Stent insertion device and methods

Abstract

An apparatus for inserting a stent into a bodily structure of a subject, the apparatus comprising: a housing; a stent guide wire having a distal terminus; a stent pusher having a distal terminus; a feeding mechanism for moving the distal terminus of the stent guide wire and the distal terminus of the stent pusher distally, the feeding mechanism including a rotatable actuator engageable to move said respective termini; wherein the feeding mechanism is configured such that rotation of the actuator in a first direction concurrently advances the distal terminus of the stent guide wire and the distal terminus of the stent pusher until the distal terminus of the stent guide wire reaches a first predetermined position at which continued rotation of the actuator in the first direction advances only the distal terminus of the stent pusher until the distal terminus of the stent pusher reaches a second predetermined position, at which continued rotation of the actuator in the first direction is prevented and the stent is positioned at or proximate a desired stent delivery position, and wherein the feeding mechanism is further configured such that rotation of the actuator in a second direction, opposite the first direction, retracts the distal terminus of the stent guide wire until the distal terminus of the stent guide wire is retracted into the apparatus.

Description

Stent insertion device and methodsField of the invention

[0001] The present invention relates generally to a device for placing a stent at a desired location within the human body. In particular, but not exclusively, the device is configured to place a stent within the ureter or other passage or space within the human body.Background of the invention

[0002] A stent is a tubular structure placed into the human body to return a passage to patency, thereby allowing for a bodily fluid to flow therethrough. In other applications, a stent is used to encourage cross-sectional expansion of a passage within the body. In yet a further application a stent may be used prophylactically to prevent blockage.

[0003] A common site of stent placement is within the ureter. The ureter must remain patent to allow urine to drain from the kidney and into the bladder. Obstruction of the ureter often manifests symptoms including pain, fever, and vomiting. Ongoing blockage can lead to infection and serious renal damage.

[0004] The ureter may become blocked or partially occluded by an internal obstruction such as a ureteric stone. Alternatively, an external mass such as a tumour, lymph node or fibrosis may compress the ureter. In other circumstances the ureter becomes kinked or the walls thickened. A ureteric stent may be placed to prevent blockage caused by a procedure, such as kidney stone lithotripsy.

[0005] A ureteric stent generally takes the form of a hollow tube, fabricated from a flexible plastic. The length of a stent used for an adult subject is typically between about 35 cm to 45 cm in length, having a straight section of between about 22 cm to 32 cm in length, and coiled sections at each terminus. The coiled sections retain the stent in place. The coil at one terminus locates in the renal pelvis and the coil at the other terminus locates in the bladder.

[0006] Ureteric stent insertion is often performed under general anaesthesia. The stent insertion involves the insertion of a proboscis (thin tube with a camera and a light) of a cystoscope into the bladder through the urethra and locating of the ureteric orifice (UO).Once the UO is located, a flexible guide wire is fed through the working channel of the cystoscope’s proboscis into the ureter and renal pelvis. A ureteric catheter is inserted over the guidewire and through the cystoscope. After removal of the guidewire, contrast agent is administered, the guidewire replaced, and the ureteric catheter removed. The surgeon then slides the stent over the guide wire using their hands. A stent pusher (catheter-like hollow tube) is used to carefully advance the stent along the guide wire into the ureter. Once the stent is correctly positioned with one end in the kidney and the other in the bladder, the guide wire and the pusher are removed. The correct positioning of the stent is confirmed by using an X-ray.

[0007] Existing methods of ureteric stent insertion present a number of problems. A significant problem is that the insertion of a ureteric stent cannot be easily carried out in an emergency department or in a general clinic setting given to the need for a specialist urologist and specialised equipment normally only available in an operating room. Ureteric stent insertion is generally beyond the skill of a non-specialist medical practitioner. Expertise and experience is firstly required to operate the specialised equipment in the context of a complex multi-step process. Further expertise and experience is required to ensure that the stent is advanced sufficiently far such that the distal coiled portion locates in the renal pelvis, but not so far that the guide wire or stent injures any renal tissue or the stent is completely lost into the ureter. Accordingly, stent insertion is often delayed by several days given the need to assemble the required specialist team, including a urologist, and arrange for access to an operating / procedure room with general anaesthetic and X-ray capabilities. In that time, the subject may be in significant pain and at risk of renal damage arising from the ureteric blockage.

[0008] A further problem is that even in expert hands, a ureteric stent can be difficult to properly insert. A high level of manual dexterity is required to finely manipulate the guide wire and the stent pusher. Even with fluoroscopic / X-ray guidance it is possible for the subject to suffer some renal injury due to the wire or stent being advanced too far into the kidney.

[0009] It is desirable for at least one embodiment disclosed herein to provide an improvement to prior art devices and methods for inserting a stent, and particularly a ureteric stent. It is further desirable for at least one embodiment to provide a usefulalternative to prior art devices and methods for inserting a stent, and particularly a ureteric stent.

[0010] Reference to any prior art in the specification is not an acknowledgment or suggestion that this prior art forms part of the common general knowledge in any jurisdiction or that this prior art could reasonably be expected to be understood, regarded as relevant, and / or combined with other pieces of prior art by a skilled person in the art.Summary of the invention

[0011] In a first aspect, the present invention provides an apparatus for inserting a stent into a bodily structure of a subject, the apparatus comprising: a housing; a stent guide wire having a distal terminus; a stent pusher having a distal terminus; a feeding mechanism for moving the distal terminus of the stent guide wire and the distal terminus of the stent pusher distally, the feeding mechanism including a single actuator engageable to move said respective termini distally; wherein the feeding mechanism is configured to advance the distal terminus of the stent guide wire toward or along a bodily structure of the subject to a first predetermined position and to advance the distal terminus of the stent pusher to a second predetermined position, said second predetermined position being proximal the first predetermined position and coinciding with the apparatus positioning the stent at or proximate to a desired stent delivery position.

[0012] Advantageously, the feeding mechanism is able to advance both the stent guide wire and the stent pusher through user engagement with a single actuator. This enhances the ease of operating the apparatus for the user.

[0013] In an embodiment, the feeding mechanism is further configured to retract the distal terminus of the stent guide wire until the stent guide wire is disengaged from the stent.

[0014] In an embodiment, the apparatus is configured to operate in a plurality of operative modes. In an embodiment, said feeding mechanism is configured to facilitate operation of the apparatus in the plurality of operative modes. In an embodiment, at least one of said operative modes includes a loading mode, wherein, in said loading mode, the feeding mechanism is configured to load the stent into the apparatus. In an embodiment, at least one of said operative modes includes a priming mode, wherein, in said priming mode, the feeding mechanism is configured to ready the apparatus for said advancing of the distal terminus of the stent guide wire and advancing of the distal terminus of the stent pusher. In an embodiment, at least one of said operative modes includes an advancing mode, wherein, in said advancing mode, the feeding mechanism is configured to advance the distal terminus of the stent guide wire and advance the distal terminus of the stent pusher. In an embodiment, at least one of said operative modes includes a delivery mode, wherein, in said delivery mode, the feeding mechanism is configured to advance the distal terminus of the stent pusher to position the stent at or proximate to the desired stent delivery position. In an embodiment, at least one of said operative modes includes a retraction mode, wherein, in said retraction mode, the feeding mechanism is configured to retract the distal terminus of the stent guide wire until the stent guide wire is disengaged with the stent.

[0015] In an embodiment, said retraction of the distal terminus of the stent guide wire until the stent guide wire is disengaged from the stent coincides with operation of the apparatus in the retraction mode.

[0016] In an embodiment, the feeding mechanism is configured to move the stent guide wire and the stent pusher concurrently. In an embodiment, the feeding mechanism is configured to move the distal terminus of the stent guide wire and the distal terminus of the stent pusher concurrently. In an embodiment, the feeding mechanism is configured to move the stent guide wire and the stent pusher distally concurrently. In an embodiment, the feeding mechanism is configured to move the stent guide wire and the stent pusher proximally concurrently. In an embodiment, said concurrent movement of the stent guide wire and the stent pusher further moves the stent. In an embodiment, said distally concurrent movement of the stent guide wire and the stent pusher further moves the stent distally. In an embodiment, said proximally concurrent movement of the stent guide wire and the stent pusher further moves thestent proximally. In an embodiment, said concurrent distal movement of the stent guide wire and the stent pusher coincides with operation of the apparatus in the advancing mode. In an embodiment, said concurrent proximal movement of the stent guide wire and the stent pusher coincides with operation of the apparatus in the priming mode.

[0017] In an embodiment, the feeding mechanism is configured to move the stent guide wire without moving the stent pusher. In an embodiment, the feeding mechanism is configured to move the distal terminus of the stent guide wire without moving the distal terminus of the stent pusher. In an embodiment, said concurrent proximal movement of the stent guide wire and the stent pusher coincides with operation of the apparatus in the priming mode. In an embodiment, the feeding mechanism is configured to move the stent pusher without moving the stent guide wire. In an embodiment, the feeding mechanism is configured to move the distal terminus of the stent pusher without moving the distal terminus of the stent guide wire. In an embodiment, said movement of the stent pusher without movement of the stent guide wire coincides with operation of the apparatus in the delivery mode. In an embodiment, the feeding mechanism is configured to move the stent pusher and thereby the stent.

[0018] In an embodiment, the feeding mechanism includes a driving member operatively associated with the actuator. In an embodiment, the driving member is configured to transfer movement of the actuator into movement of the distal terminus of the stent guide wire. In an embodiment, the driving member is configured to transfer movement of the actuator into movement of the distal terminus of the stent pusher. In an embodiment, the driving member is configured to transfer movement of the actuator into movement of both of the distal terminus of the stent guide wire and the distal terminus of the stent pusher. Preferably, the driving member is configured to transfer movement of the actuator into movement of both of the distal terminus of the stent guide wire and the distal terminus of the stent pusher until the distal terminus of the stent guide wire reaches the first predetermined position.

[0019] In an embodiment, said driving member includes said actuator. For example, said actuator may form part of the driving member. An advantage of this arrangement is that the user can directly engage the driving member in use, thereby enhancing overall control of the apparatus.

[0020] In an embodiment, said movement of the actuator is a rotational movement with respect to the housing.

[0021] In an embodiment, said movement of the actuator in a first direction is transferred into movement of the driving member in the first direction. In an embodiment, said first direction is a first rotational direction. Preferably, said movement of the actuator in the first rotational direction is transferred into movement of the driving member in the first rotational direction. In an embodiment, said movement of the driving member in the first rotational direction moves the distal terminus of the stent guide wire distally. In an embodiment, said movement of the driving member in the first rotational direction moves the distal terminus of the stent pusher distally. In an embodiment, said movement of the driving member in the first rotational direction moves the distal terminus of the stent guide wire and the distal terminus of the stent pusher distally together. In an embodiment, said movement of the driving member in the first rotational direction coincides with operation of the apparatus in the advancing mode, whereby the distal terminus of the stent guide wire and the distal terminus of the stent pusher move distally together. In an embodiment, said movement of the driving member in the first rotational direction coincides with operation of the apparatus in the delivery mode, whereby the distal terminus of the stent pusher moves distally without moving the distal terminus of the stent guide wire.

[0022] In an embodiment, said movement of the actuator in a second direction is transferred into movement of the driving member in the second direction. In an embodiment, said second direction is a second rotational direction. In an embodiment, said second rotational direction is opposite the first rotational direction. Preferably, said movement of the actuator in the second rotational direction is transferred into movement of the driving member in the second rotational direction. In an embodiment, said movement of the driving member in the second rotational direction moves the distal terminus of the stent guide wire proximally. In an embodiment, said movement of the driving member in the second rotational direction moves the distal terminus of the stent pusher proximally. In an embodiment, said movement of the driving member in the second rotational direction moves the distal terminus of the stent guide wire and the distal terminus of the stent pusher proximally together. In an embodiment, said movement of the distal terminus of the stent guide wire and the distal terminus of thestent pusher proximally together coincides with operation of the apparatus in the priming mode.

[0023] In an embodiment, the feeding mechanism includes a first winder operatively engaged with the driving member. Preferably, movement of the driving member is transferred into movement of the first winder. In an embodiment, the driving member is configured to transfer movement of the actuator into movement of the first winder. In an embodiment, the first winder is operatively connected to the stent guide wire. In an embodiment, a portion of said stent guide wire is wound about the first winder. In an embodiment, the driving member is configured to transfer movement of the actuator into movement of the first winder and thereby movement of the distal terminus of the stent guide wire.

[0024] In an embodiment, said movement of the first winder is rotational movement.

[0025] In an embodiment, said movement of the driving member in a first direction is transferred into movement of the first winder in the first direction. In an embodiment, said first direction is a first rotational direction. Preferably, said movement of the driving member in the first rotational direction is transferred into movement of the first winder in the first rotational direction. In an embodiment, said movement of the first winder in the first rotational direction moves the distal terminus of the stent guide wire distally.

[0026] In an embodiment, said movement of the driving member in a second direction is transferred into movement of the first winder in the second direction. In an embodiment, said second direction is a second rotational direction. In an embodiment, said second rotational direction is opposite the first rotational direction. Preferably, said movement of the driving member in the second rotational direction is transferred into movement of the first winder in the second rotational direction. In an embodiment, said movement of the first winder in the second rotational direction moves the distal terminus of the stent guide wire proximally.

[0027] In an embodiment, said driving member is of substantially planar form. The driving member may be of substantially circular shape. Preferably, the driving member is in the form of a wheel or disc.

[0028] In an embodiment, said first winder is of substantially planar form. The first winder may be of substantially circular shape. The first winder may be in the form of a substantially annular disc. Preferably, the first winder is in the form of a spool.

[0029] In an embodiment, said driving member is arranged adjacent the first winder. Preferably, said driving member is arranged coaxially with the first winder.

[0030] In an embodiment, said driving member includes a first engagement feature and said first winder includes a first, operatively associated engagement feature, such that when said respective first engagement features are operatively engaged with each other, the driving member and the first winder are adapted to move together. Preferably, said movement of the driving member and the first winder results in movement of the distal terminus of the stent guide wire. In an embodiment, said movement of the driving member and the first winder in the first direction results in movement of the distal terminus of the stent guide wire distally. In an embodiment, said movement of the driving member and the first winder in the first direction coincides with operation of the apparatus in the advancing mode. In an embodiment, said movement of the driving member and the first winder in the second direction results in movement of the distal terminus of the stent guide wire proximally. In an embodiment, said movement of the driving member and the first winder in the second direction coincides with operation of the apparatus in the priming mode.

[0031] In an embodiment, said first engagement feature of the driving member includes a first latch configured to operatively engage with the first engagement feature of the first winder. Preferably, said first latch is movable between an engaged position, whereby the first latch engages with the first winder, and a disengaged position, whereby the first latch does not engage with the first winder. In an embodiment, said first latch protrudes, at least in part, from a first face of the driving member towards a first face of the first winder, wherein said first face of the driving member is arranged adjacent to the first face of the first winder. In an embodiment, said first latch is a substantially wedge-shaped body. In an embodiment, said driving member includes a guide portion configured to carry the first latch and facilitate movement of the first latch along the guide portion between the engaged and disengaged positions. In anembodiment, said first latch is configured to move between the engaged and disengaged positions in a radial direction.

[0032] In an embodiment, said first engagement feature of the first winder includes a recess configured to engage with the first latch. In an embodiment, said recess extends in a radial direction from a portion of the first winder.

[0033] In an embodiment, said first engagement feature of the driving member is in the engaged position when the apparatus is in the loading mode. In an embodiment, said first engagement feature of the driving member is in the engaged position when the apparatus is in the priming mode. In an embodiment, said first engagement feature of the driving member is in the engaged position when the apparatus is in the advancing mode. In an embodiment, said first engagement feature of the driving member is in the disengaged position when the apparatus is in the delivery mode. In an embodiment, said first engagement feature of the driving member is in the disengaged position when the apparatus is in the retraction mode.

[0034] In an embodiment, said driving member includes a second engagement feature and said first winder includes a second, operatively associated engagement feature, such that when said respective second engagement features are operatively engaged with each other, the driving member and the first winder are adapted to move together. In an embodiment, said movement of the driving member and the first winder in the second direction results in movement of the distal terminus of the stent guide wire proximally. In an embodiment, said movement of the driving member and the first winder in the second direction coincides with operation of the apparatus in the retraction mode.

[0035] In an embodiment, said second engagement feature of the driving member includes a catch configured to operatively engage with the second engagement feature of the first winder. Preferably, said catch is movable between a disengaged position, whereby the catch does not engage with the first winder, and an engaged position, whereby the catch engages with the first winder. In an embodiment, said catch protrudes tangentially from a side of the driving member. In an embodiment, said catch is of elongated form.

[0036] In an embodiment, said second engagement feature of the first winder includes a recessed portion configured to engage with the catch. In an embodiment, said recessed portion extends in a radial direction from a portion of the first winder.

