Methods and devices for urethral treatment

Abstract

To dilate and / or assist in dilating and / or maintain dilation of the urethra to relieve obstruction resulting from, for example, benign prostatic hyperplasia (BPH). A device and method for treating a urethra narrowed by benign prostatic hyperplasia (BPH) is provided, including a delivery tool (101) advanced to a position within the region of the urethra to be treated. The delivery tool (101) includes an expandable element (400) that expands within the urethra to enlarge the urethra, a tissue cutter (412) that forms an incision in the urethra after the expandable element expands to enlarge the urethra, and an implant (410) that maintains the urethra in an expanded state. The implant (410) includes a shape-memory material and is shaped to define two end sections and a middle section (1202) disposed between the two end sections. The shape-memory material is shaped so that, in the unconstrained configuration of the implant (410), the middle section (1202) is substantially straight. Other embodiments are also described.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 036,548 to Heftman et al., entitled "Method and Devices for Urethral Treatment," filed June 9, 2020, which is incorporated herein by reference.

[0002] Field of Invention Embodiments In some embodiments, the present invention relates to methods and devices for the treatment of body lumens, and more particularly to methods and devices for dilating and / or assisting in dilatation and / or maintaining dilation of the urethra, for example, but not limited to, to relieve obstruction resulting from benign prostatic hyperplasia (BPH). [Background technology]

[0003] It is common for the prostate gland to enlarge as men age. As men mature, the prostate gland undergoes two major periods of growth: first during early puberty and then again later in life when growth begins again and continues throughout life. One effect of this continued growth can be pressure on the urethra, the passageway through which urine passes from the bladder and penis.

[0004] The urethra is surrounded by the prostate gland for part of its length. Within the confines of the prostate, urine flows through a passageway with a roughly triangular cross-section. As the prostate enlarges, the layers of tissue surrounding it restrict its outward extension, causing the prostate to narrow the urethral passageway. The condition of an enlarged, non-cancerous prostate is called benign prostatic hyperplasia (BPH).

[0005] Although the prostate gland continues to grow for most of a man's life, benign prostatic hyperplasia rarely causes symptoms before age 40. However, more than half of men in their 60s and as many as 90 percent of men in their 70s and 80s have some symptoms. BPH can make it difficult to empty the bladder completely and is associated with other urinary system problems. Summary of the Invention

[0006] In some embodiments of the present invention, an apparatus and method are provided for treating a urethra narrowed by benign prostatic hyperplasia (BPH). Typically, the apparatus includes a device having a delivery tool with a proximal portion and a distal portion. The distal portion of the delivery tool is configured to be advanced to a location within the urethra to treat the region of the urethra that is due to prostatic hyperplasia and the resulting narrowing of the treatment region. In some embodiments, the distal portion includes a manipulation head having an expandable element, a tissue cutter, and an implant. The expandable element, e.g., a balloon, expands within the urethra to dilate the urethra and expand the narrowed region. The tissue cutter is typically disposed outside the outer surface of the expandable element and forms an incision on the inner surface of the urethra after the expandable element expands within the urethra.

[0007] The implant is then released into the incision in the inner surface of the urethra and implants into the prostate tissue surrounding the incision in the urethra, maintaining the urethra in an expanded state. According to some embodiments of the present invention, the implant comprises a shape memory material, which is shaped so that in the unconstrained configuration of the implant, the implant is generally straight. In some embodiments, the implant is shaped to define two end sections and a middle section disposed between the two end sections, and the shape memory material is shaped so that in the unconstrained configuration of the implant, at least the middle section is generally straight. (In some cases, such implants are described herein as "quasi-linear implants.")

[0008] According to some embodiments of the present invention, when the implant is implanted into the incision made in the urethra, the implant is constrained in a curved shape by the tissue into which it is implanted. Due to the tendency of the shape memory material to return to its preset generally linear configuration, the implant applies a radially outward pressure to the tissue. By being shaped into a generally linear configuration, the implant typically dilates the urethra more effectively than if the implant were shaped to define a less generally linear shape.

[0009] According to some embodiments of the present invention, the device further includes one or more implant delivery arms extending from the shaft of the delivery tool and disposed outside the outer surface of the expandable element. The implant delivery arms typically release the implant into the incision after the tissue cutter forms an incision in the inner surface of the urethra. In some embodiments, one or more implant holders are coupled to the implant delivery arms, and the implant is disposed between the implant delivery arms and the implant holder to hold the implant in place during delivery of the implant. After the tissue cutter forms the incision in the urethra, the implant holder is retracted proximally relative to the implant delivery arms so that the implant is released by the implant delivery arms into the incision in the urethra, maintaining the urethra in an expanded state.

[0010] Thus, according to some embodiments of the present invention: An apparatus is provided that includes a device for the treatment of a urethra narrowed by benign prostatic hyperplasia (BPH), the device comprising: a delivery tool having a proximal portion and a distal portion, the distal portion configured to be advanced to a position within the region of the urethra to be treated, the distal portion comprising: an expandable element configured to expand within the urethra to enlarge the urethra in the area to be treated, the expandable element defining an outer surface; a tissue cutter disposed outside the outer surface of the expandable element, the tissue cutter configured to form an incision on the inner surface of the urethra after the expandable element has expanded to dilate the urethra; an implant comprising a shape memory material and configured to be implanted within an incision in the inner surface of the urethra to maintain the urethra in an expanded state; Including, The implant includes two end sections and a middle section disposed between the two end sections, and the shape memory material is shaped such that in the unconstrained configuration of the implant, the middle section is generally straight.

[0011] In some embodiments, the implant is configured to be implanted within the urethral incision such that the middle section of the implant is constrained in a curved shape.

[0012] In some embodiments, the length of the intermediate section of the implant is at least 50% of the length of the implant.

[0013] In some embodiments, the length of the intermediate section of the implant is at least 60% of the length of the implant.

[0014] In some embodiments, the length of the intermediate section of the implant is at least 70% of the length of the implant.

[0015] In some embodiments, the implant is configured to be maintained in a spiral shape while the implant is disposed within the delivery tool.

[0016] In some embodiments, the implant has a length of 40 to 80 mm.

[0017] In some embodiments, the implant has a thickness of 0.01 to 1 mm.

[0018] In some embodiments, the implant has a width of 0.5 to 4 mm.

[0019] In some embodiments, the implant is configured to apply between about 25 gr and about 500 gr of pressure within the urethral incision.

[0020] In some embodiments, the tissue cutter is configured to create an incision having a depth of 2 to 10 mm.

[0021] In some embodiments, the tissue cutter has a length of 3 to 10 mm.

[0022] In some embodiments, the tissue cutter is configured to form an incision at a 90 degree angle relative to the longitudinal axis of the delivery tool.

[0023] In some embodiments, the tissue cutter is configured to form an incision at an angle other than 90 degrees relative to the longitudinal axis of the delivery tool.

[0024] In some embodiments, the tissue cutter is configured to form an incision at an angle of about 45 degrees to about 89 degrees relative to the longitudinal axis of the delivery tool.

[0025] In some embodiments, the extensible element has a length between 3 and 15 mm. 3 The inflatable housing is configured to be inflated to an internal volume of 1000 psi.

[0026] In some embodiments, the expandable element is configured to be expanded to define a diameter between 5 and 35 mm.

[0027] In some embodiments, the expandable element has a length of between 3 and 100 mm.

[0028] In some embodiments, the expandable element is configured to be inflated to an internal pressure of 1 to 20 atm.

[0029] In some embodiments, the expandable element comprises a balloon.

[0030] In some embodiments, the device further includes one or more implant carrying arms extending from the shaft of the delivery tool and disposed outside the outer surface of the expandable element.

[0031] In some embodiments, after the tissue cutter forms an incision in the interior surface of the urethra, one or more implant delivery arms are configured to release the implant into the incision.

[0032] In some embodiments, the device further comprises one or more implant holders coupled to the implant delivery arm; the implant is configured to be disposed between the implant delivery arm and the implant holder such that the implant is held in place by the implant delivery arm and the implant holder; The implant holder is configured to be retracted proximally relative to the implant delivery arm such that the implant is released by the implant delivery arm into the incision in the urethra, thereby maintaining the urethra in a dilated state.

[0033] In some embodiments, the delivery tool further includes an optical element, and the one or more implant carrying arms and the extendable element are configured to allow the optical element to visualize the urethra.

[0034] According to some embodiments of the present invention, Identifying a narrowed area of the urethra requiring treatment; inserting a delivery tool into the urethra, the delivery tool including an expandable element defining an outer surface and a tissue cutter disposed outside the outer surface of the expandable element; using a delivery tool to deliver to the identified stricture region of the urethra an implant comprising a shape memory material and having two end segments and a middle segment disposed between the two end segments, the shape memory material being shaped such that in an unconstrained configuration of the implant, the middle segment is generally straight; stretching the urethra by stretching the expandable element at the identified stricture region of the urethra; Thereafter, forming an incision on the inner surface of the urethra using a tissue cutter; Releasing the implant into the incision to maintain the urethra in a dilated state; Further provided is a method for treating a urethra narrowed by benign prostatic hyperplasia (BPH), comprising:

[0035] In some embodiments, delivering the implant to the identified stricture region of the urethra comprises delivering the implant while the implant is compressed into a spiral configuration.

[0036] In some embodiments, releasing the implant into the incision to maintain the urethra in an expanded state comprises releasing the implant into the incision while a middle section of the implant is constrained in a curved shape.

[0037] In some embodiments, the delivery tool further includes one or more implant delivery arms extending from the shaft of the delivery tool and disposed outside the outer surface of the expandable element, and delivering the implant to the identified stricture region of the urethra includes delivering the implant while the implant is removably coupled to the one or more implant delivery arms.

[0038] In some embodiments, releasing the implant into the incision includes releasing the implant from one or more implant delivery arms.

[0039] In some embodiments, the delivery tool further includes one or more implant holders coupled to the implant carrying arms, and delivering the implant to the identified stricture region of the urethra includes delivering the implant while the implant is held in a fixed position relative to the one or more implant carrying arms by being disposed between the one or more implant carrying arms and the one or more implant holders.

[0040] In some embodiments, releasing the implant into the incision includes retracting one of the one or more implant holders proximally relative to one of the one or more implant delivery arms.

[0041] In some embodiments, releasing the implant includes releasing a distal portion of the implant before stretching the expandable element and releasing a proximal portion of the implant after stretching the expandable element.

