Delivery and deployment of a prostatic implant

Abstract

This case discloses devices and methods for caring for and / or treating body tissues that obstruct hollow body cavities, including prostatic lobe tissue obstructing the urethra, such as benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), benign prostatic obstruction (BPO), and associated lower urinary tract symptoms (LUTS). The prostate implant placement and delivery system may have a controlled release mechanism, a handle mechanism, and an irrigation system. The controlled release mechanism includes a releasable connection between a pusher and a prostate implant having a control. The handle mechanism includes a plunger for advancing the pusher and an actuator for retracting the control. The irrigation system may define two fluid paths.

Description

Technical Field

[0001] This disclosure relates to a device for the care or treatment of tissues that obstruct hollow body cavities (e.g., prostatic lobular tissue obstructing the urethra). Prior Technology

[0002] The prostate gland is a walnut-shaped gland that surrounds the urethra. Urine is expelled from the bladder through it, and it plays a crucial role in the male reproductive system. Although the gland is initially small, it tends to enlarge with age. An excessively enlarged prostate can lead to a condition called benign prostatic hyperplasia (BPH), which refers to an abnormal but non-malignant (non-cancerous) growth of the prostate gland that is very common in older men. BPH is a chronic condition and is associated with the development of obstruction or narrowing of the urinary flow 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 symptoms collectively known as lower urinary tract symptoms (LUTS) can cause sexual dysfunction, frequent urination, difficulty urinating, urinary retention, urinary incontinence, and urinary tract and bladder infections, which worsen as the abnormally enlarged prostate enlarges and progresses.

[0003] Surgical methods provide relief for BPH by removing a significant portion of the prostate tissue. Several traditional surgical approaches are available, all requiring 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 incision made by the surgeon to access the prostate and remove the prostate tissue. For example, some surgeries use laser, thermal, or radiofrequency energy to remove prostate tissue. These include laser ablation, photoselective vaporization (PVP), transurethral needle ablation (TUNA) using radiofrequency energy, transurethral microwave thermotherapy (TUMT), and transurethral incision of the prostate (TUIP). However, traditional surgical methods for BPH are invasive, irreversible, and have significant drawbacks, including the placement of temporary catheters for months, risk of infection, loss of sexual function, urinary incontinence, and restenosis—specifically, recurrent urethral stricture caused by recurrent cell proliferation during prostate regeneration and recurrence of the aforementioned LUTS symptoms.

[0004] While removing prostate tissue can alleviate some BPH symptoms, the removal of tissue using traditional surgical methods is irreversible, and any adverse effects of the surgery can cause lifelong suffering or affect the patient's quality of life. Furthermore, the recovery period can be as long as 3 to 6 weeks, depending on the stage of the disease and the specific surgical method required by each patient, as well as the inherent risks of the surgery itself and the recurrence rate of prostate tissue regeneration after removal.

[0005] Due to the recognized drawbacks of traditional surgery, minimally invasive therapies have been developed. Depending on the stage of the disease, patients and their physicians can choose these therapies as an alternative to lifelong medication or surgery. These minimally invasive therapies are suitable for patients who are unwilling or medically unsuitable for surgery under general anesthesia. Furthermore, younger patients may prefer minimally invasive, reversible treatments that do not jeopardize sexual function, leaving permanent, irreversible treatments for later in life. Additionally, because less invasive therapies allow for treatment under local anesthesia in outpatient or clinic settings, the advantages compared to general anesthesia in a hospital setting include patient comfort and the cost-effectiveness of the healthcare system.

[0006] Minimally invasive techniques involve transurethral methods that actually remove enlarged prostate tissue. 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 aim to enlarge the diameter of the prostatic urethra without actually removing tissue from the prostate, such as by implanting a device designed to enlarge the urethral diameter within the prostatic urethra. Prostate implants involve a surgical procedure in which a urologist inserts a small device into the narrowed prostatic urethra caused by enlarged prostate tissue. Once in place, the implant is designed to enlarge and help keep the urethra open by pushing aside the tissue lobules, 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 urinary incontinence—risks inherent in traditional and even minimally invasive surgical methods. Because removable implants may need to be removed in the future for additional surgical treatment, the procedure is also designed to be reversible.

[0007] Therefore, there is a need for an implant delivery and placement system that allows physicians to perform procedures in outpatient settings using standard cystoscopy and urological techniques generally used to examine prostatic urethral obstruction and the degree of BPH. After confirming the implant is in the correct position, the delivery system will need to release the implant. A beneficial feature also includes the ability to reposition the implant in case of misplacement. Similarly, during urological procedures, there is a need to be able to grasp and reposition the device, remove stones using conventional graspers or other assistive devices, and combine this with imaging using endoscopy or cystoscopy. This disclosure addresses these and other needs. Summary of the Invention

[0008] This disclosure relates to a control release mechanism for a delivery and placement system for a prostate implant. The control release mechanism includes: a catheter, a prostate implant disposed within a distal portion of the catheter, a pusher coaxially disposed within the catheter near the prostate implant, a detachable connector located between the pusher and the prostate implant, and a control extending between the detachable connector and the proximal end of the catheter.

[0009] On the one hand, the driving component can be a long, tubular component.

[0010] On one hand, the actuating element can be an actuating wire and an actuating head, such that a detachable connector is located between the prostate implant and the actuating head.

[0011] On one hand, the detachable connector may be a suture pin removably disposed within the lumen of the prostate implant and a suture looped around the suture pin from the pusher. The pusher may be a pusher suture and a pusher head. The suture may be connected to the pusher head. The pusher head may have a distal portion and a proximal portion, such that the suture is connected to the proximal portion of the pusher head. The suture may be a continuous loop surrounding the pusher suture. The pusher head may be tapered and have a tapered region formed by multiple supports.

[0012] On one hand, the detachable connector can be a fastener located proximal to the prostate implant and a tilt lock connected to the control, such that the control is a pre-formed wire.

[0013] On one hand, the detachable connector may be a fastener located proximal to the prostate implant and a chamfered lock connected to the control.

[0014] On one hand, the detachable connector can be a fastener located proximal to the prostate implant and a tubular anchor connected to the control.

[0015] On one hand, the detachable connector can be a hook extending from the pusher, such that when the hook is supported by the control member, it remains in an outward configuration.

[0016] On one hand, the detachable connector includes a locking line extending into the inner diameter of the prostate implant, the locking line having a hole at its distal end, and the control bypassing the prostate implant structure and passing through the hole.

[0017] On one hand, the detachable connector can be a suture that connects to the control and loops through a hole formed in the proximal portion of the prostate implant.

[0018] This disclosure also includes a method for placing and removing a prostate implant. The method may involve providing a catheter having a prostate implant disposed within a distal portion of the catheter, a pusher coaxially disposed within the catheter adjacent to the prostate implant, and a detachable connector located between the pusher and the prostate implant. The pusher may be advanced distally until the prostate implant extends beyond the distal end of the catheter. A control connected to the detachable connector may be actuated at the proximal end of the catheter to release the prostate implant.

[0019] On one hand, the actuation control may involve retracting the suture pin from the lumen of the prostate implant, causing the suture pin to disengage from the suture looped around the suture pin by the actuator.

[0020] On one hand, the actuation control may involve disengaging a locking element associated with the actuation element from a fastener at the proximal end of the prostate implant.

[0021] On one hand, by means of a control member in the support position maintaining the outward configuration of the hook extending from the push member to engage with a corresponding notch in the proximal portion of the prostate implant, the actuation control member can be involved in retracting the control member from the support position.

[0022] On one hand, the actuation control may involve compressing and retracting an expandable locking device via the proximal neck of the prostate implant.

