Tissue manipulation systems and methods of use

Abstract

It addresses the need to treat the minimum amount of tissue necessary to relieve the symptoms of BPH in a minimally invasive, low-risk procedure. The present invention discloses devices, systems, and associated methods for cutting, manipulating, and stabilizing tissue. A system for manipulating tissue within the prostatic urethra includes a handle body (110) having a deployment or cutter actuator (112) with an inflation port (116). An elongate member (150) is coupled to a distal end of the handle body, and an expandable member (180), also including a delivery or cutter body, is coupled to the distal end of the elongate member. The expandable member is configured to stabilize the delivery or cutter body relative to the target tissue when the expandable member is expanded. A tissue manipulation structure, such as a cutter (172), is configured to move from a first position to a second position in which at least a portion of the structure extends into the surrounding prostatic tissue.

Description

[Technical field]

[0001] [Claim of priority] The benefit of priority is hereby claimed to U.S. Provisional Patent Application No. 63 / 322,662, entitled "TISSUE CUTTING SYSTEM AND METHODS OF USE," filed March 23, 2022, and U.S. Provisional Patent Application No. 63 / 350,929, entitled "TISSUE MANIPULATING SYSTEM AND METHODS OF USE," filed June 10, 2022, each of which is incorporated by reference in its entirety herein.

[0002] The present disclosure relates generally to medical devices and methods, and more particularly to systems and associated methods for manipulating, cutting, and / or storing tissue and anatomical or other structures within a human or animal subject for the purpose of treating a disease or disorder, such as a prostate condition. [Background technology]

[0003] One example of a condition in which it is desirable to manipulate or store tissue is benign prostatic hyperplasia (BPH). BPH is one of the most common conditions affecting men, particularly older men. In the United States, more than half of all men have histopathological evidence of BPH by age 60, and by age 85, approximately 9 in 10 men suffer from the condition. Furthermore, the incidence and number of patients with BPH are expected to increase as the average age of the population in developed countries increases.

[0004] Certain treatments for BPH involve gaining access to the urinary tract. New devices and methods are being developed for a variety of procedures to manipulate or retract prostate tissue, either individually or in combination with treating BPH. Some procedures remove tissue, others alter tissue.

[0005] One example of a surgical procedure to treat BPH symptoms is a transurethral incision of the prostate (TUIP). In this procedure, resistance to urine flow is reduced by making one or more incisions in the prostate in the area where the urethra reaches the bladder, also known as the bladder neck. This procedure is performed under general or spinal anesthesia. In this procedure, one or more incisions are made in the muscle of the bladder neck. These incisions are deep enough in most cases to cut the surrounding prostate tissue, including the prostatic capsule. This releases any compression against the bladder neck and separates it in one go. These incisions can be made using a resectoscope, a laser beam, or other methods.

[0006] Another method of interest uses a drug-coated balloon to widen the urinary passage in the area of ​​the prostatic urethra. The drug-coated balloon expands, causing damage to at least the invaded tissue and possibly the underlying tissue. In a typical balloon procedure, tissue around the entire inner circumference of the prostatic urethra is damaged by the expanding balloon. The drug coating on the balloon helps to reduce the hyperproliferative healing response so that the prostatic urethra remains less blocked than it was before the procedure. However, this procedure may cause more tissue damage than is necessary to treat the symptoms of BPH. Summary of the Invention [Problem to be solved by the invention]

[0007] The inventors have recognized that there remains a need to treat the minimum amount of tissue necessary to alleviate the symptoms of BPH in a minimally invasive, low-risk procedure. The present disclosure addresses these needs. [Means for solving the problem]

[0008] Aspects of the present disclosure relate to systems and methods for treating, manipulating, and stabilizing tissue within the prostatic urethra to ameliorate symptoms of BPH. Certain embodiments involve treating tissue within the prostatic urethra by cutting the tissue and delivering a therapeutic substance.

[0009] An embodiment of the disclosure relates to a system for treating tissue within a prostatic urethra including a handle body having a cutter actuator and an inflation port. An embodiment of the system may also include an elongate member coupled to a distal end of the handle body and to the cutter body. An expandable member may be coupled to the distal end of the elongate member. The expandable member may be configured to stabilize the cutter body against the target tissue when the expandable member is expanded. The cutter may be configured to move from a first position within the cutter body to a second position protruding from the cutter slot and back to a third position within the cutter body. An injection port on the handle body in fluid communication with the cutter slot may be configured to deliver a therapeutic substance through the cutter slot to the target tissue.

[0010] An embodiment of the disclosure relates to a system for manipulating tissue within a prostatic urethra including a handle body having a deployment actuator and an inflation port. An embodiment of the system can include an elongate member coupled to a distal end of the handle body. The system can include a delivery body and an expandable member coupled to a distal end of the elongate member. The expandable member can be configured to stabilize the delivery body relative to the target tissue when the expandable member is expanded. The tissue manipulation structure can be configured to move from a first position within the delivery body to a second position at least partially within the prostatic tissue. Movement of the tissue manipulation structure can be controlled through the deployment actuator.

[0011] Other features and advantages of embodiments of the present invention will become apparent from the following description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, certain principles of the invention. These illustrative aspects are mentioned not to limit or define the disclosure of the present invention, but rather to provide examples to aid in its understanding.

[0012] The features, aspects, and advantages of the present disclosure will be better understood upon reading the following Detailed Description of the Invention with reference to the accompanying drawings, in which like numerals may be used to describe like features and components throughout the several views, and which illustrate generally, by way of example, but not by way of limitation, various device and method aspects discussed in this patent document. [Brief description of the drawings]

[0013] [Figure 1] FIG. 1 is a cross-sectional view showing the anatomical structures surrounding the prostate gland in a human subject. [Diagram 2] FIG. 1 is a diagram of tissue from within the prostatic urethra. [Diagram 3] FIG. 1 is a perspective view of a system according to an aspect of the present disclosure. [Figure 4A] FIG. 2 is a perspective view of a distal portion of a system according to an aspect of the present disclosure. [Figure 4B] FIG. 2 is a perspective view of a distal portion of a system according to an aspect of the present disclosure. [Diagram 5] FIG. 2 is a perspective view of a distal portion of a system according to an aspect of the present disclosure. [Figure 6A] FIG. 13 is a partially transparent side view of a distal portion of a system according to an aspect of the present disclosure. [Figure 6B] FIG. 13 is a partially transparent side view of a distal portion of a system according to an aspect of the present disclosure. [Figure 6C] FIG. 13 is a partially transparent side view of a distal portion of a system according to an aspect of the present disclosure. [Figure 6D] FIG. 13 is a partial perspective side view of a distal portion of a system according to an aspect of the present disclosure. [Figure 6E] FIG. 2 is a perspective view of a distal portion of a system according to an aspect of the present disclosure. [Figure 7A] FIG. 13 is a plan view of a proximal portion of a system according to an aspect of the present disclosure. [Figure 7B] FIG. 13 is a plan view of a proximal portion of a system according to an aspect of the present disclosure. [Figure 8A] FIG. 13 is a perspective view of a proximal portion of a system according to an aspect of the present disclosure. [Figure 8B] FIG. 13 is a perspective view of a proximal portion of a system according to an aspect of the present disclosure. [Figure 9A] 1 is a flow diagram illustrating steps in a method of using a system according to an aspect of the present disclosure. [Figure 9B] 11 is a flow diagram illustrating steps of another method of using a system according to an aspect of the present disclosure. [Figure 10] FIG. 2 is a perspective view of another system according to an aspect of the present disclosure. [Figure 11] FIG. 1 is a perspective view of a system according to an aspect of the present disclosure. [Figure 12] 1 is a perspective view of a tissue manipulation construct according to an aspect of the present disclosure; FIG. [Figure 13] FIG. 2 is a perspective view of a distal portion of a system according to an aspect of the present disclosure. [Figure 14] FIG. 2 is a perspective view of a distal portion of a system according to an aspect of the present disclosure. [Figure 15] FIG. 13 is a partial perspective side view of a distal portion of a system according to an aspect of the present disclosure. [Figure 16A] 1 is a flow diagram illustrating steps in a method of using a system according to an aspect of the present disclosure. [Figure 16B] 11 is a flow diagram illustrating steps of another method of using a system according to an aspect of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] In this specification, numerous specific details are set forth to provide a thorough understanding of the claimed subject matter. However, it will be understood by those skilled in the art that the claimed subject matter may be practiced without the use of these specific details. In other instances, methods, apparatus, or systems that would be known to those skilled in the art have not been described in detail so as not to obscure the claimed subject matter.

[0015] The use of "adapted to" or "configured to" herein is meant to be open-ended and inclusive language that does not exclude devices adapted or configured to perform additional tasks or steps. The use of "proximal" and "distal" herein refers to the relative location of the elongated minimally invasive device to the user, with "proximal" meaning relatively toward the user and "distal" meaning relatively away from the user. The headings, lists, and numbering contained herein are for ease of description only and are not meant to be limiting.

[0016] The term "manipulating" as used herein can refer to "cutting," "storing," and / or "stabilizing" tissue. In other examples, "manipulating" can refer to an activity separate from terms such as "cutting." For example, cutting tissue can refer to slicing tissue using the system 100 depicted in FIG. 3, whereas manipulating tissue can refer to creating an opening in the tissue and / or stabilizing the tissue using the systems depicted in FIG. 10 and / or FIG. 11.

