Fluid shunt devices and methods

Abstract

A glaucoma shunt device (100) for draining fluid from an eye is provided. The glaucoma shunt device includes a primary tube (102), a secondary tube (104), and a shunt body (106). The primary tube has a primary proximal end (108), a primary distal end (110), and a primary conduit (112) extending therebetween. The secondary tube has a secondary proximal end (114), a secondary distal end (116), and a secondary conduit (118) extending therebetween. The secondary tube is inserted at least partially through the primary conduit via the primary distal end. The secondary tube defines a flow resistance for the primary and secondary tubes. The shunt body has a reservoir therein and is integrated with the primary tube near the primary distal end, such that the primary and secondary conduits are fluidly coupled to the reservoir.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 324,777, filed March 29, 2022, which is incorporated herein by reference in its entirety for all purposes.

[0002] Field of Disclosure The present disclosure relates generally to devices and methods for draining bodily fluids and diverting the fluids to be reabsorbed elsewhere in the body. More particularly, the present disclosure relates to devices and methods for draining aqueous humor from the anterior chamber of a patient's eye so that it can be reabsorbed into the body. [Background technology]

[0003] background Various medical interventions involve draining excess fluid from one part of the body and redirecting it to another part of the body where it can be reabsorbed. In certain cases, this drainage is achieved through minimally invasive procedures such as endoscopic third ventriculostomy (ETV) and choroid plexus ablation (CPC). In other cases, this drainage is achieved postoperatively through implantable medical devices such as shunts. Various forms of shunts have proven useful in a variety of medical procedures and have been used to treat many diseases, such as hydrocephalus and glaucoma.

[0004] If left untreated, excess fluid can lead to an unhealthy buildup of pressure. For example, glaucoma is a progressive eye disease characterized by elevated intraocular pressure. Aqueous humor is the fluid that fills the anterior chamber (AC) of the eye and contributes to intraocular, or intraocular, pressure. This elevated intraocular pressure usually occurs because an insufficient amount of aqueous humor is absorbed by the body. In some cases, aqueous humor is not absorbed quickly enough or at all, while in other cases, aqueous humor may additionally or alternatively be produced too rapidly. Elevated intraocular pressure is associated with gradual, and sometimes permanent, loss of vision in the affected eye.

[0005] Various attempts have been made to treat glaucoma, including devices that are relatively bulky, inflexible, and poorly adaptable, lacking the ability to securely anchor to surrounding tissue and resulting in relative device-to-tissue movement. This movement can continually irritate the surrounding tissue and cause discomfort at the implant site. The discomfort can increase a chronic inflammatory tissue response, leading to excessive scarring at the device site and increasing the risk of device erosion due to conjunctivitis and endophthalmitis. Scar tissue can effectively prevent aqueous humor reabsorption without erosion, interfering with device function. Summary of the Invention

[0006] Abstract Disclosed herein are shunt devices for draining fluid from the eye to tissue surrounding the eye, as well as methods for forming shunt devices that are at least partially implantable within the tissue of the eye, and methods for using the shunt devices to treat glaucoma.

[0007] According to one example ("Example 1"), a glaucoma shunt device for draining fluid from an eye is provided, the glaucoma shunt device including a primary tube, a secondary tube, and a shunt body. The primary tube has a primary proximal end, a primary distal end, and a primary conduit extending therebetween. The secondary tube has a secondary proximal end, a secondary distal end, and a secondary conduit extending therebetween. The secondary tube is at least partially inserted into the primary conduit via the primary distal end. The secondary tube defines a flow resistance for the primary and secondary tubes. The shunt body has an internal reservoir and is integrated with the primary tube near the primary distal end, and the primary and secondary conduits are fluidly coupled to the reservoir.

[0008] In addition to Example 1, according to another example ("Example 2"), the secondary tube is permanently attached to the primary tube.

[0009] In addition to Example 2, according to another example ("Example 3"), permanent attachment is facilitated by an adhesive disposed between the exterior surface of the secondary tube and the interior surface of the primary conduit.

[0010] In addition to Example 2, according to another example ("Example 4"), permanent attachment is facilitated by a friction fit between the exterior surface of the secondary tube and the interior surface of the primary conduit.

[0011] According to another example ("Example 5"), in addition to any one of the previous examples, the secondary distal end extends distally beyond the primary distal end and into the reservoir.

[0012] According to another example ("Example 6") in addition to any one of Examples 1-4, the shunt body includes a neck portion at which the primary tube is attached to the shunt body.

[0013] In addition to Example 6, according to another example ("Example 7"), the primary distal end and the secondary distal end are both located at the neck portion of the shunt body.

[0014] In addition to Example 6, according to another example ("Example 8"), the primary distal end is positioned at the neck portion of the shunt body and the secondary distal end is positioned proximal to the neck portion.

[0015] In addition to Example 6, according to another example ("Example 9"), the primary distal end extends distally beyond the neck portion of the shunt body into the reservoir, and the secondary distal end is disposed at the neck portion.

[0016] In addition to Example 6, according to another example ("Example 10"), the primary distal end extends distally beyond the neck portion of the shunt body into the reservoir, and the secondary distal end is positioned proximally relative to the neck portion.

[0017] In addition to Example 6, according to another example ("Example 11"), the secondary tube is positioned entirely at or within the neck portion.

[0018] In addition to any of the previous examples, according to another example ("Example 12"), the primary tube is permanently attached to the shunt body at or near the primary distal end.

[0019] According to another example ("Example 13"), in addition to any one of the previous examples, the primary proximal end extends a predetermined length proximally beyond the secondary proximal end to define a trimmable portion of the primary tube. The entire length of the primary tube defines a first state in which the primary tube and secondary tube are combined untrimmed, and further defines a second state in which the primary tube and secondary tube are combined trimmed to a shorter length of the trimmable portion. Both the first state and the second state have the same flow resistance.

[0020] In addition to Example 13, according to another example ("Example 14"), the secondary conduit maintains a constant flow rate therethrough before and after the primary tube is shortened.

[0021] In addition to any of the previous examples, according to another example ("Example 15"), the secondary conduit has a smaller diameter than the primary conduit such that the diameter of the secondary conduit is the primary determinant of the flow resistance of fluid entering the reservoir.

[0022] In addition to any of the previous examples, according to another example ("Example 16"), the length of the secondary conduit is a secondary determinant of the flow resistance of fluid entering the reservoir.

[0023] According to one example ("Example 17"), a glaucoma shunt device for draining fluid from an eye includes tubing and a shunt body. The tubing includes a primary section with a primary conduit and a secondary section with a secondary conduit. The primary conduit has a primary diameter that is larger than a secondary diameter of the secondary conduit. The primary section is disposed proximal to the secondary section. The secondary conduit has a flow resistance. The shunt body has an internal reservoir and is integrated with the tubing at the secondary section, whereby the primary conduit and the secondary conduit are fluidly coupled to the reservoir.

[0024] In addition to Example 17, according to another example ("Example 18"), a portion of the secondary portion extends distally into the reservoir.

[0025] In addition to Example 18, according to another example ("Example 19"), the shunt body includes a neck portion at which the tubing is attached to the shunt body.

[0026] In addition to Example 19, according to another example ("Example 20"), the distal end of the tube is disposed in the neck portion of the shunt body.

[0027] In addition to Example 19, according to another example ("Example 21"), the secondary section of the tube is located entirely at or within the neck portion.

