Delivery systems and devices for the treatment of benign prostatic hyperplasia and related lower urinary tract symptoms

Abstract

Disclosed are devices and systems for managing and / or treating bodily tissue obstructing a hollow bodily lumen, including prostatic lobe tissue obstructing the urethra, for example, conditions including benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), benign prostatic obstruction (BPO), and related lower urinary tract symptoms (LUTS). An implant is maintained in a constrained configuration within a distal portion of an elongate sheath so that it can be deployed by driving the implant with a pusher coaxially disposed within the sheath. An implant engaging element helps maintain control of the implant during deployment.

Description

Disclosed Content

[0001] 〔Field of the Present Disclosure〕 The present disclosure relates to devices and systems for managing or treating body tissues that occlude a hollow body lumen, such as prostate tissue that occludes the urethra.

[0002] 〔Background〕 The prostate is a walnut-shaped gland that surrounds the urethra through which urine is discharged from the bladder and plays an important role in the male reproductive system. This gland is initially small but tends to enlarge as a man ages. When the prostate enlarges excessively, a disease known as benign prostatic hyperplasia (BPH) occurs. Benign prostatic hyperplasia (BPH) refers to an abnormal but non-malignant (non-cancerous) growth of the prostate that is very common in aging men. BPH is a chronic disease and is associated with the onset of urinary outflow obstruction or luminal stenosis in the prostatic urethra. Bladder outlet obstruction (BOO) refers to an obstruction at the base of the bladder that reduces or stops the flow of urine into the urethra and may be secondary to BPH. A series of related diseases collectively referred to as lower urinary tract symptoms (LUTS) can occur, including sexual dysfunction, frequent urination, difficulty urinating, urinary retention, urinary leakage, and urinary tract infections and bladder infections that worsen as the abnormal growth of the prostate expands and progresses.

[0003] Surgical techniques relieve BPH by removing a substantial portion of the prostate tissue. Several conventional surgical techniques are available, all of which require hospitalization and some form of spinal anesthesia, epidural anesthesia, or general anesthesia. Transurethral resection of the prostate (TURP) is the primary surgical treatment for BPH and continues to be the gold standard against which other treatments are compared. Conventional surgical techniques differ in the location of the incision made by the surgeon to access the prostate and the method of removing the prostate tissue. For example, in some surgeries, laser energy, heat, or radiofrequency is used to remove tissue from the prostate. These include laser enucleation, photoselective vaporization (PVP), transurethral needle ablation (TUNA) using radiofrequency energy, transurethral microwave thermotherapy (TUMT), and transurethral incision of the prostate (TUIP). However, these conventional surgical approaches to treating BPH are invasive, irreversible, and have significant drawbacks including several months of temporary catheterization, risk of infection, loss of sexual function, urinary incontinence, and restenosis. Recurrent hypertrophy of cells in the prostate regrows to cause recurrence of stricture at the urethral opening and also causes recurrence of the LUTS symptoms described above.

[0004] Removing prostate tissue relieves some BPH symptoms, but tissue removal by conventional surgical approaches is irreversible and any side effects of the surgery can potentially afflict the patient for life or affect the patient's quality of life. Furthermore, surgical approaches are associated with the inherent risks of the surgery itself and the risk of recurrence due to regrowth of the removed prostate tissue and may require a recovery period as long as three to six weeks, depending on the extent of the disease and the specific surgical approach required for the individual patient.

[0005] Because the drawbacks of traditional surgery have been recognized, less invasive treatment methods have been developed and can be selected by patients and physicians as an alternative to lifelong medication or surgery, depending on the extent of the disease. These less invasive treatment methods may be suitable for patients who do not wish to undergo or are not medically suitable for surgical procedures performed under general anesthesia. Furthermore, younger patients also desire less invasive reversible procedures without compromising sexual function, leaving the option of undergoing permanent irreversible procedures that may affect sexual function later in life.

[0006] Less invasive techniques include transurethral methods that actually remove enlarged prostate tissue, which are generally less traumatic than traditional surgery, but both destroy prostate tissue and are irreversible. To avoid destruction of prostate tissue, other treatment techniques have been developed that are designed to increase the diameter of the prostatic urethra without actually removing tissue from the prostate, such as by implanting a device designed to expand the diameter of the urethra within the prostatic urethra. Prostate implants involve a procedure in which a urologist inserts a small device into the prostatic urethra, which has been narrowed by enlarged prostate tissue. Once in the correct position, this implant expands and helps to keep the urethra open by pushing out tissue lobes, and is designed to protect the enlarged prostate tissue from total impingement and opening of the urethra. Ideally, the prostate implant is expected to eliminate the need for surgical removal of prostate tissue and reduce the risks of infection, sexual dysfunction, and incontinence, which are also inherent and traditional in less invasive surgical approaches. This procedure can also be designed to be reversible since the implant can be removed and additional surgical procedures can be performed in the future.

[0007] In addition, it is desirable to have features on the implant and delivery system so that the procedure can be performed in a hospital using standard cystoscopes and common urological techniques that a physician uses to examine the degree of BPH and obstruction in the prostatic urethra. It is also desirable to be able to reposition the implant if it is misdeployed. Features for holding and repositioning the device are needed, using a conventional grasper or other assisting device for retrieving a calculus during urological procedures, in conjunction with imaging using an endoscope or cystoscope. The present disclosure addresses these and other needs.

[0008] 〔Summary〕 The present disclosure includes a system for delivering and deploying an implant to a desired location within a body lumen. The system includes an elongate sheath configured to be introduced through the working channel of a cystoscope having a non-traumatic tip at its distal end, a handle fixed to the proximal end of the elongate sheath, a pusher coaxially disposed within the elongate sheath, a deployment actuator coupled to the handle and connected to the pusher, and an implant maintained in a constrained configuration within the elongate sheath adjacent the non-traumatic tip. Operation of the deployment actuator causes relative movement between the pusher and the elongate sheath to deploy the implant from the non-traumatic tip of the elongate sheath.

[0009] In one aspect, a forward knob on the handle is configured to adjust the working length of the elongate sheath.

[0010] In one aspect, the deployment actuator is a slider coupled to the proximal end of the pusher. Operation of the deployment actuator can cause the elongate sheath to be retracted to deploy the implant from the non-traumatic tip of the elongate sheath, or can cause the pusher to be moved distally to deploy the implant from the non-traumatic tip of the elongate sheath.

[0011] In one aspect, the fluid coupling is in fluid communication with the lumen of a pusher configured to be coupled to a handle and direct irrigation fluid to the atraumatic tip. A continuous flow of irrigation fluid is required for visualization or imaging during the procedure for deploying an implant in the prostatic urethra. The fluid coupling may be movable with the deployment actuator.

[0012] In one aspect, an implant actuator may be coupled to a handle and connected to an implant engagement element, and the implant actuator is configured to selectively or gradually release or retract the implant in a controlled manner during deployment.

[0013] In one aspect, the implant engagement element may be configured to maintain control of the implant during deployment. For example, the implant engagement element may be of a preformed shape disposed within the implant, and the preformed shape is configured to retard distal movement of the implant during deployment. Alternatively, the implant engagement element may be a releasable tether coupled to the proximal end of the implant. The implant engagement element may also include interlocking features at the distal end of the pusher and the proximal end of the implant. Further, the implant engagement element may be a wire passed through a hole formed in the tissue-engaging portion of the implant that restrains the implant when tension is applied, or a wire passed around the tissue-engaging portion of the implant that restrains the implant when tension is applied.

[0014] The present disclosure also includes an apparatus for delivering and deploying an implant to a desired location within a body lumen. The apparatus includes an elongate sheath configured to be introduced through a working channel of a cystoscope and having a non-traumatic tip at its distal end, a handle fixed to the proximal end of the elongate sheath, a pusher coaxially disposed within the elongate sheath, and a deployment actuator coupled to the handle and connected to the pusher. Operation of the deployment actuator causes relative movement between the pusher and the elongate sheath to deploy an implant maintained in a constrained configuration within the elongate sheath adjacent the non-traumatic tip outside the non-traumatic tip of the elongate sheath.

[0015] In one aspect, operation of the deployment actuator moves the pusher distally to deploy the implant from the non-traumatic tip of the elongate sheath.

[0016] In one aspect, a forward knob on the handle can be configured to adjust the working length of the elongate sheath.

