Devices and methods for deploying expandable implants

Abstract

A device for deploying an implant in a patient's body comprises an elongated delivery tube having one internal element with an imaging head, one intermediate element with a plurality of implant retainer arrays, and one external element with an external sheath, wherein the internal and external elements are retractable relative to the intermediate element. A handle at one proximal end of the delivery tube incorporates a hub assembly including the hubs of the internal, intermediate, and external elements. A hub casing, longitudinally movable within the handle relative to the intermediate element hub, supports the internal and external element hubs to retract them relative to the intermediate element by movement using the hub carriage.

Description

Technical Field of the Invention

[0001] The present disclosure relates to delivery devices for expandable implants and methods for using such devices. Specifically, but not exclusively, the delivery devices described above deploy self-expanding implants or expanders to expand the prostatic urethra of a patient, thereby providing a solution for treating diseases such as benign prostatic hyperplasia (BPH). Accordingly, certain aspects and embodiments of the present invention relate to delivery devices for positioning expandable implants, such as within the prostatic urethra, for treating BPH, and methods for delivering or deploying the implants described above.

[0002] BPH is a non-cancerous disease that leads to enlargement of the prostate. The prostate surrounds a portion of the urethra adjacent to the bladder, namely the prostatic urethra. Therefore, when the prostate enlarges, the prostate tends to compress the prostatic urethra and the neck of the bladder inward, making it difficult for the patient to urinate.

[0003] In the United States alone, more than $5 billion per year is spent on drug treatment for managing BPH. It is also known to use various surgical techniques to treat BPH. However, certain surgical solutions can be particularly invasive and painful for patients. Summary of the Invention

[0004] There has been a movement towards the use of expandable implants or stents that can respond to the inward pressure that may be exerted on the urethra and bladder neck by an enlarged prostate when inserted into the prostatic urethra.

[0005] Expandable implants offer a minimally invasive and low-cost solution for treating BPH. However, positioning the implant correctly within the urethra, while essential, can be challenging for clinicians. If the implant is not deployed correctly, it may not provide adequate symptom relief, may fail to function due to migration or excessive encrustation, and may be difficult and invasive to retrieve from the urethra after deployment.

[0006] Various examples of expanders for treating BPH are disclosed in WO 2017 / 081326, which is incorporated herein by reference in its entirety. The expanders of WO 2017 / 081326 are designed to be positioned, for example, within the prostatic urethra between the bladder neck and the external sphincter, and then to self-expand laterally. In one embodiment, the expander contacts the outer wall of the prostatic urethra and applies a radially outward force to alleviate the symptoms of BPH.

[0007] In some embodiments, accurate deployment of the expander within the prostatic urethra requires precise positioning of the expander in two directions: longitudinal and circumferential, or longitudinal and oblique. Specifically, the expander can be positioned longitudinally at a location between the bladder neck and the external sphincter, and can also be oriented to engage with the three lobes of the prostate. Inaccurate deployment is likely to occur if the expander is deployed incorrectly or prematurely, or if the clinician is unable to properly visualize the prostatic urethra before deployment.

[0008] If an expander is deployed in the wrong position or orientation, undesirable consequences may occur, and complex procedures may be required to remove or reposition the expander. As a result, there is a need for minimally invasive delivery devices that allow clinicians to accurately position and deploy expandable implants within a patient's prostatic urethra.

[0009] WO 2017 / 081326 describes several embodiments of a device for delivering an expander to a target site within a body cavity, such as the prostatic urethra. In some embodiments, the delivery device comprises a single discharge element having a triangular cross-section, configured to engage with and support the expander. A single delivery tube of the delivery device can be inserted into the penile urethra, and its distal end can be advanced along the urethra to the target site within the prostatic urethra. When the clinician is confident that the expander is correctly positioned longitudinally and obliquely to the lobes of the prostate, the discharge element can be advanced distally to discharge the expander from the outer sheath of the delivery tube.

[0010] Certain single-step delivery devices may benefit from several refinements that have been implemented. For example, single-step delivery devices can be susceptible to accidental or premature deployment. Also, some single-step delivery devices may not allow complete visual confirmation of the correct position of the expander relative to the surrounding anatomical structures before the clinician must decide whether or not to deploy the expander. Furthermore, if the clinician does not retract the delivery tube of the single-step delivery device proximal while advancing the discharge element distally, the expander may spring or jump forward during deployment. Unhelpfully, this can result in changes in the position of the expander within the prostatic urethra, both longitudinally and circumferentially, as a result of the deployment procedure. In this regard, expecting the expander to self-position relative to the anatomical structures can be unreliable and unpredictable.

[0011] WO 2021 / 099646, which is incorporated herein in its entirety by reference, discloses several embodiments of an improved delivery device for deploying an expander in the prostatic urethra. Among the improvements of the delivery device, WO 2021 / 099646 discloses equipment features for preventing accidental deployment of the expander, equipment features for improving the pre-deployment visibility of the expander relative to the surrounding anatomical structures, and equipment features for pausing deployment or performing the reverse deployment procedure if the clinician determines that the expander may otherwise be mispositioned at the target site. WO 2021 / 099646 also discloses equipment features for maneuvering the delivery tube along the penile urethra to the target site.

[0012] Multiple embodiments of the present invention provide elegant, compact, effective, and reliable solutions for operating a detent mechanism and for driving and controlling the longitudinal differential motion of the concentric elements of the delivery tube during visualization and deployment at its location. As a result, some embodiments of the present invention provide ergonomically designed delivery devices that enable implants to be deployed easily, safely, and accurately, primarily with one-handed operation.

[0013] In some embodiments, a device for deploying an implant in a patient's body is a single elongated delivery tube having a plurality of concentric delivery tube elements, wherein the delivery tube elements are arranged radially outward to form a delivery tube comprising one inner element having one imaging head, one intermediate element having a plurality of implant retainer arrays, and one outer element having one outer sheath capable of cooperating with the implant retainer arrays, wherein the inner and outer elements are retractable relative to the intermediate element along one long axis of the delivery tube, and a handle at one proximal end of the delivery tube, wherein the handle comprises one inner element hub and one The system comprises a housing containing a hub assembly comprising an intermediate element hub and one outer element hub, each of which has a handle positioned proximal to each of the delivery tube elements; a hub carriage that is longitudinally movable relative to the housing and the intermediate element hub, and which supports the inner element hub and the outer element hub so as to move the inner element and the outer element relative to the intermediate element of the delivery tube by the movement using the hub carriage; and a deployment drive device configured to drive the movement of the hub carriage in response to the operation of a deployment control element located outside the housing. In some embodiments, the hub carriage is a hub casing.

[0014] In some embodiments, a device for deploying an implant in a patient's body comprises a single elongated delivery tube having a plurality of concentric delivery tube elements, wherein the delivery tube elements are arranged radially outward and include one inner element having one imaging head, one intermediate element having a plurality of implant retainer arrays, and one outer element having one outer sheath capable of cooperating with the implant retainer arrays, wherein the inner and outer elements are retractable relative to the intermediate element along one long axis of the delivery tube, and a handle at one proximal end of the delivery tube. The handle may comprise a housing comprising a hub assembly including one inner element hub, one intermediate element hub, and one outer element hub, wherein the inner element hub is mounted proximally to the inner element of the delivery tube, the intermediate element hub is mounted proximally to the intermediate element of the delivery tube, and the outer element hub is mounted proximally to the outer element of the delivery tube; a hub carriage configured to move longitudinally with respect to the housing and the intermediate element hub, and supporting the inner element hub and the outer element hub to retract the inner element and the outer element hub relative to the intermediate element of the delivery tube by longitudinal movement using the hub carriage; and a deployment drive device configured to drive the longitudinal movement of the hub carriage in response to the operation of a deployment control element located outside the housing.

[0015] In some embodiments, the hub carriage may be moved by the deployment drive device to move proximal to the housing and the intermediate element hub along a longitudinally extending retraction path, from an undeployed position where the outer sheath faces the implant retainer array and is advanced distally to the implant retainer array, through an intermediate partially deployed position where the outer elements are retracted proximal to the distally advanced position while still facing the implant retainer array, to a fully deployed position where the outer sheath is retracted proximal to the implant retainer array.

[0016] The outer element hub and the inner element hub may be moved proximally from the undeployed position to the partially deployed position together with the hub trolley. In that case, the outer element hub and the inner element hub may be reversed distally along the retraction path from the partially deployed position to the undeployed position together with the hub trolley.

[0017] The outer element hub may be configured to move toward the inner element hub together with the hub carriage when the hub carriage moves from the partially deployed position to the fully deployed position. In this case, the outer element hub may be fixed relative to the hub carriage, or the inner element hub may be latched to the hub carriage in a releasable manner. For example, a stop array fixed to the housing can be placed in the retraction path closer to the inner element hub than the inner element hub to prevent the inner element hub from moving toward the hub carriage beyond the partially deployed position. This allows the inner element hub to be released from the hub carriage, and simultaneously enables uninterrupted toward movement of the hub carriage and the outer element hub from the partially deployed position to the fully deployed position.

[0018] The hub trolley can be releasably latched to the housing when it is in the undeployed position, and this latching can be released by operating the deployment control element. In one embodiment, the hub trolley can be releasably latched to the housing when it is in the undeployed position, and is configured to be released by operating the deployment control element.

[0019] The deployment drive device preferably includes a detent mechanism configured to prevent the hub bogie from moving from the partially deployed position to the fully deployed position, and a detent release element that is operable to release the detent mechanism, allowing the hub bogie to move from the partially deployed position to the fully deployed position. For example, the detent release element may release the detent mechanism by moving the deployment control element acting on the deployment drive device to move the hub bogie from the undeployed position to the partially deployed position. In this regard, the deployment control element may prevent the detent release element from moving when the hub bogie is in the undeployed position.

[0020] In some embodiments, a device configured to deploy an implant in a patient's body comprises a delivery tube including one internal element having one imaging head, one intermediate element having two or more implant retainer arrays, and one external element having one external sheath, wherein the internal element, intermediate element, and external element are arranged concentrically, and the internal element and external element are movable relative to the intermediate element along one long axis of the delivery tube, and a handle. The handle may comprise a housing, a hub assembly including one inner element hub, one intermediate element hub, and one outer element hub, characterized in that the inner element hub is mounted proximally to the inner element of the delivery tube, the intermediate element hub is mounted proximally to the intermediate element of the delivery tube, and the outer element hub is mounted proximally to the outer element of the delivery tube; a hub carriage configured to move longitudinally with respect to the housing and the intermediate element hub, and supporting the inner element hub and the outer element hub to retract the inner element and the outer element hub relative to the intermediate element of the delivery tube by the longitudinal movement using the hub carriage; and a deployment drive device configured to drive the longitudinal movement of the hub carriage in response to the operation of a deployment control element located outside the housing.

[0021] The outer element hub, intermediate element hub, and inner element hub described above can be arranged in close proximity along the hub trolley. The hub trolley may include one distal portion supporting the outer element hub, one proximal portion supporting the inner element hub, and one longitudinally extending intermediate portion connecting the distal and proximal portions and bridging the intermediate element hub. The intermediate element hub can be appropriately sandwiched between the outer element hub and the inner element hub and may be at least partially housed within the hub trolley.

[0022] The intermediate element hub may have at least one support extending laterally beyond the hub carriage to fix the intermediate element hub so as not to move relative to the housing. In this case, one side wall of the hub carriage may have a longitudinally extending slot that accommodates the laterally extending support of the intermediate element hub, allowing the hub carriage to move relative to the intermediate element hub. The slot appropriately has one open proximal end.

[0023] The deployment drive device may comprise a pair of gears that operate between the deployment control element and the hub carriage. In this case, the hub carriage may have a longitudinally extending rack array that engages with one of the gears of the deployment drive device gear pair. For example, the rack array may be located on an arm extending proximal to the hub carriage. The arm may be laterally deviated from a central long axis extending proximal to the housing from the delivery tube, in which case the rack array may face the axis.

[0024] In one embodiment, the concept of the present invention includes a corresponding method for operating an implant deployment device having a plurality of concentrically arranged elongated delivery tube elements extending from a housing, wherein the elements are arranged radially outward to form an inner element comprising a single imaging head, an intermediate element comprising a plurality of implant retainer arrays, and an outer element comprising an outer sheath capable of cooperating with the implant retainer arrays. In some embodiments, the method includes providing the device in an unextended state in which the outer sheath is positioned distal to the implant retainer array, thereby keeping a certain implant engaged with the array; and retracting the outer and inner elements into a partially extended state relative to the intermediate elements by moving one hub carriage of the device relative to one hub of the intermediate elements which are held in a fixed relationship with the housing, such that the hub carriage carries one hub of the outer element and one hub of the inner element; and further retracting the hub carriage carrying the hub of the outer element relative to the hub of the intermediate element, so that the outer element is retracted proximal to the intermediate elements, so that the outer sheath is retracted beyond the retainer array to release the implant.