[0028] In addition to Example 18, according to another example ("Example 22"), the tube includes a proximal primary portion disposed proximally relative to the secondary portion and partially defining the primary conduit, a distal primary portion disposed distally relative to the secondary portion and partially defining the primary conduit, a first transition portion disposed between the proximal primary portion and the secondary portion, and a second transition portion disposed between the distal primary portion and the secondary portion.

[0029] In addition to Example 22, according to another example ("Example 23"), the distal end of the tube is positioned at the neck portion of the shunt body, and the first transition portion and the second transition portion are both positioned proximal to the neck portion.

[0030] In addition to Example 22, according to another example ("Example 24"), the distal end of the tube extends distally beyond the neck portion of the shunt body into the reservoir, the second transition portion is positioned at the neck portion, and the first transition portion is positioned proximally relative to the neck portion.

[0031] In addition to Example 22, according to another example ("Example 25"), the distal end of the tube extends distally beyond the neck portion of the shunt body into the reservoir, and both the first transition portion and the second transition portion are positioned proximal to the neck portion.

[0032] In addition to any one of Examples 17 to 25, according to another example ("Example 26"), the primary portion extends a predetermined length proximally relative to the secondary portion, and by cutting the primary portion of the tube along the portion that extends proximally beyond the secondary portion, the overall length of the tube can be shortened without affecting the flow resistance of the secondary conduit.

[0033] In addition to Example 26, according to another example ("Example 27"), the secondary conduit maintains a constant flow rate therethrough before and after the primary portion of the tube is shortened.

[0034] According to another example ("Example 28") in addition to any one of Examples 17-27, the secondary conduit has a smaller diameter than the primary conduit such that the diameter of the secondary conduit is the primary determinant of the flow resistance of fluid entering the reservoir.

[0035] According to any one of Examples 17-28 and another Example ("Example 29"), the length of the secondary conduit is a secondary determinant of the flow resistance of fluid entering the reservoir.

[0036] According to one example ("Example 30"), a method of forming a drainage device at least partially implantable within ocular tissue is disclosed. The method includes forming a shunt body having a reservoir defined therein, the reservoir configured to receive and accumulate bodily fluid; preparing a primary tube having a primary proximal end, a primary distal end, and a primary conduit extending therebetween; and a secondary tube having a secondary proximal end, a secondary distal end, and a secondary conduit extending therebetween, the secondary conduit having a flow resistance; inserting the secondary tube through the primary conduit, at least in part, via the primary distal end; and integrating the shunt body with the primary tube near the primary distal end such that the primary conduit and the secondary conduit are fluidly coupled to the reservoir and the primary proximal end of the primary tube is deliverable into the eye to facilitate drainage of bodily fluid into the primary conduit.

[0037] In addition to Example 30, according to another example ("Example 31"), the method includes permanently attaching the secondary tube to the primary tube.

[0038] In addition to Example 31, according to another example ("Example 32"), the method includes disposing an adhesive between an outer surface of the secondary tube and an inner surface of the primary conduit before inserting the secondary tube at least partially through the primary conduit via the primary distal end.

[0039] According to another example ("Example 33") in addition to any one of Examples 30-32, the method includes positioning the secondary distal end to extend distally beyond the primary distal end into the reservoir.

[0040] According to another example ("Example 34") in addition to any one of Examples 30-33, the method includes permanently attaching the primary tube to the shunt body at or near the primary distal end.

[0041] According to another example ("Example 35") in addition to any one of Examples 30-34, the method includes positioning the primary proximal end to extend proximally beyond the secondary proximal end by a predetermined length such that the overall length of the primary tube can be shortened without affecting the flow resistance of the secondary conduit by cutting the primary tube along a portion that extends proximally beyond the secondary tube.

[0042] In addition to Example 35, according to another example ("Example 36"), the method includes maintaining a constant flow rate through the secondary conduit before and after shortening the primary tube by the secondary conduit.

[0043] According to another example ("Example 37") in addition to any one of Examples 30-36, the method includes forming the secondary tube such that the secondary conduit has a smaller diameter than the primary conduit, and the diameter of the secondary conduit is a primary determinant of flow resistance of fluid entering the reservoir.

[0044] According to another example ("Example 38") in addition to any one of Examples 30-37, the length of the secondary conduit is a secondary determinant of the flow resistance of fluid entering the reservoir.

[0045] According to one example ("Example 39"), a method of forming a drainage device at least partially implantable within ocular tissue is disclosed. The method includes forming a shunt body having a reservoir defined therein, the reservoir configured to receive and accumulate bodily fluid; preparing tubing having a primary portion with a primary conduit and a secondary portion with a secondary conduit, the primary conduit having a primary diameter larger than a secondary diameter of the secondary conduit, the primary portion being positioned proximal to the secondary portion, the secondary conduit having a flow resistance; and integrating the shunt body with the tubing at the secondary portion such that the primary and secondary conduits are fluidly coupled to the reservoir, the primary portion of the primary tubing being deliverable into the eye and facilitating drainage of bodily fluid into the primary conduit.

[0046] In addition to Example 39, according to another example ("Example 40"), the method includes extending the secondary portion of the tube distally at least partially into the reservoir.

[0047] In addition to Example 39 or 40, according to another example ("Example 41"), the method includes forming a tube such that the primary portion extends a predetermined length proximally relative to the secondary portion, and cutting the primary portion of the tube along a portion that extends proximally beyond the secondary portion, thereby allowing the overall length of the primary portion to be shortened without affecting the flow resistance of the secondary conduit.

[0048] In addition to Example 41, according to another example ("Example 42"), the method includes maintaining a constant flow rate through the secondary conduit before and after shortening the primary section of the tube by the secondary section.

[0049] According to another example ("Example 43") in addition to any one of Examples 39-42, the method includes forming a tube such that the secondary conduit has a smaller diameter than the primary conduit, and such that the diameter of the secondary conduit is a primary determinant of flow resistance of fluid entering the reservoir.

[0050] According to another example ("Example 44") in addition to any one of Examples 39-43, the length of the secondary conduit is a secondary determinant of the flow resistance of fluid entering the reservoir.

[0051] According to one example ("Example 45"), a method of draining bodily fluid from a human eye through tubing extending from a glaucoma shunt body is disclosed, the tubing having a proximal tube end positioned within the human eye to receive the bodily fluid and a distal tube end engaging the glaucoma shunt body to fluidly connect the proximal tube end to a reservoir positioned within the glaucoma shunt body. The method includes flowing bodily fluid through the tubing with a first flow resistance at the proximal tube end, flowing bodily fluid through the tubing with a second flow resistance between the proximal tube end and the distal tube end, where the second flow resistance is greater than the first flow resistance, and flowing the bodily fluid from the distal tube end to the reservoir.

[0052] According to one example ("Example 46"), a method for reducing fluid pressure within a human eye to reduce the risk of intraocular hypotony is disclosed. The method includes directing fluid within the eye toward a proximal end of a tube having a first flow resistance, subsequently directing the fluid toward a portion of the tube having a second flow resistance greater than the first flow resistance, and subsequently directing the fluid from the distal end of the tube into a reservoir.

[0053] In addition to Example 45 or 46, according to another example ("Example 47"), the method includes trimming the proximal end of the tube to shorten the length of the tube while maintaining the second flow resistance.

[0054] According to another example ("Example 48") in addition to any one of Examples 45-47, the first flow resistance and the second flow resistance define a composite tube flow resistance, and the method includes trimming the tube proximal end to shorten the length of the tube while maintaining the composite tube flow resistance.

