Delivery devices and delivery methods

Abstract

A delivery device comprises: an inner shaft having a delivery platform for deploying an intraluminal device; an outer sheath surrounding the inner shaft, and the outer sheath is configured to cover the delivery platform as pre-deployed, and the outer sheath is configured to be withdrawn from at least one of the delivery platforms as part of the deployment of the intraluminal device; an outer sheath rack comprising a plurality of teeth and connected to the outer sheath; a handle housing, the inner shaft and the outer sheath rack being at least partially positioned within the handle housing, the handle housing comprising at least one pawl configured to engage with a plurality of teeth on the outer sheath rack to prevent the outer sheath from being re-wrapped on the delivery platform after deployment; a shuttle member having a pair of deflection arms configured to selectively engage with a plurality of teeth on the outer sheath rack; and a trigger mechanically connected to the shuttle member such that actuation of the trigger causes movement of the shuttle member, and movement of the shuttle member withdraws the outer sheath so as to avoid covering the delivery platform.

Description

[0001] This application is a divisional application of the application with application date of January 29, 2016 (divisional filing date of February 28, 2018), application number 201810168955.6, and invention name “delivery device and delivery method”. In addition, the 201810168955.6 patent application is a divisional application of the application with application date of January 29, 2016 (entered the Chinese national phase on July 21, 2017), national application number 201680006766.8 (international application number PCT / US2016 / 015793), and invention name “delivery device and delivery method”. Technical Field

[0002] Delivery devices and delivery methods are disclosed herein. Certain embodiments are described with reference to the sequential delivery of multiple intraluminal devices by a delivery device. The delivery devices and methods can be used in surgical treatments for treating atherosclerotic occlusive disease, but are not limited to these surgical treatments. Background Art

[0003] There are many medical conditions and surgical treatments where devices such as stents are placed in the body to create or maintain a passageway. There are a variety of stents for different purposes, from expandable coronary stents, vascular stents, and bile duct stents to plastic stents used to allow urine to flow between the kidney and bladder.

[0004] Stents are often placed in the vascular system following a medical procedure such as balloon angioplasty. Balloon angioplasty is commonly used to treat atherosclerotic occlusive disease. Atherosclerotic occlusive disease is the leading cause of stroke, heart attack, amputation, and death in the United States and the industrialized world. Atherosclerotic plaques form a hard layer along the walls of arteries and can include calcium, cholesterol, compacted thrombi, and cellular debris. As atherosclerotic disease progresses, the blood supply intended to pass through a particular blood vessel is diminished or even prevented by the occlusive process. One of the most widely used methods for treating severe atherosclerotic plaques clinically is balloon angioplasty, which may be accompanied by stent placement. Summary of the invention

[0005] Currently available stents and stent delivery systems have a number of limitations and disadvantages.There is a continuing need for improved intraluminal devices and related delivery devices.

[0006] According to certain embodiments, a delivery device is provided for sequentially delivering a plurality of intraluminal devices (e.g., stents, nails, staples, etc.) that are retained in a compressed state on the delivery device. For the purposes of this disclosure, the word nail will be used to describe an intraluminal device among the many intraluminal devices that can be deployed from the delivery device. The delivery device may include a plurality of delivery platforms, each of which is configured to be used to pin in a compressed position on the delivery device, and each of which has a unique shape portion, such as a non-constant outer diameter portion, an hourglass-shaped portion, a tapered proximal half, a ridge portion, a recessed portion, etc. The unique shape portion may be positioned between an annular pusher band, which may also be a radiopaque marker.

[0007] In some embodiments, the unique shape is provided by a uniquely shaped sleeve made of a flexible material that surrounds a stiffer inner shaft. Additionally, the annular pusher band may be made of a wire or segment made of a material that increases flexibility while maintaining radiopacity.

[0008] The staple deployment method may include aligning a radiopaque marker on the outer sheath with a radiopaque marker on the staple to be deployed prior to deployment.

[0009] A method of marker band alignment and intraluminal device or nail delivery can be performed. The method may include: advancing a delivery device having a plurality of nails in a compressed state to a treatment area; each nail including a plurality of struts and a radiopaque marker positioned in a central region of the nail, each nail having the same size and the radiopaque marker positioned in the same position; the delivery device including an inner core and an outer sheath, the inner core having a plurality of delivery platforms, each delivery platform having one of the plurality of nails, the outer sheath covering the inner core and the delivery platform, the outer sheath having a radiopaque marker band positioned at the proximal end of the distal end; withdrawing the outer sheath until the radiopaque marker band on the outer sheath is aligned with the radiopaque marker on the first nail to be delivered; before releasing the nail, aligning the two radiopaque markers with the treatment area (such as a tissue peel or lesion to be treated); then withdrawing the outer sheath to release the nail.

[0010] In some embodiments, the delivery device may include an inner shaft, a delivery platform, and an outer sheath. The delivery platform may include: a pair of annular bands around the inner shaft, two of the annular bands having a first outer diameter; and a sleeve. The sleeve may be fastened to the inner shaft and positioned between the annular bands. The sleeve may have a hardness lower than the hardness of the inner shaft and preferably also lower than the hardness of the pair of annular bands. The sleeve may also have a non-constant outer diameter smaller than the first outer diameter of the annular band. The delivery platform may be configured to receive an intraluminal device to deploy the intraluminal device from the delivery device into a blood vessel, and the delivery platform is configured to receive the intraluminal device between the annular bands and on the sleeve. The outer sheath may be positioned on the inner shaft and the delivery platform and is capable of sliding on the inner shaft and the delivery platform, the outer sheath having a pre-deployment position and at least one delivery position, the pre-deployment position covering the delivery platform, in the at least one delivery position, the outer sheath is withdrawn to expose at least one of the annular bands of the delivery platform and the sleeve.

[0011] According to some embodiments, multiple additional delivery platforms for sequentially delivering multiple intraluminal devices may be included. Each additional delivery platform may include additional sleeves and additional annular bands. Each of the annular bands may have a radius on the proximal portion and / or include a radiopaque spiral coil. The radiopaque spiral coil may be enclosed in a polymer having a hardness higher than that of the polymer forming the sleeve.

[0012] The sleeve may include any number of different shapes and sizes, and may include ridges, dots, depressions, and the like.

[0013] In some embodiments, a delivery device may include: an inner shaft having a front cone on a distal tip; a delivery platform; and an outer sheath. The delivery platform may include: a pair of annular bands fixed to the inner shaft, both of which have a first outer diameter; and a sleeve, which is fastened to the inner shaft and positioned between the annular bands. The sleeve may have a hardness that is less than the hardness of the inner shaft and optionally less than the hardness of the pair of annular bands. The sleeve may also have a first constant outer diameter section and a second constant outer diameter section, the outer diameter of the second constant outer diameter section being greater than the outer diameter of the first constant outer diameter section but less than the first outer diameter of the annular band, and the axial length of the second constant outer diameter section being less than the axial length of the first constant outer diameter section, and the sleeve also having a smooth tapered transition between the first constant outer diameter section and the second constant outer diameter section. The delivery platform may be configured to receive an intraluminal device to deploy the intraluminal device from the delivery device into a blood vessel, and the delivery platform may be configured to receive the intraluminal device between the annular bands and on the sleeve. The outer sheath can be positioned on the inner shaft and the delivery platform and can slide on the inner shaft and the delivery platform. The outer sheath can have a pre-deployment position and at least one delivery position, the pre-deployment position covers the delivery platform, and in the at least one delivery position, the outer sheath is withdrawn to expose at least one of the annular bands of the delivery platform and the sleeve.

[0014] The intraluminal device deployment method may include one or more of the following steps. A delivery device having a plurality of intraluminal devices in a compressed state is advanced to a treatment area. Each of the plurality of intraluminal devices may include a plurality of struts and a radiopaque marker positioned in a central region of the intraluminal device. Each of the plurality of intraluminal devices may have the same size and the radiopaque marker is positioned at the same position. The delivery device may include an inner shaft and an outer sheath, the inner shaft having a plurality of delivery platforms, each of the plurality of intraluminal devices being positioned at a corresponding delivery platform of the plurality of delivery platforms, the outer sheath covering the inner shaft and the plurality of delivery platforms, the outer sheath having a radiopaque marker band positioned at a proximal end of a distal end of the outer sheath. The outer sheath is withdrawn until the radiopaque marker band on the outer sheath is aligned with the radiopaque marker on the first intraluminal device to be delivered among the plurality of intraluminal devices. Before releasing the first intraluminal device, the aligned radiopaque marker band and the radiopaque marker are aligned with the treatment area. The outer sheath is withdrawn to release the first intraluminal device. The outer sheath is withdrawn until the radiopaque marker band on the outer sheath is aligned with the radiopaque marker on a second intraluminal device to be delivered of the plurality of intraluminal devices.

[0015] In some embodiments of the method, aligning the aligned radiopaque marker band and radiopaque marker with the treatment area may include: centrally positioning the aligned radiopaque marker band and radiopaque marker at the tissue peeling portion before releasing the first intraluminal device. In some embodiments of the method, withdrawing the outer sheath until the radiopaque marker band on the outer sheath is aligned with the radiopaque marker on the first intraluminal device to be delivered among the multiple intraluminal devices may include: withdrawing the outer sheath until the outer sheath's distal-most end is aligned with the distal-most end of the first intraluminal device. In some embodiments of the method, withdrawing the outer sheath until the radiopaque marker band on the outer sheath is aligned with the radiopaque marker on the first intraluminal device to be delivered among the multiple intraluminal devices may include: withdrawing the outer sheath until the radiopaque marker band is positioned in the middle of the first intraluminal device. In some embodiments of the method, the first intraluminal device may have a single radiopaque marker column, and withdrawing the outer sheath until the radiopaque marker band on the outer sheath is aligned with the radiopaque marker on the first intraluminal device to be delivered among the multiple intraluminal devices may include: withdrawing the outer sheath until the radiopaque marker band surrounds the single radiopaque marker column.

[0016] In some embodiments, the delivery device may include an inner shaft, an outer sheath, an outer sheath rack, a handle housing, a shuttle and a trigger. The inner shaft may have one or more delivery platforms for deploying one or more intraluminal devices. The outer sheath may surround the inner shaft, and the outer sheath may be configured to cover the one or more delivery platforms into pre-deployment, and the outer sheath may be configured to be withdrawn from at least one of the one or more delivery platforms as part of the deployment of the one or more intraluminal devices. The outer sheath rack may include a plurality of teeth, and the outer sheath rack is coupled to the outer sheath. The inner shaft and the outer sheath rack are at least partially positioned in the handle housing. The handle housing may include at least one pawl, the at least one pawl being configured to engage with the plurality of teeth on the outer sheath rack to prevent the outer sheath from being re-coated on the one or more delivery platforms after deployment. The shuttle may have a pair of deflection arms, the pair of deflection arms being configured to selectively engage with the plurality of teeth on the outer sheath rack. The trigger may be mechanically coupled to the shuttle such that actuation of the trigger causes movement of the shuttle, which movement of the shuttle draws the outer sheath out of the way of covering the one or more delivery platforms.

[0017] According to some embodiments, the plurality of teeth may include a plurality of first teeth on the top of the rack and a plurality of second teeth on the bottom of the rack. The plurality of first teeth may include a repeating set of teeth having a first tooth having a pitch greater than the pitch of the other teeth in the repeating set of teeth. The trigger may be configured such that actuation of the trigger from a starting position to a terminal position causes the outer sheath to be withdrawn so as not to cover one of the one or more delivery platforms, thereby releasing one of the one or more intraluminal devices from the inner shaft. A counter and a shuttle pawl may also be included, wherein the shuttle pawl is configured to engage with the counter to change the indication of the number of intraluminal devices available for deployment.

[0018] In some embodiments, the handle housing may further include an arcuate channel, and the trigger is positioned within the arcuate channel to move along an arcuate path. A safety button may be provided to lock the trigger in place, such that actuation of the safety button is required to allow actuation of the trigger.

[0019] In some embodiments, a control device may be provided for deploying a self-expanding medical device within a blood vessel of a living body. The control device may include a restraining sheath and a control mechanism. The restraining sheath may have a proximal portion and a distal portion, the restraining sheath being adapted to extend over one or more self-expanding medical devices to hold the medical devices in a retracted position, and the restraining sheath being adapted to be retractable to expose the retracted one or more medical devices for deployment. The control mechanism may include: an actuation assembly coupled to the proximal portion of the restraining sheath to retract the restraining sheath; a slider assembly capable of moving along an arcuate motion path, the retraction of the restraining sheath being actuated by an actuation force applied by a user to a movable member of the control mechanism that moves along the arcuate path, thereby changing the angle of force application and the mechanical advantage of the force applied by the user according to the position of the movable member along the arcuate path.

[0020] The delivery device according to some embodiments may include an inner shaft, an outer sheath, a handle housing, an interlocking piece and a bevel interface. The inner shaft may have one or more delivery platforms for deploying one or more intraluminal devices. The outer sheath may surround the inner shaft, and the outer sheath may be configured to cover the one or more delivery platforms into pre-deployment and the outer sheath may be configured to be extracted from one of the one or more delivery platforms as part of the deployment of one of the one or more intraluminal devices. The handle housing may have a trigger, and the trigger is mechanically connected to the outer sheath so that the actuator of the trigger extracts the outer sheath so as not to cover one of the one or more delivery platforms. The interlock engages with the trigger and the inner shaft when in a locked position, thereby preventing the movement of the outer sheath. The bevel interface may be located between the interlock and the inner shaft, wherein the bevel interface is configured to adjust the position of the inner shaft relative to the outer sheath when the interlock is removed from the engagement with the inner shaft.

