Patent Description:
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 that, "An implant for creating incisions in the tissues surrounding the bladder neck and the urethra of a patient, for relaxing the opening of the bladder, the implant includes a central connector and at least one wire, the wires extend radially outwardly from the center of the central connector, the wires apply continuous pressure on the surrounding tissues, the wires are foldable within an implant sheath for enabling delivery and extraction thereof, the implant is implanted within a restricted location of the urethra for a period of time for creating incisions at the locations where the wires apply pressure on the surrounding tissues.

Patent Application Publication no. <CIT> appears to disclose, "A stent with at least one cross-section having either a vertex or having first and second contour points where the radius of curvature of the first point is at least <NUM> times the radius of curvature of the second point.

International Patent Application Publication no. <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.

International Patent Application Publication no. <CIT> appears to disclose a, "Device for removing prostate tissue from within the urethra, the device including a plurality of arms, and an actuating mechanism coupled to the arms, the arms being rotatable about a longitudinal axis of the urethra, the arms being divided into arm pairs, each of the arm pair being apart from each other in a first configuration and attempting to get closer to each other, in a second configuration, wherein the device is inserted in the urethra toward the prostate, in the first configuration, and wherein after the device is placed adjacent to the prostate, within the urethra, the actuating mechanism moves the arms to the second configuration, thereby pinching the prostate through the urethra.

The invention is defined by appended claim <NUM>. Optional features are presented in the dependent claims. The present invention relates to a urological (prostatic) implant for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes.

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.

Implementation of some embodiments of the disclosure can involve performing or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of some embodiments of the invention, several selected tasks could be implemented by hardware, by software, by firmware, or a combination thereof, using a computerized operating system.

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 invention relates to the field of urological medical devices and applications thereof, and more particularly to a urological (prostatic) implant for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes.

As briefly explained hereinabove in the Background section, benign prostate hyperplasia (hypertrophy) (BPH) is commonly treated by surgical techniques, catheter based techniques, or/and ablation techniques, among other known techniques. Treating subjects having BPH by such techniques may involve, or cause, any number of various complications and problems. Such complications and problems may be directly associated with performing a given BPH treatment technique itself, for example, as directly relating to equipment (medical devices) or/and procedures (methods) used in a surgical technique, a catheter based technique, or an ablation technique. Alternatively, or additionally, situations may arise where such complications and problems are not be directly associated with performing a given BPH treatment technique itself, however, they may be an indirect result or unintended consequence (e.g., side effect) during or/and after performing a given BPH treatment technique.

Some embodiments of the presently disclosed invention are suitable for treating subjects having conditions of benign prostate hyperplasia (hypertrophy) (BPH), where such treatment is expected to be absent of various possible complications and problems of, or associated with, known BPH treatment techniques. Accordingly, implementation and practice of some embodiments of the present invention may provide at least some solutions to at least some problems associated with known teachings in the field of urological medical devices and applications thereof that are currently used for treating subjects having BPH.

For purposes of better understanding embodiments of the present invention, in the following illustrative description thereof, reference is made to the figures. Throughout the following description and accompanying drawings, same reference notation and terminology (i.e., numbers, letters, symbols, terms, and phrases) are consistently used and refer to same components, elements, or features. It is to be understood that the invention is not necessarily limited in its application to particular details of construction or/and arrangement of device, apparatus, or/and system components, or to any particular sequential ordering of method steps or procedures, set forth in the following illustrative description.

Referring now to the drawings, <FIG> schematically illustrates a cross sectional side view of a typical human anatomical region <NUM> encompassing the lower part of the urinary bladder <NUM>, the prostate <NUM>, and the prostatic urethra <NUM>, where the anatomical region is absent of benign prostate hyperplasia (BPH). The prostatic urethra <NUM> is surrounded by and extends through the prostate <NUM> towards the bladder neck <NUM> of the urinary bladder <NUM>.

In the context of schematically illustrating and visualizing benign prostate hyperplasia (BPH), of particular interest are characteristics and parameters of, or relating to, position, configuration, and size (diameter) of the prostatic urethra <NUM> relative to those of the various prostatic lobes of the prostate <NUM> surrounding the prostatic urethra <NUM>. <FIG> schematically illustrates a cross sectional top view of a portion <NUM> of the anatomical region <NUM> shown in <FIG> (indicated by the dashed line double arrow 1B-1B therein), highlighting exemplary relative positions, configurations, and sizes of a prostatic urethra <NUM> in a normal open condition and selected prostatic lobes [dashed line circles], namely, left and right prostatic lateral lobes 114a and 114b, respectively, and prostatic medial lobe <NUM>, during 'normal' conditions absent of BPH.

<FIG> schematically illustrates a cross sectional top view of the same portion <NUM> of the anatomical region <NUM> shown in <FIG>, exhibiting benign prostate hyperplasia (BPH), highlighting exemplary relative positions, configurations, and sizes of the prostatic urethra <NUM> in an abnormal compressed condition and selected prostatic lobes [dashed line circles], namely, left and right prostatic lateral lobes 114a and 114b, respectively, and prostatic medial lobe <NUM>, during 'abnormal' conditions due to BPH. For additional illustrative purposes, <FIG> also shows the anterior interlobar groove <NUM>, and, the left and right posterolateral interlobar grooves 120a and 120b, respectively, so formed as a result of 'abnormal' enlargement of prostatic lobes 114a, 114b, and <NUM>, along with 'abnormal' compression of prostatic urethra <NUM>.

I n the context of the relevant medical fields relating to, and associated with, the present invention, for the purpose of further enhancing understanding of the illustrative description of the numerous exemplary embodiments of the invention, herein following are meanings of structural and anatomical reference directions used in the hereinbelow illustrative description. The following meanings are presented in a non-limiting manner, whereby, other similar meanings may also be applicable to exemplary embodiments of the herein disclosed invention.

The term 'distal' (direction), as used herein, refers to the direction away from a medical practitioner performing a method or using a device, and closer to a subject's body or towards the midline of the subject's body. The term 'proximal' (direction), as used herein, refers to the direction towards the medical practitioner performing a method or using a device, and farther from a subject's body or away from the midline of the subject's body.

The term 'cranial' (direction), as used herein, refers to the direction generally towards a subject's head or brain, or, for example, in a direction towards a urinary bladder and away from a prostate of same subject. The term 'caudal' (direction), as used herein, refers to the direction opposite that of a subject's head or brain, or/and situated in or directed toward the part of the subject's body from which the tail arises.

The term 'anterior' (direction), as used herein, refers to the direction towards the front plane of a subject's body. The term posterior' (direction), as used herein, refers to the direction towards the rear plane of a subject's body.

