Prostate urethral implant for treating prostatic hyperplasia

Abstract

The present disclosure relates to a prostatic urethral implant comprising: at least two cutting lines, each of the cutting lines having a proximal section, a distal section, and two lateral sections extending longitudinally between the proximal section and the distal section, each of the lateral sections of each of the cutting lines is joined with another lateral section of another of the cutting lines; and a first anchor line extending outwardly from at least one of the proximal sections and through one of the cutting lines, the first anchor line being sufficiently long to compress the middle lobe when the prostatic urethral implant is located in the prostatic urethra, where each of the at least two cutting lines and the first anchor line are elastic and have a shape memory, the first connector has an expanded configuration and can also be compressed into a compressed configuration. And wherein, in the deployed configuration, the cutting wire cuts tissue in the prostatic urethra via an outward radial pressure, and the first anchoring wire applies an outward radial pressure to the medial leaf.

Description

Technical Field

[0001] The disclosed technology generally relates to systems and methods for alleviating prostate enlargement (eg, due to benign prostatic hyperplasia), and to systems and methods for dilating the prostatic urethra and for anchoring the median lobe of the prostate. Background Art

[0002] 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, which stores urine. The urethra is the passage that connects the bladder to the penis, through which urine is discharged from the body. In the male reproductive system, the ejaculatory duct is a tube that connects the testicles to the urethra, through which semen is discharged from the body. The prostate surrounds a portion of the urethra (referred to herein as the prostatic urethra), and the ejaculatory duct also passes through the prostate and connects to the prostatic urethra. The prostate itself is anatomically composed of four lobes (anterior, middle, posterior, and lateral lobes). The anterior, middle, and posterior lobes surround the urethra, while the ejaculatory duct passes through the middle and posterior lobes. The lateral lobes are located around the anterior, middle, and posterior lobes. An anatomical landmark on the prostatic urethra that is used to classify certain urethral abnormalities is called the colliculus seminalis. The colliculus seminalis is located between the ejaculatory duct, the prostatic capsule, and the prostatic duct, below the urethral crest.

[0003] Now refer to Figure 1A and Figure 1B , which are schematic diagrams of the male reproductive system and prostate (generally designated 10 and 40, respectively) as known in the prior art. Figure 1A , shows a schematic diagram of the male reproductive system from a sagittal view. As can be seen, the bladder 12 is connected to the urethra 16, which flows to the penis 28. The prostate 14 below the bladder 12 surrounds the urethra 16. The portion of the urethra 16 surrounded by the prostate 14 is shown as the prostatic urethra 24. Multiple ejaculatory ducts 18 connect to the urethra 16 in the prostatic urethra 24. The urethral ridge 26, the prostatic capsule 20, and the spermatophore 22 are shown in cross-section of the prostatic urethra. Figure 1B , shows a schematic diagram of the prostate from a sagittal view 42A and a cross-sectional view 42B. Like elements in the sagittal view 42A and the cross-sectional view 42B are shown using the same reference numerals. As can be seen from the sagittal view 42A, the anterior lobe 44, the posterior lobe 46, and the middle lobe 48 surround the urethra 52. The ejaculatory duct 54 passes through the posterior lobe 46 and the middle lobe 48. Also shown is a spermatic caruncle 56 on the proximal end of the posterior lobe 46. As can be seen from the cross-sectional view 42B, multiple lateral lobes 50 surround the anterior lobe 44, the posterior lobe 46, and the middle lobe 48, and the urethra 52 flows between the various lobes of the prostate.

[0004] Common medical conditions of the prostate include inflammation, noncancerous enlargement of the prostate, and prostate cancer. Noncancerous enlargement of the prostate (also known as benign prostatic hyperplasia) occurs primarily in older men (generally over 50 years old) and is a medical condition in which the prostate enlarges in size but is not due to metastasis or uncontrolled cell proliferation. As the prostate enlarges and increases in size, such as from Figure 1A As can be seen from its anatomical location in human males shown in the figure, it can put pressure on the urethra, especially the prostatic urethra, as well as adjacent anatomical parts such as the bladder neck (the lower part of the bladder that connects to the urethra) and the ejaculatory duct. Generally speaking, when the prostate is enlarged, it is the lateral lobes that enlarge and put pressure on the prostatic urethra. However, in some cases, the middle lobe may also be enlarged. An enlarged prostate can lead to many medical problems, such as benign prostatic hyperplasia (abbreviated herein as BPH), prostatic bladder neck obstruction (abbreviated herein as BNO), etc. BPH causes increased pressure on the prostatic urethra, making urination difficult and painful. BNO can lead to complete obstruction of the prostatic urethra, and the muscles around the bladder neck (such as the internal urethral sphincter) cannot relax and contract, making urination almost impossible and usually requiring medical intervention to empty the bladder with urine.

[0005] Treatments for the medical problems caused by an enlarged prostate range from oral medications (to reduce the size of the prostate by reducing hormone production), various types of stents and implants (to dilate the prostatic urethra), the use of catheters (to enable a path from the bladder to the penis to drain urine), and surgery (to remove part of the prostate (such as transurethral resection of the prostate) or the entire prostate (such as prostatectomy). Stents and implants for opening the prostatic urethra are known in the art. PCT Patent Application Publication No. WO 2006 / 040767 A1, entitled "Prostate Treatment Stent" by Kilemnik, relates to a tissue dissecting implant. The implant is spring-shaped and includes a plurality of rings elastically connected therebetween. Adjacent rings apply pressure to tissue clamped between the rings, thereby squeezing the clamped tissue and inducing necrosis.

[0006] Kilemnik's U.S. Patent Application Publication No. 2011 / 0276081A1, entitled "Radial Cutter Implant," relates to an implant for applying radial force to surrounding tissue. The implant includes wires for applying radial pressure to the surrounding tissue. Each of the wires extends in a different radial direction, so that each wire applies pressure to a different tissue. The implant may also include a longitudinal central tube, with the wires connected to the proximal and distal ends of the tube. The tube supports the wires and provides structural stability to the implant. The distal end of the wires is positioned within the subject's bladder and can stimulate the bladder.

[0007] Kilemnik's U.S. Patent No. 11,304,724 B2, entitled "Incising Implant For The Prostatic Urethra," relates to an implant for forming an incision in the prostatic urethra of a subject. The implant comprises at least two closed-shaped wires, each of which has a proximal section, a distal section, and two longitudinal sections extending between the proximal section and the distal section. Each of these closed-shaped wires is elastic and therefore compressible into a compressed configuration. Each of the longitudinal sections of each of the wires is coupled to another longitudinal section of another of the wires. In an open configuration, the implant incises tissue in the prostatic urethra, with the wires bifurcating at the distal section so that the distal section forms a simple closed curve shape at the end of the implant.

[0008] U.S. Patent No. 8,715,239 B2, entitled “Devices, Systems, and Methods for Treating Benign Prostatic Hyperplasia and Other Conditions,” by Lamson et al., relates to a system comprising a rigid guide device that can be used to facilitate insertion of an implant into the prostate. The implant includes a proximal anchor connected to a distal anchor by a tensioning element, and the guide device includes a rigid extension that can be inserted into the urethra of a subject. The guide device also includes a rigid scope lumen and a rigid working lumen that is configured to accommodate a cystoscope or other endoscopic device. The working lumen is used to place a prostate compression implant and has an outlet through which the implant can be advanced through the urethra wall to a position within or near the prostate.

