Patent Application
20220176087
Chronic and acute congestive heart failure (CHF) generally occurs when the heart is incapable of circulating an adequate blood supply to the body. This is typically due to inadequate cardiac output, which has many causes. In CHF decompensation fluids back up in a retrograde direction through the lungs and venous/lymphatic systems throughout the body, causing discomfort and organ dysfunction. Many diseases can impair the pumping efficiency of the heart to cause congestive heart failure, such as coronary artery disease, high blood pressure, and heart valve disorders.
In addition to fatigue, one of the prominent features of congestive heart failure is the retention of fluids within the body. Commonly, gravity causes the retained fluid to accumulate to the lower body, including the abdominal cavity, liver, and other organs, resulting in numerous related complications. Fluid restriction and a decrease in salt intake can be helpful to manage the fluid retention, but diuretic medications are the principal therapeutic option, including furosemide, bumetanide, and hydrochlorothiazide. Additionally, vasodilators and inotropes may also be used for treatment.
While diuretics can be helpful, they are also frequently toxic to the kidneys and if not used carefully can result in acute and/or chronic renal failure. This mandates careful medical management while in a hospital, consuming large amounts of time and resources. Hence, the ability to treat fluid retention from congestive heart failure without the need for toxic doses of diuretics would likely result in better patient outcomes at substantially less cost.
Fluid retention is not limited only to CHF. Conditions such as organ failure, cirrhosis, hepatitis, cancer, and infections can cause fluid buildup near the lungs, referred to as pleural effusion. The space is lined by two thin membranes (the visceral and parietal pleura) that line the surface of the lungs and the inside of the chest wall. Normally, only a few teaspoons of fluid are located in this space so as to help the lungs to move smoothly in a patient's chest cavity, but underlying diseases can increase this amount. Patients with pleural effusion may need frequent draining directly via a guided needle and catheter introduced directly to the pleura. These procedures are expensive, traumatic, and require hospitalization.
In this regard, what is needed is an improved treatment option for fluid buildup in the body, whether that buildup is caused by CHF, cirrhosis, organ failure, cancer, infections, or other underlying diseases.
The present invention is generally directed to devices and methods of treating fluid retention caused by congestive heart failure or other conditions resulting in pleural effusion, edema, lymphoedema, or significant fluid retention (e.g., deep vein thrombosis, cellulitis, venous stasis insufficiency, or damage to the lymphatic network). Specifically, a treatment device is used to create a temporary or permanent passage either directly or via a cannula between the lymphatic system (or other area such as the visceral and parietal pleura around the lungs) and an external drainage device which may be either active (suction) or passive (internal hydrodynamic pressure or gravity). This device can be temporarily located in the patient or can be implanted within the patient for longer periods of time. The physician can safely and reliably remove excess fluid from the lymphatic system via the device and, in some embodiments, inject other treatment agents (e.g., electrolytes, chemotherapeutic agents, inotropes, steroids, antibiotics, or other heart failure, infectious, or cancer treatment agents).
These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which
Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.
The lymphatic system is part of the vascular system and an important component of the immune system, comprising a network of lymphatic vessels that carry lymph directionally toward the heart. The human circulatory system typically processes an average of 10 liters of blood per day into the lymphatics via capillary filtration, which removes plasma while leaving the blood cells. Most of the filtered plasma is reabsorbed directly into the blood vessels, while the remaining plasma remains within the body's interstitial fluid. The lymphatic system provides an accessory return route to the blood for this unabsorbed plasma, as well as other biological materials, known as lymph. Some diseases, such as congestive heart failure, can result in lymphedema or an accumulation of lymph/fluid within the lymphatic system, as well as accumulation of fluid in other parts of the body.
