Delivery system for endoluminal prostheses and methods of use thereof - Patents.com

Abstract

An endoluminal prosthesis delivery system comprising an outer sheath having a distal end region, a proximal end region, and a lumen extending along a longitudinal axis between the proximal end region and the distal end region. An inner member extends through the lumen of the outer sheath, at least a portion of the inner member configured to support an expandable device within the lumen proximate the distal end region of the outer sheath. A release mechanism is configured to move at least one of the outer sheath and inner member an initial distance in a controlled manner to release friction between the expandable device and the outer sheath prior to deploying the expandable device from the lumen. Related systems, devices, and methods are provided.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority under 35 U.S.C. §119(e) to provisional patent application serial number 63 / 287,282, filed December 8, 2021. The disclosure of the provisional application is incorporated by reference in its entirety.

[0002] The present disclosure relates to endoluminal prostheses, such as stents, stent grafts, etc. More specifically, a delivery system and methods for their use are described for precise and safe placement of endoluminal prostheses within body lumens, particularly within the vasculature, for the treatment of aneurysms, stenoses, etc., with a mechanism for releasing static friction and slack prior to placement of the prosthesis within a blood vessel. [Background technology]

[0003] Stent grafts and self-expanding stents are elastic structures biased to expand against the surrounding lumen wall. To deliver these structures to a target site, they are tightly compressed within a delivery system. A "pin-and-pull" stent delivery system typically includes an inner support catheter (e.g., a tube or rod) and an outer sheath. The outer sheath moves longitudinally relative to the inner support catheter, deploying the expandable structure that was compressed within the distal end region of the outer sheath. This deployment involves "pinning" the inner support catheter relative to the patient and "retracting" the outer sheath to expose the expandable structure and allow it to expand outwardly into the vessel.

[0004] These delivery systems must typically be maneuvered within highly tortuous anatomy to reach the target stenosis or aneurysm. After passing through several curves to reach the target site, the catheter system encounters resistance and can build up tension proximal to the distal tip. As the distal tip of the delivery system passes through a straight section of the vessel and enters a bend, tension builds up. As it exits the bend and enters another straight section, tension is released and the entire system "jumps" forward. The downward force pushing down on the outer sheath can cause the system to sag or buckle. Tension built up within the sheath can be problematic when tension is released, such as when the sheath is removed from a self-expanding stent for deployment to the target site, as it can propel the entire system distally. Release of the built-up tension as the proximal end is retracted for deployment can cause the distal end of the sheath to move, potentially positioning the stent out of the target site when the sheath is removed.

[0005] The forces between the outer sheath of the delivery system and the expandable structure, in combination with tension built up in the sheath during navigation to the target site, can cause a rapid increase in deployment force at the beginning of deployment of the expandable structure, followed by a rapid decrease in deployment force for the remainder of deployment. The change in deployment force can adversely affect the accuracy of deployment at the placement site. The deployment force is highest during the initial phase as the outer sheath is retracted. Once the initial friction between the sheath and the compressed expandable structure is eliminated, the deployment force of the structure drops almost instantly. This can result in the expandable structure being ejected from the delivery system and / or inadvertent actions by the user causing the expandable structure to be incorrectly deployed relative to the target site.

[0006] Conventional pin-and-pull systems do not provide the user with a mechanism to control the speed or force of deployment. Some stent delivery systems include mechanisms to control the deployment of the expandable structure, such as a mechanical handle with a thumb wheel that incrementally retracts the outer sheath, or stops to prevent the stent from inadvertently popping out of the sheath. While these mechanical systems provide control and improve precision, they are cumbersome to use and do not offer the quick and convenient deployment of pin-and-pull systems. Summary of the Invention

[0007] Thus, a need exists for rapid and convenient deployment of expandable structures that are safe, precise and controllable.

