Patent Description:
The present disclosure, in some embodiments thereof, relates to the field of urological medical devices and applications thereof, and more particularly, but not exclusively, to a urological (prostatic) implant, system, and method for retracting or/and supporting a prostatic urethra and/or periurethral tissue enclosing a prostatic urethra along a length of prostate lobes.

Benign prostate hyperplasia (BPH), also known as benign prostatic hypertrophy, is a urological disease in which the prostate enlarges and constricts the urethra. BPH affects a majority of the male population over <NUM> years of age, and is thus of great medical and commercial importance.

Surgical treatment of hypertrophy of the prostate has been a routine procedure for many years. One method of such surgical treatment is open prostatectomy wherein the gland is totally or partially removed. Another method of surgical treatment is transurethral resection of the prostate (TURP). Surgical treatment is an invasive procedure that may be debilitating, painful and traumatic to the patient. Such surgical treatment may result in various complications including impotence, incontinence, bleeding, infection, and other undesirable problems.

Another procedure to treat prostatic hypertrophy is to place a catheter at the external opening of the urethra and into the obstructed portions of the urethra, allowing urine to pass from the bladder by way of the catheter lumen. These urinary catheters typically employ a positioning or retention balloon at the distal tip which inflates at the bladder neck and prevents the expulsion of the catheter from the body.

Ablation techniques based on using heat, such as produced by microwave or laser energy, may be provided in combination with such catheters for treating the enlarged portion of the prostate. However, such a procedure may result in pain and discomfort to the patient.

In spite of extensive teachings and practices in the field of urology, there is an on-going need for developing and practicing improved and new urological medical devices and applications thereof, for treating benign prostate hyperplasia (BPH).

International Patent Application Publication no. <CIT> appears to disclose, "Urological (prostatic) implant, system, and method for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along lengths of prostate lobes, for example, in BPH patients. Prostatic implant (<NUM>) includes independently actuatable distal retractor (<NUM>) incorporating craniolateral corners (204a, 204b) and proximal retractor (<NUM>) incorporating caudolateral corners (208a, 208b). Retractors may be connected via elongated spine member (<NUM>), and formed as paired curved wing-liked structures having interconnecting members (<NUM>). May further include tissue support members extending between elongated edge members connecting retractors to spine member, and tissue support members extending between elongated edge members and spine member. Tissue support members are sized and configured for supporting portions of prostatic lateral lobes when spine member engages anterior interlobar groove extending between prostatic lateral lobes, and when elongated edge members engage posterolateral interlobar grooves. System and method include implant manipulator (<NUM>) detachably connected to implant elongated edge members, for manipulating and forcing implant caudolateral corners into close proximity, for delivery into subject.

<CIT> appears to disclose, "A dilating device for the prostatic urethra comprising: at least three, laterally connected ridges, wherein each ridge is configured to longitudinally engage with a different substantially longitudinal groove of the prostatic urethra of a patient, and wherein the at least three laterally connected ridges are configured to laterally compress to enable insertion into the prostatic urethra in a compressed configuration, and wherein the at least three laterally connected ridges are configured to laterally expand to a normally-open configuration upon deployment within the prostatic urethra, to exert a radially outwards force that dilates the prostatic urethra.

The present disclosure, in some embodiments thereof, relates to a urological (prostatic) implant, system, and method for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes.

According to an aspect of some embodiments, there is provided a urological implant, including: an connecting member; a first longitudinal rib and a second longitudinal rib symmetrically opposing each other and elastically shiftable away from each other between a collapsed state and a expanded state, relative to a longitudinal axis of the implant; the expanded state for retracting or/and supporting periurethral tissue enclosing a prostatic urethra; and an implant extraction handle connected at one side thereof to the first longitudinal rib and at second side thereof to the second longitudinal rib, wherein the extraction handle is configured to shift elastically, under a pulling force away from the connecting member to facilitate and/or force approximation of the first and second longitudinal ribs relative to the longitudinal axis.

According to some embodiments, the connecting member includes at least one arched member connecting at one end thereof to the first longitudinal rib and on a send end thereof to the second longitudinal rib.

According to some embodiments, the arched member is inclined distally in the expanded state.

According to some embodiments, an implant is configured to collapse to an insertion configuration fitting into a urinary catheter wherein the handle is collapsed distally.

According to some embodiments, implant is configured to collapse to an extraction configuration fitting into a urinary catheter wherein the handle is collapsed proximally.

According to some embodiments, a distal end of the connecting member is configured to remain proximal to a distal end of the rib in the expanded state.

According to some embodiments, a distal end of the connecting member is configured to remain proximal to a distal end of the rib in the collapsed state.

According to an aspect of some embodiments, there is provided a urological implant having extraction handle. Optionally, the implant has an elongated implant body having a longitudinal axis and two or more longitudinal ribs elastically shiftable away from each other between a collapsed state and an expanded state, relative to the longitudinal axis. Optionally, the device may be biased to the expanded state. For example, the device may be configured for supporting periurethral tissue enclosing a prostatic urethra in the expanded state. Optionally, in the collapsed state the device may be inserted and/or extracted from the urethra (for example using a sheath and/or a catheter for example the sheath may have an internal diameter between <NUM> to <NUM> and/or between <NUM> to <NUM> and/or between <NUM> to <NUM>), for example the device may collapse to a width of between <NUM> to <NUM> and/or <NUM> to <NUM> and/or between <NUM> to <NUM> and/or between <NUM> to <NUM>. In some embodiments, pulling implant extraction handle proximally urges the device toward the collapsed state.

