Urological implant

Abstract

Disclosed are embodiments of a urological implant, comprising an implant having an elongated body with a longitudinal axis. Optionally, pairs of longitudinal ribs are symmetrically disposed opposite each other and connected to the elongated body. The longitudinal ribs are optionally resiliently movable relative to the longitudinal axis of the spine between a collapsed state and an expanded state to retract and / or support urethral surrounding tissue. Optionally, the system comprises an extraction handle of the implant. The extraction handle is optionally positioned proximally of the elongated body and connected to the longitudinal ribs and subjected to a pulling force to urge and / or force the longitudinal supports towards the longitudinal axis. In some embodiments, an implant body comprises longitudinally spaced arch members sequentially interconnected along a length of a first longitudinal rib and a second longitudinal rib by arch ends.

Description

[0001] This application is a divisional application of application number 201880078997.9 (PCT application number PCT / IL2018 / 051321), filed on December 3, 2018, entitled "Urological Implant with Extraction Grip and / or Arched Member".

[0002] Related applications

[0003] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 595,147, filed December 6, 2017, and U.S. Provisional Patent Application No. 62 / 644,627, filed March 19, 2018, pursuant to 35 U.S.C. §119(e) of the United States Patent and Trademark Office, the entire contents of which are incorporated herein by reference. Technical Field

[0004] The present invention relates, in some embodiments thereof, to the field of urological medical devices and their applications, and more specifically, but not exclusively, to a urological (prostate) implant, system, and method for contracting and / or supporting a prostatic urethra and / or surrounding periurethral tissue along a length of a plurality of prostatic lobes. Background Technology

[0005] Benign prostatic hyperplasia (BPH), also known as benign prostatic hyperplasia, is a urinary tract disease in which the prostate gland enlarges and compresses the urethra. BPH affects most men over the age of 50 and therefore has significant medical and commercial implications.

[0006] Surgical treatment for benign prostatic hyperplasia (BPH) has been a routine procedure for many years. One method of this surgical treatment is open prostatectomy, in which the gland is completely or partially removed. Another surgical treatment method is transurethral resection of the prostate (TURP). Surgical treatment is an invasive procedure that can leave patients feeling weak, in pain, and suffering. This surgical treatment can lead to a variety of complications, including erectile dysfunction, urinary incontinence, bleeding, infection, and other adverse problems.

[0007] Another method of treating benign prostatic hyperplasia (BPH) involves placing a catheter at the external opening of the urethra and into the obstructed portion of the urethra to allow urine to drain from the bladder through the catheter lumen. These catheters typically employ a positioning or indwelling balloon at the distal tip, which inflates at the bladder neck and prevents the catheter from exiting the body.

[0008] Ablation techniques, based on the use of heat, such as heat generated by microwave or laser energy, can be combined with this catheter to treat enlarged parts of the prostate. However, such a procedure can cause pain and discomfort for the patient.

[0009] Despite extensive teaching and practice in the field of urology, there is still a need to develop and implement improved and new urological medical devices and their applications for the treatment of benign prostatic hyperplasia (BPH). Summary of the Invention

[0010] In some embodiments, the present invention relates to a urological (prostate) implant, system, and method for contracting and / or supporting periurethral tissue surrounding the prostatic urethra along a length of a plurality of prostatic lobes.

[0011] According to one aspect of some embodiments of the present invention, a urological implant is provided, the urological implant comprising: a connecting member; a first longitudinal rib and a second longitudinal rib, symmetrically disposed opposite to each other relative to a longitudinal axis of the implant, and elastically movable away from each other between a folded state and an expanded state; the expanded state being for contracting and / or supporting a periurethral tissue surrounding a prostatic urethra; and an implant retrieval grip connected to the first longitudinal rib on one side of the implant retrieval grip and connected to the second longitudinal rib on a second side of the implant retrieval grip, wherein the retrieval grip is configured to elastically move under a pulling force away from the connecting member to induce and / or force the first longitudinal rib and the second longitudinal rib to approach each other relative to the longitudinal axis.

[0012] According to some embodiments of the present invention, the connecting member includes at least one arched member connected at one end to the first longitudinal rib and at a second end to the second longitudinal rib.

[0013] According to some embodiments of the present invention, the arched member is tilted to the distal side in the expanded state.

[0014] According to some embodiments of the invention, the implant is configured to fold into an insertion configuration to fit into a catheter, wherein the grip portion is folded distally.

[0015] According to some embodiments of the invention, the implant is configured to fold into an extraction configuration to fit into a catheter, wherein the grip portion is folded proximally.

[0016] According to some embodiments of the present invention, a distal end of the connecting member is configured to remain close to a distal end of the rib in the expanded state.

[0017] According to some embodiments of the present invention, a distal end of the connecting member is configured to remain close to a distal end of the rib in the folded state.

[0018] According to one aspect of some embodiments of the present invention, a urological implant is provided having an extraction grip. Optionally, the implant has an elongated implant body having a longitudinal axis and two or more longitudinal ribs resiliently movable away from each other relative to the longitudinal axis between a folded state and an expanded state. Optionally, the device may be biased to the expanded state. For example, the device may be configured to support periurethral tissue surrounding a prostatic urethra in the expanded state. Optionally, in the folded state, the device may be inserted and / or extracted from the urethra (e.g., using a sheath and / or a catheter, for example, the sheath may have an inner diameter between 2 and 4 mm, and / or between 4 and 6 mm, and / or between 6 and 10 mm), for example, the device may be folded to a width between 2 and 4 mm, and / or between 4 and 6 mm, and / or between 6 and 8 mm, and / or between 8 and 10 mm. In some embodiments, pulling the implant extraction grip proximally causes the device to fold toward the folded state.

[0019] In some embodiments, the extraction grip is connected to the implant body, such as its proximal portion. Optionally, one side of the longitudinal rib is connected to a first longitudinal rib, and a second side is connected to a second longitudinal rib. Optionally, the extraction grip is configured to move elastically away from the implant body under tension to induce and / or force the first and second longitudinal ribs to approach relative to the longitudinal axis.

[0020] In some embodiments, the plurality of longitudinal ribs are interconnected by a connecting member. For example, the connecting member may include a longitudinal ridge and / or one or more arched members. Optionally, the first and second longitudinal ribs are symmetrically opposite each other. Optionally, in the expanded state when the connecting member is in a relaxed state and / or when the device is folded toward the folded state, the device body forces the plurality of longitudinal ribs to face outward.

[0021] A further feature of some embodiments is that the shape of the implant extraction grip corresponds to the outline of the urological implant at a proximal end of the urological implant in the expanded and relaxed state.

[0022] A further feature of some embodiments is that the extraction gripping portion includes a vertex.

[0023] A further feature of some embodiments is that the vertex is located at the center between the first longitudinal rib and the second longitudinal rib.

[0024] A further feature of some embodiments is that, in the relaxed state, the vertex is adjacent to a proximal end of the implant body, and the tension causes the vertex to move in a proximal direction away from the proximal end of the implant body.

[0025] A further feature of some embodiments is that the implant extraction grip is symmetrically connected to the first longitudinal rib and the second longitudinal rib.

[0026] According to one aspect of some embodiments of the present invention, a urological implant is provided, comprising:

[0027] A slender implant body having a longitudinal axis;

[0028] A first longitudinal rib and a second longitudinal rib, symmetrically opposite each other relative to the longitudinal axis and connected to the implant body, and elastically movable away from each other between a folded state and an expanded state, for contracting and / or supporting the periurethral tissue surrounding a prostatic urethra; and

[0029] An implant extraction grip is disposed proximally away from the implant body and symmetrically connected to the first longitudinal rib on one side and symmetrically connected to the second longitudinal rib on the second side.

