Systems and methods for minimally invasive treatment of lymphedema

Abstract

Systems, devices, and methods of connecting two anatomical structures to facilitate fluid communication between the structures may utilize percutaneous and / or endovascular entry routes to the anatomical structures so that they may be positioned proximate to one another and a channel for facilitating fluid communication between them may be formed. In some cases, a first anatomical structure is a vein and a second anatomical structure is a lymph node and, in these instances, the lymph node may be positioned proximate to the vein so that a channel that allows lymphatic fluid to drain into the vein may be formed as a way of treating and / or preventing lymphedema.

Description

SYSTEMS AND METHODS FOR MINIMALLY INVASIVE TREATMENT OF LYMPHEDEMARELATED APPLICATION

[0001] The present patent application claims benefit of co-pending U.S. provisional application Serial No. 63 / 638,143, filed April 24, 2024, the entire disclosure of which is expressly incorporated by reference herein.TECHNICAL HELD

[0002] The present patent application is directed to medical devices and methods of use thereof. In particular, the present application is directed to systems and devices of connecting two anatomical structures together so that they may be in fluid communication with one another.BACKGROUND

[0003] Lymphedema is a chronic and oftentimes debilitating disease in which the function of the lymphatic system is disrupted. The most common type of lymphedema in the general population is classified as secondary (acquired) lymphedema, typically arising from the disruption of the lymphatic system as a result of cancer or the treatment thereof, but other secondary and primary causes exist. The lymphatic system is a network of tissues and organs that rid the body of waste by draining excess fluid in the interstitial space. This disruption and damage of the lymphatic system leads to an increased collection of lymphatic fluid, lymph, in the interstitial tissues. Over time, the progressive accumulation of the lymph exceeds the capacity of the impaired lymphatic system to transport the fluid to its ultimate intended destination within the venous system, the thoracic duct. This dysfunction manifests as swelling in the extremities which causes pain, restricted range of motion due, altered sensation, limb heaviness, and an increased risk of tissue infection.

[0004] Currently, treatment for lymphedema is tailored according to its clinical stage (as defined by the International Society of Lymphology or ISL) and initial interventions include ready-made and / or custom compression garments, followedby pneumatic compression devices and physical therapist-guided complete decongestive therapy. These volume control strategies are cumbersome, patients need to wear these garments / devices indefinitely, and their efficacy wanes as the disease progresses. In this current landscape of treatments for lymphedema, there is a need for a solution that provides improved efficacy, access and affordability.SUMMARY

[0005] The present invention describes a novel device that provides access to the lymphatic system via a more minimally invasive approach, which could be leveraged endovascularly or percutaneously. The device may have a series of features that allows for physical approximation of two or more anatomical structures. For example, the approximation of a lymph node and vein. The device may have a series of features that allows for the creation of a connection between two or more structures, in whichever anatomical location those parts can be approximated and for whichever size of the aforementioned parts, such that if they contain fluid, the aforementioned fluid Is able to flow between the two. For example, creating a connection between a lymph node and vein. This embodiment may be utilized with or without the concomitant or exclusive use of open surgery and / or use of microsurgical equipment, manual or robotic in nature. The embodiment is intended to be accessible to a broader set of operators, who may be trained in image-guided percutaneous and / or endovascular procedures. The device could potentially be used to establish access and connection between other anatomical structures included but not limited to those of comparable size, properties or positioning, independent of them containing fluid in their interior.

[0006] Systems and devices disclosed herein may comprise an elongated shaft with a central lumen, a distal end effector, a positioning member, a handle, and an interaction feature. The distal end effector may be coupled to a first end of the elongated shaft and may include one or more opening(s) and a lumen in communication with the central lumen of the elongated shaft. In some embodiments, the device may include a delivery sheath with a delivery sheath lumen therein. The delivery sheath lumen may be sized and configured to accept insertion of the distal end effector therein and guide the distal end effector into, and through, the blood vessel.

[0007] In some embodiments, the distal end effector may be configured to deliver at least one of radiofrequency ablation, electrocautery, cryoablation to patient tissue, electromagnetic energy, magnetic force, and mechanical force to patient tissue.

[0008] The positioning member may include a flexible rod that terminates with a tip that may include at least one flange. The tip and a first portion of the flexible rod may be resident within the lumen of the distal end effector and a second portion of the flexible rod may be resident within the central lumen of the elongated shaft. Articulation of the flexible rod within the distal end effector may cause the flange(s) to extend out of, or retract into, the opening of the distal end effector to, for example, extend into tissue (e.g. , a lymph node) and retract from the tissue, respectively.

[0009] The handle may be coupled to a second end of the elongated shaft. The user interaction feature may be resident within the handle and may be configured to control an operation of the device and / or a component thereof. For example, the user interaction feature may be configured to control articulation of the positioning member within the lumen of the distal end effector.

[0010] In some embodiments, a portion of the elongated shaft and the distal end effector may be configured to be placed within a blood vessel (e.g., a vein) of a patient so that when the distal end effector is proximate to a target tissue (e.g., a lymph node) positioned outside the blood vessel, the distal end effector may be configured to exit the blood vessel and enter the target tissue responsively to, for example, user input received via the user interaction feature. In some embodiments, the device may include a delivery sheath with a delivery sheath lumen therein. The delivery sheath lumen may be sized and configured to accept insertion of the distal end effector therein and guide the distal end effector into, and through, the blood vessel.

[0011] In some embodiments, the positioning member and / or flexible rod may include a lumen and the tip may include an opening. In these embodiments, the device may further include a guidewire positioned within the lumen of the flexible rod. The guidewire may be configured to articulate within the lumen to extend through the opening into the target tissue.

[0012] In some embodiments, the one or more flanges may be configured to exit the opening(s) of the distal end effector when the distal end effector ispositioned within a target tissue, thereby engaging, or grabbing, the target tissue. The positioning member may then be retracted within the lumen of the distal end effector and / or central lumen of the elongated shaft, thereby pulling the target tissue toward the blood vessel so that a connection between the blood vessel and target tissue may be formed a junction, or path, between the target tissue and the blood vessel caused by the positioning member. The connection may be formed using one or more of radiofrequency ablation, electrocautery, cryoablation to patient tissue, electromagnetic energy, magnetic force, and mechanical force. Additionally, or alternatively, the connection may be formed using mechanical fixation such as a suture, a clip, a staple, and / or an adhesive.

[0013] In some embodiments, the connection may be formed through placement of an implant (e.g., a conduit or stent) configured to aid in the formation and / or maintenance of the connection between the target tissue and the blood vessel. At times, the implant may comprises and / or be coated with a pharmaceutical agent (e.g., anti-coagulant, antibacterial, etc.) configured to assist with maintaining the connection and / or keeping the connection open.

[0014] In some embodiments, placement of the implant may be achieved by advancing the implant over the flexible rod until it is in position within the connection. Additionally, or alternatively, placement of the implant may be achieved by advancing an assembly of an implant catheter and the implant over the flexible rod until it is in position in the connection. Then, the implant may be disengaged from the implant catheter and seated in the connection and the implant catheter positioning member and / or distal end effector may be removed from the patient’s body.

