Patent Application
20220387217
The present technology relates to adjustable flow glaucoma shunts and methods for making and using such devices.
Glaucoma is a degenerative ocular condition involving damage to the optic nerve that can cause progressive and irreversible vision loss. Glaucoma is frequently associated with ocular hypertension, an increase in pressure within the eye, and may result from an increase in production of aqueous humor (“aqueous”) within the eye and/or a decrease in the rate of outflow of aqueous from within the eye into the blood stream. Aqueous is produced in the ciliary body at the boundary of the posterior and anterior chambers of the eye. It flows into the anterior chamber and eventually into the venous vessels of the eye. Glaucoma is typically caused by a failure in mechanisms that transport aqueous out of the eye and into the blood stream.
Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the component is necessarily transparent. Components may also be shown schematically.
The present technology is directed to adjustable flow glaucoma shunts, systems, and methods for making and using such devices. In many of the embodiments described herein, the shunts include a drainage element (e.g., a flow tube) having a first opening, a second opening, and a lumen extending between the first opening and the second opening. The first opening can be positioned in the anterior chamber, and the second opening can be positioned in a target outflow location, such as a subconjunctival bleb space. The shunts can further include a flow control assembly coupled to the drainage element and configured to control the flow of fluid (e.g., aqueous) through at least one of the first opening or the second opening. For example, in some embodiments the flow control assembly is coupled to the drainage element proximate the second opening and controls the flow of fluid as it exits the drainage tube. In other embodiments, the flow control assembly is coupled to the drainage element proximate the first opening and controls the flow of fluid as it enters the drainage tube. Regardless of its orientation, the shunts can further include an outer membrane or bladder that encases the flow control assembly. The outer membrane can include a plurality of apertures that fluidly couple an interior of the outer membrane with an environment exterior to the outer membrane.
Specific details of various embodiments of the present technology are described below with reference to
Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.
Reference throughout this specification to relative terms such as, for example, “generally,” “approximately,” and “about” are used herein to mean the stated value plus or minus 10%.
Although certain embodiments herein are described in terms of shunting fluid from an anterior chamber of an eye, one of skill in the art will appreciate that the present technology can be readily adapted to shunt fluid from and/or between other portions of the eye, or, more generally, from and/or between a first body region and a second body region. Moreover, while the certain embodiments herein are described in the context of glaucoma treatment, any of the embodiments herein, including those referred to as “glaucoma shunts” or “glaucoma devices” may nevertheless be used and/or modified to treat other diseases or conditions, including other diseases or conditions of the eye or other body regions. For example, the systems described herein can be used to treat diseases characterized by increased pressure and/or fluid build-up, including but not limited to heart failure (e.g., heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, etc.), pulmonary failure, renal failure, hydrocephalus, and the like. Moreover, while generally described in terms of shunting aqueous, the systems described herein may be applied equally to shunting other fluid, such as blood or cerebrospinal fluid, between the first body region and the second body region.
The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology.
Glaucoma refers to a group of eye diseases associated with damage to the optic nerve which eventually result in vision loss and blindness. As noted above, glaucoma is a degenerative ocular condition characterized by an increase in pressure within the eye resulting from an increase in production of aqueous within the eye and/or a decrease in the rate of outflow of aqueous from within the eye into the blood stream. The increased pressure leads to injury of the optic nerve over time. Unfortunately, patients often do not present with symptoms of increased intraocular pressure until the onset of glaucoma. As such, patients typically must be closely monitored once increased pressure is identified even if they are not symptomatic. The monitoring continues over the course of the disease so clinicians can intervene early to stem progression of the disease. Monitoring pressure requires patients to visit a clinic site on a regular basis which is expensive, time-consuming, and inconvenient. The early stages of glaucoma are typically treated with drugs (e.g., eye drops) and/or laser therapy. When drug/laser treatments no longer suffice, however, surgical approaches can be used. Surgical or minimally invasive approaches primarily attempt to increase the outflow of aqueous from the anterior chamber to the blood stream either by the creation of alternative fluid paths or the augmentation of the natural paths for aqueous outflow.
Referring to
Outflow resistance can change over time for a variety of reasons, e.g., as the outflow location goes through its healing process after surgical implantation of a shunt (e.g., shunt 100) or further blockage in the drainage network from the anterior chamber through the trabecular meshwork, Schlemm's canal, the collector channels, and eventually into the vein and the body's circulatory system. Accordingly, a clinician may desire to modify the shunt after implantation to either increase or decrease the outflow resistance in response to such changes or for other clinical reasons. For example, in many procedures the shunt is modified at implantation to temporarily increase its outflow resistance. After a period of time deemed sufficient to allow for healing of the tissues and stabilization of the outflow resistance, the modification to the shunt is reversed, thereby decreasing the outflow resistance. In another example, the clinician may implant the shunt and after subsequent monitoring of intraocular pressure determine a modification of the drainage rate through the shunt is desired. Such modifications can be invasive, time-consuming, and/or expensive for patients. If such a procedure is not followed, however, there is a high likelihood of creating hypotony (excessively low eye pressure), which can result in further complications, including damage to the optic nerve. In contrast, intraocular shunting systems configured in accordance with embodiments of the present technology allow the clinician to selectively adjust the flow of fluid through the shunt after implantation without additional invasive surgical procedures.
The shunts described herein can be implanted having a first drainage rate and subsequently remotely adjusted to achieve a second drainage rate. The adjustment can be based on the needs of the individual patient. For example, the shunt may be implanted at a first lower flow rate and subsequently adjusted to a second higher flow rate as clinically necessary. The shunts described herein can be delivered using either ab interno or ab externo implant techniques, and can be delivered via needles. The needles can have a variety of shapes and configurations to accommodate the various shapes of the shunts described herein. For example, in some embodiments, the needles may be hinged to facilitate implantation through the sclera. Details of the implant procedure, the implant devices, and bleb formation are described in greater detail in International Patent Application No. PCT/US20/41152, filed Jul. 8, 2020, the disclosure of which is hereby incorporated by reference herein for all purposes.
In many of the embodiments described herein, the flow control assemblies are configured to introduce features that selectively impede or attenuate fluid flow through the shunt during operation. In this way, the flow control assemblies can incrementally or continuously change the flow resistance through the shunt to selectively regulate pressure and/or flow. The flow control assemblies configured in accordance with the present technology can accordingly adjust the level of interference or compression between a number of different positions, and accommodate a multitude of variables (e.g., IOP, aqueous production rate, native aqueous outflow resistance, and/or native aqueous outflow rate) to precisely regulate flow rate through the shunt.