[0042] According to some embodiments of the present invention, Further provided is an apparatus including a device for the treatment of a urethra narrowed by benign prostatic hyperplasia (BPH), the device comprising: a delivery tool having a proximal portion and a distal portion, the distal portion configured to be advanced to a position within the region of the urethra to be treated, the distal end comprising: one or more implant carrying arms extending from the shaft of the delivery tool; one or more implant holders coupled to the one or more implant delivery arms; an implant configured to be disposed between the one or more implant delivery arms and the one or more implant holders so as to be held in place by the one or more implant delivery arms and the one or more implant holders; Including, The one or more implant holders are configured to be retracted proximally relative to the one or more implant delivery arms such that the implant is released from the one or more implant delivery arms into the incision in the urethra, thereby maintaining the urethra in a dilated state.

[0043] In some embodiments, the implant is held in a spiral configuration between one or more implant delivery arms and one or more implant holders.

[0044] In some embodiments, the one or more implant holders are configured to be retracted proximally to release a distal end of the implant before releasing a proximal end of the implant.

[0045] In some embodiments, the device further includes a tissue cutter configured to create an incision in the interior surface of the urethra, the implant being configured to be released into the incision.

[0046] In some embodiments, the device further includes an optical element, and the one or more implant delivery arms and the extendable element are configured to allow the optical element to visualize the urethra.

[0047] In some embodiments, the device further comprises an expandable element configured to expand within the urethra to stretch the urethra in the area to be treated.

[0048] In some embodiments, one of the one or more implant holders is configured to be retracted proximally to release the distal end of the implant before extension of the expandable element, and the proximal end of the implant is configured to be released after extension of the expandable element.

[0049] According to some embodiments of the present invention, Identifying a narrowed area of the urethra requiring treatment; In the urethra, an extensible element defining an outer surface; a tissue cutter disposed outside the outer surface of the expandable element; one or more implant carrying arms extending from the shaft of the delivery tool; one or more implant holders coupled to the implant delivery arm; an implant disposed between the one or more implant delivery arms and the one or more implant holders so as to be held in place by the one or more implant delivery arms and the one or more implant holders; inserting a longitudinal delivery tool comprising: delivering an implant for deployment in the identified stricture region of the urethra; Releasing a distal portion of the implant by retracting one of the one or more implant holders relative to the implant delivery arm; stretching the urethra using an expandable element at a specified narrowed region of the urethra; making an incision on the inner surface of the urethra; Releasing a proximal portion of the implant by proximally retracting one of the one or more implant holders relative to the one or more implant delivery arms, thereby releasing the implant into the incision; Further provided is a method for treating a urethra narrowed by benign prostatic hyperplasia (BPH), comprising:

[0050] In some embodiments, delivering the implant for deployment in the identified stricture region of the urethra includes delivering the implant while the implant is held in a spiral configuration between one or more implant delivery arms and one or more implant holders.

[0051] In some embodiments, releasing the distal portion of the implant comprises releasing the distal portion of the implant before stretching the expandable element, and releasing the proximal portion of the implant comprises releasing the proximal portion after stretching the expandable element.

[0052] According to some embodiments of the present invention, a. Quasi-linear implant; b. at least two arms connected to the shaft and including an implant holder to which a quasi-linear implant is removably attached; c. an expandable body surrounded by at least two arms, the expandable element having the quasi-linear implant wrapped therearound; d. an optical element extending from the handle within the shaft; There is further provided an operating head for an implantation system for dilating a urethra at least partially obstructed by an enlarged prostate, comprising: The at least two arms and the extendable element are configured to allow the optical element to visualize the urethra.

[0053] In some embodiments, the implant is configured to be implanted at least partially through the wall of the enlarged portion of the prostate gland surrounding the narrowed portion of the urethra.

[0054] In some embodiments, the quasi-linear implant includes pad-like terminations at each end.

[0055] In some embodiments, the quasi-linear implant includes one or more protrusions located on each end configured to stabilize the quasi-linear implant when implanted within the incision.

[0056] In some embodiments, the quasi-linear implant comprises a length of about 40 mm to about 80 mm.

[0057] In some embodiments, the quasi-linear implant comprises a thickness of about 0.01 mm to about 1 mm.

[0058] In some embodiments, the quasi-linear implant comprises a width of about 0.5 mm to about 4 mm.

[0059] In some embodiments, the quasi-linear implant comprises a middle straight section and two slightly curved end sections.

[0060] In some embodiments, the quasi-linear implant is configured to apply a force of about 25 gr to about 500 gr to the wall.

[0061] In some embodiments, at least two of the arms include a sleeve that partially covers the arm.

[0062] In some embodiments, the manipulation head includes three arms.

[0063] In some embodiments, the at least two arms are configured to perform inward and outward movement as the extendable body expands and contracts.

[0064] In some embodiments, the width / thickness relationship of the at least two arms provides the at least two arms with the necessary strength to resist bending due to rotational movement of the shaft.

[0065] In some embodiments, the implant holder is covered by a sleeve.

[0066] In some embodiments, the implant holder is configured to move proximally and distally relative to the at least two arms.

[0067] In some embodiments, the operating head further includes a tissue cutter extending from the handle to the operating head and configured to perform an incision in the wall, the incision being where the implant is to be at least partially implanted.

[0068] In some embodiments, the cutter includes an L-shaped operating configuration.

[0069] In some embodiments, the cutter is configured to cut by rotating the shaft.

[0070] In some embodiments, the cutter is configured to perform an incision having a depth of about 2 mm to about 10 mm.

[0071] In some embodiments, the tissue cutter comprises a length of about 3 mm to about 10 mm.

[0072] In some embodiments, the cutter is connected to electrical or electromechanical energy.

[0073] In some embodiments, the cutter includes a distal end that includes a T-shaped configuration.

[0074] In some embodiments, the cutter includes a distal end that includes a rounded shape.

[0075] In some embodiments, the cutter is configured to be deployed and / or inserted from the shaft by a user.

[0076] In some embodiments, the cutter performs the incision at a 90 degree angle relative to the longitudinal axis of the device.

[0077] In some embodiments, the cutter performs the incision at an angle other than 90 degrees relative to the longitudinal axis of the device.

[0078] In some embodiments, the cutter performs the incision at an angle of about 45 degrees to about 89 degrees relative to the longitudinal axis of the device.

[0079] In some embodiments, the extensible body is about 3 mm 3 Approximately 15 mm from 3 Includes the internal volume of

[0080] In some embodiments, the expandable body comprises a diameter of about 5 mm to about 35 mm.

[0081] In some embodiments, the expandable body comprises a length of about 3 mm to about 100 mm.

[0082] In some embodiments, the expandable body can be inflated to an internal pressure of about 1 atm to about 20 atm.

[0083] In some embodiments, the expandable body comprises a balloon.

[0084] In some embodiments, the expandable body is a balloon.

[0085] In some embodiments, the extensible body is made of an elastic material.

[0086] In some embodiments, the expandable body is in communication with a tube extending from the handle, the tube being configured to transport a material that expands / contracts the expandable body.

[0087] In some embodiments, the expandable body is surrounded by a jacket configured to protect the expandable body.

[0088] In some embodiments, the jacket limits the expansion of the extensible body.

[0089] In some embodiments, the distal end of the optical element is located in front of the proximal end of the operating head.

[0090] In some embodiments, the distal end of the optical element is located approximately ±2 mm from the distal end of the shaft.

[0091] In some embodiments, the optical element comprises a field of view from about 0 degrees to about ±120 degrees.

[0092] In some embodiments, the handle includes one or more controllers configured to operate at least two motors.

[0093] In some embodiments, the handle includes one or more controllers configured to synchronize the operation of at least two motors.

[0094] In some embodiments, the at least two motors are configured to operate at a speed of from about 1 RPM to about 1000 RPM.

[0095] In some embodiments, the at least two motors are configured to provide a force of about 1 Kg to about 5 Kg.

[0096] In some embodiments, the at least two motors are configured to provide linear and / or rotational motion to one or more of the elongated body and the shaft.

[0097] In some embodiments, the rotational movement comprises a speed of about 1 revolution per second to about 1 revolution every 3 seconds.

[0098] In some embodiments, the rotational movement comprises a rotational force (torque) of about 50 Nmm to about 300 Nmm.

[0099] In some embodiments, the linear motion comprises a velocity of about 1 mm / sec to about 10 mm / sec.

[0100] In some embodiments, the elongate body comprises an inner diameter of about 3 mm to about 20 mm.

[0101] In some embodiments, the shaft comprises an inner diameter of about 3 mm to about 20 mm.

[0102] In some embodiments, the device including the operating head includes an internal guide element including one or more channels configured to provide dedicated channels for elements extending from the handle to the operating head.

[0103] In some embodiments, the system including the manipulation head includes an outer sheath configured to allow for cleaning during the implantation procedure.

[0104] According to some embodiments of the present invention, a. a quasi-linear implant configured to be implanted at least partially through the wall of an enlarged portion of the prostate gland surrounding a narrowed portion of the urethra; b. a handle including a first motor configured to actuate linear motion, a second motor configured to actuate rotary motion, and a controller configured to synchronize actuation between the first motor and the second motor; c. an elongated body extending from the handle, connected to the first motor, and configured to house an internal shaft including an operating head; d. a shaft extending from the handle, connected at a proximal end to the second motor, and including an operating head at a distal end; There is further provided an implant system for dilating a urethra at least partially obstructed by an enlarged prostate, comprising:

[0105] In some embodiments, the operating head includes at least two arms connected to the shaft and including an implant holder to which the quasi-linear implant is removably attached, the implant holder being connected to the elongate body.

[0106] In some embodiments, the operating head includes a tissue cutter extending from the handle to the operating head and configured to perform an incision in the wall, the tissue cutter configured to rotate with the shaft.

[0107] In some embodiments, the operating head includes an expandable body surrounded by at least two arms, and the quasi-linear implant is wrapped around the expandable element.

[0108] In some embodiments, the system further includes an optical element extending from the handle within the shaft and configured to allow the user to visualize the location of the stricture in the urethra.

[0109] In some embodiments, the implant is configured to be implanted at least partially through the wall of the enlarged portion of the prostate gland surrounding the narrowed portion of the urethra.

[0110] According to some embodiments of the present invention, a. Releasing the distal end of the implant; b. stretching the stretchable body, thereby stretching the urethra; c. Releasing the proximal end of the implant; There is further provided a method for dilating the urethra using an implant and a delivery system including an expandable body, comprising:

[0111] In some embodiments, the method further comprises loading the spirally configured implant into a delivery system.

[0112] In some embodiments, the method further comprises inserting the delivery system into the urethra.

[0113] In some embodiments, the method further includes rotating the delivery system to expose the tissue cutter and perform an incision in the wall of the urethra.