The term 'lateral' (direction), as used herein, refers to the direction away from the median and sagittal plane of a subject's body. The term 'medial' (direction), as used herein, refers to the direction towards the median and sagittal plane of a subject's body.

An aspect of some embodiments of the present invention is an implant (herein, also referred to as a prostatic implant) for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes. <FIG> schematically illustrates a side view of an exemplary embodiment of an implant (indicated as, and referred to by, reference number <NUM>) for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes, highlighting some prostatic implant components. Exemplary prostatic implant <NUM>, in a non-limiting manner, includes: a distal retractor <NUM> incorporating a first craniolateral corner 204a and a second craniolateral corner 204b, and a proximal retractor <NUM> incorporating a first caudolateral corner 208a and a second caudolateral corner 208b.

In exemplary embodiments, the prostatic implant <NUM> additionally includes an elongated spine member <NUM>. In such exemplary embodiments, the distal retractor <NUM> is connected to, or integrally formed as a single structure with, the proximal retractor <NUM>, via the elongated spine member <NUM> extending along a spinal longitudinal axis <NUM> or/and a plurality of elongated edge members <NUM> and <NUM>.

In exemplary embodiments, the distal retractor <NUM> and the proximal retractor <NUM> are independently actuatable. Specifically, actuation (i.e., movement or/and change in configuration, shape or form, or/and position) of the distal retractor <NUM> is independent of actuation (movement or/and change in configuration, shape or form, or/and position) of the proximal retractor <NUM>, and vice versa. Such independent actuation of the distal retractor <NUM> and the proximal retractor <NUM> is exemplified in <FIG> schematically illustrates the exemplary prostatic implant <NUM> shown in <FIG>, highlighting the implant distal retractor <NUM> exhibiting a non-stressed configuration, and the implant proximal retractor <NUM> exhibiting a stressed configuration. <FIG> schematically illustrates the exemplary prostatic implant <NUM>, highlighting both the implant distal retractor <NUM> and the proximal retractor <NUM> exhibiting a non-stressed configuration.

Accordingly, exemplary prostatic implant <NUM> is capable of undergoing a structural change in a manner whereby, for example, the distal retractor <NUM> is not actuated and remains in a non-stressed configuration (as shown in both <FIG>), whereas the proximal retractor <NUM> is actuated and changes or shifts from a stressed configuration (<FIG>) to a non-stressed configuration (<FIG>). Such actuation, in the form of configurational change or shift, of the proximal retractor <NUM> is independent of non-actuation of the distal retractor <NUM>.

An additional example showing preceding illustratively described structural change of the exemplary prostatic implant <NUM> is provided in <FIG> schematically illustrates a front view of the prostatic implant <NUM> shown in <FIG> exhibiting a stressed configuration, while <FIG> schematically illustrates a front view of the prostatic implant <NUM> shown in <FIG> exhibiting a non-stressed configuration. Such structural change of the exemplary prostatic implant <NUM> (in changing from a stressed configuration of <FIG> to a non-stressed configuration of <FIG>) is accompanied by radially directed forces outwardly originating from the distal and proximal retractors <NUM> and <NUM>, respectively, in a manner such that the prostatic implant <NUM> laterally expands and changes from a stressed configuration (<FIG>) to a non-stressed configuration (<FIG>).

Exemplary implementation and use of a prostatic implant, for example, prostatic implant <NUM>, for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes, according to some embodiments of the invention, are illustratively described with reference to <FIG>.

<FIG> schematically illustrates the exemplary embodiment of the stressed prostatic implant <NUM> shown in <FIG> immediately following insertion thereof into the (BPH exhibiting) anatomical region portion <NUM> shown in <FIG>. <FIG> highlights exemplary (insertion stage) positioning and configuration of the stressed prostatic implant <NUM> relative to the compressed prostatic urethra <NUM> and the prostatic lobes (left and right prostatic lateral lobes 114a and 114b, respectively, and prostatic medial lobe <NUM>).

<FIG> schematically illustrates the exemplary prostatic implant <NUM> shown in <FIG> following release thereof inside the (BPH exhibiting) anatomical region portion <NUM>. <FIG> highlights exemplary (release stage) positioning and configuration of the prostatic implant <NUM> now being 'less-stressed' (e.g., by undergoing elastic deformation under smaller external stresses, resulting in less strain thereof) relative to the compressed prostatic urethra <NUM> and the prostatic lobes. Structural change of the prostatic implant <NUM> (in changing from a stressed configuration of <FIG> to a non-stressed configuration of <FIG>) is accompanied by radially directed forces FR outwardly originating from the distal and proximal retractors <NUM> and <NUM>, respectively, in a manner such that the prostatic implant <NUM> laterally expands and changes from a stressed configuration (<FIG>) to a partially- or less-stressed configuration (<FIG>). This, at least, effects anchoring of implant <NUM> within the particular anatomy of the BPH prostatic urethra, which prevents dislodgement or migration thereof in cranial or caudal directions, as well as rotational movement. Moreover, such structural change of the prostatic implant <NUM>, via the radially directed forces FR outwardly originating from the distal and proximal retractors <NUM> and <NUM>, respectively, translates into laterally directed pushing or pressure forces FL exerted by the distal and proximal retractors <NUM> and <NUM>, respectively, upon those potions of the prostatic lobes (left and right prostatic lateral lobes 114a and 114b, respectively, and prostatic medial lobe <NUM>) in contact with the prostatic implant <NUM>, in general, and in contact with the distal and proximal retractors <NUM> and <NUM>, respectively, in particular.

Additional exemplary and optional technical features, characteristics, and properties of an implant, for example, prostatic implant <NUM>, for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes, according to some embodiments of the invention, are illustratively described as follows.

In exemplary embodiments, the distal retractor <NUM> or/and the proximal retractor <NUM> are in a form of a pair of first and second curved wing-like structures connected to spine member <NUM> via interconnecting members <NUM>, and symmetrically opposing each other relative to the spinal longitudinal axis <NUM>. In exemplary embodiments, each interconnecting member includes at least one elastic portion, for example, elastic portion <NUM>, adjoining the spine member <NUM>, such that the elastic portion is non-stressed when the first curved wing-like structure in the pair is pivotally positioned centrally away from the second curved wing-like structure in the pair about the spinal longitudinal axis <NUM>, so as to form a predetermined maximal elongated edge member spanning angle. In exemplary embodiments, each elastic portion adjoining the spine member <NUM> exhibits an increase in stress (e.g., bending or/and compression) when subjected to a moment of force that pivotally shifts the first curved wing-like structure towards the second curved wing-like structure about the spinal longitudinal axis <NUM>.