[0017] FIG. 1 is a cross-sectional view showing the anatomical structures surrounding the prostate gland in a human subject. The prostate PG is a walnut-sized muscular gland located adjacent to the urinary bladder UB. The urethra UT extends through the prostate PG. The prostate PG secretes fluids that protect and nourish the sperm. The prostate PG contracts to release the semen during ejaculation and to provide a valve to keep the urine out of the semen. The bladder UB holds the urine. The vas deferens VD defines a duct that carries the semen, and the seminal vesicles secrete the semen. The rectum R is the terminal segment of the large intestine tract through which waste products are excreted. The urethra UT carries both urine and semen out of the body. Thus, the urethra connects to the bladder UB to form a passage to the vas deferens VD and the seminal vesicles. Additionally, the trigone T is the smooth triangular end of the bladder. The trigone T is sensitive to distension and signals the brain when the bladder UB is full. The verumontanum is the apex within the wall of the urethra UT where the vas deferens enters. The prostatic urethra is the section of the urethra UT that extends through the prostate.

[0018] The prostate can be described by reference to its lobes. In pathology, a zonal classification is typically used, whereas in anatomy, a lobar classification is more commonly used. The central zone of the prostate PG is approximately 25% of the normal prostate and surrounds the ejaculatory ducts. There is some prevalence of benign prostatic hyperplasia within this transition zone. The fibromuscular zone is usually devoid of glandular components and, as the name suggests, consists only of muscular and fibrous tissue. The transition zone is the region of the gland that approximately overlies the proximal urethra and grows throughout life. Similarly, this lobe is often associated with the pathology of benign prostatic hyperplasia. Finally, the peripheral zone is the subcapsular portion of the posterior aspect of the prostate that surrounds the distal urethra.

[0019] Lobe characteristics differ from zonal characteristics, although there is some overlap. The anterior lobe lacks glandular tissue and is formed entirely of fibromuscular tissue. This lobe therefore corresponds approximately to the anterior part of the transition zone. The posterior lobe corresponds approximately to the peripheral zone and can be palpated through the rectum during a rectal examination. The posterior lobe is the site involved in 70-80% of prostate cancers. The lateral lobe is the main mass of the prostate and is separated by the urethra. The lateral lobe is described as spanning the entire zone. Finally, the middle lobe corresponds approximately to a portion of the central zone. The middle lobe varies greatly in size and in some cases lacks glandular tissue.

[0020] The urethra is present where the lobes abut each other near the anterior medial aspect of the urethra. In some aspects of the present disclosure, the systems and methods relate to cutting, manipulating, and / or stabilizing tissue at the urethra. The embodiments may further involve applying a therapeutic substance to the urethra, e.g., at the cut site. The tissue cut, manipulated, and / or stabilized at the urethra can provide an opening to the stenosed prostatic urethra other than allowing fluid pressure from the bladder to allow urine flow through the prostatic urethra. The estimated length of the urethra in various examples may range from about 10 mm to about 50 mm, with a typical length range of 25±5 mm. Various lengths of the urethra can be manipulated and treated according to the examples described herein.

[0021] Figure 2 is a view of tissue from within the prostatic urethra. Figure 2 illustrates two lateral lobes of the prostate gland PG abutting one another to define a conjunct C. In Figure 2, the prostatic section of the urethra UT is illustrated as having a significantly reduced cross-sectional area due to intrusion of the prostate. Thus, Figure 2 shows a view of the prostatic tissue that requires cutting, manipulation, and / or stabilization by the systems and methods disclosed herein.

[0022] FIG. 3 is a perspective view of a system according to an aspect of the present disclosure. The system 100 is illustrated coupled to an endoscope body 200 at a proximal end of its handle body 110. The handle body 110 includes an actuator 112 operatively connected to a distal section 160 of the system 100. Specifically, the actuator 112 may be operatively connected to a cutter in the distal section 160 of the system 100, and may therefore be referred to as a "cutter actuator" in various embodiments. The handle body 110 in the illustrated example further includes a lock 115 engaged with the actuator 112 to lock or unlock the actuator 112. The lock 115 may engage the actuator 112 to lock the actuator 112 in the sense that the lock 115 prevents the actuator 112 from being actuated when in a locked position, thereby preventing movement of the cutter as described herein. Conversely, the lock 115 may disengage the actuator 112 to unlock the actuator 112 and allow the actuator to be actuated from the unlocked position.

[0023] 3 includes an inflation port 116 and an injection port 118. Both the inflation port 116 and the injection port 118 are configured to deliver fluid to the distal section 160 of the system. The inflation port 116 is configured to deliver inflation fluid through an inflation lumen in the handle body 110 and in the elongate member 150 of the system to the distal section 160 of the system 100. Similarly, the injection port 118 is configured to deliver injection fluid through an injection lumen in the handle body 110 and in the elongate member 150 of the system to the distal section 160 of the system 100. In some examples of the system 100, the injection lumen is also the lumen through which a cutter wire is connected between the actuator 112 and the distal section 160.

[0024] The elongated member 150 connects the handle body 110 to the distal section 160. The elongated member 150 may include an endoscope lumen for an elongated portion of an endoscope configured for use within a patient's body. The elongated member 150 may further include an inflation lumen and an infusion lumen as described above. In some examples of the system, the elongated member 150 includes a cutter wire within the infusion lumen, while in other examples the cutter wire occupies space within the elongated member 150 but is separate from the infusion lumen. The elongated member 150 may be rigid, semi-rigid, or semi-flexible. The elongated member 150 is configured to be insertable within a patient's urethra and is constructed of a material suitable for medical use.

[0025] 4A and 4B are each a perspective view of a distal portion of a system 100 according to an embodiment of the present disclosure. In the illustrated example, an elongate member 150 of the system is connected to a cutter body 170 and an expandable member 180 through a curved portion or articulation 165 (or "articulation section"). An endoscope distal tip 205 can be seen at the distal end of the elongate member 150. In this non-limiting example, the endoscope distal tip 205 is a 30 degree cystoscope. Additional endoscopes may be used.

[0026] Beyond the distal end of the elongated member 150 is an articulation 165, which may have greater flexibility than the elongated member 150. The articulation 165 may be configured to bend at a predefined angle relative to the long axis of the elongated member 150. The predefined curvature at the articulation 165 may be configured to approximately conform to the typical anatomical curvature of the urethra near the prostate and bladder neck. The articulation 165 may be flexible such that it conforms to the curvature of the urethra and allows the distal section 160 to be positioned at the prostatic urethra without puncturing the urethral wall. The articulation 165 presents the cutter body 170 within the field of view that is easily visible through a 30 degree cystoscope. The articulation 165 may be formed from plastic, shape memory material, or other flexible to semi-flexible material suitable for medical applications. The flexibility of articulation 165 allows for easier urethral navigation compared to a completely rigid device, in addition to presenting cutter body 170 at a desired angle relative to the long axis of elongate member 150 within the anatomy. Articulation 165 can include an inflation lumen, an infusion lumen, and a cutter wire.

[0027] The cutter body 170 and the expandable member 180 cooperate to position the cutter (e.g., cutter 172 shown in FIGS. 6A, 6B, 6C, and 6D) in the prostatic urethra, for example, in the correct position against the target prostatic lobe pressing against the urethra. FIG. 4B depicts the expandable member 180 in an expanded configuration compared to the unexpanded configuration shown in FIG. 4A. The expandable member 180 is expanded to press the cutter body 170 against the prostatic urethra when the cutter body 170 is positioned in the desired location within the prostatic urethra. The expandable member 180 ensures that there is sufficient contact between the cutter body 170 and the prostatic tissue to allow the cutter to cut the tissue. The expansion and contraction of the expandable member 180 can be controlled by inflation fluid conducted through an inflation lumen from an inflation port on the handle body 110 of the system 100.

[0028] 5 is a perspective view of a distal portion of a system according to an embodiment of the present disclosure. This view illustrates the side of the cutter body 170 that faces the tissue to be treated. The cutter body 170 includes a cutter slot 175 that provides access for both the cutter (e.g., cutter 172) and the injectable material (not shown). The cutter slot 175 can be about 1.0 cm to about 10 cm in length, including less than about 1.0 cm, or about 1.5 cm, about 2.0 cm, about 2.5 cm, about 3.0 cm, about 3.5 cm, about 4.0 cm, about 4.5 cm, about 5.0 cm, about 5.5 cm, about 6.0 cm, about 6.5 cm, about 7.0 cm, about 7.5 cm, about 8.0 cm, about 8.5 cm, about 9.0 cm, about 9.5 cm, or more than 10.0 cm. In some examples, the length of the cutter slot 175 is preferably about 5.0 cm. The cutter slot 175 can occupy a substantial portion of the tissue-facing surface of the cutter body 170, for example, greater than or equal to about 50% of the length of the cutter body 170, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, or about 95% or more.

[0029] 5 illustrates that the articulation 165 can have flexibility such that the cutter body 170 can be positioned along the same axis as the axis of the elongate member 150, for example, when required to accommodate the shape of the associated anatomical structure. Thus, the flexibility of the articulation 165 can configure the articulation 165 to assume various degrees of curvature (including zero) to accommodate various anatomical features. In some examples, the articulation 165 can be biased into a particular configuration, for example, a straight or curved configuration.

[0030] FIGURES 6A, 6B, 6C, and 6D each show a partial perspective side view of a distal portion of a system according to an embodiment of the present disclosure. In addition to expandable member 180 and cutter body 170, FIGURES 6A, 6B, 6C, and 6D show cutter 172, cutter distal recess 176, cutter track 177, and cutter proximal recess 178. Cutter 172, cutter distal recess 176, cutter track 177, and cutter proximal recess 178 cooperate to enable controlled cutting of tissue when cutter 172 is pulled proximally by a cutter wire through actuation of actuator 112 on handle body 110. Although Figures 6A, 6B, 6C, and 6D each show cutter 172 having distal lobe 181 and proximal lobe 182, other cutter shapes may be desirable and advantageous so long as they allow cutter 172 to fit within cutter body 170 and to at least partially emerge from cutter body 170 when cutter 172 is actuated.

