Adjustable-flow glaucoma shunts, and associated systems and methods

Abstract

To provide adjustable-flow glaucoma shunts, and associated systems and methods.SOLUTION: The present technology is directed to adjustable-flow glaucoma shunts and methods for making and using such devices. In many of the embodiments described herein, the shunts include a generally flat frame. The frame can include an elongated portion having a lumen extending therethrough, and a bladder portion defining an interior chamber that is in fluid communication with the lumen. When implanted in a patient's eye, aqueous humor can be drained from the anterior chamber to a target outflow location via the lumen and interior chamber. In some embodiments, the shunts include a flow control assembly positioned within the interior chamber of the bladder portion to control the flow of aqueous humor through the lumen.SELECTED DRAWING: Figure 4

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATION(S) This application is the sole pending application of the following: U.S. Provisional Patent Application No. 62 / 913,703, filed October 10, 2019; and U.S. Provisional Patent Application No. 62 / 937,667, filed November 19, 2019; claims priority to the

[0002] All of the aforementioned applications are incorporated herein by reference in their entirety. Furthermore, the elements and features of the embodiments disclosed in the applications incorporated by reference may be combined with various elements and features disclosed and claimed in the present application.

[0003] The present technology relates to adjustable flow glaucoma shunts, and methods of making and using such devices. [Background technology]

[0004] Glaucoma is a degenerative condition of the eye involving damage to the optic nerve that can cause progressive and irreversible vision loss. Glaucoma is often associated with ocular hypertension, an elevated intraocular pressure, and can result from increased production of aqueous humor ("aqueous humor") and / or reduced outflow of aqueous humor from within the eye into the bloodstream. Aqueous humor is produced within the ciliary body at the border of the posterior and anterior chambers of the eye. It flows into the anterior chamber and eventually into the venous blood vessels of the eye. Glaucoma is usually caused by a failure in the mechanism that transports aqueous humor out of the eye into the bloodstream.

[0005] 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 has been placed on clearly illustrating the principles of the present technology. Additionally, components may be shown as transparent in certain drawings for clarity of illustration, but this is not intended to imply that the components are necessarily transparent. Additionally, components may be shown in schematic form. Summary of the Invention [Means for solving the problem]

[0006] The present technology is directed to flow-regulating glaucoma shunts, as well as methods of making and using such devices. In many of the embodiments described herein, these shunts include a generally flat outer frame. The frame can include an elongated portion having a lumen through which the lumen extends, and a bladder portion defining an internal chamber in fluid communication with the lumen. When implanted in a patient's eye, aqueous humor can be drained from the anterior chamber to a target outflow location by flowing through the lumen and the internal chamber. In some embodiments, the shunt includes a flow control assembly positioned within the internal chamber of the bladder portion to control the flow of aqueous humor through the lumen.

[0007] As defined above, in some embodiments, the present technology includes a flow control assembly for controlling the flow rate of a fluid through a shunt. The flow control assembly generally includes an anchor element, one or more actuating elements, and a gate element. The anchor element can be designed to reside within a portion of the shunt (e.g., within a chamber formed by a frame). The gate element can include a lever or arm that can at least partially block a portion of the shunt lumen. The actuating element can move the gate element back and forth to selectively block and / or unblock the lumen, thereby decreasing or increasing the flow rate through the shunt.

[0008] The present technology further includes methods of manufacturing the shunts and flow control assemblies described herein. These methods can include manufacturing (e.g., laser cutting) a unitary structure corresponding to the flow control assembly from a single material (e.g., a Nitinol sheet or strip). The unitary structure can include an anchor element, an actuating element, and a gate element. The actuating element can include a first end extending from the gate element and a second end not connected to another portion of the unitary structure. To form the flow control assembly from the unitary structure, the actuating element can be deformed (e.g., prestressed and / or prestrained) to its preferred geometry and the second end of the actuating element can be secured to the anchor. Once formed, the flow control assembly can be coupled to the shunt such that the flow control assembly is configured to at least partially control the flow of fluid through the shunt. The present invention provides, for example, the following: (Item 1) 1. A method of manufacturing an adjustable flow shunt having a shunt and a flow control assembly, comprising: fabricating a structure corresponding to the flow control assembly from a single material, the structure including an anchor element, an actuation element, and a gate element, the actuation element including a first end extending from the gate element and a second end not connected to another portion of the structure; securing the second end of the actuation element to the anchor element to form the flow control assembly; coupling the assembled flow control assembly to the shunt such that the flow control assembly is configured to at least partially control a flow of fluid through the shunt; A method comprising: (Item 2) 2. The method of claim 1, wherein the anchor element includes a notch, and wherein securing the second end of the actuation element to the anchor element includes positioning the second end of the actuation element within the notch. (Item 3) Item 13. The method of item 1, wherein fixing the second end of the actuation element to the anchor element comprises welding or affixing the second end of the actuation element to the anchor element. (Item 4) 2. The method of claim 1, wherein fixing the second end of the actuation element to the anchor element comprises at least partially deforming the actuation element relative to its manufactured geometry. (Item 5) 5. The method of claim 4, wherein at least partially deforming the actuating element relative to its manufacturing geometry comprises prestressing and / or prestraining the actuating element. (Item 6) 5. The method of claim 4, wherein at least partially deforming the actuation element comprises compressing the actuation element. (Item 7) 5. The method of claim 4, wherein at least partially deforming the actuation element comprises lengthening the actuation element. (Item 8) 2. The method of claim 1, wherein fabricating the structure corresponding to the flow control assembly from the single material comprises laser cutting the structure from the single material. (Item 9) 2. The method of claim 1, wherein the single material is a Nitinol sheet and / or a Nitinol strip. (Item 10) 2. The method of claim 1, wherein the actuating element is a first actuating element and the structure further comprises a second actuating element, the second actuating element including, after the manufacturing step, a first end coupled to the anchor element and a second end coupled to the gate element. (Item 11) Item 11. The method of item 10, wherein fixing the second end of the first actuating element to the anchor element includes at least partially deforming both the first actuating element and the second actuating element relative to their manufacturing geometries. (Item 12) 2. The method of claim 1, further comprising biasing the actuation element prior to coupling the assembled flow control assembly to the shunt. (Item 13) 2. The method of claim 1, wherein coupling the assembled flow control assembly to the shunt includes positioning the flow control assembly within a frame. (Item 14) 1. A method of manufacturing a flow control assembly for use in an implantable medical device, comprising: cutting a unitary structure corresponding to the flow control assembly from a Nitinol sheet and / or Nitinol strip, the unitary structure including an anchor element, one or more actuating elements, and a gating element, the actuating elements having a first geometry when cut from the Nitinol sheet and / or Nitinol strip; securing a free end of the actuating element to the anchor element to form the flow control assembly, wherein securing the free end of the actuating element to the anchor element deforms the actuating element such that it has a second geometry that is different from the first geometry; and A method comprising: (Item 15) Item 15. The method of item 14, wherein fixing the free end of the working element to the anchor element comprises compressing the working element. (Item 16) Item 15. The method of item 14, wherein fixing the free end of the working element to the anchor element comprises lengthening the working element. (Item 17) Item 15. The method of item 14, wherein the first geometry has a longer length than the second geometry. (Item 18) Item 15. The method of item 14, wherein the first geometry has a shorter length than the second geometry. (Item 19) Item 15. The method of item 14, wherein the actuating element is a first actuating element, and the unitary structure further includes a second actuating element, the second actuating element having a third geometry when cut from the Nitinol sheet and / or the Nitinol strip. (Item 20) 20. The method of claim 19, wherein the third geometry is different from the first geometry. (Item 21) 20. The method of claim 19, wherein the third geometry is the same as the first geometry. (Item 22) 20. The method of claim 19, wherein fixing the free end of the actuation element to the anchor element at least partially deforms the second actuation element such that it has a fourth geometry that is different from the third geometry. (Item 23) 23. The method of claim 22, wherein the fourth geometry is different from the second geometry. (Item 24) 23. The method of claim 22, wherein the fourth geometry is the same as the second geometry. (Item 23) 1. A method of manufacturing a flow control assembly for use in an implantable medical device, comprising: manufacturing a unitary structure corresponding to a flow control assembly, the unitary structure including an anchor element, one or more actuation elements, and a gate element, the actuation elements having a first geometry when manufactured; securing a free end of the actuating element to the anchor element to form the flow control assembly, wherein securing the free end of the actuating element to the anchor element deforms the actuating element such that it has a second geometry that is different from the first geometry; and A method comprising: (Item 24) 24. The method of claim 23, wherein fixing the free end of the working element to the anchor element comprises pre-stressing and / or pre-straining the working element. (Item 25) 24. The method of claim 23, wherein fixing the free end of the working element to the anchor element comprises compressing the working element. (Item 26) 24. The method of claim 23, wherein fixing the free end of the working element to the anchor element comprises lengthening the working element. (Item 27) 24. The method of claim 23, wherein the actuating element is a first actuating element, and the unitary structure further includes a second actuating element, the second actuating element having a third geometry when manufactured. (Item 28) 28. The method of claim 27, wherein fixing the free end of the actuation element to the anchor element at least partially deforms the second actuation element such that it has a fourth geometry that is different from the third geometry. (Item 29) 1. An adjustable flow shunt for treating glaucoma in a patient, comprising: an elongated portion having a lumen extending therethrough; and a bladder portion defining an interior chamber, the lumen being fluidly coupled to the interior chamber through an aperture; a frame having a generally flat profile, a flow control assembly positioned within the internal chamber, a gating element, the gating element being transitionable between a first position in which the gating element at least partially blocks the aperture and a second position in which the gating element does not block the aperture and / or blocks less of the aperture than the first position; and an actuation element operably coupled to the gating element, the actuation element being comprised of a shape memory material and configured to transition the gating element from the first position, to and / or toward the second position; a flow control assembly including: Including, adjustable flow shunts. (Item 30) 30. The flow adjustable shunt of item 29, wherein the actuating element is a first actuating element and the flow control assembly further includes a second actuating element, the second actuating element being constructed from a shape memory material and configured to transition the gate element from the second position to and / or toward the first position. (Item 31) 30. The flow control assembly of claim 29, further comprising an anchor element designed to secure the flow control assembly within the internal chamber by fitting along a portion of the internal chamber. (Item 32) 32. The flow adjustable shunt of claim 31, wherein the actuation element, the gate element, and the anchor element form a unitary structure formed from a single sheet of material. (Item 33) 30. The flow adjustable shunt of item 29, wherein the lumen has a rectangular cross-sectional shape. (Item 34) 30. The flow adjustable shunt of item 29, wherein the frame has a longitudinal cross-sectional dimension of less than about 100 μm. (Item 35) 30. The flow adjustable shunt of item 29, wherein the frame has a longitudinal cross-sectional dimension of less than about 80 μm. (Item 36) 30. The flow adjustable shunt of item 29, wherein the frame has a longitudinal cross-sectional dimension of less than about 60 μm. (Item 37) 30. The flow adjustable shunt of item 29, wherein the bladder portion includes a first longitudinal axis extending therethrough and the elongated portion includes a second longitudinal axis extending therethrough, the first longitudinal axis not parallel to the second longitudinal axis. (Item 38) Item 38. The adjustable flow shunt of item 37, wherein the first longitudinal axis and the second longitudinal axis form an angle between about 90 degrees and about 180 degrees. (Item 39) 30. The flow adjustable shunt of claim 29, wherein the flow control assembly is constructed at least in part from Nitinol. (Item 40) 30. The flow adjustable shunt of item 29, wherein the bladder portion comprises a plurality of holes. [Brief description of the drawings]