In exemplary embodiments, the prostatic implant <NUM> additionally includes at least one tissue support member extending between a first elongated edge member, for example, first elongated edge member <NUM>, and the spinal longitudinal axis <NUM>, and at least one other tissue support member extending between a second elongated edge member, for example, second elongated edge member <NUM>, and the spinal longitudinal axis <NUM>. In exemplary embodiments, each tissue support member is sized and configured for supporting a portion of a prostatic lateral lobe, for example, left prostatic lateral lobe 114a or right prostatic lateral lobe 114b, when the spine member <NUM> engages an anterior interlobar groove, for example, anterior interlobar groove <NUM>, that extends between left and right prostatic lateral lobes 114a and 114b, respectively, and when the first and second elongated edge members <NUM> and <NUM>, respectively, engage corresponding posterolateral interlobar grooves, for example, left and right posterolateral interlobar grooves 120a and 120b, respectively.

I n exemplary embodiments, the spine member <NUM> has a length being equal to or less than length of the anterior interlobar groove <NUM> or/and substantially less than the length of each of the first and second elongated edge members <NUM> and <NUM>, respectively. In exemplary embodiments, the first elongated edge member <NUM> is sized for positioning in the left posterolateral interlobar groove 120a that extends between the left prostatic lateral lobe 114a and the prostatic medial lobe <NUM>, and the second elongated edge member <NUM> is sized for positioning in the right posterolateral interlobar groove 120b that extends between the right prostatic lateral lobe 114b and the prostatic medial lobe <NUM>.

<FIG> schematically illustrate a perspective view, a frontal view, and a top view, respectively, of another exemplary embodiment of an implant (indicated as, and referred to by, reference number <NUM>) for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes, highlighting some prostatic implant components. According to such an exemplary embodiment, exemplary prostatic implant <NUM>, in a non-limiting manner, includes: a distal retractor <NUM> incorporating a first craniolateral corner 304a and a second craniolateral corner 304b, and a proximal retractor <NUM> incorporating a first caudolateral corner 308a and a second caudolateral corner 308b.

In exemplary embodiments, the prostatic implant <NUM> additionally includes an elongated spine member <NUM>. In such exemplary embodiments, the distal retractor <NUM> is connected to, or integrally formed as a single structure with, the proximal retractor <NUM>, via the elongated spine member <NUM> extending along a spinal longitudinal axis <NUM> or/and a plurality of elongated edge members, for example, first and second elongated edge members, <NUM> and <NUM>, respectively.

In exemplary embodiments, the distal retractor <NUM> and the proximal retractor <NUM> are independently actuatable. Specifically, actuation (i.e., movement or/and change in configuration, shape or form, or/and position) of the distal retractor <NUM> is at least partly, or entirely, independent of actuation (movement or/and change in configuration, shape or form, or/and position) of the proximal retractor <NUM>, and vice versa. In exemplary embodiments, such actuation may be in the form of an 'indirect' actuation, for example, by indirectly actuating the distal retractor <NUM> or/and the proximal retractor <NUM> using external means. In such exemplary embodiments, the indirect external means may include or involve using an implant delivery system, for example, in a form of an operative combination of an implant manipulator and a compression sleeve, for example, implant manipulator <NUM> and compression sleeve <NUM> illustratively described hereinbelow and shown in <FIG>, and <FIG>, in the context of an exemplary embodiment of a prostatic implant system).

Independent actuation of the distal retractor <NUM> and the proximal retractor <NUM> of prostatic implant <NUM> is analogous to that exemplified for the distal retractor <NUM> and the proximal retractor <NUM> of prostatic implant <NUM> shown in <FIG>. Thus, similar to that shown in <FIG>, for the exemplary prostatic implant <NUM> shown in <FIG>, the implant distal retractor <NUM> may exhibit a non-stressed configuration, while the implant proximal retractor <NUM> may exhibit a stressed configuration. Additionally, similar to that shown in <FIG>, for the exemplary prostatic implant <NUM>, both the implant distal retractor <NUM> and the proximal retractor <NUM> may exhibit a non-stressed configuration.

Accordingly, exemplary prostatic implant <NUM> is capable of undergoing a structural change in a manner whereby, for example, the distal retractor <NUM> is not actuated and remains in a non-stressed configuration (analogous to that shown in both <FIG>), whereas the proximal retractor <NUM> is actuated and changes or shifts from a stressed configuration (analogous to that shown in <FIG>) to a non-stressed configuration (analogous to that shown in <FIG>). Such actuation, in the form of configurational change or shift, of the proximal retractor <NUM> is independent of non-actuation of the distal retractor <NUM>.

Preceding illustratively described structural change of the exemplary prostatic implant <NUM> shown in <FIG> is analogous to that illustratively described hereinabove regarding structural change of the exemplary prostatic implant <NUM> as shown in <FIG>. Accordingly, such structural change of the exemplary prostatic implant <NUM> in changing from a stressed (e.g., compressed) configuration (analogous to that shown in <FIG>) to a non-stressed (e.g., non-compressed) configuration (analogous to that shown in <FIG>), is accompanied by radially directed forces outwardly originating from the distal and proximal retractors <NUM> and <NUM>, respectively, in a manner such that the prostatic implant <NUM> laterally expands and changes from a stressed configuration to a non-stressed configuration.

Exemplary implementation and use of the prostatic implant <NUM>, for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes, according to some embodiments of the invention, are analogous to that illustratively described hereinabove regarding the exemplary prostatic implant <NUM> as shown in <FIG>.

Accordingly, in a manner analogous to that shown in <FIG>, prostatic implant <NUM>, when in a stressed (e.g., compressed or folded) configuration, may be inserted into the (BPH exhibiting) anatomical region portion <NUM> shown in <FIG>. For example, with reference made to <FIG>, exemplary prostatic implant <NUM> can be substituted with exemplary prostatic implant <NUM>, for highlighting exemplary (insertion stage) positioning and configuration of the stressed (compressed or folded) prostatic implant <NUM> relative to the (compressed) prostatic urethra <NUM> and the prostatic lobes (left and right prostatic lateral lobes 114a and 114b, respectively, and prostatic medial lobe <NUM>).