[0037] In an embodiment, said second engagement feature of the driving member is in the engaged position when the apparatus is in the retraction mode. In an embodiment, said second engagement feature of the driving member is in the disengaged position when the apparatus is in the loading mode. In an embodiment, said second engagement feature of the driving member is in the disengaged position when the apparatus is in the priming mode. In an embodiment, said second engagement feature of the driving member is in the disengaged position when the apparatus is in the advancing mode. In an embodiment, said second engagement feature of the driving member is in the disengaged position when the apparatus is in the delivery mode.

[0038] In an embodiment, the driving member is configured to move with respect to the first winder. In other words, the driving member can move whilst the first winder remains substantially fixed. In an embodiment, the driving member is configured to disengage from the first winder. In other words, during operation, the driving member may no longer be operatively engaged with the first winder. In an embodiment, the driving member is configured to disengage from the first winder when the apparatus completes the advancing mode of operation. In an embodiment, the driving member is configured to remain disengaged from the first winder during the delivery mode of operation. In an embodiment, the driving member is configured to re-engage with the first winder during the retraction mode of operation. In an embodiment, said disengagement of the driving member and the first winder occurs when said first engagement feature of the driving member disengages from the first engagement feature of the first winder. For example, said disengagement of the driving member and the first winder occurs when the first latch of the driving member moves from the engaged position to the disengaged position.

[0039] In another embodiment, the first winder is configured to be locked, thereby enabling movement of the driving member with respect to the first winder.

[0040] In an embodiment, the first winder includes an anchoring region at which the stent guide wire is connected to the first winder. The first winder may include ananchoring assembly configured to secure the stent guide wire in connection with the first winder at the anchoring region. In an embodiment, the anchoring assembly is configured to secure a portion of the stent guide wire in connection with the first winder. Preferably, the anchoring assembly is configured to secure an origin of the stent guide wire in connection with the first winder. The anchoring assembly may include an anchoring formation configured to fix the stent guide wire in connection with the first winder. In an embodiment, the anchoring formation includes a recess or opening configured to receive a portion of the stent guide wire. In an embodiment, the stent guide wire is received through a hole formed in the anchoring formation. In an embodiment, the anchoring formation is configured to be received in a cavity formed in the first winder. Preferably, the anchoring formed is formed of substantially corresponding shape to the cavity such that the cavity receives the anchoring formation in a tight fit.

[0041] In an embodiment, said first winder includes a circumferential groove configured to receive at least a portion of the stent guide wire. Preferably, said stent guide wire is configured to be wound around said first winder via the groove. In an embodiment, said groove is disposed on an outer circumference of the first winder.

[0042] In an embodiment, the first winder includes a third engagement feature configured to engage with a corresponding engagement feature carried on or formed with another component of the feeding mechanism, such that when said third engagement feature and corresponding engagement feature are operatively engaged with each other, the first winder is adapted to move with respect to said another component. In an embodiment, the housing includes a first portion having an inner surface, wherein said inner surface carries or has therewith formed said corresponding engagement feature.

[0043] In an embodiment, said third engagement feature of the first winder is in the form of a projection extending from the first winder towards the another component of the feeding mechanism (e.g. the first portion of the housing). In an embodiment, said first winder includes a biasing mechanism operatively associated with the third engagement feature of the first winder. In an embodiment, the third engagement feature of the first winder assumes an unbiased state when the apparatus is operating in theloading mode. In an embodiment, the third engagement feature of the first winder assumes an unbiased state when the apparatus is operating in the priming mode. In an embodiment, the biasing mechanism includes a resilient arm operatively connected to the third engagement feature of the first winder. In one example, the resilient arm is operatively connected to the projection, wherein the projection assumes a biased state when the apparatus completes the advancing mode of operation. In an embodiment, the first winder includes a catch configured to retain the arm in the biased state. In an embodiment, said catch is in the form of a resilient finger, wherein movement of the arm against the finger urges the finger out of the path of the arm until the arm moves past and out of engagement with the finger, upon which the finger moves back into the path of the arm and prevents the arm from moving back into the unbiased state.

[0044] In an embodiment, said corresponding engagement feature of said another component includes a guide configured to operatively engage with the third engagement feature of the first winder. In an embodiment, said guide may include a track configured to operatively engage with the third engagement feature of the first winder. In an embodiment, said track is disposed on the inner surface of the first portion of the housing, said inner surface arranged adjacent the first winder. In an embodiment, said track includes a first terminal end and a second terminal end.

[0045] In an embodiment, said track is spaced radially from and extends circumferentially about an axis of rotation of the driving member.

[0046] In an embodiment, said track includes a first track portion and a second track portion. In an embodiment, said first track portion is curved. In an embodiment, said first track portion is in the form of a substantially circular arc. In an embodiment, said second track portion is curved. In an embodiment, said second track portion is of substantially circular form. In an embodiment, said first track portion and said second track portion are generally coaxial. In an embodiment, said first track portion is disposed radially inwardly of the second track portion. In an embodiment, said first terminal end is disposed at a first terminal end of the first track portion. In an embodiment, said second terminal end is disposed at a second terminal end of the second track portion. In an embodiment, the track includes a transitional portion, wherein said transitional portiongenerally defines a second terminal end of the first track portion and a first terminal end of the second track portion.

[0047] In an embodiment, said track includes a first position intermediate the first terminal end and the second terminal end, said first position defining a starting position of the third engagement feature of the first winder. In an embodiment, said first position is closer to the first terminal end than the second terminal end. In an embodiment, said third engagement feature of the first winder is located at said first position when the apparatus is in the loading mode of operation. In an embodiment, said first intermediate position is located on the first track portion.

[0048] In an embodiment, said third engagement feature of the first winder is configured to move from the first position to a second position when the apparatus is in the priming mode of operation, wherein said second position is at or proximate to the first terminal end. In an embodiment, said movement from the first position to the second position coincides with movement of the first winder in the second direction. In an embodiment, further movement from the second position in the second direction is prevented by engagement between the third engagement feature of the first winder and a stop formation at the first terminal end of the track. Said stop formation may include a projecting wall that at least in part defines said track. In an embodiment, said second position is located on the first track portion, and said stop formation defines a closed portion of said first track portion.

[0049] In an embodiment, said third engagement feature of the first winder is configured to move from the second position to a third position when the apparatus is in the advancing mode of operation, wherein said third position is intermediate to the first terminal end and the second terminal end of the track, wherein said third position is closer to the second terminal end than the first terminal end. In an embodiment, said movement from the second position to the third position coincides with movement of the first winder in the first direction. In an embodiment, further movement from the third position in the first direction is prevented, at least in part, by disengagement between the first winder and the driving member. In an embodiment, said third position is located at the transitional portion between the first track portion and second track portion.

[0050] In an embodiment, said movement from the second position to the third position causes the third engagement feature of the first winder to move from the unbiased state to the biased state. In an embodiment, said track is configured to cause the third engagement feature of the first winder to become biased when the third engagement feature moves from the second position to the third position. In an embodiment, at least said transitional portion is configured to cause the third engagement feature of the first winder to move from the unbiased state to the biased state. In an embodiment, said transitional portion is configured to urge the third engagement feature radially outwardly towards the second track portion. In an embodiment, at least a part of said transitional portion defines a path that is radially offset from the path otherwise defined by the first track portion, wherein movement of the third engagement feature along the transitional portion causes the third engagement feature to move radially outwardly towards the second track portion.

[0051] In an embodiment, said third engagement feature of the first winder is configured to move from the third position to a fourth position when the apparatus is in the retraction mode of operation, wherein said fourth position is at or proximate to the second terminal end. In an embodiment, said movement from the third position to the fourth position coincides with movement of the first winder in the second direction. In an embodiment, further movement from the fourth position in the second direction is prevented by engagement between the third engagement feature of the first winder and a stop formation at the second terminal end of the track. Said stop formation may include a projecting wall that at least in part defines said track. In an embodiment, said fourth position is located on the second track portion, and said stop formation defines a closed portion of said second track portion.

[0052] In an embodiment, said track includes a gate configured to provide one-way passage of the third engagement feature of the first winder. In an embodiment, said gate provides passage of the third engagement feature to the second terminal end. In an embodiment, said third engagement features passes through the gate at or towards the completion of the retraction mode of operation. In an embodiment, said gate prevents passage of the third engagement feature back towards the first terminal end of the track. In an embodiment, said gate prevents passage of the third engagement feature back in the first direction. In an embodiment, said gate is in the form of amovable member. In an embodiment, said movable member is configured to move out of a path of the third engagement feature when the third engagement feature is moved to the fourth position. In an embodiment, said movable member is moved out of the path of the third engagement feature when the third engagement feature urges upon a portion of the movable member when moving to the fourth position. Preferably, the movable member is resilient such that after the third engagement feature traverses past the movable member when moving to the fourth position, the movable member moves from a disturbed position back to an initial position, wherein in said initial position the movable member obstructs passage of the third engagement feature back towards the first terminal end. In an embodiment, said gate is disposed in the second track portion, proximate to the second terminal end.

[0053] In an embodiment, said track is spaced radially from and extends circumferentially about an axis of rotation of the first winder. Preferably, said track is of spiral form.

[0054] In an embodiment, the feeding mechanism includes a second winder operatively engaged with the driving member. Preferably, movement of the driving member is transferred into movement of the second winder. In an embodiment, the driving member is configured to transfer movement of the actuator into movement of the second winder. In an embodiment, the second winder is operatively connected to the stent pusher. In an embodiment, a portion of said stent pusher is wound about the second winder. In an embodiment, the driving member is configured to transfer movement of the actuator into movement of the second winder and thereby movement of the distal terminus of the stent pusher.

[0055] In an embodiment, said movement of the second winder is rotational movement.

[0056] In an embodiment, said movement of the driving member in the first direction is transferred into movement of the second winder in the first direction. In an embodiment, said first direction is the first rotational direction. Preferably, said movement of the driving member in the first rotational direction is transferred into movement of the second winder in the first rotational direction. In an embodiment, said movement of thesecond winder in the first rotational direction moves the distal terminus of the stent pusher distally.

[0057] In an embodiment, said movement of the driving member in the second direction is transferred into movement of the second winder in the second direction. In an embodiment, said second direction is the second rotational direction. Preferably, said movement of the driving member in the second rotational direction is transferred into movement of the second winder in the second rotational direction. In an embodiment, said movement of the second winder in the second rotational direction moves the distal terminus of the stent pusher proximally.

[0058] In an embodiment, said second winder is of substantially planar form. The second winder may be of substantially circular shape. The second winder may be in the form of a substantially annular disc. Preferably, the second winder is in the form of a spool.

[0059] In an embodiment, said driving member is arranged adjacent the second winder. Preferably, said driving member is arranged coaxially with the second winder. In an embodiment, said first winder is arranged coaxially with the second winder. In an embodiment, the said driving member is arranged coaxially with the first winder and the second winder.

[0060] In an embodiment, said driving member includes a third engagement feature and said second winder includes a first, operatively associated engagement feature, such that when said first engagement feature of the second winder and said third engagement feature of the driving member are operatively engaged with each other, the driving member and the second winder are adapted to move together. Preferably, said movement of the driving member and the second winder results in movement of the distal terminus of the stent pusher. In an embodiment, said movement of the driving member and the second winder in the first direction results in movement of the distal terminus of the stent pusher distally. In an embodiment, said movement of the driving member and the second winder in the first direction coincides with operation of the apparatus in the advancing mode. In an embodiment, said movement of the driving member and the second winder in the first direction coincides with operation of the apparatus in the delivery mode. In an embodiment, said movement of the drivingmember and the second winder in the second direction results in movement of the distal terminus of the stent pusher proximally. In an embodiment, said movement of the driving member and the second winder in the second direction coincides with operation of the apparatus in the priming mode.

[0061] In an embodiment, said third engagement feature of the driving member includes a second latch configured to operatively engage with the first engagement feature of the second winder. Preferably, said second latch is movable between an engaged position, whereby the second latch engages with the second winder, and a disengaged position, whereby the second latch does not engage with the second winder. In an embodiment, said second latch protrudes, at least in part, from a second face of the driving member towards a first face of the second winder, wherein said second face of the driving member is arranged adjacent to the first face of the second winder. In an embodiment, said second latch is a substantially wedge-shaped body. In an embodiment, said driving member includes a second guide portion configured to carry the second latch and facilitate movement of the second latch along the second guide portion between the engaged and disengaged positions. In an embodiment, said second latch is configured to move between the engaged and disengaged positions in a radial direction.

[0062] In an embodiment, said first engagement feature of the second winder includes a recess configured to engage with the second latch. In an embodiment, said recess extends in a radial direction from a portion of the second winder.

[0063] In an embodiment, said third engagement feature of the driving member is in the engaged position when the apparatus is in the loading mode. In an embodiment, said third engagement feature of the driving member is in the engaged position when the apparatus is in the priming mode. In an embodiment, said third engagement feature of the driving member is in the engaged position when the apparatus is in the advancing mode. In an embodiment, said third engagement feature of the driving member is in the engaged position when the apparatus is in the delivery mode. In an embodiment, said third engagement feature of the driving member is in the disengaged position when the apparatus is in the retraction mode.

[0064] In an embodiment, the driving member is configured to move with respect to the second winder. In other words, the driving member can move whilst the second winder remains substantially fixed. In an embodiment, the driving member is configured to disengage from the second winder. In other words, during operation, the driving member may no longer be operatively engaged with the second winder. In an embodiment, the driving member is configured to disengage from the second winder when the apparatus completes the delivery mode of operation. In an embodiment, the driving member is configured to remain disengaged from the second winder during the retraction mode of operation. In an embodiment, said disengagement of the driving member and the second winder occurs when said third engagement feature of the driving member disengages from the first engagement feature of the second winder. For example, said disengagement of the driving member and the second winder occurs when the second latch of the driving member moves from the engaged position to the disengaged position.

[0065] In an embodiment, the second winder is configured to be locked, thereby enabling movement of the driving member with respect to the second winder. In an embodiment, when the second winder is locked, the driving member and the first winder are configured to move together with respect to the second winder. This may coincide with operation of the apparatus in the retraction mode. In an embodiment, said movement of the first winder and the driving member when the second winder is locked results in movement of the distal terminus of the guide wire proximally. In an embodiment, when the first winder is locked, the driving member and the second winder are configured to move together with respect to the first winder. In an embodiment, said movement of the second winder and the driving member when the first winder is locked results in movement of the distal terminus of the stent pusher distally. This may coincide with operation of the apparatus in the delivery mode.

[0066] In an embodiment, the second winder includes an anchoring region at which the stent pusher is connected to the second winder. The second winder may include an anchoring assembly configured to secure the stent pusher in connection with the second winder at the anchoring region. In an embodiment, the anchoring assembly is configured to secure a portion of the stent pusher in connection with the second winder. Preferably, the anchoring assembly is configured to secure an origin of the stent pusherin connection with the second winder. The anchoring assembly may include an anchoring formation configured to fix the stent pusher in connection with the second winder. In an embodiment, the anchoring formation includes a recess or opening configured to receive a portion of the stent pusher. Preferably, the stent pusher is received through a hole formed in the anchoring formation. In an embodiment, the anchoring formation is configured to be received in a cavity formed in the second winder. Preferably, the anchoring formation is formed of substantially corresponding shape to the cavity such that the cavity receives the anchoring formation in a tight fit. The cavity and the anchoring formation may be substantially arcuate-shaped.

[0067] In an embodiment, said second winder includes a circumferential groove configured to receive at least a portion of the stent guide wire. Preferably, said stent guide wire is configured to be wound around said second winder via the groove. In an embodiment, said groove is disposed radially inward of an outer circumference of the second winder.

[0068] In an embodiment, the second winder includes a second engagement feature configured to engage with a corresponding engagement feature carried on or formed with another component of the feeding mechanism, such that when said second engagement feature and corresponding engagement feature are operatively engaged with each other, the second winder is adapted to move with respect to said another component. In an embodiment, the housing includes a second portion having an inner surface, wherein said inner surface carries or has therewith formed said corresponding engagement feature.

[0069] In an embodiment, said second engagement feature of the second winder is in the form of a projection extending from the second winder towards the another component of the feeding mechanism (e.g. the second portion of the housing).

[0070] In an embodiment, said corresponding engagement feature of said another component includes a guide configured to operatively engage with the second engagement feature of the second winder. In an embodiment, said guide may include a track configured to operatively engage with the second engagement feature of the second winder. In an embodiment, said track is disposed on the inner surface of thesecond portion of the housing, said inner surface arranged adjacent the second winder. In an embodiment, said track includes a first terminal end and a second terminal end.

[0071] In an embodiment, said track is spaced radially from and extends circumferentially about the axis of rotation of the driving member.