[0023] On one hand, the suture extends into the inner diameter of the prostate implant and surrounds the structure of the prostate implant, thereby bypassing the hole at the distal end of the locking suture, and the actuation control includes retracting the suture.

[0024] On one hand, the actuation control may involve retracting the control to disengage the suture, which loops around a hole formed in the proximal portion of the prostate implant. Retracting the control may damage the suture.

[0025] This disclosure also includes a handle for a prostate implant delivery and placement system. The handle may have a handle body, a plunger configured to be coupled to a pusher of a control release mechanism, and an actuator configured to be coupled to a control of the control release mechanism. Actuation of the plunger is configured to cause the pusher to place the prostate implant from the control release mechanism. The actuator is configured to retract the control to disengage the prostate implant from the control release mechanism when the prostate implant extends beyond the distal end of the control release mechanism.

[0026] On the one hand, during prostate implantation, the locking mechanism prevents the actuator from operating before the plunger has fully advanced.

[0027] On the one hand, the plunger can be configured to provide tactile feedback during different stages of prostate implant placement.

[0028] On the one hand, the plunger's advance can be configured to be non-reversible after the plunger has advanced beyond a predetermined position.

[0029] On the one hand, the actuator can be configured to operate automatically when the plunger is fully advanced.

[0030] On the other hand, the handle may also have a release assembly linkage to accelerate at least one of the plunger advance and actuator operation. The release assembly may be configured to provide a free-traffic capability.

[0031] On one hand, the handle also includes a telescopic sleeve controlled by a knob rib, which is configured to change the exposed length of the conduit by extending and retracting. The telescopic sleeve and the knob rib can be coupled by a protrusion on the outer surface of the telescopic sleeve, which engages with a thread formed on the inner surface of the knob rib.

[0032] This disclosure also includes a method for placing and removing a prostate implant. The method involves providing a control release mechanism and a handle, advancing a plunger of the handle coupled to a pusher element of the control release mechanism to place the prostate implant from the control release mechanism, and, when the prostate implant extends beyond the distal end of the control release mechanism, operating an actuator of the handle of a control element coupled to the control release mechanism to retract the control element and disengage the prostate implant from the control release mechanism.

[0033] On the one hand, the actuator can operate automatically when the plunger is fully advanced.

[0034] On the one hand, tactile feedback regarding the prostate implant placement phase can be provided during plunger advancement.

[0035] On one hand, the exposed length of the catheter can be adjusted by extending or retracting the telescopic sleeve of the handle. The exposed length of the catheter can be adjusted to match the size of the working channel of the cystoscope.

[0036] This disclosure also includes an irrigation system for a prostate implant delivery and placement system. The irrigation system may have a handle; a catheter connected to the handle via a catheter hub including at least one inlet port; a catheter hub seal; a cylinder connected to the handle and surrounding the proximal portion of the catheter; and a liquid inlet in fluid communication with the interior of the cylinder for receiving irrigation fluid.

[0037] On one hand, the cylinder can be extended or retracted relative to the handle to change the length of the catheter exposed from the cylinder.

[0038] On one hand, the irrigation system may have a first irrigation path, which is defined by the irrigation fluid flowing into a liquid inlet, passing through the interior of the cylinder, entering at least one inlet hole of the catheter hub, and being defined by the internal channel of the catheter. When the catheter is placed in the working channel of the cystoscope, it may have a second irrigation path, which is defined by the irrigation fluid flowing into a liquid inlet, passing through the interior of the cylinder, and entering the outer cavity formed by the outer diameter of the catheter and the inner diameter of the working channel of the cystoscope.

[0039] This disclosure further includes a method of using a prostate implant delivery and placement system. The method may involve providing a handle having a catheter connected to the handle via a catheter hub including at least one inlet port; a catheter hub seal; a cylinder connected to the handle, surrounding the proximal portion of the catheter; and a liquid inlet in fluid communication with the interior of the cylinder; and supplying irrigation fluid through the liquid inlet.

[0040] On one hand, the catheter can be advanced through the working channel of the cystoscope to provide a first irrigation path, which is defined by the irrigation fluid flowing into the liquid inlet, through the interior of the cylinder, into at least one inlet hole of the catheter hub and through the internal channel of the catheter, and a second irrigation path, which is defined by the irrigation fluid flowing into the liquid inlet, through the interior of the cylinder and into the outer cavity formed by the outer diameter of the catheter and the inner diameter of the working channel of the cystoscope. Simple Explanation of the Diagram

[0041] As illustrated in the accompanying figures, further features and advantages of this disclosure will become apparent from the following and more specific description of preferred embodiments, wherein similar reference characters generally refer to the same portions or elements throughout the document, and wherein:

[0042] Figure 1 is a cross-sectional view of male anatomy, including the lower part of the bladder and the prostatic urethra in the typical physiological structure of a patient with BPH. It shows that, according to one embodiment, an implant configured using the disclosed device and system can be placed in the prostatic urethra and engaged with prostatic tissue on either side between the bladder neck opening and the verumontanum.

[0043] Figure 2 schematically depicts a system for placing and removing a prostate implant according to an embodiment.

[0044] Figure 3 schematically depicts the use of a system with a cystoscope according to an embodiment.

[0045] Figure 4-6 schematically depicts a control release mechanism employing a pusher according to an embodiment.

[0046] Figure 7 schematically depicts a control release mechanism employing a push head and a push wire according to an embodiment.

[0047] Figure 8-10 schematically depicts a control release mechanism employing a push head with a wire pin cavity according to an embodiment.

[0048] Figures 11-12 schematically depict a control release mechanism employing a two-part push head according to an embodiment.

[0049] Figures 13-14 schematically depict a control release mechanism employing a knotted suture loop according to an embodiment.

[0050] Figures 15-16 schematically depict a control release mechanism employing a continuous suture loop according to an embodiment.

[0051] Figure 17-20 schematically depicts a control release mechanism employing a conical push head according to an embodiment.

[0052] Figures 21-22 schematically depict a control release mechanism employing a tilt lock according to an embodiment.

[0053] Figures 23-24 schematically depict a control release mechanism employing a chamfered lock according to an embodiment.

[0054] Figures 25-26 schematically depict a control release mechanism using tubular anchors according to an embodiment.

[0055] Figures 27-28 schematically depict a control release mechanism employing a pusher with a hook extension according to an embodiment.

[0056] Figures 29-30 schematically depict a control release mechanism employing an expandable locking member according to an embodiment.

[0057] Figures 31-32 schematically depict another embodiment of the expandable lock.

[0058] Figure 33 schematically depicts a control release mechanism employing a locking line according to an embodiment.

[0059] Figures 34-35 schematically depict a control release mechanism using a stitch lock according to an embodiment.

[0060] Figures 36-38 schematically depict a handle mechanism for placing and removing a prostate implant according to an embodiment.

[0061] Figures 39-41 schematically depict different stages of placement according to the implementation method.

[0062] Figures 42-43 schematically depict the disengagement of the prostate implant using a handle mechanism according to an embodiment.

[0063] Figure 44 schematically depicts the release of the handle mechanism according to an embodiment.

[0064] Figures 45-50 schematically depict different stages of placement of the release component of Figure 44 according to the embodiment.

[0065] Figures 51-54 schematically depict an escape procedure using the release component of Figure 44 according to an embodiment.

[0066] Figure 55 schematically depicts the release assembly of the handle mechanism according to an embodiment.

[0067] Figures 56-59 schematically depict different stages of placement of the release component of Figure 55 according to the embodiment.

[0068] Figures 60-61 schematically depict an escape procedure using the release component of Figure 55 according to an embodiment.