Additionally, for example, with reference made to <FIG>, exemplary prostatic implant <NUM> can be substituted with exemplary prostatic implant <NUM>, for schematically illustrating the stressed (compressed or folded) configuration of exemplary prostatic implant <NUM> following release thereof inside the (BPH exhibiting) anatomical region portion <NUM>. According to such analogy, <FIG>, prostatic implant <NUM> being replaced by prostatic implant <NUM>, would then highlight exemplary (release or unfolding stage) positioning and configuration of the 'less-stressed' (partially or entirely unfolded) prostatic implant <NUM> relative to the 'more-stressed' prostatic urethra <NUM> and the prostatic lobes. Structural change of the prostatic implant <NUM> (in changing from the stressed (compressed or folded) configuration to the non-stressed (partially or entirely unfolded) configuration is accompanied by radially directed forces outwardly originating from the distal and proximal retractors <NUM> and <NUM>, respectively, in a manner such that the prostatic implant <NUM> laterally expands (i.e., unfolds) and changes from a stressed (compressed or folded) configuration to a non-stressed (partially or entirely unfolded) configuration. Moreover, such structural change of the prostatic implant <NUM>, via the radially directed forces outwardly originating from the distal and proximal retractors <NUM> and <NUM>, respectively, translates into laterally directed pushing or pressure forces exerted by the distal and proximal retractors <NUM> and <NUM>, respectively, upon those potions of the prostatic lobes (left and right prostatic lateral lobes 114a and 114b, respectively, and prostatic medial lobe <NUM>) in contact with the prostatic implant, in general, and in contact with the distal and proximal retractors <NUM> and <NUM>, respectively, in particular.

Reference is again made to <FIG>, schematically illustrating a perspective view of exemplary prostatic implant <NUM>, for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes, highlighting some prostatic implant components. According to such an alternative exemplary embodiment, exemplary prostatic implant <NUM>, in a non-limiting manner, includes: an elongated spine member <NUM> having a spinal longitudinal axis <NUM>, and, a first elongated edge member <NUM> and a second elongated edge member <NUM> symmetrically opposing each other relative to the spinal longitudinal axis <NUM>. Therein, each of the first and second elongated edge members <NUM> and <NUM>, respectively, is interconnected to the spine member <NUM> via at least one interconnecting member, for example, interconnecting member <NUM>.

According to this exemplary embodiment, exemplary prostatic implant <NUM> additionally includes at least one tissue support member, for example, first tissue support member <NUM>, extending between the first elongated edge member <NUM> and the spinal longitudinal axis <NUM>, and at least one other tissue support member, for example, second tissue support member <NUM>, extending between the second elongated edge member <NUM> and the spinal longitudinal axis <NUM>. Therein, each of the tissue support members, for example, each of the first and second tissue support members <NUM> and <NUM>, respectively, is sized and configured for supporting a portion of a prostatic lateral lobe (for example, left or right prostatic lateral lobe 114a or 114b, respectively, shown in <FIG>, <FIG>) when the spine member <NUM> engages an anterior interlobar groove (for example, anterior interlobar groove <NUM> shown in <FIG>, <FIG>) that extends between prostatic lateral lobes, and when the first and second elongated edge members <NUM> and <NUM>, respectively, engage corresponding posterolateral interlobar grooves (for example, left and right posterolateral interlobar grooves 120a and 120b, shown in <FIG>, <FIG>).

In exemplary embodiments, the spine member <NUM> has a length being equal to or less than length of the anterior interlobar groove <NUM> or/and substantially less than the length of each of the first and second elongated edge members <NUM> and <NUM>, respectively. In exemplary embodiments, the first elongated edge member <NUM> is sized for positioning in the left posterolateral interlobar groove 120a that extends between the left prostatic lateral lobe 114a and the prostatic medial lobe <NUM>, and the second elongated edge member <NUM> is sized for positioning in the right posterolateral interlobar groove 120b that extends between the right prostatic lateral lobe 114b and the prostatic medial lobe <NUM>.

In exemplary embodiments, the prostatic implant <NUM> is configured to anchor the anterior interlobar groove <NUM>, and, the left and right posterolateral interlobar grooves 120a and 120b, respectively, by continuously exerting a radially directed pushing force thereupon, within a range of between about <NUM> grams and about <NUM>,<NUM> grams (between <NUM> N and <NUM> N), so as to prevent or minimize axial or/and rotational movement of the anchored anterior interlobar groove <NUM>, and, the posterolateral interlobar grooves 120a and 120b. In exemplary embodiments, the prostatic implant <NUM> is configured to anchor the anterior interlobar groove <NUM>, and, the left and right posterolateral interlobar grooves 120a and 120b, respectively, by continuously exerting a radially directed pushing force thereupon, so as to increase distance separating superior portions of the interlobar grooves and increase distance separating left and right inferior portions of the interlobar grooves, or/and to maintain a distance of at least <NUM> between the prostatic lateral lobes, by exerting lateral forces thereupon within a range of between about <NUM> grams and about <NUM>,<NUM> grams (between <NUM> N and <NUM> N).

In exemplary embodiments, implant <NUM> is shown in <FIG> as fully unfolded and fully unstressed, having its double wings-like structure fully opened and expanded laterally. In exemplary embodiments, each of the interconnecting members, for example, interconnecting member <NUM>, includes at least one elastic portion, for example, elastic portion <NUM>, adjoining the spine member <NUM>, such that the elastic portion <NUM> is non-stressed when the first and second elongated edge members <NUM> and <NUM>, respectively, are pivotally positioned centrally away from each other about the spinal longitudinal axis <NUM>, so as to form a predetermined maximal spanning angle between opposing interconnecting members. In exemplary embodiments, the predetermined maximal spanning angle is within a range of between about <NUM>° and about <NUM>°. In exemplary embodiments, each elastic portion, for example, elastic portion <NUM>, adjoining the spine member <NUM> exhibits an increase in stress (compression) when subjected to a moment of force that pivotally shifts the first and second elongated edge members <NUM> and <NUM>, respectively, towards each other about the spinal longitudinal axis <NUM>.

In exemplary embodiments, the first and second edge members <NUM> and <NUM>, respectively, are configured to approach each other so as to form an elongated edge member spanning angle being equal to or greater than about <NUM>° degrees. In such exemplary embodiments, each of the first and second elongated edge members <NUM> and <NUM>, respectively, or/and each of the first and second tissue support members <NUM> and <NUM>, respectively, exerts a total lateral pressing force upon a corresponding prostatic lateral lobe. In exemplary embodiments, the total lateral pressing force is in a range of between about <NUM> grams and about <NUM>,<NUM> grams (between <NUM> N and <NUM> N).

In exemplary embodiments, each of the first and second tissue support members <NUM> and <NUM>, respectively, is configured as a curvilinear portion of the first elongated edge member <NUM> or/and the second elongated edge member <NUM> protruding towards the spinal longitudinal axis <NUM>. In exemplary embodiments, each of the first and second tissue support members <NUM> and <NUM>, respectively, is configured as a curvilinear portion of the first elongated edge member <NUM> or/and the second elongated edge member <NUM> that protrudes laterally outwardly from an area encompassed by the first elongated edge member <NUM> or/and the second elongated edge member <NUM> and the spine member <NUM>.