[0031] 6A, cutter 172 is at least partially disposed within cutter distal recess 176 such that no portion of cutter 172 emerges partially through cutter slot 175. With cutter 172 at least partially disposed within cutter distal recess 176, cutter body 170 can be safely introduced into a tissue lumen, e.g., the urethra, and positioned at a desired procedure site, e.g., the prostatic urethra. In some embodiments, cutter slot 175 includes a cutter slot distal lip 173 that helps retain cutter 172 within cutter distal recess 176. That is, when cutter 172 is within cutter distal recess 176, at least a portion of cutter 172 is disposed beneath cutter slot distal lip 173, which helps prevent cutter 172 from inadvertently emerging from cutter slot 175.

[0032] 6B, cutter 172 has begun to advance proximally within cutter body 170 after being initially actuated by actuator 112 on handle body 110. Cutter 172 is completely outside of cutter distal recess 176, with a portion of cutter 172 emerging from cutter slot 175. In this position, cutter 172 is configured to move proximally along cutter trajectory 177, thereby cutting tissue. Cutter trajectory 177 is configured to position cutting edge or face 184 of cutter 172 laterally within cutter slot 175 and also beyond the tissue-facing surface of cutter body 170.

[0033] In FIG. 6C , cutter 172 nearly completes proximal progression within cutter body 170. In the example illustrated by FIG. 6C , cutter trajectory 177 positions the same amount of cutting edge or cutting surface 184 of cutter 172 beyond the tissue-facing surface of cutter body 170 as cutter 172 moves proximally along cutter trajectory 177. In other examples, cutter trajectory 177 positions more or less of cutting edge or cutting surface 184 of cutter 172 beyond the tissue-facing surface of cutter body 170 as cutter 172 moves proximally along cutter trajectory 177. That is, cutter trajectory 177 can be configured to vary the depth of cut into tissue as cutter 172 moves proximally along cutter trajectory 177.

[0034] In some embodiments, the incision depth into the tissue ranges from about 2 mm to about 5 mm, including about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, or about 4.5 mm, with a preferred incision depth of 2.5 mm in some cases. In some cases, it may be desirable to limit the incision depth to 5 mm or less to avoid severing certain anatomical features that may be present in the area, such as the dorsal venous plexus and / or vascular network. In some embodiments, the incision length into the tissue ranges from about 10 mm to about 50 mm, including about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, or about 45 mm, with a preferred incision length of about 20 mm in some cases.

[0035] 6D , cutter 172 has traveled proximally furthest within cutter body 170. At least a portion of cutter 172 is within cutter proximal recess 178, and no portion of cutter 172's cutting edge or cutting face 184 is exposed to tissue. Cutter 172 is completely within cutter body 170 and is positioned directly below cutter slot proximal lip 174, which helps prevent cutter 172 from inadvertently emerging from cutter slot 175 when cutter 172 is within cutter proximal recess 178.

[0036] FIG. 6E is a perspective view of a distal portion of a system according to an embodiment of the present disclosure. FIG. 6E illustrates the presence of a cutter recess 179 in the distal section of the cutter body 170. Although FIG. 6E illustrates the cutter recess 179 as having approximately the same length as the cutter slot 175, the cutter recess 179 can have a length that is longer or shorter than the length of the cutter slot 175. Preferably, the width of the cutter recess 179 is at least about twice the maximum cut depth possible by the configuration of the features of the cutter body 170. In any case, the cutter recess 179 should adequately cover the tissue cutting area. The cutter recess 179 can function to provide a reservoir for the injectable substance so that a sufficient amount of the injectable substance is provided to the treatment target area.

[0037] Each of Figures 7A and 7B is a plan view of a proximal portion of a system according to an embodiment of the present disclosure. Each figure shows that the handle body 110 can include an actuator 112 and a lock 115. In the example shown in Figures 7A and 7B, the lock 115 is a dial or knob that can be rotated from a locked position, shown in Figure 7A, with its indicator portion pointing to the lock indicator 113, and to an unlocked position, shown in Figure 7B, with its indicator portion pointing to the unlock indicator 114. Each of the lock indicator 113 and the unlock indicator 114 can use symbols, words, colors, and / or tactile features to indicate the state of the lock 115 to a user. The lock 115 provides a safety feature that mechanically, electromagnetically, electrically, or otherwise interacts with the actuator 112 to help prevent inadvertent actuation of the cutter.

[0038] 7A and 7B each show a delivery device connected to a port on the handle body 110. An inflation delivery device 117 is configured to connect to and seal or lock with the inflation port 116 to deliver inflation fluid to the system for inflating the expandable member on the distal section. Similarly, an injection delivery device 119 is configured to connect to and seal or lock with the injection port 118 to deliver an injectable material to the system through a cutter slot on the distal section.

[0039] In some examples of the invention, the handle body includes one or more pressure relief valves associated with the inflation source and / or the infusion source. The pressure relief valves can help reduce or prevent over-pressurization within the system or tissue. For example, upon the occurrence of an occlusion in the inflation or infusion flow channel, the pressure relief valves can release fluid pressure after such pressure has increased to a predetermined threshold, thereby preventing serious damage to the system and / or patient.

[0040] 8A and 8B are each perspective views of the proximal portion of the system showing features on the proximal portion handle body 110 according to an embodiment of the present disclosure. Specifically, FIG. 8A shows the actuator 112 in an initial position corresponding to an initial most distal position of the cutter 172 within the cutter body 170, and FIG. 8B shows the actuator 112 in a final position corresponding to a final most proximal position of the cutter 172 within the cutter body 170. Thus, FIGS. 8A and 8B show that the actuator 112 can be depressed toward the handle body 110 to initiate the movement of the cutter. The movement of the cutter can be driven by mechanical, electrical, electromagnetic, hydraulic, pneumatic, or other forces. In some embodiments, the cutter 172 is configured to be resettable to its initial or intermediate position. After being reset, the cutter 172 can be actuated again to make another cut. This reset process can be optionally performed multiple times to allow for additional cuts to be made in tissue after the device is repositioned to a new treatment target area or rotated within the area of ​​an existing treatment target. Repositioning the device may require contraction of the expandable member 180.

[0041] 9A is a flow diagram illustrating steps of a method of using a system disclosed herein (e.g., system 100) according to aspects of the present disclosure. This exemplary method may be utilized in the particular order depicted or in one or more different sequences according to the system and device embodiments described herein. Fewer or more steps may be performed according to variations of the method shown in FIG. 9A and consistent with the remainder of the present disclosure.

[0042] As a first step 300 of the method, a user gains access to the prostatic urethra by inserting a system into the patient's urethra, either directly or through an intermediate device partially positioned within the patient's urethra, such as an access sheath, introducer, guidewire, or combination thereof. In a second step 310 of the method, the prostatic urethra and tissue regions therein are visualized using an endoscope connected to the system. The endoscope can be inserted into and coupled to the system before the system is inserted into the patient or after the system is inserted into the patient. The endoscope is connected to a viewing system.

[0043] In a third step 320 of the method, a treatment target is identified using an endoscope connected to the system. In some aspects of the present disclosure, the treatment target is a ligament in the prostatic urethra, and in some cases, the target is a preligament in the prostatic urethra. In a fourth step 330 of the method, a cutting body is positioned relative to the treatment target. Positioning the cutting body can include rotating the system to radially align the cutting body with the treatment target, axially moving the system to longitudinally align the cutting body with the treatment target, and / or lateral moving the system. These movements can be made in any combination or sequence. In some aspects, a user can position the cutting body by visualizing the prostatic urethra, identifying the treatment target, and / or positioning the endoscope just past the sphincter so that only a proximal portion of the cutter body is visible.

[0044] 9A , in a fifth step 340 of the method, the cutting body is stabilized relative to the treatment target. When the cutting body is in a desired position relative to the treatment target, the expandable member can be expanded to stabilize the cutting body in that position. Alternatively, the cutting body can be positioned close to, but not in contact with, the treatment target such that expansion of the expandable member moves the cutting body from a position close to, to a position in contact with, the treatment target. The expandable member can be expanded by a user using an inflation delivery device connected to an inflation port on the handle body. In one example, a user can depress the plunger of an inflation fluid syringe while viewing the distal section of the system through an endoscope to ensure proper positioning and stabilization of the cutter body in contact with the treatment target. In other examples, other imaging methods can be used, such as fluoroscopy, where a contrast-containing fluid visualizes the expansion of the expandable member and the positioning and stabilization of the cutting body.

[0045] In a sixth step 350 of the method, the cutter is deployed to cut tissue within the treatment target. In one example, the cutter is actuated by a user unlocking a lock on the handle body and depressing an actuator. The cutter moves from a distal position completely within the cutter body to a position where the cutting edge or cutting face protrudes from the cutter body, then moves proximally to cut tissue of the treatment target, and then reaches a proximal position where the cutting edge or cutting face is again completely within the cutter body. In some examples, the cutter can be actuated multiple times such that it then moves distally back to its original position, thereby cutting any tissue it encounters within the treatment target. Additionally, the cutter can be actuated again to make a third and subsequent passes through the treatment target. In some embodiments, the cutter is configured to be resettable to an initial or intermediate position. After being reset, the cutter can be actuated again to make another cut. This reset process can optionally be performed multiple times to make additional cuts within tissue after the device is repositioned to a new treatment target area or rotated within the area of ​​an existing treatment target. Repositioning the device may require retraction of the expandable member. In these cases where the cutter is reset, the method may iteratively return to any one of steps 310 (visualizing the prostatic urethra), 320 (identifying the treatment target), or 330 (positioning the cutter body).

[0046] 9A , in a seventh step 360 of the method, one or more therapeutic substances can be applied to the treatment target. Such one or more therapeutic substances can be applied through the cutter slot by an infusion delivery device connected to an infusion port on the handle body of the device. The infusion delivery device can contain one or more therapeutic substances, and in some instances, another infusion delivery device containing such one or more other therapeutic substances can be connected to the infusion port for subsequent application of one or more other therapeutic substances to the treatment target.