[0009] The prior art provides solutions to the pressure exerted on the prostatic urethra when the lateral lobes of the prostate are enlarged (this is the more common form of BPH). However, when the lateral and medial lobes of the prostate are enlarged, further complications may arise. As described below, the enlarged median lobe may exhibit sufficient movement within the prostatic urethra to block the bladder neck after urination, thereby causing BNO. With regular urination in men, when the muscles around the bladder contract and squeeze the bladder, the muscles around the bladder neck (such as the internal urethral sphincter) relax, allowing urine to enter the prostatic urethra. When urine is discharged from the bladder, air pressure is generated in the bladder, forcing urine to leave the bladder and enter the urethra. Once urination is completed, the muscles around the bladder relax and the muscles around the bladder neck contract to close the bladder neck, and negative pressure and suction may be generated in the prostatic urethra. In the case of BPH, when only the lateral lobes of the prostate are enlarged, the negative pressure may have no effect on the opening of the bladder neck. However, in the case of BPH, when the lateral and median lobes are enlarged, negative pressure (i.e., suction) can pull the enlarged middle lobe toward the bladder neck, thereby also causing BNO. In this case (BPH and BNO with middle lobe enlargement), previous treatments typically used some form of laparoscopic surgery to remove a portion of the middle lobe to relieve symptoms. Therefore, there is a need for a minimally invasive treatment (such as an implant) that can open the prostatic urethra to treat the symptoms of BPH while also preventing the middle lobe from obstructing the bladder, thereby also treating the symptoms of BNO. Summary of the Invention

[0010] An object of the disclosed technology is to provide methods and systems for a prostatic urethral implant for treating an enlarged prostate when both the lateral and medial lobes are enlarged. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The disclosed technology will be more fully understood and appreciated through the following detailed description taken in conjunction with the accompanying drawings, in which:

[0012] Figure 1A and Figure 1B is a schematic diagram of the male reproductive system and prostate as known in the art;

[0013] Figure 2A 、 Figure 2B and Figure 2C is a schematic diagram of a prostatic urethral implant constructed and operative in accordance with an embodiment of the disclosed technology for forming an incision in tissue of the inner wall of the prostatic urethra and for compressing the median lobe;

[0014] Figure 3A 、 Figure 3B and Figure 3Cis a schematic diagram of a second prostatic urethral implant constructed and operative in accordance with another embodiment of the disclosed technology for forming an incision in tissue of an inner wall of the prostatic urethra;

[0015] Figure 4 is a schematic diagram of a third prostatic urethral implant constructed and operative in accordance with yet another embodiment of the disclosed technology for forming an incision in tissue of the inner wall of the prostatic urethra;

[0016] Figure 5A and Figure 5B is a schematic diagram of a proximal recess of a proximal cover of a prostatic urethra implant constructed and operative in accordance with yet another embodiment of the disclosed technology;

[0017] Figure 6A and Figure 6B is a schematic diagram of a fourth prostatic urethral implant constructed and operative in accordance with yet another embodiment of the disclosed technology for forming an incision in tissue of the inner wall of the prostatic urethra;

[0018] Figure 7 is a schematic diagram of a fifth prostatic urethral implant constructed and operative in accordance with yet another embodiment of the disclosed technology for forming an incision in tissue of an inner wall of the prostatic urethra;

[0019] Figure 8 is a schematic diagram illustrating placement of a prostatic urethra implant within the prostatic urethra, constructed and operative in accordance with yet another embodiment of the disclosed technology; and

[0020] Figures 9A to 9L is a schematic diagram of a method for deploying and for withdrawing a prostatic urethra implant, operated in accordance with yet another embodiment of the disclosed technology. DETAILED DESCRIPTION

[0021] The disclosed technology overcomes the shortcomings of the prior art by providing a prostatic urethra implant that is located in the prostatic urethra (or in its vicinity, such as in the bladder neck). The implant includes wires that apply radial force to the surrounding tissue of the inner wall of the prostatic urethra. Over time, these wires cause longitudinal incisions in the prostatic urethra and induce infarction (i.e., tissue death due to lack of blood supply) therein. The incisions and the resulting infarction relieve the constriction of the prostatic urethra by killing a portion of the tissue in the prostatic urethra that causes urethral obstruction. The implant also includes at least one anchor that is used to simultaneously hold the implant in place and prevent it from migrating into the bladder, while also applying pressure to the median lobe of the prostate, thereby preventing the median lobe from moving after urination (due to suction). Therefore, the implant provides a solution to the prostatic urethra constriction caused by BPH, as well as a solution to prevent BNO caused by enlargement of the median lobe.

[0022] As mentioned above, in some cases of BPH, not only the lateral lobes of the prostate may be enlarged during prostate enlargement, but also the medial lobe. In these cases, the proximal side of the median lobe closest to the prostatic urethra may form a bulbous overhang. Due to the suction created during urination, when a man stops urinating, the suction from the bladder may pull the bulbous overhang toward the bladder neck, thereby causing BNO. Therefore, even in cases where the prostatic urethra has relaxed the general constriction caused by the enlargement of the lateral lobes of the prostate, the bulbous overhang of the median lobe has sufficient movement to obstruct the bladder neck.

[0023] According to an embodiment of the disclosed technology, the implant is formed by three (or more) closed-shaped cutting wires, which have at least one additional closed-shaped anchoring wire, which serves as an anchor for limiting the movement of the spherical overhanging end of the enlarged middle lobe and preventing the implant from migrating toward the bladder. The cutting wires and the anchoring wires are both connected to a hollow cap, which provides the basic structure of the implant while allowing urine to pass through the implant. The shape of each cutting wire can be roughly divided into a proximal section, a distal section, and two lateral sections extending between the proximal section and the distal section. The shape of the anchoring wire is similar to the outline of a leaf or teardrop with a distal curvature for applying pressure radially outward. Each wire (cutting wire and anchoring wire) is made of elastic and shape memory material so that it can be compressed into the sheath and then unfolded to its initial shape when released from the sheath.

[0024] The lateral segments of each cutting wire join with the lateral segments of adjacent cutting wires. Thus, the cutting wires are connected to form a wire frame. Each cutting wire forms a face of the wire frame, while the joined lateral segments form the edges of the wire frame. The edges of the wire frame exert outward radial pressure on the tissue of the inner wall of the prostatic urethra, thereby forming a longitudinal incision that relieves urethral narrowing and enlarges the urinary tract.

[0025] When pressure is applied to the surrounding tissue, the cutting wires press against each other (i.e., each wire presses against the adjacent wire to which it is connected at the corresponding lateral segment). Thus, the wire frame is self-supporting, wherein the cutting wires support each other. When the cutting wires exert a force on the tissue, the tissue exerts an opposing force of equal magnitude (according to Newton's third law of motion). Thus, the cutting wires are pressed against the connected adjacent cutting wires. These connected cutting wires are then pushed against the inner wall of the tissue in the prostatic urethra. In this way, the wire frame is self-supporting without the need for additional support elements (such as a central support tube). Additionally, each edge of the wire frame is formed by two connected cutting wires, thereby doubling the pressure applied to the tissue and allowing the use of thinner wires.