[0017] In one aspect, a fluid fitting coupled to the handle can be in fluid communication with the lumen of the pusher and configured to direct irrigation fluid to the non-traumatic tip. A continuous flow of irrigation fluid is required for visualization or imaging during a procedure for deploying an implant in the prostatic urethra. The fluid fitting can be movable with the deployment actuator.

[0018] In one aspect, the elongate sheath can be configured to fit within a working channel having an outer diameter of 2 mm (6 French) or less.

[0019] In one aspect, the handle can have a deployment lock that selectively limits the operation of the deployment actuator.

[0020] In one aspect, the handle can further have a connector coaxially disposed around the elongate sheath for engaging a lock of the working channel of the cystoscope.

[0021] The present disclosure also includes a method of delivering and deploying an implant to a desired location within a body lumen. The method can include providing an elongate sheath having a non-invasive distal tip and an implant maintained in a constrained configuration within the elongate sheath adjacent the non-invasive tip, introducing the elongate sheath through a working channel of a cystoscope, positioning the distal tip at a target site within the urethra, and operating a deployment actuator to cause relative movement between a pusher coaxially disposed within the elongate sheath and the elongate sheath to deploy the implant from the non-invasive tip of the elongate sheath.

[0022] In one aspect, the working length of the elongate sheath can be adjusted prior to deployment of the implant.

[0023] In one aspect, an implant actuator can be operated to maintain control of the implant during deployment. Such control can include partial deployment of the implant or retraction of the implant. Such control can also include rotation and positioning of the implant for optimal positioning to push against a prostate lobe to form an opening prior to releasing the implant at any point during deployment.

[0024] In one aspect, the implant actuator can be operated to release the implant after being driven distally out of the sheath.

[0025] In one aspect, the implant length can be determined by using a balloon catheter.

[0026] In one aspect, the implant length can be determined by using a laser marker catheter.

[0027] Further features and advantages will become apparent from the following more detailed description of the preferred embodiments of the present disclosure, as illustrated in the accompanying drawings. In the accompanying drawings, like reference numerals generally refer to the same parts or elements throughout the figures.

Brief Description of the Drawings

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[0029] 〔Detailed Description〕 First, it should be understood that the present disclosure is not limited to the specifically exemplified materials, architectures, routines, methods or structures and thus can vary. Accordingly, some such options that are similar or equivalent to those described herein can be used in the practice or embodiments of the present disclosure, but the preferred materials and methods are described herein.

[0030] Also, it should be understood that the terms used in this specification are for the purpose of describing particular embodiments of the present disclosure only and are not intended to be limiting.

[0031] The detailed description set forth below in connection with the accompanying drawings is intended as a description of exemplary embodiments of the present disclosure and is not intended to represent the only exemplary embodiments in which the present disclosure can be practiced. The term "exemplary" as used throughout this description means "serving as an example, instance, or illustration" and should not necessarily be construed as preferred or advantageous over other exemplary embodiments. The detailed description includes specific details for the purpose of providing a thorough understanding of the exemplary embodiments of the present specification. It will be apparent to those skilled in the art that the exemplary embodiments of the present specification can be practiced without these specific details. In some instances, well-known structures and devices are shown in block diagram form in order to avoid obscuring the novelty of the exemplary embodiments presented herein.

[0032] For convenience and clarity purposes only, terms indicating directions such as top, bottom, left, right, up, down, over, above, below, beneath, rear, back, and front can be used with respect to the accompanying drawings. These and similar terms indicating directions should not be construed as limiting the scope of the disclosure in any way.

[0033] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Further, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise.

[0034] Definition: The terms "therapeutically effective displacement" or "therapeutically effective retraction" or "therapeutically effective dilation" are used interchangeably herein and refer to the amount of displacement of prostatic tissue adjacent to a limited area of the urethra sufficient to increase the urethral lumen and treat, ameliorate, or prevent the symptoms of benign prostatic hyperplasia (BPH) or associated diseases or conditions, including lower urinary tract symptoms (LUTS), bladder outlet obstruction (BOO), and benign prostatic obstruction (BPO), and the displacement of the prostatic tissue exhibits a detectable therapeutic, prophylactic, or inhibitory effect. This effect can be detected, for example, by improvement in the clinical condition, or reduction in symptoms or absence of co-morbidities. Examples of clinical measures include a decrease in the International Prostate Symptom Score (IPSS), a decrease in the post-void residual (PVR) volume in the bladder, or an increase in the maximum urinary flow rate (Qmax), or improvement in quality of life (QoL), or improvement in sexual health after treatment (Sexual Health Inventory for Men i.e., SHIM score, Male Sexual Health Questionnaire i.e., MSHQ score) for males. The exact distance or amount of displacement of the prostatic tissue is determined by the weight, size, and health status of the subject; the nature and degree of the hypertrophied or diseased prostatic condition, and the size of the implant selected for placement within the patient.

[0035] As used herein, a "patient in need of treatment for BPH" is a patient who benefits from the presence of hypertrophied prostatic tissue or the resulting reduction in symptoms caused by non-malignant hypertrophy of the prostate, as well as related disorders including LUTS, urinary outflow obstruction symptoms, and luminal stricture of the prostatic urethra. As used herein, the terms "implant" or "expander" or "device" refer to a prosthetic device implanted within the prostatic urethra to relieve LUTS associated with or caused by BPH.

[0036] As used herein, the term "tissue engagement" with respect to an arm, strut, or other extension of the implant structure refers to the length of the physical structure of the implant that engages prostate tissue along the major portion of the lobe of the organ compressing the urethra and limits further influence of the tissue on the viability of the urethra. "Tissue retraction" refers to the ability of the implant structure to exert the force necessary to move tissue away from the compressed or stenotic urethra. This necessary force can be provided by the inherent structure of the implant or, in particular, by expansion of the implant from a compressed configuration to an expanded configuration when the implant is manufactured from a shape memory or superelastic material having a predetermined expansion configuration designed to exert the necessary tissue retraction force when engaged with hypertrophic prostate tissue. The length of the tissue engagement or tissue retraction structural feature in contact within these definitions is remote from the intralobular sulcus extending along the length of the prostate surrounding the urethra and requires contact with the length of tissue along the length of the two lateral lobes or the lateral and middle lobes.

[0037] With respect to the various structural orientations and anatomical related expressions described herein, the terms "proximal" and "distal" are related to the perspective of a medical professional such as a urologist operating the delivery system of the present disclosure to deploy the implants described herein. Thus, the features of the delivery system held by the urologist's hand are at the "proximal" end, and the assembled system and implant, initially in a compressed configuration, are located at the "distal" end of the delivery system.

[0038] Referring to FIG. 1, a cross-sectional view of the male anatomical structure shows the prostate 1 surrounding the urethra 2. The urethra 2, in a normal state, provides fluid communication from the urine stored in the bladder 3 that is to be excreted from the body under the voluntary muscle control of the external urethral sphincter. Normal or “true” prostate tissue 4 surrounds the urethra 2 and, in the absence of disease, does not affect the patency of the urethra 2. In patients suffering from benign prostatic hyperplasia (BPH), the urethra 2 is narrowed by hypertrophic tissue, i.e., prostate tissue 4 that shows excessive growth towards the urethra 2. This excessive non-cancerous cell growth results in the symptoms of BPH described above, including lower urinary tract symptoms (LUTS) and urinary outflow obstruction, and urinary incontinence. In FIG. 1, the implant 5 delivered using the devices and systems of the present disclosure is shown engaging the prostate tissue 4 along the length of the implant 5 to restore the patency of the urethra 2 and to allow urine flow from the bladder 3 to be unobstructed. As shown, selectively placing the implant 5 at the target site between the bladder neck opening 6 and the seminal colliculus 7 is an important feature to prevent the implant 5 from puncturing, perforating, or incising the surrounding tissue. The implant 5 is designed to remain in the correct position within the prostatic urethra 2. The implant 5 does not extend into the bladder 3, as the structural material of the implant 5 would then be constantly exposed to urine, which could form a coating or otherwise deteriorate, causing complications and making retrieval even more difficult, and the implant 5 does not interfere with the voluntary control of the external urethral sphincter or sexual function.

