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

Abstract

Disclosed are devices and systems for the treatment and / or management of obstructed body lumens, including prostatic lobe tissue obstructing the urethra, such as conditions including benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), benign prostatic obstruction (BPO), and lower urinary tract symptoms (LUTS) associated therewith. The implant is maintained in a constrained configuration within a distal portion of an elongated sheath so as to be deployable by driving the implant with a pusher coaxially disposed within the sheath. The implant engagement element assists in maintaining control of the implant during deployment.

Description

Technical Field

[0001] This disclosure relates to devices and systems for the care or treatment of body tissues that obstruct hollow body cavities, such as prostatic lobe tissue obstructing the urethra. Background Technology

[0002] The prostate is a walnut-shaped gland that surrounds the urethra and plays a crucial role in the male reproductive system, through which urine is expelled from the bladder. Although the gland is initially small, it tends to enlarge as men age. An excessively enlarged prostate leads to a condition called benign prostatic hyperplasia (BPH). BPH refers to an abnormal but non-malignant (non-cancerous) growth of the prostate gland, which is very common in older men. BPH is a chronic condition and is associated with the development of obstruction or narrowing of the urinary tract in the prostatic urethra. Bladder outlet obstruction (BOO) refers to a blockage at the base of the bladder that reduces or prevents urine from flowing into the urethra and may be secondary to BPH. A range of related disorders collectively known as lower urinary tract symptoms (LUTS) can lead to sexual dysfunction, frequent urination, difficulty urinating, urinary retention, urinary incontinence, and urethral and bladder infections, which worsen as the abnormal prostate enlarges and progresses.

[0003] Surgical procedures provide relief for BPH by removing most of the prostate tissue. Several traditional surgical procedures are available, all of which require hospitalization and some form of spinal, epidural, or general anesthesia. Transurethral resection of the prostate (TURP) is the primary surgical treatment for BPH and remains the gold standard compared to other treatments. Traditional surgical techniques differ in the location of the incision made by the surgeon to access the prostate and the method by which the prostate tissue is removed. For example, some surgeries use laser energy, thermal energy, or radiofrequency energy to remove tissue from the prostate. These include laser ablation, photoselective vaporization (PVP), transurethral needle ablation using radiofrequency energy (TUNA), transurethral microwave thermotherapy (TUMT), and transurethral prostatectomy (TUIP). However, these traditional surgical methods for treating BPH are invasive, irreversible, and have significant drawbacks, including the placement of temporary catheters for several months, risk of infection, loss of sexual function, urinary incontinence, and restenosis, including recurrence of urethral orifice narrowing due to recurrent cell proliferation during prostate regeneration, as well as recurrence of LUTS symptoms mentioned above.

[0004] While removing prostate tissue may alleviate some BPH symptoms, the removal of tissue via traditional surgical methods is irreversible, and any adverse effects of surgery can cause lifelong suffering or impact a patient's quality of life. Furthermore, surgical methods are associated with inherent risks from the surgery itself, the risk of recurrence from the regeneration of prostate tissue after removal, and recovery periods of up to 3 to 6 weeks may be required, depending on the severity of the disease and the specific surgical approach needed for each individual patient.

[0005] Due to the recognized drawbacks of traditional surgery, minimally invasive therapies have been developed, and depending on the severity of the disease, patients and their doctors can choose these therapies as alternatives to lifelong medication or surgery. These minimally invasive therapies are suitable for patients who are unwilling or medically unfit for surgical procedures under general anesthesia. Furthermore, younger patients often prefer minimally invasive, reversible treatments that do not jeopardize sexual function, reserving the option of permanent, irreversible treatments affecting sexual function for later in life.

[0006] Minimally invasive techniques involve transurethral methods that actually remove tissue from the enlarged prostate gland. These methods are generally less invasive than traditional surgery, but each one damages prostate tissue and is irreversible. To avoid damaging prostate tissue, other treatment procedures have been developed that are designed to increase the diameter of the prostatic urethra without actually removing tissue from the prostate gland, such as by implanting a device designed to increase the urethral diameter within the prostatic urethra. Prostate implants involve a procedure in which a urologist inserts a small device into the prostatic urethra, which has narrowed due to enlarged prostate tissue. Once in place, the implant is designed to dilate and help keep the urethra open by pushing away lobules of tissue, while preventing the enlarged prostate tissue from being completely affected and opening the urethra. Ideally, prostate implants eliminate the need for surgical removal of prostate tissue and are expected to reduce the risks of infection, sexual dysfunction, and incontinence, risks inherent and traditional to even minimally invasive, surgical methods. Because the implant is removable and can be followed by additional surgical treatment in the future, the procedure can also be designed to be reversible.

[0007] It is also desirable to have features (or structural features) on the implant and delivery system that allow physicians to perform the procedure in the clinic using standard cystoscopy and general urological techniques for examining obstruction in the prostatic urethra and the degree of BPH. It is also desirable to have the ability to reposition the implant in the event of accidental deployment. Features for holding and repositioning the device are needed to remove stones during urological procedures using conventional graspers or other assistive devices in conjunction with endoscopic or cystoscopic imaging. This disclosure addresses these and other needs. Summary of the Invention

[0008] This disclosure includes a system for delivering and deploying an implant at a desired location within a lumen of the body. The system comprises an elongated sheath configured for insertion through a working channel of a cystoscope, having an atraumatic end at its distal end; a handle fixed to a proximal end of the elongated sheath; a pusher coaxially disposed within the elongated sheath; a deployment actuator associated with the handle and coupled to the pusher; and an implant held in a restraint configuration within the elongated sheath, adjacent to the atraumatic end, wherein manipulation of the deployment actuator results in relative movement between the pusher and the elongated sheath to induce deployment of the implant from the atraumatic end of the elongated sheath.

[0009] On one hand, the push knob on the handle is configured to adjust the working length of the elongated sheath.

[0010] On one hand, the deployment actuator is a slider attached to the proximal end of the pusher. Manipulating the deployment actuator can retract the elongated sheath to cause the implant to deploy from the non-invasive end of the elongated sheath, or can move the pusher distally to cause the implant to deploy from the non-invasive end of the elongated sheath.

[0011] On one hand, the fluid connector is associated with the handle and in fluid communication with the lumen of the actuator, configured to guide flushing fluid to a non-invasive end. During the treatment procedure used to deploy the implant in the prostatic urethra, the flushing fluid must flow continuously for visualization or imaging. The fluid connector can move together with the deployment actuator.

[0012] On one hand, the implant actuator may be associated with a handle and connected to an implant engagement element, wherein the implant actuator is configured to selectively or gradually release or retract the implant in a controlled manner during deployment.

[0013] On one hand, the implant engagement element can be configured to maintain control of the implant during deployment. For example, the implant engagement element can be a pre-shaped component disposed within the implant, configured to slow distal movement of the implant upon deployment. Alternatively, the implant engagement element can be a releasable tether attached to the proximal end of the implant. The implant engagement element may also include interlocking features at the distal end of the actuator and the proximal end of the implant. Furthermore, the implant engagement element can be a filament delivered through an opening formed in the tissue junction portion of the implant, the filament securing the implant when tensioned, or the implant engagement element can be a filament delivered around the tissue junction portion of the implant, the filament securing the implant when tensioned.

[0014] This disclosure also includes a device for delivering and deploying an implant at a desired location within a lumen of the body. The device is characterized by: an elongated sheath configured for insertion through a working channel of a cystoscope, having a non-invasive end at its distal end; a handle fixed to a proximal end of the elongated sheath; a pusher coaxially disposed within the elongated sheath; and a deployment actuator associated with the handle and coupled to the pusher, wherein manipulating the deployment actuator results in relative movement between the pusher and the elongated sheath to cause the implant, held in a restraint configuration within the elongated sheath adjacent to its non-invasive end, to deploy from the non-invasive end of the elongated sheath.