<FIG> schematically illustrates a top view of the exemplary prostatic implant <NUM> shown in <FIG>, in a fully non-stressed configuration, highlighting a cranial-nose portion <NUM> thereof and a caudal-nose portion <NUM> thereof.

In exemplary embodiments, for example, as shown in <FIG>, at least one of the first and second elongated edge members <NUM> and <NUM>, respectively, has a cranial-nose portion, for example, cranial-nose portion <NUM>, shaped and configured for resting against a ledge imposed by a urinary bladder neck segment adjacent the prostatic urethra (e.g., <NUM> in <FIG>), so as to prevent cranial dislodgement of the prostatic implant <NUM> into the urinary bladder (e.g., <NUM> in <FIG>), when the spine member <NUM> engages an anterior interlobar groove (e.g., <NUM> in <FIG>) that extends between the prostatic lateral lobes (e.g., 114a and 114b in <FIG>, <FIG>), and when the first and second elongated edge members <NUM> and <NUM>, respectively, engage corresponding posterolateral interlobar grooves (e.g., 120a and 120b in <FIG>, <FIG>). In such exemplary embodiments, the cranial-nose portion <NUM> is "L" shaped.

In exemplary embodiments, for example, as also shown in <FIG>, at least one of the first and second elongated edge members <NUM> and <NUM>, respectively, has a caudal-nose portion, for example, caudal-nose portion <NUM>, shaped and configured for resting against a narrowing imposed by the external urethral sphincter adjacent to the verumontanum of the prostatic urethra, so as to prevent caudal migration of the prostatic implant <NUM> through the external sphincter and into the bulbar urethra, when the spine member <NUM> engages an anterior interlobar groove (e.g., <NUM> in <FIG>) that extends between the prostatic lateral lobes (e.g., 114a and 114b in <FIG>, <FIG>), and when the first and second elongated edge members <NUM> and <NUM>, respectively, engage corresponding posterolateral interlobar grooves (e.g., 120a and 120b in <FIG>, <FIG>). In such exemplary embodiments, the caudal-nose portion <NUM> is "L" shaped.

<FIG> schematically illustrates the exemplary prostatic implant shown in <FIG>, highlighting inclusion therein of a plurality of exemplary tissue support members <NUM>, <NUM>, <NUM>, and <NUM>, where each such tissue support member is configured as a rib or rib-type member.

<FIG> schematically illustrates the exemplary prostatic implant shown in <FIG>, highlighting inclusion therein of a pair of exemplary first and second tissue support members <NUM> and <NUM>, with each such tissue support member including a tissue contacting surface, for example, first and second tissue contacting surfaces <NUM> and <NUM>, respectively.

In exemplary embodiments, at least one of the tissue support members, for example, at least one of the first and second tissue support members <NUM> and <NUM>, respectively, or/and rib or rib-type tissue support member <NUM>, includes a tissue contacting surface, such as tissue contacting surface <NUM> or <NUM>, sized or/and shaped according to dimensions of a portion of a prostatic lateral lobe (for example, left or right prostatic lateral lobe 114a or 114b, respectively, shown in <FIG>, <FIG>).

An aspect of some embodiments of the present invention is a system (herein, also referred to as a prostatic implant system) for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes. In exemplary embodiments, the prostatic implant system, in a non-limiting manner, includes: an implant (prostatic implant), and an implant (prostatic implant) manipulator detachably connected to the implant (prostatic implant). Therein, the prostatic implant includes a plurality of elongated edge members interconnected in a form of a collapsible-expandable frame expandable to retract or/and support periurethral tissue by exerting pushing forces upon interlobar grooves located along the prostatic urethra. Additionally, therein, a first one of the elongated edge members includes a first craniolateral corner and a first caudolateral corner, and a second one of the elongated edge members includes a second craniolateral corner opposing the first craniolateral corner and a second caudolateral corner opposing the first caudolateral corner. In such exemplary embodiments, the implant manipulator is configured to manipulate and force the implant first and second caudolateral corners into close proximity with each other.

Any of the hereinabove illustratively described exemplary embodiments of an implant (prostatic implant), such as exemplary prostatic implant <NUM> or exemplary prostatic implant <NUM>, for retracting or/and supporting periurettiral tissue enclosing a prostatic urethra along a length of prostate lobes may be included as part of, and used for implementing, the herein disclosed exemplary embodiments of a system (prostatic implant system) for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes.

For example, reference is made to <FIG> which schematically illustrates an exemplary embodiment of a system (prostatic implant system), indicated as, and referred to by, reference number <NUM>, for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes, highlighting some system components. Therein, an exemplary prostatic implant (such as prostatic implant <NUM> shown in <FIG>), in a stressed (e.g., bent, contracted or/and compressed, folded type) configuration and operatively connected to the distal end of an exemplary cystoscope <NUM>, is entirely held within an exemplary compression sleeve <NUM> by an implant manipulator <NUM> (also described below and shown in more details in <FIG>, and <FIG>).

With reference to <FIG>, and <FIG>, exemplary prostatic implant system <NUM>, in a non-limiting manner, includes: an implant (prostatic implant) <NUM>, and an implant (prostatic implant) manipulator <NUM> detachably connected to the prostatic implant <NUM>. Therein, the prostatic implant <NUM> includes a plurality of elongated edge members, for example, first and second elongated edge members <NUM> and <NUM>, respectively, interconnected in a form of a collapsible-expandable frame expandable to retract or/and support periurethral tissue by exerting pushing forces upon interlobar grooves located along the prostatic urethra (e.g., as illustratively described hereinabove with reference to <FIG>, and <FIG>). Additionally, therein, the first elongated edge member <NUM> includes a first craniolateral corner 304a and a first caudolateral corner 308a, and the second elongated edge member <NUM> includes a second craniolateral corner 304b opposing the first craniolateral corner 304a and a second caudolateral corner 308b opposing the first caudolateral corner 308a. In such exemplary embodiments, the implant manipulator <NUM> (e.g., <FIG>) is configured to manipulate and force the prostatic implant first and second caudolateral corners 308a and 308b, respectively, into close proximity with each other.

Additional exemplary and optional technical features, characteristics, and properties, as well as exemplary implementation and use, of a system, for example, prostatic implant system <NUM>, for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes, according to some embodiments of the invention, are illustratively described as follows.