In some embodiments, the extraction handle is attached to the implant body, for example to a proximal portion thereof. Optionally, one side of the longitudinal rib is connected at to a first longitudinal rib and at second side thereof to a second longitudinal rib. Optionally, the extraction handle is configured to shift elastically, under a pulling force away from the implant body to facilitate and/or force approximation of the first and second longitudinal ribs relative to the longitudinal axis.

In some embodiments, the longitudinal ribs are interconnected by a connecting member. For example, the connecting member may include a longitudinal spine and/or one or more arched members. Optionally the first and second longitudinal ribs symmetrically oppose each other. Optionally, the device is in the expanded state when the connecting member is in a relaxed state and/or the device body forces the longitudinal ribs outward as the device collapses towards the collapsed state.

Some embodiments are further characterized in that the implant extraction handle is shaped to correspond to an outline of the urological implant at a proximal end thereof in the expanded relaxed state.

Some embodiments are further characterized in that the extraction handle includes an apex.

Some embodiments are further characterized in that the apex is centered between the first and second longitudinal ribs.

Some embodiments are further characterized in that in the relaxed state the apex is adjacent to a proximal end of the implant body and the pulling causes the apex to move in a proximal direction away from the implant body proximal end.

Some embodiments are further characterized in that the implant extraction handle is symmetrically connected to the first and second longitudinal ribs.

According to an aspect of some embodiments, there is provided a urological implant, comprising:.

In some embodiments, the implant extraction handle is shaped to correspond an outline of the urological implant formed by the first and second longitudinal ribs with an extraction handle apex thereof provided adjacent a proximal end of the implant body,.

In some embodiments, the implant extraction handle is configured to shift elastically, when under a pulling force originating therefrom, such that the extraction handle apex points in a proximal direction towards and/or along the longitudinal axis and away from the implant body proximal end, so as to facilitate and/or force approximation of the first and second longitudinal ribs relative to the longitudinal axis.

In some embodiments, the implant body includes a spine member.

In some embodiments, the implant extraction handle configured to recollapse the first and second longitudinal ribs into the collapsed state, when the urological implant is pulled proximally from the implant extraction handle against an edge of a retraction sheath enclosing a lumen sized to accommodate the urological implant therein when in the collapsed state.

In some embodiments, each the first and second longitudinal ribs includes a proximally projecting lateral corner and a distally projecting lateral corner, relative to the longitudinal axis, and the implant extraction handle is connected to the first and second longitudinal ribs at the proximally projecting lateral corners thereof so as to facilitate forcing of the proximally projecting lateral corners to approximate each other when the urological implant is pulled proximally from the implant extraction handle against the sheath edge.

In some embodiments, each the first and second longitudinal ribs is curved and includes a proximal rib end joined to a proximal end of the spine member, a distal rib end joined to a distal end of the spine member, and an elongated rib edge portion provided between the proximal and distal corresponding rib ends that is sized and shaped for positioning in a corresponding posterolateral interlobar groove, when the spine member is positioned in and along an anterior interlobar groove in the prostatic urethra.

According to an aspect of some embodiments, there is provided a method for extracting the urological implant, comprising:.

In some embodiments, pulling the urological implant deforms the implant extraction handle such that deformation stresses developed thereinside force the first and second longitudinal ribs to approximate one to other until reaching the collapsed state.

In an aspect of some embodiments, there is provided a urological implant for retracting or/and supporting a prostatic urethra wall. The implant comprising an elongated implant body having a longitudinal axis, the longitudinal axis is perpendicular to a transverse plane and extending between a cranial end and a caudal end of the implant body along a median plane. Optionally the longitudinal axis divides the implant body into two symmetrical halves.

In some embodiments, the implant body includes longitudinally spaced arched members, each of the arched members includes an unsupported arch apex located between a first arch end and a second arch end, forming together an arched member plane being perpendicular to the median plane.

In some embodiments, the arched members are interconnected via arch ends thereof. For example, the first arch ends of the arched members may connected sequentially along a length of a first longitudinal rib portion, and/or the second arch ends of the arched members may be connected sequentially along a length of a second longitudinal rib portion. Optionally, each of the first and second longitudinal rib portions extends through the transverse plane;.

In some embodiments, each one of the arched members is elastically bendable so as to facilitate elastic contractibility of the implant body when the implant body is subjected to a transverse compressive force crossing the median plain.

In some embodiments, the implant body is sized and configured to retract or/and support an anterior portion of the prostatic urethra wall, and allowing collapse of an unsupported posterior portion of the prostatic urethra wall opposing the anterior portion.

In some embodiments, the implant body further includes a first lateral spacer emerging from the first longitudinal rib and a second lateral spacer emerging from the second longitudinal rib, being independently contractible when subjected to a sagittal compressive force parallel to the median plane.

In an aspect of some embodiments, there is provided a method for supporting or/and extracting a wall of a partially constricted prostatic urethra, the method comprising:.

All technical or/and scientific words, terms, or/and phrases, used herein have the same or similar meaning as commonly understood by one of ordinary skill in the art to which the invention pertains, unless otherwise specifically defined or stated herein. Methods, materials, and examples described herein are illustrative only and are not intended to be necessarily limiting. Although methods or/and materials equivalent or similar to those described herein can be used in practicing or/and testing embodiments of the invention, exemplary methods or/and materials are described below.

Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative description of some embodiments of the present invention. In this regard, the description taken together with the accompanying drawings make apparent to those skilled in the art how some embodiments of the present invention may be practiced.

The present dislosure, in some embodiments thereof, relates to the field of urological medical devices and applications thereof, and more particularly, but not exclusively, to a urological (prostatic) implant, system, and method for retracting or/and supporting a wall of a prostatic urethra and/or periurethral tissue enclosing a prostatic urethra along a length of prostate lobes.