[0072] In an embodiment, said track includes a first track portion, a second track portion and a third track portion. In an embodiment, said first track portion is curved. In an embodiment, said first track portion is of substantially circular form. In an embodiment, said second track portion is curved. In an embodiment, said second track portion is of substantially circular form. In an embodiment, said third track portion is curved. In an embodiment, said third track portion is of substantially circular form. In an embodiment, said first track portion, said second track portion and said third track portion are generally coaxial. In an embodiment, said first track portion is disposed radially outwardly of the second track portion. In an embodiment, said second track portion is disposed radially outwardly of the third track portion. In an embodiment, said first terminal end is disposed at a first terminal end of the first track portion. In an embodiment, said second terminal end is disposed at a second terminal end of the first track portion.

[0073] In an embodiment, said track includes a first position intermediate the first terminal end and the second terminal end, said first position defining a starting position of the second engagement feature of the second winder. In an embodiment, said first position is closer to the first terminal end than the second terminal end. In an embodiment, said second engagement feature of the second winder is located at said first position when the apparatus is in the loading mode of operation. In an embodiment, said first intermediate position is located on the first track portion.

[0074] In an embodiment, said second engagement feature of the second winder is configured to move from the first position to a second position when the apparatus is in the priming mode of operation, wherein said second position is at or proximate to the first terminal end. In an embodiment, said movement from the first position to the second position coincides with movement of the second winder in the second direction. In an embodiment, further movement from the second position in the second direction is prevented by engagement between the second engagement feature of the secondwinder and a stop formation at the first terminal end of the track. Said stop formation may include a projecting wall that at least in part defines said track. In an embodiment, said second position is located on the first track portion, and said stop formation defines a closed portion of said first track portion.

[0075] In an embodiment, said track includes a first gate configured to provide one-way passage of the second engagement feature of the second winder. In an embodiment, said first gate provides passage of the second engagement feature from the first position to the second position along the track. Said movement from the first position to the second position may coincide with movement of the second winder in the second direction. In an embodiment, said first gate is configured to prevent passage of the second engagement feature along the track in the first direction. Preferably, said first gate is configured to prevent passage of the second engagement feature along the track in the first direction until after the priming mode of operation. In an embodiment, said first gate is in the form of a movable member. In an embodiment, said movable member is configured to move out of a path of the second engagement feature when the second engagement feature is moved from the first position to the second position. In an embodiment, said movable member is moved out of the path of the second engagement feature when the second engagement feature urges upon a portion of the movable member when moving from the first position to the second position. Preferably, the movable member is prevented from moving back into the path of the second engagement feature such that after the second engagement feature traverses past the movable member, the movable member does not move back into the path of the second engagement feature.

[0076] In an embodiment, said second engagement feature of the second winder is configured to move from the second position to a third position when the apparatus is in the advancing mode of operation, wherein said third position is intermediate the first terminal end and the second terminal end of the track, wherein said third position is located on the first track portion. In an embodiment, said movement from the second position to the third position coincides with movement of the second winder in the first direction. In an embodiment, said movement from the second position to the third position causes the first engagement feature of the driving member to move, wherein when the second engagement feature of the second winder reaches the third position,the first engagement feature of the driving member disengages from the first engagement feature of the first winder.

[0077] In an embodiment, said driving member includes a fourth engagement feature configured to engage with a corresponding engagement feature carried on or formed with another component of the feeding mechanism, such that when said fourth engagement feature and corresponding engagement feature are operatively engaged with each other, the second winder is adapted to move with respect to said another component. In an embodiment, said inner surface of the second portion of the housing carries or has therewith formed said corresponding engagement feature. In an embodiment, said corresponding engagement feature is the second track portion. In an embodiment, said fourth engagement feature of the driving member is in the form of a projection extending from the driving member towards the second portion of the housing. In an embodiment, said fourth engagement feature of the driving member is operatively associated with the first engagement feature of the driving member. For example, said fourth engagement feature of the driving member and the first engagement feature of the driving member may be coupled so that movement of the fourth engagement feature corresponds to movement in the first engagement feature. Said movement may be movement in a radial direction.

[0078] In an embodiment, said second track portion is configured to cause the fourth engagement feature of the driving member to move radially inwardly, thereby moving the first engagement feature of the driving member radially inwardly. In an embodiment, said second track portion is configured to urge the fourth engagement feature of the driving member to move radially inwardly until the first engagement feature of the driving member moves to the disengaged position, whereby the driving member is disengaged from the first winder. Said second track portion may include a ramped surface extending radially inwardly into the path of the second track portion, wherein movement of the fourth engagement feature along said ramped surface urges the fourth engagement feature radially inwardly until the first engagement feature of the driving member moves to the disengaged position, whereby the driving member is disengaged from the first winder.

[0079] In an embodiment, said second engagement feature of the second winder is configured to move from the third position to a fourth position when the apparatus is in the delivery mode of operation, wherein said fourth position is at or proximate to the second terminal end. In an embodiment, said movement from the third position to the fourth position coincides with movement of the second winder in the first direction. In an embodiment, further movement from the fourth position in the first direction is prevented by engagement between the second engagement feature of the second winder and a stop formation at the second terminal end of the track. Said stop formation may include a projecting wall that at least in part defines said track. In an embodiment, said fourth position is located on the first track portion, and said stop formation defines a closed portion of said first track portion.

[0080] In an embodiment, said track includes a second gate configured to provide oneway passage of the second engagement feature of the second winder. In an embodiment, said second gate provides passage of the second engagement feature to the second terminal end. In an embodiment, said second engagement features passes through the second gate at or towards the completion of the delivery mode of operation. In an embodiment, said second gate prevents passage of the second engagement feature back towards the first terminal end of the track. In an embodiment, said second gate prevents passage of the second engagement feature back in the second direction. In an embodiment, said second gate is in the form of a movable member. In an embodiment, said movable member is configured to move out of a path of the second engagement feature when the second engagement feature is moved to the fourth position. In an embodiment, said movable member is moved out of the path of the second engagement feature when the second engagement feature urges upon a portion of the movable member when moving to the fourth position. Preferably, the movable member is resilient such that after the second engagement feature traverses past the movable member when moving to the fourth position, the movable member moves from a disturbed position back to an initial position, wherein in said initial position the movable member obstructs passage of the second engagement feature back towards the first terminal end. In an embodiment, said second gate is disposed in the first track portion, proximate to the second terminal end.

[0081] In an embodiment, said driving member includes a fifth engagement feature configured to engage with a corresponding engagement feature carried on or formed with another component of the feeding mechanism, such that when said fifth engagement feature and corresponding engagement feature are operatively engaged with each other, the second winder is adapted to move with respect to said another component. In an embodiment, said inner surface of the second portion of the housing carries or has therewith formed said corresponding engagement feature. In an embodiment, said corresponding engagement feature is the third track portion. In an embodiment, said fifth engagement feature of the driving member is in the form of a projection extending from the driving member towards the second portion of the housing. In an embodiment, said fifth engagement feature of the driving member is operatively associated with the third engagement feature of the driving member. For example, said fifth engagement feature of the driving member and the third engagement feature of the driving member may be coupled so that movement of the fifth engagement feature corresponds to movement in the third engagement feature. Said movement may be movement in a radial direction.

[0082] In an embodiment, said third track portion is configured to cause the fifth engagement feature of the driving member to move radially inwardly, thereby moving the third engagement feature of the driving member radially inwardly. In an embodiment, said third track portion is configured to urge the fifth engagement feature of the driving member to move radially inwardly until the third engagement feature of the driving member moves to the disengaged position, whereby the driving member is disengaged from the second winder. Said third track portion may include a ramped surface extending radially inwardly into the path of the third track portion, wherein movement of the fifth engagement feature along said ramped surface urges the fifth engagement feature radially inwardly until the third engagement feature of the driving member moves to the disengaged position, whereby the driving member is disengaged from the second winder.

[0083] In an embodiment, said track is spaced radially from and extends circumferentially about an axis of rotation of the second winder.

[0084] In an embodiment, the housing includes a body portion. In an embodiment, the body portion is of substantially circular form. In an embodiment, the housing includes a handling portion that extends from the body portion, wherein the handling portion is configured to be gripped by a user when the apparatus is in use. In an embodiment, the handling portion extends generally tangentially from the body portion.

[0085] In an embodiment, the first portion of the housing and the second portion of the housing define respective half shells of the housing, wherein the first and second portions are substantially symmetric about a plane extending along a longitudinal axis of the apparatus.

[0086] In an embodiment, the apparatus includes a delivery portion. In an embodiment, the delivery portion is elongated. In an embodiment, the elongated delivery portion extends generally tangentially with respect to the substantially circular body portion. In an embodiment, said delivery portion is a proboscis. In an embodiment, the delivery portion is in part received by the housing. In an embodiment, the delivery portion is in part received by the handling portion of the housing. In an embodiment, the proboscis includes a lumen.

[0087] In an embodiment, when the apparatus is operating in the loading mode, a portion of the guide wire extends beyond the proboscis, thereby facilitating loading of a stent into the apparatus. In an embodiment, when the apparatus completes operation of the priming mode, said guide wire is withdrawn into the proboscis. Preferably, when the apparatus completes operation of the priming mode, said guide wire is disposed substantially flush with a tip of the proboscis. In an embodiment, when the apparatus completes operation of the advancing mode, said distal terminus of the guide wire is located at the first predetermined position. In an embodiment, when the apparatus completes operation of the delivery mode, said distal terminus of the stent pusher is located at the second predetermined position. Preferably, when the apparatus completes operation of the delivery mode, said stent pusher is disposed substantially flush with the tip of the proboscis and said stent is fully ejected from the apparatus. In an embodiment, when the apparatus complete operation of the retraction mode, the stent guide wire is fully withdrawn back into the apparatus. Preferably, when theapparatus completes operation of the retraction mode, said guide wire is disposed substantially flush with the tip of the proboscis.

[0088] In an embodiment, the apparatus includes an initiator operatively associated with the feeding mechanism. In an embodiment, upon activation, the initiator is configured to allow operation of the feeding mechanism. In an embodiment, prior to activation of the initiator, the initiator prevents operation of the feeding mechanism. In an embodiment, upon activation, the initiator is configured to allow movement of the actuator. In an embodiment, prior to activation of the initiator, the initiator prevents movement of the actuator. In an embodiment, upon activation, the initiator is configured to allow movement of the driving member. In an embodiment, prior to activation of the initiator, the initiator prevents movement of the driving member.

[0089] In an embodiment, the initiator includes a movable portion configured to operatively engage with the feeding mechanism. In an embodiment, the movable portion is configured to operatively engage with the driving member. In an embodiment, the movable portion includes one or more contacting portions configured to urge upon one or more bearing portions of the driving member. In an embodiment, the one or more bearing portions are deformable when the one or more contacting portions are urged against them. In an embodiment, the one or more bearing portions include one or more tabs. In an embodiment, the one or more tabs are configured to lockingly engage with a portion of the housing. In an embodiment, when the one or more tabs are lockingly engaged with the portion of the housing, the feeding mechanism assumes a locked state in which operation of the feeding mechanism is prevented. In an embodiment, the one or more tabs are configured to lockingly engage with the first portion of the housing. In an embodiment, when the one or more tabs are no longer lockingly engaged with the portion of the housing, the feeding mechanism assumes an unlocked state in which operation of the feeding mechanism is allowed.

[0090] In an embodiment, the movable portion is configured to operatively engage with the second winder, thereby preventing movement of the actuator when the moveable portion is in a locked position.

[0091] In an embodiment, the apparatus includes a camera assembly configured to capture video and / or images of a procedure. In an embodiment, said camera assemblyis at least in part disposed in the delivery portion, e.g. in the proboscis. In an embodiment, the camera assembly includes an imaging sensor. Preferably, the imaging sensor is in the form of a camera. In an embodiment, the camera assembly includes one or more light sources configured to illuminate a region about the proboscis. In an embodiment, a plurality of light sources is spaced about the imaging sensor. In an embodiment, the one or more light sources are in the form of one or more LEDs. In an embodiment, the camera assembly includes a housing configured to house the imaging sensor. In an embodiment, the housing is further configured to house the one or more light sources. In an embodiment, the housing is in the form of a tubular housing. In an embodiment, the camera assembly is operatively connected to a printed circuit board disposed within the housing.

[0092] In an embodiment, the apparatus includes an adaptor configured to be attached to the delivery portion, wherein said adaptor is configured to house or support the camera assembly or at least part of the camera assembly. In an embodiment, the adaptor is configured to be attached at a distal end of the proboscis. In an embodiment, the adaptor includes a generally tubular body. In an embodiment, the adaptor includes one or more engagement features, and the proboscis includes one or more complementary engagement features, such that when the respective engagement features are suitably engaged together, the adaptor is attached to the proboscis. In an embodiment, the one or more engagement features of the adaptor includes a deflectable boss, and the one or more complementary engagement features of the proboscis includes a slot, such that when the deflectable boss and the slot are aligned, the deflectable boss moves into the slot to thereby retain the adaptor with respect to the proboscis. In an embodiment, the one or more engagement features of the adaptor includes a key, and the one or more complementary engagement features of the proboscis includes a keyway, such that the keyway and key are aligned when the adaptor is suitably positioned with respect to the proboscis.

[0093] In an embodiment, the proboscis is configured to slidingly receive the adaptor. In an embodiment, the adaptor includes a lumen configured to communicate with the lumen of the proboscis when the adaptor is attached to the proboscis. In an embodiment, the guide wire is configured to pass through the lumens of the adaptor and the proboscis. In an embodiment, the stent is configured to pass through the lumens ofthe adaptor and the proboscis. In an embodiment, the pusher is configured to pass through the lumens of the adaptor and the proboscis. In an embodiment, a flushing fluid is configured to pass through the lumens of the adaptor and the proboscis. In an embodiment, one or more guiding features extend into the lumen of the adaptor, wherein the one or more guiding features are configured to linearly align the guide wire with respect to the proboscis and / or the adaptor.

[0094] In an embodiment, the adaptor includes a passage generally extending between a proximal end and a distal end of the body, wherein said passage is configured to house or support the camera assembly. In an embodiment, the passage is configured to guide wiring to the camera assembly, e.g. wiring from the proboscis to the adaptor. In an embodiment, said passage is configured to support the housing of the camera assembly.

[0095] In an embodiment, said driving member is configured to be nested between the first winder and the second winder.

[0096] In an embodiment, said apparatus includes the stent pre-loaded into the apparatus. In an embodiment, said stent is a double-J ureteric stent.

[0097] In an embodiment, said apparatus is configured for single-use.

[0098] In a second aspect, the present invention provides an apparatus for inserting a stent into a bodily structure of subject, the apparatus comprising: a housing; a stent guide wire having a distal terminus; a stent pusher having a distal terminus; a feeding mechanism for moving the distal terminus of the stent guide wire and the distal terminus of the stent pusher distally, wherein a distal portion of the stent guide wire projects outside the apparatus before operation of the feeding mechanism to facilitate loading of a stent into the apparatus;wherein the feeding mechanism is configured to advance the distal terminus of the stent guide wire toward or along a bodily structure of the subject to a first predetermined position and to advance the distal terminus of the stent pusher to a second predetermined position, said second predetermined position being proximal the first predetermined position and coinciding with the apparatus positioning the stent at or proximate to a desired stent delivery position.

[0099] It will be appreciated that features disclosed with respect to the first aspect of the invention are also applicable with respect to the second aspect of the invention, including different combinations of features disclosed.

[0100] In a third aspect, the present invention provides an apparatus for inserting a stent into a bodily structure of subject, the apparatus comprising: a housing; a stent guide wire having a distal terminus; a stent pusher having a distal terminus; a feeding mechanism for moving the distal terminus of the stent guide wire and the distal terminus of the stent pusher; wherein the feeding mechanism is configured to retract the distal terminus of the guide wire and a stent into the apparatus, advance the distal terminus of the stent guide wire toward or along a bodily structure of the subject to a first predetermined position and to advance the distal terminus of the stent pusher to a second predetermined position, said second predetermined position being proximal the first predetermined position and coinciding with the apparatus positioning the stent at or proximate to a desired stent delivery position.

[0101] It will be appreciated that features disclosed with respect to the third aspect of the invention are also applicable with respect to the other aspects of the invention, including different combinations of features disclosed.

[0102] In a fourth aspect, the present invention provides an apparatus for inserting a stent into a bodily structure of subject, the apparatus comprising:a housing; a stent guide wire having a distal terminus; a stent pusher having a distal terminus; a feeding mechanism for moving the distal terminus of the stent guide wire proximally and distally, and the distal terminus of the stent pusher; wherein the feeding mechanism is configured to advance the distal terminus of the stent guide wire toward or along a bodily structure of the subject to a first predetermined position, to advance the distal terminus of the stent pusher to a second predetermined position, said second predetermined position being proximal the first predetermined position and coinciding with the apparatus positioning the stent at or proximate to a desired stent delivery position, and to retract the distal terminus of the guide wire into the apparatus after the stent is at the desired stent delivery position, wherein the feeding mechanism is configured to prevent further movement of the distal terminus of the stent guide wire after the stent is delivered to the desired stent delivery position.

