Patent Description:
Benign prostatic hyperplasia (BPH) is a common condition affecting middle- and older-aged men. Major manifestations of BPH include prostatic stromal and glandular hyperplasia, benign prostatic enlargement (BPE), lower urinary tract symptoms (LUTS), bladder outlet obstruction (BOO), etc..

Currently, BPH is treated by medication or surgery. Available surgical therapies include <NUM>) transurethral resection, <NUM>) suprapubic or retropubic resection and <NUM>) laser enucleation or resection of the prostate and <NUM>) minimally invasive implants, among others. A conventional permanently implantable product for BPH treatment, when implanted into the body using a delivery system, can mechanically hold apart the prostatic lobes and open up the obstructed urethra. The in vivo implantation approach can provide continuous symptom relief to BPH patients and dispenses with resection or ablation of prostatic tissue. Therefore, it can alleviate patients' pain and return them to normal life as soon as possible.

The conventional delivery system utilizes a puncture needle to deliver the implant into the human body, and the puncture needle is then withdrawn from the body. Finally, a cutting and pushing mechanism in the delivery system cuts excess tether from the implant. However, due to a deficient design, a physician tends to mistakenly operate the delivery system during use. Consequently, the cutting and pushing mechanism may cut the tether at the same time as the withdrawal of the puncture needle, leading to failure of implantation. Moreover, during use of the conventional delivery system, the implant tends to be stuck and fails to be released due to device faults. All these problems affect reliability of the delivery system during use.

Document <CIT> discloses a tool that includes a case assembly enclosing an anchor delivery and assembly structure, a needle spool assembly and a suture spool assembly. Extending from the case assembly is a shaft assembly. Also, extending through the shaft assembly are a pusher assembly, a needle, and a cutter assembly. Operatively associated with the needle spool and suture spool assemblies are a needle actuator and a needle retraction actuator (e.g., a lever). An assembly actuator is operatively associated with the anchor assembly structure. Safety lock and lock-out structures are also operatively associated with the needle actuator and assembly actuator. Activation of the needle actuator accomplishes the advancement of a needle assembly and a first component of an anchor assembly attached to a connector member, to an interventional site. Activation of the needle retraction actuator withdraws the needle assembly leaving the first component of the anchor assembly at the interventional site. Thereafter, manipulation of the assembly actuator results in lockingly engaging a second anchor component with the connector member and cutting the connector member below the second anchor component.

It is an objective of the present invention to provide an operating system for use in an implant delivery system and an implant delivery system which ensure that, during the release of an implant, a tether is cut strictly after a puncture needle has been withdrawn, thus avoiding failed release due to mistaken operation, ensuring safety of use of the device, and reducing patient damage caused by device faults and the associated risk. Moreover, the operating system overcomes the problem of failed release of a stuck implant and imparts higher reliability to the device during its use.

To this end, the operating system provided in the present invention, as defined in claim <NUM>, is for use in an implant delivery system and comprises a housing and a trigger. The housing defines an internal cavity in which part of the trigger is movably disposed. The trigger includes a withdrawal lock, a cutting lock and a cutting and pushing mechanism. The cutting and pushing mechanism is configured to cut off a connecting element from an implant delivered by the implant delivery system.

The operating system has an initial configuration.

The trigger configured so that, in the initial configuration, the withdrawal lock is locked and locks the cutting lock which locks the cutting and pushing mechanism, and that when the withdrawal lock is unlocked, the withdrawal lock releases the locked cutting lock under the action of an external force, followed by the cutting lock releasing the locked cutting and pushing mechanism under the action of an external force.

The trigger further includes a limiting mechanism, a release member and a transmission member, the release member rotatably disposed in the internal cavity, the transmission member movably disposed in the internal cavity and coupled to the withdrawal lock,
wherein the limiting mechanism is configured to lock the withdrawal lock in the initial configuration, and the release member is configured to, when rotated in a first direction over a predetermined angle under the action of an external force, urge the limiting mechanism to deform, thereby releasing the locked withdrawal lock, followed by the withdrawal lock releasing the locked cutting lock under the action of an external force and simultaneously driving movement of the transmission member, which causes the release member to rotate in a second direction opposite to the first direction.

Optionally, the trigger may further include a release lock configured to lock the release member in the initial configuration.

Optionally, the release lock may include a first manipulation mechanism and a second manipulation mechanism, the first manipulation mechanism is configured to lock the second manipulation mechanism, which is configured to lock the release member, in the initial configuration.

Optionally, the housing may be provided therein with a first window in communication with the internal cavity, wherein the operating system further includes a manual manipulation mechanism, and
wherein the trigger is further configured so that the second manipulation mechanism releases the locked release member under the action of a force exerted on the second manipulation mechanism by the manual manipulation mechanism inserted into the internal cavity from the first window.

Optionally, the second manipulation mechanism may include a manipulation member and a first limiting element, the manipulation member disposed partially outside the housing and partially in the internal cavity, the first limiting element disposed in the internal cavity,
wherein the second manipulation mechanism is configured so that, in the initial configuration, the manipulation member abuts against the first manipulation mechanism, with the first limiting element abutting against both the manipulation member and the release member, thereby locking the release member, and that under the action of an external force, the manipulation member drives the first limiting element to move away from the release member, thereby releasing the locked release member.

Optionally, the first window in the housing may be arranged in positional correspondence with the manipulation member,.

wherein the second manipulation mechanism is further configured so that the manipulation member is able to drive the first limiting element to move away from the release member and thus release the locked release member under the action of a force exerted on the manipulation member by the manual manipulation mechanism inserted into the internal cavity from the first window.

Optionally, the first window in the housing may be arranged in positional correspondence with the first limiting element,
wherein the second manipulation mechanism is further configured so that the first limiting element is able to release the locked release member under the action of a force exerted on the first limiting element by the manual manipulation mechanism inserted into the internal cavity from the first window.

Optionally, the first limiting element may be made of an elastic material.