[0025] In some embodiments, a method of operating an implant deployment device includes providing the implant deployment device in an undeployed state, the implant deployment device comprising a single elongated delivery tube comprising a plurality of elongated delivery tube elements concentrically arranged and extending from a single housing, the delivery tube elements comprising a radially outward-facing arrangement comprising a single inner element comprising a single imaging head, a single intermediate element comprising a plurality of implant retainer arrays, and a single outer element comprising a single outer sheath capable of cooperating with the implant retainer arrays. The undeployed state may include the outer sheath being positioned opposite the implant retainer arrays and advanced distally relative to the implant retainer arrays, thereby keeping the implant engaged with the implant retainer arrays. The above method may include moving one hub carriage of the implant deployment device relative to one intermediate element hub, which is fixedly held to the housing, thereby retracting the outer element and the inner element to a partially deployed state relative to the intermediate element, wherein the hub carriage is carrying one outer element hub and one inner element hub, and moving the hub carriage carrying the outer element hub relative to the intermediate element hub and the inner element hub, thereby retracting the outer element to a fully deployed state relative to the intermediate element and the inner element, wherein the fully deployed state is characterized in that the outer sheath is retracted proximal beyond the implant retainer array to release the implant (for example, in the urethra).

[0026] In some embodiments, the method includes moving the outer element hub and the inner element hub together with the hub carriage in a proximal direction to move the hub carriage to the partially deployed state. The method may also include moving the outer element hub together with the hub carriage in a proximal direction relative to the inner element hub to move the hub carriage to a fully deployed state, which is configured for the release of the implant into the urethra.

[0027] In some embodiments, the hub trolley can be releasably latched to the housing when it is in the unextended state. Similarly, the hub of the inner element can be latched to the hub trolley during movement of the hub trolley between the unextended state and the partially extended state. The hub of the inner element can be unlatched from the hub trolley by preventing its relative movement to the housing during movement of the hub trolley between the partially extended state and the fully extended state.

[0028] In some embodiments, when the hub carriage is moved to the partially deployed state, the outer element hub and the inner element hub also move proximally together with the hub carriage. Alternatively, when the hub carriage is moved to a fully deployed state, the outer element may move proximally together with the hub carriage relative to the inner element hub. The hub carriage can be released from latching to the housing by operating a certain deployment control element. In such embodiments, the operation of the deployment control element may drive one of the device's deployment drivers to move the hub carriage from the undeployed state to the partially deployed state. In some embodiments, one of the deployment drivers' detent mechanisms prevents the hub carriage from moving from the partially deployed position to the fully deployed position. In such embodiments, the operation of a certain deployment control element may cause a detent release element to release the detent mechanism. For example, the detent release element can release the detent mechanism, allowing the hub carriage to move from the partially deployed position to the fully deployed position. In one embodiment, the deployment control element can be operated to engage a pair of gears in the deployment drive device, and the gear pair can engage with a single extension rack array of the hub trolley to control the movement of the hub trolley. The operation of a certain deployment control element can enable both movement of the hub trolley from the undeployed state to the partially deployed state, or movement of the hub trolley from the partially deployed state to the undeployed state.

[0029] In some embodiments, the method can include moving the outer element hub and the inner element hub proximally together with the hub carriage to move the hub carriage to the partially deployed state. The method can include moving the outer element hub proximally relative to the inner element hub together with the hub carriage to move the hub carriage to a fully deployed state. The method can include latching the inner element hub to the hub carriage during movement of the hub carriage between the undeployed state and the partially deployed state. The method can include preventing relative movement of the inner element hub with respect to the housing during movement of the hub carriage between the partially deployed state and the fully deployed state. The method can include releasably latching the hub carriage to the housing when the hub carriage is in the undeployed state. The method can include operating a deployment control element to drive longitudinal movement of the hub carriage. The method can include operating the deployment control element to cause movement of the hub carriage from the undeployed state to the partially deployed state by one of the deployment driving devices of the implant deployment device. The method can include using a detent mechanism of one of the deployment driving devices to prevent movement of the hub carriage from the partially deployed position to the fully deployed position. The deployment control element can release the detent mechanism by moving a detent release element. The method can include depressing the detent release element to release the detent mechanism, thereby enabling movement of the hub carriage from the partially deployed position to the fully deployed position. The method can include operating the deployment control element to engage a pair of gears of the deployment driving device, the gear pair engaging a single extended rack arrangement of the hub carriage to control movement of the hub carriage. The method can include operating the deployment control element to enable movement of the hub carriage from the undeployed state to the partially deployed state and / or from the partially deployed state to the undeployed state of the hub carriage.

[0030] In some embodiments, the present invention can be described as a deployment system for deploying an implant in a patient's body, comprising: a deployment drive unit that operates in response to the movement of a deployment control element from a first position in which the implant is not deployed to a second position in which the implant is partially deployed, and to a third position in which the implant is fully deployed; a detent mechanism configured to prevent the movement of the deployment control element from the second position to the third position, wherein the detent mechanism comprises a follower that can be moved to a deployment stop position as a result of the movement of the deployment control element from the first position to the second position, and thus prevents further movement of the deployment control element to the third position; and a detent release element that can be moved to an unlocked position, wherein the movement of the detent release element acts on the follower to move the follower from the deployment stop position to a deployment release position that releases the deployment control element for movement from the second position to the third position. The above detent release element may, for example, be adjacent to the above unfolding control element.

[0031] In one embodiment, a deployment system for deploying an implant within a patient's body includes one deployment drive device operable in response to movement of a deployment control element from a first position where the implant is undeployed to a second position where the implant is partially deployed and to a third position where the implant is fully deployed, and one detent mechanism configured to prevent movement of the deployment control element from the second position to the third position, the detent mechanism including one follower that can move to a deployment stop position upon movement of the deployment control element from the first position to the second position, thereby preventing further movement of the deployment control element to the third position, and one detent release element that can move to an unlock position, the detent release element in the unlock position being configured to act on the follower to move the follower from the deployment stop position to a deployment release position, thereby releasing the deployment control element for movement from the second position to the third position.

[0032] The follower may be movable from a detent stop position, which in one embodiment prevents movement of the detent release element to the unlock position, to the deployment stop position. In that case, the detent release element may be substantially unable to move from a locked position to the unlock position until activated by movement of the follower to the deployment stop position. The detent release element may be substantially unable to move from a locked position to the unlock position until activated by movement of the follower from the detent stop position to the deployment stop position.

[0033] The follower may be in the detent stop position when the deployment control element is in the first position and may be biased toward the detent stop position. More generally, the follower may be movable in a direction opposite the bias to the deployment stop position and the deployment release position.

[0034] The deployment control element may be movable between the first, second, and third positions along a trigger axis, the follower may be movable between one detent stop position (e.g., detent stop position) and multiple detent release positions (e.g., undeployed positions) along a follower axis traversing the trigger axis, and the detent release element may be movable between the locked position and the unlocked position along a detent axis. The detent axis may be substantially parallel to the trigger axis.

[0035] A trigger ramp can be positioned opposite the follower and move together with the deployment control element, and this can also be tilted relative to the trigger axis so that the ramp array slides relative to the follower as the deployment control element moves toward the second position along the trigger axis, driving the follower to move toward the detent release position along the follower axis. The trigger ramp can be shaped to engage with the follower when the deployment control element reaches the second position, thereby preventing further movement of the deployment control element toward the third position. The trigger ramp can include, for example, a shoulder portion that extends transversely to one of the inclined surfaces of the trigger ramp and faces the follower. The deployment control element can include a plurality of grip arrays arranged to facilitate grasping and pulling it outward from the second position to the first position.

[0036] In some embodiments, a deployment system for deploying an implant in a patient's body comprises: a deployment drive unit configured to operate in response to the movement of a deployment control element from a first position in which the implant is not deployed to a second position in which the implant is partially deployed, and to a third position in which the implant is fully deployed; a detent mechanism configured to prevent the movement of the deployment control element from the second position to the third position, wherein the detent mechanism comprises a follower configured to move to a deployment stop position, thereby preventing the movement of the deployment control element to the third position; and a detent release element configured to move the follower from the deployment stop position to a detent release position, wherein the detent release position is configured to release the deployment control element for movement from the second position to the third position.

[0037] The follower may comprise one barrier member that obstructs a sequence of detent release elements when it is in the detent stop position, and one opening that receptively faces the sequence when it is in the detent release position. For example, the barrier member and the opening may be arranged continuously along the follower axis.

[0038] The above arrangement of detent release elements may comprise a single detent lamp facing the follower and tilted with respect to the detent axis so as the detent release element moves toward the unlocked position along the detent axis, the detent lamp slides relative to the follower and drives a movement toward a certain release position that releases the deployment control element for movement from the second position to the third position, beyond the activated position of the follower along the follower axis. The movement of the follower toward the release position, for example by lifting the follower and separating it from the shoulder, appropriately disengages the follower from the trigger lamp.

[0039] The above-described deployment control element may comprise a plurality of grip arrays arranged to facilitate grasping and pulling it outward from the second position to the first position.

[0040] Some embodiments of the present invention are a method for operating an implant deployment device, the method of which can also be expressed as a method of which: moves one deployment control element of the device from a first position in which an implant is not deployed to a second position in which the implant is partially deployed; acts on one follower of the device, the movement of the deployment control element causing the follower to move to a deployment stop position that prevents further movement of the deployment control element to a third position in which the implant is fully deployed; and moves one detent release element of the device to an unlocked position, the movement of the detent release element being a movement acting on the follower to move to an unlocked position that releases the deployment control element for movement from the second position to the third position.

[0041] In one embodiment, a method for operating an implant deployment device (for example, optionally to treat benign prostatic hyperplasia) may include: moving one deployment control element of the device from a first position where an implant is not deployed to a second position where the implant is partially deployed in the urethra, wherein moving the deployment control element from the first position to the second position acts on one follower of the device, thereby moving the follower to a deployment stop position that prevents further movement of the deployment control element to a third position where the implant is fully deployed in the urethra; and moving one detent release element of the device to an unlocked position, wherein moving the detent release element acts on the follower, thereby moving the follower to a deployment release position that releases the deployment control element for movement from the second position to the third position.

[0042] The above follower can move from a certain detent stop position that prevents the detent release element from moving to the above unlock position to the above unfolded stop position.

[0043] The deployment control element and the detent release element act appropriately on the follower by utilizing their respective cam movements. The deployment control element and the detent release element may move along substantially parallel and separate axes.

[0044] The follower can also be moved in one direction that crosses the respective movement directions of the deployment control element and the detent release element. The follower can be deflected in the opposite direction to the deployment control element and the detent release element. Similarly, the follower can be moved to the deployment stop position and the deployment release position in the opposite direction to the deflection.

[0045] In some embodiments, the method includes an implant deployment device comprising a housing and an elongated delivery tube. The elongated delivery tube may include an inner element comprising an imaging head, an intermediate element comprising a plurality of implant retainer arrays, and an outer element capable of cooperating with the implant retainer arrays. In one embodiment, the inner element, the intermediate element, and the outer element are arranged continuously in a radially outward direction. In some embodiments, moving the deployment control element from the first position to the second position includes retracting the outer element and the inner element relative to the intermediate element. In one embodiment, moving the detent release element to the unlock position includes retracting the outer element relative to the intermediate element and the inner element, characterized in that the outer sheath is retracted proximal beyond the implant retainer array to release the implant.

[0046] In some embodiments, a method of operating an implant deployment device (for example, to treat benign prostatic hyperplasia) includes moving one deployment control element of the device from a first position to a second position, wherein an implant is undeployed at the first position, the implant is partially deployed at the second position, and by moving the deployment control element from the first position to the second position, a follower is moved to a deployment stop position that prevents the deployment control element from moving from the second position; and moving one detent release element of the device, thereby moving the follower and the deployment control element from the second position to a third position in which the implant is fully deployed in the urethra.

[0047] The above method may include moving the follower from a detent stop position that prevents the follower from moving the detent release element to the unlocked position to a deployment stop position. The above method may include causing the deployment control element and the detent release element to act on the follower using their respective cam movements. According to some embodiments, the above method may also include moving the deployment control element and the detent release element along separate axes that are substantially parallel; moving the follower in one direction that crosses each of the deployment control element and the detent release element; deflecting the follower in the opposite direction to the deployment control element and the detent release element; and / or moving the follower in the opposite direction to the deflection to the deployment stop position and the deployment release position.