[0103] It will be appreciated that features disclosed with respect to the fourth aspect of the invention are also applicable with respect to the other aspects of the invention, including different combinations of features disclosed.

[0104] In a fifth aspect, the present invention provides an apparatus for inserting a stent into a bodily structure of subject, the apparatus comprising: a housing; a stent guide wire having a distal terminus; a first rotatable winder about which a portion of the stent guide wire is wound, the first winder being rotatable relative to the housing to move the distal terminus of the stent guide wire distally toward or along a bodily structure of a subject; a stent pusher disposed about another portion of the stent guide wire, the stent pusher having a distal terminus;a second rotatable winder about which a portion of the stent pusher is wound, the second winder being rotatable relative to the housing to advance the distal terminus of the stent pusher distally; a rotatable driver configured to move the first and second rotatable winders; wherein the rotatable driver is configured to advance the distal terminus of the stent guide wire toward or along a bodily structure of the subject to a first predetermined position and to advance the distal terminus of the stent pusher to a second predetermined position, said second predetermined position being proximal the first predetermined position and coinciding with the apparatus positioning the stent at or proximate to a desired stent delivery position.

[0105] It will be appreciated that features disclosed with respect to the fifth aspect of the invention are also applicable with respect to the other aspects of the invention, including different combinations of features disclosed.

[0106] In a sixth aspect, the present invention provides an apparatus for inserting a stent into a bodily structure of subject, the apparatus comprising: a housing; a stent guide wire having a distal terminus; a first rotatable winder about which a portion of the stent guide wire is wound, the first winder being rotatable relative to the housing to move the distal terminus of the stent guide wire distally toward or along a bodily structure of a subject and proximally away or along a bodily structure of a subject; a stent pusher disposed about another portion of the stent guide wire, the stent pusher having a distal terminus; a second rotatable winder about which a portion of the stent pusher is wound, the second winder being rotatable relative to the housing to advance the distal terminus of the stent pusher distally; a rotatable driver configured to move the first and second rotatable winders;wherein the rotatable driver is configured to advance the distal terminus of the stent guide wire toward or along a bodily structure of the subject to a first predetermined position and to advance the distal terminus of the stent pusher distally to a second predetermined position, said second predetermined position being proximal the first predetermined position and coinciding with the apparatus positioning the stent at or proximate to a desired stent delivery position, wherein the rotatable driver is further configured to retract the distal terminus of the stent guide wire.

[0107] It will be appreciated that features disclosed with respect to the sixth aspect of the invention are also applicable with respect to the other aspects of the invention, including different combinations of features disclosed.

[0108] In a seventh aspect, the present invention provides an apparatus for inserting a stent into a bodily structure of a subject, the apparatus comprising: a housing; a stent guide wire having a distal terminus; a stent pusher having a distal terminus; a feeding mechanism for moving the distal terminus of the stent guide wire and the distal terminus of the stent pusher distally, the feeding mechanism including a rotatable actuator engageable to move said respective termini; wherein the feeding mechanism is configured such that rotation of the actuator in a first direction concurrently advances the distal terminus of the stent guide wire and the distal terminus of the stent pusher until the distal terminus of the stent guide wire reaches a first predetermined position at which continued rotation of the actuator in the first direction advances only the distal terminus of the stent pusher until the distal terminus of the stent pusher reaches a second predetermined position, at which continued rotation of the actuator in the first direction is prevented and the stent is positioned at or proximate a desired stent delivery position, and wherein the feeding mechanism is further configured such that rotation of the actuator in a second direction, opposite the first direction, retracts the distal terminus of the stent guide wire until the distal terminus of the stent guide wire is retracted into the apparatus.

[0109] It will be appreciated that features disclosed with respect to the seventh aspect of the invention are also applicable with respect to the other aspects of the invention, including different combinations of features disclosed.

[0110] In an eighth aspect, the present invention provides a method for inserting a stent into a bodily structure of a subject using the apparatus of any one of the earlier described embodiments.

[0111] It will be appreciated that features disclosed with respect to the eighth aspect of the invention are also applicable with respect to the other aspects of the invention, including different combinations of features disclosed.

[0112] In an ninth aspect, the present invention provides a method for inserting a stent into a bodily structure of a subject, the method including: providing the apparatus of any one of the earlier described embodiments; introducing the stent guide wire and stent into the body of a subject; moving the actuator in a first direction to move the stent guide wire and stent together distally toward or along a bodily structure of the subject, wherein when the distal terminus of the stent guide wire is located at a first predetermined position, continued movement of the stent guide wire in the first direction is prevented; further moving the actuator in the first direction to move the stent to a desired stent delivery position, wherein when the stent reaches the desired stent delivery position, continued movement of the stent in the first direction is prevented; moving the actuator in a second direction, opposite the first direction, to move the stent guide wire proximally towards the apparatus, wherein when the stent guide wire is fully retracted into the apparatus, continued movement of the stent guide wire in the second direction is prevented.

[0113] In an embodiment, said movement of the actuator in the first direction is undertaken continuously until continued movement of the stent in the first direction is prevented.

[0114] In an embodiment, said method further includes loading the stent into the apparatus.

[0115] In an embodiment, said method further includes priming the apparatus by moving the actuator in the second direction, thereby moving the stent guide wire and stent proximally. Preferably, said priming the apparatus occurs before said moving the actuator in the first direction.

[0116] It will be appreciated that features disclosed with respect to the ninth aspect of the invention are also applicable with respect to the other aspects of the invention, including different combinations of features disclosed.

[0117] In a tenth aspect, the present invention provides a stent insertion kit, said kit including the apparatus for inserting a stent of any one of the first to seventh aspect of the invention; and a stent for insertion into the apparatus.

[0118] It will be appreciated that features disclosed with respect to the tenth aspect of the invention are also applicable with respect to the other aspects of the invention, including different combinations of features disclosed.

[0119] In an eleventh aspect, the present invention provides a stent insertion system, the stent insertion system including: the apparatus of any one of the earlier described embodiments; and an electronic device operatively connected to the apparatus.

[0120] In an embodiment, the electronic device is a smart device, such as a smartphone, tablet, computer, etc. In an embodiment, the electronic device includes a display, wherein the display is operatively associated with the camera assembly of the apparatus such that images / video captured by the camera assembly are displayed to a user. In an embodiment, the electronic device is configured to power the apparatus.

[0121] It will be appreciated that features disclosed with respect to the eleventh aspect of the invention are also applicable with respect to the other aspects of the invention, including different combinations of features disclosed

[0122] As used herein, except where the context requires otherwise, the term "comprise" and variations of the term, such as "comprising", "comprises" and "comprised", are not intended to exclude further additives, components, integers or steps.

[0123] Further aspects of the present invention and further embodiments of the aspects described in the preceding paragraphs will become apparent from the following description, given by way of example and with reference to the accompanying drawings.Brief description of the drawings

[0124] Figure 1 is a perspective view of a stent insertion device in accordance with an embodiment of the present invention;

[0125] Figure 2 is a side view of the stent insertion device of Figure 1 ;

[0126] Figure 3 is a bottom view of the stent insertion device of Figure 1 ;

[0127] Figure 4 is a rear view of the stent insertion device of Figure 1

[0128] Figure 5 is another side view of the stent insertion device of Figure 1 ;

[0129] Figure 6 is an exploded view of the stent insertion device of Figure 1 ;

[0130] Figure 7 is another exploded view of the stent insertion device of Figure 1 ;

[0131] Figure 8 is a side view of an exterior of a first housing portion of the stent insertion device of Figure 1 ;

[0132] Figure 9 is a front view of a first housing portion of the stent insertion device of Figure 1 ;

[0133] Figure 10 is a side view of an interior of a first housing portion of the stent insertion device of Figure 1 ;

[0134] Figure 11 is a side view of an interior of a second housing portion of the stent insertion device of Figure 1 ;

[0135] Figure 12 is a front view of a second housing portion of the stent insertion device of Figure 1 ;

[0136] Figure 13 is a side view of an exterior of a second housing portion of the stent insertion device of Figure 1 ;

[0137] Figure 14 is an outer side view of a central engager of a feeding mechanism of the stent insertion device of Figure 1 ;

[0138] Figure 15 is a peripheral side view of the central engager of Figure 14;

[0139] Figure 16 is an inner side view of the central engager of Figure 14;

[0140] Figure 17 is an outer perspective view of the central engager of Figure 14;

[0141] Figure 18 is an inner perspective view of the central engager of Figure 14;

[0142] Figure 19 is an inner side view of a pusher winder of a feeding mechanism of the stent insertion device of Figure 1 ;

[0143] Figure 20 is a peripheral side view of the pusher winder of Figure 19;

[0144] Figure 21 is an outer side view of the pusher winder of Figure 19;

[0145] Figure 22 is an inner perspective exploded view of the pusher winder of Figure 19;

[0146] Figure 23 is an outer perspective exploded view of the pusher winder of Figure 19;

[0147] Figure 24 is an outer side view of a wire winder of a feeding mechanism of the stent insertion device of Figure 1 ;

[0148] Figure 25 is a peripheral side view of the wire winder of Figure 24;

[0149] Figure 26 is an inner side view of the wire winder of Figure 24;

[0150] Figure 27 is an outer perspective view of the wire winder of Figure 24;

[0151] Figure 28 is an inner perspective view of the wire winder of Figure 24;

[0152] Figure 29 is a front view of a proboscis of the stent insertion device of Figure 1 ;

[0153] Figure 30 is a partial perspective view of the stent insertion device of Figure 1 , with components omitted or transparent to see internal features;

[0154] Figure 31 is a chart illustrating a single operation cycle of the stent insertion device of Figure 1 ;

[0155] Figure 32 is a schematic view of a stent insertion system in accordance with an embodiment of the present invention;

[0156] Figure 33 is a front view of a camera assembly of the stent insertion system of Figure 32;

[0157] Figure 34 is a perspective view of another proboscis of the stent insertion device of Figure 32;

[0158] Figure 35 is a partial bottom view of the proboscis of Figure 34;

[0159] Figure 36 is a partial, transparent side view of a portion of the stent insertion device of Figure 32;

[0160] Figure 37 is a partial, transparent side view of another portion of the stent insertion device of Figure 32 with part of the housing omitted;

[0161] Figure 38 is a side view of a proboscis tip adaptor in accordance with an embodiment of the present invention;

[0162] Figure 39 is a side, section view of the proboscis tip adaptor of Figure 38;

[0163] Figure 40 is a front view of the proboscis tip adaptor of Figure 38;

[0164] Figure 41 is a top perspective view of the proboscis tip adaptor of Figure 38;

[0165] Figure 42 is a partial bottom view showing engagement between the proboscis and the proboscis tip adaptor.Detailed description of the embodiments

[0166] Reference is made to Figures 1 -5 which illustrate a stent insertion device 10 in accordance with one embodiment of the invention.

[0167] Stent insertion device 10 is adapted to provide an improved means of inserting a stent (and particularly a ureteric stent) by enabling suitably coordinated movement of a guide wire and a stent pusher. The stent pusher is separate to the stent and functions to contact the proximal end of the stent to distally advance the stent, such that when the pusher is moved by stent insertion device 10 in the distal direction, the stent is also moved in the distal direction.

[0168] Use of stent insertion device 10 simplifies the stent insertion process for a practitioner as they are not required to manually manipulate the wire and stent pusher independently or together, instead being able to insert the stent in a simplified and intuitive manner. It is proposed that stent insertion, and particularly ureteric stent insertion, will be within the ability of a non-specialist medical practitioner when utilising stent insertion device 10.

[0169] As best shown in Figures 1 , 2 and 5, stent insertion device 10 includes a housing 12 having a substantially circular, enlarged portion 13 and an elongated portion 14, which generally extends tangentially from the enlarged portion 13. Elongated portion 14 serves as a gripping region for stent insertion device 10 and, in one embodiment, can be of a length of about 100mm. Housing 12 defines an interior space in which is housed various components of stent insertion device 10, including a substantial part of feeding mechanism 30, as well as the electronic componentry, which will be described further below. As best shown in Figures 6 and 7, housing 12 is formed of two generally symmetrical half shells (when split along a longitudinal plane of stent insertion device 10) - a first housing shell portion 17 and a second housing shell portion 18. It will be appreciated that housing shell portions 17, 18 can be connected together in any suitable way known in the art (e.g. fasteners, adhesive or other mechanical joining connections).

[0170] First housing shell portion 17 includes a central circular opening 15 and second housing shell portion 18 includes a central circular opening 16, wherein circular openings 15, 16 are of substantially the same size. When housing shell portions 17, 18 are fixed together, central openings 15, 16 are arranged concentrically and also provide access to an elongated handle 11 , which generally spans across the void formed bycentral openings 15, 16. As will be discussed further below, handle 11 is configured to operate feeding mechanism 30. Handle 11 is configured to rotate about a transverse axis T, which extends through a centre of openings 15, 16, in a first rotational direction R1 (clockwise when viewing Figure 1 ) and a second rotational direction R2 (anticlockwise when viewing Figure 1 ).

[0171] The preferred orientation of use of stent insertion device 10 is as shown in Figure 1 , i.e. where the longer side of housing 12 is facing down. In this orientation, the user has greater handling of the device and can in some cases rest the device on an underlying surface.

[0172] Stent insertion device 10 includes an elongate shaft in the form of proboscis 20 having a proximal end 21 and a distal end 23. Proboscis 20 is effectively a form of cystoscope as will be appreciated from the description to follow. Proboscis 20 is configured to provide passage therethrough for a guide wire 32, a stent pusher 34 and a stent 36. In particular, passage through proboscis 20 for guide wire 32, stent pusher 34 and stent 36 is provided by a first, lower lumen 22 (Figure 29) that extends through the entire length of proboscis 20. Lower lumen 22 is also configured to provide passage for a flushing fluid (as will be described further below). Proboscis 20 further includes an upper lumen 24 (Figure 29) configured to provide passage for a video camera. In the present embodiment, lower lumen 22 and upper lumen 24 are separate passages that extend through proboscis 20. When device 10 is not in use, a proboscis protective cap 26 can be fitted over a tip of proboscis 20, which helps protect the distal portion of guide wire 32 extending from proboscis 20. Proboscis 20 is sufficiently long such that its distal terminus can be brought sufficiently close to the location within the body that is to receive the stent. In the present example, where the device is for the delivery of a ureteric stent, proboscis 20 must be sufficiently long so as to pass through the urethra until the distal end of proboscis 20 is in the bladder. Proboscis 20 would typically be of a length between about 26 cm and about 30 cm, with a length of about 27-28.5 cm preferred in various cases. Proboscis 20 can have an outer diameter of about 5 mm and an inner diameter of 4 mm in one example.

[0173] Proboscis 20 is typically rigid or semi-rigid so as to allow the user to alter the position of the proboscis terminus. For example, where the device is for insertion of aureteric stent, the practitioner may alter the angle of proboscis 20 until its terminus is directed toward the opening of the ureter to be stented. Alternatively, the proboscis 20 may be flexible, but “steerable” using mechanisms known to a person skilled in the art.

[0174] The exploded views of Figures 6 and 7 illustrate the componentry contained within housing 12. This includes feeding mechanism 30, which is configured to provide coordinated movement of guide wire 32 and stent pusher 34 in the process of stent insertion. The arrangement of guide wire 32 and stent pusher 34 are best illustrated in Figure 31 . As will become apparent from further discussion below, guide wire 32 is passed through stent pusher 34, which is in the form of a tubular wire, such that at least part of guide wire 32 is generally contained within stent pusher 34. Guide wire 32 and stent pusher 34 enter the proximal end 21 of proboscis 20 via a winding guide 27, which will be described in further detail below.

[0175] Feeding mechanism 30 is configured to concurrently advance both guide wire 32 and stent 36, the latter of which by way of advancing stent pusher 34, up until such point that guide wire 32 reaches its predetermined distalmost position. This distalmost position corresponds to the distal terminus of guide wire 32 being placed approximately 310 mm from the tip of proboscis 20. This coincides with the distal terminus of guide wire 32 being located approximately at the renal pelvis. After the distal terminus of guide wire 32 has reached its predetermined distalmost position, feeding mechanism 30 is configured to halt further distal advancement of guide wire 32, but enable continued distal advancement of stent pusher 34, and consequently distal advancement of stent 36 until stent pusher 34 reaches its predetermined distalmost position. This distalmost position corresponds to the distal terminus of stent pusher 34 being placed substantially flush with the distal terminus of proboscis 20. After the distal terminus of stent pusher 34 has reached its predetermined distalmost position, feeding mechanism 30 is configured to halt further distal advancement of stent pusher 34. At this point, feeding mechanism 30 enables retraction of guide wire 32. Once guide wire 32 is fully retracted, i.e. the distal terminus of guide wire 32 is within and substantially flush with the distal terminus of proboscis 20, feeding mechanism 30 is configured to prevent any further advancing / retracting of guide wire 32. With guide wire 32 withdrawn, stent 36 assumes its final position with its resilient terminal ends returning to their biased coiled state, such that its distal terminal end is retained in the renal pelvis and its proximal terminal end isretained in the bladder. Whilst in the present embodiment a double-J ureteric stent is utilised, it will be appreciated that other forms of stents could be used instead. In one example, it is envisaged that a standard 4.8 Fr to 5 Fr ureteric stent (having lengths ranging from 22-32cm) is manually loaded into stent insertion device 10 prior to use.