[0039] The implant 5 according to the technology of the present disclosure has a plurality of tissue engagement structures that exert a force on the hypertrophied prostate tissue 4 adjacent to the urethra 2. As will be described below, the number of the plurality of tissue engagement structures can be two, four, or tissue engagement extensions, such as struts or arms, exceeding four. The use of three extensions is avoided when the three extensions are oriented so as to fit respectively within the intralobular grooves of the prostate. Thus, any plurality of tissue engagement structures are possible as long as the structures are asymmetrically oriented to ensure that the implant 5 is oriented outside the three intralobular grooves formed by the length of the tissue contact between the two lateral lobes and one median lobe. Embodiments using three tissue engagement structures can be used to treat the anatomical structure when the anatomical structure of the urethra consists of both lateral lobes and the third lobe is not involved in urethral stricture.

[0040] The implant 5 can be manufactured from shape memory materials, alloys, spring materials, and superelastic materials including nitinol (nickel-titanium alloy), nitinol-based alloys, cobalt-chromium alloys, spring steel, and spring stainless steels. Other known shape memory materials include polyetheretherketone (PEEK), as well as shape memory and bioabsorbable polymers and metals (polylactic acid, polyglycolic acid and their copolymers; magnesium alloys). The above materials may be coated with a thin film coating to prevent outer coating formation, corrosion and calculus formation. The coating can include ceramic materials such as alumina, silicon carbide, silicon nitride and zirconia, as well as other ceramic coatings that are inert to urine, prevent outer coating formation and calculus formation, and prevent degradation of the materials forming the implant in a chemical or urinary environment. The coating may also be a polymer such as polytetrafluoroethylene (PTFE), parylene, silver and other antibacterial coatings, silicone derivatives, and other similar materials recognized by those skilled in the art.

[0041] The implant 5 may also include a therapeutic coating adhered to the surface of the implant 5 for the controlled release of a drug after being implanted into the prostatic urethra 2 in a manner known as a drug-eluting implant to reduce hypertrophy and tissue growth. The coating contains pharmaceutically active anti-inflammatory and anti-proliferative agents, including sirolimus, novolimus, everolimus, biolimus, zotarolimus, paclitaxel, and others, which are used to prevent restenosis.

[0042] The implant 5 may also be coated with a drug for treating BPH symptoms. Such embodiments have the advantage of using a high locally high tissue dose in the diseased prostatic region of the urethra 2 to enhance effectiveness so as to relax smooth muscle cells and reduce tissue growth and prostate size without suffering from side effects from drugs circulating in other parts of the body. Potential drug candidates include α-adrenergic blockers such as alfuzosin, doxazosin, tamsulosin, terazosin, and silodosin. Other drug candidates include 5-α-reductase inhibitors such as dutasteride and finasteride, as well as anticholinergic drugs. Other drug candidates are anticholinergic drugs such as oxybutynin, fesoterodine, darifenacin, tolterodine tartrate, tolterodine, and solifenacin. Combinations of drugs including an α-blocker + 5-α-reductase inhibitor or an α-blocker + anticholinergic drug can also be coated on the surface. Furthermore, anti-infective drugs or antibacterial drugs or antibiotics such as fluoroquinolones (e.g., ciprofloxacin), macrolides, tetracyclines, and trimethoprim.

[0043] Typically, the drug is mixed with a solvent and a polymer to form a solution, which is spray-coated onto the outer surface of the implant 5 to achieve the desired drug release characteristics. The manufacturing process is similar to that used for drug-eluting stents employed in the treatment of coronary artery disease. In many cases, the coating may be on the anti-luminal side to ensure more effective drug release and deposition within the urethral tissue of the prostatic urethra 2 and to minimize washout during urine flow. Also, the drug may be deposited within microreservoirs or microdepots on the outer surface of the implant 5 for filling with the drug and may be coated with a polymer coating to controllably elute the drug into the urethral tissue. Typical polymers used for filling with the drug are polylactic acid (PLA), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), and their copolymers; polyurethanes; poly(methyl methacrylate) (PMMA) or poly(n-butyl methacrylate) (PBMA); and combinations thereof. Other polymers and solvents may be used by those skilled in the art to fill with sufficient drug and maintain coating integrity with the implant surface. Multiple layers of coating may be used to achieve the desired drug filling and sustained release characteristics.

[0044] According to the technology of the present disclosure, an implant 5 for restoring the patency of the urethra 2 is delivered using a system designed to be compatible with a commercially available or standard flexible cystoscope. Specifically, the system is designed to advance through the working channel of a flexible cystoscope having an inner lumen diameter of 6-9F, i.e., 2-3 mm. Referring to FIGS. 2A and 2B, a side view and a top view of the delivery system 10 are shown, respectively. Although the implant 5 is not shown in these figures, it is held in a constrained configuration within an elongated hollow delivery tube, delivery catheter, or delivery sheath 12 adjacent to a soft and non-traumatic distal tip 14. The catheter or sheath 12 has sufficient strength to constrain the implant 5 and can be made of a thin-walled polymer tube that is flexible and has sufficient torque transferability to navigate through tortuous anatomical structures and assist in advancing into the prostatic urethra 2. Additionally, the tubular sheath 12 or catheter can be reinforced with a metal wire coil or metal wire braid to achieve the desired performance characteristics of strength, flexibility, low profile, torque transferability, flexibility, and pushability for advancing the delivery system 10 containing the implant 5 to the target site. The terms delivery sheath 12, delivery catheter, and delivery catheter tube can be used interchangeably throughout the document. The delivery sheath 12 may also have a different wall thickness or stiffness at the distal end, where the implant 5 is constrained to further improve the flexibility of the system (sheath + implant). In other embodiments, the catheter has a marker band (having a different color) at the distal end to indicate the location of the implant 5 along with the delivery sheath 12 and the position of the catheter relative to the distal end of the cystoscope or the exit point of the working channel of the cystoscope. In other embodiments, the distal tip of the catheter is soft and flexible compared to the hardness or stiffness of the shaft body, which can reduce trauma to the wall of the urethra 2. Such a soft non-traumatic tip distance can be 0.5-10 mm in length, or more preferably 1-2 mm.The proximal end of the sheath 12 is connected to the handle 16, which includes an irrigation port 18 for the delivery of saline irrigation enabling imaging, a cystoscope lock luer 20 that locks and securely attaches the delivery system 10 to a luer connector on the flexible cystoscope, enabling one-handed operation of the delivery system by a physician, and a rotation lock knob 22 that prevents rotation of the delivery handle / system during deployment or treatment procedures. For example, the knob 22 can include a screw that, when tightened, engages the luer connector hub 60 to prevent rotation of the luer connector hub. The handle 16 also has a catheter advancement knob 24 that rotates to change the working length of the delivery system 10, accommodate various scope working lengths, adjust the position of the distal end of the delivery sheath 12, and accurately position the device at the target site. A catheter position indicator 26 provides visual feedback of the length adjustment along with a reference catheter position marker 28. A deployment safety lock 30 is configured to prevent premature deployment of the implant 5 by restricting movement of a deployment actuator, such as a slider 32 in this embodiment, that, when depressed, deploys the implant 5 to the target site. An implant engagement element 46, such as a capture wire, configured to assist in the precise placement of the implant 5 as described below (not shown in this figure) is coupled to the implant actuator 34 such that the implant 5 is released operatively during deployment as described in further detail below. In other embodiments, the implant actuator 34 and associated mechanisms can be omitted.

[0045] As described above, the distal tip 14 of the delivery system 10 is soft and non-traumatic. The color difference between the distal tip and the shaft of the delivery catheter 12 can be used to provide a visual indication of a specific distance and assist in the deployment of the implant 5 several millimeters away from the target site, or the desired anatomical location. In one embodiment, the distal 5 mm at the tip 14 is colored white compared to the blue shaft to assist in placing the implant 5 5 mm from the seminal colliculus within the prostatic urethra 2. The distal tip 14 can also be made radiopaque using a special material (a polymer containing barium sulfate) to assist in placement under fluoroscopy. The distal tip 14 may be straight or curved to minimize damage to the urethral wall.

[0046] The elongated delivery sheath 12 is flexible and compatible with an operable cystoscope commonly used by urologists for the diagnosis and treatment of chronic conditions as well as symptoms related to the urinary tract 2 system and the genital system. When the implant 5 is disposed within the sheath 12, the implant is held in a constrained state at the distal end, and the implant 5 can pass through a much smaller lumen before being deployed. Irrigation also passes through the sheath 12 to keep the camera or imaging view clear of fog and debris. The sheath 12 may have a hydrophilic coating to improve lubricity during advancement, or may not be coated. Further, the sheath 12 can have multiple lumens for different functions (irrigation flow lumen, implant engagement element, deployment mechanism, light source, imaging device, and others). This can have a pre-set shape and stiffness to displace the prostate and / or conform to the anatomical structure, making it operable or advancing it to the target site.