The disclosed actuators and fluid resistors can all be operated using externally delivered (e.g., non-invasive) energy. This feature allows such devices to be implanted in the patient and then modified/adjusted over time without further invasive surgeries or procedures for the patient. Further, because the devices disclosed herein may be actuated via energy, such devices do not require any additional power to maintain a desired orientation or position. Rather, the actuators/fluid resistors disclosed herein can maintain a desired position/orientation without power. This can significantly increase the usable lifetime of such devices and enable such devices to be effective long after the initial implantation procedure.
In some embodiments, the inflow tube 210 comprises an oval cross-sectional shape. An oval cross-sectional shape can minimize the height of the inflow tube 210 and thus can reduce the interaction of the inflow tube 210 and the corneal endothelium when the shunt 200 is implanted in the eye. In other embodiments, however, the inflow tube 210 has a substantially circular cross-sectional shape. In yet other embodiments, the inflow tube 210 has yet another cross-sectional shape, such as rectangular, pentagonal, etc. The inflow tube 210 can comprise any material suitable for placement within a human eye. In some embodiments, the inflow tube 210 is a flexible material such as silicone, urethane, etc. In some embodiments, the inflow tube 210 comprises a material known in the art to induce little to no inflammatory response.
The outflow tube 220 further includes an outflow hole or aperture 228 between the proximal end portion 222 and the distal end portion 224. The aperture 228 is in fluid communication with the lumen 226. Accordingly, as aqueous flows through the lumen 226, at least a portion of the aqueous will exit the lumen 226 via the aperture 228 unless the aperture 228 is covered by the flow control assembly 230, as described below with respect to
At least a portion of the flow control assembly 230 can be composed of a shape memory material (e.g., nitinol or another suitable shape memory material) capable of activation via energy, such as light and/or heat. For example, the first actuation element 236a and the second actuation element 236b can be composed of a shape memory material, such as a shape memory alloy (e.g., nitinol). Accordingly, the first actuation element 236a and the second actuation element 236b can be transitionable at least between a first material phase or state (e.g., a martensitic state, a R-phase, a composite state between martensitic and R-phase, etc.) and a second material phase or state (e.g., an austenitic state, an R-phase state, a composite state between austenitic and R-phase, etc.). In the first material state, the first actuation element 236a and the second actuation element 236b may be deformable (e.g., plastic, malleable, compressible, expandable, etc.). In the second material state, the first actuation element 236a and the second actuation element 236b may have a preference toward a specific preferred geometry (e.g., original geometry, manufactured geometry, heat set geometry, etc.). The first actuation element 236a and the second actuation element 236b can be transitioned between the first material state and the second material state by applying energy (e.g., heat) to the actuation elements to heat the actuation elements above a transition temperature. Energy can be applied to the actuation elements via an energy source positioned external to the body (e.g., a laser), RF heating, resistive heating, or the like. In some embodiments, the transition temperature for both the first actuation element 236a and the second actuation element 236b is above an average body temperature (e.g., an average temperature in the eye). Accordingly, both the first actuation element 236a and the second actuation element 236b are generally in the deformable first state when the shunt 200 is implanted in the body until they are actuated. If an actuation element (e.g., the first actuation element 236a) is deformed relative to its preferred geometry while in the first state, heating the actuation element (e.g., the first actuation element 236a) above its transition temperature causes the actuation element to transition to the second state and therefore move from the deformed shape to and/or toward its preferred geometry. In some embodiments, the first actuation element 236a can be selectively heated independently of the second actuation element 236b, and the second actuation element 236b can be selectively heated independently of the first actuation element 236a.
The first actuation element 236a and the second actuation element 236b generally act in opposition. For example, if the second actuation element 236b is deformed relative to its preferred geometry, actuation of the second actuation element 236b (e.g., heating the second actuation element 236b above its transition temperature) causes the second actuation element 236b to move toward its preferred geometry. This causes a corresponding deformation in the first actuation element 236a, which remains in the first material state and thus is generally malleable. For example, in the illustrated embodiment, the second actuation element 236b is compressed (e.g., shortened) relative to its preferred geometry. Heating the second actuation element 236b above its transition temperature causes the second actuation element 236b to straighten out (e.g., lengthen, expend, etc.) and move toward its preferred geometry. Because the second anchoring element 232b does not move as the second actuation element 236b changes shape, the first actuation element 236a (which is not heated and therefore in the first generally malleable state) is compressed to account for the shape change of the second actuation element 236b. This moves the control element 234 toward the first anchoring element 232a. The operation can be reversed by heating the first actuation element 236a above its transition temperature, which causes it to move (e.g., expand) toward its preferred geometry, which moves the control element 234 back toward the second anchoring element 232b. Accordingly, the first actuation element 236a and the second actuation element 236b can be selectively and independently actuated to toggle the control element 234 back and forth, which as described below can selectively block and/or unblock the aperture 228. Additional details regarding the operation of flow control assemblies generally similar to the flow control assembly 220 are described below in Section C and with reference to
In some embodiments, the flow control assembly 230 is cut from sheet or strip material. In such embodiments, each component of the flow control assembly comprises the same material, such as nitinol. To manufacture such nitinol-based flow control assemblies, the desired shape of the flow control assembly can be cut from a sheet or strip (e.g., a single sheet or a single strip) of nitinol. For example, substantially flat flow control assemblies can be laser cut from a single sheet or strip of nitinol material. Non-flat (e.g., spherical, cylindrical, conical, etc.) flow control assemblies (e.g., flow control assembly 230) can be laser cut from a single sheet of nitinol material and fused or otherwise formed into the desired non-flat configuration. However, as one skilled in the art will appreciate from the disclosure herein, the flow control assemblies can be formed using other suitable methods. For example, in embodiments in which the flow control assemblies are composed of nitinol, the flow control assemblies can be formed using any technique suitable for manipulating nitinol into the desired configuration.
