Patent Grant
11517477
All of the foregoing applications are incorporated herein by reference in their entireties. Further, components and features of embodiments disclosed in the applications incorporated by reference may be combined with various components and features disclosed and claimed in the present application.
The present technology relates to adjustable flow glaucoma shunts and methods for making and using such devices.
Glaucoma is a degenerative ocular condition involving damage to the optic nerve that can cause progressive and irreversible vision loss. Glaucoma is frequently associated with ocular hypertension, an increase in pressure within the eye, and may result from an increase in production of aqueous humor (“aqueous”) within the eye and/or a decrease in the rate of outflow of aqueous from within the eye into the blood stream. Aqueous is produced in the ciliary body at the boundary of the posterior and anterior chambers of the eye. It flows into the anterior chamber and eventually into the venous vessels of the eye. Glaucoma is typically caused by a failure in mechanisms that transport aqueous out of the eye and into the blood stream.
Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the component is necessarily transparent. Components may also be shown schematically.
The present technology is directed to adjustable flow glaucoma shunts and methods for making and using such devices. In many of the embodiments described herein, the shunts include a generally flat outer frame. The frame can include an elongated portion having a lumen extending therethrough and a bladder portion defining an interior chamber that is in fluid communication with the lumen. When implanted in a patient's eye, aqueous can drain from the anterior chamber to a target outflow location by flowing through the lumen and the interior chamber. In some embodiments, the shunts include a flow control assembly positioned within the interior chamber of the bladder portion to control the flow of aqueous through the lumen.
As provided above, in some embodiments the present technology includes flow control assemblies for controlling the flow of fluid through a shunt. The flow control assemblies generally include an anchoring element, one or more actuation elements, and a gating element. The anchoring element can be designed to reside within a portion of the shunt (e.g., within a chamber formed by the frame). The gating element can include a lever or arm that can at least partially block a portion of the shunt lumen. The actuation element can move the gating element back and forth to selectively block and/or unblock the lumen, thereby decreasing or increasing flow through the shunt.
The present technology further includes methods of manufacturing the shunts and flow control assemblies described herein. The methods can include fabricating (e.g., laser cutting) a unitary structure corresponding to a flow control assembly from a single pierce of material (e.g., a sheet or a strip of nitinol). The unitary structure can include an anchoring element, an actuation element, and a gating element. The actuation element can have a first end portion extending from the gating element and a second end portion not connected to another portion of the unitary structure. To form the flow control assembly from the unitary structure, the actuation element can be deformed relative to its preferred geometry (e.g., prestressed and/or prestrained) and the second end portion of the actuation element can be secured to the anchoring. With the flow control assembly formed, it can be coupled to the shun such that the flow control assembly is configured to at least partially control the flow of fluid through the shunt.
Specific details of various embodiments of the present technology are described below with reference to
Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.
Reference throughout this specification to relative terms such as, for example, “generally,” “approximately,” and “about” are used herein to mean the stated value plus or minus 10%.
Although certain embodiments herein are described in terms of shunting fluid from an anterior chamber of an eye, one of skill in the art will appreciate that the present technology can be readily adapted to shunt fluid from and/or between other portions of the eye, or, more generally, from and/or between a first body region and a second body region. Moreover, while the certain embodiments herein are described in the context of glaucoma treatment, any of the embodiments herein, including those referred to as “glaucoma shunts” or “glaucoma devices” may nevertheless be used and/or modified to treat other diseases or conditions, including other diseases or conditions of the eye or other body regions. For example, the systems described herein can be used to treat diseases characterized by increased pressure and/or fluid build-up, including but not limited to heart failure (e.g., heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, etc.), pulmonary failure, renal failure, hydrocephalus, and the like. Moreover, while generally described in terms of shunting aqueous, the systems described herein may be applied equally to shunting other fluid, such as blood or cerebrospinal fluid, between the first body region and the second body region.
The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology.
A. Implantable Shunts for Glaucoma Treatment
Glaucoma refers to a group of eye diseases associated with damage to the optic nerve which eventually result in vision loss and blindness. As noted above, glaucoma is a degenerative ocular condition characterized by an increase in pressure within the eye resulting from an increase in production of aqueous within the eye and/or a decrease in the rate of outflow of aqueous from within the eye into the blood stream. The increased pressure leads to injury of the optic nerve over time. Unfortunately, patients often do not present with symptoms of increased intraocular pressure until the onset of glaucoma. As such, patients typically must be closely monitored once increased pressure is identified even if they are not symptomatic. The monitoring continues over the course of the disease so clinicians can intervene early to stem progression of the disease. Monitoring pressure requires patients to visit a clinic site on a regular basis which is expensive, time-consuming, and inconvenient. The early stages of glaucoma are typically treated with drugs (e.g., eye drops) and/or laser therapy. When drug/laser treatments no longer suffice, however, surgical approaches can be used. Surgical or minimally invasive approaches primarily attempt to increase the outflow of aqueous from the anterior chamber to the blood stream either by the creation of alternative fluid paths or the augmentation of the natural paths for aqueous outflow.
