Urethral implant

Abstract

The invention relates to a urethral implant. The urethral implant includes at least two struts extending longitudinally between a proximal end and a distal end of the urethral implant, each of the struts being flexible between a compressed configuration and an expanded configuration, the compression configuration enables delivery of the urethral implant to a stenosis in the urethra, and the expansion configuration facilitates expansion of the stenosis; the anchoring part extends outwards from at least one of the near end and the far end and is used for anchoring the urethral implant; and at least one drug delivery line adjoining at least one of the struts and extending in its longitudinal direction, the drug delivery line embedding a drug for release into the urethra.

Description

Technical Field

[0001] The disclosed technology relates generally to medical implant devices, and in particular, to drug-delivering urethral implant devices. Background Art

[0002] Urethral implants are generally known in the art. There is a class of urethral implants that are implanted in the male's urethra for the treatment of benign prostatic hyperplasia (BPH). BPH is a medical condition, also known as prostatic hypertrophy, in which the increase in prostate size leads to various medical problems such as urination problems (e.g., weak urination, bladder loss of control, slow or prolonged urination, increased urination frequency) and may cause lower urinary tract infection (LUTS), bladder stones, kidney and / or bladder damage and other more serious diseases. Over the years, people have proposed and used various treatment options, including oral medications (e.g., alpha receptor blockers), invasive surgery (e.g., transurethral resection of the prostate (TURP), transurethral prostatectomy (TUIP)) and minimally invasive treatment (e.g., prostate stent placement, transurethral microwave thermotherapy (TUMT), transurethral acupuncture ablation (TUNA), transurethral electrovaporization (TUVP), holmium laser enucleation of the prostate (HoLEP), etc. Each treatment technique has its inherent advantages and disadvantages.

[0003] One class of such techniques employs a urethral implant device, such as that disclosed in U.S. Pat. No. US9848905B2 to Kilemnik, entitled "Radial Cutter Implant," which is intended to provide a method for extending a toilet bowl passage and an implant for forming an incision in tissue surrounding a patient's bladder neck and urethra. According to one embodiment, the implant includes four wires, an anchoring leaflet, a distal end, and a proximal end. Each wire is connected between the proximal end and the distal end. The anchoring leaflet extends from the distal end and is positioned between two of the wires. The wire is wider at the proximal end than at the distal end to prevent the implant from moving from the bladder neck into the urethra after implantation. The anchoring leaflet prevents the implant from moving from the bladder neck into the bladder.

[0004] The method involves inducing infarction by applying continuous radial pressure on at least one of the urethral wall and the tissue surrounding the urethral wall. The method includes such a procedure, namely: an implant (which is removable) is deeply inserted into the vicinity of at least one of the bladder neck and the prostatic urethra of the bladder, the removable implant is released, and continuous pressure is applied by the removable implant. The removable implant has at least one foldable wire and an anchor capable of self-expansion. Once the implant is released, the foldable wire and the anchor will both expand to prevent the implant from moving along the urethral wall in the direction toward the bladder. The continuous pressure applied produces a longitudinal incision in the urethral wall and the tissue surrounding the urethral wall in a radial direction from the urethral axis outward. When a predetermined condition occurs, the removable implant is removed.

[0005] The U.S. patent number US11304724B2 of the patentee Kilemnik and the title "Incision implant for prostatic urethra" relates to an incision implant for making an incision in the prostatic urethra of a subject. The implant includes at least two closed-shaped wires and an anchor. Each wire has a proximal segment, a distal segment, and two longitudinal segments extending between the proximal segment and the distal segment. Each wire in the closed-shaped wire is elastic so that it can be compressed from an expanded configuration to a compressed configuration. The longitudinal segments of each wire are adjacent to other longitudinal segments of other wires along their length. In the expanded configuration, the incision implant is configured to cut tissue in the prostatic urethra. At least two wires are separated at their distal segments so that the distal segments form a simple closed curve shape at the end of the incision implant in the expanded configuration. The anchor is closed-shaped and extends outward from the proximal segment and passes through one of the closed-shaped wires in the expanded configuration. Summary of the invention

[0006] The purpose of the disclosed technology is to provide a novel implant device for the urethra of a subject. The implant includes at least two struts, an anchor and at least one drug distribution line. The at least two struts extend longitudinally between the proximal end and the distal end of the implant. Each of the struts is flexible between a compression configuration and an expansion configuration. The compression configuration enables the implant to be delivered to a stenosis in the urethra. The expansion configuration facilitates the expansion of the stenosis. The anchor extends outward from at least one of the proximal end and the distal end. The anchor is used to anchor the implant in the urethra. The at least one drug distribution line is adjacent to at least one of the struts and extends longitudinally along the at least one of the struts. The drug distribution line is embedded with a drug for release into the urethra.

[0007] According to the disclosed technology, an implant for the urethra of a subject is provided. The implant includes three closed-shaped wires, an anchor and at least one drug distribution line. Each closed-shaped wire includes two longitudinal sections extending between the proximal end and the distal end of the implant. Each longitudinal section of the closed-shaped wire is adjacent to another longitudinal section of another closed-shaped wire along its length. The closed-shaped wire is configured to engage with urethral tissue at a narrow portion in the urethra and expand the urethral tissue. The anchor includes a closed-shaped wire. The anchor is used to anchor the implant to the urethra. The at least one drug distribution line is adjacent to at least one of the closed-shaped wires and extends longitudinally along the at least one closed-shaped wire. The drug distribution line is embedded with a drug for release into the urethra. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The disclosed technology will be more fully understood and appreciated through the following detailed description taken in conjunction with the accompanying drawings, in which:

[0009] Figure 1A is a schematic diagram of a urethral implant constructed and operative in accordance with an embodiment of the disclosed technology shown in an expanded configuration;

[0010] Figure 1B is constructed and operated according to embodiments of the disclosed technology Figure 1A Schematic diagram of a urethral implant including a proximal cap;

[0011] Figure 1C is constructed and operated in accordance with an embodiment of the disclosed technology in a compressed configuration Figure 1B urethral implants;

[0012] Figure 2 is a schematic diagram of a urethral implant having twisted wires and shown in an expanded configuration, constructed and operative in accordance with another embodiment of the disclosed technology;

[0013] Figure 3A is a schematic diagram of a urethral implant constructed and operative in accordance with another embodiment of the disclosed technology, shown in an expanded configuration;

[0014] Figure 3B is constructed and operated according to embodiments of the disclosed technology Figure 3A A schematic diagram of a urethral implant including a proximal cap;

[0015] Figure 3C is constructed and operated according to embodiments of the disclosed technology Figure 3B A schematic diagram of a urethral implant from the distal end to the proximal end is shown;