[0047] The therapeutic substance that can be used in the system can be any therapeutic agent or substance. In some preferred aspects, the therapeutic substance is fibrin gel, which can act as a hemostatic agent and as a tissue scaffold to maintain the physical position and alignment of the tissue as it heals. The fibrin gel can be used alone or with other therapeutic substances mixed with it or delivered before or after its application.

[0048] Examples of other substances that are particularly useful are lipophilic, substantially water insoluble drugs such as paclitaxel, rapamycin, daunorubicin, doxorubicin, rapachone, vitamin D2 and vitamin D3, and analogs and derivatives thereof. Other drugs that may be useful include, but are not limited to, glucocorticoids (e.g., dexamethasone, betamethasone), hirudin, angiopeptin, aspirin, growth factors, antisense agents, anticancer agents, antiproliferative agents, oligonucleotides, and more generally antiplatelet agents, anticoagulants, antimitotic agents, antioxidants, antimetabolic agents, antichemotactic agents, and anti-inflammatory agents. Some drugs that may be particularly suitable for suppressing inflammation are corticosteroids such as budesonide, flunisolide, triamcinolone, beclomethasone, fluticasone, mometasone, mometasone furoate, dexamethasone, hydrocortisone, methylprednisolone, prednisone, cortisone, betamethasone, or triamcinolone acetonide. Also useful are, for example, polynucleotides, antisense, RNAi, or siRNA that inhibit inflammation and / or smooth muscle cell or fibroblast proliferation. Antiplatelet agents can include drugs such as aspirin and dipyridamole. Aspirin is classified as an analgesic, antipyretic, anti-inflammatory, and antiplatelet agent. Dipyridamole is a drug similar to aspirin in that it has antiplatelet properties. Dipyridamole is also classified as a coronary vasodilator. Anticoagulants can include drugs such as heparin, protamine, hirudin, and tick anticoagulant protein. Antioxidants can include probucol. Antiproliferative agents include drugs such as amlodipine and doxazosin. Antimitotic and antimetabolic agents that can be used include methotrexate, azathioprine, vincristine, vinblastine, 5-fluorouracil, adriamycin, and mutamycin. Antibiotic agents for use in the system include penicillin, cefoxitin, oxacillin, tobramycin, and gentamicin. Antioxidants for use in the system include probucol. Additionally, genes, nucleic acids, or portions thereof can be used as therapeutic agents. Additionally, collagen synthesis inhibitors such as tranilast can be used.Additionally, other drugs for use in the system include everolimus, somatostatin, tacrolimus, roxithromycin, zunaymycin, ascomycin, bafilomycin, erythromycin, midecamycin, josamycin, concanamycin, clarithromycin, troleandomycin, folimycin, cerivastatin, simvastatin, lovastatin, fluvastatin, rosuvastatin, atorvastatin, pravastatin, pitavastatin, vinblastine, vincristine, vindesine, vinorelbine, etoposide, teniposide, , nimustine, carmustine, lomustine, cyclophosphamide, 4-hydroxycyclophosphamide, estramustine, melphalan, ifosfamide, trofosfamide, chlorambucil, bendamustine, dacarbazine, busulfan, procarbazine, treosulfan, temozolomide, thiotepa, daunorubicin, doxorubicin, aclarubicin, epirubicin, mitoxantrone, idarubicin, bleomycin, mitomycin, dactinomycin, methotrexate, fludarabine, fludarabine-5'-dihydrogen phosphatase , cladribine, mercaptopurine, thioguanine, cytarabine, fluorouracil, gemcitabine, capecitabine, docetaxel, carboplatin, cisplatin, oxaliplatin, amsacrine, irinotecan, topotecan, hydroxycarbamide, miltefosine, pentostatin, aldesleukin, tretinoin, asparaginase, pegaspargase, anastrozole, exemestane, letrozole, formestane, aminoglutethimide, adriamycin, azithromycin, spiramycin, cepharanthin, smc increase Growth inhibitor-2w, epothilones A and B, mitoxantrone, azathioprine, mycophenolate mofetil, c-myc-antisense, b-myc-antisense, betulinic acid, camptothecin, lapachol, beta-lapachone, podophyllotoxin, betulin, podophyllic acid 2-ethylhydrazide, molgramostim (rhuGM-CSF), peginterferon a-2b, lenograstim (r-HuG-CSF), filgrastim, macrotarget, dacarbazine, basiliximab, daclizumab, selectin (cytokine antagonist),CETP inhibitors, cadherins, cytokinin inhibitors, COX-2 inhibitors, NFkB, angiopeptins, ciprofloxacin, camptothecin, fluoroblastine, monoclonal antibodies that inhibit muscle cell proliferation, bFGF antagonists, probucol, prostaglandins, 1,11-dimethoxycanthin-6-one, 1-hydroxy-methoxycanthin-6-one, scopoletin, colchicine, NO donors such as pentaerythritol tetranitrate and syndonoamine, S-nitroso derivatives, tamoxifen, staurosporine, β-estradiol , α-estradiol, estriol, estrone, ethinylestradiol, fosfestrol, medroxyprogesterone, estradiol cypionate, estradiol benzoate, tranilast, camebacurin, and other terpenoids applied in cancer therapy, verapamil, tyrosine kinase inhibitors (tyrphostins), cyclosporin A, 6-α-hydroxy-paclitaxel, baccatin, taxotere, and other macrocyclic oligomers of carbon suboxide (MCS) and their derivatives, mofebutazone, acemetacin, diclofenac , lonazolac, dapsone, o-carbamoylphenoxyacetic acid, lidocaine, ketoprofen, mefenamic acid, piroxicam, meloxicam, chloroquine phosphate, penicillamine, hydroxychloroquine, auranofin, sodium aurothiomalate, oxaceprol, celecoxib, β-sitosterol, ademetionine, myrthecaine, polidocanol, nonivamide, levomenthol, benzocaine, escin, ellipticine, D-24851 (Calbiochem), colcemid, cytochalasin AE, indanosine, nocodazole, S 100 protein, bacitracin, vitronectin receptor antagonists, azelastine, guanidyl cyclase stimulator tissue inhibitor of metalloproteinases-1 and -2, free nucleic acids, nucleic acids incorporated into viral infection media, DNA and RNA fragments, plasminogen activator inhibitor-1, plasminogen activator inhibitor-2, antisense oligonucleotides, VEGF inhibitors, IGF-1, active agents from the antibiotic group, such as cefadroxil, cefazolin, cefaclor, cefotoxin, tobramycin, gentamicin, dicloxacillin,Penicillins such as oxacillin, sulfonamides, metronidazole, antithrombotic agents such as argatroban, aspirin, abciximab, synthetic antithrombins, bivalirudin, coumadin, enoxaparin, desulfated and N-reacetylated heparin, tissue plasminogen activator, GpIIb / IIIa platelet membrane receptor, factor Xa inhibitor antibodies, heparin, hirudin, r-hirudin, PPACK, protamine, prourokinase, streptokinase, warfarin, valin, urokinase, vasodilators such as dipyridamole, trapidil, nitroprusside, PDGF antagonists such as triazolopyrimidines and ceramine, ACE inhibitors such as captopril, cilazapril, lisinopril, enalapril, losartan, thiol protease inhibitors, prostacyclin, vapiprost, interferon alpha, beta, and gamma, histamine antagonists, serotonin inhibitors, apoptosis inhibitors, apoptosis modulators such as p65 NF-kB or Bcl-xL antisense oligonucleotides, halofuginone, nifedipine, tranilast, mutamycin, tea polyphenols, epicatechin gallate, epigallocatechin gallate, boswellic acid and its derivatives, leflunomide, anakinra, etanercept, sulfasalazine, etoposide, dicloxacillin, tetracycline, triamcinolone, mutamycin, procainamide, retinoic acid, quinidine, disopyramide, flecainide, propafenone, sotalol, amidorone, natural and synthetic steroids, such as bryophylline A, inotodiol, maquiloside A, guharakinoside, manso nin, strebloside, hydrocortisone, betamethasone, dexamethasone, non-steroidal substances (NSAIDS) such as fenoprofen, ibuprofen, indomethacin, naproxen, phenylbutazone, and other antiviral agents such as acyclovir, ganciclovir, and zidovudine, antifungal agents such as clotrimazole, flucytosine, griseofulvin, ketoconazole, miconazole, nystatin, terbinafine, antiprotozoal agents such as chloroquine, mefloquine, quinine, and also natural terpenoids such as hypocaesculin, barringtogenol-C21-angelate, 14-dehydroagrostistatin,Agroskerin, agrostistatin, 17-hydroxyagrostistatin, obatodiolide, 4,7-oxycycloanisomelic acid, baccharinoids B1, B2, B3, and B7, tubeimoside, bruceanol A, B, and C, bruceantinoside C, yadandiosid N and P, isodeoxyelephantopine, tomenphantopine A and B, coronarin A, B, C, and D, ursolic acid, hyptatic acid A, zeolin, isoiridogermanal, mytenfoliol, efsanthin A, excissanin A and B, longicaurin B. , scurponeatin C, cambounin, leucamenin A and B, 13,18-dehydro-6-α-senecioyloxycaprin, taxamaylin A and B, regenilol, triptolide, as well as cymarin, apocymarin, aristolochic acid, anopterin, hydroxyanopterin, anemonin, protoanemonin, berberine, chelibrine chloride, cicutoxin, sinococulin, bombrestatin A and B, kudraisoflavone A, curcumin, dihydronitidine, nitidine chloride, 12-β-hydroxypregnadiene-3,20-dione, bile Robol, ginkgo, ginkgolic acid, helenalin, indicin, indicin-N-oxide, lasiocarpine, inotodiol, glycoside 1a, podophyllotoxin, justicidin A and B, lareatin, malotelin, malotochromanol, isobutyrylmalotochromanol, maquiloside A, marcantin A, maytansine, lycorigin, margetin, pancratistatin, liriodenine, bisparthenolidine, oxosinthunin, aristolactam-AII, bisparthenolidine, periplocoside A, gulharakinoside, ursolic acid, deo Xipsorospermine, cycorbin, ricin A, sanguinarine, manu wheat acid, methylsorbifolin, sphaceriachromene, stizophylline, mansonine, strebloside, akagerin, dihydrosambalensine, hydroxyusambalin, strychnopentamine, strychnophylline, usambalin, usambalensine, berberine, liriodenine, oxosinthunine, daphnoretin, lariciresinol, methoxylariciresinol, syringaresinol, umbelliferone, afromosone, acetylvismion B, desacetylvismion A,and Vismion A and B.