[0055] According to another example ("Example 49") in addition to any one of Examples 45-48, the distal end of the tube is positioned to extend into the reservoir.

[0056] According to another example ("Example 50") in addition to any one of Examples 45-49, the method includes, immediately after directing a fluid to a portion of the tube having a second flow resistance, subsequently directing the fluid to another portion of the tube having a third flow resistance less than the second flow resistance.

[0057] According to one example ("Example 51"), a method for reducing fluid pressure within a human eye to reduce the risk of intraocular hypotony is disclosed. The method includes directing intraocular fluid through a proximal end of a tube into a reservoir positioned at a different location relative to the proximal end of the tube. Between the proximal end of the tube and a distal end of the tube positioned adjacent the reservoir, the flow resistance of the tube is increased to restrict flow through the tube sufficiently to reduce the risk of intraocular hypotony. The increased flow resistance occurs between the proximal end of the tube and the distal end of the tube.

[0058] In addition to Example 51, according to another example ("Example 52"), the method includes trimming the proximal end of the tube to shorten the length of the tube while maintaining flow resistance.

[0059] In addition to Example 51 or 52, according to another example ("Example 53"), the distal end of the tube is positioned to extend into the reservoir.

[0060] According to another example ("Example 54") in addition to any one of Examples 51 to 53, the flow resistance decreases between the increase in flow resistance and the distal end of the tube.

[0061] The foregoing examples are exemplary only and should not be construed as limiting or narrowing the scope of any of the inventive concepts otherwise provided by this disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. [Brief explanation of the drawings]

[0062] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated in and constitute a part of this specification, illustrating embodiments and, together with the description, serve to explain the principles of the disclosure.

[0063] [Figure 1A] FIG. 1A is a cross-sectional view of a glaucoma shunt device with a tube according to an embodiment disclosed herein.

[0064] [Figure 1B] FIG. 1B is a side view of the glaucoma shunt device of FIG. 1A viewed from one end (proximal end) of the tube extending from the glaucoma shunt device.

[0065] [Figure 1C] FIG. 1C is a cross-sectional side view of an eye having a shunt device implanted therein consistent with various aspects of the present disclosure.

[0066] [Figure 1D] FIG. 1D is a cross-sectional view of a portion of a tube extending from a glaucoma shunt device according to an embodiment disclosed herein.

[0067] [Figure 1E] FIG. 1E is a cross-sectional view of a portion of a tube extending from a glaucoma shunt device according to another embodiment disclosed herein.

[0068] [Figure 2] FIG. 2 is a cross-sectional view of various glaucoma shunt devices with tubing according to different embodiments disclosed herein. [Figure 3] FIG. 3 is a cross-sectional view of various glaucoma shunt devices with tubing according to different embodiments disclosed herein. [Figure 4] FIG. 4 is a cross-sectional view of various glaucoma shunt devices with tubes according to different embodiments disclosed herein. [Figure 5] FIG. 5 is a cross-sectional view of various glaucoma shunt devices with tubes according to different embodiments disclosed herein. [Figure 6] FIG. 6 is a cross-sectional view of various glaucoma shunt devices with tubing according to different embodiments disclosed herein. [Figure 7] FIG. 7 is a cross-sectional view of various glaucoma shunt devices with tubes according to different embodiments disclosed herein.

[0069] [Figure 8A] FIG. 8A is a cross-sectional view of a glaucoma shunt device with a tube according to an embodiment disclosed herein.

[0070] [Figure 8B] FIG. 8B is a side view of the glaucoma shunt device of FIG. 8A viewed from one end (proximal end) of the tube extending from the glaucoma shunt device.

[0071] [Figure 9] FIG. 9 is a cross-sectional view of various glaucoma shunt devices, each with a tube, according to various embodiments disclosed herein. [Figure 10] FIG. 10 is a cross-sectional view of various glaucoma shunt devices, each with a tube, according to various embodiments disclosed herein. [Figure 11] FIG. 11 is a cross-sectional view of various glaucoma shunt devices, each with a tube, according to various embodiments disclosed herein. [Figure 12] FIG. 12 is a cross-sectional view of various glaucoma shunt devices, each with a tube, according to various embodiments disclosed herein. [Figure 13] FIG. 13 is a cross-sectional view of various glaucoma shunt devices, each with a tube, according to various embodiments disclosed herein.

[0072] [Figure 14]14A and 14B are cross-sectional views of a portion of a tube showing a transition portion thereof, according to various embodiments disclosed herein.

[0073] It should be understood that the drawings and photographic reproductions are not necessarily to scale. In certain instances, details that are not necessary for understanding the disclosure or that make other details difficult to perceive may have been omitted. Of course, it should be understood that the disclosure is not necessarily limited to the specific examples or embodiments shown or depicted herein. DETAILED DESCRIPTION OF THE INVENTION

[0074] Detailed Description Definitions and Terminology This disclosure is not to be construed in a limiting sense. For example, the terms used in this application should be interpreted broadly in the context of the meaning that one of ordinary skill in the art would give such terms.

[0075] With respect to the term imprecision, the terms "about" and "approximately" may be used interchangeably to refer to a stated measurement, including measurements that are reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount, as understood and easily ascertained by one of ordinary skill in the relevant art. Such deviations may result from, for example, measurement error, differences in calibration of measuring and / or manufacturing equipment, human error in reading and / or setting measurements, small adjustments made to optimize performance and / or structural parameters to account for differences in measurements associated with other components, specific implementation scenarios, imprecise adjustment and / or manipulation of objects by humans or machines, and / or the like. In cases where it is determined that a person of ordinary skill in the art would not be able to readily identify the value of such a reasonably small difference, the terms "about" and "approximately" may be understood to mean plus or minus 10% of the stated value.

[0076] The words "at least one," "one or more," and "and / or" are open-ended expressions that function as both conjunctions and disjunctions. For example, the expressions "at least one of A, B, and C," "at least one of A, B, or C," "one or more of A, B, and C," "one or more of A, B, or C," and "A, B, and / or C" mean A only, B only, C only, a combination of A and B, a combination of A and C, a combination of B and C, or a combination of A, B, and C, respectively. Each of A, B, and C in the above expressions can be an element such as X, Y, or Z, or X1-X. n , Y1-Y m , Z -Z o When referring to a class of elements such as X, Y, and Z, the phrase includes a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., X1 and X2), and a combination of elements selected from two or more classes (e.g., Y1 and Z). o ) is intended to refer to

[0077] It is to be understood that every maximum numerical limitation given throughout this disclosure is to be deemed to include, in the alternative, every lower numerical limitation, as if such lower numerical limitations were expressly written herein. Every minimum numerical limitation given throughout this disclosure is to be deemed to include, in the alternative, every higher numerical limitation, as if such higher numerical limitations were expressly written herein. Every numerical range given throughout this disclosure is to be deemed to include every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0078] Before describing embodiments of the present disclosure in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangements of components set forth in the following description or illustrated in the following drawings. The disclosure is capable of other embodiments and of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," "having," and variations thereof herein is intended to encompass the items listed thereafter and equivalents thereof, as well as additional items.

[0079] Description of Various Embodiments Various embodiments address shunts that can be implanted in the eye to drain such fluids from the AC of the eye and provide a means to avoid or prevent intraocular hypotony. However, such shunts only define a lumen for redirecting fluid from the AC to another location where the pressure is lower than the AC, and therefore do not include components that redirect fluid flow after the fluid leaves the AC. That is, the shunt does not include components that contain the fluid when it arrives at its destination (where the pressure is lower than the AC).

