WO2018065945A1 - Systèmes et procédés pour dispositif de pompage implantable - Google Patents

Systèmes et procédés pour dispositif de pompage implantable Download PDF

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Publication number
WO2018065945A1
WO2018065945A1 PCT/IB2017/056174 IB2017056174W WO2018065945A1 WO 2018065945 A1 WO2018065945 A1 WO 2018065945A1 IB 2017056174 W IB2017056174 W IB 2017056174W WO 2018065945 A1 WO2018065945 A1 WO 2018065945A1
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WO
WIPO (PCT)
Prior art keywords
pump
energy
control module
central bore
connection member
Prior art date
Application number
PCT/IB2017/056174
Other languages
English (en)
Inventor
Debasish Pradhan
Mayur Balasaheb GAIKWAD
Satyajeet PARAKH
Original Assignee
Empire Technology Development Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Empire Technology Development Llc filed Critical Empire Technology Development Llc
Publication of WO2018065945A1 publication Critical patent/WO2018065945A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/89—Valves
    • A61M60/894—Passive valves, i.e. valves actuated by the blood
    • A61M60/896—Passive valves, i.e. valves actuated by the blood having flexible or resilient parts, e.g. flap valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/424—Details relating to driving for positive displacement blood pumps
    • A61M60/438—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being mechanical
    • A61M60/451—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being mechanical generated by electro-thermomechanical actuators, e.g. shape memory alloy actuators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/585—User interfaces

Definitions

  • CHF Congestive Heart Failure
  • 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.
  • the pump assembly includes an implantable pump including a compliant member and a movable member disposed circumferentially about the compliant member, wherein the compliant member defines a central bore extending through the pump from a first end having a first valve to a second end having a second valve.
  • the pump assembly further includes a control module including an actuation module, wherein the actuation module selectively provides energy to the movable member to move the movable member and the compliant member between an expanded configuration with a convex outer surface and a comparatively greater central bore volume and a contracted configuration with a concave outer surface and a comparatively lower central bore volume to move fluid through the central bore.
  • the pump assembly also includes a connection member extending from the control module to the implantable pump, wherein the connection member delivers the energy from the actuation module to the movable member.
  • the pump assembly includes an implantable pump including a plurality of shape memory members disposed circumferentially about the pump, wherein the pump defines a central bore extending through the pump from a first end to a second end.
  • the pump assembly further includes a control module including an actuation module, wherein the actuation module selectively provides energy to the plurality of shape memory members to move the pump between an expanded configuration with a convex outer surface and a comparatively greater central bore volume and a contracted configuration with a concave outer surface and a comparatively lower central bore volume to move fluid through the central bore.
  • Another embodiment relates to a method of pumping fluid through a duct of a person.
  • the method includes positioning a pump within a duct of a person, wherein the pump includes a plurality of shape memory members disposed circumferentially about the pump, wherein the pump defines a central bore extending through the pump from a first end to a second end.
  • the method further includes selectively delivering energy to the plurality of shape memory materials to move the pump between an expanded configuration having a convex outer surface and a comparatively greater central bore volume and a contracted configuration having a concave outer surface and a comparatively lower central bore volume to pump fluid within the duct through the central bore.
  • FIG. 1 shows a partially cutaway view of a duct and a portion of a venous system of a person according to an embodiment.
  • FIG. 2 shows an illustration of an implant system used to deploy and operate a pump assembly within a person according to an embodiment.
  • FIG. 3 shows an illustration of an implant used to pump fluid out of a duct according to an embodiment.
  • FIG. 4A shows an illustration of a length of shape memory material in a first configuration according to an embodiment.
  • FIG. 4B shows an illustration of the shape memory material shown in FIG. 4A in a corresponding second configuration according to an embodiment.
  • FIG. 5A shows a cross-sectional perspective view of a first configuration of a pump according to an embodiment.
  • FIG. 5B shows a cross-sectional perspective view of a second configuration of the pump shown in FIG. 5A according to an embodiment.
  • FIG. 6A shows an illustration of a connection member used to couple a control module to an implant according to an embodiment.
  • FIG. 6B shows an illustration of one example of deploying the connection member shown in FIG. 6 A in a person's venous system according to an embodiment.