[0047] Further details of the delivery system 10 are shown in the cross-sectional view of FIG. 3. In particular, the catheter advancement knob 24 is coupled to the catheter advancement screw 38 via a locking thread. When the knob 24 rotates, the thread converts the rotation into linear motion to adjust the working length of the delivery system 10, i.e., the length of the delivery catheter 12 that is exposed from the handle 16. By using a locking thread, it is ensured that when the user activates the deployment actuator, i.e., the slider 32, the position of the delivery catheter or sheath 12 is fixed and not affected by the deployment movement. The male thread of the screw 38 mates with the knob 24 to adjust the working length of the sheath 12. Inside the lumen of the sheath 12, a pusher tube 40 with its proximal end coupled to the slider 32 is disposed. The slider 32 also actuates the movable fluid coupling 42. The lock rod 44 has a selectable engagement with the deployment safety lock 30, and when engaged, the relative distance between the movable fluid coupling 42 and the catheter advancement screw 38 is maintained. Further, the slider 32 prevents the pusher tube 40 from being displaced during pre-treatment handling, which could prematurely or accidentally deploy the implant 5. When deployment is desired, by pulling out the lock 30, the slider 32 advances and drives the pusher tube 40 distally, thereby pushing the implant 5 out of the distal end of the sheath 12 and causing deployment at the target site. The movable fluid coupling 42 provides two paths that communicate and join with the pusher tube 40 to allow for perfusion of saline through the perfusion port 18 and through the lumen for implant engagement elements 46, such as the capture wire described above, that are controlled by the implant actuator 34. The perfusion fluid enters through the perfusion port 18 and the lumen 48, the implant engagement elements 46 are sent through the lumen 50, and then they merge and continue through the lumen of the pusher tube 40. The pusher tube 40 is a hollow or solid tube depending on the desired performance characteristics of the pushability (to push the implant 5 to the target site), provides additional perfusion, increases the fluid coupling area, and can enhance imaging during cystoscopy.

[0048] The pusher seal 52 is compressed between the catheter advance screw 38 and the catheter hub 54 to prevent fluid leakage between the inner diameter of the sheath 12 and the outer diameter of the pusher tube 40. Similarly, the catheter seal 56 is compressed between the luer connector 58 and the luer connector hub 60 to prevent fluid leakage between the cystoscope working channel and the outer diameter of the sheath 12. Thus, when the rotary lock knob 22 is tightened against the luer connector hub 60, the handle 16 cannot rotate relative to the cystoscope. Other embodiments for deploying the expander implant 5 may be designed to include a mechanism in which the pusher tube is stationary and locked to the handle 16 and the implant engagement element 46. By sliding or moving the implant actuator, the sheath 12 can be retracted to expose the implant 5 and the expander implant 5 can be deployed into the prostatic urethra 2.

[0049] The implant engagement element 46 is connected to the implant actuator 34 via an implant actuator seal 62 housed inside the body 64A, and the implant actuator seal 62 and the implant actuator 34 prevent the irrigation fluid from exiting through the lumen 50. The slider 32 is connected to the movable fluid coupling 42 as described above, so that during deployment of the implant, the coupling 42 moves with the slider 32, thereby providing continuous irrigation and imaging of anatomical landmarks during the procedure. The implant actuator 34 is separated from the body 64A, and the implant engagement element 46 is withdrawn after the implant has been deployed at the target site to remove the implant 5 from the delivery system 10. Advantageously, the implant actuator 34 can facilitate an incremental and well-controlled deployment of the implant 5, such that the implant 5 does not "pop open" prematurely or "spring forward" and is not deployed in an inappropriate configuration or at a location away from the target site. By maintaining control of the implant 5 even after expansion, premature deployment or misplacement is reduced.

[0050] The movable fluid fitting 42 serves multiple functions including connecting the slider 32 to the pusher tube 40 for deployment of the implant 5, providing fluid communication between the irrigation port 18 and the pusher tube 40 through the lumen 48, maintaining clear visualization for video by flowing water, and enabling connection of the various components associated with the slider 32 during deployment of the implant 5. Further, the movable fluid fitting 42 cooperates with the lock rod 44 and the lock 30 to provide the functionality described above. The movable fluid fitting 42 also provides a lumen 50 for the implant engagement element 46 that is connected to the implant actuator 34. When the lock 30 is disengaged, the movable fluid fitting 42 can translate distally towards the catheter advancement screw 38 when the user advances the slider 32. As shown in the detailed view of FIG. 4, the movable fluid fitting 42 has a defined path that is guided by the groove 52 that mates with the rail 54 within the handle 16. Advancing the slider 32 causes the movable fluid fitting 42 to translate distally along with the pusher tube 40 to deploy the implant 5 from the distal tip of the sheath 12.

[0051] The irrigation port 18 enables irrigation connection via a common luer lock connector. It can also be used to deliver therapeutic agents to the treatment site. There may be another port that provides a lumen for inhalation or suction to facilitate transport of tissue or fluid from the target site or the patient. The suction source may be, for example, gravity, a powered vacuum pump, a wall suction outlet, or a syringe.

[0052] The pusher tube 40 is a separate flexible member within the sheath 12 and is primarily used to release or push the implant 5 from the delivery system 10, thereby deploying the implant 5 to a desired target site. Suitable materials include PEEK (polyetheretherketone), other polymers or spring materials, and superelastic materials including Nitinol (nickel-titanium alloy), Nitinol-based alloys, cobalt-chromium alloys, spring steel, and spring stainless steel that have sufficient strength, flexibility, and pushability to deploy or retract the implant 5 from the delivery system 10 without kinking. The pusher tube 40 also provides a lumen for irrigation, as described above, to provide fluid flushing to maintain clear visualization from a video camera. The pusher tube 40 is coaxially disposed within the sheath 12.

[0053] In an alternative embodiment, the safety lock function can be implemented by a push actuation as opposed to a pull. For example, FIG. 5 shows a detailed view in which like elements have the same reference numerals. Here, when the lock button 56 is depressed, a wider aperture is centered around the lock rod 44 and the movable fluid joint 42 can translate distally under the control of the slider 32.