[0080] Furthermore, such shunts only provide an initial flow restriction during the shunt implantation procedure. Using a dissolvable plug section, the shunt provides an initial outflow resistance to avoid low intraocular pressure and hypotony early after surgery, and then increases flow over time by reducing outflow resistance to compensate for the increased biological outflow resistance after surgery is complete. Thus, the shunt does not provide a long-term means of avoiding or preventing hypotony in the eye.

[0081] Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0082] Various features of the devices and methods disclosed herein can be seen in the figures. Various aspects of the present disclosure relate to bodily fluid drainage devices and methods. For example, the present disclosure deals with devices and methods for draining aqueous humor from the anterior chamber (AC) of a patient's eye 10 (FIG. 1C) so that the aqueous humor can be reabsorbed elsewhere in the body.

[0083] 1C is a diagram of an eye 10 having a subconjunctival space 11 between the conjunctiva 13 and the sclera 15 of the eye 10. A drainage system including a drainage or shunt device 100 according to the principles of the present invention is implanted within the eye 10. Embodiments of the present disclosure provide a mechanism for reabsorbing aqueous humor drained from the AC of the eye 10 to reduce or stabilize intraocular pressure. However, one skilled in the art will appreciate that embodiments of the present disclosure are also useful in other applications where drainage of fluid for redirection within the body is desired.

[0084] 1A and 2-7 illustrate various features of a shunt or glaucoma drainage device 100 for treating glaucoma, according to some embodiments. The shunt device 100 is an implantable device that, when at least partially implanted within ocular tissue, can be used to drain fluid from the eye to surrounding tissue. The shunt device 100 includes a primary tube 102 having a first length L1 (also referred to as the "total length" or "untrimmed length" when referring to the length of the tube before it is trimmed), a secondary tube 104 having a second length L2, and a shunt body 106. The primary tube has a primary proximal end 108, a primary distal end 110, and a primary conduit 112 extending between the two ends. The secondary tube 104 has a secondary proximal end 114, a secondary distal end 116, and a secondary conduit 118 extending between the two ends. The shunt body 106 includes a reservoir 120 therein. The shunt body 106 is integrated with the primary tubing 102 near the primary distal end 110 such that the primary conduit 112 and the secondary conduit 118 are fluidly coupled to a reservoir 120 .

[0085] It should be understood that the terms "proximal" and "distal" are used hereinafter from the perspective of a physician or surgeon implanting a shunt device into the tissue of a patient's eye. In various examples, the shunt device is implanted by inserting an end of the shunt body into an incision made in the tissue of the eye, after which the opposite end of the tubing is inserted into another portion of the eye, such as the AC, to drain fluid therefrom. For this reason, the shunt body is sometimes referred to as being more distal from the practitioner relative to the end of the tubing that protrudes from the shunt body.

[0086] 1D and 1E, the secondary tube 104 is inserted at least partially through the primary conduit 112 via the primary distal end 110. As shown in FIG. 1B, when viewed from the primary proximal end 108, the secondary conduit defined by the secondary tube 104 is observed to have a narrower diameter or D2 than the primary conduit 112 defined by the primary tube 102, which has an inner diameter D1. In this manner, the secondary tube 104 defines the flow resistance of both the primary and secondary tubes.

[0087] Upon implantation into ocular tissue, fluid from the environment flows from the primary proximal end 108 into the primary conduit 112, passes through the primary conduit 112, then through the secondary conduit 118, and finally exits the tube via the secondary distal end 116, as shown by the dashed arrows depicted in FIG. 1A. Because the outlet (secondary distal end 116, diameter D2) has a smaller conduit diameter than the inlet (primary proximal end 108, diameter D1), resistance to fluid flow through the tube and into the reservoir 120 is primarily determined by the smaller diameter D2 of the secondary conduit 118. Thus, the diameter of the secondary conduit is a primary determinant of the flow resistance of fluid entering the reservoir. In some instances, the length (L2) of the secondary conduit can be a secondary determinant of the flow resistance of fluid entering the reservoir. The determined flow resistance is maintained both during and after implantation of the shunt device 100, so that the flow resistance remains substantially constant throughout the use of the shunt device.

[0088] The first-order determinants are defined as those that have a greater influence on determining the value of flow resistance than the second-order determinants. Such determinants are defined by taking into account the Hagen-Poiseuille equation.

number

[0089] In some examples, the secondary tube 104 is permanently attached to the primary tube 102. As shown in Figures 1D and 1E, the permanent attachment between the secondary tube 104 and the primary tube 102 includes an attachment between an outer surface 130 of the secondary tube 104 and an inner surface 132 of the primary conduit 112 or the primary tube 102. In Figure 1D, the two tubes can be permanently attached (by a friction fit) solely through friction between the outer surface 130 and the inner surface 132. In Figure 1E, another component, such as any suitable adhesive 134, such as an adhesive polymer material, can be disposed between the outer surface 130 and the inner surface 132 to facilitate the permanent attachment. Once permanently attached, the tubes 102 and 104 are prevented from sliding relative to one another.

[0090] In some embodiments, the primary tube 102 has a portion that does not overlap with the secondary tube 104, which is referred to as the trimmable portion 122. The trimmable portion 122 extends proximally relative to the secondary proximal end 114 and is so named because the length of the primary tube 102 can be adjusted by trimming or cutting the primary tube at the trimmable portion without affecting the flow resistance of the tube. In various examples, regardless of where along the trimmable portion 122 the primary tube 102 is cut or trimmed to shorten the primary tube length L1, the resulting tube (with the shorter length L1) has the same flow resistance as before it was cut or trimmed. In some examples, the secondary conduit maintains a constant flow rate therethrough before and after the primary tube is shortened.

[0091] As shown, the shunt body 106 includes, in addition to the reservoir 120, a neck portion 124, which is the portion of the shunt body 106 that contacts the primary tube 102. The neck portion 124 can be a portion of the shunt body 106 that extends proximally a predetermined distance. In some examples, the neck portion 124 can be a continuous, elongated rectangular extension from the shunt body 106. The neck portion 124 can have a width and length sufficient to provide structural support to the primary tube 102, which is at least partially secured or attached to the neck portion 124. The primary tube 102 can be attached to the neck portion 124 in one of a variety of configurations, as described herein with respect to FIGS. 1A and 2-7.

[0092] 1A , the primary tube 102 is attached to the neck portion 124 such that the primary distal end 110 of the primary tube is located in the neck portion. That is, the primary distal end of the primary tube is located between the proximal end 126 and the distal end 128 of the neck portion. The neck portion has a length (Ln) defined by the proximal end 126 and the distal end 128, and the primary distal end 110 is located within this length. The secondary distal end 116 extends distally relative to the primary distal end 110, and the secondary distal end extends into and is located within the reservoir 120 to facilitate fluid flow into the reservoir 120, as indicated by the dotted arrow extending from the secondary distal end. The secondary proximal end 114 of the secondary tube 104 is located proximally relative to the neck portion 124.

[0093] 2 , the primary tube 102 is attached to the neck portion 124 such that the primary distal end 110 of the primary tube 102 extends distally beyond the neck portion 124, and both the primary distal end 110 of the primary tube 102 and the secondary distal end 116 of the secondary tube 104 are disposed within the reservoir 120. The secondary proximal end 114 of the secondary tube 104 is disposed proximally relative to the neck portion 124.

