Adjustable glaucoma treatment devices, and associated systems and methods
Patent Information
- Application Number
- JP2025106615
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2020-06-15
- Filing Date
- 2025-06-24
- Publication Date
- 2025-10-03
AI Technical Summary
Glaucoma, a degenerative ocular condition causing irreversible vision loss due to increased intraocular pressure, is often associated with disorders in the mechanism that transports fluid from the eye into the bloodstream, necessitating improved methods for controlling fluid flow to manage intraocular pressure.
Implantable devices with adjustable drainage elements and flow control mechanisms, featuring lumens, actuation assemblies, and ratchet mechanisms to vary fluid flow resistance and drainage rates, allowing incremental adjustments and retention in desired positions.
These devices effectively manage intraocular pressure by providing adjustable fluid flow control, thereby treating glaucoma and preventing vision loss by maintaining optimal drainage rates.
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Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to the following pending applications:
[0002] U.S. Provisional Patent Application No. 63 / 010,854, filed April 16, 2020; and U.S. Provisional Patent Application No. 63 / 039,237, filed June 15, 2020.
[0003] All of the foregoing applications are incorporated herein by reference in their entirety. Furthermore, elements and features of embodiments disclosed in the applications incorporated by reference may be combined with various elements and features disclosed and claimed in the present application.
[0004] The present technology relates generally to implantable medical devices, and more particularly to intraocular systems, devices, and related methods for selectively controlling fluid flow between different portions of a patient's eye. [Background technology]
[0005] Glaucoma is a degenerative ocular condition involving damage to the optic nerve, which can cause progressive and irreversible vision loss. Glaucoma is often associated with ocular hypertension, an increase in intraocular pressure, and can result from increased production of aqueous humor ("water") within the eye and / or a decrease in the rate at which water leaves the eye and enters the bloodstream. Water is produced within the ciliary body, which is located at the boundary between the posterior and anterior chambers of the eye. Water flows into the anterior chamber and ultimately into the capillary bed within the sclera of the eye. Glaucoma is typically caused by a disorder in the mechanism that transports water from the eye into the bloodstream. Summary of the Invention [Means for solving the problem]
[0006] The present technology is directed to implantable systems and devices for facilitating fluid flow between a first body region and a second body region. In embodiments, the devices are selectively adjustable to control the amount of fluid flowing between the first body region and the second body region. The devices generally include a drainage and / or shunting element having a lumen extending therethrough for draining or otherwise shunting fluid between the first and second body regions. Some embodiments include an actuation assembly that can drive movement of a flow control element to vary the flow resistance through the lumen, thereby increasing or decreasing the relative drainage rate of fluid between the first body region and the second body region.
[0007] In particular, some embodiments of the present technology provide an adjustable device that can be selectively titrated to provide various levels of therapy. For example, the device can be adjusted through several distinct positions or configurations, with each position or configuration providing a different flow resistance and / or drainage rate relative to other positions or configurations. Thus, the device can be incrementally adjusted through positions or configurations until a desired flow resistance and / or drainage rate is achieved. Once the desired flow resistance and / or drainage rate is achieved, the device is configured to maintain the set position or configuration until further input. In some embodiments, various components of the device operate as a ratchet mechanism, allowing incremental adjustment of the device between multiple positions or configurations, and can hold or lock the device in a desired position or configuration. The present specification provides, for example, the following: (Item 1) 1. A device for treating glaucoma, comprising: a drainage element at least partially defining a lumen configured to drain water from the anterior chamber of the eye; a flow control element movable between at least a first position and a second position and configured to vary flow resistance through the device; an actuation assembly comprising: an actuation element configured to at least partially change shape and / or size in response to energy; an arm extending from the actuation element and configured to releasably engage the flow control element; an actuation assembly, wherein when the arm engages a first region of the flow control element, actuation of the actuation element causes the arm to move the flow control element between the first position and the second position to vary the flow resistance through the device; a locking mechanism configured to at least partially reduce movement of the flow control element when the arm is disengaged from the flow control element. (Item 2) Item 10. The device of item 1, wherein the flow control element comprises a slidable rack element. (Item 3) Item 3. The device of item 2, wherein the slidable rack element has a first groove and a second groove, and the arm has an engagement element in the first groove and / or the second groove configured to releasably engage the slidable rack element. (Item 4) 4. The device of claim 3, wherein the first region of the flow control element is the first groove, and the engagement element is configured to disengage from the first groove and engage with the second groove after the flow control element moves from the first position to the second position. (Item 5) Item 5. The device of item 4, wherein the locking mechanism engages the flow control element to at least partially reduce movement of the flow control element after the engagement element disengages from the first groove and before the engagement element engages with the second groove. (Item 6) Item 4. The device of item 3, wherein the slidable rack element has a third groove and a fourth groove, and the locking mechanism includes a locking element configured to engage the third groove when the flow control element is in the first position and configured to engage the fourth groove when the flow control element is in the second position. (Item 7) Item 10. The device of item 1, wherein the locking mechanism is configured to prevent movement of the flow control element when the arm is disengaged from the flow control element via a friction fit with the arm. (Item 8) Item 10. The device of item 1, wherein the actuation element is a first actuation element, and the actuation assembly further comprises a second actuation element connected to the arm and configured to at least partially change shape and / or size in response to energy. (Item 9) 9. The device of claim 8, wherein when the flow control element is in the second position, actuation of the second actuation element causes the arm to move the flow control element from the second position to the first position. (Item 10) 10. The device of claim 9, wherein the first actuation element and the second actuation element comprise a shape memory material. (Item 11) Item 11. The device of item 10, wherein the first actuating element has a first flex region, and application of energy to the first flex region causes the first flex region to expand. (Item 12) Item 11. The device of item 10, wherein the second actuating element has a second bending region, and application of energy to the second bending region causes the second bending region to expand. (Item 13) Item 13. The device of item 12, wherein actuation of the first actuating element causes the second actuating element to compress at the second flexion region, and actuation of the second actuating element causes the first actuating element to compress at the first flexion region. (Item 14) Item 14. The device of item 1, wherein the flow control element is movable through three or more positions, each of the three or more positions being associated with a unique flow resistance through the device. (Item 15) Item 14. The device of item 1, wherein the actuating element is configured to receive energy from an energy source positioned outside the eye when the device is implanted in a human eye. (Item 16) Item 16. The device of item 15, wherein the energy source is a laser. (Item 17) Item 1, the device being configured such that when implanted in a human eye, varying the flow resistance through the device varies the drainage rate of aqueous from the anterior chamber of the eye. (Item 18) Item 10. The device of item 1, wherein the flow control element is configured to change the diameter of the lumen as it moves between the first position and the second position. (Item 19) 1. A device for controlling fluid flow between a first region and a second region, comprising: a lumen configured to drain fluid from the first region toward the second region; a ratchet mechanism configured to alter the flow of the fluid through the lumen, a rack element movable between a first position in which the lumen has a first shape and a second position in which the lumen has a second shape different from the first shape; an engagement element configured to releasably engage the rack element; and a ratchet mechanism including an actuation assembly connected to the engagement element and configured to move the rack element between the first position and the second position. (Item 20) 20. The device of claim 19, further comprising an arm connected to the actuation assembly, the arm including the engagement element and configured to drive the rack element from the first position to and / or toward the second position upon actuation of the actuation assembly. (Item 21) 20. The device of claim 19, wherein the rack element includes a plurality of teeth and a plurality of grooves, and the engagement element is configured to engage the rack element in one of the plurality of grooves. (Item 22) 21. The device of claim 20, wherein the engagement element is configured to disengage from a first groove on the rack element and engage with a second groove on the rack element after the rack element moves from the first position to and / or toward the second position. (Item 23) 20. The device of claim 19, wherein the actuation assembly includes a first actuation element configured to move the rack element in a first direction and a second actuation element configured to move the rack element in a second direction generally opposite the first direction. (Item 24) Item 24. The device of item 23, wherein the first actuating element is configured to move the rack element from the first position to the second position, and the second actuating element is configured to move the rack element from the second position to the first position. (Item 25) Item 24. The device of item 23, wherein the first actuating element and the second actuating element are configured to change dimensions upon application of energy. (Item 26) Item 24. The device of item 23, wherein the first and second working elements are constructed from nitinol. (Item 27) 20. The device of claim 19, wherein the rack element directly engages the lumen to change the lumen from the first shape to the second shape as the rack element moves from the first position to and / or towards the second position. (Item 28) 20. The device of claim 19, wherein the rack element indirectly engages the lumen to change the lumen from the first shape to the second shape as the rack element moves from the first position to and / or toward the second position. (Item 29) 29. The device of claim 28, further comprising a flow control element operably connected to the rack element, the flow control element directly engaging the lumen to change the lumen from the first shape to the second shape. (Item 30) 20. The device of claim 19, further comprising a locking mechanism configured to hold the rack element in place when the arm element disengages from the rack element. (Item 31) 20. The device of claim 19, wherein the first body region is the anterior chamber of a human eye, and the device is configured such that changing the geometric characteristics of the lumen when the device is implanted in the eye changes the rate of drainage of aqueous from the anterior chamber of the eye. (Item 32) 20. The device of claim 19, wherein the rack element is configured to change the diameter of the lumen as it moves between the first position and the second position. (Item 33) 1. A device for controlling fluid flow between a first region and a second region, comprising: a drainage element at least partially defining a lumen configured to drain fluid from the first region to the second region; a flow control element movable between at least a first position and a second position and configured to vary flow resistance through the device; an actuation assembly comprising: an actuation element configured to at least partially change shape and / or size in response to energy; an arm extending from the actuation element and configured to releasably engage the flow control element; an actuation assembly, wherein when the arm engages a first region of the flow control element, actuation of the actuation element causes the arm to move the flow control element between the first position and the second position to vary the flow resistance through the device; a locking mechanism configured to at least partially reduce movement of the flow control element when the arm is disengaged from the flow control element. (Item 34) Item 34. The device of item 33, wherein the flow control element comprises a slidable rack element. (Item 35) Item 35. The device of item 34, wherein the slidable rack element has a first groove and a second groove, and the arm has an engagement element in the first groove and / or the second groove configured to releasably engage the slidable rack element. (Item 36) Item 36. The device of item 35, wherein the first region of the flow control element is the first groove, and the engagement element is configured to disengage from the first groove and engage with the second groove after the flow control element moves from the first position to the second position. (Item 37) Item 37. The device of item 36, wherein the locking mechanism engages the flow control element to at least partially reduce movement of the flow control element after the engagement element disengages from the first groove and before the engagement element engages with the second groove. (Item 38) Item 36. The device of item 35, wherein the slidable rack element has a third groove and a fourth groove, and the locking mechanism includes a locking element configured to engage the third groove when the flow control element is in the first position and configured to engage the fourth groove when the flow control element is in the second position. (Item 39) Item 34. The device of item 33, wherein the locking mechanism is configured to prevent movement of the flow control element when the arm is disengaged from the flow control element. (Item 40) Item 34. The device of item 33, wherein the actuation element is a first actuation element, and the actuation assembly further comprises a second actuation element connected to the arm and configured to at least partially change shape and / or size in response to energy. (Item 41) Item 41. The device of item 40, wherein when the flow control element is in the second position, actuation of the second actuation element causes the arm to move the flow control element from the second position to the first position. (Item 42) Item 42. The device of item 41, wherein the first actuation element and the second actuation element comprise a shape memory material. (Item 43) Item 43. The device of item 42, wherein the first actuating element has a first flex region, and application of energy to the first flex region causes the first flex region to expand. (Item 44) Item 43. The device of item 42, wherein the second actuating element has a second flex region, and application of energy to the second flex region causes the second flex region to expand. (Item 45) Item 45. The device of item 44, wherein actuation of the first actuating element causes the second actuating element to compress at the second flexion region, and actuation of the second actuating element causes the first actuating element to compress at the first flexion region. (Item 46) Item 34. The device of item 33, wherein the flow control element is movable through three or more positions, each of the three or more positions associated with a different flow resistance through the device. (Item 47) Item 34. The device of item 33, wherein the device is configured such that varying the resistance to flow through the device when the device is implanted varies the rate of drainage of fluid from the first region. (Item 48) Item 34. The device of item 33, wherein the first region is the anterior chamber of the eye. (Item 49) Item 34. The device of item 33, wherein the flow control element is configured to change the diameter of the lumen as it moves between the first position and the second position. (Item 50) 1. An implantable medical device for draining fluid from a first body region to a second body region, comprising: a drainage element having a lumen extending therethrough and configured to fluidly connect the first body region and the second body region; a flow control element movable through a plurality of distinct positions, each distinct position associated with a relative resistance to flow through the device, the flow control element being selectively movable between the plurality of distinct positions. (Item 51) Item 51. The device of item 50, further comprising a ratchet mechanism configured to move the flow control element through the plurality of discrete positions. (Item 52) Item 51. The device of item 50, further comprising an actuation assembly configured to move the flow control element through the plurality of discrete positions, the actuation assembly including at least one actuation element and a ratchet mechanism. (Item 53) 53. The device of item 52, wherein the implantable medical device is a glaucoma shunt and the first body region is the anterior chamber of the eye. (Item 54) Item 51. The device of item 50, wherein the flow control element is configured to change the diameter of the lumen as it moves between the plurality of distinct positions. (Item 55) 1. An implantable medical device for draining fluid from a first body region to a second body region, comprising: a drainage element configured to fluidly connect the first body region and the second body region when the device is implanted in a patient; an actuation assembly configured to regulate the flow of fluid through the drainage element, the actuation assembly including a shape-memory actuation element movable between a pre-actuated configuration and an actuated configuration; The device comprises: when activated, the shape memory actuation element moves from the pre-actuated configuration to and towards the actuated configuration to adjust the resistance to flow through the device; and The device is configured such that, following actuation, (a) the shape memory actuation element recoils toward the pre-actuation configuration, and (b) the adjusted fluid resistance is maintained as the shape memory actuation element recoils toward the pre-actuation configuration. (Item 56) a flow control element operably coupled to the shape memory actuation element and configured to control the flow resistance through the device; the flow control element is configured to move from a first position to and / or towards a second position when the shape memory actuation element moves from the pre-actuated configuration to and / or towards the actuated configuration; Item 56. The device of item 55, wherein the flow control element is configured to be retained in and / or proximate to the second position when the shape memory actuation element recoils toward the pre-actuation configuration. (Item 57) Item 57. The device of item 56, further comprising a ratchet configured to hold the flow control element in and / or proximate to the second position. (Item 58) Item 56. The device of item 55, wherein the shape memory actuation element is configured to move from the pre-actuated configuration to and / or towards the actuated configuration when heated above a transition temperature, and wherein the shape memory actuation element is configured to recoil towards the pre-actuated configuration when cooled below the transition temperature. (Item 59) Item 56. The device of item 55, further comprising a resilient member configured to drive the recoil of the shape memory element toward the pre-actuated configuration. (Item 60) Item 56. The device of item 55, wherein the shape memory actuation element is configured to repeatedly transition between the pre-actuated configuration and the actuated configuration to further adjust the fluid resistance through the device. (Item 61) 1. A method of controlling fluid flow from a first body region to a second body region using an adjustable shunt device, comprising: heating a shape memory actuating element of the adjustable shunt device above a transition temperature to move the shape memory actuating element from a first configuration to and / or toward a second configuration, wherein moving the shape memory actuating element from the first configuration and / or toward the second configuration adjusts the resistance to flow through the adjustable shunt device; heating the shape memory actuating element and then recoiling the shape memory actuating element toward the first configuration as the shape memory actuating element cools below the transition temperature; maintaining the adjusted fluid resistance as the shape memory actuation recoils toward the first configuration. (Item 62) the adjustable shunt device includes a flow control element configured to control the flow resistance through the device; moving the shape memory actuation element from the first configuration to and / or towards the second configuration moves the flow control element from a first position to and / or towards a second position; Item 62. The method of item 61, wherein maintaining the adjusted fluid resistance comprises holding the flow control element at and / or proximate to the second position as the shape memory actuation element recoils toward the first configuration. (Item 63) Item 63. The method of item 62, wherein retaining the flow control element at and / or proximate to the second position comprises mechanically retaining the flow control element. (Item 64) the adjusted fluid resistance is a first adjusted fluid resistance, and the method comprises: after maintaining the first adjusted fluidic resistance, reheating the shape memory actuation element above the transition temperature to move the shape memory actuation element to and / or towards the second configuration to further adjust the fluidic resistance to a second adjusted fluidic resistance; Item 62. The method of item 61, further comprising: maintaining the second adjusted fluid resistance as the shape memory actuation element cools below the transition temperature and recoils toward the first configuration. (Item 65) Item 62. The method of item 61, wherein recoiling the shape memory actuation element toward the first configuration comprises biasing the shape memory actuation element toward the first configuration using a resilient element. (Item 66) 1. An implantable medical device for draining fluid from a first body region to a second body region, comprising: a fluid resistor; an actuation element that is transferable between a plurality of geometric shapes; a ratchet operably coupled to the actuation element, the ratchet configured to induce a discrete change in resistance generated by the fluidic resistor in response to the actuation element transitioning between geometric shapes. (Item 67) 1. An implantable device for shunting fluid within a patient, comprising: a drainage element having a lumen extending therethrough; a flow control element movable between at least a first position and a second position and configured to vary flow resistance through the device; a first actuation element operably coupled to the flow control element, the first actuation element including a first targeting feature for receiving energy from an energy source positioned external to the patient; a second actuating element operably coupled to the flow control element, the second actuating element including a second targeting feature for receiving energy from the energy source positioned external to the patient. (Item 68) Item 68. The device of item 67, wherein the flow control element is configured to move from the first position toward the second position when energy is applied to the first target feature, and the flow control element is configured to move from the second position toward the first position when energy is applied to the second target feature. (Item 69) Item 68. The device of item 67, wherein the first actuating element includes a first bending region, the second actuating element includes a second bending region, the first target feature is positioned in the first bending region, and the second target feature is positioned in the second bending region. (Item 70) Item 70. The device of item 69, wherein the first targeting feature is configured such that energy received at the first actuation element preferentially heats the first flexure region, and the second targeting feature is configured such that energy received at the second actuation element preferentially heats the second flexure region. (Item 71) Item 68. The device of item 67, wherein the first actuating element includes a plurality of first target features and the second actuating element includes a plurality of second target features. (Item 72) the first actuating element includes a plurality of first bending regions, each first bending region of the plurality of first bending regions having a corresponding first target feature; Item 72. The device of item 71, wherein the second actuating element includes a plurality of second bending regions, each second bending region of the plurality of second bending regions having a corresponding second target feature. (Item 73) Item 73. The device of item 72, wherein each of the plurality of first target features can be individually energized to selectively actuate the corresponding first bending region, and each of the plurality of second target features can be individually energized to selectively actuate the corresponding second bending region. (Item 74) Item 74. The device of item 73, wherein the flow control element is movable to a plurality of distinct positions between the first position and the second position by selectively actuating individual first and / or second bending regions. (Item 75) Item 68. The device of item 67, wherein the first targeting feature is a first recess extending at least partially into the first actuating element and configured to allow energy to penetrate the first actuating element, and the second targeting feature is a second recess extending at least partially into the second actuating element and configured to allow energy to penetrate the second actuating element. (Item 76) Item 68. The device of item 67, wherein the first target