Optionally, the housing may be provided therein with a second window in communication with the internal cavity, wherein the operating system further includes a manual manipulation mechanism, and
wherein the trigger is further configured so that the limiting mechanism is able to deform to release the locked withdrawal lock under the action of a force exerted on the limiting mechanism by the manual manipulation mechanism inserted into the internal cavity from the second window.

Optionally, the limiting mechanism may include a first limiting post and a second limiting post,
wherein the limiting mechanism is configured so that the first limiting post limits movement of the withdrawal lock in a third direction in the initial configuration and deforms to release the limited withdrawal lock under the action of an external force and that the second limiting post limits movement of the withdrawal lock in a fourth direction opposite to the third direction.

Optionally, the second window in the housing may be arranged in positional correspondence with the first limiting post,
wherein the first limiting post is able to deform under the action of a force exerted thereon by the manual manipulation mechanism inserted into the internal cavity from the second window.

Optionally, the first limiting post may be configured to abut against the transmission member and thereby limit movement of the withdrawal lock in the third direction.

Optionally, the cutting and pushing mechanism may include a slide channel, a first push block, a biased push element, a second push block and a second limiting element. The slide channel disposed in the internal cavity, the first and second push blocks movably provided on the slide channel, the biased push element coupled to both the first and second push blocks and configured to store potential energy, the second limiting element rotatably disposed in the internal cavity,
wherein the cutting and pushing mechanism is configured so that: in the initial configuration, the first push block is coupled to the cutting lock and is thus locked, the second limiting element is disposed between the first push block and the second push block, and the second limiting element abuts against the second push block to lock the second push block, and under the action of an external force exerted on the cutting lock, the first push block is disengaged from the cutting lock and urged by the biased push element to move within the slide channel toward the second push block until it comes into contact with and exerts a force on the second limiting element, which causes the second limiting element to move away from the second push block and thus releases the locked second push block, followed by the second push block being urged by the biased push element to move toward the first push block.

Optionally, the housing may be provided therein with a third window in communication with the internal cavity, wherein the operating system further includes a manual manipulation mechanism, and
wherein the cutting and pushing mechanism is further configured so that the second limiting element is able to move away from the second push block under the action of a force exerted on the second limiting element by the manual manipulation mechanism inserted into the internal cavity from the third window.

Optionally, the withdrawal lock may be further configured to lock the second limiting element in the initial configuration and release the locked second limiting element under the action of an external force.

Optionally, the release member may define a first abutment feature adapted to deform the limiting mechanism by exerting a force thereon.

Optionally, the transmission member may be rotatably disposed in the housing so as to be coaxial with the release member and define a second abutment feature adapted to be brought into contact with the release member and drive it to rotate.

Optionally, the release member may further define a third abutment feature adapted to be brought into contact with the second abutment feature of the transmission member to enable the transmission member to drive the release member to rotate.

Optionally, the transmission member may define a protrusion adapted to be brought into contact with the limiting mechanism and thus limit movement of the withdrawal lock in a third direction.

Optionally, the transmission member may be provided with ratchet teeth and the housing with a contact tab, which is disposed in the internal cavity and brought into contact with the ratchet teeth.

Optionally, the withdrawal lock may be rotatably disposed on the housing.

Additionally or alternatively, the cutting lock may be rotatably disposed on the housing.

Additionally or alternatively, the first manipulation mechanism may be rotatably disposed on the withdrawal lock.

Additionally or alternatively, the second manipulation mechanism may be rotatably disposed on the withdrawal lock.

Optionally, the withdrawal lock may be provided with a push slot which is located outside the housing, wherein the first manipulation mechanism is provided with a push stud which is movably disposed in the push slot.

Optionally, the housing may includes a first housing and a second housing, which are joined together to delimit the internal cavity therebetween.

To the above end, the implant delivery system provided in the present invention is for delivering an implant provided with a connecting element and includes a puncture needle, a delivery tube and the operating system as defined above.

The delivery tube defines a first lumen and a second lumen. A first portion of the implant is received in the puncture needle, and the puncture needle is movably disposed in the first lumen. A second portion of the implant is disposed in the second lumen. Part of the cutting and pushing mechanism of the operating system is movably disposed in the second lumen. The cutting and pushing mechanism is configured to cut off the connecting element from the implant.

To the above end, the implant delivery method provided in the present disclosure is based on the above implant delivery system, which is in the initial configuration before the implant is delivered and includes:.

Optionally, the trigger of the operating system may further include a release member, a transmission member and a limiting mechanism, the release member coupled to the puncture needle, the transmission member coupled to the withdrawal lock, the limiting mechanism configured to lock the withdrawal lock in the initial configuration, wherein:.

Optionally, the trigger may further include a release lock which is adapted to lock the release member in the initial configuration,
wherein prior to the application of an external force to the release member, the implant delivery method further includes unlocking the release member from the release lock by exerting an external force on the release lock.

Optionally, the release lock may include a first manipulation mechanism and a second manipulation mechanism, the first manipulation mechanism is configured to lock the second manipulation mechanism, which is configured to lock the release member, in the initial configuration,
wherein unlocking the release member from the release lock by exerting an external force on the release lock includes: unlocking the second manipulation mechanism from the first manipulation mechanism by exerting an external force on the first manipulation mechanism; and then unlocking the release member from the second manipulation mechanism by exerting an external force on the second manipulation mechanism.

Optionally, the housing may be provided therein with a first window in communication with the internal cavity, wherein the operating system further includes a manual manipulation mechanism; and
wherein in the event of the implant being stuck in the course of unlocking the release member from the second manipulation mechanism, the manual manipulation mechanism is inserted into the internal cavity from the first window to exert a force on the second manipulation mechanism and thereby release the locked release member.

Optionally, the housing may be provided therein with a second window in communication with the internal cavity, wherein: the operating system further includes a manual manipulation mechanism; and
in the event of the implant being stuck in the course of releasing the locked withdrawal lock as a result of the release member hitting the limiting mechanism, the manual manipulation mechanism is inserted into the internal cavity from the second window to exert a force on the limiting mechanism, which deforms the limiting mechanism and thus releases the locked withdrawal lock.

