MX2008008577A - Stent delivery system - Google Patents

Abstract

One preferred embodiment includes a stent delivery system (100) including a retractable sheath and an outer stability sheath. The stability sheath freely rotates relative to the retractable sheath, relieving compression forces caused by twisting of stability sheath in when in a tortuous conformation.

Description

STENT SUPPLY SYSTEM RELATED REQUEST The present application claims priority according to 35 U.S.C. d119 (e) to the provisional request of E.U.A. 60 / 759,136, filed on January 13, 2006 and provisional application 60 / 789,734, filed on April 5, 2006.

FIELD OF THE INVENTION This invention relates broadly to medical devices. More particularly, this invention relates to an instrument for supplying a self-expanding stent to the body of a mammal and releasing the stent in a controlled manner.

BACKGROUND OF THE INVENTION Transluminal prostheses are widely used in medical technology to implant in blood vessels, bile ducts, or other similar organs of the living body. These prostheses are commonly known as stents and are used to maintain, open or dilate tubular anatomical structures. The underlying structure of the stent can be virtually any stent design. Typically, there are two types of stents: self-expanding stents and balloon expandable stents. Stents are typically formed from malleable metals, such as 300 series stainless steel, or from resilient metals, such as super-elastic shape memory alloys, for example, Nitinol ™ alloys, stainless steels, and the like. However, they can also be formed from non-metallic materials such as non-degradable or biodegradable polymers or from bio-resorbable materials such as levogylating polylactic acid (L-PLA), polyglycolic acid (PGA) or other materials such as those described in the Patent. from the USA No. 6,660,827, the contents of which are incorporated herein by reference. Self-expanding stents are delivered through the body lumen into a catheter for treatment of the site where the stent is released from the catheter, allowing the stent to automatically expand and remain in contact with the luminal wall of the vessel. Examples of a self-expanding stent suitable for the purposes of this invention are described in U.S.A. No. 2002/0116044, which is incorporated herein by reference. For example, the self-expanding stent described in the Publication of E.U.A. No. 2002/116044, comprises a crystalline structure having two different types of propellers forming a hollow tube that has no free ends. The first type of helix is formed of a plurality of undulations, and the second type of helix is formed of a plurality of connection elements in series with the corrugations, wherein the connecting elements connect few instead of all the undulations in turns adjacent to the first type of helix. The first and second types of helices proceed circumferentially in opposite directions along the longitudinal axis of the hollow tube. The design provides a stent that has a high degree of flexibility as well as radial resistance. It will be apparent to those skilled in the art that other self-expanding stent designs (such as elastic stent designs) can be used in accordance with this invention. The stent may also be a balloon expandable stent, which is expanded using an inflatable balloon catheter. Balloon expandable stents can be implanted by mounting the stent in an unexpanded or folded state in a balloon segment of a catheter. The catheter, after having the folded stent placed in it, is inserted through a puncture in the wall of a vessel and moves through the vessel until it is placed in the portion of the vessel that needs to be repaired. The stent is then expanded by inflating the balloon catheter against the inner wall of the vessel. Specifically, the stent is plastically deformed by inflating the balloon so that the diameter of the stent is increased and remains in an increased state, as described in the U.S. patent. No. 6,500,248 B1, which is incorporated herein by reference. The stents are delivered to the implant site with the use of a delivery system. Delivery systems for self-expanding stents generally comprise an internal tubular member on which the stent is loaded and which can be fed through a guide wire, and an outer tubular member or sleeve longitudinally slidable through the internal tubular member and adapted to extend over the stent during delivery to the implant site. The liner is retracted along the internal tubular member to release the self-expanding stent from the internal tubular member. In several available delivery systems, the sleeve and the inner member can move freely relative to each other and must be manually and separately held in the hands of the doctor. After, the distant end of the system is located at the implant site, the internal member must be maintained to avoid dislocation. However, it is very difficult to maintain the position of the internal member while moving the external member to deploy the stent. As such, the degree of control during deployment is limited. Under such limited control, there is a tendency for the stent to escape from the inner member before the sleeve is fully retracted and jumps from the desired deployment site. This may result in a deployment of the stent at a location other than the desired implant site. A handle can be provided to move the outer tubular member relative to the inner tubular member with greater control. For example, Medtronic Inc. uses a handle that can lock the inner tube and outer sleeve relative to each other and effect the relative movement of the two to cause stent deployment. However, said handles have several disadvantages. First, the magician is not particularly suited to short stents since there is very little fine control. Secondly, the handle is not very suitable for long stents, for example, of a length of 90 mm, since the control requires the operator to change his grip during the deployment in order to generate a large relative movement of the components Tubular Third, it is possible for the stent to be automatically released before the sleeve retract completely from the stent. This is because the super-elastic expansion of the stent causes the stent to slide distally out of the deployment system before the operator retracts the sheath. The result may be an unintentionally rapid and possibly uneven deployment of the stent. Fourth, without reference to a fluoroscope that verifies the stent, there is no way to determine from the near end of the instrument, the progress of stent deployment. Fifth, the construction of the inner tubular member and the outer jacket can cause the inner member and the sleeve to be crushed during use. In addition, the inner tubular member is subjected to a compressive force during deployment and may deform while the stent is in motion from the desired deployment location. Another stent delivery system can be seen in the U.S. Patent. No. 2004/0006380 entitled Stent Supply System and Patent Publication of E.U.A. No. 2005/0273151 also entitled Stent Supply System, the contents of which are incorporated herein by reference. Like other stent systems available, the designs in these publications provide an individual drive mechanism for moving the outer sleeve relative to the internal tubular member, specifically shown as a thumb wheel. In these designs, the retraction speed of the sleeve member is limited both by the user's ability to operate the thumb wheel (i.e. the speed at which the user can move his thumb) and the retraction ratio of the wheel of thumb. This "speed limit" especially can be difficult for a user when deploying longer stents such as those with a length of 100 and 200 mm, since it greatly increases the time of deployment of the stent. In addition, the thumb wheel may have only a retraction ratio, which increases the difficulty of retracting the shirt at substantially different speeds. What is needed in a stent delivery system that overcomes the limitations of the prior art and facilitates retraction of the liner at different speeds. In addition, a stent delivery system that provides the user with greater dynamic control of the sleeve to increase delivery accuracy while reducing deployment time is necessary.