[0114] In some embodiments, releasing the proximal end allows the implant to be implanted within the incision in the wall of the urethra.

[0115] In some embodiments, the implant is formed of a material that stretches outward within the incision in the urethral wall during and / or after implantation.

[0116] In some embodiments, expanding the expandable body radially expands the implant from a helical configuration to a C-shaped arc configuration.

[0117] In some embodiments, the implant provides a gap between the enlarged prostate gland and the lumen of the urethra, preventing recompression of the urethra by further enlargement of the prostate gland.

[0118] In some embodiments, the method includes selecting the length and position of the implant so as not to interfere with the internal bladder valve.

[0119] According to some embodiments of the present invention, a. a quasi-linear implant configured to be implanted at least partially through the wall of an enlarged portion of the prostate gland surrounding a narrowed portion of the urethra; b. A delivery device for a quasi-linear implant, comprising: i. a handle including at least one operating button and at least two motors; ii. an elongated body connected to the handle and configured to house an inner shaft including an operating head; iii. a shaft extending from the handle and interconnected at a proximal end to at least two motors and including an operating head at a distal end; iv. An operating head, A. at least two arms connected to a shaft and including an implant holder to which a quasi-linear implant is removably attached; B. a tissue cutter extending from a handle to an operating head and configured to make an incision in a wall, the incision being a location where an implant is to be at least partially implanted; C. an extensible body surrounded by at least two arms, the extensible element having the quasi-linear implant wrapped therearound; an operating head including: a delivery device comprising: c. an optical element extending from the handle within the shaft and configured to allow a user to visualize the location of the stricture in the urethra; There is further provided an implant system for dilating a urethra at least partially obstructed by an enlarged prostate, comprising:

[0120] According to some embodiments of the present invention, a. a quasi-linear implant configured to be implanted at least partially through the wall of an enlarged portion of the prostate gland surrounding a narrowed portion of the urethra; b. at least two arms connected to the shaft and including an implant holder to which a quasi-linear implant is removably attached; c. a tissue cutter extending from a handle to an operating head and configured to make an incision in the wall, the incision being a location where the implant is to be at least partially implanted; d. an expandable body surrounded by at least two arms, the expandable element having the quasi-linear implant wrapped therearound; e. an optical element extending from the handle within the shaft and configured to allow a user to visualize the location of the stricture in the urethra; There is further provided an operating head for an implant system for dilating a urethra at least partially obstructed by an enlarged prostate, comprising:

[0121] According to some embodiments of the present invention, a. Quasi-linear implant; b. at least two arms connected to the shaft and including an implant holder to which a quasi-linear implant is removably attached; c. an expandable body surrounded by at least two arms, the expandable element having the quasi-linear implant wrapped therearound; d. an optical element extending from the handle within the shaft and configured to allow a user to visualize the location of the stricture in the urethra; There is further provided an operating head for an implant system for dilating a urethra at least partially obstructed by an enlarged prostate, comprising:

[0122] According to some embodiments of the present invention, a. Quasi-linear implant; b. at least two arms connected to the shaft, each arm including at least two implant holders to which a quasi-linear implant is removably attached; There is further provided an operating head for an implantation system for dilating a urethra at least partially obstructed by an enlarged prostate, comprising: The implant holder is configured to sequentially release the quasi-linear implants to allow for controllable deployment of the assist quasi-linear implants.

[0123] According to some embodiments of the present invention, a. A quasi-linear body; b. Pad-like terminations on each end; c. one or more protrusions located on each end configured to stabilize the implant once implanted; Further provided is an implant for dilating a urethra at least partially obstructed by an enlarged prostate, comprising:

[0124] The present invention will be more fully understood from the following detailed description of the embodiments thereof, when read in conjunction with the drawings. [Brief explanation of the drawings]

[0125] [Figure 1a] 1 is a schematic diagram of the general appearance of a device for dilating a subject's urethra that is at least partially obstructed by an enlarged prostate gland, according to some embodiments of the present invention. [Figure 1b] 1 is a schematic diagram of the general appearance of a device for dilating a subject's urethra that is at least partially obstructed by an enlarged prostate gland, according to some embodiments of the present invention. [Figure 2]1A-1C are schematic diagrams of exterior views of an exemplary elongate body of a device for dilating a subject's urethra at least partially obstructed by an enlarged prostate gland, according to some embodiments of the present invention. [Figure 3] 1 is a schematic diagram of an exemplary embodiment of an internal operating element according to some embodiments of the present invention. [Figure 4a] 1 is a schematic diagram of an exemplary embodiment of an operating head in an expanded configuration, according to some embodiments of the present invention. [Figure 4b] 1 is a schematic diagram of an exemplary embodiment of an operating head in an expanded configuration, according to some embodiments of the present invention. [Figure 5a] 1 is a schematic diagram of an exemplary extendible body according to some embodiments of the present invention. [Figure 5b] FIG. 1 is a schematic diagram of an exemplary jacket in an open configuration prior to installation on an expandable body, according to some embodiments of the present invention. [Figure 5c] 1 is a schematic diagram of an exemplary jacket in a closed configuration after installation on an expandable body according to some embodiments of the present invention. [Figure 6] 1 is a schematic diagram of an exemplary implant holder / release mechanism located within a manipulation head, the manipulation head shown in a retracted configuration, according to some embodiments of the present invention. [Figure 7a] 10A-10C are schematic illustrations of movement of a movable implant holder according to some embodiments of the present invention. [Figure 7b] 10A-10C are schematic illustrations of movement of a movable implant holder according to some embodiments of the present invention. [Figure 7c] 10A-10C are schematic illustrations of movement of a movable implant holder according to some embodiments of the present invention. [Figure 7d] 10A-10C are schematic illustrations of movement of a movable implant holder according to some embodiments of the present invention. [Figure 7e] 10A-10C are schematic illustrations of movement of a movable implant holder according to some embodiments of the present invention. [Figure 8a] 1A-1C are schematic diagrams of exemplary tissue cutters disposed within and outside a shaft, according to some embodiments of the present invention. [Figure 8b] 1A-1C are schematic diagrams of exemplary tissue cutters disposed within and outside a shaft, according to some embodiments of the present invention. [Figure 8c] 1A-1C are schematic diagrams of a cutting mechanism using a round head cutter according to some embodiments of the present invention. [Figure 8d] 1A-1C are schematic diagrams of a cutting mechanism using a round head cutter according to some embodiments of the present invention. [Figure 8e] 1A-1C are schematic diagrams of a cutting mechanism using a round head cutter according to some embodiments of the present invention. [Figure 8f] 1A-1C are schematic diagrams of a cutting mechanism using a round head cutter according to some embodiments of the present invention. [Figure 8g] 1A-1C are schematic diagrams of a cutting mechanism using a round head cutter according to some embodiments of the present invention. [Figure 8h] 1 is a schematic diagram of a cutting mechanism using a straight or "T" head cutter, according to some embodiments of the present invention. [Figure 8i] 1 is a schematic diagram of a cutting mechanism using a straight or "T" head cutter, according to some embodiments of the present invention. [Figure 8j] 1 is a schematic diagram of a cutting mechanism using a straight or "T" head cutter, according to some embodiments of the present invention. [Figure 8k] 1 is a schematic diagram of a cutting mechanism using a straight or "T" head cutter, according to some embodiments of the present invention. [Figure 8l] 1 is a schematic diagram of a cutting mechanism using a straight or "T" head cutter, according to some embodiments of the present invention. [Figure 8m] 1A-1C are schematic diagrams of incision angles according to some embodiments of the present invention. [Figure 8n] 1A-1C are schematic diagrams of incision angles according to some embodiments of the present invention. [Figure 8o] 1A-1C are schematic illustrations of exemplary incision directions in tissue, as implemented by some embodiments of the present invention. [Figure 8p]1A-1C are schematic illustrations of exemplary incision directions in tissue, as implemented by some embodiments of the present invention. [Figure 9a] 1A-1C are schematic diagrams of various views of an exemplary internal guide element according to some embodiments of the present invention. [Figure 9b] 1A-1C are schematic diagrams of various views of an exemplary internal guide element according to some embodiments of the present invention. [Figure 9c] 1A-1C are schematic diagrams of various views of an exemplary internal guide element according to some embodiments of the present invention. [Figure 10] FIG. 1 is a schematic diagram of an exploded view of an exemplary handle according to some embodiments of the present invention. [Figure 11a] 1 is a schematic isometric view of an exemplary internal actuation mechanism according to some embodiments of the present invention. [Figure 11b] 1 is an exploded view of an exemplary internal actuation mechanism according to some embodiments of the present invention. [Figure 12a] 1 is a schematic illustration of an exemplary implant according to some embodiments of the present invention. [Figure 12b] 1 is a schematic illustration of an exemplary implant according to some embodiments of the present invention. [Figure 12c] 1 is a schematic illustration of an exemplary implant according to some embodiments of the present invention. [Figure 12d] 1 is a schematic illustration of an exemplary implant according to some embodiments of the present invention. [Figure 13a] 10A-10C are schematic diagrams of additional exemplary hardware for use with a device for dilating a subject's urethra that is at least partially obstructed by an enlarged prostate gland, according to some embodiments of the present invention. [Figure 13b] 10A-10C are schematic diagrams of additional exemplary hardware for use with a device for dilating a subject's urethra that is at least partially obstructed by an enlarged prostate gland, according to some embodiments of the present invention. [Figure 14a] 10A-10C are schematic diagrams of additional exemplary hardware for use with a device for dilating a subject's urethra that is at least partially obstructed by an enlarged prostate gland, according to some embodiments of the present invention. [Figure 14b] 10A-10C are schematic diagrams of additional exemplary hardware for use with a device for dilating a subject's urethra that is at least partially obstructed by an enlarged prostate gland, according to some embodiments of the present invention. [Figure 15] 1 is a flowchart illustrating an exemplary method implemented by some embodiments of the present invention. [Figure 16] 1 is a flowchart illustrating an exemplary semi-automated method implemented by some embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0126] Detailed Description The present invention, in some embodiments thereof, relates to methods and devices for the treatment of body lumens, and more particularly, to methods and devices for dilating and / or assisting in dilatation and / or maintaining dilation of the urethra to relieve obstruction resulting from, for example, but not limited to, benign prostatic hyperplasia (BPH). A broad aspect of some embodiments of the present invention relates to increasing reliability in urethral implantation procedures by improving devices and implants through improved engineering, interfacing, and automation.

