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Title:
SYSTEMS AND METHODS FOR RESERVOIR WITH INLET-OUTLET CONNECTORS HAVING UNIDIRECTIONAL VALVES
Document Type and Number:
WIPO Patent Application WO/2018/087642
Kind Code:
A1
Abstract:
Systems and methods for draining fluid out of a patient's body are described. An implant assembly includes a first connector having a first main passage with a first connector port, and a second connector having a second main passage with a second connector port. The implant assembly also includes a reservoir assembly with an interior in fluid communication with an inlet port, an outlet port, and a drainage port. A filter member is disposed in the interior across a fluid path from the inlet port to the outlet port. An inlet conduit is in fluid communication with the first connector port and the inlet port, an outlet conduit is in fluid communication with the outlet port and the second connector port, and a drainage conduit is in fluid communication with the drainage port and an exit port.

Inventors:
SHELKE RAJESH TULSIRAM (IN)
PARAKH SATYAJEET (US)
Application Number:
PCT/IB2017/056914
Publication Date:
May 17, 2018
Filing Date:
November 06, 2017
Export Citation:
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Assignee:
EMPIRE TECHNOLOGY DEV LLC (US)
International Classes:
A61M1/34
Domestic Patent References:
WO2014015377A12014-01-30
Foreign References:
US4411792A1983-10-25
US5807356A1998-09-15
US20120029466A12012-02-02
US20090287178A12009-11-19
US20090277850A12009-11-12
US20090234266A12009-09-17
US6022333A2000-02-08
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Claims:
Claims:

1. An implant assembly, comprising:

a first connector including a first main passage disposed between opposing open ends of the first connector and in fluid communication with a first connector port disposed between the opposing open ends of the first connector;

a second connector including a second main passage disposed between opposing open ends of the second connector and in fluid communication with a second connector port disposed between the opposing open ends of the second connector;

a reservoir assembly including an interior, an inlet port, an outlet port, a drainage port, and a filter member, wherein the interior is in fluid communication with the inlet port, the outlet port, and the drainage port, and wherein the filter member is disposed in the interior across a fluid path from the inlet port to the outlet port;

an inlet conduit coupled to and providing fluid communication between the first connector port and the inlet port;

an outlet conduit coupled to and providing fluid communication between the outlet port and the second connector port; and

a drainage conduit coupled to and proving fluid communication between the drainage port and an exit port.

2. The implant assembly of claim 1, wherein the filter member defines a first chamber and a second chamber in the interior of the reservoir.

3. The implant assembly of claim 1, wherein the first connector port includes a first connector valve, wherein the first connector valve is a unidirectional valve permitting fluid flow from the first main passage toward the inlet conduit, and wherein the second connector port includes a second connector valve, wherein the second connector valve is a unidirectional valve permitting fluid flow from the outlet conduit toward the second main passage.

4. The implant assembly of claim 1, wherein the first and second connectors are T- shaped connectors.

5. The implant assembly of claim 1, wherein the first and second connectors are implantable within a person, and wherein the reservoir and the exit port are implantable within the person.

6. An implant assembly, comprising:

first and second implantable connectors;

a reservoir assembly including an interior and a drainage port, wherein the interior is in fluid communication with the first and second implantable connectors and the drainage port; and

a filter disposed within the interior and defining a first chamber and a second chamber, wherein the first chamber is in fluid communication with the first connector, and wherein the second chamber is in fluid communication with the first chamber and the second connector.

7. The implant assembly of claim 6, wherein the first and second implantable connectors include unidirectional valves such that fluid is permitted to flow through the first connector only toward the reservoir assembly and through the second connector only away from the reservoir assembly.

8. The implant assembly of claim 6, further comprising an exit port in fluid receiving communication with the drainage port and implantable beneath the skin of a person such that fluid within the exit port is accessible by way of a needle from an exterior of the person.

9. A method of directing fluid through an implant, comprising:

positioning a first main passage of a first connector within a duct and in line with a fluid flow in the duct at a first location;

positioning a second main passage of a second connector within the duct and in line with the fluid flow in the duct at a second location;

fluidly coupling an interior of a reservoir to the first and second main passages of the first and second connectors;

receiving fluid at the interior of the reservoir from the duct via the first main passage of the first connector; and

selectively directing the fluid from the interior of the reservoir to one of the second main passage of the second connector and an exit port fluidly coupled to a drainage port disposed at the reservoir, based on a pressure within at least one of the duct and the exit port.

10. The method of claim 9, further comprising directing fluid within the interior of the reservoir from a first chamber through a filter to a second chamber, wherein the first chamber receives fluid from the first main passage of the first connector and wherein the second main passage of the second connector receives fluid from the second chamber.