[0021] In some embodiments, the interlock can engage the trigger through the distal end of the interlock and engage the inner shaft through the proximal end. The proximal end can engage the inner shaft and the handle housing. The distal end of the interlock can be hook-shaped. The ramp interface can include a first ramp on the protrusion of the interlock and a second ramp on the inner shaft, wherein sliding disengagement of the first ramp and the second ramp forces the inner shaft to move.

[0022] According to some embodiments, the delivery device may include an inner shaft, an outer sheath, an outer sheath rack, a handle housing, and a retraction override switch. The inner shaft may have one or more delivery platforms for deploying one or more intraluminal devices. The outer sheath may surround the inner shaft, and the outer sheath may be configured to cover the one or more delivery platforms as pre-deployed and the outer sheath may be configured to be withdrawn as part of the deployment of one of the one or more intraluminal devices. The outer sheath rack may include a plurality of teeth, the outer sheath rack being coupled to the outer sheath, such as at a proximal end. The inner shaft and the outer sheath rack are at least partially positioned within the handle housing. The handle housing may include at least one pawl, the at least one pawl being configured to engage with the plurality of teeth on the outer sheath rack to prevent the outer sheath from being re-wrapped on the one or more delivery platforms after deployment. The retraction override switch may be coupled to the outer sheath rack and the inner shaft, wherein actuation of the retraction override switch is configured to disengage the at least one pawl from the plurality of teeth on the outer sheath rack to allow the outer sheath to be re-wrapped on the one or more delivery platforms after deployment.

[0023] In some embodiments, the delivery device may further include a retraction override lock feature, wherein the retraction override lock is configured to lock the retraction override switch in an actuated position when the at least one pawl is disengaged from the outer sheath rack. The retraction override lock may include a spring metal plate, and the retraction override switch further includes a cam that engages the spring metal plate, and actuation of the cam may cause the cam to move to a locked position that prevents further movement. The outer sheath rack and the outer sheath may be coupled to the retraction override switch such that actuation of the retraction override switch causes the outer sheath rack to move out of engagement with the at least one pawl. The retraction override switch may be configured such that actuation of the retraction override switch causes the retraction override switch to rotate relative to the handle housing. The outer sheath rack may be configured such that actuation of the retraction override switch causes the outer sheath rack and the outer sheath to rotate relative to the handle housing.

[0024] In some embodiments, a system for deploying two or more intraluminal devices in a blood vessel of a living body is provided. The system may include two or more intraluminal devices. Each intraluminal device may include at least one radiopaque marker. The inner shaft of the system may have a proximal portion and a distal portion, the distal portion having two or more delivery platforms for deploying the two or more intraluminal devices, each intraluminal device being in a contracted state and located in a separate delivery platform. A limiting sheath may be provided, the limiting sheath having a proximal portion and a distal portion, the limiting sheath being adapted to extend over the one or more intraluminal devices to keep the intraluminal devices in a contracted position and the limiting sheath being adapted to be able to retract to expose the contracted one or more intraluminal devices for deployment. The limiting sheath may also include a sheath radiopaque marker located in the distal portion of the sheath, the sheath radiopaque marker being located at a set distance relative to the most distal intraluminal device. The control mechanism may include an actuation assembly coupled to the proximal portion of the limiting sheath for retracting the limiting sheath relative to the inner shaft. The retraction of the limiting sheath may be actuated by an actuation force applied by a user to a movable trigger component of the control mechanism. Actuation of the trigger from the starting position to the ending position can completely withdraw the outer sheath so as not to cover one of the one or more delivery platforms, thereby releasing one of the one or more intraluminal devices from the inner shaft into a position within the body. This can also position a sheath radiopaque marker located at the distal end of the limiting sheath at a set distance relative to the remaining distal-most intraluminal device.

[0025] In some embodiments, a delivery device for delivering a device in a cavity is provided. The delivery device may include: an inner shaft, an outer sheath, a handle housing, and an interlock. The inner shaft may have at least one delivery platform for deploying at least one intraluminal device. The outer sheath may surround the inner shaft, and the outer sheath may have a pre-deployment configuration and a deployment configuration. When in the pre-deployment configuration, the outer sheath may cover the at least one delivery platform, and when in the deployment configuration, the outer sheath may expose at least one of the at least one delivery platform to deploy at least one intraluminal device in the at least one intraluminal device. The handle housing may have a trigger, which is operatively connected to the outer sheath, wherein the trigger is configured to withdraw the outer sheath from the inner shaft and is configured to facilitate the movement of the outer sheath from the pre-deployment configuration to the deployment configuration. The interlock may engage with at least one of the trigger, the outer sheath, and the inner shaft, and the interlock may have a locked position and an unlocked position. The interlock can be configured to substantially prevent movement of at least one of the inner shaft and the outer sheath relative to the handle housing when in the locked position, and the interlock can be configured to prevent movement of at least one of the inner shaft and the outer sheath relative to the handle housing when in the unlocked position. The inner shaft adjuster can be operatively coupled to one or more of the handle housing and the interlock and the inner shaft. In addition, the inner shaft adjuster can be configured to change the position of the inner shaft relative to at least one of the handle housing and the outer sheath.

[0026] In some embodiments, the inner shaft adjuster includes at least one pin associated with the inner shaft, wherein the at least one pin is configured to extend through a portion of the handle housing.

[0027] In some embodiments, the inner shaft adjuster further includes a cover configured to cooperate with the at least one pin, and wherein cooperative movement of the cover and the at least one pin causes movement of the inner shaft.

[0028] In some embodiments, the inner shaft adjuster further includes a cover having at least one inner helical groove configured to mate with the at least one pin.

[0029] In some embodiments, the cover is configured to be rotated relative to the handle housing, wherein rotation of the cover in a first direction moves the at least one pin in a distal direction, and rotation of the cover in an opposite second direction moves the at least one pin in a proximal direction.

[0030] In some embodiments, movement of the at least one pin in the distal direction causes movement of the inner shaft in the distal direction, and movement of the at least one pin in the proximal direction causes movement of the inner shaft in the proximal direction.

[0031] In some embodiments, the at least one pin associated with the inner shaft includes a medial portion and a lateral portion.

[0032] In some embodiments, the at least one pin extends through at least one opening in a wall of the handle housing, and the at least one pin is configured to slide within the at least one opening in at least one of a proximal direction and a distal direction.

[0033] In some embodiments, the at least one opening comprises at least one elongated slot in a wall of the handle housing, wherein the at least one elongated slot extends in a generally proximal-distal direction.

[0034] In some embodiments, the handle housing further includes a proximal extension having at least one of a medial slot and a lateral slot, wherein the at least one of the medial slot and the lateral slot extends in a generally proximal-distal direction.

[0035] In some embodiments, the delivery device may further include a cover that is movable relative to the housing.

[0036] In some embodiments, the cover has a lock, wherein the cover is configured to prevent the interlock from moving from the locked position to the unlocked position when locked, and wherein the cover is configured to allow the interlock to move from the locked position to the unlocked position when unlocked.

[0037] In some embodiments, the cover is rotatable and the cover includes a lip having a window, and the interlock includes a proximal extension configured to be positioned within the lip and fit through the window, wherein when the proximal extension is positioned within the lip, the interlock is prevented from moving from a locked position to an unlocked position, and wherein when the window is aligned with the proximal extension, the interlock is permitted to move from the locked position to the unlocked position.

[0038] In some embodiments, the cover is rotatable relative to the handle housing and is fixed in a generally proximal-distal orientation relative to the handle housing.

[0039] In some embodiments, the cover includes at least one helical groove on an inner surface of the cover.

[0040] In some embodiments, the at least one helical groove is configured to receive a protrusion that is associated with at least one of the handle housing, the outer sheath, and the inner shaft, and wherein the interaction between the at least one helical groove and the protrusion causes relative movement between the handle housing, the outer sheath, the inner shaft, and the cover.

[0041] In some embodiments, the inner shaft adjuster is configured to change a position of the inner shaft relative to at least one of the handle housing and the outer sheath before the trigger causes the outer sheath to be withdrawn from the inner shaft.

[0042] In some embodiments, the inner shaft adjuster includes a protrusion associated with the inner shaft and an angled surface movable relative to the handle housing, wherein the protrusion and the angled surface have an engaged position and a disengaged position.

[0043] In some embodiments, movement of the protrusion and the angled surface from the engaged position to the disengaged position causes the angled surface to push on the protrusion, thereby forcing the inner shaft to move.

[0044] In some embodiments, the angled surface is coupled to the interlocking member.

[0045] In some embodiments, disengagement of the interlock relative to the handle housing moves the projection and the angled surface to the disengaged position, thereby causing sliding disengagement of the projection and the angled surface and forcing movement of the inner shaft.

[0046] In some embodiments, the inner shaft adjuster includes a ramped interface between the interlock and the inner shaft, wherein the ramped interface is configured to adjust a position of the inner shaft relative to the outer sheath when the interlock is removed from engagement with the outer sheath.

[0047] In some embodiments, the distal end of the interlock engages the trigger and the proximal end of the interlock engages the inner shaft.

[0048] In some embodiments, the proximal end of the interlock engages the inner shaft and the handle housing.

[0049] In some embodiments, a device for delivering an intraluminal device is provided. The device may include: an inner shaft, an outer sheath, a handle housing, an interlocking piece, and an inner shaft regulator. The inner shaft may have a delivery platform for deploying the intraluminal device. The outer sheath may surround the inner shaft and the outer sheath has a pre-deployment configuration in which the outer sheath covers the delivery platform and a deployment configuration in which the outer sheath exposes the delivery platform. The handle housing may have an actuator, which is coupled to the outer sheath and is configured to cause the outer sheath to move in at least one direction in a proximal direction and a distal direction. The interlocking piece is engageable with at least one of the trigger and the inner shaft, and the interlocking piece has a locking position, which prevents at least one of the handle housing, the outer sheath, and the inner shaft from moving relative to at least one of the handle housing, the outer sheath, and the inner shaft, and the interlocking piece has an unlocking position, which allows at least one of the handle housing, the outer sheath, and the inner shaft to move relative to at least one of the handle housing, the outer sheath, and the inner shaft. The inner shaft adjuster may be coupled to at least one of the handle housing, the outer sheath, and the inner shaft, and the inner shaft adjuster may be configured to adjust a position of the inner shaft relative to at least one of the handle housing and the outer sheath.

[0050] In some embodiments, the inner shaft adjuster is configured to prevent the interlock from alternating between a locked position and an unlocked position before the inner shaft adjuster has adjusted the position of the inner shaft relative to at least one of the handle housing and the outer sheath, and wherein the inner shaft adjuster is configured to allow the interlock to alternate between a locked position and an unlocked position after the inner shaft adjuster has adjusted the position of the inner shaft relative to at least one of the handle housing and the outer sheath.

[0051] In some embodiments, a method of delivering at least one intraluminal device within a cavity is provided. A delivery device that can be used may include: an inner shaft having at least one delivery platform for deploying at least one intraluminal device; an outer sheath, the outer sheath surrounds the inner shaft, and the outer sheath has a pre-deployment configuration covering the at least one delivery platform and a deployment configuration that exposes at least one of the at least one delivery platform; a handle housing having a trigger, the trigger operatively coupled to the outer sheath, the trigger configured to facilitate movement of the outer sheath relative to the handle housing; an interlock, the interlock capable of engaging at least one of the trigger and the inner shaft, and the interlock having a locked position and an unlocked position, the locked position substantially preventing movement of at least one of the inner shaft and the outer sheath relative to the handle housing, the unlocked position allowing movement of at least one of the inner shaft and the outer sheath relative to the handle housing; and an inner shaft adjuster, the inner shaft adjuster operatively coupled to one or more of the handle housing and the interlock and the inner shaft. The method may include the following steps: advancing a portion of a delivery device that carries at least one intraluminal device to a target area; preventing movement of the delivery device relative to the target area; actuating an inner shaft adjuster to change the position of the inner shaft relative to at least one of a handle housing and an outer sheath; moving an interlock from a locked position to an unlocked position to allow movement of at least the outer sheath relative to the handle housing; and actuating a trigger to withdraw the outer sheath proximally from the inner shaft.

[0052] In some embodiments, the inner shaft adjuster is configured to maintain the interlock in the locked position until the inner shaft adjuster has been actuated to change the position of the inner shaft relative to at least one of the handle housing and the outer sheath.

[0053] In some embodiments, the inner shaft has a length of travel defined by a proximal-most position and a distal-most position, wherein the inner shaft is in the proximal-most position before advancing the portion of the delivery device carrying the at least one intraluminal device to the target area, and wherein the inner shaft is in the proximal-most position during advancement of the portion of the delivery device carrying the at least one intraluminal device to the target area.

[0054] In some embodiments, the inner shaft has a length of travel defined by a proximal-most position and a distal-most position, wherein the inner shaft is in the proximal-most position prior to actuating the inner shaft adjuster to change the position of the inner shaft.

[0055] In some embodiments, actuating the inner shaft adjuster to change the position of the inner shaft moves the inner shaft to a distal-most position of the inner shaft.