[0015] In some embodiments, a connection, channel, and / or pathway between a blood vessel (e.g., vein) and a target tissue (e.g., a lymph node) of a patient may be created by, for example, delivering (e.g., percutaneously) a device to the blood vessel, causing a distal end effector of the device to exit the blood vessel and enter an interstitial space proximate to the target tissue, causing the distal end effector to enter and engage the target tissue, causing the distal end effector to pull the target tissue toward the blood vessel, creating the connection between the target tissue and the blood vessel, the connection establishing a pathway between the target tissue and the blood vessel so that the target tissue isin fluid communication with the blood vessel, and removing the device from the patient’s blood vessel.

[0016] The device may be percutaneously delivered via, for example, an access location positioned in a patient’s head, neck, thorax, abdomen, groin, an upper extremity, and / or a lower extremity. In some embodiments, causing the distal end effector to enter and engage the target tissue may be performed by inserting a guidewire into the access location and through the blood vessel until it is proximate to the target tissue, advancing the device along the guidewire and then positioning the distal end effector in the target tissue via the guidewire. In some embodiments, the device may include an elongated flexible rod configured to slidably advance over the guidewire for delivery of distal end effector to the blood vessel and the target tissue, wherein causing the distal end effector to enter and engage the target tissue comprises advancing the guidewire through the device and into the target tissue and then positioning the distal end effector in the target tissue via the guidewire. Additionally, or alternatively, engaging the target tissue may be achieved by positioning the flexible rod so that the at least one flange extends through the opening and punctures the target tissue and removing the device from the patient’s blood vessel is achieved by positioning the flexible rod so that the at least one flange retracts into the opening and disengages from the target tissue.

[0017] In some embodiments, an implant (e.g., a stent, conduit, or channel) may be placed in the connection between the target tissue and the blood vessel. The implant may be configured to hold the blood vessel and target tissue together and / or establish or maintain a connection that is open so that fluid communication between the target tissue and the blood vessel may be achieved and / or maintained. In some embodiments, placing the implant may be performed by advancing the implant over the flexible rod until it is in position in the connection and releasing, or otherwise disengaging the implant from the flexible rod so that the implant remains in the connection.

[0018] Additionally, or alternatively, placing the implant may be performed by advancing an assembly of an implant catheter and the implant over the flexible rod until it is in position in the connection and releasing, or otherwise disengaging the implant from the implant catheter and / or flexible rod so that the implant remains in the connection. In some instances, placement of the implant and / ordisengagement of the implant from the implant catheter is achieved via rotating the assembly of the implant catheter and the implant within the connection to seat the implant in the connection and / or disengage the implant from the implant catheter.

[0019] In some embodiments, the device may be delivered to the blood vessel and / or positioned proximate to the target tissue via a delivery sheath that includes an opening through which a portion the device (e.g., distal end effector, implant, and / or implant catheter assembly) extends.

[0020] Additionally, or alternatively, a connection between a blood vessel (e.g., a vein) and a target tissue (e.g., a lymph node) may be created by delivering a device percutaneously that traverses a blood vessel until it is proximate to the target tissue, approximating (e.g., pulling the target tissue engaged with the positioning member toward the blood vessel) the target and the blood vessel, and establishing a connection between the target tissue and the blood vessel in a way that facilitates fluid (e.g., lymph drainage) flow between them. Access to the target tissue may be achieved via use of a guidewire as, for example, disclosed herein and the device may include a distal tip and / or a distal end effector that is configured to penetrate patient tissue to reach the target site.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The accompanying drawings, which are incorporated In and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.

[0022] FIG. 1A provides a side view of an exemplary connection device, in accordance with some embodiments of the present invention;

[0023] FIG. 1 B provides a cross-section view of an elongated shaft of the connection device of FIG. 1 A, in accordance with some embodiments of the present invention;

[0024] FIG. 1 C is a detailed view of a portion of the connection device of FIG. 1A that includes a distal end effector, in accordance with some embodiments of the present invention;

[0025] FIG. 1 D is a detailed view of the portion of the connection device of FIG. 1 A that includes the distal end effector as it bends through a range of motion, in accordance with some embodiments of the present invention;

[0026] FIG. 2 is a detailed view of the portion of the connection device of FIG. 1 A that includes distal end effector with energy emanating from a conducting band thereof, in accordance with some embodiments of the present invention:

[0027] FIG. 3A is a side view of an assembly that includes a positioning member nested within a distal tip of the distal end effector while the positioning member is in a first state of operation, in accordance with some embodiments of the present invention;

[0028] FIG. 3B provides a vertical cross-section view of the assembly of FIG. 3A, In accordance with some embodiments of the present invention;

[0029] FIG. 4A provides a side view of the assembly of FIG. 3A when the positioning member is in a second state of operation, in accordance with some embodiments of the present invention;

[0030] FIG. 4B provides a vertical cross-section view of the assembly of FIG. 4 A when the positioning member is in the second state of operation, in accordance with some embodiments of the present invention;

[0031] FIG. 5A provides a cross-section of an assembly of a barbed positioning member and a distal tip with one or more distal tip internal flange(s) when the barbed positioning member is not engaged with the internal flange(s), in accordance with some embodiments of the present invention;

[0032] FIG. 5B provides a cross-section of an assembly of a barbed positioning member and a distal tip with one or more distal tip internal flange(s) when the barbed positioning member is engaged with the internal flange(s), in accordance with some embodiments of the present invention;

[0033] FIG. 6 provides a flowchart of an exemplary process for connecting two different target tissues, in accordance with some embodiments of the present invention;

[0034] FIG. 7 is a diagram showing portions of internal anatomy of an exemplary patient with lymphedema, in accordance with some embodiments of the present invention;

[0035] FIG. 8A shows the device in a use case example. The device is initially located in the vein, following the trajectory of a previously placed guidewire, in accordance with some embodiments of the present invention;

[0036] FIG. 8B shows the device after it has punctured and exited the sidewall of the vein following the trajectory of a previously placed guidewire, in close proximity to the outer surface of the target lymph node, in accordance with some embodiments of the present invention;

[0037] FIG. 8C shows the device once it has penetrated the target lymph node following the trajectory of a previously placed guidewire, in accordance with some embodiments of the present invention;

[0038] FIG. 8D shows the device positioned within the lymph node and the guidewire that was leveraged has been removed from the system, in accordance with some embodiments of the present invention;

[0039] FIG. 8E shows the device positioned within the lymph node, wherein the positioning member has been placed internally within the distal end effector, in accordance with some embodiments of the present invention;

[0040] FIG. 8F shows the device positioned within the lymph node, wherein he positioning member has been biased (i.e., second state of operation) to allow for internal engagement with the lymph node, in accordance with some embodiments of the present invention;

[0041] FIG. 8G shows the device positioned within the lymph node with the positioning member internally engaged with the lymph node, wherein the lymph node has been approximated to the vein taking advantage of the internal engagement of the positioning member with the lymph node, in accordance with some embodiments of the present invention;

[0042] FIG. 8H shows the device positioned within the lymph node with the positioning member internally engaged with the lymph node, which is approximated to the vein and connection of the lymph node to the vein is conducted, in accordance with some embodiments of the present invention;

[0043] FIG. 8I shows the device positioned within the lymph node with the positioning member returned to first state of operation, thus no longer engaging the lymph node, in accordance with some embodiments of the present invention;

[0044] FIG. 8J shows the device once it has exited the lymph node and is returning through the venous system, leaving a connection in place between the target lymph node and the vein, in accordance with some embodiments of the present invention:

[0045] FIG. 9 provides a flowchart illustrating a process for connecting a first and a second target tissue using magnetic force, in accordance with some embodiments of the present invention;

