URETHRAL IMPLANT

20220133462 · 2022-05-05

    Inventors

    Cpc classification

    International classification

    Abstract

    A urethral-implant is configured to be implanted within a restricted location of a urethra. The urethral-implant forms at least one closed-shape by coiling ends of a single wire section on each other. The closed-shape includes a distal section, a proximal section and two lateral sections extending between the proximal section and the distal section. The closed-shape exhibits an expanded configuration and is foldable into a compressed configuration. The urethral-implant further is configured to extend from the compressed configuration to the expanded configuration so that the distance between wire sections increases, relative to the distance between wire sections in the compressed configuration. The urethral-implant applies continuous pressure on surrounding tissue thereby applying continuous radial pressure on at least one of a urethral wall and tissue surrounding the urethral wall. The radial pressure is sufficient to cause either a widening effect, extending a urinal passage or inducing infarction.

    Claims

    1. A urethral implant configured to be implanted within a restricted location of a urethra, said urethral implant, forming at least one closed shape by coiling ends of said single wire section on each other, said at least one closed shape including a distal section, a proximal section and two lateral sections extending between the proximal section and the distal section, said at least one closed shape exhibiting an expanded configuration and is foldable into a compressed configuration, said urethral implant further being configured to extend from said compressed configuration to said expanded configuration such that the distance between sections of said wire increases, relative to the distance between said sections of said wire in said compressed configuration, said urethral implant being for applying continuous pressure on surrounding tissue thereby applying continuous radial pressure on at least one of a urethral wall and tissue surrounding the urethral wall in said restricted location, said radial pressure being sufficient to cause at least one of, a widening effect, extending a urinal passage, and inducing infarction.

    2. The urethral implant according to claim 1, wherein the shape of at least one of said at least two closed shapes is selected from the list consisting of: the shape of said at least one closed shape being wider at the proximal end than at the distal end thereof for preventing said removable implant from moving in the distal direction; the shape of at least one closed shapes being wider at the distal end than at the proximal end thereof for preventing said removable implant from moving in the proximal direction; the shape of at least one closed shapes being narrower at the middle thereof than at the distal and proximal portions thereof for preventing said removable implant from moving in the proximal direction and in the distal direction; and a butterfly wing.

    3. The urethral implant according to claim 1, further including another lateral section, connected to one of said distal section and proximal section.

    4. The urethral implant according to claim 1, wherein said at least one closed shape includes two adjacent closed shapes with a common lateral section, a first closed shaped is formed by said coiling ends of said single wire section on each other thus creating wire end extensions and thus forming a first lateral section and a second lateral section, a second closed shape is formed by coiling said two wire end extensions one with the other thus forming a third lateral section, said second lateral section being said common lateral section.

    5. The urethral implant according to claim 1, wherein said at least one closed shape includes three adjacent closed shapes with common lateral sections, a first closed shaped is formed by said coiling ends of said single wire section on each other thus creating wire end extensions and thus forming a first lateral section and a second lateral section, a second closed shape is formed by coiling said two wire end extensions one with the other thus forming a third lateral section, a third closed shape is formed by coiling said two wire end extension on said first lateral section of said first shape.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0010] The disclosed technique will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:

    [0011] FIG. 1 is a schematic illustration of a urethral implant, constructed and operative in accordance with an embodiment of the disclosed technique;

    [0012] FIG. 2 is a schematic illustration of a urethral implant, constructed and operative in accordance with another embodiment of the disclosed technique;

    [0013] FIG. 3 is a schematic illustration of a urethral implant, constructed and operative in accordance with a further embodiment of the disclosed technique;

    [0014] FIG. 4 is a schematic illustration of a urethral implant, constructed and operative in accordance with another embodiment of the disclosed technique;

    [0015] FIGS. 5A-5C are schematic illustrations of deployment of a urethral, operative in accordance with a further embodiment of the disclosed technique;

    [0016] FIGS. 6A-6E are schematic illustrations of a urethral implant, constructed and operative in accordance with another embodiment of the disclosed technique; and

    [0017] FIGS. 7A-7C are schematic illustrations of a urethral implant, constructed and operative in accordance with another embodiment of the disclosed technique.