[0056] In some embodiments, the inner shaft must be in the inner shaft's distal-most position before the interlock can move from the locked position to the unlocked position.

[0057] In some embodiments, a method of delivering at least one intraluminal device within a lumen is provided. A delivery device that can be used may include: an inner shaft, the inner shaft having at least one delivery platform, the at least one delivery platform being configured to hold at least one intraluminal device; an outer sheath, the outer sheath surrounding the inner shaft, and the outer sheath being configured to move on the inner shaft in at least one of a proximal direction and a distal direction; a handle housing, the handle housing having a trigger, the trigger being configured to facilitate movement of the outer sheath; an interlock, the interlock being engageable with at least one of the trigger and the inner shaft, and the interlock having a first position and a second position, the first position substantially preventing movement of at least one of the inner shaft and the outer sheath relative to the handle housing, and the second position allowing movement of at least one of the inner shaft and the outer sheath relative to the handle housing; and an inner shaft adjuster, the inner shaft adjuster being operatively coupled to one or more of the handle housing and the interlock and to the inner shaft, wherein the inner shaft adjuster is configured to change a position of the inner shaft relative to at least one of the handle housing and the outer sheath, and wherein the inner shaft adjuster is configured to lock the interlock until the inner shaft adjuster has changed the position of the inner shaft to prevent the interlock from moving from the first position to the second position. The method may include the following steps: advancing a portion of a delivery device to a target area; preventing movement of the delivery device relative to the target area; actuating an inner shaft adjuster to change the position of the inner shaft relative to at least one of a handle housing and an outer sheath; unlocking an interlock; moving the interlock from a locked position to an unlocked position to allow movement of at least the outer sheath relative to the handle housing; and moving the outer sheath relative to the inner shaft.

[0058] In some embodiments, the interlock includes a proximal extension, the inner shaft adjuster includes a cover having a lip with a window, and the proximal extension is configured to fit inside the lip when locked and fit through the window when unlocked.

[0059] In some embodiments, the unlocking step includes rotating the cover to align the window with the proximal extension.

[0060] In some embodiments, the interlock includes a proximal portion capable of being locked by an inner shaft adjuster, wherein the inner shaft adjuster includes a cover configured to rotate about the inner shaft while being fixed in a substantially proximal-distal direction, wherein the cover includes at least one helical groove located on an inner surface of the cover and a distal lip having a discontinuous portion.

[0061] In some embodiments, the handle housing includes a proximal portion having at least one groove extending in a proximal-distal direction, and the inner shaft includes at least one pin extending through the at least one groove, and the at least one pin is configured to cooperate with the at least one helical groove on the inner surface of the cover, wherein rotation of the cover in a first direction causes movement of the at least one pin in the at least one groove in a distal direction, and rotation of the cover in a second direction causes movement of the at least one pin in the at least one groove in a proximal direction.

[0062] In some embodiments, actuating the inner shaft adjuster includes rotating the cap in a first direction to cause movement of the at least one pin in the at least one slot in a distal direction, thereby causing movement of the inner shaft in the distal direction.

[0063] In some embodiments, unlocking the interlock includes rotating the cover until the discontinuity of the cover is aligned with the proximal portion of the interlock.

[0064] In some embodiments, the discontinuity will not align with the proximal portion of the interlock until the at least one pin has moved to a substantially distal-most end of the at least one slot in the proximal portion of the handle housing. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Various embodiments are depicted in the drawings for purposes of illustration and should not be construed as limiting the scope of the invention, wherein like drawing characters consistently denote corresponding features throughout similar embodiments.

[0066] Figure 1 is a side view of a delivery device which has been shortened to aid illustration.

[0067] Figure 2 A view of the distal end of the delivery device is shown with the outer sheath withdrawn.

[0068] Figure 3 Embodiments of intraluminal devices or tacks are shown.

[0069] Figure 3A A flat section of the nail is shown.

[0070] Figure 4 A detailed view of the distal end of the delivery device is shown with the outer sheath partially withdrawn.

[0071] Figure 5 is a cross-section of a delivery device showing an embodiment of a delivery platform.

[0072] FIG. 6A to FIG. 6EVarious embodiments of delivery platforms having different shapes are shown.

[0073] 7A to 7C Certain steps of the deployment method are shown.

[0074] Figure 8 A handle at the proximal end of another embodiment of a delivery device is shown.

[0075] Fig. 9 yes Figure 8 Partially disassembled view of the handle.

[0076] Fig.10 yes Fig. 9 Side view of the handle in a first position.

[0077] Fig. 10A The handle is in Fig.10 Illustration of a portion of the distal end of a delivery device in a first position.

[0078] Fig. 10B A detailed view of the shuttle is shown which is part of the handle.

[0079] Fig.11 yes Fig. 9 Side view of the handle in the second position.

[0080] Fig.11A The handle is in Fig.11 Illustration of a portion of the distal end of the delivery device in a second position.

[0081] Fig.12 yes Fig. 9 Side view of the handle in the third position.

[0082] Fig. 12A The handle is in Fig.12 Illustration of a portion of the distal end of the delivery device in a third position.

[0083] Fig.13 A detailed view of the retract override switch is shown in a first position.

[0084] Fig.13A yes Fig.13 Cross section of the retracted override switch.

[0085] Fig.14 A detailed view of the retract override switch is shown in a second position.

[0086] Fig.14A yes Fig.14 Cross section of the retract override switch.

[0087] Fig. 14B Shows Fig. 9 A side view of the handle with the retract override switch in the second position.

[0088] Fig.15 Shows Fig. 9 A side view of the handle of FIG. 1 , wherein the inner shaft has been re-sheathed with the outer sheath.

[0089] Fig.16 Another embodiment of a proximal Luer hub is shown in cross-section.

[0090] Fig.16A is an exploded view of the proximal Luer hub and other parts of the delivery device.

[0091] Fig.17 Another embodiment of a delivery device is shown with a handle having an inner shaft adjuster at the proximal end.

[0092] FIG. 18A to FIG. 18B yes Fig.17 Partially disassembled view of the handle.

[0093] Fig. 18C yes FIG. 18A to FIG. 18B A horizontal cross-sectional view of the proximal portion of the handle.

[0094] Fig.19 An embodiment of an inner shaft adjuster is shown.

[0095] FIG. 20A to FIG. 20B yes Fig.17 A partial cross-sectional view of the handle.

[0096] Fig. 20C yes FIG. 20A to FIG. 20B A horizontal cross-sectional view of the proximal portion of the handle.

[0097] Fig.21 yes FIG. 20A to FIG. 20B A cross-sectional view of the proximal portion of the handle showing the interaction between the interlock and the inner shaft adjuster.

[0098] Fig. 22 yes FIG. 20A to FIG. 20B A cross-sectional view of the proximal portion of the handle showing the interaction between the interlock and the window of the inner shaft adjuster. DETAILED DESCRIPTION

[0099] The delivery device 10 can be used as part of a surgical treatment for treating atherosclerotic occlusive disease. The delivery device can be used to deliver one or more intraluminal devices 2, such as tacks, to a site of plaque accumulation. The tacks can stabilize the site and / or remove pieces of plaque from the blood flow path. It should be understood that although the delivery devices and methods described herein are primarily described with reference to vascular operations, the delivery devices and methods described herein can also be used for treatment of other parts of the body.

[0100] Figure 1 and Figure 2 An embodiment of a delivery device 10 is shown that can be used to sequentially deliver multiple intraluminal devices 2. The delivery device 10 can be used in surgical procedures to treat atherosclerotic occlusive disease, but it is not limited to these surgical procedures.

[0101] Figure 1 The delivery device 10 of FIG. 1 , which has been shortened to facilitate illustration, highlights the distal end 4 and the proximal end 6. The proximal end 6 can be held by a physician or other medical professional during a medical procedure. The delivery device 10 is used to control the delivery of one or more intraluminal devices or staples 2. Figure 2 A distal portion 4 is shown with six (6) intraluminal devices 2, each positioned at a dedicated delivery platform 8. Figure 1 and Figure 2 , it can be seen that the outer sheath 12 has been Figure 2 1 and 12. The distal end of the sheath 12 is withdrawn from the delivery platform 8. This exposes the delivery platform 8 and the corresponding intraluminal device 2. The intraluminal device 2 is preferably self-expandable and is shown in its compressed position to represent how the intraluminal device 2 fits in the delivery platform. In typical use, when the intraluminal device 2 is in this position, the outer sheath 12 will cover the intraluminal device 2. As will be discussed in more detail below, the outer sheath 12 can be withdrawn in a systematic manner to deploy an intraluminal device 2 when it is in the desired treatment position.

[0102] For example, with only one ( Figure 3 and 3A ) or two unit columns of relatively small intraluminal devices 2 can be delivered at the precise treatment location and appropriately spaced so as not to overlap. Figure 3A Shows Figure 3 The flat section of the nail. It can be seen that the single unit column 14 is formed by two concentric wavy support rings 16 connected by a bridge member 18. The bridge member 18 has a pair of anchors 20 and non-transmissive markers 22. Multiple small intraluminal devices 2 can be used to treat single or multiple lesions. This can minimize the amount of foreign matter in the body while providing the required retention force. Various embodiments of the intraluminal device and delivery device are described in more detail in the applicant's following related patent applications: Patent application No. 13 / 179,458, published as US2012 / 0035705 (IVAS.002P4) filed on July 8, 2011 and Patent application No. 13 / 749,643, published as US 2013 / 0144375 (IVAS.002P6) filed on January 24, 2013, both of which are incorporated herein by reference and are part of this specification.

[0103] Each radiopaque marker can be press-fit or swaged into a circular eyelet on a corresponding bridge member of the intraluminal device. Swaging is a forging process in which the size of an item is changed using a die into which the item is pressed. Swaging is typically a cold working process; however, swaging is sometimes done as a hot working process. Swaging is typically the method of choice for expensive metals because material is not lost in the process. The radiopaque markers discussed herein for the intraluminal devices and delivery devices can be any number of different materials, including gold, platinum, and tantalum.

[0104] It should be understood that the delivery device and method may also be used with other intraluminal devices 2, including larger devices, and is not limited to use with intraluminal devices 2 having only one or two unit columns.

[0105] Now return to Figure 1 , the proximal portion 6 of the illustrated embodiment will now be described. The delivery device 10 may include an outer sheath 12, a proximal housing 24, and an inner shaft 26. The outer sheath 12 may be constructed as a laminate formed by a polymer extrusion and a braided wire embedded in the polymer extrusion. Flexibility and stiffness may be controlled by the number of braided wires, the braiding pattern, and the braiding spacing. In other embodiments, the outer sheath may be formed by a hypotube such as a metal or plastic hypotube. The flexibility and stiffness of the sheath may be controlled by many features such as the slope and frequency of the spiral groove along the length of the hypotube. The outer sheath may also include a radiopaque (RO) marker 28 located at or near the distal end. In some embodiments, the radiopaque marker 28 may be an annular band separated from the distalmost end.

[0106] As shown, the outer sheath 12 is a braided shaft and the proximal housing 24 is a bifurcated luer connected to the outer sheath by a strain relief member 30. The strain relief member 30 may take any form, such as being made of a polyolefin or other similar material.

[0107] The bifurcated Luer 24 has a main arm and a side arm for receiving the inner shaft 26. The bifurcated Luer can be provided at the proximal end of the outer sheath. The side arm includes a flushing port for flushing out air and increasing lubricity in the space between the sheath and the inner shaft.

[0108] A tuohyborst adapter, hemostatic valve or other sealing device 32 can be disposed at or integrated into the proximal end of the bifurcated luer 24 to receive and seal the proximal end of the space between the inner shaft 26 and the outer sheath 12. The tuohyborst adapter can also provide a locking interface such as a threaded lock to secure the relationship between the outer sheath and the inner shaft. This can allow the physician to properly position the distal end without prematurely deploying the nail.

[0109] The inner shaft is shown with a proximal Luer hub 34 and deployment reference markers 36. The deployment reference markers 36 can correspond to the delivery platform 8, so that the spacing between each deployment reference marker can be the same as the spacing between the features of the delivery platform. For example, the spacing between the deployment reference markers can be the same as the distance between the central portions of the delivery platform.

[0110] In some embodiments, the most distal deployment reference marker, or a marker that is different from the other markers, such as having a wider band or a different color, can indicate the original or initial position. For example, a deployment reference marker with a wider band than the other markers can be aligned with the proximal end of the bifurcated Luer 24 or the hemostatic valve 32. This can indicate to the physician that the outer sheath is in a position to completely cover the inner shaft 26 at the proximal end of the front cone 38. In some embodiments, this alignment can also be translated into the alignment of the RO mark 28 on the outer sheath with the RO mark on the distal end of the inner shaft 26.

[0111] In some embodiments, one or more deployment reference markers 36 can indicate the number of staples in the system. Thus, once the staples are released, the deployment reference markers 36 will be covered, and the physician can know that the remaining deployment reference markers correspond to the remaining number of staples that can be used. In such embodiments, the proximal end of the bifurcated Luer 24 or hemostatic valve 32 can be advanced to be centered between the two reference markers to indicate deployment.

