Expandable tissue engagement devices and methods

Abstract

A therapeutic device for engaging and manipulating the medial lobe of the prostate is provided. In one aspect, the system includes an expandable structure (200, 954) for enhancing engagement with middle lobe prostate tissue.

Description

[Technical Field]

[0001] The present disclosure relates generally to medical devices and methods, and more particularly to systems and related methods for manipulating or engaging tissues and anatomical or other structures within the body of a human or animal subject for the purpose of treating a disease or disorder. [Background technology]

[0002] One example of a condition in which it is desirable to lift, compress, or otherwise remove pathologically enlarged tissue is benign prostatic hyperplasia (BPH). BPH is one of the most common medical conditions affecting men, particularly older men. It has been reported that in the United States, more than half of all men have histopathological evidence of BPH by age 60, and nearly 9 in 10 men suffer from the condition by age 85. Furthermore, the incidence and prevalence of BPH are expected to increase as the average age of the population in developed countries increases.

[0003] The prostate gland enlarges throughout a man's lifespan. In some men, the prostatic capsule around the prostate may prevent further enlargement. This causes the inner end of the prostate to narrow the urethra. This pressure on the urethra increases resistance to urine flow through the end of the urethra enclosed by the prostate. Thus, the bladder must exert increased pressure to force urine through the increased resistance of the urethra. Chronic hyperstretching causes the muscular wall of the bladder to remodel and become stiff. This combination of increased urethral resistance to urine flow and stiffness, along with bladder wall hypertrophy, results in a variety of lower urinary tract symptoms (LUTS) that can significantly impair a patient's quality of life (QOL). Symptoms include a weak or intermittent stream of urine while urinating, straining while urinating, fidgeting before the stream begins, a feeling that the bladder is not completely empty even after urination (residual urination), dribbling at the end of urination or dribbling after urination (incontinence), frequent urination, especially at night, and a sense of urgency.

[0004] In addition to patients with BPH, LUTS may also be seen in patients with prostate cancer, prostate infections, and the continued use of certain medications (e.g., ephedrine, pseudoephedrine, phenylpropanolamine, antihistamines such as diphenhydramine, chlorpheniramine, etc.) that cause urinary retention, especially in men with benign prostatic hyperplasia.

[0005] Although BPH is rarely life-threatening, it can result in a number of clinical symptoms, including urinary retention, renal failure, recurrent urinary tract infections, incontinence, hematuria, and bladder stones.

[0006] In developed countries, a large percentage of the patient population is treated for BPH symptoms. It is estimated that by age 80, approximately 25% of the male population in the United States will have received some form of treatment for BPH. Currently, effective treatment options for BPH include supportive care, medications (both herbal and prescription), surgery, and minimally invasive procedures.

[0007] For patients who choose the expectant care option, they are not given immediate treatment and undergo regular check-ups to monitor the progress of the disease. This is usually done for patients with minimal symptoms that are not particularly bothersome.

[0008] Medical procedures to treat BPH symptoms include transurethral resection of the prostate (TURP), transurethral electrovaporation of the prostate (TVP), transurethral incision of the prostate (TUIP), laser resection of the prostate, open prostatectomy, transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), interstitial laser coagulation (ILC), and prostatic stenting.

[0009] The most effective current methods for treating BPH carry a high risk of side effects. These methods and devices require either general or spinal anesthesia, or the procedures are performed in a surgical room, with potential side effects that dictate hospitalization for the patient. BPH treatment methods with a low risk of side effects are also associated with smaller reductions in symptom scores. While some of these procedures may be performed under local anesthesia in a clinic setting, patients do not experience immediate relief and, in fact, often experience adverse symptoms for several weeks after the procedure until the body begins to heal. In addition, all instrumental methods require the placement of a urinary catheter in the bladder, potentially for several weeks. In some cases, catheterization is indicated because this treatment actually causes obstruction in the postoperative period; in other cases, catheterization is indicated due to postoperative bleeding and potentially obstructive clot formation. While drug therapy is readily available, results are suboptimal, take a significant time to take effect, and are often accompanied by undesirable side effects. Summary of the Invention [Problem to be solved by the invention]

[0010] Technological advances have been made to develop minimally invasive devices and methods for receiving supracerebrovascular pressure and displacing and / or compressing the lobes of the prostate to provide a less obstructed path through the urethra. These methods have focused on treating the lateral lobes of the prostate. However, there remains a need to develop new devices and methods that can be used for a variety of procedures in which it is desired to elevate, compress, support, or reposition the middle lobe of the prostate, either in individual procedures or in combination with the treatment of BPH. In particular, there is a need for alternative devices and treatment approaches for manipulating the middle lobe of the prostate.

[0011] Still further, there is a continuing need for minimally invasive medical devices and for devices and methods for manipulating tissue in other parts of the anatomy. [Means for solving the problem]

[0012] The present disclosure addresses these and other needs.

[0013] An embodiment of the present invention is a treatment device for engaging and manipulating a median lobe of the prostate gland, the treatment device including an elongated tissue accessing assembly coupled to a handle assembly and configured to be inserted into an introducer sheath, and a tissue engaging structure attached to a distal end portion of the elongated tissue accessing assembly, the tissue engaging structure being capable of transitioning from a contracted state to an expanded state upon exiting the distal end of the elongated tissue accessing assembly.

[0014] In another embodiment of the present invention, the tissue engagement structure includes a first expandable portion having an asymmetric cross-section. In another embodiment of the present invention, a proximal portion of the first expandable portion is attached to the elongated tissue accessing assembly. In another embodiment of the present invention, the tissue engagement structure includes a channel for receiving the distal end portion of the elongated tissue accessing assembly. In another embodiment of the present invention, movement of the tissue engagement structure relative to the elongated tissue accessing assembly is constrained to be along a longitudinal axis of the elongated tissue accessing structure. In another embodiment of the present invention, movement of the tissue engagement structure relative to the elongated tissue accessing assembly transitions the tissue engagement structure from the contracted state to the expanded state. In another embodiment of the present invention, the elongated tissue accessing assembly further includes an aperture and a needle assembly extendable through the aperture. In another embodiment of the present invention, the tissue engagement structure further includes a first visual marker indicating a tissue penetration position for the needle assembly. In another embodiment of the present invention, the tissue engagement structure further includes a second expandable portion having an asymmetric cross-section. In another embodiment of the present invention, the elongate tissue access assembly further includes an aperture and a needle assembly extendable through the aperture.

