Patent Description:
The prostate is a walnut-sized gland that forms part of the male reproductive system. The prostate is located in front of the rectum and just below the bladder, where urine is stored. The prostate surrounds the urethra, the canal through which urine passes out of the body. Prostate enlargement can result from a number of medical problems such as benign prostatic hyperplasia (BPH), prostatic Bladder neck obstruction (BNO) and the like. The enlarged prostate applies pressure on the urethra and damages bladder function.

Transurethral incision of the prostate (TUIP) is an endoscopic procedure usually performed under general anaesthetic in which a surgeon employs an instrument (e.g., a scalpel, a laser beam generator and an electrical current actuator) inserted into the urethra for making incisions in the bladder neck where the prostate meets the bladder (i.e., more specifically in the midline to the level of the verumontanum). Incising the muscles in the bladder neck area relieves the obstructive effect of the prostate on the bladder neck and prostatic urethra and relaxes the opening of the bladder, thus decreasing resistance to the flow of urine out of the bladder. It is noted that, no tissue is removed during TUIP.

Infarction is a process resulting in a macroscopic area of necrotic tissue in some organ caused by loss of adequate blood supply. The inadequate blood supply can result from pressure applied to the blood vessels. Even by applying a relative small but continuous pressure on a tissue, one can block the tiny blood vessels within the tissue and induce infarction.

<CIT> co-invented by the inventor of the present patent application, entitled "Prostate Treatment Stent" is directed at a tissue dissecting implant kit. The tissue dissecting implant kit includes an implant and a sterile package. The implant includes a plurality of rings elastically coupled there-between. An elastic pressure is applied on tissue caught between adjacent rings. The sterile package encompasses the implant. The implant has different distances between adjacent rings along its length. Alternatively, the implant has different material thickness or cross-section shape along its length. It is noted that, the tissue dissecting implant kit applies pressure on tissue caught between adjacent rings until the tissue is cut away or until the tissue falls off.

<CIT> by the inventor of the present patent application, entitled "Radial Cutter Implant" is directed at an implant for applying radial forces on the tissues surrounding it. The implant includes wire strings coupled between a proximal end and a distal end. The wires apply radial pressure on the surrounding tissues. In particular, each wire extends from the proximal end of the implant to the distal end of the implant. The implant can further include a longitudinal tube for providing structural stability to the implant wires. In some embodiments, each wire is in the shape of a butterfly wing, thereby fixing the implant in place within the bladder neck. Note that in those embodiments a portion of the wire sits within the bladder itself for preventing the implant from sliding in the proximal direction. Thereby, the portions of the wires coming into touch with the tissues of the bladder may irritate the bladder.

<CIT> issued to Roth, and entitled "Prostatic Urethra Dilatation Catheter System and Method" is directed to an instrument for performing a transurethral balloon dilatation procedure of the prostate. The balloon dilatation instrument includes a hollow catheter and optical viewing means. The hollow catheter includes a shaft, an inflatable optically transparent balloon, and at least one suitable visible marking.

The distal end portion of the shaft is made of an optically transparent material. The inflatable optically transparent balloon is coupled with the distal end portion of the shaft, and is sized to dilate the prostatic urethra. The at least one suitable visible marking is positioned on the catheter proximally to the balloon, such that the marking can be visualized relative to a predetermined anatomical landmark (e.g., verumon-tanum). In this manner, proper positioning of the balloon, relative to the prostatic urethra, is performed prior to and during the dilation of the prostatic urethra. The optical viewing means, is slidable within the catheter, for visibly viewing the marking intra-luminally from within the catheter. The balloon is correctly located relative to the prostatic urethra. The balloon is inflated so as to dilate the prostatic urethra without damaging the external sphincter at the apex of the prostate.

<CIT> issued to Tihon et al. , and entitled "Dilation Device for the Urethra" is directed to a dilation device for opening a portion of an obstructed urethra. The dilation device includes an inner hollow tubular core and an outer confining covering. The inner hollow tubular core defines a lumen therein. The lumen is a conduit of sufficient covering is capable of expanding radially outwardly to a predetermined extent. The covering has a length of at least partially that of the obstructed portion of the urethra. The dilation device can further include retractable spikes for anchoring the device in its intended position.

Patent Application Publication No.: <CIT>, titled "An Incising Implant for the Prostatic Urethra" to Kilemnik, is directed at an incising implant and method for creating incisions in the prostatic urethra of a subject using the incising implant. The implant includes at least two closed-shaped wires that are elastic thereby being compressible into a compressed configuration. The incising implant is configured for implantation within the prostatic urethra and is further configured to apply a radial outward force on the surrounding tissues of the inner walls of the urethra for the creation of longitudinal incisions.

Patent Application Publication No.: <CIT>, titled "A Dilating Device for Prostatic Urethra" is directed at a dilating device for the prostatic urethra that includes three laterally connected ridges. Each ridge is configured to longitudinally engage with a different longitudinal groove of the prostatic urethra of a patient. The three laterally connected ridges are configured to laterally compress to enable insertion into the prostatic urethra in a compressed configuration. The three laterally connected ridges are configured to laterally expand to a normally-open configuration upon deployment within the prostatic urethra, so to exert a radially outwards force that dilates the prostatic urethra.

