SHUNT SYSTEM HAVING MOLDABLE ELEMENTS AND ASSOCIATED DEVICES AND METHODS - Patent application
Patent Information
- Application Number
- JP2024505321
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-12-21
- Filing Date
- 2022-07-20
- Publication Date
- 2025-07-15
AI Technical Summary
Conventional implantable shunt systems for treating conditions like glaucoma lack the ability to adjust fluid flow rates and often require customization post-manufacturing to fit individual patient anatomy, posing risks and inefficiencies.
The development of formable/conformable shunt systems with moldable elements that can be contoured to match patient anatomy and include features like beveled edges, suture rings, and actuators for selective fluid flow control, allowing for personalized implantation and adjustable therapy.
Enhances delivery and fit of shunt systems to patient anatomy, providing customizable fluid flow control and reducing procedural complexity and risks.
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Abstract
Description
[Technical field]
[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 227,869, filed July 30, 2021, and U.S. Provisional Patent Application No. 63 / 292,164, filed December 21, 2021, the disclosures of which are incorporated by reference in their entireties herein.
[0002] FIELD OF THEINVENTION The present technology relates generally to implantable medical devices, and more particularly, to shunt systems and associated methods for controlling fluid flow between a first body region and a second body region of a patient. [Background technology]
[0003] Implantable shunt systems are widely used to treat various patient conditions by shunting fluid from a first body region / cavity to a second body region / cavity. For example, shunt systems have been proposed to treat glaucoma. Fluid flow through the shunt system is primarily controlled by the pressure gradient across the shunt and the physical properties of the flow path defined through the shunt (e.g., the resistance of the shunt lumen). Conventional early shunt systems (sometimes referred to as minimally invasive glaucoma shunts or "MIGS") have shown clinical benefits. However, improved shunt systems and techniques are needed to address the risks associated with elevated intraocular pressure and glaucoma. For example, there is a need for a shunt system that can adjust the therapy provided, including the flow rate between two fluidly connected bodies. As another example, there is a need for a shunt system that can be modified after manufacture (e.g., in the clinic) to personalize the system for the patient and / or as part of the clinician's plan for the implant procedure. Summary of the Invention [Means for solving the problem]
[0004] The present technology is generally directed to shunt systems, including shunt systems having a moldable / adaptable elongated housing or shunt element that can be contoured or otherwise shaped to improve compatibility with a patient's anatomy. For example, in some embodiments, the shunt systems described herein include a moldable / adaptable element, such as a spine element, configured to at least partially control the shape of the elongated housing and / or shunt system. The moldable element can be configured such that when the moldable element is deformed to change the shape of the elongated housing, the moldable element holds the elongated housing in the changed shape for a selected period of time or indefinitely. Thus, the systems described herein improve the deliverability of the shunt system into a patient, and once implanted, can be shaped or otherwise manipulated to a desired position during an implant procedure to better match or fit the patient's anatomy. In some embodiments, the shunt systems described herein can be pre-shaped to fit the patient's anatomy in addition to or in lieu of having a moldable / adaptable element. The shunt systems and elongate housings described herein can have a number of other advantageous features that are expected to improve the delivery process and operation of the shunt system, such as beveled leading edges, lateral exit ports, suture rings, positioning appendages, etc., each of which is described in detail below.
[0005] In some embodiments, the shunt systems described herein can also selectively control fluid flow through the system to provide titratable shunt therapy. For example, the shunt system can include a plate assembly having one or more actuators for selectively controlling fluid flow through the shunt system and / or the elongated housing. The actuators can be actuated after the system is implanted to vary the flow rate of fluid through the system. [Brief description of the drawings]
[0006] 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 are not intended to imply that the components shown are necessarily transparent. Components may also be shown in schematic form. [Figure 1A] 1 illustrates a shunt system configured in accordance with selected embodiments of the present technology. [Figure 1B] 1A illustrates an elongated housing of a shunt system configured in accordance with selected embodiments of the present technology. [Figure 1C] 1C is a cross-sectional view of the elongated housing shown in FIG. 1B and configured in accordance with selected embodiments of the present technology. [Diagram 2] 1A illustrates an elongated moldable element of a shunt system configured in accordance with selected embodiments of the present technology. [Figure 3A] 1 illustrates another shunt system constructed in accordance with selected embodiments of the present technology. [Figure 3B] 1 illustrates another shunt system constructed in accordance with selected embodiments of the present technology. [Figure 3C] 3A and 3B are shown implanted in a patient's eye in accordance with selected embodiments of the present technology. [Figure 3D] 3A and 3B are shown implanted in a patient's eye in accordance with selected embodiments of the present technology. [Figure 4] 1 illustrates another shunt system constructed in accordance with selected embodiments of the present technology. [Figure 5A] 1 illustrates another shunt system constructed in accordance with selected embodiments of the present technology. [Figure 5B] 1 illustrates yet another shunt system constructed in accordance with selected embodiments of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0007] The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even when used in conjunction with the detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below, however, any terms intended to be interpreted in any limited manner are so clearly and specifically defined in this detailed description section. Additionally, the present technology may include other embodiments that are within the scope of the examples and claims but are not described in detail with respect to Figures 1A-5B.
[0008] Throughout this specification, references 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.
[0009] Throughout this specification, references to relative terms, such as "generally," "approximately," and "about," are used herein to mean the stated value plus or minus 10%. References throughout this specification to the term "resistance" refer to fluid resistance unless the context clearly dictates otherwise. The terms "drainage rate" and "flow rate" are used interchangeably to describe the movement of a fluid through a structure at a particular volumetric flow rate. The term "flow" is used generally herein to refer to the movement of a fluid.
[0010] Although 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 technology can be readily adapted to shunt fluid from and / or between other parts of the eye, and more generally, from and / or between a first body region and a second body region. Additionally, although certain embodiments herein are described in the context of glaucoma treatment, 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 accumulation of fluid, including, but not limited to, heart failure (e.g., heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, etc.), pulmonary failure, renal failure, hydrocephalus, etc. Additionally, 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.
[0011] 1A-1C illustrate a shunt system 100 ("system 100") configured in accordance with selected embodiments of the present technology. More specifically, FIG. 1A is a perspective view of system 100, FIG. 1B is a perspective view of an elongated housing 102 of system 100, and FIG. 1C is a perspective cross-sectional view of elongated housing 102 rotated 180° about its longitudinal axis relative to FIG. 1B. As described in more detail below, system 100 is configured to provide a titratable therapy for draining fluid from a first body region, such as draining water from the anterior chamber of a patient's eye.