OBJECTS AND BRIEF DESCRIPTION OF THE INVENTION Therefore, it is an object of the invention to provide a stent delivery system that allows a high degree of control during stent deployment. Another object of the invention is to provide a stent delivery system that more easily retract an outer sleeve at different speeds. Another object of the invention is to provide a stent delivery system having multiple controls for retracting an outer sleeve. Yet another object of the invention is to provide a stent delivery system with independent external sleeve retraction controls that allow switching from one control to another without a delay in retraction of the sleeve. The present invention seeks to achieve these and other objects in a preferred embodiment by providing a stent delivery system having three independent controls for retracting an outer sleeve to deliver a stent or similar prosthesis. More specifically, the stent delivery system provides a thumb wheel, a thumb lever, and a pull ring that each engage a distal portion of the outer sleeve. When any of the three controls are actuated, they create a proximal force in the sleeve, retracting the sleeve and releasing a stent over the distal end of the delivery system.

Preferably, the thumb wheel and the thumb lever retracts the sleeve through a cord within the handle of the delivery system that engages a near portion of the sleeve. The thumbwheel rotates a reel, which unwinds the string and, therefore, causes the shirt to retract. The thumb lever effectively increases the trajectory of the rope within the handle by moving against a region of the rope, also causing the shirt to retract. The pull ring is preferably connected to the near end of the sleeve, allowing the user to directly pull the sleeve in a close direction. Each of the sleeve controls can be configured to provide the user with different retraction ratios (for example, for every 1 centimeter of movement of the thumb lever, the sleeve retracts 2 centimeters). In this regard, the user may use different retraction controls at different stages in the delivery procedure. For example, the user may initially wish to retract the shirt slowly to "bloom" the stent, with the thumb wheel. However, once the stent has flowered, the user may wish to retract the shirt more quickly with the lower ratio of the thumb lever or pull ring. In this aspect, the stent delivery system allows the user to more easily retract the sleeve at different speeds during the delivery procedure. Additional objects and advantages of the invention will be apparent to those skilled in the art after reference to the detailed description taken in conjunction with the drawings provided.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 illustrates a side view of a preferred embodiment of a delivery system according to the present invention; Figure 2 illustrates an exploded perspective view of the delivery system of Figure 1; Figure 3 illustrates a partially disassembled side view of the delivery system of Figure 1; Figure 4 illustrates a partially disassembled perspective view of the delivery system of Figure 1; Figure 5 illustrates a partially disassembled perspective view of the delivery system of Figure 1; Figure 6 illustrates a side s-sectional view of a portion of the delivery system of Figure 1; Figure 7 illustrates a side s-sectional view of a distal end of the supply portion of the delivery system of Figure 1; Figure 8 illustrates a side s-sectional view of a strain relief member of the delivery system of Figure 1; Figure 9 illustrates a perspective view of a spool of the supply system of Figure 1; Figure 10 illustrates a perspective view of a thumb wheel of the delivery system of Figure 1; Figure 11 illustrates a perspective view of a slide of a handle portion of Figure 1; Figure 12 illustrates a perspective view of a slide of the delivery system of Figure 1; Figure 13 illustrates a side view of the slide of Figure 12; Figure 14 illustrates a perspective view of the near end of the supply system of Figure 1; Figures 15A-15D illustrate perspective views of chord paths for a preferred embodiment of the present invention; Figure 16 illustrates a side view of a delivery system according to the present invention; Figure 17 illustrates a partially disassembled side view of the delivery system of Figure 16; Figure 18 illustrates a partially disassembled perspective view of the supply system of Figure 16; Figure 19 illustrates a partially disassembled perspective view of the supply system of Figure 16; Figure 10 illustrates a side cross-sectional view of a preferred embodiment of a delivery system according to the present invention; Figure 21 illustrates a side cross-sectional view of area 21 of Figure 20; and Figure 22 illustrates a side view of a preferred embodiment of an axially compressible stability sheath in accordance with the present invention.DETAILED DESCRIPTION OF THE INVENTION Figures 1-14 illustrate a preferred embodiment of a stent delivery system 100 in accordance with the present invention, which includes multiple mechanisms for retracting an outer tubular member 124 (also referred to as a sleeve or sheath in this specification) for supplying a prosthesis, such as a stent 160 in the current example. As seen in Figure 1, the stent delivery system 100 includes a thumb wheel 106, a deployment lever 108, and a quick deployment ring 110, each providing a different appearance for retracting the outer tubular member 124 and , therefore, by deploying the stent 160 or other prosthesis. Each of the three deployment controls provides different drive methods that facilitate the deployment of the stent 160 at different speeds. For example, the thumb wheel 106 allows the user to slowly deploy the stent 160 with a slow and precise movement of the thumb, while the rapid deployment ring 110 provides the user's strength to deploy the stent 160 in a more rapid manner. In addition, some of the deployment controls may be configured to provide different