[0030] In some embodiments, the implant retrieval grip is designed to correspond in shape to a contour of the urological implant formed by the first and second longitudinal ribs, with a apex of the retrieval grip disposed near a proximal end adjacent to the implant body.

[0031] In some embodiments, the implant retrieval grip is configured to move elastically when subjected to a pulling force emanating from the implant retrieval grip, such that the apex of the retrieval grip points in a proximal direction toward and / or along the longitudinal axis and away from the proximal end of the implant body, thereby facilitating and / or forcing the first and second longitudinal ribs to approach relative to the longitudinal axis.

[0032] In some embodiments, the connecting member includes a ridge member.

[0033] In some embodiments, when the urological implant is pulled proximally from the implant retrieval grip toward an edge of a retractable sheath surrounding a cavity, the implant retrieval grip is configured to refold the first longitudinal rib and the second longitudinal rib into the folded state, wherein the cavity is sized to accommodate the urological implant within the cavity in the folded state.

[0034] In some embodiments, each of the first longitudinal rib and the second longitudinal rib includes a proximal protruding flank and a distal protruding flank relative to the longitudinal axis, and the implant retrieval grip is connected to the first longitudinal rib and the second longitudinal rib at the plurality of proximal protruding flanks of the first longitudinal rib and the second longitudinal rib, such that when the urological implant is pulled proximally from the implant retrieval grip toward the sheath edge, the plurality of proximal protruding flanks are forced to approach each other.

[0035] In some embodiments, each of the first longitudinal rib and the second longitudinal rib is bent and includes: a proximal rib end connected to a proximal end of the spine member; a distal rib end connected to a distal end of the spine member; and an elongated rib edge portion disposed between the corresponding proximal and distal rib ends, the elongated rib edge portion being sized and shaped for positioning in a corresponding posterolateral interlobar groove when the spine member is positioned in an anterior interlobar groove in the prostatic urethra and along the anterior interlobar groove in the prostatic urethra.

[0036] According to one aspect of some embodiments of the present invention, a method for retrieving a urological implant is provided, the method comprising:

[0037] Position the edge of the extraction sheath within the prostatic urethra;

[0038] A fastener is applied to expose distally into the prostatic urethra from the extraction sheath and secured to a middle portion of an implant extraction grip; and

[0039] Pull the urological implant proximally from the implant extraction grip towards the edge of the sheath, thereby refolding the urological implant until it reaches the folded state and further withdrawing the urological implant back into the lumen of the extraction sheath.

[0040] In some embodiments, pulling the urological implant deforms the implant retrieval grip, causing multiple deformation stresses generated in the implant retrieval grip to force the first longitudinal rib and the second longitudinal rib to approach each other until the folded state is achieved.

[0041] In one aspect of some embodiments of the invention, a urological implant for contracting and / or supporting a prostatic urethral wall is provided, the implant comprising an elongated implant body having a longitudinal axis perpendicular to a transverse plane and extending along an intermediate plane between a head end and a tail end of the implant body. Optionally, the implant body is divided into two symmetrical halves.

[0042] In some embodiments, the implant body includes a plurality of longitudinally spaced arched members, each of the plurality of arched members including an unsupported arched apex located between a first arched end and a second arched end, to collectively form an arched member plane perpendicular to the intermediate plane.

[0043] In some embodiments, the plurality of arched members are interconnected by a plurality of arched ends, such that the plurality of first arched ends of the plurality of arched members are sequentially connected along a length of a first longitudinal rib, and the plurality of second arched ends of the plurality of arched members are sequentially connected along a length of a second longitudinal rib. Optionally, each of the first longitudinal rib and the second longitudinal rib extends through the transverse plane.

[0044] In some embodiments, when the implant body is subjected to a lateral compressive force passing through the intermediate plane, each of the plurality of arched members is elastically flexible to induce elastic contraction of the implant body.

[0045] In some embodiments, the implant body is designed and configured to contract and / or support an anterior portion of the prostatic urethral wall, and to allow an unsupported posterior portion of the prostatic urethral wall to collapse relative to the anterior portion.

[0046] In some embodiments, the implant body further includes: a first lateral spacer exposed from the first longitudinal rib; and a second lateral spacer exposed from the second longitudinal rib, wherein the first lateral spacer and the second lateral spacer are independently retractable when subjected to a sagittal compressive force parallel to the median plane.

[0047] In one aspect of some embodiments of the present invention, a method for supporting and / or extracting partially compressed prostatic urethral walls is provided, characterized in that the method comprises:

[0048] Provide the aforementioned urological implant;

[0049] The implant is positioned within the partially compressed prostatic urethra, wherein the implant body contracts to a selected contracted size and shape for non-invasive insertion into the partially compressed prostatic urethra, wherein each of the arched apexes is positioned adjacent to a midline of an anterior portion of the prostatic urethral wall; and

[0050] The implant body is released, thereby allowing the plurality of arched members to autonomously move the first longitudinal rib and the second longitudinal rib away from each other relative to the intermediate plane to contact the partially compressed prostatic urethral wall and retract the prostatic urethra by compressing the prostatic urethral wall.

[0051] Unless otherwise specifically defined or stated herein, all technical and / or scientific terms, terms, and / or phrases used herein have the same or similar meanings as commonly understood by one of ordinary skill in the art to which this invention pertains. The methods, materials, and examples described herein are illustrative only and are not necessarily limiting. While equivalent or similar methods and / or materials described herein may be used to implement or / and test embodiments of the invention, exemplary methods and / or materials are described below. In the event of conflict, the definition contained in the patent specification shall prevail.

[0052] Implementation of some embodiments of the present invention may involve performing or completing selected tasks manually, automatically, or in a combination thereof. Furthermore, practical instruments and devices according to some embodiments of the present invention can use a computerized operating system to implement several selected tasks through hardware, software, firmware, or a combination thereof. Attached Figure Description

[0053] This document describes some embodiments of the invention by way of example only, with reference to the accompanying drawings. Referring now specifically to the drawings, it is emphasized that the details shown are by way of example and for the purpose of illustrative description of some embodiments of the invention. In this regard, the description taken in conjunction with the drawings will make it clear to those skilled in the art how some embodiments of the invention can be practiced.

[0054] In the diagram:

[0055] Figure 1A-1D The illustration schematically depicts some embodiments of the invention, in a constricted state ( Figure 1C ) and the status of the patent Figure 1D The image shows a cross-sectional view of a male urethra.

[0056] Figure 1E-1F The illustration shows a view of an exemplary urological implant including an implant retrieval grip, according to some embodiments of the present invention.

[0057] Figure 2 This illustrates, according to some embodiments of the invention, that the urological implant described in FIG1 is deployed in a prostatic urethra model; and

[0058] Figures 3A-3FVarious exemplary scenarios are illustrated, representing multiple stages of the exemplary method for extracting the urological implant of FIG1, according to some embodiments of the present invention.

[0059] Figures 4A-4D The diagram schematically illustrates an exemplary urological implant with two spaced-apart arches, according to some embodiments of the invention.