It is an object of the disclosed technique to provide a method and system for delivering a urethral implant. In accordance with the disclosed technique, there is thus provided a urethral implant delivery system including an overtube, a camera, a urethral implant and a guidewire. The overtube includes a first elongated passage, a second elongated passage and a handle connector. The camera is located at the distal end of the first elongated passage. The urethral implant is located within the second elongated passage. The guidewire is coupled with the urethral implant and extends toward the proximal end of the overtube. The handle connector is configured to be coupled with a handle.

The urethral implant delivery system according to the invention is defined in claim <NUM>. The methods disclosed are not recited by the wording of the claims but are useful for understanding the invention.

The disclosed technique will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which <FIG> disclose a system according to the invention:.

The disclosed technique overcomes the disadvantages of the prior art by providing an implant for applying small yet continuous pressure on the tissues of the bladder neck sphincter (i.e., as well as tissues of the urethra and the prostate gland) by a plurality of wires. The pressure induces infarction in the tissues (i.e., tissues of the bladder neck, urethra, and prostate gland) which creates a plurality of desired incisions (i.e., each of the wires creates an incision). The incisions relive a prostate enlargement problem by cutting through the tissues and extending the urinal passage (i.e., the wires both incise and extend the tissues in the radial direction from the urethra axis outwardly). The disclosed technique further includes a delivery and deployment system for the incising implant. It is noted that, in this application, a radial cutter implant which applies pressure on the tissues of the bladder neck, further applies pressure on the tissues of the prostate and urethra unless specifically mentioned otherwise along the text.

The terms pressure and force (e.g., applying radial pressure and applying radial force) are employed interchangeably herein below, to describe the operation of the wires of the implant on the surrounding tissues, and vice versa. That is, the wires are described as applying pressure on the tissues, or as applying force on the tissues. Herein below, the terms proximal and distal refer to directions relative to implantable device and the delivery system. In particular, the distal end is the end of the device (or of the system) that is inserted into the body of the patient first and reaches the deepest. The proximal end is the end closer to the exit from the body of the patient.

Reference is now made to <FIG>, which is a schematic illustration of an overtube, generally referenced <NUM>, for determining the location of a bladder neck of a patient and delivering a radial cutter implant thereto, constructed and operative in accordance with an embodiment of the disclosed technique. Overtube <NUM> includes a balloon <NUM>, a balloon tube <NUM> (i.e., balloon Foley-catheter <NUM>), and a positioning tube <NUM>. Balloon <NUM> is coupled around balloon tube <NUM>. Balloon tube <NUM> slidably goes through positioning tube <NUM>.

Overtube <NUM> enables a physician (not shown) to deploy a radial cutter implant (e.g., radial cutter implant <NUM> of <FIG> and <FIG>) at the bladder neck of a patient (both bladder neck and patient are not shown). The physician inserts overtube <NUM> through the urethra of the patient until balloon <NUM> is positioned within the bladder (e.g., bladder <NUM> of <FIG>) of the patient. The physician inflates balloon <NUM> via balloon tube <NUM>. When balloon <NUM> is inflated, the physician pulls overtube <NUM> in the proximal direction (i.e., the physician pulls overtube <NUM> back towards him) until inflated balloon <NUM> is blocked by the bladder neck. Thus, the physician determines the exact position of the bladder neck of the patient. The physician deflates balloon <NUM> and removes balloon tube <NUM> from overtube <NUM> while leaving positioning tube <NUM> in place. Alternatively, the physician can determine the location of the bladder neck, and position positioning tube <NUM> accordingly, by employing any method known in the art, such as ureteroscopy, cystoscopy, ultra-sound imaging, fluoroscopy, and the like.

Reference is now made to <FIG>, which is a schematic illustration of a delivery system, generally referenced <NUM>, for delivering a radial cutter implant to the bladder neck of a patient, constructed and operative in accordance with another embodiment of the disclosed technique. Delivery system <NUM> includes an implant sheath <NUM>, an external tube <NUM>, an external tube handle <NUM>, an internal tube distal end <NUM>, an internal tube <NUM>, and an internal tube handle <NUM>. Implant sheath <NUM> is coupled with the distal end of external tube <NUM>. External tube handle <NUM> is coupled with the proximal end of external tube <NUM>. Internal tube distal end <NUM> is coupled with the distal end of internal tube <NUM>. Internal tube <NUM> slidably goes through external tube <NUM>. Internal tube handle <NUM> is coupled with the proximal end of internal tube <NUM>.

A radial cutter implant (not shown - e.g., radial cutter implant <NUM> of <FIG> and <FIG>) is detachably coupled with internal tube distal end <NUM> such that the implant is covered by implant sheath <NUM>. In particular, and relating to the configuration of delivery system <NUM>, as depicted in <FIG>, internal tube <NUM> slides along external tube <NUM> in the distal direction until implant sheath <NUM> is positioned adjacent internal tube distal end <NUM>. In this manner implant sheath <NUM> covers the radial cutter implant, thereby restraining it.

The physician inserts delivery system <NUM> into the urethra of the patient through positioning tube <NUM> of <FIG>. The physician employs positioning tube <NUM> (<FIG>) for positioning the radial cutter implant at the location of the bladder neck (i.e., or of the restricted location of the urethra) as located by employing overtube <NUM>. Once the radial cutter implant is positioned within the bladder neck, the physician exposes the radial cutter implant, as detailed further below with reference to <FIG>.