<FIG> schematically illustrate cross sectional views of a male urethra. <FIG> is a magnification of the body portion containing the prostatic urethra. The urethra connects the urinary bladder to the urinary meatus for the removal of urine and semen from the body. Furthermore, the prostatic urethra merges about mid length thereof with an ejaculatory duct for carrying semen therein from the seminal vesicle. The prostatic urethra begins at the bladder neck and runs through the prostate approximately <NUM> in length. It begins almost vertically (in a caudal direction) from the bladder then curved anteriorly. In view thereof, inventor believes a urological implant having a curved body mimicking prostatic urethra curvature is advantageous for both immediate implantation phase, and for long term presence in the prostatic urethra, so as to physically effect and maintain a healthy and patent prostatic urethra.

<FIG> illustrate a cross section of the prostatic urethra along line '1C:1C'. <FIG> shows the prostatic urethra in a constricted state, whereas a normal state would be more similar to a trefoil (three-lobed) shape. <FIG>, on the other hand, illustrates a patent, partially opened, state with an anterior lobe fully opened, yet the two posterior lobes substantially closed. The patent state shown in <FIG> is considered by the inventor of the present invention as having advantages even with respect to the natural fully opened state, since that it suppresses retrograde (cranial) flow towards the urine bladder the of semen arriving at the posterior portion of the prostatic urethra via the ejaculatory duct.

<FIG> show views of an exemplary urological implant <NUM> and <FIG> shows the urological implant <NUM> deployed in a prostatic urethra model <NUM>. Urological implant <NUM> includes:.

Implant extraction handle <NUM> is shaped to correspond an outline of the urological implant <NUM> formed by the first and second longitudinal ribs <NUM> and <NUM> with an extraction handle apex <NUM> thereof provided adjacent a proximal end <NUM> of the implant body <NUM>.

Implant extraction handle <NUM> is configured to shift elastically, when under a pulling force originating therefrom, such that the extraction handle apex <NUM> points in a proximal direction towards and/or along the longitudinal axis X and away from the implant body proximal end <NUM>, so as to facilitate and/or force approximation of the first and second longitudinal ribs <NUM> and <NUM> relative to longitudinal axis X.

Implant extraction handle <NUM> is configured to recollapse first and second longitudinal ribs <NUM> and <NUM> into the collapsed state, when the urological implant <NUM> is pulled proximally from implant extraction handle <NUM> against an edge of a retraction sheath enclosing a lumen sized to accommodate the urological implant therein when in collapsed state (as will be further detailed below in the description relating to <FIG>).

Each of first and second longitudinal ribs <NUM> and <NUM> includes a proximally projecting lateral corner <NUM> and a distally projecting lateral corner <NUM>, relative to longitudinal axis X. Implant extraction handle <NUM> is connected to first and second longitudinal ribs <NUM> and <NUM> at proximally projecting lateral corners <NUM> so as to facilitate forcing of the proximally projecting lateral corners <NUM> to approximate each other when the urological implant <NUM> is pulled proximally from implant extraction handle <NUM> against the extraction sheath edge.

Each of first and second longitudinal ribs <NUM> and <NUM> is curved and includes a proximal rib end <NUM> joined to a proximal end <NUM> of spine member <NUM>, a distal rib end <NUM> joined to a distal end <NUM> of spine member <NUM>, and an rib edge portion <NUM> provided between each pair of corresponding proximal and distal rib ends <NUM> and <NUM>. Rib edge portion <NUM> is sized and shaped for positioning in a corresponding posterolateral interlobar groove, when spine member <NUM> is positioned in and along an anterior interlobar groove <NUM> in prostatic urethra <NUM>.

Implant extraction handle <NUM> is shaped to correspond an outline formed by proximal rib ends <NUM> along a proximal portion <NUM> of first and second longitudinal ribs <NUM> and <NUM>.

<FIG> show various scenarios representing stages in an exemplary method of extracting urological implant <NUM>. Urological implant <NUM> is tethered at a distal portion <NUM> thereof, using an elastic tether <NUM>, representing and modeling normal machinal resistance exerted from walls of a prostatic urethra during withdrawal of implant <NUM>.

<FIG> shows positioning an edge <NUM> of an extraction sheath <NUM> in proximity to proximal end <NUM> of urological implant <NUM>, as in case of positioning thereof in the prostatic urethra.

<FIG> show applying of a fastening (gripping) device <NUM> to emerge from extraction sheath <NUM> distally (simulating emerging into the prostatic urethra).

<FIG> show fastener <NUM> gripping (fastening) onto a mid-portion of implant extraction handle <NUM>, and pulling of urological implant <NUM> proximally from implant extraction handle <NUM>.

<FIG> shows urological implant <NUM> pulled against edge <NUM>, then it is forced to recollapse (<FIG>) until reaching the collapsed state allowing it to be further withdrawn into lumen <NUM> of extraction sheath <NUM> (<FIG>).

As shown, pulling of urological implant <NUM> (when under mechanical resistance from prostatic urethra walls, for example) deforms implant extraction handle <NUM> such that deformation stresses developed thereinside force first and second longitudinal ribs <NUM> and <NUM> to approximate one to other until reaching the collapsed state.

Each of the following terms written in singular grammatical form: 'a', 'an', and 'the', as used herein, means 'at least one', or 'one or more'. Use of the phrase 'one or more' herein does not alter this intended meaning of 'a', 'an', or 'the'. Accordingly, the terms 'a', 'an', and 'the', as used herein, may also refer to, and encompass, a plurality of the stated entity or object, unless otherwise specifically defined or stated herein, or, unless the context clearly dictates otherwise. For example, the phrases: 'a unit', 'a device', 'an assembly', 'a mechanism', 'a component', 'an element', and 'a step or procedure', as used herein, may also refer to, and encompass, a plurality of units, a plurality of devices, a plurality of assemblies, a plurality of mechanisms, a plurality of components, a plurality of elements, and, a plurality of steps or procedures, respectively.