The present invention is generally directed to devices and methods of treating fluid retention caused by congestive heart failure or other conditions resulting in pleural effusion, edema, lymphoedema, or significant fluid retention (e.g., deep vein thrombosis, cellulitis, venous stasis insufficiency, or damage to the lymphatic network). Specifically, a treatment device is used to create a temporary or permanent passage either directly or via a cannula between the lymphatic system and an external drainage device which may be either active (suction) or passive (internal hydrodynamic pressure or gravity). This device can be temporarily located in the patient or can be implanted within the patient for longer periods of time. The physician can safely and reliably remove excess fluid from the lymphatic system (or from other locations such as the lungs) via the device and, in some embodiments, inject other treatment agents (e.g., electrolytes, chemotherapeutic agents, inotropes, steroids, antibiotics, or other heart failure, infectious, or cancer treatment agents).
In one embodiment, the radially expandable portion 102 is composed of braided, shape memory wires (e.g., Nitinol) that are heat set to expand to a conical shape. To enhance efficient flow, a film or fluid-impenetrable layer 104 (e.g., PET or an elastic polymer) is disposed over the braided wires. Both the expandable portion 102 and the cannula body 106 can be composed of a single, tubular braided shape memory layer, such that only the distal portion radially expands when unconstrained (e.g., the cannula body 106 may have one or more polymer layers that restrain its radial expansion). Alternately, only the expandable portion 102 can be composed of braided shape memory wires that are attached to the distal end of the cannula body 106. Alternately, the radially expandable portion 102 can be composed of a laser-cut tube, braided, non-shape-memory wires, an expandable polymer sleeve, or a variety of other structures known in the art. The expandable portion 102 may be cylindrical, conical, or other 3D shapes.
The device 100 may also include a mechanism to control expansion of the expandable portion 102. For example, a longitudinally moveable outer sheath 108 can be initially positioned over the expandable portion 102 to provide restraint. Moving the sheath 108 proximally exposes the expandable portion 102 to allow expansion, while subsequently moving the sheath 108 distally will collapse the portion 102. Alternately, a pull wire may be included within the device 100 to control expansion/contraction of the expandable portion 102, or a balloon expanding technique.
The device 100, as well as any other devices described in this specification, can be connected or positioned at a variety of different locations of the lymphatic system 10, and via numerous different approaches. One particularly desirable treatment location is within the thoracic duct 12, see in
The device 100 can be used for treatment via this left subclavian vein approach (or alternately via the femoral vein, internal jugular, right subclavian vein, basilic vein, and brachial vein). For example, a guidewire can be inserted into the left subclavian vein 14 and into the thoracic duct 12. Other devices commonly used for intravascular procedures may also be used. For example, an access sheath can be advanced into the left subclavian vein 14, a guide catheter can be advanced over the first guidewire, the first guidewire can be removed and replaced with a second, smaller-diameter guidewire if necessary, and the device 100 can be delivered over the second guidewire and through the guide catheter.
As seen in
The device 180 includes a catheter body 182 with a distal expandable portion 184 that expands a drainage opening 186 (which can alternately be used for infusion) against the opening or ostium 12A of the thoracic duct 12, allowing the lymph to drain into a drainage passage 188 that extends through the catheter body 182. In one example, the distal expandable portion 184 comprises a distal circular balloon 184A and a proximal circular balloon 184B that both are inflatable to cause radial expansion of the distal expandable portion 184. Preferably, the balloons 184A, 184B are positioned proximally and distally of the thoracic duct opening and within the left subclavian vein 14, which allows them to expand and isolate the opening of the thoracic duct 12. Once expanded, blood continues to pass through a perfusion passage 184C that opens at each end of the distal expandable portion 184 and this blood perfusion can be maximized by expanding the left subclavian vein 14 to a larger diameter than it would naturally have.
The device 180 also may include a structure that opens the valve leaflets of the thoracic duct 12 at the ostium 12A. In one example, this structure 187 can be an inflatable balloon structure 187 that forms a tubular shape or one or more elongated shapes that project perpendicularly relative to the axis of the device 180. In another example, the structure 187 may be a self-expanding structure composed of memory-shape wires (e.g., a perpendicular braided tubular structure or perpendicular wire loops).
While not shown in the figure, inflation passages preferably extend through the catheter body 182 and distal expandable portion 184 to connect to both balloons 184A, 184B. One advantage of this design is that high fidelity imaging such as fluoroscopy may not necessarily be needed and potentially just Transthoracic Ultrasound (TTE) may be necessary instead. Another advantage is that the balloons may help provide rigid support to the vein and thereby prevent its collapse during the draining process, especially if aspiration is applied.