[0015] On one hand, manipulating the deployment actuator moves the pusher distally to cause the implant to deploy from the non-invasive end of the elongated sheath.

[0016] On one hand, the push knob on the handle can be configured to adjust the working length of the elongated sheath.

[0017] On one hand, the fluid connector associated with the handle is in fluid communication with the lumen of the actuator and is configured to guide the flushing fluid to a non-invasive end. During the treatment procedure used to deploy the implant in the prostatic urethra, the flushing fluid must flow continuously for visualization or imaging. The fluid connector can move together with the deployment actuator.

[0018] On the one hand, the elongated sheath can be configured for fitting into a working channel with an outer diameter not exceeding 6 French.

[0019] On the one hand, the handle can have an unfolding lock that selectively restricts the operation of the unfolding actuator.

[0020] On the other hand, the handle may also have a connector coaxially arranged around the elongated sheath for engaging the lock of the working channel of the cystoscope.

[0021] This disclosure also includes a method for delivering and deploying an implant at a desired location within a lumen of the body. The method may involve providing an elongated sheath having a non-traumatic distal end and an implant held in a restraint configuration within the elongated sheath adjacent to the non-traumatic end; inserting the elongated sheath through the working channel of a cystoscope; positioning the distal end at a target site within the urethra; and manipulating a deployment actuator to cause relative movement between a pusher coaxially disposed within the elongated sheath and the elongated sheath to deploy the implant from the non-traumatic end of the elongated sheath.

[0022] On the one hand, the working length of the elongated sheath can be adjusted before the implant is deployed.

[0023] On one hand, the implant actuator can be manipulated to maintain control of the implant during deployment. Such control may include partial deployment or retraction of the implant. Such control may also include rotation and placement of the implant for optimal positioning to actuate the prostatic lobules and create openings at any time during deployment prior to implant release.

[0024] On one hand, the implant actuator can be manipulated to release the implant after it has been driven distally away from the sheath.

[0025] On the one hand, the length of the implant can be determined by using a balloon catheter.

[0026] On the one hand, the length of the implant can be determined by using a laser-marked catheter. Attached Figure Description

[0027] Further features and advantages will become apparent from the following and more specific description of preferred embodiments of the present disclosure, as illustrated in the accompanying drawings, and in which like reference characters generally refer to the same portions or elements throughout the view, and in which:

[0028] Figure 1 It is a cross-sectional view of male anatomy, including the lower part of the bladder and the prostatic urethra in the typical physiological configuration of a patient with BPH, illustrating the placement of an implant disposed in the prostatic urethra and coupled to prostatic tissue on either side between the bladder neck opening and the verumontanum, according to embodiments using the devices and systems of this disclosure.

[0029] Figure 2A and Figure 2B A top view and a side view of a system for deploying an implant according to an embodiment are schematically depicted.

[0030] Figure 3 A cross-sectional view of the unfolding system according to an embodiment is schematically depicted.

[0031] Figure 4 A detailed view of the movable fluid connector of the deployment system according to an embodiment is schematically depicted.

[0032] Figure 5 A schematic detailed view of an alternative unfolding lock of an unfolding system according to an embodiment is depicted.

[0033] Figure 6 An implant engagement element having a pre-formed shape is schematically depicted according to an embodiment.

[0034] Figures 7A to 7C The illustration schematically depicts the use of a tether loop as an implant engagement element according to an embodiment.

[0035] Figures 8A to 8C Interlocking implant engagement elements according to various embodiments are schematically depicted.

[0036] Figures 9A to 9C An implant engagement element of a restraint implant according to various embodiments is schematically depicted.

[0037] Figure 10 An illustrative depiction of a deployment device with a plunger actuator according to an embodiment is shown.

[0038] Figure 11 A manual syringe deployment actuator according to an embodiment is schematically depicted.

[0039] Figure 12 A balloon catheter for determining an appropriate implant length is schematically depicted according to an embodiment.

[0040] Figure 13 A laser marking catheter for determining the appropriate implant length is schematically depicted according to an embodiment.

[0041] Figure 14 A schematic detailed view of an alternative deployment system according to an embodiment is depicted, having an alternative deployment safety lock and a flushing connector, but without an implant actuator.

[0042] Figure 15 A schematic detailed view of an alternative deployment system according to an embodiment is depicted, having an alternative deployment safety lock and a flushing connector, but without an implant actuator. Detailed Implementation

[0043] First, it should be understood that this disclosure is not limited to the materials, architectures, routines, methods, or structures of specific examples that may vary in themselves. Therefore, although many similar or equivalent options to those described herein may be used in practice or embodiments of this disclosure, the preferred materials and methods described herein are preferred.

[0044] It should also be understood that the terminology used herein is for the purpose of describing specific embodiments of the present disclosure only and is not intended to be limiting.

[0045] The detailed description set forth below in conjunction 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 may be practiced. The term “exemplary” as used throughout this specification means “serving as an example, instance, or illustration” and should not necessarily be construed as being preferred or advantageous over other exemplary embodiments. The detailed description includes specific details intended to provide 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 may be practiced without these specific details. In some instances, well-known structures and apparatuses are shown in block diagram form to avoid obscuring the novelty of the exemplary embodiments presented herein.

[0046] For convenience and clarity only, directional terms such as top, bottom, left, right, up, down, above, higher than, lower than, below, behind, rear, and front may be used relative to the accompanying drawings. These and similar directional terms should not be construed as limiting the scope of this disclosure in any way.

[0047] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Furthermore, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural objects unless the context clearly indicates otherwise.

[0048] Definition: The terms “therapeutic effective displacement,” “therapeutic effective retraction,” or “therapeutic effective dilation” are used interchangeably in this text and refer to the amount of prostate tissue displaced immediately adjacent to the urethral confinement area, sufficient to increase the urethral lumen and treat, improve, or prevent symptoms or comorbidities or conditions of benign prostatic hyperplasia (BPH), including lower urinary tract symptoms (LUTS), bladder outlet obstruction (BOO), and benign prostatic obstruction (BPO), wherein the prostate tissue displacement exhibits a detectable therapeutic, preventative, or inhibitory effect. This effect can be detected by, for example, improvement in clinical condition, or symptom relief or absence of comorbidities. Examples of clinical interventions include a decrease in the International Prostate Symptom Score (IPSS), a reduction in post-relief residual urine volume (PVR), an increase in maximum urinary flow rate (Qmax), an improvement in quality of life (QoL), and improvements in sexual health (for men’s sexual health checklists or SHIM scores, men’s sexual health questionnaires or MSHQ scores) after treatment. The precise distance or volume of prostate tissue transplantation will depend on the subject's weight, size, and health condition; the nature and extent of the enlarged or diseased prostate condition; and the size of the implant chosen for placement in the patient.

[0049] As used in this text, patients “requiring treatment for BPH” are those who will benefit from relief of the presence or symptoms of prostatic hypertrophy caused by non-malignant enlargement of the prostate gland and related disorders, including LUTS, urinary outflow obstruction symptoms, and narrowing of the prostatic urethral lumen. As used in this text, the terms “implant,” “dilate,” or “device” refer to a prosthetic device implanted in the prostatic urethra to relieve LUTS associated with or caused by BPH.