<FIG> schematically illustrate exemplary embodiments of the prostatic implant system <NUM>, highlighting progressive (sequential) stages of operation thereof, wherein the exemplary prostatic implant <NUM> is deployed via progressively (sequentially) being pushed out of the compression sleeve <NUM> by the implant manipulator <NUM>, along with undergoing a type of unfolding of at least some of its structural members. At first (<FIG>), distal retractor <NUM> emerges and then immediately unfolds, at least partly, while the other part of implant <NUM> is held folded and compressed in compression sleeve <NUM>; followed by (<FIG>) complete extraction of implant <NUM> from within compression sleeve <NUM>, where implant <NUM> is unfolded at least partly along most or all its entire length. <FIG> schematically illustrates the exemplary prostatic implant <NUM>, following deployment by the prostatic implant system <NUM>, in a 'stand-alone' non-stressed, unfolded and expanded configuration after exiting the compression sleeve <NUM> and detachment from the implant manipulator <NUM>.

In exemplary embodiments of prostatic implant system <NUM>, the implant manipulator <NUM> (e.g., <FIG>) is configured for progressively (sequentially) changing the shape or form of the prostatic implant <NUM> according to different progressive or sequential implant deployment configurations, including at least one of the following.

In exemplary embodiments, the implant manipulator <NUM> (e.g., <FIG>), when connected to the prostatic implant <NUM>, is configured for applying thereto at least one of rotational forces, pulling forces, and pushing forces. The implant manipulator <NUM> applies such forces to the prostatic implant <NUM> so as to facilitate and effect preceding illustratively described progressive (sequential) changing of the shape or form of the prostatic implant <NUM>, according to the different progressive or sequential prostatic implant deployment configurations.

In exemplary embodiments, the implant manipulator <NUM> includes a tubular member, for example, tubular member <NUM>, and a tether, for example, tether <NUM>, releasably intertwined through both of the implant first and second caudolateral corners. In such exemplary embodiments, the implant manipulator <NUM> is configured for continuously or/and selectively pulling the prostatic implant <NUM> via an operator using the tether <NUM> against a distal end <NUM> of the tubular member <NUM>.

In exemplary embodiments, the prostatic implant system <NUM> additionally includes an over-sheath, for example, over-sheath <NUM> shown in <FIG>, sized for covering a length of the cystoscope <NUM> having a cystoscope lumen (e.g., as a type of 'working channel') dimensioned to restrain the prostatic implant <NUM> in the fully collapsed delivery configuration (e.g., <FIG>) via at least encircling the implant first and second craniolateral corners.

In such exemplary embodiments, the implant manipulator <NUM> is configured for manipulating and shifting the prostatic implant <NUM> within the over-sheath lumen between the fully collapsed (fully folded) delivery configuration (<FIG>) and the partially collapsed (and partially unfolded) positioning configuration (<FIG>). Such manipulating and shifting is effected by the implant manipulator <NUM> pushing or pulling the prostatic implant <NUM> relative to the over-sheath lumen until the implant first and second craniolateral corners 304a and 304b, respectively, are released from the implant manipulator over-sheath <NUM>. Additionally, in such exemplary embodiments, the implant manipulator <NUM> is configured for manipulating and shifting the prostatic implant <NUM> between the partially collapsed (and partially unfolded) delivery configuration (<FIG>) and the expanded (and partially or fully unfolded along most/all implant <NUM> length) deployed configuration (<FIG>). Such manipulating and shifting is effected by the implant manipulator <NUM> detaching from the prostatic implant <NUM> after release of the tether <NUM> from the implant first and second caudolateral corners 308a and 308b, respectively.

As stated above, any of the hereinabove illustratively described exemplary embodiments of an implant (prostatic implant) for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes may be included as part of, and used for implementing, the herein disclosed exemplary embodiments of a system (prostatic implant system) for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes.

Thus, with reference again made to <FIG>, and <FIG>, in exemplary embodiments of prostatic implant system <NUM>, the prostatic implant <NUM> includes: an elongated spine member <NUM> having a spinal longitudinal axis <NUM>, and, first and second elongated edge members <NUM> and <NUM>, respectively, symmetrically opposing each other relative to the spinal longitudinal axis <NUM>, and interconnected to the spine member <NUM> via at least one interconnecting member <NUM>. In such exemplary embodiments, the spine member <NUM> has a length being equal to or less than length of an anterior interlobar groove (e.g., <NUM> in <FIG>, <FIG>) that extends between prostatic lateral lobes (e.g., left and right prostatic lateral lobes 114a and 114b, respectively, in <FIG>, <FIG>), or/and substantially less than length of each of the first and second elongated edge members <NUM> and <NUM>, respectively.

Further, in such exemplary embodiments of prostatic implant system <NUM> including prostatic implant <NUM>, with additional reference made to <FIG>, <FIG>, the first elongated edge member <NUM> is sized for positioning in a left posterolateral interlobar groove 120a that extends between a left prostatic lateral lobe 114a and a prostatic medial lobe <NUM>, and the second elongated edge member <NUM> is sized for positioning in a right posterolateral interlobar groove 120b that extends between a right prostatic lateral lobe 114b and the prostatic medial lobe <NUM>.

Further, in such exemplary embodiments of prostatic implant system <NUM> including prostatic implant <NUM>, at least one of the implant first and second craniolateral corners 304a and 304b, respectively, are shaped and configured for resting against a ledge imposed by the urinary bladder neck (e.g., <NUM>) so as to prevent cranial dislodgement of the prostatic implant <NUM> into the urinary bladder (e.g., <NUM>), when the spine member <NUM> engages an anterior interlobar groove (e.g., <NUM>) that extends between prostatic lateral lobes (e.g., 114a and 114b), and when the first and second elongated edge members <NUM> and <NUM>, respectively, engage corresponding posterolateral interlobar grooves (e.g., 120a and 120b).

Further, in such exemplary embodiments of prostatic implant system <NUM> including prostatic implant <NUM>, at least one of the implant first and second caudolateral corners 308a and 308b, respectively, are shaped and configured for resting against a narrowing imposed by the external urethral sphincter adjacent the verumontanum of the prostatic urethra, so as to prevent caudal shift of the prostatic implant <NUM>, when the spine member <NUM> engages an anterior interlobar groove (e.g., <NUM>) that extends between prostatic lateral lobes (e.g., 114a and 114b), and when the first and second elongated edge members <NUM> and <NUM>, respectively, engage corresponding posterolateral interlobar grooves (e.g., 120a and 120b). In such exemplary embodiments, each of the implant first and second caudolateral corners 308a and 308b, respectively, has a shape or form of a proximally directed apex, wherein the apex is formed by intersection of converging curved slopes of respective ones of the implant first and second caudolateral corners 308a and 308b, respectively.