Referring to
Outflow resistance can change over time for a variety of reasons, e.g., as the outflow location goes through its healing process after surgical implantation of a shunt (e.g., shunt 100) or further blockage in the drainage network from the anterior chamber through the trabecular meshwork, Schlemm's canal, the collector channels, and eventually into the vein and the body's circulatory system. Accordingly, a clinician may desire to modify the shunt after implantation to either increase or decrease the outflow resistance in response to such changes or for other clinical reasons. For example, in many procedures the shunt is modified at implantation to temporarily increase its outflow resistance. After a period of time deemed sufficient to allow for healing of the tissues and stabilization of the outflow resistance, the modification to the shunt is reversed, thereby decreasing the outflow resistance. In another example, the clinician may implant the shunt and after subsequent monitoring of intraocular pressure determine a modification of the drainage rate through the shunt is desired. Such modifications can be invasive, time-consuming, and/or expensive for patients. If such a procedure is not followed, however, there is a high likelihood of creating hypotony (excessively low eye pressure), which can result in further complications, including damage to the optic nerve. In contrast, intraocular shunting systems configured in accordance with embodiments of the present technology allow the clinician to selectively adjust the flow of fluid through the shunt after implantation without additional invasive surgical procedures.
The shunts described herein can be implanted having a first drainage rate and subsequently remotely adjusted to achieve a second drainage rate. The adjustment can be based on the needs of the individual patient. For example, the shunt may be implanted at a first lower flow rate and subsequently adjusted to a second higher flow rate as clinically necessary. The shunts described herein can be delivered using either ab interno or ab externo implant techniques, and can be delivered via needles. The needles can have a variety of shapes and configurations to accommodate the various shapes of the shunts described herein. For example, in some embodiments, the needles may be hinged to facilitate implantation through the sclera. Details of the implant procedure, the implant devices, and bleb formation are described in greater detail in International Patent Application No. PCT/US20/41152, titled “MINIMALLY INVASIVE BLEB FORMATION DEVICES AND METHODS FOR USING SUCH DEVICES,” filed Jul. 8, 2020, the disclosure of which is hereby incorporated by reference herein for all purposes.
In many of the embodiments described herein, the flow control assemblies are configured to introduce features that selectively impede or attenuate fluid flow through the shunt during operation. In this way, the flow control assemblies can incrementally or continuously change the flow resistance through the shunt to selectively regulate pressure and/or flow. The flow control assemblies configured in accordance with the present technology can accordingly adjust the level of interference or compression between a number of different positions, and accommodate a multitude of variables (e.g., IOP, aqueous production rate, native aqueous outflow resistance, and/or native aqueous outflow rate) to precisely regulate flow rate through the shunt.
The disclosed flow control assemblies can be operated using energy. This feature allows such devices to be implanted in the patient and then modified/adjusted over time without further invasive surgeries or procedures for the patient. Further, because the devices disclosed herein may be actuated via energy, such devices do not require any additional power to maintain a desired orientation or position. Rather, the actuators/fluid resistors disclosed herein can maintain a desired position/orientation without power. This can significantly increase the usable lifetime of such devices and enable such devices to be effective long after the initial implantation procedure.
B. Selected Embodiments of Adjustable Flow Glaucoma Shunts
As provided above, the present technology is directed to adjustable flow glaucoma shunts.
In some embodiments, at least a portion of the elongated portion 212 is configured for placement within an anterior chamber of an eye in a region outside of the optical field of view of the eye, and the bladder portion 214 is configured for placement within a desired outflow location, such as a subconjunctival bleb space. In such embodiments, aqueous can flow from the anterior chamber and into the lumen 206 via a first (e.g., inflow) port 207. The aqueous can then flow through the lumen 206 and into the interior chamber 216. Once in the interior chamber 216, the aqueous may drain into the desired outflow location via a second (e.g., outflow) port 208. In other embodiments, the orientation of the shunt 200 can be reversed when implanted, such that the bladder portion 214 is positioned in the anterior chamber and the first port 207 of the elongated portion 212 is positioned in the desired outflow location. In such embodiments, aqueous flows in the opposite direction as described above: aqueous enters the shunt 200 at the interior chamber 216 via the second port 208, flows through the lumen 206, and drains into the desired outflow location via the first port 207.
In some embodiments, the shunt 200 has a generally flat profile (e.g., as defined by the frame 210). For example, the frame 210 (the elongated portion 212, the bladder portion 214, or both the elongated portion 212 and the bladder portion 214) can have a longitudinal cross-sectional dimension (e.g., height, width, diameter, etc.) of about 100 μm or less, 90 μm or less, 80 μm or less, 70 μm or less, 60 μm or less, and/or 50 μm or less. In some embodiments, use of a rectangular or oval-shaped lumen 206 (as opposed to a circular lumen) may help decrease one or more dimensions of the shunt 200 without substantially affecting the therapy provided by the shunt 200. Without being bound by theory, reducing the one or more dimensions of the shunt 200 may help reduce and/or minimize damage to the eye during and after implanting the shunt 200 into the eye, which in turn may reduce the recovery time following the implant procedure and/or reduce side effects associated with the shunt. The overall shape “L” shape of the shunt 200 may also help anchor the shunt in position and prevent unwanted migration of the shunt 200 despite its relatively small profile.