Each of the following terms: 'includes', 'including', 'has', 'having', 'comprises', and 'comprising', and, their linguistic / grammatical variants, derivatives, or/and conjugates, as used herein, means 'including, but not limited to', and is to be taken as specifying the stated component(s), feature(s), characteristic(s), parameter(s), integer(s), or step(s), and does not preclude addition of one or more additional component(s), feature(s), characteristic(s), parameter(s), integer(s), step(s), or groups thereof. Each of these terms is considered equivalent in meaning to the phrase 'consisting essentially of.

<FIG> schematically illustrate views of an exemplary urological implant <NUM> having two spaced arches. <FIG> shows side view of implant <NUM> when it is implanted in a portion of the prostatic urethra adjacent to the bladder neck with it cranial end <NUM> thereof, and in proximity to opening of the ejaculatory duct to the prostatic urethra with caudal end <NUM> thereof. Implant <NUM> may be sized to extend along entire length of the prostatic urethra, or only part thereof (for example, extending from a portion adjacently-caudally from the bladder neck, to a portion adjacently-cranially to the opening of the ejaculatory duct. Implant <NUM> is optionally shaped and configured to be supported against bodily protrusion which constricts the prostatic urethra opening to the bladder neck. Implant <NUM> includes an elongated implant body <NUM> having a longitudinal axis <NUM>. Longitudinal axis <NUM> is perpendicular to a transverse plane <NUM> and extending between cranial end <NUM> and caudal end <NUM> along a median plane <NUM> dividing implant body <NUM> into two symmetrical halves.

Implant body <NUM> includes longitudinally spaced arched members, including a caudal-most arch member <NUM> and a cranial-most arch member <NUM>, each including an unsupported arch apex <NUM> located between a first arch end <NUM> and a second arch end <NUM>, forming together an arched member plane being perpendicular to median plane <NUM>, including a cranial-most arched member plane 412a, formed by arch apex <NUM> and first and second arch ends <NUM> and <NUM> of cranial-most arched member <NUM>, and a caudal-most arched member plane 412b, formed by arch apex <NUM> and first and second arch ends <NUM> and <NUM> of caudal-most arched member <NUM>. Distance between each two closest arch apexes <NUM> is optionally within a range of <NUM> and <NUM>.

Arched members <NUM> and <NUM> are interconnected via arch ends thereof such that first arch ends <NUM> are connected sequentially along a length of a first longitudinal rib portion <NUM>, and second arch ends <NUM> are connected sequentially along a length of a second longitudinal rib portion <NUM>. Each of first and second longitudinal rib portions <NUM> and <NUM> extends through transverse plane <NUM>.

As illustrated in <FIG>, each one of arched members <NUM> and <NUM> is elastically bendable so as to facilitate elastic contractibility of implant body <NUM> when subjected to a transverse compressive force TF crossing median plain <NUM>. Implant body <NUM> is sized and configured to retract or/and support an anterior portion of the prostatic urethra wall, and allowing collapse of an unsupported posterior portion of the prostatic urethra wall opposing the anterior portion. Optionally and additionally, implant body <NUM> is sized and configured so as to facilitate physical resistance of the collapsed unsupported posterior portion to a retrograde flow of semen from flowing therethrough towards the bladder neck.

The intersection of transverse plane <NUM> and a cranial-most arched member plane 412a forms a cranial-most angle β within a range of <NUM> to <NUM> degrees. The intersection of transverse plane <NUM> and caudal-most arched member plane 412b forms a caudal-most angle α within a range of <NUM> to <NUM> degrees.

<FIG> schematically illustrate views of an exemplary variation <NUM>' of urological implant <NUM>, which is similar or identical in structure and function to previous variation shown in <FIG>, but which further includes two lateral spacers - a first lateral spacer <NUM> emerging from first longitudinal rib portion <NUM> and a second lateral spacer <NUM> emerging from second longitudinal rib portion <NUM>. The lateral spacers are independently contractible when subjected to a sagittal compressive force SF parallel to median plane <NUM>.

Each one of the first and second lateral spacers includes a support rib portion <NUM> curved to resemble curvature of posterior surface of the prostatic urethra. A first of the support rib portions <NUM> is interconnected with first longitudinal rib portion <NUM>, and a second of support rib portions <NUM> is interconnected with second longitudinal rib <NUM>, via an at least one support connecting portion including a first support connection portion <NUM> and a second support connection portion <NUM>. Support rib portion <NUM> and/or support connecting portions <NUM> and <NUM> are elastically bendable so as to facilitate elastic contractibility of lateral spacers <NUM> and <NUM>, as schematically illustrated in <FIG>, which facilitates recoverable approximation support rib portion <NUM> to a corresponding one of first and second longitudinal rib portions, <NUM> and <NUM>, when subjected to sagittal compressive force SF.

Each one of first and second lateral spacers <NUM> and <NUM> forms a closed figure with first or second support rib portions <NUM> and first or second longitudinal rib portions, <NUM> or <NUM>, respectively and first and second support connection portions <NUM> and <NUM>. The closed figure encloses a contact surface configured for retracting or/and supporting the prostatic urethra wall. Optionally, the closed figure resembles a meniscus lens shape with first and second support rib portions <NUM> contoured as a convex, and first and second longitudinal rib portions <NUM> and <NUM> contoured as a concave, of the meniscus lens shape. The closed figure is formed of a thin strip which incorporates support connecting portions <NUM> and <NUM>, first or second support rib portion <NUM> and first or second longitudinal rib portion <NUM> or <NUM>.