[0112] View now Figure 4 , showing a detailed view of the distal end 4 of the delivery device 10. Features of the illustrated embodiment include an inner shaft 26 having a distal soft tip 38. The tip 38 may be a tapered front cone. The front cone 38 serves as an expansion structure to atraumatically displace tissue and help guide the delivery device through the vasculature. The tip 38 itself may be radiopaque, or a radiopaque element 27 may be incorporated into or near the tip. It can be seen that the inner shaft 26 extends to the proximal Luer hub 34 ( Figure 1 ) of the guide wire cavity 40. The guide wire cavity 40 is configured to receive a guide wire and allow the guide wire to travel in the guide wire cavity 40.

[0113] Also shown is a portion of a delivery platform 8. The delivery platforms 8 are identical in the illustrated embodiment, but other embodiments may have different sizes and configurations between different delivery platforms. In the delivery platform 8, a curled or compressed staple 2 is shown.

[0114] As in Figure 2 and Figure 4 As can be seen in FIG. 1 , one or more delivery platforms 8 can be disposed on the inner shaft 26 adjacent the distal end 4 of the delivery device 10. Each of the delivery platforms 8 can include a recess 42 positioned to extend between a pair of annular pusher bands 44. Figure 5A cross section of the delivery device is shown at one embodiment of a delivery platform 8A. In the illustrated embodiment, the proximal annular pusher band 44A of the first platform 8A is also the distal annular pusher band 44A immediately adjacent to the proximal positioned platform 8B (only partially shown). The annular pusher band 44 has a larger outer diameter than the delivery platform at the recess 42. In some embodiments, the recess can be defined as a smaller diameter area adjacent to or between one or two annular pusher bands and / or additional features on the inner shaft 26.

[0115] One or more of the annular pusher bands 44 can be radiopaque marker bands. For example, a proximal radiopaque marker band and a distal radiopaque marker band 44 can be provided to make the end of the platform 8 visible using standard visualization techniques. The annular marker band 44 can take any suitable form, for example, including one or more of tantalum, iridium and platinum materials. In some embodiments, the length of the pusher band 44 can be 4mm, with a 6.75mm recess between the pusher bands 44. A 6.5mm nail can be positioned between the pusher bands 44. In some embodiments, the size of the pusher band can be 50% to 70% of the size of the recess and / or the nail. In some embodiments, the pusher band is about 60%. In other embodiments, the size of the pusher band can be smaller, that is, between 10% and 20% of the size of the recess and / or the nail. This may be particularly true for longer nails. In some embodiments, at least the proximal end of the pusher band 44 can have a radius that helps reduce the potential for hooking the deployed nail during the retraction of the delivery device.

[0116] Reducing the difference between the length of the recess and the length of the nail can increase the accuracy of nail placement, especially for nails with only one or two unit columns. In some embodiments, the recess can be less than 1mm, 0.5mm, 0.4mm, 0.3mm, 0.25mm or 0.2mm longer than the nail. The nail can be any number of different sizes, such as 4mm, 5mm, 6mm, 6.5mm, 8mm, 10mm or 12mm in length.

[0117] The outer sheath 12 can be made of polyether block amide (PEBA), which is a thermoplastic elastomer (TPE) purchased under the trade name PEBAX. In some embodiments, the outer sheath 12 can have a thinner liner made of polytetrafluoroethylene (PTFE) such as TEFLON. Any radiopaque marker band 28 or other radiopaque material can be positioned between these two layers. In other embodiments, the radiopaque marker band 28 or other radiopaque material can be embedded in one or more layers of the outer sheath 12. The width of the radiopaque marker band 28 can be in the range of 0.5mm to 5mm and the radiopaque marker band 28 is located 0.5mm to 10mm proximal to the farthest tip 52. In some embodiments, the width of the radiopaque marker band 28 can be 1mm, and the radiopaque marker band 28 is located 3mm proximal to the farthest tip 52.

[0118] exist Figure 5 In the cross section of FIG. 8 , it can be seen that a sleeve 46 is positioned around the inner shaft 26 between the two annular bands 44. In some embodiments, the delivery platform 8 may include a sleeve 46 around the shaft 26, wherein the sleeve 46 is made of a different material from the shaft 26 or has a different material property from the shaft 26. In some embodiments, the sleeve provides a material with viscosity, grip, tread pattern and / or other features to help the nail remain in place in the delivery platform. In some embodiments, the sleeve may be made of PEBA. The inner shaft according to some embodiments is a composite extrusion made of PTFE / polyimide composite material. The sleeve may be (have) softer (lower hardness) than the inner shaft and / or pusher belt 44. This may be true even if the sleeve is made of a similar type of material. In some embodiments, the sleeve may be a material with viscosity, grip, tread pattern and / or other features to help the nail remain in place (e.g., longitudinal position relative to the inner shaft) when the outer sleeve 12 is withdrawn. This can increase the amount of control during deployment and reduce the potential for staples to be ejected distally from the delivery platform (known in the industry as sowing a watermelon). In some cases, the outer sheath can be partially removed to partially expose the intraluminal device, whereby the intraluminal device can be partially expanded while being securely held by the delivery device before being fully released.

[0119] The sleeve 46 can be sized so that the space between the nails 2 in the delivery platform 8 is minimized to no space. In some embodiments, the sleeve 46 can be co-molded with the inner shaft 26 or pressed onto the inner shaft 26. In some embodiments, the delivery device 10 can be formed with a single sleeve 46 extending the length of the inner shaft 26. For example, the sleeve can extend from the first delivery platform to the last delivery platform. The annular band 44 can surround different sections of the sleeve 46, or the annular band 44 can be enclosed by the sleeve 46. In some embodiments, each delivery platform 8 has a separate sleeve 46 positioned in the recess 42. The annular band 44 can be enclosed by a different material, or the annular band 44 is not enclosed at all.

[0120] If from Figure 5 It is understood that the sleeve 46 can be cylindrical, having a circular cross-section that remains for a portion or the entire length of the sleeve. In other embodiments, the sleeve has a unique shape and can include one or more of the following: a tapered portion ( FIG. 6A to FIG. 6E ), hourglass-shaped part ( Fig. 6A ), ridge ( Figure 6B )、Depression( Figure 6C ), dot-shaped part( Fig.6D ), two or more different diameter parts ( Fig. 6E ) etc. Features such as ridges, dots and depressions may be positioned in a number of different patterns or groups. In addition, the sleeve ( FIG. 6B to FIG. 6D ) or sleeve ( Fig. 6E ) can extend along no more than the entire recess. In some embodiments, the length of the sleeve or larger outer diameter section may correspond to the length of the nail. For example, the sleeve or larger diameter section may extend 3 / 4, 2 / 3, 1 / 2, 2 / 5, 1 / 3, 1 / 4 of the recess and / or nail. In addition, the length of the sleeve or larger outer diameter section can be related to the size of the undulating ring 16, such as the struts of the most proximal undulating ring. For example, the sleeve or larger outer diameter section can extend along the entire, 3 / 4, 2 / 3 or 1 / 2 length of the struts or the most proximal undulating ring. The shorter sleeve or larger outer diameter section of the sleeve preferably extends from the proximal end of the recess to the distal end ( FIG. 6D to FIG. 6E ), but may also be centrally located in the recess, positioned at the distal end ( Figure 6C ) or at other locations within the recess.

[0121] Fig. 6EThe sleeve is shown as having two different constant outer diameter sections with a short taper between the two different constant outer diameter sections. The sleeve can be formed from two separate sections that are thermally bonded together. The taper can also be formed by thermal bonding so that there is a smooth transition between the two constant outer diameter sections. As already mentioned, the larger constant outer diameter section preferably extends from the proximal end to the distal end of the recess. As already discussed above, this larger outer diameter section, which may or may not have a constant outer diameter, may extend along no more than the entire recess.

[0122] In some embodiments, the inner shaft 26 can have a sleeve 46 with a lower hardness between the pushers 44. The nail 2 can be crimped onto the sleeve 46, and the outer sheath 12 can restrict the crimped nail in place. The gap between the sleeve 46 and the outer sheath 12 can cause a slight interference fit between the crimped nail 2 and the inner and outer elements. This slight interference allows the delivery system to restrict the crimped nail during deployment until the crimped nail is almost completely uncovered to allow the distal portion of the nail to "petal" open and engage the vessel wall, thereby reducing the potential for bounce.

[0123] According to some embodiments, the inner shaft 26 can be made of a polyimide-PEBA combination, and a low durometer PEBA sleeve 46 can be heat bonded between the pushers 44. The nail 2 can be crimped onto the sleeve 46, and the PTFE-lined outer sheath 12 can restrain the crimped nail in place.

[0124] Back to Figure 5 , showing features of certain embodiments of a radiopaque marker band 44. As already mentioned, a sleeve 46 can enclose an annular band 44. Alternatively, another material can enclose a metal band to form an annular marker band 44. The annular marker band 44 can be made of a wire 48 or multiple pieces of material or have gaps to increase flexibility while maintaining radiopacity. In some embodiments, the wire can form a helical coil that is wound around the inner shaft 26.

[0125] Now move to 7A to 7C , some deployment methods will now be described. The delivery device 10 can be used as part of a surgical treatment for treating atherosclerotic occlusive disease. The delivery device can be used to deliver one or more intraluminal devices 2, such as tacks, to a site of plaque accumulation. The tacks can stabilize the site and / or remove the plaque from the blood flow path.

[0126] The nail is preferably self-expandable. Therefore, withdrawing the sheath 12 to expose the nail 2 allows the nail to be deployed from the delivery device 10 by self-expansion. The sheath can be withdrawn in small increments to sequentially deliver the nails at the desired location in the blood vessel. In some embodiments, the small increments can correspond to deployment reference markers 36. The deployment reference markers 36 can be spaced at least the length of the nail so that each nail can be deployed immediately, rather than the typical gradual release of longer stents. This can allow for more precise placement of nails.

[0127] Balloon angioplasty is a well-known method for opening blocked or narrowed blood vessels in every vascular bed in the body. Balloon angioplasty is performed using a balloon angioplasty catheter. The balloon angioplasty catheter consists of a cigar-shaped, cylindrical balloon attached to a catheter. The balloon angioplasty catheter is placed into the artery from a distal access site created percutaneously or by open exposure of the artery. The catheter is passed along the inside of the blood vessel on a wire that guides the catheter path. The portion of the catheter to which the balloon is attached is placed at the location of the atherosclerotic plaque that needs to be treated. The balloon is expanded to a size consistent with the original diameter of the artery before occlusive disease occurs. In some cases, the balloon is coated with a drug or biologic or otherwise configured to deliver the drug or biologic to the tissue. When the balloon is expanded, the plaque is destroyed. A cleavage plane is formed within the plaque, allowing the plaque to expand in diameter with the expanded balloon. Typically, a portion of the plaque is more resistant to expansion than the rest of the plaque. When this happens, the greater pressure pumped into the balloon causes the balloon to fully expand to its intended size. The balloon is deflated and removed, and the arterial section is re-examined. The process of balloon angioplasty is a process of uncontrolled plaque rupture. The lumen of the blood vessel at the treatment site is usually slightly larger, but not always larger and unreliable.

[0128] Some of the cleavage surfaces produced by plaque rupture during balloon angioplasty can form a dissection. More generally, a dissection occurs when a portion of a plaque or tissue is lifted away from an artery, is not completely adhered to the artery, and may be mobile or loose. The plaque or tissue that has been destroyed by dissection protrudes into the flow stream. If the plaque or tissue is completely lifted in the direction of blood flow, the plaque or tissue may hinder flow or cause acute occlusion of a blood vessel. There is evidence that the dissection after balloon angioplasty must be treated to prevent occlusion and resolve residual stenosis. There is also evidence that in some cases, it is beneficial to place a metal retention structure, such as a stent or other intraluminal device to keep the artery open after angioplasty and / or force the dislodged material back and against the wall of the blood vessel to form a suitable cavity for blood flow.

[0129] Various delivery methods and devices can be used to deploy intraluminal devices, such as nail 2, some of which are described below. For example, the nail can be delivered into the blood vessel via an intravascular insert. The delivery devices for different embodiments of the plaque nail can be different or the same, and can have features specifically designed for delivering a particular nail. The nail and installation operation can be designed in a variety of ways, and the various ways share the following common methods: utilizing the expansion force of the delivery mechanism (such as balloon inflation) and / or the expansion force of the wavy ring to enable the nail to be moved to a position in the blood vessel and then released to an expanded state within the blood vessel. The nail deployment method can include aligning the radiopaque marker on the outer sheath with the radiopaque marker on the nail to be deployed before deployment.

[0130] Now refer to Fig. 7A , a delivery device 10 with an outer sheath 12 is shown in a first pre-deployed position. A plurality of staples 2 can be held in a compressed state within the delivery device 10 by the outer sheath 12. In some embodiments, the staples 2 are quickly frozen in their compressed state to facilitate loading onto the delivery device. As already described, the staples can extend over a given length of the delivery device.

[0131] The delivery device can be advanced over a guide wire 50 in the patient's vasculature to the treatment site. The guide wire 50 can be the same guide wire used in the previous steps of the surgical treatment, such as a guide wire used to position an angioplasty balloon. Once the delivery device is positioned at the treatment site, the outer sheath 12 can be withdrawn or retracted to a second pre-deployment position ( Figure 7B ). The second pre-deployment position can be used to adjust the position of the outer sheath to handle any stretching, bending, etc. that may require some adjustment before releasing the nail. In the second pre-deployment position, the distal end 52 of the outer sheath can be positioned at or slightly distal to the distal end of the nail to be deployed.