retraction ratios (e.g., 1 centimeter of the movement of the lever 108, moves the outer tubular member 124, 2 centimeters). In this way, some controls can provide "finer" retraction control (ie, a smaller movement of the outer tubular member 124) and other controls can provide "thicker" retraction control (i.e., larger movement). of the external tubular member 124). In this regard, the delivery system 100 provides the user with a broader and more dynamic scale of deployment controls for a more accurate delivery of the stent 160 within a patient. In addition, this scale of deployment controls can better adapt different types of stents or prostheses, especially those of almost any length. The stent delivery system 100 generally includes two major portions: a stent delivery portion 104 and a handle portion 102. The stent delivery portion 104 is the elongated catheter assembly, which is inserted into the patient to supply the stent 160 in a desired location. The handle portion 102 is connected to a proximal end of the stent delivery portion 104, allowing the user to place the stent delivery portion 104 inside the patient and release the stent 160. As best seen in Figures 1 and 6 -8, the stent delivery portion 104 includes an internal tubular member 128 preferably composed of a relatively rigid individual material (e.g., polyimide) that preferably forms an individual internal lumen. This allows the inner tubular member 128 to maintain some flexibility while retaining the resistance with which it will be pushed through the internal vessels of a patient. With reference to Figure 7, the distal end of the inner tubular member 128 includes a region of reduced diameter 127 between a distant dilator tip 126 (preferably composed of polyimide) and a shoulder 129. The region of reduced diameter provides a space to adapt the stent 160 in an unexpanded position below the outer tubular member 124. The shoulder 129 and the distal dilator tip 126 prevent the stent from moving laterally on the inner tubular member 128, either closely toward the handle portion 102 or distally under the outer tubular member 124. The delivery portion may also include a thrust tubing that is disposed on the inner tubular member 128, near a shoulder 129, which further supports the stent 160 when the outer tubular member 124 retracts during the supply. In this regard, the stent 160 maintains its position within the stent delivery system 100, providing a predictable supply for the user. Also as seen in Figure 7, the distal end of the inner tubular member 128 also includes washing holes 130, which are positioned below the stent 160 in the region 127 of reduced diameter and which lead to, and are unitary with. , a passage (not shown) within the inner tubular member 128, along its axis. This internal passage or lumen is connected to a liquid source at the near end of the stent delivery system 100 in the luer-type adapter 118, allowing the user to wash the stent 160 prior to delivery into the patient. As best seen in Figure 6, the near end of the inner tubular member 128 comprises a rigid area 156 composed of less flexible materials, such as metals or hard plastics. This rigid area 156 is positioned within the handle portion 102, allowing the outer tubular member 124 to easily retract over the rigid area 156 without the inner tubular member 128 bending or folding. The movement of the outer tubular member 124 on the inner tubular member 128 is discussed in more detail below. As previously mentioned, the outer tubular member 124 is positioned on the inner tubular member 128 and can move relative to the inner tubular member 128, particularly allowing the outer tubular member 124 to cover and uncover the unexpanded stent 160. Preferably, the outer tubular member 124 is comprised of a braided polyimide. Alternatively, the external tubular member 124 is composed of a three-layer, co-extruded construction. The inner layer is preferably made of polytetrafluoroethylene (PTFE), fluorinated ethylene-propylene (FEP), high density polyethylene (HDPE), or urethane. The middle layer is a braided cable, and most preferably a flat braided 304V stainless steel cable of a 1x3 (40 peaks) construction, the cables having a rectangular cross section of 0.00254 by 0.00762 centimeters. The cables of other metals and alloys can also be used, including other alloys of stainless steel, cobalt-chromium alloys, and high-strength, corrosion-resistant, high-strength metal alloys. The outer layer is preferably a thermoplastic, processable melt, polyether-based polyamide, such as PEBAX®-7033 available from Modified Polymer Components, Inc. of Sunnyvale, CA. In the extrusion process, the inner and outer layers are joined together and encapsulate the middle layer of metal reinforcement to create an integrated pipe. This pipe exhibits a high lateral flexibility combined with a high degree of longitudinal stiffness (shortening resistance), and also high torsional capacity. Referring to Figures 1, 6 and 8, the stability sheath 122 and tension relief member 120 are connected to the wizard portion 102 and are placed on the outer tubular member 124. The strain relief member 120 (FIG. preferably comprised of polyurethane or Arkema polyamide block amide Pebax®) prevents sharp bends in the outer tubular member 124 near the handle portion 102, reducing stress or strain that may otherwise be introduced at the points of contact. connection between the handle portion 102 and the outer tubular member 124. The stability sleeve 122 extends along a length portion of the outer tubular member 124 to reduce any unintentional movement of the stent delivery portion 104, while the outer tubular member 124 is being retracted (e.g., laterally or undulating movement due to friction between the outer tubular member 124 and the member internal tubular 128). As best seen in Figures 1-5, the handle portion 102 preferably includes three mechanisms for retracting the outer tubular member 124 relative to the inner tubular member 