[0016] Figure 4is a schematic diagram of a urethral implant having multiple discrete drug delivery lines constructed and operative in accordance with another embodiment of the disclosed technology;

[0017] Figure 5 is a schematic diagram of a urethral implant having a drug delivery wire coupled to an occlusive wire including an anchor, constructed and operative in accordance with another embodiment of the disclosed technology; and

[0018] Fig. 6A , Figure 6B , Figure 6C and Fig.6D are schematic diagrams of various configurations of medication delivery lines constructed and operative in accordance with embodiments of the disclosed technology. DETAILED DESCRIPTION

[0019] The disclosed technology overcomes the shortcomings of the prior art by providing an implant (referred to herein as a "urethral implant") for the urethra of a subject (i.e., a patient, a person, an implanter), wherein the implant comprises at least two struts, an anchor and at least one drug distribution line. The at least two struts may be a single line structure (e.g., a closed-shaped loop). The implant comprises a proximal end, a distal end, and a central portion (middle portion) arranged between the proximal end and the distal end. The struts extend longitudinally between the proximal end and the distal end of the implant. The struts are flexible between a compression configuration, which enables the implant to be delivered to a stenosis (i.e., a stenosis, a contraction) in the urethra, and an expansion configuration, which generally helps to expand the urethral passage, and in particular expand the stenosis. The anchor extends outward from at least one of the proximal end and the distal end, and is configured and operated to anchor the implant in the urethra of the subject. The drug distribution line is adjacent to at least one of the struts and extends longitudinally along the at least one of the struts. The drug delivery line is embedded with a drug for release into the urethra of a subject. The at least two struts are composed of a single continuous line forming a closed shape. Alternatively, the at least two struts are separate entities joined together to form a continuous line.

[0020] The struts typically provide a mechanical structural framework for the urethral implant, which allows it to be compressed and expanded. The drug distribution line typically provides a therapeutic effect of the drug on the target tissue of the urethra (e.g., a stenosis). The urethral implant of the disclosed technology provides a synergistic effect between the mechanical action of the line (strut) and the therapeutic action of the drug distribution line, which extends along the line-tissue engagement area (i.e., the area where the line (strut) contacts the tissue in the subject's urethra). Specifically, the line (strut) mechanically engages the urethral tissue at the line-tissue engagement area and applies pressure to the urethral tissue, while the drug distribution line contacts the same urethral tissue as the line (strut") and delivers the drug to these tissues (i.e., targeted drug delivery).

[0021] The urethral implant of the disclosed technology is configured and operated to self-expand by adopting a shape memory alloy (SMA) material such as nickel titanium (NiTi) (also known as the trade name "Nitlnol" (Nickel Titanium Navy Ordinance Laboratory)), which has a memory expansion and compression configuration. The urethral implant structure is usually hollow to allow urine to pass through (i.e., through the gap) when the urethral implant is implanted and in an expanded configuration in the urethra of the subject. The urethral implant of the disclosed technology can cut tissue, specifically, these wires are configured to apply continuous (ischemic) pressure to the tissue of the urethra (e.g., the prostatic urethra), thereby producing an incision (i.e., a longitudinal strut or wire that produces a corresponding longitudinal incision), which may cause infarction or tissue necrosis, thereby reshaping and expanding the urethra, making it easier for urine in subjects with BPH to flow). In addition, the wire can be equipped with at least one serrated edge (e.g., along the length of the wire or at least partially along its length) to further promote the formation of the incision. In an alternative configuration, where the urethral implant does not cut urethral tissue, it does not include a serrated edge.

[0022] The urethral implant is typically removable from the subject (via an extraction mechanism).It should be noted that all urethral implants disclosed herein are non-vascular implants, ie, not implanted in a blood vessel where blood flows, but rather implanted in the urethra where urine flows.

[0023] Now refer to Figure 1A , Figure 1B and Figure 1C . Figure 1A is a schematic illustration of a urethral implant, generally designated 100, constructed and operative in accordance with an embodiment of the disclosed technology, shown in an expanded configuration. Figure 1B is constructed and operated according to embodiments of the disclosed technology Figure 1A Schematic diagram of a urethral implant including a proximal cap. Figure 1C is constructed and operated in accordance with an embodiment of the disclosed technology in a compressed configuration Figure 1B The urethral implant 100 includes a tissue engaging thread 102 (interchangeably referred to herein as a “thread”), a tissue engaging anchor 104 (interchangeably referred to herein as an “anchor”), and a drug delivery thread 106.

[0024] The wire 102 includes two struts 102A and 102B, which extend longitudinally along a proximal end 110A (interchangeably referred to herein as the "proximal end"), a central portion 110B (interchangeably referred to herein as the "middle section"), and a distal end 110C (interchangeably referred to herein as the "distal end"), and generally extend along the longitudinal axis 101L of the urethral implant 100. Figure 1A and Figure 1BThe two struts 102A and 102B shown in the figure are continuous, i.e., made of a single line that converges at the proximal end 110A. Alternatively, the struts 102A and 102B are separate pieces (not shown) that are mechanically joined together at the distal end 110C and converge at the proximal end 110A. The central portion 110B is defined between the proximal end 110A and the distal end 110C. The length of the central portion 110B along the longitudinal axis 101L is generally longer than the combined length of the proximal end 110A and the distal end 110C. As shown in FIG. Figure 1C As shown in FIG, the urethral implant 100 is compressible between an expanded configuration having a length Li and a width Wi (strut width W2) and a compressed configuration having a length L2 and a width W3, (strut width W4 not shown). Figure 1A and Figure 1B The struts 102A and 102B of the wire 102 are shown to be geometrically symmetrical (having the same geometric properties, such as equal length, width and curvature) about the longitudinal axis 101L, and are materially identical (e.g., made of the same material, having the same mechanical properties, such as elasticity, strength, ductility, elasticity, etc.). A possible alternative configuration (not shown) is one in which the struts 102A and 102B are geometrically asymmetrical (e.g., at least one of their lengths, widths, curvatures or other geometric properties is different from each other) or materially different (i.e., the struts are not made of exactly the same material, or have different mechanical properties, such as flexibility, strength, etc.) about the longitudinal axis 101L. The wire 102 is made of a medical grade biocompatible material such as titanium, gold, stainless steel, a metal alloy such as Nitinol, a tantalum alloy, etc. According to an alternative configuration, the wire 102 is made of a polymer (e.g., a shape memory polymer).