[0127] Compendium Some embodiments of the present invention relate to synchronizing actions for implanting a graft into an incision made in the wall of the urethra. In some embodiments, one or more actions are performed by a device to dilate and / or assist in dilation and / or maintain dilation of the urethra, for example, to relieve obstruction resulting from benign prostatic hyperplasia (BPH). In some embodiments, one or more actions are performed by translating a directional motion at the handle of the device into an implantation motion at the distal end of the device. In some embodiments, the directional motion is one or more of a linear motion or a rotational motion, and any combination thereof. In some embodiments, the motion at the handle is actuated by one or more motors controlled and / or synchronized by one or more controllers. In some embodiments, synchronizing the actions includes one or more of synchronizing a rotational motion with a linear motion to precisely actuate different parts of the device. In some embodiments, one or more actions are performed automatically, one after the other, allowing for repeatability of the implantation method and potentially reducing human error during implantation. In some embodiments, after each one or more automated actions, a visual and / or audible alarm notifies the user that the action is complete.

[0128] In some embodiments, the device comprises a cutter configured to make incisions in the wall of the urethra and the tissue of the prostate to create an area shaped and sized to accommodate the implant, hi some embodiments, the incisions are made by the cutter such that the incisions are wider and deeper within the tissue compared to incisions at the surface of the tissue.

[0129] Some embodiments of the present invention relate to an implant configured to be implanted within an incision made in the wall of the urethra by a cutter. Typically, the implant is configured to be embedded at least partially through the wall of the enlarged portion of the prostate gland surrounding the narrowed portion of the urethra. In some embodiments, the implant is a thin implant configured to be implanted deeper into the tissue compared to a less thin implant.

[0130] In some embodiments, the implant is made of a shape memory alloy, such as Nitinol. Typically, the shape memory alloy of the implant is shaped so that the implant, when unconstrained (i.e., when no force is applied to the implant), assumes a generally straight shape along more than 50 percent (e.g., more than 60 percent or more than 70 percent) of its length. (In some cases, such implants are described herein as "quasi-straight implants.") Typically, upon implantation of the implant into an incision made in the urethra, the implant is constrained to a curved shape by the tissue into which it is implanted. Due to the shape memory alloy's tendency to return to its preset generally straight configuration, the implant applies a radially outward pressure to the tissue. By shaping as described above, the implant typically dilates the urethra more effectively than if the implant were shaped to define a less generally straight shape.

[0131] In some embodiments, the implant comprises a pad on an end of the implant configured to provide stability to the implant when implanted at an implantation site within an incision, hi some embodiments, the implant comprises one or more protrusions configured to stabilize the implant when implanted at an implantation site within an incision, the protrusions being blunt and therefore not damaging to tissue.

[0132] Some embodiments of the present invention relate to an implantation device configured to implant at least one implant in a urethral wall that includes at least one optical element, which allows a user to perform the implantation procedure under direct visualization of the desired implantation site and / or the implantation procedure itself and / or precise implant placement. In some embodiments, visualization of the implantation site is performed before inflating the inflatable body. In some embodiments, the optical element has a field of view from about 0 degrees (meaning a forward view) to about ±90 degrees. In some embodiments, the desired implantation site is selected so as not to interfere with the internal bladder valve. In some embodiments, the desired implantation site is selected as the site where the urethra is most obstructed. In some embodiments, visualization of the implantation procedure includes one or more of visualizing urethral stretching, visualizing an incision in the urethral wall, and optionally visualizing precise deployment of the implant within the incision.

[0133] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangements of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0134] In the following disclosure, the term "distal" refers to a general direction that is farther from a user (e.g., a physician), while the term "proximal" refers to a general direction that is closer to the user. For example, something distally located can be inside the body (e.g., closer to the bladder), and proximal can be outside the body or closer to the handle, for example.

[0135] Exemplary General Appearance Referring now to the drawings, FIGS. 1a and 1b show a schematic general overview of a device for dilating a subject's urethra at least partially obstructed by an enlarged prostate gland, according to some embodiments of the present invention. As shown, in some embodiments, the device includes a delivery tool 101 having a proximal portion and a distal portion, the distal portion configured to be advanced to a position within the urethra. In some embodiments, the device includes a handle 100 configured to be held by a user. In some embodiments, the handle 100 is optionally connected to a power source (not shown) via a cable 102. In some embodiments, the handle 100 optionally includes a power source contained therein. In some embodiments, the delivery tool further includes an elongated body 104 connected to the handle 100. In some embodiments, the device further includes a manipulation head 106, as shown in FIG. 1b, for example, in an extended configuration. In some embodiments, the device includes an inlet / outlet 108 configured to connect to a tube 110 and to allow for the insertion and removal of fluids, such as air, water, and / or saline, from the device.

[0136] Exemplary elongated bodies Referring now to FIG. 2, a schematic diagram of an exemplary elongate body 104 is shown, according to some embodiments of the present invention. In some embodiments, the elongate body 104 comprises a tube 202 with a lumen sized and shaped to fit over an inner operating element 300 (shown in FIG. 3), thereby providing a working channel for the inner operating element 300. In some embodiments, the elongate body 104 comprises a connector 204 at its proximal end configured to connect between the elongate body 104 and the handle 100 (shown in FIGS. 1a and 1b). In some embodiments, the inner diameter of the elongate body 104 is about 3 mm to about 20 mm, optionally 5 mm to 15 mm, optionally 6 mm to 10 mm, e.g., 5 mm, 6 mm, 7 mm, 8 mm, 10 mm, or 15 mm. In some embodiments, the diameter of the elongate body 104 is calculated using a French catheter scale. In some embodiments, the diameter of elongate body 104 is from about 5 Fr to about 50 Fr, optionally from about 10 Fr to about 30 Fr, and optionally from about 15 Fr to about 25 Fr, e.g., 25 Fr, 20 Fr, 15 Fr, or 10 Fr. In some embodiments, elongate body 104 is made of, for example, metal or plastic, such as PEEK, PA, PEVAX, PTFE, and / or FEP.

[0137] Exemplary Internal Operating Element 300 Referring now to Figure 3, this figure illustrates one exemplary embodiment of an inner operating element 300, according to some embodiments of the present invention. Also shown in Figure 3 is the elongated body 104 for reference. In some embodiments, the inner operating element 300 comprises a shaft 302 sized and shaped to be inserted within the elongated body 104.

[0138] In some embodiments, the proximal end of the inner operating element 300 includes a connector 304 configured to connect between the inner operating element 300 and the handle 100. In some embodiments, the inner operating element 300 includes a first gear 306 configured to interconnect at least one motor 1104 (shown in FIGS. 11a-11b) located in the handle and the operating head 106, thereby providing an actuation mechanism for the operating head 106. (Other gears and motors are disclosed in the "Exemplary Handle and Its Internal Mechanisms" section below and in FIGS. 10 and 11a-11b.) In some embodiments, the inner diameter of the shaft 302 is about 3 mm to about 20 mm, optionally 5 mm to 15 mm, optionally 6 mm to 10 mm, e.g., 5 mm, 6 mm, 7 mm, 8 mm, 10 mm, or 15 mm. In some embodiments, the diameter of the shaft 302 is calculated using a French catheter scale. In some embodiments, the diameter of shaft 302 is from about 5 Fr to about 50 Fr, optionally from about 10 Fr to about 30 Fr, optionally from about 15 Fr to about 25 Fr, e.g., 25 Fr, 20 Fr, 15 Fr, or 10 Fr. In some embodiments, shaft 302 is made of, for example, metal or plastic, such as PEEK, PA, PEVAX, PTFE, and / or FEP.

[0139] Exemplary Operating Head 4a and 4b, which illustrate an exemplary embodiment of a manipulation head 106 in an extended configuration, according to some embodiments of the present invention. In some embodiments, the manipulation head 106 comprises multiple elements configured to ensure release of the implant at a selected location. In some embodiments, the manipulation head 106 comprises an extendable body 400 (also referred to herein as an "extendable element"), one or more implant delivery arms 404 connected to the shaft 302 and comprising an implant retention / release mechanism, a tissue cutter 412, an implant 410, and an inner guide element 414.

[0140] Exemplary Extensible Body 400 and Jacket 402 4a and 4b. In some embodiments, the manipulation head 106 comprises an expandable body 400 configured to be expanded and / or retracted (in the case of a balloon, inflated and / or deflated) as selected by a user. In some embodiments, the expandable body 400 is made of one or more materials, such as PET, nylon, silicone, latex, polyurethane, Pebax®. In some embodiments, the expandable body is made of a superelastic material, such as Nitinol. In some embodiments, the expandable body is about 5 mm 3 Approximately 10 mm from 3 Optionally, the inner volume is about 3 mm 3 Approximately 15 mm from 3 Optionally, about 10 mm 3 Approximately 30 mm from 3In some embodiments, the diameter of the expandable body is about 10 mm to about 20 mm. Optionally, about 5 mm to about 35 mm. Optionally, about 3 mm to about 50 mm. In some embodiments, the length of the expandable body is about 5 mm to about 80 mm. Optionally, about 3 mm to about 100 mm. Optionally, about 20 mm to about 150 mm. In some embodiments, the expandable body 400 comprises a balloon. In some embodiments, the expandable body 400 is a balloon. In some embodiments, the expandable body can be inflated to an internal pressure of about 1 atm to about 20 atm. Optionally, about 0.5 atm to about 30 atm. Optionally, about 5 atm to about 50 atm. In some embodiments, the expandable body 400 is in communication with the tube inlet / outlet 108. In some embodiments, the expandable body 400 comprises a jacket 402 configured to surround the expandable body 400. In some embodiments, the jacket 402 is made of a non-elastic material, such as PET and / or PA. In some embodiments, the jacket 402 provides the expandable body 400 with protection against damage and / or a limit on the amount of expansion the expandable body 400 can be inflated to. Figures 4a and 4b also show the distal end of the tube 110 connected to the expandable body 400.

[0141] Referring now to FIG. 5a, it shows a schematic diagrammatic representation of an exemplary extendable body 400, according to some embodiments of the present invention. FIG. 5a shows the extendable body 400 in an expanded configuration connected to a tube. The combined extendable body 400 / tube 110 within the shaft 302 is also shown. FIG. 5a also shows a schematic diagrammatic representation of the extendable body 400 in an expanded configuration. In some embodiments, the extendable body is manually inflated / deflated by a user. In some embodiments, the extendable body is automatically inflated / deflated by a device / controller.

[0142] Referring now to Figures 5b and 5c, Figure 5b shows the exemplary jacket in an open configuration before being attached to an extensible body, and Figure 5c shows the exemplary jacket alone as it would appear once attached to an extensible body.