[0009] [Figure 1] A is a simplified frontal view of an implantable shunt and eye E, and B is an isometric view of the optic vesicle of A. [Figure 2A] 1 illustrates an adjustable flow glaucoma shunt constructed in accordance with selected embodiments of the present technology. [Figure 2B] 1 illustrates an adjustable flow glaucoma shunt constructed in accordance with selected embodiments of the present technology. [Figure 2C] 1 illustrates an adjustable flow glaucoma shunt constructed in accordance with selected embodiments of the present technology. [Figure 2D] 1 illustrates an adjustable flow glaucoma shunt constructed in accordance with selected embodiments of the present technology. [Figure 2E] 1 illustrates an adjustable flow glaucoma shunt constructed in accordance with selected embodiments of the present technology. [Figure 3A] 1 illustrates another adjustable flow glaucoma shunt constructed in accordance with selected embodiments of the present technology. [Figure 3B] 1 illustrates another adjustable flow glaucoma shunt constructed in accordance with selected embodiments of the present technology. [Figure 3C]1 illustrates another adjustable flow glaucoma shunt constructed in accordance with selected embodiments of the present technology. [Figure 3D] 1 illustrates another adjustable flow glaucoma shunt constructed in accordance with selected embodiments of the present technology. [Figure 4] 1A and 1B show various stages of a flow control assembly during manufacture of an adjustable flow glaucoma shunt constructed in accordance with selected embodiments of the present technology. [Figure 5A] 1 illustrates a flow control assembly constructed in accordance with an embodiment of the present technology. [Figure 5B] 1 illustrates a flow control assembly constructed in accordance with an embodiment of the present technology. [Figure 5C] 1 illustrates a flow control assembly constructed in accordance with an embodiment of the present technology. [Figure 5D] 1 illustrates a flow control assembly constructed in accordance with an embodiment of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Specific details of various embodiments of the present technology are described below with reference to Figures 1A-5D. Although many embodiments are described below with respect to flow-adjustable glaucoma shunts and related methods, other embodiments are within the scope of the present technology. Additionally, other embodiments of the present technology can have configurations, components, and / or procedures that differ from those described herein. For example, shunts constructed in accordance with the present technology may include additional elements and features beyond those described herein, or other embodiments may not include some of the elements and features shown and described herein. Additionally, while use of the term "shunt" generally refers to the entire device described herein, in some aspects the terms "shunt" and "tube" are used interchangeably.

[0011] Throughout this specification, reference 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 technology. Thus, the appearances of the phrase "in one embodiment" or "in an embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0012] Throughout this specification, references to relative terms such as, for example, "generally," "approximately," and "about" are used herein to mean plus or minus 10% of the stated value.

[0013] While certain embodiments herein are described in terms of shunting fluid from the anterior chamber of the eye, those skilled in the art will appreciate that the technology can be readily adapted to shunt fluid from and / or between other portions of the eye, or more generally, between a first body region and a second body region. Additionally, while certain embodiments herein are described in terms of treating glaucoma, any of the embodiments herein, including those referred to as "glaucoma shunts" or "glaucoma devices," can 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 elevated pressure and / or fluid accumulation, 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, etc. Additionally, while generally described in terms of shunting aqueous humor, the systems described herein may be equally applied to shunt other fluids, such as blood or cerebrospinal fluid, between a first body region and a second body region.

[0014] The headings provided herein are for convenience only and do not interpret the scope or meaning of the technology claimed herein.

[0015] A. Implantable shunts for treating glaucoma Glaucoma refers to a group of eye diseases associated with damage to the optic nerve, ultimately causing vision loss and blindness. As mentioned above, glaucoma is a degenerative condition of the eye characterized by increased pressure within the eye due to an increase in aqueous humor production within the eye and / or a decrease in the outflow of aqueous humor from the eye into the bloodstream. The increased pressure damages the optic nerve over time. Unfortunately, patients often do not experience symptoms of increased intraocular pressure until the onset of glaucoma. Therefore, even though patients usually do not have symptoms, they must be monitored when the increased pressure becomes evident. Monitoring continues throughout the course of the disease, allowing clinicians to intervene early to halt the progression of the disease. Pressure monitoring requires patients to visit the clinic regularly, which is costly, time-consuming, and inconvenient. Early stages of glaucoma are usually treated with drugs (e.g., eye drops) and / or laser therapy. However, when drug / laser therapy becomes insufficient, a surgical approach can be used. Surgical or minimally invasive approaches first attempt to increase the outflow of aqueous humor from the anterior chamber into the bloodstream, either by creating an alternative pathway for aqueous outflow or by dilating the natural pathway.

[0016] 1A and 1B show a human eye E and suitable location(s) where a shunt may be implanted within the eye E, in accordance with an embodiment of the present technology. More specifically, FIG. 1A is a simplified front view of the eye E in which a shunt 100 has been implanted, and FIG. 1B is an isometric view of the eye E and shunt 100 of FIG. 1A. Referring initially to FIG. 1A, the eye E includes a number of muscles that control its movement, including the superior rectus muscle SR, the inferior rectus muscle IR, the lateral rectus muscle LR, the medial rectus muscle MR, the superior oblique muscle SO, and the inferior oblique muscle IO. The eye E also includes an iris, a pupil, and a limbus.

[0017] 1A and 1B together, the shunt 100 can include a drainage element 105 (e.g., a drainage tube) that can be positioned to position the inflow portion 101 within the anterior chamber of the eye E and the outflow portion 102 at a different location within the eye E, such as the bleb space. The shunt 100 can be implanted in a variety of orientations. For example, when implanted, the drainage element 105 may extend superiorly, inferiorly, inwardly, and / or outwardly from the anterior chamber. Depending on the design of the shunt 100, the outflow portion 102 can be positioned at a number of different suitable outflow locations (e.g., between the choroid and the sclera, between the conjunctiva and the sclera, etc.).

[0018] Outflow resistance can change over time for a variety of reasons, such as after the implantation procedure of a shunt (e.g., shunt 100) or after further blockages in the drainage network from the anterior chamber, through the trabecular meshwork, Schlemm's canal, collector channels, and ultimately into the veins and the body's circulatory system, as the outflow location undergoes its healing process. As a result, a clinician may wish 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 the time of implantation to temporarily increase its outflow resistance. After a period of time deemed sufficient to allow for tissue healing and stabilization of outflow resistance, the modification to the shunt is reversed, thereby decreasing the outflow resistance. In another example, a clinician may monitor intraocular pressure after implanting a shunt and then determine that a modification of the outflow rate through the shunt is desirable. Such modifications may be invasive, time-consuming, and / or costly for the patient. However, if such procedures are not followed, there is an increased likelihood of hypotony (too low intraocular pressure), which may result in further complications including damage to the optic nerve. In contrast, intraocular shunt systems configured in accordance with embodiments of the present technology allow clinicians to selectively adjust the flow rate of fluid through the shunt after implantation, without additional invasive surgical procedures.