[0094] 3 , the primary tube 102 is attached to the neck portion 124 such that the primary distal end 110 of the primary tube 102 and the secondary distal end 116 of the secondary tube 104 are both located at or within the neck portion 124. That is, the locations of the primary distal end 110 and the secondary distal end 116 can be at or within the length Ln of the neck portion 124. The secondary proximal end 114 of the secondary tube 104 is disposed proximally relative to the neck portion 124, and the secondary distal end 116 is disposed proximally relative to the primary distal end 110 of the primary tube. Thus, the primary conduit 112 extends in both a distal and proximal direction relative to the secondary conduit 118.

[0095] 4 , the primary tube 102 is attached to the neck portion 124 such that the primary distal end 110 of the primary tube 102 is disposed at or within the neck portion 124 and the secondary distal end 116 of the secondary tube 104 is disposed proximally relative to the neck portion 124. The secondary proximal end 114 and secondary distal end 116 of the secondary tube 104 are both disposed proximally relative to the neck portion 124, and the secondary distal end 116 is disposed proximally relative to the primary distal end 110 of the primary tube. Thus, the primary conduit 112 extends both distally and proximally relative to the secondary conduit 118.

[0096] 5 , the primary tube 102 is attached to the neck portion 124 such that the primary distal end 110 of the primary tube 102 is disposed distally beyond the neck portion 124 into the reservoir 120, and the secondary distal end 116 of the secondary tube 104 is disposed at or within the neck portion 124. The secondary proximal end 114 of the secondary tube 104 is disposed proximally relative to the neck portion 124, and the secondary distal end 116 is disposed proximally relative to the primary distal end 110 of the primary tube 102. Thus, the primary conduit 112 extends both distally and proximally relative to the secondary conduit 118.

[0097] 6 , the primary tube 102 is attached to the neck portion 124 such that the primary distal end 110 of the primary tube 102 is disposed distally beyond the neck portion 124 into the reservoir 120, and the secondary distal end 116 of the secondary tube 104 is disposed proximally relative to the neck portion 124. As such, the neck portion 124 is disposed or located between the primary distal end 110 and the secondary distal end 116. The secondary proximal end 114 of the secondary tube 104 is disposed proximally relative to the neck portion 124, and the secondary distal end 116 is disposed proximally relative to the primary distal end 110 of the primary tube 102. Thus, the primary conduit 112 extends both distally and proximally relative to the secondary conduit 118.

[0098] In the example of Figures 3-6, the flow resistance decreases between the secondary distal end 116 of the secondary tube 104 (where the flow resistance increases relative to the primary proximal end 108 of the primary tube 102) and the primary distal end 110 of the primary tube 102.

[0099] 7, the primary tube 102 is attached to the neck portion 124 such that the primary distal end 110 of the primary tube and the secondary distal end 116 of the secondary tube 104 are both located at or within the neck portion 124. The secondary proximal end 114 of the secondary tube is also located at or within the neck portion 124 such that the entire secondary tube is located at or within the neck portion 124. That is, the length L2 can be described by the following mathematical formula: L2≦Ln.

[0100] 8A and 9-13 illustrate different examples of a shunt device 100 or glaucoma drainage device 100 for treating glaucoma, according to some embodiments. The shunt device 100 includes a tube 800 having a length L3 (also referred to as the "total length" or the "unatrimmed length" when referring to the length of the tube before it is trimmed), defined as the length of the tube between a proximal end 812 and a distal end 814. The tube 800 includes a primary section 802 having a primary conduit 804 and a secondary section 806 having a secondary conduit 808. The primary section 802 is disposed proximal to the secondary section 806, and the secondary conduit 808 has a flow resistance. The shunt body 106 of the shunt device includes a reservoir 120 therein, and the shunt body is integrated with the tube 800 at the secondary section 806, thereby fluidly coupling the primary conduit 804 and the secondary conduit 808 to the reservoir 120.

[0101] 8B, when viewed from the proximal end 812 of the tube 800, the secondary conduit 808 defined by the secondary section 806 of the tube is observed to have a narrower diameter, D2, than the primary conduit 804, which has an inner diameter D1, defined by the primary section 802 of the tube. In this manner, the secondary section 806 defines the flow resistance throughout the tube 800.

[0102] Tube 800 has a length L3 that includes the lengths of both primary portion 802 and secondary portion 806. Secondary portion 806 has a length (L4) that is shorter than length L3 and defines a distal portion of tube 800 relative to primary portion 802. Tube also includes an intermediate or transition portion 810 positioned between primary portion 802 and secondary portion 806 that defines a transition from primary conduit 804 of diameter D1 to secondary conduit 808 of diameter D2.

[0103] When implanted in ocular tissue, fluid from the environment flows into the primary conduit 804 from the proximal end 812, passes through the primary conduit 804, then through the secondary conduit 808, and finally exits the tube 800 via the distal end 814, as indicated by the dashed arrows depicted in FIG. 8A . Because the secondary conduit 808 has a smaller conduit diameter than the primary conduit 804, the resistance to fluid flow through the tube 800 and into the reservoir 120 is primarily determined by the smaller diameter D2 of the secondary conduit 808. Thus, the diameter of the secondary conduit is the primary determinant of the flow resistance of the fluid entering the reservoir. In some examples, the length L4 of the secondary conduit 808 can be a secondary determinant of the flow resistance of the fluid entering the reservoir 120.

[0104] The tube 800 has a portion extending proximally relative to the secondary portion 806 called the trimmable portion 122. The trimmable portion 122 is so named because the length of the tube 800 can be adjusted by trimming or cutting the tube at the trimmable portion without affecting the flow resistance of the tube. That is, regardless of where along the trimmable portion 122 the tube is cut or trimmed to shorten the length L3 of the tube, the resulting tube (with the shorter length L3) will have the same flow resistance as before cutting or trimming. In some examples, the secondary conduit maintains a constant flow rate therethrough before and after the tube is shortened.

[0105] In addition to the reservoir 120, the shunt body 106 includes a neck portion 124, which is the portion of the shunt body that contacts the tubing 800. The tubing 800 can be attached to the neck portion in one of different configurations, as described herein with respect to Figures 8A and 9-13.

[0106] 8A , the tube 800 is attached to the neck portion 124 such that the distal end 814 of the tube is disposed distally beyond the neck portion and extends into the reservoir 120 to facilitate fluid flow therein, as indicated by the dotted arrow extending from the distal end. The neck portion has a length (Ln) defined by a proximal end 126 and a distal end 128. A transition portion 810, which defines the transition from the primary conduit 804 to the secondary conduit 808, is disposed proximally relative to the neck portion 124.

[0107] In FIG. 9, tube 800 is attached to neck portion 124 such that distal end 814 of the tube is disposed at or within neck portion 124 and transition portion 810 is disposed proximally relative to neck portion 124 .

[0108] 10, tube 800 is attached to neck portion 124 such that both tube distal end 814 and transition portion 810 are located at or within neck portion 124, and secondary portion 806 is located entirely at or within neck portion 124. That is, length L4 can be expressed mathematically as follows: L4≦Ln (including, in the example shown, L4=Ln).

[0109] 11-13, the shunt device 100 includes two transition portions 810A, 810B and two primary portions 802A, 802B defining two primary conduits 804A, 804B, which are disposed at two opposite ends of a secondary portion 806. In these figures, the tube 800 includes a proximal primary portion 802A disposed proximally relative to the secondary portion 806 and partially defining the proximal primary conduit 804A, and a distal primary portion 802B disposed distally relative to the secondary portion 806 and partially defining the distal primary conduit 804B. The first transition portion 810A is disposed between the proximal primary portion 802A and the secondary portion 806, and the second transition portion 810B is disposed between the distal primary portion 802B and the secondary portion 806. The second transition portion 810B is located distally relative to the first transition portion 810A, and the locations of the transition portions 810A, 810B vary in the various configurations disclosed herein.