Also disclosed herein is a method (herein, also referred to as a prostatic implant method) for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes. The method does not form part of the claimed invention.

In exemplary embodiments, the prostatic implant method, in a non-limiting manner, includes:.

In alternative exemplary embodiments, the prostatic implant method, in a non-limiting manner, includes:.

Any of the hereinabove illustratively described exemplary embodiments of an implant (prostatic implant), such as exemplary prostatic implant <NUM> or exemplary prostatic implant <NUM>, and any of the hereinabove illustratively described exemplary embodiments of a system (prostatic implant system), such as exemplary prostatic implant system <NUM>, for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes, may be included as part of, and used for implementing, the herein disclosed exemplary embodiments of a method (prostatic implant method) for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes.

For example, reference is made to <FIG> which schematically illustrate various stages of delivering and deploying an exemplary prostatic implant, such as prostatic implant <NUM> illustratively described hereinabove and shown in <FIG>, and <FIG>, for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes, using an exemplary system, such as prostatic implant system, such as prostatic implant system <NUM> illustratively described hereinabove and shown in <FIG>).

As shown in <FIG>, over-sheath <NUM> is sleeved over the longitudinal body <NUM> of a urological endoscope, particularly, a cystoscope (also known as a lithoscope), for example, cystoscope <NUM>. Then some preliminary steps may be taken by an operator, such as a medical practitioner, in order to scan the treatment area or/and to measure patient-specific anatomical dimensions, optionally, in order to select an implant of proper size for a chosen result.

With reference to <FIG>, over-sheath <NUM>, together with cystoscope <NUM>, is then extended throughout the length of the prostatic urethra 106sa, where the cystoscope distal end <NUM> is provided adjacent to or inside of the urinary bladder 102sa. In <FIG>, the prostatic urethra 106sa, the urinary bladder 102sa, and the bladder neck 108sa, are drawn for illustrative purposes only, and, in a non-limiting manner, may be considered 'simulated analogs' of the corresponding bodily organs or parts, namely, prostatic urethra <NUM>, urinary bladder <NUM>, and bladder neck <NUM>, schematically shown in <FIG>.

Cystoscope <NUM> is removed from the prostatic urethra 106sa while, optionally, keeping over-sheath <NUM> in place (as shown in <FIG>). Optionally, compression sleeve <NUM> is then loaded over cystoscope outer periphery <NUM> (as shown in <FIG>), in preparation of loading prostatic implant <NUM> into the cystocope <NUM> and collapsing of the prostatic implant <NUM> using the compression sleeve <NUM>.

In order to collapse (e.g., via folding) the prostatic implant <NUM> from being in a non-stressed fully opened configuration to being in a fully collapsed (fully folded) delivery configuration, and insert prostatic implant <NUM> into the working channel <NUM> of the cystoscope <NUM>, a tether <NUM>, is first intertwined (unless it is readily provided as such), optionally, releasably, through both the first and second craniolateral corners 304a and 304b, respectively, of distal retractor <NUM> of implant <NUM>. First and second craniolateral corners are then urged the into close proximity to each other, so as to effect changing of the prostatic implant <NUM> into the partially collapsed (partially folded / partially unfolded) positioning configuration, by pulling tether <NUM> against the distal end <NUM> of the tubular member <NUM>.

The implant manipulator <NUM>, which can assist in exemplary subsequent steps, such as of implant delivery, positioning or/and activating, can be formed by threading tether <NUM> through the lumen of the tubular member <NUM>, and optionally fixating proximal end (e.g., proximal both free ends 414a and 414b) of tether <NUM> relative to the proximal end <NUM> of tubular member <NUM>. <FIG> demonstrates an exemplary formation of the implant manipulator <NUM> connected with the prostatic implant <NUM>, also forcing it into the partially collapsed (partially folded / partially unfolded) positioning configuration.

As shown in <FIG>, the implant manipulator <NUM>, with the prostatic implant <NUM> connected thereto, are then loaded into a lumen (e.g., working channel <NUM>) of the cystoscope <NUM>. Optionally, the proximal end of the implant manipulator <NUM> is passed into the distal opening of the working channel <NUM> (<FIG>(i)), while the proximal end of the implant manipulator <NUM> is drawn from a proximal opening <NUM> of the working channel <NUM> (<FIG>(ii)). <FIG> shows the prostatic implant <NUM> in its partially collapsed (partially folded / partially unfolded) positioning configuration coupled to the cystoscope <NUM> using the implant manipulator <NUM> (not shown, fully inserted within working channel <NUM>).

As shown in <FIG>, the prostatic implant <NUM> is then forced into a fully collapsed (fully folded) delivery configuration using the compression sleeve <NUM>, by drawing the compression sleeve <NUM> over entire length of the prostatic implant <NUM>. The compression sleeve <NUM> incorporates a lumen <NUM> sized for effecting changing of the configuration of the prostatic implant <NUM> from the partially collapsed (partially folded / partially unfolded) positioning configuration to the fully collapsed (fully folded) delivery configuration.

The prostatic implant <NUM> is then pushed distally through over-sheath <NUM> with the cystoscope <NUM> (<FIG>) and passed, still in its fully collapsed (fully folded) delivery configuration, in a cranial direction in the prostatic urethra 106sa, into the urinary bladder 102sa of the subject. Then, the prostatic implant distal retractor <NUM> is released from its restricting boundary, namely, the working channel <NUM> and the over-sheath <NUM>, until at least the distal retractor <NUM>, and, optionally, also the proximal retractor <NUM>, protrudes in a cranial direction from the prostatic urethra 106sa (as shown, for example, in <FIG>). This may be effected by either pushing the prostatic implant <NUM>, optionally relative to the over-sheath <NUM>, or/and the cystoscope <NUM> further into the urinary bladder 102sa, or by holding the prostatic implant <NUM> in the urinary bladder 102sa, using the implant manipulator <NUM>, while proximally pulling over-sheath <NUM> or/and the cystoscope <NUM>.

Releasing the prostatic implant <NUM> should effect expansion of the distal retractor <NUM> within inner boundaries of the urinary bladder 102sa into the partially collapsed (partially folded / partially unfolded) positioning configuration, resulting in the first and second craniolateral corners 304a and 304b, respectively, being distanced apart from each other, and, the first and second caudolateral corners 308a and 308b, respectively, being kept in close proximity to each other.

Then, under vision, using the cystoscope <NUM>, the prostatic implant <NUM> is positioned in the prostatic urethra 106sa along the length of the prostate lobes, as shown in part, in <FIG>. The prostatic implant <NUM> positioning in the prostatic urethra 106sa may include at least one of the following steps, not necessarily in same order:.