In some embodiments, the first actuation element and/or the second actuation element (e.g., first actuation element 236a and/or second actuation element 236b) are optionally biased after forming the flow control assembly. For example, the first actuation element can be manipulated (e.g., using energy) such that it has a different length than the second actuation element upon attachment to the shunt/flow tube. Biasing at least one of the actuation elements before deployment of the shunt places the shunt in an “open” (e.g., permitting flow), partially “open”, or “closed” (e.g., not permitting flow) position for the implant procedure. The biasing step can be done before or after attachment of the flow control assembly to the flow tube. The flow control assemblies can be secured to the shunt using anchoring techniques that hold the flow control assembly in the desired position and do not substantially interfere with operation of the shunt. For example, the flow control assembly (e.g., flow control assembly 230) can be secured to the flow tube (e.g., flow tube 220) via one or more anchoring elements (e.g., the first anchoring element 232a and/or the second anchoring element 232b). Once the flow control assembly is anchored to the flow tube, the flow tube 220 can be positioned within the outer membrane (e.g., outer membrane 2240) and secured in place using any suitable means.
Referring to
As described above, the actuation elements 236 are configured to slidably move (e.g., axially translate) the control element 234 back and forth along a length of the outflow tube 220 between the anchoring elements 232 For example, upon activation of at least one of the actuation elements 236, the control element 234 slidably moves along the outer surface of the outflow tube 220 in a first direction or a second direction, respectively, such that (a) the aperture 228 has a first fluid flow cross-section (e.g., completely open and accessible), or (b) the aperture 228 is at least partially covered by the control element 236 and has a second fluid-flow cross-section less than the first fluid flow cross-section (e.g., partially open/accessible). Further, in some instances the control element 236 may be slidably adjusted such that the aperture 228 is fully covered and inaccessible. The flow control assembly 230 can be selectively adjusted after placement within the eye (e.g., via an energy source positioned external to the eye) to provide a variety of different outflow resistance levels by incrementally adjusting the control element 236 relative to the aperture 228.
In some embodiments, the outflow tube 220 includes a plurality of apertures 228. In such embodiments, the flow control assembly 230 can be configured to move between a first position at least partially covering at least a first aperture and a second position not covering the first aperture. In some embodiments, movement of the flow control assembly 230 can be configured to at least partially cover or uncover more than just the first aperture. In some embodiments, at least one aperture 228 can remain at least partially uncovered at all times. In other embodiments, however, all of the apertures 228 can be covered by the flow control assembly 230 at the same time, depending on the positioning of the flow control assembly 230. The number of apertures 228 can be based at least in part on the desired aqueous drainage volume. Having a plurality of apertures 228 enables drainage of aqueous to continue even if one of the apertures 228 becomes blocked by tissue ingrowth or clotting.
The flow control assembly 330 can be substantially similar to the flow control assembly 230 described with respect to
As illustrated in
In some embodiments, the outer membrane 340 is dome-shaped. For example,
Referring to
Although the arrangement illustrated in
The shunt 400 includes an outer membrane 440 enclosing the flow control assembly 430 and at least a portion of the flow tube 410. The outer membrane 440 can include an enlarged bladder portion 442 configured to protect the flow control assembly 430 and a tubular portion 444 configured to encase at least a portion of the flow tube 410. The bladder portion 442 can have a plurality of holes, slots, or channels (not shown) that allow aqueous to exit the membrane 440. The outer membrane 440 can protect the flow control assembly 430 and permit the flow control assembly to move freely without interference from tissue. The outer membrane 440 can also keep a drainage bleb open. As illustrated, the outer membrane 440 can be substantially flat to minimize damage to the eye during and after implantation of the shunt 400. The outer membrane 440 may also help anchor the shunt 400 in a target location.
The frame 540 includes a proximal portion 542 and a distal portion 544. The proximal portion 542 is configured to sit in the drainage space (e.g., in the bleb space) and the distal portion 544 is configured to penetrate through the sclera and into the anterior chamber. The shape of the frame 540 anchors the shunt 500 in position. In some embodiments, the frame 540 can be substantially flat (e.g., have a substantially flat profile with a thickness of about 100 μm or less, 90 μm or less, 80 μm or less, 70 μm or less, 60 μm or less, and/or 50 μm or less) to minimize damage to the eye during and after implantation of the shunt 500, while still being shaped to protect a flow control assembly 530 and anchor the shunt 500 in a target position. In addition to anchoring the shunt 500 and protecting the flow control assembly 530, the frame 540 can also define one or more flow channels that permit aqueous to flow from the anterior chamber towards the flow control assembly 530. For example, the illustrated embodiment includes a first flow channel 520a and a second flow channel 520b (collectively referred to herein as “flow channels 520”). In some embodiments, and as illustrated in
As provided above, the shunt 500 further includes the flow control assembly 530 carried by the frame 540. More specifically, the flow control assembly 530 can be positioned within the proximal portion 542 of the frame and configured to selectively control the flow of fluid through the flow channels 520. For example, the flow control assembly 530 includes a first control or gating element 538a configured to interface with (e.g., block) the first flow channel 520a and a second control or gating element 538b configured to interface with the second flow channel 520b. The first control element 538a and the second control element 538b can have a generally elbow or “L” shape. The flow control assembly 530 further includes a first actuation element 536a and a second actuation element 536b. The first actuation element 536a can extend between the anchoring element 532 and a first control element interfacing component 534a, which is configured to engage a portion of the first control element 538a. The second actuation element can extend between the anchoring element 532 and a second control element interfacing component 534b, which is configured to engage a portion of the second control element 538b. In some embodiments, the control gates 538a, 538b and the actuation elements 536a, 536b can be integrated into a single component laser cut from a nitinol sheet.
In the illustrated embodiment, the first control element 538a and the second control element 538b engage the anchoring element 532, although as described below the first and second control elements 538a, 538b can be selectively moved away from the anchoring element 532 via actuation of the first and second actuation elements 536a, 536b, respectively, to partially or fully unblock the first and second flow channels 520a, 520b, respectively. For example, the first actuation element 536a can selectively open or unblock the first flow channel 520a, and the second actuation element 536b can selectively open or unblock the second flow channel 520b. In some embodiments, the first actuation element 536a and the second actuation element 536b can be composed of a shape memory material and configured to operate substantially similar to the actuation elements previously described. For example, the first actuation element 536a may be compressed relative to its preferred geometry such that heating it above its transition temperature causes the first actuation element 536a to expand (e.g., lengthen), pushing (via the first control element interfacing component 534a) the first control element 538a away from the anchoring element 532 and unblocking (or at least partially unblocking) the first flow channel 520a. Likewise, the second actuation element 536b may be compressed relative to its preferred geometry such that heating it above its transition temperature causes the second actuation element 536b to expand (e.g., lengthen), pushing (via the second control element interfacing component 534b) the second control element 538b away from the anchoring element 532 and unblocking (or at least partially unblocking) the second flow channel 520b. The first and second actuation elements 536a, 536b can therefore be selectively actuated to modify the flow through the flow channels 520.