Reference is now made to <FIG> and <FIG>, which are schematic illustrations of a system, generally referenced <NUM>, for delivering a radial cutter implant to the bladder neck of a patient, constructed and operative in accordance with a further embodiment of the disclosed technique. Prior to delivery of the implant, the subject may receive medication to relieve anxiety. The subject may also receive prophylactic antibiotics per local hospital practice. With reference to <FIG>, delivery system <NUM> includes an overtube <NUM>, substantially similar to overtube <NUM> of <FIG>. Overtube <NUM> includes a balloon <NUM>, a balloon tube <NUM> and a positioning tube <NUM>. Each of balloon <NUM>, balloon tube <NUM> and positioning tube <NUM> is substantially similar to balloon <NUM>, balloon tube <NUM> and positioning tube <NUM> of <FIG>, respectively.

The physician inserts overtube <NUM> into a penis <NUM> of the patient and through a urethra <NUM> (<FIG>) of the patient, until balloon <NUM> is positioned within a bladder <NUM> of the patient. The physician inflates balloon <NUM> via balloon tube <NUM>. Once balloon <NUM> is inflated, the physician pulls back overtube <NUM> (i.e., in the proximal direction) until balloon <NUM> is blocked by bladder neck <NUM> of the patient. The physician deflates balloon <NUM> and removes balloon tube <NUM> from within overtube <NUM> while keeping positioning tube <NUM> in place. Thus, the physician locates the exact position of bladder neck <NUM>.

With reference to <FIG>, delivery system <NUM> further includes a delivery <NUM>, substantially similar to delivery system <NUM> of <FIG>. Delivery <NUM> includes an implant sheath <NUM>, an external tube <NUM> (located within positioning tube <NUM> and is not shown in the figure), an external tube handle <NUM>, an internal tube <NUM>, and an internal tube handle <NUM>. Delivery system <NUM> further includes a radial cutter implant <NUM> within implant sheath <NUM>. Radial cutter implant <NUM> may be temporary in the sense that it may be removed from the urethral at a selected time after deployment. Each of implant sheath <NUM>, external tube <NUM>, external tube handle <NUM>, internal tube <NUM>, and internal tube handle <NUM>, is substantially similar to each of implant sheath <NUM>, external tube <NUM>, external tube handle <NUM>, internal tube <NUM>, and internal tube handle <NUM>, respectively.

After removing balloon tube <NUM> from overtube <NUM> (<FIG>), the physician inserts delivery <NUM> into positioning tube <NUM>. The physician positions delivery <NUM> such that radial cutter implant <NUM> is positioned according to the position of positioning tube <NUM>. The physician pulls external tube handle <NUM> for exposing radial cutter implant <NUM>. Radial cutter implant <NUM> expands until it is attached to the walls of bladder neck <NUM> (i.e., to the muscles of bladder neck <NUM> and the surrounding tissues). Radial cutter implant <NUM> starts applying pressure to the walls of bladder neck <NUM> and urethra <NUM> (i.e., as well as on tissues of the prostate - not shown - as detailed herein above). In the example set forth in <FIG>, radial cutter implant <NUM> is self-expanding. Alternatively, radial cutter implant <NUM> is expanded manually by the physician by employing an expander (i.e., a device for expanding implant <NUM> as known in the art - for example, a balloon).

With reference to <FIG>, radial cutter implant <NUM> is positioned within urethra <NUM> in an expanded configuration. The physician pulls positioning tube <NUM> out of the patient and leaves radial cutter implant within urethra <NUM> for a predetermined period of time (as detailed herein below - e.g., two weeks). Radial cutter implant <NUM> applies pressure on the walls of the surrounding tissues (e.g., bladder neck <NUM>, urethra <NUM>, and the prostate gland - not shown) incising the surrounding tissues over the predetermined period of time. The prolonged incision of the tissue, created by continuous pressure, decreases the pain involved in the procedure. Furthermore, by performing the incisions via continuous pressure (i.e., via infarction), bleeding is avoided.

The period of time, radial cutter implant <NUM> is implanted in the urethra of the patient, is determined by the physician at least according to the diagnosis of the patient (i.e., predetermined period of time). Alternatively, the time period is determined according to observations of the radial cutter implant effect over time (i.e., real time period determination), or any other way known in the art. Further alternatively, the time period ranges between one hour and twenty nine days.

Reference is now made to <FIG>, which are schematic illustrations of a delivery, generally referenced <NUM>, for delivering a radial cutter implant, constructed and operative in accordance with another embodiment of the disclosed technique. With reference to <FIG>, delivery <NUM> is substantially similar to delivery system <NUM> of <FIG>. Delivery <NUM> includes an implant sheath <NUM>, an external tube <NUM>, an external tube handle <NUM>, an internal tube <NUM>, and an internal tube handle <NUM>. Each of implant sheath <NUM>, external tube <NUM>, external tube handle <NUM>, internal tube <NUM>, and internal tube handle <NUM> is substantially similar to each of implant sheath <NUM>, external tube <NUM>, external tube handle <NUM>, internal tube <NUM>, and internal tube handle <NUM> of <FIG>, respectively.