[0019] The shunts described herein can be implanted to have a first output and then remotely adjusted to reach a second output. This adjustment can be based on the needs of the individual patient. For example, the shunt can be implanted at a lower first flow rate and then adjusted to a higher second flow rate if clinically necessary. The shunts described herein can be delivered using either ab interno or ab externo implantation techniques and can be delivered via a needle. The needle can have a variety of shapes and configurations to accommodate the various shapes of the shunts described herein. For example, in some embodiments, the needle can be hinged to facilitate implantation through the sclera. Details of the implantation procedure, implantation device, and bleb formation are described in more detail in International Patent Application No. PCT / US20 / 41152, entitled "MINIMALLY INVASIVE BLEB FORMATION DEVICES AND METHODS FOR USING SUCH DEVICES," filed July 8, 2020, the disclosure of which is incorporated herein by reference for all purposes.

[0020] In many embodiments described herein, the flow control assembly is configured to incorporate features that selectively impede or attenuate the flow of fluid through the shunt during operation. In this manner, the flow control assembly can gradually or continuously vary the resistance to flow through the shunt to selectively regulate pressure and / or flow. Thus, a flow control assembly configured in accordance with the present technology can adjust the level of interference or compression between several different locations to accommodate a number of variables (e.g., IOP, aqueous humor production, natural aqueous humor outflow resistance, and / or natural aqueous humor outflow) to precisely regulate the flow rate through the shunt.

[0021] The disclosed flow control assemblies can be operated using energy. This feature allows such devices to be implanted in a patient and then changed / adjusted over time without further invasive surgery or procedures on the patient. Furthermore, because the devices disclosed herein can be actuated by energy, such devices do not require any additional power to maintain a desired orientation or position. Rather, the actuators / flow resistors disclosed herein can maintain a desired position / orientation without power. This can significantly extend the usable life of such devices, allowing such devices to be effective long after the initial implantation procedure.

[0022] B. Selected Embodiments of Adjustable Flow Glaucoma Shunts As defined above, the present technology is directed to flow-adjustable glaucoma shunts. Figures 2A-2E show a flow-adjustable shunt 200 ("shunt 200") configured in accordance with selected embodiments of the present technology. Referring initially to Figures 2A and 2B, which are an isometric view and a top view, respectively, of the shunt 200, the shunt 200 includes a frame 210 (which may also be referred to as a "body element," a "drainage element," or a "shunt element") having an elongated portion 212 and a bladder portion 214. The bladder portion 214 may define an interior chamber 216 for housing various components of the shunt 200, which will be described below. A lumen 206 may extend through the elongated portion 212 and be fluidly coupled to the interior chamber 216 of the bladder portion 214. The lumen 206 may have a circular, oval, rectangular, or other cross-sectional shape. In some embodiments, for example, the lumen 206 has a rectangular cross-section that minimizes the dimensions (e.g., height, width, diameter, etc.) of the elongated portion 212. The elongated portion 212 can have a cross-sectional shape that fits the lumen 206 (e.g., rectangular). In some embodiments, the elongated portion 212 defines the lumen 206. In other embodiments, a flow tube (not shown) is positioned within the elongated portion 212 to form the lumen 206. Although the frame 210 is shown as being transparent in Figures 2A and 2B so that the internal components of the shunt 200 can be depicted, the frame 210 need not be transparent and can substantially encase portions of the shunt, as will be described in more detail with respect to Figures 2D and 2E.

[0023] In some embodiments, at least a portion of the elongated portion 212 is configured for placement within the anterior chamber of the eye in a region outside the optical field of the eye, and the bladder portion 214 is configured for placement within a desired outflow location, such as the subconjunctival bleb space. In such embodiments, aqueous humor can flow out of the anterior chamber and into the lumen 206 via the first (e.g., inflow) port 207. The aqueous humor can then flow through the lumen 206 into the internal chamber 216. Once in the internal chamber 216, the aqueous humor may be drained into a desired outflow location via the second (e.g., outflow) port 208. In other embodiments, the orientation of the shunt 200 can be reversed when implanted, such that the bladder portion 214 is positioned within the anterior chamber and the first port 207 of the elongated portion 212 is positioned within the desired outflow location. In such embodiments, the aqueous humor flows in the opposite direction to that described above, entering the shunt 200 through the second port 208 at the internal chamber 216, flowing through the lumen 206, and exiting through the first port 207 into the desired outflow location.

[0024] In some embodiments, the shunt 200 has a generally flat profile (e.g., as defined by the frame 210). For example, the frame 210 (elongated portion 212, bladder portion 214, or both elongated portion 212 and bladder portion 214) can have a longitudinal cross-sectional dimension (e.g., height, width, diameter, etc.) 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. In some embodiments, the use of a rectangular or oval lumen 206 (as opposed to a circular lumen) can help reduce one or more dimensions of the shunt 200 without substantially affecting the therapy provided by the shunt 200. Without being limited by theory, reducing one or more dimensions of the shunt 200 can help reduce and / or minimize damage to the eye during and after implantation of the shunt 200 within the eye, which in turn can shorten recovery time after the implantation procedure and / or reduce side effects associated with the shunt. Additionally, the "L" shape of the overall shape of the shunt 200 can help anchor the shunt in place and prevent undesired migration of the shunt 200, despite its relatively small profile.

[0025] The shunt 200 further includes a flow control assembly 220 (also referred to herein as an "actuation assembly") positioned within the internal chamber 216. The flow control assembly 220 may include an anchor 221, one or more actuation elements 222, and a lever or gate element 225. As described in more detail below with reference to FIG. 2C, the flow control assembly 220 is configured to control the flow of fluid through the lumen 206 by selectively blocking and / or unblocking a portion of the lumen 206 that is in fluid communication with the internal chamber 216.

[0026] FIG. 2C is an enlarged view of the flow control assembly 220 depicted in isolation, with other features of the shunt 200 (FIGS. 2A and 2B) omitted for purposes of illustration. As described above, the flow control assembly 220 includes an anchor 221, an actuating element 222 (shown as a first actuating element 222a and a second actuating element 222b, collectively referred to as "actuating elements 222"), and a gate element 225. The anchor 221 is configured to secure the flow control assembly 220 at a desired position within the internal chamber 216. For example, the anchor 221 can be along a portion of the internal chamber 216. In other embodiments, the anchor 221 can otherwise secure the flow control assembly 220 to the frame 210. The anchor 221 can also provide an anchor element for the actuating element 222. For example, the anchor 221 can include a first anchor element 223a and a second anchor element 223b extending from a body portion 223c of the anchor 221. Anchor elements 223a and 223b can be integral with body portion 223c or can be separate components that are otherwise secured to body portion 223c. Anchor elements 223a-223c remain generally stationary during operation of actuation element 222, described below.

[0027] Gate element 225 includes a first portion 227 (e.g., an "arm") positioned between first actuation element 222a and second actuation element 222b, and a second portion 226 spaced from first portion 225. Second portion 226 can be configured to at least partially block lumen 206 and / or an aperture or orifice in lumen 206 (and thus at least partially block fluid from exiting lumen 206 and entering interior chamber 216), in certain configurations, such as those shown in FIGS. 2A and 2B. Thus, second portion 226 can also be referred to as a "blocking feature" or a "flow control element." Gate element 225 can have a generally elbow or "L" shape, although other configurations are possible.

[0028] The first actuating element 222a extends between the first anchor element 223a and the first portion 227 of the gate element 225. The second actuating element 222b extends between the second anchor element 223b and the first portion 227 of the gate element 225. The actuating element 222 is configured to move the gate element 225 between a plurality of positions that control a flow rate of fluid through the shunt 200. For example, the first actuating element 222a and the second actuating element 222b can be composed of a shape memory material, such as a shape memory alloy (e.g., Nitinol). Thus, the first actuating element 222a and the second actuating element 222b can be transitionable at least between a phase or state of a first material (e.g., a martensite state, an R-phase, a composite state between martensite and R-phase, etc.) and a phase or state of a second material (e.g., an austenite state, an R-phase state, a composite state between austenite and R-phase, etc.). In the first material state, the first and second actuating elements 222a and 222b may be deformable (e.g., plastic, malleable, compressible, expansive, etc.). In the second material state, the first and second actuating elements 222a and 222b may have a preference for a specific preferred geometry (e.g., original geometry, manufacturing geometry, temperature set geometry, etc.). The first and second actuating elements 222a and 222b may be transitioned between the first and second material states by applying energy (e.g., heat) to the actuating elements to heat them above a transition temperature. Energy may be applied to the actuating elements via an energy source (e.g., laser) positioned outside the body, RF heating, resistive heating, etc. In some embodiments, the transition temperature of both the first and second actuating elements 222a and 222b is greater than average body temperature (e.g., average temperature within the eye). Thus, both the first and second actuating elements 222a, 222b are generally in a deformable first state when the shunt 200 is implanted within the body until they are actuated.If an actuating element (e.g., first actuating element 222a) is deformed relative to its preferred geometry while in a first state, heating the actuating element (e.g., first actuating element 222a) above its transition temperature causes the actuating element to move from the deformed shape to and / or toward its preferred geometry by transitioning to a second state. In some embodiments, the first actuating element 222a can be selectively heated independently of the second actuating element 222b, and the second actuating element 222b can be selectively heated independently of the first actuating element 222a.