The shunt 200 further includes a flow control assembly 220 (also referred to herein as an “actuation assembly”) positioned in the interior chamber 216. The flow control assembly 220 can include an anchor 221, one or more actuation elements 222, and a lever or gating element 225. As will be described in greater detail below with reference to
The gating element 225 includes a first portion 227 (e.g., an “arm”) positioned between the first actuation element 222a and the second actuation element 222b and a second portion 226 spaced apart from the first portion 225. The second portion 226 can be configured to at least partially block the lumen 206 and/or an aperture or orifice of the lumen 206 (thus at least partially blocking fluid from flowing out of the lumen 206 and into the interior chamber 216) in certain configurations, such as the configuration depicted in
The first actuation element 222a extends between the first anchoring element 223a and the first portion 227 of the gating element 225. The second actuation element 222b extends between the second anchoring element 223b and the first portion 227 of the gating element 225. The actuation elements 222 are configured to move the gating element 225 between a plurality of positions to control the flow of fluid through the shunt 200. For example, the first actuation element 222a and the second actuation element 222b can be composed of a shape memory material, such as a shape memory alloy (e.g., nitinol). Accordingly, the first actuation element 222a and the second actuation element 222b can be transitionable at least between a first material phase or state (e.g., a martensitic state, a R-phase, a composite state between martensitic and R-phase, etc.) and a second material phase or state (e.g., an austenitic state, an R-phase state, a composite state between austenitic and R-phase, etc.). In the first material state, the first actuation element 222a and the second actuation element 222b may be deformable (e.g., plastic, malleable, compressible, expandable, etc.). In the second material state, the first actuation element 222a and the second actuation element 222b may have a preference toward a specific preferred geometry (e.g., original geometry, manufactured geometry, heat set geometry, etc.). The first actuation element 222a and the second actuation element 222b can be transitioned between the first material state and the second material state by applying energy (e.g., heat) to the actuation elements to heat the actuation elements above a transition temperature. Energy can be applied to the actuation elements via an energy source positioned external to the body (e.g., a laser), RF heating, resistive heating, or the like. In some embodiments, the transition temperature for both the first actuation element 222a and the second actuation element 222b is above an average body temperature (e.g., an average temperature in the eye). Accordingly, both the first actuation element 222a and the second actuation element 222b are generally in the deformable first state when the shunt 200 is implanted in the body until they are actuated. If an actuation element (e.g., the first actuation element 222a) is deformed relative to its preferred geometry while in the first state, heating the actuation element (e.g., the first actuation element 222a) above its transition temperature causes the actuation element to transition to the second state and therefore move from the deformed shape to and/or toward its preferred geometry. In some embodiments, the first actuation element 222a can be selectively heated independently of the second actuation element 222b, and the second actuation element 222b can be selectively heated independently of the first actuation element 222a.
The first actuation element 222a and the second actuation element 222b generally act in opposition. For example, if the second actuation element 222b is deformed relative to its preferred geometry, actuation of the second actuation element 222b (e.g., heating the second actuation element 222b above its transition temperature) causes the second actuation element 222b to move toward its preferred geometry. This causes a corresponding deformation in the first actuation element 222a, which remains in the first material state and thus is generally malleable. For example, in the illustrated embodiment, the second actuation element 222b is compressed (e.g., shortened) relative to its preferred geometry. Heating the second actuation element 222b above its transition temperature causes the second actuation element 222b to straighten out (e.g., lengthen, expend, etc.) and move toward its preferred geometry. Because the second anchoring element 223b does not move as the second actuation element 222b changes shape, the first actuation element 222a (which is not heated and therefore in the first generally malleable state) is compressed to account for the shape change of the second actuation element 222b. This also moves the first portion 227 of the gating element 225 toward the first anchoring element 223a, which causes the second portion 226 of the gating element 225 to unblock and/or further unblock the lumen 206. This can increase flow through the lumen 206. The operation can be reversed by heating the first actuation element 222a above its transition temperature, which causes it to move (e.g., expand) toward its preferred geometry, which moves the first portion 227 of the gating element 225 back toward the second anchoring element 223b and the second portion 226 of the gating element 225 back into a blocking position. This can decrease flow through the lumen 206. Accordingly, the first actuation element 222a and the second actuation element 222b can be selectively and independently actuated to further block or unblock the lumen 206 to change the flow of fluid therethrough. In some embodiments, the gating element 225 can be moved to any number of positions between fully blocking and fully unblocking the lumen 206, and the flow control assembly 220 can be selectively adjusted after placement within the eye (e.g., via non-invasive energy) to provide a variety of different outflow resistance levels by incrementally adjusting the gating element 225 relative to the lumen 206. Additional details regarding the operation of flow control mechanisms generally similar to the flow control mechanism 220 are described below in Section D and with reference to
Referring now to
Referring next to
As one skilled in the art will appreciate, adjustable shunts configured in accordance with the present technology can include any combination of the above described features and are not limited to the specific embodiments illustrated herein. For example, while the elongated portion is depicted as intersecting with the bladder portion at a proximal corner of the bladder portion, the elongated portion can alternatively intersect the bladder portion at a central or other region of the bladder portion. Likewise, various components of the flow control assemblies described herein, such as the anchor, the actuation elements, and the gating element, can take any number of configurations without deviating from the scope of the present technology.