[0008] In one aspect, an endoluminal prosthesis delivery system is provided that includes an outer sheath having a distal end region, a proximal end region, and a lumen extending along a longitudinal axis between the proximal end region and the distal end region; an expandable device; an inner member extending through the lumen of the outer sheath, at least a portion of the inner member configured to support the expandable device within the lumen proximate the distal end region of the outer sheath; and a release mechanism configured to move at least one of the outer sheath and the inner member an initial distance in a controlled manner to release friction between the expandable device and the outer sheath prior to deploying the expandable device from the lumen.

[0009] The release mechanism may be configured to retract the outer sheath the distance. The release mechanism may be configured to advance the inner member the distance. The distance is between about 5 mm and about 1 cm. The release mechanism may comprise an actuator configured to be switched between at least a first position and at least a second position. The actuator may be switched by rotation about a longitudinal axis of the outer sheath. The release mechanism may further comprise a threaded inner part coupled to a proximal end region of the inner member. The threaded inner part may be threadably engaged with corresponding threads on an inner surface of the actuator. Switching the actuator about the longitudinal axis from the first position to the second position with the inner member fixed and the outer sheath unlocked may cause the outer sheath to retract proximally as corresponding threads of the actuator move along the threaded inner part. With the proximal end region of the outer sheath fixed and the inner member unlocked, switching the actuator about the longitudinal axis from a first position to a second position may advance the inner member distally as the threaded inner component moves along corresponding threads on the actuator.

[0010] The actuator may further comprise a protrusion on an outer surface of the actuator configured to face or be received within a first stop on a proximal end region of the outer sheath. The first stop may provide tactile and / or audio feedback regarding the position of the actuator relative to the first stop. The actuator may comprise a protrusion, the first stop comprising a first surface feature protruding a radially outward distance from the outer surface of the outer sheath and a second surface feature protruding a second radially outward distance from the outer surface of the outer sheath, the first surface feature may protrude further than the second surface feature such that the protrusion of the actuator is slidable over the second surface feature but is prevented from sliding over the first surface feature. Receiving the protrusion between the first and second surface features may provide tactile and / or audio feedback regarding the position of the actuator relative to the first stop. The system may further comprise one or more markings on the outer surface of the outer sheath relative to the first stop that provide information regarding the position of the actuator. The actuator may further include a second stop on a proximal end region of the outer sheath located less than 360 degrees about the longitudinal axis relative to the first stop. The actuator may be switched by rotation about an axis perpendicular to the longitudinal axis of the outer sheath.

[0011] The release mechanism may further comprise a cam body disposed within a cam hub coupled to the proximal end region of the outer sheath. The cam body may have an elliptical portion configured to protrude through an opening in the cam body into a lumen of the proximal end region of the outer sheath. The elliptical portion of the cam body may comprise a plurality of teeth. The inner member may have one or more surface features sized and spaced to engage with the plurality of teeth of the cam body. The inner member may have one or more surface features sized and spaced to engage with the plurality of teeth of the cam body. The cam body and the inner member may contact each other within the region of the lumen of the outer sheath. The cam body may pinch the inner member against an inner wall of the outer sheath to lock and / or drive the inner member upon rotation of the cam body. Switching the actuator may include moving the actuator relative to the lumen between a first locked position, a second released position, and a third deployed position. The first locked position may be a position in which the actuator is fully cammed and the inner member is locked by being pinched between the cam body and the lumen. The cam body may be rotated about an axis from the first locked position toward the second released position while the inner member is unlocked to advance the inner member the distance. Rotating the cam body about an axis from the first locked position toward the second released position while the inner member remains locked may retract the outer sheath a distance in a proximal direction relative to the inner member. Rotating the cam body about an axis from the second released position toward the third deployed position may fully withdraw the cam body from the lumen of the outer sheath. The cam body and / or cam hub may include one or more detents to provide tactile and / or audible feedback regarding the relative position of the actuator.

[0012] In some variations, one or more of the following may be optionally included in any feasible combination in the above methods, devices, devices, and systems, as described in detail in the accompanying drawings and the following description. Other features and advantages will be apparent from the description and drawings. [Brief description of the drawings]

[0013] These and other aspects are described in detail below with reference to the following drawings: In general, the drawings are illustrative and are not to scale, either absolutely or relatively, and are intended for illustrative purposes. The relative placement of features and components has been altered for illustrative clarity.