[0110] 11 , tube 800 is attached to neck portion 124 such that a distal end 814 of the tube is disposed at or within neck portion 124 and both transition portions 810A, 810B are disposed proximally relative to neck portion 124. Thus, distal primary conduit 804B is partially disposed within neck portion 124.

[0111] 12, the tube 800 is attached to the neck portion 124 such that the distal end 814 of the tube extends distally relative to the neck portion 124 into the reservoir 120. A transition portion 810B is disposed at or within the neck portion 124, and another transition portion 810B is disposed proximally relative to the neck portion 124. Thus, the secondary conduit 808 and the distal primary conduit 804B are partially disposed within the neck portion 124.

[0112] 13, the tube 800 is attached to the neck portion 124 such that the distal end 814 of the tube extends distally relative to the neck portion 124 into the reservoir 120. Both transition portions 810A, 810B are disposed proximally relative to the neck portion 124. Thus, the neck portion 124 is disposed between the distal end 814 of the tube 800 and the second transition portion 810B such that the distal primary conduit 804B extends the entire length Ln of the neck portion 124.

[0113] In the example of FIGS. 11-13, the flow resistance decreases between the second transition section 810B of the tube 800 (where the flow resistance increases relative to the proximal end 812 of the tube 800) and the distal end 814 of the tube 800.

[0114] 14A and 14B show two examples of a transition section 810 as disclosed herein. Note that a transition section may be defined as the portion of the tube 800 where the primary conduit 804 transitions into the secondary conduit 808, or vice versa (e.g., transition section 810B in FIGS. 11-13). In the latter case, it is understood that the configuration of the transition section 810 is the same as in FIGS. 14A and 14B, but is flipped vertically (or rotated 180 degrees).

[0115] In Figure 14A, the transition section 810 has a corner or edge 1400 such that upon entering the larger diameter primary conduit 804, the fluid bypasses the edge 1400 and flows into the smaller diameter secondary conduit 808. In Figure 14B, instead of a corner or edge, the transition section 810 has a funnel 1402 that gradually reduces the diameter of the conduit. This transitions from the larger diameter of the primary conduit 804 to the smaller diameter of the secondary conduit 808 over a predetermined distance (T), providing a smoother transition from one to the other (e.g., as opposed to an abrupt transition). Although not shown, the transition section may be curved or implement a more complex shape or configuration than that shown, such as a stepped configuration with multiple individual transition sections positioned next to each other.

[0116] Further disclosed herein is a first type of method for draining bodily fluid from a human eye via tubing extending from the shunt body 106 of a glaucoma shunt device 100. The shunt device 100 can have multiple tubes (primary and secondary tubes 102, 104) or a single tube (tube 800) having (1) a proximal end (e.g., 108 or 812) that is positioned within the human eye to receive bodily fluid, and (2) a distal end (e.g., 110, 116, or 814) that engages the shunt body 106 to fluidly connect the proximal end to a reservoir 120 positioned within the shunt body 106. When properly positioned, bodily fluid flows through the tubes with a first flow resistance at the proximal ends of the tubes, flows through the tubes with a second flow resistance between the proximal and distal ends of the tubes, and flows from the distal end of the tube into the reservoir 120.

[0117] Additionally, a second type of method for reducing fluid pressure in a human eye to mitigate the risk of intraocular hypotony is disclosed herein. In such a method, fluid within the eye is directed toward a proximal end (e.g., 108 or 812) of a tube (e.g., primary and secondary tubes 102, 104, or single tube 800) such that the tube at or near the proximal end (e.g., 108 or 812) has a first flow resistance. The fluid is then directed toward a portion of the tube at or near the proximal end having a second flow resistance greater than the first flow resistance. The fluid is then directed from a distal end (e.g., 110, 116, or 814) of the tube into reservoir 120, reducing intraocular fluid pressure.

[0118] With respect to either of the two types of methods described above, the proximal end (e.g., 108 or 812) of the tube (e.g., the combination of the primary and secondary tubes 102, 104, or the single tube 800) can be trimmed to shorten the length of the tube while maintaining the second flow resistance. In some examples, the length can refer to the overall length of the single tube 800 or the total / combined length of the combined tubes 102 and 104 operating as a single tube. In some examples, the first flow resistance and the second flow resistance define a composite tube flow resistance, and the proximal end of the tube can be trimmed to shorten the length of the tube (e.g., the overall or total / combined length) while maintaining the composite tube flow resistance. As defined herein, the composite tube flow resistance can be expressed as the sum of the first flow resistance and the second flow resistance.

[0119] In some examples of the method, a distal end (e.g., 110, 116, or 814) of a tube (e.g., a combination of primary and secondary tubes 102, 104, or a single tube 800) can be positioned or located to extend into reservoir 120. In some examples, the method can then include directing the fluid to a portion of the tube having the second flow resistance immediately after directing the fluid to another portion of the tube having a third flow resistance less than the second flow resistance.

[0120] Additionally, a third type of method is disclosed herein, which is a method for reducing fluid pressure in a human eye to mitigate the risk of intraocular hypotony. Hypotension is a condition of undesirable low intraocular pressure in the AC of the eye caused by a fluid flow rate from the AC of the eye that is greater than the fluid production rate within the AC, which can result in blurred vision, collapse of the AC, or other damage to the eye. Fluid within the eye is directed through a proximal end (e.g., 108 or 812) of a tube (e.g., a combination of primary and secondary tubes 102, 104, or a single tube 800) into a reservoir 120 located at a different position relative to the proximal end of the tube.

[0121] The flow resistance of the tube increases between the proximal and distal ends (e.g., 110, 116, or 814) of the tube located adjacent to the reservoir 120, restricting flow through the tube sufficiently to mitigate the risk of hypotony. The increase in flow resistance can occur between the proximal and distal ends of the tube. In some instances, the proximal end of the tube can be trimmed to shorten the length (i.e., overall or total length) of the tube while maintaining flow resistance through the tube. In some instances, the distal end of the tube can be positioned to extend within the reservoir 120. In some instances, the flow resistance can decrease between the increased flow resistance, i.e., the portion of the tube where flow resistance increases, and the distal end of the tube.

[0122] Also disclosed is a method of forming the drainage device 100 that is at least partially implantable within the tissue of the eye. In some configurations, the method includes forming a shunt body 106 having a reservoir 120 defined therein, the reservoir being configured to receive and accumulate bodily fluid; preparing a primary tube 102 having a primary proximal end 108, a primary distal end 110, and a primary conduit 112 extending therebetween; and a secondary tube 104 having a secondary proximal end 114, a secondary distal end 116, and a secondary conduit 118 extending therebetween, the secondary conduit having a flow resistance; inserting the secondary tube 104 at least partially through the primary conduit 112 via the primary distal end 110; and integrating the shunt body 106 with the primary tube 102 near the primary distal end 110, such that the primary and secondary conduits 112, 118 are fluidly coupled to the reservoir 120, such that the primary proximal end 108 of the primary tube 102 is deliverable into the eye, and such that drainage of bodily fluid into the primary conduit 112 is facilitated.