While the distal expandable portion 184 is illustrated as having a single aperture 186, it may also have a plurality of apertures positioned radially around the distal expandable portion 184 and in between the balloons 184A, 184B. This may obviate the need for a specific rotational orientation.
The distal expandable portion 184 is illustrated as having an outer membrane 184D on which the drainage opening 186 is located. In an alternate example, the outer membrane 184D may not be present and the drainage opening 186 may be located on an inner side of the proximal circular balloon 184B. In other words, the distal expandable portion 184 would be composed of two balloons 184A, 184B, the perfusion passage 184C, and a drainage tube through the proximal balloon 184B. In this regard, the balloons create a closed off space between the perfusion passage 184C and the inner surface of the vein 14. In another example, the distal expandable portion 184 can be composed of a single tubular balloon extending along the entire length of the distal expandable portion 184.
The device 180 may optionally include one or more feelers (e.g., elongated wires extending from a distal end of the device) to provide tactile response for achieving the desired positioning. Depth markers may also be present along the length of the catheter body 182 to further help target a desired position relative to the access point.
When the patient is in need of treatment, the percutaneous location of the proximal end of the guidewire 194 can be accessed and the drainage catheter can be advance over the guidewire 194 and into the thoracic duct 12 to begin drainage. The device 190 can be left in the patient for future treatment sessions. Alternately, the device 190 can be used for a single treatment session and removed from the patient after removal of the drainage catheter 196 and/or the drainage catheter can be permanently connected/implanted in the patient. In one embodiment, the percutaneous access site may include a port or similar device that facilitates multiple accesses of the drainage catheter.
The present invention also contemplates a method of temporarily or permanently holding open the valve leaflets of the thoracic duct 12 near the ostium 12A to allow some chronic drainage into the venous system between drainage sessions. This method includes delivering an implantable device into the thoracic duct 12, positioning the device through the thoracic duct valve so as to maintain the valve in a partially open position and allow fluid from the thoracic duct 12 to move into the left subclavian vein 14.
In one embodiment, the device 190 may allow some chronic drainage into the venous system between drainage sessions with the drainage catheter 196. For example, the stent portion 192 may be positioned at or near the leaflets of the lymph ostium 12A so as to keep the valve to the duct 12 partially open to permit passive drainage into the venous system. Alternately, the drainage catheter 196 may include a plurality of drainage apertures that are located in a proximal portion of the drainage catheter 196 such that they can be positioned in and allow drainage into the venous system. These apertures can be selectively blocked (e.g., by passing another catheter or drainage member directly through the catheter 196 so as to block the apertures. In another embodiment, the guidewire 194 may include an enlargement member that is either fixed to the guidewire 194 or slide over the guidewire 194 and positioned within the valve of the duct 14 to maintain it in a partially open position. It should be understood that other embodiments of this specification can also be used to perform this method of chronic drainage for either a short period of time (e.g., 1-2 hours during a procedure) or chronically via an implanted device (e.g., weeks, months, or years).
The delivery catheter 116 is then withdrawn from the patient, a cannula 118 is advanced within the thoracic duct 12, and the distal end of the cannula 118 is attached to the proximal end of the stent 112. Alternately, the stent 112 can be placed over the valves of the thoracic duct 12 to maintain it in an open position to achieve chronic drainage in the time between attachment of the delivery catheter, as previously discussed with other embodiments. In this embodiment, the stent 112 and/or threaded portion 114 may include a valve that can be selectively opened by the physician.
In one embodiment, the stent includes a proximal threaded portion 114. The threaded portion 114 may have threads 114A along its internal diameter, as seen in
Other attachment mechanisms for the stent 112 are also possible. For example, the proximal end of the stent may include one or more hooks that can latch on to other features of the cannula 118. In another example, the stent 112 may have an annular, flexible ring on its distal end that allows the distal end of the cannula 118 to press against. When the drainage is activated, the drainage force from the cannula 118 will press the distal end of the cannula 118 against the proximal end of the stent 112. Hence, no physical latching/connection mechanism is needed.