  • FIG. 6C shows an illustration of an alternative example of deploying the connection member shown in FIG. 6 A in a person's venous system according to an embodiment.
  • FIG. 7A shows an illustration of a control module according to an embodiment.
  • FIG. 7B shows a side perspective view of the control module shown in FIG. 7A according to an embodiment.
  • FIG. 7C shows an illustration of two example locations where the control module shown in FIG. 7A may be deployed.
  • FIG. 8 shows a block diagram of the pump assembly shown in FIG. 2 according to an embodiment.
  • FIG. 9 shows a partially cutaway view of a duct and a portion of a venous system of a person along with a deployed pump assembly according to an embodiment.
  • FIG. 10 shows a block diagram of a method of pumping fluid through a duct using a pump assembly according to an embodiment.
  • 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.
  • 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.
  • 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.
  • lymphatic ducts e.g., the thoracic duct or the right lymphatic duct
  • CHF congestive heart failure
  • 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.
  • 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.
  • fluid e.g., lymphatic fluid
  • thoracic duct which can carry 80 percent of the lymphatic fluid of the lymphatic system
  • FIG. 1 a thoracic duct and a portion of a venous system of a person are shown.
  • 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.
  • 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 or configurations.
  • Pump assembly 226 includes implant 228, control module 230, and connection member 232.
  • Implant 228 may be in an embodiment an implantable pumping mechanism that 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).
  • 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.
  • Control module 230 in an embodiment includes a device through which an external stimulus can be applied.
  • control module 230 serves as a port where an external stimulus application device can be attached.
  • control module 230 can be the external stimulus application device itself, and may include an activation switch, and may also be configured to generate an external stimulus at set or adjustable intervals.
  • Connection member 232 in an embodiment includes a conduit through which the external stimulus generated by control module 230 can be transmitted.
  • Connection member 232 may be disposed between control module 230 and implant 228 such that control module 230 may be engaged to one end of connection member 232, and implant 228 can be engaged to the other end of connection member 232.
  • an external stimulus can travel from control module 230, through connection member 232, and to implant 228. Details and features of these aspects and features of various embodiments of pump assembly 226 are discussed in further detail below.
  • FIG. 3 an illustrative diagram of implant 328 is shown according to an example embodiment.
  • Implant 328 includes pump 334 and extension 336.
  • pump 334 may be a hollow, tube shaped structure with first opening 350, which is an aperture defined by the circumference of the downstream end of pump 334, and second opening 352, which is an aperture defined by the circumference of the opposite, upstream end of pump 334.
  • Central bore 348 spans the length of implant 328 from first opening 350 to second opening 352, such that fluid can flow into second opening 352, through central bore 348, and out of first opening 350. The manner of this flow of fluid is discussed in more detail with respect to various embodiments as illustrated in FIGS. 5 A and 5B, below.
  • pump 334 includes compliant member 340 and flexible member 342.
  • Compliant member 340 can be a generally leak-proof, elastic membrane that makes up the body of pump 334. As such, complaint member 340 can accommodate various shape configurations without, for example, tearing, becoming permanently deformed, or leaking. Compliant member 340 can also take on various shape configurations upon the application of an external force (e.g., a low magnitude force, etc.) acting upon it (i.e., compliant member 340 does not significantly resist a change in shape).
  • an external force e.g., a low magnitude force, etc.
  • Flexible member 342 may be integrated into compliant member 340 throughout pump 334.
  • flexible member 342 may be disposed within compliant member 340 (i.e., inside the wall of pump 334).
  • flexible member 342 can be disposed on the outside of pump 334 (e.g., disposed on top of compliant member 340, and facing the outside of pump 334), or on the inside of pump 334 (i.e., disposed on top of the inside of compliant member 340, and facing central bore 348).
  • the actual distribution of flexible member 342 can vary (e.g., forming a series of loops along the length of pump 334 (e.g., in a serpentine manner), forming a net-like pattern throughout pump 334, forming a coil or circles annularly disposed about the circumference of pump 334, a full membrane, and the like).
  • Flexible member 342 in an embodiment includes energy delivery member 344 and shape memory material 346.
  • Energy delivery member 344 includes an energy conduit and application device that corresponds to the type of external stimuli provided by control module 330.