Description:
SYSTEMS AND METHODS FOR RESERVOIR WITH INLET-OUTLET CONNECTORS HAVING UNIDIRECTIONAL VALVES

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] One embodiment relates to a catheter assembly. The catheter assembly includes a first connector including a first main passage disposed between opposing open ends of the first connector and in fluid communication with a first connector port disposed between the opposing open ends of the first connector. The catheter assembly further includes a second connector including a second main passage disposed between opposing open ends of the second connector and in fluid communication with a second connector port disposed between the opposing open ends of the second connector. The catheter assembly includes a reservoir assembly including an interior, an inlet port, an outlet port, a drainage port, and a filter member, wherein the interior is in fluid communication with the inlet port, the outlet port, and the drainage port, and wherein the filter member is disposed in the interior across a fluid path from the inlet port to the outlet port. The catheter assembly further includes an inlet conduit coupled to and providing fluid communication between the first connector port and the inlet port. The catheter assembly includes an outlet conduit coupled to and providing fluid communication between the outlet port and the second connector port. The catheter assembly further includes a drainage conduit coupled to and proving fluid communication between the drainage port and an exit port. [0004] Another embodiment relates to an implant assembly. The implant assembly includes first and second implantable connectors. The implant assembly further includes a reservoir assembly including an interior and a drainage port, wherein the interior is in fluid communication with the first and second implantable connectors and the drainage port. The implant assembly includes a filter disposed within the interior and defining a first chamber and a second chamber, wherein the first chamber is in fluid communication with the first connector, and wherein the second chamber is in fluid communication with the first chamber and the second connector.

[0005] Another embodiment relates to a method of directing fluid through an implant. The method includes positioning a first main passage of a first connector within a duct and in line with a fluid flow in the duct at a first location. The method further includes positioning a second main passage of a second connector within the duct and in line with the fluid flow in the duct at a second location. The method includes fluidly coupling an interior of a reservoir to the first and second main passages of the first and second connectors. The method further includes receiving fluid at the interior of the reservoir from the duct via the first main passage of the first connector. The method includes selectively directing the fluid from the interior of the reservoir to one of the second main passage of the second connector and an exit port fluidly coupled to a drainage port disposed at the reservoir, based on a pressure within at least one of the duct and the exit port.

[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 an illustrative diagram of a segment of a venous system including a thoracic duct according to one embodiment.

[0008] FIG. 2 is an illustrative diagram of an implant assembly deployed on a venous system according to one embodiment. [0009] FIG. 3 is a schematic diagram of a deployed implant assembly, showing possible directions of fluid flow through the assembly according to one embodiment.

[0010] FIG. 4 is an illustrative diagram of a connector according to one embodiment.

[0011] FIG. 5A is an illustrative diagram of a frontal view of an example unidirectional fluid valve in a closed configuration according to one embodiment.

[0012] FIG. 5B is an illustrative diagram of a frontal view of an example unidirectional fluid valve in an open configuration according to one embodiment.

[0013] FIG. 5C is an illustrative diagram of an angled view of an example unidirectional fluid valve in an opened configuration according to one embodiment.

[0014] FIG. 6 is an illustrative diagram of an alternative example unidirectional fluid valve in an open configuration according to one embodiment.

[0015] FIG. 7A is an illustrative diagram of an end portion of a conduit according to one embodiment.

[0016] FIG. 7B is an illustrative diagram of a tip of conduit according to one embodiment.

[0017] FIG. 8 is an illustrative diagram of a reservoir assembly according to one embodiment.

[0018] FIG. 9 is an illustrative diagram of an exit port according to one embodiment.

[0019] FIG. 10 is an illustrative diagram of a user accessing an exit port of an implant assembly according to one embodiment.

[0020] FIGS. 11A-D are illustrative diagrams showing the deployment of a reservoir assembly according to one embodiment.

[0021] FIG. 12A is an illustrative diagram showing the location of an example deployment of a reservoir assembly within a patient's body according to one embodiment. [0022] FIG. 12B is an illustrative diagram showing the location of an example deployment of an exit port within a patient's body according to one embodiment according to one embodiment.

[0023] FIG. 13 is an illustrative diagram of a reservoir assembly showing the flow of fluid from a first chamber to a second chamber according to one embodiment.

[0024] FIG. 14A is an illustrative diagram of a deployed implant assembly showing the flow of fluid from a duct into a first chamber of a reservoir assembly according to one embodiment.

[0025] FIG. 14B is an illustrative diagram of a deployed implant assembly showing the flow of fluid from a second chamber of a reservoir assembly into a duct according to one embodiment.

[0026] FIG. 14C is an illustrative diagram of a deployed implant assembly showing the flow of fluid from a duct through a first chamber of a reservoir assembly and into an exit port according to one embodiment.

[0027] FIG. 15 is block diagram of a method of draining fluid from a duct within a patient's body according to one embodiment.

DETAILED DESCRIPTION

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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 into the venous system to the venous system, out of the body, to a temporary storage reservoir, etc.