[0029] The first actuating element 222a and the second actuating element 222b generally act in opposition. For example, if the second actuating element 222b is deformed relative to its preferred geometry, then actuation of the second actuating element 222b (e.g., heating the second actuating element 222b above its transition temperature) causes the second actuating element 222b to move toward its preferred geometry. This causes a corresponding deformation in the first actuating element 222a, which remains in its first material state and is therefore generally malleable. For example, in the illustrated embodiment, the second actuating element 222b is compressed (e.g., shortened) relative to its preferred geometry. When the second actuating element 222b is heated above its transition temperature, the second actuating element 222b straightens (e.g., lengthens, expands, etc.) and moves toward its preferred geometry. Compression of the first actuating element 222a (which is not heated and is therefore in a generally malleable first state) causes the second actuating element 222b to change shape because the second anchor element 223b does not move when the second actuating element 222b changes shape. This also causes the first portion 227 of the gate element 225 to move toward the first anchor element 223a, so that the second portion 226 of the gate element 225 unblocks and / or further unblocks the lumen 206. This can increase the flow rate through the lumen 206. This action can be reversed by heating the first actuating element 222a above its transition temperature, so that the first actuating element moves (e.g., expands) toward its preferred geometry, so that the first portion 227 of the gate element 225 moves back toward the second anchor element 223b and the second portion 226 of the gate element 225 moves back to the blocking position. This can decrease the flow rate through the lumen 206. Thus, first actuating element 222a and second actuating element 222b can be selectively and independently actuated to further block or unblock lumen 206 to vary the flow rate of fluid therethrough.In some embodiments, the gating element 225 can be moved to any number of positions between fully blocking and fully unblocking the lumen 206, and the flow control assembly 220 can be selectively adjusted to provide a variety of different levels of outflow resistance after placement within the eye (e.g., via non-invasive energy) by gradually adjusting the gating element 225 relative to the lumen 206. Additional details regarding the operation of flow control mechanisms generally similar to flow control mechanism 220 are described below in section D with reference to Figures 5A-5D.

[0030] 2D and 2E show a cover 240 encasing the shunt 200. In some embodiments, the cover 240 is a thin protective membrane that surrounds the frame 210. In other embodiments, the cover 240 is simply the exterior surface of the frame 210. In embodiments in which the cover 240 is different from the frame 210, the cover 240 includes an elongated portion 242 that corresponds to the elongated portion 212 of the frame 210. The cover 240 also includes a bladder portion 244 that corresponds to the bladder portion 214 of the frame 210. With reference to FIG. 2D, a first end (e.g., a proximal end) of the cover 240 has an opening 241 that aligns with the first port 207 to provide fluid access to the lumen 206. As shown, the opening 241 can be rectangular to fit the cross-section of the lumen 206. 2E, a second end (e.g., the distal end) of the cover 240 has an opening 245 that aligns with the second port 208 to allow fluid to exit the shunt 200. In embodiments where the bladder portion 244 is positioned in a desired exit location (e.g., the bleb space), the opening 245 directs fluid away from the eye, ensuring that any growth in the bleb due to the exit of fluid occurs in a direction away from the eye.

[0031] 3A-3D illustrate an adjustable flow shunt 300 ("shunt 300") configured in accordance with selected embodiments of the present technology. In particular, FIG. 3A is an isometric view of the shunt 300, FIG. 3B is a top view of the shunt 300, FIG. 3C is a close-up view of a flow control assembly 320 of the shunt 300, and FIG. 3D is an isometric view of a frame 310 of the shunt 300. The shunt 300 can be similar to the shunt 200. For example, with reference to FIGS. 3A and 3B, the shunt 300 includes a frame 310 having an elongated portion 312 and a bladder portion 314. The bladder portion 314 defines an interior chamber 316. A lumen 306 extends through the elongated portion 312 and is fluidly coupled to the interior chamber 316. The shunt 300 further includes a flow control assembly 320, which includes an anchor 321, an actuating element 322, and a gate element 325. With reference to FIG. 3C, the anchor 321 can include a first anchor element 323a, a second anchor element 323b, and a base 323c. The gate element 325 can include a first portion 327 and a second portion 326. The actuating element 322 can include a first actuating element 322a extending between the first anchor element 323a and the first portion 327 of the gate element 325, and a second actuating element 322b extending between the second anchor element 232b and the first portion 327 of the gate element 325. The shunt 300, including the flow control assembly 320, can operate in a manner similar to the shunt 200 described above with respect to FIGS. 2A-2D. Accordingly, the following description of the shunt 300 will focus on features of the shunt 300 that are different from the shunt 200. However, one of ordinary skill in the art will understand that descriptions of like features of shunt 200 apply to like features of shunt 300 .

[0032] 3B, the frame 310 can be angled. For example, the longitudinal axis A of the elongated portion 312 can be non-parallel to the longitudinal axis B of the bladder portion. For example, the longitudinal axis A and the longitudinal axis B can form an angle θ between about 90 degrees and about 180 degrees, e.g., about 95 degrees, about 100 degrees, about 105 degrees, about 110 degrees, about 115 degrees, about 120 degrees, about 125 degrees, about 130 degrees, about 135 degrees, about 140 degrees, about 145 degrees, about 150 degrees, about 155 degrees, about 160 degrees, about 165 degrees, about 170 degrees, or about 175 degrees. In some embodiments, the angled or non-linear configuration of the frame 310 is expected to aid in securing the shunt 300 in a desired position. For example, the bend formed by the bladder portion 314 and the elongated portion 312 can act as a wedge to help prevent and / or reduce axial or lateral migration of the shunt 300.

[0033] 3D, which shows the frame 310 with the flow control assembly 320 (FIG. 2C) omitted for purposes of illustration, the frame 310 can also include a plurality of apertures 345 configured to fluidly couple the interior chamber 316 to an environment external to the bladder portion 314. For example, when implanted in the eye, the bladder portion 314 can be positioned within a target outflow location, with the apertures 345 allowing aqueous humor to drain through the shunt 300, exit the interior chamber 316, and flow into the bleb space. In some embodiments, the plurality of apertures 345 are positioned only on the medial and / or distal portions of the bladder portion 314 (relative to the elongated portion 312), with no apertures positioned on the proximal portion of the bladder portion 314 adjacent the elongated portion 312. Such a configuration directs aqueous humor to drain and away from the eye through the apertures 345, ensuring that any growth within the drainage bleb is also directed away from the eye. Additionally, having multiple apertures 345 allows for continued drainage of aqueous humor even if one of the apertures 345 becomes blocked by tissue ingrowth or clotting. The multiple apertures 345 can be in addition to or in place of a primary outflow drainage port. As described above with respect to Figures 2C and 2D, the shunt 300 can further include a cover and / or the exterior surface of the frame can include a material suitable for exposure to tissue. If the shunt 300 has a cover, the cover can include multiple holes configured to align with the multiple apertures 345.

[0034] As one skilled in the art will appreciate, adjustable shunts constructed in accordance with the present technology can include any combination of the above features and are not limited to the specific embodiments shown herein. For example, while the elongated portion is depicted as intersecting the bladder portion at a proximal corner of the bladder portion, the elongated portion can instead intersect the bladder portion at the center or other area of ​​the bladder portion. Similarly, the various components of the flow control assemblies described herein, such as the anchors, actuation elements, and gating elements, can take on any number of configurations without departing from the scope of the present technology.

[0035] Although the shunts discussed above have been primarily described as having a flow control assembly positioned at or adjacent to the outflow end of the shunt, the flow control assemblies described herein can be positioned at other locations along the length of the shunt. For example, the flow control assembly can be positioned near the proximal (e.g., inflow) end of the shunt and / or in the anterior chamber. Thus, the shunts described above in Figures 2A-3D can be oriented in multiple directions depending on the desired placement (e.g., the shunt can be implanted with the flow control assembly proximate to the anterior chamber or proximate to the desired outflow location). In some embodiments, placing the flow control assembly 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 where the flow control assembly is positioned in the anterior chamber, the bladder portion of the outer membrane can also be positioned in the anterior chamber. When positioned in the anterior chamber, the bladder portion can serve several functions similar to those described above. For example, the bladder portion can protect the flow control assembly and / or anchor the shunt. Where a bladder portion is positioned about the flow control assembly in the anterior chamber, the shunts described herein can optionally have a second bladder surrounding the outflow end of the shunt, which can reduce backflow pressure through the shunt and / or help prevent tissue ingrowth at a bleb or other desired outflow location.