feature is a first zone on the first operating element having a higher absorption rate than a region of the first operating element surrounding the first zone, and the second target feature is a second zone on the second operating element having a higher absorption rate than a region of the second operating element surrounding the second zone. (Item 77) Item 77. The device of item 76, wherein the first zone and the second zone comprise an absorbing coating. (Item 78) Item 77. The device of item 76, wherein the first zone and the second zone are oxidized. (Item 79) Item 68. The device of item 67, wherein the first target feature is proximate to a first reflective surface configured to reflect energy received directly from the energy source positioned external to the patient, and the second target feature is proximate to a second reflective surface configured to reflect energy received directly from the energy source positioned external to the patient. (Item 80) 80. The device of claim 79, wherein energy received at the first target feature directly heats the first target feature and indirectly heats at least a portion of the first reflective surface, and energy received at the second target feature directly heats the second target feature and indirectly heats at least a portion of the second reflective surface. (Item 81) Item 68. The device of item 67, wherein the implantable device is a glaucoma shunt configured to drain aqueous from the anterior chamber of the patient's eye. (Item 82) 1. An implantable device for shunting fluid within a patient, comprising: a fluid flow path configured to drain fluid from a first location within the patient having a first pressure to a second location within the patient having a second pressure lower than the first pressure; a flow control element movable between at least a first position and a second position and configured to vary flow resistance through the fluid flow path; an actuation assembly including an actuation element operably coupled to the flow control element, the actuation element including at least one target feature for receiving energy from an energy source positioned external to the patient. (Item 83) Item 83. The device of item 82, wherein the flow control element is configured to move from the first position toward the second position when energy is applied to the target feature. (Item 84) Item 83. The device of item 82, wherein the actuation element includes a bending region and the target feature is positioned in the bending region. (Item 85) Item 85. The device of item 84, wherein the targeting feature is configured such that energy received at the actuation element preferentially heats the bending region, causing a shape change in the bending region. (Item 86) Item 83. The device of item 82, wherein the actuation element comprises a plurality of target features. (Item 87) Item 87. The device of item 86, wherein the actuation element includes a plurality of bending regions, each bending region of the plurality of bending regions having a corresponding target feature. (Item 88) Item 88. The device of item 87, wherein each of the plurality of target features can be individually energized to selectively actuate the corresponding bending region. (Item 89) Item 91. The device of item 88, wherein the flow control element is movable to a plurality of distinct positions between the first position and the second position by selectively actuating individual flex regions. (Item 90) Item 83. The device of item 82, wherein the targeting feature is a recess extending at least partially into the actuation element and configured to allow energy to penetrate the actuation element. (Item 91) 77. The device of claim 76, wherein the target feature is a zone on the actuation element having a higher absorption rate than a region of the actuation element surrounding the zone. (Item 92) Item 92. The device of item 91, wherein the zone comprises an absorbing coating. (Item 93) Item 92. The device of item 91, wherein the zone is oxidized. (Item 94) Item 83. The device of item 82, wherein the implantable device is a glaucoma shunt configured to drain aqueous from the anterior chamber of the patient's eye. (Item 95) 1. An implantable device for shunting fluid within a patient, comprising: a drainage element having a lumen extending therethrough; an actuation element operably coupled to the drainage element and configured to vary the resistance to flow through the device upon actuation, the actuation assembly including at least one target feature for receiving energy from an energy source positioned external to the patient. (Item 96) Item 96. The device of item 95, wherein the actuation element includes a bending region and the target feature is positioned in the bending region. (Item 97) Item 97. The device of item 96, wherein the targeting feature is configured such that energy received at the actuation element preferentially heats the bending region, causing a shape change in the bending region. (Item 98) Item 96. The device of item 95, wherein the actuation element comprises a plurality of target features. (Item 99) Item 99. The device of item 98, wherein the actuation element includes a plurality of bending regions, each bending region of the plurality of bending regions having a corresponding target feature. (Item 100) Item 100. The device of item 99, wherein each of the plurality of target features can be individually energized to selectively actuate the corresponding bending region. (Item 101) Item 96. The device of item 95, wherein the targeting feature is a recess extending at least partially into the actuation element and configured to allow energy to penetrate the actuation element. (Item 102) Item 96. The device of item 95, wherein the target feature is a zone on the actuation element having a higher absorption rate than a region of the actuation element surrounding the zone. (Item 103) Item 103. The device of item 102, wherein the zone comprises an absorbing coating. (Item 104) Item 103. The device of item 102, wherein the zone is oxidized. (Item 105) Item 96. The device of item 95, wherein the implantable device is a glaucoma shunt configured to drain aqueous from the anterior chamber of the patient's eye. (Item 106) 1. A method of shunting fluid using an adjustable flow shunt implanted in a patient and having an actuating element, comprising: applying energy to a first region of the actuation element, the first region including a target feature for receiving the applied energy; and inducing a geometric change in the actuating element at the first region via the applied energy to change the flow resistance through the adjustable flow shunt. (Item 107) Item 107. The method of item 106, wherein applying energy to the first region comprises applying energy to the first region using an energy source positioned external to the patient. (Item 108) Item 107. The method of item 106, wherein the targeting feature increases penetration of the energy into the actuation element in the first region relative to a second region adjacent to the first region. (Item 109) Item 107. The method of item 106, wherein the target feature increases absorption of the energy in the first region relative to a second region adjacent to the first region. (Item 110) Item 107. The method of item 106, wherein the target feature is a recess extending at least partially into the actuation element, and the applied energy penetrates the actuation element at the recess. (Item 111) Item 107. The method of item 106, wherein the target feature is an absorbent coating. (Item 112) Item 107. The method of item 106, wherein the target feature is an oxidized zone in the first region. (Item 113) Item 107. The method of item 106, wherein the adjustable shunt is implanted in the patient's eye to drain water from the anterior chamber of the eye. (Item 114) 1. An implantable device for shunting fluid within a patient, comprising: a drainage element having a lumen extending therethrough; a flow control element movable between at least a first position and a second position and configured to vary flow resistance through the device; an actuating element, at least a portion of which is capable of transitioning from a first material state to a second material state when heated above a transition temperature, the actuating element being configured to move the flow control element from the first position toward the second position when heated above the transition temperature; a biasing element configured to direct energy received at the biasing element toward the actuating element to heat at least the portion of the actuating element above the transition temperature. (Item 115) Item 109. The device of item 108, further comprising a frame coupled to the drainage element, the frame including the deflection element. (Item 116) Item 109. The device of item 108, wherein the deflection element is positioned on the drainage element. (Item 117) Item 109. The device of item 108, wherein the deflecting element is configured to direct received energy in the form of visible and / or infrared electromagnetic radiation towards the actuating element to heat at least the portion of the actuating element. (Item 118) Item 109. The device of item 108, wherein the deflection element is configured to direct received energy in the form of laser energy towards the actuation element to heat at least the portion of the actuation element. (Item 119) Item 109. The device of item 108, wherein the deflection element is constructed from a first material and the actuation element is constructed from a second material, the first material being less absorbent than the second material. (Item 120) Item 115. The device of item 114, wherein the deflecting element includes a reflective element configured to reflect energy toward the actuation element. (Item 121) Item 121. The device of item 120, wherein the reflective element is constructed at least in part from gold, palladium, and / or platinum. (Item 122) Item 121. The device of item 120, wherein the reflective element comprises a mirror. (Item 123) Item 115. The device of item 114, wherein the deflecting element comprises a refractive element configured to refract energy toward the actuating element. (Item 124) Item 124. The device of item 123, wherein the refractive element is constructed at least in part from glass. (Item 125) Item 124. The device of item 123, wherein the refractive element comprises a prism. (Item 126) Item 115. The device of item 114, wherein the device comprises a plurality of deflection elements. (Item 127) Item 115. The device of item 114, wherein the actuation element includes a plurality of actuatable regions and the deflection element includes a plurality of deflection regions, each deflection region of the deflection element corresponding to each actuatable region of the actuation element, such that each actuation region can be selectively actuated by selectively providing energy to the corresponding each deflection region. (Item 128) Item 115. The device of item 114, wherein the first material state is a martensitic material state and the second material state is an austenitic material state. (Item 129) the actuating element is a first actuating element, the biasing element is a first biasing element, and the device a second actuating element, at least a portion of which is transitionable from a third material state to a fourth material state when heated above a transition temperature of the second actuating element, the second actuating element being configured to move the flow control element from the second position toward the first position when heated above the transition temperature of the second actuating element; Item 115. The device of item 114, further comprising: a second biasing element configured to direct energy received at the second biasing element toward the second actuating element to heat the second actuating element above the second actuating element transition temperature. (Item 130) Item 130. The device of item 129, wherein the third material state is a martensitic material state and the fourth material state is an austenitic material state. (Item 131) Item 115. The device of item 114, wherein the implantable device is a glaucoma shunt configured to drain aqueous from the anterior chamber of the patient's eye. (Item 132) 1. An implantable device for shunting fluid within a patient, comprising: a fluid flow path configured to drain fluid from a first location in the patient having a first pressure to a second location in the patient having a second pressure lower than the first pressure; a flow control element movable between at least a first position and a second position and configured to vary flow resistance through the fluid flow path; an actuation element configured, upon actuation, to move the flow control element from the first position toward the second position; a biasing element configured to direct energy received at the biasing element toward the actuation element to actuate the actuation element. (Item 133) Item 133. The device of item 132, further comprising a frame coupled to the fluid flow path, the frame including the deflection element. (Item 134) Item 133. The device of item 132, wherein the deflection element is positioned on the fluid flow path. (Item 135) Item 133. The device of item 132, wherein the deflection element is configured to direct received energy in the form of visible and / or infrared electromagnetic radiation towards the actuation element to activate the actuation element. (Item 136) Item 133. The device of item 132, wherein the deflection element is configured to direct received energy in the form of laser energy towards the actuation element to actuate the actuation element. (Item 137) Item 133. The device of item 132, wherein the deflection element is constructed from a first material and the actuation element is constructed from a second material, the first material being less absorbent than the second material. (Item 138) Item 133. The device of item 132, wherein the deflecting element includes a reflective element configured to reflect energy toward the actuation element. (Item 139) Item 139. The device of item 138, wherein the reflective element is constructed at least in part from gold, palladium, and / or platinum. (Item 140) Item 139. The device of item 138, wherein the reflective element comprises a mirror. (Item 141) Item 133. The device of item 132, wherein the deflecting element comprises a refractive element configured to refract energy toward the actuating element. (Item 142) Item 142. The device of item 141, wherein the refractive element is constructed at least in part from glass. (Item 143) Item 142. The device of item 141, wherein the refractive element comprises a prism. (Item 144) Item 133. The device of item 132, wherein the device comprises a plurality of deflection elements. (Item 145) Item 133. The device of item 132, wherein the actuation element includes a plurality of actuatable regions and the deflection element includes a plurality of deflection regions, each deflection region of the deflection element corresponding to each actuatable region of the actuation element, such that the individual actuation regions can be selectively actuated by selectively providing energy to the corresponding individual deflection region. (Item 146) the actuating element is a first actuating element, the biasing element is a first biasing element, and the device a second actuation element configured, upon actuation, to move the flow control element from the second position toward the first position; and Item 133. The device of item 132, further comprising: a second biasing element configured to direct energy received at the second biasing element toward the second actuating element to actuate the second actuating element. (Item 147) Item 133. The device of item 132, wherein the implantable device is a glaucoma shunt configured to drain aqueous from the anterior chamber of the patient's eye. (Item 148) 1. An implantable device for shunting fluid within a patient, comprising: a drainage element having a lumen extending therethrough; an actuation assembly configured to alter flow resistance through the device, an actuation element, wherein at least a portion of the actuation element is capable of transitioning from a first material state to a second material state when heated above a transition temperature; an actuation assembly including: a biasing element configured to direct energy received at the biasing element toward the actuation element to heat at least the portion of the actuation element above the transition temperature. (Item 149) Item 149. The device of item 148, wherein the deflection element is configured to direct received energy in the form of visible and / or infrared electromagnetic radiation towards the actuation element to heat at least the portion of the actuation element. (Item 150) Item 149. The device of item 148, wherein the deflection element is configured to direct received energy in the form of laser energy toward the actuation element to heat at least the portion of the actuation element. (Item 151) Item 149. The device of item 148, wherein the deflection element is constructed from a first material and the actuation element is constructed from a second material, the first material being less absorbent than the second material. (Item 152) Item 149. The device of item 148, wherein the deflecting element includes a reflective element configured to reflect energy toward the actuating element. (Item 153) Item 153. The device of item 152, wherein the reflective element is constructed at least in part from gold, palladium, and / or platinum. (Item 154) Item 153. The device of item 152, wherein the reflective element comprises a mirror. (Item 155) Item 149. The device of item 148, wherein the deflecting element includes a refractive element configured to refract energy toward the actuating element. (Item 156) Item 156. The device of item 155, wherein the refractive element is constructed at least in part from glass. (Item 157) Item 156. The device of item 155, wherein the refractive element comprises a prism. (Item 158) Item 149. The device of item 148, wherein the device comprises a plurality of deflection elements. (Item 159) Item 149. The device of item 148, wherein the actuation element includes a plurality of actuatable regions and the deflection element includes a plurality of deflection regions, each deflection region of the deflection element corresponding to each actuatable region of the actuation element, such that the individual actuation regions can be selectively actuated by selectively providing energy to the corresponding individual deflection region. (Item 160) Item 149. The device of item 148, wherein the first material state is a martensitic material state and the second material state is an austenitic material state. (Item 161) Item 149. The device of item 148, wherein the implantable device is a glaucoma shunt configured to drain aqueous from the anterior chamber of the patient's eye. (Item 162) 1. A method of shunting fluid using an adjustable flow shunt implanted in a patient and having an actuating element, comprising: applying energy indirectly to the actuation element, wherein indirectly applying energy to the actuation element includes transmitting energy to a biasing element that redirects energy received at the biasing element toward the actuation element; and inducing a geometric change in the actuating element via the energy redirected to the actuating element, the geometric change resulting in a change in flow resistance through the adjustable flow shunt. (Item 163) Item 163. The method of item 162, wherein transmitting energy to the deflecting element comprises transmitting energy to the deflecting element using an energy source positioned external to the patient. (Item 164) Item 163. The method of item 162, wherein the deflecting element is implanted in the patient. (Item 165) Item 165. The method of item 164, wherein the deflection element is coupled to the shunt. (Item 166) 163. The method of claim 162, wherein the energy is visible and / or infrared electromagnetic radiation. (Item 167) Item 163. The method of item 162, wherein the energy is laser energy. (Item 168) Item 163. The method of item 162, wherein the deflection element is constructed from a first material and the actuation element is constructed from a second material, the first material being less absorbent than the second material. (Item 169) Item 163. The method of item 162, wherein the deflecting element includes a reflective element that reflects received energy toward the actuating element. (Item 170) Item 169. The method of item 169, wherein the reflective element is constructed at least in part from gold, palladium, and / or platinum. (Item 171) Item 169. The method of item 169, wherein the reflective element comprises a mirror. (Item 172) Item 163. The method of item 162, wherein the deflecting element includes a refractive element that refracts energy toward the actuating element. (Item 173) Item 173. The method of item 172, wherein the refractive element is constructed at least in part from glass. (Item 174) Item 173. The method of item 172, wherein the refractive element comprises a prism. (Item 175) Item 163. The method of item 162, wherein the adjustable shunt is implanted in the patient's eye to drain water from the anterior chamber of the eye. (Item 176) 1. A method of manufacturing an adjustable shunt having a shunt element, a flow control element, and a shape memory actuation element, comprising: depositing a first material and / or a second material onto a substrate, the first material being deposited in a pattern corresponding to the shunt element and the flow control element, and the second material being deposited in a pattern corresponding to one or more voids in the adjustable shunt; removing the deposited second material, wherein removing the deposited second material (i) creates a lumen extending through the shunt element and (ii) allows the flow control element to move relative to the shunt element; and securing the shape memory actuation element to the flow control element and / or shunt element; The method, wherein the shape memory actuation element is configured to selectively drive movement of the flow control element relative to the shunt element when the shape memory actuation element is secured to the flow control element. (Item 177) Item 177. The method of item 176, wherein depositing the first material and the second material comprises depositing the first material and the second material by a vapor deposition process. (Item 178) Item 177. The method of item 176, wherein depositing the first material and the second material comprises depositing the first material and the second material in individual layers of about 5 microns or less. (Item 179) Item 177. The method of item 176, wherein removing the second material comprises etching away the second material. (Item 180) Item 177. The method of item 176, wherein the first material is a polymer and / or a metal. (Item 181) Item 177. The method of item 176, wherein the first material is palladium, rhodium, and / or a nickel-cobalt alloy. (Item 182) Item 177. The method of item 176, wherein the second material is copper. (Item 183) Item 177. The method of item 176, wherein the shape memory actuation element is constructed from nitinol. (Item 184) 1. A method of manufacturing an adjustable shunt having a shape memory actuation element, comprising: depositing a first material and / or a second material onto a substrate, the first material being deposited in a pattern corresponding to first and second components of the adjustable shunt, and the second material being deposited in a pattern corresponding to one or more voids in the adjustable shunt; removing the deposited second material, wherein after the deposited second material is removed, the first component is at least partially constrained within and movable relative to the second component without requiring assembly of the first component and the second component; and securing the shape memory actuation element to the first component and / or the second component; wherein the shape memory actuation element, when secured to the first component and / or the second component, is configured to selectively drive movement of the first component relative to the second component. (Item 185) Item 185. The method of item 184, wherein depositing the first material and the second material comprises depositing the first material and the second material by a vapor deposition process. (Item 186) Item 185. The method of item 184, wherein depositing the first material and the second material comprises depositing the first material and the second material in individual layers of about 5 microns or less. (Item 187) Item 185. The method of item 184, wherein removing the second material comprises etching away the second material. (Item 188) Item 185. The method of item 184, wherein the first material is a polymer and / or a metal. (Item 189) Item 185. The method of item 184, wherein the first material is palladium, rhodium, and / or a nickel-cobalt alloy. (Item 190) Item 185. The method of item 184, wherein the second material is copper. (Item 191) Item 185. The method of item 184, wherein the first component is a flow control element and the second component is a shunt element. (Item 192) Item 185. The method of item 184, wherein the shape memory actuation element is constructed from nitinol. (Item 193) 1. A method of manufacturing an adjustable flow shunt, comprising: forming a shunt element and a flow control element in an assembled configuration, wherein the flow control element is movable relative to the shunt element, via a layer-by-layer deposition process; A method comprising securing an actuating element to the shunt element and / or the flow control element, the actuating element being configured to selectively move the flow control element relative to the shunt element when secured to the shunt element and / or the flow control element. (Item 194) Item 194. The method of item 193, wherein forming the shunt element and the flow control element comprises simultaneously forming the shunt element and the flow control element. (Item 195) forming the shunt element and the flow control element; depositing a first material and a second material in layers of about 5 microns or less; and etching away the second material to form the shunt element and the flow control element. (Item 196) Item 194. The method of item 193, wherein the layered deposition process is an evaporation deposition process or a chemical deposition process. (Item 197) Item 194. The method of item 193, wherein the actuating element is constructed from nitinol. (Item 198) 1. A method of manufacturing an adjustable shunt having a shunt element and a flow control element, comprising: forming the shunt element and the flow control element in an assembled configuration, wherein the flow control element is movable relative to the shunt element, via a photolithography process; and securing an actuation element to the shunt element and / or the flow control element; The method, wherein the actuation element, when secured to the shunt element and / or the flow control element, is configured to selectively move the flow control element relative to the shunt element. (Item 199) Item 199. The method of item 198, wherein the actuating element is constructed from nitinol. [Brief explanation of the drawings]
[0008] Many aspects of the present technology can be better understood with reference to the following drawings. 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 figures for clarity of illustration only, and this does not necessarily imply that the illustrated components are transparent. Components may also be shown in schematic form.