[0060] Figures 5A-5C The diagram schematically illustrates a view of an exemplary urological implant having two lateral spacers according to some embodiments of the invention;

[0061] Figures 6A-6C The diagram illustrates an exemplary urological implant having a three-spacing arch, two lateral spacers, and an extraction grip, according to some embodiments of the invention.

[0062] Figure 7 This is a flowchart of a method for retrieving a urological implant according to an embodiment of the present invention;

[0063] Figure 8 This is a block diagram of a urological implant according to an embodiment of the present invention;

[0064] Figure 9 This is a perspective view of a three-arched urological implant in an expanded state, according to an embodiment of the present invention.

[0065] Figure 10 This is a bird's-eye view of a three-arched urological implant in an expanded state, according to an embodiment of the present invention.

[0066] Figure 11 This is a side view of a three-arched urological implant in a folded state for insertion into a urethra, according to one embodiment of the present invention.

[0067] Figure 12 This is a bird's-eye view of a three-arched urological implant in a folded state for insertion into a urethra, according to an embodiment of the present invention.

[0068] Figure 13 This is a side view of a four-arched urological implant for extraction from a urethra in a folded state, according to an embodiment of the present invention. Detailed Implementation

[0069] The present invention relates, in some embodiments thereof, to the field of urological medical devices and their applications, and more specifically, but not exclusively, to a urological (prostate) implant, system, and method for retracting and / or supporting a prostatic urethral wall and / or surrounding periurethral tissue of a prostatic urethra along a length of a plurality of prostatic lobes.

[0070] Figure 1A-1D A schematic cross-sectional view of a male urethra is shown. Figure 1B This is an enlarged view of the body portion including the prostatic urethra. The urethra connects the bladder to the urethral opening for the removal of urine and semen from the body. Additionally, the prostatic urethra merges with an ejaculatory duct approximately along its mid-length for carrying semen from the seminal vesicles. The prostatic urethra begins at the bladder neck and extends approximately 3 cm through the prostate. It begins almost vertically (caudally) from the bladder and then curves anteriorly. In light of this, the inventors believe that a urological implant with a curved body mimicking the curvature of the prostatic urethra is advantageous for both immediate implantation and long-term presence in the prostatic urethra, thereby physically influencing and maintaining a healthy and patented prostatic urethra.

[0071] Figure 1C-1D The cross-section along line 1C:1C' of the prostatic urethra is shown. Figure 1C This shows the prostatic urethra under compression, whereas in its normal state it would resemble a trefoil (three lobes) shape. On the other hand, Figure 1D The patent shows a partially opened state with one anterior lobe fully open, but both posterior lobes essentially closed. Figure 1D The patented configuration shown is considered by the inventors of the present invention to be advantageous even in the naturally fully open state, because it inhibits the reverse (cranial) flow of semen from the ejaculatory duct to the posterior part of the prostatic urethra into the bladder.

[0072] Figure 1E-1F A view of an exemplary urological implant 100 is shown. Figure 2 The urological implant 100 is shown deployed in a prostate urethra model 200. The urological implant 100 comprises:

[0073] (1) A slender body includes a spine member 101 having a longitudinal axis X;

[0074] (2) A first longitudinal rib 102 and a second longitudinal rib 103 are symmetrically arranged opposite each other and connected to an elongated body (ridge member) 101. The first and second longitudinal ribs are in a folded state relative to the longitudinal axis X of the ridge (e.g., Figure 3E (as shown) and a relaxed state (e.g., Figure 1E and 1F (As shown) can elastically move away from each other in order to contract and / or support the periurethral tissue surrounding the prostatic urethra 200; and

[0075] (3) An implant retrieval grip 104 is disposed proximally away from the spinal member 101 (see gap 105) and is symmetrically connected to the first longitudinal rib 102 on one side 106 and symmetrically connected to the second longitudinal rib 103 on the second side 107.

[0076] The implant retrieval grip 104 is configured to correspond in shape to a contour of the urological implant 100 formed by the first and second longitudinal ribs 102, 103, and an apex 120 of the retrieval grip 104 is disposed at a proximal end 121 adjacent to the implant body 101.

[0077] The implant retrieval grip 104 is configured to move elastically when subjected to a pulling force, such that the apex 120 of the retrieval grip points in a proximal direction toward and / or along the longitudinal axis X, and away from the proximal end 121 of the implant body, to facilitate and / or force the first and second longitudinal ribs 102, 103 to approach relative to the longitudinal axis X.

[0078] The implant retrieval grip 104 is configured to refold the first and second longitudinal ribs 102, 103 into the folded state, wherein the urological implant 100 is pulled proximally from the implant retrieval grip 104 against an edge of a retractable sheath surrounding an inner cavity, the size of which is sufficient to accommodate the urological implant in the folded state (this will be further detailed in the following description with reference to FIG3).

[0079] Each of the first and second longitudinal ribs 102, 103 includes a proximal protruding lateral angle 108 and a distal protruding lateral angle 109 relative to the longitudinal axis X. An implant retrieval grip 104 is connected to the first and second longitudinal ribs 102, 103 at the proximal protruding lateral angle 108 such that when the urological implant 100 is pulled proximally from the implant retrieval grip 104 toward the sheath edge, the plurality of proximal protruding lateral angles 108 are forced to approach each other.

[0080] Each of the first and second longitudinal ribs 102, 103 is bent and includes a proximal rib end 110 connected to a proximal end 111 of the spine member 101; a distal rib end 112 connected to a distal end 113 of the spine member 101; and a rib edge portion 114 disposed between the corresponding proximal and distal rib ends 110, 112 of each pair. The rib edge portion 114 is sized and shaped to be positioned in a corresponding posterolateral interlobar groove when the spine member 101 is positioned in an anterior interlobar groove 201 in the prostatic urethra 200 and along the anterior interlobar groove 201 in the prostatic urethra 200.

[0081] The implant retrieval grip 104 is designed to correspond to a contour formed by a proximal portion 115 of a plurality of proximal rib ends 110 along the first and second longitudinal ribs 102, 103.

[0082] Figures 3A-3F Various scenarios are illustrated to represent multiple stages in an exemplary method for retrieving a urological implant 100. The urological implant 100 is secured to a distal portion 116 of its body using an elastic tether 202, representing and simulating normal mechanical resistance exerted from multiple walls of a prostatic urethra during implant 100 withdrawal.

[0083] Figure 3A This illustrates positioning one edge 301 of an extraction sheath 300 near the proximal end 115 of a urological implant 100, as in the case where it is positioned in the prostatic urethra.

[0084] Figure 3B The application of a fastening (clamping) device 302 exposed from the distal side of the extraction sheath 300 (simulating exposure in the prostatic urethra) is shown.

[0085] Figure 3C The fastener 302 is shown to grip (tighten) an intermediate portion of the implant extraction grip 104 and pull the urological implant 100 proximally from the implant extraction grip 104.

[0086] Figure 3D The diagram shows the urological implant 100 being pulled against edge 301, then forced to fold back. Figure 3E Until the folded state is reached, allowing it to be further retracted into the inner cavity 303 of the extraction sheath 300. Figure 3F ).

[0087] As shown in the figure, pulling on the urological implant 100 (e.g., under mechanical resistance from multiple walls of the prostatic urethra) deforms the implant extraction grip 104, causing deformation stress to occur therein to force the first and second longitudinal ribs 102, 103 to approach each other until the folded state is achieved.