[0176] It will be understood that stent insertion device 10 has a plurality of operative stages within a single operation cycle, as shown in Figure 31 . These operative stages are:1 ) A loading stage - the stage where stent 36 is loaded into device 10 until the distal terminal end of stent 36 is positioned substantially flush with the tip of proboscis 20;2) A priming stage - the stage where device 10 is made ready for use on a subject;3) An advancing stage - the stage where device 10 advances guide wire 32, stent pusher 34, and stent 36. The advancing stage concludes when the distal terminus of guide wire 32 reaches its predetermined distalmost position;4) A delivery stage - the stage where stent 36 is fully advanced such that it is completely ejected from device 10; and5) A retraction stage - the stage where guide wire 32 is retracted such that the distal terminus of guide wire 32 is substantially flush with the tip of proboscis 20, thereby allowing stent 36 to assume its final position.

[0177] In the present embodiment, feeding mechanism 30 includes a plurality of interengaging coaxial winders that together operate in conjunction with surfaces within housing 12 to provide the earlier described advancing and retracting functionality. In the present embodiment, there are three winders used: 1 ) a wire winder 40; 2) a central engager 60; and 3) a pusher winder 100. Wire winder 40, central engager 60 and pusher winder 100 are configured to rotate about a common axis of rotation, that being transverse axis T. Central engager 60 is sized to fit inside a circular hollow formed between wire winder 40 and pusher winder 100 so as to allow central engager 60 torotate within the hollow while preventing any material misalignment of the rotational axes of wire winder 40 and pusher winder 100. This also provides for a relatively lower profile arrangement of the coaxial winders, thereby providing for a more compact housing.

[0178] Feeding mechanism 30 will now be described in detail.

[0179] With reference to Figures 24-28, feeding mechanism 30 includes wire winder 40, which is substantially in the form of an annular disc. As will be described further below, guide wire 32 is fixedly connected to wire winder 40 such that rotational movement of wire winder 40 corresponds to advancing or retracting guide wire 32. In the assembled state of stent insertion device 10, rotational movement of wire winder 40 in first rotational direction R1 results in advancing guide wire 32, in particular distally advancing a distal terminus of guide wire 32, whilst rotational movement of wire winder 40 in second rotational direction R2 results in retracting guide wire 32, in particular moving proximally a distal terminus of guide wire 32.

[0180] Wire winder 40 includes a first, outward-facing side 42 (best shown in Figure 24) and an opposed second, inward-facing side 44 (best shown in Figure 26). It will be appreciated here that outward-facing refers to side 42 facing towards first housing shell portion 17 or away from central engager 60, which in this example is the centrally disposed winder. It will be further appreciated here that inward-facing refers to side 44 facing towards central engager 60 or away from the nearest housing shell portion.

[0181] Wire winder 40 includes a recessed portion 41 extending from a radially inner end thereof and generally defining a void 43. A substantially circumferentially extending finger 47 extends from a first side 45 of recessed portion 41 and across a substantial length of void 43. It will be appreciated that finger 47 is essentially cantilevered with respect to first side 45 and that a proximal end of finger 47 is integrally formed with wire winder 40. Finger 47 has a gradually increasing cross-section from its proximal end to its distal end, from which projects an engagement pin 46 outwardly from first side 42 towards first housing shell portion 17. Engagement pin 46 projects substantially perpendicular to first side 42 and is configured to engage with a track 70 formed on an interior side 19 of first housing shell portion 17. Engagement pin 46 is of substantially cylindrical form, but it will be appreciated that engagement pin 46 may adopt otherforms. At its distal end, finger 47 includes a nib portion 49 that projects further towards a second side 48 of recessed portion 41 than the remainder of the distal terminus of finger 47. As will be appreciated from Figure 24, nib portion 49 defines a shoulder 50. Finger 47 acts as a generally resilient member that is biased towards a radially inward position as shown in Figure 24, which depicts a relaxed, initial state of finger 47. Finger 47 is configured to operatively engage with a resilient one-way sprung catch 51 , which is in the form of a generally radially outwardly extending projection that extends into void 43 from second side 48 of recessed portion 41 . Catch 51 acts as a generally resilient member that is biased towards an unloaded position as shown in Figure 24, which depicts a relaxed, initial state of catch 51 . As will be described in further detail below, during operation, finger 47 is adapted to be urged radially outwardly resulting in nib portion 49 pushing against resilient catch 51 and moving catch 51 towards a loaded position. Continued radial outward movement of finger 47 eventually results in nib portion 49 moving over and out of engagement with resilient catch 51 . Once this occurs, catch 51 is free to spring back towards its unloaded position, at which point catch 51 engages with shoulder 50 (i.e. a lower surface of nib portion 49) and prevents any radially inward movement of finger 47 (and consequently, pin 46). Pin 46 therefore assumes a new, radially outward position.

[0182] Wire winder 40 further includes a radially inwardly extending indent 52 configured to receive a wire winder latch 85 provided on central engager 60. Indent 52 facilitates operative engagement between wire winder 40 and central engager 60, such that rotation of central engager 60 results in corresponding rotation of wire winder 40. Thus, when central engager 60 and wire winder 40 are operatively engaged, central engager 60 is movably associated with wire winder 40.

[0183] With reference to Figure 26, a proximal terminus of guide wire 32 is fixed with respect to wire winder 40 at anchoring region 53. Guide wire 32 can be suitably retained at anchoring region 53 in any number of ways, including adhesive, a fastener or other retaining means. As best shown in Figure 25, which depicts a peripheral side 54 of wire winder 40, there is provided a plurality of castellations 56 extending radially outwardly from said peripheral side 54 and spaced along the circumference of wire winder 40. Specifically, there is provided a first set of circumferentially spaced apart castellations 56 towards first side 42 and a second set of circumferentially spaced apart castellations56 towards second side 44. It will be appreciated that the first set of castellations 56 are angularly offset with respect to the second set of castellations 56. Castellations 56 generally serve two purposes in this embodiment - 1 ) the first and second set of castellations 56 together define a groove 57 therebetween to enable guide wire 32 to be at least partially wound around wire winder 40, and 2) castellations 56 simplify manufacture of wire winder 40 by injection moulding (eliminating moving cores in the injection moulding tool).

[0184] As best shown in Figure 26, wire winder 40 further includes a substantially circular interior rim 58 extending from and perpendicular to second side 44. Rim 58 defines in part a first radial outwardly extending indent 59 and a second radial outwardly extending indent 55 circumferentially spaced therefrom. Rim 58 does not have a constant radius of curvature, instead having a generally reducing radius of curvature along the section of rim 58 between first radial outwardly extending indent 59 and second radial outwardly extending indent 55. As will be described in further detail below, first indent 59 is configured to provide an area for resilient one-way catch 67 of central engager 60 to rest with respect to wire winder 40 during initial operative engagement (e.g. during loading, priming and advancing stages) between central engager 60 and wire winder 40, including when wire winder 40 and central engager 60 are arranged to move together in first rotational direction R1. In this respect, when one-way catch 67 is disposed directly adjacent a side of first indent 59, one-way catch 67 is in a relaxed / unloaded state. In contrast to first indent 59, second indent 55 is configured to provide an area for resilient one-way catch 67 of central engager 60 to engage with wire winder 40. In particular, when central engager 60 rotates with respect to wire winder 40 during the delivery stage, one-way catch 67 will be urged radially inwardly by the reduced radius of curvature section of rim 58 until it reaches second indent 55, at which point one-way catch releases its stored energy and moves one-way catch 67 radially outwardly and into position adjacent second indent 55. During the retraction stage, oneway catch 67 urges against second indent 59, resulting in concurrent movement of central engage 60 and wire winder 40 in second rotational direction R2.

[0185] Reference is now made to Figure 10, which illustrates interior side 19 of first housing shell portion 17. As previously mentioned, track 70 is formed on interior side 19 of first housing shell portion 17. Track 70 is defined by inwardly (i.e. directed towardsthe inside of housing 12) projecting walls which are integrally formed with first housing shell portion 17. Track 70 includes a first curved track portion 71 and a second curved track portion 72, each of said track portions configured to define a path of movement for engagement pin 46. First curved track portion 71 is disposed radially inwardly from second curved track portion 72, and extends about 270° of a revolution about central opening 15 of first housing shell portion 17. Track portion 71 includes a first terminal end 73 and a second terminal end 74, wherein second terminal end 74 generally defines an area of overlap with track portion 72, specifically at a first terminal end 75 of track portion 72. Engagement pin 46 is configured to locate about a starting position A of track portion 71 at the start of the loading stage. It will be appreciated that starting position A is not at first terminal end 73 of track portion 71 . In fact, starting position A is approximately 35° from first terminal end 73. As will be further appreciated from the discussion to follow, starting position A corresponds to providing an initial length of guide wire 32 extending outside proboscis 20. In one example, the initial length is 50 mm. The initial length of guide wire 32 extending outside proboscis 20 is provided to facilitate loading of the stent into stent insertion device 10 during the loading stage. When the stent has been fully loaded within stent insertion device 10 (i.e. the distal terminal end of stent 36 is positioned substantially flush with the tip of proboscis 20), stent insertion device 10 is made ready for use during the priming stage by retracting guide wire 32 such that the distal terminus of guide wire 32 is substantially flush with the tip of proboscis 20. This retraction of guide wire 32 coincides with engagement pin 46 being moved from starting position A to primed position B, which is at first terminal end 73 of track portion 71 .

[0186] It will be understood that track portion 71 is not a precise circular arc with a common radius of curvature. Track portion 71 includes a ramped portion 76 at or towards second terminal end 74. Ramped portion 76 is defined by a portion of track portion 71 having an increased radius of curvature. Due to ramped portion 76, when engagement pin 46 travels along track portion 71 from primed position B towards second terminal end 74 and along ramped portion 76, ramped portion 76 will urge engagement pin 46 radially outwardly. It will be appreciated that this coincides with the earlier described movement of finger 47, which carries engagement pin 46, against resilient catch 51 , thereby moving catch 51 towards its loaded position until eventually nib portion 49 of finger 47 moves over and out of engagement with resilient catch 51.Once this occurs, catch 51 springs back towards its unloaded position, at which point catch 51 engages with shoulder 50 and prevents any radially inward movement of finger 47. The consequence of this is that engagement pin 46 will now be retained in a new, radially outward position, effectively placing pin 46 at first terminal end 75 of track portion 72. In use, this movement of engagement pin 46 from primed position B to first terminal end 75 of track portion 72 coincides with distal advancement of guide wire 32 and stent pusher 34, i.e. coinciding with the advancing stage of operation.

[0187] Track portion 72 is disposed radially outwardly from track portion 71 , and extends about 360° of a revolution about central opening 15 of first housing shell portion 17. Track portion 72 includes first terminal end 75 (as earlier described) and a second terminal end 77, wherein the second terminal end 77 defines a terminus of track 70. At terminal end 77 is provided a lock-off gate 78 that is biased radially outwardly into the path defined by track portion 72. When engagement pin 46 is moved from first terminal end 75 to second terminal end 77, engagement pin 46 moves along the path of track portion 72. Once engagement pin 46 reaches lock-off gate 78, continued movement of engagement pin 46 results in pin 46 pushing lock-off gate 78 radially inwardly in order to open the path defined by track portion 72. Once engagement pin 46 traverses past lock- off gate 78, lock-off gate 78 releases its stored energy and springs radially outwardly back into the path of track portion 72, thereby preventing movement back along the path. Given that engagement pin 46 is at the second terminal end 77, no further movement of engagement pin 46 is possible. Movement of engagement pin 46 from first terminal end 75 to second terminal end 77 coincides with the retraction stage of operation, in which guide wire 32 is retracted back into stent insertion device 10 with the end of travel of pin 46 coinciding with the distal terminus of guide wire 32 being substantially flush with the tip of proboscis 20.

[0188] With reference to Figures 14-18, feeding mechanism 30 includes central engager 60, which is substantially in the form of a circular disc with a pair of diametrically opposed, semi-circular shaped openings 61 extending through central engager 60. By virtue of openings 61 , central engager 60 defines earlier described handle 11 . As best shown in Figures 1 , 2 and 5, handle 11 is accessible from outside of housing 12 by virtue of the position of handle 11 with respect to first housing shell portion 17 and second housing shell portion 18, i.e. handle 11 is accessible throughcentral openings 15, 16 of the housing shell portions. As will be appreciated from the discussion below, handle 11 provides a user the means to operate feeding mechanism 30. In particular, the user manually operates feeding mechanism 30 by directly manipulating (in this case rotating) central engager 60, which then drives rotation of wire winder 40 and pusher winder 100 (more on this below). It will also be appreciated that by providing access to handle 11 through openings 15, 16, the user can operate stent insertion device 10 by either right or left hand.

[0189] Central engager 60 includes a first side 63 (best shown in Figure 14) and an opposed second side 64 (best shown in Figure 16). It will be appreciated here that in the assembled stent insertion device 10, first side 63 faces towards wire winder 40, whilst second side 64 faces towards pusher winder 100. Central engager 60 includes resilient one-way catch 67, which is in the form of an extension extending tangentially from an outer peripheral side of central engager 60. It will be appreciated that central engager 60 includes a truncated side 65 adjacent to one-way catch 67, wherein a slit 66 is defined between said truncate side 65 and one-way catch 67. Slit 66 provides an area of space for one-way catch 67 to flex when urged radially inwardly during rotational movement of central engager 60 with respect to wire winder 40. As will be appreciated from the later discussion, one-way catch 67 is urged radially inwardly during the delivery stage.

[0190] Central engager 60 further includes a first recess 68 extending from first side 63 towards second side 64 and a second recess 69 extending from first side 63 towards second side 64. First recess 68 and second recess 69 are circumferentially spaced apart about 39°. A first slot 80 extends radially inwardly from outer peripheral side 81 of central engager 60 and into first recess 68. In this way, first recess 68 defines a ledge 82 surrounding an outer periphery of first slot 80. Similarly, a second slot 83 extends radially inwardly from outer peripheral side 81 of central engager 60 and into second recess 69. In this way, second recess 69 defines a ledge 84 surrounding an outer periphery of second slot 83. Each of first slot 80 and second slot 83 are configured to receive respective engagement members, wherein first slot 80 is configured to receive a wire winder latch 85, and second slot 83 is configured to receive a pusher winder latch 86. Wire winder latch 85 is configured to be slidably received within first slot 80 and pusher winder latch 86 is configured to be slidably received within second slot 83.

[0191] Wire winder latch 85 is a unitary body including a substantially wedge-shaped projection 87 (best shown in Figure 17) extending towards wire winder 40 in the assembled stent insertion device 10. Projection 87 is configured to operatively engage with indent 52 of wire winder 40, such that rotation of central engager 60 is transferred into corresponding rotation of wire winder 40. Although it will be described in further detail below, it will be understood that central engager 60 becomes disengaged from wire winder 40, i.e. no longer movably associated with wire winder 40, when wire winder latch 85 is moved radially inwardly along slot 80 such that it no longer is engaged with indent 52. Wire winder latch 85 further includes a substantially block-shaped projection 88 extending towards pusher winder 100 in the assembled stent insertion device 10. Wire winder latch 85, including projection 87, has a width substantially equal to the width of first recess 68, such that when wire winder latch 85 is slidably received within first slot 80, wire winder latch 85 is snugly received within first recess 68 such that wire winder latch 85 is generally prevented from moving in a direction other than along the length of first slot 80 (i.e. in the radial direction). In order to facilitate suitable mounting of wire winder latch 85 into first slot 80, wire winder latch 85 includes a notch 89 extending from a lower end thereof (when viewed as shown in Figure 14) upwardly that provides a degree of resilience and flexibility for wire winder latch 85 to be moved along slot 80 during operation. When wire winder latch 85 is suitably received within slot 80, an underside of wire winder latch 85 bears against ledge 82, whilst the narrower projection 88 resides snugly between the opposed peripheral sides of slot 80. Extending towards pusher winder 100 from wire winder latch 85 is an engagement pin 90 configured to engage with a track 120 formed on an interior side 121 of second housing shell portion 18. Engagement pin 90 is of substantially cylindrical form, but it will be appreciated that engagement pin 90 may adopt other forms.