[0054] In another embodiment, there are two push safety locks that allow for a partial deployment of the implant 5 before full deployment. For example, FIGS. 14 and 15 show a pusher tube or pusher rod or pusher wire 152 disposed within the lumen of the sheath 12, the proximal end of which is connected to a pusher block 160. The slider 32 actuates the movable pusher block 160. The deployment track 161 has a selectable engagement with the deployment safety locks 150 and 151, and when engaged, the relative distance between the pusher block 160 and the catheter advance screw 38 is maintained. Further, the slider 32 is prevented from prematurely displacing the pusher tube 152 or accidentally deploying the implant 5 during handling prior to the procedure. Initially, the lock 151 cannot be depressed due to interference with the auto-lock 153, and the lock 150 is in contact with the stop 158. If the placement is desired, depressing the lock 150 causes the pusher block 160 to advance, driving the pusher tube 152 distally, the lock 151 to contact the stop 159, and the implant 5 to be partially deployed from the sheath 12, allowing the orientation and position of the implant 5 to be viewed before releasing the implant 5 for full deployment. When the lock 151 is in contact with the stop 159, the lock 151 can be depressed to allow the pusher block 160 and the pusher tube 152 to translate further distally, thereby fully deploying the implant 5 outside the distal end of the sheath 12 at the target site. The spring 157 returns the pusher block 160 and the pusher tube 152 proximally, thus re-restraining the protrusion 64B (as shown in FIGS. 8A-8C) within the restraint of the sheath 12 and preventing damage to the urethra and damage to the cystoscope during withdrawal of the delivery system 10. The irrigation fluid enters through the irrigation port 154 and the irrigation tube 155. The movable deployment track 161 provides a fluid passage 156 that telescopically fits over the fixed irrigation tube 155. The irrigation seal 162 is compressed between the deployment track 161 and the seal nut 163 to prevent fluid leakage between the inner diameter of the deployment track 161 and the outer diameter of the irrigation tube 155. An exemplary method for using the delivery system 10 is as follows.Once a subject is diagnosed with BPH / LUTS using transrectal or transabdominal ultrasound, an appropriate delivery system 10 is selected that can accommodate an implant 5 of a length sufficient to treat the length of the prostatic urethra. Further, cystoscopy may be performed to further confirm the target length of the treatment in the prostatic urethra 2. Typically, the length of the treatment is taken as the length from the bladder neck to the seminal colliculus. The implant 5 is desirably positioned between the bladder neck 6 and the seminal colliculus 7. In some cases, the implant 5 can be positioned between the bladder neck 6 and the external sphincter. First, a flexible cystoscope is inserted through the urinary tract to reach the prostatic urethra 2, and the target treatment length of the prostatic urethra 2 is measured. The cystoscope tip is positioned near the seminal colliculus 7. An appropriate delivery system 10 having an implant 5 of the appropriate length is selected. The length of the catheter shaft is adjusted using the catheter advancement knob 24. The catheter position indicator 26 is aligned with the appropriate catheter position marker 28. The saline bag and connector tube are disconnected from the cystoscope and connected to the irrigation port 18 of the delivery system 10 to enable irrigation with saline. The sheath 12 is introduced through the instrument channel of the cystoscope, and the cystoscope lock lever 20 on the handle 16 is locked to the luer connector of the cystoscope by rotating it in the clockwise direction. Next, the handle 16 is rotated to the desired position and engaged and locked to the rotation lock knob 22. The sheath 12 is further advanced using the catheter advancement knob 24 until the white distal marker at the distal tip 14 of the sheath 12 appears within the field of view of the cystoscope. Once the target site for deployment of the implant 5 is confirmed, the deployment safety lock 30 is disengaged by pulling it vertically away from the handle 16. While holding the cystoscope in a fixed position, the implant 5 is deployed at the target site by slowly advancing the deployment slider 32 distally along the handle 16. The implant 5 can be partially deployed to confirm its position and then retracted and repositioned and deployed at the desired location. The orientation of the implant 5 can be controlled by rotating the delivery catheter or delivery sheath when the implant 5 is partially deployed.The opening of the prostatic urethra 2 can be confirmed by fully deploying the implant 5, but cannot be confirmed by releasing it from the implant engagement element 46. If an alternative or better orientation of the implant 5 relative to the prostatic tissue lobe, or a position relative to the bladder neck 6 or seminal colliculus 7 is desired, the implant 5 can be retracted into the sheath 12, repositioned or reoriented, and then deployed to the desired location. Once the implant 5 is deployed at the target site, the implant actuator 34 is operated, such as by unscrewing to disengage the implant engagement element 46. In some embodiments, such as those using a capture wire, this corresponds to retracting the implant engagement element 46 by a minimum distance (e.g., 6 cm) to disengage the delivery system 10 from the implant 5. Finally, the handle 16 is unlocked from the cystoscope by freeing the cystoscope lock lever 20, and the system 10 is retracted from the instrument channel of the cystoscope.

[0055] In other embodiments, the delivery system 10 may be adapted to incorporate a light source and an image capture element to eliminate the need for compatibility with a commercially available flexible cystoscope. Using such modifications, there are several advantages to deploying the implant 5 at the target site. First, the profile (or outer diameter) of the delivery system 10 introduced into the urethra 2 can be reduced. A system with a smaller profile is more flexible, less traumatic, and less likely to induce pain. Second, the delivery system 10 of the present disclosure can incorporate and deliver more implant 5 designs (folded into a larger restraint diameter) without the constraints imposed by the working channels of existing delivery systems. Third, the delivery system 10 can be a disposable medical device that does not require the use of an expensive cystoscope that needs to be resterilized, freshly renewed periodically, and avoid the risks associated with resterilization. Such embodiments include the foregoing aspects, along with actuation / articulation elements to enable navigation and visualization, a video connector to interface with a standard VGA, smartphone, or tablet display, a catheter shaft with an increased lumen for improved perfusion, and connector wiring for the light source and image capture. The distal tip correspondingly includes a light source, a camera, and a combined perfusion and implant exit.

[0056] Next, referring to FIG. 6, an exemplary embodiment of the implant 5 is shown with the implant engagement element 46. As can be seen in the figure, the implant engagement element 46 includes a pre-formed wire 60 at its distal end configured to delay the release of the implant 5 during deployment to facilitate a more accurate placement. In other embodiments, the implant engagement element 46 can be a threaded rod or tube threaded onto the implant 5, or a tube or rod or tube having features that interact with features on the implant 5 to allow for controlled release during deployment. Further, the implant engagement element 46 can be a braided or monofilament thread, line, suture or wire that functions similarly to temporarily restrain the implant 5 during deployment.

[0057] Another aspect of the technology of the present disclosure is shown in FIGS. 7A-7C, which illustrate the cooperation between the pusher tube 40 and the implant engagement element 46 during deployment of the implant 5. First, FIG. 7A shows the implant 5 in its constrained configuration disposed within the distal end of the sheath 12. The pusher tube 40 engages a distal feature of the implant 5, such as an arm or hub, to release the implant from the sheath 12 by distal movement of the pusher tube 40. The implant engagement element 46 includes a tether loop connected to the proximal portion of the implant 5. In this state, the tether loop is substantially slack. When the implant 5 is deployed by the distal movement of the pusher tube 40, as shown in FIG. 7B, tension is applied to the implant engagement element 46 against the force applied by the pusher tube 40, which can control the speed of deployment, prevent the implant 5 from jumping away from the desired position, and help maintain the implant 5 in its constrained configuration. Once the implant 5 has reached its desired location, the pusher tube 40 can be withdrawn proximally and / or the implant engagement element 46 can be loosened, which can cause the elasticity of the implant 5 to cause expansion into a configuration that maintains the patency of the urethra 2. Once deployed, the tether loop can be cut and removed from the system 10.

[0058] Yet another embodiment is shown in FIGS. 8A-8C, which illustrate alternative configurations of the implant engagement elements. For example, the top view of FIG. 8A shows a pusher tube 40 having a keyed projection 64B at its distal end that interlocks within a recess 66 formed in the proximal hub or similar element of the implant 5. When the implant 5 is disposed within the sheath 12, the inner diameter holds the projections 64B substantially aligned with the longitudinal axis of the pusher tube 40 and locks them within the recess 66 to prevent unrestrained distal movement of the implant 5 during deployment. Once positioned at the desired location within the urethra 2, further relative distal displacement of the implant 5 frees the projections 64B from the restraint of the sheath 12 and can return them to a preformed configuration that radially expands outwardly from the longitudinal axis of the pusher tube 40, as shown in the side view of FIG. 8B, disengaging the implant 5 from the pusher rod 40. Alternatively, the projection 64B can be controlled by any suitable mechanical linkage, such as by pivoting on a hinge 68 when actuated by a pull wire extending through the lumen of the pusher tube 40, and the projection 64B can deflect either outwardly or inwardly as shown. With these designs, the engagement between the projection 64B and the recess 66 keeps the components connected, so that the implant 5 is positioned in the desired radial orientation and rotation of the handle 16 can be transmitted to the implant 5. As described above, this can help to position the arms of the implant 5 so that they do not align with the intralobular grooves of the prostate. The projection 64B can be formed from nitinol, spring tempered stainless steel, a polymer, or other materials having elasticity, or a mechanical linkage as described above can be used. Further, the projection 64B can be formed as part of the implant 5 and configured to fit within the recess 66 of the pusher tube 40. One or more keyed projections 64B may be formed on the pusher tube 40 to lock with the recess 66 on the implant hub. Alternatively, the projection 64B can be formed on the implant 5 and locked with the recess 66 on the pusher tube 40.