Each one of first and second longitudinal rib portions <NUM> and <NUM> forms a first upper corner <NUM> with first support connecting portion <NUM> and a second upper corner <NUM> with second support connecting portion <NUM>, wherein caudal-most arched member <NUM> extends between respective first upper corners <NUM>, and cranial-most arched member <NUM> extends between respective second upper corners <NUM>.

<FIG> illustrate views of an exemplary urological implant <NUM> for retracting or/and supporting a prostatic urethra wall. Implant <NUM> includes an elongated implant body <NUM> having a longitudinal axis <NUM>, which is perpendicular to a transverse plane <NUM> and extends between a cranial end <NUM> and a caudal end <NUM> of implant body <NUM> along a median plane <NUM> dividing implant body <NUM> into two symmetrical halves.

Implant body <NUM> incorporates longitudinally spaced arched members, including a caudal-most arched member <NUM>, a cranial-most arched member <NUM> and an intermediate arch member <NUM>. Each arched member includes an unsupported arch apex <NUM> located between a first arch end <NUM> and a second arch end <NUM>, forming together an arched member plane being perpendicular to median plane <NUM>. Each of the arched members is unsupported or interconnected along its length, including with apex <NUM>, but only via arch ends thereof such that first arch ends <NUM> are connected sequentially along a length of a first longitudinal rib portion <NUM>, and second arch ends <NUM> are connected sequentially along a length of a second longitudinal rib portion <NUM>; both first and second longitudinal rib portions <NUM> and <NUM> extend through transverse plane <NUM>. The distance between each two closest of arch apexes <NUM> is within a range of <NUM> and <NUM>.

Each one of arched members <NUM>, <NUM> and <NUM> is elastically bendable about longitudinal axis <NUM> so as to facilitate elastic contractibility of implant body <NUM> when it is subjected to a transverse compressive force crossing median plain <NUM>. Implant body <NUM> is sized and configured to retract or/and support an anterior portion of the prostatic urethra wall, thereby allowing collapse of an unsupported posterior portion of the prostatic urethra wall opposing said anterior portion, and to facilitate physical resistance of the collapsed unsupported posterior portion to a retrograde flow of semen from flowing therethrough towards the bladder neck.

The intersection of transverse plane <NUM> and a cranial-most arched member plane <NUM>, formed by arch apex <NUM> and first and second arch ends <NUM> and <NUM> of cranial-most arched member <NUM>, forms a cranial-most angle β within a range of <NUM> to <NUM> degrees. The intersection of transverse plane <NUM> and a caudal-most arched member plane <NUM>, formed by arch apex <NUM> and first and second arch ends <NUM> and <NUM> of caudal-most arched member <NUM>, forms a caudal-most angle α within a range of <NUM> to <NUM> degrees. The arch apex <NUM> and first and second arch ends <NUM> and <NUM> of intermediate arch member <NUM> forms an intermediate arched member plane being parallel to transverse plane <NUM>.

A first lateral spacer <NUM> emerges from first longitudinal rib <NUM> and a second lateral spacer <NUM> emerges from second longitudinal rib <NUM>, each is individually contractible when subjected to a sagittal compressive force parallel to median plane <NUM>. First and second lateral spacers <NUM> and <NUM> are configured to approximate each other towards median plane <NUM> when arched members are bent about longitudinal axis <NUM> and implant body <NUM> is contracted. First lateral spacer <NUM> includes a first support rib portion <NUM> interconnected with first longitudinal rib portion <NUM>, and second lateral spacer <NUM> includes a second support rib portion <NUM> interconnected with second longitudinal rib <NUM>, via a first support connecting portion <NUM> and a second support connecting portion and <NUM>. Support rib portions <NUM> and <NUM> and/or support connecting portions <NUM> and <NUM> are elastically bendable so as to facilitate said elastic contractibility of lateral spacers <NUM> and <NUM>, wherein elastic contractibility of first and second lateral spacers <NUM> and <NUM> facilitates recoverable approximation support rib portion <NUM> and <NUM> to a respective (first or second) longitudinal rib portion (<NUM> or <NUM>) when subjected to sagittal compressive force.

Each of first and second lateral spacers <NUM> and <NUM> forms a closed figure with its respective support rib portions and longitudinal rib portion, together with first and support connecting portions <NUM> and <NUM>. The closed figure encloses a contact surface configured for retracting or/and supporting the prostatic urethra wall and resembles a meniscus lens shape with support rib portions <NUM> and <NUM> contoured as a convex, and first and second longitudinal rib portions <NUM> and <NUM> contoured as a concave, of the meniscus lens shape. The closed figure is formed of a thin strip which incorporates its respective support connecting portions, support rib portion and longitudinal rib portion.

Each one of first and second longitudinal rib portions <NUM> and <NUM> forms a first upper corner <NUM> with first support connecting portion <NUM> and a second upper corner <NUM> with second support connecting portion <NUM>. Cranial-most arched member <NUM> extends between corresponding first upper corner <NUM>, and caudal-most arched member <NUM> extends between corresponding second upper corner <NUM>.

Arch apex <NUM> in each arch member is located above, and directed away from, first and second longitudinal rib portions <NUM> and <NUM> relative to longitudinal axis <NUM>, such that when the implant supports the prostatic urethra wall, arch apex <NUM> is located adjacent midline of an anterior portion of the prostatic urethra wall and first and second longitudinal rib portions <NUM> and <NUM> are positioned closer to a posterior portion of the prostatic urethra wall.