[0009] [Figure 1A] FIG. 1 is a simplified front view of an eye with an implanted shunt configured in accordance with one embodiment of the present technology. [Figure 1B] FIG. 1B is an isometric view of the eye and implanted shunt of FIG. 1A. [Figure 2] 1 is a perspective view of an adjustable glaucoma treatment device configured in accordance with select embodiments of the present technology; FIG. [Figure 3A] FIG. 3 is a front view of the adjustable glaucoma treatment device shown in FIG. 2, illustrating the path of movement of the arms of the adjustable device in accordance with select embodiments of the present technology. [Figure 3B] 3 is an enlarged view of a portion of the adjustable glaucoma treatment device shown in FIG. 2, illustrating select features of the adjustable device in accordance with select embodiments of the present technology. [Figure 4A] 3A-3C illustrate the adjustable glaucoma treatment device shown in FIG. 2 in two different configurations in accordance with select embodiments of the present technology. [Figure 4B] 3A-3C illustrate the adjustable glaucoma treatment device shown in FIG. 2 in two different configurations in accordance with select embodiments of the present technology. [Figure 4C] 3A-3C illustrate the adjustable glaucoma treatment device shown in FIG. 2 in two different configurations in accordance with select embodiments of the present technology. [Figure 4D] 3A-3C illustrate the adjustable glaucoma treatment device shown in FIG. 2 in two different configurations in accordance with select embodiments of the present technology. [Figure 5A] 1 shows an adjustable glaucoma treatment device configured in accordance with selected embodiments of the present technology. [Figure 5B] 1 shows an adjustable glaucoma treatment device configured in accordance with selected embodiments of the present technology. [Figure 5C] 1 shows an adjustable glaucoma treatment device configured in accordance with selected embodiments of the present technology. [Figure 5D] 1 shows an adjustable glaucoma treatment device configured in accordance with selected embodiments of the present technology. [Figure 6A] 1 shows an adjustable glaucoma treatment device configured in accordance with selected embodiments of the present technology. [Figure 6B] 1 shows an adjustable glaucoma treatment device configured in accordance with selected embodiments of the present technology. [Figure 7A] 10 shows another adjustable glaucoma treatment device configured in accordance with select embodiments of the present technology. [Figure 7B] 10 shows another adjustable glaucoma treatment device configured in accordance with select embodiments of the present technology. [Figure 7C] 10 shows another adjustable glaucoma treatment device configured in accordance with select embodiments of the present technology. DETAILED DESCRIPTION OF THE INVENTION
[0010] The terminology used in the description provided below is intended to be interpreted in its broadest reasonable manner, even when used in conjunction with detailed descriptions of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restrictive manner is clearly and specifically defined as such in this "Detailed Description of the Invention" section. Additionally, the present technology may include other embodiments within the scope of the examples that are not described in detail with respect to FIGS. 1A-7C.
[0011] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with that 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 are not necessarily all referring 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, when reference is made to relative terms such as "generally," "approximately," and "about," this specification is used to mean the stated value plus or minus 10%. Throughout this specification, reference to the term "resistance" refers to fluid resistance unless the context clearly dictates otherwise. The terms "drainage rate," "flow rate," and "flow" are used interchangeably to describe the movement of fluid through a structure.
[0013] While certain embodiments herein are described with respect to shunting fluid from the anterior chamber of the eye, those skilled in the art will understand that the present technology can be readily adapted to shunt fluid from and / or between other portions of the eye, or more generally, from and / or between a first body region and a second body region. Furthermore, while certain embodiments herein are described in the context of treating glaucoma, any embodiment herein, including those referred to as "glaucoma shunts" or "glaucoma devices," may nevertheless be used and / or modified to treat other diseases or conditions, including other diseases or conditions of the eye or other body regions. For example, the systems described herein can be used to treat diseases characterized by increased pressure and / or fluid 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. Furthermore, although generally described with respect to shunting water, 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 claimed technology.
[0015] A. Intraocular shunts for the treatment of glaucoma Glaucoma refers to a group of eye diseases associated with optic nerve damage, ultimately leading to vision loss and blindness. As mentioned above, glaucoma is a degenerative ocular condition characterized by increased intraocular pressure resulting from increased intraocular water production and / or a decreased rate of water outflow from the eye into the bloodstream. Over time, this increased pressure leads to optic nerve damage. Unfortunately, patients often do not experience symptoms of increased intraocular pressure until glaucoma develops. Therefore, patients typically must be closely monitored once increased pressure is identified, even if they are symptomless. Monitoring continues throughout the course of the disease, allowing clinicians to intervene early to halt disease progression. Pressure monitoring requires patients to visit the clinic regularly, which is expensive, time-consuming, and inconvenient. Early stages of glaucoma are typically treated with medications (e.g., eye drops) and / or laser treatment. However, when medication / laser treatments are insufficient, surgical approaches can be used. Surgical or minimally invasive approaches primarily attempt to increase the outflow of water from the anterior chamber into the bloodstream by either creating alternative fluid pathways or enhancing the natural pathways for aqueous outflow.
[0016] 1A and 1B illustrate a human eye E and a suitable location where a shunt may be implanted within the eye E, according to an embodiment of the present technology. More specifically, FIG. 1A is a simplified front view of the eye E with a shunt 100 implanted therein, 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 several muscles for controlling 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 10. The eye E also includes an iris, a pupil, and a limbus.
[0017] 1A and 1B , the shunt 100 can have a drainage element 105 (e.g., a drain) positioned such that the inflow portion 101 is positioned within the anterior chamber of the eye E and the outflow portion 102 is positioned 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 can extend superiorly, inferiorly, medially, and / or laterally from the anterior chamber. Depending on the design of the shunt 100, the outflow portion 102 can be placed in a number of different suitable outflow locations (e.g., between the choroid and sclera, between the conjunctiva and sclera, etc.).
[0018] Outflow resistance can change over time for a variety of reasons, such as, for example, as the outflow location undergoes a healing process after surgical implantation of a shunt (such as shunt 100) or due to further blockages in the drainage network from the anterior chamber through the trabecular meshwork, Schlemm's canal, collector channels, and ultimately the veins and the body's circulatory system. Thus, in response to such changes or other clinical reasons, a clinician may wish to modify the shunt after implantation to either increase or decrease outflow resistance. For example, in many procedures, the shunt is modified at the time of implantation to temporarily increase outflow resistance. After a period of time determined to be sufficient to allow tissue healing and stabilization of outflow resistance, the modification to the shunt is reversed, thereby decreasing outflow resistance. In another example, a clinician may implant a shunt and, after subsequent monitoring of intraocular pressure, determine whether modification of the drainage rate through the shunt is desired. Such modifications can be invasive, time-consuming, and / or expensive for the patient. However, failure to follow such procedures increases the likelihood of creating hypotony (excessively low intraocular pressure), which can lead to 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 fluid flow through the shunt after implantation without additional invasive surgical procedures.
[0019] The shunts described herein can be implanted with a first drainage rate and then remotely adjusted to achieve a second, different drainage rate. The adjustment can be based on the needs of the individual patient. For example, the shunt can be implanted with a first, lower flow rate and then adjusted to a second, higher flow rate if clinically indicated. 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 various shapes and configurations to accommodate the various shapes of the shunts described herein. Details of the implantation procedure, implant device, and bleb formation are described in more detail in International Patent Application No. PCT / US20 / 41152, the disclosure of which is incorporated herein by reference for all purposes.
[0020] In many of the embodiments described herein, the flow control assembly is configured to incorporate features that selectively impede or attenuate fluid flow through the shunt during operation. In this manner, the flow control assembly can vary the flow resistance through the shunt in a stepwise or continuous manner 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 and accommodate many variables (e.g., IOP, water production rate, natural water outflow resistance, and / or natural water outflow rate) 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 within a patient and modified / adjusted over time without further invasive surgery or procedures on the patient. Furthermore, because the devices disclosed herein can be actuated via energy from an external energy source (e.g., a laser), such devices do not require any additional power to maintain a desired orientation or position. Rather, the actuators / fluidic resistors disclosed herein can maintain a desired position / orientation without power. This can significantly increase the usable lifespan of such devices, allowing them to be effective long after the initial implant procedure.
[0022] B. Operation of the actuating element Some embodiments of the present technology include an actuation assembly (e.g., flow control assembly, flow control mechanism, etc.) having at least one actuation element coupled to a movable element (e.g., an arm, a control element, a gate element, a flow control element, a rack element, etc.). As described in detail below, the movable element can be configured to interface with a lumen (FIGS. 2A-4D) and / or to interface with (e.g., at least partially block) a port providing inflow or outflow to the lumen (FIGS. 5A-5D and 7A-7C). Movement of the actuation element generates (e.g., translational and / or rotational) movement of the movable element.
[0023] The actuating element can include a shape memory material (e.g., a shape memory alloy or a shape memory polymer). Movement of the actuating element can be generated by applied stress and / or the use of the shape memory effect (e.g., driven by a temperature change). The shape memory effect allows a deformation that alters the element from its preferred geometric configuration (e.g., an original or fabricated configuration, a shape-set configuration, a heat-set configuration, etc.) to be largely or completely reversed during operation of the actuating assembly. For example, thermal actuation (heating) can reverse the deformation by inducing a change in state (e.g., a phase change) in the actuator material, inducing a temporary increase in internal stress that promotes the shape change to the preferred geometric configuration. In the case of a shape memory alloy, the change in state can be a change 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 temperature or a melting temperature. The change in state can reverse the deformation of the material, e.g., to its preferred geometric configuration, without applying any (e.g., external) stress to the actuating element. That is, a deformation imparted to a material at a first temperature (e.g., body temperature) can be recovered and / or modified (e.g., thermally) by raising the material to a second (e.g., higher) temperature. Upon cooling (and changing state, e.g., returning to the martensitic phase), the actuating element retains its preferred geometric configuration. When the material is in this relatively cooler state, less force or stress may be required to thermoelastically deform the material, and then, when an external stress is applied, the actuating element can again deform from its original geometric configuration.
[0024] The actuating element can be processed such that the transition temperature (e.g., the austenite start temperature, the austenite finish temperature, etc.) at which a change in state occurs is above a threshold temperature (e.g., body temperature). For example, the transition temperature can be set to about 45°C, about 50°C, about 55°C, or about 60°C. In some embodiments, the actuator material is heated from body temperature to a temperature above the austenite start temperature (or alternatively, above the R-phase start temperature, the austenite finish temperature, or the R-phase finish temperature) such that the upper plateau stress of the material in the first state (e.g., the thermoelastic martensite phase or the thermoelastic R-phase at body temperature) (e.g., "UPS_body temperature") is 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, the actuator material is heated from body temperature to a temperature above the austenite start temperature (or alternatively, above the R-phase start temperature) such that the upper plateau stress of the material in the first state (e.g., thermoelastic martensite or thermoelastic R-phase at body temperature) is lower than the lower plateau stress of the material in the heated 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, the actuator material is heated from body temperature to a temperature above the austenite start temperature (or alternatively, above the R-phase start temperature) such that the upper plateau stress of the material in the first state (e.g., thermoelastic martensite or thermoelastic R-phase) is higher than the lower plateau stress of the material in the heated state, thereby achieving partial or complete free recovery. For example, the actuator material can be aged such that LPS_activation temperature < UPS_body temperature.
[0025] The actuating assembly can be formed such that the actuating elements have a preferred geometric configuration (e.g., a memory shape, or length, L0) that is substantially the same. When the actuating assembly is introduced (e.g., implanted) into a patient, at least one (e.g., the first) actuating element / shape memory element is deformed relative to its preferred geometric configuration (e.g., such that L1≠L0), while at least one other opposing (e.g., the second) actuating element / shape memory element positioned adjacent to the first actuating element can be assembled such that it is substantially in its preferred geometric configuration (e.g., L0). However, in other embodiments, both the first and second actuating elements can be deformed relative to their corresponding preferred geometric configurations when introduced into the patient (e.g., the first actuating element is contracted relative to its preferred geometric configuration and the second actuating element is expanded relative to its preferred geometric configuration).
[0026] In some embodiments of the present technology, L1>L0. For example, the deformed first actuating element is stretched relative to its preferred "shape memory" length. In some embodiments, L1<L0. For example, the deformed first actuating element is compressed relative to its preferred shape memory length. The actuating assembly can be formed such that its overall dimensions (e.g., overall length) are substantially fixed during operation (e.g., L0+L1 = constant). For example, the (e.g., outermost) end portions of the actuating elements can be fixed such that movement of the actuating elements occurs between fixed points. Along with the length, the overall geometric shape of the actuating element can be selected such that deformation within the actuating element remains below about 10%, about 9%, about 8%, about 7%, about 6%, about 5%, about 4%, about 3%, about 2%, or about 1% during operation.
[0027] The (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. The movement can be deflection or deformation. During operation, selective heating of a first actuating element of the actuation assembly moves and / or directs the first actuating element to its preferred geometric configuration (e.g., from L1 back to L0) and moves the associated movable element. Simultaneously, movement of the first actuating element causes corresponding movement of the second actuating element in the opposite direction. For example, contraction of the first actuating element accompanies (e.g., causes) stretching of the second actuating element (e.g., from L0 to L1). The second actuating element is not heated (e.g., remains at body temperature), and therefore the second actuating element deforms (e.g., remains martensite and stretches). Following heating, the first actuating element cools and returns to an LPS state, moving to an equilibrium point relative to the second actuating element. To reverse the configuration of the actuating assembly (e.g., the position of the movable element), the second actuating element is heated to move and / or orient it toward its preferred geometric configuration (e.g., from L1 to L0). The return of the second actuating element toward its preferred geometric configuration causes the movable element to move back to its previous position, stretching the first actuating element (e.g., from L0 to L1). The position of the movable element of the actuating assembly can be repeatedly toggled (e.g., between an open and a closed state) by repeating the above-described operation. Heating of the actuating element can be achieved by application of incident energy (e.g., via laser or inductive coupling). Additionally, as mentioned above, the source of incident energy can be external to the patient's body (e.g., non-invasive).
[0028] C. Adjustable glaucoma shunt Some embodiments of the present technology are directed to an adjustable device for treating glaucoma. The device can include a drainage element having a lumen extending therethrough for draining aqueous from the anterior chamber. Some embodiments include an actuation assembly that can drive movement of a flow control element to vary the flow resistance through the lumen, thereby increasing or decreasing the relative drainage rate of aqueous from the anterior chamber. In particular, some embodiments of the present technology provide an adjustable device that can be selectively titrated to provide various levels of treatment. For example, the device can be adjusted through several positions or configurations, with each position or configuration representing a different relative flow resistance and / or drainage rate relative to other positions or configurations. Thus, the device can be adjusted incrementally until the desired flow resistance and / or drainage rate is achieved. Once achieved, the device is configured to maintain the set position or configuration until further input. In some embodiments, various components of the device operate as a ratchet mechanism that facilitates incremental adjustment of the device between multiple positions or configurations, and can hold or lock the device in a desired position or configuration.