[0059] Further features of the present disclosure can be understood with reference to FIGS. 9A - 9C, which show various exemplary implant 5 designs that use implant engagement element 46 configured to assist in restraining implant 5 in a constrained configuration to facilitate deployment. In the embodiment of FIG. 9A, holes 70 are formed in a low - strain flat area of implant strut 72 or hub so that the overall mechanical properties and integrity of implant 5 are maintained. A pre - formed wire 74 or thread passes through hole 70 in a route (only one wire route is shown for clarity) that causes strut 72 to assume a constrained configuration by being substantially aligned with the longitudinal axis of implant 5 when tension is applied. Wire 74 can also assist in the controlled deployment and / or re - positioning of implant 5 at the target site, as desired, by pulling wire 74, partially deploying, and then refolding the wire - engaged implant 5 back into delivery system 10. Once implant 5 is fully expanded or deployed at the target site, wire 74 can be disengaged and delivery system 10 can be removed. Optionally, this wire 74 and slotted implant mechanism can be used to restrain and deploy implant 5 without the need for a restraining sheath 12. It will be understood that similar results can be obtained using any suitable variation of these designs. For example, FIG. 9B shows a lasso configuration where loop 76 surrounds strut 72 of implant 5. This design avoids the need to have holes 70 in strut 72 but provides similar functionality in that the tension applied to loop 76 restrains implant 5, and implant 5 is released to allow expansion when the desired position is achieved. Yet another example is shown in FIG. 9C, which uses one wire 74 per strut 72. The intermediate section of each strut 72 can have a concave configuration to assist in positioning wire 74. When tension is applied to wire 74 or loop 76, they compress implant strut 72 and restrain it (or fold it) into a low - profile (small - diameter) configuration. Implant 5 remains compressed while wire 74 or loop 76 is in a tensioned state.Under tension, each wire 74 or loop 76 rests on the surface of the implant 5 with a minimum gap. The wire or thread may be a single wire or a bundle, as determined by the particular configuration. They can be made from stainless steel, nitinol, or other materials used to make wires and springs. They can also be made from strong biocompatible polymer materials, fabrics or threads used to make sutures or grafts.

[0060] In addition to the above-described embodiments, it will be understood that various modifications to the devices and systems of the present disclosure are within the scope of the present disclosure. For purposes of illustration, FIG. 10 schematically shows an alternative handle having similar functionality with respect to the deployment of the implant 5 for treating or managing BPH. Notably, the handle 80 is shown with a plunger 82 for actuating the pusher rod 40 as opposed to a slider. The implant 5, although not shown here, is held in a constrained configuration within the elongate delivery sheath 12 in a manner consistent with the above-described embodiments. The bladder scope lock lever 84 functions similarly. Further, the handle 80 has a catheter advancement knob 86 that uses the above-described techniques to adjust the position of the distal end of the delivery sheath 12 and accurately position the device at the target site. The catheter position indicator 26 provides visual feedback for length adjustment in relation to the reference catheter position marker 28. The irrigation port 88 provides fluid communication for introducing saline for visualization during the procedure, but in this embodiment is separated from the movement of the pusher tube 40. The implant engagement element 46 according to the above teachings can be used as desired, along with the associated components.

[0061] In yet another aspect, the slider 32 of the handle 16 or the plunger 82 of the handle 80 can be replaced with other suitable mechanisms for actuating the distal movement of the pusher tube 40 to deploy the implant 5. For example, FIG. 11 schematically shows a hand syringe 90 that provides this functionality. In this embodiment, the implant 5 is similarly constrained inside a long flexible tube (a polymer sheath or a metal coiled wire having a lumen). The inner lumen of the tube houses the implant 5 at the distal end of the tube in a constrained state. The pusher tube 40 engages the implant 5 and is connected to an intermediate ring of the syringe 90 and, when actuated, pushes the implant 5, thereby deploying it to the target site. In this embodiment, the delivery system does not incorporate an irrigation lumen or an implant engagement / disengagement element. A T-connector having two ports or a rotary hemostatic valve having two lumens can be connected to the irrigation port of the working channel of the cystoscope. Irrigation is connected to one port of the T-connector or to the valve lumen. A second port and lumen having a seal and a seal cap. Loosen the seal cap and introduce the delivery system through the valve port. When the delivery system is introduced, the valve is lightly tightened to prevent leakage during advancement of the delivery system. When the delivery system reaches the target site, the cap is fully tightened and the implant 5 is deployed to the target site. After deployment, loosen the valve and retract the delivery system. Desirably, the delivery system using the syringe 90 is adaptable to different cystoscope lengths without the need for a long handle or an adjustment knob within the handle for adjusting the catheter position during deployment of the implant 5. It can be made in the longest length to fit all commercially available flexible cystoscopes. In this embodiment, irrigation is provided by a fluid passage through the working channel of the cystoscope along the outer surface of the delivery system. In other similar embodiments, features such as implant engagement / disengagement elements may be incorporated into the syringe as needed.

[0062] For the treatment of LUTS related to BPH, it is necessary to accurately place an implant 5 of sufficient length in the prostatic urethra. The length of the urethra is often measured from the bladder neck to the external sphincter using abdominal or transrectal ultrasound. To accurately place the implant 5, it is necessary to know the length of the prostatic urethra from the bladder neck 6 to the seminal colliculus 7, which can only be measured by cystoscopy. There are few conventional measurement tools and devices for accurately measuring the length of the urethra regardless of whether a measurement tool is introduced into the working channel of a flexible cystoscope. Accordingly, the present disclosure also includes an apparatus configured to accurately measure the length of the prostatic urethra between the bladder neck 6 and the seminal colliculus 7 using a cystoscope.

[0063] As an example, FIG. 12 shows a low-profile catheter 100 having a highly flexible balloon 102 at its distal end that can be inserted through the working channel of a cystoscope or adjacent to the cystoscope. The balloon 102 on the distal end of the catheter 100 is inflated through a side arm port 104 and a light tension is applied to position it at the bladder neck 6, and the length of the urethra 2 from the bladder neck 6 to the seminal colliculus 7 and the external sphincter is measured. A marker 106 helps to measure the length of the urethra 2. The balloon 102 is deflated and the catheter 100 is removed prior to the treatment procedure.

[0064] Yet another example is shown in FIG. 13, which depicts a laser marker catheter 110 that is also a low-profile (or diameter) hollow polymer tube that is compatible with the instrument channel of a cystoscope. This features a scale mark 112 at the proximal end and a radially projected laser light source 114. A predetermined length of markers 112 on the distal body of the catheter 110 is used to measure the length of the prostatic urethra. The catheter 110 is inserted through the instrument channel of the cystoscope, and the radial laser source 114 projects laser marks into the urethra. Using this system, the user holds the cystoscope firmly in a predetermined anatomical location, such as the seminal colliculus 7, until the laser light projected by the source 114 just disappears (from the cystoscope's field of view) as the catheter 110 approaches the bladder neck 6 and enters the bladder 3, and continues to advance the laser marker catheter (24). By counting these scale marks 112, the length of the urethra 2 is determined. The catheter 110 can be inserted through the working channel of the cystoscope or adjacent to the cystoscope. When the cystoscope and catheter 110 are introduced in tandem, they are both positioned at the bladder neck 6, and the cystoscope is withdrawn until the target site for deployment is within the field of view. Again, by counting the scale marks 112 on the body of the catheter 110, the length of the urethra 2 is determined.

[0065] Accordingly, the present disclosure encompasses devices, systems, and methods of treatment for providing and deploying an implant for managing urinary outflow obstruction symptoms and lower urinary tract symptoms associated with, caused by, or subsequent to benign prostatic hyperplasia. The implant is designed to meet several performance and operational criteria to overcome challenges in the treatment of BPH. The implant is adaptable to a range of possible prostate sizes, lengths, and tissue morphologies that may be encountered in the adult male population. The implant is designed to resist movement due to urethral hydrodynamics and movement once placed at the target site. The implant is also configured to allow placement and retrieval using minimally invasive techniques with a flexible endoscope under local anesthesia (or topical anesthesia, or no anesthesia). The implant is designed with a minimal mass and surface area to prevent encapsulation while providing sufficient retraction force to push open the stricture of the prostatic urethra. The implant is sized and shaped to be delivered and retrieved in a compressed configuration through conventional imaging and delivery systems, such as a conventional flexible cystoscope, that are used in urological procedures and that allow for delivery, visualization, deployment, and retrieval of the implant.

[0066] Under direct visualization, methods of deploying and retrieving an implant through a cystoscope include retrieval and removal within one month to several years after implantation. The overall configuration of the device folds the implant to a reduced diameter and facilitates atraumatic removal through a catheter, sheath, cystoscope, or the distal end of an endoscope channel that confines the implant for atraumatic removal by confining the implant within a catheter or sheath in which the implant is housed. The structural profile of the implant and delivery system design minimizes bleeding, swelling, spasms, or injury to the urethra during placement, restores urinary function, and eliminates future risks of pain, sexual dysfunction, or urinary dysfunction. The design of the delivery system includes visual markings that enable the user to place the implant in the correct location relative to anatomical landmarks within the urethra. Such visual markings include marker bands, notches, color differentiations, graduated edges, diameter changes on the delivery system. The design and placement of the device do not interfere with urinary function (prevent incontinence and facilitate urination upon activation of the external sphincter). The method of design and placement also minimizes the potential for movement of the implant along the urethra, toward the bladder, or toward the penis.