[0026] In a first embodiment of the disclosed technology, an implant has two anchoring wires, each having a shape resembling the outline of a leaf, lobule, or teardrop. The first anchoring wire is used to anchor the wire frame of the cutting wire, preventing the implant from migrating into the bladder. The second anchoring wire is used to anchor the spherical overhang of the middle lobe, preventing it from moving when suction is generated after urination. Both the first and second anchoring wires have an outward curvature, thereby applying outward radial pressure. The two anchoring wires are connected to the hollow cap of the implant and have different lengths corresponding to the structure of the prostatic urethra to which they are anchored. The first anchoring wire is sufficiently long that, when the implant is located within the prostatic urethra, it applies pressure against the verumontanum, thereby preventing the implant from migrating into the bladder. The first anchoring wires substantially hold the implant in place without requiring the implant to be permanently attached to the tissue within the prostatic urethra (e.g., without the need for glue, sutures, or other means of attaching the implant to tissue within the body). The second anchoring wire is long enough so that when the implant is located within the prostatic urethra, the second anchoring wire applies pressure to the bulbous, hanging end of the median lobe, thereby preventing the bulbous, hanging end of the median lobe from being drawn toward the bladder and obstructing the bladder neck after urination. Given the anatomy of the prostate and prostatic urethra and the insertion of the implant into the urethra from the penis, the second anchoring wire is longer than the first anchoring wire because the bulbous end of the median lobe is further away from the penis than the verumontanum.

[0027] In a second embodiment of the disclosed technology, the implant comprises a single anchoring thread with two extensions, each of which has a forked shape. The first extension is used to anchor the implant to the prostatic urethra, for example, by applying pressure to the verumontanum, while the second extension is used to apply pressure to the bulbous end of the median lobe. This embodiment is similar to the embodiment described above, however, the anchoring thread has a single structure and only a single connection point to the hollow cap. In this embodiment, each extension performs the function of the corresponding anchoring thread in the previous embodiment.

[0028] In a third embodiment of the disclosed technology, the implant has a single anchoring thread that has a shape similar to the outline of a leaf, leaflet, or teardrop, for applying pressure to the bulbous end of the median lobe. The single anchoring thread in this embodiment is similar to the second anchoring thread in the first embodiment mentioned above. In this embodiment, other means are used to maintain the position of the implant within the prostatic urethra and prevent migration toward the bladder. For example, in this embodiment, biological glue, sutures, and / or pins can be used to anchor the implant within the prostatic urethra.

[0029] It is noteworthy that according to the disclosed technology, since the implant has an anchoring line or extension for preventing the spherical end of the median lobe from moving, the implant of the disclosed technology is intended to be permanently or semi-permanently retained as implanted in the prostatic urethra. This is because the implant of the disclosed technology does not reduce the size of the enlarged median lobe and / or change its composition, so the implant must be permanently retained in place to prevent the spherical end of the median lobe from causing BNO. In the event that the size of the median lobe is reduced (e.g., by medication, by surgery, or by other techniques) and the spherical end of the median lobe is no longer a problem causing BNO, the implant of the disclosed technology can be removed from the prostatic urethra. In this regard, the implant of the disclosed technology can be semi-permanent.

[0030] According to another embodiment of the disclosed technology, a method for deploying a prostatic urethra implant in a patient's prostatic urethra is provided. The method includes enclosing the implant within a sheath. The implant is elastic and therefore adapted to fit within the sheath's circumference, which is smaller than the implant's circumference when deployed. The sheath is inserted into the urethra and pushed until its distal end extends into the subject's bladder. The implant is pushed into the sheath until it extends from the distal end of the sheath and is thereby released from the sheath. Once released, the elastic implant returns to its initial, extended configuration due to the shape-memory material from which it is made. The implant is then pulled into the prostatic urethra and positioned appropriately. Positioning the implant may include its physical location within the prostatic urethra and its rotational orientation. As described below, the implant can be rotated within the prostatic urethra to appropriately position the anchoring wire for anchoring the implant to the verumontanum and applying pressure to the bulbous end of the median lobe. Once the implant is appropriately positioned, the sheath is removed from the urethra.

[0031] As mentioned above, the implant may include a hollow proximal cap with a recess (or protrusion). The recess is non-circular, which can transmit rotational motion from the corresponding pin (or in the case of a protrusion, from the corresponding recess). Thus, the implant can be rotated to a desired rotational orientation within the prostatic urethra.

[0032] As mentioned, the implant is pulled back in a proximal direction from the bladder until it is positioned in the prostatic urethra (and / or bladder neck). The implant remains in the prostatic urethra permanently or semi-permanently for a period of time. During this period, the cutting line in the implant forms a longitudinal incision in the surrounding tissue of the inner wall of the prostatic urethra to relieve urethral constriction, while one of the anchoring lines applies pressure to the spherical end of the median lobe. If the implant is to be removed from the patient, a sheath is inserted into the urethra and the implant is compressed, thereby folding the implant back into its compressed configuration. After this, the implant can be removed from the urethra via the sheath.

[0033] In this specification, the terms "pressure" and "force" (e.g., applying radial pressure or applying radial force) are used interchangeably hereinafter to describe the operation of the implant's wires on the surrounding tissue and anatomical landmarks in the prostatic urethra. That is, the wires (cutting wires and anchoring wires) are described as applying pressure on the tissue, or applying outward radial forces on the tissue. Hereinafter, the terms "proximal" and "distal" refer to directions relative to the implantable device and delivery system. In particular, the distal end is the end of the device (or system) that is first inserted into the patient's body and reaches the deepest point. The proximal end is the end that is closer to the exit from the patient's body. Thus, with reference to the disclosed technology, the bladder is the most distal point, while the opening of the urethra in the penis is the most proximal point.

[0034] It is worth noting that while the disclosed technology is generally described using an embodiment having two anchoring wires, a person skilled in the art can readily understand how to modify the description to apply the disclosed technology to the other embodiments mentioned above. This applies to embodiments having a single anchoring wire with two extensions, as well as embodiments having a single anchoring wire and no anchoring wire for anchoring the implant within the prostatic urethra. Furthermore, the disclosed technology is described with reference to the human male reproductive system, however, the disclosed technology (i.e., the implant and its delivery method) can be equally applied to the reproductive system of male animals having a prostate or a gland that is anatomically and homologously similar to the human male prostate.

[0035] Now refer to Figure 2A 、 Figure 2B and Figure 2C , which are schematic illustrations of a prostatic urethral implant, generally designated 100, constructed and operative in accordance with an embodiment of the disclosed technology for forming an incision in the tissue of the inner wall of the prostatic urethra and for compressing the median lobe. Figure 2A The implant is depicted from a top view perspective (ie, as would be seen if the viewer were at the distal end of the implant), and Figure 2B and Figure 2CThe implant 100 includes three closed-shaped wires 102A, 102B, and 102C, a first anchoring wire 104 , a second anchoring wire 105 , a proximal cap 106 , and a withdrawal cord 108 .

[0036] The closed shape of each of the wires 102A to 102C can be roughly divided into a proximal section 112, a distal section 114, and two lateral sections 116 extending between the proximal and distal sections. Figures 2A to 2B 102C, the proximal, distal, and lateral segments are numbered for only one of the lines 102A to 102C to reduce clutter. As shown, the proximal segment 112 can be a U-shaped proximal end from which a lateral segment 116 extends. The distal segment 114 is a segment connecting the lateral segments 116. Each of the lines 102A to 102C is connected to an adjacent line in the lines 102A to 102C on either side. Thus, as shown, the lateral segments of each of the lines 102A to 102C are connected to the lateral segments of the adjacent line, shown as connected lateral segments 103A, 103B, and 103C, respectively. For example, one lateral segment of line 102A is connected to a lateral segment of line 102B as connected lateral segment 103B, another lateral segment of line 102A is connected to a lateral segment of line 102C as connected lateral segment 103A, and another lateral segment of line 102B (not connected to line 102A) is connected to another lateral segment of line 102C (also not connected to line 102A) as connected lateral segment 103C.