[0050] As used herein, the term "tissue engagement" in relation to the arms, struts, or other extensions of an implant structure refers to the length of the physical structure of the implant that engages prostate tissue along the major portion of the organ lobules compressed against the urethra and inhibits that tissue from further affecting urethral patency. "Tissue retraction" refers to the implant's structural ability to apply the necessary force to displace tissue away from a compressed or narrowed urethra. This necessary force can be supplied by the implant's inherent structure or by the implant expanding from a compression configuration to an expansion configuration, particularly when the implant is made of shape memory or hyperelastic materials with a predetermined expansion configuration designed to engage hyperplastic prostate tissue and apply the necessary tissue retraction force. Within these definitions, the length of the contacting tissue-engagement or tissue-retraction structural feature is separated from the lobular groove extending along the length of the prostate surrounding the urethra and needs to contact tissue of a certain length along the length of the two lateral lobules or the lateral and median lobules.

[0051] Regarding the orientation of the various structural and anatomical references described herein, the terms "proximal" and "distal" are used relative to the perspective of a medical expert, such as a urologist, who is manipulating the delivery system of this disclosure to deploy the implant described herein. Therefore, the features of the delivery system held by the urologist are located at the "proximal" end, while the assembled system and the implant initially in its compressed configuration are located at the "distal" end of the delivery system.

[0052] Reference Figure 1 A cross-sectional diagram of male anatomy shows the prostate gland 1 surrounding the urethra 2. Under normal conditions, the urethra 2 provides fluid communication from urine stored in the bladder 3, allowing it to be expelled from the body under the voluntary muscle control of the external urethral sphincter. Normal or “true” prostate tissue 4 surrounds the urethra 2 and does not affect its patency in the absence of disease. In patients with benign prostatic hyperplasia (BPH), the urethra 2 becomes narrowed due to hyperplastic tissue (i.e., prostate tissue 4 that grows excessively toward the urethra 2). This non-cancerous overgrowth leads to the BPH symptoms described above, including lower urinary tract symptoms (LUTS) and obstruction of urinary outflow, as well as urinary incontinence. Figure 1In this embodiment, the implant 5 delivered by the device and system using the present disclosure is shown to engage with prostate tissue 4 along the length of the implant 5 to restore patency of the urethra 2 and allow unobstructed flow of urine from the bladder 3. As shown, a key feature is the selective placement of the implant 5 at a target site between the bladder neck opening 6 and the verumontanum 7, ensuring that the implant 5 does not puncture, penetrate, or cut through surrounding tissue. The implant 5 is designed to remain in place within the prostatic urethra 2. The implant 5 does not extend into the urobladder 3, where the structural material of the implant 5 may crust or otherwise degrade under continuous exposure to urine, causing complications and making retrieval more difficult, and the implant 5 does not interfere with voluntary control of the external urethral sphincter or disrupt its function.

[0053] The implant 5 according to the technology of this disclosure has multiple tissue-engagement structures to apply force against the hypertrophic prostatic tissue 4 immediately adjacent to the urethra 2. As described below, the number of multiple tissue-engagement structures can be two, four, or more than four tissue-engagement extensions, such as struts or arms. The use of three extensions is avoided when three extensions are oriented to fit within the lobular grooves of the prostate. Therefore, any multiple tissue-engagement structures are possible, as long as the structures are asymmetrically oriented to ensure that the implant 5 is oriented outside the three lobular grooves formed by the length of tissue contact between the two lateral lobules and one medial lobule. Embodiments using three tissue-engagement structures can be used to treat anatomical structures when the urethral anatomy consists of two lateral lobules and the third lobule does not involve urethral narrowing.

[0054] Implant 5 may be made of shape memory materials, alloys, spring materials, and hyperelastic materials including Nitinol (nickel-titanium alloy), Nitinol alloys, cobalt-chromium alloys, spring steel, and spring stainless steel. 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 crusting, corrosion, and stone formation. The coating may include ceramic materials such as alumina, silicon carbide, silicon nitride, and zirconium oxide, as well as other ceramic coatings that are inert to urine and prevent crusting, stone formation, and material degradation in chemical or urinary environments. The coating may also be a polymer, such as polytetrafluoroethylene (PTFE), parylene, silver, and other antimicrobial coatings, silicone derivatives, and other similar materials recognized by those skilled in the art.

[0055] The implant 5 may also include a therapeutic coating adhered to its surface for controlled drug release in a manner known for drug-eluting implants after implantation into the prostatic urethra 2, to reduce cell proliferation and tissue proliferation. The coating contains pharmaceutically active anti-inflammatory and antiproliferative agents, including sirolimus, novolimus, everolimus, biolimus, zotarolimus, paclitaxel, and other drugs for the prevention of restenosis.

[0056] Implant 5 may also be coated with medication to treat BPH symptoms. This type of embodiment offers the advantage of using a high local, high tissue dose in the diseased prostatic region of the urethra 2 to more effectively relax smooth muscle cells, reduce tissue proliferation and prostate size without the side effects caused by the drug circulating to other parts of the body. Potential candidates include alpha-adrenergic blockers such as alfuzosin, doxazosin, tamsulosin, terazosin, and silodosin. Other candidates include 5-alpha-reductase inhibitors such as dutasteride and finasteride, as well as anticholinergic agents. Other candidates are anticholinergic agents such as oxybutynin, fesoterodine, darifenacin, tolterodine tartrate, tolterodine, and solifenacin. Combinations of drugs can also be coated onto surfaces, including alpha blockers + 5-alpha reductase inhibitors or alpha blockers + anticholinergic agents. Additionally, anti-infectives or antimicrobial agents or antibiotics, such as fluoroquinolones (e.g., ciprofloxacin), macrolides, tetracyclines, and trimeprilin, can also be used.

[0057] Typically, the drug is mixed with a solvent and polymer to form a solution and sprayed onto the outer surface of implant 5 to achieve the desired drug release characteristics. The manufacturing process is similar to that used for drug-eluting stents, which are used to treat coronary artery disease. Often, the coating is applied on the luminal side to ensure more efficient drug release and deposition into the urethral tissue of the prostatic urethra 2 and to minimize washout during urine outflow. The drug may also be deposited in microreservoirs or microcatheters on the outer surface of implant 5 to load the drug and be covered by a polymer coating for controlled elution of the drug into the urethral tissue. Typical polymers used for drug loading are polylactic acid (PLA), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), and copolymers thereof; polyurethanes; poly(methyl methacrylate) (PMMA) or poly(n-butyl methacrylate) (PBMA); and combinations thereof. Those skilled in the art may use other polymers and solvents to load sufficient drug and maintain the integrity of the coating on the implant surface. Multilayer coatings can be used to achieve the desired drug loading and controlled release characteristics.