[0123] The method includes permanently attaching a secondary tube to a primary tube; disposing an adhesive 134 between an outer surface of the secondary tube and an inner surface of the primary conduit prior to at least partially inserting the secondary tube into the primary conduit via the primary distal end; positioning the secondary distal end to extend distally beyond the primary distal end into the reservoir; permanently attaching the primary tube to the shunt body at or near the primary distal end; positioning the primary proximal end to extend proximally beyond the secondary proximal end a predetermined length; and positioning the secondary tube to extend proximally beyond the primary conduit. the primary tube along a portion of the secondary conduit that allows the overall length of the primary tube to be shortened without affecting the flow resistance of the secondary conduit; maintaining a constant flow rate through the secondary conduit before and after shortening the primary tube by the secondary conduit; and / or forming the secondary tube such that the secondary conduit has a smaller diameter than the primary conduit, the diameter of the secondary conduit being a primary determinant of the flow resistance of fluid entering the reservoir, wherein the length of the secondary conduit can be a secondary determinant of the flow resistance of fluid entering the reservoir.

[0124] In some configurations, the method includes forming a shunt body 106 having a reservoir 120 defined therein, the reservoir configured to receive and accumulate bodily fluid; preparing a tube 800 having a primary portion 802 having a primary conduit 804 and a secondary portion 806 having a secondary conduit 808, the primary conduit 804 having a primary diameter larger than a secondary diameter of the secondary conduit 808, the primary portion 802 being positioned proximally relative to the secondary portion 806, and the secondary conduit 808 having a flow resistance; and integrating the shunt body 106 with the tube 800 at the secondary portion 806 so that the primary conduit 804 and the secondary conduit 808 are fluidly coupled to the reservoir 120, the primary portion 802 of the tube 800 is deliverable into the eye, and bodily fluid is easily drained into the primary conduit 804.

[0125] The method also includes extending the secondary portion of the tube at least partially distally into the reservoir; forming the tube so that the primary portion extends a predetermined length proximally relative to the secondary portion and the overall length of the primary portion can be shortened by cutting the primary portion of the tube along a portion that extends proximally beyond the secondary portion without affecting the flow resistance of the secondary conduit; maintaining a constant flow rate through the secondary conduit by the secondary portion before and after shortening the primary portion of the tube; and / or forming the tube so that the secondary conduit has a smaller diameter than the primary conduit, the diameter of the secondary conduit being a primary determinant of the flow resistance of fluid entering the reservoir, wherein the length of the secondary conduit can be a secondary determinant of the flow resistance of fluid entering the reservoir.

[0126] The presence of a trimmable portion along the length of the tubing allows the tubing to be trimmed without affecting flow resistance within the tubing, and therefore beneficially contributes to the tailorability of the shunt device placement in a given patient anatomy, allowing the physician or surgeon using the shunt device to freely trim the tubing to a length suitable for safe placement, both with respect to placement of the tubing within the patient's anterior chamber and placement of the shunt device reservoir on the surface of the sclera and under the conjunctiva.

[0127] Additionally, the shunt body, physically and functionally coupled to the tubing, advantageously provides a means for storing and controllably releasing fluid directed into the tubing in the form of a reservoir defined by the shunt body. The neck portion of the shunt body also beneficially provides structural support for the tubing attached to the shunt body without adversely affecting the flow resistance of the tubing.

[0128] The material selection for the shunt device, including the shunt body, can include biocompatible materials, such as microporous materials such as expanded polytetrafluoroethylene (ePTFE), described below. The tubing can be made from materials that are flexible and suitable for use in constructing the elongate member, including biocompatible materials. Some such suitable materials include, but are not limited to, fluorosilicone, polytetrafluoroethylene, perfluorovinyl ether (PAVE), polypropylene, thermoplastic polyurethane, silicone, styrene block copolymer, polyether block amide, or polyolefin elastomer, as well as any suitable combination thereof. In some instances, suitable materials can also include metal. In certain instances, the shunt material, including the shunt body, can include, for example, a fluoropolymer, such as polytetrafluoroethylene (PTFE) polymer or ePTFE polymer, or any suitable combination thereof. In some instances, materials can include, but are not limited to, polyesters such as Dacron, silicone, polyurethane, carboxymethylcellulose fabric, or other biocompatible polymers, or any suitable combination thereof. Various modifications and additions can be made to the embodiments disclosed herein without departing from the scope of the disclosure. For example, while the above embodiments refer to particular features, the scope of the disclosure also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the disclosure is intended to encompass all alternatives, modifications, and variations that fall within the scope of the claims, together with all equivalents.