[0029] FIG. 2 illustrates an adjustable glaucoma treatment device 200 (“device 200”) configured in accordance with select embodiments of the present technology. Device 200 includes a base 202 (e.g., a plate) and a lumen 204 extending through at least a portion of base 202. Lumen 204 extends between an inflow port 204a positionable within the anterior chamber and an outflow port 204b positionable within a desired outflow location, such as the bleb space (FIG. 4A). As described in more detail below, base 202 comprises an at least partially solid structure that provides a mounting surface for various components of device 200. Base 202 can be constructed from any biocompatible material suitable for implantation in the human eye and / or can include a biocompatible coating. When implanted in a patient's eye, device 200 is configured to drain water from the anterior chamber of the eye to a desired outflow location (e.g., the bleb space). Thus, in at least some embodiments, lumen 204 is configured to be in fluid communication with and receive fluid from the anterior chamber of the eye.
[0030] The device 200 includes a frame 206 extending from the base 202 (e.g., as a ridge or other feature offset from a surface of the base 202). The frame 206 includes a first fixation element 206a, a second fixation element 206b, and a spine 206c extending therebetween. In some embodiments, the first fixation element 206a and the second fixation element 206b can extend from opposite end portions of the spine 206c and are generally perpendicular thereto. In the illustrated embodiment, the spine 206c is at least partially offset from a laterally extending central axis of the device 200, and the first fixation element 206a and the second fixation element 206b extend generally toward the laterally extending central axis of the device 200. In some embodiments, as described in more detail below, spine 206c can optionally have a deflecting surface 208 configured to redirect (e.g., reflect or refract) energy (e.g., laser energy) from an energy source positioned outside the eye to actuation assembly 210. In some embodiments, frame 206 can be fixed to or integral with base 202 such that frame 206 does not move relative to base 202 when device 200 is adjusted.
[0031] Device 200 further includes actuation assembly 210, arm 220, and rack element 230. In some embodiments, actuation assembly 210, arm 220, and rack element 230 together operate as a ratchet mechanism to selectively change the shape and / or size (e.g., length, width, or other dimension) of lumen 204 and / or to selectively change the resistance to flow through lumen 204. For example, as described in more detail below, actuation assembly 210 can move arm 220 and rack element 230 through a plurality of positions. As described with respect to FIGS. 4A-4C , at least a portion of rack element 230 may be positionable within lumen 204 such that actuation of actuation assembly 210 moves rack element 230 relative to lumen 204 to change the resistance to flow through lumen 204. Thus, actuation assembly 210, arm 220, and rack element 230 allow a user to selectively adjust the therapy provided by device 200.
[0032] The actuation assembly 210 can include a first actuation element 212 and a second actuation element 214. The first actuation element 212 and the second actuation element 214 can resemble at least partially flat (e.g., linear) springs and, therefore, can have a generally serpentine or curved shape with several expandable and contractible flex regions. For example, in the illustrated embodiment, the first actuation element 212 includes a first end portion 212a, a first flex region 212b, a second flex region 212c, a third flex region 212d, a fourth flex region 212e, and a second end portion 212f. Similarly, the second actuating element 214 includes a first end portion 214a, a first flex region 214b, a second flex region 214c, a third flex region 214d, a fourth flex region 214e, and a second end portion 214f. However, in other embodiments, the first actuating element 212 and / or the second actuating element 214 can have a different number of flex regions than those shown in FIG. 2. For example, the first actuating element 212 and / or the second actuating element 214 can have one, two, three, four, five, or more flex regions. As described in more detail below, the actuating elements 212, 214 are configured to expand and / or contract at their respective flex regions as the actuating assembly 210 is actuated.
[0033] The first actuating element 212 generally extends between the first fixation element 206a and the arm 220. For example, the first end portion 212a of the first actuating element 212 can be received within the first notch 207a of the first fixation element 206a (e.g., via a friction fit), and the second end portion 212f can be connected to the arm 220 at the first end portion 220a. The second actuating element 214 generally extends between the second fixation element 206b and the arm 220. For example, the first end portion 214a of the second actuating element 214 can be received within the second notch 207b of the second fixation element 206b (e.g., via a friction fit), and the second end portion 212f can be connected to the arm 220 at the first end portion 220a. Thus, the first end portion 220 a of the arm 220 is generally between the first actuating element 212 and the second actuating element 214 .
[0034] As described above in Section B, the first actuating element 212 and the second actuating element 214 can comprise a shape memory material configured to at least partially transition from a first phase / state (e.g., a martensitic or intermediate state) to a second phase / state (e.g., an intermediate or austenitic state) upon application of energy. In some embodiments, for example, the first actuating element 212 and the second actuating element 214 can be comprised of a shape memory alloy, such as Nitinol. In some embodiments, the phase change corresponds to a dimensional change of the actuating element. Thus, the first actuating element 212 and the second actuating element 214 can change shape (e.g., expand and / or contract in length, width, etc.) in response to exposure to energy, such as light, heat, etc., that creates an increase in the temperature of the material. In such embodiments, the actuating assembly 210 can be selectively actuated by applying energy directly or indirectly to the first actuating element 212 and / or the second actuating element 214. In some embodiments, the energy can be applied from an energy source (e.g., a laser) positioned external to the eye. In some embodiments, one or more heating wires can be threaded through or wrapped around at least a portion of the actuation element, and energy can be applied to provide resistive heating to the desired actuation element by operating at least one of the heating wires. In some embodiments, actuation assembly 210 can be remotely actuated.
[0035] The first actuating element 212 and the second actuating element 214 generally act in opposite directions as the actuating assembly 210 is actuated. However, the distance between the first and second locking elements 206a, 206b does not change as the actuating assembly 210 is actuated. Thus, actuation of the first actuating element 212, which causes a first shape change in the first actuating element 212, causes a corresponding deformation or second shape change in the second actuating element 214. For example, when the first actuating element 212 is actuated (e.g., via heat), the first actuating element 212 can straighten (e.g., lengthen, expand, etc.) at one or more bending regions 212b-e, thereby increasing the distance between two adjacent bending regions 212b-e. Because the first fixed element 206a is fixed to the base 202 and does not move as the first actuating element 212 changes shape, the second actuating element 214 is compressed at one or more bending regions 214b-e to account for the shape change of the first actuating element 212. This reduces the distance between two adjacent bending regions 214b-e and pushes the first end portion 220a of the arm 220 toward the second fixed element 206b. This movement can be reversed when the second actuating element 214 is actuated (e.g., heated). For example, when the second actuating element 214 is actuated, the second actuating element 214 can straighten (e.g., lengthen, expand, etc.) at one or more bending regions 214b-e, thereby increasing the distance between two adjacent bending regions 214b-e. Because the second fixed element 206b is fixed to the base 202 and does not move as the second actuating element 214 changes shape, the first actuating element 212 is compressed at one or more flex regions 212b-e to account for the shape change of the second actuating element 214. This reduces the distance between two adjacent flex regions 212b-e, forcing the first end portion 220a of the arm 220 back toward the first fixed element 206a. Although described as extending upon actuation, the first and second actuating elements 212, 214 can alternatively be under tension (e.g., lengthening) relative to their preferred geometric shapes such that actuation of the first or second actuating elements 212, 214 causes the actuating elements to contract (e.g., shorten).
[0036] In some embodiments, individual flex regions 212b-e on the first actuating element 212 and individual flex regions 214b-e on the second actuating element 214 can be individually targeted to increase the granularity of actuation. In some embodiments, individual flex regions 212b-e can include corresponding targets 213b-e. Similarly, individual flex regions 214b-e can include corresponding targets 215b-e. The targets 213b-e and 215b-e can be recesses, wells, channels, divots, or other features configured to facilitate penetration of energy into the corresponding flex regions of the actuating elements, thereby providing relatively more uniform heating of the entire thickness of the actuating element 212 or 214 at the targeted flex regions. For example, target 213b is a cylindrical recess extending at least partially into the first actuating element 212 at the first flex region 212b. Application of energy to target 213b is expected to provide more uniform heating across the entire thickness of first actuating element 212 at first bending region 212b (as opposed to heating only the surface of first actuating element 212). Without being bound by theory, it is expected that the relatively uniform application of energy across the entire thickness of various regions of actuating elements 212 and 214 will, in turn, improve the repeatability and consistency of the movement of actuating elements 212 and 214, which is expected to increase the accuracy of adjustments to lumen 204.
[0037] In some embodiments, targets 213b-e and 215b-e can include a material or coating that is more absorbent than the portions of the flexure region and actuation element surrounding the target. For example, targets 213b-e and 215b-e can be oxidized, such as using titanium dioxide, to create a "blackening" effect that causes targets 213b-e and 215b-e to absorb energy more readily than the surrounding region. By being more absorbent, targets 213b-e and 215b-e retain more energy and heat more readily than the surrounding region, enabling selective actuation of individual flexure regions corresponding to targets 213b-e and 215b-e without inducing substantial phase and / or shape changes in the surrounding material. In such embodiments, targets 213b-e and 215b-e can cover a larger surface area of the corresponding flexure region than shown in FIG. 2 (e.g., the oxidized surface occupies the entire flexure region). Without being bound by theory, making targets 213b-e and 215b-e more absorptive than the surrounding areas is expected to improve the granularity and consistency of movement of actuating elements 212 and 214, which in turn is expected to increase the precision of adjustment to lumen 204. In some embodiments, the material or coating may further provide a thermal barrier that reduces energy transfer between actuating elements 212, 214 and their surrounding environment.
[0038] In some embodiments, the portions of the first actuating element 212 between adjacent targets 213b-e and the portions of the second actuating element 214 between adjacent targets 215b-e may include a material or coating that is more reflective than the targets 213b-e and 215b-e themselves. This may be true regardless of whether the targets 213b-e and 215b-e themselves have a coating or are otherwise treated to increase their absorbency. In such embodiments, energy received at the reflective portions between the targets 213b-e and 215b-e is generally reflected and does not substantially heat the corresponding actuating element. However, in some embodiments, energy received at the targets 213b-e and 215b-e may indirectly heat the surrounding reflective portions. Without being bound by theory, making the area between targets 213b-e and 215b-e more reflective than targets 213b-e and 215b-e is expected to improve the granularity and consistency of the movement of actuating elements 212 and 214, which in turn is expected to increase the accuracy of adjustment to lumen 204.
[0039] The rack element 230 can be a movable linear rack having a plurality of teeth 231 and a plurality of corresponding grooves 232 between the teeth 231, although other suitable configurations are within the scope of the present technology. In some embodiments, for example, the rack element 230 can be a sawtooth wire or other suitable feature that provides a frictional interface with the engagement element 223. A distal end portion (not shown) of the rack element 230 can be at least partially positioned within the lumen 204 (FIGS. 4A-4D). The rack element 230 can include two, three, four, five, six, seven, eight, or more grooves 232. As will be understood by those skilled in the art from the following description, increasing the number of grooves 232 on the rack element 230 generally increases the number of distinct positions the rack element 230 can occupy. The number of grooves 232 can be increased by increasing the overall length of the rack element 230 and / or decreasing the spacing between adjacent grooves 232 (e.g., increasing the pitch of the grooves 232). Increasing the pitch of the grooves 232 may generally increase the granularity of the potential flow resistance adjustment by allowing relatively smaller movements of the rack element 230 .
[0040] In at least some configurations, rack element 230 can be operably coupled to actuation assembly 210 via arm 220. As described in detail below with reference to FIGS. 3A and 3B, actuation assembly 210, through arm 220, can move rack element 230 to a plurality of different positions. As described in detail below with reference to FIGS. 4A-4D, linear movement of rack element 230 through a plurality of positions adjusts the relative flow resistance through lumen 204. For example, as described below, in some embodiments, a portion of rack element 230 itself (e.g., a distal end portion) can function as a flow control element configured to directly change the shape and / or size of lumen 204 and / or directly change the flow resistance through the lumen. In such embodiments, the distal end portion can have a substantially uniform cross-section (e.g., the distal end portion does not have grooves 232 and corresponding teeth 231). In other embodiments, the flow control element is separate from, but coupled to, rack element 230. Thus, in various embodiments, the rack element 230 may directly engage the lumen 204 (e.g., by occupying a portion of the lumen 204 and / or pushing against the lumen 204) or may indirectly engage the lumen 204 (e.g., by moving a plug, dam, or other flow control element to at least partially block and / or at least partially unblock the lumen 204).
[0041] Device 200 further includes channel 240, which serves as a track for rack element 230, such that movement of rack element 230 is constrained to a predetermined linear track. In some embodiments, as shown in FIG. 2, channel 240 can be an elongated recess in base 202 that is sized and shaped to retain rack element 230. As actuation assembly 210 drives rack element 230 through multiple positions, rack element 230 can slide within the length of channel 240. However, in other embodiments, channel 240 is not necessarily an elongated recess, but rather has another configuration suitable for constraining rack element 230 to a predetermined path of motion.
[0042] The arm 220 has a first end portion 220a coupled to the actuation assembly 210 and a second end portion 220b configured to engage with the rack element 230. In the illustrated embodiment, the arm 220 is generally elbow- or "L"-shaped, although in other embodiments, the arm 220 may have other suitable shapes (e.g., "T"-shaped, "I"-shaped, etc.). The second end portion 220b of the arm 220 includes an engagement element 223 (e.g., a pawl) that can fit within a groove 232 on the rack element 230. The engagement element 223 can thus mechanically couple the arm 220 to the rack element 230 such that movement of the arm 220 causes corresponding movement of the rack element 230. The second end 220b of the arm 220 further includes a first recess 222a, a second recess 222b, and a third recess 222c. 3B and described below, first recess 222a and third recess 222c may be formed at an acute angle relative to a longitudinal axis of arm 220. As described in more detail below, first recess 222a, second recess 222b, and third recess 222c allow second end portion 220b of arm 220 to disengage from rack element 230 when actuation assembly 210 is actuated.
[0043] In some embodiments, frame 206 includes surface 208 configured to deflect (e.g., reflect and / or refract) energy toward first actuating element 212 and / or second actuating element 214. In such embodiments, first actuating element 212 and / or second actuating element 214 can be actuated by directing energy (e.g., from an energy source external to the patient) toward surface 208 rather than directly toward first actuating element 212 (e.g., target 213b-e) or second actuating element (e.g., target 215b-e). In other embodiments, energy can be directed toward surface 208 in addition to directing energy toward first actuating element 212 or second actuating element 214. As energy is applied to surface 208, surface 208 deflects the received energy and redirects it toward the corresponding actuating element, driving a shape change of the actuating element. In some embodiments, surface 208 can include distinct targets or zones (not shown) that direct energy to corresponding individual bending regions 212b-e or 214b-e. In some embodiments, first actuating element 212 (e.g., targets 213b-e) and / or second actuating element 214 (e.g., targets 215b-e) are treated with an absorbing material or otherwise configured to absorb deflected energy. Without being bound by theory, it is expected that the use of surface 208 can enable energy application to otherwise blocked or hard-to-reach surfaces of the actuating elements (e.g., surfaces facing base 202 and / or surfaces facing the back of the eye). Surface 208 can include any material suitable for deflecting energy (e.g., laser energy). For example, surface 208 can be constructed from materials such as gold, palladium, platinum, etc., and can be configured to reflect energy such as visible and / or infrared electromagnetic radiation. In another example, surface 208 may be constructed of a material, such as glass, and may be configured to refract energy, such as visible and / or infrared electromagnetic radiation.
[0044] In some embodiments, the deflecting surface 208 extends from or is otherwise at least partially spaced apart from the frame 206. For example, the deflecting surface 208 may be a prism, mirror, or other refractive or reflective structure that is tethered to or decoupled from the frame 206 rather than being directly carried by the frame 206. In such embodiments, the deflecting surface 208 may be used in a manner similar to that described above to indirectly drive the actuation of the actuating elements 212, 214. However, in such embodiments, most (or all) of the frame 206 may be located within the eye but outside the anterior chamber (e.g., externally, on the sclera, or in another area not directly accessible via laser energy), while the deflecting surface 208 is positioned within the anterior chamber (e.g., so as to be accessible via laser energy). The actuating elements 212, 214 can be actuated by applying energy (e.g., laser energy) to the deflecting surface 208 positioned in the anterior chamber, which then redirects the energy toward the actuating elements 212, 214 positioned substantially outside the anterior chamber. Without being bound by theory, spacing the deflecting surface 208 away from the frame 206 may allow a significant portion of the device 200 to remain outside the anterior chamber, reducing associated complications (e.g., endothelial cell loss).
[0045] Device 200 may further include first blocking element 224a and a second blocking element (not shown) positioned on the opposite side of arm 220 from first blocking element 224a. First blocking element 224a and second blocking element may be knobs, tabs, or other features that prevent arm 220 from disengaging from rack element 230 in at least some configurations. However, first blocking element 224a and second blocking element are sized and shaped such that they can fit through at least one of the recesses (first recess 222a, second recess 222b, and / or third recess 222c) on arm 220. As described in more detail below, this allows arm 220 to disengage from rack element 230 during actuation of actuation assembly 210.
[0046] The device 200 can further include a locking mechanism 235 including a fixed arm 237 having a locking element 236 (e.g., a pawl) that fits into a groove 232 on the rack element 230. The fixed arm 237 can be secured to or integral with the base 202 to prevent the fixed arm 237 from moving relative to the base 202. The locking element 236 can prevent movement of the rack element 230 within the channel 240 when the arm 220 disengages from the rack element 230, as described below with respect to FIG. 3 . In some embodiments, the force required to move the locking element 236 out of the corresponding groove 232 is less than the force required to move the engagement element 223 of the arm 220 out of the corresponding groove 232. Thus, when the actuation assembly 210 is actuated, the engagement element 223 initially remains in the same groove 232, moving the rack element 230 and the locking element 236 into a groove different from the original groove. However, once the arm 220 disengages from the rack element 230, the locking element 236 remains in the same groove 232, preventing further movement of the rack element 230.
