Systems and methods for body fluid drainage systems

Abstract

A system and method are provided for a body fluid management system for pumping body fluids such as lymph. The body fluid management system may include an implantable pump having: a rotor having a magnetic portion; and inlet and outlet pipes connected to a fluid chamber. The fluid chamber has a volume that can be selectively decreased or increased via the rotor. The rotor is designed to periodically open and close a bend valve at each of the inlet and outlet pipes to allow body fluid to enter the fluid chamber during an inhalation cycle and exit the fluid chamber during an exhalation cycle. The magnetic portion of the rotor can be rotated by an external controller positioned outside the body and near the pump. The external controller may have a magnet magnetically coupled to the rotor to rotate it.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Patent Application No. 18 / 634,830, filed April 12, 2024, and U.S. Patent Application No. 18 / 430,634, filed February 1, 2024, now U.S. Patent No. 12,138,378, which claims priority to U.S. Provisional Patent Application No. 63 / 609,535, filed December 13, 2023, the entire contents of each of which are incorporated herein by reference. Technical Field

[0003] This technology generally relates to fluid drainage, such as lymphatic drainage systems that include pumps for moving lymph fluid within a patient's body. Background Technology

[0004] The lymphatic system is a network of lymphatic vessels, tissues, and organs that transport lymph fluid throughout the body. The accumulation of lymphatic fluid (also known as lymph) under the skin (a condition called lymphedema) is often a result of chronic illness or medical treatments (such as certain cancer treatments, e.g., radiation therapy). It is estimated that approximately 10 million people in the United States and Europe suffer from lymphedema.

[0005] When the lymphatic system is no longer able to properly distribute lymph fluid throughout the body due to illness or medical treatment, this fluid may begin to accumulate and cause swelling in limbs (such as an individual's arm or leg). Swelling caused by lymph fluid accumulation is known to result in significant pain and recurrent infections. To date, there is no cure for lymphedema.

[0006] While lymphedema cannot be cured, various therapies and treatments have been developed. For example, manual lymphatic drainage via massage is often used to promote and / or facilitate lymphatic drainage. Compression therapy may also be used, such as by applying elastic or pressure bandages to the swollen limb. While manual lymphatic drainage may help provide temporary relief, it is time-consuming and provides only limited and temporary relief. Further compression therapy requires strict patient compliance, is time-consuming, and restricts activity.

[0007] In addition to the complications associated with lymphedema mentioned above, lymphatic flow is also known to be associated with neurodegenerative diseases such as Parkinson's disease and Alzheimer's disease. For example, fluid accumulation due to meningeal lymphatic dysfunction may have undesirable effects beyond those listed above regarding lymphedema.

[0008] Therefore, there is a need for improved methods and systems for lymphatic management to redistribute lymphatic fluid accumulation in order to alleviate the symptoms of lymphedema and other related symptoms and effects. Summary of the Invention

[0009] This document provides systems and methods for fluid management using a pump, which in some preferred embodiments is implantable. For example, the implantable pump can be connected to an implanted catheter for moving fluid from one location within the body to another. The implantable pump can be externally driven by an external controller located outside the patient and positioned near the implantable pump, such that a magnetic portion of the external controller magnetically engages with a magnetic portion of the implantable pump. The implantable pump may include one or more bend valves to selectively move fluid from an inlet catheter to an outlet catheter. Using the implantable pump, fluid can be drained from an edematous area to the interstitial space in a drainage area.

[0010] This document provides a lymphatic drainage system for lymphatic fluid management in a patient. The lymphatic drainage system may include: a housing designed for implantation in the patient; an inlet tube positioned within the housing and designed to be in fluid communication with a first body portion to receive bodily fluid; an outlet tube positioned within the housing and designed to be in fluid communication with a second body portion; a fluid chamber positioned within the housing and designed to be in fluid communication with the inlet and outlet tubes; a rotor positioned within the housing and designed to rotate to change the volume of the fluid chamber; and a lever mechanically communicated with the rotor and designed to move between an open and closed position in response to rotation of the rotor to periodically bend the inlet tube, thereby pumping bodily fluid from the first body portion toward the second body portion via the inlet tube, the fluid chamber, and the outlet tube.

[0011] The first body portion is in fluid communication with the patient's lymphatic system such that the body fluid pumped by the implantable pump includes lymph. The rotor may include a first magnetic portion, and the lymphatic drainage system may further include an external controller comprising a second magnetic portion and a motor, the motor being designed to move the second magnetic portion to induce movement in the first magnetic portion, thereby rotating the rotor. The inlet tube may be designed to form a U-shape when the lever is in the closed position. When the inlet tube is bent by the lever, fluid flow in the inlet tube may be completely blocked. The lever may cause the inlet tube to bend as the rotor rotates to reduce the volume of the fluid chamber. The rotor may be rotatably coupled to the housing at an eccentric position of the rotor.

[0012] The implantable pump may further include a cam mechanically communicated with the rotating body and designed to engage with a cam receiving portion of the lever to move the lever between the open and closed positions as the rotor rotates. The implantable pump further includes a biasing portion designed to engage with the cam to bias the lever to the closed position. The implantable pump may further include a second lever mechanically communicated with the rotor and designed to move between a second open and a second closed position in response to rotation of the rotor to periodically bend the outlet tube. The implantable pump may further include a piston designed to engage with the rotor such that rotation of the rotor causes the piston to increase and decrease the volume of the fluid chamber.

[0013] An elastic membrane may be positioned between the piston and the fluid chamber such that the piston does not contact the lymph fluid in the fluid chamber. The fluid chamber may include a rigid shell and an inner membrane connected to the elastic membrane, such that fluid entering the fluid chamber is contained between the inner membrane and the elastic membrane. The lymphatic drainage system may further include an inlet connector, and the outlet of the inlet tube may be coupled to the fluid chamber. The inlet of the inlet tube may be coupled to the inlet connector, the inlet connector including at least one protrusion designed to couple to an inlet conduit designed to deliver lymph fluid to the implantable pump. The lymphatic drainage system may further include an inlet conduit coupled to the inlet tube, the inlet conduit including a first lumen, a second lumen, a first plurality of openings located at a first end region of the inlet conduit, and a second plurality of openings located between the first end region and a second end region of the inlet conduit, the first plurality of openings being in fluid communication with the first lumen and the second plurality of openings being in fluid communication with the second lumen. The inlet conduit may include a main lumen in fluid communication with at least the first lumen and the second lumen. The lymphatic drainage system may further include an outlet catheter coupled at a first end to the outlet tube, the outlet catheter including a second end designed to be positioned within the interstitial space of the patient. The external controller may further include a worm gear and the motor is designed to rotate the worm gear to rotate the second magnetic portion.

[0014] This document provides a method for pumping lymph fluid into a patient's body. The method may include: implanting an implantable pump comprising a housing, an inlet tube, a fluid chamber, an outlet tube, and a rotor; rotating the rotor between an inhalation position and an exhaust position to change the volume of the fluid chamber; and periodically bending the inlet tube and the outlet tube in response to rotation of the rotor, wherein the implantable pump is designed to allow lymph fluid to enter the fluid chamber via the inlet tube when the rotor is in the inhalation position, and to allow the lymph fluid to exit the fluid chamber via the outlet tube when the rotor is in the exhaust position, thereby pumping the lymph fluid from a first body portion toward a second body portion. The rotor may be rotatably coupled to the housing at an off-center position on the rotor. Rotating the rotor may include rotating the rotor in response to an external magnet worn by the patient. Implanting the implantable pump may include implanting the implantable pump into the patient's arm to drain the lymph fluid from an edematous area of ​​the patient's arm to the patient's supraclavicular region. Implanting the implantable pump may include implanting the implantable pump in the patient's leg to drain lymph fluid from an edematous area of ​​the patient's leg to a subcutaneous space in the patient's abdomen or back region. Implanting the implantable pump may also include implanting the implantable pump in the patient's upper body to drain lymph fluid from the patient's cerebral lymphatic system to axillary lymph nodes.

[0015] This document provides another lymphatic drainage system for lymphatic fluid management in a patient. The lymphatic drainage system may include an implantable pump comprising: a housing designed for implantation in the patient; an inlet tube designed for fluid communication with a first body portion to receive bodily fluid; an outlet tube designed for fluid communication with a second body portion; a fluid chamber positioned within the housing and designed for fluid communication with the inlet and outlet tubes; a rotor positioned within the housing and designed to rotate to change the volume of the fluid chamber; and a membrane defining the wall of the fluid chamber, the membrane being designed to stretch in response to rotation of the rotor to reduce the volume of the fluid chamber toward a closed position, such that the bodily fluid is pumped from the first body portion toward the second body portion via the inlet tube, the fluid chamber, and the outlet tube.

[0016] The lymphatic drainage system may further include a second membrane defining a second wall of the fluid chamber, wherein the second membrane does not change shape in response to rotation of the rotor, and wherein the first membrane and the second membrane are hermetically sealed to form the fluid chamber. The lymphatic drainage system may further include an inlet conduit in fluid communication with the first body portion and the inlet tube, and an outlet conduit in fluid communication with the second body portion and the outlet tube. The inlet tube, the inlet conduit, the outlet tube, the outlet conduit, the first membrane, and the second membrane may all be made of the same material. The same material may comprise a silicone elastomer coated with covalent heparin, and the body fluid may come into contact with the same material only when the implantable pump is used. The ends of the membranes may be fixed within the housing, and a portion of the membrane covering a piston abutting the rotor may stretch in response to rotation of the rotor.

[0017] This document provides a method for increasing lymphatic flow from the brain using a lymphatic drainage system. The method may include: providing a pump having an inlet tube in fluid communication with a neck, occipital bone, and / or postauricular region, and an outlet tube in fluid communication with another body region; activating the pump to locally reduce interstitial pressure in the neck, occipital bone, and / or postauricular region, where lymph nodes and lymphatic vessels are located, to increase lymphatic flow from the brain via the inlet tube and the outlet tube. The method may further include activating the pump to increase lymphatic flow from the brain for the treatment of neurodegenerative diseases. The method may further include implanting the pump.

[0018] The outlet of the outlet tube may be in fluid communication with a lymphatic vessel, such as a thoracic tube, a right lymphatic vessel, or a lymphatic trunk, or may be subcutaneously placed in the subclavian region. The outlet of the outlet tube may be in fluid communication with the subclavian lymphatic trunk. The inlet of the inlet tube may be inserted into a lymphatic vessel in the neck region or a higher accessible lymphatic vessel and may be designed to increase the flow rate from the cervical lymphatic vessels. The lymphatic vessels may be the upper left or upper right cervical lymphatic trunk. The inlet of the inlet tube may be subcutaneously placed in the neck region and may be designed to draw free fluid from the tissues in the neck region and increase the flow rate in the neck region. The pump may include a bend valve designed to increase the lymphatic flow.

[0019] This document provides a catheter for use in a lymphatic drainage system. The catheter may include an elongated shaft having an inlet region configured for implantation in a patient to drain fluid accumulated in the subcutaneous interstitial space. The elongated shaft further includes an outlet region designed to couple to an implantable pump. The elongated shaft includes a first lumen, a second lumen, a main lumen in fluid communication with at least the first and second lumens, a first plurality of openings located at a first end region of the elongated shaft, and a second plurality of openings located between the first end region and a second end region of the elongated shaft, the first plurality of openings being in fluid communication with the first lumen and the second plurality of openings being in fluid communication with the second lumen.

[0020] The conduit may further include a third lumen in fluid communication with the main lumen, and the conduit further includes a third plurality of openings positioned between the second plurality of openings and the second end region of the elongated shaft, the third plurality of openings being in fluid communication with the third lumen. The conduit may further include a fourth lumen in fluid communication with the main lumen, and the conduit further includes a fourth plurality of openings positioned between the third plurality of openings and the second end region of the elongated shaft, the fourth plurality of openings being in fluid communication with the fourth lumen. The first plurality of openings may be circumferentially offset along the elongated shaft from the second plurality of openings.

[0021] The foregoing overview is illustrative only and is not intended to be limiting in any way. Other aspects, embodiments, and features, besides those described above, will become apparent from the following drawings and detailed description.

[0022] This document provides a lymphatic drainage system for lymphatic fluid management in a patient. The lymphatic drainage system may include: a housing designed for implantation in the patient; an inlet tube positioned within the housing and designed to be in fluid communication with a first body portion to receive bodily fluid; an outlet tube positioned within the housing and designed to be in fluid communication with a second body portion; a fluid chamber positioned within the housing and designed to be in fluid communication with the inlet and outlet tubes; a rotor positioned within the housing and designed to rotate to change the volume of the fluid chamber; and a lever mechanically communicated with the rotor and designed to move between an open and closed position in response to rotation of the rotor to periodically bend the inlet tube, thereby pumping bodily fluid from the first body portion toward the second body portion via the inlet tube, the fluid chamber, and the outlet tube.

[0023] The first body portion is in fluid communication with the patient's lymphatic system such that the body fluid pumped by the implantable pump includes lymph. The rotor may include a first magnetic portion, and the lymphatic drainage system may further include an external controller comprising a second magnetic portion and a motor, the motor being designed to move the second magnetic portion to induce movement in the first magnetic portion, thereby rotating the rotor. The inlet tube may be designed to form a U-shape when the lever is in the closed position. When the inlet tube is bent by the lever, fluid flow in the inlet tube may be completely blocked. The lever may cause the inlet tube to bend as the rotor rotates to reduce the volume of the fluid chamber. The rotor may be rotatably coupled to the housing at an eccentric position of the rotor.

[0024] The implantable pump may further include a cam mechanically communicated with the rotating body and designed to engage with a cam receiving portion of the lever to move the lever between the open position and the closed position as the rotor rotates. The implantable pump further includes a biasing portion designed to engage with the cam to bias the lever to the closed position. The implantable pump further includes a second lever mechanically communicated with the rotor and designed to move between a second open position and a second closed position in response to rotation of the rotor to periodically bend the outlet tube. The implantable pump may further include a piston designed to engage with the rotor such that rotation of the rotor causes the piston to increase and decrease the volume of the fluid chamber.

[0025] An elastic membrane may be positioned between the piston and the fluid chamber such that the piston does not contact the lymph fluid in the fluid chamber. The fluid chamber may include a rigid shell and an inner membrane connected to the elastic membrane, such that fluid entering the fluid chamber is contained between the inner membrane and the elastic membrane. The lymphatic drainage system may further include an inlet connector, and the outlet of the inlet tube may be coupled to the fluid chamber. The inlet of the inlet tube may be coupled to the inlet connector, the inlet connector including at least one protrusion designed to couple to an inlet conduit designed to deliver lymph fluid to the implantable pump. The lymphatic drainage system may further include an inlet conduit coupled to the inlet tube, the inlet conduit including a first lumen, a second lumen, a first plurality of openings located at a first end region of the inlet conduit, and a second plurality of openings located between the first end region and a second end region of the inlet conduit, the first plurality of openings being in fluid communication with the first lumen and the second plurality of openings being in fluid communication with the second lumen. The inlet conduit may include a main lumen in fluid communication with at least the first lumen and the second lumen. The lymphatic drainage system may further include an outlet catheter coupled at a first end to the outlet tube, the outlet catheter including a second end designed to be positioned within the interstitial space of the patient. The external controller may further include a worm gear and the motor is designed to rotate the worm gear to rotate the second magnetic portion.