[0067] The implant exerts an expansion or tissue retraction force greater than 0.5 N, preferably greater than 2 N, and most preferably 5 - 30 N along a substantial portion of the length of the implant, is radially directed, and counteracts the compressive force that constricts the lumen along the urethra due to prostatic tissue hypertrophy. Since the prostate has three lobes and is asymmetric, the implant preferably has two or more tissue engagement regions such that the tissue contact regions are not disposed within three grooves formed by adjacent lateral and middle lobes of the prostate. When the design has three tissue engagement regions, the design is preferably asymmetric with respect to the physiology of the prostate such that the implant is not disposed within the interlobular groove. Instead, the tissue engagement regions of the implant directly engage each of the three lobes of the prostate along a length for retracting the hypertrophied tissue, rescuing and expanding the fluid communication ability or lumen of the urethra. Visual markings such as marker bands, notches, coloring, etching, surface finish changes, etc. can be placed on the implant to facilitate visualization and accurate placement or deployment of the implant in the urethra.

[0068] The implant can fit within a delivery system having an outer diameter (OD) of less than 4.667 mm (14 French) and can have a diameter of less than 2 mm (6 French). The delivery system can advance with minimal resistance through the working instrument channel of an endoscope or cystoscope. Additionally, the delivery system also incorporates sufficient free lumen to enable direct visualization of the urethra during advancement and placement of the implant and to allow for sufficient saline perfusion for sailing flow or fluid flow, typically at a minimum flow rate of 0.25 mL / sec. The delivery system has a working port for connection to a perfusion source. In a preferred embodiment, the implant is confined in a folded configuration at the distal end of delivery having a soft tip for atraumatic deployment of the implant. The delivery system can be traversed by a guidewire having a soft tip at its most distal end and by a pusher rod or pusher tube that ends just proximal to the implant.

[0069] In another embodiment, the imaging device is integrated into the delivery system. These imaging devices are compatible with existing video display systems manufactured by Olympus, Stryker, Karl-Storz. The overall system profile is less than 26F (9 millimeters), or more preferably 17 - 12F (6 millimeters) or less, further minimizing pain during implant delivery and placement. Additionally, the integrated delivery system incorporating the implant and imaging device may be a single-use or disposable medical device as compared to embodiments where it is inserted through a re-sterilizable and reusable flexible and rigid cystoscope.

[0070] The methods of the present disclosure include methods of treating lower urinary tract symptoms associated with benign prostatic hyperplasia by implanting an implant and, optionally, subsequent retrieval thereof. The delivery system is configured to maintain the implant in a compressed configuration at the distal end of an elongate sheath and deploy it in an expanded configuration within the prostatic urethra.

[0071] A method for implantation includes performing a diagnostic cystoscopy to determine the length of the prostatic urethra from the seminal colliculus to the bladder neck, optionally using the device disclosed above, then determining the diameter of the urethra and selecting an appropriately sized implant based at least in part on the diameter of the selected implant, which can be measured by the diameter of the opposing tissue engagement regions of the implant in the expanded configuration. Alternatively, diagnostic measurements of the urethral length can be obtained using abdominal or transrectal ultrasound imaging. Measurement of the urethral length from the bladder neck to the external sphincter is also used to determine the appropriate implant size. In one deployment method, the clinician selects an implant having a pre-specified size that is maintained in a folded configuration at the distal end of the delivery system. The appropriately sized implant housed within the delivery system is introduced into the working channel of the cystoscope. The distal end of the delivery system is preferably advanced under direct visualization, such that the distal end of the delivery system is proximal to the seminal colliculus for deployment. To improve the deployment accuracy of the implant, the implant engagement element described above enables continuous connection to the implant after expansion within the prostatic urethra and allows for further adjustment.

[0072] The integrated device and delivery system are achieved using common surgical instruments, particularly a standard cystoscope used with other urological procedures, so that the implant can be placed and retrieved by a urologist in a hospital environment and on an outpatient basis, under local anesthesia, without special equipment.

[0073] The method of the present disclosure includes placing the device described herein below the bladder neck, within the urethra proximate to the prostate, including at a particular distance between the bladder neck opening and the external urethral sphincter. The method includes orienting the distal tip of the delivery system within the prostate and deploying the implant from a compressed configuration to an expanded configuration. The method also includes orienting the device such that the contact region of the implant engages a portion of the prostate away from the three apices formed by the adjacent lobes of the prostate and engages the prostatic tissue at a point away from each apex.

[0074] Thus, the method includes visualizing the prostate lobes and their respective apices during implant implantation and orientation using a delivery system that specifically engages a portion of the prostate tissue by an apparatus to place the implant in a desired configuration with accurate placement and orientation of the implant along the length of the urethra, distally to the bladder neck, preferably without disturbing the seminal colliculus, within the transitional (or T) zone of the prostate. The method also includes the deployment of a plurality of implants selected and sized for the physiological state of a particular BPH patient, which includes the selective deployment of different embodiments of the implant as described herein and in the accompanying drawings.

[0075] This application describes a delivery system that delivers an implant to a target location (the prostatic urethra), accurately deploys and positions the implant, and retracts the delivery system. Thus, the delivery system can have several features including: <It can hold a mechanical implant in a constrained (low profile or compressed to a small diameter) configuration of less than 4.667 mm (14F), ideally <2 mm (6F). Be non-traumatic to the urethra and other anatomical structures during advancement, deployment, and retraction. Produce little pain or bleeding during use. Be of sufficient length to reach the target site. Be compatible with the use of an existing, commercially available, or standard flexible cystoscope with a length of 40 - 60 cm. Have sufficient flexibility to pass through the tortuosity of the urethra from the penis to the bladder. Do not interfere with the scope's ability to visualize anatomical features and landmarks (external sphincter, seminal colliculus, bladder neck, and bladder) during advancement and deployment. Have flexibility that allows articulation at the distal end of the cystoscope. Provide a saline irrigation flow for imaging. Integrate with a light source and an image capture element. Accurately position the implant at the target location (within + / - 5 mm from the target site; or within + / - 2 mm, etc.). Provide a visual indicator for identifying the mechanical implant position. Enable a single operator to complete the procedure (advance the delivery system to the prostatic urethra and implant the implant) without the assistance of a nurse or technician. Implant deployment force that is clinically acceptable, i.e., not too high that requires excessive force for deployment and not too low that may lead to premature deployment. The deployment force should be less than 44.48 N (10 lbf), ideally less than 13.34 N (3 lbf). Compatibility with standard video displays such as VGA, smartphones, or tablets. Compatibility with the workflow of urologists currently performing cystoscopy in the hospital. Ability to fix / lock the implant in a constrained state and unlock it before deployment. Ability to adjust the working length of the device to fit various cystoscopes.

[0076] In some embodiments, the actuating / articulating element can be locked before disengaging the lock for implant deployment.

[0077] In some embodiments, the system further includes an engaging / re-engaging element for repositioning, orienting, and reorienting the implant (with respect to anatomical landmarks) after implant deployment or implantation, and a disengaging mechanism for completely separating the implant from the delivery system.

[0078] Also, it is desirable to simplify and ease the delivery system and the treatment steps as much as possible for the physician, thereby reducing the procedure time, complexity, and the need for assistants.

[0079] The exemplary embodiments disclosed above are merely intended to illustrate the various utilities of the present disclosure. Numerous modifications, variations, and combinations of the functional elements and features of the present disclosure are possible in light of the above teachings, and thus, within the scope of the appended claims, the present disclosure can be practiced other than as particularly disclosed, and it is understood that the principles of the present disclosure can be readily extended to other applications with appropriate modifications.

[0080] All patents and publications are incorporated herein by reference for the purpose of reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. Although the present disclosure has been specifically disclosed by preferred embodiments and optional features, modifications and changes to the concepts disclosed herein may be made by those skilled in the art, and it should be understood that such modifications and changes are considered to be within the scope of the present disclosure.