[0047] In some embodiments, the locking arm 237 can include a shape memory material configured to at least partially transition from a first phase / state (e.g., a martensite or R-phase state) to a second phase / state (e.g., an R-phase or austenite state) upon application of energy. In some embodiments, for example, the locking arm 237 can be constructed from a shape memory alloy, such as Nitinol. In some embodiments, the phase change corresponds to a dimensional change (e.g., length, width, etc.) of the locking arm 237. For example, the locking arm 237 can be moved from a first position ( FIG. 2 ) in which the locking element 236 engages the rack element 230 and a second position (not shown) in which the locking element 236 disengages from the rack element 230. In such embodiments, the locking arm 237 can be selectively actuated to engage the rack element 230 when the arm 220 disengages from the rack element 230, thereby preventing movement of the rack element 230. Similarly, the locking arm 237 can be selectively actuated to disengage from the rack element 230 during actuation of the actuation assembly 210, thereby allowing movement of the rack element 230. By actively moving the locking mechanism 235 between the engaged and disengaged positions, the force required to disengage the rack element 230 from the locking mechanism 235 need not be less than the force required to move the engaging elements 223 of the arms 220 out of the corresponding grooves 232. Rather, the locking mechanism 235 can simply be actively moved from the rack element 230 prior to actuation of the actuation assembly 210.
[0048] Device 200 may include additional components or features not shown. In some embodiments, for example, device 200 includes a cover or other feature configured to mate with base 202 to provide a protective housing for certain aspects of device 200, such as actuation assembly 210, arm 220, rack element 230, and / or locking mechanism 235. The cover can reduce and / or prevent bodily tissue from interfering with the function of the aforementioned components. Device 200 may also include a funnel or inflow element that directs fluid (e.g., water) into input port 204a of lumen 204. Device 200 may also include a drainage element that extends lumen 204 to a desired drainage location (e.g., a bleb space). The drainage element may be a linear tubular element, a bent tubular element, or any other element capable of transporting fluid from lumen 204 to a desired outflow location.
[0049] 3A illustrates a first path 301 (indicated by a solid arrow) and a second path 302 (indicated by a dashed arrow) along which the arm 220 can move during actuation of the actuation assembly 210. By way of example, when the first actuation element 212 is actuated, the arm 220 moves toward the locking mechanism 235. During this initial phase, the first blocking element 224a prevents nonlinear movement of the arm 220 and instead moves the second end portion 220b of the arm 220 from Position A to Position B (e.g., along an axis extending parallel to the axial length of the second end portion 220b of the arm 220 and the axial length of the rack element 230). Due to the connection between the engagement element 223 and the first groove 232a, actuation of the first actuation element 212 initially causes the rack element 230, along with the arm 220, to slide toward the locking mechanism 235. As discussed above, because the fit between locking element 236 and its corresponding groove 232 (e.g., third groove 232c) is weaker than the fit between engaging element 223 and first groove 232a, movement of rack element 230 toward locking mechanism 235 (from position A to position B) causes locking element 236 to disengage from third groove 232c and move into fourth groove 232d. As discussed above, this movement of rack element 230 changes the properties of lumen 204, affecting the flow of fluid therethrough.
[0050] As the arm 220 moves toward position B, a first recess 222a (FIG. 3B) on the arm 220 aligns with the first block element 224a. Referring to FIG. 3B, the first recess 222a can extend through the arm 220 at an acute angle (e.g., non-perpendicular) to the longitudinal axis of the arm 220. Thus, when the arm reaches position B, the first recess 222a receives the first block element 224a. Referring to FIG. 3A, this causes the second end portion 220b of the arm 220 to disengage from the rack element 230 and swing outward from position C as the first block element 224a slides through the first recess 222a. When the second end 220b is in position C, the engagement element 223 is no longer positioned within the first groove 232a, and the arm 220 is disengaged from the rack element 220. However, as described above, the rack element 230 retains its position due to the engagement between the locking element 236 and the fourth groove 232d.
[0051] In some embodiments, second end portion 220b remains in position C until further actuation of actuation assembly 210. For example, when first actuation element 212 is actuated to change shape (e.g., expand, lengthen, etc.) and move second end portion 220b from position A to position B to position C, actuation assembly 210 can hold that position (actuation assembly 210 exhibits little or no recoil) until further energy is input into the system. In such embodiments, energy (heat) must be applied to second actuation element 214 to drive actuation assembly 210 back to its original configuration, as described above with respect to FIG. 2 . In such embodiments, when second actuation element 214 is actuated to change shape (e.g., expand, lengthen, etc.), second end portion 220b moves from position C to position D while arm 220 remains disengaged from rack element 230. At position D, second recess 222b can align with first block element 224a, allowing arm 220 to swing back toward rack element 230 and engaging element 223 to re-engage rack element 230 in a second groove 232 (not visible in FIG. 3A ) that is different from first groove 232a. At this point, second end 220b of arm returns to position A.
[0052] In some embodiments, the first actuating element 212 exhibits a partial or complete recoil or rebound effect (e.g., a return to and / or movement toward a pre-actuation geometric shape). In such embodiments, once the applied energy (e.g., heat) dissipates such that the first actuating element 212 has a temperature drop below its transition temperature, the first actuating element 212 returns to and / or is pushed back toward its original pre-energization shape. For example, once the first actuating element 212 returns to a pre-actuation thermoelastic material state (e.g., a martensitic material state), a force applied to the first actuating element 212 by the second actuating element 214 and / or another elastic element (e.g., a spring) can (e.g., automatically) drive the first actuating element 212 to and / or toward its pre-actuation shape. In such embodiments, the second actuating element 214 does not need to be actuated to move the arm second end portion 220b from position C to position D. Rather, the recoil of the first actuating element 212 moves the arm's second end portion 220b from position C to position D (and thus back to position A when the second recess 222b aligns with the first block element 224a). In some embodiments, the recoil effect can be achieved by keeping the strain induced in the non-actuated actuating element (e.g., the second actuating element 214) below a threshold value (e.g., below about 10%, below about 5%, etc.). Without being bound by theory, maintaining the strain induced in the non-actuated actuating element below a threshold value causes the non-actuated actuating element 212 to resume the shape shown in FIG. 2 (e.g., its original shape) when the first actuating element 212 cools below a transition temperature. This resets the actuating assembly 210 to the original configuration shown in FIG. 2. As one skilled in the art will appreciate, the recoil effect can be achieved by manipulating material properties in other suitable ways than those explicitly disclosed herein. A recoil effect may also be achieved by including a spring or other elastomeric material that biases the first actuation element 212 toward its pre-actuation shape.The biasing force of the spring or other elastomeric material is generally low enough that the first actuating element 212 still undergoes a shape change (e.g., acts against a biasing force) when the first actuating element 212 is heated above its transition temperature. However, the biasing force can be high enough to urge the first actuating element 212 to and / or toward its pre-actuation shape after the first actuating element 212 cools below its transition temperature and returns to its pre-actuation thermoelastic material state (e.g., martensitic material state).
[0053] Regardless of whether actuation assembly 210 exhibits a recoil effect, the net result of arm 220 moving along first path 301 is movement of rack element 230 in a first direction relative to base 202 and lumen 204. For example, actuation of actuation assembly 210 to move arm 220 through first path 301 may move rack element 230 from a first position that imparts a first size, shape, and / or geometry to lumen 204 to a second position that imparts a second size, shape, and / or geometry to lumen 204 that is different from the first size, shape, and / or geometry. As a result, the first position can provide a first flow resistance through lumen 204, and the second position can provide a second flow resistance through lumen 204 that is different from the first flow resistance. Thus, once device 200 is implanted in the eye, actuation assembly 210 can be selectively actuated to change the flow resistance of lumen 204 and alter the drainage of aqueous from the anterior chamber.
[0054] The movement of rack element 230, and therefore the change to lumen 204, is reversible by moving second end portion 220b of arm 220 through second path 302. Movement of arm 220 through second path 302 occurs in a manner similar to movement of arm 220 through first path 301. For example, upon initial actuation of second actuation element 214, second end portion 220b of arm 220 moves from Position A to Position E, sliding rack element 230 along it, away from locking mechanism 235 and toward lumen 204. Once in Position E, third recess 222c (FIG. 3B) aligns with second blocking element 224b, allowing arm 220 to swing outward, disengage from second groove 232 (not shown) of rack element 230, and occupy Position F. For example, referring to FIG. 3B , the third recess 222c can extend through the arm 220 at an acute angle (e.g., not perpendicular) to the longitudinal axis of the arm 220. Thus, the third recess 222c receives the second block element 224b when the arm reaches position E, further swinging the arm 220 outward to position F as the first block element 224a slides through the first recess 222a. Returning to FIG. 3A , once in position F, the arm 220 can automatically move toward position G (if the second actuating element 214 exhibits a recoil effect), or the first actuating element 212 can be actuated to move the arm to position G (if the actuating element does not exhibit a recoil effect). At position G, the second recess 222b aligns with the second block element 224b, allowing the arm 220 to re-engage with the rack element 230 at the first groove 232a. The net effect of the arm moving through the second path 302 is movement of the rack element 230 in a second direction (e.g., toward the lumen 204) that is generally opposite to the first direction that the rack element 230 moved when the arm 220 traversed the first path 301. For example, actuation of the actuation assembly 210 to move the arm 220 through the second path 302 can move the rack element 230 from the second position to the first position.
[0055] Although the foregoing describes rack element 230 moving from a first position to a second position via movement of the arm through first path 301 and from the second position back to the first position via movement of the arm through second path 302, device 200 can move between other configurations. For example, arm 220 can be driven through first path 301 multiple times without driving arm 220 through second path 302. Each time arm 220 moves through first path 301, rack element 230 slides further in a first direction (e.g., further out of lumen 204, as illustrated in FIGS. 4A-4C ). Similarly, arm 220 can be driven through second path 302 to move rack element 230 in a second direction opposite the first direction (e.g., further into lumen 204, as illustrated in FIGS. 4A-4C ) without first moving arm 220 through first path 301. Accordingly, rack element 230 can be selectively moved in opposite directions by selectively actuating actuation assembly 210 to move the arm through first path 301 and / or second path 302, respectively. As described in more detail in Figures 4A-4D, moving rack element 230 in a first direction can decrease the flow resistance through lumen 204, and moving rack element 230 in a second direction can increase the flow resistance through lumen 204.
[0056] 4A-4D illustrate how linear movement of rack element 230 changes the flow resistance through lumen 204. FIG. 4A is a cross-sectional view of device 200 in a first configuration, showing, among other things, rack element 230 extending partially into lumen 204. Rack element 230 includes proximal end portion 230a and distal end portion 230b. Proximal end portion 230a includes a plurality of grooves 232 for receiving engagement elements 223 of arms 220. The plurality of grooves 232 remain substantially unobstructed (i.e., proximal end portion 230a does not generally extend into lumen 204) as rack element 230 moves back and forth. In some embodiments, proximal end portion 230a has a larger cross-sectional size (not shown) than lumen 204. This is expected to prevent proximal end portion 230a from entering lumen 204 and ensure that rack element 230 remains engaged with locking element 236. In such embodiments, flow through lumen 204 can be substantially reduced (e.g., stopped) by moving proximal end portion 230a toward lumen 204 until proximal end portion 230a engages and blocks an inflow port (e.g., inflow port 204a, FIG. 4B). Returning to the illustrated embodiment, engagement element 223 engages proximal end portion 230a of rack element 230 at first groove 232a.
[0057] In at least some configurations, the distal end portion 230b of the rack element 230 can extend at least partially within the lumen 204. For example, the distal end portion 230b can enter the lumen 204 at the inflow port 204a and extend along the length of the lumen 204 toward the outflow port 204b. In some embodiments, the distal end portion 230b has a generally rectangular, circular, or other solid cross-sectional area that is generally similar in shape to the inner circumference of the lumen (e.g., the distal end portion 230b does not include the plurality of grooves 232). In some embodiments, the distal end portion 230b can be tapered such that the cross-sectional area of the distal end portion 230b decreases as it transitions from a first region adjacent the proximal end portion 230a to a second region spaced apart from the proximal end portion 230a. In such embodiments, the lumen 204 can also be tapered such that the distal end portion 230b and the lumen 204 form a needle valve. Incorporating a configuration such as a needle valve can enhance the ability to vary the fluid resistance through lumen 204 (e.g., the rate of change of flow resistance is non-linear). Regardless of the configuration, at least the distal-most region of distal end portion 230b can have a cross-sectional area that is smaller than the cross-sectional area of lumen 204. Thus, even when distal end portion 230b is within lumen 204, fluid can still flow through lumen 204.
[0058] For example, Figure 4B is an enlarged view of the portion of device 200 shown in Figure 4A. As shown, distal end portion 230b extends into lumen 204. In particular, distal end portion 230b extends into the lumen a distance D1, as measured from inflow port 204a. Although distal end portion 230b occupies a portion or even a significant volume of lumen 204, fluid can still flow from inflow port 204a to outflow port 204b around distal end portion 230b.
[0059] FIG. 4C is a cross-sectional view of device 200 in a second configuration different from the first configuration. In particular, relative to the first configuration shown in FIG. 4A, actuation assembly 210 (FIGS. 2 and 3) has been actuated to drive rack element 230 away from outlet port 204b (e.g., moving rack element 230 at least partially out of lumen 204). As a result, engagement element 223 engages second groove 232b, which is different from first groove 232a. FIG. 4D is an enlarged view of an embodiment of device 200 in the second configuration. As shown, distal end portion 230b still extends into lumen 204 in the second configuration. Distal end portion 230b extends into lumen 204 by distance D2, as measured from inlet port 204a. In some embodiments, distance D2 is less than distance D1. Thus, the length of lumen 204 occupied by rack element 230 is reduced in the second configuration relative to the first configuration. Without being bound by theory, it is expected that at any given pressure differential between inlet port 204a and outlet port 204b, reducing the length of lumen 204 occupied by rack element 230 (e.g., by moving from a first configuration to a second configuration) will decrease the flow resistance through lumen 204 and therefore increase fluid flow through lumen 204. Furthermore, in some embodiments, distal end portion 230b of rack element 230 may be completely removable from lumen 204 upon repeated actuation of actuation assembly 210. While the above describes using linear motion of rack element 230 to adjust the flow resistance through lumen 204, the flow resistance through lumen 204 may instead be adjusted by using actuation assembly 210 to contract or expand the diameter of the lumen, thereby increasing or decreasing the flow resistance through lumen 204.
[0060] 5A-5D show another embodiment of an adjustable flow glaucoma treatment device 500 ("device 500") configured in accordance with embodiments of the present technology. Device 500 may be similar to device 200 in certain aspects. For example, with reference to FIG. 5A, device 500 may include a base 502 implantable in a portion of the eye (e.g., the anterior chamber) and having a lumen 204 extending therethrough. Device 500 may further include an actuating assembly 510 having a first actuating element 512 and a second actuating element 514. In some embodiments, first actuating element 512 is generally similar to first actuating element 212 (FIG. 2), and second actuating element 514 is generally similar to second actuating element 214 (FIG. 2). Device 500 may further include an arm 520, a rack element 530, and a locking mechanism 535. As described in detail above with reference to device 200, actuation assembly 510 can be actuated to move rack element 530 in and out of lumen 504 to vary the resistance to flow through the lumen.
[0061] FIG. 5B is a front view of device 500, and FIG. 5C is an enlarged view of a portion of device 500 shown in FIG. 5B. Referring together to FIGS. 5B and 5C, rack element 530 includes a plurality of teeth or other protrusions 532 defining corresponding grooves therebetween. As described above with respect to rack element 230, rack element 530 may also be a sawtooth wire or other element that creates an engageable surface for releasably mating with arm 520. Latch mechanism 535 may include a locking element 536 that may engage with rack element 530 in the groove between two adjacent teeth 532. Device 500 may further include a first blocking element 524a and a second blocking element 524b. As described in more detail below with reference to FIG. 5D, first blocking element 524a and second blocking element 524b constrain movement of arm 520 to a predetermined path.
[0062] Arm 520 includes a distal end portion 520b having a generally "L" shape. Distal end portion 520b includes an engagement element 523 at or near the bend of the "L" that can engage with rack element 530. Distal end portion 520b also includes a knob element 521. Knob element 521 can protrude from distal end portion 520b toward base 502. Knob element 521 is sized and shaped to engage or otherwise contact first and second block elements 524a and 524b. In the illustrated configuration, first block element 524a, through engagement with knob element 521, restrains movement of distal end portion 520b of arm 520 in a first direction (indicated by arrow X). Similarly, second block element 524b, through engagement with knob element 521, restrains movement of distal end portion 520b of arm 520 in a second direction (indicated by arrow Y). However, as described below with reference to FIG. 5D , actuation of first actuation element 512 moves knob element 521 out of contact with first block element 524 a, allowing distal end portion 520 b to move in first direction X. Similarly, actuation of second actuation element 514 moves knob element 521 out of contact with second block element 524 b, allowing distal end portion 520 b to move in second direction Y. However, when device 500 is in the configuration shown in FIG. 5C , movement of arm 520 is minimized at its distal end portion 520 b in both first direction X or second direction Y, such that arm 520 remains engaged with rack element 530. As will be apparent from the description below, unlike device 200 described above, device 500 does not require a channel cut in arm 520 to facilitate disengagement of arm 520 from rack element 530.