[0058] According to the technology disclosed herein, an implant 5 for restoring patency of the urethra 2 is delivered using a system designed to be compatible with commercially available or standard flexible cystoscopes. Specifically, the system is designed to be advanced through the working channel of the flexible cystoscope, the channel having a lumen diameter between 6-9F and 2-3 mm. Reference Figure 2A and Figure 2BThe following figures show a side view and a top view of the delivery system 10, respectively. An implant 5 (not shown in these views) is held in a binding configuration within an elongated, hollow delivery tube, delivery catheter, or delivery sheath 12, adjacent to a soft and non-invasive distal end 14. The catheter or sheath 12 may be made of a thin-walled polymer tube, possessing sufficient strength to bind the implant 5 while also being flexible and torsional enough to navigate tortuous anatomy and assist in advancement to the prostatic urethra 2. Furthermore, the tubular sheath 12 or catheter may be reinforced with wire coils or wire braids to achieve the desired strength, flexibility, low profile, torsional flexibility, and maneuverability performance characteristics 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" are used interchangeably throughout the document. The delivery sheath 12 may also have different wall thicknesses or rigidities at the distal end, in which the implant 5 is bound to further improve the flexibility of the system (sheath plus implant). In other embodiments, the catheter may have a marking band (of different colors) at its distal end to indicate the position of the implant 5 and the delivery sheath 12, as well as the position of the catheter relative to the distal end of the cystoscope or the exit point of the cystoscope's working channel. In other embodiments, the distal end of the catheter may be more flexible and softer than the rigidity of the shaft body to facilitate reduced trauma to the urethral wall 2. Such a soft, non-invasive distal end may be 0.5-10 mm long, or more preferably 1-2 mm. The proximal end of the sheath 12 is connected to a handle 16, characterized by a flushing port 18 for delivering saline flushing to allow imaging; a cystoscope locking luer 20 that locks and securely attaches the delivery system 10 to the luer connector on the flexible cystoscope, allowing the physician to operate the delivery system with one hand; and a rotation locking knob 22 to prevent rotation of the delivery handle / system during deployment or treatment procedures. For example, the knob 22 may include a screw that engages with the luer connector hub 60 when tightened to prevent its rotation. The handle 16 also has a catheter advance knob 24, which is rotated to change the working length of the delivery system 10 to accommodate various endoscope working lengths and adjust the position of the end of the delivery sheath 12 and accurately position the device at the target site. A catheter position indicator 26, together with a reference catheter position mark 28, provides visual feedback for length adjustment. An deployment safety lock 30 is configured to prevent premature deployment of the implant 5 by restricting the movement of the deployment actuator (e.g., slider 32), which in this embodiment deploys the implant 5 at the target site when pushed. An implant engagement element 46 is configured to assist in the accurate placement of the implant 5 (not shown in this view), as discussed below. This implant engagement element (e.g., a capture filament) is coupled to the implant actuator 34 to manipulate the release of the implant 5 during deployment, as discussed in further detail below.In other embodiments, the implant actuator 34 and associated mechanisms may be omitted.

[0059] As mentioned, the distal tip 14 of the delivery system 10 is flexible and non-invasive. Color contrast between the distal tip and the axis of the delivery catheter 12 can be used to provide visual indication of a prescribed distance to assist in the deployment of the implant 5 at the target site or a few millimeters away from the desired anatomical location. In one embodiment, the distal 5 mm of the tip 14 is colored white relative to the blue axis to assist in placement of the implant 5 within the prostatic urethra 2 at a distance of 5 mm from the verumontanum. The distal tip 14 may also be made of a radiopaque material (a polymer containing barium sulfate) to assist in placement under X-ray fluoroscopy. The distal tip 14 may be straight or curved to minimize damage to the urethral wall.

[0060] The elongated delivery sheath 12 is flexible and compatible with steerable cystoscopes commonly used by urologists for the diagnosis and treatment of chronic conditions and symptoms related to the urethra and reproductive system. The implant 5 is positioned within the sheath 12 and held in a restrained position at its distal end, allowing it to be delivered through a much smaller lumen before dilation. Flushing is also delivered through the sheath 12 to clear turbidity and debris from the camera or imaging field of view. The sheath 12 may have a hydrophilic coating to improve lubrication during advancement, or it may be uncoated. Furthermore, the sheath 12 may have more than one lumen for different functions (flushing flow lumen, implant engagement element, deployment mechanism, light source, imaging element, etc.). It may have a pre-defined shape and rigidity to displace the prostate and / or conform to anatomy and allow it to be steered or advanced to the target site.

[0061] Further details of delivery system 10 are in Figure 3The cross-sectional view shows that, specifically, the catheter advancement knob 24 is connected to the catheter advancement screw 38 via a locking thread. When the knob 24 is rotated, the thread converts rotation into linear motion and adjusts the working length of the delivery system 10, i.e., the length of the delivery catheter 12 exposed from the handle 16. When the user activates the deployment actuator, i.e., the slider 32, the locking thread ensures that the position of the delivery catheter or sheath 12 is fixed and unaffected by deployment movement. The external thread of the screw 38 engages with the knob 24 to adjust the working length of the sheath 12. A pusher tube 40 is disposed within the lumen of the sheath 12, its proximal end connected to the slider 32. The slider 32 also actuates the movable fluid connector 42. The locking lever 44 can optionally engage with the deployment safety lock 30, such that when engaged, the relative distance between the movable fluid connector 42 and the catheter advancement screw 38 is maintained. Additionally, during pre-procedure processing, the slider 32 is prevented from displacing the pusher tube 40 and prematurely or accidentally deploying the implant 5. When desired deployment is achieved, the retraction lock 30 allows the slider 32 to advance distally and drive the actuator tube 40, thereby pushing the implant 5 away from the distal end of the sheath 12 to facilitate deployment at the target site. The movable fluid connector 42 provides two passages communicating with the actuator tube 40 to allow saline flushing through the flush port 18, and a lumen for the implant engagement element 46 (e.g., the capture wire mentioned above), controlled by the implant actuator 34. Flushing fluid enters through the flush port 18 and the lumen 48, while the implant engagement element 46 is delivered through the lumen 50 before they are connected and continue through the lumen of the actuator tube 40. Depending on the desired performance characteristics of the advanceability (to push the implant 5 and deploy at the target site), the actuator tube 40 may be a hollow or solid tube, and provides additional flushing and increased fluid connection area to enhance imaging during cystoscopy.

[0062] The actuator 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 actuator 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. Therefore, when the rotating locking knob 22 is tightened against the Luer connector hub 60, the handle 16 cannot be rotated relative to the cystoscope. Other embodiments for deploying the dilator implant 5 may be designed to include a mechanism in which the actuator tube is stationary and locked to the handle 16 and the implant engagement element 46. Sliding or moving the implant actuator can retract the sheath 12 to expose the implant 5 and deploy the dilator implant 5 in the prostatic urethra 2.

[0063] The implant engagement element 46 is connected to the implant actuator 34 via an implant actuator seal 62 housed within the body 64A, such that the implant actuator seal 62 and the implant actuator 34 prevent flushing fluid from being drawn out through the lumen 50. A slider 32 is connected to a movable fluid connector 42 as described, such that the connector 42 moves together with the slider 32 during implant deployment, thereby providing continuous flushing and imaging of anatomical landmarks during the treatment procedure. After the implant has deployed at the target site, the implant actuator 34 disconnects from the body 64A and the implant engagement element 46 retracts, removing the implant 5 from the delivery system 10. Advantageously, the implant actuator 34 facilitates incremental and well-controlled deployment of the implant 5, preventing premature “bounce” or “forward bounce” and deployment in an unsuitable configuration or far from the target site. Premature deployment or misplacement is reduced by maintaining control of the implant 5 even after expansion.

[0064] The movable fluid connector 42 is suitable for a variety of functions, including connecting the slider 32 to the actuator tube 40 for implant deployment 5, providing fluid communication through the lumen 48 between the flushing port 18 and the actuator tube 40, maintaining clear visualization for video by flushing, and connecting the various components associated with the slider 32 mentioned above during implant deployment 5. Furthermore, the movable fluid connector 42 cooperates with the locking lever 44 and the lock 30 to provide the functions discussed above. The movable fluid connector 42 also provides a lumen 50 for the implant engagement element 46 connected to the implant actuator 34. When the lock 30 is disengaged, the movable fluid connector 42 allows distal translation toward the catheter advance screw 38 when the user advances the slider 32. Figure 4 As shown in the detailed view, the movable fluid connector 42 has a defined path guided by a groove 52 that engages with a guide rail 54 in the handle 16. Advancing the slider 32 causes the movable fluid connector 42 to translate distally, together with the actuator tube 40, unfolding the implant 5 outside the distal end of the sheath 12.

[0065] The flushing port 18 allows for flushing connections via a standard Luer lock connector. It can also be used to deliver therapeutic agents to the treatment site. Another end □ may be present, providing a lumen for aspiration or suction to facilitate the transport of tissue or fluid away from the target site or patient. The aspiration source may be, for example, a gravity-driven, powered vacuum pump, a wall-mounted suction outlet, or a syringe.