[0036] C. Method of Manufacturing a Flow Control Assembly with a Shape Memory Actuation Element Additionally, aspects of the present technology are directed to methods of manufacturing the devices described herein. As described herein, selected embodiments of the present technology include flow control assemblies (e.g., flow control assemblies 220 and 320 of shunts 200 and 300, respectively) that are at least partially constructed from a shape memory material such as Nitinol. To manufacture such Nitinol-based flow control assemblies, the desired shape of the flow control assembly can be manufactured (e.g., cut, such as laser cut) from a piece of Nitinol (a Nitinol sheet, a Nitinol strip, etc.). In some embodiments, the flow control assembly can be manufactured from a single piece of Nitinol.

[0037] 4A and 4B illustrate various stages of manufacture of a flow control assembly 420 (which may also be referred to herein as an "actuation assembly") manufactured from a single Nitinol or other suitable material (e.g., a sheet or strip thereof) in accordance with selected embodiments of the present technology. More specifically, FIG. 4A illustrates a structure corresponding to the flow control assembly 420 after it has been cut from a Nitinol sheet (e.g., an "as manufactured" or "cut" configuration), and FIG. 4B illustrates the flow control assembly 420 after it has been manipulated into an operating position (e.g., an "assembled" or "operating" configuration). As described below, in at least some embodiments, the flow control assembly is manufactured as a unitary structure from a single material. The flow control assembly 420 may include features generally similar to those described above with respect to the flow control assemblies 220 and 320. For example, the flow control assembly 420 may include an anchor 421 having anchor elements 423a and 423b. The flow control assembly 420 may also include actuation elements 422a and 422b, as well as a gate element 425. As described above, the gate element 425 can include a first portion 427 and a second portion 426. In the illustrated embodiment, the flow control assembly 420 further includes a notch 428 in the first anchor element 423a.

[0038] 4A, the illustrated embodiment shows the flow control assembly in its manufactured configuration before being formed into an operating configuration. As described above with respect to FIGS. 2C and 3C, the first actuating element 422a has a first end coupled to the arm 427 and a second end spaced apart from the arm 427. In the manufactured configuration, the second end of the first actuating element 422a is free (i.e., the second end is not secured to the anchor 421 and / or the first anchor element 423a) and both the first actuating element 422a and the second actuating element 422b are in their preferred geometries (e.g., their original geometries, manufactured geometries). In some embodiments, the first actuating element 422a and the second actuating element 422b can have the same preferred geometry. In other embodiments, the first actuating element 422a and the second actuating element 422b can have different preferred geometries.

[0039] The manufactured configuration can be converted to an operational configuration by securing the second end (i.e., the free end) of the first actuating element 422a to the anchor 421 and / or the first anchor element 423a. The process of securing the free end of the first actuating element 422a to the first anchor element 423a deforms the first actuating element 422a and / or the second actuating element 422b to its preferred geometry (thereby "prestraining" and / or "prestressing" the first actuating element 422a and / or the second actuating element 422b). For example, in the embodiment shown in FIG. 4B, the first actuating element 422a and the second actuating element 422b can be bent or otherwise compressed such that the second end of the first actuating element 422a is positioned within the notch 428 of the first anchor element 423a to secure the flow control assembly 420 in the operational configuration. Thus, the first actuating element 422a and / or the second actuating element 422b are at least partially bent, compressed, or otherwise deformed relative to their preferred geometry (shown in FIG. 4A ) when they are placed in the operating configuration. In the operating configuration, the first actuating element 422a can exert a generally outward and / or upward force on the first anchor element 423a to ensure that the first actuating element 422a remains within the notch 428 and the flow control assembly 420 remains in the operating configuration. In some embodiments, the first actuating element 422a can be secured to the first anchor element 423a by other means in addition to or in lieu of the outward and / or upward force generated by the first actuating element 422a. For example, the first actuating element 422a can be welded, affixed, or otherwise secured to the first anchor element 423a.

[0040] In some embodiments, the first actuating element 422a and / or the second actuating element 422b are stretched or otherwise lengthened when placing the flow control assembly 420 in the operating configuration. For example, in some embodiments, the first anchor element 423a may be spaced apart from the second anchor element 423b by a length that is greater than the combined length of the first actuating element 422a and the second actuating element 422b in the manufactured configuration. Thus, to transition the flow control assembly 420 to the operating configuration, the first actuating element 422a and / or the second actuating element 422b may be stretched or lengthened relative to their preferred geometry. Once stretched, the first actuating element 422a may be secured (e.g., via welding, affixing, or other suitable technique) to the first anchor element 423a such that the flow control assembly 420 may be held in the operating configuration.

[0041] Once in an operational configuration, the flow control element 420 can be positioned within the shunt (e.g., inserted into an internal chamber, such as internal chambers 216 or 316 described above with respect to shunts 200 and 300, respectively). In some embodiments, the geometry / topography of the anchor 421 conforms to a portion of the internal chamber such that the flow control assembly 421 is automatically anchored in place when positioned within the internal chamber. Alternatively, or in addition, the flow control assembly 420 can be secured to the shunt using other anchoring techniques that do not substantially interfere with the operation of the shunt. Once positioned within the shunt, the flow control assembly 420 can be operated as described below in section D with respect to FIGS. 5A-5D.

[0042] In some embodiments, the first actuating element 422a and / or the second actuating element 422b are optionally biased after placing the flow control assembly in an operating configuration. For example, the first actuating element 422a can be manipulated (e.g., using energy) to have a different length than the second actuating element 422b. In such embodiments, the first actuating element 422a is configured to retain its biased shape (e.g., the first actuating element 422a can be composed of a shape memory material such as Nitinol). Biasing at least one of the actuating elements prior to deployment of the shunt places the shunt in an "open position" (e.g., flow-enabled), a "partially open position," or a "closed position" (e.g., flow-disabled) for the implantation procedure. The biasing step can occur before or after placing the flow control assembly 420 in the shunt.

[0043] Without being limited by theory, the above-described method of manufacturing the flow control assemblies described herein provides several advantages. For example, it is expected that the manufacturing process will be simplified, as the flow control assembly can be manufactured (e.g., cut) as a unitary structure from a single material. As another example, because it is formed from a single structure, the flow control assembly can have fewer connected parts that can fail after implantation in a patient, which may, at least in some cases, increase the lifespan of the shunts described herein. However, as one of ordinary skill in the art will appreciate from the disclosure herein, the flow control assemblies described herein can be formed by methods other than those described above with respect to FIGS. 4A and 4B. For example, in embodiments in which the flow control assembly includes Nitinol, the flow control assembly can be formed using any technique suitable for manipulating Nitinol into a desired configuration. Thus, the present technology is not limited to the manufacturing methods explicitly described herein. Rather, the shunts described herein can be manufactured using other suitable methods not explicitly described herein.

[0044] D. Operation of Shape Memory Actuating Element As noted 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 through which the lumen extends to drain or otherwise shunt fluid between the first body region and the second body region. Additionally, devices constructed in accordance with the present technology may be selectively adjustable to control the flow of fluid between the first body region and the second body region. In some embodiments, for example, the device includes a flow control assembly or actuation assembly that drives movement of a gating element to adjust the resistance to flow through the lumen, thereby increasing or decreasing the relative drainage of fluid between the first body region and the second body region.

[0045] In some embodiments of the present technology, a flow control assembly (e.g., actuation assembly, fluidic resistor, etc.) includes at least two actuation elements coupled to a movable element (e.g., gate element, arm, etc.). The movable elements can be configured to interface with (e.g., at least partially block) a lumen and / or lumen orifice. The orifice can be an inflow or outflow orifice. In other embodiments, the movable elements can be intermediate elements between the actuation elements and a flow control element that interfaces with or otherwise engages a shunt lumen or orifice. In such embodiments, movement of the movable elements can adjust the geometry of the flow control element, which in turn adjusts the size, shape, or other dimension of the shunt lumen or orifice. Movement of the actuation elements causes movement (e.g., translation and / or rotation) of the movable elements.

[0046] The actuation element(s) can include a shape memory material (e.g., a shape memory alloy, or a shape memory polymer), and movement of the actuation element(s) can occur by applied stress and / or by use of a shape memory effect (e.g., driven by a change in temperature). The shape memory effect allows deformations that have changed the element from its preferred geometric configuration (e.g., an original configuration, a shape set configuration, a temperature set configuration, etc.) to be largely or completely reversed during operation of the flow control assembly. For example, thermal actuation (heating) can reverse the deformation(s) by inducing a change in state (e.g., a phase change) in the actuator material, inducing a temporarily elevated internal stress that drives the shape change toward the preferred geometric configuration. In the case of a shape memory alloy, the change in state can be from a martensite phase (alternatively, an R-phase) to an austenite phase. In the case of a shape memory polymer, the change in state can be due to a glass transition or melting temperature. The change in state can reverse the deformation(s) of the material (e.g., deformation to its preferred geometric configuration) without applying any stress (e.g., externally) to the actuating element. That is, the deformation present in the material at a first temperature (e.g., body temperature) can be reversed (e.g., thermally) and / or altered by raising the material to a second (e.g., higher) temperature. Upon cooling (and changing state, e.g., back to the martensitic phase), the actuating element retains its preferred geometric configuration. Because the material is in this relatively cool state, the force or stress required to thermoelastically deform the material can be lower, and any subsequent application of external stress can cause the actuating element to deform again away from the preferred geometric configuration.