[0063] FIG. 5D illustrates a first path 501 (indicated by a solid arrow) and a second path 503 (indicated by a dashed arrow) along which the arm 520 can move during actuation of the actuation assembly 510. For example, referring to FIGS. 5C and 5D together, upon initial actuation of the first actuation element 512, the distal end portion 520b of the arm 520 moves toward the locking mechanism 535. Because the arm 520 is engaged with the rack element 530 via the engagement element 523, movement of the distal end portion 520b toward the locking mechanism 535 also causes the rack element 530 to slide in the same direction (i.e., pulling the rack element 530 further out of the lumen 504, as described in detail with respect to the device 200 of FIGS. 4A-4D ). As the distal end portion 520b moves toward the locking mechanism 535, the knob element 521 moves out of engagement with the first block element 524a. This allows the distal end portion 520b of the arm 520 to swing upward (e.g., as shown by the arrow along the first path 501 in FIG. 5D ) and disengage from the rack element 530. When the arm 520 disengages from the rack element 530, the locking mechanism 535 holds the rack element 530 in place. In embodiments in which the actuation assembly 510 exhibits a recoil effect, the distal end portion 520b of the arm can automatically move through the remainder of the first path 501 until the knob element 521 returns to its original position between the first and second block elements 524a and 524b. In embodiments in which the actuation assembly 510 does not exhibit a recoil effect, the second actuation element 514 can then be actuated to drive the distal end portion 520b through the remainder of the first path 501 until the knob element 521 returns to its original position between the first and second block elements 524a and 524b. When knob element 521 returns to its original position, engagement element 523 re-engages rack element 530, but in a different groove than it engaged before moving through first path 501. The net effect of arm 520 moving through first path 501 is movement of rack element 530 in a first direction (e.g., away from lumen 504) that can reduce flow resistance through lumen 504.
[0064] The movement of rack element 530, and therefore the changes to lumen 504, is reversible by moving distal end portion 520b of arm 520 through second path 503 (FIG. 5D). Movement of arm 520 through second path 503 occurs in a manner similar to movement of arm 520 through first path 501. For example, upon initial actuation of second actuation element 514, distal end portion 520b of arm 520 moves away from locking mechanism 535. Because arm 520 is engaged with rack element 530 via engagement element 523, movement of distal end portion 520b away from locking mechanism 535 also causes rack element 530 to slide in the same direction (i.e., pushing rack element 530 further into lumen 504, as described in detail with respect to device 200 of FIGS. 4A-4D). As distal end portion 520b moves away from locking mechanism 535, knob element 521 moves out of engagement with second block element 524b. This allows distal end portion 520b of arm 520 to swing downward (e.g., as shown by the arrow along second path 503 in FIG. 5D ) and disengage from rack element 530. Locking mechanism 535 holds rack element 530 in place as arm 520 disengages from rack element 530. In embodiments in which actuation assembly 510 exhibits a recoil effect, arm distal end portion 520b can automatically move through the remainder of second path 503 until knob element 521 returns to its original position between first block element 524a and second block element 524b. In embodiments in which actuation assembly 510 does not exhibit a recoil effect, first actuation element 512 can then be actuated to drive distal end portion 520b through the remainder of second path 503 until knob element 521 returns to its original position between first block element 524a and second block element 524b. As knob element 521 returns to its original position, engagement element 523 re-engages rack element 530, but in a different groove than it engaged before moving through second path 501. The net effect of arm 520 moving through second path 503 is movement of rack element 530 in a second direction (e.g., further into lumen 204) that is generally opposite to the first direction in which rack element 530 moved when arm 520 traversed first path 501.For example, movement of arm 520 through second pathway 503 can increase the flow resistance through lumen 504 .
[0065] Although the foregoing describes rack element 530 moving from a first position to a second position via movement of the arm through first path 501 and from the second position back to the first position via movement of the arm through second path 503, device 500 can move between other configurations. For example, arm 520 can be driven through first path 501 multiple times without driving arm 520 through second path 503. Each time arm 520 moves through first path 501, rack element 530 slides further in a first direction (e.g., further out of lumen 204). Similarly, arm 520 can be driven through second path 503 to move rack element 530 in a second direction opposite the first direction (e.g., further into lumen 204) without first moving arm 520 through first path 501. Thus, the rack element 530 can be selectively moved in opposite directions by selectively actuating the actuation assembly 510 to move the arm through the first path 501 and / or the second path 503, respectively.
[0066] At least some aspects of the devices described herein (e.g., device 200 or device 500) can be formed using a photolithography process. For example, a photomask having a desired geometric pattern (e.g., having channel 240, frame 206, etc.) can be placed on a photosensitive substrate. Upon application of light, the geometric pattern is imprinted on the substrate, forming a base (e.g., base 202). In some embodiments, aspects of device 200 or 500 (e.g., the base) can be formed as layered sheets (e.g., laminates) of material to enhance the structural integrity of the component (e.g., the base).
[0067] In some embodiments, devices described herein (e.g., device 200 or 500) can be fabricated using a deposition process using polymers and / or metals. For example, in some embodiments, a vapor deposition process can deposit a process metal, such as palladium, rhodium, nickel-titanium, and / or nickel-cobalt alloy, onto a substrate. The process metal can be deposited in relatively thin layers (e.g., about 5 microns) that form various structures of the device. In some embodiments, a sacrificial material (e.g., copper) can be deposited as a placeholder during deposition and then selectively etched away to form various voids within the device (e.g., lumens) and / or between components (e.g., between rack elements and channels). One expected advantage of relying on a deposition manufacturing process is that individual portions of the device (including movable components, such as rack elements) can be fabricated simultaneously in an assembled configuration. This is expected to reduce the time required to assemble the device compared to methods in which the various components of the device are fabricated individually.
[0068] In some embodiments, some or all of a device, such as actuation assembly 210, can be laser cut from a single piece (e.g., sheet, strip, tube, etc.) of Nitinol or other suitable material. First actuation element 212 and second actuation element 214 can be shape set to have a desired configuration or shape (e.g., length) when first actuation element 212 and second actuation element 214 are heated above a certain temperature (e.g., above body temperature). Once shape set, at a temperature below a transition temperature, first actuation element 212 and / or second actuation element 214 can be compressed or otherwise inwardly stressed (or stretched in embodiments operating under tension) and secured to fixation elements 206a and 206b (e.g., via notches 207a, 207b). Optionally, one of the actuating elements 212, 214 can be heated to adopt a shape memory state before securing the actuating element 212, 214 to the securing elements 206a, 206b and energizing the actuating assembly 210.
[0069] In some embodiments, individual components of a device described herein (e.g., device 200 or device 500) are laser cut from a piece of material (e.g., nitinol) and then secured together using pins, welding, or other fastening mechanisms. For example, FIG. 6A shows a device 600 manufactured through such a process. FIG. 6B shows device 600 in an exploded view, illustrating the various individually cut components before being assembled together. Referring to FIG. 6B, the individual components include a first base portion 602, a second base portion 604 defining a channel, a rack element 630 positionable within the channel in second base portion 604, a third base portion 606, an actuation assembly 610, and a cover 608. A plurality of pins 605 or other suitable fastening mechanisms can be used to secure each of the aforementioned components together to form assembled device 600 ( FIG. 6A ). Device 600 can also include an individually manufactured drainage element 603 for directing fluid to a desired drainage location.
[0070] As those skilled in the art will appreciate, the present technology is not limited to the embodiments explicitly described above. Rather, certain features described above can be incorporated into other suitable glaucoma devices or shunts, such as those described in U.S. Patent Application No. 17 / 175,332, U.S. Patent Application Publication No. 2020 / 0229982, and International Patent Applications Nos. PCT / US20 / 55144, PCT / US20 / 55141, and PCT / US21 / 14774, the disclosures of which are incorporated herein by reference in their entireties. For example, in some embodiments, the present technology provides an adjustable flow shunt having a drainage element and an actuation assembly, but omitting the rack element and associated features (e.g., rack element 230 and / or arm 220 shown in FIGS. 2 and 3). In other embodiments, the present technology provides an adjustable flow shunt having a ratchet mechanism rather than surface 208.
[0071] 7A-7C, for example, illustrate an embodiment of a device 700 configured in accordance with select embodiments of the present technology, omitting rack elements and associated features. Referring to FIG. 7A, device 700 includes a drainage element 702 (e.g., a tube or other suitable feature) having a first end portion 704 and a second end portion 706. The drainage element 702 can have a plurality of first ports or openings 708 (FIG. 7B) at or adjacent the first end portion 704, and a second port 707 at or adjacent the second end portion 706. A lumen can extend through the drainage element 702 to fluidly connect the plurality of first ports 708 and the second port 707.
[0072] The device 700 can include an actuating assembly 710 positioned at a first end portion 704 of the drainage element 702. When the device 700 is implanted in the eye, the first end portion 704 can reside in the anterior chamber and the second end portion 706 can reside in a desired outflow location (e.g., the bleb space). In such embodiments, the actuating assembly 710 is located in the anterior chamber. In other embodiments, the first end portion 704 can reside in a desired outflow location and the second end portion 706 can reside in the anterior chamber. In such embodiments, the actuating assembly 710 is positioned outside the anterior chamber (e.g., in the bleb space). Regardless of the orientation of the device 700, the device 700 is configured to drain water from the anterior chamber when the device 700 is implanted in the eye. The device 700 can optionally have additional features that help secure the device 700 in place when implanted in the eye. For example, device 700 may include arms, anchors, plates, or other suitable features configured to secure device 700 to natural tissue.
[0073] 7B, the actuation assembly 710 includes a plurality of flow control mechanisms 711a-d arranged in series along the length of the drainage element 702. Each flow control mechanism 711a-d can interface with a corresponding first port 708, and each flow control mechanism 711a-d can be individually actuable. Each flow control mechanism 711a-d further includes a movable gate element 416, a first actuation element (e.g., first actuation element 714b) extending between a first anchor (e.g., first anchor 712a) and the gate element 416, and a second actuation element (e.g., second actuation element 714b) extending between a second anchor (e.g., second anchor 712b) and the gate element 416. Each gate element 416 is configured to interface with (e.g., at least partially block) a corresponding first port 708.
[0074] Actuating elements 714a, 714b can operate in a manner similar to actuating elements 212 and 214 of device 200 described above with reference to Figure 2. However, rather than moving an arm to engage and disengage a rack element, actuating elements 714a, 714b reciprocate gate element 416 back and forth to open (or partially open) or close (or partially close) the corresponding port 708. Thus, actuating elements 714a, 714b can be selectively adjusted to vary the flow characteristics of device 700 (e.g., to target energy from an energy source external to the patient).
[0075] As discussed above in Section B and with respect to actuating elements 212 and 214 (FIGS. 2 and 3), actuating elements 714a, 714b may include a shape memory material configured to change shape upon application of energy. For example, in some embodiments, actuating element 714 is constructed from nitinol. In such embodiments, application of energy (e.g., heat, light, etc.) to actuating element 714 causes the energized actuating element to transition from a first state (e.g., a martensitic or intermediate state) to a second state (e.g., an intermediate or austenitic state). The transition from the first state to the second state can induce a dimensional change in the actuating element. In some embodiments, the dimensional change is an expansion. In other embodiments, the dimensional change is a reduction (e.g., compression). Energy may be applied from an energy source (e.g., a laser) positioned external to the eye, allowing a user to adjust the device remotely.
[0076] 7C , the actuating elements (e.g., first actuating element 714a and second actuating element 714b) can include one or more targets 713. As described above with respect to targets 213b-e and 215b-e on device 200 ( FIG. 2 ), the targets 713 can be recesses, wells, channels, divots, or other features configured to facilitate penetration of energy into the corresponding actuating element, thereby providing relatively more uniform heating across the entire thickness of the actuating element. For example, in the illustrated embodiment, the targets 713 are cylindrical recesses that extend at least partially into the first actuating element 714a and second actuating element 714b. Applying energy to one of the targets 713 is expected to provide more uniform heating across the entire thickness of the actuating element adjacent to the heated target 713 (rather than just heating the surface of the actuating element). Without being bound by theory, it is expected that the relatively even application of energy across the entire thickness of various regions of the actuating elements 714a, 714b will in turn improve the repeatability and consistency of the movement of the actuating elements 714a, 714b which is expected to increase the accuracy of adjustments to the flow rate through the device 700.
[0077] As one skilled in the art will understand, the devices described herein can include additional or fewer components than those explicitly described without departing from the scope of the present technology. Furthermore, the devices described herein can be constructed from any material suitable for implantation into the human eye. In some embodiments, the material can be selected based, at least in part, on one or more desired characteristics of the device. By way of non-limiting example, and as one skilled in the art will understand, the devices can be constructed with treatments and / or materials to prevent biofilm growth on one or more surfaces of the device. Thus, in some embodiments, the devices described herein can include a coating or material configured to reduce biofilm formation. Furthermore, in some embodiments, at least some components of the devices described herein can be treated with beta radiation (or other suitable radiation or substance) to prevent and / or reduce biofilm growth on the components. The components can also be treated with beta radiation or other suitable techniques to reduce and / or remove biofilm formation already formed on the device. Thus, the components can be treated before the device is implanted in the human eye, after the device is implanted in the human eye, or both before and after the device is implanted in the human eye. [Example]
[0078] Some aspects of the present technology are described in the following examples: 1. A device for treating glaucoma, comprising: a drainage element at least partially defining a lumen configured to drain water from the anterior chamber of the eye; a flow control element movable between at least a first position and a second position and configured to vary the resistance to flow through the device; an actuation assembly comprising: an actuation element configured to at least partially change shape and / or size in response to energy; an arm extending from the actuation element and configured to releasably engage the flow control element; an actuation assembly, wherein when the arm engages a first region of the flow control element, actuation of the actuation element causes the arm to move the flow control element between a first position and a second position to vary the flow resistance through the device; a locking mechanism configured to at least partially reduce movement of the flow control element when the arm is disengaged from the flow control element.
[0079] 2. The device of example 1, wherein the flow control element comprises a slidable rack element.
[0080] 3. The device of Example 2, wherein the slidable rack element has a first groove and a second groove, and the arm has an engagement element configured to releasably engage the slidable rack element in the first groove and / or the second groove.
[0081] 4. The device of example 3, wherein the first region of the flow control element is a first groove, and wherein the engagement element is configured to disengage from the first groove and engage with the second groove after the flow control element moves from the first position to the second position.
[0082] 5. The device of example 4, wherein the locking mechanism engages with the flow control element to at least partially reduce movement of the flow control element after the engagement element disengages from the first groove and before the engagement element engages with the second groove.
[0083] 6. A device described in any one of Examples 3 to 5, wherein the slidable rack element has a third groove and a fourth groove, and the locking mechanism includes a locking element configured to engage with the third groove when the flow control element is in the first position and configured to engage with the fourth groove when the flow control element is in the second position.
[0084] 7. The device of any one of Examples 1-7, wherein the locking mechanism is configured to prevent movement of the flow control element when the arm is disengaged from the flow control element via a friction fit with the arm.
[0085] 8. The device of any one of Examples 1-8, wherein the actuation element is a first actuation element and the actuation assembly further comprises a second actuation element connected to the arm and configured to at least partially change shape and / or size in response to energy.
[0086] 9. The device of example 8, wherein when the flow control element is in the second position, actuation of the second actuation element causes the arm to move the flow control element from the second position to the first position.
[0087] 10. The device of example 9, wherein the first actuating element and the second actuating element comprise a shape memory material.
[0088] 11. The device of example 10, wherein the first actuating element has a first bending region, and wherein application of energy to the first bending region causes the first bending region to expand.
[0089] 12. The device of example 10 or 11, wherein the second actuating element has a second bending region, and application of energy to the second bending region causes the second bending region to expand.
[0090] 13. The device of example 12, wherein actuation of the first actuating element causes the second actuating element to compress in the second flexion region, and actuation of the second actuating element causes the first actuating element to compress in the first flexion region.
[0091] 14. A device according to any one of Examples 1-13, wherein the flow control element is movable through three or more positions, each of the three or more positions being associated with a unique flow resistance through the device.
[0092] 15. A device described in any one of Examples 1 to 14, wherein the working element is configured to receive energy from an energy source positioned outside the eye when the device is implanted in a human eye.
[0093] 16. The device of example 15, wherein the energy source is a laser.
[0094] 17. The device of any one of Examples 1-16, wherein the device is configured such that when implanted in a human eye, varying the resistance to flow through the device varies the rate of drainage of aqueous from the anterior chamber of the eye.
[0095] 18. The device of any one of Examples 1-17, wherein the flow control element is configured to change the diameter of the lumen as it moves between the first position and the second position.
[0096] 19. A device for controlling the flow of a fluid between a first region and a second region, comprising: a lumen configured to drain fluid from the first region toward the second region; a ratchet mechanism configured to alter the flow of fluid through the lumen, a rack element movable between a first position in which the lumen has a first shape and a second position in which the lumen has a second shape different from the first shape; an engagement element configured to releasably engage the rack element; and a ratchet mechanism including an actuation assembly connected to the engagement element and configured to move the rack element between a first position and a second position.
[0097] 20. The device of Example 19, further comprising an arm connected to the actuation assembly, the arm including an engagement element and configured to drive the rack element from the first position to and / or toward the second position upon actuation of the actuation assembly.
[0098] 21. A device described in Example 19 or 20, wherein the rack element includes a plurality of teeth and a plurality of grooves, and the engagement element is configured to engage with the rack element in one of the plurality of grooves.
[0099] 22. The device of example 20 or 21, wherein the engagement element is configured to disengage from the first groove on the rack element and engage with the second groove on the rack element after the rack element moves from the first position to and / or toward the second position.
[0100] 23. A device described in any one of Examples 19-22, wherein the actuation assembly includes a first actuation element configured to move the rack element in a first direction and a second actuation element configured to move the rack element in a second direction generally opposite to the first direction.
[0101] 24. The device of example 23, wherein the first actuating element is configured to move the rack element from the first position to the second position, and the second actuating element is configured to move the rack element from the second position to the first position.
[0102] 25. The device of example 23 or 24, wherein the first actuating element and the second actuating element are configured to change dimensions upon application of energy.