[0046] FIG. 10 provides a side view of a magnetic probe and a magnetic implant, in accordance with some embodiments of the present invention;

[0047] FIG. 11 A provides an illustration of an exemplary magnetic implant delivery device in the form of a needle or catheter inserted through the patient’s interstitial space and proximate to the patient’s second target tissue, in accordance with some embodiments of the present invention;

[0048] FIG. 11 B provides illustration of the magnetic implant delivery device when inserted into the target lymph node, in accordance with some embodiments of the present invention;

[0049] FIG. 11C provides an illustration of a magnetic insert deployed within the target lymph node, in accordance with some embodiments of the present invention:

[0050] FIG. 11 D provides an illustration of endovascular delivery of a magnetic probe to a position proximate to the target lymph node, in accordance with some embodiments of the present invention;

[0051] FIG. 11 E shows the magnetic probe and magnetic implant coming into close proximity to one another through use of a magnetic field, in accordance with some embodiments of the present invention;

[0052] FIG. 11 F shows the magnetic probe and the magnetic implant within the target lymph node in contact with one another, creating an opening between the lymph node and vein, in accordance with some embodiments of the present invention;

[0053] FIG. 11G shows the magnetic probe and the magnetic implant exiting through the vein, in accordance with some embodiments of the present invention;

[0054] FIG. 12A provides an illustration of a side view of an exemplary connection device with a rigid, or semi-rigid shaft, in accordance with some embodiments of the present invention;

[0055] FIG. 12B provides an illustration of the connection device of FIG. 12A when in use, in accordance with some embodiments of the present invention;

[0056] FIG. 13 provides an illustration of a device (e.g., a conduit) for mechanical fixation of a connection between a target lymph node and a vein, in accordance with some embodiments of the present invention;

[0057] FIG. 14 provides an illustration of an exemplary adhesive fixation between a target lymph node and a vein, in accordance with some embodiments of the present invention;

[0058] FIG. 15 is a schematic diagram of a side view of a distal tip of a delivery sheath of a connection device, the distal tip including a distal end effector, a positioning member, and an assembly of an implant catheter and an implant, in accordance with some embodiments of the present invention;

[0059] FIG. 16 is a schematic diagram of a cross-section view of the distal tip of FIG. 15 so that the assembly of the implant catheter and the implant, in accordance with some embodiments of the present invention;

[0060] FIG. 17 is a flowchart showing a process for placing an implant in a connection between a blood vessel and a target tissue, in accordance with some embodiments of the present invention;

[0061] FIG. 18A is a cutaway view of the distal tip of FIG. 15 positioned in a blood vessel proximate a target tissue via guidewire, in accordance with some embodiments of the present invention:

[0062] FIG. 18B is a cutaway view of a positioning member extending from the device of FIG. 15 with a distal end effector thereof inserted into the target tissue, in accordance with some embodiments of the present invention;

[0063] FIG. 18C is a cutaway view of flanges of the positioning member extending into the target tissue after the target tissue has been approximated to the blood vessel, in accordance with some embodiments of the present invention;

[0064] FIG. 18D is a cutaway view of the assembly of the implant catheter and the implant advancing along the positioning member within the delivery sheath of FIG. 15, in accordance with some embodiments of the present invention;

[0065] FIG. 18E is a cutaway view of the assembly of the implant catheter and the implant of FIG. 18D positioned within a connection between the target tissue and the blood vessel, in accordance with some embodiments of the present invention;

[0066] FIG. 18F is a schematic diagram of a cutaway view of the implant attached to the implant catheter and positioned within the connection between the blood vessel and the target tissue with the flanges retracted so that the distal end effector may be removed from the target tissue, in accordance with some embodiments of the present invention;

[0067] FIG. 18G is a cutaway view of the implant within the connection prior to removal of the device from the blood vessel, in accordance with some embodiments of the present invention; and

[0068] FIG. 18H is a cutaway view of the implant of FIG. 15 positioned within the connection between the target tissue and the blood vessel when the device has been removed from the patient’s blood vessel, in accordance with some embodiments of the present invention.

[0069] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.DETAILED DESCRIPTION

[0070] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0071] For clarity of disclosure, with respect to anatomy, the terms “proximal” and “distal” are defined herein relative to the center of the human body or torso. The term “proximal” refers to a part of the body that is closer to the center of the body relative to a part that is “distal", meaning further from the center of the body. With respect to devices, the terms “proximal” and “distal” are defined herein relative to the device operator. The term “proximal" refers to a part of the device that is closer to the operator relative to a part that is “distal”, meaning further away from the operator. To the extent that spatial terms such as “ upper”, “lower”, “vertical”, “horizontal”, or the like are used herein with reference to the drawings, it will be appreciated that such terms are used for exemplary description purposes only and are not intended to be limiting or absolute. In that regard, it will be understood that instruments such as those disclosed herein may be used in a variety of orientations and positions not limited to those shown and described herein.

[0072] As used herein, the terms “about” and “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.

[0073] The most common type of lymphedema in the general population is classified as secondary (acquired) lymphedema, typically arising from the disruption of the lymphatic system as a result of cancer, the treatment thereof, or other reasons (e.g. , an obstruction within the lymphatic system). As an example, it has been documented that one in five people who survive breast cancer and have a surgical intervention or radiation with lymph node involvement will develop lymphedema within the first few years after their cancer treatment. Current microsurgery procedures which address lymphedema physiologically result in efficacy within a reasonable range but lack broad accessibility for patients for a variety of reasons such as complexity of microsurgery procedures and limited availability of trained clinicians capable of performing the microsurgery procedures.

[0074] The systems, devices, and methods described herein allow for the creation of a connection, fistula, and / or channel, connecting (e.g., anastomosis) two bodily structures such as a target lymph node or subcapsular space and vein so that, for example, the target tissues may be in communication with one another. When the two bodily structures are a target lymph node and a vein, the connection,fistula, and / or channel may put the target lymph node and vein in fluid communication with one another. Then, lymph may drain from the target lymph node via the channel into the coupled anatomical structure for evacuation away from the lymph node. In some embodiments, the systems, devices, and / or methods disclosed herein may use minimally invasive techniques that do not require the specialized skill sets of microsurgeons and thus may be performed by a larger base of physicians or interventionalists such as an interventional radiologist, interventional cardiologist, vascular surgeon, or any other such physician trained in the performance of endovascular and / or microsurgical procedures.

[0075] Turning now to the figures, FIG. 1A shows a side view of an example of a connection device (10) for use in connecting two or more bodily structures, such as a vein and a target lymph node according to, for example, one or more methods disclosed herein. Connection device can include a distal end effector (20), an elongated shaft (30), a handle (40), a user interaction feature (50), an axial channel port (60), and an axial channel (65). The elongated shaft (30) can have a proximal portion (70) and distal portion (80) and may be configured to be delivered endovascularly to a treatment site proximate to internal bodily structures such as a target lymph node and vein. In some embodiments, elongated shaft (30) can be configured to be received over a guidewire for endovascular delivery to the treatment site. The device can include a handle portion (40) that can have one or more user interaction features (50) configured to receive user input and / or allow for actions to be carried out by connection device (10) sequentially and / or simultaneously. Exemplary user interaction features (50) include, but are not limited to, buttons, levers, dials, track pads, keyboards, and touchscreen display devices. Connection device (10) may also include one or more axial channel(s) (60) to allow for additional tools to have access through the elongated shaft (30). Distal portion (80) may be configured to be flexible so that it may articulate and / or bend during use.