[0047] The actuating element(s) can be processed such that the transition temperature (e.g., Austenite start temperature, Austenite finish temperature, etc.) at which a change in state occurs is higher than a threshold temperature (e.g., body temperature). For example, the transition temperature can be set to be about 45 °C, about 50 °C, about 55 °C, or about 60 °C. In some embodiments, as a result of the actuator material being heated from body temperature to a temperature higher than the Austenite start temperature (or alternatively, higher than the R-phase start temperature), the upper plateau stress of the material in the first state (e.g., the thermoelastic martensite phase or thermoelastic R-phase at body temperature) (e.g., "UPS_body temperature") becomes lower than the upper plateau stress of the material in the heated state (e.g., the superelastic state) (e.g., "UPS_operating temperature"), thereby achieving partial or complete free recovery. For example, the actuator material can be heated such that UPS_operating temperature > UPS_body temperature. In some embodiments, as a result of the actuator material being heated from body temperature to a temperature higher than the Austenite start temperature (or alternatively, higher than the R-phase start temperature), the upper plateau stress of the material in the first state (e.g., "thermoelastic martensite or thermoelastic R-phase at body temperature") becomes lower than the lower plateau stress of the material in the heated state (e.g., the superelastic state) (e.g., "LPS"), thereby achieving partial or complete free recovery. For example, the actuator material can be aged such that LPS_activation temperature > UPS_body temperature. In some embodiments, as a result of the actuator material being heated from body temperature to a temperature higher than the Austenite start temperature (or alternatively, higher than the R-phase start temperature), the upper plateau stress of the material in the first state (e.g., thermoelastic martensite or thermoelastic R-phase) becomes higher than the lower plateau stress of the material in the heated state, thereby achieving partial free recovery. For example, the actuator material can be aged such that LPS_activation temperature < UPS_body temperature.

[0048] The flow control assembly can be formed such that the actuating elements have substantially the same preferred geometry configuration (e.g., memory shape, or length, L0). The flow control assembly can be assembled such that, upon introduction (e.g., implantation) into a patient, at least one (e.g., first) actuating / shape memory element is deformed relative to its preferred geometry configuration (e.g., having L1≠L0), while at least one other opposing (e.g., second) actuating / shape memory element positioned adjacent to the first actuating element is substantially in its preferred geometry configuration (e.g., L0). However, in other embodiments, both the first and second actuating elements may be deformed relative to their corresponding preferred geometry configurations upon introduction into the patient (e.g., the first actuating element contracts relative to its preferred geometry configuration and the second actuating element expands relative to its preferred geometry configuration).

[0049] In some embodiments of the present technology, L1>L0, e.g., the deformed first actuating element is longer relative to its preferred “shape memory” length. In some embodiments, L1<L0, e.g., 、 the deformed first actuating element is compressed relative to its preferred shape memory length. The flow control assembly can be formed such that, during operation, its overall dimensions (e.g., total length) are substantially fixed (e.g., L0+L1 = constant). For example, the ends (e.g., outermost) of the actuating elements can be fixed such that movement of the actuating elements occurs between fixed points. In addition to these lengths, the overall geometry of the actuating elements can be selected such that, during operation, the deformation within the actuating elements remains less than about 10%, about 9%, about 8%, about 7%, or about 6%.

[0050] The actuating elements (e.g., first and second actuating elements) are arranged such that movement (e.g., deflection or deformation) of the first actuating element / first shape memory element accompanies (e.g., causes) an opposing movement of the second actuating element / second shape memory element. This movement can be a deflection or deformation. In operation, selective heating of the first actuating element of the flow control assembly causes the first actuating element to move (e.g., from L1 back to L0) into and / or toward its preferred geometric configuration, thereby moving the coupled moveable element. At the same time, elongation of the first actuating element accompanies (e.g., causes) compression of the second actuating element (e.g., from L0 to L1). Because the second actuating element is not heated (e.g., remains at body temperature), the second actuating element deforms (e.g., remains martensite and compresses). The first actuating element is cooled after heating and returns to a state in which it can be plastically deformed. To restore the configuration of the flow control assembly (e.g., the position of the movable element), the second actuating element, upon heating, moves to and / or toward its preferred geometric configuration (e.g., from L1 to L0). When the second actuating element returns to its preferred geometric configuration, the movable element returns to its previous position and the first actuating element is compressed (e.g., from L0 to L1). The position of the movable element of the flow control assembly can be repeatedly toggled (e.g., between open and closed) by repeating the above-described operations. Heating of the actuating element can be achieved by applying incident energy (e.g., by laser or inductive coupling). Additionally, as noted above, the source of incident energy can be external to the patient (e.g., non-invasive).

[0051] 5A-5D are schematic illustrations of the operation of a flow control assembly 500 for use in an adjustable flow shunt, constructed in accordance with selected embodiments of the present technology. Although the flow control assembly 500 is shown schematic, those skilled in the art will understand that the principles and modes of operation discussed with respect to the flow control assembly 500 may be applied to any of the flow control assemblies disclosed herein. Thus, the flow control assembly 500 may be generally similar and / or the same as the flow control assemblies 220, 320, and 420 described above.

[0052] 5A-5D together, the flow control assembly 500 can include a first actuating element 501 and a second actuating element 502, which can be generally similar to the actuating elements described above with respect to FIGS. 2A-4B. The first actuating element 501 can extend between the gate element 503 and the first anchor element 504. The second actuating element 502 can extend between the gate element 503 and the second anchor element 505. The first anchor element 504 and the second anchor element 505 can be fixed to a generally stationary component of the shunt (not shown). In other embodiments, the first anchor element 504 and / or the second anchor element 505 can be omitted, and the first actuating element 501 and / or the second actuating element 502 can be fixed directly to a portion of a device or system for shunting fluid (not shown). In any of these embodiments, selectively altering the flow rate of fluid through the shunt by moving the gate element 503 occurs without damaging or otherwise adversely affecting the patient's tissue.

[0053] The first and second actuating elements 501 and 502 can be composed of a shape memory material, such as a shape memory alloy (e.g., Nitinol). Thus, the first and second actuating elements 501 and 502 can be transitionable between 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 and second actuating elements 501 and 502 can be deformable (e.g., plastic, malleable, compressible, expansive, etc.). In the second state, the first and second actuating elements 501 and 502 can have a preference for a specific preferred geometry (e.g., an original geometry, a manufactured geometry, a temperature set geometry, etc.). The first and second actuating elements 501 and 502 can be transitioned between the first and second states by providing energy (e.g., heat) to the actuating elements to heat the actuating elements above a transition temperature. In some embodiments, the transition temperatures of both the first actuating element 501 and the second actuating element 502 are greater than the average body temperature (e.g., the average temperature within the eye). Thus, both the first actuating element 501 and the second actuating element 502 are typically in a deformable first state when the flow control assembly 500 is implanted within the body until they are heated (e.g., actuated).

[0054] If an actuating element (e.g., first actuating element 501) is deformed relative to its preferred geometry while in a first state, heating the actuating element (e.g., first actuating element 501) above its transition temperature causes the actuating element to transition from the deformed shape to and / or toward its preferred geometry by transitioning to a second state. Heat can be applied to the actuating element via an energy source (e.g., laser) positioned outside the body, RF heating, resistive heating, etc. In some embodiments, the first actuating element 501 can be selectively heated independently of the second actuating element 502, which can be selectively heated independently of the first actuating element 501.

[0055] 5A, the first actuating element 501 and the second actuating element 502 are shown prior to being secured to the first and second anchor elements. In particular, the first actuating element 501 and the second actuating element 502 are in their unbiased preferred geometry. In the illustrated embodiment, the first actuating element 501 has a length L x1 and the second actuation element 502 has an original shape having a length L y1 In some embodiments, the original shape has L x1 L y1 In another embodiment, L x1 L y1 Less than or greater than (i.e., not equal to).

[0056] 5B illustrates the flow control assembly 500 in a first configuration (e.g., assembled or operative configuration) after the first actuating element 501 is secured to the first anchor element 504 and the second actuating element 502 is secured to the second anchor element 505. In the first configuration, both the first actuating element 501 and the second actuating element 502 are at least partially deformed (e.g., prestressed and / or prestrained) relative to their preferred geometries. For example, the first actuating element 501 is compressed (e.g., shortened) relative to its preferred geometry ( FIG. 5A ) such that the second length L x2 is the first length L x1 Similarly, the second actuation element 502 is also compressed (e.g., shortened) relative to its preferred geometry (FIG. 5A), such that the second length L y2 is the first length L y1 In the illustrated embodiment, L x1 L y1 However, in other embodiments, L x1 L y15. In some embodiments, the first actuating element 501 and / or the second actuating element 502 are stretched (e.g., lengthened) relative to their preferred geometry prior to being secured to the anchor element. For example, in some embodiments, both the first actuating element 501 and the second actuating element 502 are stretched relative to their preferred geometry. In other embodiments, the first actuating element 501 is compressed (e.g., shortened) relative to its preferred geometry and the second actuating element 502 is stretched (e.g., lengthened) relative to its preferred geometry. In some embodiments, only one of the actuating elements (e.g., the first actuating element 501) is deformed relative to its preferred geometry and the other actuating element (e.g., the second actuating element 502) retains its preferred geometry.