[0049] 9B is a flow diagram illustrating steps of another method of using a system disclosed herein (e.g., system 100) according to aspects of the present disclosure. This exemplary method may be utilized in the particular order depicted or in one or more different sequences according to the system and device embodiments described herein. Fewer or more steps may be performed according to variations of the method shown in FIG. 9B and consistent with the remainder of the present disclosure.

[0050] As a first step 301 of the method, a user gains access to the prostatic urethra by inserting a system into the patient's urethra, either directly or through an intermediate device partially positioned within the patient's urethra, such as an access sheath, introducer, guidewire, or combination thereof. In a second step 311 of the method, the prostatic urethra and tissue regions therein are visualized using an endoscope connected to the system. In a third step 321 of the method, a treatment target is identified using an endoscope connected to the system. In a fourth step 331 of the method, a cutting body is positioned relative to the treatment target. In a fifth step 341 of the method, the cutting body is stabilized relative to the treatment target. In a sixth step 351 of the method, a cutter is deployed to cut tissue within the treatment target. In a seventh step 356 of the method, an acute wound treatment is applied to the treatment target, including but not limited to hot water treatment, light treatment, air treatment, heat treatment, energy treatment (such as using radio frequency energy) to control bleeding and / or otherwise prepare the cut tissue for the next step. The acute wound treatment step is intended to take into account acute tissue reactions to the cutting step. In an eighth step 361 of the method, one or more therapeutic substances are applied to the treatment target. In a ninth step 366 of the method, a mechanical stabilizer is applied to the treatment target to maintain the position and / or alignment of the cut tissue. One or more mechanical stabilizers, including but not limited to tissue anchors, tissue containments, implants, stents, catheters, and the like, can be placed at or near the treatment target area where the cut tissues are expected to join together after being cut or otherwise be positioned to reverse or reduce the therapeutic gains made through cutting the tissue. These mechanical stabilizers can be temporary or permanent. In some embodiments, it may be desirable to place a catheter in the patient, as is commonly done in similar procedures.

[0051] 9B, in optional step 336 of the method, the treatment target area may be purged by irrigation and / or aspiration. This optional step 336 may be used one or more times in the method and may be used at various times in the method, for example, between steps 311 and 321, between steps 321 and 331, between steps 331 and 341, between steps 341 and 351, between steps 351 and 356, and between steps 356 and 361. In some embodiments, optional step 336 may be used between steps 351 and 361 if step 356 is not used in the method.

[0052] Among the desirable features of the systems and methods disclosed herein is the ability to control the location, depth, and length of the incision into the tissue. Generally, the systems and methods provide the ability to cut at a variety of locations for the treatment of BPH, but some locations within the anatomy may provide greater therapeutic benefit than others. The location of greatest benefit may vary from patient to patient or may be commonly understood. Embodiments of the disclosed systems and methods explicitly involve identifying the desirability of treatment target locations based on a given patient's anatomy, disease state, and other relevant factors.

[0053] This method of use includes other applications of the system. For example, it may be desirable to use the system to cut a "hypertonic" bladder neck to facilitate a patient's urination. In such uses, the methods of Figures 9A and 9B are applicable.

[0054] FIG. 10 is a perspective view of another system according to aspects of the present disclosure. The system 400 is illustrated coupled to an endoscope body 500 at a proximal end of its handle body 410. The handle body 410 in the illustrated example includes an actuator 412 operatively connected to a distal section 460 of the system 400. Specifically, the actuator 412 can be operatively connected to a deployment or delivery mechanism in the distal section 460 of the system 400, and thus may be referred to as a "deployment actuator" in various embodiments. The handle body 400 further includes a lock 415 engaged with the actuator 412 to lock or unlock the actuator 412. The lock 415 can engage the actuator 412 to lock the actuator 412 in the sense that the lock 415 prevents the actuator 412 from being actuated when in a locked position. Conversely, the lock 415 can disengage the actuator 412 to unlock the actuator 412 and allow the actuator to be actuated from the unlocked position.

[0055] In the example shown in Figure 10, lock 415 is a dial or knob that can be rotated from a locked position in the same or similar manner as lock 115 shown in Figures 7A and 7B. Each of lock indicator 413 and unlock indicator 414 can use symbols, words, colors, and / or tactile features to indicate the state of lock 415 to a user in the same or similar manner as lock indicator 113 and unlock indicator 114 also shown in Figures 7A and 7B. Lock 415 provides a safety feature that mechanically, electromagnetically, electrically, or otherwise interacts with actuator 412 to help prevent inadvertent actuation of the delivery mechanism.

[0056] As shown in FIG. 10, the handle body 410 can include an inflation port 416 configured to deliver fluid through an inflation lumen in the handle body 410 and in the elongate member 450 of the system to the distal section 460 of the system 400. The system 400 includes an elongate member 450 connecting the handle body 410 to the distal section 460. The elongate member 450 includes an endoscope lumen for an elongate portion of an endoscope for use within a patient's body. The elongate member 450 can further include an inflation lumen as described above. Also in some examples of the system, the elongate member 450 includes an actuation wire therein but separate from the inflation lumen. The elongate member 450 can be rigid, semi-rigid, or semi-flexible. The elongate member 450 is configured to be insertable into the urethra of a patient and is constructed from a material suitable for medical use.

[0057] 11 is a perspective view of a system according to an embodiment of the present disclosure. An inflation supply device 417 is connected to the inflation port 416 and configured to seal or lock with the inflation port 416 to supply inflation fluid to the system for inflating the expandable member 480 on the distal section. In some examples, the handle body can include one or more pressure relief valves that can be connected to an inflation source. The pressure relief valves can help reduce or prevent over-pressurization in the system or tissue. For example, upon the occurrence of an occlusion in the inflation flow channel, the pressure relief valves can release such pressure after fluid pressure increases to a predetermined threshold, thereby preventing damage to the system and / or patient.

[0058] 10 and 11 each show that the elongate member 450 of the system is connected to a distal section 460 through an articulation 465 (or "articulation section"). At the distal end of the elongate member 450, an endoscope distal tip 505 can be seen. In this non-limiting example, the endoscope distal tip 505 is a 30 degree cystoscope. Additional endoscopes may be used.

[0059] The articulation 465, which has a higher flexibility than the elongated member 450, can be configured to bend at a pre-formed angle relative to the long axis of the elongated member 450. The pre-determined curvature at the articulation 465 can be configured to approximately conform to the typical anatomical curvature of the urethra near the prostate and bladder neck. The articulation 465 can have a flexibility such that it conforms to the curvature of the urethra and allows the distal section 460 to be positioned at the prostatic urethra without puncturing the urethral wall. The articulation 465 presents the distal section 460 within a field of view that is easily visible with a 30-degree cystoscope. The articulation 465 can be formed from plastic, shape memory material, or other flexible to semi-flexible materials suitable for medical applications. The flexibility of the articulation 465, in addition to presenting the distal section 460 at a desired angle relative to the long axis of the elongated member 450 within the anatomy, allows for easier urethral navigation compared to a completely rigid device. The articulation portion 465 can include an inflation lumen and an actuation wire.

[0060] 12 is a perspective view of a tissue manipulation structure 600 according to an embodiment of the present disclosure. The tissue manipulation structure 600 includes a tissue stabilization member 620 that can be configured to manipulate and stabilize tissue. The tissue stabilization member 620 can stabilize the tissue within the junction such that the junction is held open wider than without the tissue stabilization member 620, e.g., the junction is held longer or wider than without the tissue stabilization member 620. This stabilized opening in the tissue at the junction provides the beginning of a flow channel for urine to begin to flow, and then the fluid pressure opens the remainder of the prostatic urethra. In some embodiments, more than one tissue stabilization member 620 can be delivered to the prostatic urethra to manipulate and stabilize the tissue to create some or all of the flow channels.

[0061] 12, the tissue stabilization members 620 can have a length ranging from about 10 mm to about 50 mm, and in some examples, a length ranging from about 25 mm to about 30 mm. In other examples, multiple tissue stabilization members 620 of relatively shorter lengths can be used with a single elongate member. In such examples, one or more of the tissue stabilization members 620 can have a length ranging from about 5 mm to about 15 mm, including about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, or about 14 mm. The tissue stabilization members 620 can have a width ranging from about 3 mm to about 10 mm, including about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, or about 9 mm, and in some examples, a preferred width is in the range of about 5 mm to about 6 mm.

[0062] The tissue stabilization member 620 can be solid, perforated, fenestrated, or can have some solid portions and some perforated and / or fenestrated portions. Figure 12 illustrates the tissue stabilization member 620 as having six fenestrations 625. In some embodiments, the fenestrations 625 can facilitate tissue ingrowth and / or tissue healing. The tissue stabilization member 620 can have a height ranging from about 1 mm to about 3 mm, and preferably has a height of about 1 mm.