[0143] Exemplary Arm 404 4a and 4b, in some embodiments, the manipulation head 106 further comprises one or more arms 404 connected to the shaft 302. In some embodiments, the arms 404 are flexible. In some embodiments, the arms 404 are made of stainless steel or any other suitable metal. In some embodiments, there may be one arm, optionally two arms, optionally three arms, optionally four arms, or optionally more. In some embodiments, a potential advantage of having three arms 404 is that it provides a good balance between functionality and stability. In some embodiments, each arm 404 is covered by a sleeve 406. In some embodiments, the sleeve 406 does not cover the entire length of the arm 404. In some embodiments, the manipulation head 106 further comprises a movable implant holder 408 located between the arm 404 and the sleeve 406. In some embodiments, the movable implant holder 408 is configured to hold an implant 410 in place.

[0144] In some embodiments, the order of components, from inside to outside, is as follows: Expandable body 400 is covered by jacket 402. The bottom portion of sleeve 406, which is in contact with jacket 402, is optionally attached to jacket 402. Within sleeve 406 is arm 404. On top of arm 404 is implant 410, and on top of implant 410 is movable implant holder 408. In some embodiments, implant 410 is held between arm 404 and movable implant holder 408, which are held together by sleeve 406. And, outermost is the top portion of sleeve 406.

[0145] In some embodiments, the arms 404 are configured to move inward and outward relative to the longitudinal axis of the device. In some embodiments, the inward and outward movement accompanies expansion / contraction of the extendable body. In some embodiments, the inward and outward movement occurs due to expansion / contraction of the extendable body. In some embodiments, the arms 404 are configured to resist rotational movement relative to the longitudinal axis of the device when the shaft 302 is rotated. In some embodiments, the resistance to rotational movement is provided by the width of the arms 404. In some embodiments, the arms 404 have a thickness of about 0.2 mm, optionally about 0.1 mm to about 0.3 mm, optionally about 0.05 mm to about 0.5 mm. In some embodiments, the arms 404 have a width of about 2.5 mm, optionally about 2 mm to about 3 mm, optionally about 1.5 mm to about 5 mm. In some embodiments, the relationship between arm width and arm thickness is about 1 / 0.08, optionally about 1 / 0.01 to about 1 / 0.1, optionally about 1 / 0.05 to about 0.5. In some embodiments, arms 404 are made of, for example, stainless steel (e.g., 302 stainless hard steel), with an exemplary modulus of elasticity of about 200 GPa ± 20% and a yield strength of about 1110 MPa ± 20%.

[0146] Exemplary Implant Holder / Release Mechanism Referring now to FIG. 6, this figure illustrates an exemplary implant holder / release mechanism located within a manipulation head, the manipulation head being shown in a retracted configuration, according to some embodiments of the present invention. In some embodiments, as disclosed above, the manipulation head comprises arms 404 extending over an extendable body 400, for example, as shown in FIG. 6. In FIG. 6, the extendable body 400 is in a retracted configuration (shown without jacket 402). Also as disclosed above, each arm 404 comprises a sleeve 406 and a movable implant holder 408. An enlarged view shows a space 500 created between the arm 404 and the movable implant holder 408. In some embodiments, the space 500 is configured to accommodate an implant 410 (not shown). In some embodiments, each arm comprises one or more positions comprising an implant retention position. In some embodiments, some implant holding locations are located near the distal end of the device, thereby designated distal implant holders 602, and are configured to hold the distal end and / or distal portion of the implant 410. In some embodiments, some implant holding locations are located near the proximal end of the device, thereby designated proximal implant holders 604, and are configured to hold the proximal end and / or proximal portion of the implant 410. In some embodiments, as shown in FIG. 12b, for example, the implant is wrapped around the manipulation head 106 so that the distal end of the implant 410 is held by one of the distal implant holders 602, and then the implant is wrapped around the manipulation head to contact the other implant holders until all implant holders have a portion of the implant therein, and the proximal end of the implant is held by the last proximal implant holder 604.

[0147] 7a through 7e, which illustrate schematic diagrams of movement of the movable implant holder 408 according to some embodiments of the present invention. FIG. 7a illustrates an exemplary implant 410 disposed between the movable implant holder 408 and the arm 404 (not shown because it is obscured by the implant) while held together by the sleeve 406. FIGS. 7b through 7e illustrate exemplary movement of the movable implant holder 408 according to some embodiments of the present invention without the implant (for clarity only). As can be seen in FIG. 7b, the movable implant holder 408 is in its closed configuration just prior to the start of movement. FIG. 7c illustrates the movement of the movable implant holder 408, following the arrows. FIG. 7d illustrates the movement of the movable implant holder 408, following the arrows, approximately at the end of movement. FIG. 7e illustrates the movable implant holder 408 in its open configuration (the movable implant holder 408 is not actually shown because it is obscured by the sleeve 406), thereby allowing for release of the implant 410. In some embodiments, proximal movement of the movable implant holder 408 first causes the release of the implant 410 from the distal implant holder 602, and continued proximal movement causes the release of the implant 410 from the proximal implant holder 604, thereby providing a controllable and regulated release of the implant.

[0148] Exemplary Tissue Cutter 412 Referring back to Figures 4a and 4b, in some embodiments, the operating head 106 comprises a tissue cutter 412 configured to cut the tissue of the urethra to create a space into which the implant 410 is implanted.

[0149] 8a-8b, which show schematic diagrammatic representations of an exemplary tissue cutter 412 within (FIG. 8a) and outside (FIG. 8b) the shaft 302, according to some embodiments of the present invention. In some embodiments, the tissue cutter 412 extends proximally at the handle and terminates distally at the operating head of the device. In some embodiments, at the distal end, the tissue cutter 412 comprises a generally L-shaped operating configuration. In some embodiments, the tissue cutter 412 rotates (see methods below), with the distal end of the generally L-shaped operating configuration causing the tissue cutter 412 to perform the incision while in contact with the tissue surface. In some embodiments, the tissue cutter 412 is delivered to the treatment area in a retracted configuration. In some embodiments, the tissue cutter 412 is subsequently released and assumes the L-shaped operating configuration when actuated by the user. In some embodiments, once the tissue cutter 412 has performed its function, it is retracted proximally to avoid causing undesired damage to the tissue. In some embodiments, the tissue cutter 412 is configured to perform an incision in the tissue having a depth of about 2 mm to about 10 mm, optionally about 1 mm to about 8 mm, and optionally about 4 mm to about 15 mm, e.g., 3 mm, 5 mm, 7 mm, 10 mm, 12 mm. In some embodiments, the tissue cutter 412 is made of a resilient metal, such as nitinol or stainless steel. In some embodiments, the tissue cutter is connected to electrical or electromechanical energy, such as a diathermy machine or piezoelectric transducer. In some embodiments, cutting the tissue comprises using an electrified tissue cutter.

[0150] In some embodiments, the head of the tissue cutter 412 has a rounded end, as shown in FIG. 8b, or a "T" shape (not shown), configured to create a narrower incision on the surface of the tissue but a wider incision deeper in the tissue. In some embodiments, the length of the tissue cutter is about 3 mm to about 10 mm, optionally about 5 mm to about 8 mm, optionally about 4 mm to about 6 mm, e.g., 4 mm, 5 mm, 6 mm, 7 mm, 8 mm.

[0151] 8c-8g, which show schematic diagrams of an incision mechanism using a round-head cutter, according to some embodiments of the present invention. FIG. 8c shows a schematic diagram of tissue 800 in which an incision is to be made. In some embodiments, a round-head cutter 412 makes an incision in the tissue, as shown, for example, in FIG. 8d. In some embodiments, due to the cutter's configuration with a head having round elements, the incision is made to create a wider incision 806 in the interior 808 of the tissue 800, as shown, for example, in FIG. 8e, but define a narrower region 802 near the inner surface 804 of the tissue 800 (or optionally at the surface itself). In some embodiments, an implant 410 is then inserted into the wider region of the incision 806 in the tissue 800 through the narrower region 802, as shown, for example, in FIG. 8f. In some embodiments, because the incision made on the surface of the tissue is narrow, this potentially allows for faster healing of the surface, thereby confining the implant 410 within the tissue, as shown, for example, in FIG. 8g.

[0152] 8h-8l, which show schematic diagrammatic representations of a cutting mechanism using a straight or "T"-head cutter, according to some embodiments of the present invention. FIG. 8h shows a schematic diagrammatic representation of tissue 800. In some embodiments, the head cutter 412 performs an incision in the tissue, as shown, for example, in FIG. 8i. In some embodiments, due to the configuration of the cutter with a straight or "T"-head, the incision made optionally creates a wider incision 806 in the interior 808 of the tissue 800, but comprises a narrow region 802 near (or optionally at) the inner surface 804 of the tissue 800. In some embodiments, an implant 410 is then inserted through the narrow region 802 into the optionally wider incision 806 in the tissue 800, as shown, for example, in FIG. 8k. In some embodiments, the incision made on the surface of the tissue is narrow, potentially allowing for faster healing of the surface, thereby confining the implant 410 within the tissue, as shown, for example, in FIG. 8l.

[0153] In some embodiments, the angle between the device and the cutter is 90 degrees, such that when the cutter cuts the tissue, the incision is shaped to define a generally straight incision configuration, as shown schematically in Figure 8m. In some embodiments, the angle between the device and the cutter is other than 90 degrees, such that when the cutter cuts the tissue, the incision is shaped to define an angled configuration having angle X, as shown schematically in Figure 8n. In some embodiments, the angle is between about 45 degrees and about 89 degrees, optionally between about 55 degrees and about 80 degrees, or optionally between about 60 degrees and about 75 degrees.

[0154] 8o-8p, which show schematic diagrams of exemplary cutting directions according to some embodiments of the present invention. In some embodiments, the angle between the device and the cutter remains the same during the cutting operation, thereby providing an incision having a linear direction, as shown, for example, in FIG. 8o. In some embodiments, the angle between the device and the cutter varies during the cutting operation, thereby providing an incision having a non-linear direction relative to the longitudinal axis L of the urethra, as shown, for example, in FIG. 8p.