[0066] The actuator tube 40 is a separate flexible component within the sheath 12, primarily used to eject or actuate the implant 5 from the delivery system 10, thereby deploying the implant 5 at the desired target site. Suitable materials include PEEK (polyetheretherketone), other polymers, or spring materials, as well as hyperelastic materials including nitinol (nickel-titanium alloy), nitinolite alloys, cobalt-chromium alloys, spring steel, and spring stainless steel, possessing sufficient strength, flexibility, and maneuverability to deploy or retract the implant 5 from the delivery system 10 without kinking. The actuator tube 40 also provides a flushing lumen, as discussed above, to provide fluid flushing to maintain clear visualization of the video camera. The actuator tube 40 is coaxially disposed within the sheath 12.

[0067] In an alternative embodiment, the safety lock function can be implemented using push actuation rather than pull. For example, Figure 5 Detailed views are shown, in which similar elements have the same reference numerals. Here, when the locking button 56 is pressed, a wider opening is centered around the locking lever 44, allowing the movable fluid connector 42 to translate distally under the control of the slider 32.

[0068] In another embodiment, two push-lock safety mechanisms are present, allowing partial deployment of the implant 5 before full deployment. For example, Figure 14 and Figure 15 Shown is an actuator tube, actuator rod, or actuator wire 152 disposed within the lumen of the sheath 12, its proximal end connected to the actuator block 160. A slider 32 actuates the movable actuator block 160. An deployment track 161 selectively engages with deployment safety locks 150 and 151, such that when engaged, the relative distance between the actuator block 160 and the catheter advance screw 38 is maintained. Additionally, during pre-procedure processing, the slider 32 is prevented from prematurely or accidentally deploying the implant 5 by moving the actuator tube 152. Initially, lock 151 cannot be pressed due to interference with the automatic lock 153, and lock 150 contacts the stop 158. When desired to unfold, pressing lock 150 allows pusher block 160 to advance distally and drive pusher tube 152 until lock 151 contacts stop 159, wherein implant 5 partially unfolds from sheath 12, allowing observation of the orientation and position of implant 5 before release and completion of unfolding. When lock 151 contacts stop 159, pressing lock 151 allows pusher block 160 and pusher tube 152 to translate further distally, thereby fully unfolding implant 5 at the target site away from the distal end of sheath 12. Spring 157 returns pusher block 160 and pusher tube 152 proximally, thus returning protrusion 64B (as shown in the image) Figures 8A to 8C(As shown) is re-secured to the sheath 12 to prevent damage to the urethra and cystoscope during withdrawal of the delivery system 10. Fluid enters through the flush port 154 and flush tube 155. A movable deployment track 161 provides a fluid path 156 that overlays the fixed flush tube 155. A flush seal 162 is compressed between the deployment track 161 and a sealing nut 163 to prevent fluid leakage between the inner diameter of the deployment track 161 and the outer diameter of the flush tube 155. An exemplary method for employing 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 containing an implant 5 of sufficient length to treat the prostatic urethra is selected. Furthermore, cystoscopy may be performed to further verify the target length of treatment in the prostatic urethra 2. Typically, the treatment length is taken as the length from the bladder neck to the verumontanum. The implant 5 is desiccated between the bladder neck 6 and the verumontanum 7. In some cases, the implant 5 may be placed 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 treatment length of the target prostatic urethra 2 is measured. The distal end of the cystoscope is positioned near the verumontanum 7. A delivery system 10 with an implant 5 of appropriate length is selected. The catheter shaft length is adjusted using the catheter advancement knob 24. The catheter position indicator 26 is aligned with the appropriate catheter position mark 28. The saline bag and connector tube are disconnected from the cystoscope and connected to the flushing port 18 of the delivery system 10 to allow saline flushing. The sheath 12 is inserted through the instrument channel of the cystoscope, and the cystoscope locking lug 20 on the handle 16 is locked to the cystoscope's lug connector by rotating it clockwise. The handle 16 is then rotated to the desired position and the locking engagement rotation locking knob 22 is locked. The sheath 12 is further advanced using the catheter advancement knob 24 until the white distal mark at the distal end 14 of the sheath 12 appears in the field of view of the cystoscope. Once the target site for implant 5 deployment is identified, 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 verify its position and then retracted to reposition and deploy in the desired location. When the implant 5 is partially deployed, its orientation can be controlled by rotating the delivery catheter or delivery sheath. The opening in the prostatic urethra 2 can be verified by fully deploying the implant 5 without releasing it from the implant engagement element 46. If a preferred or alternative implant 5 orientation relative to the prostatic lobules or relative to the bladder neck 6 or verumontanum 7 is desired, the implant 5 can be retracted into the sheath 12 for repositioning or reorientation and then deployed in the desired location.Once the implant 5 is deployed at the target site, the implant actuator 34 is manipulated, for example by loosening, to disengage the implant engagement element 46. In some embodiments, such as those employing a capture filament, 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 releasing the cystoscope locking lug 20, and the system 10 is retracted from the instrument channel of the cystoscope.

[0069] In other embodiments, the delivery system 10 may be adapted to incorporate a light source and image capture element to eliminate the need for compatibility with commercially available flexible cystoscopes. Using such modifications to deploy the implant 5 at the target site has several advantages. First, it reduces the profile (or outer diameter) of the delivery system 10 inserted into the urethra 2. A smaller profile system is more flexible, less invasive, and causes less pain. Second, the delivery system 10 of this disclosure can incorporate and deliver more implant 5 designs (collapsed to a larger constrained diameter) without the constraints imposed by the working channels of existing delivery systems. Third, the delivery system 10 can be a disposable medical device, eliminating the need for expensive cystoscopes requiring re-sterilization and periodic refurbishment, and avoiding the risks associated with re-sterilization. Such embodiments include the aspects discussed above, along with actuation / hinged elements to allow navigation and visualization, video connectors for interfacing to standard VGA, smartphones, or flat panel displays, conduit shafts with enlarged lumens for improved flushing, and connector cabling for light sources and image capture, with the distal end correspondingly including a light source, camera, and combined flushing and implant exit point.

[0070] Now go to Figure 6 This illustration shows an exemplary embodiment of an implant 5 coupled with an implant engagement element 46. As can be seen, the implant engagement element 46 includes a pre-formed filament 60 at its distal end, which is configured to slow the release of the implant 5 during deployment to facilitate more accurate placement. In other embodiments, the implant engagement element 46 may be a threaded rod or tube screwed onto the implant 5, or a tube or rod or tube having features interlocked with those on the implant 5 to allow controlled release during deployment. Alternatively, the implant engagement element 46 may also be a braided or single thread, suture, or cord that functions in a similar manner to temporarily restrain the implant 5 during deployment.

[0071] Another aspect of the technology disclosed herein is Figures 7A to 7C The illustration shows the cooperation between the actuator tube 40 and the implant engagement element 46 when the implant 5 is deployed. First, Figure 7AThe implant 5 is shown positioned within the distal end of the sheath 12 in a restraining configuration. An actuator tube 40 engages a distal feature of the implant 5, such as an arm or hub, such that distal movement of the actuator tube 40 ejects the implant from the sheath 12. The implant engagement element 46 includes a tether loop attached to the proximal portion of the implant 5. In this state, the tether loop is substantially loose. Figure 7B As shown, when the implant 5 is deployed by distal movement of the actuator tube 40, tension can be applied to the implant engagement element 46 in opposition to the force applied by the actuator tube 40 to control the deployment rate, prevent the implant 5 from bouncing away from the desired position, and help hold the implant 5 in its restraint configuration. Once the implant 5 is in its desired position, the actuator tube 40 can be withdrawn proximally and / or the implant engagement element 46 can be relaxed, allowing the implant 5 to recover and cause expansion to a configuration that maintains patency of the urethra 2. Once deployed, the tether loop can be cut and withdrawn from the system 10.