The shunt 500 can further include an outer membrane or cover 550 that encases the flow control assembly 530 and the frame 540, and which functions similarly to the outer membranes discussed above with respect to the shunts 300, 400, and 500. In some embodiments, the cover 550 can be substantially flat to minimize damage to the eye during and after implantation of the shunt 500, while still being shaped to protect a flow control assembly 530 and anchor the shunt 500 in a target position. The cover 550 can comprise a thin and flexible material to avoid excessive irritation of tissue.
The flow tube 640 further includes an outflow hole or aperture 643 between the proximal end portion 641 and the distal end portion 642. The aperture 643 is in fluid communication with the lumen 644. Accordingly, as aqueous flows through the lumen 644, at least a portion of the aqueous will exit the lumen 644 via the aperture 643 unless the aperture 643 is covered (partially or completely) by the flow control assembly 650, as described below. As one skilled in the art will appreciate from the disclosure herein, the flow tube 640 can have a plurality of apertures 643 along its length and/or at the distal end portion 642.
The flow control assembly 650 can be generally similar to or the same as the flow control 230 described in detail with respect to
As best seen in
The bladder portion 620 can encase the flow control assembly 650 and the distal end portion of the flow tube 640. The bladder portion 620 can include a plurality of apertures 621 configured to fluidly connect an interior chamber defined by the bladder portion 620 and an environment external to the bladder portion 620. Accordingly, when implanted within the eye, the bladder portion 620 can be configured to reside within a target outflow location, such as a subconjunctival bleb space. The apertures 621 permit aqueous draining through the aperture 643 of the flow tube 640 to exit the interior chamber of the bladder portion 620 and flow into the bleb space. In some embodiments, the apertures 621 are positioned at a distal end portion of the bladder portion 620. A proximal end portion 622 of the bladder 620 adjacent the elongated portion 612 can be generally free from apertures. Without being bound by theory, the foregoing placement of apertures along the bladder portion 620 is expected to improve the drainage characteristics of the shunt 600, as described in detail below with respect to
The bladder portion 620 can serve a number of functions. First, the bladder portion 620 can protect the flow control assembly 650 and permit the flow control assembly 650 to move freely without interference from tissue. Second, the shape of the bladder portion 620 can help anchor the shunt 600 in a target position when the shunt 600 is implanted in an eye, and/or the bladder portion 620 can include additional anchoring features (e.g. suture holes, ribs, wings, etc.). This can be especially beneficial in the first few days or weeks following implantation before tissue ingrowth into the shunt 600 has occurred. Third, the bladder portion 620 can help keep a drainage bleb open by minimizing tissue ingrowth into the drainage space surrounding the outflow end of the flow tube 640. Fourth, the bladder portion 620 can reduce a backflow pressure through the flow tube 640. Reducing the backflow pressure through the flow tube can help maintain drainage of aqueous through the flow tube, even in embodiments without a flow control assembly 650.
Although shunt 600 is described as having the flow control assembly 650 positionable at or adjacent an outflow end of the shunt, the flow control assemblies described herein can also be positioned at other positions along the length of the shunt. For example, the flow control assembly 650 can be positioned near a proximate (e.g., inflow) end of the shunt and/or within an anterior chamber. Accordingly, shunt 600 can be oriented in multiple directions, depending on the desired arrangement (e.g., the shunt 600 can be implanted with the flow control assembly proximate the anterior chamber or with the flow control assembly proximate the desired outflow location). In some embodiments, placing the flow control assembly 650 in the anterior chamber is expected to reduce the amount of tissue interference with the non-invasive energy used to selectively adjust the flow control assembly. In embodiments in which the flow control assembly 650 is positioned within the anterior chamber, the bladder portion 620 of the outer membrane 605 can also be positioned within the anterior chamber. When placed in the anterior chamber, the bladder portion 620 can serve several similar functions to those described above. For example, the bladder portion 620 can protect the flow control assembly and/or anchor the shunt. If the bladder portion 620 is positioned around the flow control assembly 650 in the anterior chamber, the shunt 620 can optionally have a second bladder (not shown) surrounding the outflow end of the shunt. The second bladder can reduce backflow pressure through the shunt and/or help prevent tissue ingrowth in a bleb or other desired outflow location.
Additional aspects of outer membranes/covers for adjustable shunts, such as outer membrane 605, are described below with respect to
The outer membrane 805 also includes a plurality of apertures 821 on the bladder portion 820. As described above, the apertures 821 permit aqueous to drain from an interior chamber defined by the bladder portion into the surrounding environment (e.g., the bleb space). As illustrated, the plurality of apertures 821 are positioned on a medial and distal portion 824 of the bladder portion 820. There are no apertures on the proximal portion 822. Such a configuration pushes aqueous draining through the apertures 821 away from the globe of eye and ensures any growth in the drainage bleb will also be away from the globe of the eye.
As one skilled in the art will appreciate, adjustable shunts configured in accordance with the present technology can include any combination of the above described features and are not limited to the specific embodiments illustrated herein. Moreover, although the shunts discussed above are primarily described as having the flow control assembly positioned at or adjacent an outflow end of the shunt, the flow control assemblies described herein can also be positioned at other positions along the length of the shunt. For example, the flow control assembly can be positioned near a proximate (e.g., inflow) end of the shunt and/or within an anterior chamber. Accordingly, the shunts described above in
In many of the embodiments described herein, the flow control assemblies are configured to introduce features that selectively impede or attenuate fluid flow through the shunt during operation. In this way, the flow control assemblies can incrementally or continuously change the flow resistance through the shunt to selectively regulate pressure and/or flow. The flow control assemblies configured in accordance with the present technology can accordingly adjust the level of interference or compression between a number of different positions, and accommodate a multitude of variables (e.g., TOP, aqueous production rate, native aqueous outflow resistance, and/or native aqueous outflow rate) to precisely regulate flow rate through the shunt.
The disclosed flow control assemblies can be operated using energy. This feature allows such devices to be implanted in the patient and then modified/adjusted over time without further invasive surgeries or procedures for the patient. Further, because the devices disclosed herein may be actuated via energy, such devices do not require any additional power to maintain a desired orientation or position. Rather, the actuators/fluid resistors disclosed herein can maintain a desired position/orientation without power. This can significantly increase the usable lifetime of such devices and enable such devices to be effective long after the initial implantation procedure.