[0048] In one embodiment, the implant deployment device further comprises a housing and an elongated delivery tube. The elongated delivery tube may include an internal element comprising an imaging head, an intermediate element comprising a plurality of implant retainer arrays, and an external element comprising an external sheath capable of cooperating with the implant retainer arrays.

[0049] In one embodiment, the inner element, the intermediate element, and the outer element are arranged continuously in a radially outward direction, and the arrangement is characterized in that moving the deployment control element from the first position to the second position includes retracting the outer element and the inner element relative to the intermediate element, moving the detent release element to the unlock position includes retracting the outer element relative to the intermediate element and the inner element, and the outer element is retracted proximal to the implant retainer array to release the implant.

[0050] In some embodiments, a method for operating an implant deployment device is provided, comprising a housing and an elongated delivery tube including a plurality of delivery tube elements extending from the housing, wherein the delivery tube elements are arranged radially outward, and the device includes an inner element comprising an imaging head, an intermediate element comprising two or more implant retainer arrays, and an outer element comprising an outer sheath, characterized in that the device is provided in an undeployed state, thereby keeping an implant engaged with the two or more implant retainer arrays. The procedure includes providing and moving one hub carriage to a partially deployed state relative to one intermediate element hub which is fixedly held to the housing, thereby retracting the outer element and the inner element relative to the intermediate element, wherein the hub carriage is retracted so that it is carrying one outer element hub and one inner element hub; releasing a detent mechanism which prevents a certain movement of the hub carriage from a partially deployed state to a fully deployed state; and, after moving the hub carriage to a fully deployed state, further retracting the outer element relative to the intermediate element and the inner element to release the implant.

[0051] The inner element hub may latch to the hub carriage during movement of the hub carriage between the un-deployed state and the partially-deployed state. This can prevent the inner element hub from moving relative to the housing when the hub carriage is being moved between the partially-deployed state and the fully-deployed state for the treatment of benign prostatic hyperplasia. The hub carriage can be releasably latched to the housing when it is in the un-deployed state. A deployment control element may be operated to drive the longitudinal movement of the hub carriage. Operation of the deployment control element may cause the hub carriage to move from the un-deployed state to the partially-deployed state by one of the deployment drivers of the implant deployment device. A detent mechanism of the deployment driver may prevent the hub carriage from moving from the partially-deployed state to the fully-deployed state.

[0052] In some embodiments, the concept of the present invention can also be expressed in terms of an implant delivery device comprising: an elongated flexible implant delivery element; a housing from which the delivery element extends; a steering system that acts on the delivery element to bend it along its length under the control of a user of a steering lever located within the housing and pivotable relative to the housing about a pivot axis positioned within the housing; and a plurality of mutually engaging lock arrays within the housing, including a first lock array pivotable with the steering lever and a second lock array fixed relative to the housing. The steering lever can move toward the pivot axis from a locked position where the steering lever is locked for the pivot movement by the mutual engagement of the lock arrays to an unlocked position where the steering lever is released for the pivot movement by the disengagement of the lock arrays. The steering lever may be deflected toward the locked position away from the pivot axis.

[0053] The second locking array described above may, for example, be formed integrally with the housing on one inner surface of the housing. The second locking array can be curved around the pivot axis, in which case one center of the curve of the second locking array may lie on the pivot axis.

[0054] The steering lever may be able to move toward and away from the slewing axis on a locking axis that intersects with the second locking array. The second locking array may be positioned between the slewing axis and one outer end of the steering lever.

[0055] Multiple steering wires may extend into the delivery element from a steering dial that is pivotable with the steering lever. In this case, the steering lever may be able to move relative to one hub of the steering dial along an axis intersecting the pivot axis, but may be fixed in such a way that it does not move relative to the hub about the pivot axis. [Brief explanation of the drawing]

[0056] To facilitate understanding of the various embodiments of the present invention, the following accompanying drawings are provided as examples.

[0057] Figure 1 is a side view of one expander in an expanded state, suitable for use in combination with multiple embodiments of the present invention.

[0058] Figure 2 is a cross-section of a patient's prostate, showing the expander from Figure 1 positioned within the prostatic urethra to treat BPH by applying pressure to multiple walls of the prostatic urethra, thus achieving dilation.

[0059] Figure 3 is a side view of a delivery device according to the present invention, comprising one handle and one delivery tube.

[0060] Figure 4 is an enlarged detailed perspective view of one distal end of the delivery tube containing one undeployed expander, when the device is in deployment stage 0 (zero).

[0061] Figure 5 corresponds to Figure 4, and shows the device in deployment stage 1 where the expander is partially deployed.

[0062] Figure 6 is a schematic diagram of an image acquired by one of the imaging chips of the device while the device is in deployment stage 1 as shown in Figure 5 during use.

[0063] Figure 7 corresponds to Figures 4 and 5, but shows the device in deployment stage 2 where the expander is fully deployed.

[0064] Figures 8a, 8b, and 8c are side cross-sectional views of the distal end portion of the delivery tube, corresponding to the deployment stages of the device shown in Figures 4, 5, and 7, respectively.

[0065] Figure 9 is a side view of one shell arrangement section of one housing of the handle shown in Figure 3.

[0066] Figure 10 corresponds to Figure 9 and shows several components of the handle attached to the shell.

[0067] Figure 11 is a schematic perspective view showing the device of the present invention in use, with the distal end portion of the delivery tube advanced into the prostatic urethra and the handle being grasped and operated by the user.

[0068] Figure 12 is an exploded perspective view showing multiple concentric elements of the above-mentioned delivery tube.

[0069] Figure 13 is an enlarged perspective view of a proximal hub of one inner delivery tube element shown in Figure 12.

[0070] Figure 14 is an enlarged, cropped distal perspective view of the tip of a camera that can be attached to one distal end of the internal delivery tube element shown in Figure 12.

[0071] Figure 15 is an enlarged, cropped, proximal perspective view of the camera tip shown in Figure 14.

[0072] Figure 16 is an enlarged, cropped distal perspective view of a steering tip at one distal end of an intermediate delivery tube element shown in Figure 12.

[0073] Figure 17 is an enlarged distal perspective view of the steering tip shown in Figure 16.

[0074] Figure 18 is an enlarged perspective view of a proximal hub of one outer delivery tube element shown in Figure 12.

[0075] Figures 19a and 19b are exploded perspective views of a single hub casing attached to the proximal hub of the outer delivery tube element shown in Figure 18.

[0076] Figure 20 is an enlarged perspective view of a proximal hub of an outer delivery tube element shown in Figure 12, showing where the handle engages with the housing.

[0077] Figures 21a to 21d are a series of cut perspective views showing the movement of the handle relative to the housing of the hub casing in Figures 19a and 19b during various deployment stages of the device.

[0078] Figures 22a to 22d are a series of cutaway perspective views showing the relative movement of the handle of a plurality of external control elements to the housing during various deployment stages of the device.

[0079] Figures 23a to 23d are a series of side views showing the relative movement of the control elements shown in Figures 22a to 22d and the interaction between those control elements for operating one of the detent functions of the above device.

[0080] Figures 24a and 24b are perspective views showing the operation of one of the steering mechanisms of the above device.

[0081] The above figures are non-limiting and represent some representative examples of embodiments of the present invention. Elements of different figures can be combined with each other. Detailed description

[0082] To place some embodiments of the present invention in context, we first refer to Figure 1, which shows an expandable implant, namely an expander 10, suitable for use in combination with several embodiments of the present invention. The expander 10 shown in Figure 1 is just one example, and delivery devices to be described herein may be suitable for use in combination with other implants, or may be modified for use in combination with other implants.

[0083] In some embodiments, the expander 10 comprises a single nitinol wire, the opposing ends of which are joined by a sleeve 12 to form a continuous, sinusoidal undulating ring. As shown in Figure 1, the expander 10 can self-expand when released by elastic recovery from a radially compressed state for loading to a radially expanded state for deployment. Specifically, the nitinol wiring of the expander 10 can act to utilize its superelastic shape memory properties to configure the expander 10, when compressed, to exert an outward radial force on the surrounding body structure (specifically, the prostatic urethra) into which it is deployed.

[0084] In one embodiment, the expander 10 has a proximal end comprising three proximal prongs, each having a proximal apex 14, and a distal end comprising three distal prongs, each having a distal apex 16. The proximal apex 14 and distal apex 16 may be alternately joined circumferentially by longitudinal struts 18. Each strut 18 may have an outwardly convex shape, which gives the expander 10 a barrel-shaped profile when viewed schematicly.

[0085] The expander 10 can be narrowed to the extent that it is possible to advance it along the patient's penile urethra with minimal discomfort when it is in a radially compressed state. The expander 10 can be delivered to the prostatic urethra in the above-described contracted state, and is then released and self-expands in place.

[0086] Referring here to Figure 2, the expander 10 is shown to be used inside the glandular portion 20 of the prostate gland to treat the symptoms of benign prostatic hyperplasia (BPH) according to one embodiment. Specifically, the expander 10 is positioned inside the prostatic urethra 22 of the prostate gland 20 between the bladder neck 24 and the external sphincter 26. When in the longitudinal position described above, the expander 10 abuts against several lobes of the prostatic urethra 22, applying an outward radial force to facilitate the passage of urine flowing from the bladder.

[0087] In various embodiments, care can be taken to ensure that the expander 10 is in the correct longitudinal position between the bladder neck 24 and the external sphincter 26 before deployment. In this regard, an expander 10 that is excessively close to either the bladder neck 24 or the external sphincter 26 may be undesirable, as otherwise the movement of those muscles could cause the expander 10 to move along the urethra or into the bladder over time.

[0088] In some embodiments, the expander 10 is oriented obliquely so that the undulating wires of the expander 10 do not obstruct the spermatic cumulus 28 and the vas deferens 30, thereby maintaining the patient's sexual function. Furthermore, the longitudinal struts 18 of the expander 10 are oriented to engage with each lobe of the prostate gland 20, thereby applying an outward radial force to each lobe and maintaining an open passage between the bladder neck 24 and the external sphincter 26.

[0089] Now moving to Figure 3, one embodiment of a device 32 for deploying a self-expanding implant or expander 10 includes a proximal handle 34 acting on a flexible delivery tube 36 extending from the handle 34. Initially, as shown in Figures 4 and 8a, the expander 10 is housed in a radially compressed state within a distal end portion of the delivery tube 36, ready for insertion and delivery to a target deployment site within the prostatic urethra.

[0090] As will be described later, and as shown in Figures 8a, 8b, and 8c, one embodiment of the delivery tube 36 includes three flexible tubular elements that are in a concentric sliding relationship in the longitudinal direction, namely, one outer element 38 having one outer sheath, one inner element 40 having one imaging head, and one intermediate element 42 having one steering sheath positioned in an annular gap defined between the outer sheath and the imaging sheath.

[0091] The user operating the device 32 can steer the delivery tube 36 by operating a steering lever 44 on the handle 34 while moving it to a target site along the urethra. Operating the steering lever 44 acts on the intermediate element 42 so that the distal end portion of the delivery tube 36 is deflected relative to a proximal portion of the delivery tube 36.

[0092] In some embodiments, the inner element 40 of the delivery tube 36 has an imaging system (e.g., one imaging head) at its distal end that provides the user with an image of the urethra acquired from a viewpoint on a long axis radially inward of the expander 10 inside the distal end portion of the delivery tube 36. In this example, as shown in Figures 4 and 8a, a camera tip 46 (or other imaging or sensing technology) defining the distal end of the inner element 40 initially protrudes distally from the distal end of the outer element 38, along with image acquisition and illumination components adjacent to a single perfusion tube. This ensures the best possible field of view as the delivery tube 36 moves through the anatomical structure before the expansion of the expander 10. However, in several other embodiments, the distal end of the inner element 40 may be substantially flush with the distal end of the outer element 38, and may even be slightly recessed distally, as long as a suitable field of view is maintained.

[0093] Before reaching the deployment site, the expander 10 can remain retracted inside the distal end portion of the delivery tube 36 by the outer element 38, as shown in Figures 4 and 8a. Therefore, since the deployment of the expander 10 has not yet begun, this stage will be referred to as "deployment stage 0 (zero)" in the following description.