[0015] An embodiment of the present invention is a system for engaging and manipulating a median lobe of the prostate gland, the system including an anchor delivery device including an elongated tissue accessing assembly configured to be inserted into an introducer sheath, a tissue anchor housed within the anchor delivery device, and a tissue engagement structure attached to a distal end portion of the elongated tissue accessing assembly, the tissue engagement structure being capable of transitioning from a contracted state to an expanded state upon exiting the distal end of the elongated tissue accessing assembly. In another embodiment of the present invention, the tissue engagement structure includes a first expandable portion having an asymmetric cross-section. In another embodiment of the present invention, a proximal portion of the first expandable portion is fixedly attached to the elongated tissue accessing assembly. In another embodiment of the present invention, the tissue engagement structure includes a slidable portion coupled to the elongated tissue accessing assembly. In another embodiment of the present invention, movement of the tissue engagement structure relative to the elongated tissue accessing assembly transitions the tissue engagement structure from the contracted state to the expanded state. In another embodiment of the present invention, the anchor delivery device further includes a needle assembly. In another embodiment of the present invention, the needle assembly is configured to deliver the tissue anchor. In another embodiment of the present invention, the tissue engagement assembly includes a first expandable portion. In another embodiment of the present invention, the tissue engagement structure further includes a first visual marker indicating a tissue entry position for the needle assembly. In another embodiment of the present invention, the tissue engagement structure further includes a second expandable portion.

[0016] Other features and advantages of the present disclosure will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the disclosure. [Brief explanation of the drawings]

[0017] [Figure 1] 1 is a cross-sectional view showing the anatomy of the region surrounding the prostate gland in a human subject. [Figure 2]FIG. 2 is an enlarged cross-sectional view of the area of ​​FIG. 1 showing the anatomical structures immediately surrounding and adjacent to the prostate gland. [Figure 3] FIG. 1 is a schematic diagram showing the anatomical zones of the prostate gland. [Figure 4] FIG. 4 is a schematic cross-sectional view showing further details of the anatomical zone shown in FIG. 3. [Figure 5] FIG. 1 is a cross-sectional view of a normal prostate gland. [Figure 6] FIG. 1 is a cross-sectional view of a prostate gland with enlarged lateral lobes. [Figure 7] FIG. 1 is a cross-sectional view showing a prostate gland with enlarged lateral lobes and an enlarged median lobe. [Figure 8A] FIG. 1 is a side view illustrating an embodiment of a delivery device. [Figure 8B] FIG. 10 is an enlarged perspective view of the distal end of an embodiment of a delivery device. [Figure 9A] 1A-1C are top views illustrating embodiments of expandable structures that can be used to engage and manipulate tissue. [Figure 9B] 1A-1C are perspective views illustrating an embodiment of an expandable structure that can be used to engage and manipulate tissue. [Figure 9C] 1A-1C are enlarged views showing embodiments of expandable structures that can be used to engage and manipulate tissue. [Figure 10] FIG. 10 is a perspective view of another embodiment of an expandable structure that can be used to engage and manipulate tissue. [Figure 11] FIG. 10 is a perspective view of another embodiment of an expandable structure that can be used to engage and manipulate tissue. [Figure 12A] 1A-1C are top perspective views illustrating an embodiment of an expandable engagement and manipulation device. [Figure 12B] FIG. 10 is an enlarged top perspective view of a distal end portion of the expandable engagement and manipulation device. [Figure 12C]FIG. 10 is a perspective view of another embodiment of an expandable structure that can be used to engage and manipulate tissue. [Figure 12D] FIG. 10 is an enlarged bottom perspective view showing a distal end portion of the expandable engagement and manipulation device. [Figure 12E] FIG. 10 is an enlarged bottom view showing the distal end portion of the expandable engagement and manipulation device. [Figure 12F] FIG. 10 is an enlarged side view showing a distal end portion of the expandable engagement and manipulation device. [Figure 12G] FIG. 10 is a cross-sectional view of a distal end portion of an expandable engagement and manipulation device. [Figure 13A] 1A and 1B are plan views illustrating an embodiment of an expandable structure with telescoping arms that can be used to engage and manipulate tissue. [Figure 13B] 10A-10C are various partial perspective views showing telescoping arms that can be used to engage and manipulate tissue. [Figure 13C] 10A-10C are various partial perspective views showing telescoping arms that can be used to engage and manipulate tissue. [Figure 13D] 10A-10C are various partial perspective views showing telescoping arms that can be used to engage and manipulate tissue. [Figure 14A] 10A-10C are cross-sectional views showing alternative configurations for the telescoping arms. [Figure 14B] 10A-10C are cross-sectional views showing alternative configurations for the telescoping arms. [Figure 15A] 1A-1C are various cross-sectional views detailing an approach to engaging, compressing, and manipulating the medial lobe of the prostate. [Figure 15B] 1A-1C are various cross-sectional views detailing an approach to engaging, compressing, and manipulating the medial lobe of the prostate. [Figure 15C] 1A-1C are various cross-sectional views detailing an approach to engaging, compressing, and manipulating the medial lobe of the prostate. [Figure 15D]1A-1C are various cross-sectional views detailing an approach to engaging, compressing, and manipulating the medial lobe of the prostate. [Figure 16A] FIG. 10 is a perspective view showing a distal end portion of an expandable structure that can be used to engage and manipulate tissue contained in a sheath. [Figure 16B] FIG. 16B is a perspective view showing the distal end portion of the expandable structure of FIG. 16A in an expanded state after exiting the sheath. [Figure 17A] FIG. 1 is a perspective view showing the distal end of the sheath. [Figure 17B] FIG. 10 is a perspective view showing an expanded structure that can be used to engage and manipulate tissue attached to a sheath. [Figure 18A] 1A-1C are perspective views illustrating an embodiment of an expandable structure that can be used to engage and manipulate tissue in a contracted state. [Figure 18B] 1A-1C are perspective views illustrating an embodiment of an expandable structure that can be used to engage and manipulate tissue in an expanded state. [Figure 19A] FIG. 10 is a perspective view illustrating another embodiment of an expandable wire structure that can be used to engage and manipulate tissue in a contracted state. [Figure 19B] FIG. 10 is a perspective view illustrating another embodiment of an expandable wire structure that can be used to engage and manipulate tissue in an expanded state. [Figure 20A] FIG. 10 is an enlarged perspective view showing a distal end portion of an expandable engagement and manipulation device incorporating various complementary tissue engagement structures. [Figure 20B] FIG. 10 is an enlarged perspective view showing a distal end portion of an expandable engagement and manipulation device incorporating various complementary tissue engagement structures. [Figure 20C] FIG. 10 is an enlarged perspective view showing a distal end portion of an expandable engagement and manipulation device incorporating various complementary tissue engagement structures. [Figure 20D] FIG. 10 is an enlarged perspective view showing a distal end portion of the device incorporating a tissue approximation section and various complementary tissue engaging structures. [Figure 20E]FIG. 10 is an enlarged perspective view showing a distal end portion of the device incorporating a tissue approximation section and various complementary tissue engaging structures. [Figure 20F] FIG. 10 is an enlarged perspective view showing a distal end portion of the device incorporating a tissue approximation section and various complementary tissue engaging structures. [Figure 20G] FIG. 10 is an enlarged view showing structures that may be incorporated into the distal end portion of the tissue engaging and manipulation device. [Figure 20H] FIG. 10 is an enlarged view showing structures that may be incorporated into the distal end portion of the tissue engaging and manipulation device. [Figure 21] 10A-10C are partial cross-sectional views illustrating yet another approach to engaging target tissue and manipulating a target device. [Figure 22] FIG. 10 is an enlarged view showing yet another structure incorporated into the engagement and manipulation device. [Figure 23] FIG. 10 is an enlarged view showing a capture structure forming part of the engagement and manipulation device. [Figure 24A] 10A-10C are enlarged views illustrating structures that may be incorporated into the distal end portion of a tissue engagement and manipulation device and methods for engaging and manipulating tissue. [Figure 24B] 10A-10C are enlarged views illustrating structures that may be incorporated into the distal end portion of a tissue engagement and manipulation device and methods for engaging and manipulating tissue. [Figure 25A] FIG. 10 is an enlarged view showing structures that may be incorporated into the distal end portion of the tissue engaging and manipulation device. [Figure 25B] FIG. 10 is an enlarged view showing structures that may be incorporated into the distal end portion of the tissue engaging and manipulation device. [Figure 26A] FIG. 10 is an enlarged view showing structure that may be incorporated into the handle portion of the tissue engaging and manipulation device. [Figure 26B] FIG. 10 is an enlarged view showing structure that may be incorporated into the handle portion of the tissue engaging and manipulation device. [Figure 27A] FIG. 10 is an enlarged view showing other structures that may be incorporated into the distal end portion of the tissue engaging and manipulation device. [Figure 27B] FIG. 10 is an enlarged view showing other structures that may be incorporated into the distal end portion of the tissue engaging and manipulation device. DETAILED DESCRIPTION OF THE INVENTION