[0072] exist Figures 8A to 8C Another embodiment is described, illustrating alternative configurations of the implant engagement element. For example, Figure 8A The top view depicts an actuator tube 40 with a key-like protrusion 64B at its distal end, which interlocks within a recess 66 formed in a proximal hub or similar element of the implant 5. When the implant 5 is positioned within the sheath 12, the inner diameter keeps the protrusions 64B substantially aligned with the longitudinal axis of the actuator tube 40, locking them in the recess 66 to prevent unrestrained distal movement of the implant 5 during deployment. Once positioned at the desired location in the urethra 2, further distal displacement of the implant 5 releases the protrusions 64B from the sheath 12, allowing them to return to a pre-formed configuration that opens radially outward from the longitudinal axis of the actuator tube 40, such as... Figure 8B As shown in the side view, the implant 5 is disengaged from the actuator tube 40. Alternatively, the protrusion 64B can be controlled by any suitable mechanical linkage, such as by pivoting about the hinge 68 when a traction wire extending through the lumen of the actuator tube 40 is actuated, as... Figure 8C As shown in the side view, the protrusion 64B is deflected outward or inward as depicted.

[0073] These designs allow the implant 5 to be positioned in the desired radial orientation because the engagement between the protrusion 64B and the recess 66 keeps the components connected, allowing rotation of the handle 16 to be transferred to the implant 5. As mentioned above, this helps to position the arms of the implant 5 so that they are not aligned with the lobular sulcus of the prostate. The protrusion 64B may be made of nitinol, spring-tempered stainless steel, polymer, or other resilient materials, or may employ a mechanical linkage as mentioned above. Alternatively, the protrusion 64B may be formed as part of the implant 5 and may be configured to engage within the recess 66 of the actuator tube 40. One or more key-shaped protrusions 64B may be formed on the actuator tube 40 to lock with the recess 66 on the implant hub. Alternatively, the protrusion 64B may be formed on the implant 5 to lock with the recess 66 on the actuator tube 40.

[0074] refer to Figures 9A to 9C Additional features of this disclosure will be appreciated, as these figures illustrate various exemplary implant 5 designs employing an implant engagement element 46 configured to help restrain the implant 5 within a restraint configuration to facilitate deployment. Figure 9A In this embodiment, an opening 70 is created in a low-strain, flat region of the implant strut 72 or hub, allowing the overall mechanical properties and integrity of the implant 5 to be preserved. A pre-formed filament 74 or thread is routed through the opening 70 (only one filament route is depicted for clarity), which, when tension is applied, causes the strut 72 to adopt a restraint configuration by being substantially aligned with the longitudinal axis of the implant 5. If necessary, the filament 74 can also assist in controlling the deployment and / or repositioning of the implant 5 at the target site by pulling the filament 74 and causing the partially deployed and filament-engaged implant 5 to re-collapse into the delivery system 10. Once the implant 5 has fully expanded or deployed at the target site, the filaments 74 can be disengaged and the delivery system 10 can be removed. If necessary, the filament 74 and the slotted implant mechanism can also be used to restrain and deploy the implant 5 without the need for a restraint sheath 12. It will be appreciated that any suitable changes to these designs can be made to achieve similar results. For example, Figure 9B A lasso configuration is shown, in which a loop 76 surrounds a strut 72 of the implant 5. This design avoids the need for an opening 70 in the strut 72, but provides a similar function because the tension applied to the loop 76 restrains the implant 5, and once it reaches the desired position, the implant can then be released to allow expansion. Figure 9CAnother example is depicted, employing one filament 74 for each strut 72. The middle section of each strut 72 may have a recessed configuration to aid in positioning the filament 74. When tension is applied to the filaments 74 or loops 76, they compress the implant struts 72 and bind (or collapse) them into a low-profile (small-diameter) configuration. The implant 5 remains compressed when the filaments 74 or loops 76 are under tension. Under tension, each filament 74 or loop 76 rests against the surface of the implant 5 with minimal clearance. The filaments or threads may be single filaments or bundles as required by the specific configuration. They may be made of stainless steel, nitinol, or other materials used for making filaments and springs. They may also be made of strong, biocompatible polymeric materials, fabrics, or threads used for making sutures or implants.

[0075] In addition to the embodiments described above, it will be appreciated that various modifications to the apparatus and systems of this disclosure are within the scope of this disclosure. For illustrative purposes, Figure 10 An alternative handle with similar function for deploying the implant 5 for the treatment or care of BPH is schematically illustrated. Note that the handle 80 is shown with a plunger 82 for actuating the pusher tube 40 relative to a slider. The implant 5 (not shown here) is held in a restraint configuration within the elongated delivery sheath 12 in a manner consistent with the embodiments discussed above. The cystoscope locking lug 84 also functions similarly. Additionally, the handle 80 has a catheter advancement knob 86, which uses the techniques discussed above to adjust the position of the end of the delivery sheath 12 and to accurately position the device at the target site. The catheter position indicator 26, in conjunction with the reference catheter position mark 28, provides visual feedback for length adjustment. The flushing port 88 provides fluid communication for introducing saline during the procedure for visualization, but in this embodiment, it is disengaged from the movement of the pusher tube 40. If necessary, the implant engagement element 46 and associated components may be employed in accordance with the teachings above.

[0076] On the other hand, the slider 32 of handle 16 or the plunger 82 of handle 80 can be replaced by other suitable mechanisms for actuating the distal movement of actuator tube 40 to deploy implant 5. For example, Figure 11A manual syringe 90 is schematically depicted to provide this function. In this embodiment, the implant 5 is similarly secured within a long, flexible tube (polymer sheath or a coiled metal wire with a lumen). The inner lumen of the tube houses the implant 5 in a secured state at the distal end of the tube. An actuator tube 40 engages the implant 5 and is coupled to the intermediate ring of the syringe 90 so that, upon actuation, the actuator tube pushes the implant 5 and deploys it at the target site. In this embodiment, the delivery system does not incorporate an irrigation lumen or implant engagement / disengagement element. A T-connector with two ports or a rotary hemostat valve with two lumens can be connected to the irrigation port of the cystoscope working channel. The irrigation is connected to one port of the T-connector or valve lumen. The second port and lumen have a seal and a sealing cap. The sealing cap is loosened and the delivery system is introduced through the valve port. Once introduced into the delivery system, the valve is gently tightened to prevent leakage during the advancement of the delivery system. Once the delivery system is at the target site, the cap is fully tightened, and the implant 5 is deployed at the target site. After deployment, the valve is released, and the delivery system is retracted. Ideally, the delivery system using syringe 90 is suitable for different cystoscope lengths without requiring a long handle or an adjustment knob in the handle to adjust the catheter position during implant deployment. It can be manufactured to have the longest possible length to accommodate all commercially available flexible cystoscopes. In this embodiment, flushing is provided by forward delivery of fluid along the outer surface of the delivery system through the working channel of the cystoscope. In other similar embodiments, features such as implant engagement / disengagement elements can be incorporated into the syringe as needed.

[0077] Treatment of LUTS associated with BPH requires the precise placement of an implant 5 of sufficient length in the prostatic urethra. Urethral length is typically measured from the bladder neck to the external sphincter using abdominal or transrectal ultrasound. Accurate placement of the implant 5 requires knowledge of the prostatic urethral length from the bladder neck 6 to the verumontanum 7, which can only be measured via cystoscopy. Few conventional measuring tools and devices are available for accurately measuring urethral length with or without insertion into the working channel of a flexible cystoscope. Therefore, this disclosure also includes a device configured for accurately measuring the prostatic urethral length between the bladder neck 6 and the verumontanum 7 using a cystoscope.

