Patent Description:
The invention relates to the field of urological medical devices. The invention is directed to a dilating device for a prostatic urethra as defined in claim <NUM>.

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). However, surgical treatment is an extremely invasive procedure which is debilitating, painful and often traumatic to the patient. Various complications including impotence, incontinence, bleeding, infection and other undesirable problems attendant with such surgery can result.

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.

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, this procedure may result in pain and discomfort to the patient.

<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.

<CIT> appears to disclose, "An apparatus and method for maintaining patency of a vessel or other body region is provided. The apparatus includes an appliance having a non-circumferential form and being effective in maintaining patency or openness, or causing to become patent or open, a body region in which the appliance is located. The appliance may be formed of a flexible metallic struts structured to be submucossally implanted into a wall of the vessel or other body region.

<CIT> appears to disclose, "Apparatus and methods are described including an implantable device having first and second longitudinal ends, the device having a length of less than <NUM> when the device is unconstrained. The device includes struts arranged such that, when the device is unconstrained, along a continuous portion of the device having a length that is at least <NUM>, a maximum inter-strut distance defined by any set of two adjacent struts is more than <NUM> times as great as a maximum inter-strut distance defined by any set of two adjacent struts within longitudinal portions of the device within <NUM> of the longitudinal ends of the device.

The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.

Disclosed herein is a device that is configured to dilate the prostatic urethra by engaging with the three grooves of the prostatic urethra and exerting a radially outwards force upon deployment within the urethra. The device may be normally open, and made of a resilient material allowing it to laterally compress for fitting within a deployment lumen, and to laterally expand to a normally-open configuration upon extraction from the deployment lumen, and exert the outwards radial force that dilates the prostatic urethra upon deployment.

<FIG>, wherein like parts are designated by like reference numerals throughout, illustrate a dilating device for the prostatic urethra, and a method of use according to the present invention. Although the present invention will be described with reference to the figures, it should be understood that many alternative forms can embody the present invention. One of ordinary skill in the art will additionally appreciate different ways to alter the parameters disclosed, such as the size, shape, or type of elements or materials, in a manner still in keeping with the spirit and scope of the present invention.

Reference is now made to <FIG> which illustrates a dilating device <NUM> for the prostatic urethra, from a perspective view and a top view, respectively, in accordance with an embodiment. Device <NUM> may comprise at least three laterally connected ridges 100a, 100b, 100c, each of which is configured to longitudinally engage with a different substantially longitudinal groove of the prostatic urethra of a patient. Device <NUM> may be normally-open, and may be configured to laterally compress, causing the distance between ridges 100a, 100b, 100c to decrease, thereby enabling the insertion of device <NUM> into the prostatic urethra in a compressed configuration, and to laterally expand to its normally-open configuration, causing the distance between ridges 100a, 100b, 100c to increase, upon deployment within the prostatic urethra. The lateral expansion of device <NUM> when deployed within the prostatic urethra may exert a radially outward force that causes ridges 100a, 100b, 100c to engage with the grooves of the urethra and push them outwards, thereby dilating the prostatic urethra, and allowing a free flow of a liquid, such as urine, to pass from the bladder through the urethra and out of the patient's body.

Peripheral ridges 100a, 100b may each be configured to engage with a different postero-lateral groove of the prostatic urethra, and central ridge 100c may be configured to engage with the anterior inter-lobar groove of the prostatic urethra.

Two distal connectors 100d, 100e may branch out from a V-shaped distal end of central ridge 100c and laterally connect to the distal ends of peripheral ridges 100a and 100b, respectively. Additionally, two proximal 100f, <NUM> may branch out from a proximal end of central ridge 100c and laterally connect to the proximal ends of peripheral ridges 100a, and 100b, thereby forming two closed forms that are joined at central ridge 100c. In one embodiment, proximal connectors 100f and <NUM> may branch out from a V-shaped proximal end of central ridge 100c, as illustrated in <FIG>. In the embodiment of Fig. lA, connectors 100d, 100e, 100f, and <NUM> may be substantially S-shaped, forming a butterfly shape by device <NUM> when in the normally-open configuration, where proximal connectors 100f, and <NUM> may be configured for positioning towards the distal end of the prostate urethra.