[0132] According to some embodiments, the outer sheath 12 may have a radiopaque annular marker band 28, and the nail may also have one or more radiopaque markers 22. The radiopaque marker 22 may be positioned in a column around the nail. The distance "L" from the distal end of the nail to the radiopaque marker 22 may be the same as the distance from the distal end 52 of the outer sheath 12 to the radiopaque annular marker band 28. In some embodiments, the distance is to the center of the marker 22 and the marker band 28. In some embodiments, the length "L" on the outer sheath is at least as long as the length "L" on the nail, otherwise it is slightly longer. The outer sheath may have no other radiopaque markers. In addition, the nail may also have no other radiopaque markers or radiopaque marker columns. Therefore, the outer sheath may have only a single marker band 28 at the distal end, which is spaced from the distal end 52 of the outer sheath 12 by at least the distance from the distal end of the nail 2 to the radiopaque marker 22 or radiopaque marker column. In the embodiment shown, the radiopaque marker 22 or radiopaque marker column is positioned in the middle of the device. Radiopaque markers are also positioned on the bridge member 18 connecting adjacent wavy strut rings 16. In some embodiments, the radiopaque marker 22 or radiopaque marker post can be spaced apart from the distal-most end of the nail by at least one wavy strut ring 16. In the illustrated embodiment, the radiopaque marker 22 or radiopaque marker post is not located at the distal-most end of the nail 2, but is spaced apart from the distal-most end of the nail 2.

[0133] Having corresponding radiopaque markers 22, 28 on the nail and the outer sheath can allow the physician to align the markers 22, 28 before deploying the nail. In addition, the physician can align the aligned markers with the desired area to be treated. As will be understood, all such alignments can be completed using standard visualization techniques. As already mentioned, the annular pusher band 44 on the inner shaft can also be radiopaque. In some embodiments, the pusher band 44 can be the same and can be displayed differently from the markers on the outer sheath and the markers on the nail under visualization. Therefore, the physician can clearly see where all the markers are and which is which. For example, the pusher band 44 can be longer in the axial direction than the markers 28 on the outer sheath and the markers on the nail. In addition, the markers on the delivery device can be bands, while the markers on the nail can be dots.

[0134] Reference Figure 7B , it can be seen that the marking 28 on the outer sheath 12 and the marking 22 on the first nail 2 are aligned, and the distal end of the sheath is positioned at the distal end of the first nail. The delivery device can now be positioned relative to the lesion for treatment, such as by centering the radiopaque marker at the desired location. Subsequently, the sheath can be withdrawn to place the nail at the desired location.

[0135] In some embodiments, the delivery device can have a marker band positioned from the distal end to the proximal end for at least half the length of the nail, and the nail has a single marker column at the middle of the device. The deployment method may include: the outer sheath is withdrawn until the marker on the outer sheath is aligned with the marker on the nail to be delivered, and then the two markers are aligned with the middle of the lesion (or other treatment area) to be treated before releasing the nail, and the release is achieved by further withdrawing the outer sheath. It should be understood that the marker on the pusher belt 44 can also be used to help align the delivery device before deployment.

[0136] The method can be repeated to deliver multiple staples (see Figure 7C , where the staples are shown in a compressed state for reference only). During staple deployment, the delivery device may be moved to an entirely different lesion or treatment area or simply repositioned to ensure spacing between adjacent staples that have already been placed.

[0137] As previously discussed, in some embodiments, the simultaneous placement of the entire nail can be based on the release of the nail from the delivery device. In addition, multiple nails can be placed in the treatment section of the blood vessel in a far-to-near manner as needed.

[0138] In some embodiments, the expandable nail, such as Figure 3 and Figure 3A The expandable nail shown in can apply a relatively constant force to a wide range of vascular lumen diameters, thereby allowing a single delivery catheter to deploy multiple nails to blood vessels of different sizes. Ideally, the nail can be designed to treat blood vessels with a size in the range of 2mm to 8mm, but nails of other sizes can also be delivered. It is expected that within a 3mm expansion range, the force applied to the blood vessel by the nail changes by 5N or less. More ideally, within a 3mm expansion range, the applied force changes by 1.5N or less.

[0139] There are cases where drug-coated balloons are used as an alternative to placing stents in blood vessels. The balloon can dilate stenosis in the blood vessel, and the drug helps minimize the post-dilation inflammatory response that may cause restenosis of the artery. Clinical evidence shows that the combination of balloons and drugs can provide an alternative to implanting conventional stents, which have been used to provide both short-term and long-term stents in the past. Drug-coated balloons are desirable because there are no long-term implants placed in blood vessels. However, there are cases where the expansion of drug-coated balloons may cause damage to the blood vessel in the form of tissue peeling, in which flaps or fragments of tissue extend into the lumen of the blood vessel. Peeling can occur within the balloon treatment area as well as outside or near the treatment area. In these cases, it helps to pin the peeled tissue against the arterial wall. Pins with low outward forces can be advantageously used to handle peeling in cases where treatment of stents may be unsuitable or undesirable.

[0140] In some embodiments, the precise placement of the tack can be set after the catheter is positioned within the blood vessel based on the location of the marker. Once the catheter is positioned, one or more tacks can then be deployed while the catheter is held in place and the outer sheath is slowly removed.

[0141] In some embodiments, one or more tacks may be deployed at a tissue peeling portion. When performing an angioplasty procedure, there is typically one of three outcomes: 1) an optimal outcome, where no further stenting or overtreatment is required; 2) residual stenosis, where a stent is typically placed to prop or support the vessel so that the vessel remains open and does not return to a previous occluded or partially occluded state, and 3) tissue peeling. Tissue peeling may be a situation where a vessel undergoes trauma such as arterial wall damage resulting in separation of the intimal layer. This may or may not be flow restrictive. One or more tacks may be advantageously deployed at such a tissue peeling portion. Smaller tacks allow for treatment of a subset of the vessel treated by a balloon angioplasty procedure, thereby providing a treatment treatment that does not require implantation of a long metal stent over the entire angioplasty treatment area. Ideally, one or more tacks may be used to treat 60% or less of the length of the vessel in the angioplasty treatment area. In treating tissue peeling portions, smaller tacks with single (shown) or dual-unit columns have been shown to cause less damage and have a shorter recovery time than commonly available stents.

[0142] After the nail is placed, an intravascular structure is formed in situ. The in situ placement can be carried out in any suitable blood vessel, such as in any peripheral artery. The structure does not need to be limited to only two nails. In fact, a plurality of at least three intravascular nails can be provided in the intravascular structure formed in situ. In one embodiment, the length of each nail in the uncompressed state is not greater than about 8mm, for example, about 6mm. In one configuration, at least one nail in the nail, for example, each nail in the nail is spaced apart from the adjacent nail by at least about 4mm or spaced apart by about 4mm to 8mm or about 6mm to 8mm. Although some embodiments have a length of 8mm or less, other embodiments can be longer, for example, up to about 12 or 15mm. In addition, adjacent nails can be positioned to be as close as 2mm apart, particularly in blood vessels that are not prone to bending or other movements. In some embodiments, the delivery device can be pre-loaded with six nails, each of which is about 6.5mm in length, and can be used to treat lesions up to 15cm.

[0143] In various delivery devices described herein, the spacing between implanted nails can be controlled to maintain a set distance or minimum distance between each nail. It can be seen that the delivery device and / or the nails can include features that help maintain the desired distance between the nails. Maintaining appropriate spacing between nails can help ensure that the nails are distributed over the desired length without contacting each other or gathering in a certain area of ​​the treated blood vessel. This can help prevent kinking of the blood vessel in which the nails are arranged.

[0144] Although a three-pin structure formed in situ may be suitable for certain indications, an intravascular structure having at least 5 intravascular pins may be advantageous for treating loose plaques, vascular valves, exfoliation, or other significantly more elongated diseases (non-focal). For example, although most exfoliations are focal (e.g., short axial length), a series of exfoliations may be considered and treated as a more elongated disease.

[0145] In some cases, nails with even shorter axial lengths can be used to treat more spaced locations. For example, multiple nails each having a length of no more than about 7 mm can be placed in a blood vessel to treat a tackable malady. At least some of the nails can be spaced at least about 5 mm from adjacent nails. In some cases, it is preferred that a gap in the range of about 6 mm to about 10 mm can be provided between adjacent nails.

[0146] Optionally, once the tack is in place, the angioplasty balloon can be returned to the treatment site and inflated to expand the tack to the desired expanded state.

[0147] Now turn to Figure 8 , an embodiment of a handle 60 for a delivery device is shown. The handle 60 can be used for controlled sequential delivery of staples 2. The handle 60 can beneficially provide a physician with a one-handed method of delivering staples while also providing increased placement accuracy with consistent results and other benefits.

[0148] The handle 60 may include a trigger 62 to control the extraction of the outer sheath 12. For example, each actuation of the trigger 62 may extract the outer sheath to expose at least a portion of the nail 2 and the delivery platform 8. The handle may also include several other features, such as safety features 64, 66, a counter 78, a proximal Luer hub 34, and a retraction override 80. The functions of the various features of the handle will be discussed in more detail below. It should be understood that some embodiments may include one or more of the features described.

[0149] The handle 60 may include one or more safety features that prevent the outer sheath 12 from being prematurely withdrawn, such as due to an undesired actuation of the trigger 62. For example, the handle 60 may include a safety button 64 that needs to be actuated before or when the trigger 62 is actuated. In addition, the handle may include an interlock 66. The interlock 66 may prevent actuation of the trigger, but the interlock 66 may also help maintain the relationship between the outer sheath 12 and the inner shaft 26.

[0150] View now Fig. 9 , the interlock 66 can be seen in more detail. The interlock 66 can remain in place until the physician is ready to deploy the nail 2. The interlock 66 can hold the inner shaft 26 in place and prevent movement of the trigger 62 that is mechanically linked to the outer sheath 12. In the illustrated embodiment, when the interlock 66 is removed, the interlock 66 releases full engagement with the handle 60.

[0151] The interlock 66 is shown engaging the trigger 62, the housing of the handle 60, and the inner shaft 26. The interlock 66 can engage the groove 70 on the trigger and the groove 72 on the handle body. In some embodiments, the opposite ends 68, 74 of the interlock 66 can be used to respectively engage the groove 70 of the trigger and the groove 72 of the handle. Each end 68, 74 can simply prevent movement of the inner shaft in one direction, or each end 68, 74 can prevent movement in two directions.

[0152] The interlocking member can be shaped to allow connection and disconnection in a consistent manner, such as in a first-in, last-out configuration. As shown, the distal end 68 of the interlocking member 66 can extend into the trigger, and the interlocking member 66 needs to be rotated downward to be removed. In some embodiments, the distal end 68 of the interlocking member is hook-shaped. The proximal end 74 can include a protrusion that advances into the groove 72. It should be understood that this arrangement can be reversed and the interlocking member 66 can be connected in other ways.

[0153] In some embodiments, it may be advantageous to advance the delivery device through the patient's vascular system while the inner shaft is retracted to a certain extent in the outer sheath. In other words, it may be advantageous that the outer sheath may be excessively extended to a certain extent over or beyond the inner shaft while the delivery device is advanced through a tortuous cavity. For example, it should be understood that during the advancement of the distal end of the delivery device in the vascular system, the outer sheath and the inner shaft will experience different forces due to the friction and tortuosity of the blood vessel. The initial adjustment of the inner shaft 26 can help rebalance the system and help move the first delivery platform to the second pre-deployment position. Spacing the first delivery platform proximally before deployment helps to ensure that the first nail is not released prematurely. In addition, over-extending the outer sheath during the advancement through the tortuous cavity can prevent the accidental exposure of the delivery platform, thereby preventing the accidental deployment of the nail, obstruction or other undesirable interactions between the nail / deployment platform and the surrounding environment. The inner shaft can be withdrawn to a certain extent in the outer sheath so that the amount of kink or bend will not cause the displacement of the outer sheath relative to the inner shaft sufficient to expose the first nail or the first deployment platform. Once the outer sheath is in the desired deployment position, the inner shaft can be advanced a predetermined distance to properly align the outer sheath with the inner shaft prior to deploying the spikes.

[0154] As described in detail elsewhere herein, proper alignment of the outer sheath and the inner shaft prior to deploying the nails may be critical to the proper functioning of certain embodiments disclosed herein. For example, in embodiments where multiple nails are deployed, misalignment of the outer sheath and the inner shaft may worsen as the outer sheath is withdrawn to deploy the multiple nails. Additionally, in other embodiments, misalignment of the outer sheath and the inner shaft may result in equal errors between the deployed multiple nails. As described above, once positioned at the treatment position, the outer sheath may be adjusted (e.g., withdrawn, retracted, extended, or advanced) to a second pre-deployment position ( Figure 7B Alternatively, in some embodiments, once positioned at the treatment site, the inner sheath can be adjusted (e.g., withdrawn, retracted, extended, or advanced) relative to the outer sheath and / or handle housing to be aligned with the outer sheath. Figure 7B . A second pre-deployment position (e.g., a suitable pre-deployment position) can be used to adjust the position of the outer sheath to handle any stretching, bending, etc. that may require some adjustment before releasing the nail. In the second pre-deployment position, the distal end 52 of the outer sheath can be positioned at or slightly distal to the distal end of the nail to be deployed.