[0014] [Figure 1] FIG. 1 illustrates an embodiment of a delivery system with a release mechanism. [Figure 2A] FIG. 13 is a side view of an embodiment of a delivery system including a threaded rotor release mechanism. [Figure 2B] FIG. 2B is a side view of the delivery system of FIG. 2A exposing the internal structure. [Figure 2C] FIG. 2B is a side view of the delivery system of FIG. 2A. [Figure 3A] 13A-13D show an embodiment of a delivery system with a cam handle release mechanism. [Figure 3B] FIG. 3B shows a sheath hub of the release mechanism of the cam handle of FIG. 3A with a push rod. [Figure 4A] FIG. 3B is a perspective view of a sheath hub of the release mechanism of the cam handle of FIG. 3A. [Figure 4B] FIG. 3B is a perspective view of a sheath hub of the release mechanism of the cam handle of FIG. 3A. [Figure 4C] FIG. 4B is a cross-sectional view of the sheath hub of FIG. 4A. [Figure 4D] FIG. 3B is a perspective view of a cam body for use with the release mechanism of the cam handle of FIG. 3A. [Figure 5A] FIG. 3B is a process schematic of the release mechanism of the cam handle of FIG. 3A in a locked position. [Figure 5B] FIG. 3B is a process schematic of the release mechanism of the cam handle of FIG. 3A in the released position. [Figure 5C] FIG. 3B is a process schematic of the release mechanism of the cam handle of FIG. 3A in the deployed position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] The present disclosure relates to endoluminal prostheses, such as stents, stent grafts, etc. More specifically, an improved delivery system and method of use is described for precise and safe placement of endoluminal prostheses within body lumens, particularly within the vasculature, for the treatment of aneurysms, stenoses, etc., with a handle having a mechanism for releasing static friction and slack prior to placement of the prosthesis within a blood vessel.

[0016] FIG. 1 shows a delivery system 100 comprising an inner catheter 110 disposed within an outer sheath 130 housing an expandable device 105. A proximal end region of the outer sheath 130 can be coupled to a sheath hub 140 disposed distal to a hemostatic valve 145. The hemostatic valve 145 can be part of a Y-arm connector, as known in the art. The inner catheter 110 can be longitudinally and rotationally secured at its proximal end region to a push rod 150, such as a stainless steel hypotube. The inner catheter 110 extends within the outer sheath 130 via the hemostatic valve 145. A nose cone 160 is coupled to a distal end region of the inner catheter 110 that projects distal to the outer sheath 130 and the device 105 housed within the outer sheath 130. The delivery system 100 can further comprise a release mechanism 170. The release mechanism 170 can function in one of two ways. In a first method, the release mechanism 170 retracts the outer sheath 130 proximally a set distance while the inner catheter 110 remains stationary. In this method, the device 105 does not move relative to the anatomical location. The release mechanism 170 functions to first retract the outer sheath 130 proximally a set distance in a controlled manner to relieve slack built up within the stent delivery system 100 and eliminate friction between the device 105 and the outer sheath 130 before deploying the device 105 from the system 100. Reducing or eliminating built up friction, tension, and / or slack prior to deploying the expandable device increases the accuracy and safety of device deployment. The release mechanism 170 also moves the inner catheter 110 distally a set distance while the outer sheath 130 remains stationary, for example, by a user gripping the sheath hub 140. In this manner, the device 105 moves distally a set distance (assuming the push rod 150 is in full contact with the proximal end of the device 105). The release mechanism 170 is described in more detail below.