Device <NUM> may be provided with two, or more distally positioned protrusions 102a and 102b that are configured to impinge against the postero-lateral side of the bladder neck, and prevent a migration of device <NUM> into the urinary bladder. Protrusions 102a and 102b may be integrally formed with distal connectors 100d, 100e, such as forming a portion of the S-shape of distal connectors 100d, 100e that are shown in <FIG>, <FIG>.

Device <NUM> may additionally be configured for alignment within the prostatic urethra via two proximally disposed protrusions 104a and 104b that are provided with device <NUM> to releasably connect device <NUM> to an alignment mechanism provided with the deployment lumen, and which will be described in greater detail below. Protrusions 104a and 104b may be integrally formed with proximal connectors 100f, <NUM>. For example, an operator may be guided by an external marker provided with device <NUM>, and apply a torque that is transferred to device <NUM> and that causes it to rotate, thereby aligning central ridge 100c with the anterior inter-lobar groove of the prostatic urethra.

Device <NUM> may be integrally formed, and may be made of a suitably flexible material, such as wire or cut foil made of a super-elastic alloy such as Nitinol.

Alternatively, device may be made of a super-elastic polymer or biodegradable polymer. This memory-retaining flexibility may allow distal connectors 100d and 100e and proximal connectors 100f and <NUM> to bend in a manner that decreases the distance between ridges 100a, 100b and 100c, thereby compressing device <NUM> to enable its insertion into the prostatic urethra. Additionally, distal connectors 100d and 100e and proximal connectors 100f and <NUM> may be normally unbent, and may revert to their normally unbent configuration upon deployment within the prostatic urethra, thereby increasing the distance between ridges 100a, 100b and 100c and expanding device <NUM> to enable dilating the prostatic urethra.

Reference is made to Fig. IC, which shows a profile view of the device of <FIG>, according to an embodiment. The closed form that is formed by peripheral ridge 100b, central ridge 100c, distal connector 100e, and proximal connector <NUM> resembles a 'butterfly wing'. An identical and symmetric butterfly wing (not shown) is formed by peripheral ridge 100a, central ridge 100c, distal connector 100d, and proximal connector 100f.

Reference is now made to Fig. ID, which shows a frontal view of the device of <FIG>, according to an embodiment. When normally-open, S-shaped distal connectors 100d, 100e, comprising a distal end of device <NUM>, may be configured to span an arc, such as a portion of a circle to dilate the prostatic urethra at the bladder neck.

In one embodiment, the shape of the device in the normally-open configuration may reside within the delimiting surface of a longitudinally oriented tube, such as a free-form longitudinally-oriented lumen. The shape of the lumen may be a cylinder, prism, or trunk-conical shape, to name a few, and may comprise a combination of shapes. For example, the lumen may have a cylindrical shape at the tubular ends, and a triangular prism shape at the midsection. The profile, or cross section of such shape may be circular ovoid, triangular, and may be uniform or may change in size and/or shape along the axial length. In the example given above, the cross-section at the ends of the open device may be circular due to the normally-open circular arc-shape of connector pairs 100d, 100e, and 100f, <NUM>, whereas the cross-section at the middle of <NUM> the device may be triangular due to the three ridges 100d, 100e, 100c that are 'pulled apart' by the normally open connectors. The device may have a varying cross-sectional size. For example, a portion of the device may reside within a fraction, such as <NUM>%, <NUM>%, or <NUM>% of the longitudinally oriented tube.

Similarly, in the normally-open configuration, S-shaped proximally connectors 100f, <NUM>, comprising a proximal end of device <NUM> may be configured to reside within the circular delimiting surface of a cylinder to dilate the prostatic urethra at the proximal end of device <NUM>.