Implant sheath <NUM> is coupled with the distal end of external tube <NUM>. External tube handle <NUM> is coupled with the proximal end of external tube <NUM>. A radial cutter implant <NUM> (<FIG>) is coupled, at a folded configuration thereof, with the distal end of internal tube <NUM> and is covered by implant sheath <NUM>. Radial cutter implant <NUM> may be temporary in the sense that it may be removed from the urethral at a selected time after deployment. Internal tube <NUM> is slidably coupled with external tube <NUM>. Internal tube handle <NUM> is coupled with the proximal end of internal tube <NUM>.

With reference to <FIG>, a physician (not shown) pulls external tube <NUM> via external tube handle <NUM> while keeping internal tube <NUM> in place. Thus, external tube <NUM> slides along internal tube <NUM> in the proximal direction and implant sheath <NUM> is removed from radial cutter implant <NUM>.

With reference to <FIG>, once implant sheath <NUM> is fully removed from radial cutter implant <NUM> (i.e., radial cutter implant is fully exposed), radial cutter implant <NUM> expands. In the example set forth in <FIG>, radial cutter implant <NUM> is self-expanding. Alternatively, radial cutter implant <NUM> is expanded manually by the physician employing an implant expander (not shown).

The physician leaves radial cutter implant <NUM> within the body of the patient for a predetermined period of time. When the physician wishes to remove radial cutter implant <NUM>, the physician inserts delivery <NUM> into the urethra (not shown) of the patient. The physician couples the distal end of internal tube <NUM> with radial cutter implant <NUM> by employing a coupler (not shown). The coupler can be any mechanical element that can grab the proximal end of the implant and enable the physician to pull the implant into implant sheath <NUM>. Alternatively, the coupler can be formed of coupling elements that enable the physician to grab the implant and pull it proximally, and that are not mechanical, such as a magnetic coupler.

The physician pulls back internal tube <NUM> while keeping external tube <NUM> in place. Thus, radial cutter implant <NUM> is folded within, and is restrained by, implant sheath <NUM> and can be extracted from the body (i.e., the bladder neck and the urethra) of the patient, without damaging the tissues of the urethra. It is noted that, the delivery of radial cutter implant <NUM> and the extraction thereof are substantially a reverse duplicates of each other. In other words, the steps performed upon delivery are repeated in a reverse order upon extraction.

Reference is now made to <FIG> and <FIG>, which are schematic illustrations of a radial cutter implant, generally referenced <NUM>, constructed and operative in accordance with a further embodiment of the disclosed technique. <FIG> depicts implant <NUM> from an isometric perspective. <FIG> depicts a closed shape wire of the implant of <FIG> from a side view perspective, and <FIG> depicts implant <NUM> from a top view perspective.

Implant <NUM> is constructed from three closed shaped wires 242A, 242B and 242C (also referred to herein below, together, as wires <NUM>), and further includes an anchoring leaflet <NUM>. Each of wires <NUM> is adjacently attached between the other ones of wires <NUM>, as would be detailed further below. Anchoring leaflet <NUM> extends from a proximal end (not referenced) of implant <NUM>, and is positioned between two of wires <NUM>. Implant <NUM> may be temporary in the sense that it may be removed from the urethral at a selected time after deployment.

Each of wires 242A, 242B and 242C includes three sections: a narrow U-shaped proximal end; two radially extending arms - extending radially and distally from the distal ends (not referenced) of the U-shaped proximal end; and a support crosspiece connecting the distal ends of the radially extending arms. In particular and as seen in <FIG>, closed shape wire 242A includes a U-shaped proximal end 244A, two radially extending arms 246A1 and 246A2, and a support crosspiece 248A.

Radially extending arms 246A1 and 246A2 extend radially and distally from the distal ends (not referenced) of U-shaped proximal end 244A. Support crosspiece 248A is coupled between the distal ends (not referenced) of radially extending arms 246A1 and 246A2. The components of wires 242B and 242C are similarly constructed and denoted.

In this manner and as seen in <FIG>, support crosspieces 248A, 248B, and 248C form together a support frame (not referenced) on a plane which normal is the longitudinal axis of implant <NUM> (i.e., the plane depicted in <FIG>). The support frame of the support crosspieces provides structural solidity to implant <NUM>. Specifically, the support frame provides resistance to forces applied on implant <NUM> by the surrounding tissues of the bladder neck, when implanted within the bladder neck. In other words, the radial cutter implant, and in particular, the radially extending arms thereof, apply radially outward force on the surrounding tissues for producing incisions in the tissues. Thereby, the surrounding tissues of the bladder neck apply an opposite force on the radially extending arms of the implant. The support frame formed by the support crosspieces maintains the structural stability of the implant, and enables the radially extending arms to continue to apply the incising force on the surrounding tissues.

Support crosspieces 248A, 248B and 248C form together the support frame of supporters. The radially inward force applied by the tissues surrounding implant <NUM> causes support crosspiece 248A to push against supporters 248B and 248C; support crosspiece 248B to push against supporters 248A and 248C; and causes support crosspiece 248C to push against supporters 248A and 248B. Thereby, supporters 248A, 248B and 248C support each other and resist to radially inward forces applied on the radially extending arms by the surrounding tissues.