[0069] Figure 62 schematically depicts a telescopic handle mechanism according to another embodiment.

[0070] Figures 63-64 schematically depict the extension and retraction of the telescopic handle mechanism according to the embodiment.

[0071] Figure 65 schematically depicts a handle mechanism with a dual-channel irrigation system according to an embodiment.

[0072] Figures 66-69 schematically depict two irrigation flow paths according to the handle mechanism of Figure 65 in the embodiment. Implementation

[0073] It should be understood from the outset that this invention is not limited to the materials, structures, procedures, methods, or constructions specifically exemplified therein. Therefore, while many of the foregoing options exist, those similar or equivalent to those described herein can be applied to the implementation or embodiments of the invention; however, preferred materials and methods are described herein.

[0074] It should also be understood that the terminology used in this case is for the purpose of describing specific embodiments of the invention only and is not intended to be limiting.

[0075] The detailed description following, relating to the accompanying drawings, is considered to be an illustration of exemplary embodiments of the invention and is not intended to represent the only exemplary embodiments in which the invention 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 preferred or superior to other exemplary embodiments. The detailed description includes specific details provided to offer a comprehensive understanding of the exemplary embodiments described herein. It will be apparent to those skilled in the art that the exemplary embodiments described herein may be practiced without these specific details. In some instances, known constructions and apparatuses are shown in block diagram form to avoid obscuring the novelty of the exemplary embodiments presented herein.

[0076] For convenience and clarity only, directional terms such as up, down, left, right, below, higher than, above, below, behind, rear, and front in the accompanying drawings may be used. These similar directional terms should not be construed in any way as limiting the scope of the invention.

[0077] Unless otherwise defined, all technical and scientific terms used in this document have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Furthermore, unless the context clearly indicates otherwise, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural designations.

[0078] Definition: The terms "therapeutic displacement," "therapeutic retraction," or "therapeutic dilation" are used interchangeably in this document and refer to a displacement of prostate tissue near the urethral restrictive area sufficient to increase the urethral lumen and treat, improve, or prevent symptoms or comorbidities of benign prostatic hyperplasia (BPH), including lower urinary tract symptoms (LUTS), bladder outlet obstruction (BOO), and benign prostatic obstruction (BPO), where the prostate tissue displacement exhibits a detectable therapeutic, preventative, or inhibitory effect. The effect can be detected by, for example, improvement in clinical symptoms, symptom relief, or absence of comorbidities. Clinical assessments include a decrease in the International Prostate Symptom Score (IPSS), a reduction in post-void residual urine volume (PVR), an increase in maximum urinary flow rate (Qmax), or an improvement in quality of life (QoL) and sexual health (Men's Sexual Health Checklist or SHIM score, Men's Sexual Health Questionnaire or MSHQ score). The exact distance or volume of prostate tissue displacement will depend on the subject's weight, size, and health status, as well as the nature and extent of the symptoms of the enlarged prostate lesion, and the size of the implant selected for the patient.

[0079] As used herein, patients “requiring treatment for BPH” are those who will benefit from relief of symptoms caused by prostatic hyperplasia resulting from non-malignant enlargement of the prostate and related conditions, including LUTS, urinary outflow obstruction symptoms, and prostatic urethral stricture. As used herein, 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.

[0080] 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 with the prostate tissue along the major portion of the organ lobules that compress the urethra, and inhibits the tissue from further affecting urethral patency. "Tissue retraction" refers to the ability of the implant structure to apply the necessary force to remove tissue from a compressed or narrowed urethra. The required force can be provided by the inherent structure of the implant or by the implant expanding from a compressed state into an expanded configuration, particularly when the implant is made of shape memory or hyperelastic materials with a predetermined expanded configuration designed to engage with the hyperplastic prostate tissue and apply the necessary tissue retraction force. Within these definitions, the contact length of the tissue-engagement or tissue-retraction morphology is away from the grooves spaced along the prostate lobules surrounding the urethra and requires contact with the tissue along the length of the lateral lobes or the lateral and median lobes.

[0081] Regarding the orientation of the various structural and anatomical references described herein, the terms "proximal" and "distal" are relative to the viewpoint of a medical expert, such as a urologist, who is manipulating the delivery system disclosed herein to deploy the implant described herein. Thus, those features of the delivery system held by the urologist are 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.

[0082] Referring to Figure 1, a cross-sectional view of male anatomy shows the prostate 1 surrounding the urethra 2. Under normal conditions, the urethra 2 provides fluid communication for urine stored in the bladder 3, which is 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 the patency of the urethra 2 in the absence of disease. In patients with benign prostatic hyperplasia (BPH), the urethra 2 is narrowed due to hyperplastic tissue (i.e., prostate tissue 4 that grows excessively into the urethra 2). This non-cancerous overgrowth leads to the aforementioned BPH symptoms, including lower urinary tract symptoms (LUTS) and urinary obstruction and incontinence. As shown in Figure 1, an implant 5 delivered using the disclosed device and system engages with the prostate tissue 4 along the length of the implant 5 to restore the patency of the urethra 2 and allow unobstructed flow of urine from the bladder 3. As shown in the figure, a key feature is the selective placement of the implant 5 at a target location between the bladder neck opening 6 and the verumontanum 7, ensuring that the implant 5 will not puncture, perforate, or cut into surrounding tissue. The implant 5 is designed to remain in the appropriate location within the prostatic urethra 2. The implant 5 does not extend into the bladder 3, where the structural material of the implant 5 might scale or degrade under continuous urine exposure, potentially causing complications and making implant removal more difficult. The implant 5 does not interfere with voluntary control of the external urethral sphincter or affect sexual function.

[0083] This disclosure relates to a system 8 for delivering and placing an implant at a desired location within a body cavity to treat benign prostatic hyperplasia (BPH) and associated lower urinary tract symptoms (LUTS), as exemplified in the embodiment shown in Figure 2. The system includes a controlled release mechanism 9, a handle mechanism 10, and an irrigation system 11. By way of illustration and not limitation, Figure 3 schematically depicts the use of the system 8 for delivering and placing a prostate implant 5 to relieve benign prostatic hyperplasia (BPH), in conjunction with a flexible or rigid cystoscope to assist in positioning and placing the prostate implant 5, and in conjunction with the associated irrigation system 11, into the appropriate location in the prostatic urethra 2. After positioning, the prostate implant 5 can be released and dilated to restore patency of the prostate.

[0084] A common feature of the embodiments disclosed herein involves mechanically coupling an expandable implant (such as implant 5) to a pusher, and then mechanically coupling the pusher to a plunger in a handle mechanism 10. Thus, when the user moves the plunger, the pusher and the expandable implant will move accordingly. As will be discussed below, the pusher can push the expandable implant and position it appropriately within the prostatic urethra. After positioning, the threaded pin can be retracted, causing the expandable implant to separate from the pusher. As an example, the pusher may include a push head and a pusher wire. The push head is mechanically coupled to the plunger via a pusher wire, which may be made of Nitinol, to maximize irrigation flow. Furthermore, in another aspect of this disclosure, (1) the movement or positioning of the pusher and the expandable implant, and (2) the separation between the pusher and the expandable implant, can be controlled by the stroke of a single actuator integrated within the handle mechanism 10.

[0085] In another aspect of this disclosure, the handle mechanism 10 may include an external telescopic sleeve coupled to the handle body, such that the catheter is connected to the handle body and passes through the external telescopic sleeve. Specifically, the external telescopic sleeve is telescopic relative to the handle body, so that the length of the catheter protruding from the external telescopic sleeve is adjustable. Due to this adjustable length of the catheter, the present invention is conveniently compatible with different types of commercially available cystoscopes that may require different sizes.