The device may be shaped for residing within the prostate urethra and for positioning on the longitudinal axis between the external sphincter of the urethra distally and the bladder neck proximally.

In an embodiment, connectors 100d, 100e with ridge 100c may, in the normally-open configuration, may create an arc that exerts a lateral force on the lateral prostate lobes and dilates the prostate. Similarly, connectors 100f, <NUM> with 100c may create another arc that exerts a lateral force on the lateral prostate lobes and may dilate the prostate at a region situated distally. Thus, the device may provide two or more arcs that each exert a lateral force on a different region of the lateral prostate lobes. In another embodiment additional connectors (not shown), similar and substantially parallel to connectors 100d, 100e, 100f, and <NUM>, may be provided to laterally connect each peripheral ridge 100a, 100b, to the central ridge 100c at a point on each ridge that lies between the distal and proximal ends of the peripheral and central ridges 100a, 100b, 100c, such as at a midpoint along the ridge. The distance along the long axis of the device between any such pair of connectors may be between <NUM> to <NUM>, or more explicitly between <NUM> to <NUM>. The shape of the device in the normally-open configuration may reside within the delimiting surface of an longitudinally oriented tube, such as a free-form longitudinally-oriented lumen.

In an embodiment, the length of the device may range between l cm to <NUM>. There may be different sizes suitable for different lengths of prostate urethra.

In an embodiment, the diameter of the expanded device may be between <NUM> to <NUM>, and more explicitly between <NUM> and <NUM>.

In an embodiment, the device may be compressed to a minimal diameter of <NUM> to <NUM> and more explicitly of l mm to <NUM>.

In an embodiment, in case of a Nitinol device, the wire or ribs size may range from <NUM> to <NUM> and more explicitly between <NUM> to <NUM>. In an embodiment, the dilating action of the device on the prostate urethra may be performed by the radial outward force exerted by the longitudinally oriented ridges on the prostate grooves and by an additional force exercised on the lateral lobes by the arc formed by the connection of components 100d, 100c, 100e, and the arc formed by the connection of components 100f, 100c, <NUM>.

In an embodiment, the components of the device, such as the ridges and connectors, or alternatively, the dilating means and connecting ridges of the device may be configured to maintain intimate contact with the mucosa of the prostate urethra when the device is in the open congifuration.

Alternatively, the arcs formed by connectors 100d, 100e, 100f, and <NUM> of device <NUM> may comprise at least two dilating means of the prostate urethra. Connectors 100d, 100e, 100f, and <NUM> may be connected with longitudinally oriented ridges 100a, 100b, and 100c that may be configured to fix the dilating means in place within the prostate urethra and prevent their movement or dislodgement.

In one embodiment, any of connectors 100d, 100e, 100f, and <NUM> may comprise closed rings, and any of connecting ridges may have an oblique or sinusoidal orientation. Reference is now made to <FIG>, which together show an exemplary deployment of a device for dilating a prostatic urethra, according to an embodiment. <FIG> shows a cross-section of prostatic urethra <NUM> that is obstructed by an enlarged prostate <NUM>. <FIG> shows the cross-section of the prostatic urethra of <FIG> upon deploying a dilating device, in accordance with an embodiment of the invention. The three laterally connected ridges of the device that are illustrated at a midsection view along the axially oriented device and labeled as points 204a, 204b, and 204c, are shown in the normally-open configuration and engaged within the grooves of prostatic urethra <NUM>, thereby dilating urethra <NUM> to allow a free passage of fluid therethrough.