  • control module 330 may be configured to provide energy in the form of light
  • the conduit aspect of energy delivery member 344 may be a coated fiber optic cable.
  • the application aspect of energy delivery member 344 may be an exposed portion of the fiber optic cable, where light exits the cable toward a portion of shape memory material 346.
  • Shape memory material 346 may be a deformable material that is capable of alternating between at least two shape configurations (e.g., an overall contracted shape with a lesser internal diameter and an overall expanded shape with a greater internal diameter) based on a change in external stimulus (e.g., energy in the form of electricity, heat, or light, as applied by energy delivery member 344).
  • shape memory material 346 may be a nickel-titanium alloy known as nitinol.
  • flexible member 342 can cause the overall shape of pump 334 to change upon the application of a change in external stimuli provided by control module 330.
  • the energy delivery method may be electrical energy or RF energy that can be converted into heat to cause the shape change in the shape memory material.
  • Extension 336 can be in an embodiment capable of engaging connection member 332, thereby allowing the transmission of external stimuli from connection member 332 to pump 334.
  • Extension 336 includes a segment of energy delivery member 344 (e.g., a portion of energy delivery member 344 of flexible member 342 disposed throughout pump 334) and pump connector 338.
  • Pump connector 338 can be in an embodiment provided at the end of extension 336 that may be configured to be able to engage and disengage from a corresponding end of connection member 332.
  • pump connector 338 may be made up of a magnet or a corresponding ferromagnetic material.
  • pump connector 338 may include threads or ribs disposed about its outer or inner circumference corresponding to threads or ribs on a connection member connector 372 (e.g., as discussed with respect to various embodiments as shown FIG. 6A, below). Pump connector further provides for the transfer of energy from connection member 332 to pump 334.
  • shape memory material 446 is shown according to an embodiment. As shown, when an energy source 454 is not providing an external stimulus to shape memory material 446, shape memory material 446 is in a straight, expanded configuration. Alternatively shape memory material may be straight when energy is applied to the material.
  • an external stimulus can be applied to shape memory material 446.
  • energy source 454 provides an external stimulus (e.g., heat, mechanical stress or light) to shape memory material 446.
  • an external stimulus e.g., heat, mechanical stress or light
  • shape memory material 446 transitions from the straight configuration shown in FIG. 4A to the curved configuration shown in FIG. 4B, as one side of shape memory material 446 retracts in response to the change in external stimuli. It is also possible to reverse the configurations such that shape memory material 446 is in a curved configuration in the absence of external stimuli, and transitions into a straight configuration upon an application of external stimuli.
  • pump 534 further includes first valve 556 and second valve 558.
  • First valve 556 may be a passive, one-way valve disposed adjacent to first opening 550 of central bore 548 of pump 534, and spans the cross- sectional area of first opening 550.
  • First valve 556 includes a first stationary valve member 560 and a first movable valve member 562.
  • First stationary valve member 560 can be a partial wall extending into central bore 548 at an approximately perpendicular orientation from one side of compliant member 540 towards the opposite side of compliant member 540. In one embodiment, first stationary valve 560 remains substantially stationary as fluid flows through pump 534.
  • First movable valve member 562 may be a flexible partial wall extending into central bore 548 at an approximately perpendicular orientation from the opposite side of compliant member 540, relative to first stationary valve member 560 (e.g., extending toward first stationary valve member 560). First movable valve member 562 can be in an embodiment disposed within central bore 548 at a downstream location relative to first stationary valve member 560 (i.e., first movable valve member 562 would be closer to first opening 550 than first stationary valve member 560).
  • first movable valve member 562 and first stationary valve member 560 can be such that, upon flexing inward (i.e., in an upstream direction) a certain distance, the distal end (i.e., the end protruding into central bore 548) of first movable valve member 562 can contact and form a substantially leak-proof seal with the corresponding distal end of first stationary valve member 560.
  • the heights of first movable valve member 562 and first stationary valve member 560 may also be a function of the distance between the two members, and/or the firmness of first movable valve member 562.
  • first movable valve member 562 and first stationary valve member 560 are spaced apart, the greater the respective heights of the members must be in order to for the first movable valve member 562 to reach and form a seal with first stationary valve member 560.
  • lesser respective heights of the members may be required in order for first movable valve member 562 to reach and form a seal with first stationary valve member 560.