[0155] Exemplary Internal Guide Element 114 9a-9c, which illustrate different views of an exemplary internal guide element, according to some embodiments of the present invention. In some embodiments, there may optionally be an internal guide element 414 within the shaft 302 configured to separate between different sections extending from the handle 100 to the distal end of the device. In some embodiments, the internal guide element comprises one or more channels 502, 504, 506, 508 configured to accommodate the different sections while optionally keeping them separated from one another, as shown, for example, in FIGS. 9a-9b. In some embodiments, the internal guide element 414 comprises an internal hollow channel 506. In some embodiments, the internal guide element 414 comprises channels having different widths, different depths, the same width, the same depth, and any combination thereof. In the exemplary internal guide element 414 shown in FIGS. 9 a-9 c, the channel 502, in some embodiments, is configured to accommodate the arm 404, optionally the arm 404 having a sleeve 406, optionally the arm 404 having a movable implant holder 408, optionally the arm 404 having the movable implant holder 408 having the sleeve 406. In some embodiments, the channel 502 also includes features to enable and assist rotational movement of distally located components, which reach the distal end of the device from the handle. In some embodiments, the channel 508 is configured to accommodate the tube 110 connecting between the extendable body 400 and the inlet / outlet 108. In some embodiments, the channel 504 is configured to accommodate and / or isolate the tissue cutter 412. In some embodiments, the channel 506 is configured to accommodate additional components used during the procedure, such as optical elements (e.g., a microcamera; see below). FIG. 9c shows a schematic diagram of the inner guide element 414 along with some of the different parts of the system.

[0156] Exemplary Handle and Internal Mechanisms Referring now to FIG. 10 , an exploded view of a schematic diagram of an exemplary handle according to some embodiments of the present invention is shown. In some embodiments, the handle 100 comprises dedicated covers 1002 / 1004 for the internal mechanisms of the handle 100, electronic hardware 1006, internal actuation elements 1008, and a front cover 1010 with openings for a shaft and one or more user control buttons. In some embodiments, the electronic hardware 1006 comprises a controller configured to synchronize among operations performed by the device. In some embodiments, potentially synchronized device operations include one or more of: activating a motor to perform linear and / or rotational motion, expanding / contracting an extendable body, exposing and / or retracting a cutter, and exposing and / or retracting a manipulation distal tip. In some embodiments, the controller is a mechanical controller. In some embodiments, the controller is an electronic controller.

[0157] Exemplary Internal Actuating Elements 11a-11b, which show schematic isometric (a) and exploded (b) views of an exemplary internal actuation mechanism in accordance with some embodiments of the present invention. In some embodiments, the internal actuation mechanism is carried by a chassis 1102 and one or more auxiliary / actuation rods / sleeves 1108. In some embodiments, the internal actuation mechanism includes one or more motors 1104 configured to actuate mechanisms at the distal end of the device using one or more gears 1106 / 306. In some embodiments, the one or more motors 1104 are configured to rotate and / or actuate and / or move one or more of the elongated body 104, shaft 302, internal operating element 300, operating head 106, movable implant holder 408, tissue cutter 412, and any combination thereof. In FIG. 11a, the exemplary internal actuation mechanism is shown with shaft 302 as an example. In some embodiments, the one or more motors 1104 are identical. In some embodiments, the one or more motors 1104 are different. In some embodiments, the one or more motors 1104 are configured to operate at a speed of from about 1 RPM to about 1000 RPM, optionally from about 1 RPM to about 500 RPM, and optionally from about 1 RPM to about 75 RPM.

[0158] In some embodiments, distal motor 1104A rotates gear 1106A, which in turn rotates gear 1106B, which actuates proximal / distal movement of elongate body 104 (held by connector 204) on rod 1108. In some embodiments, the motor provides a force of about 1 kg to about 5 kg. Optionally, about 2 kg to about 8 kg. Optionally, about 3 kg to about 10 kg. For example, 1 kg, 2 kg, 3 kg, 4 kg. In some embodiments, the motor provides proximal-distal (or vice versa) movement at a rate of about 1 mm / sec to about 10 mm / sec. Optionally, about 2 mm / sec to about 20 mm / sec. Optionally, about 4 mm / sec to about 30 mm / sec. For example, 2 mm / sec, 4 mm / sec, 8 mm / sec, 15 mm / sec.

[0159] In some embodiments, proximal motor 1104B rotates gears 1106C and 1106D (also numbered as gear 306 in FIG. 3 ), which actuate the rotational movement of shaft 302. In some embodiments, motor 1104B is configured to provide a rotational force (torque) on shaft 302 of about 50 Nmm to about 300 Nmm. Optionally, about 80 Nmm to about 500 Nmm. For example, 90 Nmm, 100 Nmm, 112 Nmm, 120 Nmm. In some embodiments, the rate of rotation of shaft 302 is about 1 revolution per second to about 1 revolution every 3 seconds. Optionally, about 1 revolution every 0.5 seconds to about 1 revolution every 5 seconds. For example, 1 revolution per second, 1 revolution per 2 seconds, or 1 revolution per 3 seconds.

[0160] Exemplary Implants 12a-12d, which illustrate an exemplary implant 410 according to some embodiments of the present invention. FIG. 12a illustrates the exemplary implant 410 in an open configuration, while FIG. 12b illustrates the exemplary implant in a folded, spiral configuration. In some embodiments, the implant 410 is made of a suitable elastic material, such as one or more of stainless steel, nitinol, titanium, PET, PEEK, and PA. In some embodiments, the implant 410 has a length of about 50 mm to about 70 mm, optionally about 40 mm to about 80 mm, and optionally about 30 mm to about 100 mm, for example, 50 mm, 60 mm, 70 mm, or 80 mm. In some embodiments, the implant 410 has a thickness of about 0.01 mm to about 1 mm, optionally about 0.1 mm to about 0.8 mm, optionally about 0.3 mm to about 0.6 mm, e.g., 0.1 mm, 0.25 mm, 0.3 mm, 0.5 mm. In some embodiments, the implant 410 has a width of about 0.5 mm to about 4 mm, optionally about 0.7 mm to about 2 mm, optionally about 1 mm to about 1.5 mm, e.g., 0.5 mm, 0.7 mm, 1 mm, 1.3 mm, 2 mm, 3 mm. In some embodiments, a potential advantage of creating an implant with a shorter width is that it allows the tissue surrounding the implant to close and heal better and allows the implant to be inserted deeper into the incision.

[0161] In some embodiments, the implant 410 is manufactured straight. In some embodiments, the implant 410 is manufactured slightly curved. In some embodiments, the implant 410 comprises an intermediate straight section 1202 and two slightly curved end sections 1204 (e.g., the end sections 1204 are also referred to herein as the proximal and distal portions of the implant), as shown, for example, in FIG. 12a. Note that for some embodiments, the end sections 1204 are shaped to define straight end sections / sections when the implant 410 is unconstrained. In some embodiments, the end sections of the implant 410 fold the implant, thereby creating protrusions 1206, as shown, for example, in FIGS. 12a-b. In some embodiments, the folded portions (protrusions) are used to hold the implant between the arms and the movable implant holder 408. In some embodiments, the folds (protrusions) 1206 at the ends of the implant provide additional anchoring elements once the implant is placed within the incision. In some embodiments, the shape of the implant is configured to provide the implant with an increased range of force that the implant applies to the tissue wall. In some embodiments, the force applied by the implant to the urethral wall is from about 50 gr to about 100 gr, optionally from about 40 gr to about 150 gr, and optionally from about 25 gr to about 500 gr. For example, 50 gr, 60 gr, 70 gr, 100 gr, 120 gr.

[0162] Typically, the implant 410 is made of a shape memory alloy, such as Nitinol. Typically, the shape memory alloy of the implant is shaped so that the implant assumes a generally straight shape along at least the intermediate section 1202 when in an unconstrained state (i.e., when no force is applied to the implant 410). Because the implant 410 is made of a shape memory material that tends to return to its natural, open state, upon release from the delivery device, the implant attempts to return to its shaped, generally straight, open state, thereby pushing against the urethral wall with increased force compared to an implant that is not generally straight. In some embodiments, expansion of the expandable body helps the implant return to the desired configuration. FIGS. 12a and 12c show an exemplary implant in a natural, open state having a generally straight configuration. FIG. 12d shows the shape the implant will assume within the urethral wall incision upon implantation. As shown in FIG. 12d, the implant 410 is implanted into tissue in a curved configuration. In some embodiments, due to the resistance created by the walls of the urethra, the implant is unable to return to its straight configuration, thereby continuing to push against the walls, thereby releasing the urethral obstruction.

[0163] Typically, the shape memory material of the implant is shaped so that the implant, when unconstrained (i.e., when no force is applied to the implant), assumes a generally straight shape along more than 50 percent (e.g., more than 60 percent or more than 70 percent) of its length. (In some cases, such implants are described herein as "quasi-straight implants.") Typically, upon implantation of the implant into an incision made in the urethra, the implant is constrained into a curved shape by the tissue into which it is implanted. Due to the tendency of the shape memory alloy to return to its preset generally straight configuration, the implant applies radially outward pressure to the tissue. By shaping as described above, the implant typically dilates the urethra more effectively than if the implant were shaped to define a less generally straight shape.

[0164] In some embodiments, the implant comprises padded terminal ends 1208, as shown, for example, in Figures 12c-12d. In some embodiments, the padded terminal ends 1208 contribute to one or more of: accurately positioning the implant within the incision by preventing the implant from rotating around its axis once inside the incision; and / or potentially avoiding perforation and / or damage to tissue once inside the incision.

[0165] In some embodiments, the implant comprises one or more protrusions configured to stabilize the implant upon implantation at the implantation site within the incision, and the protrusions are configured to be blunt so as not to damage tissue.

[0166] In some embodiments, the implant is removed after a predetermined period of time, such as 3 months, 6 months, 12 months, or 36 months. Alternatively, the implant is formed of a material that is biodegradable. In some embodiments, the implant biodegrades over a period of time selected by the physician, such as 3 months, 6 months, 12 months, or 36 months.

[0167] Exemplary Additional Hardware 13a-13b and 14a-14b, which illustrate two exemplary additional hardware for use with a device for dilating a subject's urethra at least partially obstructed by an enlarged prostate gland, according to some embodiments of the present invention. In some embodiments, the device is used with an outer sheath 1302. In some embodiments, the device further comprises an optical element 1304. FIG. 13a illustrates the device separated from the additional hardware, outer sheath 1302 and optical element 1304, while FIG. 13b illustrates the device with the additional hardware, outer sheath 1302 and optical element 1304, incorporated therein.

[0168] Exemplary Outer Sheath (Obturator) In some embodiments, an outer sheath (obturator) 1302 is used during treatment, as is known in the art, and in some embodiments, the outer sheath (obturator) 1302 is sized and shaped to accommodate the device.