[0017] 2A-2C show an embodiment of a release mechanism 170 for use with the delivery system 100 for deployment of the expandable device 105. The release mechanism 170 includes an actuator 175 configured to move the sheath hub 140 relative to the push rod 150. The actuator 175 is switchable between a first position and a second position. The first position of the actuator 175 can be a "locked" position in which the sheath hub 140 is in a home position relative to the push rod 150. The actuator 175 can be switched by rotating the actuator 175 a certain angle about the axis A of the sheath 130, for example 180 degrees from the first position to the second position. The second position of the actuator 175 can be an "unlocked" position in which the sheath hub 140 is moved a certain distance proximally along its longitudinal axis A. The certain distance moved by the sheath hub 140 when the actuator 175 is switched can be about 5 mm to about 1 cm. The system can be designed to accommodate no sheath movement (i.e., 0 mm) as well as full deployment (e.g., 20 mm to 50 mm). The full deployment distance can be designed to accommodate the length of the implant intended to be delivered. The sheath hub 140 is coupled to the proximal end region of the outer sheath 130. Retracting the sheath hub 140 a certain distance by switching the actuator 175 to an unlocked position moves the distal end of the outer sheath 130 a certain distance relative to the expandable device 105 compressed on the inner catheter 110. Retraction of the outer sheath 130 releases any accumulated friction that exists between the device 105 and the outer sheath 130.

[0018] Actuator 175 may be a barrel-shaped component having an inner diameter dimension sized to match the outer diameter dimension of sheath hub 140. Figures 2A-2B show a proximal end region of sheath hub 140 that matches a distal end region of actuator 175. Hub 140 may include features 142 on its outer surface configured to engage corresponding features 172 on an inner surface of actuator 175. For example, hub 140 and actuator 175 may be coupled via threads or other connecting features.

[0019] The actuator 175 may also include an internal component 180 that is threaded within its inner diameter dimension. The internal component 180 and the actuator 175 are configured to threadably engage one another such that the internal component 180 is axially biased along the longitudinal axis A as the actuator 175 toggles about the longitudinal axis A. The internal component 180 may have threads 182 on an outer surface that engage with corresponding threads 171 on the inner surface of the actuator 175. Alternatively, one component may have a single pin that is configured to engage and move within a corresponding thread of the other component. For example, the internal component 180 may have a pin rather than threads 182 that engages and slides within the threads 171 on the inner surface of the actuator 175. Additionally, the inner component 180 may have an inner diameter dimension sized to receive the push rod 150 of the inner catheter 110 or another hypotube or push rod connected to the push rod 150 of the delivery system 100 such that the inner component 180 is secured to the push rod 150. The push rod 150 may be secured by a user to prevent movement of the push rod 150 such that when the actuator 175 is toggled from the locked position to the unlocked position about the longitudinal axis A, the inner component 180 moves axially relative to the actuator 175. The actuator 175 and inner component 180 may be moved apart by the actuator 175 moving proximally in the case of a standard pin / pull unlocking, or by the inner component 180 moving distally if not secured during unlocking by the actuator 175. For example, the actuator 175 may move proximally along the threads 182 of the inner component 180, retracting the hub 140 a distance along the longitudinal axis A, thereby retracting the sheath 130 a similar distance. It should be understood that any number of screw turning mechanisms are contemplated herein to switch between the two positions and achieve proximal retraction of the outer sheath 130. Also, in some embodiments, the push rod 150 is not fixed and the user holds the sheath hub 140 fixed while switching the actuator 175.The inner part 180 and the push rod 150 can move distally along the threads 171 of the actuator 175, causing the device 105 and tip at the distal end to move distally the same distance.