[0088] Each of the following terms, written in singular grammatical form: “a (a, an)” and “the”, means “at least one” or “one or more” herein. The use of the phrase “one or more” herein does not alter the intended meaning of “a (a, an)” or “the”. Therefore, unless expressly defined or stated herein, or unless clearly defined in the text, the terms “a (a, an)” and “the” as used herein may also mean and include multiple stated entities or objects. For example, the phrases used herein: “a unit,” “a device,” “a component,” “a mechanism,” “a part,” “an element,” and “a step or procedure” may also mean and include multiple units, multiple devices, multiple components, multiple mechanisms, multiple parts, multiple elements, and multiple steps or procedures, respectively.

[0089] Each of the following terms—“includes,” “has,” “having,” and “comprises,” as used herein, and their language / grammatical variations, derivatives, and / or conjugates—means “includes but is not limited to” and should be considered as specifying the stated components, features, properties, parameters, integers, or steps, without excluding the addition of one or more additional components, features, properties, parameters, integers, or steps, or groups thereof. Each of these terms is semantically equivalent to the phrase “consisting essentially of.”

[0090] Figures 4A-4D A schematic view of an exemplary urological implant 400 with two spaced arches is shown. Figure 4AThe illustration shows a side view of the implant 400 inserted into a portion of the prostatic urethra adjacent to the bladder neck, having a head end 401 and a tail end 402 near the opening of the ejaculatory duct into the prostatic urethra. The implant 400 may be sized to extend along the entire length of the prostatic urethra or only a portion thereof (e.g., from a portion near the tail of the bladder neck to a portion near the head of the opening of the ejaculatory duct). The implant 400 may optionally be shaped and configured to support a protrusion against the body to constrict the prostatic urethra opening to the bladder neck. The implant 400 includes an elongated implant body 403 having a longitudinal axis 404. The longitudinal axis 404 is perpendicular to a transverse plane 405 and extends between a head end 401 and a tail end 402 to divide the implant body 403 into two symmetrical halves along a median plane 406.

[0091] The implant body 403 includes a plurality of longitudinally spaced arched members, including a rearmost arched member 407 and a headmost arched member 408, each including an unsupported arched apex 409 located between a first arched end 410 and a second arched end 411 to collectively form an arched member plane perpendicular to the intermediate plane 406, including a headmost arched member plane 412a formed by the arched apex 409 and the first and second arched ends 410, 11 of the headmost arched member 407, and a rearmost arched member plane 412b formed by the arched apex 409 and the first and second arched ends 410, 11 of the tailmost arched member 408. The distance between any two closest arched apexes 409 may optionally be in the range of 5 mm to 15 mm.

[0092] Multiple arched members 407 and 408 are interconnected by multiple arched ends, such that multiple first arched ends 410 are sequentially connected along a length of a first longitudinal rib 413, and multiple second arched ends 411 are sequentially connected along a length of a second longitudinal rib 414. Each of the first and second longitudinal ribs 413 and 414 extends through a transverse plane 405.

[0093] like Figure 4DAs shown, each of the plurality of arched members 407 and 408 is elastically bendable to induce elastic contraction of the implant body 403 when subjected to a lateral compressive force TF passing through the intermediate plane 406. The implant body 403 is sized and configured to contract and / or support an anterior portion of the prostatic urethral wall, and to allow an unsupported posterior portion of the prostatic urethral wall to collapse relative to the anterior portion. Optionally and additionally, the implant body 403 is sized and configured to induce a physical resistance of the collapsed unsupported posterior portion to a retrograde flow of semen, wherein the retrograde flow of semen flows from the collapsed unsupported posterior portion toward the bladder neck.

[0094] The intersection of the transverse plane 405 and the plane 412a of the first arch member forms an angle β at the first arch member, which falls within the range of 20 to 40 degrees. The intersection of the transverse plane 405 and the plane 412b of the last arch member forms an angle α at the last arch member, which falls within the range of 10 to 50 degrees.

[0095] Figures 5A-5C A schematic view of an exemplary variant 400' of a urological implant 400 is shown, which is structurally and functionally similar to... Figure 2 The previous variations shown are similar or identical, but they also include two lateral spacers: a first lateral spacer 415 protruding from the first longitudinal rib 413 and a second lateral spacer 416 protruding from the second longitudinal rib 414. These lateral spacers are independently retractable when subjected to a sagittal compressive force parallel to the median plane 406.

[0096] Each of the first and second lateral spacers includes a support rib 417 curved to a curvature similar to a posterior surface of the prostatic urethra. A first portion of the plurality of support ribs 417 is interconnected with a first longitudinal rib 413 via at least one support connection portion, and a second portion of the plurality of support ribs 417 is interconnected with a second longitudinal rib 414. The at least one support connection portion includes a first support connection portion 418 and a second support connection portion 419. The support ribs 417 and / or the plurality of connection portions 418 and 419 are elastically bendable, such as… Figure 5C As schematically shown, when subjected to a sagittal compressive force SF, the elastic contraction of the lateral spacers 415 and 416 causes the support rib 417 to return to a corresponding one of the first longitudinal rib 413 and the second longitudinal rib 414.

[0097] Each of the first and second lateral spacers 415 and 416 forms a closed pattern with a first or second support rib 417 and a first longitudinal rib 413 or a second longitudinal rib 414, as well as a first support connection portion 418 and a second support connection portion 419. The closed pattern surrounds a contact surface configured to contract and / or support the prostatic urethral wall. Optionally, the closed pattern resembles a meniscus lens shape, having: first and second support ribs 417 with a convex profile designed as a meniscus lens shape, and first longitudinal ribs 413 and second longitudinal ribs 414 with a concave profile designed as a meniscus lens shape. The closed pattern is formed by a thin strip that combines multiple support connection portions 418 and 419, the first or second support rib 417, and the first or second longitudinal rib 413 or 414.

[0098] Each of the first longitudinal rib 413 and the second longitudinal rib 414 forms: a first upper corner 420 having a first support connection portion 418; and a second upper corner 421 having a second support connection portion, wherein the rearmost arched member 408 extends between the respective plurality of first upper corners, and a frontmost arched member 407 extends between the respective plurality of second upper corners.

[0099] Figures 6A-6C This diagram shows a view of an exemplary urological implant 500 for contracting and / or supporting a prostatic urethral wall. The implant 500 includes an elongated implant body 501 having a longitudinal axis 502 perpendicular to a transverse plane 503 and extending between a head end 504 and a tail end 505, dividing the implant body 501 into two symmetrical halves along a mid-plane 506.

[0100] The implant body 501 includes a plurality of longitudinally spaced arched members, comprising a rearmost arched member 507, a headmost arched member 508, and an intermediate arched member 509. Each arched member includes an unsupported arched apex 510 located between a first arched end 511 and a second arched end 512, collectively forming an arched member plane perpendicular to the intermediate plane 506. Each of the plurality of arched members is unsupported or interconnected along its length, including an apex 510, but connected only by its plurality of arched ends such that a plurality of first arched ends 511 are sequentially connected along a length of a first longitudinal rib 513, and a plurality of second arched ends 512 are sequentially connected along a length of a second longitudinal rib 514; both the first longitudinal rib 513 and the second longitudinal rib 514 extend through the transverse plane 503. The distance between any two closest plurality of arched apexes 510 falls within the range of 5 mm to 15 mm.