During insertion of implant <NUM> into the bladder neck (and extraction out of), implant <NUM> is folded with an implant sheath (e.g., implant sheath <NUM> of <FIG>). When exposed from the implant sheath, implant <NUM> expands (or is being expanded) to an expanded configuration depicted in <FIG> and <FIG>. Therefore, implant <NUM> should be flexible.

Each of closed shape wires 242A, 242B and 242C is made from a shape-memory Alloy (SMA), such as Nickel Titanium alloy (Nitinol). Alternatively, each of wires 242A, 242B and 242C is made from any material which is flexible enough to be folded within an implant sheath and is strong enough (e.g., <NUM> Newton) to apply pressure on the surrounding tissues and induce infarction.

Each of wires 242A, 242B and 242C is flexible such that it can be straightened in order for radial cutter <NUM> to be folded within an implant sheath (not shown - e.g., implant sheath <NUM> of <FIG>). Each of wires 242A, 242B and 242C springs back to expanded state, once not limited by an obstacle (e.g., implant sheath <NUM> of <FIG>, the walls of the bladder neck of the patient). In this manner, when radial cutter implant <NUM> is positioned within the bladder neck of the patient, wires 242A, 242B and 242C, apply pressure to the surrounding tissues (e.g., bladder neck, urethra and prostate).

Alternatively, implant <NUM> is made of biodegradable materials, such that there is no need to remove implant <NUM> from the body of the patient. In this manner, implant <NUM> is constructed such it biodegrades, ceases from functioning and dissolves within the patient after the predetermined period of time, or after a triggering event initiated by the physician, as known in the art.

Anchoring leaflet <NUM> is in the shape of a tongue extending substantially in the distal-normal direction (i.e., the normal direction refers to a direction normal to the distal-proximal axis - e.g., the dorsal direction). In this manner, anchoring leaflet <NUM> prevents implant <NUM> from moving from the bladder neck into the bladder. In particular, anchoring leaflet <NUM> is blocked by the bladder neck such that implant <NUM> cannot move into the bladder. It is noted that, anchoring leaflet <NUM> can be a wire leaflet (e.g., as depicted in <FIG>) or a full surface leaflet.

Alternatively, anchoring leaflet <NUM>, extends in the proximal-normal direction and prevents radial cutter implant <NUM> from moving in the proximal direction towards the urethra. Further alternatively, there are at least two leaflets <NUM> extending in both directions and fixing implant <NUM> in place. Anchoring leaflet <NUM> is constructed of similar materials to those of wires <NUM>.

As mentioned above U-shaped proximal ends 244A, 244B and 244C are coupled together, such that each one is adjacently attached between the other two. In this manner U-shaped proximal ends 244A, 244B and 244C also provide structural solidity to implant <NUM>, similarly to support crosspieces 248A, 248B and 248C. Additionally the U-shape proximal ends 244A, 244B and 244C enable the physician to hook implant <NUM> by employing a coupler device for extracting implant <NUM> out of the body of the patient.

As mentioned above, closed shape wires 242A, 242B and 242C are coupled to each other. The wires can be coupled by employing various techniques. For, example the wires can be welded together. The wires can be wound around each other at selected sections thereof (e.g., radially extending arm 246A1 is wound around arm 246B2; arm 246B1 is wound around arm 246C2; and arm 246C1 is wound around arm 246A2). The wires can be glued together. The wires can be coupled by any other coupling mechanism, element or method.

In accordance with an alternative embodiment of the disclosed technique, implant can comprise other numbers of closed shaped wires, and at least one closed shape wire, such as four wires, five wires, and the like. If there is more than a single wire, each wire is adjacently attached between two adjacent wires as described above. Similarly, for any number of closed shape wires, the support crosspieces thereof form together a support frame providing structural solidity to implant, as described above.

Radial cutter implant <NUM> is located and expanded such that it does not extend distally beyond the bladder neck of the patient (i.e., does not extend into the bladder). Specifically, the support frame formed of the support crosspieces is located within the bladder neck before the bladder, and does not come into contact with the tissues of the bladder itself. Thereby, implant <NUM> does not irritate the bladder of the patient. It is noted that irritation of the bladder tissues may stimulate urinary activity.

In accordance with another embodiment of the disclosed technique, the radial cutter implant is colored in such a manner that enables the physician to easily position it in order. For example, the wires of the implant are color coded such that sections that should be positioned on top are colored blue, and sections that should be positioned on the bottom are colored white.

Reference is now made to <FIG>, which is a schematic illustration of a method for creating incisions in the muscles of the bladder neck by infarction, operative in accordance with a further embodiment of the disclosed technique. In procedure <NUM>, the location of the bladder neck of a patient is found. With reference to <FIG>, the physician inserts overtube <NUM> into the urethra of the patient until balloon <NUM> is inside bladder <NUM>. The physician inflates balloon <NUM> and pulls overtube <NUM> back until balloon <NUM> is blocked by the bladder neck.