The shunts described herein can be implanted having a first drainage rate and subsequently remotely adjusted to achieve a second drainage rate. The adjustment can be based on the needs of the individual patient. For example, the shunt may be implanted at a first lower flow rate and subsequently adjusted to a second higher flow rate once inflammation reduces. The shunts described herein can be delivered using either ab interno or ab externo implant techniques, and can be delivered via needles. The needles can have a variety of shapes and configurations to accommodate the various shapes of the shunts described herein. For example, in some embodiments, the needles may be hinged to facilitate implantation through the sclera. Details of the implant procedure, the implant devices, and bleb formation are described in greater detail in PCT Patent Application No. PCT/US20/41152, titled “MINIMALLY INVASIVE BLEB FORMATION DEVICES AND METHODS FOR USING SUCH DEVICES,” filed Jul. 8, 2020, the disclosure of which is hereby incorporated by reference herein for all purposes.
Aspects of the present technology are further directed to methods of manufacturing the shunts described herein. As described herein, for example, select embodiments of the present technology include a flow control assembly composed, at least in part, of nitinol. To manufacture such nitinol-based flow control assemblies, the desired shape of the flow control assembly can be cut from a sheet or strip of nitinol. For example, substantially flat flow control assemblies (e.g., flow control assemblies 430 and 530 of shunts 400 and 500) can be laser cut from a single sheet or strip of nitinol material. Non-flat (e.g., spherical, cylindrical, conical, etc.) flow control assemblies (e.g., flow control assemblies 230 and 330 of shunts 200 and 300) can be laser cut from a single sheet or strip of nitinol material and fused or otherwise formed into the desired non-flat configuration. However, as one skilled in the art will appreciate from the disclosure herein, the flow control assemblies can be formed using other suitable methods. For example, in embodiments wherein the flow control assemblies comprise nitinol, the flow control assemblies can be formed using any technique suitable for manipulating nitinol into the desired configuration. As one skilled in the art will appreciate from the disclosure herein, the present technology is not limited to the methods of manufacture expressly described herein. Rather, the shunts described herein can be manufactured using other suitable methods not expressly set forth herein.
As discussed above, the present technology is generally directed to implantable systems and devices for facilitating the flow of fluid between a first body region and a second body region. The devices generally include a drainage and/or shunting element having a lumen extending therethrough for draining or otherwise shunting fluid between the first and second body regions. Further, devices configured in accordance with the present technology may be selectively adjustable to control the amount of fluid flowing between the first and second body regions. In some embodiments, for example, the devices comprise an actuation assembly that drives movement of a flow control element to modulate flow resistance through the lumen, thereby increasing or decreasing the relative drainage rate of fluid between the first body region and the second body region.
In some embodiments of the present technology, the flow control assemblies (e.g., actuation assemblies, flow control mechanisms, fluid resistors, etc.) comprise at least two actuation elements coupled to a moveable element (e.g., a control element, a gating element, an arm, etc.). The moveable element can be formed to interface with (e.g., at least partially block) a corresponding port, such as a lumen orifice. The port can be an inflow port or an outflow port. In other embodiments, the moveable element can be an intermediate element between the actuation element and a flow control element that interfaces with or otherwise engages a shunt lumen or orifice. In such embodiments, movement of the moveable element can adjust a geometry of the flow control element, which in turn adjusts a size, shape, or other dimension of a shunt lumen or orifice. Movement of the actuation elements generates (e.g., translational and/or rotational) movement of the moveable element.
The actuation element(s) can include a shape memory material (e.g., a shape memory alloy, or a shape memory polymer). Movement of the actuation element(s) can be generated through applied stress and/or use of a shape memory effect (e.g., as driven by a change in temperature). The shape memory effect enables deformations that have altered an element from its preferred geometric configuration (e.g., original configuration, shape-set configuration, heat-set configuration, etc.) to be largely or entirely reversed during operation of the flow control assembly. For example, thermal actuation (heating) can reverse deformation(s) by inducing a change in state (e.g., phase change) in the actuator material, inducing a temporary elevated internal stress that promotes a shape change toward the preferred geometric configuration. For a shape memory alloy, the change in state can be from a martensitic phase (alternatively, R-phase) to an austenitic phase. For a shape memory polymer, the change in state can be via a glass transition temperature or a melting temperature. The change in state can reverse deformation(s) of the material—for example, deformation with respect to its preferred geometric configuration—without any (e.g., externally) applied stress to the actuation element. That is, a deformation that is present in the material at a first temperature (e.g., body temperature) can be (e.g., thermally) recovered and/or altered by raising the material to a second (e.g., higher) temperature. Upon cooling (and changing state, e.g., back to martensitic phase), the actuation element retains its preferred geometric configuration. With the material in this relatively cooler-temperature condition it may require a lower force or stress to thermoelastically deform the material, and any subsequently applied external stress can cause the actuation element to once again deform away from the original geometric configuration.
The actuation element(s) can be processed such that a transition temperature at which the change in state occurs (e.g., the austenite start temperature, the austenite final temperature, etc.) is above a threshold temperature (e.g., body temperature). For example, the transition temperature can be set to be about 45 deg. C., about 50 deg. C., about 55 deg. C., or about 60 deg. C. In some embodiments, the actuator material is heated from body temperature to a temperature above the austenite start temperature (or alternatively above the R-phase start temperature) such that an upper plateau stress (e.g., “UPS_body temperature”) of the material in a first state (e.g., thermoelastic martensitic phase, or thermoelastic R-phase at body temperature) is lower than an upper plateau stress (e.g., “UPS_actuated temperature”) of the material in a heated state (e.g., superelastic state), which achieves partial or full free recovery. For example, the actuator material can be heated such that UPS_actuated temperature>UPS_body temperature. In some embodiments, the actuator material is heated from body temperature to a temperature above the austenite start temperature (or alternatively above the R-phase start temperature) such that an upper plateau stress of the material in a first state (e.g., thermoelastic martensite or thermoelastic R-phase at body temperature”) is lower than a lower plateau stress (e.g., “LPS”) of the material in a heated state (e.g., superelastic state), which achieves partial or full free recovery. For example, the actuator material can be aged such that LPS activated temperature>UPS_body temperature. In some embodiments, the actuator material is heated from body temperature to a temperature above the austenite start temperature (or alternatively above the R-phase start temperature) such that an upper plateau stress of the material in a first state (e.g., thermoelastic martensite or thermoelastic R-phase) is higher than a lower plateau stress of the material in a heated state, which achieves partial free recovery. For example, the actuator material can be aged such that LPS activated temperature<UPS_body temperature.