[0094] In one embodiment, when the expander 10 is in or near the deployment site, the user operates one deployment control element, namely a trigger 48 located outside the handle 34, which acts on the delivery tube 36 to partially release the expansioner 10, as shown in Figures 5 and 8b. This stage or intermediate state will be referred to as "Deployment Stage 1" in the following description. The imaging system at the camera tip 46 can then provide an image of the distal end of the expander 10 in comparison with the surrounding structure of the prostatic urethra.

[0095] The operation of the deployment trigger 48 in deployment phase 1 can be reversed to return the device 32 to deployment phase 0. Thus, the expander 10 can be re-stored if the user decides to substantially reposition the expander 10 or abandon the procedure.

[0096] Figure 8b shows how, in the partially deployed configuration of deployment stage 1, the outer element 38 and the inner element 40, including the camera tip 46, are pulled back proximally relative to the intermediate element 42 and therefore relative to the expander 10. Thus, beneficially, when the camera tip 46 is in the retracted position, the imaging device can visualize the expander 10 from a viewpoint inside the expander 10, with adjacent anatomical structures in the background. The retracted outer element 38 remains outside the field of view of the imaging device.

[0097] The prongs terminating at the distal apex 14 of the expander 10 can contact the lobes of the prostate 20, so that the user can see and fully understand the position of the expander 10 relative to the surrounding structure of the prostatic urethra 22 before full deployment. Advantageously, this allows the user to verify whether the expander 10 is correctly positioned before full deployment.

[0098] To illustrate this, Figure 6 is a schematic diagram of an image acquired by an imaging device at the camera tip 46 when the outer element 38 is in the partially deployed position described above. This shows the distal apex 14 of the expander 10 aligned with and in contact with a plurality of lateral lobes surrounding the prostatic urethra 22. Specifically, it shows that the two anterior prongs 54 of the expander 10 are oriented to engage with a plurality of lateral anterior lobes 56, while the one posterior prong 50 of the expander 10 surrounds or straddles the spermatic cumulus 28.

[0099] It is clear that the images provided to the user by the imaging device at the tip of the camera 46 are useful in enabling simultaneous visualization of the longitudinal position of the expander 10 relative to anatomical structures such as the spermatic cumulus 28 and the bladder neck 24, as well as simultaneous visualization of the oblique position of the expander 10 relative to the spermatic cumulus 28 and the lobes 56 of the prostate. This facilitates the precise positioning of the expander 10 in the prostatic urethra 22.

[0100] From Figures 5, 6, and 8b, it can also be noticed that the aforementioned barrel-shaped contour of the expander 10 causes the distal apex 14 of the expander 10 to converge toward a single central long axis 58 when the camera tip 46 of the inner element 40 is retracted within the expander 10. As a result, the distal apex 14s come into contact with each other or nearly so, and are therefore positioned in a highly visible central location within the user's field of view, thus functioning as an effective aiming point for guiding the user.

[0101] In one embodiment, when the user is confident that the expander 10 is correctly positioned at the deployment site, the user can operate the deployment trigger 48, as shown in Figures 7 and 8c, to completely release the expander 10 for deployment. This stage or final deployed state will be referred to as "Deployment Stage 2" in the following description. Once fully released by the retraction of the outer element 38, the expander 10 expands radially at the target site, thereby being released from the delivery tube 36 within the prostatic urethra 20 and becoming fully deployed. In the example of the present invention to be described, the inner element 40 does not retract further with the outer element 38, and as a result, the viewpoint of the camera tip 46 remains fixed from Deployment Stage 1 to Deployment Stage 2.

[0102] A detent mechanism prevents accidental deployment of the expander 10 by preventing operation of the deployment trigger 48, which otherwise could completely release the expander 10 from its storage position. Specifically, in deployment stage 1, the user must carefully press a detent release element such as a detent button 60, and then in deployment stage 2, they can operate the deployment trigger 48 to release the expander 10 from its storage position and deploy it.

[0103] The deployment button 60 is disabled when device 32 is in deployment stage 0. The movement of the deployment trigger 48 to transition device 32 to deployment stage 1 enables the operation of the detent button 60. Then, the detent button 60 can be operated by the user's independent and intentional movement of one finger, releasing the deployment trigger 48 to move device 32 to deployment stage 2.

[0104] During partial and full un-stowed operation, the axial and oblique positions of the expander 10 remain fixed relative to the handle 34, except for steering, in order to maintain the precise positioning of the expander 10 at the deployment point. The oblique position of the expander 10 also remains fixed relative to the imaging device of the camera tip 46.

[0105] Next, looking at Figures 9 and 10, the handle 34 comprises a single hollow housing 62 made of a molded polymer material, divided according to one embodiment into two shells 64 along a central longitudinal plane. The shells 64 are substantially mirror images of each other with respect to the planar interface between them. The shells 64 are held together by a number of screws spaced apart from each other and also spaced apart from the components located within the housing 62.

[0106] As will be described later, the shell 64 includes integrally molded positioning and guidance arrays 66 on their recessed inner sides, which are located within the housing 62 and assist in and guide the movement of various components extending from there. As can be seen in Figure 10, these components are grouped into various subassemblies, namely, one hub assembly 68 at one proximal end of the delivery tube 36, one deployment system 70 that acts on the hub assembly 68 to drive the relative longitudinal movement of specific elongated elements of the delivery tube 36, and one steering system 72 for flexing one distal end portion of the delivery tube 36 when it moves to a deployment site in the patient's body. The hub of the hub assembly 68, which is responsive to the deployment system 70, can move relative to the housing 62 along a central long axis 58 that extends along the housing 62 and inside it, aligned with the proximal end of the delivery tube 36.

[0107] The housing 62 of the handle 34, when viewed from the outside, has a slender waist portion 74 with a roughly elliptical cross-section and a widened proximal portion 76, in which control elements and steering systems 72 that can be operated by the user of the deployment system 70 protrude from inside the handle 34 through openings in the housing 62.

[0108] Specifically, in one embodiment, the control elements of the control system 70 are a deployment trigger 48 and a deployment button 60, which are located in close proximity to each other. The deployment trigger 48 and the deployment button 60 can move in and out of the housing 62 along their respective operating axes that traverse the central long axis 58 of the housing 62, namely one trigger axis 78 and one detent axis 80. The trigger axis 78 and the detent axis 80 are located close to each other and, in this example, are substantially straight and parallel.

[0109] Conversely, in one embodiment, the control element of the steering system 72 is a steering lever 44 that can pivot relative to the housing 62 with respect to a single pivot axis 82 within the housing 62. The pivot axis 82 crosses the central long axis 58 of the housing 62, as well as the trigger axis 78 and the detent axis 80. The steering lever 44 can also move within and out of the housing 62 on a lock axis 84 that intersects the pivot axis 82, thereby allowing the pivoting movement of the steering lever 44 to be unlocked and locked in accordance with each of the above movements, as will be described later.

[0110] Figure 11 shows that in some embodiments, the device 32 is configured primarily for one-handed operation and also allows the user to grasp and operate the device 32 with either their left or right hand, according to their preference. Accordingly, the control elements of the control system 70 and steering system 72, namely the deployment trigger 48, the detent button 60, and the steering lever 44, are located on a central longitudinal plane that divides the shell 64 of the housing 62 and are substantially symmetrical with respect to that plane.

[0111] Device 32 is configured to be held by the user in a pistol grip position, either tilted or upright. When Device 32 is held in the manner described above, the user's index finger aligns with the deployment trigger 48 and detent button 60 of the deployment system 70, and thus they can be easily operated. Alternatively, the user may use their middle finger to operate the detent button 60 and the deployment trigger 48. Conversely, the user's thumb aligns with the steering lever 44 of the steering system 72, which protrudes from the opposite side of the housing 62 and faces the deployment trigger 48 and detent button 60 with respect to the central long axis 58 of the housing 62, and thus it can be easily operated.

[0112] The user's other fingers support the broader proximal portion 76 of the housing 62 in the palm, while holding the device 32 in the palm by surrounding the slender waist portion 74 of the housing 62. Thus, the delivery tube 36 initially extends generally downward and distally from the housing 62, but can then curve along its length, so that its distal portion follows a desired insertion path along the penile urethra into the patient's prostatic urethra.

[0113] The housing 62 further includes a perfusion port 86, such as a Luer connector located distal to the waist portion 74 of the housing 62, for transporting perfusion fluid from an external liquid source into the delivery tube 36. The housing 62 also includes a power / data port 88 located distal to the perfusion port 86. The power / data port 88 enables the transmission of power from an external power source to the imaging electronic components of the delivery tube 36, and also enables the transmission of image data from the imaging electronic components to an external monitor.

[0114] As described above, the delivery tube 36 includes three flexible tubular elements that slide concentrically along the longitudinal direction: one outer element 38 having one outer sheath 90, one inner element 40 having one imaging sheath 92, and one intermediate element 42 having one steering sheath 94 positioned in an annular gap defined between the outer sheath 90 and the imaging sheath 92. Figure 12 shows the elements 38, 40, and 42 individually. It will be apparent that the sheaths 90, 92, and 94 are fixed to hubs 96, 98, and 100, respectively, which are located at or adjacent to the proximal ends of the associated elements 38, 40, and 42.

[0115] As described later, the intermediate element 42 is fixed so as to prevent axial movement relative to the handle 34, while the outer element 38 and inner element 40 can move axially relative to both the intermediate element 42 and the handle 34. The hubs 96, 98, and 100 lock each element 38, 40, and 42 in the system so as to prevent the outer element 38 and inner element 40 from moving in any direction other than axial along a fixed travel path aligned with the central long axis 58 of the handle 34, as controlled by a user operating the deployment trigger 48 of the handle 34.

[0116] In this example, sheaths 90, 92, and 94 are all tubular, but the imaging sheath 92 is, in principle, not tubular, but rather a solid but flexible rod with any wires, cables, or ducts embedded inside (e.g., within each parallel channel having an extruded profile). In any case, any of the above wires or cables must be insulated from each other and from any flow of perfusion fluid that may be carried along the perfusion sheath 92.

[0117] In some embodiments, the sheaths 90, 92, and 94 should be as thin as possible to ensure that the overall diameter of the delivery tube assembly is advantageously small [for example, in the described application, the outer diameter of the assembly is less than 16 French (5.33 mm)]. As one non-limiting specific example, in one embodiment, the outer sheath 90 has a wall thickness of 0.159 mm to 0.254 mm (e.g., about 0.160 mm, 0.165 mm, 0.170 mm, 0.175 mm, 0.180 mm, 0.185 mm, 0.190 mm, 0.195 mm, 0.200 mm, 0.210 mm, 0.220 mm, 0.230 mm, 0.240 mm, 0.250 mm, etc., and within those limits The main proximal portion of the steering sheath 94 can have a wall thickness of approximately 0.394 mm to 0.464 mm (e.g., 0.400 mm, 0.410 mm, 0.420 mm, 0.430 mm, 0.440 mm, 0.450 mm, 0.460 mm, etc., and values ​​and ranges within these limits), thus ensuring 0.61 mm for the expander 10 and clearance. The wall thickness of the imaging sheath 92 below the expander 10 can be approximately 0.114 mm to 0.159 mm (e.g., 0.120 mm, 0.130 mm, 0.140 mm, 0.150 mm, etc., and values ​​and ranges within these limits).

[0118] In some embodiments, the sheaths 90, 92, and 94 are flexible enough to accommodate a deflection angle along their respective lengths, for example, 40° to 90° (values ​​and ranges within 45°, 50°, 60°, 65°, 70°, 75°, 80°, and within those values) to adapt to the anatomical structure of the male urethra and access the prostatic urethra 22. In detail, the sheaths 90, 92, and 94 can be configured to bend along their respective lengths as they extend along the urethra from the insertion point in the penile meatus to the bladder neck 24. Thus, each of the sheaths 90, 92, and 94, in some embodiments, is provided with deflection driven by a steering mechanism controlled by a steering system 72 of a handle 34 at the proximal end of the delivery tube 36, by having one flexible steering section. Sheaths 90, 92, and 94 each have a flexible proximal portion, which allows them to accommodate the bending imposed by the anatomical structure, such as following the entire curvature of the penile canal.

[0119] For example, one or more of the sheaths 90, 92, and 94 can be braided or coiled to obtain flexibility, thereby adapting to the curvature of the anatomical structure and the deflection of the imaging tip. However, the structure of the delivery tube 36 can be made sufficiently rigid in the axial and circumferential directions to resist the forces of insertion, steering, movement, and release of the expander 10, and, if necessary, re-storage of the expander 10. As will be described later, for these purposes, any or all of the sheaths 90, 92, and 94 can have individually tuned stiffness and flexibility characteristics.