[0192] Similar to wire winder latch 85, pusher winder latch 86 is a unitary body, including a substantially wedge-shaped projection 91 , which is narrower than the rest of pusher winder latch 86, extending towards pusher winder 100 in the assembled stent insertion device 10. Projection 91 is configured to operatively engage with indent 102 of pusher winder 100 (discussed further below), such that rotation of central engager 60 is transferred into corresponding rotation of pusher winder 100. Although it will be described in further detail below, it will be understood that central engager 60 becomes disengaged from pusher winder 100, i.e. no longer movably associated with pusherwinder 90, when pusher winder latch 86 is moved radially inwardly along slot 83 such that it no longer is engaged with indent 102. Pusher winder latch 86 has a width substantially equal to the width of second recess 69, such that when pusher winder latch 86 is slidably received within second slot 83, pusher winder latch 86 is snugly received within second recess 69 such that pusher winder latch 86 is generally prevented from moving in a direction other than along the length of second slot 83 (i.e. in the radial direction). In order to facilitate suitable mounting of pusher winder latch 86 into second slot 83, pusher winder latch 86 includes a notch 92 extending from a lower end thereof (when viewed as shown in Figure 14) upwardly that provides a degree of resilience and flexibility for pusher winder latch 86 to be moved along slot 83 during operation. When pusher winder latch 86 is suitably received within slot 83, an underside of pusher winder latch 86 bears against ledge 84, whilst the narrower projection 91 resides snugly between the opposed peripheral sides of slot 83. Extending towards pusher winder 100 from pusher winder latch 86 is an engagement pin 93 configured to engage with track 120 formed on interior side 121 of second housing shell portion 18. Engagement pin 93 is of substantially cylindrical form, but it will be appreciated that engagement pin 93 may adopt other forms.

[0193] With reference to Figures 19-23, feeding mechanism 30 includes pusher winder 100, which is substantially in the form of an annular disc. As will be described further below, stent pusher 34 is fixedly connected to pusher winder 100 such that rotational movement of pusher winder 100 corresponds to advancing or retracting stent pusher 34. In the assembled state of stent insertion device 10, rotational movement of pusher winder 100 in first rotational direction R1 results in advancing stent pusher 34, in particular advancing a distal terminus of stent pusher 34, whilst rotational movement of pusher winder 100 in second rotational direction R2 results in retracting stent pusher 34, in particular retracting a distal terminus of stent pusher 34. As described earlier, the distal terminus of stent pusher 34 is positioned directly adjacent a proximal terminal end of stent 36 loaded into stent insertion device 10, such that rotational movement of pusher winder 100 in first rotational direction R1 to advance stent pusher 34 results in pushing stent 36 distally.

[0194] Pusher winder 100 includes a first, outward-facing side 103 (best shown in Figure 21 ) and an opposed second, inward-facing side 104 (best shown in Figure 19). Itwill be appreciated here that outward-facing refers to side 103 facing towards second housing shell portion 18 (or away from central engager 60). It will be further appreciated here that inward-facing refers to side 104 facing towards central engager 60 (or away from the nearest housing shell portion).

[0195] As best shown in Figure 21 , pusher winder 100 includes an engagement pin 105, which extends outwardly from and substantially perpendicular to first side 103 (i.e. towards second housing shell portion 18). Engagement pin 105 is configured to engage with track 120 formed on interior side 121 of second housing shell portion 18.Engagement pin 105 is of substantially cylindrical form, but it will be appreciated that engagement pin 105 may adopt other forms.

[0196] Pusher winder 100 further includes a radially inwardly extending indent 102 configured to receive pusher winder latch 86 provided on central engager 60, specifically projection 91. Indent 102 facilitates operative engagement between pusher winder 100 and central engager 60, such that rotation of central engager 60 results in corresponding rotation of pusher winder 100. Thus, when central engager 60 and pusher winder 100 are operatively engaged, central engager 60 is movably associated with pusher winder 100.

[0197] With reference to Figure 19, a proximal terminus of stent pusher 34 is fixed with respect to pusher winder 100 at anchoring region 106. Anchoring region 106 includes a substantially arcuate-shaped pocket 107 configured to receive therein the proximal terminus of stent pusher 34, with a substantially arcuate-shaped cover 108 (Figure 22) configured to fixedly secure the proximal terminus of stent pusher 34 within pocket 107 and therefore fixedly secure stent pusher 34 to pusher winder 100. A snap-fit connection is envisaged between cover 108 and pocket 107. However, it will be appreciated that stent pusher 34 can be suitably retained at anchoring region 106 in any number of ways known in the art.

[0198] As best shown in Figure 20, which depicts a peripheral side 109 of pusher winder 100, there is provided a plurality of castellations 101 extending from said peripheral side 109 and spaced along the circumference of pusher winder 100. Specifically, there is provided a first set of circumferentially spaced apart castellations towards first side 103 and a second set of circumferentially spaced apart castellationstowards second side 104. It will be appreciated that the first set of castellations are angularly offset with respect to the second set of castellations. Castellations 101 generally serve two purposes in this embodiment - 1 ) the first and second set of castellations 101 together define a groove 110 therebetween to enable stent pusher 34 to be wound around pusher winder 100, and 2) castellations 110 simplify manufacture of pusher winder 100 by injection moulding (eliminating moving cores in the injection moulding tool). It will be noted that pocket 107 forms a shallow angle relative to the tangent formed with an inner circumferential edge face of second side 104 so as to limit bending of guide wire 32 as it transitions out of pocket 107 and into groove 110.

[0199] Reference is now made to Figure 11 , which illustrates interior side 121 of second housing shell portion 18. As previously mentioned, track 120 is formed on interior side 111 of second housing shell portion 18. Track 120 is defined by inwardly (i.e. directed towards the inside of housing 12) projecting walls which are integrally formed with second housing shell portion 18. Track 120 includes a first curved track portion 122, a second curved track portion 123 and a third curved track portion 124. First curved track portion 122 is disposed radially inwardly from second curved track portion 123, which is disposed radially inwardly from third curved track portion 124.

[0200] First curved track portion 122 is a closed circular loop and thus extends 360° of a revolution about central opening 16 of second housing shell portion 18. Track portion 122 defines a path for movement of engagement pin 90 of wire winder latch 85. The starting position of engagement pin 90 with respect to track portion 122 is denoted C. Track portion 122 further includes a disengagement ramp 125, which projects into the path of track portion 122, and is configured to engage with engagement pin 90 when engagement pin 90 encounters disengagement ramp 125 during rotation of central engager 60 with respect to track 120. In particular, as engagement pin 90 encounters disengagement ramp 125, engagement pin 90 is urged along sloped surface 126 of disengagement ramp 125, thereby causing wire winder latch 85 of central engager 60 to move radially inwardly along slot 80 until ultimately wire winder latch 85 moves out of engagement with indent 52 of wire winder 40, thereby disengaging central engager 60 from wire winder 40 such that continued movement of central engager 60 in the first rotational direction R1 does not cause any rotation of wire winder 40.

[0201] Second curved track portion 123 is a closed circular loop and thus extends 360° of a revolution about central opening 16 of second housing shell portion 18. Track portion 123 defines a path for movement of engagement pin 93 of pusher winder latch 86. The starting position of engagement pin 93 with respect to track portion 123 is denoted D. Track portion 123 further includes a disengagement ramp 127, which projects into the path defined by track portion 123, and is configured to engage with engagement pin 93 when engagement pin 93 encounters disengagement ramp 127 during rotation of central engager 60 with respect to track 120. In particular, as engagement pin 93 encounters disengagement ramp 127, engagement pin 93 is urged along sloped surface 128 of disengagement ramp 127, thereby causing pusher winder latch 86 of central engager 60 to move radially inwardly along slot 83 until ultimately pusher winder latch 86 moves out of engagement with indent 102 of pusher winder 100, thereby disengaging central engager 60 from pusher winder 100 such that continued movement of central engager 60 in the first rotational direction R1 does not cause any rotation of pusher winder 100.

[0202] Third curved track portion 124 defines a substantially circular path that extends just short of a 360° revolution about central opening 16 of second housing shell portion 18. Thus, track portion 124 defines a first terminal end 129 and a second terminal end 130. Track portion 124 defines a path for movement of engagement pin 105 of pusher winder 100. The starting position of engagement pin 105 with respect to track portion 124 is denoted E. As will be best appreciated from Figure 11 , a one-way, movable starting latch 131 is provided within track portion 124. Latch 131 includes a first, capturing end 132 and an opposed second, hinged end 133. Latch 131 is configured to prevent rotational movement of pusher winder 100 in the first rotational direction R1 during the loading stage of operation by preventing engagement pin 105 from moving beyond latch 131 along track portion 124, but allow rotational movement of pusher winder 100 in the second rotational direction R2 during the priming stage of operation by allowing engagement pin 105 to move along track portion 124. Movement of pusher winder 100 in first rotational direction R1 is prevented during the loading stage of operation because the loading stage involves a terminal portion of guide wire 32 protruding out of proboscis 20 to facilitate loading of stent 36 into stent insertion device 10. Once the stent has been fully received within the stent insertion device 10, the only action allowed by feeding mechanism 30 is the initial retraction in which guide wire 32,stent pusher 34 and stent 36 are together retracted, during the priming stage, so that stent insertion device 10 is ready for use. This initial retraction is allowed by latch 131 . As the user rotates central engager 60 in the second rotational direction R2 during the priming stage, a corresponding rotation of pusher winder 100 is affected. Rotation of pusher winder 100 causes engagement pin 105 to urge against capturing end 132, causing latch 131 to rotate about hinged end 133 and out of the path defined by track portion 124. Engagement pin 105 can therefore move towards first terminal end 129, and once there, no further rotation in second rotational direction R2 is allowed. This completes the priming stage of operation with stent insertion device 10 ready for use. Hinged end 133 of latch 131 is configured to remain in the pivoted position, away from the path of track portion 124, such that rotational movement of pusher winder 100 in first rotational direction R1 is no longer prevented, i.e. engagement pin 105 is no longer prevented from moving in first rotational direction R1 along track portion 124 by latch 131 . Latch 131 is received by a suitably shaped indent 134 formed by track portion 124.

[0203] At terminal end 130 of track portion 124 is provided a lock-off gate 135 (similar to lock-off gate 78) that is biased radially inwardly into the path of track portion 124. When engagement pin 105 is moved from first terminal end 129 to second terminal end 130, engagement pin 105 moves along track portion 124. Once engagement pin 105 reaches lock-off gate 135, continued movement of engagement pin 105 results in pin 105 pushing lock-off gate 135 radially outwardly in order to open the path defined by track portion 124. Once engagement pin 105 traverses past lock-off gate 135, lock-off gate 135 releases its stored energy and springs radially inwardly back into the path of track portion 124, thereby preventing movement back along the path of track portion 135. Given that engagement pin 105 is at the second terminal end 130, no further movement of engagement pin 105 is possible. Movement of engagement pin 105 from first terminal end 129 to second terminal end 130 coincides with distally advancing stent pusher 34 until the distal terminus of stent pusher 34 reaches its final predetermined position, which is substantially flush with a tip of proboscis 20. During part of this travel of stent pusher 34, guide wire 32 is also being advanced as part of the advancing stage of operation, whilst the latter part of this travel of stent pusher 34, stent pusher 34 is being advanced without advancing of guide wire 32 as part of the delivery stage. When engagement pin 105 reaches the end of its path, pusher winder 100 is prevented from any further rotation in either the first or second rotational direction, thereby representingthe end of movement of stent pusher 34. This coincides with the end of the delivery stage, i.e. the stent has now been fully ejected from within stent insertion device 10.

[0204] Thus, with the components of feeding mechanism 30 now described, a summation of the operation of feeding mechanism 30 will now be provided based on typical operational stages of stent insertion device 10 previously described (see Figure 31 ).

[0205] At the loading stage, a distal portion of guide wire 32 (e.g. about 50 mm) extends from the tip of proboscis 20. This distal portion of guide wire 32 facilitates loading of stent 36, as guide wire 32 is passed through the lumen of stent 36 and the stent is pushed proximally along guide wire 32 and into stent insertion device 10 via proboscis 20 until the stent is fully within stent insertion device 10 (i.e. with the distal terminus of stent 36 being substantially flush with the tip of the proboscis 20).

[0206] With regards to feeding mechanism 30, at this loading stage:1 ) central engager 60 is operatively engaged with wire winder 40 and pusher winder 100. This is due to wire winder latch 85 being engaged with indent 52 of wire winder 40 and pusher winder latch 86 being engaged with indent 102 of pusher winder 100.2) engagement pin 46 of wire winder 40 is positioned at starting point A with respect to track 70 (in track portion 71 ).3) engagement pin 105 of pusher winder 100 is positioned at starting point E with respect to track 120 (in track portion 124).4) latch 131 blocks engagement pin 105 of pusher winder 100 from moving in first rotational direction R1 . As central engager 60 is operatively engaged with pusher winder 100, central engager 60 is therefore also prevented from moving in first rotational direction R1 . Thus, central engager 60 can only move in second rotational direction R2.5) engagement pin 90 of wire winder latch 85 is positioned at point C with respect to track 120 (in track portion 122) and engagement pin 93 ofpusher winder latch 86 is positioned at point D with respect to track 120 (in track portion 123).

[0207] During the priming stage, the user rotates central engager 60 in second rotational direction R2 so that the distal portion of guide wire 32 is retracted into proboscis 20, such that the distal terminus of guide wire 32 is substantially flush with the tip of proboscis 20, and stent insertion device 10 is ready for use. This retraction involves:1 ) central engager 60 being rotated in second rotational direction R2, resulting in corresponding rotation in second direction R2 of both wire winder 40 and pusher winder 100, until further movement in second rotational direction R2 is prevented.2) rotation of central engager 60 in the second direction involves engagement pin 46 of wire winder 40 rotating from point A towards first terminal end 73, and engagement pin 105 of pusher winder 100 rotating from starting point E towards first terminal end 129. The latter involves engagement pin 105 urging against latch 131 , causing latch 131 to rotate out of the path of track portion 124 (with latch 131 remaining in this rotated position within indent 134).3) rotation of central engager 60 in second rotational direction R2 also involves engagement pin 90 of wire winder latch 85 and engagement pin 93 of pusher winder latch 86 moving a commensurate amount in the second rotational direction within track portions 122 and 123, respectively.4) further movement in the second rotational direction of central engager 60 is ultimately prevented by the simultaneous abutment of engagement pin 46 of wire winder 40 against terminal end 73 of track portion 71 and abutment of engagement pin 105 of pusher winder 100 against terminal end 129 of track portion 124.

[0208] Once stent insertion device 10 is primed, the advancing stage can begin. This stage involves the concurrent advancement, i.e. in the distal direction, of guide wire 32 and stent pusher 34 (and consequently, stent 36). This advancement involves:) central engager 60 being rotated in first rotational direction R1. ) movement of central engager 60 corresponds in movement of wire winder 40 in first rotational direction R1 . Engagement pin 46 moves along the path in track portion 71 from terminal end 73 towards terminal end 74. Before reaching terminal end 74, engagement pin 46 traverses across ramped portion 76, which causes engagement pin 46 to be urged radially outwardly until nib portion 49 of finger 47, which carries engagement pin 46, moves over and out of engagement with resilient catch 51 of wire winder 40. Once this occurs, catch 51 springs back towards its unloaded position, at which point catch 51 engages with shoulder 50 and prevents any radially inward movement of finger 47. The consequence of this is that engagement pin 46 will now be retained in a new, radially outward position, effectively placing pin 46 at first terminal end 75 of track portion 72. ) movement of central engager 60 corresponds in movement of pusher winder 100 in first rotational direction R1. Engagement pin 105 moves along the path in track portion 124 from terminal end 129 towards terminal end 130. ) rotation of central engager 60 in first rotational direction R1 also involves engagement pin 90 of wire winder latch 85 and engagement pin 93 of pusher winder latch 86 moving a commensurate amount in the first rotational direction R1 within track portions 122 and 123, respectively. During the advancing stage, engagement pin 90 will encounter disengagement ramp 125, by which engagement pin 90 is urged along sloped surface 126 of disengagement ramp 125 radially inwardly. This causes wire winder latch 85 of central engager 60 to move radially inwardly along slot 80 until ultimately wire winder latch 85 moves out of engagement with indent 52 of wire winder 40, thereby disengaging central engager 60 from wire winder 40 such that continued movement of central engager 60 in first rotational direction R1 does not cause any rotation of wire winder 40. This completes the advancing stage, at which point the distal terminus of guide wire 32 is at its distalmost point. This distalmost point is about 310mm from the tip of the proboscis 20. This length is considered suitable for the majority of the population to ensure the ureteric stent is suitably delivered such that its ends coil up and are suitably retained between the bladder and kidney.