[0012] 1A-1C collectively, the system 100 includes an elongated housing 102 and a flow control plate assembly 120. The elongated housing 102 (which may also be referred to as a casing, membrane, shunt element, etc.) extends between a first (proximal) end portion 102a and a second (e.g., distal) end portion 102b. The first end 102a of the elongated housing 102 includes a chamber 105 (FIG. 1C) and an opening 106. As shown in FIG. 1A, a flow control plate assembly 120 (which may also be referred to as a flow control plate, flow control cartridge, plate structure, plate assembly, etc.) is positioned within the chamber 105 of the elongated housing 102 and is configured to control the flow of fluid through the system 100. In particular, one or more fluid inlets or openings 122 of the flow control plate assembly 120 are aligned with the openings 106 of the elongated housing 102. The fluid inlet 122 allows fluid to enter the interior of the plate assembly 120 (and thus the interior of the elongated housing 102) from an environment external to the system 100. The flow control plate assembly 120 further includes one or more channels 124 for transporting fluid entering the plate assembly 120 via the fluid inlet 122 to the primary exhaust lumen 104 of the elongated housing 102. In some embodiments, the top surface of the plate assembly 120 forms a substantial fluid seal with the interior surface of the elongated housing 102 at the first end portion 102a such that the only path for fluid to enter the system 100 is through the fluid inlet 122. Thus, for fluid to flow through the system 100, the fluid must generally flow through the plate assembly 120. The flow control plate assembly 120 can also include one or more actuators 126 (e.g., shape memory actuators) for selectively controlling the flow of fluid through the plate assembly 120 (e.g., by selectively interfering with and not interfering with fluid flow through the inlet 122).In some embodiments, the flow control plate assembly 120, actuator 126, and other related elements may be substantially similar to those described in U.S. Pat. No. 11,291,585, U.S. Pat. No. 11,166,849, and International Application Nos. PCT / US22 / 13336, PCT / US20 / 55144, PCT / US20 / 55141, PCT / US21 / 14774, PCT / US21 / 18601, PCT / US21 / 23238, and PCT / US21 / 27742, the disclosures of which are incorporated herein by reference in their entireties for all purposes.
[0013] Fluid flowing through the plate assembly 120 flows into the primary exhaust lumen 104 as it travels toward the second end 102b of the system 100. Thus, the second end 102b can include multiple outlets for exhausting fluid from the primary exhaust lumen 104 to a desired exhaust location (e.g., the bleb space). For example, the second end 102b can have an axial outlet or opening 108 aligned with the longitudinal axis of the primary exhaust lumen 104. The second end 102b can also have one or more lateral outlets or openings 110a1-110c2 (collectively referred to herein as "lateral outlets 110") disposed along the sides of the elongated housing 102 (the lateral outlets 110 are not shown in FIG. 1B). For example, in the illustrated embodiment, the elongated housing 102 includes a first pair of side outlets 110a1 and 110a2, a second pair of side outlets 110b1 and 110b2, and a third pair of side outlets 110c1 and 110c2. In some embodiments, the elongated housing 102 can have more or fewer pairs of side outlets, such as 1 pair, 2 pairs, 4 pairs, 5 pairs, 6 pairs, 7 pairs, 8 pairs, or more. Additionally, in some embodiments, the elongated housing 102 has a side outlet 110 on only one side, laterally offset side outlets 110 on both sides, and / or has an unequal number of side outlets 110 on each side.
[0014] In addition to facilitating fluid evacuation, the lateral outlets 110 can also provide a visual cue to the physician implanting the device. For example, in some implant procedures, depending on the patient's anatomy, the physician may need to remove a portion of the elongated housing second end 102b to "fit" the system 100 to the patient. This can be done before or during the implant procedure. The lateral outlets 110 can have the same or substantially the same width (e.g., 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, etc.) and can be spaced apart by a predetermined known dimension (e.g., 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, etc.). Thus, a physician can quickly determine the length of the elongate housing 102 that is removed by counting the number of side outlets 110 that are removed by cutting. For example, if the side outlets 110 have a length of 1 mm and are separated by 1 mm, then each side outlet that is removed represents a 2 mm reduction in the length of the system 100 in addition to the length of the elongate housing between the axial outlet 108 and the side outlet 110 closest to the axial outlet 108 (shown in FIGS. 1A and 1C as the third pair of side outlets 110c1, 110c2).
[0015] In some embodiments, the lateral exit 110 also provides a natural hinge point around which the elongated housing 102 can flex or bend. Without being bound by theory, it is expected that allowing the elongated housing 102 to flex at the lateral exit 110 allows the elongated housing 102 to better conform to the patient's anatomy (e.g., the curvature of the patient's eye). Indeed, in some embodiments, the lateral exit 110 need not be an exit, but instead may be a thinned portion in a surface defining the elongated housing 102 that allows the elongated housing 102 to flex thereat.
[0016] The elongated housing 102 may include several other features that aid in the delivery and positioning of the system 100 within a patient. For example, the elongated housing 102 may include a beveled or tapered edge 112 at the first end 102a. Although the beveled edge 112 is shown as having an angled surface 112a extending from the top surface of the system 100, in other embodiments, the beveled edge 112 may take other suitable configurations where the first end 102a converges toward a pointed / tapered end. For example, in some embodiments, the beveled edge 112 may include an angled surface (not shown) extending from a bottom surface of the system 100 in addition to or instead of the angled surface 112a extending from the top surface of the system 100. During delivery, the beveled edge 112 (which is the leading edge of the system 100 during delivery) aids the system 100 in entering and passing through a slit or gap in the patient's tissue. For example, in the context of delivering system 100 to a patient's eye to treat glaucoma, beveled edge 112 can be inserted into a slit in the patient's sclera to aid in advancing system 100 toward the patient's anterior chamber. Without being bound by theory, beveled edge 112 is expected to reduce complications in delivering system 100 into patient tissue as compared to other shunt systems having flat or non-beveled leading edges.
[0017] The elongated housing 102 further includes a first appendage, bumper, or stopper 114a and a second appendage, bumper, or stopper 114b (collectively referred to herein as "appendages 114"). The appendages 114 may generally be positioned between the first and second ends 102a, 102b of the device and may protrude laterally relative to the longitudinal axis of the elongated housing 102. The appendages 114 may also take the form of a raised ring of material or other surface treatment around the housing (not shown). In use, the appendages 114 may abut against patient tissue to prevent the system 100 from advancing / moving too far into the patient (e.g., beyond a target location within the patient), may be used to provide tactile feedback to a physician deploying the system 100, and / or may reduce and / or eliminate peritubular leakage around the system 100. For example, in the context of delivering the system 100 to a patient's eye to treat glaucoma, the attachment 114 can be configured to abut the edge of the patient's anterior chamber when the first end 102a of the system 100 is advanced into the anterior chamber. Thus, the attachment 114 can provide tactile feedback to the physician when the first end 102a is correctly positioned within the anterior chamber and / or can prevent or at least reduce the first end 102a from being advanced too far into the anterior chamber. The attachment 114 can also reduce water leaking out of the anterior chamber around the system 100 (e.g., "pericanal leakage") through the slit used to insert the first end 102a into the anterior chamber.