128. Specifically, the handle portion 102 includes the thumb wheel 106, the deployment lever 108, and the rapid deployment ring 110 which are each used to cause retraction of the outer tubular member 124 through different mechanisms within the portion of handle 12. Referring to Figures 2-5, the retraction mechanisms are constructed on an inner frame member 146 which is enclosed by body shell members 132A and 132B. As seen in Figures 2 and 11, the inner frame member 146 includes an elongated slot 146A extending over the length of the frame member 146. A slider 152, best seen in Figures 11-13, is placed across of and coupled with the groove 146A in order to slide along the length of the groove 146A. The slide 152 is also fixed to the near end of the outer tubular member 124, preferably through an adhesive. In this way, as the slider 152 slides from the distal end of the slot 146A towards a near end of the slot 146A, the outer tubular member 124 similarly moves over the rigid area 156 of the inner tubular member 128. Optionally, a portion of the slide 152 contacts the support 140 to provide a tactile and audible "click" as the slider 152 slides closely along the slot 146A. The teeth of the support 140 also allow the slide 152 to move only in a near direction including an angled distant surface and a perpendicular near surface. In this way, the contact portion of the slide 152 simply moves up and over the angled surface when it moves closely, but movement is stopped by the perpendicular surface when the distant movement is attempted. These "one-way" teeth prevent the user from moving the outer tubular member 124 distally in an attempt to recapture a partially deployed stent 160. The thumb wheel 106, the deployment lever 108 and the rapid deployment ring 110 can each apply a force in a direction close to the slide 152, causing the slide 152 and, therefore, the outer tubular member 124 to be move in a close direction. As described in detail below, each deployment control uses different mechanisms within the handle portion 102 to create a force on the slide 152. The distance that the slide 152 moves will vary between each deployment control based, at least in part, how the mechanisms of each deployment control are configured. These mechanisms and their possible configurations will be evident from the following description. As best seen in Figures 2, 4, 9 and 10, the thumb wheel 106 provides a close force on the slide 152 through the use of a rope 180 wound on a reel 154 at one end and attached to the slide 152 at the other end. The rope 180 is either attached to or positioned around the slider 152 so that the increased tension on the chord 180 provides a close force in the slider 152, ultimately causing movement of both the slider 152 and the outer tubular member 124. Preferably, the rope 180 is composed of a material that imparts little or no stretch for the length of the rope 180. For example, polyethylene, nylon, stainless steel wire, or braided stainless steel fibers. While the rope 180 is preferred in the present preferred embodiment, almost any flexible elongate member can be used, having different shapes, thicknesses, flexibilities and compositions. For example, a relatively flat ribbon shape or alternatively a rope having a generally square cross section can be used. In another example, the rope may be composed of a continuous, individual material such as plastic, or multiple strands woven together. Turning first to the rotation of the reel 154, one side of the inner frame member 146 includes an axis 155 on which the reel 154 and the thumb wheel 106 are rotatably mounted through openings through their respective centers. When the handle portion 102 is fully assembled, the reel 154 is placed inside the thumb wheel 106, compressing against one side of the thumb wheel 106. As best seen in Figures 9 and 10, the thumb wheel 106 it engages the reel 154 with a "one-way" coupling mechanism that allows the thumb wheel 106 only to engage and rotate the reel 154 in one direction. In this regard, the user is limited to retracting the outer tubular member 124 only, avoiding attempts to re-capture a partially deployed stent 160. The coupling mechanism includes raised members 106A, best seen in Figure 10, placed in a circular pattern on the inner surface of the thumb wheel 106. Each raised member 106A includes a first surface 106B perpendicular to the inner surface of the wheel. thumb 106 and an angled surface 106C. The angled surface 106C of a raised member 106A is positioned near the flat surface 106B of another raised member 106A, orienting all surfaces in a single direction (e.g., all angled surfaces 106C face a clockwise direction) , while all flat surfaces 106B face a counter-clockwise direction).

The reel 154 includes two floating arms 154A having an outwardly extending region 154B, positioned to have a similar circumferential position as the raised members 106A. When the handle portion 102 is assembled, the extension region 154B contacts either the raised members 106A or the space between the raised members 106A, depending on the rotational orientation of the thumb wheel 106. As the wheel of thumb 106 is rotated in one direction, the flat sides 106B of the raised members 106A make contact with the extension region 154B, causing the spool 154 to rotate and, therefore, wind the cord 180. However, if the wheel of thumb 106 is rotated in the opposite direction. The angled surface 106 makes contact with the extension region 154B, causing the floating arm 154A to move towards the inner frame member 146. As the thumb wheel 106 continues to rotate, the extension region 154B passes over the top of the raised member 106A until the end of the raised member 106A is reached, at that time, the floating arm 154A jumps back to its original position. In this manner, the thumb wheel 106 rotates, but the reel 154 is not engaged and, therefore, does not rotate, effectively limiting the rotation of the reel 154 by the thumb wheel 106 only in one direction.