[0037] The proximal cap 106 holds the proximal ends of the wires 102A to 102C together. As shown, the proximal cap 106 has a hollow portion 107. Since the proximal cap 106 is placed within the urethra, it must be hollow to allow urine to pass through the urethra. A withdrawal cord 108 is connected to the wires 102A to 102C, the proximal cap 106, or both. As shown, the first anchoring wire 104 and the second anchoring wire 105 both have a shape similar to the outline of a leaf. The first anchoring wire 104 and the second anchoring wire 105 can also have a shape similar to the outline of a leaflet, a teardrop, or the like to apply outward radial pressure. Similar to the proximal cap 106, the first anchoring wire 104 and the second anchoring wire 105 have a substantially hollow profile and therefore do not obstruct the passage of any liquid and / or fluid through the prostatic urethra in which they are located. The first anchoring wire 104 serves as an implant anchor for anchoring the implant 100 in the prostatic urethra. | The second anchoring wire 105 acts as a median lobe compressor, which is used to apply pressure to the bulbous end of the median lobe and to prevent it from moving around (especially after urination).

[0038] The following paragraphs describe the use of implant 100. Thereafter, the components of implant 100 are described in greater detail. Implant 100 is permanently or semi-permanently implanted in the prostatic urethra to form a longitudinal incision in the tissue of the inner wall of the prostatic urethra, thereby relieving urethral strictures, and also to apply pressure to the bulbous end of the median lobe to prevent BNO.

[0039] The implant 100 is implanted using a sheath (not shown) for inserting the implant into the urethra. The implant 100 is compressed within the sheath so that the diameter of the periphery of the implant 100 (shown by the dotted circle 110) adapts to the inner diameter of the sheath when deployed. The wires 102A to 102C and the anchor wires 104 and 105 are made of an elastic material with shape memory so that they can be compressed and so that when released from the enclosing sheath, they return to their original, extended shape and configuration, deploying to the original outer diameter of the dotted circle 110. When located in the prostatic urethra, the deployed diameter and configuration of the implant 100 are constrained by the inner diameter of the urethral wall surrounding it.

[0040] Wires 102A to 102C push against the surrounding tissue (i.e., apply an outward radial force to the tissue of the prostatic urethra). Over time, the force applied by wires 102A to 102C weakens the blood (and oxygen) supply to the portion of the tissue that is in direct contact with wires 102A to 102C, thereby inducing tissue necrosis and forming an infarct incision. Over time, the incision becomes deeper until wires 102A to 102C reach their full expansion (i.e., until the implant 100 recovers its initial outer diameter, as illustrated by dotted circle 110). Once fully expanded, the prostatic urethral constriction is greatly alleviated. The first anchoring wire 104 is positioned so that the distal end 113 of the first anchoring wire 104 is at the distal end of the seminal caruncle of the prostatic urethra. The distal end 113 substantially ensures that the implant 100 will not move and / or migrate toward the bladder once implanted. The second anchoring wire 105 is positioned so that the distal end 115 of the second anchoring wire 105 is at the distal end of the spherical end of the median lobe. The distal end 115 compresses the bulbous end of the median lobe and ensures that it does not move around when suction is created in the prostatic urethra (particularly after urination).

[0041] The implant 100 is implanted so that the wires 102A to 102C and the anchoring wires 104 and 105 are aligned with the longitudinal direction of the urethra. Thus, the wires 102A to 102C form a longitudinal incision in the tissue of the inner wall of the prostatic urethra extending along the urinary tract.

[0042] The time period required to form an incision sufficient to relieve the urethral stricture depends on various factors, such as the degree of stricture, the material of the wires 102A to 102C, the size of the initial fully extended shape of the wires 102A to 102C, etc. As mentioned above, the implant 100 can remain in the prostatic urethra indefinitely or for a predetermined period of time (i.e., semi-permanently). The incision formed by the implant 100 is created over time without causing pain or bleeding to the patient. After the implant 100 is implanted, the patient can be discharged from the hospital and resume his normal lifestyle without any hindrance. The pressure applied by the anchoring wires 104 and 105 is sufficient to maintain the position of the implant 100 in the prostatic urethra and compress the median lobe without causing any pain and / or discomfort to the patient. Furthermore, the shape of anchor lines 104 and 105 is free of protrusions (as the shapes of the anchor lines are essentially hollow), thereby allowing fluids and liquids (such as urine, prostate secretions, semen, etc.) to pass over and through anchor lines 105 and 104 unimpeded.

[0043] The implant 100 is implanted in the prostatic urethra to relieve urethral constriction and to compress the enlarged middle lobe with a bulbous end (both of which are caused by, for example, an enlarged prostate). The implant 100 can be positioned in other or additional areas of the urinary tract, such as the bladder neck. Depending on the desired placement, the lengths of the anchoring wires 104 and 105 may need to be changed accordingly to achieve their respective anchoring and compression functions. Alternatively, the implant 100 can be implanted in any tubular organ, such as a tubular organ of the digestive system, a blood vessel, or the like, where it is desired to relieve constriction while limiting the mobility of the anatomical structure.

[0044] Wires 102A to 102C and anchoring wires 104 and 105 are all closed-shaped wires made of elastic material. The material of all wires of the disclosed technology (cutting and anchoring) should have enough elasticity to allow the wire to be compressed in the sheath and adapt to the inner diameter of the sheath during insertion into the urethra. These wires also need shape memory so that once released from the sheath, they can recover their initial, extended shape and configuration (and their initial outer diameter). Additionally, the cutting wire should be strong enough to apply force to the surrounding tissue to induce necrosis of the tissue (e.g., a force of 0.5 Newtons), thereby forming a longitudinal incision of the infarction. The anchoring wire should be strong enough to apply enough radial force to compress the middle lobe and caruncle of the urethra so that fluid and liquid will not displace the anchoring wire through the urethra. Wires 102A to 102C and anchoring wires 104 and 105 can be made of, for example, nickel-titanium alloy (nitinol). All parts of the implant 100 should be made of biocompatible materials so that there is no risk of the implant 100 causing infection in the patient's body.

[0045] As mentioned above, the closed shape of the cutting line can be roughly divided into three sections, a proximal section 112, a middle section consisting of lateral sections 116, and a distal section 114. The distal section serves as a supporting crossbar connecting the lateral sections of the cutting line. An exemplary closed shape of the cutting line is shown in FIG. Figures 2A to 2C 、 Figures 3A to 3C and Figure 4 middle.

[0046] The lateral segments of each of the threads 102A to 102C (shown as connected lateral segments 103A to 103C) are the segments that come into contact with the surrounding tissue of the prostatic urethra. In other words, the lateral segments are the segments that push against the tissue to form the incision. As mentioned above, the lateral segments of each of the threads 102A to 102C are connected (i.e., bonded, braided, and / or attached) to the lateral segments of the adjacent threads. In this way, the bonded threads together form a support thread frame, such that each closed-shaped thread forms a face of the frame, and each pair of bonded lateral segments of adjacent threads forms an edge of the frame.