[0103] 26. The device of any one of Examples 23-25, wherein the first and second actuating elements are constructed from nitinol.
[0104] 27. A device described in any one of Examples 19 to 26, wherein the rack element directly engages the lumen and causes the lumen to change from a first shape to a second shape as the rack element moves from a first position to and / or toward a second position.
[0105] 28. A device described in any one of Examples 19 to 26, wherein the rack element indirectly engages the lumen to change the lumen from a first shape to a second shape as the rack element moves from a first position to and / or toward the second position.
[0106] 29. The device of Example 28, further comprising a flow control element operably connected to the rack element, the flow control element directly engaging the lumen to change the lumen from the first shape to the second shape.
[0107] 30. The device of any one of examples 19-29, further comprising a locking mechanism configured to hold the rack element in place when the arm element disengages from the rack element.
[0108] 31. A device described in any one of Examples 19 to 30, wherein the first body region is the anterior chamber of a human eye, and the device is configured to change the geometric characteristics of the lumen when the device is implanted in the eye, thereby changing the rate of drainage of aqueous from the anterior chamber of the eye.
[0109] 32. A device described in any one of Examples 19-31, wherein the rack element is configured to change the diameter of the lumen as it moves between the first position and the second position.
[0110] 33. A device for controlling the flow of a fluid between a first region and a second region, comprising: a drainage element at least partially defining a lumen configured to drain fluid from the first region to the second region; a flow control element movable between at least a first position and a second position and configured to vary the resistance to flow through the device; an actuation assembly comprising: an actuation element configured to at least partially change shape and / or size in response to energy; an arm extending from the actuation element and configured to releasably engage the flow control element; an actuation assembly, wherein when the arm engages a first region of the flow control element, actuation of the actuation element causes the arm to move the flow control element between a first position and a second position to vary the flow resistance through the device; a locking mechanism configured to at least partially reduce movement of the flow control element when the arm is disengaged from the flow control element.
[0111] 34. The device of example 33, wherein the flow control element comprises a slidable rack element.
[0112] 35. The device of Example 34, wherein the slidable rack element has a first groove and a second groove, and the arm has an engagement element configured to releasably engage with the slidable rack element in the first groove and / or the second groove.
[0113] 36. The device of example 35, wherein the first region of the flow control element is a first groove, and the engagement element is configured to disengage from the first groove and engage with the second groove after the flow control element moves from the first position to the second position.
[0114] 37. The device of example 36, wherein the locking mechanism engages with the flow control element to at least partially reduce movement of the flow control element after the engaging element disengages from the first groove and before the engaging element engages with the second groove.
[0115] 38. A device described in any one of Examples 35 to 37, wherein the slidable rack element has a third groove and a fourth groove, and the locking mechanism includes a locking element configured to engage with the third groove when the flow control element is in the first position and configured to engage with the fourth groove when the flow control element is in the second position.
[0116] 39. A device described in any one of examples 33 to 39, wherein the locking mechanism is configured to prevent movement of the flow control element when the arm is disengaged from the flow control element.
[0117] 40. A device described in any one of Examples 33-40, wherein the actuation element is a first actuation element and the actuation assembly further comprises a second actuation element connected to the arm and configured to at least partially change shape and / or size in response to energy.
[0118] 41. The device of example 40, wherein when the flow control element is in the second position, actuation of the second actuation element causes the arm to move the flow control element from the second position to the first position.
[0119] 42. The device of example 41, wherein the first actuation element and the second actuation element comprise a shape memory material.
[0120] 43. The device of example 42, wherein the first actuating element has a first bending region, and application of energy to the first bending region causes the first bending region to expand.
[0121] 44. The device of example 42 or 43, wherein the second actuating element has a second bending region, and application of energy to the second bending region causes the second bending region to expand.
[0122] 45. The device of Example 44, wherein actuation of the first actuating element causes the second actuating element to compress in the second bending region, and actuation of the second actuating element causes the first actuating element to compress in the first bending region.
[0123] 46. A device described in any one of Examples 33-45, wherein the flow control element is movable through three or more positions, each of the three or more positions being associated with a different flow resistance through the device.
[0124] 47. A device described in any one of Examples 33 to 46, wherein the device is configured such that changing the resistance to flow through the device when the device is implanted changes the rate of drainage of fluid from the first region.
[0125] 48. The device of any one of examples 33-47, wherein the first region is the anterior chamber of the eye.
[0126] 49. A device described in any one of Examples 33 to 48, wherein the flow control element is configured to change the diameter of the lumen as it moves between the first position and the second position.
[0127] 50. An implantable medical device for draining fluid from a first body region to a second body region, comprising: a drainage element having a lumen extending therethrough and configured to fluidly connect the first body region and the second body region; a flow control element movable through a plurality of distinct positions, each distinct position associated with a relative flow resistance through the device, the flow control element being selectively movable between the plurality of distinct positions.
[0128] 51. The device of example 50, further comprising a ratchet mechanism configured to move the flow control element through a plurality of discrete positions.
[0129] 52. A device described in Example 50 or 51, further comprising an actuation assembly configured to move the flow control element through a plurality of discrete positions, the actuation assembly including at least one actuation element and a ratchet mechanism.
[0130] 53. The device of example 52, wherein the implantable medical device is a glaucoma shunt and the first body region is the anterior chamber of the eye.
[0131] 54. A device described in any one of Examples 50 to 53, wherein the flow control element is configured to change the diameter of the lumen as it moves between a plurality of distinct positions.
[0132] 55. An implantable medical device for draining fluid from a first body region to a second body region, comprising: a drainage element configured to fluidly connect the first body region and the second body region when the device is implanted in a patient; an actuation assembly configured to regulate fluid flow through the drainage element, the actuation assembly including a shape-memory actuation element movable between a pre-actuated configuration and an actuated configuration; The device is Upon actuation, the shape memory actuation element moves from a pre-actuated configuration to and towards the actuated configuration to adjust the resistance to flow through the device; The device is configured such that, following actuation, (a) the shape memory actuation element recoils toward a pre-actuation configuration, and (b) the adjusted fluid resistance is maintained as the shape memory actuation element recoils toward the pre-actuation configuration.
[0133] 56. a flow control element operably coupled to the shape memory actuation element and configured to control flow resistance through the device; the flow control element is configured to move from a first position to and / or toward a second position when the shape memory actuation element moves from a pre-actuated configuration to and / or toward the actuated configuration; A device as described in Example 55, wherein the flow control element is configured to be retained in and / or proximal to the second position when the shape memory actuation element recoils toward the pre-actuation configuration.
[0134] 57. The device of Example 56, further comprising a ratchet configured to hold the flow control element in and / or proximal to the second position.
[0135] 58. The device of Example 55, wherein the shape-memory actuation element is configured to move from a pre-actuated configuration to and / or toward an actuated configuration when heated above a transition temperature, and wherein the shape-memory actuation element is configured to recoil toward a pre-actuated configuration when cooled below the transition temperature.
[0136] 59. The device of any one of examples 55-58, further comprising an elastic member configured to drive recoil of the shape memory element toward the pre-actuated configuration.
[0137] 60. A device described in any one of Examples 55-59, wherein the shape-memory actuation element is configured to repeatedly transition between a pre-actuated configuration and an actuated configuration to further adjust fluid resistance through the device.
[0138] 61. A method of controlling fluid flow from a first body region to a second body region using an adjustable shunt device, comprising: heating a shape memory actuating element of an adjustable shunt device above a transition temperature to move the shape memory actuating element from a first configuration to and / or toward a second configuration, wherein moving the shape memory actuating element from the first configuration and / or toward the second configuration adjusts the resistance to flow through the adjustable shunt device; heating the shape memory actuation element and then recoiling the shape memory actuation element toward the first configuration as the shape memory actuation element cools below a transition temperature; and maintaining the adjusted fluid resistance as the shape memory actuation recoils toward the first configuration.
[0139] 62. The adjustable shunt device includes a flow control element configured to control fluid resistance through the device; moving the shape memory actuation element from the first configuration to and / or towards the second configuration moves the flow control element from the first position to and / or towards the second position; The method of Example 61, wherein maintaining the adjusted fluid resistance includes holding the flow control element at and / or proximate to the second position as the shape memory actuation element recoils toward the first configuration.
[0140] 63. The method of example 62, wherein holding the flow control element at and / or proximal to the second position comprises mechanically holding the flow control element.
[0141] 64. The adjusted fluid resistance is a first adjusted fluid resistance, and the method comprises: after maintaining the first adjusted fluidic resistance, reheating the shape memory actuation element above a transition temperature to move the shape memory actuation element to and / or towards a second configuration to further adjust the fluidic resistance to the second adjusted fluidic resistance; 62. The method of example 61, further comprising maintaining the second adjusted fluid resistance as the shape memory actuation element cools below a transition temperature and recoils toward the first configuration.
[0142] 65. The method of any one of examples 61-64, wherein recoiling the shape-memory actuation element toward the first configuration comprises biasing the shape-memory actuation element toward the first configuration using an elastic element.
[0143] 66. An implantable medical device for draining fluid from a first body region to a second body region, comprising: a fluid resistor; an actuation element that is transferable between a plurality of geometric shapes; a ratchet operably coupled to an actuation element, the ratchet configured to induce a discrete change in resistance generated by a fluidic resistor in response to the actuation element transitioning between geometric shapes.
[0144] 67. An implantable device for shunting fluid within a patient, comprising: a drainage element having a lumen extending therethrough; a flow control element movable between at least a first position and a second position and configured to vary flow resistance through the device; a first actuation element operably coupled to the flow control element, the first actuation element including a first target feature for receiving energy from an energy source positioned external to the patient; a second actuating element operably coupled to the flow control element, the second actuating element including a second targeting feature for receiving energy from an energy source positioned external to the patient.
[0145] 68. The device of Example 67, wherein the flow control element is configured to move from the first position toward the second position when energy is applied to the first target feature, and the flow control element is configured to move from the second position toward the first position when energy is applied to the second target feature.
[0146] 69. The device of Example 67, wherein the first actuating element includes a first bending region, the second actuating element includes a second bending region, the first target feature is positioned in the first bending region, and the second target feature is positioned in the second bending region.
[0147] 70. The device of example 69, wherein the first targeting feature is configured such that energy received at the first actuation element preferentially heats the first bending region, and the second targeting feature is configured such that energy received at the second actuation element preferentially heats the second bending region.
[0148] 71. A device described in any one of examples 67-70, wherein the first actuating element includes a plurality of first target features and the second actuating element includes a plurality of second target features.
[0149] 72. the first actuating element includes a plurality of first bending regions, each of the plurality of first bending regions having a corresponding first target feature; A device as described in Example 71, wherein the second actuating element includes a plurality of second bending regions, and each second bending region of the plurality of second bending regions has a corresponding second target feature.
[0150] 73. The device of Example 72, wherein each of the plurality of first target features can be individually energized to selectively actuate a corresponding first bending region, and each of the plurality of second target features can be individually energized to selectively actuate a corresponding second bending region.
[0151] 74. The device described in Example 73, wherein the flow control element is movable to a plurality of distinct positions between a first position and a second position by selectively actuating individual first bending regions and / or second bending regions.
[0152] 75. A device described in any one of Examples 67 to 74, wherein the first targeting feature is a first recess extending at least partially into the first operating element and configured to allow energy to penetrate into the first operating element, and the second targeting feature is a second recess extending at least partially into the second operating element and configured to allow energy to penetrate into the second operating element.
[0153] 76. A device described in any one of Examples 67 to 74, wherein the first target feature is a first zone on the first operating element having a higher absorption rate than a region of the first operating element surrounding the first zone, and the second target feature is a second zone on the second operating element having a higher absorption rate than a region of the second operating element surrounding the second zone.
[0154] 77. The device of example 76, wherein the first zone and the second zone comprise an absorbing coating.
[0155] 78. The device of example 76, wherein the first zone and the second zone are oxidized.
[0156] 79. A device described in any one of Examples 67 to 74, wherein the first target feature is proximate to a first reflective surface configured to reflect energy received directly from an energy source positioned external to the patient, and the second target feature is proximate to a second reflective surface configured to reflect energy received directly from an energy source positioned external to the patient.
[0157] 80. The device of example 79, wherein energy received at the first target feature directly heats the first target feature and indirectly heats at least a portion of the first reflective surface, and energy received at the second target feature directly heats the second target feature and indirectly heats at least a portion of the second reflective surface.
[0158] 81. The device of any one of examples 67-80, wherein the implantable device is a glaucoma shunt configured to drain aqueous from the anterior chamber of the patient's eye.
[0159] 82. An implantable device for shunting fluid within a patient, comprising: a fluid flow path configured to drain fluid from a first location within the patient having a first pressure to a second location within the patient having a second pressure lower than the first pressure; a flow control element movable between at least a first position and a second position and configured to vary the flow resistance through the fluid flow path; a device comprising: an actuation assembly including an actuation element operably coupled to a flow control element, the actuation element including at least one target feature for receiving energy from an energy source positioned external to the patient;
[0160] 83. The device of example 82, wherein the flow control element is configured to move from a first position toward a second position when energy is applied to the target feature.
[0161] 84. The device of example 82, wherein the actuation element comprises a bending region and the target feature is positioned in the bending region.
[0162] 85. The device of example 84, wherein the targeting feature is configured such that energy received at the actuation element preferentially heats the bending region, causing a shape change in the bending region.
[0163] 86. A device described in any one of Examples 82-85, wherein the actuation element comprises a plurality of targeting features.
[0164] 87. The device of example 86, wherein the actuating element comprises a plurality of bending regions, each bending region of the plurality of bending regions having a corresponding target feature.
[0165] 88. The device of example 87, wherein each of the multiple target features can be individually energized to selectively actuate the corresponding bending region.
[0166] 89. The device of example 88, wherein the flow control element is movable to a plurality of distinct positions between a first position and a second position by selectively actuating individual bending regions.
[0167] 90. A device described in any one of Examples 82 to 89, wherein the targeting feature is a recess extending at least partially into the actuation element and configured to allow energy to penetrate the actuation element.
[0168] 91. A device described in any one of examples 76-83, wherein the target feature is a zone on the actuation element having a higher absorption rate than a region of the actuation element surrounding the zone.
[0169] 92. The device of example 91, wherein the zone comprises an absorbing coating.
[0170] 93. The device of example 91, wherein the zone is oxidized.
[0171] 94. The device of any one of Examples 82-93, wherein the implantable device is a glaucoma shunt configured to drain aqueous from the anterior chamber of the patient's eye.
[0172] 95. An implantable device for shunting fluid within a patient, comprising: a drainage element having a lumen extending therethrough; A device comprising: an actuation element operably coupled to the drainage element and configured to vary flow resistance through the device upon actuation, wherein the actuation assembly includes at least one target feature for receiving energy from an energy source positioned external to the patient.
[0173] 96. The device of example 95, wherein the actuation element comprises a bending region and the target feature is positioned in the bending region.
[0174] 97. The device of example 96, wherein the targeting feature is configured such that energy received at the actuation element preferentially heats the bending region, causing a shape change in the bending region.
[0175] 98. A device described in any one of Examples 95-97, wherein the actuation element comprises a plurality of targeting features.
[0176] 99. The device of Example 98, wherein the actuating element includes a plurality of bending regions, each bending region of the plurality of bending regions having a corresponding target feature.
[0177] 100. The device of example 99, wherein each of the plurality of target features can be individually energized to selectively actuate the corresponding bending region.
[0178] 101. A device described in any one of Examples 95 to 100, wherein the targeting feature is a recess extending at least partially into the actuation element and configured to allow energy to penetrate the actuation element.
[0179] 102. A device described in any one of Examples 95-100, wherein the target feature is a zone on the actuation element having a higher absorption rate than a region of the actuation element surrounding the zone.
[0180] 103. The device of example 102, wherein the zone comprises an absorbing coating.
[0181] 104. The device of example 102, wherein the zone is oxidized.
[0182] 105. The device of any one of Examples 95-104, wherein the implantable device is a glaucoma shunt configured to drain aqueous from the anterior chamber of the patient's eye.
[0183] 106. A method of shunting fluid using an adjustable flow shunt implanted in a patient and having an actuating element, comprising: applying energy to a first region of the actuation element, the first region including a target feature for receiving the applied energy; and inducing, via applied energy, a geometric change in the actuating element at a first region to vary flow resistance through the adjustable flow shunt.
[0184] 107. The method of example 106, wherein applying energy to the first region comprises applying energy to the first region using an energy source positioned external to the patient.
[0185] 108. The method of embodiment 106 or 107, wherein the targeting feature increases penetration of energy into the actuation element in a first region relative to a second region adjacent to the first region.
[0186] 109. The method of any one of Examples 106-108, wherein the target feature increases absorption of energy in a first region relative to a second region adjacent to the first region.
[0187] 110. The method of any one of Examples 106-109, wherein the target feature is a recess extending at least partially into the actuation element, and wherein the applied energy penetrates the actuation element at the recess.
[0188] 111. The method of any one of examples 106-109, wherein the targeting feature is an absorbent coating.
[0189] 112. The method of any one of examples 106-109, wherein the target feature is an oxidized zone in the first region.
[0190] 113. The method of any one of embodiments 106-112, wherein an adjustable shunt is implanted in the patient's eye to drain water from the anterior chamber of the eye.
[0191] 114. An implantable device for shunting fluid within a patient, comprising: a drainage element having a lumen extending therethrough; a flow control element movable between at least a first position and a second position and configured to vary the resistance to flow through the device; an actuating element, at least a portion of which is capable of transitioning from a first material state to a second material state when heated above a transition temperature, the actuating element being configured to move the flow control element from the first position toward the second position when heated above the transition temperature; a biasing element configured to direct energy received at the biasing element toward an actuation element to heat at least a portion of the actuation element above a transition temperature.
[0192] 115. The device of example 108, further comprising a frame coupled to the drainage element, the frame comprising a deflection element.
