Adjustable flow glaucoma shunt and methods of making and using the same

Abstract

Disclosed herein are adjustable flow glaucoma shunts. For example, in one embodiment, an adjustable flow shunt can include an outflow drainage tube having a proximal inflow region and a distal outflow region. The proximal inflow region can include one or more apertures defining a fluid entry range, disposed in a position to allow fluid to flow therethrough. The shunt further includes an inflow control assembly positioned at the proximal inflow region. The inflow control assembly can include a control element configured to slidably mate with the proximal inflow region and a spring element. The spring element is configured to be activated by a non-invasive energy, and upon activation, slidably move the control element along the proximal inflow region such that (a) the one or more apertures are accessible and have a first fluid flow cross-section, or (b) the one or more apertures are at least partially covered by the control element and have a second, different fluid flow cross-section.

Description

[0001] Cross-referencing related applications

[0002] This application claims priority to the following U.S. provisional patent applications: No. 62 / 643,125, filed March 14, 2018; No. 62 / 626,615, filed February 5, 2018; and No. 62 / 535,125, filed July 20, 2017, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This technology relates to adjustable flow glaucoma shunts and methods for manufacturing and using such devices. Background Technology

[0004] Glaucoma, or ocular hypertension, is a disease associated with increased intraocular pressure due to increased production of aqueous humor (watery fluid) and / or decreased rate of outflow of aqueous humor from the eye into the bloodstream. Aqueous humor is produced in the ciliary body at the junction of the posterior and anterior chambers of the eye. It flows into the anterior chamber and eventually into the capillary bed of the sclera. Glaucoma usually results from a failure of the mechanism that transports aqueous humor from the eye into the bloodstream.

[0005] For example, the normal flow rate of aqueous humor is approximately 2.5 μL / min. If we assume the minimum pressure at which aqueous humor drains into the capillary bed is 0 Torr, the maximum outflow resistance of a normal eye under maximum normal pressure is expected to be approximately 9 Torr / (μL / min). Normal intraocular pressure ranges from 12 Torr to 22 Torr. As mentioned above, glaucoma is usually associated with high intraocular pressure, which can damage eye tissues and lead to vision loss. Pressure significantly below this range is called hypotony or low intraocular pressure. In some patients, hypotony (if it does not exceed this range) is as harmful as glaucoma.

[0006] Early-stage glaucoma is usually treated with medication. However, when medication is no longer sufficient, surgery is employed. Surgical or minimally invasive procedures primarily reduce the resistance to the outflow of aqueous fluid from the anterior chamber to the bloodstream by creating alternative fluid pathways or enlarging natural pathways for the outflow of aqueous fluid.

[0007] Devices used to reduce outflow resistance are commonly referred to as “glaucoma diverters” or “dipers.” For example, Figures 1A-1C show several different conventional glaucoma plate diverters 100 (each labeled 100a-c) configured to provide constant resistance to the fluid. For instance, diverter 100a of Figure 1A includes a plate 103a, multiple outlets 102a, one or more inlets 101, and a fastening or fitting feature 104a. Diverters 100b and 100c shown in Figures 1B and 1C each include several features similar to those of diverter 100a. For example, these diverters 100b-c include plates 103b-c, outlets 102b-c, and fastening or fitting features 104b-c. However, diverters 100b-c include an inlet pipe 105 instead of the inlet 101 of diverter 100a.

[0008] Figures 2A and 2B show suitable locations within the eye for implantation of the human eye E and the shunt 100a-c. More specifically, Figure 2A This is a simplified front view of eye E. Figure 2B yes Figure 2A An isometric view of the ocular sac. First refer to... Figure 2A The eye (E) comprises many muscles that control its movement, including the superior rectus (SR), inferior rectus (IR), lateral rectus (LR), medial rectus (MR), superior oblique (SO), and inferior oblique (IO). The eye (E) also includes the iris, pupil, and limbus.

[0009] Let's refer to each other. Figure 2A and 2B The shunt 100c is positioned such that the inflow tube 105 is located in the anterior chamber of the eye, and the outflow outlet 102c is located at different locations within the eye. Depending on the design of the device, the outflow outlet 102c can be located at several different suitable outflow locations (e.g., between the choroid and sclera, or between the conjunctiva and sclera). For illustrative purposes, only the shunt 100c is shown implanted in the eye E. However, it should be understood that shunts 100a-b can be similarly implanted in the eye E.

[0010] Outflow resistance typically depends on the outflow location. Furthermore, outflow resistance changes over time as the outflow location undergoes a healing process after surgical device implantation. Because outflow resistance changes over time, in many procedures, the shunt 100a-c is modified at implantation to temporarily increase its outflow resistance. After a period deemed sufficient to allow tissue healing and for outflow resistance to stabilize, the modification of the shunt 100a-c is reversed, thus reducing outflow resistance. Such modifications can be invasive, time-consuming, and expensive for the patient. However, failure to follow such procedures carries a high likelihood of developing low intraocular pressure and the resulting problems. Attached Figure Description

[0011] Referring to the following figures will provide a better understanding of several aspects of this technology. The components in the figures are not necessarily drawn to scale. Instead, the focus is on clearly illustrating the principles of the technology. Furthermore, components may appear transparent in some views only for illustrative purposes and not to indicate that the component must be transparent. Components may also be shown schematically.

[0012] Figures 1A-1C show conventional glaucoma plate shunts configured to provide constant flow resistance.

[0013] Figure 2A This is a simplified front view of eye E with an implanted shunt. Figure 2B yes Figure 2A An isometric view of the eye sac.

[0014] Figure 3A and 3B An adjustable flow glaucoma shunt configured according to one embodiment of the present technology is shown.

[0015] Figure 3C This is a partial schematic diagram showing the ocular sac of a human patient, illustrating its implantation within the sac. Figure 3A and 3B Adjustable flow glaucoma shunt.

[0016] Figure 3D and 3E An inflow area configured according to an additional embodiment of the present technology is shown.

[0017] Figures 4A-4C An adjustable flow glaucoma shunt configured according to another embodiment of the present technology is shown.

[0018] Figures 5A-6B An inflow control component configured according to an embodiment of this technology is shown.

[0019] Figures 7A-7E A variable flow splitter configured according to an embodiment of this technology is shown.

[0020] Figures 8A-9B An additional embodiment of a variable flow glaucoma shunt device configured according to the present technology is shown.

[0021] Figure 10 A variable flow splitter device according to an embodiment of the present technology is shown, the variable flow splitter device including an actuable element located at the outlet end of the device.

[0022] Figure 11A-11C A strip or filament made of shape memory material and configured according to an embodiment of the present technology is shown.

[0023] Figure 12A and 12BA fluid control element comprising a variable fluid resistance device made of shape memory material is shown according to an embodiment of the present technology.

[0024] Figure 13A and 13B This is a partial schematic cross-sectional view of a variable fluid resistance device including a double-cavity elastomer tube configured according to an embodiment of the present technology.

[0025] Figure 13C-13F An additional embodiment of a variable fluid resistance device configured according to the present technology is shown.

[0026] Figure 14A and 14B An additional embodiment of the present technology is shown, comprising a fluid control element including a variable fluid resistance device made of shape memory material.

[0027] Figures 15A-15C An adjustable flow glaucoma shunt configured according to another embodiment of the present technology is shown.

[0028] Figures 16A-16E An adjustable flow glaucoma shunt configured according to another embodiment of the present technology is shown. Specific Implementation

[0029] This technology applies to adjustable flow glaucoma shunts and methods of manufacturing and using such devices. In several embodiments disclosed herein, the adjustable flow glaucoma shunt includes an adjustable fluid resistance (in the context of this document, "resistance" refers to a fluid resistance), an actuator, and / or an actuation mechanism. Furthermore, in some embodiments, the shunt may also include an adjustable opening pressure control mechanism. These mechanisms can be selectively adjusted or modified to increase or decrease the shunt's outflow resistance and / or opening pressure in response to changes in intraocular pressure (IOP), aqueous fluid generation rate, natural aqueous fluid outflow resistance, and / or natural aqueous fluid outflow rate (or any combination thereof).

[0030] For example, in one embodiment, an adjustable flow shunt for treating glaucoma in a human patient includes an extended outflow drain having a proximal inflow region and a distal outflow region. The proximal inflow region may include one or more orifices defining a fluid inlet range positioned to allow fluid to flow through and into the outflow drain. The adjustable flow shunt also includes an inflow control assembly at the proximal inflow region. The inflow control assembly may include a control element sized and shaped to slidably engage with the proximal inflow region and a spring element operatively coupled between the control element and an anchor element engaging with the proximal inflow region. The spring element is configured to be activated by non-invasive energy and, upon activation, to slidably move the control element along the proximal inflow region such that (a) one or more orifices are accessible and have a first fluid flow cross-section, or (b) one or more orifices are at least partially covered by the control element and have a second fluid flow cross-section smaller than the first fluid flow cross-section.