[0120] In some embodiments, the torsional rigidity of the sheaths 90, 92, and 94 may be sufficient to allow oblique alignment of the expander 10 around the central long axis 58. In this regard, the circumferential or oblique positioning of the expander 10 within the prostatic urethra 22 is controlled by the full rotation of the handle 34. In one embodiment, the rotation of the handle 34 applies torque to the sheaths 90, 92, and 94 attached to it, ensuring that the sheaths 90, 92, and 94 are fixed so as not to move obliquely in the circumferential vertical direction relative to the handle 34, and therefore cannot rotate independently of the handle 34.

[0121] The simplest and most basic form of a sheath would be a single extruded product containing a polymer material having a certain jurometer value. However, a single-material extruded product with necessarily thin wall thickness may twist or buckle when deflected by a steering mechanism or under axial compression or other bending loads. For these reasons, any or all of the sheaths 90, 92, and 94 can benefit from unique material properties along their respective lengths to provide the individual sheaths 90, 92, and 94 of the delivery tube 36 and the stacked sheath assembly with the design characteristics necessary for accessing the prostatic urethra 22, moving the aforementioned anatomical structures, and steering and supporting the expander 10.

[0122] Examples of characterizing attributes that should be individually tuned along the lengths of each sheath 90, 92, and 94 include flexibility, torsional resistance, conformability, ability to apply axial force parallel to the long axis 58 (i.e., "pushyability"), and ability to apply torque around the long axis 58 (i.e., "torqueability"). Individual tuning can be achieved, for example, by one or more of the following options:

[0123] A hybrid extruded product in which two or more materials having different hardness or durometer properties are joined together by reflow soldering or joints.

[0124] A single sheath that is entirely braided, which is a single custom-made multi-layer braided sheath having a specific pitch design or braiding angle individually adjusted to desired and / or required hardness characteristics. The braiding may be uniform along its length.

[0125] A sheath that is entirely braided and coiled, and is a custom-made multi-layer coiled sheath having a specific pitch design or twist angle individually adjusted to desired and / or required stiffness characteristics. The coil winding may be uniform along its length.

[0126] A single hybrid braided sheath, which is also a single custom-made multi-layer braided sheath having a specific pitch design or braiding angle individually adjusted to desired and / or required stiffness characteristics. In this case, however, the braiding can be changed along its length, for example, using stiffer blades and looser blades, or using denser blades and less dense blades, at various positions along the longitudinal direction where the sheath is required to have higher or lower flexibility. The angle of the blades with respect to the central long axis 58 can also be changed to adjust the flexibility along the length of a sheath.

[0127] A single hybrid coil-wound sheath, which is also a single custom-made multi-layer coil-wound sheath having a specific pitch design or twist angle individually adjusted to desired and / or required stiffness characteristics. In this case, however, the coil winding can be changed along its length, for example, using stiffer coils and looser coils, or using denser coils and less dense coils, at various positions along the longitudinal direction where the sheath is required to have higher or lower flexibility. The angle of the coils with respect to the central long axis 58 can also be changed to adjust the flexibility along a certain length of the sheath.

[0128] A hybrid of a braided sheath and a coiled sheath, which is also a custom-made multi-layer braided coiled sheath having a specific pitch design or braiding angle and twist angle individually adjusted to desired and / or required stiffness characteristics, wherein certain portions of the sheath are braided and certain portions of the sheath are coiled. The braiding and coiling can be changed along its length at various positions along the longitudinal direction where the sheath is required to have higher or lower flexibility, for example, by using stiffer blades / coils and looser blades / coils, or by using denser blades / coils and less dense blades / coils. The angle of the blades / coils with respect to the central long axis 58 can also be changed to adjust flexibility along a certain length of the sheath.

[0129] All of the above examples may have polymer jackets of various durometers reflow-soldered through the blade or coil, depending on whether the sheath is required to have higher or lower flexibility. Varying the thickness of this polymer can also be used to change the properties of the sheath when higher or lower flexibility is required.

[0130] A rigid, molded tip may be reflow soldered, bonded, or overmolded onto a braided sheath in various embodiments.

[0131] Referring here to Figure 13, the inner element 40 comprises an imaging sheath 92 and an inner element hub 98 fixed to the imaging sheath 92, adjacent to one proximal end of the imaging sheath 92. Conversely, Figures 14 and 15 show a molded camera tip 46 fixed to one distal end of the imaging sheath 92 and forming part of the inner element 40, but the camera tip 46 is not shown in Figure 13.

[0132] The inner element hub 98 protrudes laterally from the imaging sheath 92. In this example, the imaging sheath 92 extends through the inner element hub 98, but it would also be possible for the imaging sheath 92 to terminate at or inside the inner element hub 98. The inner element hub 98 is overmolded onto the imaging sheath 92, but it could also be bonded or welded to the imaging sheath 92, and / or form a mated interface around the imaging sheath 92.

[0133] In this example, the inner element hub 98 is roughly cubic, and the imaging sheath 92 is received by a single through-hole 102 centered on the proximal and distal faces of the inner element hub 98, which are parallel to each other. A pair of parallel transverse holes 104, one on each side of the central through-hole 102, extending between the proximal and distal faces, also pass through the inner element hub 98. As shown in Figure 12, and as will be described later, the transverse holes 104 house a pair of steering wires 106 extending proximal from the intermediate element 42 of the delivery tube 36.

[0134] The opposing sides of the medial element hub 98 are generally perpendicular to the proximal and distal surfaces and generally parallel to each other and to the long axis of the imaging sheath 92. One wedge array 108 protrudes laterally from either of the above sides and tapers proximally from one distal shoulder to intersect with the above side.

[0135] A lug 110 is mounted on the proximal surface of the inner element hub 98, protruding perpendicularly from the inner element hub 98 to the long axis of the imaging sheath 92. The lug 110 ensures that the inner element hub 98 is correctly oriented when it is incorporated into the hub assembly 68, so that the wedge array 108 on either of the sides protrudes from the correct side of the hub assembly 68.

[0136] The imaging sheath 92, also shown in Figures 14 and 15, incorporates one perfusion channel and one electronic component channel 114, which are parallel to each other and located in close proximity. Specifically, the perfusion channel is defined by a laterally deviated perfusion tube 112 located within the lumen of the imaging sheath 92, while the electronic component channel 114 is defined by the remaining space within the lumen near the perfusion tube 112. The perfusion tube 112 is fluidly connected to a perfusion port 86 in the handle 34, thereby allowing the perfusion fluid to flow from the proximal end to the distal end of the imaging sheath 92.

[0137] The close sliding contact between the inner element 40 and the intermediate element 42 is desirable for maintaining a seal in order to minimize the ingress of liquid into the distal end of the delivery tube 36 located between the inner element 40 and the intermediate element 42.

[0138] Figure 13 shows that the inner element 40 has a single socket 116 at the distal end of the imaging sheath 92. The camera tip 46 shown in Figures 14 and 15 has a single proximal outer socket 118 that is received by the socket 116. The camera tip 46 further defines a single perfusion outlet 120 that is distally oriented in fluid communication with the perfusion tube 112. For this purpose, the camera tip 46 has a single proximal tubular inner socket 122 that is received at the distal end of the perfusion tube 112. Thus, the perfusion channel extends longitudinally from the perfusion tube 112 through the camera tip 46 from the inner socket 122 to the perfusion outlet 120.

[0139] Inside the camera tip 46, the perfusion channel has a bent shape that deflects the perfusion outlet 120 laterally from the long axis of the perfusion tube 112. As a result, the perfusion outlet 120 is laterally deflected from and located near a single recess that opens distally and houses a single PCB 124, a plurality of light-emitting elements 126 such as LEDs, and a single CMOS imaging chip 128 that is exposed at the distal end of the camera tip 46. The light-emitting elements 126 are located near the imaging chip 128, preferably one on each side of the CMOS chip 128.

[0140] The ratio of the length of the internal space of the camera tip 46 to the lengths of the PCB 124 and the CMOS chip 128 is such that the CMOS chip 128 does not sit inside the camera tip 46 to the extent that the field of view of the CMOS chip 128 might otherwise be limited by the camera tip 46. Therefore, the CMOS chip 128 is preferably located at the distal end of the camera tip 46 or substantially flush with its distal end.

[0141] A single cable 130 extending along an electronic component channel 114 near the perfusion tube 112 transmits power from the power / data port 88 of the housing 62 to the PCB, LEDs, and the imaging chip, and transmits image data from the imaging chip in the reverse direction along the inner element 40 to the power / data port. In this example, the cable 130 is surrounded by a protective sleeve 132 and received by a longitudinal groove externally formed on the wall of the perfusion tube 112.

[0142] Referring again to Figure 12, the intermediate element 42 comprises a steering sheath 94, an inner element hub 100 fixed to one proximal end of the steering sheath 94, and a molded steering tip 134 fixed to one distal end of the steering sheath 94. The steering sheath 94 is positioned on and surrounds the imaging sheath 92, leaving a portion of the imaging sheath 92 that protrudes distally, as defined by the camera tip 46, exposed.

[0143] The intermediate element hub 100 comprises several internally molded tabs 136 that are diametrically opposed to the long axis of the steering sheath 94 and extend radially from the long axis, parallel to the long axis. As described later, these protruding tabs 136 are received by a complementary arrangement of the housing 62 of the handle 34, thereby positioning the intermediate element 42 so as to prevent axial and circumferential movement relative to the handle 34. In addition, several integrally molded sets of projections 138 extend laterally from the opposing sides of the intermediate element hub 100 between the opposing tabs 136. In this example, the intermediate element hub 100 is overmolded onto the steering sheath 94, but it may also be bonded or welded to the steering sheath 94, and / or receive the steering sheath 94 as an interface fit.

[0144] Now, looking at Figures 16 and 17, the intermediate element 42 further comprises a rigid steering tension ring 140 that is circumferentially oriented within the distal end of the steering sheath 94, initially aligned axially with the central long axis 58 of the steering sheath 94. In this example, the steering ring 140 is embedded or housed within the tubular wall of the steering sheath 94 and sandwiched between the inner and outer layers of the steering sheath 94. The steering tip 134 receives, surrounds, and engages with the steering ring 140 within a socket 142 formed within a proximal portion of the steering tip 134 by being overmolded or bonded onto the distal end portion of the steering sheath 94.

[0145] The steering ring 140 and the steering tip 134 are located at the interface between the imaging sheath 92 and the steering sheath 94, facilitating longitudinal movement of the imaging sheath 92 relative to the steering sheath 94. In detail, the imaging sheath 92 slides longitudinally within and relative to a single implant holder defined by the steering sheath 94, the steering ring 140, and the steering tip 134.

[0146] The pair of steering wires 106 acting on opposing sides of the steering ring 140 extend proximal along the steering sheath 94, maintaining a parallel relationship with respect to the central long axis 58. The steering wires 106, like the steering ring 140, are embedded in the tubular wall of the steering sheath 94 (for example, embedded together with or through one of the braided structures of the wall). The steering wires 106 extend proximal from the steering ring 140 along the steering sheath 94 and through the intermediate element hub 100, where they are crimped to the corresponding wires of the steering system 72 and protrude proximal from there. As described above, the steering wires 106 extend through the parallel transverse holes 104 of the inner element hub 98 when the intermediate element hub 100 and the inner element hub 98 are joined within the hub assembly 68.

[0147] When the steering system 72 selectively applies greater tension to one of the steering wires 106 during the use of device 32, this tension pulls the corresponding side of the steering ring 140, causing the steering ring 140 to tilt away from its axial alignment with the central long axis 58. The steering tip 134 also tilts together with the steering ring 140 due to its engagement with the steering ring 140 at its socket 142.

[0148] As a result, the steering sheath 94 curves along its length toward the steering wire 106 which is under greater tension, similarly forcing the outer sheath 90 and imaging sheath 92 of the delivery tube 36 to curve along their respective lengths. These concentric elements of the delivery tube 36 curve together preferentially at a certain position distal to the steering sheath 94 in the longitudinal direction, very close to the steering ring 140. The inner ring of the curve corresponds to the steering wire 106 which is under greater tension, and the outer ring of the curve corresponds to the steering wire 106 which is under less tension or no tension at all.

[0149] The steering tip 134 functions as a holder for implants such as the expander 10 during use. For this purpose, the steering tip 134 has a stepped profile in the longitudinal direction such that its distal portion 144 is narrower than its proximal portion 146. One radially outer side of the distal portion 144 defines a cylindrical support surface of a smaller diameter, while one radially outer side of the proximal portion 146 defines a cylindrical seating surface of a larger diameter. More specifically, the proximal portion 146 of the steering tip 134 is radially larger in size relative to the diameter of the steering sheath 94, and therefore the seating surface is raised above the steering sheath 94. It is desirable that the steering sheath 94 does not become wider than the proximal portion 146 of the steering tip 134 in order to facilitate the nesting insertion of the intermediate element 42 into the outer element 38 during the assembly of the delivery tube 36. In this example, the proximal portion 146 of the steering tip 134 has a chamfered proximal edge to facilitate assembly.