[0063] FIG. 12 illustrates that the tissue manipulation structure 600 can include one or more tissue fixation members 610. FIG. 12 illustrates that there are eight tissue fixation members 610 in the tissue manipulation structure 600. The tissue fixation members 610 can be arranged in a pattern such that there is a set of tissue fixation members 610 on each side of the junction, with each set extending generally along the longitudinal axis of the prostatic urethra and penetrating the tissue of the prostatic lobes. The term "side of the junction" can refer to a portion of one of the lateral lobes that abut to form the junction. Thus, one set of tissue fixation members 610 can penetrate one of the lateral lobes and the other set of tissue fixation members 610 can penetrate the other lateral lobe. The tissue fixation members 610 in each set can be positioned equidistant from each other through the tissue stabilization member 620, or the distance between the tissue fixation members 610 across the tissue stabilization member 620 can be variable. For example, the pairs of sets of tissue fixation members 610 across the tissue stabilization member 620 may form a "V" shape, a "zigzag" shape, or other shape that is advantageous for spanning a line. In some aspects, the tissue fixation members 610 of one set are not directly across the tissue stabilization member 620 from the members of the other set. In a manner in which multiple tissue manipulation structures 600 are deployed in the prostatic urethra, the placement of the tissue fixation members 610 on the tissue stabilization member 620 can vary among the multiple tissue manipulation structures 600.

[0064] The tissue fixation members 610 may have a height ranging from about 2 mm to about 6 mm, including about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, or about 5.5 mm, with a height of about 3 mm being preferred in some instances. Thus, the overall height of the tissue manipulation structure 600 may vary from about 3 mm to about 8 mm, inclusive, with about 4 mm being preferred in some instances. The tissue fixation members 610 may be of uniform height or of non-uniform height. The height of the tissue fixation members 610 may vary in any suitable pattern between sets of tissue fixation members 610 and between sets of tissue fixation members 610.

[0065] The tissue fixation members 610 include one or more features that allow for stable fixation within tissue. Although FIG. 12 shows the tissue fixation members 610 each having two tissue fixation barbs 612, more or fewer tissue fixation barbs 612 can be present on each tissue fixation member 610. The number of tissue fixation barbs 612 or any fixation features present on an individual tissue fixation member 610 can be the same or different than the number of tissue fixation barbs 612 or any fixation features present on any other tissue fixation members 610 of the same tissue manipulation structure 600. The tissue fixation barbs 612 can have different flexibility compared to prostate tissue, and thus the tissue fixation barbs 612 can flex toward the tissue fixation member 610 or remain immobile when inserted into tissue. An important aspect of the tissue fixation barbs 612 is that they are capable of resisting migration of the tissue fixation member 610 out of the tissue after the tissue has been penetrated by the tissue fixation member 610.

[0066] In some cases, it may be desirable to limit the penetration depth into the tissue to about 5 mm or less to avoid damaging certain anatomical features that may be present in the region, such as the dorsal venous plexus and / or vascular network.

[0067] 13 and 14 are perspective views of a distal section of an exemplary system according to an embodiment of the present disclosure. The side of the delivery body 470 facing the tissue to be treated is shown. The delivery body 470 includes a delivery body chamber 475 from which the tissue manipulation construct 600 can be delivered to the tissue. The delivery body chamber 475 is configured to be sized appropriately for delivery of one or more tissue manipulation constructs 600. Thus, the delivery body chamber 475 can have a length ranging from about 10 mm to about 50 mm, and preferably has a length ranging from about 25 mm to about 30 mm. The delivery body chamber 475 can have a width ranging from about 3 mm to about 10 mm, and preferably has a width ranging from about 5 mm to about 6 mm. Additionally, the delivery body chamber 475 can have a depth that varies from about 4 mm to about 10 mm, and in some instances can be preferably about 5 mm. The delivery body chamber 475 can occupy a substantial portion of the tissue-facing surface of the delivery body 470, e.g., about 50% or more of the length of the tissue-facing surface, e.g., about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, or about 95% or more.

[0068] The delivery body 470 and the expandable member 480 cooperate to position the tissue manipulation structure 600 at the correct location within the prostatic urethra. The expandable member 480 expands when the delivery body 470 is positioned at the desired location within the prostatic urethra, pressing the delivery body 470 against the prostatic urethra. The expandable member 480 ensures that there is sufficient contact between the delivery body 470 and the prostatic tissue to allow for accurate placement of the tissue manipulation structure 600 around the urethra. The expansion and contraction of the expandable member 480 can be controlled by inflation fluid conducted through an inflation lumen from an inflation port on the handle body of the system.

[0069] 15 is a partial perspective side view of a distal portion of a system according to an embodiment of the present disclosure. As shown, a delivery body mechanism 478, actuated, for example, through an actuation wire, is actuated to deliver the tissue manipulation structure 600. In one example, the delivery body mechanism 478 is a ramp feature that pushes the tissue manipulation structure 600 out of the delivery body chamber 475 when pulled proximally into the delivery body 470 by the actuation wire. For example, it may be desirable to push the tissue manipulation structure 600 out of the delivery body 470 quickly enough to comfortably penetrate the prostate tissue so that undesirable lateral tearing of the tissue is avoided. The delivery motion can be driven by a variety of mechanisms or forces, including mechanical, electrical, electromagnetic, hydraulic, and / or pneumatic forces. In some embodiments, the delivery body mechanism 478 can be configured to be resettable to an initial or intermediate position. After being reset, the delivery body mechanism 478 can be actuated again to deliver another tissue manipulation structure 600. This resetting process can optionally be performed multiple times so that additional tissue manipulation structures 600 can be placed into the tissue after the device has been repositioned to a new treatment target area or within the area of ​​an existing treatment target. Repositioning the device may require contraction of the expandable member 480.

[0070] 16A is a flow diagram illustrating steps of a method of using a system disclosed herein (e.g., system 400) according to aspects of the present disclosure. This exemplary method may be utilized in the particular order depicted, or in one or more different sequences, according to the system and device embodiments described herein. Fewer or more steps may be performed according to variations of the method shown in FIG. 16A and consistent with the remainder of the present disclosure.

[0071] As a first step 700 of the method, a user gains access to the prostatic urethra by inserting a system into the patient's urethra, either directly or through an intermediate device partially positioned within the patient's urethra, such as an access sheath, introducer, guidewire, or a combination thereof. In a second step 710 of the method, the prostatic urethra and tissue regions therein are visualized using an endoscope connected to the system. The endoscope may be inserted into and coupled with the system before the system is inserted into the patient or after the system is inserted into the patient. The endoscope is connected to a viewing system. In a third step 720 of the method, a treatment target is identified using an endoscope connected to the system. In some aspects of the present disclosure, the treatment target is a segment within the prostatic urethra, and in some cases, the target is a pre-segment segment within the prostatic urethra. In a fourth step 730 of the method, a delivery body is positioned relative to the treatment target. Positioning the delivery body can include rotating the system to radially align the delivery body with the treatment target, axially translating the system to longitudinally align the delivery body with the treatment target, and / or laterally translating the system. These movements can be performed in any combination or sequence. In some aspects, a user can position the delivery body by visualizing the prostatic urethra, identifying the treatment target, and / or positioning the endoscope slightly past the sphincter so that only a proximal portion of the delivery body is visible.

[0072] 16A , in a fifth step 740 of the method, the delivery body is stabilized relative to the treatment target. When the delivery body is in a desired position to contact the treatment target, the expandable member can be expanded to stabilize the delivery body in that position. Alternatively, the delivery body can be positioned close to the treatment target but not in contact with it, such that expansion of the expandable member moves the delivery body from a position close to the treatment target to a position in contact with the treatment target. The expandable member can be expanded by a user using an inflation delivery device connected to an inflation port on the handle body. In one example, a user can depress the plunger of an inflation fluid syringe while viewing the distal section of the system through an endoscope to ensure proper positioning and stabilization of the delivery body in contact with the treatment target. In other examples, other imaging methods can be used, such as fluoroscopy, where a contrast-containing fluid visualizes the expansion of the expandable member and the positioning and stabilization of the delivery body.

[0073] In a sixth step 750 of the method, a tissue manipulation structure is deployed to manipulate and stabilize tissue within the treatment target. In one example, the tissue manipulation structure is deployed by a user unlocking a lock on the handle body and depressing the actuator. In some aspects, the actuator is configured to be resettable to an initial or intermediate position. Once reset, the actuator can be actuated again to deploy another tissue manipulation structure. This reset process can optionally be performed multiple times so that additional tissue manipulation structures can be placed on the tissue after the device is repositioned to a new treatment target area or rotated within the area of ​​an existing treatment target. Repositioning the device may require contraction of the expandable member. In these cases where the cutter is reset, the method can iteratively return to any one of steps 710 (visualizing the prostatic urethra), 720 (identifying the treatment target), or 730 (positioning the cutter body).

[0074] 16B is a flow diagram illustrating steps of another method of using a system disclosed herein (e.g., system 400) according to aspects of the present disclosure. This exemplary method may be utilized in the particular order depicted or in one or more different sequences according to the system and device embodiments described herein. Fewer or more steps may be performed according to variations of the method shown in FIG. 16B and consistent with the remainder of the present disclosure.

[0075] As a first step 701 of the method, a user gains access to the prostatic urethra by inserting a system into the patient's urethra, either directly or through an intermediate device partially positioned within the patient's urethra, such as an access sheath, introducer, guidewire, or combination thereof. In a second step 711 of the method, the prostatic urethra and tissue regions therein are visualized using an endoscope connected to the system. In a third step 721 of the method, a treatment target is identified using an endoscope connected to the system. In a fourth step 731 of the method, a delivery body is positioned relative to the treatment target. In a fifth step 741 of the method, the delivery body is stabilized relative to the treatment target. In a sixth step 751 of the method, a tissue manipulation structure is deployed to manipulate and stabilize tissue within the treatment target. In a seventh step 756 of the method, an acute wound treatment can be applied to the treatment target, including but not limited to hot water treatment, light treatment, air treatment, heat treatment, energy treatment (such as using radio frequency energy) to control bleeding and / or otherwise treat the manipulated tissue. The acute wound treatment phase is intended to take into account acute tissue reactions to the deployment phase. In some aspects, it may be desirable to position a catheter within the patient's body as is commonly done in similar procedures.