[0031] In another embodiment of this technology, an adjustable flow shunt for treating glaucoma may include an elongated outflow tube having (a) a proximal inflow portion configured to be placed in an area outside the optical field of vision of the patient's eye in the anterior chamber, and (b) a distal outflow portion at different locations in the eye. The adjustable flow shunt also includes an actuator positioned along the outflow tube between the inflow and outflow portions. The actuator can switch between an open position allowing fluid to flow through the outflow tube and a resistance position partially obstructing fluid flow through the outflow tube. During operation, the actuator moves between positions in response to non-invasive energy.

[0032] An adjustable flow shunt assembly configured according to another embodiment of the present technology may include an elongated drainage tube having a proximal portion and a distal portion. The proximal portion includes an inlet configured to be in fluid communication with a fluid chamber in a patient's eye. The adjustable flow shunt may also include a variable resistance assembly configured to selectively control the flow rate of fluid flowing into the inlet. The variable resistance assembly in this embodiment includes a base and an orifice plate supported by the base. The orifice plate includes a plurality of first orifices extending therein. The variable resistance assembly also includes a separator plate supported by and extending outward from the orifice plate. The separator plate includes a plurality of second orifices extending therein, wherein the second orifices are aligned with corresponding first orifices of the orifice plate. The variable resistance assembly also includes a membrane disposed on and supported thereon on the separator plate. The membrane is positioned to sealably cover the open end of each of the second orifices. During operation of the shunt assembly, a portion of the membrane above one or more second holes of the isolation plate is configured to be selectively targeted and removed by non-invasive energy, thereby creating a flow channel from a fluid site in the patient through the accessible opening of the targeted second hole, the corresponding first hole, and into the drainage tube.

[0033] The following is for reference Figure 3A-16E Specific details of various embodiments of the present technology are described herein. Although many embodiments of adjustable flow glaucoma shunts and related methods are described below, other embodiments are also within the scope of the present technology. Furthermore, other embodiments of the present technology may have different configurations, components, and / or processes than those described herein. For example, a shunt configured according to the present technology may include additional elements and features beyond those described herein, or other embodiments may exclude some elements and features shown and described herein.

[0034] For ease of reference, the same reference numerals are used in this disclosure to identify similar or related parts or features, but the use of the same reference numerals does not mean that these parts should be interpreted as identical. In fact, in many of the examples described herein, the parts marked with the same reference numerals differ in structure and / or function.

[0035] Variable Flow Glaucoma Shunt Selection Example

[0036] Figure 3A-16E Several different embodiments of a variable flow glaucoma shunt device are illustrated, along with specific components and features associated with such devices. For example, Figure 3A A variable flow glaucoma shunt 300 (“shunt 300”) configured according to one embodiment of the present technology is shown. The shunt 300 includes an inflow control assembly 338 and an outflow drain or outflow assembly 327. The inflow control assembly 338 of the shunt 300 is configured to be placed in an area outside the anterior chamber’s optical field of vision, but within an area visible through the cornea (see below). Figure 3C The outflow drainage tube 327 includes a tube (e.g., a thin-walled tube with a fine orifice) whose size and shape are formed to span the region between the anterior chamber and the desired outflow location. As described in more detail below, the inflow control assembly 338 includes a control mechanism configured to act as a variable resistance during operation.

[0037] Figure 3B This is a partially exploded view of the diverter 300. For illustrative purposes, a portion of the inflow control assembly 338 is removed from the outflow drain 327. Ideally, as... Figure 3BAs shown, the proximal end 360 of the outflow drainage tube 327 includes a proximal inflow region defined by a core element or core feature 342 extending therefrom. The core element 342 may be constructed of a relatively rigid material or a combination of rigid materials, including but not limited to polyetheretherketone (PEEK), acrylates, polycarbonate, metals, ceramics, quartz, and / or sapphire. The portion of the outflow drainage tube 327 not included in the core element 342 may be constructed of a relatively flexible material (e.g., silicone, urethane, or other suitable materials). The core element 342 includes one or more orifices or openings 341 defining a fluid inlet range 362 (only one is shown in the illustrated embodiment). The fluid inlet range 362 is in fluid communication with the lumen of the outflow drainage tube 327. In other embodiments, the one or more orifices 341 may have different arrangements and / or may have different numbers of orifices 341. For example, in another embodiment, the orifices 341 may extend helically around the core element 342. One or more orifices 341 are provided at locations that allow fluid to flow through them during operation of the distributor 300.

[0038] For example, refer to together Figure 3A and 3B The inflow control assembly 338 in the illustrated embodiment includes a control element 339, which is configured to be positioned on or around the outer surface of the core element 342 (e.g., Figure 3B (As indicated by the arrow in the diagram). During operation, the control element 339 can be adjusted to cover more or less of the fluid inlet range 362. For example, in some embodiments, the control element 339 can be adjusted to increase or decrease the length of the flow channel between the edge of the control portion 339 and one or more orifices 341. Figure 3B In some embodiments, a hydrogel coating may be applied to the inner surface of the control element 339 to further enhance the ability of the control element 339 to slide relative to the core element 342 and to enhance the sealing of the component during operation. In additional embodiments, the hydrogel coating may also be applied to the core element 342 (additionally or alternatively, to a coating applied to the control element 339). Further details regarding the adjustment / manipulation of the control element 339 are described below.

[0039] The inflow control assembly 338 in the illustrated embodiment may further include adjustable spring elements (shown as first and second spring elements 340 and 340') arranged on both sides of the control element 339. Each spring element 340 and 340' may also include a corresponding anchor element 310.

[0040] exist Figure 3A and 3BIn the illustrated embodiment, the control element 339 is made of a single material. For example, the control element 339 may be made of materials such as (but not limited to) ceramics, alumina, silica, sapphire, and / or quartz. Such materials can be ground to very high tolerances / precise dimensions. However, in other embodiments, the control element 339 may have different portions / areas made of different materials. The first and second spring elements 340 and 340' may be made of shape memory materials (e.g., nickel-titanium alloys or other suitable shape memory materials) that can be activated by non-invasive energy such as light (and / or heat). The anchor element 310 may be made of one or more similar materials or other suitable materials.

[0041] In operation, the first and second spring elements 340 and 340' are configured to be selectively activated by non-invasive energy, and upon activation, the control element 339 is slidably moved along the proximal inflow region in a first or second direction, such that (a) one or more orifices 341 have a first fluid flow cross-section (e.g., fully open and accessible), or (b) one or more orifices are at least partially covered by the control element 339 and have a second fluid flow cross-section smaller than the first fluid flow cross-section (e.g., partially open / accessible). Furthermore, in some cases, the control element 339 can be slidably adjusted such that one or more orifices 341 are completely covered and inaccessible. Figure 3A and 3B A feature of the arrangement shown is that, after placement inside the eye, the inflow control assembly 338 can be selectively adjusted (e.g., by non-invasive energy) to provide a variety of different outflow resistance levels by progressively adjusting the control element 339 relative to one or more orifices 441.

[0042] Figure 3C This is a partial schematic diagram showing the ocular sac of a human patient, illustrating its implantation within the sac. Figure 3A and 3B An adjustable flow glaucoma shunt. Specifically, a typical surgical procedure for implanting the shunt 100 into the ocular capsule includes the following: (a) a portion of the conjunctiva is posteriorly dissected; (b) a portion of the sclera is removed to form a pouch for the placement plate; (c) an inflow control assembly 338 is introduced into the anterior chamber of the ocular capsule; (d) an outflow drainage tube 327 extends through the tissue and into the desired pouch; and (e) the outflow drainage tube 327 and any other portion of the shunt 300 not embedded in other tissue are covered by the conjunctiva. For example, in Figure 3CIn the illustrated embodiment, the shunt 300 is configured to pass through a region in the anterior chamber and be placed in a location on the choroid of the eye. However, in other embodiments, the shunt 300 may be adapted to be placed within different parts of the eye. For example, in one embodiment, the shunt configured according to the present technology may be positioned in a region under the conjunctiva within the eye.

[0043] 3D and 3E illustrate core components configured according to different embodiments of the present technology. For example, firstly refer to... Figure 3D The core element 342 includes a plurality of holes or openings 341' extending therethrough, and the plurality of holes or openings 341' at least partially define flow channels communicating with the inner cavity of a corresponding outflow drain 327. The holes 341' in the illustrated embodiment have different characteristics from those described above. Figure 3A and 3B The arrangement / configuration of the holes 341. It should be understood that, although Figure 3D The diagram shows six holes 341', but in other embodiments, the core element 342 may include a different number of holes 341'. Furthermore, the holes 341' may have different arrangements relative to each other. Figure 3E Another embodiment of a core element 342 having a hole 341” with a different arrangement according to the present technology is shown. In this embodiment, the hole 341” includes a plurality of elongated slots arranged around the core element 342. In other embodiments, the hole 341' / 341” may have a variety of other suitable shapes / sizes.