[0025] Figure 1A , Figure 1B and Figure 1C The urethral implant 100 is shown in an expanded configuration. When the urethral implant 100 is implanted in a subject, it promotes expansion of a stricture in the subject's urethra by applying pressure to the surrounding tissue. In this regard, the urethral implant 100 generally acts as a compressible and expandable mechanical spring having intermediate compression states between two extremes (i.e., a fully expanded configuration and a fully compressed configuration). The main structural members of the urethral implant, i.e., struts 102A and 102B, are in a compressed configuration (i.e., fully expanded configuration) capable of delivering the urethral implant 100 to a stricture in the urethra. Figure 1C ) and the expanded configuration ( Figure 1A and Figure 1B ) are flexible. Figure 1CThe sheath 114 is configured and operable to enclose the urethral implant 100 in a compressed configuration, which allows the urethral implant 100 to be delivered within the body of a subject via a delivery device (not shown) toward a desired anatomical location within the urethra, typically to a stricture, where the urethral implant is deployed by release from the sheath 114, thereby self-expanding to Figure 1A and Figure 1B The sheath 114 is generally a hollow tube (eg, cylindrical and medical grade) configured to cover, encapsulate, wrap, and compress the urethral implant 100 in a compressed configuration.

[0026] The anchor 104 is typically a continuous wire structure that includes two sides represented by two struts 104A and 104B that extend outward from the proximal end 110A into the central portion 110B to one side of the urethral implant 100 of the longitudinal axis 101L (i.e., the proximal to distal direction). The struts 104A and 104B of the anchor 104 are typically composed of a single continuous wire that converges at the proximal end 110A. Alternatively, the struts 104A and 104B are separate pieces (not shown) that are mechanically joined together at the apex (i.e., the end of the anchor 104). The anchor 104 is in a compressed configuration ( Figure 1A and Figure 1B ) and expansion configuration ( Figure 1C ) is flexible. Once released from the sheath 114, the anchor 104 has the ability to self-expand to an expanded configuration. The anchor 104 is typically arcuate, which defines a bilaterally symmetrical closed shape (e.g., a closed loop) having an internal hole and two struts. Alternatively, the anchor 104 is bilaterally asymmetrical. The anchor 104 is constructed and operated to engage with and attach (anchor) to the urethral tissue of the subject in an expanded configuration. When the urethral implant 100 is removed from the subject, the anchor 104 can be separated from the tissue. The anchor 104 is made of the same wire 102. Alternatively, the anchor 104 is not made of exactly the same wire 102. Typically, as Figure 1A and Figure 1B As shown in FIG, the wires constituting anchor 104 are thinner than the wires constituting wire 102. Alternatively, the wires constituting anchor 104 and wire 102 have the same thickness (not shown). Other alternative configurations of anchor 104 are possible (not shown) (e.g., closed polygons, etc.).

[0027] The expanded width of the urethral implant 100 in the urethra varies from person to person (i.e., depending on anatomical factors and factors related to the stricture (e.g., stricture size, stricture tissue characteristics, etc.). According to an alternative embodiment, there are multiple anchors (not shown) such as a second anchor, which extend outward from the distal end 110C to the central portion 110B on the other side of the urethral implant 100 relative to the longitudinal axis 101L (i.e., the side different from the extension of the first anchor). In addition, there are two anchors (not shown) that are constructed and operated to extend from the same end (i.e., the proximal end 110A or the distal end 110C) toward the opposite direction thereof (i.e., in the distal-to-proximal direction defined from the distal end 110C to the proximal end 110A, or in the proximal-to-distal direction defined from the proximal end 110A to the distal end 110C).

[0028] The drug delivery line 106 is joined (connected) (e.g., continuously wound) to the line 102 along the length of the struts 102A and 102B starting from and ending at the proximal end 110A (i.e., both ends of the drug delivery line 106 end at the proximal end 110A). The two ends of the drug delivery line 106 can be open or closed. The two ends of the drug delivery line 106 contact each other, thereby defining a closed shape. The drug delivery line 106 is joined to the struts 102A and 102B by spirally winding along its entire length (e.g., Figure 1A and Figure 1B ). An alternative connection configuration between the drug delivery line 106 and the closed-shaped line 102 is a parallel connection (the two lines extend parallel to each other, i.e., non-helical and not shown). The drug delivery line 106 has a total length greater than the length of the line 102. The drug delivery line 106 is embedded with a drug, which is delivered (i.e., released, administered) into the urethra when the urethral implant 100 is implanted in the subject. The drug includes a chemical substance that is configured to produce or perform a biological effect on the subject. Example drugs (drugs) include sirolimus (rapamycin) and everolimus. The drug can typically be formulated to include a time release mechanism (e.g., liposomes), also known as a sustained release dose, which acts to deliver the drug over a period of time (i.e., gradually rather than an "immediate release" formulation) so that the drug dissolves, diffuses (or both) at a controlled rate (e.g., controlled release, sustained release, delayed release, extended release, etc.). The drug can be (completely or partially) coated on the drug delivery line 106.

[0029] Special reference Figure 1B and Figure 1C The proximal end 110A of the urethral implant 100 includes a proximal cap 112, which covers the end (tip) of the wire 102, the end of the wire of the anchor 104, and the end of the drug delivery wire 106. The proximal cap 112 is typically made of a medical grade plastic material (e.g., polyethylene that is substantially non-degradable in the body, etc.).

[0030] Before the drug dissolves in the body after implantation, the drug distribution line 106 has a larger surface contact area (i.e., the surface area of ​​the implant engaging the tissue) than the line 102. Once the drug distribution line 106 is implanted, the drug is configured to gradually dissolve at a controlled rate according to its specific time-release drug curve. The drug distribution line 106 is made of a single strand or multiple strands of material (e.g., fibers such as cotton fibers, synthetic fibers such as polyester, etc.), which can absorb and exude the embedded drug when the urethral implant 100 is implanted. In addition or alternatively, the drug distribution line 106 is made of a biodegradable material that dissolves when implanted in the urethra of the implanter. According to this alternative scheme, both the embedded drug and the drug distribution line 106 will dissolve over time (e.g., at the same rate or at different rates). The drug distribution line 106 can be compressed between the compressed configuration and the expanded configuration of the urethral implant 100.

[0031] An alternative configuration (not shown) for the drug delivery line 106 includes being adjacent to (e.g., spirally wound) only one of the struts 102A and 102B. Another alternative configuration involves having multiple drug delivery lines, each of which is embedded with a different drug or the same drug. In the case of at least two different drug delivery lines, each line is embedded with a different drug with a different time release curve. Alternatively, the two drug delivery lines can be embedded with the same drug, but with different time release curves (linear, nonlinear, burst, etc.). In addition, the different drug delivery lines can be composed of different materials. When at least two drug delivery lines are intertwined with the struts, there may be multiple intersections between the two drug delivery lines. These intersections may have knots or may not have knots. Another alternative is that when an integer N>2 drug delivery lines are wound or intertwined around the struts, they may form an N-dimensional braided pattern. This N-dimensional braided pattern can arrange each of the struts in the same way (or different ways) and can also be twisted in the same direction (or different directions). The following is a connection Figure 6B An example of a three-strand braid configuration is described.

