WO2018116025A1

WO2018116025A1 - Systems and methods for implantable drainage device

Info

Publication number: WO2018116025A1
Application number: PCT/IB2017/057153
Authority: WO
Inventors: Debasish Pradhan; Mayur Balasaheb GAIKWAD; Rahul S NAIR; Satyajeet PARAKH
Original assignee: Empire Technology Development Llc
Priority date: 2016-12-21
Filing date: 2017-11-16
Publication date: 2018-06-28

Abstract

A drainage assembly includes an implant with a main body having an inner wall defining a central bore, an outer wall configured to engage a vessel wall, an annular cavity disposed between the inner and outer walls, and a plurality of apertures extending through the inner wall and in fluid communication with the cavity and the central bore. A drainage extension at the main body includes a drainage channel in fluid communication with the cavity and an implant connector. A guide wire member is engageable to the implant connector to move the implant connector between a closed position and an open position. A suction catheter receives at least a portion of the implant connector and includes a suction channel, wherein the suction channel is in fluid flow receiving communication with the drainage channel when the implant connector is in the open position.

Description

SYSTEMS AND METHODS FOR IMPLANTABLE DRAINAGE

DEVICE

BACKGROUND

[0001] Congestive Heart Failure (CHF) is a complex clinical syndrome that impairs the ability of the heart ventricles to fill with and/or eject blood. Weakened heart chambers permit blood pooling within the heart, triggering fluid retention, particularly in the lungs, legs, and abdomen. CHF may be a result of past heart attacks (e.g., from coronary heart disease), high blood pressure, malfunctioning of the heart valves, or any of a number of other conditions.

[0002] Also, damage to the muscles of the heart can result in decreased pumping ability of the heart, resulting in volume overload and residual fluid in interstitial spaces and the lymphatic system, which can in turn lead to CHF.

SUMMARY

[0003] An embodiment relates to a drainage assembly. The drainage assembly includes an implant. The implant includes a main body having an inner wall defining a central bore from a first opening at a first end to a second opening at a second end, an outer wall configured to engage a vessel wall, an annular cavity disposed between the inner and outer walls, and a plurality of apertures extending through the inner wall and in fluid communication with the cavity and the central bore. The implant further includes a drainage extension at the second end of the main body including a drainage channel in fluid communication with the cavity. The implant includes an implant connector at a proximal end of the drainage extension configured to be movable between an open position allowing a fluid flow from the drainage channel and a closed position blocking the fluid flow from the drainage channel. The drainage assembly further includes a guide wire member including a distal end, wherein the distal end is engageable to the implant connector to move the implant connector between the closed position to the open position. The drainage assembly includes a suction catheter, wherein the suction catheter receives at least a portion of the implant connector and includes a suction channel, and wherein the suction channel is in fluid flow receiving communication with the drainage channel when the implant connector is in the open position. [0004] Another embodiment relates to an implantable device. The implantable device includes a main body having an inner wall defining a central bore from a first opening at a first end to a second opening at a second end, an outer wall configured to engage a vessel wall, an annular cavity disposed between the inner and outer walls, and a plurality of apertures extending through the inner wall and in fluid communication with the cavity and the central bore. The implantable device further includes a frame disposed within the main body, the frame including a shape memory material, wherein the shape memory material is responsive to application of energy to move the main body from a collapsed configuration to an expanded configuration. The implantable device also includes a drainage extension at the second end including a drainage channel in fluid communication with the cavity. The implantable device includes an implant connector at a proximal end of the drainage extension configured to be movable between an open position allowing a fluid flow from the drainage channel and a closed position blocking the fluid flow from the drainage channel.

[0005] Another embodiment relates to a method of draining fluid from a duct. The method includes positioning an implant within a duct of a person. The implant includes a main body having an inner wall defining a central bore from a first opening at a first end to a second opening at a second end, an outer wall configured to engage a vessel wall, an annular cavity disposed between the inner and outer walls, and a plurality of apertures extending through the inner wall and in fluid communication with the cavity and the central bore. The implant further includes a drainage extension at the second end of the main body including a drainage channel in fluid communication with the cavity. The implant also includes an implant connector at a proximal end of the drainage extension configured to be movable between an open position allowing a fluid flow from the drainage channel and a closed position blocking the fluid flow from the drainage channel. The method further includes engaging the implant connector with a guide wire member to move the implant connector from a closed position to an open position. The method includes applying a negative pressure through the implant connector and to the cavity to draw fluid from the central bore through the plurality of apertures, into the cavity, and toward the implant connector.

[0006] The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] FIG. 1 is a partially cutaway view of a duct and a portion of a venous system of a person according to an embodiment.

[0008] FIG. 2 is an illustration of an implant system used to deploy and operate a drainage assembly within a person according to an embodiment.

[0009] FIG. 3A is an illustration of an implant used to drain fluid out of a duct according to an embodiment.

[0010] FIG. 3B is an illustration of a frame usable with the implant shown in FIG. 3A, according to an embodiment.

[0011] FIG. 3C is a side cross-sectional view of the implant shown in FIG. 3A, according to an embodiment.

[0012] FIG. 3D is a front cross-sectional perspective view of the implant shown in FIG. 3A, according to an embodiment.

[0013] FIG. 4A is an illustration of an implant with a drainage extension having two cross sectional planes, according to an embodiment.

[0014] FIG. 4B is a cross-sectional perspective view of section 4B-4B in FIG. 4A, according to an embodiment.

[0015] FIG. 4C is a cross-sectional perspective view of section 4C-4C in FIG. 4A, according to an embodiment.

[0016] FIG. 5A is an illustration of an implant connector, according to an embodiment.

[0017] FIG. 5B is an exploded view of the implant connector shown in FIG. 5A, according to an embodiment.

[0018] FIG. 5C is a cross-sectional view of the implant connector shown in FIG. 5A, according to an embodiment.

[0019] FIG. 6 is an illustration of a guide wire according to an embodiment. [0020] FIG. 7A is an illustration of a catheter according to an embodiment.