[0044] Figures 4A-4C A variable flow glaucoma shunt 400 (“shunt 400”) configured according to another embodiment of the present technology is shown. The shunt 400 includes an inflow control assembly 438 and an outflow drain or outflow assembly 427. The inflow control assembly 438 includes components as described above. Figure 3A and 3B The inflow control assembly 338 of the diverter 300 has some similar features. For example, the inflow control assembly 438 includes a first or proximal spring element 440' and a second or distal spring element 440 arranged adjacent to each other. The inflow control assembly 438 also includes a core element or feature 442 coupled to the internal portion of the inflow control assembly at an anchor point 442' between the spring elements 440 and 440' (ideally as shown in the image). Figure 4B and 4C(As shown). A retaining ridge 451 extends between and is operatively coupled to spring elements 440 and 440'. Although only one retaining ridge 451 is shown in the illustrated embodiment, in other embodiments, the shunt 400 may include one or more additional retaining ridges. In the illustrated embodiment, the retaining ridge 451, as well as the first and second spring elements 440 and 440', are integrally formed from the same tube using a laser-cutting process. However, in other embodiments, spring elements 440 and 440' and / or the retaining ridge 451 may be separate, discrete components formed from different materials.

[0045] In operation, the splitter 400 is configured to work in accordance with the above reference. Figures 3A-3C The diverter 300 operates in a similar manner. Specifically, the first and second spring elements 440 and 440' are configured to be selectively activated by non-invasive energy, and upon activation, the core element 442 is slidably moved to change the length of the flow path in the opening or slit 460 of the inflow control assembly 438. (See reference...) Figure 4B For example, when the distal spring 440 is expanded / actuated, the core element 442 moves proximally and the length of the core portion 442 within the uncut portion of the splitter 400 (and the corresponding flow F through the opening 460 and along the flow path FP in the flow control assembly 438) is minimized.

[0046] However, reference Figure 4C When the distal spring 440 is compressed and the proximal spring 440' is expanded / actuated, the length of the core portion 442 within the uncutable portion (and the corresponding flow F along the flow channel FP) is maximized. The disclosed arrangement is expected to provide an efficient and predictable way to progressively increase / decrease flow resistance linearly via the diverter 400. In other embodiments, the diverter 400 may be configured to provide a two-state on / off arrangement by selectively actuating the first and second spring elements 440 and 440', rather than... Figures 4A-4C The flow rate is progressively regulated by the diverter 400, as shown. Furthermore, in some embodiments, the width and / or shape of the opening / slit 460 can be modified to allow for further control over the flow resistance of the diverter 400. In another embodiment, the core can be fixed to the proximal end of the spring element 440' without extending into the flow channel. In such an embodiment, the flow channel is altered by expanding or compressing the space between the elements of springs 440 and 440'. In other embodiments, the shape of the pin and / or cavity can be modified to allow for non-linear flow control based on the travel of the core.

[0047] Figures 5A-6B An inflow control component configured according to a further embodiment of the present technology is shown. For example, first refer to Figure 5A and 5BThe inflow control assembly 538 is located on or around the outer surface of the core element 542 at the inflow or inlet region of the drainage tube 527. The inflow control assembly 538 includes a control element 539 and a spring element 540, which is fixed to the inflow control assembly 538 and extends towards the proximal end of the drainage tube 527. The inflow control assembly 538 also includes an anchor element 510 operatively coupled to the spring element 540 at the proximal region of the inflow control assembly 538. Figure 5A An inflow control assembly 538 is shown in a low-flow or minimum-flow configuration, wherein a control element 539 is fully or approximately fully located in a hole 541 within a core element 542. Figure 5B Above. Figure 5B The inflow control assembly 538 in the maximum flow configuration is shown, wherein the spring element 540 has been actuated. In some embodiments, for example, the spring element 540 may be heated by non-invasive energy (e.g., laser energy), causing the spring element 540 to bend outward and the control element 539 to be slidably moved in the proximal direction, such that the orifice 541 is exposed and fluid may flow from there into the drainage tube 527.

[0048] Figure 6A and 6B Another embodiment of the inflow control assembly 638 configured according to the present technology is shown. In this embodiment, the inflow control assembly 638 includes a control element 639 and first and second spring elements 640 and 640' fixed thereon and extending toward the proximal end of the drainage tube 627. The first and second spring elements 640 and 640' have different characteristics from those described above. Figure 5A and 5B The configuration of the spring elements 540 and 540'. Furthermore, each spring element 640 and 640' is operatively coupled to a corresponding anchor element 610 and 610'. Since each spring element 640 and 640' has its own anchor element 610 and 610', the spring elements 640 and 640' can be independently configured in the initial setup and independently controlled during operation. For example, as... Figure 6B As shown, spring elements 640 and 640' can each be actuated (e.g., by heat) to make spring elements 640 and 640' more tightly wound and to slidably move control element 639 along core element 642 in the proximal direction, and to create an open flow channel (to the inner cavity of drainage tube 627) through exposed hole 641.

[0049] Figure 3A-6B In the illustrated embodiments, the inlet end of various illustrated splitters is sealed. Such splitters (as referenced above) can be delivered by passing a needle (not shown) through the desired flow path. Figure 3C(as described above). However, in other embodiments, the inlet end of the shunt may be initially open (allowing the shunt to be delivered via the guide wire) and then sealed after delivery and placement.

[0050] Additional embodiments of adjustable flow glaucoma shunt

[0051] The following is for reference Figure 7A-16E Additional embodiments of glaucoma shunts, including plates with adjustable flow rates and / or adjustable calibrated pressures, are described. These can be described as above and as... Figure 3C The shunt shown is implanted in this manner, or one or more shunts can be implanted in other suitable locations within the eye using other suitable techniques. In some of these embodiments, an additional tube is added to the conventional outlet to distribute the aqueous solution over a larger area of ​​tissue. One or more outlet tubes are at least covered by the conjunctiva. Several embodiments of this technology also include adjustable fluid resistance devices, some of which may also include adjustable opening pressure control mechanisms. These mechanisms can be adjusted to increase or decrease the shunt's outflow resistance and / or opening pressure in response to changes in intraocular pressure, aqueous solution production rate, natural water outflow resistance, natural water outflow rate, and combinations thereof.

[0052] Figures 7A-7E Another embodiment of a variable flow splitter 700 configured according to the present technology is shown. For example, Figure 7A This is a schematic top view of the shunt 700, configured for minimally invasive placement (similar to the reference above). Figure 3A-6B The diverter 700 includes an elongated drain tube 702 having a proximal portion having an inlet 701 and a distal portion opposite to the proximal portion. The diverter 700 differs from the diverters described above in that it selectively controls the fluid resistance of the diverter 700 by modifying the number of orifices allowing fluid to flow through the inlet 701. For example, in some embodiments, the diverter 700 may be configured to allow only a successive decrease in outflow resistance. However, in other embodiments, the diverter 700 may be configured to selectively allow both a limited decrease and a limited increase in outflow resistance. Further details regarding the diverter 700 and its operation are described below.

[0053] Figure 7B It is along Figure 7A A magnified schematic cross-sectional view of the shunt 700 obtained from line BB. Figure 7C yes Figure 7B A magnified view of area C marked in the image. Please refer to it as well. Figure 7B and 7CThe inlet 701 of the diverter 700 also includes a variable resistance assembly 720 configured to selectively control the flow rate into the inlet (and outlet 702). The variable resistance assembly 720 includes a membrane 745 disposed on and carried thereon on a partition plate 746. The partition plate 746 is operatively coupled to and extends from an orifice plate 747. The orifice plate 747 is carried by the base or housing 748 of the diverter 700.

[0054] The perforated plate 747 includes a plurality of first holes or first openings 760 extending therethrough. Each first hole 760 has a first cross-sectional dimension D1 (not shown). The first holes 760 can be precisely formed such that each opening is identical or nearly identical, and all first holes 760 are of predetermined dimensions. The partition plate 746 includes a plurality of second holes or second openings 741 extending therethrough. The second holes 741 have a second cross-sectional dimension D2 larger than the first cross-sectional dimension D1. As will be described in more detail below, the second holes 741 do not need to be formed as precisely as the first holes 760. Figure 7C As shown, the membrane 745 completely covers one end (upper or first end) of each second hole 741. The opposite end (second or lower end) of each second hole 741 is aligned with the corresponding first hole or first opening 760 extending through the perforated plate 747.