    DETAILED DESCRIPTION OF THE EMBODIMENTS

    [0018] The disclosed technique overcomes the disadvantages of the prior art by providing a urethral implant for applying continuous pressure on the surrounding tissue, thereby causing ischemia, which results in necrosis. The urethral implant is made of a single wire section, forming at least one closed shape which includes a distal section, a proximal section and two lateral sections extending between the proximal section and the distal section. The closed shape exhibits an expanded configuration and is foldable into a compressed configuration. The urethral implant is further configured to extend from the compressed configuration to the expanded configuration such that the distance between sections of said wire increases, relative to the distance between these sections in the compressed configuration. The urethral is configured to be implanted within urethra. For example, the urethral implant may be implanted at a urethral stricture location, for applying pressure on the surrounding tissue (i.e., the inner wall) of the urethra, thereby causing ischemia at the stricture location, which results in necrosis and the widening of the urethra, allowing fluid to flow through the urethra. The urethral implant may include at least two closed shapes where each closed shape has a proximal section, a distal section and two lateral sections extending between the respective proximal section and the distal section. Adjacent pairs of the at least two closed shapes share at least one common lateral section.

    [0019] Reference is now made to FIG. 1, which is a schematic illustration of a urethral implant, generally referenced 100, constructed and operative in accordance with an embodiment of the disclosed technique. Urethral implant 100 is made of a single wire section 102, forming a closed shape, which includes a distal section 104, a proximal section 106 and two lateral sections 108.sub.1 and 108.sub.2 extending between distal section 104 and the proximal section 106. Urethral implant 100 is formed by creating the closed shape with wire 102 and then coiling wire 102 on itself.

    [0020] Reference is now made to FIG. 2, which is a schematic illustration of a urethral implant, generally referenced 150, constructed and operative in accordance with another embodiment of the disclosed technique. Urethral implant 150 is made of a single wire section 152, forming two closed shapes. The first closed shape includes a distal section 154.sub.1, a proximal section 156.sub.1 and two lateral sections 158.sub.1 and 158.sub.2 extending between distal section 154.sub.1 and the proximal section 156.sub.1. The second closed shape includes a distal section 154.sub.2, a proximal section 156.sub.2 and two lateral sections 158.sub.2 and 158.sub.3 extending between distal section 154.sub.2 and the proximal section 156.sub.2. Lateral section 158.sub.2 is a common lateral section between the two closed shapes. Urethral implant 150 is formed by first creating the first closed shape with wire 152 and then coiling wire 152 on itself. Coiling wire 152 on itself creates to wire end extensions of wires section 152. Then, the second closed shape is formed from the two wire end extensions of wire 152 and coiling the two wire end extensions of wire 152 one with the other.

    [0021] Reference is now made to FIG. 3, which is a schematic illustration of a urethral implant, generally referenced 200, constructed and operative in accordance with a further embodiment of the disclosed technique. Urethral implant 200 is made of a single wire 202, forming three closed shapes. The first closed shape includes a distal section 204.sub.1, a proximal section 206.sub.1 and two lateral sections 208.sub.1 and 208.sub.2 extending between distal section 204.sub.1 and the proximal section 206.sub.1. The second closed shape includes a distal section 204.sub.2, a proximal section 206.sub.2 and two lateral sections 208.sub.2 and 208.sub.3 extending between distal section 204.sub.2 and the proximal section 206.sub.2. The third closed shape includes a distal section 204.sub.3, a proximal section 206.sub.3 and two lateral sections 208.sub.3 and 208.sub.1 extending between distal section 204.sub.3 and the proximal section 206.sub.3. Thus, lateral section 208.sub.1 is common to the first and the third closed shapes. Thus, lateral section 208.sub.2 is common to the first and the second closed shapes and lateral section 208.sub.2 is common to the second and the third closed shapes.

    [0022] Urethral implant 200 is formed by first creating the first closed shape with wire 202 and then coiling wire 202 on itself forming lateral sections 208.sub.1 and 208.sub.2 similar to as described above in conjunction with FIG. 1. Then, the second closed shape is formed with the wire end extensions of wire 202 and coiling the two extensions of wire 202 one with the other, similar to as described above in conjunction with FIG. 2, thus forming lateral section 208.sub.3. The third closed shape is formed with the two wire end extensions of wire 202, by coiling the two wire end extension of wire 202 on lateral section 208.sub.1.

    [0023] Reference is now made to FIG. 4, which is a schematic illustration of a urethral implant, generally referenced 250, constructed and operative in accordance with another embodiment of the disclosed technique. Urethral implant 250 is similar in construction form and functionality to urethral implant 200 (FIG. 3).