Reference is now made to <FIG> which together illustrate an apparatus for deploying a dilating device for the prostatic urethra, in accordance with an embodiment. <FIG> shows a dilating device <NUM> in the normally-open configuration such as after deployment, and <FIG> shows device <NUM> in the compressed configuration while housed within a deployment lumen <NUM>, prior to deployment. The apparatus for deployment and the dilating device may be jointly referred to as a "kit". <NUM> Turning to <FIG>, to deploy device <NUM>, deployment lumen <NUM> may be retracted relative to device <NUM> to expose device <NUM> from the distal end <NUM> of lumen <NUM>, allowing device <NUM> to protrude from lumen <NUM> and expand to its normally-open configuration, as shown in <FIG>. Upon protruding from lumen <NUM> and during the expansion of device <NUM>, the ridges of device <NUM> may engage with the grooves of the prostatic urethra and cause it to dilate, as described above. To reposition device <NUM> within the prostatic urethra after its exposure from lumen <NUM>, device <NUM> may be retracted relative to lumen <NUM>, such as by pulling a string <NUM> that is releasably attached to device <NUM> and that is exposed from a proximal end of deployment lumen <NUM>. The distal opening <NUM> of lumen <NUM> may press on the expanded ridges of device <NUM>, causing device <NUM> to compress and allowing its retreat into lumen <NUM> where it may be housed for subsequent redeployment.

The retraction of either deployment lumen <NUM> or device <NUM> in relation to each other may be performed mechanically by a practitioner, such as via a work channel of a cystoscope, and which will be described in greater detail below.

Dilating device <NUM> may be provided with one or more proximally disposed protrusions 304a and 304b that are that may be integrally formed with the proximal end of device <NUM> and that are configured to releasably connect device <NUM> to an alignment mechanism <NUM> that is configured for being housed within deployment lumen <NUM>.

Alignment mechanism <NUM> may comprise an alignment lumen <NUM> concentrically housed within deployment lumen <NUM>, as well as releasable string <NUM>. String <NUM> may 100p through protrusions 304a and 304b of device <NUM> and may run through alignment lumen <NUM> and may be exposed from a proximal end of alignment lumen <NUM> for subsequent removal upon deployment of device <NUM>. Device <NUM> may be configured for alignment within the prostatic urethra via a torque that is transferred from alignment mechanism <NUM> to device <NUM>. For example, an operator may rotate alignment lumen <NUM> to align alignment lumen <NUM> with an externally provided alignment mark, thereby applying a torque to alignment lumen <NUM> that is transferred by alignment mechanism <NUM> to device <NUM> and causes device <NUM> to be aligned within the prostatic urethra.

Alternatively, referring to <FIG> a cystoscope <NUM> disposed with a work channel <NUM> may be used for deploying device <NUM> of <FIG> from the distal end <NUM> of cystoscope <NUM>. Device <NUM> housed within deployment lumen <NUM> and optionally with alignment lumen <NUM> may be inserted into work channel <NUM>. The deployment and alignment of device <NUM> may be controlled from a proximal end <NUM> of work channel <NUM>.

In an embodiment, cystoscope <NUM> may be provided with a fluid delivery lumen and a balloon (not shown) that are configured to deliver a fluid to inflate the patient's bladder. The device may be configured for delivery into the inflated bladder, where it may be extracted from the deployment lumen to expand within the bladder, and then retracted for final deployment within the prostate urethra.

Reference is made to to <FIG> which shows a close-up view of distal end <NUM> of cystoscope <NUM>, a camera <NUM> and illuminator <NUM> provided with cystoscope <NUM> may be utilized, in an embodiment, for aligning and deploying device <NUM> using conventional techniques. Deployment lumen <NUM> housing device <NUM> and alignment mechanism <NUM>, and optionally the fluid delivery lumen and balloon, may be inserted into work channel <NUM> of cystoscope <NUM> and may be manipulated from a proximal end <NUM> of work channel <NUM> to deploy device <NUM> within the pro static urethra. The patient's bladder may be filled via the fluid delivery lumen and bal100n, allowing deployment of device <NUM> within the prostatic urethra via the bladder.

Reference is now made to <FIG> which is a flowchart of a method for deploying a dilating device into a prostatic urethra.