[0076] FIG. 1B provides a diagram of a cross-section of elongated shaft 30 showing a central lumen (35) thereof. Central lumen (35) may be in communication with channel (65) so that an instrument (e.g., guide wire, positioning member, etc.) may be inserted into port (60), pushed through axial channel (65), and pushed through elongated shaft (30) until it reaches distal end effector (20). Additionally, oralternatively, an instrument may be resident within distal end (20), central lumen (35), and / or elongated shaft (30) and pulled away from distal end (20) via articulation within central lumen (35) and / or elongated shaft (30) via, for example, pulling on an extension of the instrument that extends from port (60).

[0077] As may be seen in the detailed view of FIG. 1C, distal end effector (20) may include an open hole (140) positioned at an end of a distal tip (150). Open hole (140) may be in communication with central lumen 35 so that an instrument may be pushed through open hole (140) as, for example, shown and described herein. Distal end effector (20) also includes two distal tip side openings (170) positioned approximately 180 degrees apart from one another on distal tip (150) as shown. In addition, distal end effector (20) includes a conductive band (190) configured to, for example, conduct heat or energy (e.g., electricity). Conductive band (190) may be made from tungsten, copper, and / or other substances through which thermal energy is leveraged such that radiofrequency ablation, electrocautery, cryoablation or others can be applied. In some embodiments, conductive band (190) is communicatively and / or electrically coupled to an external controller via a filament embedded in a sidewall of elongated shaft (30).

[0078] Energy delivery can be applied to the conducting band (190) via, for example, an external controller and power source (not shown) that is physically, thermally, and / or electrically coupled to conducting band (190). FIG. 2 provides a side view of distal end effector (20) when conductive band 190 is emitting energy (200) that may perform, for example, radiofrequency ablation, electrocautery, and cryoablation.

[0079] As may be seen in FIG. 1 D, in some embodiments, distal end effector (20) may be flexible up to a determined angle 0 in two and / or three dimensions in the X-, Y-, and / or Z- directions.

[0080] In some embodiments, a positioning member (160) that includes a tip (150), one or more flange(s) (180), and a flexible rod (185) configured for use with connecting device (10) according to one or more embodiments disclosed herein may be resident within connecting device (10) as, for example, shown in FIGs. 3A, 3B, 4A and 4B, wherein FIG. 3A provides a side view of an assembly 201 of positioning member (160) and connecting device (10) when positioning member(160) is nested within the distal tip (150) and is in a first state of operation, wherein distal tip (150) is shown in the figure as being transparent so that positioning member (160) may be seen (distal tip (150) need not be transparent); FIG. 3B provides a vertical cross-section of assembly 201 when positioning member (160) is in the first state of operation as shown in FIG. 3A; FIG. 4A provides a side view of assembly 201 of positioning member (160) and connecting device (10) when positioning member (160) is in a second state of operation, wherein distal tip (150) is shown in the figure as being transparent so that positioning member (160) may be seen (distal tip (150) need not be transparent); and FIG. 4B provides a vertical cross-section of assembly 201 when positioning member (160) is in the second state of operation as shown in FIG. 4A. Flange(s) (180) may be deformable and / or flexible.

[0081] Prior to and / or during use, positioning member (160) may be inserted through axial channel (65) via port (60) and passed through to distal end effector (20) and be in a first state of operation (i.e., flange(s) (180) are resident within distal tip (150)) as shown in FIGs. 3A and 3B. The location of the positioning member (160) within connecting device (10) can be intentionally manipulated through user input as it is passed through the axial channel (65).

[0082] When positioning member (160) is retracted, via, for example, pulling flexible rod (185) through extended shaft (30), axial channel (65), and / or port (60), positioning member (160) may translate from the first state of operation to the second state of operation, wherein flange(s) (180) flare outward and engage with / extend through distal tip side opening(s) (170) as shown in, for example, FIGs. 4A and 4B. While in the second state of operation, flange(s) (180) may engage with target anatomy (e.g., a target lymph node) to releasably attach distal end effector (20) to the target anatomy as, for example, disclosed herein. Stated differently, while positioning member (160) is being retracted proximally and distal tip (150) is stationary with respect to the positioning member (160), flange(s) (180) may be deployed to protrude through distal tip side opening(s) (170) (i.e., be in the second state of operation) to releasably anchor distal end effector (20) of connection device (10) within the target anatomy. When disengagement between distal end effector (20) of connection device (10) within the target anatomy is desired, positioning member (160) may be pushed distally relative to the distal tip (150) and as the tip ofpositioning member (160) moves distally within distal tip (150), flange(s) (180) may be pushed downward (as oriented in FIG. 4A) and disengage with distal tip side opening(s) (170) so that positioning member (160) returns to the first state of operation and is nested in distal tip (150) as shown in FIGs. 3A and 3B. Optionally, energy (200) may be emitted via conductive band (190) when in assembly 201 is in the first and / or second state(s) of operation as shown in FIGs. 3B and 4B.

[0083] Also shown in FIGs. 3B and 4B is an insulation member (210) positioned along a length of elongated shaft (20). Insulation member (210) may be configured to insulate one or more components of connecting device (10) from conduction band (190) by, for example, facilitating reduction of energy dissipation / damage thereto. Materials for insulating member (210) include, but are not limited to, plastics such as polytetrafluoroethylene (RTFE), silicone, and / or other materials with insulating properties.

[0084] FIGs. 5A and 5B provide cross-section views of an assembly (201’) of a barbed positioning member (160’) and a distal tip (150’) with one or more distal tip internal flange(s) (220). Barbed positioning member (160') may be similar to positioning member 160 in that it includes flange(s) (180) and flexible rod (185). In addition, barbed positioning member (160') includes a barbed tip (230) with one or more detent feature(s) (230) configured to engage with distal tip internal flanges (220) (as shown in FIG. 5B) to hinder inadvertent motion of the positioning member (160). When barbed positioning member (160’) is being inserted into distal tip (150’), or pushed upward as shown in FIG. 5A, flange(s) 180 may be in a first state of operation and, when positioning member (160’) is fully inserted into distal tip (150’), detent features (230) may engage with and / or be held by distal tip internal flange(s) (220) as shown in FIG. 5B. Engagement between detent features (230) and distal tip internal flange(s) (220) may be configured to avoid inadvertent movement of positioning member (160’) upon, for example, proximal return. Barbed positioning member (160’) may be configured to translate between a first state of operation (i.e., flange(s) (180) are resident within distal tip (150’) and a second state of operation where flange(s) (180) extend from distal tip side openings (170) as, for example, described above with regard to positioning member (160).

[0085] FIG. 6 provides a flowchart of an exemplary process 600 for connecting two different target tissues, such as a target lymph node and bloodvessel (e.g. , vein) together using one or more devices and / or systems described herein. Process 600 is discussed with regard to FIGs. 7 and 8A-8J, wherein FIG. 7 is a diagram showing portions of an exemplary patient (101) with lymphedema. In particular, FIG. 7 shows patient's 101 forearm (110), neck (100), skin (90), a plurality of veins (120), and a target lymph node (130) and FIGS. 8A-8J show representative steps of performing process 600 utilizing the connection device (10) to access and connect the target anatomies endovascularly.