[0150] The concentric sheaths of the delivery tube 36 can slide past each other with minimal frictional resistance, while the proximal portion 146 of the steering tip 134 can selectively facilitate relative sliding movement of the outer sheath 90 with the steering sheath 94.

[0151] More specifically, referring to Figure 17, the distal portion 144 of the steering tip 134 defining the support surface is integral with the proximal portion 146 of the steering tip 134 and comprises a support tube that extends distally beyond the steering sheath 94, having a smaller outer diameter than the proximal portion 146. A single circumferential step 148 causes a sharp decrease in the outer diameter of the steering tip 134 from the proximal portion 146 to the distal portion 144. The step 148 corresponds to a single circumferential shoulder between the proximal portion 146 and the distal portion 144, which lies in a plane substantially perpendicular to the long axis of the steering sheath 94.

[0152] In some embodiments, one or more diagonally spaced implant retainer arrays (e.g., implant retainer arrays), exemplified herein by retainer lug 150, project radially from the distal portion 144 of the steering tip 134. In various embodiments, one, two, three, four, five, or more implant retainer arrays, such as lug 150, are provided. The height or radial projection of retainer lug 150 is equal to or slightly less than the height of step 148, defined by the extent of the shoulder portion beyond the distal portion 144. Conversely, the wire diameter of expander 10 is slightly less than the height of step 148. Expander 10 extends from a proximal end where it is supported by the distal portion 144 of the steering tip 134 to a distal end where it is supported by the camera tip 46 of the imaging sheath 92 in deployment stage 0 (zero). The retaining lugs 150 fix the expander 10 so as to prevent axial and circumferential movement relative to the steering sheath 94.

[0153] In one embodiment, for example, there are two retaining lugs 150, both deviating to one side of the central long axis 58 of the steering sheath 94 and spaced circumferentially apart from each other. The pair of lugs 150 are spaced apart by a smaller sector spanning an arc of about 120° toward one side of the steering tip 134 and a larger sector spanning an arc of about 240° toward the other side of the steering tip 134. The third proximal apex of the expander 10 is housed between the larger of the two lugs 150.

[0154] The retaining lugs 150 are spaced distally from the shoulder defined by the step 148 of the steering tip 134, defining a number of slots or gaps 152 between the lugs 150 and the shoulder. These gaps 152 receive each proximal apex 16 of the expander 10 supported by the device 32 when one expander 10 is in contact with and fixed to the support surface of the distal portion 144 by the outer sheath 90. Therefore, the wire diameter of the expander 10 is slightly less than the length of the gaps 152 between the lugs 150 and the step 148. Thus, the shoulder defined by the step 148 functions as another proximal retaining array cooperating with the retaining lugs 150, fixing the proximal apex 16 of the expander 10 between the shoulder and each lug 150 so as not to move axially relative to the steering tip 134.

[0155] The retaining lugs 150 are also received between the struts 18 of the expander 10, which converge at each proximal apex 14. Thus, the retaining lugs 150 position the expander 10 so as not to move circumferentially or obliquely relative to the steering tip 134.

[0156] The shoulder portion defined by the retaining lug 150 and the step 148 positions the expander 10 so as to prevent axial and oblique movement relative to the handle 34, except to the extent that the distal end of the steering sheath 94, and therefore the steering tip portion 134 and the expander 10, can be deflected relative to the handle 34 by the operation of the steering system 72.

[0157] Internally, as shown in Figure 16, the steering tip 134 has a circumferential shoulder 154 that results in a stepwise change in the diameter of the longitudinal lumen of the steering tip 134, from a wider proximal portion 146 to a narrower distal portion 144. The inner diameter of the distal portion 144 is a sliding fit with the imaging sheath 92 which slides longitudinally relative to the distal portion 144 within the distal portion 144.

[0158] The proximal portion 146 of the steering tip 134 accommodates the steering ring 140 as a single interface fit. The steering ring 140 may be further, or alternatively, fixed within the steering tip 134 by some polymer-appropriate bonding or welding process, such as reflow soldering or overmolding. Adhesives and curing may also be used. The distal end of the steering ring 140 faces or abuts an internal shoulder 154 oriented in the proximal direction.

[0159] Therefore, this example has a single implant fixation and steering function, in which the steering tip 134 not only fixes the expander 10 but can also steer the expander 10, and thus the sheath supporting the expander 10 can also be steered. In this respect, it is advantageous to steer from behind the expander 10, that is, from a position proximal to the expander 10, to guide the expander 10 forward through the anatomical structure to the deployment site.

[0160] Therefore, the steering sheath 94, to which the steering ring 140 and steering tip 134 are attached, is adjacent to the expander 10 and provides multiple fixing functions for fixing and oriented the expander 10, one steering mechanism acting on one flexible steering section, and one flexible proximal section for following the entire penile canal. Together with the imaging sheath 92 and the outer sheath 90, the structure of the steering sheath 94 must also achieve sufficient tensile and axial strength for unfolding and refolding the expander 10, and for allowing the expander 10 to flex throughout all stages of deployment. The structure of the steering sheath 94 must also achieve sufficient torsional strength to orient the expander 10 obliquely with respect to its central long axis 58 in response to the user's corresponding angle operation of the handle 34.

[0161] Referring again to Figure 12, the outer element 38 comprises a tubular outer sheath 90 and an outer element hub 96 that rests on the outer sheath 90 at or near its proximal end. The outer sheath 90 comprises a distal end portion that can be coiled rather than braided to improve the retention of the expander 10 and to adapt to deflection during steering, and a proximal portion that is flexible to facilitate the movement of the delivery tube 36, including various steering operations of the delivery tube 36, driven by the deflection of the steering sheath 94 located within the outer sheath 90. The outer sheath 90 also has a series of graduated and numbered external markings 156 along its proximal portion as an indicator of the depth of insertion of the delivery tube 36 into the penile urethra.

[0162] As is best seen in Figure 18, the outer element hub 96 comprises a single tubular body 158 having a circular cross-section, concentric with the outer sheath 90. In this example, the outer element hub 96 is overmolded onto the outer sheath 90. In several other examples, the outer sheath 90 may extend within the outer element hub 96 as a single interface fitting, or, instead or additionally, may be bonded or welded to the outer element hub 96.

[0163] Multiple integrally molded positioning arrays protrude from the body 158 of the outer element hub 96, i.e., from a proximal flange 160 surrounding the body 158 and in a plane perpendicular to the central long axis 58 on which the outer sheath 90 is located, and from an elongated, radially projecting lug 162 extending in the plane including the axis 58. These positioning arrays 160, 162 are received in each complementary array at one distal end of one hub casing 164 of the hub assembly 68, positioning the outer element 38 so as to prevent axial and circumferential movement relative to the hub assembly 68. In some embodiments, one hub casing 164 functions as one hub trolley. In some embodiments, one hub casing 164 is one hub trolley.

[0164] Therefore, moving to Figures 19a and 19b, the hub casing 164 of the hub assembly 68 is a single elongated hollow enclosure extending along the central long axis 58 of the housing 62 of the handle 34, aligned with the corresponding axis of the delivery tube 36. The hub casing 164 comprises a generally cubic body 166 and a single, integrated, open-ended, tubular extension 168 extending distally from the body 166, the center of which the tubular extension 168 lies on the central long axis 58 and communicates with the interior of the body 166.

[0165] The hub casing 164 is divided into two casing portions along a central longitudinal plane that bisects the tubular extension 168 and a pair of opposing sides of the cubic body 166. The casing portions are joined and fixed together with respect to their planar interface. In this example, the casing portions are fixed at the joint between the body 166 and the tubular extension 168 of the hub casing 164 by screws 170, one on each side of the central long axis 58.

[0166] In this assembled state, the hub casing 164 receives, surrounds, and holds the hubs 96, 98, and 100 of the outer element 38, intermediate element 42, and inner element 40 of the delivery tube 36. As a result, the outer element hub 96, intermediate element hub 100, and inner element hub 98 are arranged in close proximity within the hub casing 164. The hub casing 164 supports the outer element hub 96 at one distal end and the inner element hub 98 at one proximal end, and has a longitudinally extending intermediate portion that connects the distal and proximal ends and bridges the intermediate element hub 100.

[0167] The tubular extension 168 of the hub casing 164 defines an internal channel having a circular cross-section, which is a tight fit around the body 158 of the outer element hub 96. Screws 170 that fasten the casing portion together may help to tighten the outer element hub 96 between the distal ends of the casing portion defining the tubular extension 168.

[0168] The tubular extension 168 of the hub casing 164 also has a plurality of integrated positioning arrays that complement the external positioning array of the outer element hub 96. Specifically, the flange 160 of the outer element hub 96 is received in one circumferential groove within the tubular extension 168, preventing axial movement of the outer element 38 relative to the hub casing 164. Thus, the outer element 38 of the delivery tube 36 is forced to move longitudinally relative to the housing 62 of the handle 34 together with the hub casing 164. Similarly, the rub 162 of the outer element hub 96 is received in one longitudinal slot within the tubular extension, locking the outer element 38 so as to prevent oblique movement relative to the hub casing 164 with respect to the central long axis 58.

[0169] Referring here to Figure 20, the outer element 38 and inner element 40 of the delivery tube 36 can move axially relative to both the intermediate element 42 and the handle 34, as previously described. For this purpose, the hub casing 164 can reciprocate within the housing 62 and relative to it, along the central long axis 58, over a certain range of strokes. The hub casing 164 is supported between longitudinally extending parallel rail arrays 172 integrally molded within the inner surface of each shell 64 of the housing 62, and can slide along the rail arrays 172. Thus, the hub casing 164 functions as a single carriage for the outer element hub 96 and the inner element hub 98, transporting the hubs 96, 98 for movement along a longitudinally extending retraction path within the housing 62, parallel to the central long axis 58.

[0170] Conversely, as mentioned earlier, the intermediate element 42 of the delivery tube 36 is fixed in such a way that it does not move axially relative to the handle 34. Therefore, the hub casing 164 is equipped to move longitudinally around and relative to the intermediate element hub 100 housed within its main body 166. For this purpose, the opposing edges of the casing portions are cut off at their planar interface to define opposing longitudinal slots 174 when the casing portions are assembled together. Each slot 174 has one closed distal end and one open proximal end.

[0171] Referring to Figure 20, the slot 174 accommodates diametrically opposed tabs 136 that extend laterally from the intermediate element hub 100, passing through the aforementioned pair of sides of the body of the hub casing 164. These tabs 136 protrude from the hub casing 164 through the slot 174 and engage within each socket array 176 integrally molded within the inner surface of each shell 64 of the housing 62. In this way, the intermediate element hub 100 is locked to prevent axial or oblique movement relative to the housing 62, while the slot 174 provides clearance around the tabs 136 for the hub casing 164, as well as the outer element hubs 96 and inner element hubs 98, to move longitudinally relative to the intermediate element hub 100. The hub casing 164 slides over the aforementioned projections 138 of the intermediate element hub 100, which are positioned between the opposing tabs 136, maintaining lateral alignment between the hub casing 164 and the intermediate element hub 100.

[0172] Returning to Figure 19a, the cubic body 166 of the hub casing 164 has another side 178 positioned between the pair of slotted side surfaces described above. Multiple slits in a C-shaped arrangement pass through this other side 178, defining elastically flexible tongues 180,182 formed integrally with the body. One of the tongues 180 is located at one distal point on the side 178, and the other of the tongues 182 is located at one proximal point on the side 178.

[0173] The distal tongue 180 has a single integrated flange 184 at the distal free end of the tongue 180, which protrudes outward from the outer peripheral side 178 of the body 166. As shown in Figure 21a, the flange 184 snaps into place within a complementary inward-facing groove 186 in an adjacent rail arrangement of the housing 62, which guides the longitudinal movement of the hub casing 164 relative to the handle 34. The engagement between the flange and the groove latches the hub casing 164 so as not to cause the longitudinal movement. This is to prevent accidental retraction of the outer element 38 of the delivery tube 36 until the user applies sufficient force to the deployment trigger 48 to intentionally achieve the transition of the device 32 from deployment stage 0 (zero) to deployment stage 1, and thus to prevent the transition. In that case, as shown in Figure 21b, the distal tongue 180 flexes inward, disengaging the flange 184 from the groove 186, thereby freeing the hub casing 164 for movement relative to the housing 62.