[0032] Once the urethral implant 100 is delivered to the stenosis of the subject's urethra (e.g., the stenosis of the prostatic urethra), the implant will expand to an expanded configuration, which is configured to apply continuous pressure to the surrounding tissues of the urethra at the stenosis, thereby expanding the stenosis (e.g., remodeling and expanding the bladder neck and prostatic urethra). Anchor 104 expands to an expanded configuration and engages with the surrounding tissues of the urethra, thereby anchoring the urethral implant 100 in place. Anchor 104 helps the urethral implant 100 to be relatively immobile (thereby avoiding inadvertent migration into the subject's bladder while implanting). The urethral implant 100 is configured and operated to apply continuous pressure, thereby expanding the internal cross-section at the stenosis, thereby increasing the ability of urine to flow through the urethra. When the urethral implant 100 is implanted, the drug distribution line 106 is configured to release the drug at a controlled rate at the implantation site. The urethral implant 100 can be removed from the urethra (via an implant extraction mechanism, not shown).

[0033] Now refer to Figure 2 , which is a schematic diagram of a urethral implant (generally designated 150) having twisted wires and shown in an expanded configuration, constructed and operative in accordance with another embodiment of the disclosed technology. The urethral implant 150 is generally similar in structure and function to the Figures 1A to 1C The urethral implant 100 is different in that, compared with the urethral implant 100, the urethral implant 150 includes two twisted or interwoven wires (ie, a twisted pair of wires) instead of only one wire.

[0034] In particular, the urethral implant 150 includes two wires 1521 and 1522, an anchor 154, a drug delivery wire 156, and a proximal cap 162. In an alternative configuration (not shown), the proximal cap 162 is optional. The wires 1521 and 1522 are joined together (spirally wound or interwoven), and each wire includes two struts extending longitudinally along a proximal portion 160A (interchangeably referred to herein as "proximal"), a central portion 160B (interchangeably referred to herein as "midsection"), and a distal portion 160C (interchangeably referred to herein as "distal"), and extending longitudinally generally along a longitudinal axis 161L of the urethral implant 150. In particular, the wire 1521 includes two struts 1521A and 1521B, and the wire 1522 includes two struts 1522A and 1522B. The struts 1521A and 1521B of line 1521 are continuous (i.e., made of a single wire) and converge at the proximal end 160A. Similarly, the struts 1522A and 1522B of line 1522 are continuous (i.e., made of a single wire) and converge at the proximal end 160A. In an alternative configuration (not shown), the struts 1521A and 1521B of line 1521 are separate pieces that are mechanically joined together at the distal end 160C and converge at the proximal end 160A. In a similar alternative configuration (not shown), the struts 1522A and 1522B of line 1522 are separate pieces that are mechanically joined together at the distal end 160C and converge at the proximal end 160A. The central portion 160B is defined as between the proximal end 160A and the distal end 160C. Wires 1521 and 1522 are similar in function to wires 102 of urethral implant 100. Likewise, anchor 154 and proximal cap 162 are similar in structure and function to anchor 104 and proximal cap 112 (respectively) of urethral implant 100 ( Figures 1A to 1C ).

[0035] Urethral implant 150 is compressible between an expanded configuration and a compressed configuration (similar to urethral implant 100). Wires 1521 and 1522 typically have the same structural characteristics (e.g., equal length, thickness, cross-section) and the same material properties (e.g., made of the same material and have the same mechanical properties such as elasticity, strength, ductility, resilience, etc.). An alternative configuration (not shown) is one in which wires 1521 and 1522 are dissimilar with respect to at least one attribute such as structurally, geometrically (e.g., length, thickness, curvature), and the material is different (i.e., not made of exactly the same material or have different mechanical properties, such as flexibility, strength, etc.). Wires 1521 and 1522 are typically made of medical grade biocompatible materials (similar to wire 102).

[0036] Anchor 154 and Figures 1A to 1C161L. The anchor is a continuous wire structure that includes two sides represented by two struts 154A and 154B that extend outward from the proximal end 160A to the central portion 160B and reach one side of the urethral implant 150 of the longitudinal axis 161L. The struts 154A and 154B are typically made of a single continuous wire that converges at the proximal end 160A. Alternatively, the struts 104A and 104B are separate pieces (not shown) that are mechanically joined together at the apex (i.e., the end of the anchor 104). The anchor 154 is flexible between a compressed configuration and an expanded configuration. Once removed from a delivery sheath (e.g., Figure 1C The sheath 114 of the urethra implant 150 is released, and the anchor 104 has the ability to self-expand to the expanded configuration. The anchor 154 is generally arched, which defines a bilaterally symmetrical closed shape (e.g., a closed loop) with an internal hole and two struts. The anchor 154 is constructed and operated to engage with the urethra tissue of the subject in the expanded configuration and attach (anchor) to the urethra tissue. When the urethra implant 150 is removed from the subject, the anchor 154 can be separated from the tissue. The anchor 154 is made of the same material as the lines 1521 and 1522. Alternatively, the anchor 154 is not made of the same material as the lines 1521 and 1522.

[0037] The drug delivery line 156 is similar in structure, composition and function to Figures 1A to 1CThe drug dispensing line 106 of the closed-shaped line. The drug dispensing line 156 is adjacent (e.g., continuously and spirally wound) to the lines 1521 and 1522 along the length of the line corresponding to the struts 1521A and 1521B for the struts 1522A and 1522B for the line 1522. The drug dispensing line 156 starts and ends at the proximal end 160A (i.e., so that its two ends terminate at the proximal end 160A). The drug dispensing line 106 is adjacent to the struts of the lines 1521 and 1522 by spirally winding circumferentially and along its entire length. An alternative connection configuration between the drug dispensing line 156 and the closed-shaped line is a parallel connection (i.e., the lines extend parallel to each other, i.e., non-spiral). The drug dispensing line 156 has a total length greater than the length of each line 1521 and 1522, and according to one configuration, it is smaller than the combined length of the lines 1521 and 1522. According to another configuration (not shown), the drug delivery line 156 can be tightly spirally wound so that its total length is greater than the combined length of lines 1521 and 1522. The drug delivery line 156 is embedded with one or more drugs that are the same as the drug delivery line 106. When the urethral implant 150 is implanted in the subject, the drug acts to be distributed (i.e., released) into the urethra. Once the drug delivery line 156 is implanted, the drug is configured to gradually dissolve at a controlled rate according to its characteristic time-release drug curve. The drug delivery line 156 is made of a single strand or multiple strands of material (e.g., fibers) that can absorb and exude the embedded drug when the urethral implant 150 is implanted. The drug delivery line 156 can be compressed between the compressed configuration and the expanded configuration of the urethral implant 150.