[0086] Furthermore, in another aspect of this disclosure, the irrigation system provides at least one fluid path to facilitate visualization during cystoscopy. For example, a suitable irrigation solution of saline may be guided through the inner channel of the catheter or through the outer lumen of the catheter.

[0087] Although this disclosure has been described and illustrated with reference to the following embodiments, it should be understood that this disclosure is not limited to the disclosed embodiments, but rather is intended to cover various modifications and equivalent configurations included within the spirit and scope of this disclosure. Control release mechanism

[0088] The disclosed release mechanism relates to the configuration between the prostate implant and the engagement element. For example, the engagement element may be a releasable tether of suture material coupled to the proximal end of the prostate implant. The engagement element may also include interlocking features at the distal end of the pusher and the proximal end of the prostate implant. Furthermore, the engagement element may be a suture or thread that passes through a hole formed in the tissue-joint portion of the prostate implant, which binds the prostate implant when tightened; or the engagement element may be a suture surrounding the tissue-joint portion of the prostate implant, which binds the prostate implant when tightened. The control element may be configured to extend from the interior of the catheter toward the distal end of the catheter and overlap with the prostate implant beyond the distal end. After the pusher pushes the prostate implant beyond the distal end of the catheter, the control element may be configured to retract from the overlap with the prostate implant and withdraw toward the interior of the catheter via the distal end. This section of the disclosure relates to several embodiments of the control release mechanism. 1. Wire latch or wire bolt

[0089] The disclosed embodiments include a control release mechanism employing a wire pin (or wire latch) to hold, push, lock, and unlock a prostate implant, as shown in FIG4. The control release mechanism includes a prostate implant 5; a catheter 12 connected to, for example, a handle mechanism of FIG2; a pusher 13, which may be a tube, connected to a plunger (not shown) in the handle mechanism 10; a suture 14 connected to the pusher 13 or the handle mechanism 10; and a control element, such as including a wire pin (or wire latch) 15, connected to an actuator on the plunger and passing through an inner lumen in the pusher 13. A recess 16 is formed in the proximal sidewall of the prostate implant 5 and connects to the inner lumen. As shown, the prostate implant 5 and the pusher 13 are engaged by the wire pin 15, which passes through the inner lumen of the prostate implant 11, and the annular portion of the suture 14 extends from the pusher 13 into the recess 16.

[0090] Figures 5 and 6 schematically depict an exemplary technique for employing this embodiment. The detachable connector includes a suture 14 looped around a threaded pin 15 from a pusher 13. Before placement, the prostate implant 5 is positioned within the distal end of the catheter 12 and locked in place by the loop of the suture 14 and the threaded pin 15, as discussed above. Accordingly, the prostate implant 5 can be released by a placement step including pushing the prostate implant 5 out of the distal end of the catheter 12, as shown. At this stage, the threaded pin 15 still engages the loop of the suture 14 with the prostate implant 5. Next, a prostate implant release step, as shown in Figure 6, can be performed. Notably, the loop of the suture 14 is released by retracting the threaded pin 15 using the actuator of the plunger of the handle mechanism 10, thereby releasing the prostate implant 5.

[0091] The implementation of this control release mechanism may include the use of a push wire as shown in the embodiment of FIG. 7, wherein FIG. 7 shows a prostate implant 5, a catheter 12 connected to a handle mechanism such as FIG. 2, a push member 13 including a push wire 17 and a push head 171, a suture 14 with an annular profile connected to the push head 171 at the distal end of the push member 13, and a wire pin 15 connected to an actuator in the handle mechanism. The push wire 17 extends through the push head 171 and connects to a plunger in the handle mechanism. The push member 13 and the wire pin 15 may be adjacent and can be operated independently. The prostate implant 5 is held by the push head 171 by the engagement of the wire pin 15 and the annular portion of the suture 14 extending within a recess 16, the wire pin 15 being retractable from the lumen of the prostate implant 5 as described above. In one embodiment, when the plunger in the handle mechanism moves, the push wire 17 then transmits force to push or pull the push head 171. Because the push head 171 engages with the prostate implant 5 at this stage, the prostate implant 5 can be easily positioned or placed by the operation of the push member 13.

[0092] Compared to the embodiments shown in Figures 4-6, where the pusher 13 can be implemented using a tubular structure, the pusher wire 17 is used to couple to the pusher head 171, which may have a larger outer diameter than the pusher wire 17. The pusher head 171 may also be formed as part of the pusher wire 17. To improve irrigation function and / or ease of clinical operation, the pusher wire 17 may be a flexible metal, such as a nickel-titanium alloy like Nitinol. Because the cross-sectional area of ​​the pusher wire 17 is smaller than that of a tubular structure, this embodiment provides more space between the catheter 12 and the pusher 13, which facilitates cystoscopic observation.

[0093] Another embodiment of the control release mechanism 9 is shown in front, top, and side views in Figures 8-10. In these views, the control release mechanism 9 is shown as having a prostate implant 5, a catheter 12 (e.g., connected to the handle mechanism of Figure 2), a pusher 13 (including a pusher filament 17 and a pusher head 171), a ring-shaped suture 14 connected to the pusher head 171, and a suture pin 15 (connected to the actuator of the handle mechanism 10). The pusher head 171 has a groove 131 and a pusher head cavity 132 aligned with the inner cavity of the prostate implant 5. The suture 14 is arranged in a ring shape in the groove 131. The suture pin 15 extends through the pusher head cavity 132, the inner cavity of the prostate implant 5, and the ring portion of the suture 14 to engage the prostate implant 5 and hold or fix it to the pusher head 171.

[0094] Another embodiment of the control release mechanism 9 is shown in front and side views in Figures 11-12. In these views, the control release mechanism 9 is shown as having a prostate implant 5, a catheter 12 (e.g., connected to the handle mechanism of Figure 2), a pusher 13 (including a pusher filament 17 and a pusher head 171), a ring-shaped suture 14 connected to the pusher head 171, and a suture pin 15 (connected to the actuator of the handle mechanism 10). The pusher head 171 has a first pusher head 134 and a second pusher head 135. The second pusher head 135 is located distal to the first pusher head 134 and is connected to the first pusher head 134 by an anti-rotation pin 136 to maintain their rotational alignment. The first pusher head 134 has two suture anchor holes 137, allowing the ends of the suture 14 to pass through and be secured at the proximal openings by suture knots 133 to form an annular portion that engages with the suture pin 15. The pusher filament 17 of the pusher 13 is connected to the proximal end of the first pusher head 171. In one example, the suture 14 may be a nitinol suture and fixed to the first push head 134. Both the first and second push heads 134, 135 have a push head cavity 132 aligned with the lumen of the prostate implant 5, such that the suture pin 15 can pass through the push head cavity 132, the lumen of the prostate implant 5, and the annular portion of the suture 14 to engage the prostate implant 5 with the push head 171 within the recess 16. As with other embodiments disclosed herein, the prostate implant 5 can be controlled by the push head 171 or the push suture 17 during placement due to engagement.