[0169] Exemplary Optical Elements (Camera) 14a-14b, which illustrate an exemplary optical element at the distal end of a device, e.g., the distal end of a camera, according to some embodiments of the present invention. In some embodiments, the device further comprises an optical element 1304, which extends from the proximal end of the device slightly beyond the end of the shaft to approximately ±2 mm of the end of the shaft. In some embodiments, the optical element extends to the front of the extendable body. In some embodiments, the optical element has a field of view from about 0 degrees (meaning forward looking) to about ±90 degrees, optionally from about 0 degrees to about ±70 degrees, and optionally from about 0 degrees to about ±120 degrees. In some embodiments, the optical element is configured to allow a user to navigate through the urethra, visualize the location of the prostate, and place an implant at a desired location under direct visualization.

[0170] Exemplary Methods Exemplary Manual Method Referring now to FIG. 15 , a flowchart is shown disclosing an exemplary method implemented by some embodiments of the present invention. In some embodiments, the following method is performed by a user during operation of the device. In some embodiments, the method begins by connecting an irrigation tube to the outer sheath of the obturator (1502). The user then inserts the outer sheath with the obturator into the patient (1504). The user then removes the obturator, leaving the outer sheath in place (1506). The user then inserts the device into the outer sheath (1508). In some embodiments, optionally, the user then inserts an optical element (e.g., a camera) into the device (1510). In some embodiments, the user then assesses the position of the distal end of the device with the optical element (camera) (1512). In some embodiments, the elongated body 104 is then retracted (moved proximally) about 30 mm to about 40 mm, preferably 36 mm, so that the operating head is exposed beyond the distal end of the device (1514). In some embodiments, the distal end of the implant is then released from the device (1514) by further retracting (moving proximally) the elongate body 104 about 3 mm to about 7 mm, preferably 5 mm. In some embodiments, releasing the distal end of the implant allows the expandable body to expand because if both ends of the implant are captured, the implant will retain the arms and therefore will not allow the arms to extend and provide the space necessary for the expandable body to expand. In some embodiments, the tissue cutter is then released (1518). In some embodiments, the tissue cutter is retained within the outer tube of the device until this point. In some embodiments, the tissue cutter is released from the outer tube only when an incision is required. In some embodiments, the release of the implant distal end (1516) and the release of the tissue cutter (1518) are optionally performed concomitantly. In some embodiments, the expandable body is then expanded (1520). In some embodiments, expansion of the expandable body causes the previously half-released implant to expand from its collapsed configuration to an expanded configuration.In some embodiments, the tissue cutter is then rotated, thereby creating an incision in the tissue 1522. In some embodiments, the rotation of the cutter is accomplished by rotating the outer tube along with all of its internal components. In some embodiments, the next action is to release the proximal end of the implant 1524 by further retracting (moving proximally) the elongate body 104 about 5 mm to about 9 mm, preferably 7 mm.

[0171] In some embodiments, releasing the proximal end of the implant will allow the implant to unwind from a folded spiral configuration (folded configuration shown in FIG. 12b) to a curved configuration (curved configuration as shown in FIG. 12d) in which it is released and implanted within the incision. The release of the implant is performed near the incision so that the implant enters the incision. In some embodiments, the expandable body is then retracted (1526). In some embodiments, optionally at this point, the user may evaluate the insertion of the implant into the incision (1528). In some embodiments, the elongate body is then slid forward so that the operating head, optionally along with the tissue cutter, is reinserted into the elongate body for subsequent removal from the body (1530). In some embodiments, optionally, the user then evaluates the deployment of the implant within the incision (again, if previously done, or for the first time, if not previously done) (1532). In some embodiments, the method concludes by removing 1534 the device along with the outer sheath from the patient's body.

[0172] Exemplary Semi-Automatic Method Referring now to FIG. 16 , a flowchart disclosing an exemplary semi-automatic method implemented by some embodiments of the present invention is shown. In some embodiments, the following semi-automatic method is performed by a user during operation of the device. In the flowchart, solid-lined boxes are manual actions, while dashed-lined boxes are automatic actions initiated by the user (e.g., by pressing a button). In some embodiments, the method begins by connecting an irrigation tube to the outer sheath of the obturator (1602). The user then inserts the outer sheath with the obturator into the patient (1604). The user then removes the obturator, leaving the outer sheath in place (1606). The user then inserts the device into the outer sheath (1608). In some embodiments, optionally, the user then inserts an optical element (e.g., a camera) into the device (1610). In some embodiments, the user then assesses the position of the distal end of the device with the optical element (camera) (1612). In some embodiments, the user presses the button a first time (1614), which automatically exposes the manipulation head beyond the distal end of the device (1616) by retracting (moving proximally) the elongate body 104 about 30 mm to about 40 mm, preferably 36 mm. In some embodiments, the user then presses the button a second time (1618), which causes an automatic release of the proximal end of the implant (1620) by retracting (moving proximally) the elongate body 104 an additional 3 mm to about 7 mm, preferably 5 mm. In some embodiments, releasing the distal end of the implant allows the expandable body to expand because if both ends of the implant are captured, the implant will hold the arms and therefore will not allow the arms to extend, providing the space necessary for the expandable body to expand. In some embodiments, optionally, releasing the distal end of the implant (1620) automatically releases the tissue cutter (1622). In some embodiments, the expandable body is then manually expanded 1624. In some embodiments, expansion of the expandable body expands the previously half-released implant from its collapsed configuration to an expanded configuration.In some embodiments, the user then presses the button a third time 1626, which causes the tissue cutter to automatically rotate, thereby creating an incision in the tissue 1628. In some embodiments, the rotation of the cutter is accomplished by rotating the outer tube along with all of its internal components.

[0173] In some embodiments, the automatic rotation (1628) is followed by an automatic release (1630) of the proximal end of the implant by further retracting (moving proximally) the elongate body 104 about 5 mm to about 9 mm, preferably 7 mm. In some embodiments, the release of the proximal end of the implant will allow the implant to unfold from a folded, spiral configuration (the folded configuration shown in FIG. 12b) to a curved configuration (the curved configuration as shown in FIG. 12d) in which it is released and implanted into the incision. The release of the implant is performed near the incision so that the implant enters the incision. In some embodiments, the user then manually retracts (1632) the expandable body. Optionally, in some embodiments, the user then evaluates (1634) the insertion of the implant into the incision. In some embodiments, the user then presses (1636) the button a fourth time, which causes (1638) the automatic insertion of the manipulating head, optionally together with the tissue cutter, into the outer tube. In some embodiments, the user optionally then evaluates 1640 the deployment of the implant within the incision (again if previously done, or for the first time if not previously done). In some embodiments, the method concludes 1642 by removing the device along with the outer sheath from the patient.

[0174] In some embodiments useful for any of the methods disclosed herein, the rotational movement of the device performing the incision is accompanied by a gradual release of the implant into the incision, such that at the end of the rotation, the implant is completely released.

[0175] Exemplary Automatic Method Controlled by a Controller In some embodiments, the user controls the movement of the mechanism by pressing a single button that activates the controller to perform a synchronized, stepwise implant release method. In some embodiments, as mentioned above, the delivery system consists of two controlled motors: a linear motor that moves the outer sheath (left to right and right to left as described above), and a rotary motor that moves the shaft assembly in a clockwise direction to create a circumferential incision in the tissue. In some embodiments, software in the controller also includes instructions to control and synchronize the motor movement with the cutter.

[0176] Table A below discloses exemplary relationships between the operation of the linear motor, the operation of the rotary motor, the operation of portions of the device, and the operation of the implantation method. Table A below is not intended to be limiting and is presented to enable one skilled in the art to understand the present invention.

[0177] [Table 1]

[0178] Exemplary Emergency Stop Button In some embodiments, the device comprises at least one panic button configured to stop the operation the device is performing at that moment. In some embodiments, pressing the panic button once stops the operation being performed at that moment. In some embodiments, pressing the panic button a second time causes the device to fully retract into the shaft, including, but not limited to, when relevant, retracting the expandable body, retracting the cutter, and rotating the implant for insertion into the shaft.

[0179] Exemplary Visual Display to the User In some embodiments, each time the user presses a button, a visual indication is shown to the user to inform the user that the automatic operation has finished and that the next step in the method may be performed. In some embodiments, the visual indication may be an LED light of various colors. In some embodiments, the visual indication may be a digital screen.

[0180] Exemplary Non-Urethral Use In some embodiments, the implantation devices and methods are used in other parts of the body, such as the digestive system, vascular system, etc., requiring opening of tubular organs or any other body lumen.

[0181] The various embodiments and aspects of the present invention as described above and as claimed in the claims section below find support in the following examples.

[0182] Example of operating instructions for using the device For some embodiments, the devices described herein are used in conjunction with one or more of the following instruments: 380mm, 2.9mm, 12° telescope (CL-SCOPE) 24F sheath (CL-SHEATH) Visual Obturator (CL-VO) Cystoscope camera, light box / cables and monitor Olympus ESG-400 general-purpose HF generator Standard fluid irrigation system including new sterile fluid piping Standard Endoscopic Grasper Kit

[0183] For some such implementations, the operating instructions for using the device include one or more of the following steps, which are provided purely by way of example, and some or all of which may not necessarily be performed:

[0184] 1. Pre-procedure cystoscopy 1.1 Assemble the 2.9 mm 12° telescope (CL-SCOPE), visual obturator (CL-VO), and 24F (CL-SHEATH). 1.2 Visualize both the urethra and bladder by advancing the telescope assembly through the urethra and into the bladder. 1.3 Remove the telescope and visual obturator, leaving the sheath in the bladder.

[0185] 2. Preparation 2.1 Check that the packaging is unopened and undamaged. 2.2 Inspect all parts for damage that may have occurred during shipping or other handling. 2.3 While holding the handle end (heavy end) of the pouch, open the pouch by peeling back the side (device handle end) to access the sterile contents. 2.4 Using sterile technique, remove the plastic tray from the pouch. 2.5 Using sterile technique, remove the device from the packaging by grasping the handle and pulling the device from the tray. 2.6 Inspect the tip of the device to ensure the distal balloon is not visible. 2.7 Connect the delivery system to the auxiliary equipment as follows: 1. Insert a 2.9mm 12° telescope (CL-SCOPE) into the device with the telescope light post at the 6 o'clock position. Secure the scope by applying constant forward pressure to the telescope, holding the telescope light post at the 6 o'clock position, and pushing the scope in until you hear a "click." 2. Connect the telescopic cystoscope camera and light source to the light post connector. 3. Connect the power cable to the power source. 4. Connect the blue electrode connector to an Olympus ESG-400 general-purpose HF generator and set it to the BLENDCUT 50 setting. 5. Insert the delivery system through the outer sheath (CL-SHEATH).