In procedure <NUM>, a radial cutter implant is delivered to the constricted location. With reference to <FIG> and <FIG>, the physician inserts delivery <NUM> into positioning tube <NUM> and delivers radial cutter implant <NUM> to the location of the bladder neck (i.e., the constricted location). It is noted that implant <NUM> is located such that it does not extend into the bladder itself, thereby avoiding bladder irritation. Alternatively, the physician delivers the implant to a different constricted location within the urinal system, and outside of the bladder, for relieving the constriction. In procedure <NUM>, the radial cutter implant is released and the delivery system is removed. The implant is released where it does not extend distally beyond the bladder neck and into the bladder itself, thereby avoiding bladder irritation. With reference to <FIG> and <FIG>, the physician exposes radial cutter implant <NUM> from implant sheath <NUM>. Radial cutter implant <NUM> expands and attaches itself to the surrounding tissues (i.e., the closed shape wires of radial cutter implant <NUM> are attached to the tissues surrounding the implant and apply pressure thereon). The physician removes delivery system <NUM> from urethra <NUM> of the patient.

In procedure <NUM>, continuous pressure is applied on the tissues surrounding the implant by employing the radial cutter implant, and without irritating the bladder. With reference to <FIG> and <FIG>, the closed shape wires of radial cutter implant <NUM> apply continuous pressure on the surrounding tissues. Implant <NUM> does not irritate the bladder since it does not come into contact there-with.

In procedure <NUM>, at the appearance of a predetermined condition, the radial cutter implant is extracted from the patient. With reference to <FIG> and <FIG>, the physician extracts radial cutter implant <NUM> from the patient at the appearance of a predetermined condition. The predetermined condition can be the passage of a predetermined period of time, the appearance of desired incisions on the surrounding tissues, the appearance of a predetermined physiological effect, and the like.

Reference is now made to <FIG>, which is a schematic illustration of a radial cutter implant, generally referenced <NUM>, depicted from a top view perspective, constructed and operative in accordance with a further embodiment of the disclosed technique. Implant <NUM> is constructed from three closed shaped wires 342A, 342B and 342C (also referred to herein below, together, as wires <NUM>), and further includes an anchoring leaflet <NUM>. Each of wires <NUM> is adjacently attached between the other ones of wires <NUM>, as would be detailed further below. Anchoring leaflet <NUM> extends from a proximal end (not referenced) of implant <NUM>, and is positioned between two of wires <NUM>.

Each of wires 342A, 342B and 342C includes three sections: a narrow U-shaped proximal end; two radially extending straight arms - extending in the radial-distal from the distal ends (not referenced) of the U-shaped proximal end; and a support crosspiece connecting the distal ends of the radially extending straight arms. In particular, closed shape wire 342A includes a U-shaped proximal end 344A, two radially extending straight arms 346A1 and 346A2, and a support crosspiece 348A.

Radially extending straight arms 346A1 and 346A2 extend in the radial-distal direction from the distal ends (not referenced) of U-shaped proximal end 344A. Support crosspiece 348A is coupled between the distal ends (not referenced) of radially extending straight arms 346A1 and 346A2. The respective sections of wires 342B and 342C are similarly constructed denoted.

Wires <NUM> form together a triangular pyramid with the U-shaped proximal heads of the wires forming the apex of the pyramid and the support crosspieces of the wires forming the base of the pyramid. Specifically, support crosspieces 348A, 348B, and 348C form together a support frame (not referenced) defining the base of pyramid-shaped implant <NUM>. The pyramidal shape of implant <NUM>, and in particular the support frame formed by the support crosspieces, provides structural solidity to implant <NUM>. Specifically, the support frame provides resistance to forces applied on implant <NUM> by the surrounding tissues of the bladder neck, when implanted within the bladder neck. Thus, the support frame maintains the structural stability of the implant, and enables the radially extending straight arms to continue to apply the incising force on the surrounding tissues.

Implant <NUM> is inserted and extracted in a similar manner, to that described above with reference to <FIG>, <FIG>, <FIG> and <FIG>. Radial cutter implant <NUM> may be temporary in the sense that it may be removed from the urethral at a selected time after deployment. Additionally, implant <NUM> is made from similar materials to the implants describes above.

In accordance with an alternative embodiment of the disclosed technique, implant <NUM> can comprise other numbers of closed shaped wires, and at least one closed shape wire, such as four wires, five wires, and the like. If there is more than a single wire, each wire is adjacently attached between two adjacent wires as described above. Similarly, for any number of closed shape wires, the support crosspieces thereof form together a support frame providing structural solidity to implant, as described above.

Radial cutter implant <NUM> is located and expanded such that it does not extend distally beyond the bladder neck of the patient (i.e., does not extend into the bladder). Specifically, the support frame formed of the support crosspieces is located within the bladder neck before the bladder, and does not come into contact with the tissues of the bladder itself. Thereby, implant <NUM> does not irritate the bladder of the patient.

Reference is now made to <FIG>, which are schematic illustrations of a radial cutter implant, generally referenced <NUM>, constructed and operative in accordance with another embodiment of the disclosed technique. <FIG> depicts implant <NUM> from an isometric perspective, and <FIG> depicts a closed shape wire of the implant of <FIG> from a side view perspective.

Implant <NUM> is composed of three closed shaped wires 382A, 382B and 382C (also referred to herein below, together, as wires <NUM>), and further includes an anchoring leaflet <NUM>. Each of wires <NUM> is adjacently attached between the other ones of wires <NUM>, as would be detailed further below. Anchoring leaflet <NUM> extends from a proximal end (not referenced) of implant <NUM>, and is positioned between two of wires <NUM>.