[0101] Each of the plurality of arched members 507, 508, and 509 is elastically bendable about a longitudinal axis 502 to induce elastic contraction of the implant body 501 when subjected to a lateral compressive force passing through the intermediate plane 506. The implant body 501 is sized and configured to contract and / or support an anterior portion of the prostatic urethral wall, thereby allowing an unsupported posterior portion of the prostatic urethral wall to collapse relative to the anterior portion, and causing a physical resistance to a retrograde flow of semen from the collapsed unsupported posterior portion toward the bladder neck.

[0102] The angle β formed by the intersection of the transverse plane 503 and a plane 515 of the first arched end 511 and the second arched end 512 of the first arched member 508 and the arched vertex 510 falls within the range of 20 to 40 degrees. The angle α formed by the intersection of the transverse plane 503 and a plane 516 of the last arched member 507, formed by the first arched end 511 and the second arched end 512 of the last arched member 507 and the arched vertex 510, falls within the range of 10 to 50 degrees. The arched vertex 510 and the first arched end 511 and the second arched end 512 of the intermediate arched member 509 form an intermediate arched member plane, which is parallel to the transverse plane 503.

[0103] A first lateral spacer 517 protrudes from a first longitudinal rib 513, and a second lateral spacer 518 protrudes from a second longitudinal rib 514. Each is independently retractable when subjected to a sagittal compressive force parallel to the median plane 506. The first and second lateral spacers 517 and 518 are configured to approach each other toward the median plane 506 as the plurality of arched members are bent about the longitudinal axis 502 and the implant body 501 is retracted. The first lateral spacer 517 includes a first support rib 519 interconnecting with the first longitudinal rib 513, and the second lateral spacer 518 includes a second support rib 520 interconnecting with the second longitudinal rib 514 via a first support connection portion 521 and a second support connection portion 522. Multiple support ribs 519 and 520 and / or multiple connecting portions 521 and 522 are elastically bendable to induce elastic contraction of lateral spacers 517 and 518, wherein, when subjected to sagittal compressive force, the elastic contraction of the first lateral spacer 517 and the second lateral spacer 518 induces the support ribs 519 and 520 to return to a corresponding (first or second) longitudinal rib (513 or 514).

[0104] Each of the first and second lateral spacers 517 and 518, together with its respective plurality of support ribs and longitudinal ribs, and together with the first and support connection portions 521 and 522, forms a closed pattern. The closed pattern surrounds a contact surface configured to contract and / or support the prostatic urethral wall, and is resembling a meniscus lens shape having: a plurality of support ribs 519 and 520, profiled as a convex surface of the meniscus lens shape; and a first longitudinal rib 513 and a second longitudinal rib 514, profiled as a concave surface of the meniscus lens shape. The closed pattern is formed by a thin strip that incorporates its respective plurality of support connection portions, support ribs, and longitudinal ribs.

[0105] Each of the first and second longitudinal ribs 513 and 514 forms a first upper corner 523 having a first support connection portion 521; and a second upper corner 524 having a second support connection portion 522. The rearmost arched member 508 extends between the corresponding first upper corners 523, and the headmost arched member 507 extends between the corresponding second upper corners 524.

[0106] The arch apex 510 of each arched member is located above the first longitudinal rib 513 and the second longitudinal rib 514 relative to the longitudinal axis 502, and points away from the first longitudinal rib 513 and the second longitudinal rib 514, such that when the implant supports the prostatic urethral wall, the arch apex 510 is located on a midline adjacent to an anterior portion of the prostatic urethral wall, and the first longitudinal rib 513 and the second longitudinal rib 514 are positioned closer to a posterior portion of the prostatic urethral wall.

[0107] When in a relaxed but non-folded configuration (e.g.) Figures 6A-6C As shown, the implant body 501 has a total height H ranging from 10 mm to 40 mm and a width W ranging from 8 mm to 30 mm. When the implant body 501 is in a relaxed but not folded configuration, a plurality of arched members form a nominal angle ranging from 0 to 60 degrees along their respective arched member planes. The implant body 501 is configured to apply a contractile resistance of at least 100 grains of force (grf) when the plurality of arched members are forced into a compression angle at least 20% less than their nominal angle, thereby contracting and / or supporting the prostatic urethral wall to form a selected nominal opening size across the prostatic urethra. The selected nominal opening size optionally has a cross-sectional area of ​​at least 10 square millimeters.

[0108] The implant 500 further includes an implant retrieval grip 525, which is configured to be located distally away from the implant body 501 and symmetrically connected to a first lateral spacer 517 on one side 526 of the implant body 501, and symmetrically connected to a second lateral spacer 518 on a second side 527 of the implant body 501. The shape of the implant retrieval grip 525 corresponds to a profile of the urological implant 500, which is formed by the first lateral spacer 517 and the second lateral spacer 518. The profile has a retrieval grip apex 528 of the implant retrieval grip 525, which is positioned adjacent to the arch apex 510 of the distal arched member 507 and configured to respond to a pulling force PL (e.g., ...) originating from the implant retrieval grip 525. Figure 6B (Illustrated by the dashed line in the diagram) under the action of elastic movement, such that the apex 528 of the extraction grip points in a tail direction toward the longitudinal axis 502 and / or along the longitudinal axis 502, and away from the arch apex 510 of the most tail arched member 507.

[0109] When the implant 500 is pulled toward the tail via / from the implant retrieval grip 525, the implant retrieval grip 525 is configured to retract the first and second lateral spacers 517 and 518, optionally opposite a surface, for example, when in a folded state, opposite an edge of a retractable sheath surrounding an inner cavity, wherein the size of the inner cavity is for accommodating the implant.

[0110] Each of the first support rib 519 and the second support rib 520 forms a lower corner 529 having a corresponding tail-end support connection portion 522, wherein the implant extraction grip 525 is connected at one side 526 of the implant extraction grip 525 to one of the plurality of lower corners 529 at the first lateral spacer 517, and to the other of the plurality of lower corners 529 at the second side 527 of the implant extraction grip 525 to the second lateral spacer 518.

[0111] The present invention further describes a method for supporting and / or extracting partially compressed prostatic urethral walls by applying a urological implant of the present invention, such as implant 400 (optionally, particularly variant 400') or implant 500. The method comprises at least one of several steps, not necessarily in the same order:

[0112] The implant body 401 / 501 is retracted from a relaxed, non-contraction configuration by elastically bending multiple arched members 407 and 408 / 507, 508 and 509, and the first and second longitudinal ribs 413 and 414 / 513 and 514 are brought together.

[0113] The implant 400 / 500 is positioned in the partially compressed prostatic urethra, wherein the implant body 401 / 501 is contracted into a selected contracted size and shape to be configured for non-invasive insertion into the partially compressed prostatic urethra, wherein each arched apex 409 / 510 is positioned adjacent to a midline of an anterior portion of the prostatic urethral wall.

[0114] The implant body 401 / 501 is released, thereby allowing the plurality of arched members 407 and 408 / 507, 508 and 509 to autonomously distance the first and second longitudinal ribs 413 and 414 / 513 and 514 from each other relative to the intermediate plane 406 / 506 to contact the partially compressed prostatic urethral wall and retract the prostatic urethra by compression against the prostatic urethral wall. The release step may include: retracting and / or supporting an anterior portion of the prostatic urethral wall and allowing an unsupported posterior portion of the prostatic urethral wall to collapse relative to the anterior portion. The release step may include: allowing the implant body to cause a physical resistance to a retrograde flow of semen from the collapsed unsupported posterior portion toward the bladder neck.