[0018] Referring now to the drawings, which are provided by way of example and not limitation, the present disclosure is directed to a device configured to engage and manipulate tissue within a patient's body for therapeutic purposes. The disclosed device can be used for a variety of medical purposes, such as retracting, lifting, compressing, supporting, and / or repositioning tissue, organs, anatomical structures, grafts, or other materials found within a patient's body. Such tissue manipulation is intended to facilitate treatment of diseases or disorders, such as displacement, compression, and / or retraction of the middle lobe of the prostate.

[0019] In one aspect of the disclosure, the tissue engagement or manipulation forms the primary interventional procedure. In another aspect, the tissue engagement or manipulation forms part of an interventional procedure, such as for the treatment of BPH, or to retract, elevate, compress, approximate, support, or reposition a first portion of an anatomical structure relative to a second portion of the anatomical structure.

[0020] With reference to Figures 1-4, various features of the urinary anatomy of a human male subject are provided. The prostate gland (PG) is a walnut-sized gland located adjacent to the bladder (UB). The urethra (UT) extends through the prostate gland (PG) and the penis (P). The prostate gland (PG) secretes fluids that protect and nourish the sperm. The prostate gland (PG) also contracts during ejaculation to expel sperm and provides a valve to prevent urine from entering the semen. A capsule surrounds the prostate gland.

[0021] The urinary bladder UB holds urine. The vas deferens VD constitutes the transport duct through which semen is carried, and the seminal vesicles SV secrete semen. The rectum R is the end of the large intestine that excretes waste. The urethra carries both urine and sperm out of the body. Thus, the urethra connects to the bladder UB and also provides a passageway to the vas deferens VD and seminal vesicles SV. The verumontanum VM is the crest of the urethral wall where the vas deferens enter. The prostatic urethra is the portion of the urethra that extends through the prostate. The trigone T (see Figure 3) is a smooth, triangular region of the bladder. The trigone T is distension-sensitive and sends a signal to the brain when the bladder UB is full.

[0022] The prostate can be classified by zones or described by referring to its lobes (see Figure 4). Zone classification is typically used in pathology, while lobe classification is more often used in anatomy. The central zone (a) of the prostate is approximately 25% of the normal prostate; this zone surrounds the ejaculatory ducts. The transitional zone contains some transmission of benign prostatic hyperplasia. The fibromuscular zone (b) typically lacks glandular components and, as the name suggests, is composed of muscular and fibrous tissue. The transitional zone (c) is the region of the prostate that extends above the proximal urethra and grows throughout life. This zone is often associated with the condition benign prostatic hyperplasia. Finally, the peripheral zone (d) is the posterior subcapsular portion of the prostate that surrounds the distal urethra.

[0023] Lobe characterization differs from zone characterization, although there is some overlap. The posterior lobe lacks glandular tissue and is formed of fibromuscular tissue. The anterior lobe roughly corresponds to the anterior portion of the transitional zone (c). The posterior lobe roughly corresponds to the peripheral zone (d) and can be palpated through the rectum during digital rectal examination. The posterior lobe is the site of 70-80% of prostate cancers. The lateral lobe is the main mass of the prostate and is separated by the urethra. All pathological zones can be found in the lateral lobe. Finally, the middle lobe roughly corresponds to part of the central zone. The middle lobe varies greatly in size from subject to subject and, in some cases, lacks glandular tissue.

[0024] A large or enlarged middle lobe can act as a ball valve, closing the bladder neck or opening into the urethra. To address this condition, various approaches are possible, including compressing, displacing, and / or retracting the middle lobe to eliminate or reduce the obstruction of the bladder neck opening.

[0025] Referring now to Figures 5-7, various prostate glands are shown in cross section. Figure 5 illustrates the bladder UB and prostate gland PG of a healthy subject. Figure 6 illustrates an individual with a prostate gland having an enlarged lateral lobe LL, while Figure 7 illustrates a subject suffering from both an enlarged lateral lobe LL and an enlarged median lobe ML. It should be understood that such enlarged anatomical structures impinge on the urethra UT and adversely affect normal bladder function. The following devices can be used to access and manipulate prostate tissue during interventional or diagnostic procedures:

[0026] 8A and 8B, a treatment device 100 is shown. The treatment device 100 includes a handle assembly 102 and an elongated access assembly 104. The elongated access assembly 104 may be configured to access an intervention site and to engage and manipulate target tissue. The treatment device 100 may be configured to assemble and implant one or more assemblies or implants within a patient's body. The device is further contemplated to be compatible for use with minimally invasive techniques (such as cystoscopy) so that the patient can tolerate the procedure while awake or under light sedation rather than under general anesthesia. The device further includes structure configured to accept a conventional remote viewing device (e.g., an endoscope) to allow the physician to observe the steps being performed at the intervention site.

[0027] The elongate assembly 104 may house elements for manipulating the target tissue, such as the needle assembly 106. The elongate device 104 may also include features for manipulating the target tissue and / or stabilizing the device at the intervention site. The elongate assembly 104 may be inserted through a sheath of a size compatible with conventional cystoscopy, including sizes such as those shown in FIG. 19F or FIG. 21F. The elongate assembly 104 may be rigid or flexible. In some preferred embodiments, the elongate assembly 104 may be sufficiently rigid (or may be adapted to be sufficiently rigid when in the intervention position) to allow manual compression of tissue at the intervention site by leveraging or compressing the handle assembly 102. Various embodiments of the treatment device 100 may include subassemblies and components for dissecting, resecting, or otherwise modifying prostatic lobes.