[0021] FIG. 7B is a cross-sectional perspective view of the catheter shown in FIG. 7A, according to an embodiment.

[0022] FIG. 7C is an illustration of the distal end of the catheter shown in FIG. 7A, according to an embodiment.

[0023] FIG. 8A is an illustration of a guide wire connecting to an implant connector, according to an embodiment.

[0024] FIG. 8B is a partially cutaway view of a catheter, showing a seal formed around an implant connector connected to a guide wire, according to an embodiment.

[0025] FIG. 8C is a partially cutaway view of a catheter, showing an open configuration of the implant connector connected to a guide wire, according to an embodiment.

[0026] FIG. 9A is an illustration of a catheter system according to an embodiment.

[0027] FIG. 9B is a block diagram of the catheter system shown in FIG. 9A, according to an embodiment.

[0028] FIG. 10A is a partially cutaway view of a duct and a portion of a venous system of a person along with a deployed drainage assembly, according to an embodiment.

[0029] FIG. 10B is a partially cutaway view of the duct, venous system, and deployed drainage assembly shown in FIG. 10A, but with the termination point of the duct at an alternative location, according to an embodiment.

[0030] FIG. IOC is a partially cutaway view of the duct, venous system, and deployed drainage assembly shown in FIG. 10A, but with the termination point of the duct at yet another alternative location, according to an embodiment.

[0031] FIG. 11A is a cross-sectional view of an implant indicating various paths for fluid flow, according to an embodiment. [0032] FIG. 11B is the cross-sectional view of the implant in FIG. 11 A, shown as deployed between a terminal duct valve and a first internal duct valve, according to an embodiment.

[0033] FIG. l lC is the cross-sectional view of the implant in FIG. 11 A, indicating a path for fluid flow as suction is applied, according to an embodiment.

[0034] FIG. 12 is a block diagram of a method of draining fluid through a duct using a drainage assembly according to an embodiment.

DETAILED DESCRIPTION

[0035] In the following detailed description, reference is made to the accompanying drawings, which form a part thereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here.

[0036] Referring to the figures generally, various embodiments disclosed herein relate to facilitating the flow of fluids through ducts of various system of a person (e.g., a vascular system, a lymphatic system, etc.). Some embodiments are directed to facilitating the flow of fluid through the lymphatic system, and more specifically, through the lymphatic duct to either direct the lymphatic fluid to the vascular system, out of the body, etc. It should be noted that for the purposes of this disclosure, the term duct when used in a general sense may refer to various types of fluid carrying vessels, conduits, ducts, veins, etc. within a person.

[0037] The lymphatic system is connected to the interstitial fluid space, and moves fluid from the interstitial space, through the lymphatic system, and eventually through the lymphatic ducts (e.g., the thoracic duct or the right lymphatic duct) and into one of two subclavian veins near their junctions with the internal jugular veins.

[0038] In persons suffering from congestive heart failure (CHF) or other conditions, the human heart may suffer from decreased pumping capabilities, resulting in volume overload and increased residual fluid in the interstitial space and the lymphatic system. This can in turn lead to a decrease of fluid entering the vascular system. As a result, such persons often experience pulmonary edema and general edema. One potential source of relief (at least temporarily) is intervention to facilitate the flow of fluid (e.g., lymphatic fluid) through the thoracic duct (which can carry 80 percent of the lymphatic fluid of the lymphatic system) to direct the lymphatic fluid to the venous system, out of the body, to a temporary storage reservoir, etc.

[0039] Referring now to FIG. 1, a thoracic duct and a portion of a venous system of a person are shown according to an embodiment. The portion of the venous system shown in FIG. 1 includes right internal jugular vein 12, left internal jugular vein 14, right subclavian vein 16, and left subclavian vein 18. As shown in FIG. 1, left internal jugular vein 14 and left subclavian vein 18 join at junction 20. Thoracic duct 10 drains into left internal jugular vein 14 and/or left subclavian vein 18 at terminal point 22 to drain lymphatic fluid 24 from thoracic duct 10. While in one arrangement, terminal point 22 of thoracic duct 10 is located at junction 20, in other arrangements, thoracic duct 10 may terminate in left internal jugular vein 14, left subclavian vein 18, or at multiple points in left internal jugular vein 14, left subclavian vein 18, and/or junction 20 (as shown in broken lines in FIG. 1). The various embodiments disclosed herein may be applicable to any of these arrangements.

[0040] Referring now to FIG. 2, an illustrative diagram of drainage assembly 226 is shown according to an example embodiment. Drainage assembly 226 includes implant 228, catheter 230, and guide wire 232. In an embodiment, implant 228 can be a double-walled, implantable drainage mechanism having an approximately tubular shape with interior-facing apertures that allow for the passive flow of fluid through the interior of implant 228 in one aspect, and a suctioning of fluid from the interior of implant 228 in another aspect.

[0041] In some embodiments, catheter 230 can be a hollow, tube-shaped extension configured to provide suction to implant 228. In some embodiments, catheter 230 can be disposed between implant 228 and a pressure source, such that implant 228 is in fluid communication with a distal end of catheter 230, and the pressure source is in fluid communication with a proximal (i.e., opposite) end of catheter 230. In such an arrangement, the pressure source can cause a reduction in fluid pressure in implant 228 through catheter 230. In some embodiments, catheter 230 can be configured to be readily attached and detached from implant 228. In other embodiments, catheter 230 can be configured to be permanently engaged to implant 228. [0042] In an embodiment, guide wire 232 can be a steering mechanism disposed along the length catheter 230. In some embodiments, guide wire 232 can be in the form of an extension of wire that can be conformed at a user's discretion. In an embodiment, guide wire 232 includes a shape memory material (e.g., a nickel-titanium alloy known as nitinol, or another similar material) configured to change shape upon the application of energy (e.g., light, thermal, electric, etc.), which may be provided by an energy source disposed at or otherwise operatively connected to the proximal end of catheter 230. As such, in some embodiments, guide wire 232 can allow a user to steer catheter 230 through a person's venous system and ultimately engage implant 228. Details and features of these aspects and features of various embodiments of drainage assembly 226 are discussed in further detail below. Guidewire 232 may also change direction of insertion through mechanical manipulation (e.g., by twisting or torqueing guidewire 232 by a user or automated/robotic insertion device).