[0032] Referring now to FIG. 1, thoracic duct 10 and a portion of a venous system of a person are shown according to an example. 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 into blood 25 in the veins. While in one arrangement, terminal point 22 of thoracic duct 10 is located at junction 20, in other arrangement, 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. The various embodiments disclosed herein may be applicable to any of these arrangements. [0033] Referring now to FIG. 2, an illustrative diagram of implant assembly 226 is shown according to an example embodiment. Implant assembly 226 can include a first connector 228, a second connector 230, a reservoir assembly 236, and an exit port 248. First connector 228 can be deployed into thoracic duct 210 at an upstream location relative to the location of second connector 230. First connector 228 can also be connected to inlet conduit 232, which in turn is connected to inlet port 238 of reservoir assembly 236. Second connector 230 can be deployed into thoracic duct 210 at a downstream location relative to first connector 228. Second connector 230 can be connected to an outlet conduit 34, which in turn is connected to outlet port 240 of reservoir assembly 236. Exit port 248 can be connected to drainage conduit 246, which in turn is connected to a drainage port 244 of reservoir assembly 236. The features and operation of these various components of FIG. 2 are discussed with regards to various embodiments in more detail below.

[0034] Referring to FIG. 3, a schematic diagram of implant assembly 326 in a deployed configuration is shown according to an example embodiment. Implant assembly 326 can be similar to various implant assemblies disclosed herein (e.g., implant assembly 226). First connector 328 can be a flexible, three-way tube junction with a hollow bore extending the entirety of first connector 328 in three directions with openings at each end, as discussed, for example, with respect to FIG. 4, below. In some embodiments, first connector 328 may further include a passive, unidirectional first connector valve 350 disposed at one opening. First connector 328 can be deployed in fluid communication with the flow of fluid through duct 310 (e.g., a thoracic duct, etc.) at an upstream location relative to second connector 330 (which shares similar or identical structural features with first connector 228), and can be further deployed in fluid communication with inlet conduit 332. Inlet conduit 332 can be a flexible tube extension with openings at both ends and a hollow bore spanning the length between both ends of inlet conduit 332, with one end in fluid communication with first connector 328, and a second end in fluid communication with inlet port 338. As shown in FIG. 3, fluid in duct 310 flowing downstream into first connector 328 can either flow straight through first connector 328 and remain in duct 310, or the fluid can alternatively flow through first connector valve 350 and into inlet conduit 332. [0035] Still referring to FIG. 3, according to an embodiment, reservoir assembly 336 may be a flexible, hollow, leak-proof fluid compartment with three apertures (e.g., inlet port 338, outlet port 340, and drainage port 344) that allow fluid to flow into and out of interior 342 of reservoir assembly 336. In some embodiments, reservoir assembly 336 can expand and contract as the fluid volume within increases and decreases. Reservoir assembly 336 can include inlet port 338, drainage port 344, outlet port 340, and filter member 362. In one embodiment, filter member 362 may be a passive, semi-permeable membrane that selectively allows reusable fluid (e.g., fluid— including cells and other beneficial or benign particulate matter— that is suitable to return to thoracic duct 10 and ultimately a patient's vascular system) to flow through it. In some embodiments, the membrane allows most lymphatic proteins to pass through along with some other constituents. The membrane may have a pore size between 0.001 um (micrometer) up to 15 um. In some embodiments the filter could also or alternatively be designed based on polar changes on the membrane to selectively allow certain proteins and other cells, such as Red Blood Cells (RBC), White Blood Cells (WBC) or Platelets to pass through. In some embodiments, filter member 362 may span an entire cross section of interior 342, dividing interior 342 into first chamber 358 and second chamber 360. As such, fluid in first chamber 358 cannot flow to second chamber 360 without passing through filter member 362, and vice- versa. The filter member 362 may define the first chamber 358 and the second chamber 360 in the interior 342 of the reservoir assembly 336.

[0036] Still referring to FIG. 3, according to an embodiment, first chamber 358 is shown to include inlet port 338 and drainage port 344. Inlet port 338 and drainage port 344 may define apertures in fluid communication with first chamber 358 in interior 342. Inlet port 338 provides fluid connection between inlet conduit 332 and first chamber 358. In some embodiments, inlet port 338 can include a passive, unidirectional inlet port valve 354 that allows fluid to flow from inlet conduit 332 into first chamber 358. In some embodiments, inlet port valve 354 requires a minimum fluid pressure differential before allowing fluid to flow into first chamber 358.

[0037] Still referring to FIG. 3, according to an embodiment, drainage port 344 can provide fluid communication between drainage conduit 346 and first chamber 358. In an embodiment, drainage conduit 346 can be a flexible tube extension with openings at both ends and a hollow bore spanning the full length of drainage conduit 346, with one end in fluid communication with drainage port 344, and a second end in fluid communication with exit port 348. In some embodiments, drainage port 344 can include drainage port valve 364 that regulates the flow of fluid at drainage port 344. In some embodiments, drainage port valve 364 can be a unidirectional valve that requires a minimum fluid pressure differential before allowing fluid to flow from first chamber 358 to drainage conduit 346. In other embodiments, drainage port valve 364 can be a passive bidirectional valve, allowing fluid to flow in and out of drainage port 344.