[0095] Further embodiments of the control release mechanism 9 are shown in front and side views in Figures 13-14. In these views, the control release mechanism 9 is shown as having a prostate implant 5, a catheter 12 (e.g., connected to the handle mechanism of Figure 2), a pusher 13 (including a pusher filament 17 and a pusher head 171), a ring-shaped suture 14 connected to the pusher head 171, and a suture pin 15 (connected to the actuator of the handle mechanism 10). Here, the pusher head 171 of the pusher 3 has a suture anchor groove 138 at its proximal end, so that the suture 14 can be connected to the pusher head 171 by passing both ends of the suture anchor groove 138 and knotting it, thereby forming a ring or ring profile for engagement with the suture pin 15. Accordingly, the suture pin 15 can also pass through the suture anchor groove 138 into the lumen of the prostate implant 5 in a manner similar to other embodiments. The pusher filament 17 of the pusher 3 is connected to the proximal end of the pusher head 171. As described above, the prostate implant 5 engages with the push head 171, and the thread pin 15 extends through the annular portion of the suture 14 within the inner cavity and recess 16 of the prostate implant 5, so that the prostate implant 5 can be controlled by the movement of the push head 171 or the push thread 17.

[0096] Another embodiment of the control release mechanism 9 is shown in front and side views in Figures 15-16. In these views, the control release mechanism 9 is shown as having a prostate implant 5, a catheter 12 (e.g., connected to the handle mechanism of Figure 2), a pusher member 13 (including pusher filament 17 and pusher head 171), a ring-shaped suture 14 connected to the pusher head 171, and a suture pin 15 (connected to the actuator of the handle mechanism 10). In this embodiment, the pusher head 171 of the pusher member 13 has a groove 139 for receiving the suture 14 and the suture pin 15. The suture 14 may be a continuous loop or coil surrounding the suture pin 15 and the pusher filament 17. The pusher filament 17 is connected to the proximal end of the pusher head 171. As described above, the prostate implant 5 engages with the push head 171, and the thread pin 15 extends through the annular portion of the suture 14 within the inner cavity and recess 16 of the prostate implant 5, so that the prostate implant 5 can be controlled by the movement of the push head 171 or the push thread 17.

[0097] Further embodiments of the control release mechanism 9 are shown in Figures 17-20. In these views, the control release mechanism 9 is shown as having a prostate implant 5, a catheter 12 (e.g., connected to the handle mechanism of Figure 2), a pusher 13 (including a pusher suture 17 and a pusher head 171), a suture 14 with an annular profile connected to the pusher head 171, and a suture pin 15 (connected to the actuator of the handle mechanism 10). Figures 17 and 18 depict a detailed front view and a proximal view of the pusher head 17, respectively. As shown, the pusher head 171 is tapered and has a distal portion 172, a flared region 173, and a proximal neck 174. A gap 175 on the distal portion 172 accommodates the suture 14, which extends from the pusher head 171 and is configured as an annular shape, as shown in Figure 19. The flared region 173 is formed by a support strip 176, the size of which allows the suture pin 15 to pass through it. The neck 174 connects the suture 14 and the pusher 17, so that when engaged in a similar manner as described above, as shown in FIG20, the prostate implant 5 can be controlled by the pusher head 171 or the pusher 3. 2. Prostate implant fasteners

[0098] The disclosed embodiments include a control release mechanism employing a locking element that engages a fastening structure to retain, push, lock, and unlock the prostate implant, as shown in Figures 21 and 22. The detachable connector includes a fastener 18 located proximally to the prostate implant 5 and a tilt locker 19 connected to a control element. The control release mechanism includes the fastener 18 proximally to the prostate implant 5, a catheter 12 connected to, for example, a handle mechanism of Figure 2, a pusher 13 connected to a plunger (not shown) in the handle mechanism 10, and a tilt locker 19 connected to the control element, which may be, for example, a pre-formed wire 20 extending through the pusher 13, thereby being actuated at the handle mechanism 10. The tilt locker 19 and the fastener 18 are configured to engage when axially aligned, for example, when the tilt locker 19 is confined within the catheter 12, as shown in Figure 21. As shown in Figure 22, when the prostate implant 5 is placed, the end of the pre-formed wire 20 connected to the tilt lock 19 automatically deflects when it is not constrained by the catheter 12, causing the tilt lock 19 to disengage from the fastener 18 of the prostate implant 5.

[0099] Another embodiment includes a control release mechanism employing a chamfered locking element as shown in Figures 23 and 24. The detachable connector may be a fastener 18 located proximally to the prostate implant 5 and a chamfered locking device 21 connected to a control element. The control release mechanism includes a fastener 18 proximally to the prostate implant 5, a catheter 12 connected to, for example, a handle mechanism as shown in Figure 2, a pusher 13 connected to a plunger (not shown) in the handle mechanism 10, and a chamfered locking device 21 formed at the distal end of the pusher 13 or connected to a control element, such as a control wire 22, which extends through the pusher 13 so that it can be actuated at the handle mechanism 10. The chamfered locking device 21 engages with the fastener 18 when axially aligned. Because the contact surfaces of the chamfered locking device 21 have opposing chamfers or wedge-shaped configurations, the prostate implant 5 is held in place when the chamfered locking device 21 is confined within the catheter 12 as shown in Figure 23. When the prostate implant 5 is placed, the chamfered surface allows the chamfered locking device 21 to slide and release the fastener 18 of the prostate implant 5, as shown in Figure 24.

[0100] A further embodiment includes a control release mechanism employing an anchoring locking element as shown in Figures 25 and 26. The detachable connector includes a fastener 18 located proximally to the prostate implant 5 and a tubular anchor 23 connected to the control element. The control release mechanism includes the fastener 18 proximally to the prostate implant 5, a catheter 12 connected to, for example, a handle mechanism 10 of Figure 2, a pusher 13 connected to a plunger (not shown) in the handle mechanism 10, and an anchor 23 fixed to a control element (such as a control suture 24). In this embodiment, the anchor 23 is configured as tubular, but other configurations may be used. When the anchor 23 engages with the fastener 18 and is confined within the catheter 12, the prostate implant 5 is held and controlled by the control suture 24 and the pusher 13 before release, while when unconstrained, the anchor 23 will slide smoothly relative to the chamfer of the fastener 18. 3. Hooks

[0101] The disclosed embodiments include a control release mechanism employing hooks to hold, push, lock, and unlock the prostate implant, as shown in Figures 27 and 28. The control release mechanism is characterized in that the catheter 12 is connected to the handle mechanism of Figure 2, for example, the pusher 13 is connected to the plunger (not shown) in the handle mechanism 10, and the detachable connector has a hook 25 extending from its distal end. When the coaxial extension control 26 is longitudinally adjacent to the hook 25, the coaxial extension control 26 supports the hook 25, holding it in an outward configuration. The prostate implant 5 has a notch 27 corresponding to and engaging with the hook 25, but a window, recess, or other similar structure may be used instead. Therefore, when the coaxial extension control 26 is in the supported position with the hook 25 as shown in Figure 27, it is engaged with the notch 27. The hook 25 is designed to bend relative to the pusher 13, for example, made of nitinol or other flexible material, and can be pre-formed to bend inward to deflect inward as the control 26 is retracted, as shown in FIG28, to disengage from the notch 27 and release the prostate implant 5 to complete placement. 4. Expandable locking mechanism

[0102] Other embodiments disclosed herein include a control release mechanism employing expandable components to hold, push, lock, and unlock the prostate implant, as shown in Figures 29 and 30. The control release mechanism is characterized by a catheter 12 connected to a handle mechanism of Figure 2, for example, a pusher 13 connected to a plunger (not shown) in handle mechanism 10, and a locking member 28 having an expandable head 29 and a support portion 30 sized to be retracted into the pusher 13. The head 29, when expanded, has a larger diameter than the neck 31 of the prostate implant 5, thus engaging and holding the prostate implant 5, which can be controlled by the pusher 13, as shown in Figure 29. A control member 32 is connected to the support portion 30 and can be used to compress and retract the expandable locking member 28 at least near the neck 31 to release the prostate implant 5 when placement is complete. It should be understood that the expandable locking member 28 may employ different head 29 configurations, as long as it has flexible and / or expandable characteristics and can anchor the prostate implant 5, as non-limiting examples are provided in Figures 31 and 32. 5. Locking line