[0057] 5C illustrates the flow control assembly 500 in a second configuration that is different from the first configuration. In particular, in the second configuration, the flow control assembly 500 has been actuated to transition the first actuating element 501 from a first (e.g., martensitic) state to a second (e.g., austenitic) state relative to the first configuration shown in FIG. 5B. Because the first actuating element 501 has been deformed (e.g., compressed) relative to its preferred geometry while in the first configuration, heating the first actuating element 501 above its transition temperature causes the first actuating element 501 to expand in length L x1 (FIG. 5A). As described above, the first anchor element 504 and the second anchor element 505 are fixed to a generally stationary structure (e.g., such that the distance between the first anchor element 504 and the second anchor element 505 does not change during actuation of the first actuation element 501). Thus, as the first actuation element 501 expands in length toward its preferred geometry, the second actuation element 502, because it is not heated, remains in a generally deformable (e.g., martensitic) state, and thus, L y1 and L y2 Shorter length L y3In the illustrated embodiment, this causes the gate element 503 to move away from the first anchor element 504 and towards the second anchor element 505.

[0058] 5D illustrates the flow control assembly 500 in a third configuration that is different from the first and second configurations. In particular, in the third configuration, the flow control assembly 500 has been actuated to transition the second actuating element 502 from a first (e.g., martensitic) state to a second (e.g., austenitic) state relative to the second configuration shown in FIG. 5C. Because the second actuating element 502 has been deformed (e.g., compressed) relative to its original shape while in the second configuration, heating the second actuating element 502 above its transition temperature causes the second actuating element 502 to expand in length L y1 (FIG. 5A). As described above, the first anchor element 504 and the second anchor element 505 are fixed to a generally stationary structure (e.g., such that the distance between the first anchor element 504 and the second anchor element 505 does not change during actuation of the second actuation element 502). Thus, as the second actuation element 502 expands in length toward its preferred geometry, the first actuation element 501 remains in a generally deformable (e.g., martensitic) state because it is not heated, and thus moves in length toward its preferred geometry (FIG. 5B). x1 and L x2 Shorter length L x3 5A, the gate element 503 is further deformed (e.g., compressed) relative to its original shape until the gate element 503 is moved away from the second anchor element 505 and toward the first anchor element 504 (e.g., generally opposite the direction that the gate element 503 moves when the first actuation element 501 is actuated).

[0059] The flow control assembly 500 can be repeatedly transitioned between the second and third configurations. For example, the flow control assembly 500 can be transitioned from the third configuration back to the second configuration by heating the first actuating element 501 above its transition temperature, which returns the second actuating element 502 to its deformable first state (e.g., by allowing the second actuating element 502 to cool below its transition temperature). Heating the first actuating element 501 above its transition temperature moves the first actuating element 501 to and / or toward its preferred geometry, which in turn pushes the gate element 503 back toward the second anchor element 505, transitioning the flow control assembly 500 to the second configuration (FIG. 5C). Thus, the flow control assembly 500 can be selectively transitioned between various configurations by selectively actuating either the first actuating element 501 or the second actuating element 502. After actuation, the flow control assembly 500 can be configured to substantially retain a given configuration until further actuation of the opposing actuating element. In some embodiments, the flow control assembly 500 can be transitioned to an intermediate configuration between the second configuration and the third configuration (e.g., the first configuration) by heating a portion of the first actuating element 501 or the second actuating element 502.

[0060] Heat can be applied to the actuating elements via an energy source (e.g., laser), RF heating, resistive heating, etc., positioned external to the body, as defined above. In some embodiments, an external device (e.g., external device 220) directs an energy source to heat one or more of the actuating elements based on a readout from one or more sensors (e.g., sensor 210). In other embodiments, a user (e.g., physician) operates an energy source to heat one or more of the actuating elements based on a readout from one or more sensors. In some embodiments, the first actuating element 501 can be selectively heated independently from the second actuating element 502, and the second actuating element 502 can be selectively heated independently from the first actuating element 501. For example, in some embodiments, the first actuating element 501 is on a first electrical circuit and / or responsive to a first frequency range for selectively and resistively heating the first actuating element 501, and the second actuating element 502 is on a second electrical circuit and / or responsive to a second frequency range for selectively and resistively heating the second actuating element 502. As described in detail above, selective heating of the first actuating element 501 causes the gating element 503 to move in a first direction, and selective heating of the second actuating element 502 causes the gating element 503 to move in a second direction generally opposite the first direction. Thus, the flow control assembly 500 can be adjusted to achieve any of the operations described herein with respect to the adjustable shunt.

[0061] As one skilled in the art will appreciate from the disclosure herein, various components of the shunt systems and devices described herein can be omitted without departing from the scope of the technology. Similarly, additional components not explicitly described above can be added to the systems and devices described herein without departing from the scope of the technology. Thus, the technology is not limited to its configurations articulated herein, but rather encompasses variations and alternatives of the described embodiments.

[0062] E. Working Example Several aspects of the present technology are described in the following examples. Example 1. A method of manufacturing an adjustable flow shunt having a shunt and a flow control assembly, comprising: fabricating a structure corresponding to the flow control assembly from a single material, the structure including an anchor element, an actuation element, and a gate element, the actuation element including a first end extending from the gate element and a second end not connected to another portion of the structure; securing the second end of the actuation element to the anchor element to form the flow control assembly; coupling the assembled flow control assembly to the shunt such that the flow control assembly is configured to at least partially control a flow of fluid through the shunt; A method comprising:

[0063] Example 2. The method of example 1, wherein the anchor element includes a notch, and fixing the second end of the actuating element to the anchor element includes positioning the second end of the actuating element within the notch.

[0064] Example 3. The method of example 1, wherein fixing the second end of the actuating element to the anchor element includes welding or affixing the second end of the actuating element to the anchor element.

[0065] Example 4. The method of any of Examples 1-3, wherein fixing the second end of the actuation element to the anchor element includes at least partially deforming the actuation element relative to its manufactured geometry.

[0066] Example 5. The method of example 4, wherein at least partially deforming the actuation element relative to its manufactured geometry includes pre-stressing and / or pre-straining the actuation element.

[0067] Example 6. The method of example 4 or 5, wherein at least partially deforming the actuation element comprises compressing the actuation element.

[0068] Example 7. The method of example 4 or 5, wherein at least partially deforming the actuation element comprises lengthening the actuation element.

[0069] Example 8. The method of any of Examples 1-7, wherein fabricating the structure corresponding to the flow control assembly from the single material includes laser cutting the structure from the single material.

[0070] Example 9. The method of any of Examples 1-8, wherein the single material is a Nitinol sheet and / or Nitinol strip.

[0071] Example 10. The method of any of Examples 1-9, wherein the actuating element is a first actuating element and the structure further includes a second actuating element, the second actuating element including, after the manufacturing step, a first end coupled to the anchor element and a second end coupled to the gate element.

[0072] Example 11. The method of example 10, wherein fixing the second end of the first actuating element to the anchor element includes at least partially deforming both the first actuating element and the second actuating element relative to their manufacturing geometries.

[0073] Example 12. The method of any of Examples 1-11, further comprising biasing the actuation element prior to coupling the assembled flow control assembly to the shunt.

[0074] Example 13. The method of any of Examples 1-12, wherein coupling the assembled flow control assembly to the shunt includes positioning the flow control assembly within a frame.

[0075] Example 14. A method of manufacturing a flow control assembly for use in an implantable medical device, comprising: cutting a unitary structure corresponding to the flow control assembly from a Nitinol sheet and / or Nitinol strip, the unitary structure including an anchor element, one or more actuating elements, and a gating element, the actuating elements having a first geometry when cut from the Nitinol sheet and / or Nitinol strip; securing a free end of the actuating element to the anchor element to form the flow control assembly, wherein securing the free end of the actuating element to the anchor element deforms the actuating element such that it has a second geometry that is different from the first geometry; and A method comprising:

[0076] Example 15. The method of example 14, wherein fixing the free end of the working element to the anchor element includes compressing the working element.

[0077] Example 16. The method of example 14, wherein fixing the free end of the working element to the anchor element includes lengthening the working element.

[0078] Example 17. The method of example 14, wherein the first geometry has a longer length than the second geometry.

[0079] Example 18. The method of example 14, wherein the first geometry has a shorter length than the second geometry.

[0080] Example 19. A method as described in any of Examples 14-18, wherein the actuating element is a first actuating element and the unitary structure further includes a second actuating element, the second actuating element having a third geometry when cut from the Nitinol sheet and / or the Nitinol strip.

[0081] Example 20. The method of example 19, wherein the third geometry is different from the first geometry.

[0082] Example 21 The method of example 19, wherein the third geometry is the same as the first geometry.

[0083] Example 22. A method as described in any of Examples 19 to 21, wherein fixing the free end of the actuating element to the anchor element at least partially deforms the second actuating element such that it has a fourth geometry that is different from the third geometry.

[0084] Example 23. The method of example 22, wherein the fourth geometry is different from the second geometry.