[0038] Still referring to FIG. 3, in an embodiment, exit port 348 can be in fluid communication with drainage conduit 346 and include a drainage area 366. In an embodiment, exit port 348 may be a fluid compartment with an aperture leading to drainage conduit 346. Drainage area 366 is a portion of exit port 348 that selectively allows fluid to flow through it. In various embodiments (e.g., as discussed with respect to FIGS. 9 and 10, below), a drainage area of an implant assembly can be punctured, opened, or otherwise accessed by a user in order to manipulate the fluid pressure of the fluid within exit port 348.

[0039] Still referring to FIG. 3, according to an embodiment, second chamber 360 can include outlet port 340. In an embodiment, outlet port 340 may provide fluid communication between second chamber 360 and outlet conduit 334. Outlet conduit 334 can be a flexible tube extension with openings at both ends and a hollow bore spanning the full length of outlet conduit 334, with one end in fluid communication with outlet port 340, and a second end in fluid communication with second connector 330. In some embodiments, outlet port 340 may include a passive, unidirectional outlet port valve 356 that allows fluid to flow from second chamber 360 into outlet conduit 334. In some embodiments, outlet port valve 356 may require a minimum fluid pressure differential before allowing fluid to flow into outlet conduit 334.

[0040] Still referring to FIG. 3, in an embodiment, second connector 330 can be a flexible tube junction with a hollow bore extending the entirety of second connector 330 in three directions with three openings, as similarly discussed below with respect to first connector 428 shown in FIG. 4. Second connector 330 can be deployed in fluid communication with the flow of fluid through thoracic duct 10 at a downstream location relative to first connector 328, and also be deployed in fluid communication with outlet conduit 334. In some embodiments, second connector 330 may further include a passive, unidirectional second connector valve 352 disposed at the opening in fluid communication with outlet conduit 334, as shown here. Fluid in outlet conduit 334 can enter second connector 330 and subsequently re-enter the thoracic duct 10.

[0041] Referring now to FIG. 4, an illustrative diagram of first connector 428 is shown according to an example embodiment. First connector 428 may be in one embodiment a flexible, leak proof, "T"-shaped tube junction extending in three directions, with a hollow bore extending through the entire length of first connector 428 in each direction with an opening at each end. First connector 428 can include first passageway 468 allowing a straight flow of fluid entering from one opening and exiting at an opposite opening, and a second passageway 470 allowing a perpendicular flow of fluid, entering from one opening and exiting at an adjacent opening. First passageway 468 and second passageway 470 share a common upstream fluid entry opening in first connector 428. In some embodiments, first connector 428 may further include unidirectional first connector valve 450, disposed at the exit opening of second passageway 470. First connector valve 450 may initially be in a closed position, but allows fluid to flow out of the exit opening of second passageway 470, upon fluid pressure exceeding a threshold pressure differential across first connector valve 450. If the pressure differential across first connector valve 450 is insufficient to open the valve, fluid in the first connector 428 will continue down first passageway 468 and exit out the opposite opening back into the duct. Second connectors and second connector valves as discussed herein can take on a similar configuration.

[0042] Referring now to FIG. 5A, an illustrative diagram of first connector valve 550 in a resting, closed configuration is shown according to an example embodiment. First connector valve 550 can include a body 572 and flaps 574. Body 572 can be in one embodiment a rigid or semi-rigid circular housing configured to provide structural integrity to first connector valve 550 and to accommodate flaps 574 disposed within. Body 572 can be of a sufficient size to engage the entire inner circumference of the conduit, connector, or port wherein the valve may be deployed. Here, flaps 574 can be panels disposed within body 572 such that flaps 574 form a leak-proof or nearly leak-proof seal with body 572 in the resting or closed configuration shown in FIG. 5A.

[0043] Referring now to FIG. 5B, an illustrative diagram of a first connector valve 550 in an open configuration is shown according to an example embodiment. Flaps 574 can pivot outward about an extension spanning the diameter of body 572 upon the application of a minimum amount of fluid pressure on the back side of flaps 574. In other words, flaps 574 may resist pivoting until a minimum amount of net force pushes flaps 574 open. An indented seat 580 around the inner circumference of body 572 can be configured to engage flaps 574 as they pivot back inward with a reduction in fluid pressure, such that flaps 574 and seat 580 create a leak-proof or nearly leak-proof seal in the closed configuration shown in FIG. 5A if the fluid pressure falls below some minimum level.