[0026] This document provides a method for pumping lymph fluid into a patient's body. The method may include: implanting an implantable pump comprising a housing, an inlet tube, a fluid chamber, an outlet tube, and a rotor; rotating the rotor between an inhalation position and an exhaust position to change the volume of the fluid chamber; and periodically bending the inlet tube and the outlet tube in response to rotation of the rotor, wherein the implantable pump is designed to allow lymph fluid to enter the fluid chamber via the inlet tube when the rotor is in the inhalation position, and to allow the lymph fluid to exit the fluid chamber via the outlet tube when the rotor is in the exhaust position, thereby pumping the lymph fluid from a first body portion toward a second body portion. The rotor may be rotatably coupled to the housing at an off-center position on the rotor. Rotating the rotor may include rotating the rotor in response to an external magnet worn by the patient. Implanting the implantable pump may include implanting the implantable pump into the patient's arm to drain the lymph fluid from an edematous area of ​​the patient's arm to the patient's supraclavicular region. Implanting the implantable pump may include implanting the implantable pump in the patient's leg to drain lymph fluid from an edematous area of ​​the patient's leg to a subcutaneous space in the patient's abdomen or back region. Implanting the implantable pump may also include implanting the implantable pump in the patient's upper body to drain lymph fluid from the patient's cerebral lymphatic system to axillary lymph nodes.

[0027] This document provides another lymphatic drainage system for lymphatic fluid management in a patient. The lymphatic drainage system may include an implantable pump comprising: a housing designed for implantation in the patient; an inlet tube designed for fluid communication with a first body portion to receive bodily fluid; an outlet tube designed for fluid communication with a second body portion; a fluid chamber positioned within the housing and designed for fluid communication with the inlet and outlet tubes; a rotor positioned within the housing and designed to rotate to change the volume of the fluid chamber; and a membrane defining the wall of the fluid chamber, the membrane being designed to stretch in response to rotation of the rotor to reduce the volume of the fluid chamber toward a closed position, such that the bodily fluid is pumped from the first body portion toward the second body portion via the inlet tube, the fluid chamber, and the outlet tube.

[0028] The lymphatic drainage system may further include a second membrane defining a second wall of the fluid chamber, wherein the second membrane does not change shape in response to rotation of the rotor, and wherein the first membrane and the second membrane are hermetically sealed to form the fluid chamber. The lymphatic drainage system may further include an inlet conduit in fluid communication with the first body portion and the inlet tube, and an outlet conduit in fluid communication with the second body portion and the outlet tube. The inlet tube, the inlet conduit, the outlet tube, the outlet conduit, the first membrane, and the second membrane may all be made of the same material. The same material may comprise a silicone elastomer coated with covalent heparin, and the body fluid may come into contact with the same material only when the implantable pump is used. The ends of the membranes may be fixed within the housing, and a portion of the membrane covering a piston abutting the rotor may stretch in response to rotation of the rotor.

[0029] This document provides a method for increasing lymphatic flow from the brain using a lymphatic drainage system. The method may include: providing a pump having an inlet tube in fluid communication with a neck, occipital bone, and / or postauricular region, and an outlet tube in fluid communication with another body region; activating the pump to locally reduce interstitial pressure in the neck, occipital bone, and / or postauricular region, where lymph nodes and lymphatic vessels are located, to increase lymphatic flow from the brain via the inlet tube and the outlet tube. The method may further include activating the pump to increase lymphatic flow from the brain for the treatment of neurodegenerative diseases. The method may further include implanting the pump.

[0030] The outlet of the outlet tube may be in fluid communication with a lymphatic vessel, such as a thoracic tube, a right lymphatic vessel, or a lymphatic trunk, or may be subcutaneously placed in the subclavian region. The outlet of the outlet tube may be in fluid communication with the subclavian lymphatic trunk. The inlet of the inlet tube may be inserted into a lymphatic vessel in the neck region or a higher accessible lymphatic vessel and may be designed to increase the flow rate from the cervical lymphatic vessels. The lymphatic vessels may be the upper left or upper right cervical lymphatic trunk. The inlet of the inlet tube may be subcutaneously placed in the neck region and may be designed to draw free fluid from the tissues in the neck region and increase the flow rate in the neck region. The pump may include a bend valve designed to increase the lymphatic flow.

[0031] This document provides a catheter for use in a lymphatic drainage system. The catheter may include an elongated shaft having an inlet region configured for implantation in a patient to drain fluid accumulated in the subcutaneous interstitial space. The elongated shaft further includes an outlet region designed to couple to an implantable pump. The elongated shaft includes a first lumen, a second lumen, a main lumen in fluid communication with at least the first and second lumens, a first plurality of openings located at a first end region of the elongated shaft, and a second plurality of openings located between the first end region and a second end region of the elongated shaft, the first plurality of openings being in fluid communication with the first lumen and the second plurality of openings being in fluid communication with the second lumen.

[0032] The conduit may further include a third lumen in fluid communication with the main lumen, and the conduit further includes a third plurality of openings positioned between the second plurality of openings and the second end region of the elongated shaft, the third plurality of openings being in fluid communication with the third lumen. The conduit may further include a fourth lumen in fluid communication with the main lumen, and the conduit further includes a fourth plurality of openings positioned between the third plurality of openings and the second end region of the elongated shaft, the fourth plurality of openings being in fluid communication with the fourth lumen. The first plurality of openings may be circumferentially offset along the elongated shaft from the second plurality of openings.

[0033] This document provides an implantable pump for lymphatic fluid management in a patient. The implantable pump may include: a housing configured for implantation in the patient; a fluid chamber disposed within the housing and configured to be in fluid communication with an inlet conduit in fluid communication with a first body portion and an outlet conduit in fluid communication with a second body portion; a rotor disposed within the housing and configured to rotate eccentrically to change the volume of the fluid chamber to move bodily fluid from the inlet conduit to the outlet conduit; and a valve actuator configured to engage with the rotor as the rotor rotates to sequentially block fluid communication between the inlet conduit and the fluid chamber and between the outlet conduit and the fluid chamber, such that the inlet conduit is blocked when the outlet conduit is open and the outlet conduit is blocked when the inlet conduit is open.

[0034] The implantable pump may further include a first lever and a second lever, each fixed to the housing and mechanically in communication with the valve actuator. The valve actuator may include: a first cam configured to engage with the first lever to engage with the inlet conduit; and a second cam configured to engage with the second lever to engage with the outlet conduit. The housing may include a guide shaft configured to receive the valve actuator, and the valve actuator includes a plurality of protrusions configured to engage with the rotor to allow the valve actuator to move within the guide shaft as the rotor rotates. The implantable pump may include a piston configured to engage with the rotor and a portion of the fluid chamber to translate movement of the rotor into the fluid chamber, wherein the piston includes a tapered portion.

[0035] This document provides a method for managing lymphatic fluid in a patient using a lymphatic drainage system. The method may include: positioning an externally located external controller above an implantable pump implanted in the patient's body, such that the external controller is configured to magnetically engage with a rotor disposed within the housing of the implantable pump, the implantable pump including a fluid chamber mechanically in communication with the rotor and fluidly in communication with an inlet catheter and an outlet catheter; and using the external controller to eccentrically rotate the rotor within the housing of the implantable pump, such that the rotor, as it rotates, reduces the volume of the fluid chamber to shift the fluid chamber between an inhalation position and an outlet position, wherein the rotor is mechanically in communication with a valve actuator disposed within the housing of the implantable pump and configured to engage with the rotor as it rotates to sequentially block fluid communication between the inlet catheter and the fluid chamber and between the outlet catheter and the fluid chamber, such that the inlet catheter is blocked when the outlet catheter is open and the outlet catheter is blocked when the inlet catheter is open.

[0036] The implantable pump may further include a first lever and a second lever, each fixed to the housing and mechanically in communication with the valve actuator. The valve actuator may include: a first cam designed to engage with the first lever to engage the first lever with the inlet conduit; and a second cam designed to engage with the second lever to engage the second lever with the outlet conduit. The housing may include a guide shaft configured to receive the valve actuator, and the valve actuator may include a plurality of protrusions configured to engage with the rotor to allow the valve actuator to move within the guide shaft as the rotor rotates. The implantable pump may further include a piston configured to engage with the rotor and a portion of the fluid chamber to translate movement of the rotor into the fluid chamber, wherein the piston includes a tapered portion.

[0037] This document provides a lymphatic regulation system for lymphatic fluid management in a patient. The lymphatic regulation system may include: a pump configured to direct body fluid from a pump inlet to a pump outlet; an inlet catheter coupled at a first end to the pump inlet and positioned at a second end near a deep cervical lymph node, the second end of the inlet catheter including a plurality of through-holes positioned along the end region of the catheter, wherein the pump is configured to be activated to cyclically generate negative pressure at the second end of the inlet catheter via the plurality of through-holes, resulting in pressure regulation of at least some of the deep cervical lymph nodes or lymphatic vessels, thereby increasing lymphatic flow from the patient's brain.

[0038] The lymphatic regulation system may further include an external controller, wherein the pump is implantable, and the external controller is configured to be externally positioned above the pump and magnetically docked with the pump. The second end of the inlet catheter may have a closed end. The lymphatic regulation system may further include an outlet catheter coupled to the pump outlet at a main end and configured to extend into a first body portion at a secondary end. The pump may include: a housing configured to be implanted in the patient; a fluid chamber disposed within the housing and configured to be in fluid communication with the inlet and outlet catheters; a rotor disposed within the housing and configured to rotate eccentrically to change the volume of the fluid chamber to move body fluid from the inlet catheter to the outlet catheter; and a valve actuator configured to dock with the rotor as the rotor rotates to sequentially block fluid communication between the inlet catheter and the fluid chamber and between the outlet catheter and the fluid chamber, such that the inlet catheter is blocked when the outlet catheter is open and the outlet catheter is blocked when the inlet catheter is open.

[0039] This document provides a method for lymphatic regulation using a fluid management system. The method may include: positioning a first end of an inlet catheter near a patient's deep cervical lymph nodes, the inlet catheter including a plurality of through-holes in an end region; coupling a pump inlet to a second end of the inlet catheter, the pump being configured to move bodily fluid from the pump inlet to the pump outlet; and causing the pump to circulate and generate negative pressure at the first end of the inlet catheter, resulting in pressure regulation of at least some of the deep cervical lymph nodes or lymphatic vessels. The method may further include implanting the pump into the patient. The method may further include externally positioning an external controller above the pump and magnetically engaging it to generate the negative pressure.

[0040] The method may further include coupling the outlet catheter to the pump outlet at the main end of the outlet catheter and positioning the secondary end of the outlet catheter in a first body portion. The pump may include: a housing configured for implantation in the patient; a fluid chamber disposed within the housing and configured to be in fluid communication with the inlet and outlet catheters; a rotor disposed within the housing and configured to rotate eccentrically to change the volume of the fluid chamber to move bodily fluid from the inlet catheter to the outlet catheter; and a valve actuator configured to engage with the rotor as the rotor rotates to sequentially block fluid communication between the inlet catheter and the fluid chamber and between the outlet catheter and the fluid chamber, such that the inlet catheter is blocked when the outlet catheter is open and the outlet catheter is blocked when the inlet catheter is open.

[0041] This document provides a method for increasing lymphatic flow from the brain using a lymphatic drainage system. The method includes: providing a pump having an inlet tube in fluid communication with a neck, occipital bone, and / or postauricular region; activating the pump to locally reduce interstitial pressure in the neck, occipital bone, and / or postauricular region, where lymph nodes and lymphatic vessels are located, to increase lymphatic flow from the brain. The pump may further include an outlet tube in fluid communication with a body region different from the neck, occipital bone, and / or postauricular region. Activation of the pump increases lymphatic flow between the inlet tube and the outlet tube. The method may include implanting the pump into a patient. Activation of the pump increases lymphatic flow from the brain to treat neurodegenerative diseases. The inlet tube may have a closed end.

[0042] The outlet of the outlet tube coupled to the pump is in fluid communication with the thoracic tube, right lymphatic vessel, or lymphatic trunk. The outlet of the outlet tube may be coupled to the pump and placed subcutaneously in the subclavian region. The outlet of the outlet tube coupled to the pump may be in fluid communication with the subclavian lymphatic trunk. The inlet of the inlet tube may be inserted via cannulation into a lymphatic vessel in the neck region and may be designed to increase the flow rate from the lymphatic vessel. The inlet of the inlet tube may be inserted via cannulation into or near the upper left or upper right cervical lymphatic trunk. The inlet of the inlet tube may be placed subcutaneously in the neck region and configured to absorb free fluid from the tissue in the neck region and increase the flow rate in the neck region. The pump includes a bend valve designed to increase the lymphatic flow.

[0043] This document provides a catheter for a lymphatic drainage system. The catheter may include an elongated shaft comprising an inlet region configured for implantation in a patient to drain fluid accumulated in a subcutaneous interstitial space, the elongated shaft further comprising an outlet region configured for coupling to an implantable pump, the elongated shaft including a first lumen, a second lumen, a main lumen in fluid communication with at least the first and second lumens, a first plurality of openings disposed at a first end region of the elongated shaft, and a second plurality of openings disposed between the first end region and a second end region of the elongated shaft, the first plurality of openings being in fluid communication with the first lumen and the second plurality of openings being in fluid communication with the second lumen. The catheter may further include a third lumen in fluid communication with the main lumen, and the catheter further includes a third plurality of openings disposed between the second plurality of openings and the second end region of the elongated shaft, the third plurality of openings being in fluid communication with the third lumen. The conduit may further include a fourth lumen in fluid communication with the main lumen, and the conduit further includes a fourth plurality of openings disposed between the third plurality of openings and the second end region of the elongated shaft, the fourth plurality of openings being in fluid communication with the fourth lumen. The first plurality of openings are circumferentially offset from the second plurality of openings along the elongated shaft.

[0044] The foregoing overview is illustrative only and is not intended to be limiting in any way. Other aspects, embodiments, and features, besides those described above, will become apparent from the following drawings and detailed description. Attached Figure Description

[0045] Figure 1A The description includes an example fluid drainage system comprising an implantable pump implanted in the patient's leg for managing bodily fluids within the patient's body.

[0046] Figure 1B The description includes an example fluid drainage system comprising an implantable pump that is implanted in a patient's arm to manage bodily fluids within the patient's body.

[0047] Figure 2 Explain the front and bottom views of an implantable pump used to manage bodily fluids in a patient.

[0048] Figures 3A to 3D An internal view illustrating an implantable pump used to manage bodily fluids in a patient.

[0049] Figures 4A to 4B This describes the implantable pump housing, inner diaphragm, elastic diaphragm, inlet tube, outlet tube, and connector.

[0050] Figures 5A to 5B This is a cross-sectional view illustrating an implantable pump with its fluid chambers in the intake and discharge positions.