[0055] Figure 7D This is a top view of the variable resistance assembly 720. (See attached image.) Figure 7D As shown, the variable resistance assembly 720 also includes a plurality of target marks or symbols 713 (“targets 713”). Each target 713 corresponds to and is aligned with each first hole 741. Figure 7B ). refer to Figure 7E After the shunt 700 is implanted in a patient and it is desired to reduce the fluid resistance of the shunt 700, non-invasive energy (e.g., a surgical laser) can be applied to selected targets 713 on the membrane 745. For example, in embodiments using laser energy, a laser can be activated or emitted to selectively ablate the targeted material of the membrane 745, thereby removing the membrane material and exposing the open end of the corresponding second orifice 741. Without membrane obstruction of the targeted second orifice 741, fluid can flow through it (as indicated by arrow F), then through the corresponding first orifice 760, and into the outflow drainage tube 702. If further reduction in fluid resistance is required, one or more additional targets 713 on the membrane 745 can be ablated to expose additional second orifices 741, allowing additional fluid to flow from them into the outflow drainage tube 702.

[0056] In the illustrated embodiment, once the corresponding targeted portion of membrane 745 is removed to open the second orifice 741 to allow the aqueous sample to flow, there is no way to seal the second orifice 741 of the implanted splitter 700, and the outflow resistance can only be reduced. However, in other embodiments, there are techniques available to subsequently prevent or block fluid flow by blocking one or more open second orifices 741. For example, see reference... Figure 7B and 7C In some embodiments, the membrane 745 and the separator 746 may be at least partially composed of a hydrophobic material (e.g., a low-melting-point wax) suitable for melting by a surgical laser (not shown) at a temperature that will not cause specific damage to the aqueous sample. In these embodiments, a relatively small, fine beam of light from a laser source can be used to melt the wax material of the target membrane 754 and open the corresponding second orifice 741. At a subsequent point in time, if it is necessary to slow or restrict the flow of the aqueous sample, a larger beam of light from the laser source can be used to melt the wax material of the separator 746, causing the material to "puddle" or accumulate on the corresponding second orifice 760 within the previously opened second orifice 741, and closing or blocking fluid flow through the first orifice 760.

[0057] exist Figures 7A-7E In the illustrated embodiment, the components of the variable resistance assembly 720 are separate, discrete parts operatively coupled together prior to implantation into the shunt 700. The parts may be made of similar materials or one or more different materials. However, in other embodiments, the membrane 745 and the separator 746 may be manufactured as a single, integral part made of the same material, for example, in the example described above, the membrane 745 and separator 746 comprise an integral part made of a hydrophobic material. However, in other embodiments, the integral membrane 745 / separator 746 may be made of other suitable materials. In other embodiments, the separator 746 and the perforated plate 747 may be made as a single, integral part made of the same material in which first and second orifices 741 and 760 are formed. In another additional embodiment, the perforated plate 747 may be integrally formed with the base 748 of the shunt 700.

[0058] Figures 8A-9B Additional embodiments of a variable-flow glaucoma shunt device configured according to the present technology are shown. In these embodiments, the shunt is configured to be delivered via a guidewire to a target location within the patient's ocular capsule, and then switch between a delivery configuration and a deployment configuration upon removal of the guidewire. For example, Figure 8A A shunt 800 in a delivery configuration on a guidewire W is shown. The shunt 800 includes an inflow control assembly 838 and an outflow tube or outflow assembly 827. The inflow control assembly 838 may include components referenced above. Figure 3A-6BThe diverters described generally share some similar features. For example, diverter 800 includes a control element 839 positioned on one or more orifices or openings 841 (shown in dashed lines) extending through the body portion 848 of the inflow control assembly 838. When one or more orifices 841 are at least partially exposed, they are configured to allow a sample solution to flow through and into an outflow tube 827. Diverter 800 also includes a pair of adjustable spring elements 840 and 840' arranged on either side of the control element 839. Spring elements 840 and 840' are coupled between the body portion 848 and the control element 839. In some embodiments, spring elements 840 and 840' are made of a shape memory material (e.g., a nickel-titanium alloy) and are adapted to expand / contract upon application of heat. For example, applying heat to the first spring element 840 may cause it to coil more tightly, thereby moving the control element 839 toward the first spring element 840 and stretching or expanding the second spring element 840'. Similar to the above references Figures 3A to 6B In the described technique, the movement control element 839 also exposes at least partially one or more holes 841 to allow the aqueous sample liquid to flow through.

[0059] In the illustrated embodiment, the inflow control component 838 is made of a first material having a first hardness, and the outflow pipe 827 is made of a second material having a second hardness, the second hardness being less than the first hardness. (See also...) Figure 8A and 8B The diverter 800 can be pre-shaped before implantation, such that the diverter 800 includes one or more bends along its length. For example, in the illustrated embodiment, the diverter 800 includes a generally "L"-shaped arrangement and includes a bend or elbow 854 located in or near the distal region of the outflow tube 827.

[0060] When the shunt 800 is placed on the guide wire W for delivery, the shunt 800 is assumed to be in a linear, straight delivery configuration. However, as Figure 8B As shown, when the guidewire W is removed, the shunt 800 switches between its delivery configuration and expansion / deployment configuration, in which the shunt 800 is assumed to be in a predetermined "L"-shaped configuration including the elbow 865. This configuration is intended to allow for rapid and reliable delivery of the shunt 800 via the guidewire W, and to enable precise placement of the inflow control assembly 838 within the patient's eye capsule once the guidewire is removed, with the shunt 800 in its predetermined shape.

[0061] Figure 9A and 9BA shunt 900 configured according to another embodiment of the present technology is shown. The shunt 900 includes several features generally similar to those of the shunt 800. The difference between the shunt 900 and the shunt 800 is that the shunt 900 is not constructed of different materials with different hardnesses. Instead, the shunt 900 includes an inflow portion or region 938 and an outflow portion or outlet tube 927, which is constructed of a single material (e.g., a shape memory material such as a nickel-titanium alloy). Similar to the shunt 800 described above, the shunt 900 also includes a predetermined, generally "L"-shaped arrangement and includes bends or elbows 954. However, in this embodiment, removing the guidewire W does not place the shunt 900 in its delivery configuration ( Figure 9A ) and its deployment / scaling configuration ( Figure 9B Convert between ) and ). Conversely, the best way is as follows: Figure 9B As shown, once the guidewire W is removed and the shunt 900 is in the desired position within the patient's body, a laser source (e.g., an ophthalmic laser - not shown) can be used to guide a laser beam to selectively heat a portion of the shunt 900 and induce the shunt 900 to bend around the elbow 954 and return to its preset shape (generally an "L" shaped arrangement).

[0062] Figure 10 A variable flow shunt device 1000 configured according to another embodiment of the present technology is illustrated. The shunt 1000 includes an inflow assembly 1001 and an outflow drain 1027 with an outlet 1002. The shunt 1000 also includes an actuable element 1049 located at the outflow end of the outlet 1002 (opposite to the inflow assembly 1001). The actuable element 1049 includes one or more tissue interference elements 1050 (e.g., barbs or other suitable types of devices) to interfere with / impede tissue at or near the outflow end of the outlet 1001 after the shunt 1000 has been implanted into a patient. In one embodiment, an operator can move and actuate the barbs 1050 of the actuable element 1049 by using an externally applied magnetic field to interfere with target tissue adjacent to the outflow end of the shunt 1000. However, in other embodiments, other suitable techniques such as thermally induced shape change can be used to move / actuate the barbs 1050. Furthermore, it should be understood that different numbers of barbs 1050 may be used and / or the barbs 1050 may have different arrangements relative to each other and the actuating element 1049.

[0063] The various embodiments disclosed herein utilize shape memory materials (SMMs), such as nickel-titanium alloys and shape memory polymers, as control in adjustable fluid resistors. As previously described, such fluid resistors allow a aqueous solution to flow in a controlled manner from the anterior chamber of the eye to a location where the solution can drain. One such location is within or on the sclera behind the cornea. Generally, the SMM element used in the various devices disclosed herein can be repeatedly activated in one direction to increase fluid resistance and repeatedly activated in another direction to decrease fluid resistance. In some embodiments, for example, each activation of a target in one part of the actuation element progressively increases resistance, while multiple activations of a target in another part of the actuation element progressively decrease resistance. When the target is heated above its transition temperature, for example by non-invasive laser energy, the SMM transforms from its larger volume, lower hardness, lower temperature martensitic (Mar) form to its higher temperature, smaller volume, higher hardness austenitic (Aus) form.