[0018] The elongated housing 102 further includes a suture ring 116. The suture ring 116 is a recess or groove extending at least partially around the circumference of the elongated housing 102 and can be configured to receive a suture or other attachment mechanism for securing the system 100 to patient tissue after delivery of the system 100. The suture ring 116 can be configured such that when the suture is secured around the suture ring 116, the suture does not impede or block fluid flow through the system 100. For example, in some embodiments, the system 100 may include a semi-rigid or rigid wire, ridge, or other element (not shown) extending around the suture ring 116, which can be configured to resist and / or prevent collapse of the elongated housing 102 if the suture is tightened too much around the suture ring 116. Further, although shown extending around the entire circumference of the elongated housing 102, in some embodiments the suture ring 116 extends only partially around the elongated housing 102, such as only around the top surface of the elongated housing 102. Without being bound by theory, the use of the suture ring 116 can allow the system 100 to be secured to the patient tissue using a single suture, which in turn is expected to reduce the complexity and therefore the time it takes to implant and secure the system 100 in a desired location. However, in some embodiments, the elongated housing 102 may include multiple (e.g., two, three, four, or more) suture rings for securing the system 100 to the patient tissue. The elongated housing 102 may further include additional features for securing the system 100 to the patient tissue in addition to or in lieu of the suture ring 116. For example, the appendage 114 may include one or more openings (not shown) configured to receive a suture.
[0019] In some embodiments, the one or more suture rings 116 may provide additional benefits to the system 100. For example, in addition to facilitating fixation of the system 100 to patient tissue, the suture rings 116 may also form a hinge point about which the elongated housing 102 is configured to bend. Without being bound by theory, it is expected that allowing bending of the elongated housing 102 at the suture rings 116 may allow the elongated housing 102 to better conform to the patient's anatomy (e.g., the curvature of the patient's eye).
[0020] The elongated housing 102 may be constructed from a slightly elastic or flexible biocompatible material (e.g., silicone, polydimethylsiloxane (PDMS), polymethylmethacrylate (PMMA), etc.). In some embodiments, the elongated housing 102 is at least partially moldable such that when it is deformed, it is configured to at least partially retain its deformed shape. For example, a physician may desire to at least partially bend the elongated housing 102 during or after implantation of the system 100 into a patient to better conform to the patient's anatomy (e.g., the curvature of the patient's eye). The elongated housing 102 may be configured to retain any bends caused by the physician such that following implantation, the elongated housing 102 (and thus the system 100) retains its deformed configuration. For example, in some embodiments, the elongated housing 102 may include a moldable or conformable element (not shown in FIGS. 1A-1C ) that may at least partially determine the shape of the elongated housing 102 and may also be deformed or bent by the clinician to change the shape of the elongated housing 102 during and / or after the implant procedure. In alternative embodiments, other mechanisms may be provided to manipulate the shape of the elongated housing, including, but not limited to, ratchets, screws, and structures that change shape through the application of heat or fluid.
[0021] For example, FIG. 2 illustrates an elongated housing 102 having an elongated moldable element 240 ("moldable element 240"). In some embodiments, the moldable element 240 may be a malleable, flexible, or conformable band or spine that can be bent into different shapes by a deforming force (e.g., a physician intentionally bending the system 100) and retain the different shapes upon cessation of the deforming force. In some embodiments, the moldable element 240 can retain a selected shape indefinitely. However, in other embodiments, the moldable element 240 may be comprised of a material (e.g., a hydrogel, a polymer, etc.) with material properties that change over time such that the moldable element 240 only retains a selected shape for a period of time (during delivery and for a selected period of time thereafter) and then assumes a different shape.
[0022] The shapeable element 240 can also be coupled to the elongated housing 102 such that as the shapeable element 240 is deformed, the shape / orientation of the elongated housing 102 also changes. The shapeable element 240 can also be sufficiently rigid to at least partially resist deformation from relatively small forces (e.g., to avoid unintended deformation) and / or to aid in delivery of the device. The shapeable element 240 can be positioned anywhere within or along the elongated housing 102 to manipulate the shape of the elongated housing. It does not have to be along the "spine" or other specific location of the elongated housing 102. Additionally, while the shapeable element 240 is shown to have a serpentine shape, in other embodiments the shapeable element 240 can have other suitable shapes, such as linear, curved, etc. Similarly, while shown to extend only partially along the length of the elongated housing 102, in other embodiments the shapeable element 240 can extend along substantially the entire length of the elongated housing 102.
[0023] In some embodiments, the shapeable element 240 may be at least partially comprised of a polymer, hydrogel, gold, silver, titanium, platinum, rhodium, or other suitable material. In some embodiments, the material(s) may be coated or plated with a second material, such as gold, platinum, rhodium, titanium, or a polymer. Shapeability / conformability may also be achieved through composite construction, which may include braiding, weaving, coiling, and the like. In other embodiments, the shapeable element 240 is omitted and the elongated housing 102 itself is at least partially comprised of a shapeable material to aid in changing the shape of the elongated housing 102 for delivery and / or operation after implantation.
[0024] In operation, system 100 may be initially delivered in a relatively straight or linear configuration (e.g., to fit within a delivery needle or other delivery device). Once deployed within a patient, a physician can bend system 100 to shape it to the patient's anatomy. For example, in the context of delivering system 100 to a patient's eye to treat glaucoma, a physician can bend system 100 to match the curvature of the patient's eye. System 100 is configured to retain the bent shape based on shapeable element 240. Without being bound by theory, this is expected to improve the "fit" of system 100 in the patient.
[0025] In addition to facilitating preferential bending of the system 100 to better conform to the patient's anatomy, the formable element 240 is also expected to increase the overall stiffness of the elongated housing 102 and / or the system 100. This is expected to simplify the delivery process by allowing the clinician to more easily push or otherwise deploy the system 100 from a delivery device (e.g., needle, catheter, etc.) and / or push the system 100 into the patient's tissue (e.g., even when already deployed from the delivery device). Once the system 100 is deployed from the delivery device, the elongated housing 102 can be shaped / conformed to its desired configuration, and the formable element 240 is expected to help hold the elongated housing 102 in the desired configuration for a selected period of time, as discussed above. Thus, in some embodiments, the formable element 240 is expected to both (a) provide a desired stiffness to assist in delivering the device to the target implantation location, and (b) provide a desired formability / conformability to assist in holding the desired configuration of the device to better conform to the patient's anatomy.
[0026] Although primarily described with respect to metal or other solid structures, in some embodiments, the formable element 240 may be comprised of a stiffening element or material that undergoes a change in stiffness / compliance / conformity when implanted in the eye. For example, the stiffening material may be configured to transition from a first state before the system 100 is implanted in the eye to a second state when the system 100 is implanted in the eye. In some embodiments, the stiffening element transitions from the first state to and / or toward the second state in response to exposure to patient fluids such as water or blood (e.g., via hydration, liquefaction, etc.) and / or body heat (e.g., via melting). In the first state, the stiffening material may cause the system 100 to have a first stiffness and a first compliance. In the second state, the stiffening material may cause the system 100 to have a second stiffness and a second compliance. The first stiffness is generally greater than the second stiffness, and the first compliance is generally less than the second compliance. Thus, the stiffening elements are configured to reduce the stiffness and / or increase the compliance / conformity of system 100 after the device is implanted. This is expected to be beneficial because (a) the relatively high stiffness / relatively low compliance of system 100 during implantation allows system 100 to be deployed by a grasping tool or from a needle, catheter, or other delivery device (e.g., by making system 100 easier to "push" compared to many conventional systems that are highly flexible / conformable prior to implantation and therefore difficult to "push" through a needle or delivery device), and (b) the relatively low stiffness / relatively high compliance of system 100 after implantation allows elongated body 102 of system 100 to more easily conform to a patient's anatomy (e.g., due to forces imparted to system 100 by the patient's anatomy) and / or allows a clinician to bend elongated body 102 into a desired configuration after implantation.