[0038] When urethral implant 150 is implanted in a subject, it promotes dilation of a stricture in the subject's urethra by applying pressure to the surrounding tissue. Urethral implant 150 has two lines 1521 and 1522 (as opposed to one line in urethral implant 100), which enables it to apply a greater force (pressure) per unit area to the surrounding tissue than urethral implant 100. Urethral implant 150 is able to store more mechanical energy when compressed than urethral implant 100. Urethral implant 150 is compressible between two extremes: a fully compressed configuration and a fully expanded configuration, wherein a continuous range of intermediate compression states can be achieved between these two extremes.

[0039] The urethral implant 150 provides a synergistic effect between the mechanical action of the wires 1521 and 1522 and the therapeutic action of the drug delivery wire 156 extending along the wire-to-tissue engagement region. Specifically, the wires 1521 and 1522 mechanically engage and apply pressure to the urethral tissue at the wire-to-tissue engagement region, while the drug delivery wire 156 contacts the same urethral tissue as the wires 1521 and 1522 and delivers the drug to these same tissues (i.e., targeted drug delivery).

[0040] Now refer to Figure 3A , Figure 3B and Figure 3C . Figure 3A is a schematic illustration of a urethral implant, generally designated 200, constructed and operative in accordance with another embodiment of the disclosed technology, shown in an expanded configuration. Figure 3B is constructed and operated according to embodiments of the disclosed technology Figure 3A Schematic diagram of a urethral implant including a proximal cap. Figure 3C is constructed and operated according to embodiments of the disclosed technology Figure 3B A shows a schematic diagram of a urethral implant from the distal to the proximal direction.

[0041] The urethral implant 200 is generally composed of a wireframe structure that includes three types of closed shape substructures with different shapes and functions. The first type of substructure is the mechanical structural framework of the urethral implant 200, which includes three closed shapes for engaging with urethral tissue, cutting the urethral tissue, and expanding urethral tissue at a specific urethral location where a stenosis (i.e., contraction) occurs. The second type of substructure is an anchor that includes at least one closed shape structure for engaging with urethral tissue and anchoring the urethral implant 200 in place. The third type of substructure includes at least one drug distribution line that is embedded with a drug for distribution in the subject's urethra. The urethral implant 100 defines a proximal end 210A, a central portion 210B, and a distal end 210C.

[0042] Specifically, FIG. 3A to FIG. 3C As shown in FIG. 1 , the urethral implant 200 includes three closed-shaped wires 202A, 202B, and 202C (i.e., the first type of substructure, i.e., the wireframe structure), an anchor 204 (i.e., the second type of substructure), and a drug delivery wire 206 (i.e., the third type of substructure). According to another configuration, as shown in FIG. Figure 3B and Figure 3C As shown in FIG. 1 , the urethral implant 200 includes a proximal cap 212 located at the proximal end 210A. Figure 3A In the minimal configuration shown in , the proximal cap 212 is not present (ie, optional).

[0043] Each closed line includes two longitudinal segments extending between the proximal end 210A and the distal end 210C. Each closed line may include a transverse segment between the two transverse segments. Specifically, the closed line 202A includes the longitudinal segments 202A1 and 202A2 and the transverse segment 203A (e.g., Figure 3C The closed line 202B includes longitudinal sections 202B1 and 202B2 and a transverse section 203B (as shown in FIG. Figure 3CThe closed line 202C includes longitudinal sections 202C1 and 202C2 and a transverse section 203C (as shown in FIG. Figure 3C ). Each longitudinal segment of the closed shape line is adjacent to another longitudinal segment of another closed shape line along its length. Specifically, the longitudinal segment 202A2 of the closed shape line 202A is adjacent to the longitudinal segment 202B1 of the closed shape line 202B along its length, the longitudinal segment 202B2 of the closed shape line 202B is adjacent to the longitudinal segment 202C1 of its closed shape line 202C along its length, and the longitudinal segment 202A2 of the closed shape line 202A is adjacent to the longitudinal segment 202C2 of the closed shape line 202C along its length. According to a preferred configuration, each closed shape is composed of a single continuous line defining at least two longitudinal segments. Alternatively, there are three segments (a transverse segment between two longitudinal segments). As FIG. 3A to FIG. 3C As shown in , the method of abutting the wires is by helically wrapping one wire around another wire (longitudinal segment) to form a pair of twisted or interwoven wires, wherein one wire is twisted clockwise and the other is twisted counterclockwise (left-handed / right-handed twist). In a preferred configuration, the wires are made of the same material and have the same physical properties (e.g., width, cross-section). In an alternative configuration (not shown), the wires are different in at least one aspect (e.g., composition, physical properties, etc.).

[0044] Special reference Figure 3C , the urethral implant 200 forms a triangular pyramid structure having a triangular base formed by transverse segments 203A, 203B and 203C at the distal end 210C and an apex at the proximal end 210A where the longitudinal lines converge (at Figure 3B and Figure 3C At the proximal cap 212 shown in Figure 3A There is no proximal cap in the Figure 3B and Figure 3C As shown in FIG. 1 , the proximal cap 212 covers the ends (terminals) of the first, second, and third types of wires at the proximal end 210A. Specifically, the proximal cap 112 covers the ends (terminals) of the wires 202A, 202B, 202C, the end of the anchor 204, and the end of the drug delivery line 206 at the proximal section 120A. Figure 3B and Figure 3C ). In an alternative configuration (not shown), lines 202A, 202B, and 202C are closed curves (ie, have no endpoints).

[0045] Anchor 204 and Figures 1A to 1C The anchor member 104 and Figure 2The anchor 204 is a continuous wire structure including two sides represented by two struts 204A and 204B, which extends outward from the proximal end 210A to the central portion 210B, reaches one side of the urethral implant 200, and terminates at a distal end (i.e., the distal end, apex, of the anchor 204). The anchor 204 generally originates from the proximal end 210A and passes through one of the closed-shaped wires (e.g., Figure 3B and Figure 3C 202B). Struts 204A and 204B are typically made of a single continuous line that converges at two points, namely the proximal end 210A and the end point of anchor 204, namely the origin. In an alternative configuration, struts 204A and 204B are separate pieces (not shown) that are mechanically joined together at the apex or end of the anchor. In another alternative configuration (not shown), anchor 204 is a closed curve (i.e., has no end points). Anchor 204 is flexible between a compressed configuration and an expanded configuration. Once removed from a delivery sheath (e.g., Figure 1C The sheath 114 of the urethra implant 200 is released, and the anchor 204 has the ability to self-expand to the expanded configuration. The anchor 204 is generally arched, which defines a bilaterally symmetrical closed shape (e.g., a closed loop) with an internal hole and two struts. When in the expanded configuration, the anchor 204 extends beyond the width of the closed shape line, thereby effectively widening the overall width of the urethra implant 200. The anchor 204 is constructed and operated to engage with the urethra tissue of the subject in the expanded configuration and attach (anchor) to the urethra tissue. When the urethra implant 200 is removed from the subject, the anchor 204 can be separated from the tissue. The anchor 204 is made of the same material as the closed shape line. Alternatively, the anchor 204 is not made of the same material as the material constituting the closed shape line.