[0078] As an example, Figure 12A low-profile catheter 100 is depicted with a highly conformable balloon 102 at its distal end, which can be inserted through the working channel of a cystoscope or adjacent to the cystoscope. The balloon 102 at the distal end of the catheter 100 is inflated through a side arm port 104, and slight 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 verumontanum 7 and external sphincter is measured. Marking 106 aids in measuring the length of the urethra 2. Prior to the treatment procedure, the balloon 102 is deflated and the catheter 100 is removed.

[0079] Another example is shown in Figure 13 The image depicts a laser marking catheter 110, which is also a low-profile (or diameter) hollow polymer tube compatible with the instrument channel of a cystoscope. It is characterized by graduation marks 112 and a radially projected laser source 114 at its proximal end. The predetermined length mark 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 within the urethra. Using this system, the user will hold the cystoscope stably in a predetermined anatomical position, for example, assumed to be at the verumontanum 7, and continue to advance the laser marking catheter (24) until the laser light projected by the source 114 disappears (outside the cystoscope's field of view), as the catheter 110 approaches the bladder neck 6 and enters the urobladder 3. The graduation marks 112 correspondingly determine the length of the urethra 2. 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 one after the other, both are positioned at the bladder neck 6, and the cystoscope is pulled back until the target area for deployment is in the field of view. Again, the length of the urethra 2 is determined by the graduations 112 on the body of the catheter 110.

[0080] Therefore, this disclosure covers devices, systems, and treatment methods for providing and deploying implants to care for urinary outflow obstruction and lower urinary tract symptoms associated with, caused by, or secondary to benign prostatic hyperplasia (BPH). The implants are designed to meet several performance and operational standards to overcome the challenges of treating BPH. The implants are suitable for a range of potential prostate sizes, lengths, and histological morphologies that may be encountered in the adult male population. The implants are designed to resist migration due to urethral hemodynamics and movement once placed at the target site. The implants are also configured to allow placement and recovery using a flexible endoscope under local anesthesia (or topical anesthesia or no anesthesia) and with minimally invasive procedures. The implants are designed with minimal mass and surface area to prevent crusting while providing sufficient retraction force to push open narrowed prostatic urethras. The implant is configured in size and shape to be delivered and retrieved in a compressed configuration using conventional diagnostic imaging and delivery systems, such as a conventional flexible cystoscope, which is used in urological procedures and here is used to allow for the delivery, visualization, deployment and retrieval of the implant.

[0081] Methods involving the deployment and retrieval of implants under direct visualization via cystoscopy include retrieval and removal from one month to several years post-implantation. The overall configuration of the device facilitates non-invasive removal through the catheter or sheath containing the implant by collapsing the implant to a reduced diameter and restraining it at the distal end of a catheter, sheath, cystoscope, or endoscope channel for abductive removal. The structural contours of the implant and delivery system are designed to minimize bleeding, swelling, spasm, or urethral injury during placement, while restoring urinary function and eliminating the risk of future pain, sexual dysfunction, or urinary dysfunction. The delivery system is designed with visual markings to allow the user to place the implant at a precise location relative to anatomical landmarks within the urethra. Such visual markings include marking bands, notches, color recognition, gradient edges, and diameter variations on the delivery system. The device is designed and placed without interfering with urinary function (preventing incontinence and facilitating urination during external sphincter activity). The design and placement method also minimizes the possibility of the implant migrating along the urethra and toward the bladder or toward the penis.

[0082] Along most of the length of the implant, the implant applies an expansion or tissue retraction force greater than 0.5 N, or preferably greater than 2 N, and most preferably between 5 N and 30 N, to counteract the compressive force directed radially and contracting along the urethra due to prostatic hypertrophy. Because the prostate has three lobules and is asymmetrical, the implant preferably has two, four, or more tissue engagement areas, such that the tissue contact areas are not located within the three grooves formed by the adjacent lateral and medial lobules of the prostate. If the design has three tissue engagement areas, the design is preferably asymmetrical relative to prostatic physiology, such that the implant is not located in the interlobular grooves. Alternatively, the tissue engagement areas of the implant directly engage each of the three lobules of the prostate along its length to retract the hypertrophied tissue to reduce and expand the fluid connectivity or lumen of the urethra. Visual markings such as marking bands, notches, stains, etchings, and surface finish alterations may be placed on the implant to facilitate visualization and accurate placement or deployment of the implant in the urethra.

[0083] The implant is fitted within a delivery system having an outer diameter (OD) of less than 14 French and may have a diameter of less than 6 French. The delivery system is capable of being advanced through the working instrument channel of an endoscope or cystoscope with minimal resistance. Furthermore, the delivery system incorporates a sufficiently empty lumen to allow adequate saline flushing for initiating (or generating, sailing) flow or fluid flow, typically with a minimum flow rate of 0.25 mL per second, to allow direct visualization of the urethra during implant advancement and placement. The delivery system has a working port for connection to a flushing source. In a preferred embodiment, at the distal end of the delivery system, the implant is restrained in a collapsed configuration, and the delivery system has a soft tip for non-invasive deployment of the implant. The delivery system is traversed (or moved back and forth) by a guidewire with a soft tip at the distal end and a pusher rod or pusher tube terminating just proximal to the implant.

[0084] In another embodiment, the imaging element is integrated into the delivery system. The imaging element is compatible with existing video display systems manufactured by Olympus, Stryker, and Karl-Storz. The overall system profile is less than 26F (9 mm), or more preferably between 17-12F (6 mm) or smaller, to further minimize pain during implant delivery and placement. Furthermore, compared to embodiments involving insertion through resterilized and reusable flexible and rigid cystoscopes, the integrated delivery system combining the implant and imaging element can be a single-use or disposable medical device.

[0085] The methods disclosed herein include methods for treating lower urinary tract symptoms associated with benign prostatic hyperplasia by implanting (and optionally subsequently retrieving) an implant. The delivery system is configured to maintain the implant in a compression configuration at the distal end of an elongated sheath and to deploy in an expansion configuration within the prostatic urethra.

[0086] Methods for implantation optionally include performing diagnostic cystoscopy to determine the length of the prostatic urethra from the verumontanum to the bladder neck, for example using the apparatus disclosed above, subsequently 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 tissue-junction region of the implant in its expanded configuration. Alternatively, diagnostic measurements of urethral length can also be obtained using abdominal ultrasound or transrectal ultrasound imaging methods. Measurements of the urethral length from the bladder neck to the external sphincter can also be used to determine the appropriate implant size. In one deployment method, the clinician selects an implant of a pre-specified size, which is maintained in a collapsed configuration at the distal end of the delivery system. The appropriately sized implant, contained within the delivery system, is inserted into the working channel of the cystoscope. The distal end of the delivery system is advanced, preferably under direct visualization, to bring the distal end of the delivery system close to the verumontanum for deployment. To improve implant deployment accuracy, the implant engagement element mentioned above allows for continued connection to the implant after dilation within the prostatic urethra, thus allowing for further adjustments.

[0087] Because the integrated device and delivery system are achieved with general surgical instruments, particularly with a standard cystoscope used in conjunction with other urological procedures, the implant can be placed and retrieved by urologists without the need for specialized equipment and in a clinic setting and on an outpatient basis under local anesthesia.

[0088] The method disclosed herein includes placing the device described herein within the urethra immediately adjacent to the prostate and below the bladder neck, at a specific distance between the bladder neck opening and the external urethral sphincter. The method includes a distal end of a prostate-directed delivery system and unfolding the implant from a compression configuration to an expansion configuration. The method also includes orienting the device such that a contact area of ​​the implant engages a portion of the prostate, away from three apexes formed by adjacent lobules of the prostate, and for engaging prostate tissue at sites spaced apart from each apex.