[0027] The stiffening element can be any material configured to reduce the stiffness of the system 100 and / or increase the compliance of the system 100 after implantation of the system 100 in a patient's eye. For example, in some embodiments, the stiffening element can be a material configured to transition from a solid (e.g., when in a first state) to a liquid (e.g., when in a second state). For example, the stiffening element can be a polysaccharide or other soluble element capable of transitioning between a solid and a liquid state. In other embodiments, the stiffening element can be solid in both the first and second states, but can nevertheless decrease in stiffness when implanted. For example, the stiffening element can be a hydrogel or other material that loosens upon exposure to liquid and / or heat. In some embodiments, the stiffening material remains within the elongate body 102 after undergoing a stiffness change. In other embodiments, the material can be washed out of the elongate body 102 after undergoing a stiffness change. In some embodiments, the stiffening element can be bioabsorbable such that it can be absorbed by the body when in the second state. Regardless of the material, the stiffening material, when in the first state, may at least partially block one or more outflow ports (e.g., axial outlet 108 and / or lateral outlet 110 shown in FIGS. 1A and 1C ). In such embodiments, the stiffening material may at least partially reduce the likelihood that a patient will experience hypotony immediately after implantation of system 100 (e.g., due in part to a time delay between implantation and removal from system 100).
[0028] In some embodiments, the shunt systems described herein can be pre-shaped to fit a patient's anatomy, for example, in addition to or instead of having a shapeable element. For example, Figures 3A-3D show another shunt system 300 ("system 300") that is pre-shaped to fit a patient's anatomy and configured in accordance with selected embodiments of the present technology. More specifically, Figure 3A is a top view of system 300, Figure 3B is a side view of system 300, Figure 3C is a partial cross-sectional view of system 100 implanted in an eye, and Figure 3D is a partial cross-sectional view showing various stages of implanting system 300 in an eye.
[0029] System 300 may include certain features generally similar to those described above with respect to system 100 (FIGS. 1A-2). For example, with reference to FIG. 3A, system 300 may include an elongated housing 302 extending between a first end region 302a and a second end region 302b. First end region 302a of elongated housing 302 may house a flow control plate assembly 320 configured to control the flow of fluid through system 300. Flow control plate assembly 320 may be the same as or generally similar to flow control plate assembly 120 shown in FIG. 1A. System 300 may include other features described in detail above with reference to FIGS. 1A-1C.
[0030] 3B, system 300 is manufactured in a curved or bent configuration or shape. In the illustrated embodiment, elongated housing 302 includes a hinge or bend region 303 disposed between a first end region 302a and a second end region 302b. Bend region 303 divides elongated housing 302 into a first segment 307a extending between first end region 302a and bend region 303 and a second segment 307b extending between second end region 302b and bend region 303. Notably, a first axis X extending through the first segment 307a is angled with respect to a second axis Y extending through the second segment 307b (as described below, the second segment 307b may be curved, and thus in some embodiments, the second axis Y is defined as an axis defined by only a portion of the second segment 307b adjacent the line of best fit and / or the bend region 303, as shown in FIG. 3B). In some embodiments, the angle Z defined between the first segment 307a and the second segment 307b may be between about 90 degrees and 170 degrees, or between about 100 degrees and about 160 degrees, or between about 110 degrees and 150 degrees. In some embodiments, angle Z is selected such that when first segment 307a is inside the patient's eye, second segment 307b is angled relative to first segment 307a to an extent that allows second segment 307b to generally follow the outer surface of the patient's eye. As will be explained in more detail below with respect to FIG. 3D, in some embodiments, angle Z is selected such that before system 300 is implanted, angle Z is less than the angle system 300 will assume once implanted (e.g., system 300 is "over-curved" before implantation and straightens slightly during the implant procedure). As will be explained below, this is expected to increase the anchoring force of system 300 to the eye and keep second segment 307b in close alignment with the sclera, thereby reducing and / or avoiding erosion or damage to Tenon's and conjunctival tissue.
[0031] In addition to the bending region 303, the second segment 307b can also have a generally curved or arcuate shape configured to conform to the patient's anatomy, for example to match the curvature of the outer surface of the eye. For example, the surface 307b1 of the second segment 307b may have a slightly concave shape that conforms to the curvature of the eye. In some embodiments, both the first segment 307a and the second segment 307b have a curved or arcuate shape. However, in other embodiments, neither the first segment 307a nor the second segment 307b have a curved or arcuate shape. In some embodiments, the second segment 307b has a curvature that is higher / greater than the curvature of the outer surface of the eye, such that when implanted, the second segment 307b at least partially "straightens out" to conform to the curvature of the outer surface of the eye. In embodiments in which the shunt element 310 is at least partially elastic, this is expected to increase the adhesion between the system 300 and the eye and keep the second segment 307b in close alignment with the sclera, thereby reducing and / or avoiding erosion or damage to Tenon's and conjunctival tissue.
[0032] Thus, as discussed above, system 300 may be pre-curved or bent in two ways: (1) system 300 may include a hinge or bend region (e.g., bend region 303) that allows a first portion of system 300 (e.g., first segment 307a) to extend into the patient's eye and a second portion of system 300 (e.g., second segment 307b) to extend at an angle that approximates the angle of the outer surface of the patient's eye, and (2) the first and / or second portions of system 300 may be curved to match the contours of the patient's anatomy (e.g., the curvature of the outer surface of the patient's eye) to which it is configured to be apposed. Without wishing to be bound by theory, having a pre-shaped system such as system 300 is expected to reduce the need for a user to reshape or modify system 300 during or after an implant procedure by closely matching the shape of system 300 to fit the patient's anatomy, such as, for example, the curvature of the patient's eye.
[0033] Despite being pre-shaped to fit the patient's anatomy, in some embodiments, the elongated housing 302 may be constructed from a semi-flexible or compliant material (e.g., silicone, PDMS, PMMA) that allows the elongated housing 302 to further assume the appropriate shape upon implantation. In some embodiments, the system 300 may also include a moldable element (e.g., moldable element 240 described above with respect to FIG. 2) to further aid in the fitting of the system 300 to the patient's eye and / or to aid in the deployment of the system 300 from a delivery instrument.
[0034] FIG. 3C illustrates the system 300 implanted in a patient's eye E. As illustrated, the first segment 307a is positioned inside the patient's eye E, and the second segment 307b extends along the outer surface S of the patient's eye E. As described with respect to FIG. 3B, the angle formed in the bend region 303 between the first segment 307a and the second segment 307b can be selected such that the second segment 307b lies substantially flat with the outer surface S of the patient's eye E. As also described with respect to FIG. 3B, the second segment 307b can be curved to match the curvature of the outer surface S of the patient's eye E. Although described as extending along the outer surface S of the patient's eye E, one skilled in the art will understand that the second segment 307b can be positioned within the eye while still following the curvature of the patient's eye, such as by being positioned between the sclera and the subconjunctiva. Thus, in some embodiments, the outer surface S is the outer surface of the patient's sclera or other anatomical structure, and not the outer surface of the eye that is directly exposed to the external environment.