  • Second valve 558 is similar to first valve 556, but is disposed adjacent to second opening 552 of central bore 548.
  • Second valve 558 can include second stationary valve member 564 and second movable valve member 566 with similar aspects and features as first stationary valve member 560 and first movable valve member 562.
  • Second stationary valve member 564 can be disposed upstream within central bore 548 relative to second movable valve member 566 (e.g., second stationary valve member 564 is closer to second opening 552).
  • the distribution of fluid pressure across the various aspects of pump 534 in FIG. 5A can allow fluid to flow into second opening 552 and accumulate in central bore 548.
  • a change in external stimuli applied to across flexible member 542 can cause pump 534 to take on an expanded configuration, increasing the overall interior volume and lowering the fluid pressure within pump 534.
  • Upstream lymph 524 in the thoracic duct 10 having a higher fluid pressure enters second opening 552, and applies pressure to second movable valve member 566, pushing second movable valve member inward and increasing a gap between second movable valve member 566 and second stationary valve member 564, thereby allowing an increased volume of fluid to flow into the interior of pump 534.
  • downstream fluid at a higher fluid pressure also seeks to flow into first opening 550 of pump 534.
  • downstream fluid applies pressure to first movable valve member 562, pushing first movable valve member 562 into contact with first stationary valve member 560 and forming a seal between them.
  • first valve 556 blocks downstream fluid from entering the interior of pump 534.
  • first movable valve member 562 and second movable valve member 566 can return to their regular positions (e.g., parallel to first stationary valve member 560 and parallel to second stationary valve member 564, respectively).
  • shape memory material 546 causes pump 534 to take on a contracted configuration with a lower overall interior volume.
  • the fluid pressure within pump 534 increases relative to upstream fluid and downstream fluid outside pump 534.
  • the fluid inside pump 534 applies pressure to both first movable valve member 562 and second movable valve member 566.
  • First movable valve member 562 subsequently flexes outward (e.g., in the downstream direction), thereby opening or expanding the opening of first valve 556 and allowing fluid to flow out of first opening 550 of pump 534 in the downstream direction.
  • second movable valve member 566 also flexes outward (e.g., as shown here, in the upstream direction), thereby causing second movable valve member 566 to come in contact and form a seal with second stationary valve member 564.
  • second valve 558 blocks fluid inside pump 534 from flowing back out of second opening 552.
  • connection member 632 includes tubular portion 668 and connection member connector 672.
  • tubular portion 668 includes an outer sheath 674 and an inner fiber optic cable 676.
  • Inner fiber optic cable 676 is one or a plurality of fiber-based conduits optimized for the transmission of light energy.
  • inner fiber optic cable 676 can be replaced with other types of conduits that are configured to transmit energy (e.g., electrical cables for the transmission of electricity, etc.).
  • Outer sheath 674 can be a protective coating disposed about the exterior of tubular portion 668. In the particular embodiment shown in FIG. 6A, outer sheath 674 may be a light-proof coating that also serves to insulate light transmitted along inner fiber optic cable 676.
  • Connection member connector 672 may be an embodiment provided at distal end 670 (i.e., the end farthest along connection member 632 towards pump assembly 626) of connection member 632. Connection member connector 672 can be configured to engage and disengage a corresponding end of pump connector 638. In some embodiments, connection member connector 672 may be made up of a magnet or a corresponding ferromagnetic material. In other embodiments, connection member connector 672 includes threads or ribs disposed about its outer or inner circumference correspond to threads or ribs on a pump connector 638. Connection member connector 672 provides for the transfer of energy from tubular portion 668 to pump connector 638. [0045] Referring now to FIG.
  • FIG. 6B an illustrated diagram of a segment of the venous system with thoracic duct 610 is shown according to an embodiment.
  • FIG. 6B includes a segment of left brachiocephalic vein 615, thoracic duct 610, terminal point 622, connection member 632, and pump connector 638 of implant 628.
  • Deployment of implant 628 as shown can be accomplished in several ways.
  • implant 628 is deployed in thoracic duct 610 between a terminal valve at terminal point 622 and a first thoracic valve within thoracic duct.
  • implant 628 is surgically deployed in thoracic duct 610 by directly accessing the space between the terminal valve and the first thoracic valve via a surgical incision.