[0044] Referring now to FIG. 5C, an illustrative diagram indicating the direction of a fluid flow 582 through a first connector valve 550 is shown according to an example embodiment. As a result of fluid flow 582 providing a sufficient amount of fluid pressure, first connector valve 550 is in the open configuration as shown in FIG. 5B. As fluid flow 582 decreases, flaps 574 ma pivot inwards towards body 572, ultimately coming to rest in a seat (e.g., seat 580) disposed about the inner circumference of body 572 and preventing further flow of fluid. Embodiments of first connector valve 50 as discussed with regards to FIG. 5C may also be used for any of the one-way fluid valves discussed (e.g., inlet port valve 354, outlet port valve 356, etc.).

[0045] Referring now to FIG. 6, an illustrative diagram of alternative valve 684 in an open configuration is shown according to an example embodiment. Alternative valve 64 can be used for any of the one-way fluid valves discussed (e.g., inlet port valve 354, outlet port valve 356, etc.). Alternative valve 684 can include body 686, flap 688, hinge portion 690, and seat 692. Body 686 can be in one embodiment a rigid or semi-rigid circular housing configured to provide structural integrity to first alternative valve 684 and to accommodate flap 688 disposed within. Body 686 can include seat 692, which is indented around the inner circumference of body 686 and configured to form a leak-proof or nearly leak-proof seal when engaged with flap 688. Flap 688 can be in an embodiment a panel attached to a hinge member 690, and can be configured to engage the full circumference of seat 692 when alternative valve 684 is in a closed configuration. Hinge member 690 can be a pivot disposed between body 686 and flap 688, and be configured to resist a pivoting motion until a set minimum amount of net force (e.g., a fluid flow 694) is applied to flap 688. Below the minimum amount of force, hinge member 90 can be configured to cause flap 688 to engage the full circumference of seat 692. Here, fluid flow 694 is shown as having provided a sufficient amount of net force to flap 688, causing hinge member 690 to pivot, and opening alternative valve 684.

[0046] Referring now to FIG. 7A, an illustrative diagram of a conduit, here inlet conduit 732, is shown according to an example embodiment. At either end of inlet conduit 732 as shown is an end portion 796 that can include a connecting portion 798 at the tip of end portion 796.

[0047] Referring now to FIG. 7B, an illustrative diagram of an end portion of an inlet conduit (e.g., end portion 796 of inlet conduit 732, etc.) is shown according to an example embodiment. Disposed about the inner circumference of the tip of the end portion is connecting portion 798. Connecting portion 798 can be configured to engage an inlet port (e.g., inlet port 238). As shown in FIG. 7B, the inner circumference of connecting portion 798 may include ribs or threads capable of engaging corresponding ribs or threads disposed about the outer circumference of an inlet or other port. In other embodiments, connecting portion 798 can be made up of an elastic material that can stretch and adhere to the outer circumference of an inlet port. Other similar arrangements are also possible. Although FIGS. 7A-B are described with respect to inlet conduit 732, similar arrangements can also be applied to other conduits of the implant assembly (e.g., outlet conduit 234 and/or drainage conduit 246, etc.).

[0048] Referring now to FIG. 8, an illustrative diagram of reservoir assembly 836 is shown according to an example embodiment. Inlet port 838 and drainage port 844 can be in fluid communication with first chamber 858, while outlet port 840 can be in fluid communication with second chamber 860. Although FIG. 8 shows a particular arrangement as to the respective locations of the ports in first chamber 858 and second chamber 860, the ports can be located in various positions according to various alternative embodiments, so long as filter member 862 separates the chamber in which inlet port 838 is disposed from the chamber in which outlet port 840 is disposed. Further, any, all, or none of the ports may also include pressure sensitive valves in various embodiments.

[0049] Referring now to FIG. 9, an illustrative diagram of exit port 948 is shown according to an example embodiment. Exit port 948 can be in the portion of an implant assembly where, after implantation, a user can access and remove excess fluid from a patient's body. In some embodiments, exit port 948 can be deployed inside a patient's body adjacent to the remainder of the implant assembly. In other embodiments, exit port 948 can be deployed outside a patient's body while the remainder of implant assembly 926 is deployed inside the patient's body. Exit port 948 may be in one embodiment a fluid compartment that includes or is in fluid communication with an end portion of drainage conduit 946, an exit connector 950, and a drainage area 952. Exit connector 950 may engage and be in fluid communication with drainage conduit 946 at exit port 948 such that fluid can flow from drainage conduit 946 into exit port 948. Drainage area 952 is an aperture in exit port 948 that a user can access to draw fluid from an implant assembly. Various arrangements wherein a user draws fluid out of an implant assembly through drainage area 952 are possible. In some embodiments, drainage area 952 may be a leak-proof, self-healing material that a user can repeatedly puncture with a hollow needle. In other embodiments, drainage area 952 may be a highly fluid-resistant material that requires a strong negative pressure differential across it (e.g., an attached coupling to a suction device) before fluid can flow through it. In yet other embodiments, drainage area 952 may be a one-way flap that can be opened during a fluid draining process.