[0193] 116. The device of example 108, wherein the deflection element is positioned on the drainage element.
[0194] 117. A device described in any one of Examples 108 to 110, wherein the deflection element is configured to direct received energy in the form of visible and / or infrared electromagnetic radiation toward the actuation element to heat at least a portion of the actuation element.
[0195] 118. A device described in any one of Examples 108 to 111, wherein the deflection element is configured to direct received energy in the form of laser energy toward the actuation element to heat at least a portion of the actuation element.
[0196] 119. A device described in any one of Examples 108-112, wherein the deflection element is made of a first material, the actuation element is made of a second material, and the first material is less absorbent than the second material.
[0197] 120. The device of any one of Examples 114-119, wherein the deflecting element includes a reflective element configured to reflect energy toward the actuating element.
[0198] 121. The device of example 120, wherein the reflective element is constructed at least in part from gold, palladium, and / or platinum.
[0199] 122. The device of example 120, wherein the reflective element comprises a mirror.
[0200] 123. The device of any one of Examples 114-119, wherein the deflecting element includes a refractive element configured to refract energy toward the actuating element.
[0201] 124. The device of example 123, wherein the refractive element is at least partially composed of glass.
[0202] 125. The device of example 123, wherein the refractive element comprises a prism.
[0203] 126. The device of any one of Examples 114-125, wherein the device comprises a plurality of deflection elements.
[0204] 127. A device described in any one of Examples 114 to 126, wherein the actuation element includes a plurality of actuatable regions and the deflection element includes a plurality of deflection regions, and wherein individual deflection regions of the deflection element correspond to individual actuatable regions of the actuation element, such that individual actuation regions can be selectively actuated by selectively providing energy to the corresponding individual deflection regions.
[0205] 128. The device of any one of examples 114-127, wherein the first material state is a martensitic material state and the second material state is an austenitic material state.
[0206] 129. The actuating element is a first actuating element, the deflecting element is a first deflecting element, and the device is a second actuating element, wherein at least a portion of the second actuating element is transitionable from the third material state to a fourth material state when heated above a transition temperature of the second actuating element, and wherein the second actuating element is configured to move the flow control element from the second position toward the first position when heated above the transition temperature of the second actuating element; The device of any one of Examples 114 to 128, further comprising: a second biasing element configured to direct energy received by the second biasing element toward the second actuating element to heat the second actuating element above a second actuating element transition temperature.
[0207] 130. The device of example 129, wherein the third material state is a martensitic material state and the fourth material state is an austenitic material state.
[0208] 131. The device of any one of embodiments 114-130, wherein the implantable device is a glaucoma shunt configured to drain aqueous from the anterior chamber of the patient's eye.
[0209] 132. An implantable device for shunting fluid within a patient, comprising: a fluid flow path configured to drain fluid from a first location in the patient having a first pressure to a second location in the patient having a second pressure lower than the first pressure; a flow control element movable between at least a first position and a second position and configured to vary the flow resistance through the fluid flow path; an actuation element configured, upon actuation, to move the flow control element from the first position toward the second position; a biasing element configured to direct energy received at the biasing element toward an actuation element to actuate the actuation element.
[0210] 133. The device of example 132, further comprising a frame coupled to the fluid flow path, the frame comprising a deflection element.
[0211] 134. The device of example 132, wherein the deflection element is positioned on the fluid flow path.
[0212] 135. The device of any one of Examples 132-134, wherein the deflection element is configured to direct received energy in the form of visible and / or infrared electromagnetic radiation toward the actuation element to activate the actuation element.
[0213] 136. A device described in any one of Examples 132 to 135, wherein the deflection element is configured to direct received energy in the form of laser energy toward the actuation element to actuate the actuation element.
[0214] 137. The device of any one of Examples 132-136, wherein the deflection element is made of a first material and the actuation element is made of a second material, and the first material is less absorbent than the second material.
[0215] 138. The device of any one of Examples 132-137, wherein the deflecting element includes a reflective element configured to reflect energy toward the actuating element.
[0216] 139. The device of example 138, wherein the reflective element is constructed at least in part from gold, palladium, and / or platinum.
[0217] 140. The device of example 138, wherein the reflective element comprises a mirror.
[0218] 141. The device of any one of Examples 132-137, wherein the deflecting element includes a refractive element configured to refract energy toward the actuating element.
[0219] 142. The device of example 141, wherein the refractive element is at least partially composed of glass.
[0220] 143. The device of example 141, wherein the refractive element comprises a prism.
[0221] 144. The device of any one of Examples 132-143, wherein the device comprises a plurality of deflection elements.
[0222] 145. A device described in any one of Examples 132-144, wherein the actuation element includes a plurality of actuatable regions and the deflection element includes a plurality of deflection regions, and wherein individual deflection regions of the deflection element correspond to individual actuatable regions of the actuation element, such that individual actuation regions can be selectively actuated by selectively providing energy to the corresponding individual deflection regions.
[0223] 146. The actuating element is a first actuating element, the deflecting element is a first deflecting element, and the device is a second actuation element configured, upon actuation, to move the flow control element from the second position toward the first position; and The device of any one of Examples 132 to 145, further comprising a second biasing element configured to direct energy received by the second biasing element toward the second actuating element to actuate the second actuating element.
[0224] 147. The device of any one of examples 132-146, wherein the implantable device is a glaucoma shunt configured to drain aqueous from the anterior chamber of the patient's eye.
[0225] 148. An implantable device for shunting fluid within a patient, comprising: a drainage element having a lumen extending therethrough; an actuation assembly configured to alter flow resistance through the device, an actuation element, the actuation element being capable of transitioning from a first material state to a second material state when at least a portion of the actuation element is heated above a transition temperature; and an actuation assembly including a biasing element configured to direct energy received at the biasing element toward the actuation element to heat at least a portion of the actuation element above a transition temperature.
[0226] 149. The device of Example 148, wherein the deflection element is configured to direct received energy in the form of visible and / or infrared electromagnetic radiation toward the actuation element to heat at least a portion of the actuation element.
[0227] 150. The device of example 148, wherein the deflection element is configured to direct received energy in the form of laser energy toward the actuation element to heat at least a portion of the actuation element.
[0228] 151. The device of any one of Examples 148-150, wherein the deflection element is made of a first material and the actuation element is made of a second material, and the first material is less absorbent than the second material.
[0229] 152. The device of any one of Examples 148-151, wherein the deflecting element includes a reflective element configured to reflect energy toward the actuating element.
[0230] 153. The device of example 152, wherein the reflective element is constructed at least in part from gold, palladium, and / or platinum.
[0231] 154. The device of example 152, wherein the reflective element comprises a mirror.
[0232] 155. The device of any one of Examples 148-151, wherein the deflecting element includes a refractive element configured to refract energy toward the actuating element.
[0233] 156. The device of example 155, wherein the refractive element is at least partially composed of glass.
[0234] 157. The device of example 155, wherein the refractive element comprises a prism.
[0235] 158. The device of any one of Examples 148-157, wherein the device comprises a plurality of deflection elements.
[0236] 159. A device described in any one of Examples 148-158, wherein the actuation element includes a plurality of actuatable regions and the deflection element includes a plurality of deflection regions, and wherein individual deflection regions of the deflection element correspond to individual actuatable regions of the actuation element, such that individual actuation regions can be selectively actuated by selectively providing energy to the corresponding individual deflection regions.
[0237] 160. The device of any one of examples 148-159, wherein the first material state is a martensitic material state and the second material state is an austenitic material state.
[0238] 161. The device of any one of embodiments 148-160, wherein the implantable device is a glaucoma shunt configured to drain aqueous from the anterior chamber of the patient's eye.
[0239] 162. A method of shunting fluid using an adjustable flow shunt implanted in a patient and having an actuating element, comprising: applying energy indirectly to the actuation element, where indirectly applying energy to the actuation element includes transmitting energy to a biasing element that redirects energy received at the biasing element toward the actuation element; and inducing a geometric change in the actuating element via energy redirected to the actuating element, the geometric change resulting in a change in flow resistance through the adjustable flow shunt.
[0240] 163. The method of example 162, wherein transmitting energy to the deflection element includes transmitting energy to the deflection element using an energy source positioned external to the patient.
[0241] 164. The method of embodiment 162 or 163, wherein the deflecting element is implanted in the patient.
[0242] 165. The method of example 164, wherein the deflection element is coupled to the shunt.
[0243] 166. The method of any one of Examples 162-165, wherein the energy is visible and / or infrared electromagnetic radiation.
[0244] 167. The method of any one of Examples 162-166, wherein the energy is laser energy.
[0245] 168. A device described in any one of Examples 162-167, wherein the deflection element is made of a first material and the actuation element is made of a second material, and the first material is less absorbent than the second material.
[0246] 169. The method of any one of examples 162-168, wherein the deflecting element includes a reflective element that reflects received energy toward the actuating element.
[0247] 170. The method of example 169, wherein the reflective element is constructed at least in part from gold, palladium, and / or platinum.
[0248] 171. The method of example 169, wherein the reflective element comprises a mirror.
[0249] 172. The method of any one of examples 162-168, wherein the deflecting element includes a refractive element that refracts energy toward the actuating element.
[0250] 173. The method of example 172, wherein the refractive element is constructed at least in part from glass.
[0251] 174. The method of example 172, wherein the refractive element comprises a prism.
[0252] 175. The method of any one of Examples 162-174, wherein an adjustable shunt is implanted in the patient's eye to drain water from the anterior chamber of the eye.
[0253] 176. A method of manufacturing an adjustable shunt having a shunt element, a flow control element, and a shape memory actuation element, comprising: depositing a first material and / or a second material onto a substrate, the first material being deposited in a pattern corresponding to the shunt element and the flow control element, and the second material being deposited in a pattern corresponding to one or more voids of the adjustable shunt; removing the deposited second material, wherein removing the deposited second material (i) creates a lumen extending through the shunt element and (ii) allows the flow control element to move relative to the shunt element; and securing a shape memory actuation element to the flow control element and / or the shunt element; The method, wherein the shape memory actuation element, when secured to the flow control element, is configured to selectively drive movement of the flow control element relative to the shunt element.
[0254] 177. The method of example 176, wherein depositing the first material and the second material includes depositing the first material and the second material by a vapor deposition process.
[0255] 178. The method of example 176 or 177, wherein depositing the first material and the second material comprises depositing the first material and the second material in individual layers of about 5 microns or less.
[0256] 179. The method of any one of examples 176-178, wherein removing the second material comprises etching away the second material.
[0257] 180. The method of any one of examples 176-179, wherein the first material is a polymer and / or a metal.
[0258] 181. The method of any one of examples 176-180, wherein the first material is palladium, rhodium, and / or a nickel-cobalt alloy.
[0259] 182. The method of any one of examples 176-181, wherein the second material is copper.
[0260] 183. The method of any one of Examples 176-182, wherein the shape memory actuation element is constructed from nitinol.
[0261] 184. A method of manufacturing an adjustable shunt having a shape memory actuation element, comprising: depositing a first material and / or a second material onto a substrate, the first material being deposited in a pattern corresponding to the first and second components of the adjustable shunt, and the second material being deposited in a pattern corresponding to one or more voids of the adjustable shunt; removing the deposited second material, wherein after the deposited second material is removed, the first component is at least partially constrained within and movable relative to the second component without requiring assembly of the first component and the second component; and securing the shape memory actuation element to the first component and / or the second component; The method, wherein the shape memory actuation element, when secured to the first component and / or the second component, is configured to selectively drive movement of the first component relative to the second component.
[0262] 185. The method of example 184, wherein depositing the first material and the second material includes depositing the first material and the second material by a vapor deposition process.
[0263] 186. The method of example 184 or 185, wherein depositing the first material and the second material comprises depositing the first material and the second material in individual layers of about 5 microns or less.
[0264] 187. The method of any one of examples 184-186, wherein removing the second material comprises etching away the second material.
[0265] 188. The method of any one of examples 184-187, wherein the first material is a polymer and / or a metal.
[0266] 189. The method of any one of examples 184-188, wherein the first material is palladium, rhodium, and / or a nickel-cobalt alloy.
[0267] 190. The method of any one of examples 184-189, wherein the second material is copper.
[0268] 191. The method of any one of examples 184-190, wherein the first component is a flow control component and the second component is a shunt component.
[0269] 192. The method of any one of Examples 184-191, wherein the shape memory actuation element is constructed from nitinol.
[0270] 193. A method of manufacturing an adjustable flow shunt, comprising: forming a shunt element and a flow control element in an assembled configuration, wherein the flow control element is movable relative to the shunt element, via a layer-by-layer deposition process; A method comprising securing an actuating element to a shunt element and / or a flow control element, the actuating element being configured to selectively move the flow control element relative to the shunt element when secured to the shunt element and / or the flow control element.
[0271] 194. The method of example 193, wherein forming the shunt element and the flow control element comprises simultaneously forming the shunt element and the flow control element.
[0272] 195. Forming a shunt element and a flow control element depositing a first material and a second material in layers of about 5 microns or less; 195. The method of example 193 or 194, comprising etching away the second material to form the shunt element and the flow control element.
[0273] 196. The method of any one of examples 193-195, wherein the layered deposition process is an evaporation deposition process or a chemical deposition process.
[0274] 197. The method of any one of Examples 193-196, wherein the actuating element is constructed from nitinol.
[0275] 198. A method of manufacturing an adjustable shunt having a shunt element and a flow control element, comprising: forming, via a photolithographic process, a shunt element and a flow control element in an assembled configuration in which the flow control element is movable relative to the shunt element; and securing the actuation element to the shunt element and / or the flow control element; The method, wherein the actuation element, when secured to the shunt element and / or the flow control element, is configured to selectively move the flow control element relative to the shunt element.
[0276] 199. The method of example 198, wherein the actuating element is constructed from nitinol.
[0277] conclusion The above detailed description of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise forms disclosed above. While specific embodiments and examples of the technology have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications are possible within the scope of the technology. For example, any of the features of the intraocular shunts described herein can be combined with any of the features of the other intraocular shunts described herein, and vice versa. For example, while steps are presented in a given order, steps may be performed in a different order in alternative embodiments. The various embodiments described herein can also be combined to provide further embodiments.
[0278] From the foregoing, it will be understood that, while specific embodiments of the present technology have been described herein for purposes of illustration, well-known structures and functions associated with intraocular shunts have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.
[0279] Unless the context clearly requires otherwise, throughout the description and examples, words like "comprise," "comprising," and the like should be construed in the sense of inclusion, i.e., "including, but not limited to," as opposed to the exclusive or exhaustive sense. As used herein, the terms "connected," "coupled," or any variations of these terms, mean any direct or indirect connection or coupling between two or more elements, and the coupling between the elements may be physical, logical, or a combination thereof. Also, as used herein, the words "herein," "above," "below," and words of similar import shall refer to this application as a whole and not to any particular portions of this application. Where the context allows, words in the above detailed description using the singular or plural number may also include the plural or singular number respectively. As used herein, the phrase "and / or," such as in "A and / or B," refers to A only, B only, and A and B. Additionally, the term "comprising" is used throughout to mean including at least the recited features, without excluding any greater number of the same features and / or other features of additional types. It will also be understood that, while specific embodiments have been described herein for illustrative purposes, various modifications may be made without departing from the present technology. Furthermore, while advantages associated with some embodiments of the present technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily need to exhibit such advantages to fall within the scope of the present technology. Thus, the present disclosure and related technology may encompass other embodiments not explicitly shown or described herein.
Claims
1. An implantable medical device for draining fluid from a first body region to a second body region, the device comprising: a drainage element having a lumen extending therethrough, the drainage element configured to fluidly connect the first body region and the second body region; a flow control element selectively movable through at least three distinct positions, each distinct position associated with a corresponding flow resistance through the device; an actuation assembly configured to incrementally move the flow control element through at least one of the at least distinct positions during actuation of the actuation assembly; and A device comprising:
2. The device described in claim 1, wherein the actuation assembly includes a ratchet mechanism configured to move the flow control element through the plurality of distinct positions.
3. The device described in claim 2, wherein the ratchet mechanism includes at least three teeth.
4. The device described in claim 3, wherein the plurality of teeth correspond to the at least three distinct positions.
5. The device described in claim 1, wherein the actuating assembly includes at least one actuating element and the ratchet mechanism.
6. The device described in claim 1, wherein the implantable medical device is a glaucoma shunt and the first body region is the anterior chamber of the eye.
7. The device described in claim 1, wherein the flow control element is configured to change the diameter of the lumen as it moves between the at least three distinct positions.
8. The device described in claim 1, wherein the flow control element is selectively movable through at least four distinct positions, each of the at least four distinct positions being associated with a unique fluid resistance through the device.
9. The device described in claim 1, wherein the actuation assembly includes a shape memory actuation element.
10. The device described in claim 1, wherein the actuation assembly is further configured to hold the flow control element in a specific distinct position among the at least three distinct positions following actuation of the actuation assembly.
11. An implantable medical device for draining fluid from a first body region to a second body region, said device comprising: a drainage element having a lumen extending therethrough, the drainage element configured to fluidly connect the first body region and the second body region; a flow control element movable through at least three distinct positions; an actuator that, in response to being actuated, moves the flow control element from its current distinct position among the at least three distinct positions to a different distinct position among the at least three distinct positions; A device comprising:
12. The device described in claim 11, wherein the flow control element is movable through at least four distinct positions.
13. The device described in claim 11, wherein the flow control element is movable through at least five distinct positions.
14. The device described in claim 11, wherein at least some of the at least three distinct locations provide unique relative fluid resistance through the device.
15. The device of claim 11, wherein each of the at least three distinct locations provides a different resistance to fluid flow through the device.
16. The device described in claim 11, further comprising a ratchet configured to hold the flow control element in the different discrete positions after the actuator is actuated to move the flow control element to the different discrete positions.
17. The device described in claim 11, wherein the actuator includes a shape memory actuation element.
18. The device described in claim 11, wherein the device is an intraocular shunt device.