Implant body <NUM> has a total height H within a range of <NUM> to <NUM> and a width W within a range of <NUM> to <NUM>, when in a relaxed not collapsed configuration (as shown in <FIG>). Arched members form a nominal angle within a range of <NUM> to <NUM> degrees along their corresponding arched member plane, when implant body <NUM> is in a relaxed not collapsed configuration. Implant body <NUM> is configured to apply a contraction resistive force of at least 100grf when the arched members are forced into a compressed angle smaller than their nominal angle by at least <NUM>%, thereby retracting or/and supporting the prostatic urethra wall so as to form at a chosen nominal opening size across the prostatic urethra. The chosen nominal opening size has optionally a cross section area of at least <NUM> square.

Implant <NUM> further includes an implant extraction handle <NUM> provided caudally distant to implant body <NUM> and symmetrically connected at one side <NUM> thereof to first lateral spacer <NUM> and at a second side <NUM> thereof to second lateral spacer <NUM>. Implant extraction handle <NUM> is shaped to correspond an outline of the urological implant <NUM> formed by first and second lateral spacers <NUM> and <NUM> with an extraction handle apex <NUM> thereof provided adjacent to arch apex <NUM> of caudal-most arched member <NUM>, and is configured to shift elastically, when under a pulling force PL (as schematically illustrated in dotted line in <FIG>) originating therefrom, such that extraction handle apex <NUM> points in a caudal direction towards and/or along longitudinal axis <NUM> and away from arch apex <NUM> of caudal-most arched member <NUM>.

Implant extraction handle <NUM> is configured to contract first and second lateral spacers <NUM> and <NUM>, when the implant <NUM> is pulled caudally via/from implant extraction handle <NUM>, optionally against a countering surface, such as an edge of a retraction sheath enclosing a lumen sized to accommodate the implant therein when it is in a collapsed state.

Each of first and second support rib portions <NUM> and <NUM> forms a lower corner <NUM> with a respective caudal-most support connection portion <NUM>, wherein implant extraction handle <NUM> is connected at one side <NUM> thereof to one of the lower corners <NUM> at first lateral spacer <NUM> and at second side <NUM> thereof to another of the lower corners <NUM> at second lateral spacer <NUM>.

The present disclosure further describes a method for supporting or/and extracting a wall of a partially constricted prostatic urethra, by applying urological implant of the present invention such as implant <NUM> (optionally particularly variation <NUM>' thereof) or implant <NUM>. The method includes at least one of the following steps, not necessarily in same order:.

The chosen contracted size is optionally resulted also from elastically bending at least one of support rib portions <NUM> / <NUM> and <NUM> and support connecting portions <NUM> & <NUM> / <NUM> & <NUM> by way of approximating support rib portion to a corresponding first or second longitudinal rib portion, optionally resulted from forces applied to the support rib portion from the prostatic urethra wall during said positioning.

<FIG> is a flow chart illustration of method for extracting a urological implant in accordance with an embodiment of the current disclosure. In some embodiments, a urological implant includes an extraction handle. Optionally, the implant is provided in a relaxed state (for example as illustrated in <FIG>, <FIG> and <FIG>). For example, the implant may be expanded inside a urethra to support periurethral tissue and/or to hold open a urethra. Optionally pulling <NUM> the extraction handle proximally with respect to the implant body causes the implant to collapse <NUM> (for example as illustrated in <FIG> and <FIG>). For example, the ribs may collapse <NUM> approximately towards a longitudinal axis of the device and/or away from the walls of the urethra. In some embodiments, the extraction handle may be pulled <NUM> by a fastener into a sheath (e.g. a catheter). Optionally, as the device is pulled the extraction handle may take a wedge shape with an apex facing the sheath. For example, as the handle is pulled <NUM> into the sheath the angled sides of the handle may be pushed together by the inner walls of the sheath further collapsing <NUM> the handle. Optionally the sides of the handle are connected to the ribs of the implant and/or further collapsing <NUM> the handle further collapses <NUM> the ribs of the implant facilitating drawing the implant into the sheath.

<FIG> is a block diagram of a urological implant system in accordance with an embodiment of the current invention. In some embodiments, an implant includes a connecting member <NUM>, for example an arch and/or a spine. Optionally, the connecting member <NUM> connects to one or more longitudinal ribs <NUM>, <NUM>. The ribs <NUM>, <NUM> optionally spread away from each other (for example laterally away from a longitudinal axis of body) to a support tissue in a urethra. Optionally the ribs <NUM>, <NUM> and/or the connecting member <NUM> are attached to an extraction handle <NUM>. For example, the extraction handle <NUM> may be positioned proximally to the connecting member <NUM>. In some embodiments, when the extraction handle <NUM> is pulled proximally, ribs <NUM>, <NUM> contract towards each other (for example laterally towards a longitudinal axis of body). For example, contraction may make it easier to extract the device from a urethra. Optionally, the implant and/or the extraction handle <NUM> may include a wedge <NUM> and/or an apex <NUM>. For example, pulling extraction handle <NUM> and/or the apex <NUM> proximally positions the apex <NUM> proximal to the implant. Optionally pulling the implant and/or the extraction handle <NUM> and/or the apex <NUM> proximally into an extraction sheath <NUM> pulls the wedge <NUM> into the sheath <NUM>. For example, by pulling the wedge <NUM> into the sheath <NUM>, the walls of the sheath <NUM> may push inward against the wedge <NUM> thereby further collapsing the implant laterally inward. For example, the ribs <NUM>, <NUM> may collapse towards the longitudinal axis of the body <NUM>. For example, a distal end of the sheath <NUM> may be positioned proximal to the implant and/or a fastener <NUM> may be passed out a distal end of the extraction sheath <NUM>. Optionally the fastener <NUM> may be passed through the sheath <NUM> from a proximal end thereof. The fastener <NUM> may be fastened to the extraction handle <NUM> and/or pulled proximally into the extraction sheath <NUM> to pull the extraction handle <NUM> and/or collapse the implant and/or draw the wedge <NUM> into the sheath <NUM> and/or draw the whole implant into the sheath <NUM>.