[0043] Referring now to FIG. 3A, according to an example embodiment, implant 328 includes main body 334 and drainage extension 336. Main body 334 can be a hollow, tube shaped structure with an exterior made up of a leak-proof membrane. Main body 334 may include first opening 352, which is an aperture defined by the circumference of an upstream end (i.e., relative to the flow of fluid through implant 328) of main body 334, and may include a second opening 354, which can be an aperture defined by the circumference of the opposite, downstream end. Central bore 350 can span the length of main body 334 from first opening 352 to second opening 354, such that fluid can flow into first opening 352, through central bore 350, and out of second opening 354. The manner of this flow of fluid is discussed in more detail with respect to various example embodiments as shown in FIG. HA and FIG. 11C, below.

[0044] In some embodiments, drainage extension 336 can be a portion of implant 328 that may be capable of engaging and being in fluid communication with the distal end of a drainage assembly that includes implant 328 and a catheter (e.g., catheter 230), thereby allowing for a suction to be applied within implant 328 through the catheter. Drainage extension 336 can include a segment of a leak-proof suction conduit (e.g., similar to catheter 230) and implant connector 338. Implant connector 338 can be provided at the distal end (i.e., farther from implant 328) of drainage extension 336 and can be configured to engage and disengage from a corresponding distal end of the catheter. In some embodiments, implant connector 338 includes a magnet or a corresponding ferromagnetic material. Additional features various example embodiments of implant connector 338 are discussed in more detail with respect to FIGS. 5A-5C, below.

[0045] Referring now to FIG. 3B, in an embodiment, the overall shape of main body 334 can be maintained by an integrated frame 344. The configuration of frame 344 can provide the overall shape of main body 334, which can then be wrapped in a leak-proof elastic membrane to give shape to the main body 334 as shown in FIG. 3A. In some embodiments, frame 344 may be disposed within the walls of main body 334. In other embodiments, frame 344 may be disposed on the outside of the walls of main body 334 (e.g., exposed and facing outward from main body 334), or on the inside of main body 334 (e.g., exposed and facing central bore 350). The actual distribution of frame 344 can vary (e.g., forming a series of loops along the length of main body 334, forming a net-like pattern throughout main body 334, forming a coil or circles annularly disposed about the circumference of main body 334, making up a full membrane, and the like).

[0046] In some embodiments, frame 344 can be a wire frame made up of a lightweight, flexible material. The material can further include a shape memory material such as nitinol, or the wire frame may be made from other suitable medical grade shape memory materials with similar characteristics, such as spring stainless steel, shape memory alloys and/or shape memory polymers. In such embodiments, the shape memory material can be configured to have a first configuration in an overall collapsed shape, and upon an application of energy to the shape memory material, transition to an overall expanded shape. As such, in these embodiments, main body 334 can be configured to alternate between two shapes and sizes. It should be noted that energy may be applied to the frame while it is being deployed, and the energy stopped when the frame is ready to be deployed. So the transition of the frame may be from either an energy induced step, or an induced transition by applying energy. The application of energy may be thermal, electrical, mechanical or the like.

[0047] Referring now to FIG. 3 C, in an embodiment, main body 334 may be further made up of one portion forming an outer wall 342 defined by the external area of main body 334 between first opening 352 and second opening 354, and a corresponding second portion forming an inner wall 340 defined by the internal area of main body 334, also between first opening 352 and second opening 354. Inner wall 340 and outer wall 342 can be separated by cavity 346, which in an embodiment may be a pocket or chamber extending throughout the circumference and length of main body 334. In some embodiments, inner wall 340 and outer wall 342 can be a single membrane wrapped around the entire cavity 346, thereby giving rise to an "inner" side of the membrane and an "outer" side of the membrane. In other embodiments, inner wall 340 and outer wall 342 may be separate membranes, joined approximately about the circumference of first opening 52 and second opening 354, thereby giving rise to cavity 346. In addition, inner wall 340 in some embodiments defines several apertures 348. Apertures 348 are openings that can allow central bore 350 to be in fluid communication with cavity 346.

[0048] In some embodiments, a drainage channel 356 can be disposed along the length of drainage extension 336. In an embodiment, drainage channel 356 can be a leak-proof conduit in fluid communication with cavity 346 at a proximal end, and an opening associated with implant connector 338 at a distal end. As such, fluid can travel into first opening 352, into central bore 350, through apertures 348, into cavity 346, through drainage channel 356, and out of implant connector 338.

[0049] Referring now to FIG. 3D, in some embodiments, the shape of cavity 346 can be maintained by several supports 358 disposed throughout the area between inner wall 340 and outer wall 342. Supports 358 can take the form of any of several fixed structures between inner wall 340 and outer wall 342, including prongs, cubes, spheres, planes, and the like. In some embodiments, each support 358 may be fixed to inner wall 340 on one end and outer wall 342 on the other end. In other embodiments, supports 358 may be fixed either on inner wall 340 or outer wall 342. In yet other embodiments, supports 358 can move freely within cavity 346, but are unable to move out of (e.g., restrained within) cavity 346 (e.g., due to size of individual supports 358, size of apertures 348, or the like). In an embodiment, the size, number, and distribution of supports 358 can be such that inner wall 340 and outer wall 342 generally do not come in contact with each other under normal conditions (e.g., under normal fluid pressures in thoracic duct 10, or under the fluid pressure exerted during a suctioning process), and further, fluid is able to flow freely in cavity 346.