[0020] 2A-2C, the actuator 175 may include a protrusion 174 that projects radially outward from the outer surface of the barrel-shaped part. The protrusion 174 faces or is received within a corresponding surface feature or stop 144 on the proximal end region of the sheath hub 140. For example, FIG. 2A shows the actuator 175 positioned relative to the hub 140 in a "locked" position. The sheath hub 140 is in its most distal position relative to the device 105. The protrusion 174 on the actuator 175 contacts the stop 144 on the sheath hub 140, allowing rotation about the longitudinal axis of the sheath 130 in only one direction relative to the stop 144. FIG. 2C shows the opposite side of the sheath hub 140 from that shown in FIG. 2A. The opposite side of the sheath hub 140 includes a second stop 144 that is positioned around the circumference of the barrel-shaped part (e.g., about 180 degrees) away from the first stop 144 for an "unlocked" position. The actuator 175 can be switched about the longitudinal axis A of the sheath in the direction of arrow A away from the stop 144 in the “locked” position as seen in FIG. 2A towards the stop 144 in the “unlocked” position as seen in FIG. 2C. A protrusion 174 on the actuator 175 contacts the stop 144 in the “locked” position, allowing rotation in the direction of arrow A and preventing rotation in the opposite direction of arrow A. The protrusion 174 contacts the stop 144 again in the “unlocked” position, preventing further rotation in the direction of arrow A and allowing rotation in the opposite direction of arrow A. The first stop 144 for the “locked” position and the second stop 144 for the “unlocked” position prevent the actuator 175 from rotating a full 360 degrees about the longitudinal axis A, instead allowing the actuator to switch between two positions - the locked position and the unlocked position. 2A and 2C are positioned on the outer sheath to allow 180 degrees of rotation in a first direction and another 180 degrees of rotation in an opposite second direction, the extent of rotation may vary but is generally less than 360 degrees about axis A.

[0021] One or both of the stops 144 may provide tactile and / or auditory feedback regarding the position of the actuator 175 relative to the stop 144. The stop 144 in FIG. 2A shows a small protrusion 143 spaced a distance from the stop 144. This protrusion 143, when receiving the protrusion 174 of the actuator 175 therebetween, may provide a "click" or "snap" sound or feel to the user to understand that the actuator 175 is in a locked position. The stop 144 projects radially outward from the outer surface of the outer sheath a greater distance than the smaller protrusion 143 projects. The protrusion 174 of the actuator 175 may slide over the smaller protrusion 143 but is prevented from sliding over the larger stop 144. One or both of the stops 144 on the outer sheath may include a pair of larger and smaller sized protrusions to provide feedback to the user.

[0022] Additionally, the sheath hub 140 may include one or more markings 146 to provide a user with information regarding the position of the actuator 175. A first marking 146 may be located in a first position to provide a user with information that the actuator 175 is in a first, "locked" position, and a second marking 146 may be located in a second position to provide a user with information that the actuator 175 is in a second, "unlocked" position. The markings 146 may have a design that indicates an operational state, such as locked in a locked state and locked in an unlocked state, and may incorporate the words "locked" and "unlocked" or other words that indicate the operational state of the device.

[0023] Once the maximum force is resolved during the initial phase of withdrawal of the outer sheath 130 and the force is relaxed in a controlled manner by the release mechanism 170, longitudinal retraction of the outer sheath 130 can be achieved by conventional pin-and-pull techniques without risk of handle jerking or slippage or of the stent popping out of the delivery system 100.

[0024] 3A-3B show another embodiment of a stent delivery system 100. FIG. 3A-3B shows another embodiment of a release mechanism 170 for use with the delivery system 100. FIG. 3A-3B shows the delivery system 100 without an outer sheath 130 coupled to the sheath hub 140. The push rod 150 extends into the lumen 147 of the sheath hub 140 through the hemostatic valve 145. As with the other embodiments, the release mechanism 170 may include an actuator 175 configured to move the sheath hub 140 relative to the push rod 150. The actuator 175 is configured to rotate about an axis A′ that is perpendicular to the longitudinal axis A of the sheath 130 to achieve proximal retraction of the sheath 130. The actuator 175 may rotate about axis A′ approximately 180 degrees (see, e.g., FIG. 5A-5C), although the degree of rotation may be varied to deploy the entire stent. For example, continued rotation of the actuator 175 can result in movement between 0 mm to full deployment of the expandable device 105.