  • the terminal valve can be manually opened, a syringe containing implant 628 can be inserted through the terminal valve, and the syringe can then deploy implant 628 within thoracic duct 610.
  • implant 628 within thoracic duct 610.
  • connection member 632 can be inserted into the venous system such that connection member 632 approaches terminal point 622 of thoracic duct 610 through left brachiocephalic vein 615.
  • Connection member 632 can also access left brachiocephalic vein 615, for example, through the right jugular vein or the right subclavian vein.
  • Connection member 632 can be guided to terminal point 622 via, for example, a separate or integrated steerable guide wire, or a shape memory material disposed along the length of connection member 632.
  • a camera can also be disposed at a distal end of connection member 632 to allow a user to view the travel direction of connection member 632.
  • connection member 632 can be guided along left brachiocephalic vein 615 such that connection member connector 672 engages pump connector 638 (e.g., via corresponding magnets and/or ferromagnetic material, or corresponding ribs or threads, etc.). If an embodiment using an attraction-based engagement between pump connector 638 and connection member connector 672 is used (e.g., a pair of magnets or a magnet and a ferromagnetic material disposed on pump connector 638 and connection member connector 672), a lesser degree of guiding accuracy and control may be needed.
  • an attraction-based engagement between pump connector 638 and connection member connector 672 e.g., a pair of magnets or a magnet and a ferromagnetic material disposed on pump connector 638 and connection member connector 672
  • connection member 632 can also be guided down left internal jugular vein 614 and positioned such that connection member connector 672 may be adjacent and therefore able to engage pump connector 638 of implant 628.
  • Control module 730 can be engaged to the proximal end (i.e., the end farthest from an implant) of a connection member (e.g., connection member 732 shown in FIG. 7B), and can be configured to provide an external stimulus in the form of energy (e.g., light, heat, electricity, etc.).
  • control module 730 itself may be a source of energy that can be activated or deactivated.
  • control module 730 can be a port to which a separate source of energy can be attached.
  • control module 730 can include the energy source.
  • control module 730 includes switch 788 (e.g., a user interaction aspect of actuation module 786), battery 790, circuit board 792 (e.g., actuation module 786, a processor, and a memory, as also discussed with respect to various embodiments illustrated in FIG. 8, below), and LED 794.
  • Switch 788 may be any one of several user input devices, configured to send a signal to circuit board 792 upon user interaction (e.g., a button, a touch screen panel, a toggle switch, or the like).
  • circuit board 792 includes an actuation module (e.g., actuation module 786), a processor, a memory, and battery 790.
  • Battery 790 may be an electrical energy storage device (e.g., based on alkaline, nickel-cadmium, lithium, or other such materials) capable of discharging small amounts of electrical energy.
  • LED 794 can be a light emitting diode, which converts electrical energy into light. Other light sources may be used according to various alternative embodiments.
  • control module 730 In operation, starting with control module 730 in an "off configuration, a user can interact with switch 788, which will cause a signal to be transmitted to circuit board 792, causing control module 730 to change to an "on" configuration.
  • circuit board 792 draws electrical energy from battery 790 at set intervals and transmits energy to LED 794 at the set intervals. For each interval of transmitted energy, LED 794 converts the electrical energy received from battery 790 into light (e.g., a flash or pulse of light). The light from LED 794 is transmitted down a fiber optic conduit 796, and through connection member 732.
  • control module 730 is deployed in a first position 778 at a superficial level (i.e., above the muscle, or potentially above the skin or embedded therein) on a patient's body adjacent to the patient's chest.
  • control module 730 is deployed in a second position 780 at a superficial level on a patient's body adjacent to the patient's neck.
  • Control module 830 includes processor 882, memory 884, and actuation module 886.
  • Actuation module 886 can be configured to cause a change in energy transmitted along connection member 832.
  • Processor 882 may be implemented as a general-purpose processor, an application specific integrated circuit (ASIC), one or more field programmable gate arrays (FPGAs), a digital-signal-processor (DSP), a group of processing components, or other suitable electronic processing components.
  • Memory 884 is one or more devices (e.g., RAM, ROM, Flash Memory, hard disk storage, etc.) for storing data and/or computer code for facilitating the various processes described herein.