Another example of an attachment system can be seen in
Either of the embodiments of
Optionally, a catheter 125 with an inflatable balloon 125A can be inserted through the stent 112 via catheter 125 (or other, similar catheters described herein), as seen in
In one configuration, the port 128 is located underneath the skin, as seen in
The expandable anchor portion 122 can have a cylindrical shape that can radially expand from a smaller compressed diameter to a larger expanded diameter. The anchor portion 122 can be formed from a plurality of woven/braided metal wires or from a laser-cut cylinder. The anchor portion 122 can be composed of a shape memory material, such as Nitinol, that self-expands to its radially expanded diameter when unconstrained. Alternately or in addition to the self-expansion, a balloon catheter can be used to expand the anchor portion 122 when positioned within the thoracic duct 12. In one example, the anchor portion 12 expands to a diameter within a range of 3 mm to 8 mm.
The anchor portion 122 can optionally include a cylindrical cover 104 that is disposed over the outer surface of the anchor portion 122. This cover 104 may reduce friction between the anchor portion 122 and the delivery device (e.g., a delivery catheter) and further covers any apertures present in the anchoring portion 122 (e.g., caused by braided wires) to enhance drainage pressure. In one example, the cover 124 is composed of a biocompatible polymer film such as PET or an elastic polymer.
The elongated tubular portion 126 is preferably structured to be both flexible and kink resistant. In one embodiment, the tubular portion 126 is composed of a helical wire coil 126A (either monofilar or multifilar) that is attached, embedded, or sandwiched between biocompatible polymer layers that prevent leakage of fluid. For example, a wire can be tightly woven around a cylindrical mandrel and heat set, and then one or more fluid impenetrable layers can be attached to the coil. Use of the helical coil 126A provides additional wall strength that may better resist collapsing when suction is applied, vs. non-wire reinforced tubing. In another embodiment, a tubular braided wire structure can be used instead of or in addition to the wire coil 126A. Optionally, a plurality of drainage holes 126B can be spaced at various intervals along the length of the tubular portion 126, extending with the interior drainage passage and thereby allowing the tubular portion 126 to intake fluid, either in addition to the opening at a distal end of the tubular portion 126 or instead of the distal opening. In one example, multiple apertures can be included at locations around the circumference of the tubular portion and can be spaced apart longitudinally from each other at increments of 0.1 cm to 3 cm. In one example, the tubular portion 126 has a length between 2 cm and 64 cm, and has apertures 126B at intervals along its entire length.
The distal end of the tubular portion 126 is connected to a proximal end of the anchor portion 122 and is at least partially positioned within the thoracic duct 12 so as to create a continuous passage between the duct 12 and the port 128 at its proximal end. In one example, the tubular portion 106 has a length within the range of 0.5 m to 1 m.
The port 128 may be composed of a rigid tubular or circular structure with a self-sealing middle or inner portion that allows for penetration by a syringe needle. For example, the self-sealing portion may be composed of a flexible silicone or similar polymer. As previously discussed, the port 128 can have a relatively thin shape to allow for implantation under the skin of the patient or can have a relatively narrow shape if positioned external to the skin. In an example use where the port 128 is located outside the body or is intended to be directly accessed by cutting the patient's skin for treatment, the port 128 may include a valve that can be opened/closed by the physician (e.g., a Tuohy-Borst style valve).
As seen in
In an example use where the port 128 is located outside the body or is intended to be directly accessed by cutting the patient's skin for treatment, the device can include a removable stylet 121 that blocks the passage of the device 100 when not in use, but can be removed during a treatment procedure. The stylet 121 prevents proteins and other material from accumulating in and clogging up the passage of the device 120. Preferably, the stylet 121 has an elongated flexible body that conforms to the position/configuration of the implanted device 120. The distal end of the stylet 121 includes an annular seal 121A that is preferably composed of a resilient, compressible material that expands against the inner surface of the device 120. For example, a sponge material, silicone, or even a hydrogel material can be used for the seal 121A. The stylet 121 can be of a length so as to position the seal 121A in either the anchor portion 122, the distal conical portion of the elongated tubular portion 126, or in the more uniform portion of the elongated tubular portion 126.