[0035] In some embodiments, the predetermined angle between the first segment 307a and the second segment 307b can be less than the angle between the first segment 307a and the second segment 307b when the system 300 is implanted. For example, FIG. 3D illustrates various stages of implanting the system 300 into a patient's eye E, where the manufacturing angle between the first segment 307a and the second segment 307b is less than the angle between the first segment 307a and the second segment 307b after the system 300 is implanted. In such embodiments, the system 300 can be bent (e.g., in the direction indicated by arrow A) from its manufacturing shape to its implanted shape during the implant procedure to conform to the curvature of the patient's eye. In such embodiments, system 300 may be at least partially elastic such that bending system 300 to conform to the curvature of the patient's eye helps to hold system 300 in a desired position or configuration (e.g., once deployed, system 300 is biased toward its manufactured configuration, but is expected to be stretched beyond that, increasing the anchoring force of system 300 to the eye). The bending process described with respect to FIG. 3D is an optional step that may not be performed in some embodiments.
[0036] 4 is a top view of another shunt system 400 ("system 400") configured in accordance with selected embodiments of the present technology. System 400 includes substantially similar features as system 100 described above with reference to FIGS. 1A-1C. For example, system 400 includes an elongated housing 402 and a flow control plate assembly 420. Elongated housing 402 and flow control plate assembly 420 may be the same or substantially the same as elongated housing 102 and flow control plate assembly 130 shown in FIGS. 1A-1C. For example, elongated housing 402 may include one or more appendages 414 and suture rings 416. However, unlike system 100, system 400 does not include a side outlet 110.
[0037] The elongated housing 402 (and thus the system 400) can have an overall length L1 between the first end 402a1 and the second end 402b1 of about 4 mm to about 20 mm, e.g., about 4 mm to 15 mm, or about 4 mm to 12 mm, or about 6 mm to 10 mm, or about 8 mm. The second length L2 between the suture ring 416 and the first end 402a1 can be about 2 mm to about 8 mm, such as about 2 mm to about 6 mm, or about 3 mm to 6 mm, or about 3 mm to 5 mm, or about 4 mm. The third length L3 between the appendage 414 and the first end 402a1 can also be about 2 mm to about 8 mm, e.g., about 2 mm to about 6 mm, or about 3 mm to 6 mm, or about 3 mm to 5 mm, or about 4 mm. The fourth length L4 between the distal edge 420a of the plate assembly 420 and the first end 402a1 can be about 2 mm to about 8 mm, for example, about 2 mm to about 6 mm, or about 3 mm to 6 mm, or about 3 mm to 5 mm, or about 4 mm. The elongated housing 402 can also have a generally flat profile. For example, the elongated housing 402 can have a height of less than about 2 mm, less than about 1 mm, less than about 0.5 mm, etc. The aforementioned dimensions are provided merely as representative of certain embodiments, and other dimensions outside the ranges provided above are possible and are within the scope of the present technology. Indeed, the dimensions of the system 400 can be designed depending on the type of shunt system (e.g., glaucoma shunt vs. hydrocephalus shunt) and the intended recipient (e.g., pediatric vs. adult). As will be appreciated by one of ordinary skill in the art, any of the dimensions described with respect to the system 400 can be applied to the system 100 described with respect to FIGS. 1A-1C. Additionally, although the embodiment shown and described in connection with Figures 1A-4 is a shunt system for selectively adjusting resistance to flow (and similarly flow rate), those skilled in the art will understand that the present techniques may be equally applied to other shunts and medical devices.
[0038] The shunt systems described herein may have other suitable shapes and configurations. FIG. 5A is, for example, a perspective view of another shunt system 500 ("system 500") configured in accordance with selected embodiments of the present technology. System 500 includes certain features generally similar to system 100 described above with reference to FIGS. 1A-1C. For example, system 500 may include an elongated housing 502 that defines one or more flow passages extending between a first end 502a and a second end 502b to divert fluid therebetween. However, system 500 includes a first segment 507a having a first width W1 and a second segment 507b having a second width W2 that is different from the first width W1. In the illustrated embodiment, the second width W2 is less than the first width W1 (and thus the second segment 507b may be referred to as a "narrow neck portion" or the like). The second width W2 can be 3 / 4, 1 / 2, 1 / 3, 1 / 4, 1 / 8, or 1 / 16 of the first width W1. In some embodiments, the first width W1 can be about 0.5 mm to about 2.5 mm, and the second width W2 can be about 0.5 mm to about 2 mm. Of course, the aforementioned dimensions are provided merely as representative of certain embodiments, and other dimensions outside of the ranges and values provided above are possible and are within the scope of the present technology. In some embodiments, incorporating a second segment having a width smaller than other portions of the system 500 is expected to reduce the volume of space that the system 500 occupies in the eye outside the anterior fossa (e.g., compared to a system having an elongated housing with a substantially constant width along its length), which may in turn reduce potential side effects that may result from implanting the system 500 in a patient. Without being bound by theory, it is also expected that the reduction in the cross-sectional area of the second segment is expected to reduce its bending stiffness, thereby making it more conformable to the patient's eye. The reduced cross-sectional area of the second segment is also expected to provide improved anchoring over many conventional devices, which can prevent / mitigate drift or migration of the system after implantation within a patient.In some embodiments, the second segment 507b can be angled or otherwise curved relative to the first segment 507a, as described with respect to the system 300 shown in Figures 3A-3D.
[0039] Despite having a narrow neck portion 508b, the system 500 may otherwise be generally similar to the system 100 described above. For example, the first end 502a of the elongated housing 502 may house or otherwise include certain features similar or the same as the first end 102a of the system 100. For example, the first end 502a may include one or more fluid inlets 522 and one or more channels 524 for receiving fluid via the one or more inlets 522 (although only one channel 524 is shown in FIG. 5A, the system 500 may optionally include two, three, or more channels 524, as described with respect to the system 100 and shown below with reference to FIG. 5B). The first end 502a of the system 500 may further house a flow control plate assembly 520 having one or more actuators 526 for selectively controlling the flow of fluid through the one or more fluid inlets 522. The second end 502b of the elongated housing 502 can include a primary exhaust lumen 504, which can be fluidly coupled to and extend between one or more channels 524 and an outflow opening 508.
[0040] FIG. 5B is a top view of another shunt system 550 ("system 550") configured in accordance with selected embodiments of the present technology. System 550 includes several features generally similar to system 500 described above with reference to FIG. 5A and system 100 described above with reference to FIGS. 1A-1C. For example, system 550 includes an elongated housing 552 that defines one or more flow paths extending between a first end 552a and a second end 552b for shunting fluid therebetween. First end 552a can include one or more fluid inlets 572 and one or more channels 574 for receiving fluid via the one or more inlets 572 (though three channels 574 are shown in FIG. 5B, system 550 can optionally include one, two, four, or more channels 574, as previously described). One aspect of system 550 that differs from system 500 described above with reference to FIG. 5A is that channel 574 is generally straight / linear extending along elongated housing 552 between first end 552a and second end 552b (rather than having a serpentine arrangement like channel 524 of system 500 of FIG. 5A).