Although the shunts discussed above are primarily described as having the flow control assembly positioned at or adjacent an outflow end of the shunt, the flow control assemblies described herein can also be positioned at other positions along the length of the shunt. For example, the flow control assembly can be positioned near a proximate (e.g., inflow) end of the shunt and/or within an anterior chamber. Accordingly, the shunts described above in
C. Methods of Manufacturing Flow Control Assemblies with Shape Memory Actuation Elements
Aspects of the present technology are further directed to methods of manufacturing the devices described herein. As described herein, select embodiments of the present technology include a flow control assembly (e.g., the flow control assemblies 220 and 320 of the shunts 200 and 300, respectively) composed, at least in part, of a shape memory material such as nitinol. To manufacture such nitinol-based flow control assemblies, the desired shape of the flow control assembly can be fabricated (e.g., cut, such as laser cut) from a piece (e.g., sheet, strip, etc.) of nitinol. In some embodiments, the flow control assembly can be fabricated from a single piece of nitinol.
Referring to
The fabricated configuration can be converted into the operational configuration by securing the second end portion of the first actuation element 422a (i.e., the free end) to the anchor 421 and/or the first anchoring element 423a. The process of securing the free end of the first actuation element 422a to the first anchoring element 423a deforms the first actuation element 422a and/or the second actuation element 422b relative to its preferred geometry (thereby “prestraining” and/or “prestressing” the first actuation element 422a and/or the second actuation element 422b). For example, in the embodiment illustrated in
In some embodiments, the first actuation element 422a and/or the second actuation element 422b are stretched or otherwise lengthened when placing the flow control assembly 420 in the operational configuration. For example, in some embodiments the first anchoring element 423a may be spaced apart from the second anchoring element 423b by a length greater than a combined length of the first actuation element 422a and the second actuation element 422b in the fabricated configuration. Accordingly, to transform the flow control assembly 420 into the operational configuration, the first actuation element 422a and/or the second actuation element 422b can be stretched or lengthened relative to their preferred geometries. Once stretched, the first actuation element 422a can be secured to the first anchoring element 423a (e.g., via welding, bonding, or other suitable techniques) to hold the flow control assembly 420 in the operational configuration.
Once in the operational configuration, the flow control element 420 can be positioned within a shunt (e.g., inserted into an interior chamber, such as the interior chamber 216 or 316 described above respect to the shunts 200 and 300, respectively). In some embodiments, the geometry/topography of the anchor 421 conforms with a portion of the interior chamber such that the flow control assembly 421 is automatically anchored in position when positioned in the interior chamber. Alternatively or additionally, the flow control assembly 420 can be secured to the shunt using other anchoring techniques that do not substantially interfere with operation of the shunt. Once positioned within the shunt, the flow control assembly 420 can operate as described in Section D below with respect to
In some embodiments, the first actuation element 422a and/or the second actuation element 422b are optionally biased after placing the flow control assembly in the operational configuration. For example, the first actuation element 422a can be manipulated (e.g., using energy) such that is has a different length than the second actuation element 422b. In such embodiments, the first actuation element 422a is configured to retain its biased shape (e.g., the first actuation element 422a can be composed of a shape-memory material such as nitinol). Biasing at least one of the actuation elements before deployment of the shunt places the shunt in an “open” (e.g., permitting flow), partially “open”, or “closed” (e.g., not permitting flow) position for the implant procedure. The biasing step can be done before or after placement of the flow control assembly 420 within the shunt.
Without being bound by theory, the above method of manufacturing the flow control assemblies described herein provides several advantages. For example, it enables the flow control assembly to be fabricated (e.g., cut) as a unitary structure from a single piece of material, which is expected to simplify the manufacturing process. As another example, because it is formed from a unitary structure, the flow control assemblies may have fewer coupled parts that could malfunction after being implanted into the patient, which may in at least some cases increase the life of the shunts described herein. However, as one skilled in the art will appreciate from the disclosure herein, the flow control assemblies described herein can be formed by methods other than those described above with respect to
D. Operation of Shape Memory Actuation Elements
As described above, the present technology is generally directed to implantable systems and devices for facilitating the flow of fluid between a first body region and a second body region. The devices generally include a drainage and/or shunting element having a lumen extending therethrough for draining or otherwise shunting fluid between the first and second body regions. Further, devices configured in accordance with the present technology may be selectively adjustable to control the amount of fluid flowing between the first and second body regions. In some embodiments, for example, the devices comprise a flow control assembly or actuation assembly that drives movement of a gating element to modulate flow resistance through the lumen, thereby increasing or decreasing the relative drainage rate of fluid between the first body region and the second body region.