[0186] 3. Insertion and placement of the device 3.1 Partial exposure of the distal tip by pressing the button (Step 1 - 1st button press), exposing the dilated balloon for a wider field of view. 3.2 Localize the treatment area by visualizing the prostatic fossa from the bladder neck to the verumontanum. 3.3 Partial implant release by pressing the button (Step 2 - Second button press), initial deployment of the implant and exposure of the dissection element. The flexible nitinol implant extends 33 mm from the distal side of the dilatation balloon. 3.4 To avoid external prostate structures (e.g., neurovascular bundles), place the delivery device tip anterior to the prostate in either the 2-3 o'clock position or the 9-10 o'clock position. Orient the tip at 12 o'clock to ensure the implant is centrally deployed between the two lateral lobes (the implant deploys around the dilation balloon). Similar to cystoscopy, keep the device parallel to the prostatic fossa to avoid excessive instrument movement throughout placement and deployment. Implants are placed over the length of the lateral prostate lobes, starting 1.5 cm distal to the bladder neck, at approximately 1 cm to 1.5 cm intervals to achieve the desired urethral patency. 3.5 Position the delivery device so that the marker is oriented laterally and superiorly to the target middle lobe of the prostate. 3.6 To achieve the desired amount of urethral opening, tilt the delivery device to a 6 o'clock angle and push the distal end upward, applying slight pressure to the delivery device tip via the delivery device handle.

[0187] 4. Expansion of the Graft While holding the delivery device distal tip steady against the target tissue, the following steps are performed. 4.1 Inflate the dilatation balloon to 2 atm using a pressure-controlled syringe (Figures 4a and 4b). Full inflation of the dilatation balloon was confirmed by visualization of the inflated balloon on the screen monitor. 4.2 Trigger the urethral implant release sequence by pressing the button (Step 3 - third button press), creating a circumferential urethral incision within the prostate, and deploying the Nitinol implant within the incision. The system's circumferential urethral incision is a maximum of 5 mm deep within the prostate tissue, which, based on cadaveric and clinical studies, is sufficient to reliably place the prostate implant within the incision. 4.3 After the implant is fully deployed, hold it stationary for a maximum of 10 seconds and then deflate the dilation balloon by holding the syringe in an upward position and creating a vacuum until the syringe is filled to a maximum of 40cc. 4.4 Withdraw the delivery device and press the button (Step 4 - 4th button press) to cover the distal tip assembly. The delivery device can then be removed from the cystoscope sheath. Gently pull the delivery device back and forth with light force. As with cystoscopy, keep the device parallel to the prostatic fossa. Keep the delivery handle centered between the lobes as you advance the delivery device distally. 4.5 To deploy additional implants, remove the delivery device from the sheath and replace it with a new system. Implants are placed throughout the length of the prostatic urethra, approximately 1 cm apart, to achieve the desired urethral patency. 4.6 If additional implants are required, cystoscopy may be performed between and / or after implant deployment to address cystoscopically. If additional implants are required, see Section 4, Delivery Device Placement: Lateral Lobe. If obstruction does not persist, continue with Section 6, Cystoscopy.

[0188] 5. Cystoscopy Cystoscopy of the urethra and bladder was performed between and after implant deployment to · Verify that the desired effect has been achieved. Ensure that all implant components are fully embedded within the mucosal tissue within the prostatic urethra. Ensure that the implant is not present in the bladder or at the bladder neck extending into the bladder vesicle. -Assess the trigone and bladder for injury. If necessary, use a foreign body retrieval grasper or other applicable device. Improperly placed implants (i.e., implants placed in the bladder or exposed to standing urine) Implants that are not adequately apposed to the tissue (i.e., untensioned implants or loose implant / device components) Removed.

[0189] It is understood that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as appropriate with any other described embodiment of the invention. Particular features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperable without those elements.

[0190] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and scope of the appended claims.

[0191] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the present patent specification, including definitions, will control. Additionally, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0192] As will be appreciated by those skilled in the art, some embodiments of the present invention may be embodied as a system, a method, or a computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.), or an embodiment combining software and hardware aspects, all of which may be generally referred to herein as a "circuit," "module," or "system." Some embodiments of the present invention may also take the form of a computer program product embodied in one or more computer-readable medium(s) having computer-readable program code embodied therein. Implementation of the methods and / or systems of some embodiments of the present invention may involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Furthermore, depending on the actual instrumentation and equipment of some embodiments of the methods and / or systems of the present invention, some selected tasks may be implemented by hardware, software, firmware, and / or a combination thereof, for example, using an operating system.

[0193] For example, hardware for performing selected tasks according to some embodiments of the present invention may be implemented as a chip or circuit. As software, selected tasks according to some embodiments of the present invention may be implemented as a plurality of software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks according to some exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage, such as a magnetic hard disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is also provided. A display and / or a user input device, such as a keyboard or mouse, are also optionally provided.

[0194] Some embodiments of the present invention may utilize any combination of one or more computer-readable media. The computer-readable medium may be a computer-readable signal medium or a computer-readable storage medium. The computer-readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (not an exhaustive list) of computer-readable storage media would include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer-readable storage medium may be any tangible medium that can contain or store a program for use by or in connection with an instruction execution system, apparatus, or device.

[0195] A computer-readable signal medium may include a propagated data signal having computer-readable program code embodied therewith, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium is not a computer-readable storage medium and may be any computer-readable medium that can convey, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0196] The program code embodied on the computer-readable medium and / or data used thereby may be transmitted using any suitable medium, including but not limited to wireless, wireline, fiber optic cable, RF, etc., or any suitable combination of the foregoing.

[0197] Computer program code for carrying out operations of some embodiments of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages such as Java, Smalltalk, C++, and conventional procedural programming languages such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or a connection to an external computer may be made (e.g., via the Internet using an Internet Service Provider).

[0198] Some embodiments of the present invention may be described below with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, special-purpose computer, or other programmable data processing apparatus to produce a machine whereby the instructions, executed via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions / acts specified in one or more blocks of the flowchart illustrations and / or block diagrams.

[0199] These computer program instructions may also be stored on a computer-readable medium that can direct a computer, other programmable data processing apparatus, or other device to function in a particular manner, whereby the instructions stored on the computer-readable medium produce an article of manufacture that includes instructions that implement the functions / acts specified in one or more blocks of the flowcharts and / or block diagrams.

[0200] Computer program instructions may also be loaded into a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus, or other device to generate a computer-implemented process, whereby the instructions executing on the computer or other programmable apparatus provide a process for implementing the functions / acts specified in one or more blocks of the flowcharts and / or block diagrams.

[0201] Some of the methods described herein are generally designed for use by a computer only and may not be feasible or practical for purely manual performance by a human expert. A human expert attempting to manually perform a similar task, such as manually operating an implant device, would be expected to use an entirely different method, e.g., utilizing specialized knowledge and / or the pattern recognition capabilities of the human brain, which would be far more efficient than manually performing the steps of the methods described herein.

Claims

1. 1. An apparatus comprising a device for the treatment of a urethra narrowed by benign prostatic hyperplasia (BPH), said device comprising: a delivery tool having a proximal portion and a distal portion, the distal portion configured to be advanced to a position within the region of the urethra to be treated, the distal portion comprising: an expandable element configured to expand within the urethra to enlarge the urethra in the area to be treated, the expandable element defining an outer surface; a tissue cutter disposed outside the outer surface of the expandable element, the tissue cutter configured to form an incision on the inner surface of the urethra after the expandable element has expanded to dilate the urethra; an implant comprising a shape memory material and configured to be implanted within the incision in the interior surface of the urethra to maintain the urethra in an expanded state; It is equipped with The device, wherein the implant comprises two end sections and an intermediate section disposed between the two end sections, and the shape memory material is shaped so that in an unconstrained configuration of the implant, the intermediate section is generally straight.

2. The device of claim 1 , wherein the implant is configured to be implanted within the incision in the urethra with the middle section of the implant constrained in a curved shape.

3. The device of claim 1 , wherein the length of the intermediate section of the implant is at least 50% of the length of the implant.

4. The device of claim 1 , wherein the length of the intermediate section of the implant is at least 60% of the length of the implant.

5. The device of claim 1 , wherein the implant is configured to be maintained in a spiral shape while the implant is disposed within the delivery tool.

6. The device of claim 1, wherein the implant has a length of 40 to 80 mm.

7. The device of claim 1, wherein the implant has a thickness of 0.01 to 1 mm.

8. The device of claim 1, wherein the implant has a width of 0.5 to 4 mm.

9. 10. The device of claim 1, wherein the implant is configured to apply a pressure of about 25 gr to about 500 gr within the incision in the urethra.

10. The device of claim 1 , wherein the tissue cutter is configured to create the incision having a depth of 2 to 10 mm.

11. The device of claim 1, wherein the tissue cutter has a length of 3 to 10 mm.

12. The device of claim 1 , wherein the tissue cutter is configured to form the incision at a 90 degree angle relative to a longitudinal axis of the delivery tool.

13. The device of claim 1 , wherein the tissue cutter is configured to form the incision at an angle other than 90 degrees relative to a longitudinal axis of the delivery tool.

14. The device of claim 1 , wherein the tissue cutter is configured to form the incision at an angle of about 45 degrees to about 89 degrees relative to a longitudinal axis of the delivery tool.

15. The extensible element has a length of 3 to 15 mm. ３ 10. The device of claim 1, configured to be inflated to an internal volume of 0.1 psi.

16. The device of claim 1 , wherein the expandable element is configured to be expanded to define a diameter of between 5 and 35 mm.

17. The device of claim 1 , wherein the extendable element has a length of 3 to 100 mm.

18. The device of claim 1 , wherein the expandable element is configured to be inflated to an internal pressure of 1 to 20 atm.

19. The device of claim 1 , wherein the expandable element comprises a balloon.

20. 20. The device of any one of claims 1 to 19, further comprising one or more implant carrying arms extending from the delivery tool shaft and disposed outside the outer surface of the expandable element.

21. 21. The device of claim 20, wherein the one or more implant delivery arms are configured to release the implant into the incision after the tissue cutter forms the incision in the interior surface of the urethra.

22. further comprising one or more implant holders coupled to the implant delivery arm; the implant is configured to be disposed between the implant delivery arm and the implant holder such that the implant is held in place by the implant delivery arm and the implant holder; 21. The device of claim 20, wherein the implant holder is configured to be retracted proximally relative to the implant delivery arm such that the implant is released by the implant delivery arm into an incision in the urethra, thereby maintaining the urethra in an expanded state.

23. 21. The device of claim 20, wherein the delivery tool further comprises an optical element, and the one or more implant carrying arms and the extendable element are configured to enable the optical element to visualize the urethra.

Images