[0085] Example 24 The method of example 22, wherein the fourth geometry is the same as the second geometry.

[0086] Example 23. A method of manufacturing a flow control assembly for use in an implantable medical device, comprising: manufacturing a unitary structure corresponding to a flow control assembly, the unitary structure including an anchor element, one or more actuation elements, and a gate element, the actuation elements having a first geometry when manufactured; securing a free end of the actuating element to the anchor element to form the flow control assembly, wherein securing the free end of the actuating element to the anchor element deforms the actuating element such that it has a second geometry that is different from the first geometry; and A method comprising:

[0087] Example 24. The method of example 23, wherein fixing the free end of the working element to the anchor element includes applying a prestress and / or prestrain to the working element.

[0088] Example 25. The method of example 23 or 24, wherein fixing the free end of the working element to the anchor element includes compressing the working element.

[0089] Example 26. The method of example 23 or 24, wherein fixing the free end of the working element to the anchor element includes lengthening the working element.

[0090] Example 27. The method of any of Examples 23-26, wherein the actuating element is a first actuating element and the unitary structure further includes a second actuating element, the second actuating element having a third geometry when manufactured.

[0091] Example 28. The method described in Example 27, wherein fixing the free end of the operating element to the anchor element at least partially deforms the second operating element such that it has a fourth geometry that is different from the third geometry.

[0092] Example 29. A flow-adjustable shunt for the treatment of glaucoma in a patient, comprising: an elongated portion having a lumen extending therethrough; and a bladder portion defining an interior chamber, the lumen being fluidly coupled to the interior chamber through an aperture; a frame having a generally flat profile, a flow control assembly positioned within the internal chamber, a gating element, the gating element being transitionable between a first position in which the gating element at least partially blocks the aperture and a second position in which the gating element does not block the aperture and / or blocks less of the aperture than the first position; and an actuation element operably coupled to the gating element, the actuation element being comprised of a shape memory material and configured to transition the gating element from the first position, to and / or toward the second position; a flow control assembly including: Including, adjustable flow shunts.

[0093] Example 30. A flow-adjustable shunt as described in Example 29, wherein the actuating element is a first actuating element and the flow control assembly further includes a second actuating element, the second actuating element being constructed from a shape memory material and configured to transition the gate element from the second position to the first position and / or toward the first position.

[0094] Example 31. A flow control shunt as described in Example 29 or 30, wherein the flow control assembly further includes an anchor element, the anchor element designed to secure the flow control assembly within the internal chamber by fitting along a portion of the internal chamber.

[0095] Example 32. A flow adjustable shunt as described in Example 31, wherein the actuation element, the gate element, and the anchor element form a unitary structure formed from a single sheet of material.

[0096] Example 33. A flow-adjustable shunt according to any one of Examples 29 to 32, wherein the lumen has a rectangular cross-sectional shape.

[0097] Example 34. A flow-adjustable shunt according to any of Examples 29 to 33, wherein the frame has a longitudinal cross-sectional dimension of less than about 100 μm.

[0098] Example 35. A flow-adjustable shunt described in any of Examples 29 to 33, wherein the frame has a longitudinal cross-sectional dimension of less than about 80 μm.

[0099] Example 36. A flow-adjustable shunt according to any of Examples 29 to 33, wherein the frame has a longitudinal cross-sectional dimension of less than about 60 μm.

[0100] Example 37. A flow-adjustable shunt described in any of Examples 29 to 36, wherein the bladder portion includes a first longitudinal axis extending therethrough and the elongated portion includes a second longitudinal axis extending therethrough, and the first longitudinal axis is not parallel to the second longitudinal axis.

[0101] Example 38. A flow-adjustable shunt as described in Example 37, wherein the first longitudinal axis and the second longitudinal axis form an angle between about 90 degrees and about 180 degrees.

[0102] Example 39. A flow-adjustable shunt described in any of Examples 29 to 38, wherein the flow control assembly is constructed at least in part from Nitinol.

[0103] Example 40. A flow-adjustable shunt described in any one of Examples 29 to 39, wherein the bladder portion includes a plurality of holes.

[0104] conclusion The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Although specific embodiments of the present technology, and examples for the present technology, have been described above for illustrative purposes, various equivalent modifications are possible within the scope of the present technology, as those skilled in the art will recognize. For example, any of the features of the adjustable flow shunts described herein can be combined with any of the features of the other adjustable flow shunts described herein, and vice versa. Furthermore, although steps are presented in a given order, alternative embodiments may perform the steps in a different order. Also, the various embodiments described herein may be combined to provide further embodiments.

[0105] From the foregoing, it will be understood that, although specific embodiments of the present technology have been described herein for purposes of illustration, well-known structures and functions associated with adjustable flow shunts have not been shown or described in detail in order to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.

[0106] Further, unless the word "or" is expressly limited with reference to a list of two or more items to mean only a single item exclusively from the other items, the use of "or" in such a list should be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Furthermore, the term "comprising" is used throughout to mean including at least the recited feature(s), but not to the exclusion of any more of the same features and / or other features of additional types. Also, while specific embodiments have been described herein for illustrative purposes, it will be understood that various modifications may be made without departing from the technology. Furthermore, 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 are necessarily required to exhibit such advantages to fall within the scope of the technology. Thus, the present disclosure and related technology can encompass other embodiments not expressly shown or described herein.

Claims

1. A method for manufacturing a flow control assembly for use with an implantable medical device, the method comprising: manufacturing a unitary structure corresponding to the flow control assembly, the unitary structure including one or more actuation elements, a first portion having an unstrained end, and a second portion; forming the flow control assembly by coupling the unstrained end of the first portion to the second portion, wherein coupling the unstrained end to the second portion induces a strain in the one or more actuating elements; A method comprising:

2. The method of claim 1, wherein coupling the unstrained end to the second portion induces the strain in the one or more actuating elements by mechanically deforming the one or more actuating elements.

3. The method of claim 2, wherein coupling the unstrained end to the second portion induces the strain in the one or more actuating elements by compressing the one or more actuating elements.

4. The method of claim 2, wherein coupling the unstrained end to the second portion includes inducing the strain in the one or more actuating elements by stretching the one or more actuating elements.

5. The method of claim 1, wherein the single structure is composed of a shape memory material.

6. The method of claim 1, wherein the single structure is constructed from Nitinol.

7. The method of claim 1, wherein the second portion of the flow control assembly includes an anchor portion.

8. The one or more operating elements include a first operating element and a second operating element, the flow control assembly further includes a gate element; 2. The method of claim 1, wherein after the unstrained end is coupled to the second portion, (a) the first actuating element is configured to selectively move the gating element in a first direction in response to a decrease in the strain induced in the first actuating element, and (b) the second actuating element is configured to selectively move the gating element in a second direction, different from the first direction, in response to a decrease in the strain induced in the second actuating element.

9. A method of manufacturing a flow control assembly for use with an implantable medical device from a single structure, the single structure having one or more actuating elements, a first portion having an unstrained end, and a second portion; The method includes forming the flow control assembly by coupling the unstrained end of the first portion to the second portion; coupling the unstrained end to the second portion induces a strain in the one or more actuating elements.

10. The method of claim 9, wherein coupling the unstrained end to the second portion induces the strain in the one or more actuating elements by changing a shape of the one or more actuating elements.

11. The method of claim 10, wherein coupling the unstrained end to the second portion induces the strain in the one or more actuating elements by compressing the one or more actuating elements.

12. The method of claim 10, wherein coupling the unstrained end to the second portion includes inducing the strain in the one or more actuating elements by stretching the one or more actuating elements.

13. The method of claim 9, wherein the flow control assembly is configured to be coupled to an implantable shunt, and the flow control assembly is operable to selectively control the flow rate of fluid through the implantable shunt after the implantable shunt is implanted in a patient.

14. The one or more actuating elements include a first actuating element, the flow control assembly includes a gate element; 10. The method of claim 9, wherein when the flow control assembly is formed, the first actuating element is configured to selectively move the gating element in a first direction in response to a decrease in the strain induced in the first actuating element.

15. The one or more actuating elements further include a second actuating element, 15. The method of claim 14, wherein, upon formation of the flow control assembly, the second actuating element is configured to selectively move the gating element in a second direction, different from the first direction, in response to a decrease in the strain induced in the second actuating element.

16. A method of manufacturing an actuation assembly for use with an implantable medical device, the method comprising: receiving a unitary structure corresponding to the actuation assembly, the unitary structure including an actuation element, a first portion having an unstrained end, and a second portion, the actuation element having a first configuration; forming the actuating assembly by coupling the unstrained end of the first portion to the second portion, wherein coupling the unstrained end to the second portion deforms the actuating element such that the actuating element has a second configuration different from the first configuration; A method comprising:

17. The method of claim 16, wherein the first configuration has a length greater than that of the second configuration.

18. The method of claim 16, wherein the first configuration has a length shorter than the second configuration.

19. The method of claim 16, wherein the single structure is constructed from a shape memory material.

20. The actuating element is a first actuating element, the actuation assembly further includes a second actuation element; The method of claim 16 , wherein coupling the unstrained end of the first portion to the second portion deforms both the first actuating element and the second actuating element.

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