In some embodiments of the present technology, the flow control assemblies (e.g., actuation assemblies, fluid resistors, etc.) comprise at least two actuation elements coupled to a moveable element (e.g., a gating element, an arm, etc.). The moveable element can be formed to interface with (e.g., at least partially block) a lumen and/or a lumen orifice. The orifice can be an inflow orifice or an outflow orifice. In other embodiments, the moveable element can be an intermediate element between the actuation element and a flow control element that interfaces with or otherwise engages a shunt lumen or orifice. In such embodiments, movement of the moveable element can adjust a geometry of the flow control element, which in turn adjusts a size, shape, or other dimension of a shunt lumen or orifice. Movement of the actuation elements generates (e.g., translational and/or rotational) movement of the moveable element.
The actuation element(s) can include a shape memory material (e.g., a shape memory alloy, or a shape memory polymer), and movement of the actuation element(s) can be generated through applied stress and/or use of a shape memory effect (e.g., as driven by a change in temperature). The shape memory effect enables deformations that have altered an element from its preferred geometric configuration (e.g., original configuration, shape-set configuration, heat-set configuration, etc.) to be largely or entirely reversed during operation of the flow control assembly. For example, thermal actuation (heating) can reverse deformation(s) by inducing a change in state (e.g., phase change) in the actuator material, inducing a temporary elevated internal stress that promotes a shape change toward the preferred geometric configuration. For a shape memory alloy, the change in state can be from a martensitic phase (alternatively, R-phase) to an austenitic phase. For a shape memory polymer, the change in state can be via a glass transition temperature or a melting temperature. The change in state can reverse deformation(s) of the material—for example, deformation with respect to its preferred geometric configuration—without any (e.g., externally) applied stress to the actuation element. That is, a deformation that is present in the material at a first temperature (e.g., body temperature) can be (e.g., thermally) recovered and/or altered by raising the material to a second (e.g., higher) temperature. Upon cooling (and changing state, e.g., back to martensitic phase), the actuation element retains its preferred geometric configuration. With the material in this relatively cooler-temperature condition it may require a lower force or stress to thermoelastically deform the material, and any subsequently applied external stress can cause the actuation element to once again deform away from the preferred geometric configuration.
The actuation element(s) can be processed such that a transition temperature at which the change in state occurs (e.g., the austenite start temperature, the austenite final temperature, etc.) is above a threshold temperature (e.g., body temperature). For example, the transition temperature can be set to be about 45 deg. C., about 50 deg. C., about 55 deg. C., or about 60 deg. C. In some embodiments, the actuator material is heated from body temperature to a temperature above the austenite start temperature (or alternatively above the R-phase start temperature) such that an upper plateau stress (e.g., “UPS_body temperature”) of the material in a first state (e.g., thermoelastic martensitic phase, or thermoelastic R-phase at body temperature) is lower than an upper plateau stress (e.g., “UPS_actuated temperature”) of the material in a heated state (e.g., superelastic state), which achieves partial or full free recovery. For example, the actuator material can be heated such that UPS_actuated temperature>UPS_body temperature. In some embodiments, the actuator material is heated from body temperature to a temperature above the austenite start temperature (or alternatively above the R-phase start temperature) such that an upper plateau stress of the material in a first state (e.g., “thermoelastic martensite or thermoelastic R-phase at body temperature”) is lower than a lower plateau stress (e.g., “LPS”) of the material in a heated state (e.g., superelastic state), which achieves partial or full free recovery. For example, the actuator material can be aged such that LPS_activated temperature>UPS_body temperature. In some embodiments, the actuator material is heated from body temperature to a temperature above the austenite start temperature (or alternatively above the R-phase start temperature) such that an upper plateau stress of the material in a first state (e.g., thermoelastic martensite or thermoelastic R-phase) is higher than a lower plateau stress of the material in a heated state, which achieves partial free recovery. For example, the actuator material can be aged such that LPS_activated temperature<UPS_body temperature.
The flow control assembly can be formed such that the actuation elements have substantially the same preferred geometric configuration (e.g., memory shape, or length, L0). The flow control assembly can be assembled such that, upon introduction into a patient (e.g., implantation), at least one (e.g., a first) actuation element/shape memory element has been deformed with respect to its preferred geometric configuration (e.g., to have L1≠L0), while at least one other opposing (e.g., a second) actuation element/shape memory element positioned adjacent to the first actuation element is substantially at its preferred geometric configuration (e.g., L0). In other embodiments, however, both the first and second actuation elements may be deformed with respect to their corresponding preferred geometric configurations upon introduction into the patient (e.g., the first actuation element is contracted relative to its preferred geometric configuration and the second actuation element is expanded relative to its preferred geometric configuration).
In some embodiments of the present technology, L1>L0—for example, the deformed first actuation element is elongated with respect to its preferred “shape memory: length. In some embodiments, L1<L0—for example, the deformed first actuation element is compressed with respect to its preferred shape memory length. The flow control assembly can be formed such that, in operation, its overall dimension (e.g., overall length) is substantially fixed (e.g., L0+L1=a constant). For example, (e.g., outermost) ends of the actuation elements can be fixed, such that movement of the actuation elements occurs between the points of fixation. The overall geometry of the actuation elements, along with the lengths, can be selected such that, in operation, deformation within the actuation elements remains below about 10%, about 9%, about 8%, about 7%, or about 6%.