[0050] Referring now to FIG. 4A, in some embodiments, the cross- sectional shape along the length of drainage extension 436 can vary, as discussed with respect to FIGS. 4B and

4C. In an embodiment, upon deploying implant 428, a first portion of drainage extension

436 that includes section 4B-4B as indicated in FIG. 4A can be disposed within thoracic duct 10 and through a terminal thoracic duct valve itself. The portion of drainage extension 436 shown as section 4B-4B may be or include, in an embodiment, an elliptical or oval configuration, and may be proximal to main body 434. Such a configuration may reduce the risk of damaging the terminal thoracic duct valve during the various stages of operation of a drainage assembly that includes drainage extension 436 (e.g., including the resting stage where no suction is applied). Referring now to FIG. 4C, a portion of drainage extension 436 that includes section 4C-4C as indicated in FIG. 4A can be disposed in the venous space outside the terminal duct valve. Here, the cross-sectional plane can take on a circular orientation towards the end of drainage extension 436 with implant connector 438.

[0051] Referring now to FIG. 5 A, in some embodiments, implant connector 538 includes connector body 560 and cover 564. In an embodiment, connector body 560 may be a hollow, cylindrical housing with central bore 574 and an opening defined by the cross sectional area of connector body 560 at the proximal end (i.e., closer to an implant of a drainage assembly that includes implant connector 538). The opening at the proximal end of connector body 560 can be configured to be in fluid communication with the distal end (i.e., farther from an implant of a drainage assembly that includes implant connector 538) of drainage extension 536. Cover 564 can be a leak-proof, concave cap disposed at the distal end of body 560, and in one arrangement, can form a leak-proof barrier at the distal end of body 560. In some embodiments, cover 564 includes a magnet or a corresponding ferromagnetic material.

[0052] Referring now to FIG. 5B, in some embodiments, cover 564 can further include plunger 566 and plunger stop 568. In an embodiment, plunger 566 may be a narrow, cylindrical extension that is engaged to the center point of the inner side of cover 564 (e.g., on the inner side of the curvature of cover 564) on a first end, and plunger stop 568 at a second end. Plunger stop 568 can be a lateral protrusion on plunger 566. In an embodiment, plunger stop 568 may be a pair of firm flaps extending perpendicularly from the end of plunger 566. In another embodiment, plunger stop 568 may be a portion of plunger 566 itself, but with an increased cross-sectional diameter (e.g., a flared end, a circular ring annularly disposed about the end of plunger 566, a bulge, or the like). In some embodiments, plunger stop 568 may be a circular flap of leak-proof, elastic material with an area that almost matches the cross-sectional area of connector body 560 (e.g., can operate as a one-way valve regulating flow through a plurality of apertures 572, as discussed below). [0053] In some embodiments, a perforated end portion 562 can be disposed at the distal end of connector body 560. In an embodiment, perforated end portion 562 may be an approximately hemispherical segment at the distal end of connector body 560. In some embodiments, the size and area of perforated end portion 562 can be similar to the size and area of cover 564. Perforated end portion 562 may include several apertures 572, which are openings in perforated end portion 562 in fluid communication with central bore 574. As such, fluid can flow out from central bore 574 through apertures 572 throughout perforated end portion 562. Perforated end portion 562 may further include plunger aperture 567, which is an opening disposed at the center point of perforated end portion 562 with a larger diameter than the diameter of plunger 566, but a smaller overall size than plunger stop 568.

[0054] Referring now to FIG. 5C, in an embodiment, plunger 566 can be concentrically disposed through plunger aperture 567 in perforated end portion 562, such that cover 564 at one end of plunger 566 may be disposed on the outside of connector body 560, and plunger stop 568 at the other end of plunger 566 may be disposed on the inside of connector body 560 (e.g., within central bore 74). In this arrangement, plunger 566 can be extended and retracted through plunger aperture 567, such that when plunger 566 is fully retracted into the interior of connector body 560, cover 564 may engage the outer surface of perforated end portion 562, and forms leak-proof seals with each of apertures 572.

[0055] In an embodiment, implant connector 538 further includes retaining members 570. Retaining members 570 can be extensions joining the inner wall of connector body 560 to points on plunger 566 disposed within central bore 574. In some embodiments, retaining members 570 can be elastic lengths of string. In other embodiments, retaining members 570 can be lengths of string with some amount of slack, such that plunger 566 can translate a limited distance in and out of plunger aperture 567. As such, retaining members 570 can be used independently or in conjunction with plunger stop 568 to determine the range of motion of plunger 566.

[0056] Referring now to FIG. 6, in some embodiments, guide wire 632 includes controller

676, wire 678, and end portion 680. Wire 678 can be a thin length of material capable of changing its shape and orientation in response to a user's input. In some embodiments, wire

678 may be made from a length of shape memory material, such as nitinol, spring stainless steel or shape memory polymers or alloys. Controller 676 can be a user interaction device configured to allow a user to manipulate the shape and orientation of associated wire 678. In embodiments where wire 678 is a length of nitinol, controller 676 may allow a user to selectively transmit energy (e.g., light, heat, electricity, etc.) along wire 678 and thereby change its shape. End portion 680 is the distal end (i.e., farthest from controller 76) of wire 678. In some arrangements, end portion 680 may include a magnet or a corresponding ferromagnetic material.

[0057] Referring now to FIG. 7A, in an embodiment, wire 778 may be disposed within the length of catheter 730. As such, the shape and orientation of catheter 730 can vary, corresponding to the shape and orientation of wire 778, as determined by a user with an associated controller (not shown).

[0058] Referring now to FIG. 7B, catheter 730 further includes sidewall 782, suction channel 786, and guide wire channel 788. In an embodiment, sidewall 782 can be an elastic, leak-proof, tube-shaped extension with a hollow bore, forming an outer layer or sheath of catheter 730. Sidewall 782 can also include an inflation channel 784, which is a leak-proof fluid conduit running the length of catheter 730. In some arrangements, inflation channel 784 can be embedded within sidewall 782. In other embodiments, inflation channel 784 can be mounted on the interior-facing side of sidewall 782, or on the exterior-facing side of sidewall 782.