[0064] Austenitic oxygen (Austenitic) 75-83 GPa, relatively small volume, high temperature

[0065] Martensite (Martensite) 28-40 GPa, large volume, low temperature

[0066] Figure 11A-11C The diagram illustrates a configuration, representing a side view of a band or line arrangement according to an embodiment of this technology. First, refer to... Figure 11A The belt is configured to include a shape with multiple consistent folds. As shown, there are six folds; however, it should be understood that in other embodiments, a belt with more or fewer folds may be used depending on the required resolution and amount of displacement. Reference Figure 11B Then the belt can be installed between the two anchors, such that the constrained length is greater than the thermally set length. Now refer to... Figure 11C Heat is applied to one or more folds in the heated portion of the SMM, transforming it from a lower-stiffness, higher-volume Mar form to a harder and lower-volume Aus form. In the illustrated embodiment, even if the entire portion of the SMM is heated above the conversion temperature, the entire SMM part is not allowed to return to its thermally set shape. Unheated portions may expand further to compensate. Furthermore, heating previously unheated portions is expected to stretch both the previously unheated and heated portions to reverse the mechanism.

[0067] Figure 12A and 12B A fluid control element 1201 configured according to another embodiment of the present invention is shown. The fluid control element 1201 can be used with any variable flow splitter or other suitable splitter described herein. In this embodiment, the fluid control element 1201 includes a variable fluid resistance device (similar to the one referenced above) actuated by an SMM element. Figure 11A-11C (Those mentioned above). First refer to Figure 12A The fluid control element 1201 includes a base 1211 and a flow channel 1212 carried by and operatively coupled to the base 121. For example, the flow channel 1212 can be secured to the base 1211 by a flow anchor 1209. However, in other embodiments, other suitable techniques may be used to secure the flow channel 1212 to the base 1211. The flow channel 1212 may also operatively cooperate with an actuator 1218. In the illustrated embodiment, the actuator 1218 includes a strip or wire made of SMM and includes multiple folds. The actuator 1218 has a fixed length, and each end of the actuator 1218 is anchored to the base 1211.

[0068] Actuator 1218 can use similar references as above. Figure 11A-11C The aforementioned technology is used for actuation. For example, during operation, the top fold along the actuator 518 can be used as a target area for selective heating by non-invasive energy (e.g., laser energy) to locally heat these areas along the actuator 518. As previously mentioned... Figure 11A-11C As described, a fold heated on one side relative to the other side will allow a gradual transfer of resistance (upward or downward) to modify the state of actuator 1218, thereby changing the fluid resistance of flow channel 1212. For example, Figure 12A The low-resistance state of the fluid control element 1201 is shown, wherein the actuator 1218 is fairly consistent along its length and provides minimal resistance or disturbance to the fluid flowing through the flow channel 1212. Figure 12B The high-resistance state of the fluid control element 1201 is illustrated. For example, the high-resistance state or position is the result of multiple actuations of the flow passage 1212 by the actuating element 1218. Specifically, each fold of the actuating element 1218 on the left side of the flow passage 1212 is heated above the actuation temperature, causing the actuating element 1218 in that region to contract, thereby “pinching” and compressing the flow passage 1212 in this direction and increasing the fluid resistance therein. When needed, the fluid control element 1201 can be switched back to a higher resistance state by further manipulation / adjustment of the actuating element 1218 (e.g., heating a selected area). Figure 12B Resistance locations or directions other than those shown (e.g., back to the indicated resistance location or direction) Figure 12A (The state shown or different states).

[0069] Figure 13A and 13B This is a partially schematic cross-sectional view of a variable fluid resistance device including a dual-cavity elastomer tube 1312 configured according to another embodiment of the present technology. More specifically, Figure 13AAn elastomeric tube 1312 is shown in its initial or low-resistance state before adjustment. The elastomeric tube 1312 includes a first lumen or a fluid-passing lumen 1316 having an initial cross-sectional shape (e.g., a "D"-shaped lumen). The elastomeric tube 1312 also includes a second lumen or control lumen 1336 adjacent to the first lumen 1316 and a diaphragm therebetween. The control lumen 1336 contains one or more actuating elements 1318. For example, in the illustrated embodiment, the actuating element 1318 is constructed of an SMM and includes a first or expansion portion 1314 and a second or contraction portion 1315. Although in Figure 13A and 13B The cross-sectional view shows only a single actuating element 1318. It should be understood that in further embodiments, multiple actuating elements 618 may be arranged continuously along the length of the elastomer tube 1312.

[0070] Figure 13B An elastomer tube 1312 is shown in an increased or higher resistance state after the actuation element 1318 is activated. More specifically, non-invasive energy (e.g., heating by laser energy) is used on the expansion portion 1314 of the actuation element 1318, causing the actuation element 1318 to expand. This expansion pushes the diaphragm toward the flow cavity 1316 and reduces the cross-sectional dimensions of the flow cavity 1316. The reduction in the size of the flow cavity 1316 correspondingly increases the fluid resistance flowing through the cavity 1316. The cross-sectional dimensions of the flow cavity 1316 can be further modified by additional adjustments to the actuation element 1318. For example, the fluid resistance through the flow cavity 1316 can be further reduced by additional heating of the expansion portion 1314, or returned to a lower resistance state by heating the contraction portion 1315.

[0071] exist Figure 13C Another embodiment of the inflow according to the present technology, equipped with a variable resistance 1320, is shown. In this embodiment, a plurality of actuating elements 618 may be arranged continuously along the length of the control cavity 636. Figure 13A When the expansion portion 1314 of each target actuating element 1318 is actuated, the length of the confined range increases, thereby linearly increasing fluid resistance. Similarly, actuating one or more contraction portions 1315 of one or more target actuating elements 1318 can reduce fluid resistance. Figure 13C As shown, such a fluid control device can be incorporated into the distributor plate 1303, the inlet pipe 1305, the outlet pipe equipped with the variable resistance device 1321, and / or the outlet pipe (not shown).

[0072] Figure 13D A variable fluid resistance device configured according to another embodiment of the present technology is shown. Figure 13D The embodiments shown may include those referenced above. Figure 13A and13B The variable fluid resistance described above features several characteristics similar to those described above. However, in this embodiment, the elastomer tube 1312 includes a single fluid passage cavity 1316, while the actuation assembly 1322, placed along the elastomer tube 1312, includes a dual-cavity arrangement similar to that described above. Specifically, the actuation assembly 1322 includes a first cavity 1316' having a predetermined cross-sectional shape (e.g., a "D"-shaped cavity). The elastomer tube 1312 is located within and extends through the first cavity 1316' of the actuation assembly 1322. The actuation assembly 1322 also includes a second cavity or control cavity 1336' adjacent to the first cavity 1316. The control cavity 1336' contains one or more actuation elements 1318 similar to the actuation elements described above. For example, in this embodiment, the actuation element 1318 is constructed of an SMM and includes a first or expansion portion 1314 and a second or contraction portion 1315.

[0073] Selective heating of the expansion portion 1314 can cause the actuator 1318 to expand. (Refer to the above reference) Figure 13A and 13B The described arrangement is similar; this expansion reduces the cross-sectional size of the elastomeric tube 1312 by moving it away from the control cavity 1336' and toward the fixed inner wall of the first cavity 1316'. By reducing the cross-sectional size of the elastomeric tube 1312, the fluid resistance through the elastomeric tube 1312 is correspondingly increased. The fluid resistance through the elastomeric tube 1312 can be further reduced by additional heating of the expansion portion 1314, or the elastomeric tube 1312 can be returned to a lower resistance state by heating the contraction portion 1315 of the actuation element 1318. Although only a single actuation assembly 1322 is shown, it should be understood that in further embodiments, multiple actuation assemblies 1322 may be arranged along the length of the elastomeric tube 1312.

[0074] Figure 13E and 13F This is a partial schematic cross-sectional view of a fluid resistance device including a double-cavity elastomer tube 1312' configured according to another embodiment of the present technology. Figure 13E and 13F The fluid resistance device in the illustrated embodiment uses the same type as described above. Figure 13A and 13B It operates on a similar principle as described. For example, Figure 13E An elastomer tube 1312' in its initial or low-resistance state before adjustment is shown. The elastomer tube 1312' includes a first cavity or fluid passage cavity 1316' having an initial cross-sectional shape (e.g., a "D"-shaped cavity). The elastomer tube 1312' also includes a second cavity or control cavity 1336' adjacent to the first cavity 1316. The control cavity 1336' is filled with control fluid. Reference Figure 13F As the volume of the control fluid increases, the cross-sectional dimensions of the flow passage 1316 decrease as the elastic diaphragm 1337 expands into the flow passage 1316', thereby increasing fluid resistance and decreasing the flow rate through the flow passage 1316'. Similarly, when the control fluid is removed from the control passage 1336', the elastic diaphragm 1337 retracts, and the cross-sectional dimensions of the flow passage 1316' increase, thereby reducing fluid resistance and increasing the outflow through the passage 1316'. For example, a syringe can be used to remove or add control fluid to the control passage 1336'. In some embodiments, one or more reservoirs (not shown) may fluidly interact with the control passage 1336', and the fluid volume of the control passage 1336' can be adjusted by adding or removing fluid from one or more reservoirs. Furthermore, it should be understood that in some embodiments, the fluid control system configured according to the present technology may include a plurality of fluid-controlled sealed cavities continuously distributed along the length of the control system.