[0041] The first end 552a of the system 550 can further house a flow control plate assembly 570 having one or more actuators 576 for selectively controlling fluid flow through one or more fluid inlets 572. The second end 552b of the elongated housing 552 can include a primary exhaust lumen 554, which can be fluidly coupled to and extend between one or more channels 574 and an outflow opening 558.
[0042] The elongated housing 552 (and thus the system 550) can have an overall length L5 of about 8 mm to 12 mm, such as about 9 mm to 11 mm, or about 10 mm to 11 mm, or about 10.5 mm to 11 mm. In one particular embodiment, the length L5 is 10.8 mm. The system 550 includes a first segment 557a having a first width W3 and a length of about 4 mm to 5 mm (e.g., 4.36 mm), and a second segment 557b having a second width W4 less than the first width W3 and a length of about 4 mm to 5 mm (e.g., 4.77 mm). In some embodiments, the first width W3 can be between about 1 mm and about 2 mm (e.g., 1.63 mm), and the second width W4 can be between about 0.5 mm and about 1.5 mm (e.g., 1.13 mm). Similar to the previously described devices, the elongated housing 552 can also have a generally flat profile. For example, the elongated housing 552 may have a height of less than about 2 mm, less than about 1 mm, less than about 0.5 mm, etc. The aforementioned dimensions are provided merely as representative of certain embodiments, and other dimensions outside the ranges provided above are possible and are within the scope of the present technology. Indeed, the dimensions of the system 550 may be designed depending on the type of shunt system (e.g., glaucoma shunt vs. hydrocephalus shunt) and the intended recipient (e.g., pediatric vs. adult). As will be appreciated by one of skill in the art, any of the dimensions described with respect to the system 550 may be applied to the system 100 described with respect to Figures 1A-1C and the system 500 described with respect to Figure 5A. Additionally, while the embodiment shown and described in conjunction with Figures 1A-5B is a shunt system for selectively adjusting resistance to flow (and similarly flow rate), one of skill in the art will appreciate that the present technology may be equally applied to other shunts and medical devices.
[0043] The systems described herein can be implanted in any suitable location or locations within the eye that fluidly connect the anterior fossa to a desired outflow location, such as the subconjunctival bleb space. In some embodiments, for example, the systems described herein can be positioned such that the inflow region of the shunt system is within the anterior fossa and "above" the iris in the anterior chamber (e.g., positioned superficially relative to the iris). In such embodiments, any actuator carried by the system (e.g., actuator 126 of system 100, actuator 526 of system 500, actuator 576 of system 550) may be directly visible from outside the eye and thus can be directly targeted using a suitable energy modality (e.g., laser energy). In other embodiments, the systems described herein can be positioned such that the inflow region of the shunt system is within the anterior fossa but "below" the iris in the posterior chamber (e.g., positioned posteriorly relative to the iris). Without being bound by theory, locating the inflow region of the shunt system below the iris in the posterior chamber can reduce the possibility of endothelial cell loss due to implantation. However, implanting a system such that the inflow region is below the iris may present other challenges. For example, one or more of the inflow openings of the system (e.g., fluid inlet 122 of system 100, fluid inlet 522 of system 500, fluid inlet 572 of system 550) may need to be repositioned to ensure that they are on the side or below the system and remain in fluid communication with the anterior fossa. Furthermore, locating the inflow region of the shunt system below the iris may "block" the actuators, making them more difficult to locate and therefore actuate.In such an embodiment, the actuator may nevertheless be identified and activated by (a) performing an iridectomy (e.g., permanently removing a portion of the iris) to provide a pathway for a laser or other form of energy from an energy source positioned outside the eye to reach the actuator, (b) dilating the pupil prior to activation to expose the actuator to energy from the energy source, and / or (c) locating the actuator using a first energy modality having a first wavelength that is transparent to the iris (e.g., similar to identifying an object submerged in water using sonar), and then energizing the actuator using a second energy modality having a second wavelength without substantially heating or otherwise affecting the iris. However, as one skilled in the art will appreciate from the disclosure herein, the above-described system is not limited to any particular location or position, and thus the technology is not intended to be limited by the foregoing description. Indeed, the shunt systems described herein may be placed in or at other parts of the body to drain fluid to other parts of the eye, or more generally, from a first body region to a second body region. EXAMPLES
[0044] Several aspects of the present technology are described in the following examples. 1. An implantable shunt element for treating a patient, the implantable shunt element comprising: a first end and a second end spaced from the first end by a body of the shunt element; a drain lumen extending at least partially between the first end and the second end for transporting fluid therebetween; a conformable portion between the first end and the second end, An implantable shunt element, wherein the conformable portion is configured to facilitate bending the shunt element into a desired shape that corresponds at least in part to a patient's anatomy. 2. An implantable shunt element as described in Example 1, wherein the adaptable portion comprises one or more lateral exit ports or openings at the second end of the shunt element. 3. An implantable shunt element as described in Example 1, wherein the conformable portion comprises one or more thinned portions on the exterior surface of the body at the second end of the shunt element. 4. An implantable shunt element as described in Example 1, wherein the adaptable portion comprises one or more suture rings extending at least partially around the body of the second end of the shunt element. 5. An implantable shunt element as described in Example 1, wherein the conformable portion comprises one or more depressions or grooves extending at least partially around the body of the second end of the shunt element. 6. The first end of the shunt element has a first width and the second end of the shunt element has a second width that is less than the first width; The implantable shunt element of any of Examples 1 to 5, wherein the adaptable portion includes at least a region of the second end of the shunt element having a second width. 7. An implantable shunt element described in any of Examples 1 to 6, wherein the conformable portion is configured to facilitate bending the shunt element into a desired shape prior to implantation of the shunt element within a patient. 8. An implantable shunt element as described in any of Examples 1 to 7, wherein the adaptable portion is configured to facilitate bending of the shunt element to at least partially correspond to the curvature of the patient's eye. 9. A shunt element for treating a patient, the shunt element comprising: A first end; a second end spaced from the first end by the body of the shunt element; a drain lumen extending at least partially between the first end and the second end for transporting fluid therebetween; a soluble stiffening element carried by the shunt element, the stiffening element configured to (a) impart a first stiffness to the shunt element prior to and during implantation of the shunt element, and (b) impart a second stiffness to the shunt element after implantation of the shunt element, the stiffening element being less than the first stiffness; The shunt element comprises: 10. A shunt element as described in Example 9, wherein the stiffening element is configured to transition from a first state imparting a first stiffness to a second state imparting a second stiffness and / or toward the second state when exposed to patient fluid. 11. The shunt element of example 9 or 10, wherein the stiffening element is solid in a first state and liquid in a second state. 12. The shunt element of example 9 or 10, wherein the stiffening element is solid in the first state and in the second state. 13. A shunt element as described in Example 9, wherein the stiffening element is configured to transition from a first state imparting a first stiffness to a second state imparting a second stiffness and / or toward the second state when exposed to body heat. 14. A shunt element according to any of Examples 9 to 13, wherein the stiffening element is composed of a hydrogel. 15. The shunt element of any of Examples 9 to 13, wherein the stiffening element is composed of a polysaccharide. 16. A shunt element described in any of Examples 9 to 15, wherein the stiffening element is disposed within the shunt element. 17. A shunt element described in any of Examples 9 to 16, wherein the stiffening element is composed of a bioabsorbable material. 