As previously described, the rotation of the reel 154 reels one end of the cord 180, reducing the effective length of the cord 180 in the handle portion 102. However, the cord 180 must also be appropriately positioned within the handle portion. 102 to create a close force on the slide 152. This rope position or rope path can be more clearly observed by comparing the exploded view of Figure 2 with the rope 180 shown in Figure 15a. As seen in these figures, one end of the rope 180 is wrapped around the reel 154, passing around a stationary anchor member 150 which is fixed to the inner frame member 146, through a passage 108A of the deployment lever movable 108, rearwardly around the stationary anchor 149 which is also fixed to the inner frame member 146, then passing down along the side of the inner frame member 146, around the anchor member 148 at the near end of the member of internal frame 146 and extending back towards the distal end of inner frame member 146, and finally ending with a knot around slider 152. Each of the stationary anchors has curved surfaces, on which the rope 180 can easily travel . in this way, as the reel 154 rotates in one direction (depending on which direction the reel 154 is configured to wind the string 180), the string 180 pulls the slider 152 toward the near end of the handle portion 102. mechanisms of the deployment controls, as previously mentioned, can be configured to change the retraction ratio of the outer tubular member 124. In one example, the mechanisms of the thumb wheel 106 can be modified by changing the size of the reel 154. More specifically, the size of the reel 154 (i.e., the diameter of the reel) can be increased or reduced to change the amount of cord 180 that each rotation of the thumb wheel 106 takes. For example, decreasing the size of the reel 154 will reduce the amount of the string 180 taken by each rotation of the thumb wheel 106 and, therefore, reduce the amount that the outer tubular member 124 retracts. Similarly, the increase of the reel size 154 will increase the amount of rope 180 taken by each rotation of the thumb wheel 106, increasing the amount that the outer tubular member 124 retracts. Returning to the second deployment control, the deployment lever 108 can also retract the slide 152 and, therefore, the external tubular member 124, increasing the tension on the cord 180 and, therefore, also on the slide 152. As seen in Figures 1-5, the deployment lever 108 engages an upper portion of the inner frame member 146 on a support 144, sliding in a near direction along the upper portion of the inner frame member 146. As the deployment lever 108 moves in a close direction, it increases the trajectory that the rope 180 takes to reach the slide 152, increasing the tension on the rope 180 and generating a close force on the slide 152. Like the thumb wheel 106 and the slide 152, the deployment lever 108 only moves in one direction, allowing the user only retracts the outer tubular member 124. This "one direction" movement is preferably obtained with a steering arm 108B (Figure 3) extending from a near end of the ab part. garlic of the deployment lever 108. The steering arm 108B includes an end portion that engages the teeth of a support 144. As best seen in Figure 3, the teeth of the support 144 have a distant surface that is angled and a surface which is generally perpendicular to the inner frame member 146. When the deployment lever 108 moves in a close direction, the steering arm 108B follows the distant surface angled upwards, moving on and beyond each tooth. However, when the deployment lever 108 moves in a distal direction, the end of the steering arm 108B moves against the perpendicular near surface of the teeth. Since the near surface is not angled beyond 90 degrees (ie, beyond the perpendicular), the steering arm 108B is unable to move over the teeth. In this way, the steering arm 108B prevents the deployment lever 108 from moving in a distal direction, to re-capture the stent 160. Furthermore, the position of the deployment lever 108 is maintained when the user rotates the wheel. of thumb 106, which can create a distant force on lever 108 as the tension on cord 180 increases. Referring to Figures 2-5, the close movement of the deployment lever 108 moves the slide 152 effectively increasing the length of the path that the rope 180 must take to reach the slide 152. As previously mentioned, the rope 180 passes through the passage 108A of the mobile deployment lever 108, around the stationary anchor member 149 which is fixed on the inner frame member 146, below the length of the inner frame member 146, then around the stationary anchor member 148 at the near end of the inner frame member 146. As the deployment lever 108 moves in a close direction, the passage 108A on the deployment lever moves away from the anchor member 149 which is fixed on the member. of internal frame 146. As a result, the distance between the passage 108A and the anchor member 149 increases, creating a longer path for the rope 180. Since an e The end of the rope 180 is fixed around the spool 154, the movement of the deployment lever 108 in this way causes the slide 152 and, therefore, the outer tubular member 124 to move closely. In this regard, the close movement of a direction of the deployment lever 108 may retract the outer tubular member 124 to deploy the stent 160 within the patient. The rapid deployment ring 110 provides yet another method for retracting the outer tubular member 124 within the handle portion 102. As best seen in Figures 2-6, 11 and 13, the rapid deployment ring 110 is a pull tab having a coupled body and a sliding portion 110A configured to slidably engage the outer tubular member 124, away from the slide 152. The sliding portion 110A preferably has an opening which allows it not only to be placed on the diameter of the outer tubular member 124, but also to slide freely along its length. As shown in Figures 11 and 13, when the rapid deployment ring 110 is pulled by the user in a close direction, the sliding portion 110A pushes on a distant side of the slide 152 in a near direction as well, moving the slide 152 in a close manner and causing the outer tubular member 124 to retract. Since the rapid deployment ring 110, through its sliding portion 110A, applies a direct force on the slide 152 without any intervening mechanism (i.e., in a retraction ratio of 1: 1), the user is free of retract the outer tubular member 124 at any desired speed. This arrangement especially facilitates a rapid retraction of the outer tubular member 124 that could otherwise be difficult using the thumb wheel 106 or deployment lever 108. Referring to FIGS. 1 and 2, the ring portion of the swivel ring deployment 110 is positioned through a slot 114 in a lining member 132A and stored in a raised column 112. The raised column 112 has a diameter approximately equal to the same diameter size as the opening of the rapid deployment ring 110, allowing