[0028] In one particular, non-limiting use in treating the prostate gland, the elongated access assembly of the delivery device is placed within the patient's urethra leading to the bladder. In one approach, the delivery device may be placed within an introducer sheath that is pre-positioned in the urethra, or alternatively, the delivery device may be placed directly within the urethra. When using an introducer sheath, the sheath may be attached to a sheath mount assembly. The sheath is advanced within the patient until its leading end reaches the prostate gland. In a particular approach, a first side of the prostate gland (i.e., lateral lobe) to be treated is selected as the device extends through the bladder, and the device is adjusted accordingly. The distal end of the elongated tissue access assembly may be used to push the urethra down into the prostate gland by compressing the inner prostate tissue. The inside of the prostate gland (i.e., the adenoma) is spongy and flexible, while the outer surface of the prostate gland is hard. By rotating the elongated tissue access assembly laterally about the pubic symphysis PS relative to the patient's midline, the physician can depress the urethra into the prostate, compressing the glandular mass and creating the desired opening through the urethra. Further details and background regarding related complementary interventional procedures are provided in various U.S. patents, including U.S. Patent Nos. 8,491,606 and 8,758,366, the contents of which are incorporated herein by reference in their entireties.

[0029] When using a treatment device at an intervention site, such as the middle lobe of the prostate, before deploying an implant or modifying the prostate, the middle lobe often requires pushing into position conducive to receiving the implant. Described below are embodiments of devices and methods of use that can position and stabilize treatment devices to better engage and manipulate target tissue, including the middle lobe of the prostate. In preferred embodiments, such devices may include an expandable / foldable structure with wings that increase the distal surface area of ​​the device for engaging and manipulating tissue.

[0030] 9A-9C illustrate an expandable member 200 that may be configured to be attached to the distal end of an elongate member. The expandable member 200 may include arms 202a and 202b that are positioned parallel (or substantially parallel) and connected to a distal connecting member 206 at the distal end of the member 200. Each arm includes a portion that extends outward beyond the longitudinal axis of the arms 202a and 202b. Such expandable portions may be wings 208a and 208b. In some embodiments, the wings 208a and 208b may be connected to form a closed loop (not shown) instead of the distal connecting member 206. The distal connecting member 206 may be grooved, channeled, or otherwise indented to create an opening 210 formed in the distal connecting member 206.

[0031] Wings 208a and 208b can be configured to be biased to the extended position. In this embodiment, wings 208a and 208b are moved to the retracted position by longitudinally moving distal linking member 206 and / or arms 202a and 202b away from wings 208a and 208b. In another embodiment, wings 208a and 208b are configured in the retracted position and are moved to the extended position by longitudinally moving distal linking member 206 and / or arms 202a and 202b toward wings 208a and 208b. In some embodiments, each wing can be independently extended or retracted by longitudinally moving the arm on the same side as that wing away from or toward that wing, as the configuration requires.

[0032] The proximal end of expandable member 200 can be attached to elongate tissue approximation assembly 204 by connecting arms 202a and 202b to the shaft of elongate tissue approximation assembly 204. In some embodiments, elongate assembly 204 is inserted through expandable member 200 so that inwardly facing side 212a of arm 202a and inwardly facing side 212b of arm 202b are flush with portions of outwardly facing sides 214a and 214b of elongate assembly 204 and attached by welding or other conventional attachment means. The distal end of expandable member 200 can interact with a portion of elongate assembly 204. For example, opening 210 can be configured to snap into or otherwise be attached by elongate assembly 204. As shown in FIG. 9C , the elongate assembly 204 can include tabs 216a and 216b removably fastened onto the distal connecting member 206, thereby holding the distal end of the expandable member 200 in place. In some embodiments, for example, when the elongate assembly 104 includes holes 220, the wings 208a and 208b can be positioned in any plane relative to the holes 220. Furthermore, the wings 208a and 208b can be positioned in the same plane relative to each other or at an angle relative to each other. In some embodiments, the angle between the planes of the wings is adjustable. In some embodiments, the elongate assembly is configured to allow a treatment assembly, such as a needle assembly, to extend through the holes.

[0033] In some embodiments, the expandable member 200 can be delivered using a sheath. The sheath houses the expandable member 200 and functions to collapse or compress the wings 208a and 208b as the device is delivered to the patient's intervention site. Once at the target site, extension of the expandable member 200 through a distal opening in the sheath can be actuated by the treatment device's handle assembly. As the expandable member 200 exits the sheath, the wings 208a and 208b expand or spring open, moving away from the centerline to contact and manipulate the target tissue. This delivery maintains wing alignment while preventing tissue trauma from the wing edges. According to one embodiment, arms 202a and 202b are fixedly attached to elongate assembly 204, and distal linking member 206 is free to move longitudinally relative to wings 208a and 208b, allowing extension and retraction of wings 208a and 208b as they exit the sheath. According to another embodiment, arms 202a and 202b are free to move longitudinally relative to wings 208a and 208b, and distal linking member 206 is fixedly attached to elongate assembly 204, allowing extension and retraction of wings 208a and 208b as they exit the sheath.

[0034] FIG. 10 illustrates another embodiment of an expandable member that can be attached to the distal end of a treatment device. The expandable member 300 can include parallel or substantially parallel arms 302a and 302b. Each arm can include a portion that can extend outward beyond the longitudinal axis of the arms 302a and 302b. Wings 308a and 308b can be coupled to a distal attachment piece 306 at the distal end of the expandable member 300. In one embodiment, the distal attachment piece 306 is horseshoe-shaped. The distal attachment piece 306 can be positioned in a substantially perpendicular configuration relative to the wings 308a and 308b. The distal attachment piece 306 can include tabs 310a and 310b. The attachment piece 306 can be configured to receive and form a secure connection with a portion of the distal end of the treatment device.

[0035] 11 illustrates another embodiment of an expandable member. Expandable member 400 can include parallel or substantially parallel arms 402a and 402b. Each arm can include a portion that can extend outward beyond the longitudinal axis of arms 402a and 402b. Wings 408a and 408b can terminate in curved ends 410a and 410b, respectively, that connect to create a channel 406. Channel 406 can be configured to receive and attach a portion of the distal end of a treatment device.

[0036] 10 and 11 illustrate configurations of the distal end of the expandable member that facilitate attachment of the expandable member to a treatment device. Other configurations that facilitate attachment of the expandable member to a treatment device are contemplated, and the present disclosure is not limited to the attachment configurations shown in FIGS. 10 and 11.

[0037] Referring again to the embodiment of the treatment device shown in Figures 8A and 8B, the device is configured so that needle actuator 108 and needle retraction lever 110 are in a standby position ready to provide treatment, such as delivery of a tissue anchor. Depressing needle actuator 108 advances needle assembly 106 from within elongated tissue access assembly 104 (see Figure 8B). The needle assembly may be configured so that when the needle assembly is ejected, it curves back toward the handle. For use in prostate intervention, the needle assembly is advanced past the prostate. Spring deployment helps ensure that the needle remains within the prostate capsule and quickly passes through the prostate's tough outer capsule without missing the capsule.

[0038] After depressing the needle actuator 108 and unlocking the needle retraction lever 110, the needle lever 110 can be actuated. Such action retracts the needle assembly 106. In some embodiments, the needle assembly 106 is retracted further than its original position in device pre-deployment. In prostate interventional procedures, this action can be used to deliver various actuatable members, such as implants or tissue anchors, to facilitate modification of prostate tissue.