The flow control assembly can be formed such that the actuation elements have substantially the same preferred geometric configuration (e.g., memory shape, or length, L0). The flow control assembly can be assembled such that, upon introduction into a patient (e.g., implantation), at least one (e.g., a first) actuation element/shape memory element has been deformed with respect to its preferred geometric configuration (e.g., to have L1≠L0), while at least one other opposing (e.g., a second) actuation element/shape memory element positioned adjacent to the first actuation element is substantially at its preferred geometric configuration (e.g., L0). In other embodiments, however, both the first and second actuation elements may be deformed with respect to their corresponding preferred geometric configuration upon introduction into the patient (e.g., the first actuation element is contracted relative to its preferred geometric configuration and the second actuation element is expanded relative to its preferred geometric configuration).
In some embodiments of the present technology, L1>L0—for example, the deformed first actuation element is elongated with respect to its preferred “shape memory” length. In some embodiments, L1<L0—for example, the deformed first actuation element is compressed with respect to its preferred shape memory length. The flow control assembly can be formed such that, in operation, its overall dimension (e.g., overall length) is substantially fixed (e.g., L0+L1=a constant). For example, (e.g., outermost) ends of the actuation elements can be fixed, such that movement of the actuation elements occurs between the points of fixation. The overall geometry of the actuation elements, along with the lengths, can be selected such that, in operation, deformation within the actuation elements remains below about 10%, about 9%, about 8%, about 7%, or about 6%.
The (e.g., first and second) actuation elements are arranged such that a movement (e.g., deflection or deformation) of the first actuation element/first shape memory element is accompanied by (e.g., causes) an opposing movement of the second actuation element/second shape memory element. The movement can be a deflection or a deformation. In operation, selective heating of the first actuation element of the flow control assembly causes it to move to and/or toward its preferred geometric configuration (e.g., revert from L1 to L0), moving the coupled moveable element. At the same time, the elongation of the first actuation element is accompanied by (e.g., causes) a compression of the second actuation element (e.g., from L0 to L1). The second actuation element is not heated (e.g., remains at body temperature), and therefore the second actuation element deforms (e.g., remains martensitic and compresses). The first actuation element cools following heating, and returns to a state in which it can be plastically deformed. To reverse the configuration of the flow control assembly (e.g., the position of the moveable element), the second actuation element is heated to move to and/or toward its preferred geometric configuration (e.g., from L1 to L0). The return of the second actuation element to its preferred geometric configuration causes the moveable element to move back to its prior position, and compresses the first actuation element (e.g., from L0 to L1). The position of the moveable element for the flow control assembly can be repeatably toggled (e.g., between open and closed) by repeating the foregoing operations. The heating of an actuation element can be accomplished via application of incident energy (e.g., via a laser or inductive coupling). Further, as mentioned above, the source of the incident energy may be external to the patient (e.g., non-invasive).
Referring collectively to
The first actuation element 1001 and the second actuation element 1002 can be composed of a shape memory material, such as a shape memory alloy (e.g., nitinol). Accordingly, the first actuation element 1001 and the second actuation element 1002 can be transitionable between at least a first material phase or state (e.g., a martensitic material state, an R-phase material state, etc.) and a second material phase or state (e.g., an austenitic material state, an R-phase material state, etc.). In the first state, the first actuation element 1001 and the second actuation element 1002 may be deformable (e.g., plastic, malleable, compressible, expandable, etc.). In the second state, the first actuation element 1001 and the second actuation element 1002 may have a preference toward a specific preferred geometry (e.g., original geometry, manufactured geometry, heat set geometry, etc.). The first actuation element 1001 and the second actuation element 1002 can be transitioned between the first state and the second state by applying energy (e.g., heat) to the actuation elements to heat the actuation elements above a transition temperature. In some embodiments, the transition temperature for both the first actuation element 1001 and the second actuation element 1002 is above an average body temperature (e.g., an average body temperature in the eye). Accordingly, both the first actuation element 1001 and the second actuation element 1002 are typically in the deformable first state when the flow control assembly 1000 is implanted in the body until they are heated (e.g., actuated).
If an actuation element (e.g., the first actuation element 1001) is deformed relative to its preferred geometry while in the first state, heating the actuation element (e.g., the first actuation element 1001) above its transition temperature causes the actuation element to transition to the second state and therefore transition from the deformed shape to and/or toward its preferred geometry. Heat can be applied to the actuation elements via an energy source positioned external to the body (e.g., a laser), RF heating, resistive heating, or the like. In some embodiments, the first actuation element 1001 can be selectively heated independently of the second actuation element 1002, and the second actuation element 1002 can be selectively heated independently of the first actuation element 1001.
Referring to
The flow control assembly 1000 can be repeatedly transitioned between the second configuration and the third configuration. For example, the flow control assembly 1000 can be returned to the second configuration from the third configuration by heating the first actuation element 1001 above its transition temperature once the second actuation element 1002 has returned to the deformable first state (e.g., by allowing the second actuation element 1002 to cool below the transition temperature). Heating the first actuation element 1001 above its transition temperature causes the first actuation element 1001 to move to and/or toward its preferred geometry, which in turn pushes the control element 1003 back towards the second anchoring element 1005 and transitions the flow control assembly 1000 to the second configuration (
As provided above, heat can be applied to the actuation elements via an energy source positioned external to the body (e.g., a laser), RF heating, resistive heating, or the like. In some embodiments, the first actuation element 1001 can be selectively heated independently of the second actuation element 1002, and the second actuation element 1002 can be selectively heated independently of the first actuation element 1001. For example, in some embodiments, the first actuation element 1001 is on a first electrical circuit and/or responds to a first frequency range for selectively and resistively heating the first actuation element 1001 and the second actuation element 1002 is on a second electrical circuit and/or responds to a second frequency range for selectively and resistively heating the second actuation element 1002. As described in detail above, selectively heating the first actuation element 1001 moves the control element 1003 in a first direction and selectively heating the second actuation element 1002 moves the control element 1003 in a second direction generally opposite the first direction.
Several aspects of the present technology are set forth in the following examples.
1. A variable flow shunt for treatment of glaucoma in a human patient, the variable flow shunt comprising:
2. The variable flow shunt of example 1 wherein the outer membrane includes a bladder portion encasing the flow control assembly and an elongated portion at least partially encasing the drainage element.