In a separate configuration, a central cannula can be advanced from proximal to distal down the fluid lumen and left in place to block flow and limit subsequent obstruction if or when the device is left in place for longer time periods. The cannula/stylet can be made with a soft distal end which is capable of compression as it is in the lumen so that fluid is actively excluded. In another embodiment, the blocking stylet can be advanced out of the distal catheter, which permits expansion, and when pulled retrograde toward the distal tip blocks fluid. This configuration can be used if the device is left implanted for long time periods where maintaining patency is of substantial concern.
As with any of the embodiments of this specification, the device 120 can be delivered by accessing the left subclavian vein 14 through the shoulder or any other route to the central venous system and then advancing to the thoracic duct 12. The delivery procedure can include initially advancing a first guidewire to a desired thoracic duct location, inserting a sheath into the left subclavian vein 14, advancing a guide catheter over the first guidewire, replacing the guidewire with a smaller, second guidewire, and delivering the device 120 via a delivery catheter (such as delivery catheter 116) through the guide catheter. If the port 128 is to remain under the patient's skin, a space can be hollowed/created within the patient's shoulder.
As previously discussed, it may be desirable during a procedure to advance a guide catheter over a guidewire placed in the left subclavian vein 14 and thoracic duct 12.
Any of the embodiments of this specification may also include sensors for monitoring various aspects of a patient, such as pressure sensors, flow sensors, cellular material sensors, protein content sensors, and gene analysis sensors. For example,
While the sensor 162 can measure the environment within the thoracic duct 12, a second sensor 166 can also be positioned at a distance along the outside of the device 160 to measure data within the left subclavian vein 14 (or whatever vessel the device is positioned within to reach the thoracic duct 12). Again, pressure sensors, flow sensors, cellular material sensors, protein content sensors, and gene analysis sensors can be used here. In this respect, the device 160 can measure, for example, both thoracic duct pressure and blood pressure.
The sensors 162 and 166 are connected, e.g. via embedded wires, to a communication device 164 in the port 128. The communication device 164 may include a microcontroller (or similar processor), memory for data storage, and a wireless communication transceiver (e.g., Bluetooth, wifi), which allows it to receive and at least temporarily store sensor data, and then transmit that data to an external device.
The device 160 allows for numerous different methods of use. For example, if sensor 162 is a pressure sensor, a physician may draw off lymphatic fluid while monitoring the pressure. Once the lymphatic pressure reaches a desired level, the fluid withdrawal procedure may be stopped.
In another example, a patient could monitor their pressure at home by connecting the device 160 to their phone or similar device. An app on the device/phone can then be used to alert the patient that their lymphatic pressure has reached a level requiring withdrawal and/or can be sent to a nursing station or cloud site for a physician or nurse to determine if further treatment is necessary. The patient can then be contacted by the medical facility monitoring the pressure to schedule an appointment for fluid withdrawal.
While many patients may benefit from lymph drainage as previously described, this type of drainage is challenged by the loss of proteins and lymphatic cells which may result in compromised immune function. One approach to reducing this protein loss while still providing drainage is to create a shunt from the patient's lymphatic system to a low-pressure zone of their body. For example, the shunt may connect to the bladder, the small bowel, the right atrium, or the right ventricle.
In one embodiment seen in
The outer tubular wall 200B of the shunt 200 is preferably comprised of a water/fluid proof material (e.g., polyurethane) that prevents non-lymph fluids from being absorbed. The wall 200B may also be composed of a porous structure (e.g., 75-100 micrometer diameter) that may help create arterial endothelial and new intimal growth with the surrounding tissue. The shunt 200 may be implanted temporarily, for a short-term, or for a long term. In this example, the outer tubular wall 200B is configured as a chronic implant into interface with friable native tissues and tubes. In this example, the tubular wall 200B is composed of a porous cylindrical structure that has strong radial components preventing its collapse. It is further highly compliant and may be any spring structure or a cross-weave configuration that allows for bending and prevents collapse. the 75-100 micrometer diameter helps permit a pannus formation around the wall 200B, developing an endothelium and thus creating a completely biological surface.