The (e.g., first and second) actuation elements are arranged such that a movement (e.g., deflection or deformation) of the first actuation element/first shape memory element is accompanied by (e.g., causes) an opposing movement of the second actuation element/second shape memory element. The movement can be a deflection or a deformation. In operation, selective heating of the first actuation element of the flow control assembly causes it to move to and/or toward its preferred geometric configuration (e.g., revert from L1 to L0), moving the coupled moveable element. At the same time, the elongation of the first actuation element is accompanied by (e.g., causes) a compression of the second actuation element (e.g., from L0 to L1). The second actuation element is not heated (e.g., remains at body temperature), and therefore the second actuation element deforms (e.g., remains martensitic and compresses). The first actuation element cools following heating, and returns to a state in which it can be plastically deformed. To reverse the configuration of the flow control assembly (e.g., the position of the moveable element), the second actuation element is heated to move to and/or toward its preferred geometric configuration (e.g., from L1 to L0). The return of the second actuation element to its preferred geometric configuration causes the moveable element to move back to its prior position, and compresses the first actuation element (e.g., from L0 to L1). The position of the moveable element for the flow control assembly can be repeatably toggled (e.g., between open and closed) by repeating the foregoing operations. The heating of an actuation element can be accomplished via application of incident energy (e.g., via a laser or inductive coupling). Further, as mentioned above, the source of the incident energy may be external to the patient (e.g., non-invasive).
Referring collectively to
The first actuation element 501 and the second actuation element 502 can be composed of a shape memory material, such as a shape memory alloy (e.g., nitinol). Accordingly, the first actuation element 501 and the second actuation element 502 can be transitionable between a first material phase or state (e.g., a martensitic material state, an R-phase material state, etc.) and a second material phase or state (e.g., an austenitic material state, an R-phase material state, etc.). In the first state, the first actuation element 501 and the second actuation element 502 may be deformable (e.g., plastic, malleable, compressible, expandable, etc.). In the second state, the first actuation element 501 and the second actuation element 502 may have a preference toward a specific preferred geometry (e.g., original geometry, manufactured geometry, heat set geometry, etc.). The first actuation element 501 and the second actuation element 502 can be transitioned between the first state and the second state by applying energy (e.g., heat) to the actuation elements to heat the actuation elements above a transition temperature. In some embodiments, the transition temperature for both the first actuation element 501 and the second actuation element 502 is above an average body temperature (e.g., an average temperature in the eye). Accordingly, both the first actuation element 501 and the second actuation element 502 are typically in the deformable first state when the flow control assembly 500 is implanted in the body until they are heated (e.g., actuated).
If an actuation element (e.g., the first actuation element 501) is deformed relative to its preferred geometry while in the first state, heating the actuation element (e.g., the first actuation element 501) above its transition temperature causes the actuation element to transition to the second state and therefore transition from the deformed shape to and/or toward its preferred geometry. Heat can be applied to the actuation elements via an energy source positioned external to the body (e.g., a laser), RF heating, resistive heating, or the like. In some embodiments, the first actuation element 501 can be selectively heated independently of the second actuation element 502, and the second actuation element 502 can be selectively heated independently of the first actuation element 501.
Referring to
The flow control assembly 500 can be repeatedly transitioned between the second configuration and the third configuration. For example, the flow control assembly 500 can be returned to the second configuration from the third configuration by heating the first actuation element 501 above its transition temperature once the second actuation element 502 has returned to the deformable first state (e.g., by allowing the second actuation element 502 to cool below the transition temperature). Heating the first actuation element 501 above its transition temperature causes the first actuation element 501 to move to and/or toward its preferred geometry, which in turn pushes the gating element 503 back toward the second anchoring element 505 and transitions the flow control assembly 500 to the second configuration (
As provided above, heat can be applied to the actuation elements via an energy source positioned external to the body (e.g., a laser), RF heating, resistive heating, or the like. In some embodiments, an external device (e.g., external device 220) directs the energy source to heat the one or more of the actuation elements based on readings from one or more sensors (e.g., sensor 210). In other embodiments, a user (e.g., a physician) operates the energy source to heat one or more of the actuation elements based on readings from one or more sensors. In some embodiments, the first actuation element 501 can be selectively heated independently of the second actuation element 502, and the second actuation element 502 can be selectively heated independently of the first actuation element 501. For example, in some embodiments, the first actuation element 501 is on a first electrical circuit and/or responds to a first frequency range for selectively and resistively heating the first actuation element 501 and the second actuation element 502 is on a second electrical circuit and/or responds to a second frequency range for selectively and resistively heating the second actuation element 502. As described in detail above, selectively heating the first actuation element 501 moves the gating element 503 in a first direction and selectively heating the second actuation element 502 moves the gating element 503 in a second direction generally opposite the first direction. The flow control assembly 500 can therefore be adjusted to achieve any of the operations described herein with respect to adjustable shunts.