    [0024] Each of the single wire urethral implants 100, 150, 200 and 250 described hereinabove is made from materials such as stainless steel or Shape Memory Alloy (SMA), such as Nickel Titanium alloy (Nitinol). The transition between the compressed configuration to the expanded configuration occurs due to the elastic (i.e., spring like) characteristics of the material. Each of the single wire urethral implants 100, 150, 200 and 250 described hereinabove may be wider at the proximal end than at the distal end thereof for preventing said removable implant from moving in the distal direction. Alternatively, Each of the single wire urethral implants 100, 150, 200 and 250 described hereinabove may be wider at the distal end than at the proximal end thereof for preventing said removable implant from moving in the proximal direction. According to yet another alternative, each of the single wire urethral implants 100, 150, 200 and 250 described hereinabove may be narrower at the middle thereof than at the distal and proximal portions thereof, for preventing said removable implant from moving in the proximal direction and in the distal direction. According to yet another alternative, each of the single wire urethral implants 100, 150, 200 and 250 described hereinabove may exhibit the shape of a butterfly wing.

    [0025] Reference is now made to FIGS. 5A-5C which are schematic illustrations of deployment of a urethral implant 300, operative in accordance with a further embodiment of the disclosed technique. Initially, urethral implant is in a compressed configuration and is located within an overtube 302 also referred to as a restrainer. Overtube 302, with urethral implant 300 compressed therein is inserted into the urethra 304, until urethral implant 300 is aligned with a stricture 306 (FIG. 5B). Thereafter, overtube 302 is pulled over urethral implant 300. Once overtube 302 is removed from over urethral implant 300, urethral implant 300 expands to the expanded configuration thereof (FIG. 5C). As urethral implant extends from the compressed configuration to the expanded configuration, urethral implant 300 applies a force on stricture 306. As a result, urethral implant 300 applies pressure on the necrosis or scar tissue at stricture 306 thereby dissecting the necrosis or scar tissue and widening urethra 304 at the stricture location. After the treatment, the implant may be pulled out of urethra 304 by reinserting overtube 302 and pulling on lead wire 308 to reinsert urethral 304 into over tube 302. Over tube 302 is then pulled out of urethra. Alternatively, urethral implant 300 may be pulled out of urethra 304 directly by pulling on lead wire 308 (i.e., without reinserting overtube 302). In FIGS. 5A-5C, urethral implant 300 includes a concave portion in at least one of the lateral sections thereof. In the expanded configuration, tissue fills this concave portion, thereby anchoring urethral implant in position.

    [0026] The exemplary urethral implants described hereinabove are made of a single wire and exhibit a “closed loop configuration”. In a “closed loop configuration”, all the lateral sections are connect to both the proximal and the distal sections. However, the urethral implants according to the disclosed technique may also exhibit an “open loop configuration”, where at least one of the lateral sections is connected only to the proximal section or only to the distal section. Also, the urethral implants according to the disclosed technique may be cut out of a metal sheet or tube.

    [0027] Reference is now made to FIGS. 6A-6E, which are schematic illustrations of a urethral implant, generally referenced 320, constructed and operative in accordance with another embodiment of the disclosed technique. Urethral implant 320 includes three lateral sections 322, 324 and 326 arranged in a closed loop configuration (i.e., lateral sections 322, 324 and 326 are connected to proximal section and the distal section of urethral implant 320). Urethral implant 320 is cut out from a metal sheet or tube. FIG. 6A depicts a top view of urethral implant 320 in a compressed configuration. FIG. 6B, depicts cross-section B-B of urethral implant 320 in the compressed configuration. FIG. 6C depicts an isometric view of urethral implant 320 in a compressed configuration. FIG. 6D depicts an isometric view of urethral implant 320 in an expanded configuration. FIG. 6E, depicts cross-section A-A of urethral implant 320 in the expanded configuration.

    [0028] Reference is now made to FIGS. 7A-7C, which are schematic illustrations of a urethral implant, generally referenced 350, constructed and operative in accordance with a further embodiment of the disclosed technique. Urethral implant 350 includes three lateral sections 352, 354 and 356 arranged in an open loop configuration (i.e., where at least one of the lateral sections is connected only to the proximal section or only to the distal section). Figure Urethral implant 350, lateral section 356 is connected only to the proximal section. Urethral implant 350 is also cut out from a metal sheet or tube. FIG. 7A depicts a top view of urethral implant 350 in a compressed configuration. FIG. 7B depicts an isometric view of urethral implant 350 in an expanded configuration. FIG. 7c depicts a side view of urethral implant 350 in the expanded configuration.

    [0029] It will be appreciated by persons skilled in the art that the disclosed technique is not limited to what has been particularly shown and described hereinabove. Rather the scope of the disclosed technique is defined only by the claims, which follow.