the ring 110 is locked on the raised column 112. Optionally, the raised column 112 may also include a "print by stamping" or depression around the raised column 112, which is the size and shape of the ring portion of the ring of rapid deployment 110 and which allows the ring portion to settle within the depression without falling off. In this way, the rapid deployment ring 110 can be kept out of the way if the user decides to deploy the stent 160 with the thumb wheel 106 or deployment lever 108. Furthermore, since the sliding portion 110A can freely slide along of the outer tubular member 124 (ie, it is not fixed or adhered to in place in the tubular member 124), the use of the thumb wheel 106 or the deployment lever 108 will not cause the rapid deployment ring 110 to be released of the raised column 112 and moving down the slot 144. In other words, the position of the rapid deployment ring 110 is not affected when other deployment controls are operated by the user. Preferably, as seen in Figures 11-13, the sliding portion 110A has a profile to allow a finger member 116A of a locking fastener 116 to be positioned on both the sliding portion 110A and the slide 152. Since the slide 152 has horizontally elevated portions around both a near side and a distal side of the finger 116A of the closure fastener 116, the slide 152 moves against this finger 116A and lateral movement is prevented. In this regard, finger 116A of closure fastener 116 acts as a closure pin which prevents stent 160 from being unintentionally deployed during shipping or before insertion into a patient. The retraction ratio of both the deployment lever 108 and the thumb wheel 106 can further be adjusted by changing the path of the rope 180 within the handle portion 102. A preferred method of changing this relationship is to distribute the retraction force of the handle. user in an increased number of anchors (for example, anchor members 148 or 149). In this regard, the anchor members and the rope 180 act in a manner similar to a rope and pulley system, where additional anchors function as additional pulleys. As a pulley system, more anchors enter around the rope 180, less the outer tubular member 124 will move relative to either the thumb wheel 106 or the deployment lever 108 (and the wheel will be easier to move). thumb 106 or deployment lever 108). A more specific example of this concept can be seen in Figure 15B where the rope 108B is placed in a configuration generally similar to that of Figure 15A. Nevertheless, instead of terminating the rope 180B in the slide 152, as seen in Figures 2-5, the rope 180 passes around the slide 152 and ends in a rear anchor 151, as shown in Figure 14 at the end close to the inner frame member 146. In this aspect, the thumb wheel 106 or deployment lever 108 moves the outer tubular member 124 a smaller amount relative to the configuration shown in Figure 15A due to the previously described pulley effect. Another specific example can be seen in Figure 15C, which can be compared with the structures seen in Figures 2-5. In this example, one end of the rope 180C is wrapped around the reel 154 as previously described, passing around a stationary anchor member 150 located on an upper region of the inner frame member 146, through the lever passage 108A of mobile deployment 108, back around the anchor member 148, forwardly around the slider 152, rearwardly around the anchor member 151, and finally joining through the opening 153, which is located on a remote portion of the inner frame member 146. Similarly, the thumb wheel 106 or the deployment lever 108 moves the outer tubular member 124 a smaller amount relative to the configurations shown in Figures 15A and 15B due to the previously described pulley effect. Figure 15D illustrates another example of a rope path 180D, which passes around some anchor members and, therefore, provides a user input movement ratio to external tubular member 124 about 1: 1. For comparison, Figure 15D can be compared with Figures 2-5 to appreciate the trajectory of the rope 180D. One end of the rope 180D is wrapped around the reel 154, then passed around the stationary anchor member 150, through the opening 108A of the mobile deployment lever 108, down around the slide 152, then back to the anchor rear 156 (best seen in Figure 14). The path of the rope 180 can be configured in a variety of other arrangements according to the present invention to obtain a desired retraction ratio. Typically, a retraction ratio that provides slower retraction (e.g., 2 centimeters of the movement of the deployment lever 106 to 1 centimeter of movement of the outer tubular member 124) may be preferred for smaller stents (e.g. -90 mm), while a retraction ratio that provides a faster retraction (for example 1 centimeter of movement of the deployment lever 108 to 1 centimeter of movement of the external tubular member 124) may be preferred for larger stents (e.g. , 90-170 mm). However, it should be understood that most of the relationships can be used for any length of stent commonly used, leaving the relationship as a matter of preference for the user. Although the thumb wheel 106 and the deployment lever 106 act on the string 180 to retract the slide 152, it should be appreciated that these two mechanisms act independently of each other and, therefore, do not affect the relative performance of the other. In other words, if the user switches between these two display controls, there will be no "delay" as a looseness aspect is taken on the string 180 by the second control. Rather, the actuation of any deployment control maintains the tension in the chord 180 so that the movement of any deployment control will immediately move the slider 152. If the deployment lever 108 is initially moved, the chord 180 maintains tension so that the subsequent rotation of the thumb wheel 106 causes the immediate movement of the slide 152. In contrast, if the user initially pulls the rapid deployment ring 110, a looseness aspect can be created in the rope 180. If the thumb wheel 106 or the deployment lever 108 is moved afterwards, that looseness aspect in the rope 180 will first be taken by its movement, causing a delay in the retraction of the outer tubular member 124 until the tension in the cord 180 increases. If a user, who can not see these internal mechanisms or looseness aspect on the cord 180, does not expect this delay, he may mistakenly think that the delivery system 100 is broken or the deployment of the stent 160 is finished. , the independent arrangement of thumb wheel 106 and deployment lever 108 provides a more consistent and predictable deployment procedure. During operation, the inner tubular member 128 is fed over a guide wire and is guided to a target location within the patient. Typically, radiopaque markers within the far end of the delivery system 100 are viewed fluoroscopically to confirm that the inner tubular member 128 has reached the desired location within the patient.