Optionally, the housing may be provided therein with a third window in communication with the internal cavity, wherein: the operating system further includes a manual manipulation mechanism; and
in the event of the implant being stuck in the course of unlocking the cutting and pushing mechanism from the cutting lock, the manual manipulation mechanism is inserted into the internal cavity from the third window to release the locked cutting and pushing mechanism by exerting a force thereon.

Compared to the prior art, the operating system and the implant delivery system of the present invention have the following advantages:.

Objects, features and advantages of the present invention will become more apparent upon reading the following more detailed description thereof with reference to the accompanying drawings. Note that the figures are provided in a very simplified form not necessarily drawn to exact scale for the only purpose of facilitating easy and clear description of the disclosed embodiments.

As used herein, the singular forms "a", "an" and "the" include plural referents and the term "plurality" means two or more, unless the context clearly dictates otherwise. As used herein, the term "or" is generally employed in the sense of "and/or", unless the context clearly dictates otherwise. The terms "installation", "coupling" and "connection" should be interpreted in a broad sense. For example, a connection may be a permanent, detachable or integral connection, or a mechanical or electrical connection, or a direct or indirect connection with one or more intervening media, or an internal communication or interaction between two components. Those of ordinary skill in the art can understand the specific meanings of the above-mentioned terms herein, depending on their context. Like numerals indicate like elements throughout the accompanying drawings.

Embodiments of the present invention provide an implant delivery system and an operating system for use in the implant delivery system. The implant delivery system is adapted to deliver a medical implant into the human body. For ease of understanding, the implant delivery system is described below in the exemplary context of its use in the treatment of benign prostatic enlargement.

In one embodiment, the implant delivery system is used to implant a medical implant into prostatic tissue so that the implant mechanically holds apart the prostatic lobes and opens up the obstructed urethra. <FIG> schematically illustrates the medical implant that has been implanted in the prostate. As shown in <FIG>, the implant delivery system includes the implant <NUM> including, sequentially coupled together, a distal anchoring element <NUM>, a connecting element <NUM> and a proximal anchoring element <NUM>. The distal anchoring element <NUM> may be securely assembled with the connecting element <NUM> by crimping and pre-loaded in a puncture needle (not shown in <FIG>), and the proximal anchoring element <NUM> may be pre-loaded in a delivery tube (not shown in <FIG>). In order to deliver the implant <NUM> using the implant delivery system, the puncture needle carrying the distal anchoring element <NUM> is caused to penetrate into the prostate S through the capsule thereof and position the distal anchoring element <NUM> at a distal location of the prostate S. The implant delivery system is then operated to withdraw the puncture needle and tension the distal anchoring element <NUM>. After that, it is further operated to advance the proximal anchoring element <NUM> into engagement with the connecting element <NUM> so that the proximal anchoring element <NUM> is positioned at a proximal location of the prostate S. Finally, the implant delivery system is operated to cut off an unwanted portion of the connecting element <NUM> from the implant <NUM>, thus completing the delivery process. Depending on the patient's conditions, <NUM>-<NUM> implants <NUM> may need to be deployed on each of the prostatic lobes. The deployed implants <NUM> hold apart the lobes and open up the obstructed urethra P. Here, the term "proximal" refers to a prostate location adjacent to the urethra, and in contrast to "proximal", the term "distal" refers to a prostate location more distant from the urethra.

In order to implant the distal anchoring element <NUM> into prostatic tissue, the puncture needle is generally inserted into prostatic tissue to a depth of <NUM>-<NUM>. As shown in <FIG>, in order to facilitate the insertion of the puncture needle <NUM> into prostatic tissue, a leading portion of the puncture needle <NUM> is shaped like an arc preferably of <NUM>°. Additionally, as shown in <FIG>, the leading portion of the puncture needle <NUM> defines a sharp beveled tip with a bevel angle, which may be <NUM>- <NUM>°, for example, <NUM>°, <NUM>°, <NUM>° or the like. The leading portion is a portion of the puncture needle <NUM> that is first brought into contact with prostatic tissue.

Reference is now made to <FIG>. In one embodiment of the present invention, the implant may be released manually. Specifically, the implant delivery system includes an operating system <NUM> and a delivery tube <NUM>, which are coupled together. The delivery tube <NUM> defines at least a first lumen <NUM> and a second lumen <NUM>. The first lumen <NUM> is adapted to receive the puncture needle (not shown in <FIG> and <FIG>) in such a manner that there is a clearance between the puncture needle and a wall of the lumen, which allows the puncture needle to move axially in the first lumen <NUM>. The second lumen <NUM> is adapted to receive the proximal anchoring element (not shown in <FIG> and <FIG>) while allowing it to move axially in the second lumen <NUM>. The operating system <NUM> includes a housing <NUM> and a trigger <NUM>. The housing <NUM> has an internal cavity (not labeled in the figures). Some features of the trigger <NUM> are arranged in the internal cavity, while the remaining features are arranged outside the housing <NUM>. This arrangement of features of the trigger32 may vary depending on the needs of particular applications. The delivery tube <NUM> is coupled to the housing <NUM> and brought into communication with the internal cavity. The puncture needle is coupled to the trigger <NUM>, and the trigger <NUM> is adapted to release and withdraw the puncture needle and to cut off an undesired portion of the connecting element <NUM> from the implant. The positioning of the trigger <NUM> relative to, and its method of coupling to, the puncture needle and the proximal anchoring element, as well as how the trigger <NUM> operates, will be detailed below.

Optionally, in the present embodiment, the housing <NUM> is composed of a first housing (not labeled in the figures) and a second housing (not labeled in the figures), which are joined together to delimit the internal cavity therebetween. This multi-piece structure allows easy assembly of the operating system <NUM> and simplifies its fabrication.