[0075] Figure 14A and 14B Another embodiment of an SMM-based actuator 1418 configured according to the present technology and suitable for use in an adjustable flow glaucoma shunt is shown. In this embodiment, the actuator 1418 includes one or more coils 1424 arranged around the periphery of a clamping arm 1423. Both the one or more coils 1424 and the clamping arm 1423 can be constructed of SMM. An anchor 1410 is positioned to secure the actuator 1418 to a base 1411, thereby pressing the clamping arm 1423 against an elastomeric flow tube 1412. The stiffness of the elastomeric flow tube 1412 is sufficient to hold the outer coil 1424 in place with respect to the above reference. Figures 12A-13B The installation state of the aforementioned strip / filament actuator 1318 is quite similar.

[0076] In operation, one or more portions of the coil 1424 can be selectively actuated to adjust the clamping pressure of the clamping arm 1423 relative to the flow tube 1412, thereby adjusting the fluid resistance. For example, refer to Figure 14B The coil 1424 on one side (e.g., the right side) of the clamping arm 1423 can be heated by applying laser energy at the target site 1413. This heating actuates the selected coil 1424 and makes it more tightly wound, thereby actuating the clamping arm 1423 to increase pressure and increase resistance on the flow tube 1412. Actuation of the coil 1424 on the other side of the clamping arm 1423 (the left coil) loosens the clamping arm 1423, thereby reducing pressure and resistance on the flow tube 1412.

[0077] In alternative embodiments, actuator 1418 can be positioned in a rest or initial position such that clamping arm 1423 completely blocks flow passage 1412, and coil 1424 can be selectively adjusted to increase or decrease tension of clamping arm 1423 relative to base 1411. During operation, base 1411 acts accordingly as an anvil when clamping arm 1423 drives flow passage 1412 against it. In some embodiments, such an arrangement can be used to operate an adjustable opening pressure valve (not shown) configured to selectively control desired intraocular pressure (IOP). However, in other embodiments, actuator 1418 may have different arrangements and / or include different features.

[0078] Figures 15A-15C An adjustable glaucoma shunt 1500 configured according to another embodiment of the present technology is shown, and includes components such as those described above. Figure 14A and 14B The fluid resistance element mentioned above. For example... Figure 15A This is an exploded view of the shunt 1500. Figure 15B This is a top view of the assembled shunt 800. (See also: [link to reference]) Figure 15A and 15B The diverter 1500 includes an elastomeric flow passage 1512 carried by and operatively coupled to the control assembly 1519. The flow passage 1512 includes an inflow region or inflow portion 1505 at one end of the flow passage 1512 and an outflow assembly 1527 at or near the other end of the flow passage 1512 for one or more outflow outlets 1502.

[0079] The shunt 1500 also includes an actuator 1518 carried by and operatively coupled to the control assembly 1519. The actuator 1518 may be similar to the one described above. Figure 14A and 14B The actuator 1418 is described. For example, in the illustrated embodiment, the actuator 1518 includes a clamping arm 1523 operatively coupled to and positioned between a plurality of coils 1524. The coils 1524 (similar to the coil 1424 described above) may be constructed of SMM and are adapted to selectively adjust the flow tube 1512 to increase / decrease the pressure in the flow tube as previously described.

[0080] In the illustrated embodiment, the shunt 1500 includes a pressure port 1528 and a corresponding pressure transducer 1529, the pressure transducer 1529 being configured to reside within a pressure transducer housing 1530 on the control assembly 1519. The pressure port 1528 / pressure transducer 1529 is configured to provide pressure information to a clinician / operator during operation of the shunt 1500. In other embodiments, the pressure port and / or pressure transducer 1529 may have different arrangements relative to each other and other components of the shunt 1500. Furthermore, the pressure port 1528 / pressure transducer 1529 are optional components and may not be included in some embodiments. In some embodiments, the shunt 1500 may also optionally include a differential port 1526 in the control assembly 1519.

[0081] The shunt 1500 may further include a plate 1503 configured to be positioned on at least a portion of the control assembly 1518, the flow tube 1512, and the actuator 1518. The plate 1503 may include a window 1531, which allows for the arrangement of the shunt 1500 (e.g., ...) Figure 15B As shown, window 1531 provides access to other components carried by actuator 1518 and control assembly 1519.

[0082] Figure 15C An implantation tool 1534 according to one embodiment of the present technology is shown, configured to deliver and position a shunt 1500 within a patient's ocular sac (not shown). The implantation tool 1534 may include, for example, a guide needle 1532 configured to carry the shunt 1500 for delivery, and a guide needle release device 1533 that an operator can actuate to release the shunt 1500 once it is in the desired location / or orientation within the patient's body. However, in other embodiments, the implantation tool 1534 may have different configurations and / or other suitable means / techniques may be used to deliver the shunt 1500.

[0083] Figures 16A-16E Several features of an adjustable glaucoma shunt 1600 configured according to another embodiment of the present technology are illustrated. The shunt 1600 may include features described above. Figures 15A-15C The described shunt 1500 has several similar features. For example, optimally as... Figure 16A As shown, the diverter 1600 includes a flow pipe 1612 with an inlet or inflow area 1601 at one end and an outlet 1602 at the other end. The diverter 1600 also includes a control assembly 1619 configured to adjust the flow rate through the flow pipe 1612. The flow pipe 1612, the control assembly 1619, and several other components of the diverter are carried by a plate 1603.

[0084] However, the difference between the flow divider 1600 and the flow divider 1500 is that the flow divider 1600 includes a different system for regulating the fluid flow rate of the flow passage 1612. Specifically, the flow divider 1600 in this embodiment includes a system similar to the one described above. Figure 13E and 13F The described arrangement, rather than including the previously described actuator 1518 including clamping arm 1523 / coil 1524, for example, refers to Figure 16B-16D The control assembly 1629 of the diverter 1600 includes a control fluid 1644 contained in a control fluid chamber 1636, which includes an annular region surrounding a thin-walled tubular flow passage of the tube 1612. The control fluid chamber 1636 is fluidly separated from the flow passage. A reservoir 1643 interacts with and is in fluid communication with the control fluid chamber. The reservoir 1643 is configured to provide a larger target for convenient injection or removal of the control fluid 1636 from the system. In operation, the control fluid 1644 can be added / removed from the control fluid chamber 1636 to increase / decrease the fluid cross-sectional size of the water sample flow channel 1616 through the flow passage 1612, thereby decreasing / increasing the corresponding fluid flow rate therein.

[0085] In some embodiments, a solid core may be optionally introduced into the flow channel 1616 to initially further reduce the fluid cross-sectional size, thereby making the flow channel more sensitive to small changes in the diameter of the flow passage 1612. For example, in Figure 16E Optionally, a solid pin or element 1637 may be introduced into the flow passage 1612, and the flow passage 1616 now has an annular cross-sectional profile.

[0086] In the illustrated embodiment, the splitter 1600 further includes a pressure transducer 1629. The pressure transducer 1629 is an optional component and may not be included in some embodiments. Furthermore, it should be understood that the splitter 1600 may include features other than those described herein and / or the features of the splitter 1600 may have different arrangements from each other.

[0087] In many of the embodiments described herein, the actuator or fluid resistance is configured to compress or “pinch” the drainage tube during operation. In this way, the actuator / fluid resistance can gradually or continuously change the fluid resistance through the drainage tube to selectively regulate pressure / flow rate. Actuators and fluid resistance configured according to this technology can accordingly adjust the resistance or compression levels between multiple different locations and adapt to multiple variables (e.g., IOP, water sample production rate, natural water sample outflow resistance, and / or natural water sample outflow rate) to precisely regulate the flow rate through the drainage tube.

[0088] Both the disclosed actuators and fluid resistors can be operated using non-invasive energy. This feature allows such devices to be implanted in a patient and then modified / adjusted over time without requiring further invasive surgery or procedures. Furthermore, because the devices disclosed herein can be actuated using non-invasive energy, they do not require any additional power supply to maintain the desired orientation or position. Instead, the actuators / fluid resistors disclosed herein can maintain the desired position / orientation without power supply. This significantly increases the usable lifespan of such devices and keeps them effective long after the initial implantation procedure.