[0051] Figures 6A to 6H The illustration shows a cross-sectional view of the implantable pump as it transitions from the exhaust cycle to the intake cycle.

[0052] Figures 7A to 7C This describes the inlet connector that connects to the inlet tube of the implantable pump.

[0053] Figure 8 Explain the inlet conduit and cross-sectional views of inlet conduits containing various inlet lumens.

[0054] Figures 9A to 9B This is a perspective view of the outlet conduit, showing the anchored portion of the corresponding outlet.

[0055] Figures 10A to 10D The illustration shows a perspective view and an exploded view of an external controller used together with an implantable pump to pump bodily fluids.

[0056] Figure 11 This describes a bioimpedance measurement device that can be worn on a patient's finger.

[0057] Figure 12 This describes a bioimpedance measurement device that can be worn on a patient's leg.

[0058] Figure 13 This describes a body drainage system implanted in the patient's neck region to manage the accumulation of lymph fluid from the neck, occipital bone, and / or postauricular lymph nodes.

[0059] Figure 14 This describes a body drainage system implanted in the patient's arm to manage the accumulation of lymph fluid from the neck, occipital bone, and / or postauricular lymph nodes.

[0060] Figure 15 This describes the lymphatic regulation system located next to the lymphatic vessels and carotid artery in the neck.

[0061] Figure 16 This describes an example graphical user interface that will be displayed on the user's device and / or healthcare provider's device for monitoring the operation of the implantable pump.

[0062] Figure 17 An example architecture of an external controller for a body fluid drainage system according to one or more embodiments of the present disclosure is illustrated.

[0063] The foregoing and other features of this disclosure will become apparent from the following description taken in conjunction with the accompanying drawings and the appended claims. It should be understood that these drawings depict only a few embodiments according to this disclosure and should therefore not be construed as limiting its scope; the disclosure will be described with additional detail and nuance using the drawings. Detailed Implementation

[0064] This technology relates to a fluid drainage system, such as a lymphatic fluid (i.e., lymph) drainage system including a pump, which may include one or more bend valves. In some preferred embodiments, the pump is implantable. The implantable pump may include a rotor with a magnetic portion, which can be rotated by an external controller with a magnetic portion and a motor for rotating the magnetic portion on the external controller. The implantable pump may be connected to inlet and outlet catheters and may include bend valves for selectively guiding fluid received from the inlet catheter to the outlet catheter. The inlet catheter may be positioned in an edematous region and the outlet catheter may be positioned in the interstitial space of the drainage region. For example, the implantable pump may be positioned in a patient's leg, arm, or neck region to relieve lymphatic fluid accumulation in the patient (e.g., a user). In one example, the inlet region may be implanted in the patient to drain fluid (e.g., lymph) accumulated in the patient's subcutaneous interstitial space.

[0065] For reference Figures 1A to 1B This describes an example of a fluid drainage system that includes an implantable pump implanted in a patient's leg or arm for managing bodily fluids. For example... Figure 1A As shown, the implantable pump 102 of the body fluid drainage system 100 can be implanted in the leg 125 of the patient 115. The leg 125 of the patient 115 may have lymphatic fluid accumulation and the patient 115 may have lymphedema.

[0066] An implantable pump 102 can be connected to an inlet catheter 108 and an outlet catheter 110. The inlet catheter 108 and the outlet catheter 110 can each be implanted into the patient 115. The inlet catheter 108 may have multiple lumens and may extend along a portion of the leg 125. For example, the outlet catheter 110 may extend from the implantable pump 102 to an abdominal or back region of the patient 115. As an example, the inlet catheter 108 may be positioned in an edematous area of ​​the leg 125, and the outlet catheter may be positioned in the interstitial space of a drainage area in the abdominal or back region of the patient 115.

[0067] The implantable pump 102 may include a rotor with a magnetic portion that rotates to move a piston, changing the volume of a fluid chamber to generate negative pressure, causing lymph fluid to enter the inlet conduit 108 and the fluid chamber. The piston can then expel the lymph fluid from the fluid chamber and into an outlet conduit, ultimately draining it into a drainage area at the outlet of the outlet conduit. In this way, lymph fluid accumulated in the leg 125 can be redirected to a drainage area in the patient's abdomen or back, thereby reducing swelling in the leg 125.

[0068] The external controller 104 may be positioned near or otherwise adjacent to the implantable pump 102. For example, the external controller 104 may include a resilient and / or adjustable strap that secures the external controller 104 near the implantable pump 102, such that the magnetic portion of the external controller 104 can magnetically engage with the magnetic portion of the rotor of the implantable pump 102 via a magnetic field. The controller 104 may include a Hall effect sensor for determining alignment with the implantable pump and / or a light or other visual indicator for instructing the user on proper or improper alignment.

[0069] The external controller 104 may include input buttons, visual indicators, auditory indicators, a motor, and a magnetic portion for magnetically engaging with the magnetic portion of the implantable pump 102. The external controller 104 may further include a processor (e.g., a microprocessor) that controls the operation of the buttons, visual indicators, auditory indicators, motor, and communication with other devices. The processor may be any suitable processor that performs the operations and tasks described herein with respect to the implantable pump.

[0070] The external controller 104 can be worn by the patient for a period of time (e.g., 1 to 2 hours per day, 5 hours per day, 10 hours per day, or 24 hours per day). The external controller can be used to set operating parameters of the implantable pump 102 to achieve a desired drainage rate and / or lymph flow rate (e.g., mL / min), a running time, a recommended daily treatment time, and / or to communicate certain messages or information to the patient. The rotor of the implantable pump 102 can rotate at a rate of 1 to 20 revolutions per minute (RPM) or a rate between these rates, or any other suitable rate. The implantable pump 102 can pump fluid (e.g., lymph) at a rate between 0.1 and 2 mL / min or any other suitable rate.

[0071] External controller 104 can communicate with one or more devices via any suitable wired or wireless system (e.g., Wi-Fi, cellular network, Bluetooth, Bluetooth Low Energy (BLE), Near Field Communication Protocol, etc.). For example, external controller 104 can communicate with computing device 120, which may be a healthcare provider device (e.g., a doctor, nurse, technician, etc.). Computing device 120 can be any suitable computing device, such as a desktop computer, laptop computer, smartphone, tablet computer, wearable device, smart device, or the like. Computing device 120 can set operating parameters for external controller 104 to drive implantable pump 102.

[0072] The patient device 130 can be used by a patient or any other user (e.g., the patient's caregiver) and can similarly communicate with the external controller 104 via any well-known wired or wireless connection. The patient device 130 can be any suitable computing device, such as a desktop computer, laptop computer, smartphone, tablet computer, wearable device, smart device, or the like. The patient device 130 can receive operational and / or health information from the external controller 104 regarding the operation and / or function of the implantable pump 102.

[0073] The charging device 135 may be a charging device for charging the battery of the external controller 104. The charging device 135 may include an electrical interface for electrical communication with the external controller 104. Alternatively or additionally, the charging device 135 may include an inductive charging coil capable of electronic communication with an inductive charging coil of the external controller 104. The charging device 135 may include a visual indicator (e.g., an LED or a digital display) for indicating when charging is complete.

[0074] The charging device 135 may further include a processor (e.g., a microprocessor) for controlling the charging device 135 and / or monitoring communication with the external controller 104 and / or the implantable pump 101. Additionally, the charging device 135 may communicate with the patient device 130 and / or the computing device 120. In one example, only the charging device 135 may communicate with the implantable pump 102, and the patient device 130 and the computing device 120 may communicate with the implantable pump 102 via the external controller 104. For example, the charging device 135 may support Bluetooth and cellular communication, and may communicate with the external controller 104 via Bluetooth and with the computing device 120 and / or the patient device 130 via the Internet using cellular and / or Wi-Fi.

[0075] For reference Figure 1B The implantable pump 102 can be implanted in the arm 145 of the patient 115. The patient 115's arm 145 may have lymphatic fluid accumulation and the patient 115 may have lymphedema. The implantable pump 102 can be positioned in the upper part of the patient 115's arm 145, for example, near the shoulder. Figure 1B The implantable pump can be connected to the inlet catheter 142 and the outlet catheter 144. The inlet catheter 142 can be connected to... Figure 1A The inlet catheter 108 is similar to the outlet catheter 110, but may be sized to fit within the arm 145. The outlet catheter 144 may be similar to the outlet catheter 110, but may be sized to extend from the arm 145 of the patient 115 and may be sized to terminate in the clavicle or neck region of the patient 115 (e.g., above the clavicle). The external controller 104 may be configured using the computing device 120 based on certain operational settings to move lymphatic fluid from the arm 145 into the neck or clavicle space of the patient 115 to reduce swelling in the arm 145.

[0076] For reference Figure 2 This image shows a front and bottom view of an implantable pump used to manage bodily fluids in a patient. The implantable pump 200 can be used with... Figures 1A to 1B The implantable pump 102 is the same as or similar to the implantable pump 102. The implantable pump 200 may include a housing 202 made of any suitable biocompatible material (e.g., titanium, stainless steel, alloys, and / or plastics). The implantable pump 200 may be approximately the size of a coin. For example, the implantable pump 102 may be approximately 51 mm long, 26 mm high, and approximately 8 mm wide. The implantable pump 200 may be tapered at the end and may include beveled edges.

[0077] For example, housing 202 may include two halves secured together using a threaded engagement (e.g., screws and threads). Implantable pump 200 may include a connector 204 connectable to an outlet end of an inlet conduit and a connector 206 connectable to an inlet end of an outlet conduit. Implantable pump 200 may include an inlet connector 208, which may include a protrusion. Inlet connector 208 may connect to an inlet tube of implantable pump 200. Connector 204 may include a window 210 for receiving the protrusion of inlet connector 208 and is rotatable relative to inlet connector 208 to connector 204 and to implantable pump 100. Implantable pump may include an outlet connector 212, which may include a protrusion. Outlet connector 212 may connect to an outlet tube of implantable pump 200. Connector 206 may include a window 214 for receiving the protrusion of outlet connector 212 and is rotatable relative to outlet connector 212 to connector 206 and to implantable pump 200.

[0078] For reference Figures 3A to 3B This image shows an internal view of an implantable pump used to manage bodily fluids in a patient. The implantable pump 300 can be used with... Figures 1A to 1B The implantable pump 300 may be identical or similar to the housing 202. An inlet tube 304 may connect to a connection portion 340 at an inlet end and to a fluid chamber at an outlet end. The inlet end may be a pump port (e.g., an inlet port) and / or the outlet end may be a pump port (e.g., an outlet port). An outlet tube 306 may connect to the fluid chamber at an inlet end and to an outlet connector 346 at an outlet end. A diaphragm housing 308 may be a rigid shell over which the inlet tube 304 and outlet tube 306 extend and enter. The fluid chamber may be positioned within the housing.

[0079] An inlet pipe 304 may be positioned within a housing 302 such that a portion of the inlet pipe 304 can mate with a lever 310. A protrusion 348 may extend from the housing 302 and within the housing 302 maintain the inlet pipe 304 in a curved shape. The lever 310 may be hinged to the housing 302 at a cam mating end 314, which may have a curved surface for mechanical mating with a cam 318. The cam 318 may move left and right to rotate the lever 310 between an open position and a closed position. The lever 310, the protrusion 348, and the diaphragm housing 308 may form a bend valve, allowing fluid flow through the inlet pipe 304 when the lever 310 is in the open position, and completely blocking fluid flow when the lever 310 is in the closed position by bending the inlet pipe.

[0080] When lever 310 forms a U-shape in the inlet pipe and the lever pressurizes the inlet pipe 304 between lever 310, protrusion 348, and diaphragm housing 308, the inlet pipe may bend. The compressive force applied by lever 310 can be applied across the relatively large surface area of ​​inlet pipe 304, allowing the inlet pipe to elastically deform sufficiently to block fluid flow without damaging inlet pipe 304. The bend valve thus achieves an open position in which fluid can flow and a closed position in which fluid flow is blocked, which prevents fatigue of inlet pipe 304 and extends the life of implantable pump 300.

[0081] Lever 312 can be similarly positioned relative to outlet pipe 306 for mechanical engagement with outlet pipe 306. For example, lever 312 may have a hinged connection to housing 302 at a cam engagement portion of lever 312. Outlet pipe 306 may be positioned in a curved shape by protrusion 334. When lever 312 is switched from the open position to the closed position, outlet pipe is formed into a U-shape 316, and lever 312 may pressurize outlet pipe 306 against diaphragm housing 308 and protrusion 334 to block fluid flow in outlet pipe 306. Lever 312 may be switched to the open position to allow fluid to flow through outlet pipe 316.

[0082] Lever 310 can be switched between open and closed positions via cam 318, which can be moved via push rod 322. Cam 318 can be biased by elastic component 320, which can be a biasing component and can mechanically engage with cam 318. For example, elastic component 320 can be a spring, foam, or other elastic material or device that is compressed and returns to its original shape. Elastic component 320 can bias the cam to position lever 310 in the open position, such that when lever 310 is in the closed position, lever can be biased by elastic component 320 to return to the open position. Figure 3A In the example positions described herein, lever 310 is in the open position and lever 312 is in the closed position.

[0083] Lever 312 can similarly be shifted between open and closed positions via cam 321, which can be moved by push rod 326. Cam 321 can be biased by elastic component 324, which can be a biasing component and can mechanically engage with cam 321, similar to cam 318 and elastic component 320. Push rods 322 and 326 can be moved by rotor 330, which can be disk-shaped and supported by housing 302 via pins or similar connections, such that rotor 330 can rotate about an axis relative to housing 302. Connection 332 can be the axis of rotation of rotor 330 and can be eccentric relative to rotor 330. Rotor can include one or more magnetic components. For example, rotor 330 can include a permanent magnet disk or annular structure. In one example, rotor 330 can include a neodymium permanent magnet disk that can be coated with parylene and / or a ceramic multilayer coating.

[0084] When the rotor 330 rotates around the eccentric shaft, it moves push rods 322 and 326 toward levers 310 and 312, respectively. As the rotor 330 rotates further, push rods 322 and 326 can return to their original positions and can be biased to their original positions via elastic components 320 and 324 acting on cams 318 and 321, respectively. Cam 318 can be connected to push rod 322 and cam 321 can be connected to push rod 326.

[0085] The rotor 330 may be positioned within and / or directly mechanically docked with the piston 328. When the rotor 330 is eccentrically connected to the housing 302, the rotor 330 may move up and down as it rotates, and this movement may be translated to the piston 328, which may move up and down freely relative to the diaphragm housing 308, although the rotor may rotate freely within or near the piston 328 to move the piston 328 into and out of the diaphragm housing 308.

[0086] like Figure 3A As shown, the connecting portion 340 may include a protrusion 342 and a connecting portion 340 that may have a protrusion 344. The protrusion 342 may not extend 360 degrees around the connecting portion 340. The protrusion 344 may extend 360 degrees. The protrusion 344 may be made of the same material as the inlet tube 304, or alternatively, it may be covered only on its inner surface with the same material as the inlet tube 304. Similarly, the outlet connector 346 may have the same components and structure as the inlet connector. Figure 3A As shown, connector 350 can extend and rotate above the protrusion to lock onto it. Connector 350 can be attached to an outlet conduit.