[0089] Therefore, the method may include using a delivery system to visualize the prostatic lobules and corresponding apexes during implantation and orientation, so that the device can specifically engage portions of the prostatic tissue to place the implant into a desired configuration, wherein the implant has precise placement and orientation relative to all physiological structures of the prostate verumontanum along the length of the urethra within the transitional (or T-shaped) zone of the prostate and preferably distal to the bladder neck without obstructing the verumontanum. The method also includes deploying multiple implants selected and sized to suit the physiological condition of a specific BPH patient, including the selective deployment of different embodiments of implants as described herein and in the accompanying drawings.

[0090] This application describes a delivery system for delivering an implant to a target location (prostatic urethra), accurately deploying and placing the implant, and a retraction delivery system. Therefore, the delivery system may have several characteristics, including:

[0091] It can keep mechanical implants in a confinement configuration of less than 14F, ideally less than 6F (compressed to a low profile or small diameter).

[0092] It is non-invasive to the urethra and other anatomical structures during advancement, deployment, and retraction.

[0093] It causes minimal pain or bleeding during use.

[0094] The length sufficient to reach the target area.

[0095] It can be used in conjunction with existing or commercially available or standard flexible cystoscopes of length (40-60cm).

[0096] Sufficient flexibility to navigate the urethra's twists and turns from the penis to the urinary bladder.

[0097] It does not impede the ability to visualize anatomical features and surface landmarks (external sphincter, verumontanum, bladder neck, and urobladder) during advancement and unfolding.

[0098] Allows for flexibility at the end of the cystoscope.

[0099] A saline flushing stream is provided for imaging.

[0100] It combines a light source and an image capture element.

[0101] Position the implant precisely at the target location (e.g., within + / - 5 mm from the target site; or within + / - 2 mm).

[0102] Provides visual indicators to identify the location of mechanical implants.

[0103] It allows a single operator to complete the procedure (advancing the delivery system into the prostatic urethra and implanting the implant) without the assistance of a nurse or technician.

[0104] Clinically acceptable implant deployment force – not too high, and not too low, which could lead to premature deployment, even when high force is required for deployment. Deployment force will be less than <10 lbf, ideally <3 lbf.

[0105] Compatible with standard video displays such as VGA, smartphones, or tablets.

[0106] It is compatible with the workflow of urologists who currently perform cystoscopy in clinics.

[0107] The ability to fix / lock implants in a restrained state and unlock them before deployment.

[0108] This allows for the adjustment of the device's working length to be compatible with various cystoscopes.

[0109] In some embodiments, the actuation / hinged element can be locked to deploy the implant before disengaging.

[0110] In some embodiments, the system further includes engagement / recapture elements for repositioning, orienting, and reorienting the implant (relative to anatomical surface markings) after the implant has been deployed or implanted; and disengagement mechanisms for completely detaching the implant from the delivery system.

[0111] The goal is also to make delivery systems and treatment procedures as simple and easy as possible for doctors, thereby reducing procedural time, complexity, and the need for assistants.

[0112] The exemplary embodiments disclosed above are merely intended to illustrate various uses of this disclosure. It should be understood that, based on the teachings above, various modifications, alterations, and combinations are possible with respect to the functional elements and features of this disclosure, and therefore, within the scope of the appended claims, this disclosure may be implemented differently from what is specifically disclosed, and the principles of this disclosure may be readily extended to other applications with appropriate modifications.

[0113] All patents and publications are incorporated herein by reference to the same extent, just as each individual publication is expressly and individually indicated for inclusion by reference. It should be understood that although this disclosure has been specifically disclosed by way of preferred embodiments and optional features, modifications and alterations may be made to the concepts disclosed herein by those skilled in the art, and such modifications and alterations are considered to be within the scope of this disclosure.

Claims

1. A system for delivering and deploying an implant at a desired location in a lumen of a body, comprising: an elongated sheath configured for introduction through a working channel of a cystoscope, the elongated sheath having an atraumatic tip at a distal end; a handle fixed to a proximal end of the elongated sheath; a pusher coaxially disposed within the elongated sheath; a deployment actuator associated with the handle and coupled to the pusher, wherein manipulation of the deployment actuator causes relative movement between the pusher and the elongated sheath to urge the implant, maintained in a tethered configuration within the elongated sheath proximate the atraumatic tip, out of the atraumatic tip of the elongated sheath; and an implant maintained in a tethered configuration within a distal end of the elongated sheath proximate the atraumatic tip, wherein manipulation of the deployment actuator causes relative movement between the pusher and the elongated sheath to move the pusher distally to urge the implant to deploy from the atraumatic tip of the elongated sheath; a push knob on the handle for adjusting a working length of the elongated sheath and a deployment position of the implant, the implant being maintained in a tethered configuration within a distal end of the elongated sheath proximate the atraumatic tip when the working length of the elongated sheath is adjusted.

2. The system of claim 1, wherein, The deployment actuator is a slider coupled to a proximal end of the pusher.

3. The system of claim 1, further comprising a fluid coupler associated with the handle, in fluid communication within the elongated sheath, configured to direct irrigation fluid to the atraumatic tip.

4. The system of claim 3, wherein, The fluid coupler is movable with the deployment actuator.

5. The system of claim 1, further comprising an implant actuator associated with the handle, connected to an implant engagement element, and configured to selectively release or retract the implant during deployment.

6. The system of claim 4, further comprising an implant actuator connected to the implant engagement element and configured to selectively release the implant during deployment, wherein, The implant engagement element is delivered through the fluid coupler.

7. The system of claim 1, further comprising an implant engagement element configured to maintain control of the implant during deployment.

8. The system of claim 5, wherein, The implant engagement element includes a pre-shaped configuration disposed within the implant, the pre-shaped configuration configured to slow distal movement of the implant during deployment.

9. The system of claim 5, wherein, The implant engagement element includes a releasable tether coupled to a proximal end of the implant.

10. The system of claim 5, wherein, The implant engagement element includes interlocking features at a distal end of the pusher and a proximal end of the implant.

11. The system of claim 5, wherein, The implant engagement element includes a wire delivered through an aperture formed in a tissue engagement portion of the implant, the wire tethering the implant when tensioned.

12. The system of claim 5, wherein, The implant engagement element includes a wire delivered around a tissue engagement portion of the implant, the wire tethering the implant when tensioned.

13. A device for delivering and deploying an implant at a desired location in a lumen of a body, comprising: an elongated sheath configured for introduction through a working channel of a cystoscope, the elongated sheath having an atraumatic tip at a distal end; a handle fixed to a proximal end of the elongated sheath; a pusher coaxially disposed within the elongated sheath; a deployment actuator associated with the handle and coupled to the pusher, wherein manipulation of the deployment actuator causes relative movement between the pusher and the elongated sheath to cause the pusher to move distally to urge an implant maintained in a constrained configuration within the elongated sheath proximate the atraumatic tip to be driven out of the atraumatic tip of the elongated sheath; and an advancement knob on the handle for adjusting a working length of the elongated sheath and a deployment position of the implant maintained in a constrained configuration within a distal end of the elongated sheath proximate the atraumatic tip.

14. The device of claim 13, further comprising a fluid coupler associated with the handle in fluid communication with a lumen of the pusher configured to direct irrigation fluid to the atraumatic tip.

15. The apparatus of claim 14, wherein, the fluid coupler is movable with the deployment actuator.

16. The apparatus of claim 13, wherein, the elongated sheath is configured to fit within a working channel having a diameter no greater than 6 French.

17. The apparatus of claim 13, wherein, the handle further comprises a deployment lock selectively restricting operation of the deployment actuator.

18. The apparatus of claim 13, wherein, the handle further comprises a connector coaxially disposed about the elongated sheath for engaging a lock of the working channel of the cystoscope.

Images