[0059] In some embodiments, guide wire channel 788 contains guide wire 732. In some embodiments, guide wire channel 788 is a sheath disposed around the length of guide wire 327. In other embodiments, guide wire channel 788 may be guide wire 732 itself. In an embodiment, retaining members (e.g., retaining members 570, or firm stationary prongs, or the like) join guide wire channel 788 to the interior-facing side of sidewall 782 at several intervals. In other embodiments, guide wire channel 788 may be engaged to the interior- facing side of sidewall 782, or the exterior facing side of sidewall 782, or embedded within sidewall 782 itself.

[0060] In some embodiments, suction channel 786 may be a leak-proof fluid conduit running the length of catheter 730. In an embodiment, sidewall 782 defines the shape and volume of suction channel 786 (i.e., where suction channel 786 is the interior volume of catheter 730 that is not otherwise taken up by other aspects of catheter 730, such as guide wire channel 788). In other embodiments, suction channel 786 can be a separate leak-proof, tube-shaped fluid conduit disposed within and along the length of catheter 730. [0061] Referring further to FIGS. 7A-7B and now to FIG. 7C, catheter 730 can include balloon 789. In an embodiment, balloon 789 can be an inflatable pocket formed by a leak- proof elastic material disposed about the interior-facing circumference of catheter 730. In various embodiments, balloon 789 can be disposed along the length of catheter 730, or disposed along a short segment at the distal end of catheter 730 (e.g., closest to an implant of a drainage assembly during deployment). Balloon 789 can be configured such that balloon 789 may be in fluid communication with inflation channel 784. In an embodiment, a first portion of catheter 730 (e.g., a proximal segment between points A and B shown in FIG. 7A) has a cross-sectional configuration of FIG. 7B, and a second portion of catheter 730 (e.g., a distal segment between points B and C shown in FIG. 7A) has a cross-sectional configuration of FIG. 7C.

[0062] Referring now to FIGS. 8A-8C, in an embodiment, in operation, end portion 880 of a guide wire can be exposed beyond the terminal end of catheter 830 (e.g., by extending guide wire 832 out of catheter 830). End portion 880 of guide wire 832 containing a magnetic or ferromagnetic material can then be positioned adjacent to magnetic or ferromagnetic material-containing cover 864 of implant connector 838, such that end portion 880 and cover 864 attract. End portion 880 and cover 864 can ultimately make contact (e.g., magnetically or otherwise couple), which positions the terminal end of catheter 830 in line with implant connector 838.

[0063] Referring further to FIG. 8B, in an embodiment, in operation, the distal end of a sidewall that includes balloon 889 can be positioned around the outer circumference of implant connector 838. This can be done for example, by retracting guide wire 832 into the interior of catheter 830 after end portion 880 makes contact with cover 864, thereby pulling implant connector 838 into the distal end of catheter 830. An increase in fluid pressure to balloon 889 can be applied via an inflation channel (not shown), causing balloon 889 to inflate around implant connector 838. Upon inflation of balloon 889, a leak-proof seal can be formed between the interior-facing surface area of balloon 889 and the exterior-facing surface area of connector body 860 of implant connector 838, securing implant connector 838 within the distal end of catheter 830.

[0064] Referring further to FIG. 8C, in an embodiment, in operation, guide wire 832 can be retracted farther into catheter 830 while end portion is magnetically engaged to cover

864. With inflated balloon 889 securing implant connector 838 in place, the retraction of guide wire 832 can cause plunger 866 to extend through perforated end portion 862. In some embodiments, as a result, apertures 872 may be exposed to suction channel 886, thereby allowing fluid to flow from drainage extension 836 to catheter 830 through apertures 872.

[0065] Referring now to FIG. 9A, a catheter system 990 is shown according to an example embodiment. In an embodiment, catheter system 990 includes controller 992, imaging device 994, display 996, and drainage assembly 926. Patient 991 is an individual upon which the systems and methods of draining fluid as described herein are used. Patient 991 can include, for example, individuals suffering from various types of edemas, or who are at risk of congestive heart failure. Imaging device 994 can be a signal producing device, such that when interpreted by a controller 992, allows a user to determine the location of drainage assembly 926 within patient 991 (e.g., via display 996). Imaging device 994 can include, by way of example, an ultrasound device or wand (e.g., a stereotactic wand), or another suitable imaging device (e.g., a fluoroscopy device, an x-ray device, a magnetic resonance imaging (MRI) device, etc.). Imaging device 994 may interface with controller 992. In some embodiments, controller 992 may be implemented as or in communication with controller 676 shown in FIG. 6.

[0066] In some embodiments, drainage assembly 926 can further include a reference marker. The reference marker corresponds to the type of imaging technology employed by imaging device 994, such that the reference marker can be detected by imaging device 994 to provide an indication of the location of drainage assembly 926 within patient 991. Alternatively or in addition, other visualization techniques may be utilized, including optical coherence tomography (OCT), fluoroscopy, X-ray, heat/pressure probes, etc. In further embodiments, one or more tube portions may be transparent such that a colored die may be inserted within the tube and tracked by imaging device 994. Similarly, one or more components may be radio-opaque to enable visualization of such components (e.g., the magnetic plunger, etc.). Other techniques may be utilized according to various alternative embodiments.

[0067] Controller 992 is in some embodiments a computer-implemented device configured to allow a user to deploy and guide drainage assembly 926. Controller 992 can include display 996 and an input/output device ("I/O device") 998. Controller 992 may receive an imaging signal from imaging device 994, and present an image based on the imaging signal on display 996, such that the imaging signal can be readily perceived and understood by a user. By way of example, display 996 can include digital imaging screens or projection screens, among other audio/visual/tactile devices configured to convey imaging information. I/O device 998 enables a user to manipulate the various functionalities of controller 992, such as guiding movement of catheter 90 or imaging device 994. In various embodiments, I/O device 998 can take the form of one or a combination of a touchscreen interface, a panel of toggle switches or buttons, a joystick, among other possibilities.