[0047] As the lateral segments of wires 102A-102C push against the surrounding tissue (i.e., as implant 100 attempts to regain its original shape while being constrained by the urethral wall of the prostatic urethra), the surrounding tissue exerts opposing forces on wires 102A-102C according to Newton's third law of motion. Each of wires 102A-102C pushes against the adjacent wire to which it is attached. The wire frame increases the structural stability of implant 100, allowing implant 100 to exert sufficient force to form an incision in the surrounding tissue. Thus, the wire frame eliminates the need for additional support elements (such as a central support tube).

[0048] exist Figures 2A to 2C In the example set forth in , cutting lines 102A to 102C are combined together by winding (that is, winding and / or braiding) on each other. That is, the first lateral section of line 102A and the first lateral section of line 102B are wound on each other as lateral section 103B connected, the first lateral section of line 102A and the first lateral section of line 102C are wound on each other as lateral section 103A connected, and the second lateral section of line 102B and the second lateral section of line 102C are wound on each other as lateral section 103C connected. The torsion connection of lines 102A to 102C further provides structural robustness for implant 100. Therefore, each line in lines 102A to 102C can be made thinner without affecting the robustness of implant 100. For example, each of the wires 102A- 102C may be as thin as 0.5 mm (ie, each of the wires may have a cross-section of 0.5 mm).

[0049] For example, the winding of wires 102A to 102C can be achieved by winding the lateral segments around each other and heat treating the implant 100 to stabilize the coils. The wires 102A to 102C can be wound around each other by being placed in a mold with a rotating element that grabs the lateral segments and winds them around each other.

[0050] exist Figures 2A to 2C In the example described in , there are three wound wires, each wire consisting of two lateral segments of two adjacent wires wound around each other. Thus, the wire frame has three lateral edges forming three longitudinal incisions. According to alternative embodiments of the disclosed technology, the implant may include other numbers of closed-shaped wires, such as a single wire, two wires (a wire frame for forming two lateral edges of two longitudinal incisions), four wires (a wire frame for forming four lateral edges of four longitudinal incisions), five wires, etc.

[0051] A proximal cap 106 is connected to the proximal ends of the wires 102A to 102C for connecting the wires 102A to 102C together, thereby reinforcing the wire frame. In other words, the proximal cap 106 helps maintain the structure of the implant 100 (i.e., increases structural stability) by further bonding the wires 102A to 102C to each other. As mentioned above, the proximal cap 106 is also hollow and has an outer diameter similar to that of a non-strictured urethra, so that when located in the prostatic urethra, the proximal cap 106 does not apply any additional pressure to the inner wall of the urethra that could cause discomfort and / or pain to the patient.

[0052] exist Figures 2A to 2C In the example described in , the proximal cover 106 wraps the proximal ends of the wires 102A to 102C. Thus, the proximal cover 106 protects the tissue of the urethra from being pinched by the proximal ends of the wires 102A to 102C. Additionally, the proximal cover 106 serves to prevent the wires 102A to 102C from unfolding.

[0053] The proximal cap 106 includes a hollow portion 107, which may also be described as a proximal non-circular recess (e.g., Figure 5A and Figure 5B 104). Typically, the hollow portion 107 does not have a circular shape, thereby enabling the proximal cover 106 to be rotated with the aid of a tool (not shown) having a shape complementary to the hollow portion 107, thereby enabling the orientation of the cutting lines 102A to 102C and the anchoring lines 104 and 105 to be changed. The non-circular proximal recess of the proximal cover 106 is configured to receive a corresponding non-circular pin (i.e., the tool) and transmit the rotational motion of the pin to the implant 100. Thus, when the implant is located in the subject's bladder, the physician or user can rotate the implant 100, as will be described below with reference to Figures 5A to 5B and Figures 9A to 9L As described in further detail.

[0054] As mentioned above, the first anchoring wire 104 acts as a one-way stopper that allows the implant 100 to move from the bladder into the prostatic urethra while preventing the implant 100 from moving back toward the bladder. This can be achieved by having a first anchoring wire 104 that is wide enough when fully deployed so that it will catch on one of the urethral sphincters. This can also be achieved by having a first anchoring wire 104 that applies outward radial pressure to the verumontanum of the prostatic urethra. The first anchoring wire 104 can be a lobular wire (e.g., Figures 2A to 2C ), or may be any other form that allows it to move in the proximal direction past the urethral sphincter while preventing it from moving in the distal direction past the urethral sphincter. In other words, the first anchoring thread 104 should have a shape that provides unidirectionality for its movement in the proximal direction (i.e., toward the opening of the urethra in the penis). The first anchoring thread 104 may be connected to the implant 100 elastically or via a shaft. The first anchoring thread 104 may also be connected via another connecting mechanism that is configured to enable the first anchoring thread 104 to act as a one-way stop for movement past the urethral sphincter. Alternatively, another anchoring element or additional anchoring elements may be employed to anchor the implant 100 in its position (preventing movement in the proximal direction, distal direction, or both), such as barbs (not shown) on threads 102A to 102C. As mentioned above, in such an embodiment, the implant 100 may include only the second anchoring thread 105, while the first anchoring thread has been replaced by another mechanism for anchoring the implant 100 within the prostatic urethra and for preventing its migration toward the bladder.

[0055] The second anchoring wire 105 is used to apply pressure to the bulbous end of the median lobe, thereby preventing the bulbous end from moving towards the bladder neck after urination.

[0056] Withdrawal cord 108 enables the doctor to withdraw implant 100. Specifically, the distal end of cord 108 is connected to implant 100, and the proximal end of cord 108 (slightly) extends to the outside of the patient's body. The doctor can insert the withdrawal sheath into the urethra along cord 108, for wrapping and compressing implant 100. The doctor can withdraw the parceled implant by pulling cord 108. Cord 108 is strong enough to pull implant 100 without being torn (for example, the thickness and material of cord 108 allow pulling implant 100 via cord 108). Cord 108 can be a single strand, or a braided strand bundle, to further enhance its strength. As described below, the withdrawal sheath is inserted into the urethra by cord 108 and is guided to implant 100. By pulling cord 108, implant 100 will be subsequently pulled into the withdrawal sheath and compressed into a shape that matches in the withdrawal sheath, just like the state when implant 100 was initially deployed. The withdrawal sheath, in which the implant 100 is compressed, may then be removed by pulling on the string 108 and the withdrawal sheath.

[0057] Implant 100 is deployed so that it does not extend distally beyond the subject's bladder neck (i.e., does not extend into the bladder). Specifically, wires 102A to 102C do not contact the tissue of the bladder itself. Therefore, implant 100 does not irritate the patient's bladder.

[0058] In accordance with an embodiment of the disclosed technology, the lines of the implant 100 can be colored in a manner that enables a physician to easily position it when deploying it in the prostatic urethra. For example, the cutting lines of the implant are color-coded such that the section that should be positioned on the upper side of the prostatic urethra is colored blue and the section that should be positioned on the lower side of the prostatic urethra is colored white. The physician can observe the implant in the bladder via a cystoscope and rotate the implant to the desired orientation based on the color of the implant. Similarly, the anchoring lines 104 and 105 can be color-coded so that they are appropriately positioned distal to the verumontanum and distal to the spherical end of the median lobe, respectively. As just mentioned, by using a cystoscope, the physician can observe and verify the position of the anchoring lines to ensure correct placement.