[0087] For reference Figure 3B This illustrates a cross-sectional view of the implantable pump 300. (See attached image.) Figure 3BAs shown, inlet pipe 304 may have an outlet that connects to and terminates in fluid chamber 360, and outlet pipe 306 may have an inlet that begins in and connects to fluid chamber 360. Fluid chamber may be formed of membrane housing 308, which may be lined with an inner membrane 362.

[0088] Inlet pipe 304 can be connected to connection portion 340 at its inlet end and to fluid chamber at its outlet end. Outlet pipe 306 can be connected to fluid chamber at its inlet end and to outlet connector 346 at its outlet end. Inner membrane 362 can be lined to the inner surface of membrane housing and can mate with and / or receive the outlet of inlet pipe 304 and the inlet of outlet pipe 306. Inlet membrane can be any suitable elastic material, such as silicone.

[0089] The housing 308 and / or the inner membrane 362 may be connected at the bottom to an elastic membrane 364, which may be made of any suitable elastic material, such as silicone. The elastic membrane 364 may form the bottom portion of the fluid chamber 360, and the housing 308 and the inner membrane 362 may form the upper portion of the fluid chamber 360, allowing fluid to be positioned between the elastic membrane 364 and the inner membrane 362. The inner membrane 362 may be hermetically connected to the elastic membrane 364 to define the fluid chamber. For example, the inner membrane 362 and the elastic membrane 364 may be adhered to each other or otherwise connected to create a fluid seal. For example, the inner membrane 362 and the elastic membrane 364 may be hermetically sealed.

[0090] The inner membrane 362 may adhere to or otherwise attach to the inner surface of the membrane housing 308, such that the inner membrane 362 is not movable relative to the membrane housing. In one example, the inner membrane 362 may enter an aperture in the membrane housing 308 to mate with the membrane housing 308. However, the elastic membrane 364 may be designed to move relative to the membrane housing 308 and the inner membrane 362. For example, the elastic membrane 364 may be positioned above the top portion of the piston 328 and may move upward with the piston as the piston 328 moves upward via the rotor 330. The elastic membrane 364 may be biased to return to a rest position and thus may move downward with the piston 328 as the piston 328 moves downward. In this way, the volume of the fluid chamber may decrease as the piston 328 moves upward and may increase as the piston moves downward. A portion of the elastic membrane 364 may be glued or otherwise adhered to the piston 328 (e.g., the top portion of the piston) such that when the piston 328 moves downward during the intake cycle, the elastic membrane 364 moves downward with the piston 328. Although the elastic membrane 364 may adhere to a portion of the piston 328, the elastic membrane 364 may otherwise be freely stretched relative to the piston 328 as the piston 328 moves up and down.

[0091] For reference Figure 3C to 3D Explanation and Figures 3A to 3BAn internal view of an implantable pump 300, similar to an implantable pump used to manage bodily fluids within a patient. For example, Figure 3C and 3D The internal components described herein can be used with Figures 3A to 3B The components are the same or similar, except Figures 3A to 3B The push rods 322 and 326, cams 318 and 321, and elastic components 320 and 324 are removed and replaced with anything other than valve actuator 341. Figure 3C As shown, the valve actuator can be, for example, an integral and / or one-piece component with a central clearance 345, which allows the piston 329 and rotor 330 to extend through the central clearance 345. The piston 329 can be coupled with... Figure 3A The piston 328 is similar, but may have a tapered shape, such that the piston 329 is thinner next to the bottom and / or middle region and thicker next to the top region. The thinner profile next to the bottom and / or middle region allows the middle and / or middle region of the piston 329 to move more easily within the valve actuator 341 and / or can reduce the weight of the pump.

[0092] The valve actuator 341 may include a cam 349 at one end of the valve actuator 341 and a cam 351 at the other end of the valve actuator 341. Figure 3A Similar to cams 318 and 231, cams 349 and 351 can respectively switch levers 312 and 310 between open and closed positions, in the same way as described above. Figures 3A to 3B The push rod 322 moves the cam 318 between the open and closed positions in the same way as the lever 310 and the push rod 326 move the cam 321 between the open and closed positions.

[0093] In one example, the valve actuator may comprise a body on either side of the central clearance 345 extending between cams 348 and 351, and each body may include protrusions (e.g., two protrusions on each side). Since the rotor 330 is fixed to and rotates relative to the pump housing via connection 332, the valve actuator 341 may be shaped to avoid collision with connection 332. In one example, each body of the valve actuator 341 may include a curved portion, which may be shaped to offset each corresponding body to avoid interfering with connection 332, such that the rotor 330 can perform full rotation of the rotor 330 without interfering with the valve actuator 341.

[0094] Multiple protrusions (e.g., protrusions 343 and 347) on each body of the valve actuator 341 may be sized and positioned to engage with the rotor 330. For example, the protrusions on either side of the valve actuator 341 may be spaced apart by a distance only slightly larger than the diameter of the rotor 330, such that the rotor 330 can move between the protrusions as it moves eccentrically relative to the pump housing. In this way, the protrusions can be laterally translated (e.g., left-to-right movement of the rotor) without translating the vertical movement of the rotor. The pump housing may include a horizontal channel in which the valve actuator 341 is allowed to slide laterally as it moves in response to movement from the rotor 330.

[0095] like Figure 3C As shown, levers 312 and 310 can be coupled to the pump housing via pins. For example, lever 312 can be rotatably connected to the housing using pin 352, which allows lever 312 to rotate relative to the housing. Each lever may further include grooves for mating with inlet and outlet pipes. For example, lever 310 may have a curved surface 339, which may be shaped to match or optimize surface contact with the inlet or outlet pipe.

[0096] like Figure 3D The above description illustrates the relevant information. Figure 3C Alternative pumps to the described components. For example, valve actuator 341, piston 329, rotor 330, and levers 310 and 312 may be positioned in housing 303, which may be similar to housing 302 of FIG. 1. Housing 303 may include obstructions (e.g., obstruction 371) that allow the inlet or outlet tube to bend around the diaphragm housing 308 and otherwise orient this tube generally downward (e.g., toward the piston). Housing 303 may additionally include other obstructions (e.g., obstruction 373) that guide the inlet or outlet tube upward (e.g., away from the piston).

[0097] Connectors 377 and 379 may be received and coupled to housing 303. Inlet pipe 304 may be connected to connector 377 at one end and to a fluid chamber at the other end. Outlet pipe 306 may be connected to the fluid chamber at one end and to connector 379 at the other end. Inlet pipe 304 and outlet pipe 306 may extend into housing 308, in which the fluid chamber may be disposed. As the rotor rotates, piston 339 may move vertically relative to housing 303. Piston 339 may be positioned in piston passage 361 of housing 303, which guides the piston's vertical movement within housing 303 as rotor 330 rotates. Valve actuator 341 may slide laterally (e.g., left-right) in passage 315 as rotor 330 moves vertically. When valve actuator 341 moves left and right, a cam at the end of valve actuator 341 moves levers 310 and 312, forming a bend valve to selectively block and allow fluid movement through inlet pipe 304 and outlet pipe 306. It should be understood that the rotor can rotate clockwise or counterclockwise, and / or outlet pipe 306 can act as an inlet pipe to allow fluid to flow into the fluid chamber and inlet pipe 304 can act as an outlet pipe to allow fluid to flow out of the outlet chamber.

[0098] For reference Figures 4A to 4B This describes the implantable pump housing, inner diaphragm, elastic diaphragm, inlet pipe, outlet pipe, and connector. The diaphragm housing 408, inlet pipe 404, and outlet pipe 406 can be respectively connected to... Figures 3A to 3B The membrane housing 308, inlet pipe 304, and / or outlet pipe 306 are the same as or similar to those of the membrane housing 308, inlet pipe 304, and / or outlet pipe 306. Additionally, the inner membrane 462 and elastic membrane 464 may be similar to those of the membrane housing 308, inlet pipe 304, and / or outlet pipe 306. Figure 3A and 3B The inner membrane 362 and the elastic membrane 364 are the same or similar.

[0099] An inlet connector 420 may be connected to or extend from an inlet tube 404 and may mat with an inlet conduit. An outlet connector 422 may be connected to or extend from an outlet tube 406 and may mat with an outlet conduit. The inlet connector 420, outlet connector 422, inlet tube 404, and outlet tube 406 may be made entirely of the same material (e.g., implantable silicone with an internal hydrophilic coating (e.g., heparin coating)). Alternatively, the inlet connector 420 and outlet connector 422 may be made of a rigid material (i.e., titanium, stainless steel, rigid plastic) and covered on their inner surfaces with the same material as the inlet tube 404 and outlet tube 406 (e.g., implantable silicone with an internal hydrophilic coating (e.g., heparin coating)). The inlet connector 420 and / or outlet connector 422 may include protrusions extending 360 degrees around the inlet connector 420 and / or outlet connector 422. Each protrusion facilitates a fluid seal with the respective inlet and outlet conduits.

[0100] For reference Figures 5A to 5B This illustration shows a cross-sectional view of the implantable pump in its fluid chambers at the suction and discharge positions. The implantable pump 500 can be used with... Figures 3A to 3B The implantable pump 300 is the same as or similar to the implantable pump 300. More specifically, the housing 502, diaphragm housing 508, inner diaphragm 562, elastic diaphragm 564, piston 528, and / or rotor 530 may be the same as... Figures 3A to 3B The housing 302, membrane housing 308, inner membrane 362, elastic membrane 364, piston 328 and / or rotor 330 are the same as or similar.

[0101] like Figure 5A As shown, rotor 530 can rotate about eccentric shaft 540, such that piston 528 is in a downward position relative to membrane housing 508, inner membrane 562, and elastic membrane 564. In this downward position of piston 528, the volume of the fluid chamber defined by inner membrane 562 and elastic membrane 564 is maximized and optimized for receiving lymph fluid from the inlet tube. Figure 5A The location described in the text is called the inhalation location.

[0102] like Figure 5B As shown, rotor 530 can rotate about eccentric shaft 540, such that piston 528 is in an upward position relative to membrane housing 508, inner membrane 562, and elastic membrane 564. In this upward position of piston 528, the volume of the fluid chamber defined by inner membrane 562 and elastic membrane 564 is minimized and optimized for discharging lymph fluid from the outlet pipe. Figure 5B The location described in the text is called the emission location.

[0103] For reference Figures 6A to 6D This illustration shows a cross-sectional view of an implantable pump, illustrating the transition from the exhaust cycle to the intake cycle. (See attached image.) Figure 6A As shown in the diagram, at the start of the emission cycle, it is explained that it can be used with... Figures 3A to 3B An implantable pump 300 is identical or similar to an implantable pump. For example, lymph fluid has entered the fluid chamber 608 and the bend valve 604 has been turned to the closed position to prevent the fluid from leaving the fluid chamber from the inlet tube. The bend valve 606 may remain in the closed position until the rotor begins to rotate further after closing the bend valve 604.

[0104] like Figure 6B As shown, after rotation to close bend valve 604, the rotor can continue to rotate (e.g., clockwise), thereby opening bend valve 606. With the bend valve open in the discharge position, the rotor can continue to rotate to move the piston upward, thereby reducing the volume of the fluid chamber and discharging fluid from the outlet pipe to discharge bodily fluids from the outlet pipe. When bend valve 606 is open during discharge, bend valve 604 can remain closed.

[0105] like Figure 6CAs shown, at the start of the suction cycle, the implantable pump 602 is illustrated with the piston 612 in a fully upward position to reduce the volume of the fluid chamber 608. As the rotor 610 rotates to move the piston 612 to... Figure 6C When the rotor is in the fully upward position as shown in the diagram, bend valve 606 is closed and bend valve 604 remains closed. At this point, the rotor has moved from... Figure 6A The rotor rotates 180 degrees as described in the text. Figure 6D In the middle, rotor 610 can continue to rotate (e.g., clockwise), causing bend valve 604 to open and piston 612 to move downwards, achieving the suction position. Bend valve 606 can remain closed until the piston reaches... Figure 6A and 6B The rotational position is as described in the diagram. When the piston moves downward, the volume of the fluid chamber 608 can increase, resulting in negative pressure, which allows body fluid to enter the inlet pipe through the opened bend valve 604.

[0106] For reference Figures 6E to 6H The illustration shows a cross-sectional view of an implantable pump with a valve actuator, illustrating the transition of the implantable pump from the discharge cycle to the intake cycle. (See image.) Figure 6E The diagram shows that the implantable pump 602 can be used with... Figures 3A to 3B The implantable pump 300 is the same as or similar to it, but has a valve actuator 640 with replaceable push rods, cams, and elastic components. Figure 6E In the position described herein, the valve actuator 640 is located at the center of the guide channel 615. Figure 6E The text describes the implantable pump 602 at the start of the discharge cycle. For example, lymphatic fluid has entered the fluid chamber 608 and the bend valve 604 has been turned to the closed or near-closed position to prevent and / or block the fluid from leaving the fluid chamber from the inlet pipe. The bend valve 606 may remain in the closed or near-closed position until the rotor begins further rotation after closing the bend valve 604. Figure 6E As shown, when piston 612 is in its lowest position and the inner lining of the fluid chamber is at its minimum elongation, the fluid chamber can be completely filled.

[0107] like Figure 6F As shown, after rotation to close bend valve 604, the rotor can continue to rotate (e.g., clockwise), thereby opening bend valve 606. For example, valve actuator 640 can slide to the left in guide channel 615 and engage with lever to close bend valve 604 and open bend valve 606. At this time, the rotor has moved from... Figure 6E The rotor, as described, rotates 90 degrees. With the bend valve 606 open in the discharge position, the rotor can continue to rotate to move the piston upward, thereby reducing the volume of the fluid chamber and causing the fluid to leave the outlet pipe to discharge the bodily fluid. When the bend valve 606 is open during discharge, the bend valve 604 can remain closed.

[0108] like Figure 6G As shown, at the start of the suction cycle, the implantable pump 602 is illustrated with the piston 612 in a fully upward position to reduce the volume of the fluid chamber 608. As the rotor 610 rotates, it causes the valve actuator 640 to slide to the right in the guide passage 615. When the rotor 610 rotates to move the piston 612 to... Figure 6G When the rotor 610 is in the fully upward position as shown in the diagram, bend valve 606 is closed and bend valve 604 remains closed. At this time, the rotor 610 has moved from... Figure 6E The rotor is rotated 180 degrees as described above, and the inner membrane of the fluid chamber is at its maximum elongation. (As...) Figure 6H As shown, rotor 610 can continue to rotate (e.g., clockwise), opening bend valve 604 and moving piston 612 downward to the suction position. As rotor 610 rotates, it can move valve actuator 640 to the right in guide passage 615. Bend valve 606 can remain closed until the piston reaches... Figure 6E and 6F The rotational position is as described in the diagram. When the piston moves downward, the volume of the fluid chamber 608 increases, resulting in negative pressure, which allows body fluid to enter the inlet pipe through the opened bend valve 604 and fills the fluid chamber with body fluid. At this time, the rotor 610 has moved from... Figure 6E The rotor is described as rotating 270 degrees.