[0068] Referring now to FIG. 9B, a schematic diagram of catheter system 990 is shown according to an example embodiment. In addition to the components described with respect to FIG. 9A above, catheter system 990 may also include energy source 904, inflation source 906, and suction source 908. Energy source 904 provides energy (e.g., in the form of heat, light, electricity, and the like) and can cause changes to the energy applied to guide wire 936 disposed along a catheter of drainage assembly 926. As such, energy source 904 can enable guide wire 936 to cause the catheter to move, change shape, and navigate within the vascular system of a person (e.g., patient 991). In some arrangements, energy source 904 and guide wire 936 can be further configured to allow energy source 904 to transmit energy through guide wire 936 to a frame, causing an implant of drainage assembly 926 to change shape. In some embodiments, there can be a separate wire integrated into catheter system 90 that can be used to provide energy to implant 28 and cause implant 28 to change shape. Alternatively, in some embodiments implant 28 may be expanded into a desired position by a balloon similar to a balloon expanded stent. In some embodiments, a combination of mechanical energy (e.g., balloon inflation) and electrical or thermal energy may be used to deploy the implant.

[0069] In some embodiments, inflation source 906 can be a device (e.g., a pump, etc.) configured to increase and decrease fluid pressure. Inflation source 906 can be further configured to engage a port disposed at the proximal end (i.e., closer to controller 992) of an inflation channel within a catheter of drainage assembly 926, increase or decrease the fluid pressure within the inflation channel, and thereby inflate or deflate a balloon (e.g., a balloon of balloon assembly 932 disposed at the distal end of a catheter of drainage assembly 926).

[0070] In some embodiments, suction source 908 can be a device configured to provide a negative fluid pressure (e.g., a vacuum or suction pump, etc.). Suction source 908 can be further configured to engage a port disposed at the proximal end of suction channel 934 within a catheter of drainage assembly 926, lower the fluid pressure within suction channel 934, and thereby draw fluid into suction channel 934 through an opening at the distal end of the catheter.

[0071] In some embodiments, controller 992 may further include central processing unit ("CPU") 900 (e.g., a processor, etc.) and memory 902. Memory 902 is a digital storage medium (e.g., a disc or flash-based hard drive) that may be capable of storing patient data and software programs (e.g., software programs configuring the various aspects of controller 992). CPU 900 is a software-enabled computing device that may be capable of interpreting inputs from the various aspects of catheter system 990 (e.g., imaging device 994, I/O device 998, and the like). CPU 900 may further be configured to access the software on memory 902 and/or inputs from various aspects of catheter system 990 (e.g., I/O device 998) to effectuate certain actions on other aspects of catheter system 990 (e.g., energy source 904, inflation source 906, suction source 908, display 996, and the like). CPU 900 is thus able to cause the various functions described with respect to drainage assembly 926 to occur.

[0072] Referring now to FIG. 10A, according to various embodiments, the deployment of implant 1028 as shown can be accomplished in several ways. In some embodiments, implant 1028 can be implanted while an integrated frame is in a collapsed or low profile configuration with an overall smaller size. Implant 1028 can be surgically deployed in thoracic duct 1010 by directly accessing the space between the terminal valve and the first thoracic valve via a surgical incision. In another arrangement, the terminal valve can be manually opened, a syringe containing implant 1028 can be inserted through the terminal valve, and the syringe can then deploy implant 1028 within thoracic duct 1010. Several other arrangements for deployment are also possible.

[0073] Catheter 1030 can be deployed into a person's venous system such that catheter

1030 approaches implant 1028 through left internal jugular vein 1014. In this particular arrangement, terminal point 1022, and therefore implant 1028, would be disposed at the junction between left internal jugular vein 1014 and left subclavian vein 1018. In embodiments where guide wire 1032 and an implant connector are magnets (or a magnet and a corresponding ferromagnetic material, accordingly), the distal end of catheter 1030 can attract and magnetically couple with and physically engage the implant connector once the distal end of catheter 1030 is in the general vicinity of implant 1028. Further, in embodiments where the frame within implant 1028 includes a shape memory material in a collapsed configuration, guide wire 1032 can be configured to provide energy (e.g., as transmitted by energy source 904 shown in FIG. 9B) to the frame, causing implant 1028 to take on an expanded configuration. When implant 1028 is in an expanded configuration, the outer circumference of an outer wall of implant 1028 may form a leak-proof seal with the interior-facing side of thoracic duct 1010.

[0074] Referring now to FIG. 10B, in an embodiment, alternative terminal point 1022A is disposed in left internal jugular vein 1014. Here, the deployment of both implant 1028 and catheter 1030 can be performed in a similar fashion as discussed with respect to FIG. 10A (e.g., by accessing terminal point 1022A through the left internal jugular vein).

[0075] Referring now to FIG. IOC, in an embodiment, alternative terminal point 1022B is disposed in the person's left subclavian vein 1018. In such an embodiment, catheter 1030 can alternatively be deployed through left subclavian vein 1018. Access via left internal jugular vein 1014 is possible as well.

[0076] Referring now to FIG. 11 A, in some embodiments, in operation, implant 1128 can allow for two aspects of fluid flow. In one aspect, lymph 1124 or another fluid enters implant 1128 through first opening 1152, flows through central bore 1150, and out of second opening 1154 (e.g., traveling along a fluid pressure gradient). In a second aspect, lymph 1124 enters implant 1128 through first opening 1152, flows into central bore 1150, through apertures 1148 in inner wall 1140, into cavity 1146, through drainage extension 1136, and in an embodiment, into a catheter, traveling along a fluid pressure gradient.