Once the user is satisfied that the delivery system 100 is in the desired position, the user operates one of the three deployment controls. Typically, the outer tubular member 124 is first slowly retracted, allowing the distal end of the stent 160 to expand or "flower" against the patient's target tissue. Although the user may initially retract the outer tubular member 124 with any of the three delivery controls, the finger wheel 106 and the deployment lever 108 may allow a slower and more controlled retraction since either can be controlled with only the thumb of the user. If the user wishes to maintain a slow and highly controlled retraction of the outer tubular member 124, the use of the thumb wheel 106 or the deployment lever 108 can be continued until the stent 160 has been completely uncovered and expanded against the target area. However, if the user quickly retracts the portion of the outer tubular member 124 that remains on the stent 160, the rapid deployment ring 110 may instead be used for faster retraction. The user simply pulls the rapid deployment ring 110 along the slot 114 until the stent 160 has been fully deployed. Once the stent 160 has been fully deployed, the delivery device 100 is retracted from the patient, thus completing the delivery procedure. It should be appreciated that any of the three deployment controls can be used by the user, alone or in various combinations, to retract the outer tubular member 124 and to supply the stent 160. While the use of the deployment controls can be greatly supported by the user preference, other factors can contribute to that selection. For example, shorter stents (e.g., 20-90 mm) can be deployed more effectively with the accuracy of thumb wheel 106 or deployment lever 108, while longer stents (e.g., 100-170) mm) may be more effectively deployed with a combination of the thumb wheel 106 initially and the rapid deployment ring 110 subsequently.

Figures 16-19 illustrate another preferred embodiment of a stent delivery system 220 according to the present invention. The stent delivery system 200 is similar to the previously discussed stent delivery system 100, but lacks the deployment lever 108, providing the user with only the thumb wheel 106 and the rapid deployment ring 110 for retracting the outer tubular member. 124. The stent delivery system 200 utilizes the same inner frame member 146 and the body shell members 132A and 132B including a cover plate 210, which is positioned on the support 144 and on the sides of the frame member. internal 146. The cover plate 210 blocks the opening created by the body shell members 132A and 132B wherein the deployment lever 108 is positioned in the previously described stent delivery system 100. Further, with reference to Figures 17-19, the cover plate 210 includes an opening 212, through which the rope 180 can be placed. Since the deployment lever 108 is not present in this preferred embodiment, the opening 212 provides a passage similar to the passage 108A of the deployment lever 108. This opening 212 allows the handle portion 202 to provide similar rope trajectory configurations as those shown in Figures 11A-11D. As best seen in Figures 17 and 18, the stent delivery system 200 also includes support blocks 214 that are attached to the inner frame member 146. The support blocks 214 form an opening with the side of the inner frame member 146, which is positioned around the rigid area 156 of the inner tubular member 128. The additional support provided to the rigid area 156 further reduces the likelihood that the rigid area 156 will flex or bend during retraction of the outer tubular member 124. This flexure or bending may result from friction between the inner tubular member 128 and the outer tubular member 124 during the retraction of the slide 152. In addition, these support blocks 214 can act as stops for the slide 152, preventing the outer tubular member 124 from retracting in any way. It must be understood that different elements, assemblies or aspects of each modality can be removed from, added to, or combined with other modalities. For example, the support blocks 214 can be used with the stent delivery system 100. In another example, the preferred embodiment of Figure 1 can include only the thumb wheel 106 and the deployment lever 108, leaving the ring rapid deployment 110. (This means that the deployment lever 108 can be moved into the area otherwise occupied by the rapid deployment ring). In addition, a cover, similar to the cover plate 210, can be used to cover an open area, to allow manufacture to use similar parts (eg, external body member 132A and 132B similar for each design). Although stent delivery systems 100 and 200 have been primarily described as stent providers, these embodiments can be modified to provide other prostheses that can be delivered within a retractable outer tubular member 124. In some situations, a stent or other device it must be delivered into a patient through a convoluted supply path. As the path of the delivery device becomes more tortuous, the same delivery device may deform. In such situations, the ability of the stability sheath 122 to transmit the torque generated in the handle portion 102 can be reduced. In other words, a close end of the stability sheath 122 can be twisted without resulting in the same degree of twisting for the distal end. In one example, the user attempts to rotate the handle portion 102 but the stability sleeve 122 tends to "spiral" or twist and cause compression on the outer tubular member 124. In some circumstances, said compression force may inhibit to the outer tubular member 124 to retract and, therefore, complicate the deployment of the stent. In the worst case, such compression can result in rupture or other leakage of the supply system, thus causing other complications. Figures 20 and 21 illustrate another preferred embodiment of a stent delivery system 300 according to the present invention which seeks to eliminate the possibility of twisting by the stability sheath 122. In general, the stent delivery system 300 is similar to the delivery systems previously described in this specification, except that the stability sleeve 122 is configured to rotate relative to the other elements of the system 300, and in particular with respect to the handle 102 and the outer tubular member 124. As a result, the rotation of the handle portion 102 of the delivery system 300 may occur requiring the rotation of the stability sheath 122. As best seen in Figure 21, this rotational ability of the stability sheath 122 is preferably achieved by providing a circular disk member 304 near the near end of the stability sleeve 122. The disk member 304 is positioned within a cavity c 302A within a remote end 302 of the inner frame member 146. The circular pocket 302A is preferably slightly longer than the disk member 304 to allow rotation of both the disk member 304 and the stability sleeve 122, but not so large to introduce an unwanted amount of "game", where the disk member can move. The disc member 304 is preferably