[0209] Stent insertion device 10 can now proceed to the delivery stage, i.e. the stage where stent 36 is fully ejected from stent insertion device 10. In order for the stent to be fully ejected from stent insertion device 10, stent pusher 34 continues to be advanced, without further advancement of guide wire 32 (i.e. stent pusher 34 moves independently of guide wire 32). This delivery stage involves:1 ) central engager 60 continuing to be rotated in first rotational direction R1 .2) as central engager 60 is now disengaged from wire winder 40, central engager 60 now rotates in the first rotational direction R1 with respect to wire winder 40.3) continued rotation in the first rotational direction of central engager 60 will continue to rotate pusher winder 100 in first rotational direction R1. Engagement pin 105 will therefore continue to move along the path in track portion 124 until it reaches terminal end 130. Concurrently, engagement pin 93 of pusher winder latch 86 (and engagement pin 90 of wire winder latch 85, albeit no longer consequential) continues to move along track portion 123 (track portion 122 for engagement pin 90). Once engagement pin 105 reaches lock-off gate 135, continued movement of engagement pin 105 results in pin 105 pushing lock-off gate 131 radially outwardly in order to open the path defined by track portion 124. Once engagement pin 105 traverses past lock-off gate 135, lock-off gate 135 releases its stored energy and springs radially inwardly back into the path of track portion 124, thereby preventing movement of engagement pin 105 back along the path. Given that engagement pin 105 is at the second terminal end 130, no further movement of engagement pin 105 is possible, and pusher winder 100 is halted, i.e. pusher winder 100 can no longer rotate with respect to second housing shell portion 18. Concurrently to the above, engagement pin 93 will encounter disengagement ramp 127, by which engagement pin93 is urged along sloped surface 128 of disengagement ramp 127 radially inwardly. This causes pusher winder latch 86 of central engager 60 to move radially inwardly along slot 83 until ultimately pusher winder latch 86 moves out of engagement with indent 102 of pusher winder 100, thereby disengaging central engager 60 from pusher winder 100 such that continued movement of central engager 60 in first rotational direction R1 does not cause any rotation of pusher winder 100. Thus, simultaneously, pusher winder 100 will no longer be able to rotate with respect to second housing shell portion 18 and central engager 60 will become disengaged from pusher winder 100. This completes the delivery stage, at which point the distal terminus of stent pusher 34 is at its distalmost point. This distalmost point coincides with being substantially flush with the tip of proboscis 20. Stent 36 has therefore now been fully ejected from stent insertion device 10.4) the continued rotation in first rotational direction R1 of central engager 60 with respect to wire winder 40 will result in one-way catch 67, which was initially positioned adjacent first indent 59 and therefore in a relaxed / unloaded state, being urged radially inwardly during movement of central engager 60 until it reaches second indent 55, at which point oneway catch 67 releases its stored energy and moves one-way catch 67 radially outwardly and into position adjacent second indent 55.

[0210] It will be appreciated from the above therefore that the advancing and delivery stages occur sequentially through constant movement of central engager 60 in first rotational direction R1 . In other words, once the user wishes to begin the stent delivery process (i.e. begin the advancing stage), the user simply moves central engager 60 in first rotational direction R1 continuously until device 10 prevents further movement in first rotational direction R1 , at which point both advancing and delivery stages have been completed.

[0211] The user can now proceed to the wire retraction stage, i.e. the stage where guide wire 32 is fully withdrawn back into stent insertion device 10. Withdrawal of guide wire 32 allows the stent to assume its final position with its resilient terminal endsreturning to their biased coiled state, such that its distal terminal end is retained in the renal pelvis and its proximal terminal end is retained in the bladder. The wire retraction stage involves:1 ) central engager 60 being rotated in second rotational direction R2.2) whilst central engager 60 is not engaged to wire winder 40 by way of wire winder latch 85, central engager 60 is movably associated with wire winder 40 by way of one-way catch 67 of central engager 60 and second indent 55. Rotation of central engager 60 in the second rotational direction R2 causes one-way catch 67 to urge against second indent 55 and therefore central engager 60 drives wire winder 40 in the second rotational direction R2.3) movement of wire winder 40 involves engagement pin 46 moving along the path of second track portion 72 of track 70 from first terminal end 75 towards second terminal end 77. This movement corresponds to retraction of guide wire 32. Once engagement pin 46 traverses past lock-off gate 78, lock-off gate 78 releases its stored energy and springs radially outwardly back into the path of track portion 72, thereby preventing movement of engagement pin 46 back along the path. Given that engagement pin 46 is at the second terminal end 77, no further movement of engagement pin 46 is possible, and wire winder 40 is halted, i.e. wire winder 40 can no longer rotate with respect to first housing shell portion 17. This therefore represents a final lock-off point for stent insertion device 10 as central engager 60 can no longer move either of wire winder 40 or pusher winder 100. This also represents completion of a single operation cycle of stent insertion device 10.

[0212] Thus, the entire operation cycle of stent insertion device 10 involves: 1 ) loading the stent into device 10, 2) an initial movement of central engager 60 in second rotational direction R2 to prime device 10 for use, 3) movement of central engager 60 in first rotational direction R1 until stent 36 has been fully ejected from device 10, and 4) movement of central engager 60 in second rotational direction R2 to withdraw guide wire 32.

[0213] With reference to Figures 6 and 7, device 10 further includes electrical componentry contained within housing 12. Most of the electrical componentry is generally retained in a cavity formed between elongated portions of housing 12 in order to isolate these components from the coaxial winders of feeding mechanism 30. The electrical componentry include a printed circuit board (PCB) 140, to which is wired a battery 141 configured to power an LED 142 and a video camera (not shown). LED 142 is configured to provide the user an indication that device 10 is powered on and ready for use. In some implementations, device 10 may have a magnetic switch. In such an implementation, packaging of device 10 may include a magnet so that once device 10 is removed from the packaging, the magnetic switch is activated and device 10 is powered on. Proboscis 20 includes a camera insertion slot 28 configured to provide passage for the video camera having an integrated LED light (more on this below) allowing for visualisation of anatomical structures inside to the subject’s body. When device 10 is assembled, insertion slot 28 resides in close proximity to PCB 140. In one implementation, the camera is operatively connected to PCB 140 and inserted through insertion slot 28, where it is sealed against water ingress.

[0214] Reference is made to Figure 32, which illustrates a stent insertion system 200. Stent insertion system 200 includes stent insertion device 10 and a smart device 210 to which stent insertion device 10 is operatively connected. Smart device 210 may be in the form of a tablet, smartphone, or other electronic device. Smart device 210 includes a display 212. Raw images / video captured by the camera can be transmitted to smart device 210 and be viewable on display 212. To this end, smart device 210 can include a dedicated, custom software application pre-installed on smart device 210 to perform image processing and display a live video feed to assist a user of stent insertion device 10 during a procedure. In an alternative embodiment, some or all processing of the raw images / video can be done onboard the stent insertion device 10. For example, onboard firmware of stent insertion device 10 may be used to manage image capture and transmission, whilst the software application of smart device 210 performs image processing and displays the live video.

[0215] Connection between stent insertion device 10 and smart device 210 can be wired or wireless. In an envisaged wired implementation, raw image / video transmission can be provided via a USB-C cable of stent insertion device 10 being connected tosmart device 210. For example, Figure 32 shows stent insertion device 10 having an exit port for a USB-C cable 214 of about 2m length (although this is merely exemplary). Thus, the images / video captured by the camera are transmitted via PCB 140 and the USB-C cable to smart device 210. In such an implementation, smart device 210 can function as both a display monitor and a power source, i.e. smart device 210 can function to power stent insertion device 10. Smart device 210 providing this dual functionality can mean that battery 141 is not required as part of stent insertion device 10.

[0216] A suitable camera or camera assembly 220 is shown in Figure 33. Camera assembly 220 is configured to enable real-time, high-resolution endoscopic visualization, particularly of the ureteric opening in the bladder of a patient. In this embodiment camera assembly 220 includes an imaging sensor 222, which can be any suitable imaging sensor such as a Omnivision OCHTA10 Complementary Metal-Oxide- Semiconductor (CMOS) sensor. Positioned about imaging sensor 222 is a plurality of light sources 224 configured to illuminate a region about proboscis 20. In the depicted embodiment, light sources 224 are equispaced 90° about imaging sensor 224 and each light source 224 is a white LED. Imaging sensor 222 and light sources 24 can be encapsulated in a biocompatible epoxy adhesive and disposed within upper lumen 24 of proboscis 20. Camera assembly 220 is connected to PCB 140 via a wired connection, the wire extending from PCB 140 within housing 12 into upper lumen 24 of proboscis 20 via camera insertion slot 28 and then to camera assembly 220.

[0217] Various components can be operatively connected to PCB 140. The various components can include one or more of: a microcontroller with digital video port (DVP) camera interface and integrated high speed USB2.0 transceiver; image signal processor (ISP) to configure the imaging sensor and process analog video data output from the imaging sensor; an authentication chip; connection to the camera assembly; connection to the USB-C cable; USB power and data isolation circuitry; etc. Firmware of stent insertion device 10 can include: USB device communications for managing USB communication with a host; camera control for configuring and controlling the camera assembly and image processing; video capture; hardware abstraction layer for low level hardware interface and system services; system control for control and main application logic including memory management and USB command processing. PCB 140 can beconformally coated with an acrylic coating to provide a suitable level of water resistance and thus ensure there is no safety impact or functionally deterioration (e.g. loss of image quality from the camera assembly) throughout a procedure as a result of water ingress.

[0218] The software application of smart device 210 can have various functionality including one or more of: manage all USB device communication and control; image processing including converting raw camera sensor data to displayable images, and performing image enhancement; a user interface for displaying processed video frames and device status to a user; provide application lifecycle management and shared services; diagnostics monitoring including video frame quality monitoring, tablet system status (including battery level) monitoring, alerts and troubleshooting advice to user.

[0219] It will be appreciated from Figure 32 that a slightly different embodiment of stent insertion device 10 is illustrated. This embodiment of stent insertion device 10 includes a sliding locking switch 360, wherein when sliding locking switch 360 is in the locked position as shown in Figure 32, handle 11 is prevented from rotating, and when sliding locking switch 360 is in the unlocked position (not shown), handle 11 is free to be rotated about second rotational direction R2 for the priming stage of operation. In this embodiment, pusher winder 100 includes a locking pin (not shown) that locates on an interior side of sliding locking switch 360 when in the locked position, thereby locking rotation of pusher winder 100 and therefore prevents central engager 60 / handle 11 (which could otherwise have moved in second rotational direction R2 for the priming stage as earlier discussed) from moving. Moving sliding locking switch 360 into the unlocked position releases engagement of the locking pin from pusher winder 100 and thus allows a user to begin the priming stage. This locking feature is particularly useful during transport, storage and initial handling of stent insertion device 10, thereby obviating the potential to inadvertently begin the operation cycle before it is intended.

[0220] It will also be appreciated that this different embodiment of stent insertion device 10 also includes markings on housing 12 that indicate to the user the sequence of moving handle 11 - i.e. 1 ) in second rotational direction R2 (for priming stage), 2) in first rotational direction R1 (for advancing and delivery stages), and 3) in second rotational direction R2 (for wire retraction stage).

[0221] Proboscis 20 partially locates within and is secured to housing 12 in the assembled device. In particular, device 10 includes a junction block 143 connected to a distal end of winding guide 27. Junction block 143 includes a first axially extending bore (not shown) extending from a proximal face 144 thereof, and a second axially extending bore 145 extending from a distal face 146 thereof. The first bore and second bore 145 are in open communication with each other via a through-hole (not shown), thereby allowing passage therethrough of guide wire 32 and stent pusher 34 to proboscis 20. The first bore is configured to receive tubular end 29 of winding guide 27, with 0-rings 147 located within tubular end 29 providing a fluid seal between junction block 143 and winding guide 27 so that no flushing fluid escapes back towards feeding mechanism 30. Second bore 145 is configured to fixedly receive proximal end 21 of proboscis 20. The attachment between junction block 143 and proboscis 20 can be achieved in any suitable way known in the art. In the depicted embodiment, a keyed arrangement is provided, with a keyway 25 disposed at proximal end 21 of proboscis 20, and a corresponding key (not shown) projecting within second bore 145.

[0222] Device 10 further includes a fluid adaptor 150 configured to facilitate fluid connection between proboscis 20 and a flushing fluid source (not shown). A flushing fluid may be used to clear any suspended solids that would interfere with the vision of the camera. For example, urine within the bladder may be cloudy, having insoluble suspended materials such as blood, casts, crystals, tissue debris, colonies of microorganisms and the like. Thus, providing a means of flushing such material away from the camera lens to improve visibility is therefore desirable. Fluid adaptor 150 is of substantially tubular form having an axially extending channel 151 , with proboscis 20 extending through channel 151 such that the interior of fluid adaptor 150 is positioned about a portion of proboscis 20 that includes a fluid inlet 153 (see Figure 30). Fluid adaptor 150 further includes an inlet port 152, which extends substantially perpendicular to channel 151 (in the depicted embodiments, inlet port 152 projects in a generally upward direction), configured to admit a flushing liquid into lower lumen 22 of proboscis 20 via fluid inlet 153. The flushing liquid may travel under gravity or by way of some active transport means into device 10 via inlet port 152, channel 151 , and into the lower lumen 22 via fluid inlet 153, with the flushing fluid then generally travelling to the distal end 23 of proboscis 20 where it exits from lower lumen 22. As will be understood, thefluid used for flushing must be biocompatible, with a sterile normal saline solution being generally preferred.

[0223] Fluid adaptor 150 includes a distal end portion 154 and a proximal end portion 155, each of which define threaded male connecting ends. Distal connecting end 154 is configured to sealingly engage with a fluid adaptor tip 156, which includes a threaded female connecting end configured to mate with distal connecting end 154 with an 0-ring 157 disposed therebetween. Proximal connecting end 155 is configured to sealingly engage with a fluid adaptor cap 158, which includes a threaded female connecting end configured to mate with proximal connecting end 155 with an O-ring 159 disposed therebetween. A fluid tight seal is therefore achieved between fluid adaptor 150 and proboscis 20 such that there is no unintended fluid leakage externally or fluid leakage into housing 12. In the assembled device 10, fluid adaptor 150 is secured to housing 12 within a suitably shaped cavity 160 defined between first housing shell portion 17 and second housing portion 18, wherein cavity 160 receives fluid adaptor cap 158 and a proximal portion of fluid adaptor 150 (as best shown in Figure 30).

[0224] Reference is made to Figures 34 to 42, which illustrate a proboscis 320 and proboscis tip adaptor 330 for stent insertion device 10. In this embodiment, proboscis320 is substantially in the form of an elongate, generally uniform tube without separate upper and lower lumens in the manner previously described with respect to proboscis 20. Like proboscis 20, proboscis 320 includes a keyway 325 disposed at proximal end321 to facilitate connection with junction block 143, as well as an insertion slot 328 at an upper region of proboscis 320. However, unlike proboscis 20 that included a separate fluid inlet 153, insertion slot 328 now serves to admit a flushing liquid into proboscis 320, as well as providing passage camera assembly 220 (including wiring thereof). In this particular embodiment, as best shown in Figure 36, fluid adaptor 380 is provided. Fluid adaptor 380 is similar in many respects to fluid adaptor 150 except for the inclusion of a cable passage 382, which projects angularly and proximally with respect to fluid adaptor 380. Cable passage 382 includes an internal channel 384 through which a camera assembly cable passes through from PCB 140. As shown in Figure 37, a seal is provided within cable passage 382 to ensure that a fluid tight connection is formed so that no flushing fluid inadvertently flows back into housing 12. Further seals 382 arealso provided in other locations associated with connection of proboscis 320 with stent insertion device 10 to similarly prevent inadvertently flow back into housing 12.

[0225] Whereas proboscis 20 provided separate upper and lower lumens to separate camera assembly 220 and guide wire 32, this separation is now provided by provision of proboscis tip adaptor 330. Proboscis tip adaptor 330 is configured to be attached to proboscis 320 at or near a distal end 323 thereof. Proboscis 320 includes a connector slot 324 near to but spaced away from distal end 323 of proboscis 320 and an alignment feature in the form of a keyway 326 at distal end 323. As best shown in Figure 42, slot 324 and keyway 326 are configured to operatively engage with complementary features of proboscis tip adaptor 330 in order to suitably attach proboscis tip adaptor 330 to proboscis 320. Adaptor 330 is configured to be partially slidably received within proboscis 320 as will be described further below.

[0226] With reference to Figures 38 to 41 , proboscis tip adaptor 330 includes an elongate body 339 of generally tubular form. Body 339 has a proximal end 331 and a distal end 332. Body 339 further includes a substantially crescent-shaped lumen 334 extending between proximal end 331 and distal end 332 and configured to communicate with the interior of proboscis 320 when adaptor 330 is connected to proboscis 320. Thus, when stent insertion device 10 is in use, guide wire 32, pusher 34, stent 36 and a suitable flushing fluid all pass through lumen 334 of adaptor 330. As best shown in Figure 40, a plurality of guiding projections (in this embodiment, four) 335 generally extend radially inwardly from the interior of lumen 334 near distal end 332. Guiding projections 335 are configured to linearly align guide wire 32 with respect to proboscis 320 to aid insertion into the ureter.