As shown in <FIG>, the trigger <NUM> includes at least a withdrawal lock <NUM>, a cutting lock <NUM> and a cutting and pushing mechanism <NUM>. Both the withdrawal lock <NUM> and the cutting lock <NUM> are partially disposed in the internal cavity, and the cutting and pushing mechanism <NUM> is adapted to cut off an undesired portion of the connecting element <NUM> from the implant. Before the implant is released, the operating system <NUM> is in an initial configuration in which the withdrawal lock <NUM> is in a locked position where it locks the cutting lock <NUM> and the locked cutting lock <NUM> in turn locks the cutting and pushing mechanism <NUM>. When the withdrawal lock <NUM> is unlocked, the withdrawal lock <NUM> can release the locked cutting lock <NUM> under the action of an external force. As a result, the cutting lock <NUM> can release the locked cutting and pushing mechanism <NUM> under the action of an external force. It will be appreciated that when the operating system <NUM> is used in the implant delivery system to deliver an implant, the withdrawal lock <NUM> is unlocked after the puncture needle is released. That is, in the present embodiment, in the initial configuration, the withdrawal lock <NUM> locks the cutting lock <NUM> without undesirable unlocking of the cutting lock <NUM> prior to or during the release of the puncture needle. Here, the term "external force" refers to a force exerted on the concerned element by another element or mechanism.

The trigger <NUM> further includes a limiting mechanism <NUM>, a release member <NUM> and a transmission member <NUM>. The release member <NUM> is rotatably disposed in the internal cavity and coupled to the puncture needle. The transmission member <NUM> is movably disposed in the internal cavity and coupled to the withdrawal lock <NUM>. In the initial configuration, the limiting mechanism <NUM> locks the withdrawal lock <NUM>. When the release member <NUM> is rotated in a first direction over a predetermined angle by an external force, the puncture needle is released to penetrate into prostatic tissue. Upon the release member <NUM> being rotated over the predetermined angle, it hits the limiting mechanism <NUM> and urges it to deform, thus releasing the locked withdrawal lock <NUM>. As a result, the withdrawal lock <NUM> can release the locked cutting lock <NUM> under the action of an external force. At the same time, it drives the transmission member <NUM> to move, which in turn causes the release member <NUM> to move in a second direction that is opposite to the first direction. Thus, after the release member <NUM> releases the locked withdrawal lock <NUM> from the limiting mechanism <NUM>, the withdrawal lock <NUM> releases the locked cutting lock <NUM> and simultaneously causes movement of the transmission member <NUM>, which in turn causes the release member <NUM> to rotate in an opposite direction to withdraw the puncture needle. Finally, the cutting lock <NUM> releases the locked cutting and pushing mechanism <NUM> to allow it to perform its intended function. It will be appreciated that, in the present embodiment, if the first direction is clockwise, the second direction will be counterclockwise; and vice versa.

In other words, when the operating system <NUM> of the present embodiment is used in the implant delivery system, before the implant is released, the trigger <NUM> is in the initial configuration where the limiting mechanism <NUM>, the withdrawal lock <NUM>, the cutting lock <NUM> and the cutting and pushing mechanism <NUM> are interlocked together. Only after the release member <NUM> is rotated by an external force to release the puncture needle, will the withdrawal lock <NUM> and then the cutting lock <NUM> be unlocked. In this way, those components in the delivery system are released completely in a predetermined order. This interlocking design has the advantage that those components are unlocked and triggered according to a predetermined order during the implant delivery process of the delivery system, avoiding failed release due to a wrong unlocking order and improving the reliability and safety of the implant delivery system.

Optionally, the trigger <NUM> further includes a release lock adapted to lock the release member <NUM> in the aforementioned initial configuration. Specifically, the release lock includes a first manipulation mechanism <NUM> and a second manipulation mechanism <NUM>. In the initial configuration, the first manipulation mechanism <NUM> locks the second manipulation mechanism <NUM>, which in turn locks the release member <NUM>.

In practice, the first manipulation mechanism <NUM> may be moved by an external force to unlock the second manipulation mechanism <NUM>, and the second manipulation mechanism <NUM> may be moved by an external force to unlock the release member <NUM>. The withdrawal lock <NUM> may be moved by an external force to unlock the cutting lock <NUM>. The cutting lock <NUM> may be moved by an external force to unlock the cutting and pushing mechanism <NUM>.

Optional structures of the various components in the trigger <NUM> and how they are assembled together will be described below with reference to <FIG>. It should be understood that the specific structures of the various components in the trigger <NUM> and their assembly method described below are merely some but not all of the possible implementations of the present invention and thereby should not be construed as limiting the invention in any sense.

Generally, the withdrawal lock <NUM> is rotatably disposed on the housing <NUM>, the first manipulation mechanism <NUM> is rotatably disposed on the withdrawal lock <NUM>, the second manipulation mechanism <NUM> is rotatably disposed on the withdrawal lock <NUM> and the cutting lock <NUM> is rotatably disposed on the housing <NUM>.

Specifically, referring to <FIG>, the first manipulation mechanism <NUM> defines a third limiting element <NUM> and is provided thereon with a first circular rotary disc <NUM> and a first push member <NUM>. Referring to <FIG>, the second manipulation mechanism <NUM> may include a manipulation member <NUM> defining a fourth limiting element <NUM> and a first circular accommodating recess <NUM>. Referring to <FIG>, the withdrawal lock <NUM> has an elongate structure with a first end and an opposing second end. The first end defines a second circular accommodating recess <NUM>, and the second end defines a fifth limiting element <NUM>. The fifth limiting element <NUM> may be a curved finger. A middle section of the withdrawal lock <NUM> defines a third circular accommodating recess <NUM>, a push slot <NUM> and a second circular rotary disc <NUM>. Referring to <FIG>, the cutting lock <NUM> defines a sixth limiting element <NUM>, a locking hook <NUM>, a third circular rotary disc <NUM> and a second push member <NUM>.

Referring to <FIG>, the release member <NUM> is essentially in the shape of a round disk and defines a first abutment feature <NUM> and a third abutment feature <NUM>. Referring to <FIG>, the transmission member <NUM> defines a second abutment feature <NUM>, a protrusion <NUM> and a tether <NUM>.