[0086] Initially, in step 605, an assembly of a connector device and a guide wire may be inserted into a first target anatomy and positioned proximate to a second target anatomy so that the guide wire may be inserted into the second target tissue. FIG. 8A provides an exemplary illustration of how step 605 may be executed by showing an assembly of connector device (10) and a guide wire (250) as it extends from hole (140) and is positioned in the first target tissue (in this case, a vein (120)) so that guide wire (250) may be inserted into the second target tissue (in this case, a target lymph node (130)).

[0087] Then, a distal tip of the connection device may puncture and exit the first target anatomy and enter the second target anatomy via, for example, guidance from the guide wire (step 610). FIG. 8B illustrates an example of how distal tip (150) may puncture vein (120) by sliding over guide wire (250) and FIG. 8C illustrates an example of how distal tip (150) may be inserted into the second target tissue (in this case, target lymph node (130). Additionally, or alternatively, step 610 may be executed by advancing the connection device within a larger catheter that has already been positioned inside the second target tissue (e.g., target lymph node (130)). Optionally, in step 615, external force may be applied to soft tissue proximate to the first and / or second target tissues, which may assist the connection device and / or a portion thereof in finding purchase within the first and / or second target tissues. The external force may be applied by, for example, a clinician executing, or assisting to execute, process 600. FIG. 8C provides an illustration of how step 615 may be executed, wherein an external force (270) is exerted upon target lymph node (130). Once the distal end of the device is placed in the target lymph node, the guidewire can be removed (step 620) as, for example, shown in FIG 8D.

[0088] Following extraction of the guidewire, in step 625, an anchoring mechanism (e.g., anchoring mechanism 160 or 160’) may be inserted into the distal tip of the connection device via, for example, an axial channel and / or central lumen thereof while the distal tip is still resident within the second target tissue as shown in, for example, FIG. 8E which illustrates anchoring mechanism 160 in a first state of operation within distal tip (150) while distal tip (150) is resident within target lymph node (130).

[0089] In step 630, the anchoring mechanism may be translated from the first mode of operation to the second mode of operation so that the anchoring mechanism and distal tip releasably engage with and / or attach to the second target tissue. An example of how step 630 may be executed is shown in FIG. 8F, which illustrates connection mechanism (160) in a second stage of operation with flange(s) (180) extending from distal tip side openings (170) so that flange(s) (180) extend into target lymph node (130) and connect distal tip (150) to target lymph node (130).

[0090] In step 635, the second target tissue may be pulled toward the first target tissue until, for example, the first and second target tissues are physically proximate (e.g., touching) one another. Step 635 may be accomplished via, for example, pulling the connection device out of the first target tissue. FIG. 8G illustrates and example of how step 635 may be executed, wherein target lymph node (130) is pulled toward vein (120) (i.e., a distance “h” between target lymph node (130) and vein (120) is decreased) until the two structures are in contact, as shown in FIG. 8G.

[0091] Once the two structures are in close proximity, the connection device may be used to form a channel between the first and second target tissues (step 640) so that fluid (e.g., lymph) may flow from the second target tissue to the first target tissue. The channel may be formed by, for example, applying energy (e.g., heat and / or electricity) to a junction between the first and second target tissues. The energy may, for example, cauterize an opening in the first and / or second target tissues, fuse the first and second target tissues together, and / or form a channel of scarred tissue between the first and second target tissues. An example of how step 640 may be executed is shown in FIG. 8H, which shows energy (200) beingapplied to the target lymph node (130) and vein (120) via conductive band (190) to establish the connection and / or channel between the two structures.

[0092] Following execution of step 640 (e.g., once the channel / connection is established), the connection device may disengage from the second target tissue (step 645). Step 645 may be executed when the anchoring mechanism is translated from the second state of operation (see e.g., FIG. 8H) to the first state of operation as shown in FIG. 8! so that flange(s) thereof may be retracted from and / or disengaged with the second target tissue and the distal tip of the connection device may be extracted from the second target tissue via the channel (step 650). FIG. 8J illustrates an example of how step 650 may be executed, wherein distal tip (150) has been removed from target lymph node (130) via a channel (280) that connects target lymph node (130) and vein (120) so that lymph may drain from target lymph node (130) into vein (120), which may prevent a buildup of lymph within target lymph node (130) and therefore prevent and / or treat lymphedema.

[0093] Following execution of step 650, connection device (10) may be completely extracted from the patient anatomy and an incision made to allow access of connection device to the first target tissue may be treated (e.g., bandaged, sewn together, glued together, etc.) and process 600 may end and / or be performed on a different set of first and / or second target tissue.

[0094] FIG. 9 provides a flowchart illustrating a process 900 for connecting a first and a second target tissue using magnetic force and / or forming a channel therebetween so that first and second target tissues may be in fluid communication with one another. Process 900 may be executed using, for example, a magnetic probe (300) configured with a one or more magnets (310) configured to generate and / or produce a first type of magnetic charge (e.g., positive or negative) as shown in FIG. 10, which provides a side view of magnetic probe (300) and a magnetic implant (290). Magnetic probe 300 may also include a guide wire channel (not shown) configured to allow for articulation of a guide wire therein and a port 320 configured to allow for the ingress and / or egress of the guide wire during, for example, an insertion procedure. Magnetic probe (300) and / or magnet(s) (310) may be configured to cooperate with magnetic implant (290) as, for example, described with regard to process 900. Magnetic implant (290) may be configured to have / generate a magnetic field in opposition to the magnetic field of magnet(s)(310) so that magnetic implant (290) may be attracted to magnet(s) (310). Material included within magnetic implant (290) and / or magnet(s) (310) may have inherent magnetic properties and / or may comprise metal that can be magnetized. Magnetic implant (290) may be sized, shaped, and / or configured to be completely contained within the second target tissue (e.g., a target lymph node), without causing undue stress or displacement of the surrounding anatomical structures. Magnetic implant (290) may be configured such that it generates sufficient magnetic force to attract the magnet(s) (310) that may reside in the first target tissue (e.g., a target vein) and its size depends on the desired size of the channel and / or fistula created between the first and second target tissue(s) and their respective sizes and / or shapes. In some embodiments, magnet(s) 310 may be portions of magnetic probe capable of communicating a magnetic field provided by a magnetic field generator (not shown).

[0095] When process 900 is executed, a magnetic implant delivery device may be inserted into the patient's body and contact the second target tissue (step 905). Exemplary magnetic implant delivery devices include, but are not limited to, needles and catheters configured to house the magnetic implant and insert magnetic implant 290 into second target tissue. FIG. 11A provides an illustration of an exemplary magnetic implant delivery device (330) In the form of a needle inserted through the patient’s interstitial space (221) proximate to the patient's second target tissue (in this case, target lymph node (130)) and FIG. 11 B provides illustration of magnetic implant delivery device (330) when inserted into target lymph node (130).

[0096] Then, the magnetic implant may be positioned within the second target tissue (step 910) by, for example, ejection from the magnetic implant delivery device as, for example, shown in FIG. 11C, which depicts magnetic implant (290) when deployed, or positioned, within target lymph node (130) following ejection by magnetic implant delivery device (330). In some embodiments, execution of step 910 utilizes technology and / or techniques similar to those used to place radiological markers.