[0039] The expandable member can be used to position the elongated tissue accessing assembly 104 so that it engages the middle lobe before and during implant deployment and / or prostate tissue modification by increasing the surface area of ​​the distal end of the elongated tissue accessing assembly 104. The expandable member can also be used to displace and widen the urethral wall.

[0040] As shown in FIGS. 12A-12G, the elongate assembly 450 can include a distal end 452 with an expandable member 460. The expandable member 460 can include parallel arms 462a and 462b attached to the shaft of the distal end 452. Each arm includes expandable portions, or wings 464a and 464b, that extend outward beyond the longitudinal axis of the arms 462a and 462b. The distal end of the expandable member 460 can include a channel 466 for receiving and attaching a portion of the distal end of the elongate assembly 450. FIGS. 12F and 12G show cross-sectional views of the channel 466 with tabs 468a and 468b that fasten onto a portion of the distal end 452 of the elongate assembly 450. Inserting elongate assembly 450 into channel 466 allows the distal end of expandable member 460 to slide along the shaft of the assembly, facilitating movement of the wing positions from a "closed" (compressed toward the centerline) configuration to an "open" (displaced away from the centerline) configuration. Additionally, movement of expandable member 460 relative to the treatment device is constrained to the longitudinal axis of the treatment device. Furthermore, such alignment does not present additional obstruction to the cystoscope or endoscope when it is used during a procedure.

[0041] When elongate assembly 450 is inserted into a sheath (not shown), for example, when the device is delivered to an intervention site in a patient, wings 464a and 464b collapse toward the centerline of the longitudinal axis of the distal end of the treatment device, thereby lowering its profile. Once at the target site, wings 464a and 464b can expand away from the centerline of the treatment device as elongate assembly 450 is extended through the distal opening of the sheath.

[0042] In some embodiments, the expandable member 460 is made from stainless steel having a thickness of 0.006 inches (0.015 cm). The cross-section of the arms and / or wings of the expandable member may advantageously be asymmetric. For example, the cross-section may be rectangular or oval, with one axis substantially longer than the orthogonal axis. Stiffness facilitates tissue capture and manipulation, while flexibility facilitates expansion and retraction of the expandable member. In some or the same embodiments, the arms and / or wings are configured with rounded edges to minimize trauma during use. In some embodiments, the inner surface of wings 464a and 464b may include a visual line marker 470 that indicates an entry position for a needle assembly (not shown) exiting the side of elongate assembly 450.

[0043] Other embodiments of structures that can be used to better engage and manipulate target tissue, including the median lobe of the prostate, are considered below. In some embodiments, wings 508a and 508b can be deployed from expandable member 500 using a pair of telescoping arms. As shown in FIGS. 13A-13D, wing 508a is attached to or continuous with arm 502b. Arms 502a and 502b can be coupled within sleeve 522a such that arm 502b glides along stationary arm 502a (shown by the dashed arrow in FIG. 13C), transitioning from a contracted state to an expanded state and simultaneously transitioning wing 508a from a contracted (“closed”) state to an expanded (“open”) state outward from the longitudinal axis of member 500. Expandable member 500 can be inserted into a sheath for placement at the intervention site. Once the device is positioned at the target site, the delivery device is actuated, causing arms 502c and 502d to deploy from sleeves 502c and 502d, respectively, and engage the target tissue.

[0044] An alternative embodiment of the telescoping arms is shown in Figures 14A and 14B. In Figure 14A, interlocking arms 550a and 550b are shown. Arm 550a can include rounded edges 552 that receive and cover the top and bottom edges of arm 550b. In Figure 14B, interlocking arms 560a and 560b each have a rounded end and a flat end. When interlocked, the rounded end of each arm covers the flat end of the opposite arm.

[0045] In the telescoping arm designs of Figures 13A-13D and 14A-14B, the stationary arms may be attached to the shaft of the elongate assembly of the treatment device, providing guided and stabilized alignment and delivery of the winged or similarly looped distal end to the intervention site.

[0046] Referring now to Figures 15A-15D, an approach for engaging and manipulating the enlarged middle lobe ML is provided. Such an approach can be used as a complementary therapy to treatment for the lateral lobes or can be used exclusively to treat the middle lobe ML. Because the enlarged middle lobe ML can extend into the bladder UB and act as a ball valve that interferes with normal function (see Figures 15A and 15B, where Figure 15A is a cross-sectional view of the urethra entering the bladder), it is desirable to move tissue away from the location of the ball valve (i.e., away from the bladder neck). Avoiding such an invasive approach (such as TURP) significantly reduces the risk of disrupting nerve tissue and / or smooth muscle at the bladder neck. Reducing the disruption of these tissues is likely to result in fewer ejaculatory function and continence complications.

[0047] Therefore, approaches involving the transurethral insertion of a device into the prostatic urethra UT to compress and / or displace the middle lobe ML are contemplated. Other procedures, such as implanting tissue anchors or implants in specific directions to maintain compression or displacement of the middle lobe once the lobe has been compressed or displaced, are contemplated.

[0048] As an initial step, a sagittal section view of the patient's bladder and prostate may be taken using transabdominal or transverse ultrasound. In this manner, the patient's anatomy can be assessed. In this regard, an intravesical prostate measurement is taken to determine the vertical distance from the tip of the middle lobe process to the base of the bladder. As shown in Figures 15C-15D, after assessing the anatomy, the elongated tissue approximation assembly 104 of the anchor delivery device (see Figures 8A and 8B) is advanced into the urethra UT and into apposition with the middle lobe ML. Figure 15D is a cross-sectional view of the urethra UT showing compression and displacement of the middle lobe ML.

[0049] One particular sequence of movements positions the tissue approximation assembly 104 so that its terminal end 112 is anterior to the middle lobe ML and then displaces the surface posteriorly, moving the middle lobe away from the urethral midline. As a result, the middle lobe forms a tissue fold (see FIG. 15D ) around the delivery instrument. In embodiments in which an expandable member is used to engage and manipulate the middle lobe, the expandable member provides an increased surface area compared to the tissue approximation assembly 104 of FIG. 15D , which facilitates temporary capture of the middle lobe as it is displaced. In some embodiments, tissue of the middle lobe can be captured in the space between the wings of the expandable member and the distal end of the elongated tissue treatment device. Thus, the wings of the expandable member can be configured to facilitate such capture, including by varying the amount of expansion the wings undergo during deployment and retraction.

[0050] 16A and 16B show another embodiment of a looped or expandable member. In this embodiment, a looped member 608 can be received in the distal end of a sheath 610 such that the expandable wing portions of the looped member 608 are compressed. As the elongate assembly is moved through the sheath, it contacts the proximal end (not shown) of the looped member 608, pushing the wing portions out of the sheath 610 and causing them to expand and manipulate tissue.

[0051] In some embodiments, as shown in Figures 17A and 17B, a looped member 708 can be attached to the distal end of a sheath 710. In these embodiments, the looped member 708 can expand the elongated assembly at the intervention site and / or manipulate tissue prior to deployment. In some embodiments, the looped member 708 can be made of a level ribbon, i.e., a ribbon with a straight cross-section. In other embodiments, the looped member 708 can be made of a semicircular ribbon with a C-shaped cross-section to prevent the edges of the device from contacting the patient's tissue during delivery.