[0129] The foregoing description has been presented for purposes of illustration and description. It is not intended to limit the disclosure to the form(s) disclosed herein. For example, in the foregoing Summary, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations to streamline the disclosure. Features of the disclosed aspects, embodiments, and / or configurations may be combined into alternative aspects, embodiments, and / or configurations other than those described above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0130] Furthermore, while the description includes a description of one or more aspects, embodiments, and / or configurations, and specific variations and modifications, other aspects, combinations, and modifications are within the scope of the present disclosure as they become apparent to those skilled in the art after understanding the present disclosure. It is intended to acquire rights to include alternative aspects, embodiments, and / or configurations, including alternative, interchangeable, and / or equivalent structures, functions, ranges, or steps to those claimed, whether or not disclosed herein, and without any intention to offer patentable subject matter to the public. (Aspect) (Aspect 1) 1. A glaucoma shunt device for draining fluid from an eye, comprising: a primary tube having a primary proximal end, a primary distal end and a primary conduit extending therebetween; a secondary tube having a secondary proximal end, a secondary distal end and a secondary conduit extending therebetween; and a shunt body having a reservoir therein and integrated with the primary tube near the primary distal end, whereby the primary conduit and the secondary conduit are fluidly coupled with the reservoir; Including, A glaucoma shunt device, wherein the secondary tube is inserted at least partially through the primary conduit via the primary distal end, the secondary tube defining a flow resistance between the primary tube and the secondary tube. (Aspect 2) 2. The glaucoma shunt device of embodiment 1, wherein the secondary tube is permanently attached to the primary tube. (Aspect 3) 3. The glaucoma shunt device of embodiment 2, wherein the permanent attachment is facilitated by an adhesive disposed between an outer surface of the secondary tube and an inner surface of the primary conduit. (Aspect 4) 3. The glaucoma shunt device of embodiment 2, wherein the permanent attachment is facilitated by a friction fit between an outer surface of the secondary tube and an inner surface of the primary conduit. (Aspect 5) The glaucoma shunt device of any one of aspects 1 to 4, wherein the secondary distal end extends distally beyond the primary distal end into the reservoir. (Aspect 6) The glaucoma shunt device of any one of aspects 1 to 4, wherein the shunt body includes a neck portion where the primary tube is attached to the shunt body. (Aspect 7) 7. The glaucoma shunt device of claim 6, wherein the primary distal end and the secondary distal end are both located in the neck portion of the shunt body. (Aspect 8) The glaucoma shunt device of embodiment 6, wherein the primary distal end is disposed at the neck portion of the shunt body and the secondary distal end is disposed proximal to the neck portion. (Aspect 9) A glaucoma shunt device as described in embodiment 6, wherein the primary distal end extends distally beyond the neck portion of the shunt body into the reservoir, and the secondary distal end is disposed at the neck portion. (Aspect 10) A glaucoma shunt device as described in embodiment 6, wherein the primary distal end extends distally beyond the neck portion of the shunt body and into the reservoir, and the secondary distal end is positioned proximally relative to the neck portion. (Aspect 11) The glaucoma shunt device of embodiment 6, wherein the secondary tube is disposed entirely within the neck portion or within the neck portion. (Aspect 12) The glaucoma shunt device of any one of aspects 1-11, wherein the primary tube is permanently attached to the shunt body at or near the primary distal end. (Aspect 13) 13. The glaucoma shunt device of any one of aspects 1 to 12, wherein the primary proximal end extends proximally beyond the secondary proximal end a predetermined length to define a trimmable portion of the primary tube, the entire length of the primary tube defining a first state in which the primary tube and the secondary tube are combined untrimmed, and further defining a second state in which the primary tube and the secondary tube are combined trimmed to a shorter length of the trimmable portion, and both the first state and the second state have the same flow resistance. (Aspect 14) 14. The glaucoma shunt device of embodiment 13, wherein the secondary conduit maintains a constant flow rate therethrough before and after the primary tube is shortened. (Aspect 15) 15. The glaucoma shunt device of any one of aspects 1 to 14, wherein the secondary conduit has a smaller diameter than the primary conduit such that the diameter of the secondary conduit is the primary determinant of the flow resistance of fluid entering the reservoir. (Aspect 16) 16. The glaucoma shunt device of any one of aspects 1-15, wherein the length of the secondary conduit is a secondary determinant of the flow resistance of fluid entering the reservoir. (Aspect 17) 1. A glaucoma shunt device for draining fluid from an eye, comprising: a tube including a primary section having a primary conduit and a secondary section having a secondary conduit; and a shunt body having a reservoir therein and integrated with the tubing at the secondary section, whereby the primary conduit and the secondary conduit are fluidly coupled to the reservoir; A glaucoma shunt device, wherein the primary conduit has a primary diameter greater than a secondary diameter of the secondary conduit, the primary portion is positioned proximally relative to the secondary portion, and the secondary conduit has a flow resistance. (Aspect 18) 18. The glaucoma shunt device of embodiment 17, wherein a portion of the secondary portion extends distally into the reservoir. (Aspect 19) 20. The glaucoma shunt device of claim 18, wherein the shunt body includes a neck portion at which the tube is attached to the shunt body. (Aspect 20) 20. The glaucoma shunt device of claim 19, wherein the distal end of the tube is disposed in the neck portion of the shunt body. (Aspect 21) 20. The glaucoma shunt device of claim 19, wherein the secondary portion of the tube is disposed entirely within the neck portion or within the neck portion. (Aspect 22) The tube a proximal primary section disposed proximally relative to the secondary section and partially defining the primary conduit; a distal primary section disposed distally relative to the secondary section and partially defining the primary conduit; a first transition section disposed between the proximal primary section and the secondary section; and a second transition portion disposed between the distal primary portion and the secondary portion; 20. The glaucoma shunt device of embodiment 18, further comprising: (Aspect 23) A glaucoma shunt device as described in aspect 22, wherein the distal end of the tube is positioned in the neck portion of the shunt body, and both the first transition portion and the second transition portion are positioned proximal to the neck portion. (Aspect 24) A glaucoma shunt device as described in aspect 22, wherein the distal end of the tube extends distally beyond the neck portion of the shunt body and into the reservoir, the second transition portion is positioned at the neck portion, and the first transition portion is positioned proximally relative to the neck portion. (Aspect 25) A glaucoma shunt device as described in aspect 22, wherein the distal end of the tube extends distally beyond the neck portion of the shunt body and into the reservoir, and the first transition portion and the second transition portion are both positioned proximally relative to the neck portion. (Aspect 26) A glaucoma shunt device as described in any one of aspects 17 to 25, wherein the primary portion extends a predetermined length proximally relative to the secondary portion, and the overall length of the tube can be shortened by cutting the primary portion of the tube along the portion extending proximally beyond the secondary portion without affecting the flow resistance of the secondary conduit. (Aspect 27) 27. The glaucoma shunt device of claim 26, wherein the secondary conduit maintains a constant flow rate therethrough before and after the primary portion of the tubing is shortened. (Aspect 28) 28. A glaucoma shunt device according to any one of aspects 17 to 27, wherein the secondary conduit has a smaller diameter than the primary conduit such that the diameter of the secondary conduit is the primary determinant of the flow resistance of fluid entering the reservoir. (Aspect 29) 29. The glaucoma shunt device of any one of aspects 17 to 28, wherein the length of the secondary conduit is a secondary determinant of the flow resistance of fluid entering the reservoir.

Claims

1. 1. A glaucoma shunt device for draining fluid from an eye, comprising: a tube including a primary section having a primary conduit, a secondary section having a secondary conduit, and a transition section disposed between the primary section and the secondary section; a shunt body having a reservoir therein and integrated with the tubing at the secondary section, whereby the primary conduit and the secondary conduit are fluidly coupled to the reservoir; A glaucoma shunt device, wherein the primary conduit has a primary diameter greater than a secondary diameter of the secondary conduit, the primary portion is positioned proximally relative to the secondary portion, and the secondary conduit has a flow resistance.

2. The glaucoma shunt device of claim 1 , wherein a portion of the secondary section extends distally into the reservoir.

3. The glaucoma shunt device of claim 2 , wherein the shunt body includes a neck portion where the tubing is attached to the shunt body.

4. The glaucoma shunt device of claim 3 , wherein the distal end of the tube is disposed in the neck portion of the shunt body.

5. The glaucoma shunt device of claim 3 , wherein the secondary section of the tube is disposed entirely within or within the neck section.

6. The tube a proximal primary section disposed proximally relative to the secondary section and partially defining the primary conduit; a distal primary section disposed distally relative to the secondary section and partially defining the primary conduit; a first transition section disposed between the proximal primary section and the secondary section; and a second transition portion disposed between the distal primary portion and the secondary portion; The glaucoma shunt device of claim 2 further comprising:

7. The glaucoma shunt device of claim 6 , wherein the distal end of the tube is positioned in a neck portion of the shunt body, and both the first transition portion and the second transition portion are positioned proximal to the neck portion.

8. 7. The glaucoma shunt device of claim 6, wherein the distal end of the tube extends distally beyond the neck portion of the shunt body into the reservoir, the second transition portion is positioned at the neck portion, and the first transition portion is positioned proximally relative to the neck portion.

9. 7. The glaucoma shunt device of claim 6, wherein the distal end of the tube extends distally beyond the neck portion of the shunt body into the reservoir, and the first transition portion and the second transition portion are both positioned proximal to the neck portion.

10. A glaucoma shunt device as described in any one of claims 1 to 9, wherein the primary portion extends a predetermined length proximally relative to the secondary portion, and the overall length of the tube can be shortened by cutting the primary portion of the tube along the portion that extends proximally beyond the secondary portion without affecting the flow resistance of the secondary conduit.

11. 11. The glaucoma shunt device of claim 10, wherein the secondary conduit maintains a constant flow rate therethrough before and after the primary section of the tubing is shortened.

12. A glaucoma shunt device as described in any one of claims 1 to 9, wherein the secondary conduit has a smaller diameter than the primary conduit such that the diameter of the secondary conduit is the primary determinant of the flow resistance of fluid entering the reservoir.

13. A glaucoma shunt device according to any preceding claim, wherein the length of the secondary conduit is a secondary determinant of the flow resistance of fluid entering the reservoir.

14. A glaucoma shunt device as described in claim 1, wherein the transition portion includes a funnel shape that gradually reduces in diameter from the primary diameter to the secondary diameter.

15. A glaucoma shunt device as described in claim 1, wherein the transition portion includes one or more edges that define a step-like transition from the primary diameter to the secondary diameter.

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