[0046] The drug delivery line 206 is similar in structure, composition and function to Figures 1A to 1C The drug dispensing line 106 and Figure 2 The drug delivery line 206 is similar to the drug delivery line 156 of FIG. The drug delivery line 206 is connected to (i.e., continuously and spirally wound around) the line longitudinal segments 202A1 and 202A2 of the closed-shaped line 202A, the longitudinal segments 202B1 and 202B2 of the closed-shaped line 202B, and the longitudinal segments 202C1 and 202C2 of the closed-shaped line 202C. In addition, as Figure 3CAs shown in Figure 2, the drug distribution line 206 is adjacent to (e.g., spirally wound) transverse sections 203A and 203B, but not adjacent along the length of transverse section 203C. In an alternative configuration (not shown), the drug distribution line 206 is adjacent to the transverse section 203C (i.e., adjacent to all longitudinal and transverse lines). The drug distribution line 206 is continuous and starts and ends at the proximal end 210A (i.e., its two ends terminate at the proximal end 210A). The drug distribution line 206 is spirally wound circumferentially and along the entire length of the longitudinal section of each of the closed-shaped lines. The twisting or interweaving method of the drug distribution line 206 around the longitudinal section can be clockwise or counterclockwise (e.g., left-handed or right-handed twisting). The total length of the drug distribution line 206 is larger than the length of each closed-shaped line. The drug distribution line 206 is compressible between the compression configuration and the expansion configuration of the urethral implant 200.

[0047] The drug delivery line 206 is embedded with one or more drugs that are the same as the drugs embedded in the drug delivery line 106. When the urethral implant 200 is implanted in the subject, the drug is distributed (i.e., released, administered) into the urethra. Once the drug delivery line 206 is implanted together with the urethral implant 200, the drug will gradually dissolve at a controlled rate according to its characteristic time-release drug curve. The drug includes a chemical substance configured to produce or perform a biological effect on the subject. The drug delivery line 206 is made of a single strand or multiple strands of material (e.g., fibers), which can absorb and exude the embedded drug when the urethral implant 200 is implanted.

[0048] An alternative configuration (not shown) for the drug distribution line 206 includes being adjacent to (e.g., spirally wound) only one of the longitudinal sections. Another alternative configuration involves having multiple drug distribution lines, wherein each line is embedded with a different drug or the same drug. In the case of at least two different drug distribution lines, each line is embedded with a different drug with a different time release profile. Alternatively, the two drug distribution lines can be embedded with the same drug, but with different time release profiles (linear, non-linear, burst, etc.). In addition, the different drug distribution lines can be composed of different materials.

[0049] The urethral implant 200 (including the closure wires 202A, 202B, and 202C, the anchor 204, and the drug delivery wire 206) is compressible between an expanded configuration and a compressed configuration (similar to the urethral implants 100 and 150). The closure wires 202A, 202B, and 202C generally have the same structural characteristics (e.g., dimensions such as length, thickness, cross-section, etc.) and the same material characteristics (e.g., made of the same material and having the same mechanical properties, such as elasticity, strength, ductility, resilience, etc.). An alternative configuration (not shown) is one in which the wires 202A, 202B, and 202C are different with respect to at least one attribute such as structure, geometry (e.g., length, thickness, curvature), and are also different in material (i.e., not made of exactly the same material or have different mechanical properties, such as flexibility, strength, etc.). Wires 202A, 202B, and 202C are typically made of a medical grade biocompatible material (similar to wire 102 and wires 1521 and 1522 of the previous embodiment).

[0050] After the urethral implant 200 is implanted in a subject, the implant promotes dilation of a stricture within the urethra by applying pressure to the surrounding tissue. The double-wound wire (twisted pair) of the urethral implant 200 is capable of storing more mechanical energy in a compressed state than a single-wire urethral implant 100. The urethral implant 200 is generally compressible between two extremes: a fully compressed configuration and a fully expanded configuration, wherein a continuous range of intermediate compression states can be achieved between the two extremes. According to an alternative configuration (not shown), the urethral implant may include more than two interwoven wires (e.g., in the longitudinal direction), such as a harness.

[0051] The urethral implant 200 provides a synergistic effect between the mechanical action of the closure wires 202A, 202B, and 202C and the therapeutic action of the drug delivery wire 206 extending along the wire-to-tissue engagement region. Specifically, the longitudinal segments 202A1, 202A2, 202B1, 202B2, 202C1, and 202C2 of the closure wire mechanically engage and apply pressure to the urethral tissue at the wire-to-tissue engagement region, while the drug delivery wire 206 contacts the same urethral tissue as the longitudinal segments of the closure wire and delivers the drug to these same tissues (i.e., targeted drug delivery).

[0052] Now refer to Figure 4 , which is a schematic diagram of a urethral implant (generally designated 250) having multiple discrete drug delivery lines, constructed and operative in accordance with another embodiment of the disclosed technology. FIG. 3A to FIG. 3CThe urethral implant 250 is similar to the urethral implant 200, except that the drug delivery line has multiple discontinuous sections. The urethral implant 250 defines a proximal section 260A, a central section 260B, and a distal section 260C. Specifically, the urethral implant 250 includes three closed-shaped lines 252A, 252B, and 252C, an anchor 254, a proximal cap 262, and a plurality of drug delivery lines 2561, 2562, 2563, 2564, 2565, 2566, and 2567. Generally, the urethral implant 250 may include N drug delivery lines 2561 ... 256 N (where N is a positive integer greater than 1.) In particular, and without loss of generality, the urethral implant 250 includes seven separate and discrete drug delivery lines (as an example), each of which has a different length, and each of which is coupled to at least a portion of one of the closed-shaped lines 252A, 252B, and 252C. Specifically, the drug dispensing line 2561 is connected to the lines 252A1 and 252C2, the drug dispensing line 2562 is connected to the lines 252A1 and 252C2, the drug dispensing line 2563 is connected to the lines 252A1, 252C2, 252B1 and 252A2, the drug dispensing line 2564 is connected to the lines 252A1, 252C2, 252B2 and 252C1, the drug dispensing line 2565 is connected to the lines 252A2 and 252B1, the drug dispensing line 2566 is connected to the lines 252B2 and 252C1, and the drug dispensing line 2567 is connected to the lines 252B2, 252C1, 252A1 and 252C2. Figure 4 In an alternative configuration (not shown) to the configuration shown in , the drug distribution lines 2561...2567 have equal lengths. In one configuration, the drug distribution lines 2561...2567 are identical and have identical characteristics, i.e., embedded with the same drug composition and the same drug time release curve, physical properties (e.g., length, width, cross-section, curvature, torsion, etc.). In another configuration, at least one of the drug distribution lines of lines 2561...2567 differs from the other drug distribution lines in at least one characteristic such as drug composition, drug time release curve, mechanism of action (MOA), physical properties, etc. For example, drug distribution line 2561 is embedded with the drug sirolimus, and drug distribution line 2563 is embedded with the drug everolimus. In general, combinations of different combinations of different characteristics of different drug distribution lines are possible.