[0059] Now refer to Figure 3A 、 Figure 3B and Figure 3C , which are schematic illustrations of a second prostatic urethral implant, generally designated 200, constructed and operative in accordance with another embodiment of the disclosed technology for forming an incision in tissue of the inner wall of the prostatic urethra. Figure 3A The implant is depicted from an isometric perspective. Figure 3B The implant is depicted from a top-down perspective. Figure 3COne of the closed lines of the implant is depicted. The second implant 200 is substantially similar to the implant 100 ( ) except that the second implant 200 does not include a proximal cap and the lateral segments of the cutting line are joined together without being twisted together. Figures 2A to 2C ), as described below. Implant 200 includes three closed-shaped cutting lines 202A, 202B, and 202C, a first anchoring line 204, and a second anchoring line 206. The proximal end of implant 200 is indicated by arrow 208. The components of implant 200 are similar to those of implant 100, so for the sake of brevity, only the differences are discussed in detail below.

[0060] The closed shape of each of the lines 202A to 202C is depicted in FIG. Figure 3C The closed shape is cut off at its distal end. Therefore, the distal end of each of the lines 202A to 202C is substantially perpendicular to the longitudinal axis of the implant 200. Therefore, the cutting line does not come into contact with the tissue of the bladder, thereby preventing irritation of the bladder.

[0061] As shown, the wires 202A-202C are not wrapped around each other. Instead, the wires 202A-202C can be joined to each other in various ways (i.e., a lateral segment is joined to a lateral segment of an adjacent wire). For example, the cutting wires can be welded together, glued together, or connected by a connecting mechanism or element (e.g., a connecting wire that binds the lateral segments together).

[0062] exist Figures 3A to 3C (and below Figure 4 ), an implant without a proximal cover and an extraction cord is shown. However, it should be noted that the implant may include any one or both of the proximal cover and the extraction cord. Note also the relative positioning of the first anchoring line and the second anchoring line. As shown, the first anchoring line 204 is shorter than the second anchoring line 206. The proximal ends of the cutting lines 202A to 202C and the first anchoring line 204 and the second anchoring line 206 are all connected together at the proximal end 208 of the implant 200. The lines (202A to 202C, 204 and 206) can be connected via welding, bonding, connecting wires, etc.

[0063] Now refer to Figure 4 , Figure 4 FIG2 is a schematic diagram of a third prostatic urethral implant (generally designated 300), constructed and operative in accordance with yet another embodiment of the disclosed technology, for forming an incision in the tissue of the inner wall of the prostatic urethra. Implant 300 includes three closed-shaped cutting wires 302A, 302B, and 302C, a first anchoring wire 304, and a second anchoring wire 306. The components of implant 300 are similar to those of implant 200 ( Figures 3A to 3C) components, and for the sake of brevity, only the differences are elaborated in detail below. Implant 300 is depicted from a bottom view perspective (i.e., as seen by an observer located at the proximal end). The closed shape of lines 302A to 302C is a triangle, so that lines 302A to 302C together form a triangular pyramidal wire frame, wherein the proximal ends of the lines form the apex of the cone (indicated by arrow 310) and the distal ends form the base of the cone. As shown and numbered for cutting line 302A, the lateral segments 308A and 308B of cutting line 302A are combined with adjacent lateral segments (unlabeled) of cutting lines 302B and 302C. The combined lateral segments of lines 302A to 302C form the lateral edges of the triangular pyramid. As will be appreciated by those skilled in the art, other wire frame shapes are also possible for the prostatic urethra implant of the disclosed technology, such as a square pyramid, a pentagonal pyramid, a polygonal pyramid, etc.

[0064] Now refer to Figure 5A and Figure 5B , which are schematic illustrations of the proximal recesses (generally designated 402 and 404 , respectively) of the proximal cover of a prostatic urethra implant, constructed and operative in accordance with yet another embodiment of the disclosed technology. Figure 5A and Figure 5B A proximal cover 400 is shown that is substantially similar to proximal cover 106 ( Figures 2A to 2C ). As shown, the proximal recess has a hollow, non-circular shape to enable it to transmit rotational motion from a corresponding pin or tool (not shown) inserted into the recess to the implant. The hollow shape allows liquids and fluids to flow through the proximal cover. Thus, the physician can rotate the implant from a position external to the patient, even after the implant has been inserted into the urethra (e.g., when the implant is in the bladder). Figure 5A In the example described in FIG, the shape of the recess 402 is rectangular. Figure 5B In the example described in , the shape of the recess 404 is hexagonal. Alternatively, the proximal recess may have any shape such as a non-circular shape, a slit, an array of recesses (e.g., two holes), etc. that enables it to transmit rotational motion (i.e., rotation about the central axis (not labeled) of the proximal cover).

[0065] Now refer to Figure 6A and Figure 6B , which are schematic illustrations of a fourth prostatic urethral implant, generally designated 450, constructed and operative in accordance with yet another embodiment of the disclosed technology for forming an incision in tissue of the inner wall of the prostatic urethra. Figure 6A The implant is depicted from a top view perspective (ie, as would be seen if the viewer were located distal to the implant). Figure 6BThe implant 450 is depicted from an isometric perspective. Implant 450 includes three closed-shaped cutting wires 454A, 454B, and 454C, a bifurcated anchoring wire 458, and a proximal cap 452. Implant 450 is substantially similar to implant 100 ( Figures 2A to 2C )、200( Figures 3A to 3C ) and 300( Figure 4 ). Proximal cover 452 includes a hollow portion 455, and as shown, the lateral segments of each two adjacent cutting lines are connected together, shown as lateral segment 456AB (connecting the lateral segment of line 454A and the lateral segment of line 454B), lateral segment 456BC (connecting the lateral segment of line 454B and the lateral segment of line 454C), and lateral segment 456AC (connecting the lateral segment of line 454A and the lateral segment of line 454C). For the sake of brevity, only the differences between implant 450 and implants 100, implant 200, and implant 300 will be discussed.

[0066] As can be seen, the implant 450 includes a single anchor wire, designated as a bifurcated anchor wire 458, which includes a first extension 460A and a second extension 460B. The bifurcated anchor wire 458 is functionally equivalent to the first anchor wire 104 ( Figures 2A to 2C ) and the second anchor line 105 ( Figures 2A to 2C ), wherein the first extension 460A is functionally similar to the second anchoring wire 105 and the second extension 460B is functionally similar to the first anchoring wire 104. Thus, the first extension 460A acts as a median lobe compressor, while the second extension 460B acts as an anchor to the verumontanum to prevent the implant 450 from migrating toward the bladder after being implanted. In other words, the bifurcated anchoring wire 458 is a single anchoring wire having two extensions, one extension for anchoring the implant to the verumontanum and the other extension for compressing the median lobe. Similar to the first anchoring wire 104 and the second anchoring wire 105, the bifurcated anchoring wire 458 can be made of an elastic material with shape memory, such as nitinol. Thus, the main difference in this embodiment is that a single wire anchoring wire is attached to the proximal cover 452, rather than as, for example Figures 2A to 2C Two separate anchoring wires are shown attached to the proximal cap. A bifurcated anchoring wire 458 (ie, as a single anchoring wire) may also be used with the implant 200 ( Figures 3A to 3C ) and implant 300( Figure 4 )'s wireframe shape and configuration.