While the embodiments of this specification have been described mostly for drainage of the lymph system, it should be understood that these embodiments and methods can be used for drainage of other conditions. One example is a pleural effusion, which is when an unusually large amount of fluid builds up around the lungs and within the pleural spaces due to a number of different underlying medical conditions. This space is lined by two thin membranes (the visceral and parietal pleura) that line the surface of the lungs and the inside of the chest wall. Normally, only a few teaspoons of fluid are located in this space so as to help the lungs to move smoothly in a patient's chest cavity, but underlying diseases can increase this amount. Pleural effusion is frequently caused by organ failure, cancer, and infections. Patients with pleural effusion may need frequent draining directly via a guided needle and catheter introduced directly to the pleura. These procedures are expensive, traumatic, and require hospitalization.
Once the delivery catheter is located within the pleural space, the shunt 200 or drainage catheter can be advanced into the pleural space 42 (and especial into the areas retaining excess fluid). Depending on how and where the fluid is being retained, the shunt 200 may be positioned back and forth along the floor of the diaphragm beneath the lungs 40 (e.g., in loop formations) or along just a portion of the pleural space.
The structure of the shunt 200 may vary depending on where the shunt 200 drains to. For example, if the shunt 200 drains to a subcutaneous port 128, it may have a generally hollow, tubular passage with a plurality of drainage apertures located along the portion positioned below the lungs 40. In another example, if the shunt 200 drains to the intestine, bladder, or other internal location, the shunt 200 may be composed of dialysis fiber, as discussed in the embodiment of
In any of the previous embodiments, the anchoring portion 122 or stent 112 can include anti-thrombus and/or anti-cellular coatings. These may help reduce obstruction of the device or cellular overgrowth.
While the embodiments of this specification have primarily been described in terms of removing lymph from the lymphatic system, it should be understood that treatment agents can also be added to the lymphatic system via any of the described devices. Once a device has been inserted and/or implanted, a treatment agent can be injected into the device accordingly (e.g., into the cannula, port, or lumen). For example, treatment agents may include electrolytes, chemotherapeutic agents, steroids, antibiotics, or other heart failure or cancer treatment agents.
In any of the embodiments that include an implantable device, it should be understood that they can be removed at a later date. For example, a recovery sheath can be advanced over the implant, causing it to compress. The sheath and device can then be removed from the patient.
While the embodiments of this specification have been described as being implanted via the shoulder and left subclavian vein, other access points are also possible. For example, the device can be advanced via the groin to the subclavian vein and thoracic duct.
In another aspect of the present invention, any of the devices of this specification can be used to withdraw lymphatic fluid to screen for malignant cells or other cells indicating internal disease states, such as metastatic cancers.
Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.
This application is a divisional of U.S. patent application Ser. No. 16/541,077 filed Aug. 14, 2019 entitled System And Method For Treatment Via Bodily Drainage Or Injection, which claims benefit of and priority to Provisional Patent Application Ser. No. 62/718,863 filed Aug. 14, 2018 entitled System and Method for Treatment Via Thoracic Duct Drainage or Injection, Provisional Patent Application Ser. No. 62/744,577 filed Oct. 11, 2018 entitled System and Method for Treatment Via Thoracic Duct Drainage or Injection, Provisional Patent Application Ser. No. 62/747,644 filed Oct. 18, 2018 entitled System and Method for Treatment Via Thoracic Duct Drainage or Injection, Provisional Patent Application Ser. No. 62/804,675 filed Feb. 12, 2019 entitled Thoracic Duct Lymphatic Drainage, and Provisional Patent Application Ser. No. 62/848,468 filed May 15, 2019 entitled Pleural and Lymphatic Drainage Systems, all of which are hereby incorporated herein by reference in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| 62718863 | Aug 2018 | US | |
| 62744577 | Oct 2018 | US | |
| 62747644 | Oct 2018 | US | |
| 62804675 | Feb 2019 | US | |
| 62848468 | May 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16541077 | Aug 2019 | US |
| Child | 17652468 | US |