[0076] 16B, in optional step 736 of the method, the treatment target area is purged by irrigation and / or aspiration. This optional step 736 may be used one or more times in the method and at various times in the method, for example, between steps 711 and 721, between steps 721 and 731, between steps 731 and 741, between steps 741 and 751, and between steps 751 and 756.

[0077] Among the desirable features of the systems and methods disclosed herein is the ability to manipulate and stabilize tissue to create fluid channels. In general, the systems and methods provide the ability to manipulate and stabilize a variety of locations for the treatment of BPH, although some locations within the anatomy may provide greater therapeutic benefit than others. The location of greatest benefit may vary from patient to patient or may be commonly understood. The methods of the present disclosure explicitly involve identifying the desirability of treatment target locations based on a given patient's anatomy, disease state, and other relevant factors.

[0078] Working Example The Detailed Description is intended to be illustrative and not limiting. For example, the above-mentioned examples (or one or more features or components thereof) can be used in combination with each other. The systems 100 and 400 can be used in sequence, for example, to treat a subject. In additional embodiments, some or all of the distal sections of the systems 100 and 400 can be interchangeable, such that a single device or system can be reversibly coupled to the distal sections 160 and 460 or one or more components thereof, such as the cutter body 170 and the delivery body 470, respectively. Various features or components have been or can be grouped together to streamline the disclosure of the invention. This should not be construed as intending that any unclaimed disclosed feature is essential to the scope of any claim. Rather, the subject matter of the invention may be present in less than all features of a particular disclosed embodiment. While specific elements, embodiments, and applications of the invention have been illustrated and described, it will be understood that the invention is not limited thereto, particularly since modifications may be made by those skilled in the art without departing from the scope of the disclosure of the invention in light of the teachings set forth above. The following claim examples are hereby incorporated into the Detailed Description, with each example standing on its own as a separate embodiment.

[0079] In Example 1, a system for treating a target tissue in a prostatic urethra can include a handle body having a cutter actuator and an inflation port with an elongated member coupled to a distal end of the handle body. The system can further include a cutter body and an expandable member coupled to a distal end of the elongated member. The expandable member can be expandable through a fluid passing through the inflation port and delivered through the elongated member. The expandable member can be configured to stabilize the cutter body against the target tissue when the expandable member is expanded. The system can further include a cutter configured to move from a first position within the cutter body to a second position protruding from the cutter slot and back to a third position within the cutter body. Movement of the cutter can be controlled by the cutter actuator. The system can further include an injection port on the handle body in fluid communication with the cutter slot through the elongated member. The injection port can be configured to deliver a therapeutic substance through the cutter slot to the target tissue.

[0080] In Example 2, the system of Example 1 can optionally be configured such that the handle body is configured to mate with an endoscope.

[0081] In Example 3, the system of any one of Examples 1 or 2 may optionally be configured such that the elongated member includes an endoscope lumen configured to receive an elongated portion of an endoscope.

[0082] In Example 4, the system of any one or any combination of Examples 1 to 3 may optionally be configured such that the cutter body and the expandable member are coupled to a distal end of the elongate member through an articulation section.

[0083] In Example 5, the system of Example 4 can optionally be configured such that the articulation section is configured to bend at a pre-formed angle relative to the long axis of the elongate member.

[0084] In Example 6, the system of any one of Examples 2 or 3 can optionally be configured such that the cutter body is visible through an endoscope.

[0085] In Example 7, the system of any one or any combination of Examples 1 to 6 can optionally be configured such that the expandable member is configured to stabilize the cutter body in contact with the target tissue by expanding away from the cutter body.

[0086] In Example 8, the system of Example 7 can optionally be configured such that the expandable member engages tissue when expanded.

[0087] In Example 9, the system of any one or any combination of Examples 1 to 8 can optionally be configured such that the cutter slot is positioned along a longitudinal axis of the cutter body.

[0088] In Example 10, the system of any one or any combination of Examples 1 to 9 can optionally be configured such that the cutter is configured to move in a distal to proximal direction.

[0089] In Example 11, the system of any one or any combination of Examples 1 to 10 can optionally be configured such that the cutter is configured to move in a proximal to distal direction.

[0090] In Example 12, the system of any one or any combination of Examples 1 to 11 can optionally be configured to further include at least one cutter recess in the cutter body, wherein the cutter is configured to be fully contained within the cutter body when at least a portion of the cutter is positioned in the cutter recess.

[0091] In Example 13, the system of Example 12 can optionally be configured such that the at least one cutter recess includes two cutter recesses.

[0092] In Example 14, the system of Example 13 can optionally be configured such that the two cutter recesses include a distal cutter recess and a proximal cutter recess.

[0093] In Example 15, the system of Example 14 can be optionally further configured to include a cutter track positioned between the distal cutter recess and the proximal cutter recess.

[0094] In Example 16, the system of Example 15 can optionally be configured such that the cutter trajectory is configured to position the cutting edge of the cutter beyond the tissue-facing surface of the cutter body.

[0095] In Example 17, the system of Example 16 can optionally be configured such that the cutter trajectory is configured to vary the depth of cut into the tissue as the cutter moves along the cutter trajectory.

[0096] In Example 18, the system of any one or any combination of Examples 1 to 17 can optionally further include a cutter wire coupled between the cutter actuator and the cutter.

[0097] In Example 19, the system of Example 18 can optionally be configured such that the cutter wire is positioned within the elongate member.

[0098] In Example 20, the system of Example 19 can optionally be configured such that the cutter wire is positioned within a cutter wire lumen within the elongate member.

[0099] In Example 21, the system of Example 20 can optionally be configured such that the cutter wire lumen is in fluid communication with the injection port.

[0100] In Example 22, the system of Example 21 can optionally be configured such that the cutter wire lumen is configured to deliver fluid from the injection port to the cutter slot.

[0101] In Example 23, a method of treating tissue in a target area in a prostatic urethra can involve accessing the prostatic urethra with a treatment system. The system can include a handle body having a cutter actuator and an inflation port with an elongated member coupled to a distal end of the handle body. The system can further include a cutter body and an expandable member coupled to a distal end of the elongated member. The expandable member can be expandable through a fluid passing through the inflation port and delivered through the elongated member, and can be configured to stabilize the cutter body against the target area when expanded. The system can further include a cutter configured to move from a first position within the cutter body to a second position protruding from the cutter slot, and back to a third position within the cutter body. Movement of the cutter can be controlled by a cutter actuator. The system can further include an injection port on the handle body in fluid communication with the cutter slot through the elongated member. The injection port can be configured to deliver a therapeutic substance through the cutter slot to the target area.

[0102] In Example 24, the method of Example 23 can optionally further include stabilizing the cutter body against a target area within the prostatic urethra.

[0103] In example 25, the method of any one of examples 23 or 24 can further include cutting tissue within the prostatic urethra through movement of a cutter.

[0104] In Example 26, the method of any one or any combination of Examples 23 to 25 can further include applying a therapeutic substance to the target area through the cutter slot.

[0105] In Example 27, the method of any one or any combination of Examples 23 to 26 may further include visualizing a target area within the prostatic urethra using an endoscope coupled to the system.

[0106] In Example 28, the method of any one or any combination of Examples 23 to 26 may further include identifying tissue to be cut within the prostatic urethra using an endoscope coupled to the system.

[0107] In Example 29, the method of any one or any combination of Examples 23 to 28 can optionally be performed such that the target area includes a string.

[0108] In Example 30, the method of any one or any combination of Examples 23 to 29 can optionally be performed such that the therapeutic agent includes one or more hemostatic agents, antiproliferative agents, antiplatelet agents, anticoagulants, antimitotic agents, antioxidants, antimetabolic agents, antichemotactic agents, anti-inflammatory agents, or combinations thereof.

[0109] In Example 31, the method of any one or any combination of Examples 23 to 30 can optionally be performed where the treatment material comprises a fibrin gel.

[0110] In Example 32, a system for treating target tissue within a prostatic urethra can include a handle body having a deployment actuator and an inflation port with an elongated member coupled to a distal end of the handle body. The system can further include a delivery body and an expandable member coupled to a distal end of the elongated member. The expandable member can be expandable through a fluid passing through the inflation port and delivered through the elongated member. The expandable member can be configured to stabilize the delivery body relative to the target tissue when the expandable member is expanded. The system can further include a tissue manipulation structure configured to move from a first position within the delivery body to a second position at least partially within the prostatic tissue. Movement of the tissue manipulation structure can be controlled through the deployment actuator.

[0111] In Example 33, the system of Example 32 can optionally be configured such that the tissue manipulation structure includes a tissue stabilization member connected to the tissue fixation member.

[0112] In Example 34, the system of any one of Examples 32 or 33 can be configured such that the tissue manipulation structure includes a tissue stabilization member connected to a plurality of tissue fixation members.

[0113] In Example 35, the system of any one of Examples 33 or 34 can optionally be configured such that the tissue fixation member includes one or more tissue fixation barbs.

[0114] In Example 36, the system of any one or any combination of Examples 33 to 35 can optionally be configured such that the tissue stabilization member is completely solid.

[0115] In Example 37, the system of any one or any combination of Examples 33 to 35 can optionally be configured such that the tissue stabilization member is at least partially perforated or fenestrated.

[0116] In Example 38, the system of any one or any combination of Examples 32 to 37 can optionally be configured such that the handle body is configured to be coupled to an endoscope.

[0117] In Example 39, the system of any one or any combination of Examples 32 to 38 may optionally be configured such that the elongated member includes an endoscope lumen configured to receive an elongated portion of an endoscope.

[0118] In Example 40, the system of any one or any combination of Examples 32 to 39 can optionally be configured such that the delivery body and the expandable member are coupled to the distal end of the elongate member through an articulation section.