As one of skill in the art will appreciate from the disclosure herein, various components of the shunting systems and devices described herein can be omitted without deviating from the scope of the present technology. Likewise, additional components not explicitly described above may be added to the systems and devices described herein without deviating from the scope of the present technology. Accordingly, the present technology is not limited to those the configurations expressly identified herein, but rather encompasses variations and alterations of the described embodiments.
E. Examples
Several aspects of the present technology are set forth in the following examples:
1. A method of manufacturing an adjustable flow shunt having a shunt and a flow control assembly, the method comprising:
2. The method of example 1 wherein the anchoring element includes a notch, and wherein securing the second end portion of the actuation element to the anchoring element comprises positioning the second end portion of the actuation element into the notch.
3. The method of example 1 wherein securing the second end portion of the actuation element to the anchoring element comprises welding or bonding the second end portion of the actuation element to the anchoring element.
4. The method of any of examples 1-3 wherein securing the second end portion of the actuation element to the anchoring element includes at least partially deforming the actuation element relative to its fabricated geometry.
5. The method of example 4 wherein at least partially deforming the actuation element relative to its fabricated geometry includes prestressing and/or prestraining the actuation element.
6. The method of example 4 or 5 wherein at least partially deforming the actuation element includes compressing the actuation element.
7. The method of example 4 or 5 wherein at least partially deforming the actuation element includes lengthening the actuation element.
8. The method of any of examples 1-7 wherein fabricating the structure corresponding to the flow control assembly from the single piece of material includes laser cutting the structure from the single piece of material.
9. The method of any of examples 1-8 wherein the single piece of material is a sheet of nitinol and/or a strip of nitinol.
10. The method of any of examples 1-9 wherein the actuation element is a first actuation element, and wherein the structure further includes a second actuation element that, after the fabricating step, has a first end portion coupled to the anchoring element and a second end portion coupled to the gating element.
11. The method of example 10 wherein securing the second end portion of the first actuation element to the anchoring element includes at least partially deforming both the first actuation element and the second actuation element relative to their fabricated geometries.
12. The method of any of examples 1-11, further comprising biasing the actuation element before coupling the assembled flow control assembly to the shunt.
13. The method of any of examples 1-12 wherein coupling the assembled flow control assembly to the shunt includes positioning the flow control assembly within a frame.
14. A method of manufacturing a flow control assembly for use with an implantable medical device, the method comprising:
15. The method of example 14 wherein securing the free end of the actuation element to the anchoring element includes compressing the actuation element.
16. The method of example 14 wherein securing the free end of the actuation element to the anchoring element includes lengthening the actuation element.
17. The method of example 14 wherein the first geometry has a greater length than the second geometry.
18. The method of example 14 wherein the first geometry has a shorter length than the second geometry.
19. The method of any of examples 14-18 wherein the actuation element is a first actuation element, and wherein the unitary structure further includes a second actuation element that, once cut from the sheet and/or strip of nitinol, has a third geometry.
20. The method of example 19 wherein the third geometry is different than the first geometry.
21. The method of example 19 wherein the third geometry is the same as the first geometry.
22. The method of any of examples 19-21 wherein securing the free end of the actuation element to the anchoring element at least partially deforms the second actuation element such that it has a fourth geometry different than the third geometry.
23. The method of example 22 wherein the fourth geometry is different than the second geometry.
24. The method of example 22 wherein the fourth geometry is the same as the second geometry.
23. A method of manufacturing a flow control assembly for use with an implantable medical device, comprising:
24. The method of example 23 wherein securing the free end of the actuation element to the anchoring element includes prestressing and/or prestraining the actuation element.
25. The method of example 23 or 24 wherein securing the free end of the actuation element to the anchoring element includes compressing the actuation element.
26. The method of example 23 or 24 wherein securing the free end of the actuation element to the anchoring element includes lengthening the actuation element.
27. The method of any of examples 23-26 wherein the actuation element is a first actuation element, and wherein the unitary structure further includes a second actuation element that, once fabricated, has a third geometry.
28. The method example 27 wherein securing the free end of the actuation element to the anchoring element at least partially deforms the second actuation element such that it has a fourth geometry different than the third geometry.
29. An adjustable flow shunt for treatment of glaucoma in a patient, the adjustable flow shunt comprising:
30. The adjustable flow shunt of example 29 wherein the actuation element is a first actuation element, and wherein the flow control assembly further includes a second actuation element, wherein the second actuation element is composed of a shape memory material and is configured to transition the gating element from the second position to and/or toward the first position.
31. The adjustable flow shunt of example 29 or 30 wherein the flow control assembly further includes an anchoring element designed to conform to a portion of the interior chamber to thereby secure the flow control assembly within the interior chamber.
32. The adjustable flow shunt of example 31 wherein the actuation element, the gating element, and the anchoring element form a unitary structure formed from a single sheet of material.
33. The adjustable flow shunt of any of examples 29-32 wherein the lumen has a rectangular cross-sectional shape.
34. The adjustable flow shunt of any of examples 29-33 wherein the frame has a longitudinal cross-sectional dimension of less than about 100 μm.