[0025] The actuator 175 may be a handle that protrudes from a cam body 192 disposed within a cam hub 190 that is coupled to a region of the sheath hub 140. FIGS. 4A-4C show the sheath hub 140 coupled to a cam hub 190 configured to receive the cam body 192 shown in FIG. 4D. The cam body 192 may include a number of teeth 193 disposed on the circumference of a portion of the cam body 192 that forms an oval portion on the cam body 192. The cam body 192 may be received within the interior of the cam hub 190. The cam hub 190 may have an open cut 191 such that the interior of the cam hub 190 communicates with and intersects with the sheath hub lumen 147 (see FIG. 4C). This allows the number of teeth 193 on the cam body 192 to protrude through the opening 191 into at least a portion of the sheath hub lumen 147. The push rod 150 may include one or more surface features sized and spaced to engage the teeth 193 of the cam body 192. The push rod 150 (or a hypotube connected to the push rod 150) extending through the lumen 147 of the sheath hub 140 can contact the teeth 193 in the area of ​​the lumen 147 that intersects with the interior of the cam hub 190 (see FIG. 4C). The cam body 192 does not need to have teeth 193 that engage with the push rod 150. The oval portion of the cam body 192 alone is sufficient to pinch and lock the push rod 150 into the lumen 147 of the sheath hub 140 and / or advance the push rod 150 as the cam body 192 rotates.

[0026] As cam body 192 rotates about axis A' relative to hub 190, the region of cam body 192 having teeth 193 (or the portion of cam body 192 having a reduced cam radius) moves distally through sheath hub lumen 147 before exiting sheath hub lumen 147 and re-entering the interior of cam hub 190. Teeth 193 are received within channels or grooves 194 on the inner surface of cam hub 190 (see FIGS. 4A-4C). Grooves 194 in cam hub 190 extend the entire circumference of hub 190 such that cam body 192 can rotate 360 ​​degrees relative to cam hub 190. In other embodiments, grooves 194 extend only a short distance around the circumference such that an end of groove 194 forms a stop for rotation of the cam body along a particular direction. The grooves 194 may extend along the inner surface of the cam hub 190 at 90 degrees, 120 degrees, 150 degrees, 180 degrees, 210 degrees, and any angle in between, allowing the cam body 192 to rotate a set number of degrees relative to the hub 190 before hitting a stop.

[0027] 5A-5C illustrate switching of the actuator 175 between a first "locked", a second "released", and a third "deployed" position relative to the sheath hub lumen 147. FIG. 5A illustrates the actuator 175 fully cammed such that the push rod 150 is pinched between the teeth 193 of the cam body 192 and the lumen 147, thereby locking it in place. The user may encourage the cam body 192 to rotate about axis A' within the cam hub 190 by switching the actuator 175 away from the first "locked" position, as shown in FIG. 5B. This "released" position eliminates stiction between the sheath 130 and the device 105 being deployed, since if the push rod 150 were not locked, rotation of the actuator 175 about axis A' would drive the push rod 150 forward a set distance, either by the teeth 193 or by a reduced cam radius portion, allowing the push rod 150 to clear the wall of the lumen 147. Additionally, the teeth 193 of the cam body 192 engaging surface features of the push rod 150 can exert a force against the push rod 150, which remains fixed. Friction between the teeth 193 of the cam body 192 and the surface features of the fixed push rod 150 urges the cam body 192 and attached sheath hub 140 to move proximally relative to the fixed push rod 150 as the actuator 175 moves. Rotation of the cam body 192 translates into axial retraction of the sheath hub 140 relative to the push rod 150.

[0028] As in the previous embodiment, the distal end of the sheath hub 140 is connected to the outer sheath 130 such that the outer sheath 130 can be retracted a certain distance relative to the inner assembly (i.e., the push rod 150) in a controlled manner to release friction built up between the device 105 and the outer sheath 130. Once the maximum force is overcome during the initial phase of outer sheath withdrawal or push rod 150 advancement and released in a controlled manner by the release mechanism 170, the actuator 175 can be fully switched to the "deployed" position (see FIG. 5C). In this "deployed" position, the teeth 193 enter the cam hub 190 and the cam body 192 is fully withdrawn from the lumen 147 and free to move therethrough, so that, for example, longitudinal retraction of the outer sheath 130 can be performed by conventional pin-and-pull techniques without risk of handle jerking or slippage or stent ejection from the delivery system 100. One or more detents may be designed into the cam body 192 or cam hub 190 to provide tactile and / or audible feedback to the user regarding the rotation and position of the actuator 175. Depending on the number of clicks heard and / or felt, the user can assess whether the actuator 175 is in the "locked", "unlocked" or "deployed" position.