With continued reference to <FIG>, the release member <NUM> is disposed over a central shaft <NUM> in the internal cavity so that it can rotate about the central shaft <NUM> under the action of an external force. The transmission member <NUM> is also disposed over the central shaft <NUM> so as to be able to rotate about the central shaft <NUM> under the action of an external force. It should be understood that, in the present embodiment, the release member <NUM> and the transmission member <NUM> may be assembled in the internal cavity in a similar manner as conventional implant delivery systems.

With continued reference to <FIG>, in conjunction with <FIG> and <FIG>, a fourth circular rotary disc <NUM> and a fourth circular accommodating recess (not shown in the figures) are further disposed in the internal cavity. The second circular accommodating recess <NUM> engages the fourth circular rotary disc <NUM>, and the fifth limiting element <NUM> is coupled to the tether <NUM>. Referring to <FIG>, the first circular rotary disc <NUM> engages the third circular accommodating recess <NUM>, and the first push member <NUM> is movably disposed in the push slot <NUM>. Referring to <FIG>, the first circular accommodating recess <NUM> engages the second circular rotary disc <NUM>. Referring to <FIG>, the third circular rotary disc <NUM> engages the fourth circular accommodating recess, and the second push member <NUM> protrudes out of the housing <NUM>.

With continued reference to <FIG>, more specifically, the second manipulation mechanism <NUM> may include a first limiting element <NUM>, which is rotatably disposed in the internal cavity and located between the release member <NUM> and the manipulation member <NUM>. The limiting mechanism <NUM> includes a first limiting post <NUM> and a second limiting post <NUM>. The first limiting post <NUM> may be formed of an elastic material.

Referring to <FIG> and <FIG>, in the initial configuration, the third limiting element <NUM> abuts against the manipulation member <NUM>, thereby locking the second manipulation mechanism <NUM>. Referring to <FIG> and <FIG>, the fourth limiting element <NUM> abuts against the first limiting element <NUM> which in turn abuts against the release member <NUM>, thereby locking the release member <NUM>. Referring to <FIG> and <FIG>, the first limiting post <NUM> can limit movement of the withdrawal lock <NUM> in a third direction. For example, the first limiting post <NUM> may accomplish this by abutting against the protrusion <NUM> in the transmission member <NUM>. Referring to <FIG> and <FIG>, the second limiting post <NUM> may abut against the withdrawal lock <NUM>. For example, the second limiting post <NUM> may abut against the fifth limiting element <NUM>, thereby limiting movement of the withdrawal lock <NUM> in a fourth direction. In this way, the withdrawal lock <NUM> is locked by the limiting mechanism <NUM>. Referring to <FIG> and <FIG>, the fifth limiting element <NUM> abuts against the cutting lock <NUM>. Preferably, the fifth limiting element <NUM> abuts against the sixth limiting element <NUM>, thereby locking the cutting lock <NUM>. This arrangement not only allows a simpler structure of the trigger <NUM> and a reduced size of the operating system <NUM>, but also enables unlocking of the cutting lock <NUM> simply as a result of separating the fifth limiting element <NUM> from the sixth limiting element <NUM> in accordance with the present embodiment. Compared to other unlocking approaches such as structural breakage or structural deformation, the above various locked mechanisms can be more easily unlocked, reducing the risk of the implant being stuck during its release. In addition, referring to <FIG>, in the initial configuration, there is a circumferential clearance left between the first abutment feature <NUM> and the second limiting post <NUM> and another circumferential clearance left between the third abutment feature <NUM> and the second abutment feature <NUM>. Further, in the present embodiment, the third and fourth directions are opposite to each other. For example, the third direction may be clockwise and the fourth direction may be counterclockwise; and vice versa.

In the present embodiment, the first manipulation mechanism <NUM> serves as a safety mechanism which can move only when an external force is applied thereto. With continued reference to <FIG>, in conjunction with <FIG>, first of all, the first push member <NUM> is pushed to one side to cause the first manipulation mechanism <NUM> to rotate so that the third limiting element <NUM> no longer abuts against the manipulation member <NUM>. The manipulation member <NUM> is then pressed to rotate, urging the fourth limiting element <NUM> to abut against the first limiting element <NUM> and thereby further causing the first limiting element <NUM> to rotate away from the release member <NUM>. After that, the release member <NUM> can be driven to rotate (for example, clockwise) over a predetermined angle to release the puncture needle (as shown in <FIG>). Upon the release member <NUM> rotating to a limit position, the first abutment feature <NUM> in the release member <NUM> hits and deforms the first limiting post <NUM>, allowing the limited withdrawal lock <NUM> to move in the third direction. Meanwhile, the third abutment feature <NUM> comes into contact with the second abutment feature <NUM>. At this point, when the withdrawal lock <NUM> is pressed to rotate clockwise, the fifth limiting element <NUM> will move away from the cutting lock <NUM>, thus releasing the locked cutting lock <NUM>. At the same time, the withdrawal lock <NUM> drives the transmission member <NUM> to rotate counterclockwise (under the assumption that the release member <NUM> is rotated clockwise in order to release the puncture needle). As a result, the second abutment feature <NUM> comes into abutment against the third abutment feature <NUM> and pushes the release member <NUM> to rotate counterclockwise to withdraw the puncture needle. Finally, the second push member <NUM> is pushed to cause the cutting lock <NUM> to move, thus releasing the unlocked cutting and pushing mechanism <NUM>.

It should be understood that, in the present embodiment, the power for driving the rotation of the release member <NUM> as required by the release of the puncture needle may be provided by a motor, a spring mechanism, a magnetic mechanism or the like. The present embodiment is not limited to any means for providing the power, and this means is not shown in the figures. For one skilled in the art, regardless of what kind of the means that provides the driving power, how to make it operable with the release member would be commonly known in the art and, therefore, need not be described in further detail herein. Additionally, how to cause the transmission member <NUM> to rotate counterclockwise as a result of the clockwise rotation of the withdrawal lock <NUM> would be commonly known to those skilled in the art. Further, the first manipulation mechanism <NUM>, the second manipulation mechanism <NUM>, the withdrawal lock <NUM> and the cutting lock <NUM> may be caused to move by various means such as pressing, rotating, sliding, etc., and the present invention is not limited to any particular such means.