[0052] Alternative embodiments of the expandable member are shown in Figures 18A and 18B and 19A and 19B. The expandable member 800 may include a pair of tubes 802 and 812 attached to opposite sides of the shaft (not shown) of the elongate assembly of the delivery device. The tubes may be biased toward the distal end of the elongate assembly. The tubes 802 and 812 may house wires 804 and 806, respectively, that are threaded through the lumen of the tube and then exit the distal end of each tube. The wires exiting the tubes are positioned substantially parallel to the outer length of each tube and may be bent, bowed, arched, or otherwise curved. 18A and 18B, wire 804 includes a pair of expandable portions 804a and 804b with a constricted waist 808 therebetween, and wire 806 includes a pair of expandable portions 806a and 806b with a constricted waist 810 therebetween. In some embodiments, the constricted waist of each wire can be a compression spring coil that allows the expandable portion to collapse toward or expand away from the centerline of the elongate assembly. FIG. 18A shows expandable member 800 in a compressed or collapsed state, such as when the elongate assembly is contained within a sheath (not shown), while FIG. 18B shows expandable portion 800 in an expanded state, such as when the elongate assembly emerges from the distal end of the sheath (not shown) and the springs are free to extend, then move the expandable portion of each wire away from the centerline of the treatment device. 19A and 19B show another embodiment of an expandable wire structure that functions similarly to expandable member 800, but in which expandable member 900 includes three expandable portions.

[0053] Various approaches are contemplated to better engage the median lobe or other tissue. Additional structural features can be incorporated into the distal end of the expandable member of the treatment device 100 to increase friction between the target tissue and the distal portion of the treatment device 100 or to increase the surface area of ​​the treatment device. A knurled or roughened surface 952 can form a surface component or the entirety of the winged or expandable portion 950 of the treatment device 100. In some embodiments, as shown in FIG. 20B, one or more or combinations of spikes, fangs, hooks, barbs, or other protrusions 954 can be configured to extend from the expandable member 950 at various angles and lengths. Such protrusions can be sharp or blunt. Such structures can be one or more of: retractable, flexible, or fixed. Thus, in one or more approaches, these structures can be associated with a pop-up feature attached to a puller (not shown). In one aspect, control of the pop-up feature can be achieved by a lateral actuator for deploying and retracting the expandable tissue engagement and manipulation feature when slid along the sheath, and a spacer for varying the relationship between the sheath and shaft to control deployment of the lateral actuator. In one particular approach, the spikes, fangs, barbs, or protrusions can be angled proximally to provide enhanced tissue engagement when the delivery device is retracted and to release the enhanced tissue engagement when the delivery device is advanced.

[0054] Prior to using the treatment device 100, atraumatic tape may be placed over the spikes, fangs, hooks, barbs, or protrusions. The tape may be removed prior to performing a middle lobe procedure. It is therefore contemplated that the treatment system may be provided in two configurations. The first configuration may be for normal use, where the treatment system includes atraumatic tape covering the sharp or other tissue-engaging features and preventing them from interacting with tissue. The second configuration may be for middle lobe engagement and manipulation use, where the treatment system is assembled and shipped without atraumatic tape covering the sharp or other engaging features.

[0055] In some embodiments, tissue adhesive material 956 may be applied to the outer surface at various locations along the expandable portion 950 (see FIG. 20C). In some possible approaches, such tissue adhesive material 956 can range from an adhesive tape to a fluid-swellable material to change its adhesive properties when desired. Another possible approach to pressure adhesion involves scale-like projections (FIGS. 20F and 20G) incorporated onto the expandable portion 950. High friction is created when pulling the target tissue against the scales, but after deployment or when using the treatment device in the direction of the scales, little, no, or less friction is created. Again, such structures may be one or more of retractable, flexible, or rigid.

[0056] Enhanced friction or other engagement forces may be based on pressure-responsive adhesives. For example, the expandable distal portion of treatment device 100 may additionally or alternatively include micro-hooks similar to Velcro® technology, where tissue must be pressed against the micro-hooks to create a secure engagement.

[0057] As discussed above, such engagement structures can be located at various positions along the expandable portion of the treatment device 100. The textures or protrusions can be configured to engage tissue such that the tissue wraps with the distal end of the device as it is rotated, e.g., into a deployed position. In some embodiments, the structures can be located in lateral regions of the treatment device where there is more space; i.e., these structures can be located away from the exit point for the treatment element that can extend from the treatment device. It is particularly contemplated that the structures can be located along a "tissue contact fence." That is, the protrusions can be hidden from tissue contact in the "tissue contact fence" and configured to extend beyond this protective fence via a user-operated actuator.

[0058] 20D-20F, the elongate tissue accessing assembly 104, and in particular the distal end of the elongate tissue accessing assembly 104, may include knurled or roughened surfaces 952, spikes, fangs, barbs, or protrusions (and, optionally, atraumatic tape), and / or tissue adhesive material 956. In some embodiments, either or both of the elongate tissue accessing assembly and the expandable member may include one or more of these features. That is, the above-described embodiments shown in FIGS. 20A-20H may be incorporated into treatment device 100 to complement or enhance the tissue engagement and manipulation capabilities of the elongate tissue accessing assembly, or the distal end of both, expandable or winged portions of the device.

[0059] Vacuum forces may also be used to facilitate tissue engagement and manipulation. In this regard, a suction or vacuum source (not shown) may be incorporated into or attached to the expandable portion, and a channel may be provided to communicate with the distal end of the treatment device 100.

[0060] In another approach, as shown in FIG. 21, a partial, controlled deployment of needles 230 may be used to engage and manipulate the target tissue. The needle 230 may be retracted for full deployment after, for example, in conjunction with implantation of the anchoring device. Additionally or alternatively, one or more supplemental, laterally projecting needles 609 (shown in FIG. 21 ) may be provided for engagement and manipulation purposes. Various approaches to stiffening the needle 230 are also contemplated to provide a more robust structure for tissue manipulation. For example, a supplemental needle tip 610 may be attached to the terminal end of the needle 230. In one contemplated approach, the needle tip 610 may be attached to a structure configured to be actuated from the delivery device handle. The needle 610 may constitute a rigid member, thereby providing sufficient mechanical strength for tissue manipulation, and may be coupled to an elongated member extending within the delivery device, extending along and outside the delivery device, but within or through a hole in the introducer sheath. Both manual and automated approaches for controlling the use or removal of the needle tip 610 are contemplated.

[0061] Referring to FIG. 22 , the distal end portion of the delivery device 100 may also, additionally or alternatively, include a divot or recess having a radius of curvature that matches or entirely accommodates the contours of the median lobe or other target tissue. This recess may be configured with any of the described structures for engaging and receiving tissue. For example, FIG. 22 illustrates a recess 616 that includes a plurality of spikes 954. Referring now to FIG. 23 , a second or supplemental sheath 620 may be provided and configured around the distal portion 104 of the delivery device 100. The sheath 620 may itself include one or more of the tissue engagement and manipulation features described herein. Such features may be reserved for one or more sides of the sheath 620 or may be positioned entirely around the sheath 620. Additionally, the sheath 620 may itself include a recess 616 configured to match the anatomy of the tissue. Thus, the recess 616 can be included in the distal end 104 of the delivery device 100 by manufacturing the distal end 104 with the recess 616 or by using a sheath 620 that is manufactured with the recess 616.