[0174] Referring again to Figure 19a, the proximal tongue 182 is flush with the outer peripheral side 178 of the body 166, but the transverse slit 188 at its proximal free end is widened to receive and engage with the aforementioned wedge array 108 on one side of the inner element hub 98. Initially, this engagement fixes the inner element hub 98 to the proximal end of the hub casing 164. Referring to Figures 21a-21c, in this way the inner element hub 98 is forced to move together with the hub casing 164 and the outer element hub 96, respectively, as the device 32 transitions from deployment phase 0 (zero) to deployment phase 1. Similarly, the inner element hub 98 is forced to move together with the hub casing 164 and the outer element hub 96, respectively, as the device 32 returns from deployment phase 1 to deployment phase 0.

[0175] Unlike the outer element hub 96, the inner element hub 98 is not fixed to the outer hub casing 164, but rather can move relative to the hub casing 164 within a finite longitudinal range. Referring to Figure 21d, this allows the movement of the outer element hub 96, and therefore the movement of the outer sheath 90, to be isolated from the movement of the inner element hub 98, and therefore from the movement of the imaging sheath 92, when the device 32 transitions from deployment stage 1 to deployment stage 2.

[0176] Therefore, as shown in Figures 21a-21c, the inner element hub 98 moves proximal to deployment stage 1 from deployment stage 0 together with the hub casing 164. Then, as shown in Figure 21d, the uninterrupted proximal movement of the inner element hub 98 stops, but the hub casing 164 moves further proximal to deployment stage 2, independently of and relative to the inner element hub 98. The outward deflection of the proximal tongue 182, which allows the inner element hub 98 to pass through the wedge array 108, releases the inner element hub 98 and enables the relative movement of the hub casing 164. The proximal tongue 182 then elastically returns inward as the hub casing 164 moves proximal to the inner element hub 98, and slides smoothly down the slope of the wedge array 108.

[0177] The inner element hub 98 is decoupled from the hub casing 164 by using a single barrier that prevents proximal movement of the inner element hub 98 but allows the hub casing 164 to continue its proximal movement relative to the housing 62. Specifically, as shown in Figures 21c and 21d, the proximal movement of the inner element hub 98 is prevented by facing a single integrally molded stop array 190 of the housing 62. The stop array 190 is aligned with a longitudinal slot 174 that opens proximal to the hub casing 164, so that the proximal movement of the hub casing 164 is received by that slot 174 as it continues.

[0178] As will be explained below with reference to Figures 22a to 22d, the deployment system 70 drives the longitudinal movement of the hub casing 164 via a single integrated rack extension 192 (such as an arm) that cantilevered out from the proximal end of the main body 166. Conversely, as shown in Figures 19a and 19b, the rack extension 192 is integrally molded with either of the casing portions. The rack extension 192 is deviated laterally from the central long axis 58 of the housing 62, otherwise it would extend approximately parallel to the central long axis 58. An integrally molded rack array 194 having a series of transverse teeth extends along one surface of the rack extension 192 facing the central long axis 58.

[0179] Figures 22a and 22d show that the deployment system 70 comprises a single power transmission gear train 196 that receives a drive input from the linear motion of the deployment trigger 48 along the trigger axis 78 and, depending on the embodiment, delivers a corresponding drive output to a rack extension 192 of the hub casing 164. In one embodiment, the single gear train is a pair of gears. The rack extension 192 converts the rotational motion of the gear train 196 into the linear motion of the hub casing 164, which faithfully follows the linear motion of the deployment trigger 48 but traverses the trigger axis 78 in the longitudinal direction.

[0180] The gear train 196 comprises a single input gear 198 meshed with a single rack 200 that extends parallel to the trigger shaft 78 from the deployment trigger 48. The input gear 198 meshes with a single output gear 202 that meshes with a rack extension 192 of the hub casing 164. The reversal of the drive direction thus achieved via the gear train 196 ensures that the hub casing 164 moves proximally within the handle 34 by pressing the deployment trigger 48 along the trigger shaft 78 when the device 32 transitions from deployment stage 0 (zero) to deployment stages 1 and 2.

[0181] When the user decides to reverse the device 32 from deployment stage 1 to the previous deployment stage 0, the hub casing 164 moves distally within the handle 34 simply by the user pulling out or retracting the deployment trigger 48 from the housing 62 of the handle 34. For this purpose, there are multiple recesses 204 on opposing sides of the outer portion of the deployment trigger 48 to assist the user in grasping the deployment trigger 48 between their thumb and index finger.

[0182] The overall gear ratio of the gear train 196 was selected for mechanical advantages, allowing a user who easily operates the deployment trigger 48 to move the hub casing 164 acting on the outer element 38 and inner element 40 of the delivery tube 36. Sensitivity is also a reason for the selection of the gear ratio, as a small movement of the deployment trigger 48 along the trigger axis 78 results in a large movement of the hub casing 164 in response. This reflects the desire for the device 32 to transition quickly and forward from one deployment stage to another, and therefore, the desire that the hub casing 164 not remain in any intermediate position for any considerable period of time during the transition between deployment stages. The above detent provides protection against accidental operation of the device 32 despite having intentional sensitivity to the movement of the deployment trigger 48.

[0183] Inside the housing 62, as shown in Figures 23a to 23d, the deployment trigger 48, which functions as a deployment control element, comprises a single integrated trigger ramp 204 facing the detent axis 80. The trigger ramp 204 extends into the housing 62 parallel to the trigger axis 78, tapering inward in one direction from the detent axis 80. At one inward end of the trigger ramp 204, a base platform 206 faces the detent axis 80, while at the outward end of the trigger ramp 204, an inward shoulder portion 208 extends toward the detent axis 80.

[0184] The detent button 60, which functions as a detent release element, has on its inward-facing side a single integrated follower engagement array, namely a projection 210 that tapers in one inward direction and extends into the housing 62 parallel to the detent axis 80. The taper of the projection 210 defines a detent lamp 212 that faces away from the trigger axis 78.

[0185] The housing 62 comprises a follower 214 that acts upon and is affected by the deployment trigger 48 and the detent button 60. The follower 214 is deflected toward a single integrated spring 216 that acts in a compressed state between the follower 214 and an adjacent outer wall of the housing 62. The spring 216 sequentially presses the follower 214 against the trigger ramp 204 and the detent ramp 212, so that the ramps 204 and 212 sequentially act on the follower 214 using a certain cam action when the deployment trigger 48 and the detent button 60 are sequentially pressed inward according to one embodiment.

[0186] The follower 214 has one trigger bearing end 218 positioned to press against the trigger ramp 204 and one detent bearing end 220 positioned to press against the detent ramp 212. Specifically, the trigger bearing end 218 is at the free end of the follower 214 closest to the trigger shaft 78, while the detent bearing end 220 is closer to a spring 216 defined in this example by one inner edge of a window 222 that penetrates the follower 214. More specifically, the detent bearing end 220 is on one transverse barrier member 224 of the follower defined in this example by one inner side of a frame around the window 222, and is adjacent to the spring 216 of the follower 214. The window 222 is wide enough to accommodate the projection 210 inside the detent button 60.

[0187] Due to the interaction between the trigger ramp 204 and the trigger bearing end 218, and the interaction between the detent ramp 212 and the detent bearing end 220, the follower 214 can adopt one of three positions determined by the positions of the deployment trigger 48 and the detent button 60. Specifically, the follower 214 adopts one detent stop position when the deployment trigger 48 is in an outward position corresponding to deployment stage 0 (zero), as shown in Figure 23a; one deployment stop or trigger stop position when the deployment trigger 48 is pressed to an intermediate position corresponding to deployment stage 1, as shown in Figure 23b; and one deployment release or trigger release position when the detent button 60 is pressed in deployment stage 1, as shown in Figure 23c. This allows for further inward movement of the deployment trigger 48 to a fully inward position corresponding to deployment stage 2, as shown in Figure 23d. The movement of the follower 214 from the detent stop position to the intermediate trigger stop position, and from there to the deployment release position, all occur against the deflection of the spring 216.

[0188] Therefore, the inward movement of the deployment trigger 48 to deployment stage 1, which transitions device 32 to deployment stage 1, moves the follower 214 to the trigger stop position shown in Figure 23a, where further inward movement of the deployment trigger 48 is prevented, but inward movement of the detent button 60 is permitted. Thus, the trigger stop position can also be considered as a detent release position. The inward movement of the detent button 60 then moves the follower 214 to the trigger release position, which allows further inward movement of the deployment trigger 48, which transitions device 32 from deployment stage 1 to deployment stage 2.

[0189] Specifically, when the deployment trigger 48 is in an outward position corresponding to deployment stage 0 (zero), the trigger bearing end 218 of the follower 214 leans against the base platform 206 at the inward end of the trigger ramp 204, as shown in Figure 23a. Then, the barrier member 224 of the follower 214 aligns with the projection 210 of the detent button 60, preventing the inward movement of the detent button 60.

[0190] As shown in Figure 23b, when the deployment trigger 48 is pushed inward toward a certain inward position corresponding to deployment stage 1, the trigger ramp 204 slides past the trigger bearing end 218 of the follower 214, thereby forcing the follower 214 away from the trigger shaft 78 against the deflection of the spring 216. The inward movement of the deployment trigger 48 continues until the follower 214 faces the shoulder portion 208 at the outward end of the trigger ramp 204 at a certain position of the deployment trigger 48 corresponding to deployment stage 1. The interaction between the follower 214 and the shoulder portion 208 initially prevents further inward movement of the deployment trigger 48 beyond deployment stage 1.

[0191] As the follower 214 moves away from the trigger shaft 78 under the action of the trigger ramp 204, the barrier member 224 of the follower 214 moves out of alignment with the protrusion 210 of the detent button 60, while the window 222 of the follower 214 aligns with the protrusion 210 of the detent button 60. This allows the detent button 60 to move inward when the protrusion 210 is received by the window 222.

[0192] As the projection 210 of the detent button 60 enters the window 222 of the follower 214, the detent lamp 212 contacts the detent bearing end 220 on the transverse barrier member 224 that defines the inner edge of the window 222. The continuous inward movement of the detent button 60 causes the detent lamp 212 to slide past the detent bearing end 220, and thus forces the follower 214 further away from the trigger shaft 78 against the deflection of the spring 216. This further movement of the follower 214 releases the follower 214 from the shoulder 208 at the outward end of the trigger ramp 204, and thus the deployment trigger 48 can move further inward beyond deployment stage 1 to deployment stage 2.

[0193] If the movement of the deployment trigger 48 is reversed to return the device 32 from deployment stage 1 to deployment stage 0 (zero), the follower 214 returns to its initial position, in which position the trigger bearing end 218 of the follower 214 leans against the base platform 206 at the inward end of the trigger ramp 204. The barrier member 224 of the follower 214 then realigns with the projection 210 of the detent button 60, preventing the inward movement of the detent button 60.

[0194] Therefore, the detent button 60 is activated by the movement of the deployment trigger 48 from deployment stage 0 (zero) to deployment stage 1, thereby enabling the deployment trigger 48 to move to deployment stage 2. The inward movement of the deployment trigger 48 to transition device 32 to deployment stage 1 causes the follower 214 to move against the deflection of the spring 216. This movement enables the inward movement of the detent button 60. The inward movement of the detent button 60 enables further inward movement of the deployment trigger 48 to transition device 32 from deployment stage 1 to deployment stage 2.

[0195] Finally, referring to Figures 24a and 24b, the steering lever 44 of the steering system 72 acts on a single steering dial 226 that pivots around a pivot axis 82 within the housing 62. Multiple steering wires (not shown) extend distally from opposite sides of the steering dial 226 and are crimped to corresponding steering wires 106 that extend proximal from the intermediate element hub 100. When the steering dial 226, which is subjected to an oblique force applied via the steering lever 44, is pivoted, tension is selectively applied to the steering wires 106, resulting in the deflection of the steering sheath 94 of the delivery tube 36, as described above.

[0196] The steering lever 44 has a single integrated yoke 228 at its inward-facing end within the housing 62 that surrounds the pivot axis 82 of the steering lever 44. The aforementioned lock axis 84, which is one of the long axes of the steering lever 44, extends along a radius that intersects with the pivot axis 82.