[0155] In addition, in some embodiments, the distance between the front cone and the most distal delivery platform can be different from the distance between adjacent delivery platforms. Therefore, it may be useful and / or necessary to handle this difference by adjusting forward or backward (e.g., a smaller adjustment) relative to the relationship between the outer sheath and the inner shaft. The adjustment can position the outer sheath so that the actuation of the trigger can move the outer sheath to a pre-deployment position or a position where the first nail can be deployed.

[0156] Some embodiments of the delivery device disclosed herein include an inner shaft regulator, which is configured to adjust the inner shaft relative to (e.g., relative to) an outer sheath and / or a handle housing. Other embodiments of the delivery device disclosed herein include an inner shaft regulator, which is configured to adjust the outer sheath relative to (e.g., relative to) an inner shaft and / or a handle housing. The delivery device can generally include a handle housing, an interlocking member, a trigger, an inner shaft, an outer sheath, and an inner sheath regulator. More specifically, the inner shaft can be connected to a proximal Luer hub, which can interact with the inner shaft regulator. Of course, the inner shaft regulator can adjust the relative position as just described in any of several ways. Some systems and methods in these systems and methods for adjustment will be described in more detail below. It should be understood that these systems and methods are only for illustrative purposes, and many other adjustment systems and adjustment methods can also be used and are included in the present disclosure.

[0157] In some embodiments, the inner shaft can be adjusted relative to the outer sheath and / or housing by releasing the interlock 66 to advance the inner shaft 26 within the outer sheath 12. This can help reposition and adjust the relationship between the inner shaft 26 and the outer sheath 12 with the delivery platform 8. This adjustment can position the outer sheath in a prepared position ready for nail deployment. The interlock 66 and the inner shaft 26 can have a bevel interface 76. The bevel interface 76 can include a bevel on one or both of the interlock and the inner shaft. For example, in some embodiments, the shuttle interlock can include a bevel on the protrusion 74, and the inner shaft can include a rounded surface that engages with the bevel but does not include an actual bevel.

[0158] Removing the interlock 66 with the bevel interface 76 can force the inner shaft 26 to move distally so that the bevel on the interlock 66 disengages from the groove 72 in the handle housing. According to some embodiments, the inner shaft 26 can experience about 6 mm of travel, which can be a significant movement since the length of the nails of some embodiments is 6.5 mm as previously discussed.

[0159] Fig.17A handle 60 is shown with an inner shaft adjuster (e.g., including a handle housing) at the proximal end. It should be understood that the other parts of the handle 60 (e.g., the trigger 62, the safety button 64, the counter 78, and the retraction override switch 80) can be the same as disclosed elsewhere herein. Alternatively, the other parts of the handle 60 can be different from those described elsewhere herein. Fig.17 The inner shaft adjuster 1710 shown in FIG. 1 is a cover-based inner shaft adjuster, as will be described below.

[0160] FIG. 18A to FIG. 18B Shows Fig.17 60 . These figures show that the handle 60 generally has a proximal portion 1860, a proximal Luer hub 34, and an interlock 66. The proximal portion 1860 can be a proximal extension or proximal portion of the handle 60 that extends proximally in a generally tubular or cylindrical manner. For example, the proximal portion 1860 can have a proximal portion 1861 and a distal portion 1862 that define a generally cylindrical tube. Of course, the proximal portion 1860 can have any cross-sectional shape, for example, the proximal portion 1860 can have a generally oval or elliptical cross-sectional shape. Alternatively, the proximal portion 1860 can have a generally or true or regular triangle, rectangle, pentagon, hexagon, heptagon, octagon, or any other geometric cross-sectional shape. It should be understood that not all portions of the handle 60 or the inner shaft adjuster 1710 are shown in FIG. FIG. 18A to FIG. 18B (or other accompanying drawings). At least FIG. 18A to FIG. 18B As shown, this allows certain portions of the handle 60, such as the proximal portion 1860 and other portions, to be more clearly seen.

[0161] The portion of the inner shaft 26 located within the handle 60 is substantially located on an axis passing through or approximately at the center of the handle 60, such as the inner shaft axis, or defines an axis passing through or approximately at the center of the handle 60, such as the inner shaft axis. The proximal portion 1860 can be positioned approximately on the same axis, such as approximately on the inner shaft axis or positioned around the inner shaft axis. Thus, it can be seen that the proximal portion 1860 starts from the distal portion 1862 and extends proximally from the handle 60 and extends around the same axis as the inner shaft 26 until it ends near the proximal portion 1861 of the proximal portion 1860. When both the proximal portion 1860 and the inner shaft 26 are present, the two can be referred to as being concentric, or positioned around the same or approximately the same axis or located on the same or approximately the same axis.

[0162] The proximal portion 1860 can have any of a number of lengths. For example, the proximal portion 1860 can have a length in the range of about 0.5 cm to 6 cm, about 0.75 cm to 5.5 cm, about 1 cm to 5 cm, about 1.25 cm to 4.5 cm, about 1.5 cm to 4 cm, about 1.75 cm to 3.5 cm, and about 2 cm to 2.5 cm, or any other length that achieves the purpose of the proximal portion 1860 disclosed herein (e.g., to support the inner shaft adjuster 1710 and facilitate actuation of the inner shaft adjuster 1710). In a substantially similar manner, the proximal portion 1860 can have any of a number of diameters. For example, the proximal portion 1860 can have a diameter within the range of about 0.25 cm to 3 cm, about 0.5 cm to 2.75 cm, about 0.75 cm to 2.5 cm, about 1 cm to 2.25 cm, about 1.25 cm to 2 cm, and about 1.5 cm to 1.75 cm, or any other diameter that achieves the purpose of the proximal portion 1860 disclosed herein.

[0163] In some embodiments, the proximal portion 1860 of the handle 60 includes one or more grooves 1844. FIG. 18A to FIG. 18B The handle 60 in FIG. 1 is shown in partial cross-section so that only one slot 1844 is visible—but it should be understood that FIG. 18A to FIG. 18B The handle 60 shown in FIG. 1 has two slots 1844. However, depending on the system requirements, the proximal portion 1860 can have only one slot 1844. Alternatively, depending on the system requirements, the proximal portion 1860 can have two, three, four, five, six, seven, or even eight slots 1844 or any other number of slots that helps achieve the purpose of the system, such as advancing and / or retracting the inner shaft 26.

[0164] At least one slot 1844 can extend through the entire thickness of the wall of the proximal portion 1860. In embodiments having more than one slot 1844, the slots 1844 can be radially arranged in substantially equal increments around the proximal portion 1860. For example, when only two slots 1844 are included, the slots 1844 can be arranged 180 degrees apart from each other (e.g., as shown in FIG. FIG. 18A to FIG. 18B When three grooves 1844 are included, the grooves 1844 may be arranged to be spaced 120 degrees apart from each other; and when four grooves 1844 are included, the grooves 1844 may be arranged to be spaced 90 degrees apart from each other.

[0165] The groove 1844 can have any of several shapes. For example, in some embodiments, the groove 1844 is generally straight and extends in the proximal-distal direction. In other words, the groove 1844 can be generally parallel to the axis defined by the inner shaft 26. In other words, the groove 1844 can extend away from the handle 60 in the same direction as the proximal portion 1860. In other embodiments, the groove 1844 can be straight but not parallel to the axis defined by the inner shaft 26, that is, the groove 1844 can be at an angle to the axis defined by the inner shaft 26. In embodiments where the proximal portion 1860 is generally cylindrical, the angled groove 1844 itself appears as a spiral or thread, wherein the angle determines what kind of spiral or thread the groove 1844 presents. In other embodiments, at least a portion of the groove 1844 is not straight. For example, the groove 1844 can have any of several shapes, such as but not limited to a "J" shape, a "T" shape, a "Z" shape, etc. The reasons for including or using another shape are further discussed below. Furthermore, the slots 1844 can be substantially mirror images of each other such that when viewed horizontally from the dimensions of the handle 60, one can see straight through both slots (e.g., FIG. 18A to FIG. 18B ), but this is not required and in some embodiments is not possible.

[0166] The slot 1844 is configured or adapted to receive a pin 1834. As will be discussed below, such a pin 1834 can be associated with the proximal Luer hub 34. Thus, the width of the slot 1844 can be greater than the diameter of the pin 1834. For example, the slot can have a width in the range of about 0.25 mm to 4 mm, about 0.5 mm to 3.75 mm, about 0.75 mm to 3.5 mm, about 1 mm to 3.25 mm, about 1.25 mm to 3 mm, about 1.5 mm to 2.75 mm, about 1.75 mm to 2.5 mm, and about 2 mm to 2.5 mm, or any other width that advantageously receives the pin 1834.

[0167] As just discussed, the proximal Luer hub 34 can have a pin 1834. In some embodiments, the proximal Luer hub 34 has one pin 1834. In other embodiments, the proximal Luer hub 34 has two pins 1834 (e.g., FIG. 18A to FIG. 18B). In other embodiments, the proximal Luer hub 34 has more than two pins 1834, such as three, four, five, six, seven or eight pins 1834 or any other number of pins that facilitates the purpose of the system, such as advancing and / or retracting the inner shaft 26. The pins 1834 can have a diameter that is substantially smaller than the width of the slot 1844. When the pins 1834 are configured to move within the slot 1844, the pins 1834 can be appropriately smaller than the slot 1844, but the diameter of the pins 1834 is generally in the range of about 0.25 mm to 4 mm, about 0.5 mm to 3.75 mm, about 0.75 mm to 3.5 mm, about 1 mm to 3.25 mm, about 1.25 mm to 3 mm, about 1.5 mm to 2.75 mm, about 1.75 mm to 2.5 mm, and about 2 mm to 2.5 mm, or any other diameter that fits within the slot 1844 and allows sliding movement in the slot 1844. The length of the pin 1834 is generally greater than the thickness of the wall of the proximal portion 1860 of the handle 60, so that the pin 1834 extends beyond the outer surface of the proximal portion 1860. However, this is not required. In some embodiments, the length of the pin 1834 is less than the thickness of the wall of the proximal portion 1860. In addition, in other embodiments, the length of the pin 1834 is approximately equal to the thickness of the wall of the proximal portion 1860. However, generally, the pin will have a length in the range of about 0.5 mm to 4 mm, about 0.75 mm to 3.5 mm, about 1 mm to 3 mm, about 1.25 mm to 2.5 mm, about 1.5 mm to 2 mm, and about 1.75 mm, or any other length that facilitates the movement of the pin 1834 and / or the proximal Luer hub 34 relative to the proximal portion 1860 of the handle 60.

[0168] Fig. 18C A horizontal cross-sectional view of the handle 60 is shown, wherein the cross section cuts horizontally through the middle of the proximal portion 1860, the proximal Luer hub 34, and the inner shaft 26. It should be understood that for illustrative purposes, not all parts of the handle 60 are shown in this cross section. In this way, the structure and interaction of the various parts of the device are clearly shown.

[0169] As can be seen, the proximal portion 1860 can be hollow along its entire length. The inner diameter of the proximal portion 1860 can be just larger than the outer diameter of the proximal Luer hub 34. In this way, the proximal Luer hub 34 can be fitted into the proximal portion 1860 and slide back and forth within the proximal portion 1860. As shown, the proximal Luer hub 34 has two pins 1834 on opposite sides of the proximal Luer hub 34. However, although shown as two pins 1834, a single pin 1834 extending through the entire proximal Luer hub 34 can also be used. The pin is fitted in a slot 1844, which is located on both the inner and outer sides of the proximal portion 1860 of the handle 60. As particularly fully shown in this view, the pin 1834 extends through the slot 1844, out of the slot 1844 and extends over the outer surface of the handle 60 of the proximal portion 1860. The pin 1834 and the slot 1844 are configured such that the pin 1834 can slide back and forth in the slot 1844 from the distal end of the slot 1844 to the proximal end of the slot 1844, and the pin 1834 can slide back and forth in the slot 1844 from the proximal end of the slot 1844 (e.g., in the proximal-distal direction) to the distal end of the slot 1844. The sliding of the pin 1834 in the slot 1844 moves the proximal Luer hub 34 (e.g., in the proximal-distal direction), which in turn also moves the inner shaft 26 (e.g., in the same proximal-distal direction). Obviously, when the proximal end of the inner shaft 26 connected to the proximal Luer hub 34 moves (e.g., in the proximal-distal direction), the distal end of the inner shaft 26 (i.e., proximal to the delivery platform) will also move (e.g., in the proximal-distal direction).

[0170] Back to FIG. 18A to FIG. 18B , Fig.18A The pin 1834 is shown in the most proximal position in the slot 1844. In contrast, Fig.18B The pin 1834 is shown moving or sliding distally within the slot 1844 toward the distal-most position. In this manner, the proximal Luer hub 34 can move back and forth or in a proximal-distal manner relative to the proximal portion 1860 of the handle 60.

[0171] FIG. 18A to FIG. 18B Also shown is interlock 66 having a proximal extension 1867. 1867 may be configured to mate and lock with one or more features of inner shaft adjuster 1710, as will be discussed in greater detail below.

[0172] Fig.19 An embodiment of a cover 1713 of an inner shaft adjuster 1710 is shown. Generally, the cover 1713 includes one or more inner grooves, one or more inner ridges, and a distal lip.

[0173] like Fig.19As shown in , the cover 1713 may include one or more grooves 1960. The cover 1713 may include a single groove 1960 or more grooves 1960, including but not limited to two, three, four, five, six, seven or eight grooves 1960, or any other number of grooves that facilitate the movement or accommodation of the pin 1834. As shown, the groove 1960 can be spiral. However, in some embodiments, the groove 1960 can be any of a number of shapes, such as a straight line, a "J" shape, a "T" shape, a "Z" shape, etc.