35. The adjustable flow shunt of any of examples 29-33 wherein the frame has a longitudinal cross-sectional dimension of less than about 80 μm.
36. The adjustable flow shunt of any of examples 29-33 wherein the frame has a longitudinal cross-sectional dimension of less than about 60 μm.
37. The adjustable flow shunt of any of examples 29-36 wherein the bladder portion includes a first longitudinal axis extending therethrough and the elongated portion includes a second longitudinal axis extending therethrough, and wherein the first longitudinal axis is not parallel to the second longitudinal axis.
38. The adjustable flow shunt of example 37 wherein the first longitudinal axis and the second longitudinal axis form an angle between about 90 degrees and about 180 degrees.
39. The adjustable flow shunt of any of examples 29-38 wherein the flow control assembly is at least partially composed of nitinol.
40. The adjustable flow shunt of any of examples 29-39 wherein the bladder portion includes a plurality of holes.
Conclusion
The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, any of the features of the adjustable flow shunts described herein may be combined with any of the features of the other adjustable flow shunts described herein and vice versa. Moreover, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.
From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions associated with adjustable flow shunts have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.
Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
This application is a 35 U.S.C. § 371 U.S. National Phase application of International Patent Application No. PCT/US2020/055141, filed Oct. 9, 2020, and titled ADJUSTABLE FLOW GLAUCOMA SHUNTS AND ASSOCIATED SYSTEMS AND METHODS, which claims priority to the following provisional patent applications: U.S. Provisional Patent Application No. 62/913,703, filed Oct. 10, 2019; and U.S. Provisional Patent Application No. 62/937,667, filed Nov. 19, 2019.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2020/055141 | 10/9/2020 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2021/072315 | 4/15/2021 | WO | A |
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| WO2021007296 | Jan 2021 | WO |
| WO2021028703 | Feb 2021 | WO |
| WO2021068078 | Apr 2021 | WO |
| WO2021072315 | Apr 2021 | WO |
| WO2021072317 | Apr 2021 | WO |
| WO2021113730 | Jun 2021 | WO |
| WO2021142255 | Jul 2021 | WO |
| WO2021151007 | Jul 2021 | WO |
| WO2021163566 | Aug 2021 | WO |
| WO2021168130 | Aug 2021 | WO |
| WO2021174298 | Sep 2021 | WO |
| WO2021176332 | Sep 2021 | WO |
| WO2021188952 | Sep 2021 | WO |
| WO2021204312 | Oct 2021 | WO |
| WO 2021212007 | Oct 2021 | WO |
| WO2021230887 | Nov 2021 | WO |
| 201708295 | May 2020 | ZA |
| Entry |
|---|
| International Search Report and Written Opinion received for PCT Application No. PCT/US20/55141, filed on Oct. 9, 2020, Applicant: Shifamed Holdings, LLC, dated Jan. 29, 2021, 11 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US18/43158, filed on Jul. 20, 2018, Applicant: Shifamed Holdings, LLC, dated Nov. 23, 2018, 12 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US20/41159, filed on Jul. 8, 2020, Applicant: Shifamed Holdings, LLC, dated Oct. 28, 2020, 13 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US20/41152, filed on Jul. 8, 2020, Applicant: Shifamed Holdings, LLC, dated Oct. 28, 2020, 13 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US20/14186, filed on Jan. 17, 2020, Applicant: Shifamed Holdings, LLC, dated Jun. 4, 2020, 13 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US21/14774, filed on Jan. 22, 2021, Applicant: Shifamed Holdings, LLC, dated May 12, 2021, 10 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US21/17962, filed on Feb. 12, 2021, Applicant: Shifamed Holdings, LLC, dated Jun. 7, 2021, 12 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US21/23238, filed on Mar. 19, 2021, Applicant: Shifamed Holdings, LLC, dated Jul. 8, 2021, 10 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US21/18601, filed on Feb. 18, 2021, Applicant: Shifamed Holdings, LLC, dated Jul. 19, 2021, 12 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US21/27742, filed on Apr. 16, 2021, Applicant: Shifamed Holdings, LLC, dated Oct. 7, 2021, 13 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US21/47013, filed on Aug. 20, 2021, Applicant: Shifamed Holdings, LLC, dated Nov. 26, 2021, 28 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US21/49140, filed on Sep. 3, 2021, Applicant: Shifamed Holdings, LLC, dated Dec. 7, 2021, 22 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US21/55258, filed on Oct. 15, 2021, Applicant: Shifamed Holdings, LLC, dated Feb. 28, 2022, 18 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US22/13336, filed on Jan. 21, 2022, Applicant: Shifamed Holdings, LLC, dated Apr. 11, 2022, 9 pages. |
| International Search Report and Written Opinion received for PCT Application No. PCT/US20/55144, filed on Oct. 9, 2020, Applicant: Shifamed Holdings, LLC, dated Feb. 1, 2021, 16 pages. |
| Number | Date | Country | |
|---|---|---|---|
| 20220339035 A1 | Oct 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62937667 | Nov 2019 | US | |
| 62913703 | Oct 2019 | US |