[0050] Referring now to FIG. 10, an illustrative diagram of a deployed drainage assembly 1004 is shown according to an example embodiment. In this particular embodiment, exit port 1048 can be deployed in an area underneath a patient's skin 1012, such that a user can manually palpate the area of skin 1012 and locate exit port 1048. A drainage area (e.g., drainage area 952, etc.) may be disposed on exit port 1048 such that the drainage area faces outward (i.e., toward the underside of skin 1012). [0051] Still referring to FIG. 10, according to an embodiment, needle 1006, tube 1008, and syringe 1010 are shown engaged to drainage assembly 1004. Needle 1006 can be a thin extension with a hollow bore extending from at least one aperture at a sharpened tip, and to another aperture at the opposite end of needle 1006. Needle 1006 can be connected to and in fluid communication with hollow tube 1008, which in turn can be connected to and in fluid communication with syringe 1010. Syringe 1010 is a device capable of causing an increase or decrease of pressure through tube 1008 and needle 1006. In some embodiments, syringe 1010 can include a chamber with a movable plunger concentrically disposed within the length of the chamber that, when pulled or pushed, increases or decreases the fluid volume within the chamber. Upon inserting needle 1006 into exit port 1048, a continuous fluid conduit can be formed that includes drainage conduit 1046, exit port 1048, needle 1006, tube 1008, and syringe 1010.

[0052] Still referring to FIG. 10, according to an embodiment, needle 1006 is shown inserted through skin 1012, through a drainage area, and into exit port 1048. The air and/or fluid pressure within syringe 1010 can be decreased (e.g., by pulling a plunger disposed within syringe 1010), and as syringe 1010 is disposed in a continuous fluidic circuit that includes exit port 48, the decreased pressure in syringe 110 can cause a negative pressure differential across the segment of needle 1006 with an aperture deployed within the interior of exit port 1048. As a result, fluid can flow from drainage conduit 1046, into exit port 1048, into drainage assembly 1004 and out of the body via needle 1006.

[0053] Referring now to FIG. 11 A, the deployment of first connector 1128 and second connector 1130 is shown according to an example embodiment. Relative to the flow of lymph (e.g., lymph 24) through thoracic duct 1110 and out into a patient's venous system, first connector 1128 can be deployed in an upstream position in thoracic duct 1110 and second connector 1130 can be deployed in a downstream position in thoracic duct 1110. First connector 1128 and second connector 1130 can be hollow "T"-shaped tube junctions, similar to connectors 428, 430 as shown and discussed with respect to FIG. 4 above. Deployment of first connector 1128 and second connector 1130 can be accomplished in various ways. For example, a first connector 1128 can be deployed by first compressing and inserting first connector 1128 into a hollow needle such that the "top" of first connector 1128 (i.e., the middle of the flat top section of the "T"-shaped tube, or the center of that portion of either connector forming a first passageway similar to first passage 468) faces the tip of the needle and each of the three tube openings of first connector 1128 faces away from the tip of the needle (i.e., the side branches of the "T"-shaped tube are compressed onto either side of the center section of the tube, forming a flattened arrow shape). The needle can then be inserted into an upstream section of thoracic duct 1110, where first connector 1128 can be pushed out of the needle and into thoracic duct 1110. As first connector 1128 exits the hollow needle, the side branches of first connector 1128 can unfold and extend in an upstream and downstream direction, while the center section tube of first connector 1128 can protrude out of the opening in thoracic duct 1110 created by the needle, as shown in FIG. 11A.

[0054] Referring now to FIG. 1 IB, deployed inlet conduit 1132 and outlet conduit 1134 are shown according to an example embodiment. After first connector 1128 and second connector 1130 are deployed (e.g., as discussed with respect to FIG. 11 A), inlet tube 1132 can engage first connector 1128 and outlet tube 1134 can engage second connector 1130. Inlet tube 1132 and outlet tube 1134 can engage their respective connectors via connecting portions (e.g., connecting portions 1198) disposed at end portions (e.g., end portion 1196) of the tubes, as discussed, for example, with respect to end portion 796 and connecting portion 798 of FIGS. 7 A and 7B. Second connector 1130 can be implanted in a similar manner.

[0055] Referring now to FIG. 11C, deployed reservoir assembly 1136 is shown according to an example embodiment. Inlet tube 1132 can engage a port (e.g., inlet port 238) on reservoir assembly 1136 via a corresponding set of connecting portions (e.g., as discussed with respect to FIGs. 7A and 7B, above) on inlet tube 1132 and the port. Outlet tube 1134 can engage a separate port (e.g., outlet port 1140) on reservoir assembly 1136, also via a corresponding set of connecting portions.