During the unlocking of the trigger <NUM>, a sound may be produced upon the release member <NUM> hitting the first limiting post <NUM>, providing the operator with an indication that the release member <NUM> has reached its limit position. In addition, ratchet teeth <NUM> may be provided on the transmission member <NUM>, and a contact tab <NUM> may be provided on the housing <NUM> into contact with the ratchet teeth <NUM>. As such, when the transmission member <NUM> is rotated, sounds will be produced as a result of the ratchet teeth <NUM> successively coming into contact with the contact tab <NUM>. Thus, when the transmission member <NUM> reaches the limit position and stops rotating, the operator would readily recognize this because sounds are no longer heard.

In alternative embodiments, the second manipulation mechanism <NUM> may not include the first limiting element <NUM>. In such embodiments, the fourth limiting element <NUM> of the manipulation member <NUM> may be adapted to lock the release member <NUM> instead by directly abutting against the release member <NUM>.

Additionally, as shown in <FIG>, <FIG>, the cutting and pushing mechanism <NUM> includes a slide channel <NUM>, a first push block <NUM>, a biased push element <NUM>, a second push block <NUM>, a second limiting element <NUM>, a push rod <NUM> and a cutter <NUM>. The slide channel <NUM> may be an elongate channel arranged in the internal cavity. The first push block <NUM> and the second push block <NUM> are both movably provided on the slide channel <NUM>. The biased push element <NUM> is coupled to both the first push block <NUM> and the second push block <NUM>. The second limiting element <NUM> is rotatably disposed within the internal cavity between the first push block <NUM> and the second push block <NUM>. One end of the push rod <NUM> is coupled to the first push block <NUM>, and the other end thereof is received in the second lumen <NUM> of the delivery tube <NUM> in order to push the proximal anchoring element <NUM> also received in the second lumen <NUM>. The cutter <NUM> is disposed in the second lumen <NUM> on the side of the proximal anchoring element <NUM> away from the housing <NUM>. Moreover, the cutter <NUM> is coupled to the second push block <NUM>. In the present embodiment, the biased push element <NUM> includes, but is not limited to, a spring.

In the initial configuration, the biased push element <NUM> is stretched (from its original length). The first push block <NUM> is coupled to, and thus locked by, the locking hook <NUM> of the cutting lock <NUM>. The second limiting element <NUM> abuts against the second push block <NUM> and thereby keeps it stationary. When the cutting lock <NUM> is unlocked, it can be rotated by an external force to disengage the first push block <NUM> from the cutting lock <NUM>. As a result, the biased push element <NUM> is released and moves the first push block <NUM> in the slide channel <NUM> toward the second push block <NUM> (i.e., moves the first push block <NUM> to the left as in the orientation of <FIG>) until the first push block <NUM> hits the second limiting element <NUM>. The hit second limiting element <NUM> moves away from the second push block <NUM>, allowing the second push block <NUM> to move in the slide channel <NUM> toward the first push block <NUM> (i.e., to the right) under the action of the biased push element <NUM>. In this process, the push rod <NUM> moves to the left together with the first push block <NUM>, thus pushing the proximal anchoring element <NUM> to move in the same direction. Meanwhile, the cutter <NUM> moves to the right together with the second push block <NUM> until the proximal anchoring element <NUM> is attached to the connecting element <NUM> of the implant <NUM>. After that, the cutter <NUM> can be manipulated to cut off an undesired portion of the connecting element <NUM> from the implant <NUM>.

As can be seen from the above description, in the initial configuration of the delivery system according to the present embodiment, the first manipulation mechanism <NUM>, the second manipulation mechanism <NUM>, the withdrawal lock <NUM>, the cutting lock <NUM> and the cutting and pushing mechanism <NUM> are interlocked. In order to release the implant, the first manipulation mechanism <NUM> is first manipulated to release the locking of the second manipulation mechanism <NUM>. The unlocked second manipulation mechanism <NUM> can be triggered to release the puncture needle and simultaneously release the locking of the withdrawal lock <NUM>. The unlocked withdrawal lock <NUM> can be triggered to withdraw the puncture needle and simultaneously release the locking of the cutting lock <NUM>. The unlocked cutting lock <NUM> can be triggered to release the locking of the cutting and pushing mechanism <NUM>, and the unlocked cutting and pushing mechanism <NUM> can perform a cutting action. In this way, the components in the operating system must be triggered in a predetermined order to accomplish the implant release task without, avoiding failed release due to a wrong triggering order.

Optionally, the withdrawal lock <NUM> may lock the second limiting element <NUM> in the initial configuration, and the locking may be released by an external force exerted on the withdrawal lock <NUM>. Specifically, the withdrawal lock <NUM> may lock the second limiting element <NUM> in the initial configuration by abutting against it and thereby preventing its rotation. When the withdrawal lock <NUM> is moved by an external force, the withdrawal lock <NUM> may disengage from, and thus release the locking of, the second limiting element <NUM>.

Additionally, in order for the second manipulation mechanism <NUM> to be more easily pressed, anti-slip features may be patterned in a press area of the manipulation member <NUM> in the second manipulation mechanism <NUM>. Likewise, anti-slip features may also be patterned in a press area of the withdrawal lock <NUM>.

In the above release process of the implant delivery system, the implant may be stuck, for example, in the course of unlocking the release member <NUM> by rotating the second manipulation mechanism <NUM>, or in the course of deforming the limiting mechanism <NUM> as a result of the release member <NUM> hitting the limiting mechanism <NUM>, or in the course of unlocking the cutting and pushing mechanism <NUM> by rotating the cutting lock <NUM> in order to allow the first push block <NUM> to hit the second limiting element <NUM>. The release of the implant will fail in any of those stuck cases. In order to address this, in another embodiment of the present invention, the operating system further includes a manual manipulation mechanism, and the housing <NUM> is further provided therein with windows, from which the manual manipulation mechanism can be inserted into the internal cavity to manually trigger the various components to release the stuck implant.