[0103] Other embodiments disclosed herein include a control release mechanism employing locking lines and sutures to retain, actuate, lock, and unlock a prostate implant, as shown in FIG33. A detachable connector includes a locking line 33 extending into the inner diameter of the prostate implant 5. The control release mechanism is characterized in that the catheter 12 is connected to the handle mechanism of FIG2, for example, the actuator 13 is connected to a plunger (not shown) in the handle mechanism 10, and the locking line 33 has an aperture 34 near its distal end. The locking line 33 extends from the distal end of the actuator 13 into the inner diameter of the prostate implant 5. A control element, such as a suture 35, may pass through the prostate implant 5 and the aperture 34 and extend through the actuator 13, so that it can be actuated at the handle mechanism 10. The suture 35 bypasses a structure (e.g., a strut or support arm) of the prostate implant 5 such that tension applied to the suture 35 engages and retains the prostate implant 5, thereby allowing control with the actuator 13. By way of non-limiting illustration, the suture 35 may be implemented using 0.005-inch nitinol suture. 6. Thread lock

[0104] Further embodiments of this disclosure include a control release mechanism employing sutures and controls to hold, push, lock, and unlock a prostate implant, as shown in Figures 34 and 35. The detachable connector includes a suture 37. The control release mechanism is characterized by a connection of catheter 12 to a handle mechanism of Figure 2, for example, a pusher 13 connected to a plunger (not shown) in handle mechanism 10, and a control 36, wherein the end of the suture 37 is connected to the control 36. The suture 37 bypasses at least two holes 38 formed in the proximal end of the prostate implant 5 to engage and hold the prostate implant 5, thereby being controllable by the pusher 13, as shown in Figure 34. As shown, the control 36 extends through the pusher 13 so that it can be actuated at handle mechanism 10. When placement of the prostate implant 5 is completed after pushing the prostate implant 5 from the distal end of catheter 12 using the pusher 13, the control 36 can be actuated to disengage the suture 37 by disconnecting or retracting it according to Figure 35. Handle mechanism

[0105] Referring back to Figure 2, this disclosure also includes a handle mechanism 10, which is used in conjunction with the aforementioned control release mechanism for delivering and placing a prostate implant 5 to relieve benign prostatic hyperplasia (BPH). The following discusses the handle mechanism 10 and its features for placing and / or repositioning the expandable implant. In one aspect, this disclosure provides a handle mechanism 10 as shown in Figure 36 for placing and releasing the prostate implant 5 as needed and adjusting the length of the catheter 12 to fit different brands and configurations of cystoscopes. Specifically, the handle mechanism includes a handle body 210, a telescopic cylinder 220, a push-button lock 230, a release button 240, a plunger 250 (not shown in this figure) connected to a pusher 13, which in some embodiments is implemented as a pusher wire 17 and a pusher head 171, an actuator 260 (such as a wire pin 15) connected to a control (not shown in this figure), an actuator spring 270 configured to retract the control, and a plunger handle 280. Therefore, in the above embodiment, the movement of the plunger 250 can be used to cause a corresponding movement of the pusher 13 or the pusher head 171 via the pusher wire 17. The actuator 260 can move on the plunger 250 and can be locked by engaging the fastener 261 into the top through hole 281, as shown in FIG37.

[0106] When operating the handle mechanism 10, the prostate device can be placed and then disengaged using the aforementioned control release mechanism as part of a sequential process. The distal end of the pusher 13 or pusher head 171 is coupled to the plunger 250, allowing the prostate implant 5 to be pushed out of the distal end of the catheter 12 and then disengaged from the pusher 13 or pusher head 171. One or more grooves 251, 252 on the upper surface of the plunger 250 provide tactile signals for different placement stages. The plunger bushing 213 is configured to engage with and slide on the upper surface of the plunger 250, as shown in Figure 38. The interaction between the plunger bushing 213 and the upper surface of the plunger 250 not only provides tactile feedback to indicate different placement stages but also provides an irreversible mechanism after placement and prevents the plunger 250 from being pulled back.

[0107] At the initial placement phase, the release button 240 is locked by the button lock 230, biased by the locking spring 231 to prevent accidental triggering during plunger placement. As shown in Figure 38, the prostate implant 5 is fully flattened and positioned within the catheter 12. Next, referring to Figure 39, after the distal end of the catheter 12 is positioned at the target location for placing the prostate implant 5, the user can grasp the handle body 210 and push the plunger handle 280. The protrusion of the plunger bushing 213 falls into the first groove 251 of the plunger 250, providing tactile feedback to the user and indicating that half of the stroke has been completed. At this stage, the prostate implant 5 is still partially positioned within the catheter 12. As shown in the detailed illustration, both the distal and proximal surfaces of the first groove 251 are chamfered or beveled to allow the plunger 250 to move proximally and be pulled back. Since the prostate implant 5 is still engaged with the pusher 13 or pusher head 171, placement at this stage is reversible. Figure 40 schematically depicts placement from half-stroke to full-stroke. As shown, further operation of the plunger handle 280 to advance the plunger 250 causes the plunger bushing 213 to engage the second and subsequent slots 252. Each engagement provides tactile feedback to the user as the plastic arm on the plunger bushing 213 continuously engages and disengages from the successive slots 252. Notably, the slots 252 are configured to prevent the plunger 250 from retracting by having a 90-degree wall on the distal surface. Accordingly, once the plunger 250 has been advanced beyond the half-stroke position, the plunger bushing 213 prevents the retraction of the prostate implant 5. However, in this embodiment, once the half-stroke position is reached, the movement of the plunger 250 is irreversible, but with proper placement of the slots 251 and 252, movement at predetermined positions along the stroke range of the plunger 250 can be made irreversible. Finally, Figure 41 shows the handle mechanism 10 in the full-stroke position of the plunger 250. At this stage, the flange 283 on the plunger handle 280 abuts against the button lock 230, and the fastener 211 at the distal end of the handle bottom 212 of the handle body 210 engages the bottom notch 282 on the bottom of the plunger handle 280 to provide the user with tactile feedback indicating that the full stroke has been completed. At this stage, the plunger 250 is locked and the prostate implant 5 has been fully pushed out of the catheter 12 and is ready to disengage from the pusher 13 or pusher head 171, depending on the implementation of the control release mechanism.

[0108] After placement, the handle mechanism 10 can disengage the prostate implant 5 by actuating the wire pin 15 or another control described above. Referring first to FIG. 42, together with the fastener 211 engaging the notch 282, the flange 283 of the plunger cap 280 moves the button lock 230 distally to release the release button 240. Once the release button 240 is unrestricted, the release spring 241 (as shown in FIG. 37) actuates the release button 240 into the fastener 261 of the actuator 260, disengaging it from the hole 281, as shown in FIG. 43. Therefore, the actuator 260 is now automatically actuated proximally by the actuator spring 270. As discussed above, the actuator 260 is coupled to a control of the release mechanism, such as the wire pin 15, and triggers the release of the prostate implant 5.