[0097] In step 915, a magnetic probe (e.g., magnetic probe (300)) may be inserted into the first target tissue (e.g., advanced endovascularly in an anterograde or retrograde fashion) proximate to the second target tissue. At times, positioning ofthe magnetic probe may be facilitated by a guidewire that extends through a channel within the magnetic probe and exits the magnetic probe via a port therein. For example, magnetic probe (300) may be inserted into second target tissue in the form of a vein (120) and positioned within vein (120) so that magnet(s) (310) are proximate to second target tissue (i.e., target lymph node (130) as shown in FIG. 11D. Magnetic force / attraction between the magnetic implant (e.g., magnetic implant (290)) and the magnetic probe (e.g., magnetic probe (300)) may act to pull the magnetic implant through the second target tissue toward the magnetic probe as shown in, for example, FIG. 11 E. Then, the magnetic implant may be pulled through a wall of the second target tissue, through a wall of the first target tissue, and attach to the magnetic probe via magnetic attraction between the magnetic implant and the magnetic probe as may be seen in, for example, FIG. 11 F, which provides an illustration of an assembly of magnetic implant (290) and magnet(s) (310) of magnetic probe (300), which are held together via a magnetic force between magnetic implant (290) and magnet(s) (310).

[0098] In some embodiments, a magnetic force between the magnetic probe and magnetic implant may be sufficient to cause controlled ischemia of the tissue between the two target tissues such that over time, this tissue layer (340) erodes away as shown in FIG. 11 F and a channel and / or fistula (350) forms between the first and second target tissues where the assembly of the magnetic implant and magnetic probe reside without causing considerable damage in the target and adjacent tissues, as shown in FIG. 11 G. Once this fistula is mature (e.g., days, weeks), the assembly of the magnetic implant and the magnet(s) of the magnetic probe (300) extension may be extracted from the first target tissue (step 920) via, for example, a second procedure and / or surgery, thereby exposing a channel (350) between the first and second target tissues. Channel (350) may allow for fluid communication between first and second target tissues as, for example, described herein. Additionally, or alternatively, the assembly of the magnetic implant and magnetic probe may be absorbed through the body and / or be disposed of by other means (e.g., surgical removal or evacuation).

[0099] In some embodiments, a connection device like connection device (10) may be configured for a percutaneous access approach. In these embodiments, one of which is shown in the side view of FIG. 12A, a percutaneousconnection device (11) may include the distal end effector (20), handle (40), user interaction feature (50), port (60), and channel (65) of connection device (10) may include a rigid, or semi-rigid, tube 1230 instead of elongated sheath (30). Tube (1230) may be configured to be inserted through the skin for percutaneous delivery to the treatment site and therefore enable percutaneous entry into the patient’s body and access to the target tissue (e.g., a target lymph node). For example, FIG. 12B illustrates how tube (1230) may be inserted through patient’s tissue to push into target lymph node (130) and vein (120). Then, energy may be emitted by conduction band 190 (as described herein) to form a channel and / or fistula therebetween so that target lymph node (130) may be in fluid communication with vein (120).[000100] In some embodiments, a channel between first and second target tissues may be established and / or held open by a conduit or stent that is placed in an opening within a wall of the first and second target tissues that may be formed by, for example, one or more of the devices disclosed herein. In some embodiments, the conduit may be placed via open hole (140). At times, the conduit may be permanent, biocompatible, bioabsorbable, and / or be able to release substances to aid in the formation and / or maintenance of the connection and / or channel between lymph node and vein. A size and / or shape of the conduit may be configured to allow for a flow of fluid between the structures it connects. This shape can be achieved as a function of the conduit inherent material properties, such as shape memory, or by some other force that, when applied, gives the conduit its shape. In some embodiments, the conduit may be configured to influence the flow of fluid between the two structures via, for example, creating a pressure gradient and / or biasing unidirectional flow. An exemplary conduit 1310 is shown in FIG. 13, which illustrates target lymph node 130 being connected to vein 120 via conduit (1310). Importantly, use of conduit (1310) does not require proximity and / or a connection between target lymph node (130) and vein (120).[000101] In alternative embodiments, the act of connecting the two anatomical structures (e.g., a target lymph node and vein) can be accomplished through multiple modalities including, but not limited to, mechanical fixation (e.g., a suture, staple, clip, screw) and / or adhesion via placement of an adhesive (e.g., glue) and / or sealant. For example, an attachment mechanism may be embodied as avolume of glue (1410) as shown In FIG. 14, wherein glue (1410) is positioned between target lymph node (130) and vein (120) and surrounds conduit (1310). In the embodiment of FIG. 14, glue (1410) acts to secure conduit (1310) in place and may also seal a first end of conduit (1310) within target lymph node (130) and / or a second end of conduit (1310) within vein (120), thereby preventing leakage of lymph from target lymph node (130) and / or blood from vein (120). In some embodiments, a component of glue (1410) (e.g., a hydrogel component) may be present on an exterior surface of conduit (1310) and, when this conduit (1310) is placed within the body, it may react with fluid (e.g., water) in the body to form the glue in a manner similar to formation of a hydrogel.[000102] Attachment between a target lymph node and a vein may be accomplished via use of one or more sutures deployed in several configurations, including, but not limited to, extending outwardly from the connection device in a tangential, circular motion to effectuate a connection between targeted anatomical structures via a continuous circumferential deployment of a single suture, or a set of one or more discrete, individually placed loop sutures. Other means of connection can be accomplished through, for example, abrasion, mending, thermal energy, friction, pierce, binding, through an enclosure, chemical use, and other mechanical, electrical and chemical alternatives.[000103] In some embodiments, execution of one or more process steps disclosed herein may be performed with the aid of one or more imaging technologies (e.g., MRi. infrared venography, fluorescent dye, fluoroscopy, contrasted CT imaging, and / or ultrasound) to find, for example, locate the first and / or second target tissue, perform an operation (or process step) upon the first and / or second target tissue, and / or verify that performance of one or more steps of one or more processes disclosed herein has been done correctly and / or as desired. [000104] Additionally, or alternatively, in some embodiments, first and / or second target tissue may be oriented in space prior to and / or during performance of or more methods disclosed herein. For example, a target lymph node (e.g., target lymph node (130)) may be identified via an imaging technique and tissue over and / or underlying the target lymph node may be pressed, squeezed and / or stretched to enable and / or ease access to the target lymph node and / or a vein proximate thereto.[000105] Additionally, or alternatively, In some embodiments a counter force may be applied to the target lymph node during performance of one or more methods disclosed herein to, for example, prevent unintentional / undesired movement (e.g., deflection) of the target lymph node in response to a force exerted thereon by, for example, one of the systems, devices, and / or components thereof disclosed herein.[000106] FIG. 15 is a schematic diagram of a side view and FIG. 16 is a crosssection view of a distal tip (1620) of a connection device like connection device (10). Distal tip (1620) includes a delivery sheath (1615) with a window (1640), an optional brace (1630) configured to add structural stability to distal tip (1620), and an end portion (1610) that includes a port (1645) configured to allow a guidewire (not shown) to pass therethrough. As may be seen in FIG. 16, distal tip (1620) may also include distal end effector (20), positioning member (160) with flexible rod (185), and an assembly of an implant catheter (1635) and an implant (1625). Implant catheter (1635) may include a central lumen configured to accept insertion elongated shaft (30) therein. In addition, the central lumen of implant catheter (1635) may be configured to allow implant catheter and / or the assembly of implant catheter (1635) and implant (1625) to slide along elongated shaft (30) as for example disclosed herein. An exterior diameter of distal tip (1620) and / or delivery sheath (1615) may be sized (e.g., 2.5-5mm) to fit, and traverse, within a blood vessel[000107] Implant (1625) may be sized and / or configured to be implanted into an opening and / or a connection between first target tissue (e.g., a blood vessel or vein) and a second target tissue (e.g., a lymph node) to, for example, connect the first and second tissues, maintain a relative position between the first and second target tissues, establish a pathway for fluid communication between the first and second target tissues, and / or hold a connection between the first and second target tissues so that, for example, fluid may flow between them. Optionally, implant (1625) may include one or more ridges or bumps that may act to engage the first and / or second target tissue and / or screw into the first or second target tissue. In some cases, implant (1625) may comprise and / or be coated with one or more agents like pharmaceutical agents (e.g., antibiotics and / or anticoagulants) and / or adhesives.[000108] FIG. 17 is a flowchart showing a process (1700) for placing an implant like implant (1625) in a connection between a blood vessel and a target tissue. Execution of process (1700) is explained below with the aid of FIGs. 18A-18H, which illustrate various steps of process (1700). One or more steps of process 1700 may be performed via manipulation of a user interaction feature like user interaction feature (50). Additionally, or alternatively, process 1700 and / or steps thereof may be performed under fluoroscopic and / or visual (e.g., ultrasound) guidance.[000109] Initially, In step 1705, a guidewire may be inserted into a blood vessel of a patient via an access location (e.g., a patient’s head, neck, thorax, abdomen, groin, an upper extremity, and a lower extremity). The guidewire may be positioned (e.g., advanced along) the blood vessel until it is proximate to target tissue such as a lymph node. Then, a distal tip of a delivery sheath like distal tip (1620) may be advanced along the guidewire until it is proximate to the target tissue (step 1710) and a distal end effector (e.g., distal end effector (20)) of a connection device (e.g., connection device (10)). FIG. 18A is a cutaway view of a distal tip (1620) of a delivery sheath positioned in blood vessel (120) proximate target tissue (130) via a guidewire (250) as described in step 1710. Then, the guidewire may be removed and a distal end effector (e.g., distal end effector 20) of a connection device (e.g., connection device (10)) may be positioned in and advanced through the delivery sheath until it is proximate the target tissue (step 1715). Optionally, (step 1720) external force and / or pressure may be applied to patient tissue proximate to (e.g., overlying) the target tissue to reposition the target tissue and / or move it closer to the blood vessel. Execution of step 1720 may be similar to execution of step 610. [000110] In step 1725, the distal end effector may be advanced through a window (e.g., window (1640) and through the blood vessel wall so that it may enter the target tissue in a manner that may be similar to the execution of step 615 and / or as shown in FIG. 18B, which is a cutaway view of the delivery sheath positioned in blood vessel (120) proximate a target tissue (30) with the guidewire being removed and distal end effector (20) exiting window (1640), puncturing through a wall of blood vessel (120) proximate to target tissue (30) with distal tip (20) thereof inserted into the target tissue (30) as shown.[000111] In step 1730, an anchoring mechanism (anchoring mechanism 160 or 160’) positioned within the distal end effector may be translated from a first state of operation to a second state of operation so that one or more flanges (e.g., flanges (220)) extend into the target tissue. In some embodiments, execution of step 1730 may be similar to execution of step 630. In step 1735, the target tissue may be pulled, or approximated, toward the blood vessel so that they are proximate to and / or touching one another. An example of how steps 1730 and 1735 may be performed is provided by FIG. 18C, which shows flanges (180) extending through distal tip side openings (170) and into target tissue (30) so that they may engage, or grab, target tissue (30). FIG. 18C also shows target tissue (30) approximated toward vein (120) as may occur following execution of step 1735.[000112] Next, in step 1740, an assembly of an implant catheter (e.g., implant catheter (1635)) and an implant (e.g., implant (1625)) may be advanced along the connection device and / or a component thereof (e.g., an elongated shaft (e.g., elongated shaft (20)) and / or a tube (e.g., tube (1230)) into a connection or channel between the blood vessel and target tissue created by inserting the distal tip through the blood vessel wall and into the target tissue (see step 1725 and FIG. 18B). An example of how step 1740 may be executed is provided by FIG. 18D, which shows implant (1625) as it advances along elongated sheath (20) or tube (1230) and enters window (1640). In step 1743, the implant may be seated in the connection via, for example, mechanical engagement, a press fit, rotating, or screwing, the implant into the connection, and / or a chemical bond (e.g., glue). Additionally, or alternatively, the implant may be coated and / or impregnated with a compound, or pharmaceutical agent, that when exposed to fluid becomes a chemical that cements or bonds the implant in place. An example of how step 1735 may be performed is provided by FIG. 18E, which shows the assembly of implant catheter (1635) and implant (1625) advancing along elongated sheath (20) or tube (1230) until implant (1625) is seated in the connection between blood vessel (120) and target tissue (30).[000113] Next, in step 1750, the implant catheter may be disengaged from the implant via, for example, rotating the implant catheter or otherwise decoupling the implant catheter from the implant and then the anchoring mechanism (e.g., flanges (180)) may be disengaged from the target tissue as, for example, disclosed herein(step 1755). Following, step 1755, the implant may be positioned in the connection between the vein and target tissue as shown in FIG. 18G, which shows implant (1625) positioned within the connection. Finally, the device may be extracted from the patient’s blood vessel / body and / or moved to another target location within the vein to perform one or more steps of process 1700 on another target structure.