3. The variable flow shunt of example 2 wherein the bladder portion includes a proximal portion adjacent the elongated portion and a distal portion spaced apart from the elongated portion, and wherein the distal portion includes the plurality of apertures and the proximal portion does not include any of the plurality of apertures.
4. The variable flow shunt of example 2 wherein the bladder portion is generally dome shaped.
5. The variable flow shunt of example 2 wherein the bladder portion includes a generally curved surface and a generally flat surface.
6. The variable flow shunt of example 5 wherein the generally flat surface is textured.
7. The variable flow shunt of example 2 wherein the bladder portion has a height and a width, and wherein the width is greater than the height.
8. The variable flow shunt of any of examples 2 wherein the tubular portion includes a ring configured to reduce and/or prevent axial translation of the shunt when the shunt is implanted in the patient.
10. The variable flow shunt of example 8 wherein the ring is positionable in a region exterior to the anterior chamber.
11. The variable flow shunt of example 1 wherein the outer membrane includes one or more attachment features for securing the shunt to native tissue.
12. The variable flow shunt of example 11 wherein the one or more attachment features include one or more suture holes.
13. The variable flow shunt of example 1 wherein the outer membrane is configured to at least partially reduce a backflow pressure through the drainage element.
14. The variable flow shunt of example 1 wherein the drainage element includes a flow tube.
15. A variable flow shunt for treatment of glaucoma in a human patient, the variable flow shunt comprising:
16. The variable flow shunt of example 15 wherein the outer membrane includes a bladder portion encasing the flow control assembly and an elongated portion at least partially encasing the drainage element.
17. The variable flow shunt of example 16 wherein the bladder portion includes a proximal portion adjacent the elongated portion and a distal portion spaced apart from the elongated portion, and wherein the distal portion includes the plurality of apertures and the proximal portion does not include any of the plurality of apertures.
18. A system for treating glaucoma in a human patient, the system comprising:
19. The system of example 18 wherein the bladder includes a plurality of apertures fluidly coupling an interior of the bladder with an environment external to the bladder.
20. The system of example 18, further comprising a flow control assembly coupled to the shunt and configured to control the flow of fluid through at least one of the inflow portion or the outflow portion.
21. The system of example 20, wherein the flow control assembly is positioned within the bladder and is configured to control the flow of fluid through the outflow portion.
22. The system of example 20 wherein the bladder includes one or more attachment features for securing the shunt to native tissue.
23. The system of example 22 wherein the one or more attachment features include one or more suture holes.
24. The system of example 18 wherein the bladder is generally dome-shaped.
25. The system of example 18 wherein the bladder includes a generally curved surface and a generally flat surface.
26. The system of example 25 wherein the generally flat surface is textured.
27. The system of example 18 wherein the bladder has a height and a width, and wherein the width is greater than the height.
28. A system for treating glaucoma in a human patient, the system comprising:
29. The system of example 28 wherein the flow control assembly includes one or more shape memory actuation elements configured to control the flow of fluid through the inflow portion of the shunt.
30. A variable flow shunt for treatment of glaucoma in a human patient, the variable flow shunt comprising:
31. The variable flow shunt of example 30 wherein the control element is moveable from a first position at least partially blocking the aperture to a second position (a) not blocking the aperture and/or (b) blocking less of the aperture than the first position.
32. The variable flow shunt of example 30 or 31 wherein the control element is moveable from a first position that provides a first level of fluid flow reduction through the aperture and a plurality of second positions that provide increasing levels of fluid flow through the aperture.
33. The variable flow shunt of any one of examples 30-32 wherein the control element is moveable between a first position that provides a first level of fluid flow reduction through the aperture and a plurality of second positions that provide increasing levels of fluid flow reduction through the aperture.
34. The variable flow shunt of any one of examples 30-33 wherein the flow control assembly includes a spring element coupled to the control element, wherein the spring element is configured to move the control element through at least a subset of the plurality of positions.
35. The variable flow shunt of example 34 wherein the spring element is configured to transform from a first shape to a second shape upon application of energy to the spring element.
36. The variable flow shunt of example 34 or example 35 wherein the spring element moves the control element from a first position to a second position upon application of energy to the spring element.
37. The variable flow shunt of example 30 wherein the flow control assembly includes:
38. The variable flow shunt of example 37 wherein the first direction is away from the first anchor and the second direction is away from the second anchor.
39. The variable flow shunt of any one of examples 35-38 wherein the spring element is composed of a shape memory material.
40. The variable flow shunt of any one of examples 35-39 wherein the spring element is nitinol.
41. The variable flow shunt of any of examples 35-40 wherein the energy is light or heat.
42. The variable flow shunt of any one of examples 30-41 wherein the flow control assembly is formed from a flat nitinol sheet.
43. The variable flow shunt of any one of examples 30-42 wherein the outer membrane extends along a length of the flow tube and has a generally circular cross-sectional shape.
44. The variable flow shunt of any one of examples 30-43 wherein the outer membrane has a generally dome-shaped cross-sectional shape.
45. The variable flow shunt of any one of examples 30-44 wherein the elongated flow tube comprises:
46. An adjustable flow shunt for treating glaucoma in a human patient, the shunt comprising:
47. The adjustable flow shunt of example 46 wherein the protective membrane includes a bladder portion surrounding the flow control assembly and a tubular portion surrounding at least a portion of the elongated drainage tube.
48. The adjustable flow shunt of example 46 or example 47 wherein the protective membrane has a circular or oval cross-sectional shape.
49. The adjustable flow shunt of example 46 or example 47 wherein the protective membrane has a generally dome-shaped cross-sectional shape.
50. The adjustable flow shunt of any one of examples 46-49 wherein the elongated drainage tube has an oval cross-sectional shape.
51. The adjustable flow shunt of any one of examples 46-50 wherein the protective membrane has a height and a width, and wherein the width is greater than the height.
52. The adjustable flow shunt of any one of examples 46-51 wherein the protective membrane is substantially flat.
53. The adjustable flow shunt of any one of examples 46-52 wherein the protective membrane is configured to at least partially anchor the adjustable flow shunt in a target position when the adjustable flow shunt is implanted in an eye.
54. A method of treating glaucoma, the method comprising:
55. The method of example 54 wherein non-invasively adjusting the flow of fluid through the shunt comprises applying energy to the shunt.
56. The method of example 55 wherein the energy is light or heat.
57. The method of example 54 wherein the shunt comprises a flow control element composed at least partially of shape-memory material, and wherein non-invasively adjusting a flow of fluid through the shunt comprises transforming the flow control element from a first position to a second position.