18. A shunt element for treating a patient, comprising: A first end; a second end spaced from the first end by the body of the shunt element; a bend region between the first end and the second end, the bend region defining (a) a first segment of the shunt element extending between the first end and the bend region, and (b) a second segment of the shunt element extending between the second end and the bend region; The shunt element, wherein a first longitudinal axis extending through the first segment is angled relative to a second longitudinal axis extending through the second segment. 19. The shunt element of example 18, wherein the first longitudinal axis and the second longitudinal axis form an angle of about 90 degrees to about 170 degrees. 20. The shunt element of Example 19, wherein the shunt element is configured to increase in angle when the shunt element is implanted in a patient. 21. The shunt element of Example 19, wherein the shunt element is configured such that the angle remains substantially the same when the shunt element is implanted in a patient. 22. A shunt element described in any of Examples 18 to 21, wherein the second segment includes a curved surface configured to mate with a corresponding curved surface of a patient's eye. 23. The shunt element of Example 22, wherein the curved surface has a curvature configured to match the curvature of a corresponding curved surface of a patient's eye. 24. A shunt element as described in Example 23, wherein the curved surface is configured to have a curvature greater than the curvature of the corresponding curved surface of the patient's eye, and when implanted, the curved surface is configured to assume a new curvature that approximates the curvature of the corresponding curved surface of the patient's eye. 25. A shunt element for treating a patient, the shunt element comprising: a first end and a second end spaced from the first end by a body of the shunt element; a drain lumen extending at least partially between the first end and the second end for transporting fluid therebetween; a formable element carried by the shunt element and extending at least partially between the first end and the second end; A shunt element, wherein the shapeable element at least partially controls the shape of the shunt element, the shapeable element being configured such that deformation of the shapeable element changes the shape of the shunt element and maintains the shunt element in the changed shape for a predetermined period of time. 26. The shunt element of Example 25, wherein the moldable element is at least partially composed of a polymer and / or a hydrogel. 27. A shunt element as described in Example 25 or 26, wherein the moldable element is configured to transition from a first state imparting a first stiffness to a second state imparting a second stiffness and / or toward the second state when exposed to patient fluid. 28. The shunt element of any of examples 25 to 27, wherein the moldable element is solid in a first state and liquid in a second state. 29. The shunt element of example 27, wherein the moldable element is solid in the first state and in the second state. 30. The shunt element of example 25, wherein the moldable element is at least partially constructed of gold and / or silver. 31. A shunt element according to any of examples 25 to 30, wherein the second end comprises a beveled edge. 32. A shunt element described in any of Examples 25 to 31, further comprising one or more grooves extending at least partially around the circumference of the shunt element, the one or more grooves being configured to receive a suture to secure the shunt element to patient tissue. 33. The shunt element of example 32, wherein the one or more grooves extend around the entire circumference of the shunt element. 34. The shunt element of example 32 or 33, wherein the shunt element is configured to hinge or otherwise bend at one or more grooves. 35. A shunt element described in any of Examples 25 to 34, further comprising one or more appendages extending transversely to the longitudinal axis of the shunt element, the one or more appendages being configured to abut patient tissue when the shunt element is implanted. 36. A shunt element as described in Example 35, wherein the one or more appendages are configured to reduce periductal leakage when the shunt element is implanted in a patient. 37. A shunt element described in any of Examples 25 to 36, further comprising a plurality of outlets fluidly coupled to the drainage lumen and disposed laterally along the side of the shunt element. 38. A shunt element as described in Example 37, wherein the multiple outlets include a first multiple outlets arranged along a first side of the shunt element and a second multiple outlets arranged along a second side of the shunt element. 39. A shunt element as described in embodiment 37 or 38, wherein individual outlets of the plurality of outlets are spaced apart by predetermined increments. 40. A shunt element described in any of examples 25 to 39, wherein the shunt element includes a chamber configured to accommodate at least one shape memory actuator for selectively controlling fluid flow through the shunt element. 41. A shunt element described in any of examples 25 to 40, wherein the chamber is configured to accommodate a plate assembly having at least one shape memory actuator. 42. A shunt system for treating a patient, the shunt system comprising: an elongated housing extending between a first end and a second end, the elongated housing comprising: A chamber; an elongate housing including an exhaust lumen fluidly extending between the chamber and the second end; a shape memory actuator disposed within the chamber and configured to at least partially control a flow of fluid through the chamber; an adaptable element configured to at least partially control a shape of the elongated housing; A shunt system, wherein when the adaptable element is deformed to change the shape of the elongate housing, the adaptable element is configured to hold the elongate housing in the changed shape for a selected period of time after the shunt system is implanted within a patient. 43. The shunt system of Example 42, wherein the adaptable element is at least partially composed of hydrogel, polymer, gold, and / or silver. 44. A shunt element as described in Example 42 or 43, wherein when exposed to patient fluid, the adaptable element is configured to transition from (a) a first state imparting a first stiffness to and / or toward (b) a second state imparting a second stiffness less than the first stiffness. 45. The shunt element of example 44, wherein the adaptable element is a solid in a first state and a liquid in a second state. 46. The shunt element of example 44, wherein the adaptable element is a solid in a first state and a solid in a second state. 47. A shunt system described in any of Examples 42 to 46, wherein the elongate housing further includes one or more appendages extending transversely to the longitudinal axis of the elongate housing, the one or more appendages being configured to abut patient tissue when the shunt system is implanted in the patient's eye. 48. A shunt system as described in Example 47, wherein the one or more appendages are configured to reduce peritubular leakage when the system is implanted in a patient's eye. 49. A shunt system as described in any of Examples 42 to 48, further comprising a plurality of outlets fluidly coupled to the drain lumen and arranged laterally along a side of the elongate housing, each outlet of the plurality of outlets being spaced apart by a predetermined increment. 50. A shunt system as described in Example 49, wherein the multiple outlets include a first plurality of outlets arranged along a first side of the elongated housing and a second plurality of outlets arranged along a second side of the elongated housing. 51. A method of implanting a shunt element in a patient, the method comprising: delivering the shunt element to a target location within the patient; and selectively adjusting a shape of the shunt element to conform to the patient's anatomy, the shunt element including a shapeable element that retains the shunt element in the adjusted shape for a preselected period of time. 52. The method of example 51, wherein the target location is within the patient's eye and adjusting the shape of the shunt element includes bending the shunt element to conform to the curvature of the patient's eye. 53. The method of example 51 or 52, wherein delivering the shunt element to a target location within the patient includes advancing the shunt element until one or more appendages of the shunt element abut patient tissue. 54. The method of any of Examples 51 to 53, wherein the moldable element is comprised of a soluble material, and the moldable element is configured to (a) impart a first stiffness to the shunt element during delivery of the shunt element to a target location within the patient and for a first preselected period of time after delivery, and (b) impart a second stiffness to the shunt element that is less than the first stiffness for a second preselected period of time after the first period. 55. The method of any of examples 51 to 54, wherein the moldable element is at least partially composed of a hydrogel. 56. The method of any of examples 51-54, wherein the moldable element is at least partially composed of a polysaccharide.