[0109] In some embodiments, the handle mechanism 10 may employ alternative linkages to facilitate the placement and / or disengagement phases. For example, Figure 44 schematically depicts the use of the accelerator release assembly. As shown, this embodiment is presented in the context of use with the control release mechanism discussed above with respect to Figures 8-10, but can be adjusted as needed to operate in conjunction with other controls. In particular, the release assembly 400 may have a support frame 410, a plunger 420, a push wire retainer 440 coupled to the push wire 17, a wire pin retainer 430 coupled to the wire pin 15, a disengagement lock 450, and a gear train 460 carried by the support frame 410. In the initial placement phase, the release assembly 400 has the configuration shown in Figure 45, with the plunger 420 and the push wire retainer 440 coupled via the gear train 460, and the track of the wire pin retainer 430 uncoupled in this position. As shown in Figure 46, the disengagement lock 450 cannot rotate due to its interaction with the groove 421 of the plunger 420. In this configuration, the plunger 420 is pushed to continue placing the prostate implant 5 until it is disengaged from the distal end of the catheter 12. As shown in FIG. 47, the suture pin 15 still engages the annular portion of the suture 14 at this stage to hold the prostate implant 5. At this stage, as shown in FIG. 48, the release lock 450 can be rotated to allow the plunger 420 to travel further. Thus, the further travel of the plunger 420 causes the gear train 460 to engage with the track of the suture pin retainer 430 and retract it as shown in FIG. 49. As a result, as shown in FIG. 50, the suture pin 15 retracts proximally to release the annular portion of the suture 14 held within the recess 16, thereby releasing the prostate implant.

[0110] If necessary, a disengagement operation can be performed, as shown in Figure 51 by pulling out the gear to release the gear train 460, as shown in Figure 52 by pushing the wire retainer 440 to the far end, as shown in Figure 53 by pulling back the wire pin retainer 430 to the near end, and as shown in Figure 54 by returning to the original configuration.

[0111] In another embodiment, the release assembly 700 shown in FIG. 55 can be used in conjunction with the handle mechanism 10. As shown, the release assembly 700 includes a push wire retainer 710 coupled to the push wire 17, a plunger 720, a wire pin retainer 730 coupled to the wire pin 15, a wire pin spring 740, and a gear train 750. During the placement phase, as shown in FIG. 56, the push plunger 720 is pushed to initiate the placement of the prostate implant 5 from the distal end of the catheter 12, and the push wire retainer 710 advances due to the engagement of the gear train 750. In the side view of FIG. 57, it can be seen that the wire pin retainer 730 and the push wire retainer 710 move in unison during this phase because the wire pin 731 on the wire pin retainer 730 engages with the wire pin 711 on the push wire 710. As shown in the front view of Figure 58 and the side view of Figure 59, when the fully placed stage is reached, Figure 58 shows that the protrusion 721 on the plunger 720 engages and lifts the cantilever beam 712 coupled to the wire pin 711, causing the wire pin 711 to disengage from the wire pin 731. Once the wire pins 711 and 731 are open and no longer restrict the independent movement of the wire retainer 710 and the wire pin retainer 730, the force from the wire pin spring 740 actuates the wire pin retainer 730 to disengage proximally from the prostate implant 5. If necessary, a disengagement operation can be performed, as shown in the front view of Figure 60 and the side view of Figure 61, by depressing the rod 732 connected to the cantilever beam 733, causing the wire pin 731 to be manually offset and disengaged. Furthermore, once the wire pins 711 and 731 are opened and no longer restrict the independent movement of the wire retainer 710 and the wire pin retainer 730, the force from the wire pin spring 740 actuates the wire pin retainer 730 to disengage from the prostate implant 5 proximally.

[0112] As described above, the use of the handle mechanism 10 may also involve adjusting the exposed length of the catheter 12 when delivering and placing the prostate implant 5 to relieve benign prostatic hyperplasia (BPH). Accordingly, the system is compatible with cystoscopes of different physical dimensions. Therefore, the disclosed embodiment includes the handle mechanism 10 shown in FIG. 62, which includes the catheter 12, handle body 510, telescopic cylinder 520, knob rib 530, Luer locking ring 540, Luer connector 550, Luer connector hub 560, catheter hub 570 for receiving the catheter 12, catheter hub seal 580, and catheter retainer 590.

[0113] To provide compatibility with different cystoscopes whose working channel lengths may vary, the exposure length of catheter 12 can be adjusted by rotating the knob rib 530 to extend or retract the telescopic sleeve 520. A thread 531 formed on the inner surface of the knob rib 530 engages proximally with one or more protrusions 521 on the outer surface of the telescopic sleeve 520. Rotation of the knob rib 530 correspondingly extends or retracts the telescopic sleeve 520, thereby exposing the catheter 12 to the desired length. Catheter 12 is connected to a catheter hub 570, and a catheter hub seal 580 seals the gap between the catheter hub 570 and the telescopic sleeve 520 to prevent fluid leakage from the telescopic sleeve 520 into the handle body 510. Additionally, another sealing ring (not shown) between the catheter hub 570 and the catheter retainer 590 seals the gap between the catheter hub 570 and the catheter retainer 590. A Luer connector seal 551 prevents fluid leakage between the telescopic sleeve 520 and the Luer connector 550.

[0114] The catheter hub 570 is connected to the handle body 510 via a catheter retainer 590 to prevent relative movement between the handle body 510 and the catheter 12 during movement of the telescopic tube 520. The catheter 12 passes through the interior of the telescopic tube 520 and is exposed outside the telescopic tube 520 via a Luer connector 550. Understandably, the exposed portion of the catheter 12 will be longer when the telescopic tube 520 is retracted into the handle body 510, and will be relatively shorter when the telescopic tube 520 is extended from the handle body 510. Therefore, the exposed catheter length is adjustable by rotating the knob rib 530 to facilitate compatibility with different cystoscopes that may have working channels of different lengths. For example, Figure 63 depicts the maximum extension of the telescopic sleeve 520 when one or more protrusions 521 have reached the farthest position within the thread 531, resulting in a minimum exposed length of the conduit 12, and Figure 64 depicts the maximum retraction of the telescopic sleeve 520 when one or more protrusions 521 have reached the nearest end position within the thread 531, resulting in a maximum exposed length l of the conduit 12. rinsing system

[0115] Referring back to Figure 2, this disclosure also includes an irrigation system 11, used in conjunction with the aforementioned control release mechanism 9 and handle mechanism 10, for the delivery and placement of the prostate implant 5 to alleviate benign prostatic hyperplasia (BPH). The irrigation system 11 provides one or more fluid pathways to improve visualization or visual effects via cystoscopy during the procedure. A cleaning fluid, such as saline, flows through the internal channels of the catheter and / or through an outer diameter lumen formed by the outer surface of the catheter and the inner diameter of the working channel of the cystoscope used for irrigation. In one aspect, the irrigation system 11 provides at least one fluid pathway through a side arm of the handle mechanism 10, as shown, for example, in Figure 62.

[0116] In another embodiment, the irrigation system 11, as shown in FIG. 65, may include a conduit 12, a telescopic cylinder 610, a conduit hub 620, a conduit hub seal 630, a Luer connector seal 640, a Luer connector lock 650, a Luer connector 660, a Luer lock ring 670, and a side arm liquid inlet 680. As described above, the conduit hub seal 630 seals the gap between the conduit hub 620 and the telescopic cylinder 610 to prevent liquid from leaking from the telescopic cylinder 610 into the handle body. Furthermore, another sealing ring (not shown) between the conduit hub 620 and the conduit retainer 690 seals the gap between the conduit hub 620 and the conduit retainer 690 to prevent liquid from leaking from the telescopic cylinder 610 into the handle body. The Luer connector seal 640 prevents liquid from leaking from the gap between the telescopic cylinder 610 and the Luer connector 660. This embodiment provides dual irrigation paths. When saline solution is introduced into the cavity of the telescopic cylinder 610 from the side arm liquid inlet 680, the saline solution flows along two different paths. As shown by the dotted chain lines in the front view of Figure 66 and the side view of Figure 67, the first path is defined as saline flow flowing into the internal channel of catheter 12 through the inlet hole 621 on catheter hub 620 and flowing out from the opening at the distal end of catheter 12. As shown by the dotted chain lines in the front view of Figure 68 and the side view of Figure 69, the second path is defined as saline flow from the inner lumen of telescopic tube 610 flowing into the outer lumen formed between the outer diameter of catheter 12 and the inner diameter of cystoscope working channel 690, and flowing out from the opening at the distal end of cystoscope working channel 690.