  • Memory 884 may be or include non-transient volatile memory or non-volatile memory. Memory 884 may include database components, object code components, script components, or any other type of information structure for supporting the various activities and information structures described herein. Memory 884 may be communicably connected to processor 882 and provide computer code or instructions to processor 882 for executing the processes described herein. In some embodiments, memory 884 may include a digital storage medium containing at least one stored setting for energy transmission intervals (e.g., one half-second transmission of energy every two seconds). Processor 882 is configured to facilitate the exchange of data between actuation module 886 and memory 884.
  • energy transmission intervals e.g., one half-second transmission of energy every two seconds
  • a user may interact with actuation module 886, which activates or deactivates a series of energy transmissions.
  • Actuation module 886 can cause processor 882 to look up a setting for a series of energy transmissions in memory 884, and then transmit energy along connection member 832 at the intervals set in memory 884.
  • the series of energy transmissions transmitted along connection member 832 are received at implant 828, causing flexible member 842 to alternate between a contracted configuration and an expanded configuration at the intervals set in memory 884.
  • control module 930 transmits pulses of energy (e.g., light, heat, electricity, etc.) at along connection member 932 to implant 928 (e.g., at intervals, set intervals, etc.).
  • the beginning and end of each pulse of energy is a change of external stimuli that causes a flexible member in a pump (e.g., flexible member 342 of pump 334, etc.) to alternate from one configuration (e.g., a contracted configuration) to another configuration (e.g., an expanded configuration).
  • the alternating configurations of the pump e.g., as caused by the alternating configurations of flexible member give rise to alternating changes in internal fluid pressure within the pump.
  • the changes in internal fluid pressure within the pump in addition to the respective configurations of a first valve and a second valve disposed within (e.g., first valve 556, second valve 558 as discussed with respect to various embodiments as illustrated in FIGS. 5A and 5B, above), causes fluid (e.g., lymph 24) to flow along the thoracic duct, into the pump, and ultimately, out into the patient's venous system via the terminal point.
  • fluid e.g., lymph 24
  • Method 1000 of moving fluid through a duct is shown according to an example embodiment.
  • Method 1000 can be performed using any of the pump assembly embodiments described herein.
  • the pump assembly enables a user to draw fluid from a duct in a patient's body.
  • An implant can be positioned within a person (1002).
  • the implant e.g., implant 228, may be in an embodiment an implantable pumping mechanism that 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).
  • 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.
  • the implant can be positioned within a person's thoracic duct such that the implant may be disposed between a terminal duct valve at the terminal point of the thoracic duct (e.g., terminal point 22) and a first thoracic valve in the thoracic duct, with an extension (e.g., extension 336) protruding out from the terminal valve and into the venous space outside the terminal valve.
  • the implant can be positioned in the thoracic duct by manually opening the terminal valve of the thoracic duct, inserting a syringe, and injecting the implant within the thoracic duct after the terminal valve.
  • the implant can also be positioned in the thoracic duct via a surgical incision in the thoracic duct.
  • a control module may be positioned on a person (1004).
  • the control module e.g., control module 30
  • the control module is in some embodiments a device through which an external stimulus can be applied.
  • the control module serves as a port where an external stimulus application device can be attached.
  • the control module is the external stimulus application device itself, and may include an activation switch, and may also be configured to generate an external stimulus at set or adjustable intervals.
  • the control module may be positioned on a person such that it is accessible to a user.
  • the control module is positioned by embedding the control module in the person's skin.
  • the control module may be positioned adjacent to the person's neck or chest.
  • the control module can be coupled to the implant (1006).
  • the control module may be coupled to the implant such that energy (e.g., light, heat, electricity, and the like) can be transmitted from the control module to the implant.
  • the control module can be coupled to the implant via a connection member (e.g., connection member 332).
  • the connection member may be a conduit through which the external stimulus generated by the control module can be transmitted.
  • a connection member connector e.g., connection member connector 672 disposed at the distal end of connection member is configured to engage a corresponding pump connector (e.g., pump connector 338) associated with the implant.
  • the connectors can be made up of, for example, magnets, or a magnet and a corresponding ferromagnetic material, or corresponding ribs or threads.
  • An implant pumping action can be activated by actuating the control module (1008).