[0197] The yoke 228 surrounds and engages with one complementary hub socket 230 of the steering dial 226. Although the yoke 228 is relatively large compared to the hub socket 230 parallel to the lock shaft 84, the multiple hub sockets 230 traversing the shaft 84 form a single sliding tight fit within the yoke 228. Specifically, the parallel sides of the hub socket 230 press against the opposing sides of the yoke 228, locking the yoke 228 so as not to move diagonally relative to the hub socket 230. As a result, the dial 226 pivots around the pivot shaft 82 due to torque transmitted from the diagonal movement of the lever 44, for example, when the lever 44 is operated by the user's thumb. Conversely, the yoke 228 can reciprocate within a limited range in the direction parallel to the lock shaft 84. In that case, the side of the hub insertion opening 230 slides inside the opposing side of the yoke 228.

[0198] A single spring 232 surrounds a lock shaft 84 located one axis outside the pivot shaft 82 and, when compressed between the yoke 228 and the hub socket 230, acts to deflect the steering lever 44 outward along the lock shaft 84. Thus, the user's thumb can push the steering lever 44 inward into the translating housing 62 against the deflection of the spring 232, thereby releasing the latch for diagonal movement of the steering lever 44. When the inward pressure from the thumb is released, the deflection of the spring 232 returns the steering lever 44 to an outward position, where it latches to prevent accidental diagonal movement.

[0199] For latching the steering lever 44, the yoke 228 comprises multiple latch arrays facing outward along the lock shaft 84. These latch arrays are exemplified here by a convex array of multiple teeth 234, opposite a complementary concave array of multiple teeth 236 facing inward from one inner surface of the housing 62.

[0200] Each of the multiple tooth arrays 234, 236 is curved along its respective length with a substantially constant radius of curvature around the pivot axis 82. The teeth of arrays 234, 236 are spaced apart along the length of arrays 234, 236, and are therefore spaced obliquely with respect to the pivot axis 82. In this example, the teeth are oriented perpendicular to the respective lengths of arrays 234, 236. Remarkably, as shown here, the concave curved array 236 of teeth, which faces inward from the housing 62, is integrally molded with one or both of the shells 64 of the housing 62, having the corresponding curvature with respect to the pivot axis 82.

[0201] When the steering lever 44 is released, the deflection of the spring 232 drives the latch array of the yoke 228 outward along with the yoke 228, thereby engaging with the teeth of the inwardly facing array 236 corresponding to the oblique position of the steering lever 44. This latches the steering lever 44 at the desired oblique position. Conversely, when the steering lever 44 is pushed against the deflection of the spring 232, the latch array is released from the teeth of the inwardly facing array 236, unlatching the steering lever 44 for oblique movement.

[0202] Within the scope of the present invention, numerous other variations are conceivable. For example, the device may comprise an onboard power supply, imaging may be achieved by a non-digital imaging system other than the chip, such as transmitting images along a single optical fiber bundle, and the stiffness of the imaging sheath can be individually adjusted so that its stiffness varies along the length of the sheath—for example, using individually adjusted braids including various densities, pitches, angles, and / or thicknesses, as well as braids or coiled elements of polymer durometers—to provide stable support to the implant and even allow for easy movement within the flexible steering sheath.

[0203] In the example shown, the implant fixation function is a molded steering tip component that houses the steering ring as a separate component. However, in another embodiment, the implant fixation function and a tension ring or other steering arrangement may instead be integrated into a single component.

[0204] The ramp array of the deployment trigger and the detent button described above may be disposed on the follower, either instead or in addition.

[0205] Multiple modifications and partial modifications of the embodiments described herein can be implemented without deviation from the principles of this disclosure. Each of the embodiments and examples disclosed herein can be considered individually or in combination with other embodiments, examples, and variations of this disclosure.

[0206] The methods, devices, and systems described herein may be subject to various partial modifications and alternative forms, specific examples of which are shown in the drawings and described in detail herein. Embodiments are not limited to any particular form or method disclosed, but rather are intended to encompass partial modifications, equivalents, and alternatives that fall within the spirit and scope of the various examples and embodiments described herein and / or in the claims. Furthermore, any particular function, aspect, method, characteristic, feature, property, attribute, element, etc., disclosed herein relating to one example can be used in all other examples and embodiments described herein. In addition, unless otherwise stated, no steps of the methods disclosed herein are limited in any particular order of implementation. No method disclosed herein is required to be performed in the order described herein. Sequential or chronological expressions such as “next,” “then,” “after,” and “subsequently” are generally intended to facilitate the flow of text and not to restrict the order in which operations are performed, unless otherwise stated or interpreted differently in the context in which they are used. Thus, some examples may be performed using the order of operations described herein, while others may be performed according to a different order of operations.

[0207] The conditional expressions used herein, particularly those such as “can,” “may,” “may,” and “etc.,” are generally intended to convey that there are examples that include certain functions, elements, and / or states, while there are examples that do not, unless otherwise stated or interpreted differently in the context in which they are used. Therefore, the conditional expressions above are not intended to imply that several functions, elements, compartments, and / or states are required for one or more examples, or that one or more examples necessarily include logic for determining, with or without input or prompting from the author, whether the above functions, elements, and / or states are included in any particular example or should be implemented in that example. If some devices or methods “possess” or “include” a particular function or stage (these two non-restrictive terms are interchangeable), then such devices or methods may be such insofar as they are explicitly stated in the claim as “essentially” “composed of” or “consisting of” the above function or stage.

[0208] The methods disclosed herein may include certain actions taken by a practitioner. However, these methods may also include, explicitly or implicitly, instructions for such actions by any user or third party. For example, an action such as "positioning a device" includes "instructing the positioning of a device."

[0209] The scope disclosed herein includes all overlaps, sub-scopes, and combinations thereof. Expressions such as “maximum,” “at least,” “greater than,” “less than,” and “between” include the stated numerical values. Numerical values ​​preceded by terms such as “about” and “approximately” include the stated numerical values ​​and should be interpreted as appropriate to the context (e.g., ±5%, ±10%, ±15%, etc., as precisely as reasonable under the circumstances). For example, “about 4 mm” includes “4 mm.” Phrases preceded by terms such as “substantially” include the stated phrase and should be interpreted as appropriate to the context (e.g., to the maximum reasonably reasonable under the circumstances). For example, the phrase “substantially linear” includes “linear.” Unless otherwise stated, all measurements are under standard conditions such as temperature and pressure. The phrase “at least one of” is intended to require at least one item from the following list, rather than requiring one of each item from the following list. For example, "at least one of A, B, and C" could include A;B;C;A and B:A and C;B and C; or A, B, and C.

Claims

1. A device for deploying an implant inside a patient's body, wherein the device is A single elongated delivery tube having multiple concentric delivery tube elements, wherein the delivery tube elements are arranged radially outward and include one inner element having one imaging head, one intermediate element having multiple implant retainer arrays, and one outer element having one outer sheath capable of cooperating with the implant retainer arrays, wherein the inner element and the outer element are retractable relative to the intermediate element along one long axis of the delivery tube, A handle located at one proximal end of the delivery tube, wherein the handle is A housing has a hub assembly comprising one inner element hub, one intermediate element hub, and one outer element hub, each of which has a handle mounted proximally to each of the delivery tube elements, A hub carriage that is longitudinally movable relative to the housing and the intermediate element hub, the hub carriage supporting the inner element hub and the outer element hub so as to move the inner element and the outer element backward relative to the intermediate element of the delivery tube by the movement using the hub carriage, A device comprising: a deployment drive device configured to drive the movement of the hub trolley in response to the operation of a deployment control element located outside the housing.

2. The device according to claim 1, characterized in that the hub carriage can move proximal to the housing and the intermediate element hub along a longitudinally extending retraction path, by the deployment drive device, from an undeployed position where the outer sheath faces the implant retainer array and is advanced distally to the implant retainer array, through an intermediate partially deployed position where the outer elements are retracted proximal to the position where they remain facing the implant retainer array and are advanced distally, to a fully deployed position where the outer sheath is retracted proximal to the implant retainer array.

3. The device according to claim 2, characterized in that the outer element hub and the inner element hub can move proximally from the undeployed position to the partially deployed position together with the hub trolley.

4. The device according to claim 3, characterized in that the outer element hub and the inner element hub can be reversed distally along the retraction path from the partially deployed position to the undeployed position together with the hub trolley.

5. The device according to claim 3 or 4, characterized in that the outer element hub can move proximal to the inner element hub together with the hub trolley when the hub trolley moves from the partially deployed position to the fully deployed position.

6. The device according to claim 5, characterized in that the outer element hub is fixed relative to the hub trolley, and the inner element hub is releasably latched to the hub trolley.

7. The device according to claim 6, further comprising a stop array positioned in the retraction path, proximal to the inner element hub, which is fixedly connected to the housing and prevents the proximal movement of the inner element hub beyond the partially deployed position of the hub trolley, thereby causing the inner element hub to dislodge from the hub trolley, and enabling uninterrupted proximal movement of the hub trolley and the outer element hub from the partially deployed position to the fully deployed position.

8. The device according to any one of claims 2 to 7, characterized in that the hub trolley is latched to the housing in a releasable manner when it is in the undeployed position, and the latching can be released by operating the deployment control element.

9. The device according to any one of claims 2 to 8, characterized in that the deployment drive device includes one detent mechanism configured to prevent the hub trolley from moving from the partially deployed position to the fully deployed position, and one detent release element that is operable to release the detent mechanism so that the hub trolley can move from the partially deployed position to the fully deployed position.

10. The device according to claim 9, characterized in that the detent release element can release the detent mechanism by moving the deployment control element, which acts on the deployment drive device to move the hub trolley from the undeployed position to the partially deployed position.

11. The device according to claim 10, characterized in that the deployment control element can prevent the movement of the detent release element when the hub trolley is in the undeployed position.

12. The device according to any one of the prior claims, characterized in that the outer element hub, the intermediate element hub, and the inner element hub are arranged in close proximity along the hub trolley.

13. The device according to any one of the prior claims, characterized in that the hub carriage includes one distal portion that supports the outer element hub, one proximal portion that supports the inner element hub, and one longitudinally extending intermediate portion that connects the distal portion and the proximal portion and bridges the intermediate element hub.

14. The device according to any one of the prior claims, characterized in that the intermediate element hub is sandwiched between the outer element hub and the inner element hub and is at least partially housed within the hub carriage.

15. The device according to any one of the prior claims, wherein the intermediate element hub has at least one support extending laterally beyond the hub trolley to fix the intermediate element hub so as to prevent it from moving relative to the housing.

16. The device according to claim 15, characterized in that one side wall of the hub trolley has a longitudinally extending slot for accommodating the laterally extending support of the intermediate element hub, in order to allow movement of the hub trolley relative to the intermediate element hub.

17. The device according to claim 16, characterized in that the longitudinally extending slot has a single open distal end.

18. The device according to any one of the prior claims, characterized in that the deployment drive device comprises a pair of gears that operate between the deployment control element and the hub trolley.

19. The device according to claim 18, characterized in that the hub trolley comprises a longitudinally extending rack array that engages with one of the gears of the deployment drive gear pair.

20. The device according to claim 19, characterized in that the rack array is located on a single arm extending proximal to the hub trolley.

21. The device according to claim 20, characterized in that the arm is deviated laterally from a central long axis extending proximal from the delivery tube into the housing, and the rack arrangement faces the axis.

22. An implant deployment device having a plurality of concentrically arranged elongated delivery tube elements extending from a single housing, wherein the elements are arranged radially outward to form a single inner element comprising a single imaging head, a single intermediate element comprising a plurality of implant retainer arrays, and a single outer element comprising a single outer sheath capable of cooperating with the implant retainer arrays, wherein the method is, The device is provided in an unextended state in which the outer sheath faces the implant retainer array and is advanced distally relative to the implant retainer array, thereby maintaining an implant engaged with the array. The process involves moving one hub carriage of the device relative to one hub of the intermediate element, which is held in a fixed relationship with the housing, thereby retracting the outer element and the inner element into a partially deployed state relative to the intermediate element, wherein the retraction is such that the hub carriage supports one hub of the outer element and one hub of the inner element. A method comprising moving the hub carriage supporting the hub of the outer element relative to the hub of the intermediate element and the hub of the inner element, thereby further retracting the outer element relative to the intermediate and inner elements into a fully deployed state in which the outer sheath is retracted proximal beyond the implant retainer array to release the implant.

23. The method according to claim 22, comprising latching the hub of the inner element to the hub trolley while the hub trolley is moving between the un-deployed state and the partially-deployed state.

24. The method according to claim 22 or 23, comprising preventing the movement of the inner element relative to the housing of the hub during the movement of the hub trolley between the partially deployed state and the fully deployed state.

25. The method according to any one of claims 22 to 24, comprising releasably latching the hub trolley to the housing when it is in the unextended state.

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