[0056] Referring now to FIG. 11D, deployed exit port 1148 is shown according to an example embodiment. Drainage conduit 1146 can connect exit port 1148 to reservoir assembly 1136 via corresponding sets of connecting portions (e.g., as discussed with respect to FIGs. 7 A and 7B, above) at either end of drainage conduit 1146. At this point, the implant assembly (e.g., implant assembly 226) can be fully deployed. [0057] Referring now to FIG. 12A, a placement of deployed reservoir assembly 1236 in the body of person 1214 is shown according to an example embodiment. Reservoir assembly 1236 can be deployed such that it is placed beneath the skin of person 1214, and within a reasonably close proximity to the thoracic duct in the body of person 1214. In other embodiments, reservoir assembly 1236 can be deployed externally, such that reservoir assembly 1236 is outside the body of patient 1214.

[0058] Referring now to FIG. 12B, a placement of deployed exit port 1248 in the body of person 1214 is shown according to an example embodiment. Exit port 1248 is shown as deployed at a more superficial location (i.e., at a shallow depth, or just under the skin) on the body of person 1214, relative to the reservoir assembly. In this particular arrangement, fluid accumulating within a reservoir assembly (e.g., reservoir assembly 1236) can be accessed and drained as discussed with respect to FIG. 10. In other embodiments, exit port 1248 can be deployed externally, such that exit port 1248 is disposed outside of the body of person 1214, while the remainder of the implant assembly is deployed inside the body of person 1214.

[0059] Referring now to FIG. 13, reservoir assembly 1336 is shown according to an example embodiment. Reservoir assembly 1336 can be divided into first chamber 1358 and second chamber 1360 by filter member 1362. As shown, fluid can travel down inlet conduit 1332 and into first chamber 1358, where, upon a sufficient pressure differential across filter member 1362, the fluid can cross into second chamber 1360. If the fluid pressure within reservoir assembly is sufficiently high, fluid can flow out of outlet conduit 1334. In some embodiments, the flow of fluid out through outlet conduit 1334 can be controlled by pressure-regulated one-way valves disposed within outlet conduit 1334 (and/or associated ports). In other embodiments, flow of fluid out through outlet conduit 1334 can be controlled by the minimum pressure required for the fluid to cross filter member 1362 into second chamber 1360. In yet other arrangements, flow of fluid out through outlet conduit 1334 can be controlled by a combination of filter member 1362 and pressure-regulated one-way valves disposed within outlet conduit 1334.

[0060] Referring now to FIG. 14A, one aspect of deployed implant assembly 1426 is shown according to an example embodiment. In this aspect, fluid pressure in thoracic duct 1410 can be sufficiently high to open any one-way valves disposed within inlet conduit 1432 (e.g., valves that may be similar to first connector valve 350 and inlet port valve 354) and to overcome the fluid pressure within reservoir assembly 1436. As such, fluid flow 1418 may travel from thoracic duct 1410 into inlet conduit 1432 and into a first chamber disposed within reservoir assembly 1436. Fluid flow 1418 can result in an accumulation of fluid in reservoir assembly 1436.

[0061] Referring now to FIG. 14B, another aspect of deployed implant assembly 1426 is shown according to an example embodiment. In this aspect, fluid pressure within first chamber 1458 of reservoir assembly 1436 can be sufficient to allow for the flow of fluid through filter assembly 1462 into second chamber 1460. In some embodiments, outlet conduit 1434 can include pressure-regulated one-way valves (e.g., outlet port valve 1456 and second connector valve 1452) that require a minimum fluid pressure differential in order for fluid to flow out of second chamber 1460. In such arrangements, fluid flow 1420 can travel out of second chamber 1460 and back into thoracic duct 1410 via outlet conduit 1434 if the fluid pressure within reservoir assembly 1436 is sufficiently high to open any one-way valves associated with outlet conduit 1434, and to overcome the fluid pressure exerted in thoracic duct 1410. In other arrangements without pressure -regulated one-way valves associated with outlet conduit 1434, if the fluid pressure in second chamber 1460 is greater than the fluid pressure in thoracic duct 1410, fluid flow 1420 can travel out of second chamber 1460 and back into thoracic duct 1410 via outlet conduit 1434.

[0062] Referring now to FIG. 14C, yet another aspect of deployed implant assembly 1426 is shown according to an example embodiment. In this aspect, similar to FIG. 14A, fluid pressure in thoracic duct 1410 can be sufficiently high to cause first fluid flow 1422 into reservoir assembly 1436. In this aspect, second fluid flow 1424 travels from reservoir assembly 1436 into exit port 1448. In some embodiments, a drainage port valve (e.g., drainage port valve 264) between reservoir assembly 1436 and exit port 1448 requires a minimum pressure differential (i.e., a fluid pressure differential between reservoir assembly 1436 and exit port 1448 of at least some minimum value) across the drainage port valve before second fluid flow 1424 can occur. In other embodiments, second fluid flow 1424 can occur as reservoir assembly 1436 fills up, despite a minimal or nonexistent fluid pressure differential between reservoir assembly 1436 and exit port 1448. Consistent among these embodiments is that exit port 1448 can be accessed by a user (e.g., as discussed with respect to FIG. 10, above), and the fluid pressure in exit port 1448 can be manually reduced by the user, thereby forcing second fluid flow 1424 into exit port 1448 and subsequently out of the patient's body. It is also possible for a user, after accessing exit port 1448, to inject fluid into exit port 1448, forcing the fluid into reservoir assembly 1436, through a filter member (e.g., filter member 262) and back into thoracic duct 1410.