Each of wires 382A, 382B and 382C includes three sections: a narrow U-shaped proximal end; two radially extending arms - extending radially and distally from the distal ends (not referenced) of the U-shaped proximal end; and a support crosspiece connecting the distal ends of the radially extending arms. In particular and as seen in <FIG>, closed shape wire 382A includes a U-shaped proximal end 384A, two radially extending arms 386A1 and 386A2, and a support crosspiece 388A.

Radially extending arms 386A1 and 386A2 extend radially and distally from the distal ends (not referenced) of U-shaped proximal end 384A. Support crosspiece 388A is coupled between the distal ends (not referenced) of radially extending arms 386A1 and 386A2. The components of wires 382B and 382C are similarly constructed and denoted. Support crosspieces 388A, 388B, and 388C form together a support frame (not referenced). The support frame provides structural solidity to implant <NUM>, and enables the radially extending arms to continue to apply the incising force on the surrounding tissues.

Implant <NUM> is inserted and extracted in a similar manner, to that described above with reference to <FIG>, <FIG>, <FIG> and <FIG>. Additionally, implant <NUM> is made from similar materials to the implants describes above. Radial cutter implant <NUM> may be temporary in the sense that it may be removed from the urethral at a selected time after deployment.

Reference is now made to <FIG>, which are schematic illustrations of a step-by-step method for delivering, and for extracting, a radial cutter implant, generally referenced <NUM>, operative in accordance with a further embodiment of the disclosed technique. With reference to <FIG>, the implant <NUM> is delivered when enfolded in an implant sheath <NUM>, as detailed below. With reference to <FIG>, the physician removes a protective cover <NUM> from implant <NUM>. Protective cover <NUM> keeps implant <NUM> sterile during storage prior to use.

With reference to <FIG>, while holding a guidewire <NUM>, the physician pushes implant sheath <NUM> over implant <NUM> thereby enfolding implant <NUM> within sheath <NUM> for delivery into the urethra. With reference to <FIG>, the physician inserts a rigid cystoscope <NUM> (e.g., size 20French) into the urethra, for example, as in a routine urethral catheterization procedure. With reference to <FIG>, the physician inserts the folded implant <NUM> into cystoscope <NUM>. Using guidewire <NUM>, the physician continues pushing implant <NUM> through cystoscope <NUM> until implant <NUM> reaches the distal end of cystoscope <NUM> and opens up in the bladder.

With reference to <FIG>, the physician removes sheath <NUM> from implant <NUM> and out of cystoscope <NUM>. With reference to <FIG>, implant <NUM> expands (or is being expanded). With reference to <FIG>, the physician rotates guidewire <NUM> (<FIG>) and brings implant <NUM> to the correct orientation. The closed shape wires of implant <NUM> can be color coded, such that the sections that should be positioned on the top are colored, for example, blue; and the sections that should be positioned on the bottom are colored, for example, white. With reference to <FIG>, While holding implant <NUM> in place, the physician retracts cystoscope <NUM>. Thereby, implant <NUM> is implanted within the bladder neck and starts applying radial outward force on the surrounding tissues by the closed shape wires for inducing incisions within the surrounding tissues. Implant <NUM> is left within the bladder neck for a selected time period (e.g., ranging between one hour and one month). Thereafter implant <NUM> is removed as would be detailed below. Alternatively, implant <NUM> is made of biodegradable materials and simply dissolves after a selected time period.

When implanted within the bladder neck and the urethra of the subject, implant <NUM> applies radial outward force on the tissues surrounding it, for producing incisions in the surrounding tissues. Thereby, implant <NUM> relieves a prostate enlargement problem by cutting through the tissues and extending the urinal passage (i.e., the wires both incise and extend the tissues in the radial direction from the urethra axis outwardly).

With reference to <FIG>, the physician inserts cystoscope <NUM> through the urethra toward implant <NUM>. Cystoscope <NUM> contains therein a coupler (not shown) designed to hook onto the proximal end of implant <NUM>. With reference to <FIG>, the physician employs the coupler for hooking onto implant <NUM> and for pulling implant <NUM> into cystoscope <NUM>, thereby enfolding implant <NUM> within cystoscope <NUM>. Alternatively, an implant sheath can be employed instead of cystoscope <NUM>. With reference to <FIG>, once implant <NUM> is fully enfolded within cystoscope <NUM>, the physician pulls cystoscope <NUM> out of the urethra of the subject.

Reference is now made to <FIG>, <FIG> and <FIG>, which are schematic illustrations of a system, generally referenced <NUM>, for delivering a urethral implant to the bladder neck of a patient, constructed and operative in accordance with another embodiment of the disclosed technique. Delivery system <NUM> includes an overtube <NUM>, and a handle <NUM>. Overtube <NUM> includes two elongated passages, a first elongated passage <NUM> and a second elongated passage <NUM> and a handle connector <NUM>. Second elongated passage <NUM> includes an exit port <NUM>. Delivery system <NUM> further includes a camera <NUM> and a urethral implant <NUM>. Handle connector <NUM> is configured to connect with a handle <NUM>.