[0053] The closure lines 252A, 252B and 252C as well as the anchor 254 and the proximal cap 262 are structurally and functionally coupled to the FIG. 3A to FIG. 3C The described closure lines 202A, 202B and 202C, anchors 204 and proximal caps 212 (respectively) are identical. FIG. 3A to FIG. 3C The description of the components applies to Figure 4The same elements of the urethral implant 250.

[0054] Now refer to Figure 5 , which is a schematic diagram of a drug delivery line having a urethral implant (generally designated 300) coupled to a closed-wire including an anchor, constructed and operative in accordance with another embodiment of the disclosed technology. FIG. 3A to FIG. 3C The urethral implant 300 is similar to the urethral implant 200 of the present invention, except for the additional drug delivery line connected to the anchor. Specifically, the urethral implant 300 includes three closed-shaped lines 302A, 302B and 302C, an anchor 304, a drug delivery line 306, a drug delivery line 308 and a proximal cap 312. The urethral implant 300 defines a proximal end 310A, a central portion 310B and a distal end 310C. The anchor 304 and FIG. 3A to FIG. 3C The anchor 304 is the same as the anchor 204 in the embodiment. The anchor 304 is a continuous line structure, which includes two sides embodied as two struts 304A and 304B, which extend outward from the proximal end 310A to the central portion 310B, reach one side of the urethral implant 300, and terminate at the end (i.e., the end, the vertex of the anchor 304). The struts 304A and 304B are usually made of a continuous line, which converges at two points (i.e., the end of the proximal end 310A and the anchor 304), i.e., the origin. The anchor 304 is flexible between the compressed configuration and the expanded configuration. The anchor 304 has the ability to self-expand into the expanded configuration. The anchor 304 is usually arched, which defines a bilaterally symmetrical closed shape (e.g., a closed loop) with an internal hole and two struts 304A and 304B.

[0055] The drug delivery line 308 is coupled (i.e., continuously adjacent to and spirally wound) to the struts 304A and 304B of the anchor 304. The drug delivery line 308 and the anchor 304 are compressible between the compressed configuration and the expanded configuration of the urethral implant 300. In one configuration, the drug delivery line 308 is different from the drug delivery line 306. The differences include different structures, compositions, types of encapsulated drugs, drug time release profiles, functions, etc. For example, Figure 5 , the drug distribution line 308 is composed of thinner and shorter fibers or fiber strands than the drug distribution line 306. In addition, the drug distribution line 308 can be embedded with drugs different from the drug distribution line 306 (e.g., non-steroidal anti-inflammatory drugs (NSAIDS) etc.). In another alternative configuration (not shown), the drug distribution line 308 is the same as the drug distribution line 306 in terms of structure, composition, function, etc., and in another alternative configuration (not shown), each of the struts 304A and 304B is connected to different drug distribution lines. In this configuration, their differences can be embodied by at least one distinguishing feature (e.g., in terms of structure, composition, drug package, mechanism of action (MOA) etc.).

[0056] As joint Figure 3A As described above with respect to FIG3C , the closure wires 302A, 302B, 302C, as well as the anchor 304, the drug delivery line 306, and the proximal cap 312 are identical in structure and function to the closure wires 202A, 202B, and 202C, the anchor 204, and the proximal cap 212 (respectively). FIG. 3A to FIG. 3C The component description applies to Figure 5 The same elements of the urethral implant 300.

[0057] Now refer to Fig. 6A , Figure 6B , Figure 6C and Fig.6D , which are schematic diagrams of various configurations of drug delivery lines constructed and operated in accordance with embodiments of the disclosed technology. FIG. 6A to FIG. 6D The wires of the urethral implant wireframe structure and the drug delivery wires are respectively connected to the FIG. 3A to FIG. 3C , Figure 4 and Figure 5 The wireframe structure of the urethral implant and the wires of the drug delivery wire in the previous embodiments described are identical.

[0058] Fig. 6A is a schematic diagram showing a double helix configuration (generally designated 400) of two drug delivery lines spirally wound around two lines of a urethral implant of the disclosed technology. Specifically, Fig. 6A Two urethral implant lines 4021 and 4022 and two drug delivery lines 4061 and 4062 are illustrated (only partially shown, i.e. not their full length). In particular, the drug delivery lines 4061, 4062 appear as two helices in a double helix configuration that are spirally wound around (i.e. coupled to) the lines 4021 and 4022. The drug delivery lines 4061 and 4062 are identical or congruent (different only in translation or position along the lines 4021 and 4022) (i.e., they have the same geometry, the same composition, are embedded with the same drug, etc.). Alternatively, the drug delivery lines 4061 and 4062 are different in at least one aspect (e.g., different structures, embedded with different drugs, composed of different materials, have different time release curves, etc.).

[0059] Figure 6B is a schematic diagram showing a three-strand braid configuration (generally designated 420) including three drug delivery lines for wrapping around two lines of a urethral implant of the disclosed technology. Specifically, Figure 6BThree drug delivery lines 4261, 42622, and 4263 (shown only in part, i.e., not shown in their full length) are illustrated for wrapping around a wireframe structure (not shown) of a urethral implant of the disclosed technology. In one configuration, the drug delivery lines 4261, 42622, and 4263 are identical (different only in translation or position along the line) (i.e., they have the same geometry, the same composition, are embedded with the same drug, etc.). Alternatively, at least one drug delivery line 4261, 42622, and 4263 is different from at least one other drug delivery line in at least one aspect (e.g., different structure, embedded with a different drug, composed of a different material, having a different time release profile, etc.).