[0077] Referring to the second aspect of fluid flow, a suction provided through drainage extension 1136 (e.g., caused by suction source 908 as shown in FIG. 9B and transferred along a catheter) lowers the fluid pressure within cavity 1146, such that the fluid pressure in cavity 1146 is lower than the fluid pressure in central bore 1150. As drainage extension 1136, cavity 1146, and central bore 1150 are in fluid communication with each other (e.g., as discussed with respect to various embodiments illustrated in FIG. 3C, above), lymph 1124 flowing into central bore 1150 from first opening 1152 can therefore also flow out of implant 1128 via drainage extension 1136. The first aspect of fluid flow (i.e., out of second opening 1154) can continue to occur despite the application of a suction through drainage extension 1136. [0078] Referring now to FIG. 11B, in some embodiments, implant 1128 can be deployed within thoracic duct 1010 such that second opening 1154 is adjacent to termination valve 1110, while drainage extension 1136 protrudes through termination valve 1110 and into the person's venous space. In an embodiment, the segment of drainage extension 1136 that comes into contact with terminal valve 1110 has a cross- sectional elliptical shape.

[0079] Additionally, in some embodiments, implant 1128 can be deployed within thoracic duct 1110 such that first opening 1152 is adjacent to first internal valve 1112. In such embodiments, first internal valve can extend through first opening 1152 and into central bore 1150 of implant 1128, and operate as normal.

[0080] Referring now to FIG. 11C, in some embodiments, the second aspect of fluid flow occurs as suction is provided through draining extension 1136 (e.g., using a suction source fluidly coupled to implant connector 1138). The suction may cause all or substantially all of lymph 1124 to flow through apertures 1148 into drainage extension 1136, rather than exiting central bore 1150 via second opening 1154.

[0081] Referring now to FIG. 12, method 1220 of draining fluid from a duct is shown according to an example embodiment. Method 1220 is performed using a drainage assembly. As discussed above with respect to the construction and use of drainage assembly 226, the drainage assembly enables a user to draw fluid from a duct in a patient's body.

[0082] An implant is positioned within a person ( 1224). An implant is an implantable drainage device with an associated drainage extension that allows for both the passive flow of fluid within a duct in one aspect, and a suction of fluid out of the duct in another aspect. In an embodiment, the implant is positioned within a person's thoracic duct such that the implant is disposed between a terminal duct valve at the terminal point of the thoracic duct and a first thoracic valve in the thoracic duct, with an extension protruding out from the terminal valve and into the venous space outside the terminal valve. In an embodiment, the implant can alternate between two configurations, corresponding to the application of an external stimulus (e.g., energy in the form of light, electricity, or heat, or an external stimulus in the form of a magnetic field). In such an embodiment, the implant can be positioned in the thoracic duct by setting the configuration of the implant to a collapsed position, manually opening the terminal valve of the thoracic duct, inserting a syringe, injecting the implant within the thoracic duct after the terminal valve, and setting the implant in an expanded position. The implant can also be positioned in the thoracic duct via a surgical incision in the thoracic duct.

[0083] A guide wire is connected to an implant connector (1224). A guide wire disposed within a) includes an end portion configured to removably engage a corresponding end portion on an implant connector disposed on the extension of the implant. The connection between the end portions are such that a minimum amount of force is required to disengage the guide wire from the implant connector. The minimum amount of force required to disengage the guide wire is greater than the amount of force needed to open the implant connector. In some embodiments, the end portions of the guide wire and the implant connector include magnets, or a magnet and a corresponding ferromagnetic material. In such an embodiment, the guide wire is connected to the implant connector by causing the guide wire to be sufficiently proximal to the implant connector to allow the corresponding magnetic ends to attract and engage each other.

[0084] A seal is formed between the implant connector and a suction catheter (1226). In an embodiment, a suction catheter is disposed around the length of the guide wire, and includes a balloon assembly at the distal end (e.g., the end closest to the implant). In one such embodiment, after the guide wire is connected to the implant connector, the guide wire can translate through the catheter in a proximal direction (i.e., either the guide wire is drawn into the catheter, or the catheter is extended past the guide wire). As such, the balloon assembly at the distal end of the catheter can be disposed about the outer circumference of the implant connector. The seal can be formed by inflating the balloon assembly with an inflation source and an accompanying inflation channel.

[0085] The implant connector is opened (1228). In an embodiment, the implant connector is opened by retracting the connected guide wire farther into the catheter, thereby removing a cover containing a magnetic or ferromagnetic material off of the implant connector.

[0086] A negative pressure is applied to the implant through the implant connector (1230). A negative pressure can be applied through a suction source in fluid communication with a suction channel disposed along the length of the catheter, terminating adjacent to the opened implant connector. As such, the reduction of fluid pressure caused by the suction source travels through the catheter, ultimately causing a reduction of fluid pressure in the implant extension and the interior of the implant itself. As a result, fluid within the implant flows down the resulting fluid pressure gradient, traveling from the implant through the extension, through the implant connector and into the suction channel and ultimately exiting the person's body.

[0087] The present disclosure contemplates methods, systems, and program products on any machine -readable media for accomplishing various operations. The embodiments of the present disclosure may be implemented using existing computer processors, or by a special purpose computer processor for an appropriate system, incorporated for this or another purpose, or by a hardwired system. Embodiments within the scope of the present disclosure include program products comprising machine -readable media for carrying or having machine-executable instructions or data structures stored thereon. Such machine -readable media can be any available media that can be accessed by a general purpose or special purpose computer or other machine with a processor. By way of example, such machine- readable media can comprise RAM, ROM, EPROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to carry or store desired program code in the form of machine-executable instructions or data structures and which can be accessed by a general purpose or special purpose computer or other machine with a processor. When information is transferred or provided over a network or another communications connection (either hardwired, wireless, or a combination of hardwired or wireless) to a machine, the machine properly views the connection as a machine-readable medium. Thus, any such connection is properly termed a machine-readable medium. Combinations of the above are also included within the scope of machine-readable media. Machine-executable instructions include, for example, instructions and data which cause a general purpose computer, special purpose computer, or special purpose processing machines to perform a certain function or group of functions.