[0115] The selected shrinkage size may be generated by at least one of the plurality of support ribs 417 / 519 and 520 and the plurality of support connection portions 418 and 419 / 521 and 522 elastically bending by bringing the support rib close to a corresponding first or second longitudinal rib, or may be generated by the application of a plurality of forces from the prostatic urethral wall to the support rib during the positioning.

[0116] Figure 7 This is a flowchart of a method for retrieving a urological implant according to an embodiment of the present invention. In some embodiments, a urological implant includes a retrieval grip. Optionally, the implant is provided in a relaxed state (e.g., as shown in the diagram). Figure 1E , 1F (As shown in 2, 3A, 3B and 8). For example, the implant can expand within a urethra to support periurethral tissue and / or maintain an open urethra. Optionally, pulling the proximal portion 755 relative to the implant body causes the implant to fold 757 (e.g., as shown in 2, 3A, 3B and 8). Figure 3C and 8(As shown). For example, the plurality of ribs may be folded 757 toward and / or away from a longitudinal axis of the device and away from a plurality of walls of the urethra. In some embodiments, the extraction grip may be pulled 755 into a sheath (e.g., a catheter) by a fastener. Optionally, when the device is pulled, the extraction grip may be wedge-shaped with a apex facing the sheath. For example, when the grip is pulled 755 into the sheath 755, the plurality of angled sides of the grip may be pushed together by the plurality of inner walls of the sheath, further folding the grip 759. Optionally, the plurality of sides of the grip may be connected to the plurality of ribs of the implant and / or the grip may be further folded 759 to further fold 757 the plurality of ribs of the implant, facilitating retraction of the implant into the sheath.

[0117] Figure 8This is a block diagram of a urological implantation system according to an embodiment of the present invention. In some embodiments, an implant includes a connecting member 808, such as an arch and / or a ridge. Optionally, the connecting member 808 is connected to one or more longitudinal ribs 802, 803. The plurality of ribs 802, 803 are optionally spaced apart from each other (e.g., laterally away from a longitudinal axis of the body) and diffuse into a supporting tissue in a urethra. Optionally, the plurality of ribs 802, 803 and / or the connecting member 808 are connected to a retrieval grip 804. For example, the retrieval grip 804 may be positioned proximal to the connecting member 808. In some embodiments, when the retrieval grip 804 is pulled proximally, the plurality of ribs 802, 803 retract toward each other (e.g., laterally toward a longitudinal axis of the body). For example, retraction may make it easier to retrieve the device from a urethra. Optionally, the implant and / or the extraction grip 804 may include a wedge 886 and / or a vertex 888. For example, pulling the extraction grip 804 and / or the vertex 888 proximally positions the vertex 888 proximally on the implant. Optionally, pulling the implant and / or the extraction grip 804 and / or the vertex 888 proximally into an extraction sheath 880 may pull the wedge 886 into the sheath 880. For example, by pulling the wedge 886 into the sheath 880, the plurality of walls of the sheath 880 may push the wedge 886 inward, thereby further folding the implant laterally inward. For example, the plurality of ribs 802, 803 may fold toward the longitudinal axis of the body 801. For example, a distal end of the sheath 880 may be positioned proximally to the implant, and / or a fastener 882 may extend from the distal end of the extraction sheath 880. Optionally, the fastener 882 may pass through the sheath 880 from its proximal end. The fastener 882 may be secured to the extraction grip 804 and / or pulled proximally into the extraction sheath 880 to pull the extraction grip 804 and / or fold the implant and / or retract the wedge 886 back into the sheath 880 and / or retract the entire implant back into the sheath 880.

[0118] Figure 9This is a perspective view of a three-arched urological implant in an expanded state, according to an embodiment of the present invention. The exemplary device comprises three arched components. For example, a proximal arch includes a retrieval grip 904 and / or two distal arches 908a and 908b, the two distal arches 908a and 908b including multiple connecting members. Optionally, the proximal arch (grip 904) also includes a connecting member. For example, the grip 904 and / or connecting members 908a, 908b are connected between two longitudinal ribs 901. Optionally, each longitudinal rib 901 may have a closed form. For example, the closed form may include an almond shape (e.g., having two tips). For example, the almond shape may facilitate folding of the device. Alternatively or additionally, the closed form may comprise an ellipse and / or a rectangle and / or a parallelogram and / or an almond shape having a point and / or a curve (e.g., the ribs having one or more arches may form a wedge (e.g., a fan shape)) and / or another form. Optionally, the device is biased to and / or relaxed in the extended state.

[0119] In some embodiments, the device is configured to inhibit movement of the device into the bladder. For example, the distal arch 908a and / or an intermediate arch 908a and / or the grip 904 are tilted distally. Optionally, when the implant is disposed in the prostatic urethra and the distal side of the device faces the bladder (e.g., the proximal end of the implant faces the tail and / or the distal end faces the head), the distal tilt of the plurality of arches prevents the device from migrating distally toward the bladder. For example, forcing the device distally causes the plurality of arches to straighten and / or chisel into the urethral wall, thereby inhibiting distal movement of the device. Optionally, different connecting members may be tilted in different directions. For example, as Figure 6A As shown, a distal connector 508 may be tilted proximally and / or a proximal connector 507 may be tilted distally and / or an intermediate connector 509 may be oriented perpendicular to a rib 514.

[0120] In some embodiments, a connecting member may include a bend and / or fold (e.g., each of the plurality of arches 908a, 908b and the grip 904 includes a U-shaped fold 991 at its center along the axis of the device). For example, the fold 991 may make the device more flexible and / or easier to fold. In some embodiments, the plurality of ribs and / or the plurality of arches are configured to be flexible enough to fit urethra of different sizes. For example, the almond shape of the plurality of ribs and / or the fold 991 of the plurality of connecting members may increase the flexibility of the device. For example, a device may be flexible enough to fit a urethra with a height between 6 and 11 mm.

[0121] In some embodiments, the grip 904 is configured to be more flexible than one or more other arches 908a, 908b. For example, the grip 904 may be made of a thinner material (e.g., thinner to between 0 and 10% and / or thinner to between 10 and 50% and / or thinner to between 50 and 80%, for example, the material of the plurality of arches may be between 0.4 and 0.6 mm and / or the thickness of the material of the grip may be between 0.2 and 0.4 mm).

[0122] In some embodiments, the flexibility of a grip portion can be enhanced by the direction of a contact point and / or its curvature. For example, grip portion 904 connects to rib 901 with a contact point generally pointing proximally, and then grip portion 904 bends distally. For example, at the contact point between grip portion 904 and rib 901, the grip portion points distally than the direction in which arches 908a and 908b connect to rib 901. For example, the curvature of grip portion 904 is greater than that of arches 908a and 908b.

[0123] In some embodiments, the distal connector 908a is positioned to avoid impact to a subject's bladder. For example, connector 908a may be connected to a proximal portion of rib 901 (e.g., 50% and / or 25% of the length of the body of the device, away from rib 901 and / or the body of the device). Optionally, arches 908a, 908b and / or grip 904 are configured in an expanded configuration (e.g., as shown in the image). Figure 9 and 10 (as shown) and / or in a folded configuration (e.g., as shown) Figure 11 and 12 As shown and / or as Figure 13The distal end of rib 901 (as shown in distal connector 1308a) remains proximal. Alternatively or additionally, a connecting member (e.g., an arch and / or multiple arches) may extend distally in one or both folded states (e.g., a folded state for insertion and / or a folded state for extraction), but not in the expanded state. Alternatively or additionally, in some embodiments, a connecting member may extend distally in the expanded state and / or in both the expanded and folded states.