Referring to <FIG>, a first window <NUM> in communication with the internal cavity is provided in the housing <NUM>. When the implant is stuck in the course of unlocking the release member <NUM>, the manual manipulation mechanism <NUM> may be inserted into the internal cavity from the first window <NUM> to manipulate the second manipulation mechanism <NUM> to unlock the release member <NUM> from the second manipulation mechanism <NUM>. Specifically, the first window <NUM> in the housing <NUM> is provided in positional correspondence with the manipulation member <NUM> in order to allow the manual manipulation mechanism <NUM> to be inserted into the internal cavity from the first window <NUM> to exert a force on the manipulation member <NUM> to cause it to rotate. The rotation of the manipulation member <NUM> in turn causes the first limiting element <NUM> to rotate away from the release member <NUM>, thus releasing the locked release member <NUM>. Alternatively, the first window <NUM> in the housing <NUM> may be provided in positional correspondence with the first limiting element <NUM> in order to allow the manual manipulation mechanism <NUM> to be inserted into the internal cavity from the first window <NUM> to exert a force on the first limiting element <NUM> to cause it to rotate away from the release member <NUM>. In this embodiment, the first limiting element <NUM> is preferably made of an elastic material which allows the first limiting element <NUM> to deform under the action of the force exerted by the manual manipulation mechanism <NUM> to release the locked release member <NUM>.

A second window <NUM> in communication with the internal cavity may be further provided in the housing <NUM>. When the implant is stuck in the course of deforming the limiting mechanism <NUM> as a result of the release member <NUM> hitting the limiting mechanism <NUM>, the manual manipulation mechanism <NUM> may be inserted into the internal cavity from the second window <NUM> to exert a force on the limiting mechanism <NUM> to cause its deformation. Specifically, the second window <NUM> in the housing <NUM> may be provided in positional correspondence with the first limiting post <NUM> in order to allow the manual manipulation mechanism <NUM> to be inserted into the internal cavity from the second window <NUM> to exert a force on the first limiting post <NUM>. Preferably, the first limiting post <NUM> is made of an elastic material.

A third window <NUM> in communication with the internal cavity may be further provided in the housing <NUM>. When the implant is stuck in the course of the first push block <NUM> hitting the second limiting element <NUM>, the manual manipulation mechanism <NUM> may be inserted into the internal cavity from the third window <NUM> to exert a force on the second limiting element <NUM> to cause it to move away from the second push block <NUM>, thus releasing the locking of the second push block <NUM>.

In particular, the manual manipulation mechanism <NUM> may take a form depending on the shape and size of the various windows. <FIG> schematically illustrates a structure that the manual manipulation mechanism <NUM> may optionally employ. As shown in <FIG>, the manual manipulation mechanism <NUM> includes a first release feature <NUM>, a second release feature <NUM> and a third release feature <NUM>. In this embodiment, the individual windows differ from one another in terms of size and shape. Accordingly, the first release feature <NUM>, the second release feature <NUM> and the third release feature <NUM> are different from one another. In the illustrated case, the first release feature <NUM> is adapted for insertion into the internal cavity from the first window <NUM>, the second release feature <NUM> is adapted for insertion into the internal cavity from the second window <NUM>, and the third release feature <NUM> is adapted for insertion into the internal cavity from the third window <NUM>. In alternative embodiments, the manual manipulation mechanism may have only one release feature which can be inserted into the internal cavity from any of the three windows.

As described above, in the implant delivery process implemented by the operating system in the delivery system according to the present embodiment, the interlocked mechanisms are sequentially triggered strictly according to a predetermined order to enable the release of the implant, ensuring safety and reliability of the delivery process. Moreover, the manual manipulation mechanism is provided to address the problem of the implant being stuck, additionally increasing the delivery system's effectiveness of use.

Further, as shown in <FIG>, in practice, the delivery tube <NUM> is coupled to the housing <NUM> by means of a tube fitting <NUM>. As shown in <FIG>, the tube fitting <NUM> includes a flange <NUM> fixed to the housing <NUM>. A coupling boss <NUM> projects from the flange <NUM>, and a through bore <NUM> extends through both the coupling boss <NUM> and the flange <NUM> and communicates with the internal cavity, thus bringing the delivery tube <NUM> into communication with the internal cavity. Further, an arc-shaped fin <NUM> extends circumferentially on an outer wall of the coupling boss <NUM>.

Furthermore, in order for accurate and reliable implant delivery to be achieved by the system, the implant delivery system may be further equipped with other devices such as an endoscope and sheath. Accordingly, as shown in <FIG>, the implant delivery system further includes a sheath lock <NUM> and an endoscope lock <NUM>.

As shown in <FIG>, the sheath lock <NUM> includes a clamp lock <NUM> and an arc-shaped stop ring <NUM>. The clamp lock <NUM> is adapted for attachment to the sheath, and the arc-shaped stop ring <NUM> is adapted to engage the arc-shaped fin <NUM>. As shown in <FIG>, the endoscope lock <NUM> is rotatably disposed on the housing <NUM> and includes a mount hole <NUM> adapted for retaining the endoscope. During the implant delivery process, the endoscope is inserted into the human body. Using the endoscope, it can be observed whether the puncture needle has carried the distal anchoring element to a predetermined site. Accordingly, as shown in <FIG> and <FIG>, the delivery tube <NUM> further defines a third lumen <NUM> for receiving the endoscope therein. Walls of the first lumen <NUM>, the second lumen <NUM> and the third lumen <NUM> are joined together so that the first lumen <NUM>, the second lumen <NUM> and the third lumen <NUM> are arranged in a row along a direction perpendicular to an axis of the delivery tube <NUM>. The delivery tube <NUM> further includes a tube tip <NUM> which is joined to each of the first lumen <NUM>, the second lumen <NUM> and the third lumen <NUM>. Moreover, the tube tip <NUM> is brought into communication with the first lumen <NUM> and thus defines therewith a puncture channel. The tube tip <NUM> is adapted to guide the puncture needle from linear movement to curved movement so that it travels from the first lumen <NUM> into the tube tip <NUM> and then penetrates into prostatic tissue from the tube tip <NUM>. Further, in order to avoid sharp corners of the tube tip <NUM> from unnecessarily damaging human tissue, the tube tip <NUM> is wrapped with a protective film <NUM>. It should be understood that one skilled in the art would well know how to construct the delivery tube <NUM>, the tube fitting <NUM>, the sheath lock <NUM> and the endoscope lock <NUM> and how to couple them to the housing <NUM>.