[0119] In Example 41, the system of Example 40 can optionally be configured such that the articulation section is configured to bend at a pre-formed angle relative to the longitudinal axis of the elongate member.

[0120] In Example 42, the system of any one of Examples 40 or 41 can optionally be configured such that the delivery body is visible through an endoscope.

[0121] In Example 43, the system of any one or any combination of Examples 32 to 42 can optionally be configured such that the expandable member is configured to stabilize the delivery body in contact with the target tissue by expanding away from the delivery body.

[0122] In Example 44, the system of Example 43 can optionally be configured such that the expandable member engages tissue when it is expanded.

[0123] In Example 45, the system of any one or any combination of Examples 32 to 44 can optionally be configured to further include an actuation wire coupled between the deployment actuator and the delivery body mechanism.

[0124] In Example 46, the system of Example 45 can optionally be configured such that the actuation wire is positioned within the elongate member.

[0125] In Example 47, the system of Example 46 can optionally be configured such that the actuation wire is positioned within an actuation wire lumen within the elongate member.

[0126] In Example 48, the system of any one or any combination of Examples 45 to 47 can optionally be configured such that the delivery body mechanism is configured to move the tissue manipulation structure from a first position to a second position.

[0127] In Example 49, the system of Example 48 can optionally be configured such that the delivery body mechanism is configured to be resettable.

[0128] In Example 50, a method of treating tissue in a target area in a prostatic urethra can involve accessing the prostatic urethra with a treatment system. The system can include a handle body having a deployment actuator and an inflation port with an elongate member coupled to a distal end of the handle body. The system can further include a delivery body and an elongate member coupled to a distal end of the handle body. The expandable member can be expandable through a fluid passing through the inflation port and delivered through the elongate member, and can be configured to stabilize the delivery body relative to the target area when expanded. The system can further include a tissue manipulation structure configured to move from a first position within the delivery body to a second position at least partially within the prostatic tissue. Movement of the tissue manipulation structure can be controlled through the deployment actuator.

[0129] In Example 51, the method of Example 50 can optionally further include stabilizing the delivery body against a target area within the prostatic urethra.

[0130] In Example 52, the method of any one of Example 50 or Example 51 can optionally further include a step of deploying a tissue manipulation structure to manipulate and stabilize tissue in the target area.

[0131] In Example 53, the method of any one or any combination of Examples 50 to 52 may optionally further include a step of visualizing a target area within the prostatic urethra using an endoscope coupled to the system.

[0132] In Example 54, the method of any one or any combination of Examples 50 to 52 may optionally further include a step of identifying a target area within the prostatic urethra using an endoscope coupled to the system.

[0133] In Example 55, the method of any one or any combination of Examples 50 to 54 can optionally be performed such that the target area includes a string.

[0134] remarks Certain terms are used throughout this patent document to refer to particular features or components. As one skilled in the art will appreciate, different people may refer to the same feature or component by different names. This patent document does not intend to distinguish between components or features that differ in name but not function.

[0135] For the terms defined below, the following specific definitions shall apply unless a different definition is provided elsewhere in this patent document. The terms "a," "an," and "the" are used to include one or more than one, regardless of other instances or uses of either "at least one" or "one or more than one." The term "or" is used to mean open-ended, such that "A or B" includes "A but not B," "B but not A," and even "A and B." All numerical values, whether specified or not, are assumed to be modified by the term "about." In general, the term "about" refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the stated value (e.g., having the same function or result). In many instances, the term "about" can include numbers rounded to the nearest significant number. The recitation of numerical ranges by endpoints includes all numbers within that range and all numbers delimiting that range (e.g., 1 to 4 includes 1, 1.5, 1.75, 2, 2.3, 2.6, 2.9, etc. as well as 1 to 1.5, 1 to 2, 1 to 3, 2 to 3.5, 2 to 4, 3 to 4, etc.). The terms "patient" and "subject" are intended to include mammals, such as for human or veterinary uses.

[0136] The scope of the invention shall be determined with reference to the claims, along with the full scope of equivalents to which such claims are entitled. In the claims, the terms "including" and "in which" are used as the plain English equivalents of the terms "comprising" and "wherein." Similarly, in the following claims, the terms "including" and "comprising" are open-ended, i.e., devices, kits, or methods that include features or components in addition to those recited preceding such terms in a claim are still deemed to fall within that claim. Moreover, in the following claims, terms such as "first," "second," and "third" are used merely as labels, and these terms are not intended to impose numerical requirements on their objects.

[0137] The Abstract is provided to enable the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. [Explanation of symbols]

[0138] 100 Systems 110 Handle body 112 Actuator 116 Inflation port 118 Injection port

Claims

1. A system for treating target tissue within the urethral prostatic region, A handle body having a cutter actuator and an expansion port, An elongated member connected to the distal end of the handle body, A cutter body and an expandable member coupled to the distal end of the elongated member, wherein the expandable member is expandable through a fluid supplied through the elongated member via the expansion port, and the expandable member is configured to stabilize the cutter body relative to the target tissue when the expandable member is expanded, A cutter configured to move from a first position within the cutter body to a second position protruding from the cutter slot, and then back to a third position within the cutter body, wherein the movement of the cutter is controlled through the cutter actuator, An injection port on the handle body that is in fluid communication with the cutter slot through the elongated member, the injection port configured to supply a therapeutic substance to the target tissue through the cutter slot, A system that includes this.

2. The system according to claim 1, wherein the handle body is configured to be coupled with an endoscope.

3. The system according to claim 1, wherein the elongated member includes an endoscope lumen configured to receive the elongated portion of an endoscope.

4. The system according to claim 1, wherein the cutter body and the expandable member are connected to the distal end of the elongated member through a joint section.

5. The system according to claim 4, wherein the joint section is configured to bend at a predetermined angle with respect to the long axis of the elongated member.

6. The system according to claim 2 or 3, wherein the cutter body is visible through the endoscope.

7. The system according to claim 1, wherein the expandable member is configured to stabilize the cutter body relative to the target tissue by expanding away from the cutter body.

8. The system according to claim 7, wherein the expandable member engages with tissue when it is expanded.

9. The system according to claim 1, wherein the cutter slot is positioned along the long axis of the cutter body.

10. The system according to claim 1, wherein the cutter is configured to move from distal to proximal.

11. The system according to claim 1, wherein the cutter is configured to move in a proximal to distal direction.

12. The cutter body further includes at least one cutter recess, The cutter is configured such that at least a portion of it fits completely inside the cutter body when positioned in the cutter recess. The system according to claim 1.

13. The system according to claim 12, wherein the at least one cutter recess includes two cutter recesses.

14. The system according to claim 13, wherein the two cutter recesses include a distal cutter recess and a proximal cutter recess.

15. The system according to claim 14, further comprising a cutter track positioned between the distal cutter recess and the proximal cutter recess.

16. The system according to claim 15, wherein the cutter track is configured to position the cutting edge of the cutter beyond the tissue-facing surface of the cutter body.

17. The system according to claim 16, wherein the cutter trajectory is configured to change the depth of the cut into the tissue as the cutter moves along the cutter trajectory.

18. The system according to claim 1, further comprising a cutter wire coupled between the cutter actuator and the cutter.

19. The system according to claim 18, wherein the cutter wire is positioned within the elongated member.

20. The system according to claim 19, wherein the cutter wire is positioned within the cutter wire lumen of the elongated member.

21. The system according to claim 20, wherein the cutter wire lumen is in fluid communication with the injection port.

22. The system according to claim 21, wherein the cutter wire lumen is configured to deliver fluid from the injection port to the cutter slot.

23. A system for treating target tissue within the urethral prostatic region, A handle body having an unfolding actuator and an expansion port, An elongated member connected to the distal end of the handle body, A delivery body and an expandable member coupled to the distal end of the elongated member, wherein the expandable member is expandable through a fluid supplied through the elongated member via the expansion port, and the expandable member is configured to stabilize the delivery body relative to the target tissue when the expandable member is expanded, A tissue manipulation structure configured to move from a first position within the delivery body to a second position at least partially within the prostate tissue, wherein the movement of the tissue manipulation structure is controlled through the deployment actuator, A system that includes this.

24. The system according to claim 23, wherein the tissue manipulation structure includes a tissue stabilization member connected to a tissue fixation member.

25. The system according to claim 23, wherein the tissue manipulation structure includes a tissue stabilization member connected to a plurality of tissue fixing members.

26. The system according to claim 24, wherein the tissue fixing member includes one or more tissue fixing hook-shaped portions.

27. The system according to claim 24, wherein the tissue stabilization member is completely solid.

28. The system according to claim 24, wherein the tissue stabilizing member is at least partially perforated or fenestrated.

29. The system according to claim 23, wherein the handle body is configured to be coupled with an endoscope.

30. The system according to claim 23, wherein the elongated member includes an endoscope lumen configured to receive the elongated portion of an endoscope.

31. The system according to claim 23, wherein the delivery body and the expandable member are coupled to the distal end of the elongated member through an articulated section.

32. The system according to claim 31, wherein the joint section is configured to curve at a predetermined angle with respect to the long axis of the elongated member.

33. The system according to claim 31 or claim 32, wherein the transmission body is visible through an endoscope.

34. The system according to claim 23, wherein the expandable member is configured to stabilize the dispensing body relative to the target tissue by expanding away from the dispensing body.

35. The system according to claim 34, wherein the expandable member engages with tissue when it is expanded.

36. The system according to claim 23, further comprising an operating wire coupled between the deployment actuator and the delivery body mechanism.

37. The system according to claim 36, wherein the operating wire is positioned within the elongated member.

38. The system according to claim 37, wherein the actuating wire is positioned within the actuating wire lumen in the elongated member.

39. The system according to claim 36, wherein the dispensing body mechanism is configured to move the tissue manipulation structure from a first position to a second position.

40. The system according to claim 39, wherein the sending body mechanism is configured to be resettable.

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