[0081] [Embodiment] (1) A system for delivering and deploying an implant to a desired location within a body lumen, comprising: An elongate sheath configured to be introduced through the working channel of a cystoscope and having a non-traumatic tip at its distal end; A handle fixed to the proximal end of the elongate sheath; A pusher disposed within the elongate sheath; A deployment actuator coupled to the handle and connected to the pusher; An implant maintained in a constrained configuration within the elongate sheath adjacent the non-traumatic tip; And wherein operation of the deployment actuator causes relative movement between the pusher and the elongate sheath to deploy the implant from the non-traumatic tip of the elongate sheath. A system. (2) The system according to embodiment 1, further comprising an advancement knob on the handle for adjusting the working length of the elongate sheath and the implant deployment position. (3) The system according to embodiment 1, wherein the deploying actuator is a slider connected to a proximal end portion of the pusher. (4) The system according to embodiment 1, wherein the operation of the deploying actuator retracts the elongate sheath to deploy the implant from the atraumatic distal tip of the elongate sheath. (5) The system according to embodiment 1, wherein the operation of the deploying actuator moves the pusher distally to deploy the implant from the atraumatic distal tip of the elongate sheath.

[0082] (6) The system according to embodiment 1, further comprising a fluid coupling coupled to the handle and in fluid communication within the elongate sheath configured to direct irrigation fluid to the atraumatic distal tip. (7) The system according to embodiment 6, wherein the fluid coupling is movable with the deploying actuator. (8) The system according to embodiment 1, further comprising an implant actuator coupled to the handle and connected to an implant engagement element and configured to selectively release or retract the implant during deployment. (9) The system according to embodiment 7, further comprising an implant actuator connected to an implant engagement element and configured to selectively release the implant during deployment, wherein the implant engagement element is fed through the fluid coupling. (10) The system according to embodiment 1, further comprising an implant engagement element configured to maintain control of the implant during deployment.

[0083] (11) The system according to embodiment 8, wherein the implant engagement element includes a preformed shape disposed within the implant, the preformed shape configured to retard distal movement of the implant during deployment. (12) The system according to embodiment 8, wherein the implant engagement element includes a releasable tether connected to a proximal end portion of the implant. (13) The system according to embodiment 8, wherein the implant engagement element includes interlocking features at a distal end of the pusher and a proximal end of the implant. (14) The system according to embodiment 8, wherein the implant engagement element includes a wire fed through a hole formed in a tissue engagement portion of the implant that restrains the implant when tension is applied. (15) The system according to embodiment 8, wherein the implant engagement element includes a wire fed around a tissue engagement portion of the implant that restrains the implant when tension is applied.

[0084] (16) An apparatus for delivering and deploying an implant to a desired location within a body lumen, comprising: An elongate sheath configured to be introduced through a working channel of a cystoscope, having a non-traumatic tip at a distal end; A handle fixed to a proximal end of the elongate sheath; A pusher coaxially disposed within the elongate sheath; A deployment actuator coupled to the handle and connected to the pusher; Including, By operation of the deployment actuator, relative movement occurs between the pusher and the elongate sheath, driving an implant maintained in a constrained configuration within the elongate sheath adjacent the non-traumatic tip of the implant out of the non-traumatic tip of the elongate sheath. (17) The apparatus according to embodiment 16, wherein operation of the deployment actuator moves the pusher distally to deploy the implant from the non-traumatic tip of the elongate sheath. (18) The apparatus according to embodiment 16, further comprising a forward knob on the handle for adjusting the working length of the elongate sheath and the implant deployment location. (19) The apparatus according to embodiment 16, further comprising a fluid coupling coupled to the handle in fluid communication with a lumen of the pusher configured to direct irrigation fluid to the non-traumatic tip. (20) The fluid connector is the device according to embodiment 19, which is movable together with the deployment actuator.

[0085] (21) The elongated sheath is the device according to embodiment 16, which is configured to fit within a working channel having a diameter of 2 mm (6 French) or less. (22) The handle is the device according to embodiment 16, which further includes a deployment lock that selectively restricts the operation of the deployment actuator. (23) The handle is the device according to embodiment 16, which further includes a connector coaxially arranged around the elongated sheath for engaging with a lock of the working channel of the cystoscope. (24) A method for delivering and deploying an implant to a desired location within a body lumen, comprising: providing an elongated sheath having a non-traumatic distal tip and an implant maintained in a constrained configuration within the elongated sheath adjacent to the non-traumatic tip; introducing the elongated sheath through a working channel of a cystoscope; positioning the distal tip at a target site within the urethra; operating a deployment actuator to cause relative movement between a pusher coaxially arranged within the elongated sheath and the elongated sheath, and deploying the implant from the non-traumatic tip of the elongated sheath. A method. (25) The method according to embodiment 24, further comprising adjusting the working length of the elongated sheath before deployment of the implant.

[0086] (26) The method according to embodiment 24, further comprising operating an implant actuator to maintain control of the implant during deployment. (27) The method according to embodiment 24, further comprising operating an implant actuator to release the implant after it has distally exited outside the elongated sheath. (28) The method according to embodiment 24, further comprising determining the implant length by using a balloon catheter or a laser marker catheter.

Claims

1. An apparatus for delivering and deploying an implant to a desired location within a body lumen, comprising: An elongate sheath having a non-traumatic tip at its distal end, the elongate sheath being configured to be introduced through the working channel of a cystoscope; A handle fixed to the proximal end of the elongate sheath; A pusher coaxially disposed within the elongate sheath; A forward knob on the handle for adjusting the working length of the elongate sheath and the implant deployment location; A deployment actuator coupled to the handle and connected to the pusher; wherein operation of the deployment actuator causes relative movement between the pusher and the elongate sheath, driving the implant, which is maintained in a constrained configuration within the elongate sheath adjacent the non-traumatic tip, out of the non-traumatic tip of the elongate sheath.

2. The apparatus according to claim 1, further comprising a fluid coupling configured to direct irrigation fluid to the non-traumatic tip, the fluid coupling being coupled to a handle in fluid communication with the lumen of the pusher or the elongate sheath.

3. The apparatus according to claim 2, wherein the fluid coupling is movable with the deployment actuator.

4. The apparatus according to claim 1, wherein the elongate sheath is configured to fit within a working channel having a diameter of 2 mm (6 French) or less.

5. The handle further comprises a deployment lock for selectively restricting the operation of the deployment actuator, and / or The handle further comprises a connector coaxially disposed around the elongate sheath for engaging a lock of the working channel of the cystoscope.

6. A system for delivering and deploying an implant to a desired location within a body lumen, comprising: The apparatus according to claim 1; The implant maintained in a constrained configuration within the elongate sheath adjacent the non-traumatic tip; wherein operation of the deployment actuator causes relative movement between the pusher and the elongate sheath, deploying the implant from the non-traumatic tip of the elongate sheath.

7. The system according to claim 6, wherein the deployment actuator is a slider connected to the proximal end of the pusher.

8. By the operation of the actuator provided, the elongated sheath is retracted to deploy the implant from the atraumatic tip of the elongated sheath, or, The system according to claim 6, wherein by the operation of the actuator provided, the pusher is moved distally to deploy the implant from the atraumatic tip of the elongated sheath. **Claim 9** The system according to claim 6, further comprising a fluid fitting coupled to the handle in fluid communication within the elongated sheath configured to direct irrigation fluid to the atraumatic tip. **Claim 10** The fluid fitting is movable with the deployment actuator and / or, The system further comprises an implant actuator connected to an implant engagement element and configured to selectively release the implant during deployment, The system according to claim 9, wherein the implant engagement element is fed through the fluid fitting. **Claim 11** The system according to claim 6, further comprising an implant actuator coupled to the handle connected to the implant engagement element and configured to selectively release or retract the implant during deployment. **Claim 12** The system according to claim 6, further comprising an implant engagement element configured to maintain control of the implant during deployment. **Claim 13** The implant engagement element is disposed within the implant and has a preformed shape, and the preformed shape is configured to retard distal movement of the implant during deployment, or, The implant engagement element includes a releasable tether connected to the proximal end of the implant, or, The system according to claim 11, wherein the implant engagement element is a threaded rod or tube threaded into the implant. **Claim 14** The implant engagement element includes a wire fed through a hole formed in the tissue engagement portion of the implant that restrains the implant when tension is applied, or, The system according to claim 11, including a wire fed around the tissue engagement portion of the implant that restrains the implant when tension is applied.

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