[0029] Regardless of the particular configuration and whether the cam mechanism of Figures 3A-3B or the threaded knob of Figures 2A-2C is used, the release mechanism 170 provides the mechanical advantage of an initial sheath retraction that is controlled and limited to a fixed distance upon a single actuation of the actuator 175. Friction and / or tension built up in the outer sheath 130 is released by a single actuation of the actuator 175 prior to deployment of the expandable device 105 by a second actuation to withdraw the outer sheath 130 by pulling on the sheath hub 140, thereby providing a more precise and controlled deployment. Thus, the release mechanism 170 described herein is not used to fully deploy the expandable device 105 (i.e., to release the device 105 from its constraints and allow it to expand). Rather, a pin-and-pull mechanism is used for full deployment after the release mechanism 170 described herein is used to initially release friction and tension within the system 100. Once in the "unlocked" position, release mechanism 170 is released from engagement with push rod 150, allowing the use of a conventional pin-and-pull deployment mechanism. In the embodiment shown in Figures 2A-2C, after actuation of release mechanism 170, push rod 150 can be fixed and the outer sheath 130 can be manually retracted along longitudinal axis A relative to fixed push rod 150 (e.g., by pulling on sheath hub 140) to deploy expandable device 105 from its restraint within outer sheath 130. In the embodiment shown in Figures 3A-3B and 4A-4D, actuation of release mechanism 170 causes cam body 192 to rotate about axis A' sufficiently that teeth 193 are received within cam hub 190 and out of frictional engagement with surface features of push rod 150. Once the teeth 193 are out of engagement with the surface features of the push rod 150, the sheath hub 140 can be manually retracted proximally along the longitudinal axis A past the cam body 192 while the push rod 150 remains fixed to deploy the expandable device 105.

[0030] The components of the release mechanism 170 may be formed from industry standard materials, such as stainless steel and / or one or more polymers.

[0031] In several aspects, the description has been given with reference to the drawings. However, certain aspects may be practiced without one or more of these specific details or in combination with other known methods and configurations. Numerous specific details, such as specific configurations, dimensions, steps, etc., are given herein to provide a thorough understanding of the examples. In other instances, well-known processes and manufacturing techniques have not been described in particular detail so as not to unnecessarily obscure the description. Throughout this specification, references to "an embodiment," "an embodiment," "an aspect," "an example," "an example," and the like mean that the particular feature, structure, configuration, or characteristic described is included in at least one embodiment, aspect, or example. Thus, the appearance of the phrases "an embodiment," "an embodiment," "an aspect," "an example," and the like in various locations throughout this specification do not necessarily refer to the same embodiment, aspect, or example. Furthermore, particular features, structures, configurations, or characteristics may be combined in any suitable manner in one or more examples.

[0032] Use of relative terms throughout this specification may indicate relative positions or directions or orientations and are not intended to be limiting. For example, "distal" may indicate a first direction away from a reference point. Similarly, "proximal" may indicate a position in a second direction opposite the first direction. Use of terms such as "anterior," "lateral," "posterior," "inferior," and "superior," as well as "anterior," "posterior," "caudal," and "cephalad" are used to establish a relative frame of reference and are not intended to limit the use or orientation of the devices described herein in various embodiments.

[0033] The term "about" refers to a range of values ​​including the specified value that one of ordinary skill in the art would consider to be reasonably similar to the specified value. In embodiments, "about" refers to within the standard deviation range using measurements generally accepted in the art. In embodiments, "about" refers to a range covering ±10% of the stated value. In embodiments, "about" includes the specified value.