On the basis of the above implant delivery system, examples of the present disclosure also provide an implant delivery method. Before the implant delivery begins, the operating system is in the initial configuration. Accordingly, the implant delivery method includes:.

More specifically, the trigger includes a release member, a transmission member and a limiting mechanism. The puncture needle is coupled to the release member. The transmission member is coupled to the withdrawal lock, and the limiting mechanism is adapted to lock the withdrawal lock in the initial configuration.

An external force is exerted on the release member to drive it to rotate in a first direction, thereby releasing the puncture needle.

After the release member rotates over a predetermined angle, the release member completes the release of the puncture needle. At the same time, the release member hits and deforms the limiting mechanism, thereby releasing the locking of the withdrawal lock.

At the same time as an external force is applied to the withdrawal lock to unlock the cutting lock from the withdrawal lock, the withdrawal lock drives movement of the transmission member, which in turn causes the release member to rotate in a second direction to withdraw the puncture needle. The second direction is opposite to the first direction.

Optionally, the trigger further includes a release lock which is adapted to lock the release member in the initial configuration.

Prior to the application of an external force to the release member, the implant delivery method further includes unlocking the release member from the release lock by applying an external force to the release the lock.

Optionally, the release lock includes a first manipulation mechanism and a second manipulation mechanism. In the initial configuration, the first manipulation mechanism is adapted to lock the second manipulation mechanism, and the second manipulation mechanism is adapted to lock the release member.

Unlocking the release member from the release lock by applying an external force to the release lock include: unlocking the second manipulation mechanism from the first manipulation mechanism by applying an external force to the first manipulation mechanism; and then unlocking the release member from the second manipulation mechanism by applying an external force to the second manipulation mechanism.

Optionally, the second manipulation mechanism may be unlocked as a result of the first manipulation mechanism moving under the action of an external force; the release member may be unlocked as a result of the second manipulation mechanism moving under the action of an external force; the cutting lock may be unlocked as a result of the withdrawal lock moving under the action of an external force; and the cutting and pushing mechanism may be unlocked as a result of the cutting lock moving under the action of an external force. This interlocking design has the advantages that those components are unlocked and triggered according to a predetermined order during the implant delivery process of the delivery system, avoiding failed release due to a wrong unlocking order and improving the reliability and safety of the implant delivery system.

Optionally, if the implant is stuck in the course of unlocking the release member by moving the second manipulation mechanism, the manual manipulation mechanism is inserted into the internal cavity from the first window to manually urge the second manipulation mechanism to move.

Optionally, if the implant is stuck in the course of releasing the locked withdrawal lock as a result of the release member hitting the limiting mechanism, the manual manipulation mechanism is inserted into the internal cavity from the second window to manually urge the limiting mechanism to deform to unlock the withdrawal lock.

Optionally, if the implant is stuck in the course of unlocking the cutting and pushing mechanism by causing the cutting lock to move, the manual manipulation mechanism is inserted into the internal cavity from the third window to manually unlock the cutting and pushing mechanism by applying a force thereto.

The interlocked mechanisms in the delivery system are sequentially triggered strictly according to a predetermined order to enable the release of the implant, ensuring safety and reliability of the delivery process. Moreover, the manual manipulation mechanism is provided to address the problem of the implant being stuck, additionally increasing the delivery system's effectiveness of use.

Claim 1:
An operating system (<NUM>) for use in an implant delivery system, the operating system (<NUM>) comprising a housing (<NUM>) and a trigger (<NUM>), the housing (<NUM>) defining an internal cavity in which part of the trigger (<NUM>) is movably disposed, the trigger (<NUM>) comprising a withdrawal lock (<NUM>), a cutting lock (<NUM>) and a cutting and pushing mechanism (<NUM>), the cutting and pushing mechanism (<NUM>) configured to cut off a connecting element (<NUM>) from an implant (<NUM>) delivered by the implant delivery system,
the operating system (<NUM>) having an initial configuration,
the trigger (<NUM>) configured so that, in the initial configuration, the withdrawal lock (<NUM>) is locked and locks the cutting lock (<NUM>), the cutting lock (<NUM>) locks the cutting and pushing mechanism (<NUM>), and that when the withdrawal lock (<NUM>) is unlocked, the withdrawal lock (<NUM>) releases the locked cutting lock under the action of an external force, followed by the cutting lock (<NUM>) releasing the locked cutting and pushing mechanism (<NUM>) under the action of an external force, wherein:
the trigger (<NUM>) further comprises a limiting mechanism (<NUM>), a release member (<NUM>) and a transmission member (<NUM>), the release member (<NUM>) is rotatably disposed in the internal cavity, the transmission member (<NUM>) is movably disposed in the internal cavity and is connected to the withdrawal lock (<NUM>),
characterised in that:
the limiting mechanism (<NUM>) is configured to lock the withdrawal lock (<NUM>) in the initial configuration, the release member (<NUM>) is configured to, when rotated in a first direction over a predetermined angle under the action of an external force, urge the limiting mechanism (<NUM>) to deform, thereby releasing the locked withdrawal lock, followed by the withdrawal lock (<NUM>) releasing the locked cutting lock under the action of an external force and simultaneously driving movement of the transmission member (<NUM>), the transmission member (<NUM>) further drives the release member (<NUM>) to rotate in a second direction opposite to the first direction.