[0124] Figure 10 This is a bird's-eye view of a three-arched urological implant in an expanded state, according to an embodiment of the present invention.

[0125] Figure 11 This is a side view of a three-arched urological implant in a folded state for insertion into a urethra, according to one embodiment of the invention. For example, before insertion into a patient, the device is folded into an insertion state and inserted into a catheter 980. Optionally, in an insertion configuration, the grip 904 is folded distally toward the body of the device (e.g., toward the plurality of ribs 901 and / or the plurality of arches 908a, 908b). Optionally, in the insertion configuration, the grip 904 is folded in the same direction as one, some, or all of the plurality of arches 908a, 908b.

[0126] Figure 12 This is a bird's-eye view of a three-arched urological implant in a folded state for insertion into a urethra, according to an embodiment of the present invention.

[0127] Figure 13 This is a side view of a four-arched urological implant 1301 in a folded state for extraction from a urethra, according to an embodiment of the present invention. For example, when extracting the implant 1301, a extraction grip 1304 is pulled proximally. Pulling the extraction grip 1304 proximally and / or pulling the device into a sheath 980 may optionally fold the implant 1301 (e.g., as shown in the image). Figures 3A-3F (as described in 7 and 8). Folding the implant 1301 optionally facilitates pulling the device into the sheath 980 and / or retrieving the device from the urethra and / or repositioning the device from the urethra. In some embodiments, in the retrieved folded state, the grip 1304 is pulled proximally and / or all connecting components (e.g., distal arch 1308a, intermediate arch 1308b, and / or proximal arch 1308c) are folded distally and / or the body of the device (e.g., including the rib 1301) is folded inward.

[0128] In some embodiments, a variety of implants of different sizes may be used. For example, a four-arched implant 1301 may be larger than a three-arched implant 901.

[0129] As used herein, the phrase "consisting of" means "including and limited to". Optionally, the extraction grip is located at one proximal end and / or on the proximal side of the device.

[0130] As used herein, the phrase “consistently of” means the stated entity or item (system, system unit, system subunit, device, component, subcomponent, mechanism, structure, part, element or peripheral equipment, auxiliary equipment, fittings or materials, method or process, step or procedure, substep or subroutine) that is all or part of an exemplary embodiment of the disclosed invention, and / or that is an exemplary embodiment for carrying out the disclosed invention, and may include at least one additional “feature or characteristic” that is a system unit, system subunit, device, component, subcomponent, mechanism, structure, part, element or peripheral equipment, auxiliary equipment, fittings or materials, method or process, step or procedure, substep or subroutine), provided that each such additional “feature or characteristic” does not materially alter the essential novelty and inventiveness or particular technical features or items of the claimed entity.

[0131] As used herein, the term "method" refers to steps, procedures, manners, means, and / or techniques for accomplishing a given task, including but not limited to those steps, procedures, manners, means, and / or techniques derived from known steps, procedures, manners, means, and / or techniques by those skilled in the art of the relevant field of the disclosed invention, or those steps, procedures, manners, means, and / or techniques readily developed from known steps, procedures, manners, means, and / or techniques.

[0132] Throughout this disclosure, numerical values ​​of parameters, features, characteristics, objects, or dimensions may be stated or described in a numerical range format. As used herein, such a numerical range format illustrates implementations of some exemplary embodiments of the invention and does not rigidly limit the scope of exemplary embodiments of the invention. Therefore, a stated or described numerical range also refers to and encompasses all possible subranges and individual numerical values ​​(where numerical values ​​may be represented as wholes, integers, or fractions) within that stated or described numerical range. For example, the stated or described numerical range “1 to 6” also refers to and encompasses all possible subranges, such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc., as well as individual numerical values ​​within the stated or described numerical range of “1 to 6”, such as “1”, “1.3”, “2”, “2.8”, “3”, “3.5”, “4”, “4.6”, “5”, “5.2”, and “6”. This applies regardless of the breadth, extent, or size of the stated or described numerical range.

[0133] Throughout this disclosure, the term "proximal" refers to a location within a patient's body closest to the entry point of a medical device or implant, and the term "distal" refers to a location within a patient's body furthest from that entry point.

[0134] Furthermore, to state or describe a numerical range, the phrase "between approximately a first value and approximately a second value" is considered equivalent to the phrase "between approximately a first value and approximately a second value." Therefore, the two equivalent phrases can be used interchangeably. For example, to state or describe the numerical range of room temperature, the phrase "room temperature refers to a temperature between approximately 20°C and approximately 25°C" is considered equivalent to and refers to the term "room temperature refers to a temperature between approximately 20°C and approximately 25°C."

[0135] As used herein, the term “approximately” means ±10% of the stated value.

[0136] As used herein, the phrase “operatively connected” is equivalent to the corresponding synonym phrases “operatively joined” and “operatively attached,” which refer to operative connection, operative joining, or operative attachment in a physical and / or electrical, or / and electronic, or / and mechanical, or / and electromechanical manner or nature, involving various types and kinds of hardware and / or software devices and components.

[0137] It should be fully understood that, for clarity, certain aspects, features, and characteristics of the invention exemplarily described and presented in the context or format of multiple individual embodiments may also be exemplarily described and presented in any suitable combination or sub-combination in the context or format of a single embodiment. Conversely, various aspects, features, and characteristics of the invention illustratively described and presented in combination or sub-combination in the context or format of a single embodiment may also be illustratively described and presented in separate embodiments in the context or format of multiple embodiments.

[0138] Although the invention has been illustratively described and presented by way of specific exemplary embodiments and examples, it will be apparent to those skilled in the art that many alternatives, modifications and / or variations will be readily apparent. Therefore, all such alternatives, modifications and / or variations should fall within and be covered by the spirit and scope of the appended claims.

[0139] All publications, patents, and / or patent applications cited or referenced in this disclosure are incorporated herein by reference in their entirety as if each individual publication, patent, and / or patent application were cited separately, specifically and individually indicating their inclusion herein by reference. Furthermore, any reference or designation of any reference in this specification should not be construed or interpreted as an admission that such reference represents or corresponds to prior art of the invention. The use of section headings should not be construed as necessarily limiting.

Claims

1. A urological implant for contracting and / or supporting a prostatic urethral wall, characterized in that, The implant includes an elongated implant body having a longitudinal axis perpendicular to a transverse plane and extending between a head end and a tail end of the implant body to divide the implant body into two symmetrical halves along a mid-plane. The implant body comprises: A first longitudinal rib and a second longitudinal rib extend through the transverse plane and are planar symmetrical to each other with respect to the intermediate plane; A first lateral spacer and a second lateral spacer, the first lateral spacer protruding from a first longitudinal rib, the second lateral spacer protruding rearward from a second longitudinal rib, each of the first and second lateral spacers including a support rib connected to the first or second longitudinal rib via at least one support connection portion, wherein at least one of the support rib and the support connection portion is elastically flexible to cause elastic contraction of the first and second lateral spacers, so that when subjected to a sagittal compressive force along the median plane, the support rib can recoverably approach the longitudinal rib; and Multiple arched members connect the first lateral spacer and the second lateral spacer, each of the multiple arched members being elastically flexible to cause the implant body to elastically contract when subjected to a lateral compressive force perpendicular to the intermediate plane.