[0045] conclusion The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise forms disclosed above. Although specific embodiments and examples of the present technology are described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications are possible within the scope of the present technology. For example, any of the features of the intraocular shunt described herein can be combined with any of the features of the other intraocular shunt described herein, and vice versa. Furthermore, although steps are presented in a given order, in alternative embodiments, steps may be performed in a different order. Various embodiments described herein may also be combined to provide further embodiments.
[0046] 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 terms, respectively.
[0047] Unless the context clearly dictates otherwise, throughout the description and examples, words such as "comprise", "comprising", and the like, are to be construed in an inclusive sense, i.e., "including, but not limited to", and not in an exclusive or exhaustive sense. As used herein, the terms "connected", "coupled", or any variation thereof, refer to any direct or indirect connection or coupling between two or more elements. The coupling of connections between elements may be physical, logical, or a combination thereof. Additionally, the words "herein", "above", "below", and words of similar import, when used in this application, refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above detailed description using the singular or plural may each be in the plural or singular. As used herein, the phrase "and / or" appearing in "A and / or B" may refer to A only, B only, or both A and B. Additionally, the term "comprising" is used throughout to mean including at least the recited features, without excluding any more of the same features and / or other features of additional types. It will also be understood that, although certain embodiments have been described herein for purposes of illustration, various modifications may be made without departing from the technology. Furthermore, although advantages associated with some embodiments of the technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily exhibit such advantages to fall within the scope of the technology. Thus, the present disclosure and related technology may encompass other embodiments not explicitly shown or described herein.
Claims
1. A shunt element for treating a patient, the shunt element comprising: a first end; a second end spaced from the first end by a body of the shunt element; a drainage lumen extending at least partially between the first end and the second end for transporting fluid therebetween; a soluble stiffening element carried by the shunt element, the stiffening element configured to: (a) impart a first stiffness to the shunt element before and during implantation of the shunt element; and (b) impart a second stiffness to the shunt element after implantation of the shunt element, the second stiffness being less than the first stiffness A shunt element comprising the above.
2. The shunt element according to claim 1, wherein the stiffening element is configured to transition from a first state imparting the first stiffness to a second state imparting the second stiffness and / or towards the second state when exposed to patient fluid.
3. The shunt element according to claim 2, wherein the stiffening element is solid in the first state and liquid in the second state.
4. The shunt element according to claim 2, wherein the stiffening element is solid in the first state and the second state.
5. The shunt element according to claim 1, wherein the stiffening element is configured to transition from a first state imparting the first stiffness to a second state imparting the second stiffness and / or towards the second state when exposed to body heat.
6. The shunt element according to claim 1, wherein the stiffening element is composed of a hydrogel.
7. The shunt element according to claim 1, wherein the stiffening element is composed of a polysaccharide.
8. The shunt element according to claim 1, wherein the stiffening element is disposed within the shunt element.
9. The shunt element according to claim 1, wherein the stiffening element is composed of a bioabsorbable material.
10. A shunt element for treating a patient, comprising: a first end; a second end spaced from the first end by a body of the shunt element; a bending region between the first end and the second end comprising, wherein the bending region defines (a) a first segment of the shunt element extending between the first end and the bending region, and (b) a second segment of the shunt element extending between the second end and the bending region, A shunt element in which a first longitudinal axis extending through the first segment is angled with respect to a second longitudinal axis extending through the second segment. **Claim 11** The shunt element according to claim 10, wherein the first longitudinal axis and the second longitudinal axis form an angle of about 90 degrees to about 170 degrees. **Claim 12** The shunt element according to claim 11, wherein the shunt element is configured such that the angle increases when the shunt element is implanted in the patient. **Claim 13** The shunt element according to claim 11, wherein the shunt element is configured such that the angle remains substantially the same when the shunt element is implanted in the patient. **Claim 14** The shunt element according to claim 10, wherein the second segment includes a curved surface configured to fit a corresponding curved surface of the patient's eye. **Claim 15** The shunt element according to claim 14, wherein the curved surface has a curvature configured to match the curvature of the corresponding curved surface of the patient's eye. **Claim 16** The shunt element according to claim 15, wherein the curved surface is configured to have a higher curvature than the curvature of the corresponding curved surface of the patient's eye, and when implanted, the curved surface is configured to take on a new curvature approximating the curvature of the corresponding curved surface of the patient's eye. **Claim 17** A shunt element for treating a patient, the shunt element comprising a first end, a second end spaced from the first end by a body of the shunt element, a drain lumen extending at least partially between the first end and the second end for transporting fluid therebetween, a formable element carried by the shunt element and extending at least partially between the first end and the second end comprising The formable element at least partially controls the shape of the shunt element, and the formable element is configured such that its deformation changes the shape of the shunt element and holds the shunt element in the changed shape over a predetermined period of time. A shunt element. **Claim 18** The shunt element according to claim 17, wherein the formable element is at least partially composed of a polymer and / or a hydrogel.
19. The shunt element according to claim 18, wherein the formable element is configured to transition from a first state imparting a first rigidity to a second state imparting a second rigidity and / or toward the second state when exposed to a patient fluid.
20. The shunt element according to claim 19, wherein the formable element is solid in the first state and liquid in the second state.
21. The shunt element according to claim 19, wherein the formable element is solid in the first state and the second state.
22. The shunt element according to claim 17, wherein the formable element is at least partially composed of gold and / or silver.
23. The shunt element according to claim 17, wherein the second end includes a beveled edge.
24. The shunt element according to claim 17, further comprising one or more grooves extending at least partially around an outer periphery of the shunt element, the one or more grooves being configured to receive a suture for fixing the shunt element to patient tissue.
25. The shunt element according to claim 24, wherein the one or more grooves extend across an entire circumference of the shunt element.
26. The shunt element according to claim 24, wherein the shunt element is configured to hinge or bend in another way at the one or more grooves.
27. The shunt element according to claim 17, further comprising one or more appendages extending transverse to a longitudinal axis of the shunt element, the one or more appendages being configured to abut patient tissue when the shunt element is implanted.
28. The shunt element according to claim 27, wherein the one or more appendages are configured to reduce peritubular leakage when the shunt element is implanted in the patient.
29. The shunt element according to claim 17, further comprising a plurality of outlets fluidly coupled to the discharge lumen and disposed laterally along a side of the shunt element.
30. The shunt element according to claim 29, wherein the plurality of outlets include a first plurality of outlets arranged along a first side of the shunt element and a second plurality of outlets arranged along a second side of the shunt element.
31. The shunt element according to claim 29, wherein individual outlets of the plurality of outlets are spaced apart by a predetermined increment.
32. The shunt element according to claim 17, wherein the shunt element includes a chamber configured to accommodate at least one shape memory actuator for selectively controlling the flow of fluid through the shunt element.
33. The shunt element according to claim 32, wherein the chamber is configured to accommodate a plate assembly having the at least one shape memory actuator.