section of a vein or artery to the exposed end of a vein or artery which are of approximately the same diameter. As previously stated, the flow of lymph fluid into the vein or artery can be confirmed by detecting the fluid flow as previously stated 2068.

[0143] It will be understood by those skilled in the art that modifications and variations of the apparatus and methods described above can be made without departing from the inventive spirit disclosed herein. Therefore, this disclosure should not be considered limited except as limited by the appended claims and spirit.

Claims

1. A device for lymphatic vein bypass surgery, A connecting device for connecting one or more lymphatic channels from supporting tissue to the open end of a vein or artery, the connecting device having a first tissue gripping element extending from a first side in a first direction and configured to be attached to the vein or artery, and a second tissue gripping element extending from a second side in a second direction and configured to be attached to a portion of the supporting tissue; The connecting device is a device having an opening configured to receive the vein or artery.

2. The apparatus according to claim 1, wherein the first tissue gripping element extends from a coupling device surface on a first side of a plane extending through the coupling device, and the second tissue gripping element extends from a further coupling device surface on the opposite side of the plane.

3. The apparatus according to claim 1, wherein the coupling device has a conical surface extending around the aperture of the coupling device along a central axis perpendicular to a plane extending between opposing sides of the coupling device.

4. The apparatus according to claim 1, wherein the first tissue gripping element and the second tissue gripping element each have one or more pins.

5. The apparatus according to any one of claims 1 to 4, further comprising a first cap element surrounding the first tissue gripping element.

6. The apparatus according to claim 5, further comprising a second cap element surrounding the second tissue gripping element.

7. The apparatus according to claim 6, wherein the first cap element is connected to the second cap element.

8. The apparatus according to claim 1, wherein the coupling device has a ring having a first radius that defines the positions of a plurality of first tissue gripping elements spaced apart around a first circumference.

9. The apparatus according to claim 8, wherein the ring has a second radius that defines the positions of a plurality of second tissue-grasping elements spaced apart around a second circumference.

10. The apparatus according to claim 9, wherein the second radius is smaller than the first radius.

11. The apparatus according to claim 1, wherein the connecting device has a biocompatible polymer material.

12. The apparatus according to claim 1, wherein the supporting tissue extends around at least a portion of the outer circumference of the coupling device so as to be attached to the second tissue gripping element.

13. The apparatus according to claim 1, wherein the first tissue gripping elements are equally spaced around each of the opposing sides of the connecting device.

14. The coupling device according to claim 1, wherein the coupling device has an opening having a diameter in the range of 0.5 to 1.5 mm.

15. The apparatus according to claim 1, further comprising a gripping device including a tubular body configured to extend through an opening in a connecting element.

16. The apparatus according to claim 15, wherein the tubular body has a diameter in the range of 0.5 to 1.5 mm.

17. The apparatus according to claim 15, wherein the grasping device has one or more distal elements configured to grasp the lymphatic pathway.

18. The apparatus according to claim 15, wherein the grasping instrument further comprises an actuator for moving one or more distal elements on the tubular body to grasp tissue.

19. The apparatus according to claim 15, wherein the gripping device has a handle that is held in the user's hand.

20. The apparatus according to claim 15, wherein the gripping device has a handle having an actuator that is manually operated to grip one or more lymphatic channels.

21. The apparatus according to claim 15, wherein the tubular body grasps the lymphatic pathway using a distal element and extends through the connecting element to draw the end of the lymphatic pathway through the opening of the connecting element and into the vein or artery.

22. The apparatus according to claim 15, wherein the coupling device has an outer circumference, which is sized such that the supporting tissue is positioned around at least a portion of the circumference for engagement with the second tissue gripping element.

23. The apparatus according to claim 15, wherein the gripping device has one or more manual actuation elements connected to a distal gripping element, and the manual actuation elements have flexible surface elements so that the user can adjust the pressure applied to the gripped tissue using tactile sensing of the applied pressure.

24. The apparatus according to claim 15, further comprising a sensor for monitoring the flow of lymph fluid from the one or more lymphatic channels into the vein or artery.

25. The apparatus according to claim 15, comprising a kit having the connecting device, the gripping device, and optionally having one or more cap elements.

26. A method for performing lymphatic vein bypass surgery, The step of attaching the connecting element, which has a first tissue gripping element on the first side of the connecting element, to a patient's vein or artery; The step of inserting one or more lymphatic channels into the open end of a vein or artery in order to supply lymph fluid from one or more lymphatic channels into the vein or artery; The step of attaching the second tissue gripping element on the second side of the connecting element to the tissue including the portion of the one or more lymphatic channels, wherein the second tissue gripping element extends from the second side of the connecting element. How to prepare.

27. The method according to claim 26, further comprising a cap surrounding the first tissue gripping element.

28. The method according to claim 26, wherein the step of positioning at least one lymphatic pathway within the open end of the vein or artery is to overlap the vein by extending the at least one lymphatic pathway into the vein by a certain distance.

29. The method according to claim 26, wherein one or more of the multiple lymphatic channels extend to a depth of at least 1 mm inside the vein.

30. The method according to any one of claims 26 to 29, wherein one or more of the multiple lymphatic channels are at least partially separated from supporting tissue for insertion into the vein or artery, and the separated portion of the supporting tissue extends around the outer circumference of the connecting element.

31. The method according to claim 26, further comprising the step of attaching caps to a first plurality of tissue gripping elements.

32. The method according to claim 26, further comprising the step of operating a grasping device for grasping one or more lymphatic channels for insertion into the vein or artery.

33. The method according to claim 32, wherein the gripping device has a tubular body, and the method further comprises the step of inserting the tubular body through an opening in the connecting element to grip the one or more lymphatic channels.

34. The method according to claim 33, wherein the distal end of the tubular body has one or more movable distal elements configured to grasp tissue, and the method further comprises the step of activating the one or more movable distal elements to grasp the lymphatic pathway and position it within the vein or artery.

35. The method according to claim 34, further comprising the step of removing the gripping instrument from the separated vein or artery.

36. The method according to claim 34, wherein the tissue attached to the second tissue gripping element is positioned at least partially around the outer circumference of the connecting element and is attached to the tissue gripping element.

37. The method according to claim 36, further comprising the step of optionally positioning a cap on the tissue gripping element connected to the tissue.

38. The method according to claim 36, further comprising the step of connecting the proximal end of a separated section of the vein or artery to a healthy vein or artery using a vascular coupler in order to establish the flow of lymph fluid from the lymphatic channel into a healthy vein or artery through the opening of the connecting element.

39. The method of claim 38, further comprising the step of closing off access to the connecting element in order to implant the connecting element in the patient.

40. The method according to claim 38, further comprising the step of detecting the flow of lymph fluid using a sensor.

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