Claims

CLAIMSWhat is claimed is:1 . A device comprising: an elongated shaft with a central lumen; a distal end effector coupled to a first end of the elongated shaft, the distal end effector comprising at least one opening and a lumen of the distal end effector being in communication with the central lumen of the elongated shaft; a positioning member comprising a flexible rod that terminates with a tip that includes at least one flange, the tip and a first portion of the flexible rod being resident within the lumen of the distal end effector and a second portion of the flexible rad being resident within the central lumen of the elongated shaft, wherein articulation of the flexible rod within the distal end effector causes the at least one flange to extend out of, or retract into, the opening of the distal end effector; a handle coupled to a second end of the elongated shaft; and a user interaction feature resident within the handle, the user interaction feature being configured to control articulation of the positioning member within the lumen of the distal end effector responsively to user input.

2. The device of claim 1 , wherein the distal end effector further comprises a component configured to deliver at least one of radiofrequency ablation, electrocautery, cryoablation to patient tissue, electromagnetic energy, magnetic force, and mechanical force to patient tissue.

3. The device of claim 1 or 2, wherein a portion of the elongated shaft and the distal end effector are configured to be placed within a blood vessel of a patient so that when the distal end effector is proximate to a target tissue positioned outside the blood vessel, the distal end effector is configured to exit the blood vessel and enter the target tissue.

4. The device of claim 3, wherein the flexible rod includes a lumen and the tip includes an opening, the device further comprising: a guidewire positioned within the lumen of the flexible rod, the guidewire being configured to articulate within the lumen to extend through the opening into the target tissue.

5. The device of claim 3, wherein the one or more flanges are configured to exit the at least one opening of the distal end effector when the distal end effector is positioned within a target tissue, thereby engaging the target tissue.

6. The device of claim 5, wherein the device is configured so that the positioning member may be retracted within the lumen of the distal end effector, thereby pulling the target tissue toward the blood vessel so that a connection between the blood vessel and target tissue may be formed.