[0109] For reference Figures 7A to 7C This describes the inlet connector that connects to the inlet tube of the implantable pump. The implantable pump 700 can be used with... Figures 3A to 3B The implantable pump 300 is similar to or may include an inlet connector portion 702 for connection to an inlet connector 708. The inlet connector 708 may be connected to or create a fluid seal with an outlet end of an inlet conduit, and / or mate with an inlet conduit. The inlet connector portion 702 may include a groove for receiving an extension 704 on the inlet connector 708. The inlet connector 708 may further include a window 710 for receiving a protrusion 706 extending from an end of the inlet connector portion 702. The window 710 may be positioned above the protrusion 706 such that the extension 704 is positioned within the groove of the inlet connector portion. To lock the inlet connector 708 onto the inlet connector portion 702, the inlet connector portion may rotate while the extension 704 is within the groove of the connector portion 702. Although Figures 7A to 7C The description includes inlet connector 708 and inlet connector portion 702, but it should be understood that the same connector and / or inlet connector portion can be used to connect the outlet conduit to the outlet pipe.

[0110] For reference Figure 8This describes a cross-sectional view of the inlet conduit and inlet conduits containing various inlet lumens. The inlet conduit 800 can be connected to... Figure 1B Inlet catheter 108 and / or Figure 1B The inlet conduit 152 is the same as or similar to the inlet conduit 800. The inlet conduit may include an inlet end 805 and an outlet end 810. The inlet conduit 800 may include several lumens extending within it. For example, the inlet conduit may include lumens 812, 815, 817, and 819. Alternatively, the inlet conduit 800 may include any number of lumens (e.g., 1, 2, 3, 5, 6, etc.).

[0111] Lumens 812, 815, 817, and 819 may be eccentric relative to the central axis of the inlet conduit and may extend adjacent to each other. At a first end of lumen 812, lumen 812 may be connected to a hole 802 as illustrated in cross-sectional view 814, which may be a through-hole and / or opening extending through the wall of the inlet conduit 800 and allowing bodily fluids to enter through-hole 802 (e.g., through-hole 816) into lumen 812. Similarly, the ends of lumens 815, 817, and 819 may be connected to holes 804, 806, and 811, respectively, each of which may be a through-hole similar to through-hole 816.

[0112] Lumen 812 may be longer than lumen 817, lumen 817 may be longer than lumen 815, and lumen 815 may be longer than lumen 819. Orifices 802, 804, 806, and 811 may be positioned in alternating locations along the inlet conduit 800 (e.g., each set of orifices may be circumferentially offset by 90 degrees from the previous set). This alternating circumferential positioning along the length of the inlet conduit 800 facilitates enhanced fluid aspiration because this arrangement provides access to multiple different body sites along the inlet conduit.

[0113] Each of lumens 812, 815, 817, and 819 may include an outlet terminating in lumen 820, allowing body fluid to exit from lumens 812, 815, 817, and 819 and enter lumen 820. Each of lumens 812, 815, 817, and 819 may be independent of each other and may extend side-by-side along inlet conduit 800. As lumen 820 extends toward outlet 810 of inlet conduit 800, the inner diameter of lumen 820 may decrease, such as... Figure 8 As shown in the diagram. The inlet end 805 may further include a suture hole 813 for anchoring the inlet end 805 of the inlet catheter 800 to a tissue or body structure (e.g., via suture). The outlet end 810 may be connected to an inlet connector for securing the outlet end 810 to an implantable pump.

[0114] Orifices 802, 804, 806, and 810 may be of the same size, or alternatively, may be of different sizes. For example, orifices 802, 804, and 806 may be of different sizes to regulate the fluid flow and / or pressure of bodily fluids along the inlet conduit 800. For example, the orifices may be sized such that the hydraulic resistance of each lumen is the same. For example, the diameter of multiple sets of orifices may decrease as they move from the inlet end 805 to the outlet end 810. In another example, the lumen sizes may be different. For example, the diameter of lumen 812 may be about 1.34 mm, the diameter of lumen 817 may be 1.28 mm, the diameter of lumen 815 may be 1.15 mm, and the diameter of lumen 819 may be 1 mm. The inlet conduit 800 may be made of implantable silicone (e.g., NUSIL MED-4750) or the like. The inlet conduit may be coated with a hydrophilic coating (e.g., a heparin coating). It should be understood that the dimensions of each component of the inlet catheter may differ and / or different materials may be used than those described herein.

[0115] For reference Figure 9A To B, a perspective view of the outlet conduit including the anchored portion at the outlet. See now. Figure 9A The outlet conduit 900 can be connected to Figure 1A outlet conduit 110 and / or Figure 1B The outlet catheter 144 is the same as or similar to the outlet catheter 900. The outlet catheter may include an inlet end 904 and an outlet end 906. The outlet catheter 900 may include a single central lumen extending the length of the outlet catheter 900, said central lumen having, for example, an outer diameter of about 4 mm and an inner diameter of about 2 mm. The inlet end 904 may be connected via an outlet connector to the outlet tubing of an implantable pump (e.g., Figure 4A The outlet conduit 900 may include an adhesive portion 902 for anchoring the inlet conduit to a part of the body. For example, the adhesive portion 902 may be a polyurethane mesh for adhesion. The outlet end 906 of the outlet conduit 900 may optionally be secured to a part of the body (e.g., via sutures). Reference is now made to... Figure 9B The outlet conduit 901 can be connected with Figure 1A outlet conduit 110 and / or Figure 1BThe outlet catheter 901 is the same as or similar to the outlet catheter 144. The outlet catheter 901 may include an inlet end 905 and an outlet end 908, and may include a single central lumen extending the length of the outlet catheter 901. The outlet catheter 907 may include a butterfly feature 907 for anchoring the inlet end 905 of the outlet catheter 901 to a part of the body, including two suture holes. The outlet end 908 of the outlet catheter 901 may optionally be secured to a part of the body (e.g., via sutures). The outlet catheter 900 and / or the outlet catheter 901 may be made of implantable silicone (e.g., NUSIL MED-4750) or the like. The outlet catheter 900 and / or the outlet catheter 901 may be coated with a hydrophilic coating (e.g., a heparin coating). It should be understood that the dimensions of each component of the outlet catheter 900 and / or the outlet catheter 901 may differ and / or materials different from those described herein may be used.

[0116] For reference Figures 10A to 10B This describes a perspective and exploded view of an external controller used together with an implantable pump to pump bodily fluids such as lymph. See now for reference. Figure 10A The external controller 1000 is described below, and may be the same as or similar to the external controller 104 of FIG1. ​​The external controller 1000 may include a control unit 1002 and a strap 1008, which is connectable to the control unit 1002 and designed to secure the external controller 1000 to a user's limb (e.g., arm, leg, etc.). The control unit 1002 may include a user engagement portion 1004, which may be a button or any other input feature for controlling and / or operating the external controller 1000. The control unit 1002 may further include a visual indicator 1006 (e.g., one or more lights and / or displays) that can provide visual information to the user.

[0117] For reference Figure 10B An exploded view of the external controller. For example... Figure 10B As shown, the external controller 1000 may include an upper housing 1012 and a lower housing 1034 that together provide a housing for the control unit. An engagement portion 1004, which may be a button and / or switch, may be positioned within an opening in the housing. A printed circuit board (PCB) 1014 may be positioned directly below the upper housing 1012 and may be connected to the button 1004, monitoring user interface interactions. The PCB 1014 may include one or more Hall sensors for monitoring the angular velocity of the drive magnet 1016. The PCB 1032 may include one or more Hall sensors for generating alignment information with the magnetic portion of the implantable pump. The drive magnet 1016, which may be a permanent magnet or a disk magnet, may be positioned within a bearing 1020, facilitating low-friction rotation of the drive magnet 1016.

[0118] A bearing 1020 may be positioned within a wheel 1026, which may be a gear having teeth along its outer circumference. A motor assembly including a motor 1028, a lead screw 1024, and a frame 1022 may cause rotation of a drive magnet 1016. For example, the motor 1028 may be a DC motor and may include a transmission. The motor 1028 may be connected to and cause rotation of the lead screw 1024. The lead screw 1024 may be any suitable lead screw shape with threads and designed to rotate about its longitudinal axis. For example, the lead screw 1024 may be a worm gear or the like. The frame 1022 may be circular in shape and may receive and / or retain the wheel 1026, and may position the wheel 1026 in continuous contact with the lead screw 1024 such that the teeth of the wheel 1026 remain engaged with the threads of the lead screw 1024. When the motor 1028 rotates the lead screw 1024, the lead screw 1024 will rotate the wheel 1026, thereby rotating the drive magnet 1016. The rotational speed of the drive magnet 1016 can therefore be selectively changed using the motor 1028.

[0119] A printed circuit board (PCB) 1027 may be positioned around, below, and / or near the wheel 1026. The PCB 1027 may include one or more Hall sensors for generating alignment information with the magnetic portion of the implantable pump. A Hall sensor 1030 may be additionally positioned around, below, and / or near the wheel 1026 and may be used to generate alignment information with the magnetic portion of the implantable pump to align the drive magnet 1016 with the magnetic portion of the implantable pump. A printed circuit board (PCB) 1032 may be positioned between the upper housing 1012 and the lower housing 1034. PCBs 1032, PCB 1027, and / or PCB 1014 may include electronics for controlling the operation and functions of the external controller 1000. A charging pin 1036 may be connected to PCB 1032 and may extend through the lower housing 1034 for electrical connection to a charging device (e.g., charging device 135 of FIG. 1).

[0120] For reference Figure 10C This describes a motor assembly including a motor 1028, a lead screw, and a frame 1022. A drive magnet 1016 and a bearing 1020 are described as being positioned within the frame 1022. A wheel is positioned within the frame 1022 and can be rotated by the lead screw to rotate the drive magnet 1016. (See now for further details.) Figure 10D This describes a sectional view of a motor assembly including a motor 1028, a lead screw 1024, and a frame. Figure 10D Further explanation of wheel 1026 and drive magnet 1016 positioned within and / or near drive magnet 1016. Lead screw 1024 can be driven by motor 1028 to rotate the thread of lead screw 1024, such as... Figure 10DAs shown, the thread directly engages with the teeth of wheel 1026 to rotate the wheel and drive magnet 1016. PCB 1027 may be generally circular in shape and positioned near and / or below wheel 1026 and drive magnet 1016. In one example, the external controller may be the same as or similar to the external controller described in more detail in U.S. Patent Application Publication No. 2020 / 0197675, published June 25, 2020, the entire contents of each of which are incorporated herein by reference.

[0121] For reference Figure 11 This describes a bioimpedance measurement device that can be worn on a patient's finger. The bioimpedance measurement device 1100 can be ring-shaped and sized to fit on the patient's finger. Figure 11 As shown, for example, the bioimpedance device 1100 can be used to measure the bioimpedance of a user's arm. The bioimpedance of a user's arm can refer to the effective resistance of a current passing through the user's arm. Bioimpedance measurements before and after treatment of the arm using a fluid drainage system (e.g., fluid drainage system 100) can provide information about the efficacy of the treatment.

[0122] The bioimpedance measurement device 1100 may include a ring structure 1101, which may be a rigid, fabric, or elastic ring structure. The bioimpedance measurement device 1100 may include a sensing electrode 1104 and an excitation electrode 1122, each of which may be one, two, or more electrodes for contact with a user's skin. The sensing electrode may be electrically communicated with a sensing circuit 1106, which may be electrically communicated with a microcontroller unit 1108. The microcontroller unit 1108 may be electrically communicated with an excitation circuit 1110, which may be electrically communicated with an excitation electrode 1112. The microcontroller unit 1108 may cooperate with the sensing circuit 1106 and the excitation circuit 1110 to cause the excitation electrode to generate an excitation signal and receive a signal corresponding to the excitation signal from the sensing electrode 1104, which may be for impedance measurement of the user's arm. The bioimpedance measurement device 1100 may further include a battery 1107 to power the components of the bioimpedance measurement device 1100.

[0123] For reference Figure 12 This describes a bioimpedance measurement device that can be worn on a patient's leg. The bioimpedance measurement device 1200 may include a sensing device 1202 and an excitation device 1204, the excitation device 1204 being connected to the sensing device 1202 via a wired connection. The sensing device 1202 and the excitation device 1204 may be positioned adjacent to or separate from each other.

[0124] Sensing device 1202 may include sensing electrodes 1206, each of which may be one, two, or more electrodes for contacting a user's skin. Similarly, actuation device 1202 may include actuation electrodes 1216, each of which may include one, two, or more electrodes for contacting a user's skin. Sensing electrodes 1206 may be electrically communicated with sensing circuit 1210, which may be electrically communicated with microcontroller unit 1212. Microcontroller unit 1212 may be electrically communicated with actuation circuit 1210, which may be electrically communicated with sensing circuit 1210. Microcontroller unit 1212 may cooperate with sensing circuit 1210 and actuation circuit 1208 to cause actuation electrode 1216 to generate an actuation signal and to receive a signal corresponding to the actuation signal from sensing electrode 1206. Impedance measurement of the user's leg may be based on the signal received by sensing electrode 1206. Bioimpedance measurement device 1200 may further include a battery 1207 to power the components of bioimpedance measurement device 1200.

[0125] For reference Figure 13 This describes a body drainage system implanted in the patient's neck region to manage the accumulation of lymph fluid from the cervical lymph nodes. For example... Figure 13 As shown, a fluid drainage system, identical or similar to the fluid drainage system 100 of Figure 1, can be implanted next to the user's neck area. The fluid drainage system may include an implantable pump 1304, which may be identical or similar to the implantable pump 102 of Figure 1 and may include an inlet catheter 1302 and an outlet catheter 1306, which can be respectively connected to… Figure 8 The inlet conduit 800 and the outlet conduit 900 in Figure 9 are the same or similar. For example... Figure 13 As shown, the inlet catheter 1302 can be positioned in the cervical region, near the cervical lymph nodes. For example, the inlet of the inlet catheter can be inserted into a lymphatic vessel in the cervical region or a higher lymphatic vessel that is accessible to increase the flow rate from the cervical lymphatic vessels. For example, the lymphatic vessel can be the upper left or upper right cervical lymphatic trunk. In one example, the inlet catheter 1302 can be in fluid communication with the neck, occipital bone, and / or postauricular region.

[0126] The implantable pump 1304 can be implanted next to the user's neck and can generate negative pressure in the neck region next to the entrance of the inlet catheter 1302. When lymph fluid moves into the inlet catheter 1302 due to the negative pressure, the lymph fluid can be guided downward away from the brain lymphatic system. For example, activating the pump can locally reduce interstitial pressure in the neck, occipital bone, and / or postauricular region where lymph nodes and lymphatic vessels are located to increase lymphatic flow from the brain via the inlet and outlet catheters.