[0067] Now refer to Figure 7 , which is a schematic illustration of a fifth prostatic urethral implant, generally designated 500, constructed and operative in accordance with yet another embodiment of the disclosed technology for forming an incision in tissue of the inner wall of the prostatic urethra. Figure 7The implant is depicted from a top view perspective (i.e., as it would be viewed if the viewer were located distal to the implant). Implant 500 includes three closed-shaped cutting wires 504A, 504B, and 504C, an anchoring wire 510, and a proximal cap 502. Implant 500 is substantially similar to implant 100 ( Figures 2A to 2C ), implant 200( Figures 3A to 3C ), implant 300( Figure 4 ) and implant 450( Figures 6A-6B ). The body 506 of the proximal cover 502 is shown. Similar to other implants of the disclosed technology, the lateral segments of each two adjacent cutting lines are connected together (not labeled). For the sake of brevity, only the differences between the implant 500 and the implants 100, 200, 300 and 450 will be described.

[0068] As can be seen, the implant 500 includes only a single anchoring wire that functions similarly to the second anchoring wire 105 ( Figures 2A to 2C ), thereby playing the role of compressing the median lobe. Therefore, the implant 500 does not include an anchoring wire for preventing it from migrating toward the bladder. Instead of an anchoring wire for this purpose, the body 506 includes a plurality of barbs 508 (as an example) for holding the proximal cover 502 within the prostatic urethra. The plurality of barbs 508 will prevent the implant 500 from migrating toward the bladder. When the sheath is arranged on the implant 500, the plurality of barbs 508 are covered and do not contact the tissue of the inner wall of the urethra. Therefore, the implant 500 can be inserted into and retracted from the urethra using a sheath (not shown) that covers the plurality of barbs 508 and prevents the plurality of barbs 508 from abrading the tissue of the inner wall of the urethra. As mentioned above, other mechanisms (instead of the plurality of barbs 508) can be used to fix the position of the implant 500 so that it does not migrate toward the bladder after being implanted.

[0069] Now refer to Figure 8 , which is a schematic diagram illustrating the placement of a prostatic urethra implant, generally designated 550, within the prostatic urethra, constructed and operative in accordance with yet another embodiment of the disclosed technology. Figure 8 Shown is a sagittal cross-section of the prostatic urethra, an implant 566 of the disclosed technology (e.g., substantially similar to Figure 2A Implant 100 (shown in Figure 100) is located within the prostatic urethra. Urethra 552 is shown entering a prostate 554 having a posterior lobe (not shown), lateral lobes 556, a medial lobe 558, and an anterior lobe (not shown). The ejaculatory duct 562 enters the prostate 554 between the posterior and medial lobes 558. The median lobe 558 has been enlarged, presenting a bulbous, overhanging end 564. Also shown are the spermatocarpus 572 of the prostatic urethra and the bladder 560.

[0070] Implant 566 comprises multiple cutting lines, these cutting lines are schematically shown as cutting line 570, first anchoring line 574, second anchoring line 576 and proximal cover 568.Once implanted, as shown, second anchoring line 576 is located proximal to the prostatic urethra at the opposite end of bladder neck (not shown). Cutting line 570 is located in the prostatic urethra and applies outward radial force along the tissue of the inner wall of prostatic urethra. As mentioned above, this force can cause incision in the inner wall of prostatic urethra, thereby causing infarction and relieving the contraction pressure of the lateral lobe 556 of prostate. First anchoring line 574 is long enough to apply pressure to verumontanum 572, applying the outward radial force shown by arrow 578B, while second anchoring line 576 is even longer than first anchoring line 574 and applies the outward radial force indicated by arrow 578A to spherical end 564. The radial force 578B is sufficient to keep the implant 566 from moving toward the bladder neck, and the radial force 578A is sufficient to prevent the ball end 564 from moving around (especially after urination), where the ball end 564 may be drawn toward the bladder neck and may cause BNO. The proximal cap 568 is hollow, thereby allowing fluids and liquids to pass through it. As mentioned above, the implant 566 is permanent or semi-permanent and remains in the prostatic urethra.

[0071] Now refer to Figures 9A to 9L , which are schematic illustrations of a method for deploying and for withdrawing a prostatic urethra implant in accordance with yet another embodiment of the disclosed technology. Figure 9A , shows a prostatic urethral implant 500 of the disclosed technology, together with a deployment sheath 502 and a guide wire 506. The implant 500 includes a proximal cover (not shown) having a non-circular proximal recess. The guide wire 506 includes a distal head (i.e., a distal pin) having a shape corresponding to the shape of the non-circular proximal recess of the proximal cover of the implant 500. The guide wire 506 also includes an internal channel (not shown). The distal head of the guide wire 506 is inserted into the non-circular proximal recess of the proximal cover of the implant 500. The implant 500 is attached to the distal end of the deployment sheath 502 so that the guide wire 506 passes through the deployment sheath 502.

[0072] refer to Figure 9B , the physician removes the protective cover 504 from the implant 500, thereby allowing the implant 500 to expand to its expanded, open configuration (e.g., Figures 2A to 2C 、 Figures 3A to 3C 、 Figure 4 、 Figures 6A to 6B and Figure 7 The protective cover 504 keeps the implant 500 sterile during storage prior to use. Figure 9CWhile holding the guidewire 506, the physician pushes the deployment sheath 502 over the implant 500, thereby encasing (and thereby compressing) the implant 500 within the deployment sheath 502 for delivery into the urethra.

[0073] refer to Figure 9D , the physician inserts a rigid cystoscope 508 (e.g., 20-gauge French) into the urethra 509 (e.g., as in a conventional catheterization procedure) until its distal end enters the bladder 511. Figure 9E , the physician inserts the deployment sheath 502 (including the compressed implant 500 located inside the deployment sheath) into the cystoscope 508. The physician continues to push the implant 500 through the cystoscope 508 by pushing the guide wire 506 until the implant 500 extends through the distal end of the cystoscope 508. Figure 9F , the physician removes the sheath 502 from the implant 500 and moves it out of the cystoscope 508. This action essentially releases the implant 500 so that it can deploy to its open configuration. Figure 9G Once released from the deployment sheath 502 and cystoscope 508, the implant 500 expands (ie, returns to its original extended shape). Figure 9G A first anchor line 514 and a second anchor line 516 are shown in FIG.

[0074] refer to Figure 9H The physician rotates the implant 500 to the desired orientation by rotating the guide wire 506 (whose distal head is inserted into the proximal recess of the implant 500), as shown by arrow 518. The first anchor wire 514 and the second anchor wire 516 of the implant 500 (e.g., Figures 2A to 2C The first anchoring line 104 and the second anchoring line 105 in the implant 500 should be positioned on the bulbous ends of the verumontanum and the middle lobe (neither of which is marked). The lines of the implant 500 (cutting lines and / or anchoring lines) can be color-coded so that the section that should be positioned above is colored, for example, blue, and the section that should be positioned below is colored, for example, white. The physician rotates the implant 500 using the proximal cap, as described in detail above.

[0075] refer to Figure 9I , while holding the implant 500 in place using the guide wire 506, the physician retracts the cystoscope 508. Thereafter, the physician pulls the implant 500 via the guide wire 506 until the first and second anchor wires of the implant 500 slide past the internal urethral sphincter. The physician continues to pull the implant 500 into the prostatic urethra via the guide wire 506 until the first anchor wire is positioned on the verumontanum and the second anchor wire is positioned on the ball end of the median lobe. The implant 500 is now positioned accordingly within the prostatic urethra. Reference Figure 9JWhere the implant 500 includes a withdrawal string 510, the physician cuts the knot 512 at the proximal end of the withdrawal string 510 and withdraws the guidewire 506 from the urethra.