58. A method of treating a patient having glaucoma, the method comprising:
59. The method of example 58 wherein selectively adjusting the flow control mechanism comprises non-invasively adjusting the flow control mechanism.
60. The method of example 58 or example 59 wherein selectively adjusting the flow control mechanism comprises applying energy to at least a portion of the flow control mechanism from a source external to the patient.
61. The method of example 60 wherein applying energy causes the flow control mechanism to transition from a first position to a second position.
62. The method of example 61 wherein the first position enables a first rate of fluid flow through the shunt and the second position enables a second rate of fluid flow greater than the first rate through the shunt.
63. The method of example 61 wherein the first position enables a first rate of fluid flow through the shunt and the second position enables a second rate of fluid flow less than the first rate through the shunt.
64. The method of any one of examples 60-63 wherein the energy is heat or light.
65. A method of treating a patient having glaucoma, the method comprising:
66. The method of example 65 wherein axially translating at least a portion of the flow control mechanism comprises applying energy to the shunt.
67. The method of example 66 wherein the energy is light or heat.
68. The method of any one of examples 65-67 wherein the tubular element includes an outflow aperture, and wherein axially translating at least a portion of the flow control mechanism changes the flow of fluid through the outflow aperture. 69. A method of manufacturing an adjustable flow shunt having a shunt and a flow control assembly, the method comprising:
70. The method of example 69 wherein forming the flow control assembly comprises laser cutting the flow control assembly from the sheet of nitinol.
71. The method of example 69 or example 70, further comprising biasing the spring element before attaching the formed flow control assembly to the shunt.
72. A variable flow shunt, comprising:
73. The variable flow shunt of example 1 wherein the outer membrane includes a bladder portion encasing the flow control assembly and an elongated portion at least partially encasing the drainage element.
74. The variable flow shunt of example 73 wherein the bladder portion includes a proximal portion adjacent the elongated portion and a distal portion spaced apart from the elongated portion, and wherein the distal portion includes the plurality of apertures and the proximal portion does not include any of the plurality of apertures.
75. The variable flow shunt of example 73 or 74 wherein the bladder portion is generally dome shaped.
76. The variable flow shunt of any of examples 73-75 wherein the bladder portion includes a generally curved surface and a generally flat surface.
77. The variable flow shunt of example 76 wherein the generally flat surface is textured.
78. The variable flow shunt of any of examples 73-77 wherein the bladder portion has a height and a width, and wherein the width is greater than the height.
79. The variable flow shunt of any of examples 72-77 wherein the tubular portion includes a ring configured to reduce and/or prevent axial translation of the shunt when the shunt is implanted in the patient.
80. The variable flow shunt of example 79 wherein the ring is positionable in a region exterior to the anterior chamber.
81. The variable flow shunt of any of examples 72-80 wherein the outer membrane includes one or more attachment features for securing the shunt to native tissue.
82. The variable flow shunt of example 81 wherein the one or more attachment features include one or more suture holes.
83. The variable flow shunt of any of examples 72-82 wherein the outer membrane is configured to at least partially reduce a backflow pressure through the drainage element.
84. The variable flow shunt of any of examples 72-83 wherein the drainage element includes a flow tube.
85. A variable flow shunt, comprising:
86. The variable flow shunt of example 85 wherein the outer membrane includes a bladder portion encasing the flow control assembly and an elongated portion at least partially encasing the drainage element.
87. The variable flow shunt of example 86 wherein the bladder portion includes a proximal portion adjacent the elongated portion and a distal portion spaced apart from the elongated portion, and wherein the distal portion includes the plurality of apertures and the proximal portion does not include any of the plurality of apertures.
88. A system for treating a medical condition in a patient, the system comprising:
89. The system of example 88 wherein the bladder includes a plurality of apertures fluidly coupling an interior of the bladder with an environment external to the bladder.
90. The system of example 88 or 89, further comprising a flow control assembly coupled to the shunt and configured to control the flow of fluid through at least one of the inflow portion or the outflow portion.
91. The system of example 90, wherein the flow control assembly is positioned within the bladder and is configured to control the flow of fluid through the outflow portion.
92. The system of any of examples 88-91 wherein the bladder includes one or more attachment features for securing the shunt to native tissue.
93. The system of example 92 wherein the one or more attachment features include one or more suture holes.
94. The system of any of examples 88-93 wherein the bladder is generally dome-shaped.
95. The system of any of examples 88-94 wherein the bladder includes a generally curved surface and a generally flat surface.
96. The system of example 95 wherein the generally flat surface is textured.
97. The system of any of examples 88-96 wherein the bladder has a height and a width, and wherein the width is greater than the height.
98. The system of any of examples 88-97 wherein the shunt is configured to be implanted in the patient's eye, and wherein the first body region is an anterior chamber and the second body region is a target outflow location within the patient's eye.
99. A system for treating a medical condition in a patient, the system comprising:
100. The system of example 99 wherein the flow control assembly includes one or more shape memory actuation elements configured to control the flow of fluid through the inflow portion of the shunt.
101. The system of example 100 wherein the shunt is configured to be implanted in the patient's eye, and wherein the first body region is an anterior chamber and the second body region is a target outflow location within the patient's eye.
102. An implantable medical device, comprising:
103. The device of example 102 wherein the bladder includes a plurality of apertures.
104. The device of example 102 or 103 wherein the bladder includes one or more attachment features for anchoring at least a portion of the implantable medical device when the device is implanted in a patient.
The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, any of the features of the adjustable flow shunts described herein may be combined with any of the features of the other adjustable flow shunts described herein and vice versa. Moreover, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.
From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions associated with adjustable flow shunts have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.
Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
The present application claims priority to the following pending applications: U.S. Provisional Patent Application No. 62/913,694, filed Oct. 10, 2019; U.S. Provisional Patent Application No. 62/913,700, filed Oct. 10, 2019; U.S. Provisional Patent Application No. 62/937,676, filed Nov. 19, 2019; and U.S. Provisional Patent Application No. 62/937,680, filed Nov. 19, 2019. All of the foregoing applications are incorporated herein by reference in their entireties. Further, components and features of embodiments disclosed in the applications incorporated by reference may be combined with various components and features disclosed and claimed in the present application.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2020/055144 | 10/9/2020 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62913694 | Oct 2019 | US | |
| 62913700 | Oct 2019 | US | |
| 62937676 | Nov 2019 | US | |
| 62937680 | Nov 2019 | US |