[0227] Adaptor 330 further includes an upper passage 340 generally extending between proximal end 331 and distal end 332. As will be appreciated from Figure 39, upper passage 340 generally consists of three distinguishable portions - a first passage portion 342 generally in the form of a narrow open slit that extends between proximal end 331 and an approximate mid-point of body 339; a second passage portion 344 generally in the form of a relatively wider and deeper open slit that extends from first passage portion 342 towards, but short of, distal end 332; and a third passage portion 346 in the form of a closed tubular end. In use, wiring for camera assembly 220 passesthrough proboscis 320 and is then guided along the top of adaptor 330 through first and second passage portions 342, 344 until they reach camera assembly 220, which is housed within third passage portion 346. Thus, adaptor 330 ensures that the wiring for camera assembly 220 can be clear of guide wire 32, which would be within lumen 334, as well as guide the flow of irrigation fluid through first and second passage portions 342, 344 past camera assembly 220 to clear debris from the field of view and assist in heat dissipation. Camera assembly 220 can be contained within a tubular housing (e.g. a stainless-steel housing) that is fitted within third passage portion 346.

[0228] Adaptor 330 further includes a deflectable boss 352 extending from a lower side of body 339. Boss 352 is configured to locate within slot 324 of proboscis 320 in order to lock adaptor 330 to proboscis 320 when adaptor 330 is slidably received within proboscis 320. In order to slide adaptor 330 into proboscis 320, boss 352 is deflected inwardly, in order for slide adaptor to fit within proboscis 320. Adaptor 330 is then slid until boss 352 aligns with slot 324, at which point boss 352 springs back to its initial position, thereby residing tightly within slot 324. Boss 352 is of generally wedge-shape, whereby once positioned within slot 324, a thicker portion of the wedge abuts the internal periphery of slot 324, thereby preventing adaptor 330 from being pulled distally out of engagement with proboscis 320. To assist in proper alignment between adaptor 330 and proboscis 320, adaptor 330 includes a proximally extending key 354 configured to complementarily engage with keyway 326 of proboscis 320. Key 354 is provided on an enlarged distal portion 356 of body 339 such that when adaptor 330 is slidably received within proboscis 320, enlarged distal portion 356 of body 339 extends beyond the distal tip of proboscis 320 (e.g. extends about 4mm from the distal tip of proboscis 320). Figure 42 shows the connection between adaptor 330 and proboscis 320. It will be appreciated that when adaptor 330 is connected to proboscis 320, the external diameter of the proboscis / adaptor assembly is uniform (e.g. about 5mm) to allow safe insertion into the urethra without the creation of any catch points that could cause patient harm.

[0229] A typical procedure for inserting a ureteric stent using stent insertion device 10 will now be described.

[0230] After administration of adequate paint relief, a patient is positioned in a frog leg position and a sterile field is prepared. Stent insertion device 10 is provided and, in thisembodiment, is connected to a smart device 210 by wired connection such that smart device 210 powers stent insertion device 10. An IV administration set is connected to fluid adaptor 150 via inlet port 152 (e.g. through a luer-lock connection) and the guide wire 32 of stent insertion device 10 is primed with saline solution for a few seconds before being switched off.

[0231] At this stage, ureteric stent 36 can now be loaded into stent insertion device 10 in the manner previously described with respect to the loading stage of the feeding mechanism. In an embodiment where stent insertion device 10 includes sliding locking switch 360, sliding locking switch 360 must be moved to its unlocked position before being able to begin the priming stage. Once sliding locking switch 360 is in the unlocked position, handle 11 is rotated about second rotational direction R2 so that the distal portion of guide wire 32 is retracted into proboscis 20, such that the distal terminus of guide wire 32 is substantially flush with the tip of proboscis 20.

[0232] Saline solution flow can now be restarted, and a distal portion of proboscis 20 can be inserted in the patient’s urethra and guided into the bladder. Using display 212 of smart device 210, a user locates the ureteric opening of interest and positions a distal tip of proboscis 20 near the ureteric opening (e.g. about 1 -2 cm away from the ureteric opening). At this stage, the saline solution flow can be turned off. The user can now proceed to the advancing and delivery stage of the operation cycle by rotating handle 11 about first rotational direction R1 as previously described, with a smooth operational transition taking place between the advancing stage and the delivery stage, i.e. between the stage where both guide wire 32, stent pusher 34 and stent 36 are all advancing concurrently, and the stage where only stent pusher 34 and stent 36 are advancing. It will be understood that during the advancing stage the user will be able to confirm that guide wire 32 enters the ureteric opening and that it is followed by the stent. At the end of the delivery stage, stent insertion device can provide a positive indication, such as a clicking sound, to indicate that further rotation of handle 11 about first rotational direction R1 is not possible.

[0233] The user can now proceed to the wire retraction stage of the operation cycle by rotating handle 11 about second rotational direction R2 as previously described until guide wire 32 is fully withdrawn back into stent insertion device 10. Withdrawal of guidewire 32 allows the stent 36 to assume its final position with its resilient terminal ends returning to their biased coiled state, such that its distal terminal end is retained in the renal pelvis and its proximal terminal end is retained in the bladder. The user can now verify (at least in part) suitable stent positioning visually using display 212 of smart device 210, particularly whether a proximal end of stent 36 has assumed the correct position in the bladder. A scan (such as an x-ray) can be used after the procedure to verify overall stent positioning.

[0234] Stent insertion device 10 is typically adapted for single-use application. Once feeding mechanism 30 has completed its operational cycle, device 10 is rendered inactive (device 10 cannot be ‘reset’, and attempts to do so will damage the device). Housing 12, wire winder 40, central engager 60 (and associated latched) and pusher winder 100 can be made of a suitable plastic material. Examples of suitable plastic material include a polycarbonate ABS blend and polyoxymethylene (POM). Adaptor 300 can be made of a suitable polymer material, such as a polypropylene. The various engagement pins can be made of a metal material, such as aluminium or stainless steel. The O-rings can be made from a suitable rubber material such as butyl rubber. The proboscis can be made from a suitable metal material such as stainless steel (e.g. a single walled tube of 304-grade). A person skilled in the art will appreciate that these materials are all exemplary, and that other suitable materials may be utilised that serve the desired function, including any biocompatibility requirements. A person skilled in the art will also appreciate that stent insertion device 10 could be made more durable so that it provides more than a single use. In such circumstances, there may be certain components of the device that may need to be replaced and / or resterilised in order to enable re-useability and other materials may need to be used for this purpose. It will be understood that stent insertion device 10 includes a predetermined length of guide wire 32. For example, a suitable length may be between 1.1 and 1.3m, although it will be appreciated that the length is designed based on the feeding mechanism utilised (e.g. based on the diameter of wire winder 40, central engager 60 and pusher winder 100) as well as the anticipated length needed for the patient population.

[0235] It will be understood that the invention disclosed and defined in this specification extends to all alternative combinations of two or more of the individual featuresmentioned or evident from the text or drawings. All of these different combinations constitute various alternative aspects of the invention.

Claims

CLAIMS1 . An apparatus for inserting a stent into a bodily structure of a subject, the apparatus comprising: a housing; a stent guide wire having a distal terminus; a stent pusher having a distal terminus; a feeding mechanism for moving the distal terminus of the stent guide wire and the distal terminus of the stent pusher distally, the feeding mechanism including a rotatable actuator engageable to move said respective termini; wherein the feeding mechanism is configured such that rotation of the actuator in a first direction concurrently advances the distal terminus of the stent guide wire and the distal terminus of the stent pusher until the distal terminus of the stent guide wire reaches a first predetermined position at which continued rotation of the actuator in the first direction advances only the distal terminus of the stent pusher until the distal terminus of the stent pusher reaches a second predetermined position, at which continued rotation of the actuator in the first direction is prevented and the stent is positioned at or proximate a desired stent delivery position, and wherein the feeding mechanism is further configured such that rotation of the actuator in a second direction, opposite the first direction, retracts the distal terminus of the stent guide wire until the distal terminus of the stent guide wire is retracted into the apparatus.

2. The apparatus of claim 1 , wherein the feeding mechanism includes: a first rotatable winder about which a portion of the stent guide wire is wound, the first winder being rotatable relative to the housing to move the distal terminus of the stent guide wire distally toward or along a bodily structure of a subject and proximally away or along a bodily structure of a subject; a second rotatable winder about which a portion of the stent pusher is wound, the second winder being rotatable relative to the housing to advance the distal terminus of the stent pusher distally; anda rotatable driver configured to move the first and second rotatable winders.

3. The appartus of claim 2, wherein the rotatable driver is configured to advance the distal terminus of the stent guide wire toward or along a bodily structure of the subject to the first predetermined position and to advance the distal terminus of the stent pusher distally to the second predetermined position, said second predetermined position being proximal the first predetermined position and coinciding with the apparatus positioning the stent at or proximate to the desired stent delivery position, wherein the rotatable driver is further configured to retract the distal terminus of the stent guide wire.

4. The appartus of claim 2 or 3, wherein the actuator forms part of the rotatable driver.

5. The apparatus of any one of claims 2 to 4, wherein said rotatable driver includes a first engagement feature and said first winder includes a first, operatively associated engagement feature, such that when said respective first engagement features are operatively engaged with each other, the rotatable driver and the first winder are adapted to move together resulting in movement of the distal terminus of the stent guide wire proximally and / or distally.

6. The apparatus of claim 5, wherein the rotatable driver is configured to disengage from the first winder and move with respect to the first winder when the stent guide wire reaches the first predetermined position.

7. The apparartus of claim 5 or 6, wherein said rotatable driver includes a second engagement feature and said first winder includes a second, operatively associated engagement feature, such that when said respective second engagement features are operatively engaged with each other, the rotatable driver and the first winder are adapted to move together to move the distal terminus of the stent guide wire proximally to retract the distal terminus of the stent guide wire.

8. The appartus of any one of claims 5 to 7, wherein the first winder includes a third engagement feature configured to engage with a corresponding engagement feature carried on or formed with an inner surface of a first portion of the housing, such that when said third engagement feature and corresponding engagement feature areoperatively engaged with each other, the first winder is adapted to move with respect to said inner surface of the first portion of the housing.

9. The apparatus of claim 8, wherein the third engagement feature of the first winder is in the form of a projection extending from the first winder towards the first portion of the housing, and said corresponding engagement feature of said inner surface of the first portion of the housing includes a track configured to operatively engage with the third engagement feature of the first winder.

10. The apparatus of claim 9, wherein the track is spaced radially from and extends circumferentially about an axis of rotation of the rotatable driver.11 . The apparatus of claim 9 or 10, wherein said track includes a gate configured to provide one-way passage of the third engagement feature of the first winder, wherein the third engagement features passes through the gate when the distal terminus of the stent guide wire is retracted into the apparatus, thereby preventing passage of the third engagement feature back in the first direction.

12. The apparatus of any one of claims 2 to 11 , wherein said rotatable driver includes a third engagement feature and said second winder includes a first, operatively associated engagement feature, such that when said first engagement feature of the second winder and said third engagement feature of the rotatable driver are operatively engaged with each other, the rotatable driver and the second winder are adapted to move together resulting in movement of the distal terminus of the stent pusher distally.

13. The apparatus of claim 12, wherein the rotatable driver is configured to disengage from the second winder and move with respect to the second winder when the stent pusher reaches the second predetermined position.

14. The appartus of claim 12 or 13, wherein the second winder includes a second engagement feature configured to engage with a corresponding engagement feature carried on or formed with an inner surface of a second portion of the housing, such that when said second engagement feature and corresponding engagement feature are operatively engaged with each other, the second winder is adapted to move with respect to said inner surface of the second portion of the housing.

15. The apparatus of claim 14, wherein the second engagement feature of the second winder is in the form of a projection extending from the second winder towards the second portion of the housing, and said corresponding engagement feature of said inner surface of the second portion of the housing includes a track configured to operatively engage with the second engagement feature of the second winder.

16. The apparatus of claim 15, wherein the track is spaced radially from and extends circumferentially about an axis of rotation of the rotatable driver.

17. The apparatus of claim 15 or 16, wherein said track includes a gate configured to provide one-way passage of the second engagement feature of the second winder, wherein the second engagement features passes through the gate when the distal terminus of the stent pusher reaches the second predetermined position, thereby preventing passage of the third engagement feature back in the second direction.

18. The apparatus of any one of the preceding claims, further including a proboscis extending from the housing, the proboscis having a lumen through which the stent guide wire, the stent pusher and the stent pass.

19. The appartus of claim 18, wherein an operation cycle of the feeding mechanism of the apparatus includes: a loading stage in which the stent is loaded into the apparatus until a distal terminus of the stent is positioned substantially flush with a tip of the proboscis, wherein said distal terminus of the guide wire projects outside the proboscis to faciliateb loading of the stent; a priming stage in which the distal terminus of the guide wire is retracted by rotation of the actuator in the second direction; an advancing stage in which the actuator is rotated in said first direction concurrently advancing the distal terminus of the stent guide wire and the distal terminus of the stent pusher until the distal terminus of the stent guide wire reaches the first predetermined position; a delivery stage in which said continued rotation of the actuator in the first direction advances only the distal terminus of the stent pusher until the distal terminusof the stent pusher reaches the second predetermined position, at which continued rotation of the actuator in the first direction is prevented and the stent is positioned at or proximate the desired stent delivery position; and a retraction stage in which the actuator is rotated in said second direction retracting the distal terminus of the stent guide wire until the distal terminus of the stent guide wire is retracted into the apparatus.20 The apparatus of claim 19 insofar as dependent on any one of claims 15 to 17, wherein said track of the second portion of the housing includes a further gate configured to provide one-way passage of the second engagement feature of the second winder, wherein said further gate provides passage of the second engagement feature in the second direction but prevents passage of the second engagement feature in the first direction during the loading stage.21 . The apparatus of any one of the preceding claims, wherein the apparatus includes an initiator operatively associated with the feeding mechanism, wherein, upon activation, the initiator is configured to allow operation of the feeding mechanism, and prior to activation of the initiator, the initiator prevents operation of the feeding mechanism.

22. The apparatus of claim 21 , wherein the initiator includes a movable portion configured to operatively engage with the second winder, thereby preventing movement of the movable driver when the moveable portion is in a locked position.

23. The apparatus of any one of the preceding claims, wherein the apparatus includes a camera assembly configured to capture video and / or images of a procedure.

24. The apparatus of claim 23, wherein the camera assembly includes an imaging sensor and one or more light sources configured to illuminate a region about the apparatus when in use.

25. The apparatus of claim 24, wherein the camera assembly includes a housing configured to house the imaging sensor and the one or more light sources.

26. The apparatus of any one of claims 23 to 25, wherein the camera assembly is operatively connected to a printed circuit board disposed within the apparatus housing.

27. The apparatus of any one of claims 23 to 26 insofar as dependent on claim 18, further including an adaptor configured to be attached to the proboscis, wherein said adaptor is configured to house or support the camera assembly or at least part of the camera assembly.

28. The apparatus of claim 27, wherein the adaptor is configured to be attached at a distal end of the proboscis.

29. The apparatus of claim 27 or 28, wherein the adaptor includes one or more engagement features, and the proboscis includes one or more complementary engagement features, such that when the respective engagement features are suitably engaged together, the adaptor is attached to the proboscis.

30. The apparatus of any one of claims 27 to 29, wherein the proboscis is configured to slidingly receive the adaptor.31 . The apparatus of any one of claims 27 to 30, wherein the adaptor includes a lumen configured to communicate with the lumen of the proboscis when the adaptor is attached to the proboscis.

32. The apparatus of claim 31 , wherein the adaptor includes one or more guiding features extending into the lumen of the adaptor, wherein the one or more guiding features are configured to linearly align the guide wire with respect to the proboscis and / or the adaptor.

33. The apparatus of any one mof claims 27 to 32, wherein the adaptor includes a passage generally extending between a proximal end and a distal end thereof, wherein said passage is configured to house or support the camera assembly.

34. The apparatus of claim 33, wherein the passage is configured to guide wiring to the camera assembly.

35. The apparatus of any one of the preceding claims, wherein the stent is a double-J ureteric stent.

36. A method for inserting a stent into a bodily structure of a subject using the apparatus of any one of the preceding claims.

37. A stent insertion kit, said kit including the apparatus of any one claims 1 to 35; and a stent for insertion into the apparatus.

38. A stent insertion system, the stent insertion system including: the apparatus of any one claims 1 to 35; and an electronic device operatively connected to the apparatus.

39. The system of claim 38, wherein the electronic device is a smart device including one of: a smartphone, tablet, or computer.

40. The system of claim 38 or 39, wherein the electronic device includes a display, wherein the display is operatively associated with a camera assembly of the apparatus such that images / video captured by the camera assembly are displayed to a user.41 . The system of any one of claims 38 to 40, wherein the electronic device is configured to power the apparatus.

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