[0174] The groove 1960 is generally defined by one or more ridges 1962. The cover 1713 may include a single ridge 1962 or more ridges 1962, including but not limited to two, three, four, five, six, seven, or eight ridges 1962, or any other number of grooves that facilitates movement or accommodation of the pin 1834. As shown, the ridge 1962 may be spiral. However, in some embodiments, the ridge 1962 may be any of a number of shapes, such as linear, "J" shaped, "T" shaped, "Z" shaped, etc. Alternatively, the ridge 1962 may not be included. Instead, the groove 1960 may simply be manufactured in the wall of the cover 1713 (e.g., leaving the wall thickness of the cover 1713 except for the groove 1960 cut out).

[0175] As will be further described below, the groove 1960 can be configured to receive the pin 1834. Much like the slot 1844, the width of the groove 1960 can be just greater than the width of the diameter of the pin 1834. In other words, the ridges 1962 can be positioned to be spaced apart from each other by a distance just greater than the diameter of the pin 1834. For example, the groove can have a width in the range of about 0.25 mm to 4 mm, about 0.5 mm to 3.75 mm, about 0.75 mm to 3.5 mm, about 1 mm to 3.25 mm, about 1.25 mm to 3 mm, about 1.5 mm to 2.75 mm, about 1.75 mm to 2.5 mm, and about 2 mm to 2.5 mm, or any other width that advantageously receives the pin 1834.

[0176] The cover 1713 has a proximal end 1711 and a distal end 1712. One or both of the proximal end 1711 and the distal end 1712 can be substantially flat ends. However, in some embodiments, the distal end 1712 can have one or more features, such as a first distal lip portion 1920, a second distal lip portion 1922, a first step 1930, a second step 1931, a third step 1932, and a window 1950 (e.g., a discontinuity in the distal lip). The features of the distal lip of the distal end portion advantageously allow the cover 1713 to interact and lock with the interlock 66, as will be discussed below. In some embodiments, the distal end 1712 has two steps, i.e., a first step 1930 and a second step 1931, which together define the window 1950. However, as shown, other steps, such as a third step 1932, can be included. Except for the window 1950, the distal lip can be generally flat (e.g., lying in a plane that is generally perpendicular to the axis of the inner shaft 26). However, in other embodiments, the distal lip can include more than one portion, such as a first distal lip portion 1920 and a second distal lip portion 1922. It should be understood that more than just two portions can be included. The first distal lip portion 1920 and / or the second distal lip portion 1922 can be flat, as just discussed. However, one or both of the distal lip portions can be beveled or angled, such as Fig.19 as shown in .

[0177] FIG. 20A to FIG. 20B A partial cross-sectional view of the handle 60 and the inner shaft adjuster 1710 with the cover 1713 in place is shown. These figures are similar to the FIG. 18A to FIG. 18B is very similar, and the section is positioned away from the page "closer" to the viewer (i.e., at FIG. 18A to FIG. 18B In the embodiment, the proximal portion 1860 of the handle 60 is bisected, and in FIG. 20A to FIG. 20B In the embodiment, the proximal portion 1860 is not cut into Fig.18A and Fig.18B In addition, as FIG. 18A to FIG. 18B , except for the position of the proximal Luer hub 34 and the pin 1834 within the slot 1844 (and concomitantly, the rotational orientation of the cover 1713), FIG. 20A to FIG. 20B are the same.

[0178] In some embodiments, the proximal portion 1860 of the handle 60 can include one of more portions that keeps the cover 1713 substantially fixed in the proximal-distal direction while allowing the cover 1713 to rotate. FIG. 20A to FIG. 20B, the more portions are shown as ridges or protrusions that interact with one or more surfaces on the interior of the hood 1713. However, it should be understood that there are a variety of ways in which the hood can remain axially fixed while allowing rotational movement. It can be seen that the groove 1960 on the inner surface of the hood 1713 receives the pin 1834. Because the groove 1960 is helical, rotation of the hood 1713 causes the edge of the groove (i.e., the ridge 1962) to abut against the pin 1834 and push the pin 1834 upward. If the hood 1713 is rotated sufficiently, the spiral groove 1960 will continue to push the pin 1834. In this way, the pin 1834 can slide along the groove 1844. Obviously, rotation of the hood 1713 in a first direction will cause the pin 1834 to move in a distal direction. In FIG. 20A to FIG. 20B In the figure, the first direction is shown as a clockwise direction, however, it should be understood that the first direction can be a clockwise direction or a counterclockwise direction. In the same manner, rotation of 1713 in a second direction (e.g., the opposite direction) will push pin 1834 to move in the proximal direction. FIG. 20A to FIG. 20B , the second direction is shown as being counterclockwise, but it should be understood that the second direction can be counterclockwise or clockwise (but will generally be opposite to the direction of the first direction). In this manner, the proximal Luer hub 34, and therefore the inner shaft 26, can be moved in a proximal-distal direction by rotating only the cover 1713 of the inner shaft adjuster 1710.

[0179] Fig. 20C and Fig. 18C Almost the same, except Fig. 20C The inner shaft adjuster 1710 is shown with the cover 1713 in place. This horizontal cross-sectional view of the handle 60 taken through the horizontal center of the proximal portion 1860, the proximal Luer hub 34 and the inner shaft 26 clearly shows the interaction of the pin 1834, the slot 1844 and the groove 1960.

[0180] Fig.21 The handle 60 is shown with Fig. 20ASimilar cross-sectional view, except that the cross section is taken directly through the center of the device rather than offset from the center. This view particularly clearly shows the interaction between the proximal extension 1867 of the interlock 66 and the distal end 1712 (i.e., the distal lip) of the cover 1713. As can be seen, the cover 1713 is mounted on the proximal portion 1860 of the handle 60 through the extension, and the diameter of the cover 1713 must be greater than the diameter of the proximal portion 1860. In addition, the height of the ridge 1962 defines the depth of the groove 1960 (i.e., the space between the bottom of the groove and the outer surface of the proximal portion 1860). In some embodiments, the proximal extension 1867 is configured to fit inside the distal lip of the cover 1713. That is, the thickness of the proximal extension 1867 is less than the depth of the groove 1960 or the height of the ridge 1962. In this manner, the distal lip of cover 1713 locks interlock 66 in the first position, which, as described elsewhere herein, prevents movement of trigger 62 and, therefore, the outer sheath.

[0181] Fig.19 Window 1950, as clearly shown in FIG. 1 , has a width and a depth. Proximal extension 1867 also has a width that is less than the width of window 1950 and a depth that is also less than the depth of window 1950. As cover 1713 is rotated about proximal portion 1860, the radial position of window 1950 will change. Cover 1713 can be rotated until window 1950 and proximal extension 1867 are substantially aligned, as shown in FIG. Fig. 22 At this point, the proximal extension 1867 of the interlock 66 can fit through the window 1950 to release the interlock 66 so that the interlock 66 can be unlocked to move from the first position to the second position (e.g., removed from the device), thereby allowing movement of the trigger 62 and the outer sheath.

[0182] like Fig. 20A , pin 1834 is limited in its possible proximal travel within slot 1844. That is, pin 1834 may eventually reach the proximal-most end of slot 1844, at which point pin 1834 will not move any further in the proximal direction. By virtue of the extension, once pin 1834 has reached its proximal-most orientation, hood 1713 of inner shaft adjuster 1710 will not rotate further. This is because of the interaction between pin 1834 and ridge 1962 / groove 1960. As already discussed, hood 1713 can be rotated to push pin 1834 within slot 1844 / advance pin 1834 within slot 1844. Additionally, by virtue of the extension, as Fig. 20B, pin 1834 is limited in its possible distal travel within slot 1844. That is, pin 1834 may eventually reach the distal end of slot 1844, at which point pin 1834 will not move further in the distal direction. By extension, once pin 1834 has reached its distal-most orientation, cover 1713 of inner shaft adjuster 1710 will not rotate further. In some embodiments, cover 1713 may be rotated less than once to move pin 1834 from the proximal position to the distal-most position. In other embodiments, cover 1713 may be rotated a single time to move pin 1834 from the proximal position to the distal-most position. In other embodiments, cover 1713 may be rotated more than once, such as but not limited to two, three, or four times to move pin 1834 from the proximal position to the distal-most position.

[0183] In some embodiments, the rotation of the cover is used to lock the interlock 66 in a first position, in which the interlock 66 prevents the movement of the trigger 62 (as disclosed elsewhere herein). The cover 1713 can be used as an automatic lock that must be fully actuated before unlocking. In this way, potential user errors can be eliminated-that is, to unlock the interlock 66 and use the device (something the user is unlikely to do), the user must (possibly without actual knowledge of the user) also take the action of automatically realigning the inner shaft 26 relative to the outer sheath (something that a general user may easily forget or ignore are two actions that are not interdependent). For example, this embodiment of locking the cover 1713 may require less than one full turn to move the pin 1834 from the most proximal position to the most distal position. In addition, the window 1950 can be aligned with the proximal extension 1867 at the end of the travel of the pin 1834 and the rotation of the cover 1713. In this way, in this embodiment, the cover 1713 must be rotated until the window 1950 can no longer be rotated so that the window 1950 is aligned with the proximal extension 1867. Once the window 1950 has been aligned with the proximal extension 1867 (and the pin 1834 has also been moved to its most distal position and the position of the inner shaft 26 has also been adjusted), the interlock 66 can be fitted through the window 1950 and the interlock 66 can be removed from the device so that the device can be used. Other types of locking covers that prevent the removal of the interlock 66 before the pin 1834 is fully advanced are also possible.

[0184] Other embodiments of the inner shaft adjuster 1710 are included below. For example, the proximal Luer hub 34 can be spring loaded and biased toward the proximal end of the device, and the proximal Luer hub 34 can have a pin 1834 that travels and slides through a locking groove 1844, such as a "J"-shaped groove. In such an embodiment, the proximal Luer hub 34 can be maintained in a proximal / retracted position when stationary. Subsequently, in order to be used, the proximal Luer hub 34 can be pushed against the spring distally so that the pin 1834 follows the "J"-shaped groove 1844. Once pushed forward and twisted (to follow the shape of the "J"), the shape of the groove 1844 can cooperate with the proximal biasing force of the spring to hold the pin 1834 in place. Many other such embodiments are obvious when considering the present disclosure and are included within the scope of the present disclosure.

[0185] In some embodiments, rather than including an inner shaft adjuster 1710, the inner shaft 26 can be coupled to a proximal Luer hub 34, which can be fixed to the handle housing. This can prevent movement of the inner shaft 26 relative to the outer sheath 12 at the proximal end, but as already mentioned, the distal end may experience some relative movement.

[0186] Now turn to Fig.10 , it can be seen that the interlock 66 of the embodiment has been removed. The trigger 62 and safety button 64 can now be actuated. The safety button 64 can be connected to a safety release yolk 88. The yolk 88 can be pivoted at point "P" so that advancement of the safety button 64 causes the yolk to pivot away from a protrusion or notch 90 in the trigger 62. The engagement between the yolk 88 and the protrusion 90 prevents the trigger from advancing. Once the yolk is out of the way, the trigger can move freely, as can be seen in FIG. Fig.11 It should be appreciated that the safety feature may function in many other ways while providing similar benefits.

[0187] Re-view Fig.10 and Fig.11 It can also be seen that the trigger 62 moves along a curved path. The handle housing may include an arcuate channel, and the trigger may be positioned within the arcuate channel to move along the arcuate path. The trigger 62 may be spring loaded to bias it to a starting position or Fig.10 The trigger 62 is moved upwardly to the first extended position. Actuation of the trigger can compress the spring 86 and advance the trigger into the handle housing. This movement of the trigger can be assisted by a rod 92. The rod 92 can have a pin or other protrusion 94 positioned within a slot 96 in the handle body. When the trigger 62 is advanced upwardly, the pin 94 can slide forward in the slot 96. This can help keep the trigger from binding as it is advanced.

[0188] In some embodiments, a control device may be provided to deploy a self-expanding medical device within a blood vessel of a living being. The control device may include a restraining sheath and a control mechanism or trigger. The restraining sheath may have a proximal portion and a distal portion, the restraining sheath being adapted to extend over one or more self-expanding medical devices to hold the medical devices in a retracted position, and the restraining sheath being adapted to be retractable to expose the one or more retracted medical devices for deployment. The control mechanism may include: an actuation assembly coupled to the proximal portion of the restraining sheath to retract the restraining sheath; a slider assembly capable of moving along an arcuate motion path, the retraction of the restraining sheath being actuated by an actuation force applied by a user to a movable member of the control mechanism that moves along the arcuate path, thereby changing the angle of force application and the mechanical advantage of the force applied by the user according to the position of the movable member along the arcuate path.

[0189] The advancement of the trigger 62 may also cause the movement of the shuttle 84. The shuttle 84 may be mechanically linked and connected to the outer sheath 12. Therefore, the advancement of the shuttle 84 may cause the outer sheath 12 to advance, thereby withdrawing the outer sheath 12 and deploying the nail 2. Each complete actuation of the trigger 62 from the starting position to the end position may cause the outer sheath 12 to be fully withdrawn to deploy the nail and remain in the withdrawn position. The shuttle 84 may also be spring loaded by a return spring 86. This may cause the shuttle 84 to return to the initial position or starting position of the shuttle 84 after the trigger is actuated, while the outer sheath remains in its withdrawn position. Therefore, each advancement of the trigger 62 further withdraws the outer sheath 12 from the distal end of the inner shaft 26. This may be achieved by revisiting Fig. 10A , Fig.11A and Fig. 12A see, Fig. 10A , Fig.11A and Fig. 12A Indicates that the handle is located Fig.10 , Fig.11 and Fig.12 The respective first position, second position and third position are part of the distal end of the delivery device.