[0089] Example

[0090] The following examples illustrate some aspects of this technology.

[0091] 1. An adjustable flow shunt for treating glaucoma in human patients, the shunt comprising:

[0092] An elongated outflow drain with a proximal inflow region and a distal outflow region; and

[0093] An inflow control component at the proximal inflow region, wherein the inflow control component includes -

[0094] Control elements, whose size and shape are configured to slidably mate with the proximal inflow region; and

[0095] A spring element is operatively coupled between the control element and an anchor element that mates with the proximal inflow region;

[0096] The proximal inflow region includes one or more orifices defining a fluid inlet range, which is positioned to allow fluid to flow through and into the outflow drain.

[0097] The spring element is configured to be activated by non-invasive energy and, upon activation, to slidably actuate the control element along the proximal inflow region such that (a) the one or more orifices are accessible and have a first fluid flow cross-section, or (b) the one or more orifices are at least partially covered by the control element and have a second fluid flow cross-section smaller than the first fluid flow cross-section.

[0098] 2. The adjustable flow splitter according to Example 1, wherein the proximal inflow region includes a core element operatively coupled to and extending therefrom the proximal end of the outflow drain, and wherein one or more orifices extend through the sidewall of the core element to define the fluid inlet range.

[0099] 3. The adjustable flow divider according to Example 2, wherein the core element is made of a different material than the outflow drain tube.

[0100] 4. The adjustable flow divider according to Example 2, wherein the core element is made of a first material having a first hardness, and wherein the outflow drain is made of a second material having a second hardness, the second hardness being less than the first hardness.

[0101] 5. The adjustable flow splitter according to Example 2, wherein the core element is made of polyetheretherketone (PEEK), acrylate, polycarbonate, metal, ceramic, quartz, and / or sapphire.

[0102] 6. The adjustable flow divider according to any one of Examples 1-5, wherein the extended outflow tube is made of silicone and / or urethane.

[0103] 7. The adjustable flow splitter according to any one of Examples 1-6, wherein the spring element is made of a shape memory material.

[0104] 8. The adjustable flow splitter according to any one of Examples 1-6, wherein the spring element is made of nickel-titanium alloy.

[0105] 9. An adjustable flow diverter according to any one of Examples 1-8, wherein the inflow control component is configured to be placed in the anterior chamber in an area outside the optical field of vision of the eye.

[0106] 10. The adjustable flow diverter according to Example 9, wherein the outflow drain is shaped to a certain size and form to pass through the region between the anterior chamber and the choroid of the eye.

[0107] 11. The adjustable flow diverter according to Example 9, wherein the outflow tube is shaped to a certain size and form to pass through the region between the anterior chamber and the subconjunctival region of the eye.

[0108] 12. An adjustable flow splitter according to any of Examples 1-11, wherein the one or more orifices include a single elongated slot extending axially along the proximal inflow region.

[0109] 13. An adjustable flow splitter according to any of Examples 1-11, wherein the one or more orifices comprise a plurality of orifices extending radially around the proximal inflow region.

[0110] 14. An adjustable flow splitter according to any of Examples 1-11, wherein the one or more orifices comprise a plurality of orifices extending helically around the proximal inflow region.

[0111] 15. An adjustable flow splitter according to any of Examples 1-14, wherein the spring element is configured to be activated by laser energy.

[0112] 16. The adjustable flow diverter according to any one of Examples 1-15, wherein the spring element includes a first spring, and the anchor includes a first anchor, and wherein the first spring and the first anchor are positioned on a first side of the control element, and wherein the inflow control assembly further includes:

[0113] The second spring and the corresponding second anchor on the second, opposite side of the control element;

[0114] The first and second spring elements are configured to be selectively activated by non-invasive energy, and upon activation, the control element is slidably moved along the proximal inflow region in a first direction or a second direction, such that (a) the one or more orifices have a first fluid flow cross-section, or (b) the one or more orifices are at least partially covered by the control element and have a second fluid flow cross-section smaller than the first fluid flow cross-section.

[0115] 17. The adjustable flow divider according to Example 16, wherein the first and second spring elements are configured such that, when activated, the control element is slidably moved along the proximal inflow region such that the one or more orifices are completely covered and inaccessible.

[0116] 18. An adjustable flow divider according to any of Examples 1-15, wherein the spring element and the corresponding anchor element are positioned at the proximal end of the control element between the control element and the outflow drain.

[0117] 19. An adjustable flow splitter according to any of Examples 1-15, wherein the spring element comprises one or more coil springs extending around the proximal inflow region.

[0118] 20. An adjustable flow divider according to any of Examples 1-15, wherein the spring element comprises one or more elongated bow springs extending between the control element and the anchor element.

[0119] 21. An adjustable flow shunt assembly for treating glaucoma, the shunt assembly comprising:

[0120] An elongated drainage tube having a proximal portion and a distal portion, wherein the proximal portion includes an inlet configured to be in fluid communication with a fluid chamber in a patient's eye;

[0121] A variable resistance assembly configured to selectively control the flow rate of fluid flowing into the inlet, wherein the variable resistance assembly includes -

[0122] Base;

[0123] A perforated plate supported by the base, wherein the perforated plate includes a plurality of first holes extending therein;

[0124] A partition plate supported by and extending outwardly from the perforated plate, wherein the partition plate includes a plurality of second holes extending therein, and wherein the second holes are aligned with corresponding first holes in the perforated plate; and

[0125] A membrane is arranged to be carried by the partition plate, wherein the membrane is positioned to sealably cover the open end of each of the second holes;

[0126] During operation, a portion of the membrane above one or more second holes of the isolation plate is configured to be selectively targeted and removed by non-invasive energy, thereby creating a flow channel from a fluid site in the patient's body through the accessible opening of the targeted second hole, corresponding to the first hole, and into the drainage tube.

[0127] 22. The adjustable flow splitter assembly according to Example 21, wherein:

[0128] The first hole has a first cross-sectional dimension; and

[0129] The second hole has a second cross-sectional dimension, which is larger than the first cross-sectional dimension.

[0130] 23. The adjustable flow splitter assembly according to Example 21, wherein the first orifice has the same cross-sectional dimensions.

[0131] 24. The adjustable flow splitter assembly according to any one of Examples 21-23, wherein the isolation plate is at least partially composed of a hydrophobic material configured to be at least partially melted by non-invasive energy.

[0132] 25. The adjustable flow splitter assembly according to any one of Examples 21-23, wherein the isolation plate is at least partially composed of a wax material configured to be at least partially melted by non-invasive energy.

[0133] 26. The adjustable flow splitter assembly according to any of Examples 21-23, wherein the base, orifice plate, and separator plate of the variable resistance assembly are separate, discrete components operably coupled together.

[0134] 27. The adjustable flow splitter assembly according to any of Examples 21-23, wherein the separator and membrane are made as a single, integral component of the same material.

[0135] 28. The adjustable flow splitter assembly according to any of Examples 21-23, wherein the orifice plate and the isolation plate are made as a single, integral component of the same material.

[0136] 29. The adjustable flow splitter assembly according to any one of Examples 21-28, wherein:

[0137] The membrane also includes a plurality of target marks aligned with and corresponding to each of the second pores; and

[0138] During operation, the non-invasive energy is delivered to the corresponding target markers on the membrane to selectively remove membrane material at the target location.

[0139] 30. An adjustable flow shunt for treating glaucoma in human patients, the adjustable flow shunt comprising:

[0140] An elongated outflow tube having (a) a proximal inflow portion configured to be placed in an area outside the optical field of vision of the patient's eye in the anterior chamber, and (b) distal outflow portions at different locations in the eye; and

[0141] An actuator is disposed along the outlet pipe at a position between the inflow portion and the outflow portion, wherein the actuator is switchable between an open position that allows fluid to flow through the outlet pipe and a resistance position that partially obstructs fluid flow through the outlet pipe.

[0142] During operation, the actuator moves between positions in response to non-invasive energy.

[0143] 31. The adjustable flow splitter according to Example 30, wherein the actuator is configured to partially block fluid flow through the outflow pipe at the resistance location by cooperating with the outflow pipe and changing the diameter and / or cross-sectional shape of the outflow pipe.

[0144] 32. An adjustable flow splitter according to Example 30 or Example 31, wherein the actuator responds to the movement of laser energy between positions.

[0145] 33. The adjustable flow splitter according to Example 30, wherein:

[0146] The outflow tube includes a double-lumen tube having a first inner lumen for carrying fluid through it and a second inner lumen adjacent to the first inner lumen, and the second inner lumen is separated from the first inner lumen by a diaphragm.