  • the implant pumping action is a result of the implant alternating between an expanded configuration and a retracted configuration (e.g., as discussed with respect to FIGS. 5A and 5B).
  • the control module can be actuated by a user interacting with a switch (e.g., switch 788), which can include any of several switches (e.g., a button, a touchscreen, a toggle switch, or the like).
  • the switch can signal an actuation module (e.g., actuation module 786), which can cause a processor (e.g., processor 882) to retrieve an energy transmission interval from a memory (e.g., memory 884).
  • the actuation module can be configured to then use an energy source (e.g., battery 790) to transmit pulses of energy at the interval set in the memory through connection member 732 (e.g., via LED 794).
  • the intervals of energy transmissions cause a shape memory material (e.g., shape memory material 346) disposed throughout the implant to alternate between two configurations (e.g., an expanded configuration upon the application of light energy, and a retracted configuration upon the absence of light energy).
  • the energy transmissions can be distributed across the shape memory material in the implant via a corresponding energy delivery member (e.g., energy delivery member 344).
  • the alternating configurations of the implant causes fluid in the thoracic duct to flow downstream into the implant, and subsequently out of the terminal valve of the thoracic duct, and into the person's venous system.
  • control module 830 can include a processor and can include a memory.
  • 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.
  • 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.
  • a network or another communications connection either hardwired, wireless, or a combination of hardwired or wireless
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Cardiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Mechanical Engineering (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Human Computer Interaction (AREA)
  • External Artificial Organs (AREA)

Abstract

Un ensemble pompe comprend une pompe implantable comportant un élément souple et un élément mobile, un module de commande comprenant un module d'actionnement, et un élément de raccordement s'étendant du module de commande à la pompe implantable. Le module d'actionnement fournit sélectivement de l'énergie à l'élément mobile en vue de déplacer l'élément mobile et l'élément souple entre une configuration étendue et une configuration contractée de sorte à déplacer le fluide à travers un alésage central.
PCT/IB2017/056174 2016-10-06 2017-10-06 Systèmes et procédés pour dispositif de pompage implantable WO2018065945A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201611034291 2016-10-06
IN201611034291 2016-10-06

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024033880A1 (fr) * 2022-08-12 2024-02-15 Sequana Medical Nv Appareil et procédés de drainage de fluide provenant du conduit thoracique

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5045064A (en) * 1990-06-01 1991-09-03 Infusaid, Inc. Constant pressure implantable pump reservoir
US20030127090A1 (en) * 2001-11-14 2003-07-10 Emphasys Medical, Inc. Active pump bronchial implant devices and methods of use thereof
US20050016637A1 (en) * 2003-07-22 2005-01-27 Tomoyuki Yambe Conveying device with peristaltic movement
US20090240100A1 (en) * 2007-10-11 2009-09-24 Milux Holding S.A. Schneider, Luxembourg Method for controlling flow of intestinal contents in a patient's intestines
US20120197392A1 (en) * 2009-07-20 2012-08-02 Micardia Corporation Adjustable annuloplasty ring with subcutaneous activation port
US9339636B1 (en) * 2012-09-06 2016-05-17 Mubashir H Khan Subcutaneous fluid pump

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5045064A (en) * 1990-06-01 1991-09-03 Infusaid, Inc. Constant pressure implantable pump reservoir
US20030127090A1 (en) * 2001-11-14 2003-07-10 Emphasys Medical, Inc. Active pump bronchial implant devices and methods of use thereof
US20050016637A1 (en) * 2003-07-22 2005-01-27 Tomoyuki Yambe Conveying device with peristaltic movement
US20090240100A1 (en) * 2007-10-11 2009-09-24 Milux Holding S.A. Schneider, Luxembourg Method for controlling flow of intestinal contents in a patient's intestines
US20120197392A1 (en) * 2009-07-20 2012-08-02 Micardia Corporation Adjustable annuloplasty ring with subcutaneous activation port
US9339636B1 (en) * 2012-09-06 2016-05-17 Mubashir H Khan Subcutaneous fluid pump

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024033880A1 (fr) * 2022-08-12 2024-02-15 Sequana Medical Nv Appareil et procédés de drainage de fluide provenant du conduit thoracique

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