[0190] When the shuttle returns to the initial position, the shuttle can engage the counter 78. The counter 78 can be of the ratchet type so that each engagement of the shuttle can cause the counter to ratchet in the same direction, thereby counting down the number of nails available for deployment. In some embodiments, the shuttle includes a counter pawl 98. Each time the shuttle returns to the initial position, the counter pawl 98 can engage a different tooth on the counter 78. Re-view Fig.10 , Fig.11 and Fig.12 , it can be seen that the counter pawl 98 engages the teeth on the counter 78 as the shuttle advances and then disengages ( Fig.11), which then engages a new tooth, thereby advancing or rotating the counter ( Fig.12 ).

[0191] Now turn to Fig. 10B , showing a detailed view of the shuttle 84. The proximal end of the outer sheath can include an outer sheath rack 82. The rack can include a plurality of teeth 104, 110, 112, as will be described in more detail below. The shuttle can engage and disengage with the teeth 104 to advance the outer sheath rack 82, thereby extracting the outer sheath from the distal end of the inner shaft 26. A pawl 108 on the handle housing can engage one or more teeth 110, 112 to hold the outer sheath in the extracted position.

[0192] The rack 82 may include one or more sets of teeth. As shown, the rack includes a top set of teeth 110, 112 and a bottom set of teeth 104. Both sets of teeth are used to secure the outer sheath in place, but the top set of teeth is more specifically designed to prevent the rack from reversing direction, and the bottom set of teeth is designed to control the advancement and withdrawal of the rack 82 through the shuttle. The shuttle 84 may include one or more deflection members 100, 102. In the detailed view, it can be seen that the shuttle 84 includes a pair of deflection members 100, 102.

[0193] In the initial position, the deflection members 100, 102 can be positioned on either side of the tooth 104. This can prevent the rack 82 from moving relative to the housing. The trigger 62 and the shuttle 84 can be mechanically linked so that actuation of the trigger 62 causes advancement of the shuttle 84. Fig. 9 and 10B As best shown in FIG. 1 , the trigger and shuttle 84 have a bevel interface 114. The bevel and / or angled surface at the bevel interface 114 advances the shuttle proximally as the trigger moves upward along a curved path. As the shuttle advances, the protrusion 106 on the housing contacts the deflection member 100. This allows the tooth 104 to move past the deflection member 100 when the deflection member 100 is forced downward, as can be seen in FIG. Fig.11 The pawl 108 engages the teeth 110, 112 on the top of the rack 82 to prevent the rack from moving distally after the trigger 62 is actuated. Once the shuttle returns to the initial position, the deflection members 100, 102 engage the new teeth 104, as can be seen in FIG. Fig.12 See. View Figures 10 to 12A , it can be seen how the trigger and shuttle work through the deployment of the first nail.

[0194] In some embodiments, the rack 82 may include features that allow for re-sheathing of the nails after partial actuation of the trigger. For example, the pitch on the first tooth 110 may be increased when compared to the other teeth 112. This may allow the user to begin actuating the trigger and subsequently re-sheath the nails. In the illustrated embodiment, the user has the ability to release the trigger at about 1 / 6 of the trigger stroke (1 mm of nail exposure), and the outer sheath is able to re-sheath the nails. Once the trigger is actuated beyond 1 / 6 of the stroke, the pawl 108 engages the next tooth 112 on the rack and prevents the outer sheath from re-sheathing the exposed nails. However, the pawl engagement on the rack does give the user the opportunity to release the trigger during partial deployment while maintaining the position of the trigger in the event that the delivery device needs to be repositioned. In other embodiments, the trigger may be released and the nails may be re-sheathed after about 1 / 2, 1 / 3, 1 / 4, or 1 / 5 of the trigger stroke. In some embodiments, the rack has a series of teeth, wherein the pitch of the first tooth 110 is larger than the pitch of the adjacent teeth 112. In some embodiments, the rack can have a space between the first set of teeth and the second set of teeth. For example, tooth 110 can be removed from the rack. In some embodiments, the length of one or more teeth on the rack can be 4 / 5, 3 / 4, 2 / 3, 1 / 2, 40%, 1 / 3, 30%, 1 / 4 of the length of the shortest pillar on the farthest end of the nail. Alternatively, two adjacent teeth can be spaced 4 / 5, 3 / 4, 2 / 3, 1 / 2, 40%, 1 / 3, 30%, 1 / 4 of the length of the shortest pillar on the farthest end of the nail. For example, the length of the short pillar can be 2mm, and the length of the tooth can be 1mm.

[0195] Now turn to Figures 13 to 15 , re-wrapping after deployment will now be described. After the physician has determined that the delivery device is no longer needed, such as after delivering one or more nails, it may be desirable to re-wrapp the distal end of the inner shaft 26 with the outer sheath 12. Since re-wrapping may mislead the physician into believing that there are additional nails that can be deployed, it may also be desirable to lock the outer sheath in place after re-wrapping.

[0196] The handle 60 may include a retraction override switch 80. Actuation of the retraction override switch 80 may disengage the internal locking features of the handle, such as one or more of the deflection members 100, 102 and the pawl 108. In the illustrated embodiment, the retraction override switch 80 is a rotating lever. Rotation of the lever 80 ( Figure 13 to Figure 14 ) rotates the teeth 104, 110, 112 on the rack 82 so that the teeth 104, 110, 112 are no longer engaged by the deflection members 100, 102 or the pawl 108, such as Fig. 14BThen, the outer sheath can be advanced distally to re-cover the distal end of the inner shaft 26 with the outer sheath 12, as shown in FIG. Fig.15 as shown in .

[0197] The retraction override switch 80 may also include a locking feature. The locking feature may be used to ensure that the trigger cannot engage the rack after re-wrapping. Fig.13A and Fig.14A , shows an implementation of a locking feature. Fig.13A , the retraction override switch 80 is in a first disengaged position. A spring loaded member 116, such as a spring steel plate, can engage one or more protrusions and / or slots on the retraction override switch 80. The one or more protrusions and / or slots can be located on a cam 118 that rotates as part of the retraction override switch 80. The cam 118 can have a first slot 120 that can engage the spring loaded member 116 during initial use of the handle, such as during actuation of the trigger. Once the desired nails have been deployed, the retraction override switch 80 can be rotated, causing the cam to rotate. The slot 120 can become disengaged from the spring loaded member 116. The cam can be rotated until a land 124 contacts a surface (not shown) on the housing. The surface can be a protrusion or other surface feature that prevents the cam from further rotating. In this position, a second land 122 can engage the spring loaded member 116 and prevent the cam from rotating back to the previous initial position in the opposite direction. In this manner, the rack can be tightened on its side so that the trigger no longer operates to advance the outer sheath proximally.

[0198] The outer sheath 12 may then be manually advanced distally to re-sheath the distal end of the inner shaft 26 .

[0199] Now turn to Fig.16 and Fig.16A , another feature of the delivery device is shown. Another embodiment of a proximal Luer hub 24' is shown. The proximal Luer hub 24' can be similar to the proximal Luer hub 24 previously described. As will be appreciated, a sealing structure 32 is provided that is integrated into the bifurcated Luer hub 24' to receive and seal the proximal end of the space between the inner shaft 26 and the outer sheath 12. The proximal Luer hub 24' can include a two-piece assembly having a sealing housing 128 attached to the main housing.

[0200] There are a large number of patients with critical lower limb ischemia, and these patients are not suitable for distal arterial surgical reconstruction and are therefore facing distal major amputation. Methods such as balloon angioplasty and stent placement provide the choice of opening the blocked or narrowed arteries of these patients. These techniques usually require a certain degree of vascular patency so that guide wires and catheters can advance to the blocked or narrowed portion for further treatment. In some patients, the blood vessels are almost or completely occluded, and are therefore not suitable for many transvascular techniques. Distal venous arterialization is a surgical treatment in which the venous bed is used as an alternative catheter for peripheral tissue perfusion. By means of minimally invasive techniques, the blocked area of ​​the artery is bypassed by using adjacent venous catheters. Typically, the most distal satisfactory artery is used for proximal bypass anastomosis. The venous valve used to prevent the retrograde flow of blood in the venous system causes insufficiency or destruction by a probe, cutting balloon, Fogarty catheter and valve cutter to allow normal operation as an arterial catheter. Alternatively, the venous valve can cause insufficiency by a stent or nail that can be delivered by a plurality of nails / pillar delivery systems described herein.

[0201] Although the present invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments and to other alternative embodiments and / or uses of the present invention and its obvious modifications and equivalents. In addition, although many variations of the present invention have been shown and described in detail, other modifications within the scope of the present invention will be obvious to those skilled in the art based on the present disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be performed and still fall within the scope of the present invention. Therefore, it should be understood that the various features and aspects of the disclosed embodiments may be combined or substituted with each other to form a variation pattern of the disclosed invention. Therefore, it is contemplated that the scope of the present invention disclosed herein should not be limited by the above-mentioned specific embodiments disclosed, but should only be determined by a fair reading of the appended claims.

[0202] Similarly, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than expressly recited in the claim. Rather, as the appended claims reflect, inventive aspects reside in a combination of less than all of the features of any single previously disclosed embodiment. Therefore, the claims following the detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment.

Claims

1. A delivery device for deploying a self-expanding medical device within a blood vessel, the delivery device comprising: a restraining sheath having a proximal end and a distal end, the restraining sheath being adapted to extend over one or more self-expanding medical devices to retain the medical devices in a retracted position and the restraining sheath being retractable to expose the retracted one or more self-expanding medical devices for deployment; as well as a control mechanism, the control mechanism comprising: an actuation assembly coupled to the proximal end portion of the limiting sheath to retract the limiting sheath; a slider assembly capable of sliding along an arcuate motion path, the retraction of the limiting sheath being actuated by an actuation force applied by a user to a movable member of the control mechanism that slides along the arcuate path, thereby changing an angle of force application and a mechanical advantage of the force applied by the user according to a position of the movable member along the arcuate path, In which, the actuation assembly includes a shuttle member, which is configured to be mechanically connected to the limiting sheath, and the movable part has a bevel interface with the shuttle member, and the bevel interface has one or more bevels or angled surfaces, and the one or more bevels or angled surfaces are configured to cause the shuttle member to advance proximally when the movable part slides along the arc path.

2. A system for deploying two or more intraluminal devices within a blood vessel, the system comprising: two or more intraluminal devices, each intraluminal device comprising at least one radiopaque marker; an inner shaft having a proximal end and a distal end, the distal end having two or more delivery platforms for deploying the two or more intraluminal devices, each intraluminal device being in a collapsed state and located in a separate delivery platform; a restraining sheath having a proximal portion and a distal portion, the restraining sheath being adapted to extend over the two or more intraluminal devices to hold the intraluminal devices in a retracted position and being retractable to expose the retracted two or more intraluminal devices for deployment, the restraining sheath further comprising a sheath radiopaque marker located in the distal portion of the restraining sheath, the sheath radiopaque marker being located at a set distance relative to the distal-most intraluminal device; a control mechanism comprising: an actuation assembly coupled to the proximal end of the limiting sheath to retract the limiting sheath relative to the inner shaft, the retraction of the limiting sheath being actuated by an actuation force applied by a user to a movable trigger component of the control mechanism, wherein the movable trigger component is configured such that actuation of the movable trigger component from a starting position to an ending position completely withdraws the limiting sheath so as not to cover one of the two or more delivery platforms, thereby releasing one of the two or more intraluminal devices from the inner shaft to a position within a living body, and further thereby, the sheath radiopaque marker located at the distal end of the limiting sheath is located at a set distance relative to the remaining most distal intraluminal device; wherein the movable trigger component is configured to slide along an arcuate path, In which, the actuation assembly includes a shuttle member, which is configured to be mechanically connected to the limiting sheath, and the movable trigger component has a bevel interface with the shuttle member, and the bevel interface has one or more bevels or angled surfaces, and the one or more bevels or angled surfaces are configured to cause the shuttle member to advance proximally when the movable trigger component slides along the arc path.

3. The system according to claim 2, wherein the control mechanism further comprises: a rack having a plurality of teeth, the rack coupled to the restraining sheath; and at least one pawl configured to engage the plurality of teeth on the rack; Wherein the shuttle is configured to selectively engage the plurality of teeth on the rack.

4. The system according to claim 2, wherein: The sheath radiopaque marker is located at a set distance from the distal end of the restricting sheath, the set distance being half of the total length of each of the intraluminal devices.

5. The system according to claim 4, wherein: The sheath radiopaque marker is 3 mm from the distal end of the limiting sheath.

6. The system according to claim 2, wherein: Each of the two or more intraluminal devices includes a frame comprised of a single unit column extending circumferentially.

7. The system according to claim 6, wherein: The at least one radiopaque marker on each of the two or more intraluminal devices comprises a plurality of radiopaque markers positioned in a central portion of the intraluminal device and equally spaced around a circumference.

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