<FIG> is a perspective view of a three arched urological implant in an expanded state accordance with an embodiment of the current invention. The exemplary device includes three arched members. For example, a proximal most arch includes an extraction handle <NUM> and/or two distal arches 908a and 908b include connecting members. Optionally, the proximal arch (handle <NUM>) also includes a connecting member. For example, handle <NUM> and/or connecting members 908a, 908b connect between two longitudinal ribs <NUM>. Optionally, each longitudinal rib <NUM> may have a closed form. For example, the closed form may include an almond shape (for example with two pointed ends). For example, the almond shape may facilitate collapsing the device. Alternatively or additionally, the closed form may include an oval and/or a rectangle and/or a parallelogram and/or an almond shape with one point and/or a curve (for example, the rib with one or more of the arches may form a wedge shape (e.g. pie shape)) and/or another form. Optionally, the device is biased to the expanded state and/or is relaxed in the expanded state.

In some embodiments, the device is configured to inhibit the device from moving into the bladder. For example, distalmost arch 908a and/or an intermediate arch 908a and/or handle <NUM> tilts distally. Optionally, when the implant is in place in the prostatic Urethra with the distal end of the device facing the bladder (e.g. the proximal end of the implant facing caudally and/or the distal end facing cranially) the distal tilt of the arches prevents the device from migrating distally towards the bladder. For example, forcing the device distally causes the arches to straighten and/or dig into the wall of the urethra, inhibiting distal migration of the device. Optionally, different connecting members may be inclined in different directions. For example, as illustrated in <FIG> a distal connector <NUM> may be inclined proximally and/or a proximal connector <NUM> may be inclined distally and/or an intermediate connector <NUM> may be directed perpendicular to a rib <NUM>.

In some embodiments, a connecting member may include a bend and/or fold (e.g. each of arches 908a, 908b and handle <NUM> include a U-shaped fold <NUM> in its center along the axis of the device). For example, the fold <NUM> may make the device more flexible and/or facilitate collapsing the device. In some embodiments, the ribs and/or arches are configured to flexible enough to fit into different sized urethras. For example, the almond shape of the ribs and/or the fold <NUM> of the connecting members may increase the flexibility of the device. For example, a device may be flexible enough to fit in a Urethra having a height of between <NUM> to <NUM>.

In some embodiments, handle <NUM> is configured to me more easily bent than one or more of the other arches 908a, 908b. For example, handle <NUM> may be made of thinner material (for example between <NUM> to <NUM>% thinner and/or between <NUM> to <NUM>% thinner and/or between <NUM> to <NUM>% thinner, for example the material of the arches may be between <NUM> to <NUM> and/or the thickness of the material of the handle may be between <NUM> to <NUM>).

In some embodiments, flexibility of a handle may be enhanced by direction of a joint and/or by its curvature. for example, handle <NUM> is connected to rib <NUM> with a joint that points approximately proximally and then handle <NUM> curves distally. For example, at the joint of handle <NUM> and rib <NUM>, the handle points more distally than the direction a arches 908a and 908b where they join rib <NUM>. For example, handle <NUM> include more curvature than arches 908a and 908b.

In some embodiments, the distal most connector 908a is positions to avoid impinging on a bladder of a subject. For example, connector 908a may be connected to a proximal portion of rib <NUM> (for example distal to <NUM>% of the length of rib <NUM> and/or body of the device and/or distal to <NUM>% of the length of the device). Optionally, the arches 908a, 908b and/or handle <NUM> are configured to remain proximal of the distal end of rib <NUM> in the expanded configuration (for example as illustrated in <FIG>) and/or in the collapsed configuration (for example as illustrated in <FIG> and/or as illustrated for example by distal connector 1308a of <FIG>). Alternatively or additionally, a connecting member (e.g. an arch and/or arches) may extend distal to one, some and/or all of the ribs in one or both of the collapsed states (e.g. the collapsed state for insertion and/or the collapsed state for extraction) but not in the expanded state. Alternatively or additionally, in some embodiments, a connecting member may extend distal to one, some or all of the ribs in the expanded state and/or in the expanded and collapsed state.

<FIG> is a bird's eye view of a three arched urological implant in an expanded state in accordance with an embodiment of the current invention.

<FIG> is a side view of a three arched urological implant in a collapsed state for insertion into a urethra in accordance with an embodiment of the current invention. For example, before insertion into a subject the device is collapsed into an insertion state and inserted into a catheter <NUM>. Optionally, in an insertion configuration handle <NUM> is folded distally towards the body of the device (e.g. towards ribs <NUM> and/or arches 908a, 908b). Optionally, in the insertions configuration handle <NUM> is folded in the same direction of one, some or all of arches 908a, 908b.

<FIG> is a bird's eye view of a three arched urological implant in a collapsed state for insertion into a urethra in accordance with an embodiment of the current invention.

<FIG> is a side view of a four arched urological implant <NUM> in a collapsed state for extraction from a urethra in accordance with an embodiment of the current invention. For example, when extracting implant <NUM>, an extraction handle <NUM> is pulled proximally. Pulling extraction handle <NUM> proximally and/or pulling the device into a sheath <NUM> optionally causes the implant <NUM> to collapse (for example, as described in <FIG>, <FIG>). Collapsing the implant <NUM> optionally facilitates pulling the device into the sheath <NUM> and/or extracting the device from the Urethra and/or repositioning the device from the Urethra. In some embodiments, in the extraction collapsed state handle <NUM> is pulled proximally and/or connecting members (e.g. distal arch 1308a, intermediate arch 1308b and/or proximal arch 1308c) all fold distally and/or the body of the device (for example including rib <NUM>) collapses inward.