[0127] like Figure 13As shown, the implantable pump 103 can be positioned in the lower neck (e.g., near the collar area), and the outlet catheter 1306 can be positioned in the axillary region for absorption by the user's axillary lymph nodes. However, it should be understood that the implantable pump 1304 can be placed in any other body location, and the outlet catheter 1306 can be placed in any other area of ​​the body with functional lymph nodes other than the cervical lymph nodes. Alternatively or additionally, the outlet of the outlet catheter can be positioned such that it is in fluid communication with a lymphatic vessel (e.g., the thoracic or right lymphatic vessel, lymphatic trunk), or otherwise placed subcutaneously in the subclavian region.

[0128] For reference Figure 14 This describes a body drainage system implanted in the patient's arm to manage the accumulation of lymph fluid from the cervical lymph nodes. For example... Figure 14 As shown, the body fluid drainage system may be the same as or similar to the body fluid drainage system 100 in Figure 1. The body fluid drainage system may include an implantable pump 1404, which may be the same as or similar to the implantable pump 102 and may include an inlet catheter 1402 and an outlet catheter 1406, the inlet catheter 1402 and the outlet catheter 1406 being respectively connected to… Figure 8 The inlet catheter 800 and the outlet catheter 900 in Figure 9 are the same or similar. The implantable pump 1404 can be implanted in the user's arm.

[0129] like Figure 14 As shown, the inlet catheter 1402 can be positioned in the neck region, near the cervical lymph nodes. For example, the inlet of the inlet catheter can be cannulated into a lymphatic vessel in the neck region or a higher accessible lymphatic vessel to increase the flow rate from the cervical lymphatic vessels. For example, the lymphatic vessel could be the upper left or upper right cervical lymphatic trunk. The outlet catheter can be positioned in the axillary region to be absorbed by the user's axillary lymph nodes. In another embodiment, the inlet catheter 1302 can be in fluid communication with the neck, occipital bone, and / or postauricular region, and / or the outlet of the outlet catheter can be positioned to be in fluid communication with a lymphatic vessel (e.g., the thoracic canal or right lymphatic vessel, lymphatic trunk), or can otherwise be subcutaneously placed in the subclavian region.

[0130] The implantable pump 1404 can generate negative pressure in the neck region via the inlet catheter 1402, inducing downward lymphatic flow from the cerebral lymphatic system. For example, activating the pump can locally reduce interstitial pressure in the neck, occipital, and / or postauricular regions where lymph nodes and lymphatic vessels are located, thereby increasing lymphatic flow from the brain via the inlet and outlet catheters. A wristband can be used to drive the pump, which is consistent with... Figure 1A The external controller described herein is similar. The lymphatic fluid output can be absorbed by the axillary lymph nodes. However, it should be understood that the implantable pump 1404 can be placed in any other body location, and the outlet catheter 1406 can be placed in any other area of ​​the body with functional lymph nodes other than the cervical lymph nodes.

[0131] For reference Figure 15 This describes a lymphatic regulatory system located near lymphatic circulation pathways (e.g., adjacent to cervical lymphatic vessels and carotid arteries). This system can be designed to modulate interstitial pressure, thereby engaging and / or activating pressure-dependent receptors on lymphatic vessels (e.g., those connecting to deep cervical lymph nodes) to influence the frequency of lymphatic vessel contraction. By modulating the contraction frequency, lymphatic outflow can be increased, thereby mechanically increasing lymphatic outflow (e.g., cervical lymphatic outflow) and enhancing the removal of brain waste via the lymphatic system.

[0132] like Figure 15 As shown, the lymphatic regulation system may include an implantable pump 1504, an inlet catheter 1502, and an outlet catheter 1506. The implantable pump 1504 may be associated with the implantable pump 102 of FIG1 or any other implantable pump described herein (e.g., Figure 6E The implantable pump 602 is the same as or similar to it. Figure 15 As shown, the inlet conduit may include a distal region 1510, which optionally has a closed distal end and a plurality of through-holes (e.g., through-holes 1512) arranged in the distal region for pressure regulation by cyclic suction. In one example, the inlet conduit 1502 may have a diameter between 0.5 and 1.5 mm (e.g., 1 mm), and the through-holes 1512 may have a diameter between 0.3 and 0.8 mm (e.g., 0.5 mm). However, the inlet conduit 1502 and the through-holes 1512 may have any other suitable size, shape, and / or dimensions. The through-holes may be positioned in any suitable pattern, such as a spiral or matrix pattern.

[0133] The distal portion of the inlet catheter 1502 may be located adjacent to or otherwise near the lymphatic circulation pathway and / or deep cervical lymph nodes. In addition to modulating pressure adjacent to the lymph nodes to activate pressure-dependent receptors, lymph fluid accumulation from the cervical lymph nodes can be aspirated into the distal end 1510 of the inlet catheter 1502, travel via pump 1504, and be discharged elsewhere (e.g., elsewhere in the patient's body) via outlet catheter 1506. Outlet catheter 1506 may be the same as or similar to outlet catheter 900 of Figure 9.

[0134] Pump 1504 can be used to alter the external pressure of the relevant lymphatic vessels and / or regulate the internal pressure of the lymphatic vessels, resulting in lymphatic vessel constriction. The frequency of lymph node constriction near the distal zone 1510 can be significantly increased by regulating the negative pressure induced by pump 1504 to increase lymphatic flow. For example, a change as small as 0.5 cm H2O can significantly increase the frequency of constriction (e.g., double the frequency of constriction).

[0135] The outlet conduit 1506 may have a closed end and / or may be made of a flexible and / or elastic material, such that the outlet conduit 1506 or a portion thereof expands as fluid is pumped into the outlet conduit 1506 to increase the volume of the outlet conduit 1506 or this portion thereof. When the outlet conduit 1506 expands, the pressure within the outlet conduit 1506 may increase. The pump 1504 may then be switched to a position where fluid can flow back from the outlet conduit and through the inlet conduit due to the higher pressure in the outlet conduit 1506 or its portion. For example, in the case of pump 1504 being the same as implantable pump 102, a bend valve may be opened to allow fluid to flow from the outlet conduit 1506 to the inlet conduit 1502. Alternatively or additionally, the pump 1504 may be moved in the opposite direction to pump fluid from the outlet conduit 1506 to the inlet conduit 1502. Those skilled in the art will understand that increasing or decreasing the internal volume of the outlet conduit 1506 (e.g., after the pump 1054 is activated to open the valve and / or reverse the direction of fluid flow) can respectively decrease or increase the pressure in the inlet conduit 1502, and thus decrease or increase the pressure in the external space of the through-hole 1512.

[0136] Pump 1504 can be used to treat traumatic brain injury (TBI) and for other purposes. For example, early cerebral lymphatic drainage after TBI can reduce neuroinflammation and intracranial pressure. Increasing lymphatic flow to the deep cervical lymph nodes, for instance, can be used alternatively to treat neurodegenerative diseases such as Alzheimer's disease (AD), Parkinson's disease (PD), chronic traumatic encephalopathy (CTE), and / or post-traumatic dementia (PTD). Its use in lymphatic regulation systems is also anticipated. Figure 3A Pump 300 or Figure 6E Pump 602, because such pumps may be smaller in size and / or may be low profile.

[0137] Although Figure 15 The pump 1504 and / or inlet catheter 1502 are described as being located near the patient's head and / or neck (e.g., near the lymphatic circulation pathway and / or deep cervical lymph nodes), but the pump 1504, inlet catheter 1502 and / or outlet catheter 1506 may alternatively be located in any other location within the body near lymph nodes and / or lymphatic vessels for pressure regulation of such lymph nodes and / or lymphatic vessels to increase lymphatic flow in various other areas of the patient's body (e.g., limbs, such as near the patient's arms or legs).

[0138] For reference Figure 16This describes an example graphical user interface to be displayed on a user device and / or healthcare provider device for monitoring the operation of an implantable pump and external controller. Interfaces 1602, 1604, and / or 1606 may be displayed on the patient device 120 and / or computing device 120. Interface 1602 depicts an example login screen for providing a username (e.g., email) and password for a user or healthcare provider to log in to a platform used to manage the body fluid management system.

[0139] Interface 1604 describes an interface for monitoring external controllers connected to the implantable pump. For example, a user may have two external controllers for controlling the implantable pump, and interface 1604 displays battery charge levels regardless of whether the external controllers have been calibrated (e.g., for a particular user) and / or indicates any errors (e.g., misalignment). Interface 1604 may further include buttons for adding new controllers and dashboards for accessing the platform for monitoring the body fluid drainage system. Interface 1606 describes an alert page for the platform that displays alert messages such as a misalignment message indicating at a certain time, "Your implant is not aligned with your controller." A low battery alert may be included at a certain time and may state, "Note that controller B has less than 20% battery." The platform may also maintain a patient usage log and monitor pumping progress throughout the day and / or generate messages regarding the user's pumping compliance and / or progress. For example, interface 1606 may include congratulatory alerts indicating "You have reached 50% of your daily treatment" and "Keep going." It should be understood that any other alerts or messages may be used.

[0140] Figure 17 This is a schematic block diagram of an illustrative external controller 1700 according to one or more exemplary embodiments of the present disclosure. The external controller 1700 may be associated with the external controller 104 of FIG1 or... Figures 2 to 15 It is the same as or similar to any other external controller.

[0141] In the illustrative configuration, the external controller 1700 may include one or more processors (processors) 1702 (which may be one or more PCBs), one or more memory devices 1704 (collectively referred to herein as memory 1704), one or more input / output (I / O) interfaces 1706 (which may be one or more contact parts or buttons), one or more network interfaces 1708, one or more transceivers 1712, and one or more antennas 1734. The external controller 1700 may further include one or more buses 1718 that functionally couple various components of the external controller 1700. The external controller 1700 may further include one or more antennas 1734, which may include, but are not limited to, cellular antennas for transmitting or receiving signals to and from cellular network infrastructure, antennas for transmitting or receiving Wi-Fi signals to and from access points (APs), GNSS antennas for receiving GNSS signals from Global Navigation Satellite System (GNSS) satellites, Bluetooth antennas for transmitting or receiving Bluetooth signals including BLE signals, NFC antennas for transmitting or receiving Near Field Communication (NFC) signals, 900 MHz antennas, and so on. These various components will be described in more detail later.

[0142] Bus 1718 may include at least one of a system bus, memory bus, address bus, or message bus, and may allow the exchange of information (e.g., data (including computer-executable code), signaling, etc.) between various components of external controller 1700. Bus 1718 may include, but is not limited to, a memory bus or memory controller, a peripheral bus, an accelerated graphics port, etc. Bus 1718 may be associated with any suitable bus architecture, including but not limited to Industry Standard Architecture (ISA), Micro Channel Architecture (MCA), Enhanced ISA (EISA), Video Electronics Standards Association (VESA) architecture, Accelerated Graphics Port (AGP) architecture, Peripheral Component Interconnect (PCI) architecture, PCI-Express architecture, Personal Computer Memory Card International Association (PCMCIA) architecture, Universal Serial Bus (USB) architecture, etc.

[0143] The memory 1704 of the external controller 1700 may include volatile memory (memory that maintains its state when powered, such as random access memory (RAM)) and / or non-volatile memory (memory that maintains its state even when not powered), such as read-only memory (ROM), flash memory, ferroelectric RAM (FRAM), etc. The term persistent data storage device, as used herein, may include non-volatile memory. In some exemplary embodiments, volatile memory can achieve faster read / write access than non-volatile memory. However, in some other exemplary embodiments, certain types of non-volatile memory (e.g., FRAM) can achieve faster read / write access than certain types of volatile memory.

[0144] In various implementations, memory 1704 may include various types of memory, such as various types of static random access memory (SRAM), various types of dynamic random access memory (DRAM), various types of non-modifiable ROM and / or writable variants of ROM, such as electrically erasable programmable read-only memory (EEPROM), flash memory, etc. Memory 1704 may include main memory and various forms of cache memory, such as instruction cache, data cache, translation lookup buffer (TLB), etc. Furthermore, cache memory, such as data cache, may be a multi-level cache organized into one or more cache levels (L1, L2, etc.).

[0145] Data storage device 1720 may include removable and / or non-removable storage devices, including but not limited to magnetic storage devices, optical disc storage devices, and / or magnetic tape storage devices. Data storage device 1720 provides non-volatile storage of computer-executable instructions and other data. Memory 1704 and data storage device 1720 (removable and / or non-removable) are examples of computer-readable storage media (CRSM) as used herein.

[0146] Data storage device 1720 may store computer-executable code, instructions, or the like that can be loaded into memory 1704 and executed by processor 1702 to cause processor 1702 to perform or initiate various operations. Data storage device 1720 may additionally store data that can be copied to memory 1704 for use by processor 1702 during the execution of computer-executable instructions. Furthermore, output data generated as a result of processor 1702 executing computer-executable instructions may be initially stored in memory 1704 and may ultimately be copied to data storage device 1720 for non-volatile storage.

[0147] More specifically, data storage device 1720 may store one or more operating systems (O / S) 1722; one or more database management systems (DBMS) 1724; and one or more program modules, applications, engines, computer-executable code, scripts, or the like, for example, one or more implementation modules 1726, one or more setup modules 1727, one or more communication modules 1728, and / or one or more motor modules 1729. Some or all of these modules may be submodules. Submodules or all of these modules may be part of a directory service, and some or all of these modules may be part of a system. Any component depicted as stored in data storage device 1720 may comprise any combination of software, firmware, and / or hardware. The software and / or firmware may comprise computer-executable code, instructions, or the like that can be loaded into memory 1704 for execution by one or more processors 1702. Any component depicted as stored in data storage device 1720 may support the functionality described with reference to the components previously named accordingly in this disclosure.

[0148] Data storage device 1720 may further store various types of data utilized by components of external controller 1700. Any data stored in data storage device 1720 may be loaded into memory 1704 for use by processor 1702 when executing computer-executable code. Additionally, any data depicted as being stored in data storage device 1720 may potentially be stored in one or more data repositories and may be accessed via DBMS 1724 and loaded into memory 1704 for use by processor 1702 when executing computer-executable code. Data repositories may include, but are not limited to, databases (e.g., relational, object-oriented, etc.), file systems, flat files, distributed data repositories where data is stored on more than one node of a computer network, peer-to-peer network data repositories, or the like.

[0149] Processor 1702 may be configured to access memory 1704 and execute computer-executable instructions loaded therein. For example, processor 1702 may be configured to execute various program modules, application programs, engines, or similar computer-executable instructions of external controller 1700 to cause or facilitate various operations to be performed according to one or more embodiments of this disclosure. Processor 1702 may include any suitable processing unit capable of accepting data as input, processing the input data according to the stored computer-executable instructions, and generating output data. Processor 1702 may include any type of suitable processing unit, including but not limited to a central processing unit, microprocessor, reduced instruction set computer (RISC) microprocessor, complex instruction set computer (CISC) microprocessor, microcontroller, application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), system-on-a-chip (SoC), application-specific integrated circuit, digital signal processor (DSP), etc. Furthermore, the processor 1702 may have any suitable microarchitecture design, which includes any number of components, such as, for example, registers, multiplexers, arithmetic logic units, cache controllers for controlling read / write operations to cache memory, branch predictors, or the like. The microarchitecture design of the processor 1702 may be able to support any of a variety of instruction sets.