Camera <NUM> is located at the distal end <NUM> of first elongated passage <NUM>, and the wiring of camera <NUM> is located within first elongated passage <NUM>. The optical axis of camera <NUM> may be aligned with axis of overtube <NUM>. Alternatively, the optical axis of camera <NUM> may be at an angle (e.g., <NUM> degrees, <NUM> degrees, <NUM> degrees and the like) relative to the axis overtube <NUM>. Urethral implant <NUM> is pre-loaded (i.e., prior to the procedure) within the distal end of second elongated passage <NUM> of overtube <NUM>. Urethral implant <NUM> is coupled with a guidewire <NUM>, located within second elongated passage <NUM>. Guidewire <NUM> extends toward the proximal end of overtube <NUM> and exits handle connector <NUM> at the proximal end of overtube <NUM>. Second elongated passage <NUM> may further be employed to deliver fluids to or from the urethra or the bladder.

Handle <NUM> includes a connector lock <NUM>, a saline delivery port <NUM>, an optics cable <NUM>, an optics connector <NUM>, and a guidewire exit port <NUM>.

Prior to delivery of urethral implant <NUM>, the subject may receive medication to relieve anxiety. The subject may also receive prophylactic antibiotics per local hospital practice. Also prior to deploying urethral implant <NUM>, a physician connects handle <NUM> to saline <NUM> via saline port <NUM>, and to a display monitor <NUM> via optics connector <NUM>. Then the physician connects handle connector <NUM> of overtube <NUM> to handle <NUM> by first inserting urethral implant <NUM> into the distal end of handle <NUM> until guidewire <NUM> exits guidewire exit port <NUM>, and overtube handle connector <NUM> locks with connector lock <NUM>.

As depicted in <FIG>, the physician inserts overtube <NUM> into the penis <NUM> of the patient and through the urethra of patient, until exit port <NUM> is positioned within the bladder <NUM> of the patient. The physician fills the bladder of the patient with saline and then pushes guidewire <NUM> until urethral implant <NUM> exits overtube <NUM> through exit port <NUM>, and enters bladder <NUM> of the patient. The physician withdraws handle <NUM> until camera <NUM> reaches the bladder neck of the patient and urethral implant <NUM> comes into view. The physician maneuvers urethral implant <NUM> by turning guidewire <NUM>. The physician then pulls guidewire <NUM> to position urethral implant <NUM> into the patient's prostatic urethra. The physician than pulls overtube <NUM> out of penis <NUM> while urethral implant <NUM> stays in the prostatic urethral with a wire extending from the penis to enable removal of the implant at a later time. Urethral implant <NUM> may be temporary in the sense that it may be removed from the urethral at a selected time after deployment. Also, system <NUM> is disposable. In other words, once the urethral implant <NUM> is deployed and overtube <NUM> is retracted from penis <NUM>, overtube <NUM> may be disposed along with camera <NUM>. Also, urethral implant <NUM> may be a temporary radial cutter such as described above.

Reference is now made to <FIG>, which are a schematic illustrations of an overtube, generally referenced <NUM>, according to a further embodiment of the disclosed technique. Overtube <NUM> may be employed in a delivery system such as described above in conjunction with <FIG>. Overtube <NUM> includes a first elongated passage <NUM>, a second elongated passage <NUM> and a handle connector <NUM>. <FIG> depicts an isometric view overtube <NUM>. <FIG>, depicts an isometric view of the distal end of over tube <NUM>. <FIG> depicts a front view of the distal end of overtube <NUM>. <FIG> depicts an isometric view of the proximal end of overtube <NUM> and <FIG> depicts a back view of the proximal end of overtube <NUM>. In overtube <NUM> first elongated passage <NUM> and second elongated passage <NUM> are separate creating two lumens.

In general, the first elongated passage and the second elongated passage may exhibit different configurations. Reference is now made to <FIG>, which are schematic illustrations of different cross section configurations of an overtube, in accordance with another embodiment of the disclosed technique. With reference to <FIG>, overtube <NUM> includes first elongated passage <NUM> and second elongated passage <NUM>. With reference to <FIG>, overtube <NUM> includes first elongated passage <NUM> and second elongated passage <NUM>. With reference to <FIG>, overtube <NUM> includes first elongated passage <NUM> and second elongated passage <NUM>. In <FIG>, the first and second elongated passages are separate creating two lumens. With reference to <FIG>, overtube <NUM> includes first elongated passage <NUM> and second elongated passage <NUM>. In <FIG>, first elongated passage <NUM> and second elongated passage <NUM> are connected creating a single lumen.

Claim 1:
A urethral implant delivery system (<NUM>) comprising:
a handle (<NUM>);
an overtube (<NUM>), including a first elongated passage (<NUM>), a second elongated passage (<NUM>), and a handle connector (<NUM>);
a camera (<NUM>), located at a distal end (<NUM>) of said first elongated passage;
a urethral implant (<NUM>), located within said second elongated passage; and
a guidewire (<NUM>), coupled with said urethral implant, said guidewire enables to push said urethral implant through said overtube until said urethral implant exits said overtube, said guidewire extends toward a proximal direction of said overtube and exits said handle;
wherein said handle connector is configured to be coupled with said handle (<NUM>).