The laterally compressed dilating device may by inserted into the urethra of a patient via a deployment lumen that is releasably connected to the device (Step <NUM>). The patient's bladder may be filled according to conventional techniques, such as via a fluid delivery lumen disposed with a balloon (Step <NUM>). The device may be extracted from the deployment lumen and inserted into the urinary bladder, such as by retracting <NUM> the deployment lumen relative to the device, and, upon exiting from the deployment lumen, the dilating device may expand to a normally-open configuration in the partially filled urinary bladder of the patient (Step <NUM>). A torque may be applied to align the device via an alignment mechanism connected to the device, such as by rotating an alignment lumen of the alignment mechanism and transferring the torque to the device, where alignment may comprise aligning a central ridge of the device for engaging with the anterior inter-lobar groove of the prostatic urethra and aligning two peripheral ridges of the device to each engage with a different postero-lateral groove of the prostatic urethra (Step <NUM>). The application of the torque may be guided via a cytoscope, or alternatively, via an external mark indicating that the device is aligned. The aligned device may be positioned in the prostate urethra, such as by pulling on the deployment mechanism to draw the device in from the bladder into the prostate urethra (Step <NUM>). Two protrusions disposed at the distal end of the device may be caused to impinge against the postero-lateral side of the bladder neck, thereby securing the position of the device, and preventing a migration of the device into the urinary bladder (Step <NUM>). The device, thus deployed and aligned within the prostatic urethra, may exert an outwards radial force that pushes the inter-lobar grooves of the urethra outwards, and dilate the urethra (Step <NUM>).

If the positioning or alignment of the device is incorrect, the device may be retracted relative to the deployment lumen, causing the device to laterally compress and retreat within the deployment lumen (Step <NUM>). The retreated device may be repositioned or realigned within the prostatic urethra and redeployed (Steps <NUM>-<NUM>). If the positioning and alignment of the device is correct, The device may be disconnected from the deployment and alignment lumens (Step <NUM>), such as by removing a string that releasably connects the device to the alignment lumen.

Numerous modifications and alternative embodiments of the present invention will be apparent to those skilled in the art in view of the foregoing description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the best mode for carrying out the present invention.

Claim 1:
A dilating device (<NUM>, <NUM>) for a prostatic urethra (<NUM>) comprising:
two dilating means interconnected by a proximal connector (100f, <NUM>) and a distal connector (100d, 100e), the dilating means opening symmetrically on opposite lateral sides of the device (<NUM>, <NUM>) in a normally open configuration,
each of said dilating means including a longitudinally oriented peripheral ridge (100a, 100b, 204a, 204b) configured to fix the dilating means in place within the prostate urethra (<NUM>) and prevent movement or dislodgement;
wherein the dilating means and the distal connector (100d, 100e) and the proximal connector (100f, <NUM>) are configured to laterally expand said longitudinally oriented peripheral ridges (100a, 100b, 204a, 204b) to said normally open configuration upon deployment within the prostatic urethra (<NUM>) to exert a lateral outwards force that dilates the prostatic urethra (<NUM>);
characterized by
each of said dilating means having a closed form;
in said normally open configuration the device (<NUM>, <NUM>) having a form resembling of a pair of butterfly wings having an open posterior side interconnected across a closed anterior side by said by a proximal connector (100f, <NUM>) and a distal connector (100d, 100e);
two protrusions, each of said two protrusions protruding distally from a respective peripheral ridge (100a, 100b, 204a, 204b) of said longitudinally oriented peripheral ridges (100a, 100b, 204a, 204b), said two protrusions positioned on opposing postero-lateral sides of the device (<NUM>, <NUM>) and extending distally beyond the rest of the device (<NUM>, <NUM>) to impinge against opposite postero-lateral sides of a bladder neck of the prostatic urethra (<NUM>), thereby preventing a migration of the device (<NUM>, <NUM>) into a urinary bladder.