[0062] The target tissue or medial lobe can be specifically prepared to facilitate engagement with the treatment device 100. In this regard, it is contemplated that the target tissue can be subjected to electrocautery, Botox, or other treatments to alter its mechanical contours. The target tissue can alternatively or additionally be prepared completely or partially by creating an incision in the target tissue. Finally, the target tissue can be lassoed to support the tissue or achieve the desired manipulation.

[0063] It should be appreciated that a variety of materials are within the scope of the present disclosure for fabricating the disclosed devices. Additionally, one or more of the components disclosed herein may be fully or partially biodegradable or biodisintegrable.

[0064] Furthermore, as noted, the devices and methods disclosed herein can be used to treat a variety of pathologies in a variety of lumens or organs, including cavities or walls, such as the intestine, stomach, esophagus, trachea, bronchi, bronchial passages, veins (e.g., to treat varicose veins or valvular insufficiency), arteries, lymphatic vessels, urethra, bladder, atria or chambers of the heart, uterus, fallopian tubes, etc.

[0065] Finally, while the present disclosure has been described above in connection with several examples or embodiments of the disclosure, it should be understood that various additions, deletions, modifications, and alterations may be made to those examples and embodiments without departing from the intended spirit and scope of the present disclosure. For example, it should be understood that any element or attribute of one embodiment may be incorporated into or used with another embodiment or example, unless doing so would render the embodiment unpatentable or unsuitable for its intended use. Furthermore, for example, if the steps of a method are described or listed in a particular order, the order of such steps may be changed unless doing so would render the method unpatentable or unsuitable for its intended use. All reasonable additions, deletions, modifications, and alterations should be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims.

[0066] Briefly and in general, the present disclosure is directed to devices and methods for engaging and manipulating internal body structures. Such engagement and manipulation may primarily, or alternatively, form a supplemental or integral part of a multi-step interventional procedure. In one aspect, the device includes an elongate member configured to engage tissue to manipulate or reposition the tissue. In some embodiments, the tissue is the median lobe of the prostate gland.

[0067] In various approaches, the device includes a portion with structure that increases friction between the device and the tissue to be manipulated. The device may additionally or alternatively include an extendable needle that can be partially deployed to engage and manipulate the target tissue. A retractable sheath may also additionally or alternatively be provided to facilitate engagement and manipulation of tissue. Furthermore, the surface area of ​​the distal end portion of the device may include structure intended to increase the surface area, thus providing a structure specifically configured to effectively engage or manipulate tissue. Furthermore, the device may be configured and used to prepare the target tissue by applying energy or material to the tissue that alters its mechanical contour or by creating an incision in the tissue.

[0068] Thus, the delivery devices of the present disclosure may additionally include various subassemblies that are mobilized via actuators or other manual access structures, with the operation of the subassemblies being coordinated and synchronized to ensure precise navigation and placement of the tissue engaging or manipulating structures.

[0069] 24A-24B, in some embodiments, the expandable member 200 is adjustable. FIGS. 24A and 24B show the elongate tissue approximation assembly 104 and the distal end of the expandable member 200 present on one side of the elongate tissue approximation assembly 104. That is, in this particular embodiment, there is only one set of arms or wings. FIG. 24A shows the expandable member 200 in an expanded state, while FIG. 24B shows the expandable member 200 in a contracted state. The middle lobe ML can be captured within the space between the expandable member 200 and the elongate tissue approximation assembly 104. The expandable member 200 can then be contracted or clamped such that the middle lobe ML is attached within the space between the expandable member 200 and the elongate tissue approximation assembly 104. In this position, the middle lobe ML can be manipulated and / or pushed aside.

[0070] 25A-25B, the expandable member 200 can be adjusted from a larger size (FIG. 25A) to a smaller size (FIG. 25B) in embodiments in which the expandable member 200 includes two or more sets of arms and wings. In these embodiments, the expandable member 200 can be used to capture tissue in the space between the expandable member 200 and the elongate tissue approximation assembly 104, or, according to other embodiments disclosed herein, the expandable member 200 can be used to manipulate and / or displace tissue. The individual arms of the expandable member 200 can be adjusted individually or together.

[0071] In embodiments in which the expandable member 200 can be adjusted, it is contemplated that the adjustment may occur prior to placing the device in the patient (or prior to placing the device within the sheath in embodiments in which a sheath is used), or the adjustment may occur at or near the site of tissue manipulation within the patient. A physician may set the size of the expandable member 200 based on, for example, the patient's anatomy. The physician may be able to determine the desired dimensions for the expandable member 200 based on measurements and / or observations of the patient's anatomy before or during the procedure.

[0072] 26A-26B and 27A-27B, the handle of device 100 may include a wheel 1000 or slider 1100, each of which is coupled to and configured to expand or contract expandable member 200. In some embodiments, wheel 1000 and slider 1100 provide continuous adjustment from a "small" expansion size to a "medium" expansion size to a "large" expansion size, with the expansion range indicated by a tactile indicator. Optionally, a lock is provided on wheel 1000 or slider 1100 to lock the size of the expandable member. In some other embodiments, wheel 1000 and slider 1100 provide discrete adjustment from a "small" expansion size to a "medium" expansion size to a "large" expansion size. That is, there are two or more pre-set sizes for the expandable member 200, and the wheel 1000 or slider 1100 allows the physician to select between or only among those sizes.

[0073] A variety of alternative uses are contemplated: The disclosed devices can be used to facilitate improved flow of bodily fluids through a bodily lumen, alter the size and shape of a bodily lumen or cavity, treat prostate enlargement, treat urinary incontinence, support or maintain tissue positioning, close tissue wounds, organs or grafts, perform cosmetic lifting or repositioning procedures, form anatomical connections, and / or treat a variety of other disorders in which natural or pathological tissue or organs press against or interfere with adjacent anatomical structures.

[0074] One aspect of the present invention is a system for engaging and manipulating a median lobe of the prostate gland, the system including a sheath and a tissue engagement or manipulation device housed within the sheath, the tissue engagement or manipulation device sized and shaped to be inserted into a patient's urethra and extend within prostate tissue, the tissue engagement or manipulation device including a movable engagement structure that can be transitioned from a compressed state to an expanded state to enhance contact with the median lobe, wherein the engagement structure is biased against a distal end of the tissue engagement or manipulation device.

[0075] In another aspect of the invention, the engagement structure includes a first arm and a second arm secured to opposite sides of a shaft of the tissue engaging or manipulating structure.

[0076] In another aspect of the invention, the first arm includes a first expandable portion and the second arm includes a second expandable portion, the first expandable portion and the second expandable portion compressing toward the shaft when the tissue engagement or manipulation device is housed in the sheath.