7. The device of claim 6, wherein the connection is formed using at least one of radiofrequency ablation, electrocautery, cryoablation to patient tissue, electromagnetic energy, magnetic force, and mechanical force.

8. The device of claim 6, wherein the connection is formed using mechanical fixation.

9. The device of claim 8, wherein the mechanical fixation includes at least one of a suture, a clip, a staple, and an adhesive.

10. The device of any of claims 1-9, further comprising: a delivery sheath with a delivery sheath lumen therein, the delivery sheath lumen being sized and configured to accept insertion of the distal end effector therein.11.The device of any of claims 6-9, wherein the connection is formed through placement of an implant configured to aid in the formation and / or maintenance of the connection between the target tissue and the blood vessel.

12. The device of claim 11, wherein the implant comprises a pharmaceutical configured to assist with maintaining the connection.

13. The device of claim 11, wherein placement of the implant is achieved by advancing the implant over the flexible rod until it is in position in the connection.

14. The device of claim 11, further comprising: an assembly of an implant catheter and the implant, wherein placement of the implant is achieved by advancing the assembly of an implant catheter and the implant over the flexible rod until it is in position in the connection.

15. The device of any of claims 1-9, further comprising:a delivery sheath with a delivery sheath lumen therein, the delivery sheath lumen being sized and configured to accept insertion of the assembly of the implant catheter and the implant therein.

16. The device of any of claims 1-9, wherein the target tissue is a lymph node and the blood vessel is a vein.

17. A method of using the device of any of claims 1-16 to create a connection between a blood vessel and a target tissue.

18. The method of claim 17, wherein the target tissue is a lymph node and the blood vessel is a vein.

19. A method of creating a connection between a blood vessel and a target tissue of a patient, the method comprising: delivering a device to the blood vessel; causing a distal end effector of the device to exit the blood vessel and enter an interstitial space proximate to the target tissue; causing the distal end effector to enter and engage the target tissue; causing the distal end effector to pull the target tissue toward the blood vessel; creating the connection between the target tissue and the blood vessel, the connection establishing a pathway between the target tissue and the blood vessel so that the target tissue is in fluid communication with the blood vessel; and removing the device from the patient’s blood vessel.

20. The method of claim 19, wherein the target tissue Is a lymph node and the blood vessel is a vein.21.The method of claim 19 or 20, wherein device enters the blood vessel of the patient via an access location positioned in at least one of a patient’s head, neck, thorax, abdomen, groin, an upper extremity, and a lower extremity.

22. The method of any of claims 19-21 , wherein causing the distal end effector to enter and engage the target tissue comprises inserting a guidewire into the access location and through the blood vessel until it is proximate to the target tissue, advancing the device along the guidewire and then positioning the distal end effector in the target tissue via the guidewire.

23. The method of any of claims 19-22, wherein the device comprises an elongated flexible rad configured to slidably advance over a guidewire for delivery of distal end effector to the blood vessel and the target tissue, wherein causing the distal end effector to enter and engage the target tissue comprises advancing the guidewire through the device and into the target tissue and then positioning the distal end effector in the target tissue via the guidewire.

24. The method of any of claims 19-23, wherein the distal end effector comprises an opening and the device comprises a positioning member that includes a flexible rod that terminates with a tip, there being at least one flange extending from the tip, wherein articulation of the flexible rod within the device causes the at least one flange to extend out of, or retract into the opening, further wherein engaging the target tissue is achieved by positioning the flexible rod so that the at least one flange extends through the opening and punctures the target tissue and removing the device from the patient’s blood vessel is achieved by positioning the flexible rod so that the at least one flange retracts into the opening and disengages from the target tissue.

25. The method of claim of any of claims 19-23, further comprising: placing an implant in the connection between the target tissue and the blood vessel, the implant being configured to hold the connection open to achieve fluid communication between the target tissue and the blood vessel.

26. The method of any of claims 19-23, wherein the device comprises a positioning member that includes a flexible rod that terminates with a tip, there being at least one flange extending from the tip, wherein articulation of the flexible rod within the device causes the at least one flange to extend out of, or retract into the opening, further wherein engaging the target tissue is achieved by positioning the flexible rod so that the at least one flange extends through the opening and punctures the target tissue and removing the device from the patient's blood vessel is achieved by positioning the flexible rod so that the at least one flange retracts into the opening and disengages from the target tissue, the method further comprising: placing an implant in the connection between the target tissue and the blood vessel by advancing the implant over the flexible rod until it is in position in theconnection, the implant being configured to hold the connection open to achieve fluid communication between the target tissue and the blood vessel.

27. The method of any of claims 19-23, wherein the device comprises a positioning member that includes a flexible rod that terminates with a tip, there being at least one flange extending from the tip, wherein articulation of the flexible rod within the device causes the at least one flange to extend out of, or retract into the opening, further wherein engaging the target tissue is achieved by positioning the flexible rod so that the at least one flange extends through the opening and punctures the target tissue and removing the device from the patient’s blood vessel is achieved by positioning the flexible rod so that the at least one flange retracts into the opening and disengages from the target tissue, the method further comprising: placing an implant in the connection between the target tissue and the blood vessel by advancing an assembly of an implant catheter and the implant over the flexible rod until it is in position in the connection, the implant being configured to hold the connection open to achieve fluid communication between the target tissue and the blood vessel; and removing the implant catheter from the connection so that the implant remains in the connection.

28. The method of claim 27, wherein placing the implant further comprises: rotating the assembly of the implant catheter and the implant within the connection to seat the implant in the connection.

29. The method of claim 27 or 28, wherein removing the implant catheter further comprises: rotating the assembly of the implant catheter and the implant to disengage the implant from the implant catheter: positioning the flexible rod so that the at least one flange retracts into the opening of the distal end portion and disengages from the target tissue; retracting an assembly of the insert catheter and the positioning member from the connection; and removing the assembly from patient’s blood vessel.

30. The method of any of claim 19-29, wherein the device is delivered to the blood vessel via a delivery sheath, the delivery sheath comprising an opening through which a portion the device extends.31.The method of any of claims 28-30 wherein the device is delivered to the blood vessel via a delivery sheath, the delivery sheath comprising an opening through which the assembly of an implant catheter and the implant extends.

32. A method for creating a connection between a blood vessel and a target tissue, the method comprising: delivering a device percutaneously that traverses the blood vessel until it is proximate to the target tissue; approximating the target tissue and the blood vessel; and establishing a connection between the target tissue and the blood vessel in a way that facilitates fluid flow between them.

33. The method of claim 32, wherein the target tissue is a lymph node and the blood vessel is a vein.

34. The method of claim 32 or 33, wherein device enters the blood vessel of the patient via an access location positioned in at least one of a patient’s head, neck, thorax, abdomen, groin, upper extremity, and lower extremity.

35. The method of any of claims 32-34, wherein access to the target tissue is achieved by placement of a guidewire in the target tissue and advancing the device over the guidewire.

36. The method of claim 32-35, wherein access to the target anatomical sites is achieved by direct placement of a device comprising of at least a distal tip is configured to penetrate patient tissue to reach the target site.

37. The method of claim 32-36, wherein the device includes a positioning member and approximating the target tissue and blood vessel comprises deploying the positioning member into the target tissue so that it engages the target tissue and retracting the device to pull the target tissue engaged with the positioning member toward the blood vessel.

38. The method of claim 32-37, further comprising: inserting an implant into the connection to maintain an opening between the target tissue and the blood vessel so that fluid flows between them.

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