[0076] Thus, implant 500 is implanted within the prostatic urethra and begins to exert a radially outward force on the surrounding tissue of the inner wall of the prostatic urethra to form a longitudinal incision. Furthermore, the second anchoring wire compresses the spherical end of the median lobe and holds it in place. Implant 500 may remain permanently within the prostatic urethra or may remain semi-permanently. If desired, implant 500 may be removed as described in detail below.

[0077] refer to Figure 9K To remove the implant 500, the physician inserts the cystoscope 508 through the urethra on the withdrawal string 510 in the direction of the bladder 511 toward the implant 500. Alternatively, the physician may insert the deployment sheath 502 (instead of the cystoscope 508) into the urethra. The physician pushes the cystoscope 508 (and / or deployment sheath 502) until it wraps around and compresses the implant 500. The implant is then positioned within the cystoscope 508 and / or deployment sheath 502. Figure 9L The physician can then extract the implant 500 encased within the cystoscope 508 by pulling the implant via the extraction string 510. Alternatively, the physician can insert a tool (not shown) within the deployment sheath 502 for pulling and removing the implant 500. The physician then withdraws the cystoscope 508 and / or the deployment sheath 502 from the urethra.

[0078] It will be appreciated by those skilled in the art that the disclosed technology is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the disclosed technology is limited only by the appended claims.

Claims

1. A prostatic urethra implant for creating an incision in a patient's prostatic urethra and for compressing the middle lobe of the prostate, the prostatic urethra implant comprising: at least two cutting lines of a closed shape, each of the cutting lines having a proximal segment, a distal segment, and two lateral segments extending longitudinally between the proximal segment and the distal segment, each of the lateral segments of each of the cutting lines being joined to another lateral segment of another of the cutting lines; as well as a closed-shaped first anchoring line extending outwardly from at least one of the proximal sections and passing through one of the cutting lines, the first anchoring line compressing the median lobe when the prostatic urethra implant is located in the prostatic urethra, wherein each of the at least two cutting lines and the first anchoring line are elastic and have shape memory, thereby having an expanded configuration and also being compressible into a compressed configuration; and Wherein, in the deployed configuration, the cutting wire cuts tissue in the prostatic urethra via outward radial pressure, and the first anchoring wire applies outward radial pressure to the middle lobe.

2. The prostatic urethra implant according to claim 1, wherein Each of the lateral segments of each of the cutting lines is wrapped around the other lateral segment of the other one of the cutting lines.

3. The prostatic urethra implant according to claim 1, wherein Each of the lateral sections of each of the cutting lines are joined together via a joining technique.

4. The prostatic urethra implant according to claim 3, wherein: The connection technology is selected from the list consisting of: bonding; welding; and Connecting wires are used to bind the lateral sections together.

5. The prostatic urethral implant of claim 1 , further comprising a hollow proximal cap connected to the proximal segment of each of the cutting wires and to the first anchoring wire, the hollow proximal cap being configured to hold the cutting wires and the first anchoring wire together.

6. The prostatic urethra implant according to claim 5, wherein The hollow proximal cover includes a proximal non-circular recess configured to receive a corresponding mechanism; and Wherein, the proximal non-circular recess is configured to transmit rotational motion of the corresponding mechanism to the prostatic urethra implant.

7. The prostatic urethra implant according to claim 6, wherein: The corresponding institution is selected from the list consisting of: Sales; and tool.

8. The prostatic urethral implant of claim 1, further comprising a withdrawal string connected to the prostatic urethral implant, the withdrawal string being arranged to allow the prostatic urethral implant to be pulled out of the patient's body.

9. The prostatic urethra implant according to claim 1, wherein: The at least two cutting lines and the first anchoring line are made of a material selected from the list consisting of: nickel-titanium alloys; and Biocompatible materials.

10. The prostatic urethral implant according to claim 1, further comprising a second anchoring line, the second anchoring line being shorter than the first anchoring line, the second anchoring line being configured to prevent the prostatic urethral implant from moving distally in the direction of the patient's bladder neck after being implanted.

11. The prostatic urethra implant according to claim 1, wherein the first anchoring thread comprising at least two extensions, a first extension of the at least two extensions being configured to compress the median lobe, and a second extension of the at least two extensions being configured to prevent distal migration of the prostatic urethral implant in the direction of the patient's bladder neck after implantation; and Wherein, the first extension portion of the at least two extension portions is longer than the second extension portion of the at least two extension portions.

12. The prostatic urethra implant according to claim 5, wherein The hollow proximal cap also includes a plurality of barbs.

13. The prostatic urethra implant according to claim 1, wherein The at least two cutting lines are bifurcated at their respective distal sections such that the distal sections form a simple closed curve shape at the distal end of the prostatic urethra implant in the deployed configuration.

14. The prostatic urethra implant according to claim 13, wherein The simple closed curve shape is selected from the list consisting of: triangle; square; pentagon; and Polygon.

15. A prostatic urethra implant, comprising: at least two cutting lines of a closed shape, each of the cutting lines having a proximal segment, a distal segment, and two lateral segments extending longitudinally between the proximal segment and the distal segment, the cutting lines cutting tissue in the prostatic urethra via outward radial pressure; a first anchoring line having a closed shape and extending distally and outwardly from the location of the proximal section of the cutting line, the first anchoring line applying outward radial pressure to the middle lobe of the prostate when the prostatic urethra implant is implanted; A second anchoring line, the second anchoring line being shorter than the first anchoring line, the second anchoring line extending distally and outwardly such that the second anchoring line prevents the prostatic urethral implant from moving distally in the direction of the bladder neck once implanted.

16. The prostatic urethra implant according to claim 15, wherein The first anchoring wire is positioned such that a distal end of the first anchoring wire is distal to the bulbous end of the median lobe when the prostatic urethra implant is implanted.

17. The prostatic urethra implant according to claim 15, wherein The second anchoring wire is positioned such that a distal end of the second anchoring wire is distal to the verumontanum of the prostatic urethra when the prostatic urethra implant is implanted.

18. The prostatic urethra implant according to any one of claims 15 to 17, wherein The second anchoring line also extends from the location of the proximal section.

19. The prostatic urethra implant according to any one of claims 15 to 17, wherein The first anchoring line and the second anchoring line are combined into a double-pronged anchoring line. The bifurcated anchoring line includes a first extension portion as the first anchoring line and a second extension portion as the second anchoring line. The second anchor line extends from the first anchor line.

20. The prostatic urethra implant according to any one of claims 15 to 17, wherein The first anchoring line and the second anchoring line have a hollow profile shape.

21. The prostatic urethra implant according to any one of claims 15 to 17, wherein The prostatic urethra implant also includes a proximal cap connected to the proximal segment of each of the cutting wires and to the first anchoring wire, the proximal cap configured to hold the cutting wires and the first anchoring wire together.

22. The prostatic urethra implant of claim 21, wherein The proximal cover has a hollow portion that does not have a circular shape.

23. The prostatic urethra implant according to any one of claims 15 to 17, wherein The cutting line and / or the first and second anchoring lines are color coded.

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