[0150] Now refer to Figure 17 The various program modules described herein support functionality, and implementation module 1726 may include computer-executable instructions, code, or the like that can perform, in response to execution by one or more of the processors 1702, functions including, but not limited to, supervising the coordination and interaction between one or more modules and the computer-executable instructions in the data storage device 1720. Implementation module 1726 may further coordinate with communication module 1728 to send messages to and receive messages from other devices.

[0151] The setting module 1727 may contain computer-executable instructions, code, or similar that, in response to execution by one or more of the processors 1702, perform functions including, but not limited to, determining settings for operating the motor, including pump parameters, operating frequency, and / or any patient parameters or settings.

[0152] The communication module 1728 may include computer-executable instructions, code, or the like that can perform, in response to execution by one or more of the processors 1702, functions including, but not limited to, communicating with one or more devices or servers via wired or wireless communication, communicating with electronic devices, communicating with one or more servers (e.g., remote servers), communicating with remote data repositories and / or databases, sending or receiving notifications or commands / instructions, conveying cache memory data, and the like.

[0153] The motor module 1729 may contain computer-executable instructions, code, or the like that, in response to execution by one or more of the processors 1702, perform functions including, but not limited to, operating the motor to move the drive magnet based on pump parameters and patient-specific parameters or information determined by the setting module 1727.

[0154] Referring now to other illustrative components of the external controller 1700, the optional input / output (I / O) interface 1706 facilitates the external controller 1700 receiving input information from one or more I / O devices and outputting information from the external controller 1700 to one or more I / O devices. The I / O devices may include any of a variety of components, such as buttons, switches, or displays with touch surfaces or touchscreens; audio output devices for generating sound, such as speakers; audio capture devices, such as microphones; image and / or video capture devices, such as cameras; haptic units; and so on. Any of these components may be integrated into the external controller 1700 or may be separate. The I / O devices may further include, for example, any number of peripheral devices, such as data storage devices, printing devices, and so on.

[0155] Depending on the communication protocol used, for example, to transmit or receive signals via antenna 1734, antenna 1734 may comprise any suitable type of antenna. Non-limiting examples of suitable antennas may include directional antennas, non-directional antennas, dipole antennas, folded dipole antennas, patch antennas, multiple-input multiple-output (MIMO) antennas, or the like. Antenna 1734 may be communicatively coupled to one or more transceivers 1712 or radio components capable of transmitting or receiving signals thereto.

[0156] As previously described, antenna 1734 may include a Bluetooth antenna configured to transmit or receive signals according to established standards and protocols (e.g., Bluetooth and / or BLE). Alternatively or additionally, antenna 1734 may include a cellular antenna configured to transmit or receive signals according to established standards and protocols, such as cellular antennas configured to transmit or receive signals according to established standards and protocols, such as Global System for Mobile Communications (GSM), 3G standards (e.g., Universal Mobile Telecommunications System (UMTS), Wideband Code Division Multiple Access (W-CDMA), CDMA2000, etc.), 4G standards (e.g., Long Term Evolution (LTE), WiMax, etc.), direct satellite communication, or the like. Antenna 1734 may additionally or alternatively include a Wi-Fi® antenna configured to transmit or receive signals via a 2.4 GHz channel (e.g., 802.11b, 802.11g, 802.11n), a 5 GHz channel (e.g., 802.11n, 802.11ac), or a 60 GHz channel (e.g., 802.11ad) according to established standards and protocols, such as the IEEE 802.11 family of standards. In alternative embodiment, antenna 1734 may be configured to transmit or receive radio frequency signals (e.g., 900 MHz) within any suitable frequency range that forms part of the unlicensed portion of the radio spectrum.

[0157] Transceiver 1712 may include any suitable radio components for transmitting or receiving radio frequency (RF) signals within a bandwidth and / or channel corresponding to a communication protocol used by external controller 1700 to communicate with other devices (in cooperation with antenna 1734). Transceiver 1712 may include hardware, software, and / or firmware for modulating, transmitting, or receiving communication signals according to any communication protocol discussed above, including but not limited to one or more Wi-Fi® and / or Wi-Fi® Direct protocols, one or more non-Wi-Fi® protocols, or one or more cellular communication protocols or standards (possibly in cooperation with any of antennas 1734) standardized by the IEEE 802.11 standard. Transceiver 1712 may further include hardware, firmware, or software for receiving GNSS signals. Transceiver 1712 may include any known receiver and baseband suitable for communication via a communication protocol utilized by external controller 1700. The transceiver 1712 may further include a low-noise amplifier (LNA), an additional signal amplifier, an analog-to-digital (A / D) converter, one or more buffers, a digital baseband or the like.

[0158] It should be understood that, Figure 17The program modules, applications, computer-executable instructions, code, or the like depicted as stored in data storage device 1720 are merely illustrative and not exhaustive, and processes described as being supported by any particular module may alternatively be distributed across multiple modules or executed by different modules. It should be further understood that, without departing from the scope of this disclosure, external controller 1700 may include alternative and / or additional hardware, software, or firmware components other than those described or depicted. More specifically, it should be understood that the software, firmware, or hardware components depicted as forming part of external controller 1700 are merely illustrative, and some components may be absent or additional components may be provided in various embodiments. While various illustrative program modules have been depicted and described as software modules stored in data storage device 1720, it should be understood that functionality described as being supported by program modules may be implemented by any combination of hardware, software, and / or firmware. It should be further understood that, in various embodiments, each of the above modules may represent a logical division of the supported functionality. This logical division is depicted for ease of interpretation of the functionality and may not represent the structure of the software, hardware, and / or firmware used to implement the functionality. Therefore, it should be understood that in various embodiments, functionality described as being provided by a particular module may be provided at least in part by one or more other modules. Furthermore, in some embodiments, one or more of the depicted modules may be absent, while in other embodiments, additional modules not depicted may be present and may support at least a portion of the described functionality and / or additional functionality. Moreover, although certain modules(s) may be depicted and described as submodules of another module, in some embodiments, such modules(s) may be provided as independent modules or submodules of other modules.

[0159] Although embodiments have been described using language specific to structural features and / or method actions, it should be understood that this disclosure is not necessarily limited to the specific features or actions described. Rather, specific features and actions are disclosed as illustrative forms of implementing embodiments. Unless specifically stated otherwise or understood otherwise in the context in which they are used, conditional language, such as “may,” “may,” “can,” or “can,” is generally intended to convey that certain embodiments may include certain features, elements, and / or steps, while other embodiments do not. Therefore, this conditional language is not generally intended to imply that one or more embodiments require features, elements, and / or steps in any way, or that one or more embodiments necessarily include logic for determining whether such features, elements, and / or steps are included in or will be performed in any particular embodiment, with or without user input or prompting.

[0160] It should be understood that any computer operation described above herein can be implemented, at least in part, as computer-readable instructions stored on a computer-readable storage medium. It will be understood that the embodiments described herein are illustrative, and components can be arranged, replaced, combined, and designed in various different configurations, all of which are considered and fall within the scope of this disclosure.

[0161] For purposes of illustration and description, the foregoing description of illustrative embodiments has been presented. It is not intended to be exhaustive or limiting in terms of precise forms disclosed, and modifications and variations are possible given the foregoing teachings, or may be obtained from practice of the disclosed embodiments. The scope of this disclosure is intended to be defined by the appended claims and their equivalents.

Claims

1. A lymphatic drainage system for lymphatic fluid management in a patient, the lymphatic drainage system comprising an implantable pump, the implantable pump comprising: A shell configured for implantation into the patient; An inlet tube, disposed within the housing, is configured to be in fluid communication with a first body portion to receive bodily fluids; An outlet pipe, disposed within the housing, is configured to be in fluid communication with a second body portion; A fluid chamber disposed within the housing and configured to be in fluid communication with the inlet pipe and the outlet pipe; A rotor, which is disposed within the housing and configured to rotate to change the volume of the fluid chamber; and A lever, which is mechanically connected to the rotor and configured to move between an open and a closed position in response to rotation of the rotor, causes the inlet tube to bend periodically, such that the body fluid is pumped from the first body portion toward the second body portion via the inlet tube, the fluid chamber, and the outlet tube.

2. The lymphatic drainage system of claim 1, wherein the first body portion is in fluid communication with the patient's lymphatic system such that the body fluid pumped by the implantable pump includes lymph.

3. The lymphatic drainage system according to claim 1, wherein the rotor includes a first magnetic portion, and the lymphatic drainage system further includes: An external controller includes a second magnetic portion and a motor configured to move the second magnetic portion to induce movement in the first magnetic portion, thereby causing the rotor to rotate.

4. The lymphatic drainage system of claim 3, wherein the external controller further includes a worm gear, and the motor is configured to rotate the worm gear to rotate the second magnetic portion.

5. The lymphatic drainage system of claim 1, wherein the inlet tube is configured to form a U-shape when the lever is in the closed position.

6. The lymphatic drainage system of claim 5, wherein when the inlet tube is bent by the lever, the fluid flow in the inlet tube is completely blocked.

7. The lymphatic drainage system of claim 1, wherein the lever causes the inlet tube to bend as the rotor rotates to reduce the volume of the fluid chamber.

8. The lymphatic drainage system according to claim 1, wherein the rotor is rotatably coupled to the housing at an eccentric position of the rotor.

9. The lymphatic drainage system of claim 1, wherein the implantable pump further includes a cam mechanically connected to the rotating body and configured to engage with a cam receiving portion of the lever to move the lever between the open position and the closed position as the rotor rotates.

10. The lymphatic drainage system of claim 9, wherein the implantable pump further includes a biasing portion configured to engage with the cam to bias the lever to shift to the closed position.

11. The lymphatic drainage system of claim 1, wherein the implantable pump further includes a second lever mechanically connected to the rotor and configured to move between a second open position and a second closed position in response to rotation of the rotor to periodically bend the outlet tube.

12. The lymphatic drainage system of claim 1, wherein the implantable pump further comprises a piston configured to engage with the rotor such that rotation of the rotor causes the piston to increase and decrease the volume of the fluid chamber.

13. The lymphatic drainage system of claim 11, wherein the elastic membrane is disposed between the piston and the fluid chamber such that the piston does not contact the lymph fluid in the fluid chamber.

14. The lymphatic drainage system of claim 11, wherein the fluid chamber comprises a rigid shell and an inner membrane coupled to the elastic membrane, such that fluid entering the fluid chamber is contained between the inner membrane and the elastic membrane.

15. The lymphatic drainage system of claim 1, wherein the lymphatic drainage system further includes an inlet connector, and wherein the outlet of the inlet tube is coupled to the fluid chamber and the inlet of the inlet tube is coupled to the inlet connector, the inlet connector including at least one protrusion configured to couple to an inlet catheter configured to deliver lymph fluid to the implantable pump.

16. The lymphatic drainage system of claim 1, wherein the lymphatic drainage system further comprises an inlet conduit coupled to the inlet tube, the inlet conduit comprising a first lumen, a second lumen, a first plurality of openings disposed at a first end region of the inlet conduit, and a second plurality of openings disposed between the first end region and a second end region of the inlet conduit, the first plurality of openings being in fluid communication with the first lumen and the second plurality of openings being in fluid communication with the second lumen.

17. The lymphatic drainage system of claim 16, wherein the inlet catheter includes a main lumen in fluid communication with at least the first lumen and the second lumen.

18. The lymphatic drainage system of claim 1, wherein the lymphatic drainage system further comprises an outlet catheter coupled to the outlet tube at a first end thereof, the outlet catheter including a second end configured to be positioned in the interstitial space of the patient.

19. The lymphatic drainage system of claim 1, further comprising a membrane defining the wall of the fluid chamber, the membrane being configured to move in response to rotation of the rotor to reduce the volume of the fluid chamber toward a closed position, such that the body fluid is pumped from the first body portion toward the second body portion via the inlet tube, the fluid chamber, and the outlet tube.

20. The lymphatic drainage system of claim 19, further comprising a second membrane defining a second wall of the fluid chamber. The first membrane and the second membrane are hermetically sealed to form the fluid chamber.

21. The lymphatic drainage system of claim 20, further comprising an inlet conduit in fluid communication with the first body portion and the inlet tube, and an outlet conduit in fluid communication with the second body portion and the outlet tube.

22. The lymphatic drainage system of claim 21, wherein the inlet tube, the inlet conduit, the outlet tube, the outlet conduit, the first membrane, and the second membrane are all made of the same material.

23. The lymphatic drainage system of claim 22, wherein the same material comprises a silicone elastomer coated with covalent heparin, and The bodily fluids therein come into contact with the same material only when the implantable pump is used.

24. The lymphatic drainage system of claim 19, wherein one end of the membrane is fixed within the housing, and a portion of the membrane covering a piston abutting the rotor moves in response to rotation of the rotor.

25. A method for pumping lymph fluid into a patient, the method comprising: An implantable pump is included, comprising a housing, an inlet pipe, a fluid chamber, an outlet pipe, and a rotor. The rotor is rotated between an intake position and an exhaust position to change the volume of the fluid chamber, and the inlet pipe and the outlet pipe are periodically bent in response to the rotation of the rotor. The implantable pump is configured to allow lymph fluid to enter the fluid chamber via the inlet tube when the rotor is in the suction position, and to allow the lymph fluid to exit the fluid chamber via the outlet tube when the rotor is in the discharge position, thereby pumping the lymph fluid from the first body portion toward the second body portion.

26. The method of claim 25, wherein the rotor is rotatably coupled to the housing at an eccentric position on the rotor.

27. The method of claim 25, wherein changing the rotor comprises changing the rotor in response to an external magnet worn by the patient.

28. The method of claim 25, wherein implanting the implantable pump comprises implanting the implantable pump in the patient's arm to drain the lymph fluid from an edematous area of ​​the patient's arm to the patient's supraclavicular region.

29. The method of claim 25, wherein implanting the implantable pump comprises implanting the implantable pump in the patient's leg to drain the lymph fluid from an edematous area of ​​the patient's leg to a subcutaneous space in the patient's abdominal or back region.

30. The method of claim 25, wherein implanting the implantable pump comprises implanting the implantable pump in the upper body of the patient to drain the lymph fluid from the patient's cerebral lymphatic system to the axillary lymph nodes.

31. A lymphatic drainage system for lymphatic fluid management in a patient, the lymphatic drainage system comprising an implantable pump, the implantable pump comprising: A shell configured for implantation into the patient; An inlet tube, configured to be in fluid communication with the first body part to receive bodily fluids; An outlet pipe, configured to be in fluid communication with the second body section; A fluid chamber disposed within the housing and configured to be in fluid communication with the inlet pipe and the outlet pipe; A rotor, which is disposed within the housing and configured to rotate to change the volume of the fluid chamber; and A first membrane, which defines the wall of the fluid chamber, is configured to stretch in response to rotation of the rotor to reduce the volume of the fluid chamber toward a closed position, such that the body fluid is pumped from the first body portion toward the second body portion via the inlet pipe, the fluid chamber, and the outlet pipe.

32. The lymphatic drainage system of claim 31, further comprising a second membrane defining a second wall of the fluid chamber, wherein the first membrane and the second membrane are hermetically sealed to form the fluid chamber.

33. The lymphatic drainage system of claim 32, wherein the second membrane does not change shape in response to rotation of the rotor.