[0063] Referring now to FIG. 15, method 130 of draining fluid from a duct is shown according to an example embodiment. Method 130 can be performed using implant assemblies (e.g., implant assembly 226, etc.) deployed in a patient's body as described herein. As discussed above with respect to the construction and use of the various implant assemblies, the implant assemblies enable a user to draw fluid from a duct in a patient's body.

[0064] Fluid can be directed from a duct to a first chamber (132) of an implant assembly (e.g., implant assembly 226, as discussed with respect to FIG. 2, etc.). A fluid conduit including an inlet conduit (e.g., inlet conduit 232), a reservoir assembly (e.g., reservoir assembly 236, including a first chamber associated with the inlet conduit and a second chamber associated with an outlet conduit), and an outlet conduit (e.g., outlet conduit 234) can be disposed in parallel with the flow of fluid through a duct (e.g., thoracic duct 10) such that fluid flowing down the duct can either flow through the inlet conduit and then into a first chamber within the reservoir assembly, or the fluid can bypass the inlet conduit and continue flowing down the duct. At least one unidirectional valve associated with the inlet conduit (e.g., disposed at the opening of the inlet conduit, disposed somewhere in the middle of the inlet conduit, or disposed at the exit opening of the inlet conduit leading to the reservoir assembly) can allow fluid to flow from the duct into the inlet conduit if the fluid pressure in the duct is sufficiently high. In other words, fluid can be directed into the inlet conduit if the fluid pressure differential across the unidirectional valve associated with the inlet conduit exceeds a minimum value. The fluid then flows from the inlet conduit and into a first chamber of a reservoir assembly. [0065] After fluid is directed from a duct and into a first chamber, the fluid pressure in the duct can determine the direction of fluid flow (134). The flow of fluid throughout the implant assembly can be largely regulated by fluid pressure levels throughout the individual parts of the implant assembly relative to the fluid pressure within the corresponding duct.

[0066] If the fluid pressure in the duct is low relative to the fluid pressure in the reservoir assembly, the fluid in the first chamber of the reservoir assembly will be directed to a second chamber in the reservoir assembly (136). A filter member (e.g., filter member 862) can divide the reservoir assembly into the first chamber and the second chamber. In some embodiments, the filter member may only allow for unidirectional flow and may require a minimum pressure differential between the two chambers in order for fluid to flow across it. In some embodiments, the filter member may allow for bidirectional flow, but at least one unidirectional valve associated with the outlet conduit connecting the second chamber to the duct requires a minimum pressure differential between the reservoir assembly and the duct in order to draw fluid across the filter member and into the second chamber.

[0067] After fluid has been directed into the second chamber, the fluid can be directed back to the duct (138). At least one unidirectional valve associated with the outlet conduit permits fluid at a higher fluid pressure in the second chamber to flow through the outlet conduit and into a duct containing fluid at a lower fluid pressure.

[0068] If, on the other hand, the fluid pressure in the duct is high relative to the fluid pressure in the first chamber of the reservoir assembly, the fluid in the first chamber can be directed to an exit port (e.g., exit port 248) (140). In some embodiments, a valve (e.g., unidirectional or bidirectional) disposed between the first chamber and the exit port may regulate the flow of fluid to the exit port (e.g., by requiring a minimum pressure differential between the exit port and the first chamber before allowing fluid to flow). In other embodiments, fluid in the first chamber can passively flow into and out of the exit port.

[0069] After fluid is directed into the exit port, the fluid can be drained out of the exit port (142). Fluid in the exit port can be drained, for example, by a user using a syringe to access a drainage area (e.g., drainage area 102) on the exit port. After inserting a syringe into the drainage area, the user can create a negative pressure differential between the syringe and the exit port (e.g., by pulling a plunger disposed within the syringe), and draw fluid in the exit port out of the patient's body. As draining the fluid in the exit port causes a corresponding decrease in the fluid pressure in the exit port, fluid in the first chamber of the reservoir assembly can feed additional fluid into the exit port to be drained. As this further causes a decrease in fluid pressure in the first chamber, additional fluid in the duct may be directed up through the inlet conduit and into the first chamber, and ultimately be drained as well.

[0070] The implant assembly and related systems and methods disclosed herein can provide a longer term solution for draining fluid (e.g., lymphatic fluid) that is repeatable and minimally invasive after a first implantation. The implant assembly provides easy access to the fluid in the thoracic duct, and the exit port provides a fast, minimally invasive mechanism for removal of fluid from patients.

[0071] 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.

[0072] 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.