[0060] Figure 6C is a schematic diagram showing a two-line drug delivery fabric configuration (generally designated 440) covering a urethral implant of the disclosed technology. Specifically, Figure 6C Threads 4421 and 4422 of a urethral implant and a drug dispensing fabric 446 (shown only in part, i.e., not in its full length) covering the threads are illustrated. Drug dispensing fabric 446 is embedded with a drug according to the principles described above (e.g., drug dispensing thread 306). Fabric 446 can be woven or non-woven (e.g., bonded together). According to one configuration, drug dispensing fabric 446 is cloth (e.g., cotton, polyester) embedded with a drug that can dispense the drug when implanted in a subject. According to an alternative configuration, fabric 446 is a material other than cloth woven into a pattern (e.g., a polymer). Multiple materials can be interwoven into various patterns (e.g., a plain weave, etc.).

[0061] Fig.6D is a schematic diagram showing two different drug delivery line configurations (generally designated 460) for two lines of a urethral implant of the disclosed technology. Specifically, Fig.6D Wires 4621 and 4622 of a urethral implant and three drug delivery wire groups are illustrated. The first drug delivery wire group includes a drug delivery wire 4661, which is connected to the wire 4621 and extends parallel to the wire 4621. The second drug delivery wire group includes a plurality of discrete drug delivery wires 4662, which are connected to the wire 4622 and extend perpendicular to the extension direction of the wire 4622, partially extending along the length of the wire 4622. The third drug delivery wire group includes a plurality of discrete drug delivery wires 4663, which are connected to the wire 4622 and extend in an X pattern or a cross pattern along the extension direction of the wire 4622, partially extending along the length of the wire 4622. Alternative configurations (not shown) are possible (e.g., oblique patterns, O-shaped patterns, V-shaped patterns, etc.).

[0062] It will be appreciated by those skilled in the art that the disclosed techniques are not limited to those particularly shown and described above.

Claims

1. A urethral implant, comprising: at least two struts extending longitudinally between a proximal end and a distal end of the urethral implant, each of the struts being flexible between a compressed configuration that enables delivery of the urethral implant to a stricture in the urethra and an expanded configuration that facilitates dilation of the stricture; an anchor extending outwardly from at least one of the proximal end and the distal end for anchoring the urethral implant; and At least one drug delivery line is adjacent to and extends longitudinally along at least one of the struts, the drug delivery line being embedded with a drug for release into the urethra.

2. The urethral implant according to claim 1, wherein Each of the at least two struts, the anchor, and the at least one drug delivery line is a continuous line.

3. The urethral implant of claim 2, further comprising a proximal cap at the proximal end, the proximal cap being configured to cover the ends of each of the continuous lines of the at least two struts, the anchor, and the at least one drug delivery line.

4. The urethral implant according to claim 1, wherein: The urethral implant is configured to apply pressure on tissue of the urethra.

5. The urethral implant according to claim 1, wherein: The drug embedded in the at least one drug delivery line is selected from the group consisting of: sirolimus; everolimus.

6. The urethral implant according to claim 1, wherein: The at least one drug delivery line is helically wound around at least one of the struts.

7. The urethral implant according to claim 1, wherein: The at least one drug dispensing line includes a plurality of drug dispensing lines, wherein each drug dispensing line is embedded with a different drug.

8. The urethral implant according to claim 1, wherein: The at least one drug delivery line is made from at least one strand of material configured to absorb and exude the drug.

9. The urethral implant according to claim 1, wherein: The at least one drug delivery line is configured to dissolve at a controlled rate according to its characteristic time release profile after the urethral implant is implanted in a subject.

10. The urethral implant according to claim 1, wherein: Each of the at least two struts includes a twisted pair of wires extending longitudinally between the proximal end and the distal end.

11. The urethral implant according to claim 1, wherein: The urethral implant is configured to be enclosed in a sheath in the compressed configuration.

12. The urethral implant according to claim 1, wherein: The urethral implant is configured to be implanted in a prostatic urethra of a subject and to apply pressure to surrounding tissue of the prostatic urethra in the expanded configuration.

13. The urethral implant according to claim 1, wherein: The anchor is configured to prevent migration of the urethral implant toward a bladder of a subject.

14. The urethral implant according to claim 1, wherein: The urethral implant has an intermediate compressed state between the expanded configuration and the compressed configuration.

15. The urethral implant according to claim 1, wherein: The urethral implant is removable from the subject.

16. A urethral implant, comprising: three closed-shaped wires, each closed-shaped wire comprising two longitudinal segments extending between a proximal end and a distal end of the urethral implant, each longitudinal segment of a closed-shaped wire being adjacent along its length to another longitudinal segment of another of the closed-shaped wires, the closed-shaped wires being configured to engage with and dilate urethral tissue at a stricture in the urethra; an anchor, the anchor comprising an occlusive wire for anchoring the urethral implant to the urethra; and At least one drug delivery line is adjacent to and extends longitudinally along at least one of the closed-shaped lines, the drug delivery line being embedded with a drug for release into the urethra.

17. The urethral implant according to claim 16, wherein: Each of the three closed-shaped lines, the anchor and the at least one drug delivery line is a continuous line.

18. The urethral implant of claim 17, further comprising a proximal cap at the proximal end, the proximal cap being configured to cover an end of each of the three closure-shaped wires, the anchor, and the at least one drug delivery line.

19. The urethral implant according to claim 16, wherein: The urethral implant is configured to apply pressure to tissue of the prostatic urethra.

20. The urethral implant of claim 16, wherein: The drug embedded in the at least one drug delivery line is selected from the group consisting of: sirolimus; everolimus.

21. The urethral implant of claim 16, wherein: The at least one drug dispensing wire is helically wound around at least one of the three closed-shaped wires.

22. The urethral implant of claim 16, wherein: The at least one drug dispensing line includes a plurality of drug dispensing lines, wherein each drug dispensing line is embedded with a different drug.

23. The urethral implant of claim 16, wherein: The at least one drug delivery line is made from at least one strand of material configured to absorb and exude the drug.

24. The urethral implant of claim 16, wherein: The at least one drug delivery line is configured to dissolve at a controlled rate according to its characteristic time release profile after the urethral implant is implanted in a subject.

25. The urethral implant of claim 16, wherein: The urethral implant is configured to be enclosed in a sheath in a compressed configuration.

26. The urethral implant of claim 16, wherein: The urethral implant is configured to be implanted in a prostatic urethra of a subject and to apply pressure to surrounding tissue of the prostatic urethra in an expanded configuration.

27. The urethral implant of claim 16, wherein: The anchor is configured to prevent migration of the urethral implant toward a bladder of a subject.

28. The urethral implant of claim 16, wherein: The urethral implant has an intermediate compression state between the expanded configuration and the compressed configuration.

29. The urethral implant of claim 16, wherein: The urethral implant is removable from the subject.

30. The urethral implant of claim 16, wherein: The at least one drug delivery line comprises at least two drug delivery lines, whereby at least one drug delivery line adjoins at least one of the three closed-shaped lines and at least another drug delivery line adjoins the anchor.

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