[0088] Although the figures may show a specific order of method steps, the order of the steps may differ from what is depicted. Also two or more steps may be performed concurrently or with partial concurrence. Such variation will depend on the software and hardware systems chosen and on designer choice. All such variations are within the scope of the disclosure. Likewise, software implementations could be accomplished with standard programming techniques with rule based logic and other logic to accomplish the various connection steps, processing steps, comparison steps and decision steps. [0089] While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.

Claims

CLAIMS:

1. A drainage assembly, comprising:

an implant including:

a main body having an inner wall defining a central bore from a first opening at a first end to a second opening at a second end, an outer wall configured to engage a vessel wall, an annular cavity disposed between the inner and outer walls, and a plurality of apertures extending through the inner wall and in fluid communication with the cavity and the central bore;

a drainage extension at the second end of the main body including a drainage channel in fluid communication with the cavity; and

an implant connector at a proximal end of the drainage extension configured to be movable between an open position allowing a fluid flow from the drainage channel and a closed position blocking the fluid flow from the drainage channel;

a guide wire member including a distal end, wherein the distal end is engageable to the implant connector to move the implant connector between the closed position to the open position; and

a suction catheter, wherein the suction catheter receives at least a portion of the implant connector and includes a suction channel, and wherein the suction channel is in fluid flow receiving communication with the drainage channel when the implant connector is in the open position.

2. The drainage assembly of claim 1, wherein the implant further includes a frame disposed in at least one of the inner wall and the outer wall, wherein the frame is movable to reconfigure the main body between a collapsed configuration and an expanded configuration.

3. The drainage assembly of claim 2, wherein the frame includes a light- responsive shape memory material.

4. The drainage assembly of claim 1, wherein the drainage assembly is further configured such that a first portion of fluid passing through the first opening at the first end of the central bore passes through the second opening at the second end of the central bore, and a second portion of fluid passing through the first opening at the first end of the central bore passes through the plurality of apertures and through the drainage extension.

5. The drainage assembly of claim 1, wherein the main body further includes a plurality of support members, each of the plurality of support members coupled to the inner wall and the outer wall, wherein the plurality of support members maintain a distance between the inner wall and the outer wall within the cavity when a negative pressure is applied to the cavity through the suction catheter.

6. The drainage assembly of claim 1, wherein the implant connector includes a magnetic cover movable between the open position and the closed position relative to a connector body, wherein the distal end of the guide wire member includes a magnetic end, and wherein the magnetic end of guide wire member magnetically couples to the magnetic cover of the connector body.

7. The drainage assembly of claim 6, wherein the connector body includes a central bore extending therethrough and a one way valve disposed within the central bore.

8. The drainage assembly of claim 6, wherein the implant connector includes an elastic retaining member extending between the connector body and the magnetic cover and providing a biasing force tending to dispose the magnetic cover toward the connector body.

9. The drainage assembly of claim 1, wherein the suction catheter further includes a balloon assembly disposed at a distal end thereof, wherein the balloon assembly is inflatable to form a seal between the implant connector and an inner surface of the suction catheter.

10. An implantable device, comprising:

a main body having an inner wall defining a central bore from a first opening at a first end to a second opening at a second end, an outer wall configured to engage a vessel wall, an annular cavity disposed between the inner and outer walls, and a plurality of apertures extending through the inner wall and in fluid communication with the cavity and the central bore; a frame disposed within the main body, the frame including a shape memory material, wherein the shape memory material is responsive to application of energy to move the main body from a collapsed configuration to an expanded configuration;

a drainage extension at the second end including a drainage channel in fluid communication with the cavity; and

an implant connector at a proximal end of the drainage extension configured to be movable between an open position allowing a fluid flow from the drainage channel and a closed position blocking the fluid flow from the drainage channel.

11. The implantable device of claim 10, wherein the frame is disposed in at least one of the inner wall and the outer wall.

12. The implantable device of claim 10, wherein the drainage assembly is further configured such that a first portion of fluid passing through the first opening at the first end of the central bore passes through the second opening at the second end of the central bore, and a second portion of fluid passing through the first opening at the first end of the central bore passes through the plurality of apertures and through the drainage extension.

13. The implantable device of claim 10, wherein the main body further includes a plurality of support members, each of the plurality of support members coupled to the inner wall and the outer wall, wherein the plurality of support members maintain a distance between the inner wall and the outer wall within the cavity when a negative pressure is applied to the cavity through the suction catheter.

14. The implantable device of claim 10, wherein the implant connector includes a magnetic cover movable between the open position and the closed position relative to a connector body.

15. The implantable device of claim 14, wherein the implant connector includes an elastic retaining member extending between the connector body and the magnetic cover and providing a biasing force tending to dispose the magnetic cover toward the connector body.

16. A method of draining fluid from a duct, comprising: positioning an implant within a duct of a person, wherein the implant includes: a main body having an inner wall defining a central bore from a first opening at a first end to a second opening at a second end, an outer wall configured to engage a vessel wall, an annular cavity disposed between the inner and outer walls, and a plurality of apertures extending through the inner wall and in fluid communication with the cavity and the central bore;

engaging the implant connector with a guide wire member to move the implant connector from a closed position to an open position; and

applying a negative pressure through the implant connector and to the cavity to draw fluid from the central bore through the plurality of apertures, into the cavity, and toward the implant connector.

17. The method of claim 16, further comprising extending a suction catheter over at least a portion of the implant connector and inflating a balloon assembly between the implant connector and an inner surface of the suction catheter.

18. The method of claim 16, wherein engaging the implant connector with the guide wire member includes forming a magnetic coupling between an end of the guide wire member and a cover of the implant connector.

19. The method of claim 16, wherein the duct is a thoracic duct and the fluid is lymphatic fluid.

20. The method of claim 19, wherein positioning the implant within the duct includes positioning the implant between a terminal valve of the thoracic duct and an adjacent internal valve of the thoracic duct.