[0034] Although many specific details are described herein, these should not be construed as limitations on the scope of what is or can be claimed, but rather as descriptions of features specific to particular embodiments. Certain features described herein in the context of separate embodiments may be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a particular combination and may initially be claimed as such, one or more features from the claimed combination may in some cases be excluded from the combination, and the claimed combination may be directed to a subcombination or variation of the subcombination. Similarly, although operations are depicted in the figures in a particular order, this should not be understood as requiring such operations to be performed in the particular order shown, or sequentially, or that all of the illustrated operations be performed in order to achieve desired results. Only a few examples, embodiments, aspects, and implementations are disclosed. Variations, modifications, and enhancements may be made to the described examples and embodiments, as well as other embodiments, based on what is disclosed.

[0035] In the above description and in the claims, phrases such as "at least one" or "one or more" may appear following a connectable list of components or features. Also, the term "and / or" may appear in a list of two or more components or features. Such phrases are intended to mean any of the listed components or features individually, or any of the listed components or features in combination with any of the other listed components or features, unless otherwise implicitly or explicitly contradicted by the context in which they are used. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and / or B" are intended to mean "A alone, B alone, or A and B together," respectively. A similar interpretation is intended for lists containing more than two items. For example, the phrases "at least one of A, B, and C," "one or more of A, B, and C," and "A, B, and / or C" are each intended to mean "A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together."

[0036] Use of the term "based on" above and in the claims is intended to mean "based at least in part on," in which case unrecited features or components are also permitted.

Claims

1. an outer sheath having a distal end region, a proximal end region, and a lumen extending along a longitudinal axis between the proximal end region and the distal end region; Expandable devices and an inner member extending through the lumen of the outer sheath, at least a portion of the inner member configured to support the expandable device within the lumen near a distal end region of the outer sheath; a release mechanism configured to move at least one of the outer sheath and the inner member an initial distance in a controlled manner to release friction between the expandable device and the outer sheath prior to deploying the expandable device from the lumen; and 1. An endoluminal prosthesis delivery system comprising:

2. The delivery system of claim 1 , wherein the release mechanism is configured to retract the outer sheath the distance.

3. The delivery system of claim 1 , wherein the release mechanism is configured to advance the inner member the distance.

4. The delivery system of claim 1 , wherein the distance is from about 5 mm to about 1 cm.

5. The delivery system of claim 1 , wherein the release mechanism comprises an actuator configured to be switched between at least a first position and at least a second position.

6. The delivery system of claim 5 , wherein the actuator is switched by rotation of the outer sheath about the longitudinal axis.

7. 7. The delivery system of claim 6, wherein the release mechanism further comprises a threaded internal component coupled to a proximal end region of the inner member, the threaded internal component being threadably engaged with corresponding threads on an interior surface of the actuator.

8. 8. The delivery system of claim 7, wherein the actuator further comprises a protrusion on an outer surface of the actuator configured to face against or be received within a first stop on a proximal end region of the outer sheath.

9. 9. The delivery system of claim 8, wherein the first stop provides tactile and / or auditory feedback regarding the position of the actuator relative to the first stop.

10. 9. The delivery system of claim 8, further comprising a second stop on a proximal end region of the outer sheath that is positioned less than 360 degrees about the longitudinal axis relative to the first stop.

11. The delivery system of claim 5 , wherein the actuator is switched by rotation about an axis perpendicular to the longitudinal axis of the outer sheath.

12. The delivery system of claim 11 , wherein the release mechanism further comprises a cam body disposed within a cam hub coupled to a proximal end region of the outer sheath.

13. The delivery system of claim 12 , wherein the cam body has an oval portion configured to protrude through an opening in the cam body and into the lumen of the proximal end region of the outer sheath.

14. The delivery system of claim 13 , wherein the oval portion of the cam body comprises a plurality of teeth.

15. 15. The delivery system of claim 14, wherein the inner member has one or more surface features sized and spaced to engage a plurality of teeth on the cam body.

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