[0117] The illustrative embodiments disclosed above are intended only to illustrate various uses of this disclosure. It should be understood that, based on the above teachings, various modifications, variations, and combinations can be made to the functional elements and forms of this disclosure. Therefore, within the scope of the appended claims, the contents of this disclosure can be implemented in ways different from those specifically disclosed, and the principles of this disclosure can be easily extended by appropriate modifications for other applications.

[0118] All patents and published applications are incorporated herein by reference to the same extent, just as each individual published application is expressly and individually indicated by reference and incorporated herein. It should be understood that although this disclosure has been specifically disclosed by way of preferred embodiments and optional features, modifications and variations of the concepts disclosed herein may be made by those skilled in the art, and such modifications and variations should be considered to be within the scope of this disclosure.

[0119] 1: Prostate 2: Urethral 3: Bladder 4: Prostate tissue 5: Implants 6: Bladder neck opening 7: Jingfu 8: System 9: Control release mechanism 10: Handle Mechanism 11: Irrigation System 12: Catheter 13: Pushing component 14, 35, 37: Seam threads 15, 711, 731: Wire plug 16: concave part 17: Push the wire 18, 211, 261: Fasteners 19: Tilt Locker 20: Preformed wire 21: Chamfer Locker 22: Control cables 23: Anchors 24: Controlling the sutures 25: Hook 26, 32, 36: Control components 27, 282: Notch 28: Locks 29: Head 30: Support section 31, 174: Neck 33: Locking Line 34, 38: Hole 131, 139: Groove 132: Pushing the head cavity 133: Sewing knot 134: First Push Head 135: Second push head 136: Anti-rotation pin 137: Seam anchor hole 138: Seam anchor groove 171: Push Head 172: Remote portion 173: Expanded area 175: Gap 176: Support bar 210, 510: handle body 212: Bottom of the handle 213: Plunger Bushing 220, 520, 610: Telescopic cylinder 230: Button Lock 231: Locking spring 240: Release button 241: Spring 250, 420, 720: plunger 251, 252, 421: slots 260: Actuator 270: Actuator Spring 280: Plunger Handle 281: Top perforation 283: Flange 400, 700: Release components 410: Supporting Frame 430, 730: Wire plug retainer 440, 710: Wire retainer 450: Unlock 460, 750: Gear system 521, 721: protrusion 530: Knob Rib 531: Thread 540, 670: Luer lock ring 550, 660: Luer connectors 551, 640: Luer connector seals 560: Luer connector hub 570, 620: Guide tube hub 580, 630: Conduit hub seal 590, 690: Catheter retainer 621: Inlet Hole 650: Luer connector lock 680: Side Arm Liquid Inlet 712, 733: Cantilever beams 732: Rod 740: Wire Pin Spring

Claims

1. A controlled release mechanism for a prostate implant delivery and placement system, comprising: a catheter; a prostate implant disposed within a distal portion of the catheter; a pusher coaxially disposed within the catheter proximal to the prostate implant; and a control member configured to extend from the interior of the catheter toward the distal end of the catheter and beyond the distal end to overlap with the prostate implant, wherein after the pusher pushes the prostate implant beyond the distal end of the catheter, the control member is configured to retract from the overlap with the prostate implant and retract through the distal end of the catheter toward the interior of the catheter.

2. The control release mechanism as described in claim 1, wherein the actuating element comprises an elongated tubular member.

3. The control release mechanism as described in claim 1, wherein the actuating member includes an actuating wire and an actuating head, and the control member passes through the prostate implant and the actuating head.

4. The control release mechanism as claimed in claim 1 further includes a detachable connector, the control member including a wire pin, and the detachable connector including a thread looped around the wire pin from the push member.

5. The control release mechanism as described in claim 4, wherein the actuating element comprises an actuating wire and an actuating head.

6. The control release mechanism as described in claim 5, wherein the seam is connected to the push head.

7. The control release mechanism as claimed in claim 6, wherein the push head includes a distal portion and a proximal portion, and wherein the suture is connected to the proximal portion of the push head.

8. The control release mechanism as described in claim 5, wherein the stitch comprises a continuous loop surrounding the actuating thread.

9. The control release mechanism as described in claim 5, wherein the push head is conical and has a conical region formed by a plurality of supports.

10. The control release mechanism as claimed in claim 1 further includes a detachable connector comprising a fastener located at the proximal end of the prostate implant and a tilt lock connected to the control member, wherein the control member is a pre-formed wire.

11. The control release mechanism as claimed in claim 1 further includes a detachable connector comprising a fastener located at the proximal end of the prostate implant and a chamfered lock connected to the control.

12. The control release mechanism as claimed in claim 1 further includes a detachable connector comprising a fastener located at the proximal end of the prostate implant and a tubular anchor connected to the control.

13. The control release mechanism as claimed in claim 1 further includes a detachable connector comprising a hook extending from the pusher, and which remains in an outward configuration when supported by the control member.

14. The control release mechanism as claimed in claim 1 further includes a detachable connector comprising a locking line extending into the inner diameter of the prostate implant, the locking line having a hole at a distal end, and the control member bypassing the prostate implant structure and passing through the hole.

15. The control release mechanism as claimed in claim 1 further includes a detachable connector comprising a suture connected to the control and looped through a hole formed in the proximal portion of the prostate implant.

16. A method for placing and removing a prostate implant, comprising: providing a catheter having a prostate implant disposed within a distal portion of the catheter, a pusher coaxially disposed within the catheter adjacent to the prostate implant, and a control configured to extend from the interior of the catheter toward and beyond the distal end of the catheter and overlap with the prostate implant; advancing the pusher distally until the prostate implant extends beyond the distal end of the catheter; and actuating the control to retract the control from the overlap with the prostate implant and retract toward the interior of the catheter via the distal end of the catheter to release the prostate implant.

17. The method of claim 16, further comprising a detachable connector between the pusher and the prostate implant, the control comprising a wire pin, the detachable connector comprising a suture looped around the wire pin, wherein actuating the control comprises retracting the wire pin from the lumen of the prostate implant, thereby disengaging the wire pin from the suture looped around the wire pin by the pusher.

18. The method as described in claim 16, wherein actuating the control includes disengaging a locking member associated with the push member from a fastener at the proximal end of the prostate implant.

19. The method as described in claim 16, wherein the control in the supported position maintains an outwardly oriented configuration from a hook extending from the pusher to engage a corresponding notch in the proximal portion of the prostate implant, and actuating the control includes retracting the control from the supported position.

20. The method as described in claim 16, wherein the control is actuated to compress and retract an expandable locking member through the proximal neck of the prostate implant.

21. The method of claim 16, wherein a suture extends into the inner diameter of the prostate implant and around the structure of the prostate implant, thereby bypassing a hole at the distal end of a locking suture, and actuating the control includes retracting the suture.

22. The method as described in claim 16, wherein actuating the control comprises retracting the control to disengage a suture surrounding a hole formed in the proximal portion of the prostate implant.

23. The method as described in claim 22, wherein retracting the control would destroy the suture.

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