[0077] In another aspect of the invention, the first expandable portion and the second expandable portion expand away from the shaft when the tissue engaging or manipulating device exits the sheath.

[0078] In another aspect of the invention, the engagement structure further includes a channel for receiving and attaching a portion of the tissue engaging or manipulating device.

[0079] In another aspect of the invention, when the tissue engaging or manipulating device is attached to the channel, movement of the engagement structure is constrained to the longitudinal axis of the tissue engaging or manipulating device.

[0080] In another aspect of the invention, movement of the tissue engaging or manipulating device along its longitudinal axis provides a transition of the engagement structure from a compressed state to an expanded state.

[0081] In another aspect of the invention, the engagement structure is a ribbon with rounded edges to reduce trauma to tissue, the ribbon being made from a ribbon with an asymmetric cross section.

[0082] In another aspect of the invention, the engagement structure is made from a ribbon with a c-shaped cross section that reduces trauma to tissue.

[0083] In another aspect of the invention, the shaft of the tissue engagement or manipulation device includes a side aperture and a needle assembly exiting the side aperture, the side aperture being aligned between the first expandable portion and the second expandable portion of the engagement structure.

[0084] In another aspect of the invention, the first expandable portion includes a first visual line marker and the second expandable portion includes a second visual line marker.

[0085] In another aspect of the invention, the first expandable portion and the second expandable portion of the engagement structure indicate the entry position for the needle assembly after exiting the side aperture.

[0086] In another aspect of the invention, the first arm and the second arm of the engagement structure are configured to be telescopic.

[0087] In another aspect of the invention, the engagement structure is a loop attached to a terminal portion of the shaft of the tissue engaging or manipulating device.

[0088] In another aspect of the invention, the engagement structures are adjustable before or during a procedure, and the adjustment may be continuous or discrete via controls on the system's handle.

[0089] In another aspect of the invention, the engagement structure is configured to enhance frictional contact with the middle lobe.

[0090] In another aspect of the invention, the engagement structures include one or more spikes, fangs, hooks, barbs, or other protrusions disposed at various angles and having various lengths.

[0091] In another aspect of the invention, the engagement structure comprises a knurled surface.

[0092] In another aspect of the invention, the engagement structure comprises an adhesive surface that is optionally expandable.

[0093] In another aspect of the invention, the engagement structures are comprised of scales.

[0094] In another aspect of the invention, a system includes a first extensible needle and a second extensible needle.

[0095] In another aspect of the invention, a reinforcing structure is attached to one or more ends of the first and second extensible needles.

[0096] In another aspect of the invention, the engagement structure includes an atraumatic tape configured to cover the engagement structure.

[0097] In another aspect of the invention, the engagement structure comprises a divot formed on the distal end of the system, the divot being sized and shaped to substantially match the contours of the target tissue.

[0098] In another aspect of the invention, the tissue is pretreated prior to being manipulated by the engaging structure, the pretreatment comprising one or more of electrocautery, botox, or dissection.

[0099] Thus, it will be apparent from the foregoing that, while particular forms of the disclosure have been illustrated and described, various modifications can be made without departing from the spirit and scope of the disclosure. [Explanation of symbols]

[0100] 100 treatment equipment 102 Handle assembly 104 Elongated tissue approximation assembly 106 Needle assembly 200 Expandable Members

Claims

1. an elongated tissue accessing assembly coupled to the handle assembly and configured to be inserted into the introducer sheath, the elongated tissue accessing assembly further including an aperture and a needle assembly extendable through the aperture; 11. A treatment device, comprising: a tissue engagement structure configured to engage and manipulate a medial lobe of the prostate, the tissue engagement structure fixedly attached to a distal end portion of the elongate tissue access assembly or to the introducer sheath, the tissue engagement structure including a distal end portion with an expandable member, the expandable member including curved portions such that the tissue engagement structure is transitionable from a contracted state in which the curved portions are compressed toward a centerline defined by a longitudinal axis between the curved portions to an expanded state in which the curved portions expand outwardly beyond the centerline defined by the longitudinal axis.

2. The treatment device of claim 1 , wherein the curved portion is biased toward the expanded state.

3. 2. The treatment device of claim 1, wherein the elongated tissue access assembly is inserted through the expandable member such that one or more inwardly facing surfaces of the curved portion are flush with a portion of an outwardly facing surface of the elongated tissue access assembly.

4. The treatment device of claim 3 , wherein the elongated tissue approximation assembly is releasably fastened onto a distal portion of the expandable member.

5. The treatment device of claim 1 , wherein the engagement structure further comprises a distal attachment component positioned substantially perpendicular to the curved portion.

6. The treatment device of claim 1 , wherein the curved portion includes two arms that terminate in curved ends that together create a distal channel configured to receive a distal end of a treatment device.

7. The device of claim 1 , wherein the needle assembly is configured to bend toward the handle assembly when the needle assembly is expelled through the aperture.

8. The treatment device of claim 1 , wherein the tissue engagement structure further comprises a telescoping arm coupled within a sleeve and configured to deploy the curved portion.

9. The treatment device of claim 1 , wherein the tissue engaging assembly further comprises interlocking telescoping arms.

10. The treatment device of claim 1 , wherein the curved portion is attached to the distal end portion of the elongated tissue access assembly and combines to form a looped expandable member that is slidable through the introducer sheath.

11. The treatment device of claim 1 , wherein the curved portions join to form a looped expandable member attached to a distal end of the introducer sheath.

12. an anchor delivery device including an elongated tissue accessing assembly configured to be inserted into an introducer sheath, the anchor delivery device further including a needle assembly configured to bend when the needle assembly is ejected through an aperture defined by a distal end portion of the elongated tissue accessing assembly; a tissue anchor contained within the anchor delivery device; and a tissue engaging structure configured to engage and manipulate the prostate, the tissue engaging structure fixedly attached to a distal end portion of the elongate tissue access assembly or to the introducer sheath, the tissue engaging structure including a distal end portion with an expandable member, the expandable member including curved portions such that the tissue engaging structure is transitionable from a contracted state in which the curved portions are compressed toward a centerline defined by a longitudinal axis between the curved portions to an expanded state in which the curved portions expand outwardly beyond the centerline defined by the longitudinal axis.

13. 13. The system of claim 12, wherein the elongated tissue access assembly is inserted through the expandable member such that one or more inwardly facing surfaces of the curved portion are flush with a portion of an outwardly facing surface of the elongated tissue access assembly.

14. The system of claim 12 , wherein the engagement structure further comprises a distal attachment component positioned substantially perpendicular to the curved portion.

15. The system of claim 12 , wherein the curved portion includes two arms that terminate in curved ends that together create a distal channel configured to receive a distal end of a treatment device.

16. The system of claim 12 , wherein the tissue engagement structure further comprises a telescoping arm coupled within a sleeve and configured to deploy the curved portion.

17. The system of claim 12 , wherein the curved portion is attached to the distal end portion of the elongated tissue access assembly and couples to form a looped expandable member that is slidable through the introducer sheath.

18. The system of claim 12 , wherein the curved portions join to form a looped structure attached to a distal end of the introducer sheath.

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