2. The urological implant as described in claim 1, characterized in that, Each of the first longitudinal rib and the second longitudinal rib forms: a first upper corner having a first portion of the plurality of support connection portions; and a second upper corner having a second portion of the plurality of supporting connection portions, wherein a first of the plurality of arched members extends between the plurality of corresponding corners of the first upper corner, and a second of the plurality of arched members extends between the plurality of corresponding corners of the second upper corner.

3. The urological implant as described in claim 1, characterized in that, The arched member tilts to the distal side in an expanded state.

4. The urological implant as described in claim 1, characterized in that, The implant is configured to fold into an insertion configuration to fit into a urinary catheter.

5. The urological implant as described in claim 1, characterized in that, One distal end of the arched member is configured to remain close to one distal end of the rib in an expanded state.

6. The urological implant as described in claim 1, characterized in that, One distal end of the arched member is configured to remain close to one distal end of the rib in a folded state.

7. The urological implant as described in claim 1, characterized in that, The proximal end of the urological implant is formed by the first longitudinal rib and the second longitudinal rib.

8. The urological implant as described in claim 1, characterized in that, The urological implant includes a spinal component.

9. The urological implant as described in claim 8, characterized in that, Each of the first longitudinal ribs and the second longitudinal ribs is bent and includes: a proximal rib end connected to a proximal end of the spine member; a distal rib end connected to a distal end of the spine member; and an elongated rib edge portion disposed between the corresponding proximal and distal rib ends, the elongated rib edge portion being sized and shaped for positioning in a corresponding posterolateral interlobar groove when the spine member is positioned in an anterior interlobar groove in the prostatic urethra and along the anterior interlobar groove in the prostatic urethra.

10. The urological implant as claimed in claim 1, characterized in that, The implant body is designed and configured to contract and / or support an anterior portion of the prostatic urethral wall, and This allows an unsupported posterior portion of the prostatic urethral wall to collapse relative to the anterior portion.

11. The urological implant as claimed in claim 10, characterized in that, The anterior portion extends between a bladder neck and an opening in the prostatic urethral wall, the opening opening into an ejaculatory duct, wherein the implant body is designed and configured to induce a physical resistance to a retrograde flow of semen from the collapsed, unsupported posterior portion toward the bladder neck.

12. The urological implant as claimed in claim 1, characterized in that, The distance between the two closest arch members of the plurality of arch members falls within the range of 5 mm and 15 mm.

13. The urological implant as claimed in claim 1, characterized in that, The plurality of arched components includes a rearmost arched component and a headmost arched component.

14. The urological implant as described in claim 13, characterized in that, The implant also includes, and at least one intermediate arched member disposed therebetween.

15. The urological implant as described in claim 13, characterized in that, The angle of the head, formed by the intersection of the transverse plane and the plane of the head arch member formed by the first arch end and the second arch end of the head arch member and a vertex of the arch member, falls within the range of 20 to 40 degrees.

16. The urological implant as claimed in claim 13, characterized in that, The angle of the tail end, formed by the intersection of the transverse plane and the plane of the tail end arch member formed by the first arch end, the second arch end, and a vertex of the tail end arch member, falls within the range of 10 to 50 degrees.

17. The urological implant as claimed in claim 14, characterized in that, One vertex of the arched member forms an intermediate arched member plane with at least one of the first arched end and the second arched end of the intermediate arched member, and the intermediate arched member plane is parallel to the transverse plane.

18. The urological implant as claimed in claim 1, characterized in that, The implant body further includes: a first lateral spacer exposed from the first longitudinal rib; and a second lateral spacer exposed from the second longitudinal rib, wherein the first lateral spacer and the second lateral spacer are independently retractable when subjected to a sagittal compressive force parallel to the intermediate plane.

19. The urological implant as claimed in claim 18, characterized in that, Each of the first lateral spacer and the second lateral spacer includes a support rib that is curved to a curvature similar to a posterior surface of the prostatic urethra, wherein a first portion of the support rib is interconnected with the first longitudinal rib via at least one support connection, and a second portion of the support rib is interconnected with the second longitudinal rib.

20. The urological implant as claimed in claim 19, characterized in that, When subjected to the sagittal compressive force, the elastic contraction of the first lateral spacer and the second lateral spacer causes the support rib to return to a corresponding one of the first longitudinal rib of the first lateral spacer and the second longitudinal rib of the second lateral spacer.

21. The urological implant as claimed in claim 19, characterized in that, Each of the first lateral spacer and the second lateral spacer includes two of the said support connection portions, which respectively form a closed pattern with the first support rib or the second support rib and the first longitudinal rib or the second longitudinal rib.

22. The urological implant as claimed in claim 21, characterized in that, The closed pattern surrounds a contact surface configured to contract and / or support the prostatic urethral wall.

23. The urological implant as claimed in claim 21, characterized in that, The closed shape resembles a meniscus lens shape, which has: a first support rib and a second support rib, the outline of which is designed as a convex surface of the meniscus lens shape; and a first longitudinal rib and a second longitudinal rib, the outline of which is designed as a concave surface of the meniscus lens shape.

24. The urological implant as claimed in claim 21, characterized in that, The closed pattern is formed by a thin strip that combines multiple support connection portions, the first support rib or the second support rib, and the first longitudinal rib or the second longitudinal rib.

25. The urological implant as claimed in claim 21, characterized in that, Each of the first longitudinal rib and the second longitudinal rib forms: a first upper corner having a first portion of a plurality of supporting connecting portions; and a second upper corner having a second portion of a plurality of supporting connection portions, wherein a rearmost arched member of the plurality of arched members extends between a plurality of corresponding corners of the first upper corner, and a headmost arched member of the plurality of arched members extends between a plurality of corresponding corners of the second upper corner.

26. The urological implant as claimed in claim 19, characterized in that, The first lateral spacer and the second lateral spacer are configured to approach each other toward the central plane when the plurality of arched members bend and the implant body contracts.

27. The urological implant as claimed in claim 1, characterized in that, When in an expanded configuration, the implant body has a total height ranging from 10 mm to 40 mm and a width ranging from 8 mm to 30 mm.

28. The urological implant as claimed in claim 1, characterized in that, The implant body is configured to apply a contractile resistance of at least 100 grains when the plurality of arched members are forced into a compression angle less than a stress-free angle of at least 20%, thereby contracting and / or supporting the prostatic urethral wall to form a selected nominal opening size across the prostatic urethra.

29. The urological implant as claimed in claim 19, characterized in that, The implant further includes an implant retrieval grip, which is configured to be located at a tail portion away from the implant body and symmetrically connected to the first lateral spacer on one side of the implant body, and symmetrically connected to the second lateral spacer on the second side of the implant body.

30. The urological implant as claimed in claim 29, characterized in that, The implant retrieval grip is configured to retract the first lateral spacer and the second lateral spacer when the implant is pulled from the implant retrieval grip toward the tail of an edge of a retractable sheath surrounding an inner cavity, wherein the size of the inner cavity is configured to accommodate the urological implant in a folded state.

31. The urological implant as described in claim 29, characterized in that, Each of the first support rib of the first lateral spacer and the second support rib of the second lateral spacer forms a lower corner, the lower corner having a corresponding tail-end support connection portion of the plurality of support connection portions, wherein the implant extraction grip is connected at one side of the implant extraction grip to one of the lower corners at the first lateral spacer, and at a second side of the implant extraction grip to the other of the lower corners at the second lateral spacer.

Images