In some embodiments, different sized implants may be available. For example, a four arched implant <NUM> may be larger than a three arched implant <NUM>.

Each of the phrases 'consisting of and 'consists of, as used herein, means 'including and limited to'. Optionally the extraction handle is on a proximal end thereof and/or proximal of the device.

The phrase 'consisting essentially of, as used herein, means that the stated entity or item (system, system unit, system sub-unit, device, assembly, sub-assembly, mechanism, structure, component, element, or, peripheral equipment, utility, accessory, or material, method or process, step or procedure, sub-step or sub-procedure), which is an entirety or part of an exemplary embodiment of the disclosed invention, or/and which is used for implementing an exemplary embodiment of the disclosed invention, may include at least one additional 'feature or characteristic' being a system unit, system sub-unit, device, assembly, sub-assembly, mechanism, structure, component, or element, or, peripheral equipment, utility, accessory, or material, step or procedure, sub-step or sub-procedure), but only if each such additional 'feature or characteristic' does not materially alter the basic novel and inventive characteristics or special technical features, of the claimed entity or item.

The term 'method', as used herein, refers to steps, procedures, manners, means, or/and techniques, for accomplishing a given task including, but not limited to, those steps, procedures, manners, means, or/and techniques, either known to, or readily developed from known steps, procedures, manners, means, or/and techniques, by practitioners in the relevant field(s) of the disclosed invention.

Throughout this disclosure, a numerical value of a parameter, feature, characteristic, object, or dimension, may be stated or described in terms of a numerical range format. Such a numerical range format, as used herein, illustrates implementation of some exemplary embodiments of the invention, and does not inflexibly limit the scope of the exemplary embodiments of the invention. Accordingly, a stated or described numerical range also refers to, and encompasses, all possible sub-ranges and individual numerical values (where a numerical value may be expressed as a whole, integral, or fractional number) within that stated or described numerical range. For example, a stated or described numerical range 'from <NUM> to <NUM>' also refers to, and encompasses, all possible sub-ranges, such as 'from <NUM> to <NUM>', 'from <NUM> to <NUM>', 'from <NUM> to <NUM>', 'from <NUM> to <NUM>', 'from <NUM> to <NUM>', 'from <NUM> to <NUM>', etc., and individual numerical values, such as '<NUM>', '<NUM>', '<NUM>', '<NUM>', '<NUM>', '<NUM>', '<NUM>', '<NUM>', '<NUM>', '<NUM>', and '<NUM>', within the stated or described numerical range of 'from <NUM> to <NUM>'. This applies regardless of the numerical breadth, extent, or size, of the stated or described numerical range.

Throughout this disclosure, the term 'proximal' shall mean a location in a patient's body situated closest to entry point of a medical device or implant, and the term 'distal' shall mean a location in a patient's body situated farthest from such entry point.

Moreover, for stating or describing a numerical range, the phrase 'in a range of between about a first numerical value and about a second numerical value', is considered equivalent to, and meaning the same as, the phrase 'in a range of from about a first numerical value to about a second numerical value', and, thus, the two equivalently meaning phrases may be used interchangeably. For example, for stating or describing the numerical range of room temperature, the phrase 'room temperature refers to a temperature in a range of between about <NUM> and about <NUM>', and is considered equivalent to, and meaning the same as, the phrase 'room temperature refers to a temperature in a range of from about <NUM> to about <NUM>'.

The term 'about', as used herein, refers to ± <NUM> % of the stated numerical value.

The phrase 'operatively connected', as used herein, equivalently refers to the corresponding synonymous phrases 'operatively joined', and 'operatively attached', where the operative connection, operative joint, or operative attachment, is according to a physical, or/and electrical, or/and electronic, or/and mechanical, or/and electro-mechanical, manner or nature, involving various types and kinds of hardware or/and software equipment and components.

Claim 1:
An implant (<NUM>) for retracting or/and supporting a prostatic urethra wall, the implant (<NUM>) having
an elongated body (<NUM>) having a longitudinal axis (<NUM>), extending between a cranial end (<NUM>) and a caudal end (<NUM>) of said elongated body (<NUM>) and a median plane (<NUM>) including said longitudinal axis (<NUM>) and an anterior-posterior axis perpendicular to said longitudinal axis (<NUM>);
a pair of cranial corners (<NUM>) configured to rest on a ledge of a bladder neck thereby preventing cranial drift of the implant (<NUM>) into a bladder and wherein a line connecting said cranial corners is (<NUM>) perpendicular to said median plane (<NUM>);
a pair of posterolateral ribs (<NUM>);
at least one cranial interconnecting member (908a) connecting a cranial portion of each of said pair of posterolateral ribs (<NUM>) to a cranial anterior apex (<NUM>) located on said median plane (<NUM>), wherein in an unstressed configuration said at least one cranial interconnecting member (908a) extends laterally and posteriorly from said cranial anterior apex (<NUM>) to each of said posterolateral ribs (<NUM>);
at least one caudal interconnecting member (<NUM>) connecting a caudal portion of each of said pair of posterolateral ribs (<NUM>) to a caudal anterior apex (<NUM>) located on said median plane (<NUM>), wherein in an unstressed configuration said at least one caudal interconnecting member (<NUM>) extends laterally and posteriorly from said caudal anterior apex (<NUM>) to each of said posterolateral ribs (<NUM>);
and wherein said one of said pair of cranial corners (<NUM>) projects from each of said posterolateral ribs (<NUM>) in a cranial direction beyond said cranial interconnecting member (908a); and
characterized by
at least one intermediate interconnecting member (908b) connected between said pair of posterolateral ribs (<NUM>) across an intermediate anterior apex (<NUM>) between said at least one cranial interconnecting member (908a) and said least one caudal interconnecting member (<NUM>).