34. The lymphatic drainage system of claim 32, further comprising a rigid shell, wherein the second membrane is coupled to the rigid shell and its movement is restricted by the rigid shell.

35. The lymphatic drainage system of claim 32, wherein the fluid chamber is configured to receive the body fluid from the inlet tube, and wherein the body fluid is contained between the first membrane and the second membrane.

36. The lymphatic drainage system of claim 31, further comprising a catheter including a first end positioned in the first body portion and a second end coupled to the inlet tube.

37. The lymphatic drainage system of claim 36, wherein the catheter comprises a plurality of lumens, each lumen having a different length.

38. The lymphatic drainage system of claim 37, wherein each of the plurality of lumens includes an opening, and each corresponding opening is axially displaced along the conduit from each other opening in the plurality of lumens.

39. The lymphatic drainage system of claim 37, wherein each of the plurality of lumens includes an opening, and each respective opening is radially displaced along the conduit from each other opening in the plurality of lumens.

40. The lymphatic drainage system of claim 37, wherein each of the plurality of lumens converges into the outlet lumen of the catheter.

41. The lymphatic drainage system of claim 36, wherein the inlet tube, the conduit, the outlet tube, and the first membrane are all made of the same material.

42. The lymphatic drainage system of claim 41, wherein the material comprises a silicone elastomer coated with covalent heparin, and The bodily fluids only come into contact with the material when the implantable pump is used.

43. The lymphatic drainage system of claim 41, further comprising a piston configured to engage with the rotor, wherein the rotor causes the piston to shift between a first position and a second position.

44. The lymphatic drainage system of claim 43, wherein the piston is configured to engage with the first membrane, and wherein the first membrane is stretched as the piston changes between the first position and the second position.

45. The lymphatic drainage system of claim 41, further comprising a lever mechanically connected to the rotor and configured to move between an open position and a closed position in response to rotation of the rotor to periodically bend the inlet tube, such that the body fluid is pumped from the first body portion toward the second body portion via the inlet tube, the fluid chamber, and the outlet tube.

46. ​​A method for pumping lymph fluid into a patient, the method comprising: An implantable pump is included, comprising a housing, an inlet tube, a fluid chamber, an outlet tube, and a rotor, wherein the fluid chamber includes a first membrane defining the wall of the fluid chamber; and Rotating the rotor to change its position between an intake and an exhaust position alters the volume of the fluid chamber, thereby moving the body from the first body portion from the inlet pipe to the outlet pipe. The first membrane is configured to stretch in response to a rotor to reduce the volume of the fluid chamber, such that body fluid is pumped from the first body portion into the fluid chamber via the inlet pipe and pumped out to the second body portion via the outlet pipe, the inlet pipe being in fluid communication with the first body portion and the fluid chamber, and the outlet pipe being in fluid communication with the second body portion and the fluid chamber.

47. The method of claim 46, wherein the implantable pump further comprises a second membrane defining a second wall of the fluid chamber, wherein the first membrane and the second membrane are hermetically sealed to form the fluid chamber.

48. The method of claim 47, wherein the second membrane does not change shape in response to rotation of the rotor.

49. The method of claim 47, wherein the implantable pump further comprises a rigid housing, and wherein the second membrane is coupled to the rigid housing and its movement is restricted by the rigid housing.

50. The method of claim 46, further comprising changing the rotor from the discharge position to the intake position to alter the volume of the fluid chamber, so that bodily fluid from the first body portion moves from the inlet tube into the fluid chamber.

51. The method of claim 46, wherein the inlet tube is coupled to a catheter, the catheter including a first end positioned in the first body portion and a second end coupled to the inlet tube.

52. The method of claim 51, wherein the catheter comprises a plurality of lumens, each lumen having a different length.

53. The method of claim 52, wherein each of the plurality of lumens includes an opening, and each respective opening is axially displaced along the conduit from each other opening in the plurality of lumens.

54. The method of claim 52, wherein each of the plurality of lumens includes an opening, and each respective opening is radially displaced along the conduit from each other opening in the plurality of lumens.

55. The method of claim 52, wherein each of the plurality of lumens converges into the outlet lumen of the catheter.

56. The method of claim 46, wherein the inlet tube, the conduit, the outlet tube, and the first membrane are all made of the same material.

57. The method of claim 56, wherein the material comprises a silicone elastomer coated with covalent heparin, and The bodily fluids only come into contact with the material when the implantable pump is used.

58. The method of claim 46, wherein the implantable pump further comprises a piston configured to engage with the rotor and the first membrane, and wherein changing the rotor between the inhalation position and the discharge position causes the piston to change between a first position and a second position.

59. The method of claim 58, wherein the piston is configured to engage with the first membrane, and wherein the membrane is stretched as the piston changes between the first position and the second position.

60. The method of claim 46, wherein the implantable pump further comprises a lever in mechanical communication with the rotor, wherein the lever is configured to move between an open position and a closed position in response to rotation of the rotor to periodically bend the inlet tube such that the body fluid is pumped from the first body portion toward the second body portion via the inlet tube, the fluid chamber, and the outlet tube.

61. An implantable pump for lymphatic fluid management in a patient, the implantable pump comprising: A shell configured for implantation into the patient; A fluid chamber disposed within the housing and configured to be in fluid communication with an inlet conduit in fluid communication with a first body portion and an outlet conduit in fluid communication with a second body portion; A rotor, which is housed within the housing and configured to rotate eccentrically to change the volume of the fluid chamber so that bodily fluid moves from the inlet conduit to the outlet conduit; and A valve actuator configured to engage with the rotor as the rotor rotates to sequentially block fluid communication between the inlet conduit and the fluid chamber and between the outlet conduit and the fluid chamber, such that the inlet conduit is blocked when the outlet conduit is open and the outlet conduit is blocked when the inlet conduit is open.

62. The implantable pump of claim 61, further comprising a first lever and a second lever, each fixed to the housing and in mechanical communication with the valve actuator.

63. The implantable pump of claim 62, wherein the valve actuator comprises: A first cam is configured to engage with the first lever so that the first lever engages with the inlet conduit; and a second cam, which is configured to engage with the second lever so that the second lever engages with the outlet conduit.

64. The implantable pump of claim 61, wherein the housing includes a guide shaft configured to receive the valve actuator, and the valve actuator includes a plurality of protrusions configured to engage with the rotor so that the valve actuator moves within the guide shaft as the rotor rotates.

65. The implantable pump of claim 61, further comprising a piston configured to engage with the rotor and a portion of the fluid chamber to translate movement of the rotor into the fluid chamber, wherein the piston includes a tapered portion.

66. A method for managing lymphatic fluid in a patient using a lymphatic drainage system, the method comprising: An externally positioned controller is positioned above an implantable pump implanted in the patient's body, such that the external controller is configured to magnetically engage with a rotor housed within the housing of the implantable pump, the implantable pump including a fluid chamber in mechanical communication with the rotor and in fluid communication with an inlet catheter and an outlet catheter; and Using the external controller, the rotor is eccentrically rotated within the housing of the implantable pump, causing the volume of the fluid chamber to decrease as the rotor rotates, thereby shifting the fluid chamber between a suction position and a discharge position. The rotor is mechanically connected to a valve actuator housed within the housing of the implantable pump and is configured to engage with the rotor as the rotor rotates to sequentially block fluid communication between the inlet conduit and the fluid chamber and between the outlet conduit and the fluid chamber, such that the inlet conduit is blocked when the outlet conduit is open and the outlet conduit is blocked when the inlet conduit is open.

67. The method of claim 66, wherein the implantable pump further comprises a first lever and a second lever, each fixed to the housing and in mechanical communication with the valve actuator.

68. The method of claim 67, wherein the valve actuator comprises: A first cam is configured to engage with the first lever so that the first lever engages with the inlet conduit; and a second cam, which is configured to engage with the second lever so that the second lever engages with the outlet conduit.

69. The method of claim 66, wherein the housing includes a guide shaft configured to receive the valve actuator, and the valve actuator includes a plurality of protrusions configured to engage with the rotor to allow the valve actuator to move within the guide shaft as the rotor rotates.

70. The method of claim 66, further comprising a piston configured to engage with the rotor and a portion of the fluid chamber to translate movement of the rotor into the fluid chamber, wherein the piston includes a tapered portion.

71. A lymphatic regulation system for lymphatic fluid management in a patient, the lymphatic regulation system comprising: Pump; A catheter, coupled to the pump at a first end and positioned near a lymph node and / or lymphatic vessel at a second end, the second end of the catheter including a plurality of through-holes positioned along the end region of the catheter. The pump is configured to be activated to circulate negative pressure at the second end of the conduit via the plurality of through-holes, resulting in pressure regulation of at least some of the lymph nodes and / or lymphatic vessels, thereby increasing lymphatic flow in the lymph nodes and / or lymphatic vessels.

72. The lymphatic regulation system of claim 71, further comprising an external controller, wherein the pump is implantable and the external controller is configured to be externally positioned above the pump and magnetically docked with the pump.

73. The lymphatic regulation system of claim 71, wherein the second end of the catheter has a closed end.

74. The lymphatic regulation system of claim 71, further comprising a second catheter coupled to a pump port at a main end and configured to extend into a first body portion at a secondary end.

75. The lymphatic regulation system of claim 71, wherein the pump comprises: A shell configured for implantation into the patient; A fluid chamber disposed within the housing and configured to be in fluid communication with the conduit and the second conduit; A rotor, which is housed within the housing and configured to rotate eccentrically to change the volume of the fluid chamber so that bodily fluid moves from the conduit to the second conduit; and A valve actuator configured to engage with the rotor as the rotor rotates to sequentially block fluid communication between the conduit and the fluid chamber and between the second conduit and the fluid chamber, such that the conduit is blocked when the second conduit is open and the second conduit is blocked when the second conduit is open.

76. The lymphatic regulation system of claim 71, further comprising coupling the second catheter to a pump port at the main end of the second catheter, the second catheter being configured to resiliently expand and including a closed secondary end.

77. The lymphatic regulation system of claim 71, wherein the lymph nodes and / or lymphatic vessels are deep cervical lymph nodes and / or lymphatic vessels, and the pump is activated to circulatoryly generate negative pressure at the second end of the second catheter to increase lymphatic flow from the patient's brain.

78. A method for lymphatic regulation using a fluid management system, the method comprising: The first end of the catheter is positioned near the patient’s lymph nodes and / or lymphatic vessels, and the catheter includes multiple through-holes in the end region; A first pump port is coupled to a second end of the conduit, and the pump is configured to move body fluid between the first pump port and the second pump port; and The pump circulates negative pressure at the first end of the conduit, resulting in pressure regulation of at least some of the lymph nodes and / or lymphatic vessels.

79. The method of claim 78, further comprising implanting the pump into the patient.

80. The method of claim 79, further comprising externally positioning an external controller above the pump and magnetically engaging it with the pump to generate the negative pressure.

81. The method of claim 78, further comprising coupling the second conduit to the second pump port at the main end of the second conduit and positioning the secondary end of the second conduit into the first body portion.

82. The method of claim 78, further comprising coupling the second conduit to the second pump port at the main end of the second conduit, the second conduit being configured to resiliently expand and including a closed secondary end.

83. The method of claim 78, wherein the lymph nodes and / or lymphatic vessels are deep cervical lymph nodes and / or lymphatic vessels, and wherein the pump circulatorily generates negative pressure at the first end of the catheter to increase lymphatic flow from the patient's brain.

84. The method of claim 76, wherein the pump comprises: A shell configured for implantation into the patient; A fluid chamber disposed within the housing and configured to be in fluid communication with the conduit and the second conduit; A rotor, which is housed within the housing and configured to rotate eccentrically to change the volume of the fluid chamber so that bodily fluids can move between the conduit and the second conduit; and A valve actuator configured to engage with the rotor as the rotor rotates to sequentially block fluid communication between the conduit and the fluid chamber and between the second conduit and the fluid chamber, such that the conduit is blocked when the second conduit is open and the second conduit is blocked when the outlet conduit is open.

85. A method for increasing lymphatic flow from the brain using a lymphatic drainage system, the method comprising: A pump is provided, the pump having an inlet tube in fluid communication with the neck, occipital bone and / or postauricular region; The pump is activated to locally reduce interstitial pressure in the cervical, occipital, and / or postauricular regions where lymph nodes and lymphatic vessels are located, thereby increasing lymphatic flow from the brain.

86. The method of claim 85, wherein the pump further comprises an outlet tube in fluid communication with a body region different from the neck, occipital bone and / or postauricular region.

87. The method of claim 86, wherein activating the pump increases lymphatic flow between the inlet pipe and the outlet pipe.

88. The method of claim 85, further comprising implanting the pump into a patient.

89. The method of claim 85, wherein activating the pump to increase lymphatic flow from the brain is used to treat neurodegenerative diseases.

90. The method of claim 85, wherein the outlet of the outlet pipe coupled to the pump is in fluid communication with the chest tube, right lymphatic vessel, or lymphatic trunk.

91. The method of claim 85, wherein the inlet pipe has a closed end.

92. The method of claim 85, wherein the outlet of the outlet pipe coupled to the pump is subcutaneously placed in the subclavian region.

93. The method of claim 85, wherein the outlet of the outlet pipe coupled to the pump is in fluid communication with the subclavian lymphatic trunk.

94. The method of claim 85, wherein the inlet of the inlet tube is inserted into a lymphatic vessel in the neck region and configured to increase the flow rate from the lymphatic vessel.

95. The method of claim 85, wherein the inlet of the inlet tube is inserted into or near the upper left or upper right cervical lymphatic trunk.

96. The method of claim 85, wherein the inlet of the inlet tube is subcutaneously placed in the neck region and configured to absorb free fluid from the tissue in the neck region and increase the flow rate in the neck region.

97. The method of claim 85, wherein the pump includes a bend valve configured to increase the lymph flow.

98. A catheter for use in a lymphatic drainage system, the catheter comprising: An elongated shaft includes an inlet region configured for implantation in a patient to drain fluid accumulated in a subcutaneous interstitial space, the elongated shaft further including an outlet region configured for coupling to an implantable pump, the elongated shaft including a first lumen, a second lumen, a main lumen in fluid communication with at least the first lumen and the second lumen, a first plurality of openings disposed at a first end region of the elongated shaft, and a second plurality of openings disposed between the first end region and a second end region of the elongated shaft, the first plurality of openings being in fluid communication with the first lumen and the second plurality of openings being in fluid communication with the second lumen.

99. The catheter of claim 98, further comprising a third lumen in fluid communication with the main lumen, the catheter further comprising a third plurality of openings disposed between the second plurality of openings and the second end region of the elongated shaft, the third plurality of openings being in fluid communication with the third lumen.

100. The catheter of claim 99, further comprising a fourth lumen in fluid communication with the main lumen, the catheter further comprising a fourth plurality of openings disposed between the third plurality of openings and the second end region of the elongated shaft, the fourth plurality of openings being in fluid communication with the fourth lumen.

101. The conduit of claim 98, wherein the first plurality of openings are offset circumferentially from the second plurality of openings along the elongated shaft.

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