The prostatic implant <NUM> positioning should result, if the prostatic implant <NUM> is in its partially collapsed (partially folded / partially unfolded) positioning configuration, in effecting expansion of a distal region of the prostatic urethra 106sa, using the distal retractor <NUM>, into a greater lumen size than an adjacent proximal region of the prosthetic urethra 106sa. The distal retractor <NUM> may also be partially collapsed into conformity with anatomy of the distal region of the prostatic urethra 106sa. <FIG> provides a frontal (caudally directed) view for an exemplary representation of proper positioning of the prostatic implant <NUM> within the prostatic urethra 106sa. By also expanding (unfolding) the proximal retractor <NUM>, the configuration of the prostatic implant <NUM> can be changed from the fully collapsed (fully folded) delivery configuration into an expanded (fully unfolded) deployed configuration. Optionally, in exemplary embodiments, such expansion (unfolding) of the prostatic implant <NUM> is effected in a partial manner, whereby at least most, but not necessarily all, of the prostatic implant <NUM> structural members change into a fully expanded (unfolded) configuration, for example, possibly due to physical size and dimensional restrictions imposed by the in-vivo environment of the periurethral tissue and the surrounding prostatic lobes. The expansion (unfolding) procedure results in the first and second craniolateral corners 304a and 304b, respectively, to become distanced apart from each other, and, the first and second caudolateral corners 308a and 308b, respectively, to become distanced apart from each other as well. The first and second tissue support members <NUM> and <NUM>, respectively, of the prostatic implant <NUM> are also released for supporting respective portions of the lateral prostatic lobes following implant positioning.

The cystoscope <NUM> is then removed from the prostatic urethra 106sa, and from the entire urethra of the subject, while keeping the over-sheath <NUM> in place.

Any of the hereinabove illustratively described steps or procedures of the herein disclosed exemplary embodiments of a method (prostatic implant method) for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes, may be repeated in case there is a need to change (e.g., correct) positioning of the prostatic implant <NUM>, or of any portion or member thereof, in relation to chosen anatomical or/and physiological considerations. Repeating any of the previous steps may include, be preceded by, or be followed by, re-collapsing the prostatic implant <NUM> back into the fully collapsed delivery configuration or/and passing the prostatic implant <NUM> back into the urinary bladder 102sa. Repeating may be persistent until reaching a chosen result. The chosen result can be verified under vision, for example, using the cystoscope <NUM>. The chosen result may include anchoring different portions of the prostatic implant <NUM> in at least two of the anterior interlobar grooves, the left posterolateral interlobar groove, and the right posterolateral interlobar groove, of the prostatic urethra 106sa, within the boundaries of the prostate lobes. The chosen result may also include lifting both prostatic lateral lobes so as to enlarge minimal lumen size of the prostatic urethra 106sa, optionally, to at least <NUM>, or at least <NUM>, along a continuous length of the prostatic urethra, optionally along its entire length, optionally, by shifting each of the prostatic lateral lobes, pivotally, relative to the anterior interlobar groove.

Once it is verified that the prostatic implant <NUM> is in appropriate positioning within the prostatic urethra 106sa, final deployment and implantation stages can take place, and the prostatic implant <NUM> should be left therein, with no further interaction with the implant manipulator <NUM>. Accordingly, the fully deployed and implanted prostatic implant <NUM> is thereby configured and positioned to continuously exert radially directed pushing forces upon the anterior interlobar groove and at least one of the left and right posterolateral interlobar grooves. This may facilitate preventing or minimizing possible axial or/and rotational movement of the prostatic implant <NUM>, or/and to increase distance separating the superior interlobar grooves and to increase distance separating the left and right inferior-lateral interlobar grooves. Such may also facilitate the prostatic implant <NUM> to exert lateral pressing forces upon each prostatic lateral lobe, thereby, retracting or/and supporting the periurethral tissue.

As shown in <FIG>, the implant manipulator <NUM> is taken apart into its main parts, namely, the tubular member <NUM> and the tether <NUM> (partly shown in <FIG>, illustrating scissoring of the implant manipulator <NUM>), and the tether <NUM> is pulled and withdrawn from holding the prostatic implant <NUM> and subsequently, from the subject's body (<FIG>).

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'.

Each of the phrases 'consisting of and 'consists of', as used herein, means 'including and limited to'.

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.

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.

It is to be fully understood that certain aspects, characteristics, and features, of the invention, which are, for clarity, illustratively described and presented in the context or format of a plurality of separate embodiments, may also be illustratively described and presented in any suitable combination or sub-combination in the context or format of a single embodiment. Conversely, various aspects, characteristics, and features, of the invention which are 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 the context or format of a plurality of separate embodiments.

Claim 1:
An implant (<NUM>) for retracting or/and supporting periurethral tissue enclosing a prostatic urethra along a length of prostate lobes (114a, 114b), the implant comprising:
an elongated spine member (<NUM>) having a spinal longitudinal axis (<NUM>, <NUM>) ;
a first elongated edge member (<NUM>)and a second elongated edge member (<NUM>) symmetrically opposing each other relative to said spinal longitudinal axis (<NUM>, <NUM>) , each said elongated edge member (<NUM>, <NUM>) is interconnected to said spine member (<NUM>) via at least one interconnecting member (<NUM>); and
at least one tissue support member (<NUM>, <NUM>, <NUM>, <NUM>) extending between said first elongated edge member (<NUM>) and said spinal longitudinal axis(<NUM>, <NUM>) , and at least one other tissue support member (<NUM>, <NUM>, <NUM>, <NUM>) extending between said second elongated edge member (<NUM>) and said spinal longitudinal axis (<NUM>, <NUM>), wherein each said tissue support member (<NUM>) is sized and configured for supporting a portion of a prostatic lateral lobe (114a, 114b) when said spine member (<NUM>) engages an anterior interlobar groove (<NUM>) that extends between said prostatic lateral lobes (114a, 114b), and when said first and second elongated edge members (<NUM>, <NUM>) engage corresponding posterolateral interlobar grooves (120a, 120b), wherein said spine member (<NUM>) has a length being substantially less than a length of each of said first and second elongated edge members (<NUM>, <NUM>), wherein said first elongated edge member (<NUM>) is sized for positioning in a left posterolateral interlobar groove (120a) that extends between a left prostatic lateral lobe (114a) and a prostatic medial lobe (<NUM>), and said second elongated edge member (<NUM>) is sized for positioning in a right posterolateral interlobar groove (120b) that extends between a right prostatic lateral lobe (114b) and said prostatic medial lobe (<NUM>).