[0147] The actuator is positioned within the second cavity, and the actuator includes one or more actuating elements configured to switch between an expanded state and an initial state in response to the non-invasive energy.

[0148] In the expanded state, the actuating element cooperates with the diaphragm and pushes the diaphragm toward the first inner cavity, reducing its cross-sectional size.

[0149] 34. An adjustable flow splitter according to any of Examples 30-33, wherein the actuator is configured to remain in the open position or one of the resistance positions in the absence of power supply.

[0150] 35. An adjustable flow splitter, comprising:

[0151] An elongated outflow tube having a proximal inflow portion configured to be placed at a first location within a patient's eye, and a distal outflow portion located at a second location in the eye spaced apart from the first location.

[0152] The outflow tube includes a double-lumen tube, which has a first lumen through which fluid flows and a second lumen adjacent to and separated from the first lumen; and

[0153] The control fluid arranged in the second inner cavity,

[0154] And in the process of operation -

[0155] Increasing the volume of the control fluid within the second inner cavity reduces the cross-sectional size of the first inner cavity, thereby partially blocking the fluid flow through the first inner cavity.

[0156] Reducing the volume of the control fluid within the second cavity increases the cross-sectional size of the first cavity, thereby increasing the amount of fluid flowing through the first cavity.

[0157] 36. The adjustable flow splitter according to Example 35, wherein the elongated outlet tube comprises an elastomeric tube.

[0158] 37. The adjustable flow splitter according to Example 35 or Example 36 further includes a reservoir in fluid communication with the second inner cavity, wherein the volume of control fluid within the second inner cavity is changed by transferring control fluid to and / or from the reservoir.

[0159] 38. An adjustable flow divider according to any of Examples 35-37, wherein the volume of control fluid in the second cavity is changed by transferring control fluid into and / or from the second cavity via a syringe.

[0160] 39. An adjustable flow splitter according to any one of Examples 35-38, wherein the first inner cavity is separated from the second inner cavity by a diaphragm, and wherein:

[0161] Increasing the volume of the control fluid in the second inner cavity causes the diaphragm to move toward the first inner cavity and reduce its cross-sectional dimensions; and

[0162] Reducing the volume of the control fluid in the second cavity causes the diaphragm to move away from the first cavity and increase its cross-sectional dimensions.

[0163] 40. A shunt for treating glaucoma in human patients, the shunt comprising:

[0164] An elongated outflow tube with a proximal inflow region and a distal outflow region;

[0165] The inflow control component at the proximal inflow region; and

[0166] Along the outflow tube in the transition region between the inflow and outflow regions, wherein, during operation, the transition region may switch between a first shape that is generally linear in delivery shape and a second shape that is different from the first shape, in order to anchor the diverter at the desired location of the eye.

[0167] 41. The shunt according to Example 40, wherein the outflow drain is configured to be delivered via a guidewire, and wherein the transition region is configured to transition between a first delivery shape and a second shape upon removal of the guidewire.

[0168] 42. The shunt according to Example 40 or Example 41, wherein the transition region is configured to transition between a first delivery shape and a second shape when non-invasive energy is applied to one or more selected regions of the transition region.

[0169] 43. The shunt according to Example 40 or Example 41, wherein the transition region is configured to transition between a first delivery shape and a second shape in response to applying non-invasive laser energy to one or more selected regions of the transition region.

[0170] 44. The shunt according to any of Examples 40-43, wherein the second shape includes a generally “L” shaped configuration.

[0171] Summarize

[0172] The specific embodiments of this technology described above are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments and examples of this 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 this technology. For example, any feature of the variable flow splitter described herein can be combined with any feature of other variable flow splitters described herein, and vice versa. Furthermore, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein can also be combined to provide further embodiments.

[0173] Based on the foregoing, it should be understood that, for illustrative purposes, specific embodiments of the technology have been described herein; however, well-known structures and functions associated with variable flow splitters have not been shown or described in detail to avoid unnecessarily obscuring the description of embodiments of the technology. Where the context permits, singular or plural terms may also include plural or singular terms, respectively.

[0174] Furthermore, unless the word “or” is explicitly limited to referring only to a single item in two or more lists that is unrelated to other items, its use in the list should be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term “comprising” is used throughout to mean including at least one or more features listed, such that further identical features and / or features of other types are not excluded. It should also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the art. Furthermore, while advantages associated with some embodiments of the art have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments need to exhibit such advantages to fall within the scope of the art. Therefore, this disclosure and related art may include other embodiments not expressly shown or described herein.

Claims

1. An adjustable flow shunt for treating glaucoma in a human patient, the shunt comprising: an elongated outflow conduit having a proximal inflow region and a distal outflow region; and an inflow control assembly at the proximal inflow region, wherein the inflow control assembly comprises a control element sized and shaped to slidably mate with the proximal inflow region; and a spring element operably coupled between the control element and an anchor element that non-sidably mates with the proximal inflow region, and the spring element is comprised of a shape memory material; wherein the proximal inflow region comprises one or more apertures that define a fluid entry range disposed at a location that allows fluid to flow therethrough and into the outflow conduit, wherein the spring element is configured to be activated by non-invasive energy, and upon activation, slidably actuates the control element along the proximal inflow region, whereby the inflow control assembly is at least configured such that: (a) the one or more apertures are accessible and have a first fluid flow cross-section, or (b) the one or more apertures are at least partially covered by the control element and have a second fluid flow cross-section that is smaller than the first fluid flow cross-section.

2. The adjustable flow shunt of claim 1, wherein the proximal inflow region includes a core element operably coupled to and extending from a proximal end of the outflow conduit, and wherein the one or more apertures extend through a sidewall of the core element to define the fluid entry range.

3. The adjustable flow shunt of claim 2, wherein the core element is comprised of a different material than the outflow conduit.

4. The adjustable flow shunt of claim 2, wherein the core element is comprised of a first material having a first durometer, and wherein the outflow conduit is comprised of a second material having a second durometer that is less than the first durometer.

5. The adjustable flow shunt of claim 2, wherein the core element is comprised of polyether ether ketone (PEEK), acrylate, polycarbonate, metal, ceramic, quartz, and / or sapphire.

6. The adjustable flow shunt of claim 1, wherein the elongated outflow conduit is comprised of silicone and / or urethane.

7. The adjustable flow shunt of claim 1, wherein the spring element is comprised of nickel titanium alloy.

8. The adjustable flow shunt of claim 1, wherein the inflow control assembly is configured to be placed within an area of the anterior chamber that is outside of the optical field of view of the eye.

9. The adjustable flow shunt of claim 8, wherein the outflow conduit is shaped to a size and shape to pass through an area between an area of the anterior chamber to a location on the choroid of the eye.

10. The adjustable flow shunt of claim 8, wherein the outflow conduit is shaped to a size and shape to pass through an area between an area of the anterior chamber to a location under the conjunctiva of the eye.

11. The adjustable flow shunt of claim 1, wherein the one or more apertures comprise a single elongated slot extending axially along the proximal inflow region.

12. The adjustable flow shunt of claim 1, wherein the one or more apertures comprise a plurality of apertures extending radially around the proximal inflow region.

13. The adjustable flow shunt of claim 1, wherein the one or more apertures comprise a plurality of apertures extending helically around the proximal inflow region.

14. The adjustable flow shunt of claim 1, wherein the spring element is configured to be activated by laser energy.

15. The adjustable flow shunt of claim 1, wherein the spring element comprises a first spring element and the anchor element comprises a first anchor element, and wherein the first spring element and the first anchor element are disposed at a first side of the control element, and wherein the inflow control assembly further comprises: a second spring element and a corresponding second anchor element on a second side of the control element opposite the first side, wherein the second spring element is disposed at the second side of the control element; wherein the first and second spring elements are configured to be selectively activated by non-invasive energy and, upon activation, slidably move the control element along the proximal inflow region in a first direction or a second direction opposite the first direction, respectively, such that the inflow control assembly is configured at least so that: (a) the one or more apertures have a first fluid flow cross-section, or (b) the one or more apertures are at least partially covered by the control element and have a second fluid flow cross-section smaller than the first fluid flow cross-section.

16. The adjustable flow shunt of claim 15, wherein the first and second spring elements are configured, upon activation, to slidably move the control element along the proximal inflow region such that the one or more apertures are completely covered and inaccessibly.

17. The adjustable flow shunt of claim 1, wherein, in an axial direction of the proximal inflow region, the spring element and the corresponding anchor element are disposed at a proximal end of the control element between the control element and the outflow conduit.

18. The adjustable flow shunt of claim 1, wherein the spring element is configured to be more tightly coiled upon activation.

19. The adjustable flow shunt of claim 1, wherein the spring element comprises one or more bow springs configured to bend outward away from the elongated outflow conduit upon activation.

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