attached to the stability sheath 122 or alternatively may be integrally formed with the stability sheath 122. In this regard, the disc member 304 retains the axial position of the stability sheath 122 on the device 330 supply, while also allowing the free rotation of the stability sheath 122. Since the configuration described above results in independent rotation of the stability sheath 122 relative to the delivery system 300. It is desirable to minimize the friction between the strain relief member 120 and stability sleeve 122. In this regard, a low friction coating can be applied to the inner passage of tension relief member 120 and the outer surface of stability sleeve 122. Alternatively, it can be introduce a lubricant between these surfaces. The friction may also preferably be minimized between the inner surface of the stability sheath 122 and the outer surface of the outer tubular member 124. This further facilitates independent rotation of the stability sheath 122. During operation, the user advances the supply portion 104 of the delivery system 300 to the patient and rotate the handle portion 102 to obtain a desired orientation of the delivery portion 104. As with the previously described embodiments, the handle portion 102 and the supply portion 104 are they fix in relation to each other and in this way the rotation of the handle portion 102 will result in a corresponding rotation of the supply portion 104. However, due to the use of the circular disc member 304 described above, the stability sleeve 122 is not forced to rotate together with the supply portion 104 or handle portion 102. As a result, the fun Stability measure 122 does not inadvertently inhibit (eg, through compression, friction, etc.) the movement of the delivery portion 104 within the patient. Therefore, complications during the delivery procedure are minimized. Figure 22 illustrates another preferred embodiment of a stent delivery system according to the present invention, which seeks to reduce the complications resulting from the twisting by the stability sheath 340. Although the preferred embodiment illustrated in Figures 20 and 21 it seeks to avoid twisting, the present mode compensates for the effects of twisting by providing a region on the stability sleeve 340 that compresses in length. This allows a near end of the stability sleeve 340 to remain secured to the handle portion 102, while allowing a distal end of the stability sleeve 340 to axially retract together with the outer tubular member 124 if the two frictionally engage one. the other. The stability sheath 340 includes a plurality of circumferential shrinkage zones 342 located along a length of the sheath 340. Preferably, these shrinkage zones 342 are located near the near end of the sheath 340, just distantly to the relief member. of tension 120. Each shrinkage zone 342 is configured to compress under axial pressure an "accordion" region of a flexionable straw. Therefore, if the stability sheath 340 is bent and therefore fritically engages the outer tubular member 124, the shrinkage zones 342 will be compressed in length when the user retracts the outer tubular member 124 (i.e., when the user retracts). external tubular member 124 for deploying the stent or other prosthesis). In this aspect, the shrinkage zones 342 allow the distal end of the stability sleeve 340 to move with the outer tubular member 124 instead of preventing retraction. Preferably, the shrinkage zones 342 allow an axial compression length at least equal to the length of the prosthesis that will be deployed. In other words, if the stability sheath 340 rests on the outer tubular member 124, the shrinkage zones 342 will allow the stability sheath 340 to move with the outer tubular member 124 until the prosthesis has been delivered.

Preferably, each of the shrinkage zones 342 is compressed in length by bending or buckling, similar to an accordion. In one example, this bending can be achieved by reducing the thickness of each shrinkage zone 342 relative to the thickness of the surrounding portions of the stability sheath 340. When an axial force is applied to the stability sheath 340 (i.e. Through retraction of the outer tubular member 124), the weakest areas of the shrinkage zones 342 buckle, reducing the full length of the stability sheath 340. The shrinkage zones 342 with reduced thicknesses can be created with various known techniques in field. For example, zones 342 may be formed as a unitary part of stability sheath 340. Alternatively, areas of reduced thickness may be cut or otherwise removed with laser or mechanical cutting tools. In another example, areas of reduced thickness can be created by adding additional layers of material around each shrinkage zone 342. In another preferred embodiment, each of the shrinkage zones 342 can be created by introducing five-way accordion pleats throughout of the stability sheath 340 (i.e., folds oriented inwardly and outwardly of the sheath 340 similar to a folded region of a flexionable straw). In another preferred additional embodiment, the shrinkage zones 34 can be created with perforations or small punctures to weaken the stability sheath 340 and promote buckling. During operation, the user advances the delivery portion 104 of the delivery system toward the patient and rotates the handle portion 102 to obtain a desired orientation of the delivery portion 104. As with the previously described embodiments, the handle portion 102 and the supply portion 104 are fixed relative to one another and thus rotation of the handle portion 102 will result in the corresponding rotation of the supply portion 104. If such rotation results in the twisting of the sleeve of stability 340 in the outer tubular member 124, the shrinkage zones 342 will be compressed in length as the outer tubular member retracts. As a result, the stability sheath 340 does not inadvertently inhibit (e.g., through compression, friction, etc.) the movement of the delivery portion 104 within the patient. Therefore, complications during a delivery procedure are minimized. Another preferred embodiment according to the present invention seeks to eliminate the twisting of the stability sheath 122 with a break connection between the stability sheath 122 and the handle portion 102. Preferably, the sheath 122 and the handle portion 102 can be arranged similarly to the modalities of Figures 1-19. However, a reduced amount of bonding material can be used to secure the stability sleeve 122 to the frame member 146, allowing the stability sleeve 122 to break freely under pressure and move with the outer tubular member 124. The user can adjust the amount of "breaking force" needed to break the stability sleeve 340 in free form by varying the amount and type of adhesive or bonding agent. Since the user rotates the handle portion 102 during a delivery procedure, the near end of the stability sleeve 122 can be twisted relative to the distal end, creating a force on the joint between the stability sleeve 122 and the handle portion. 102. As the force in the joint reaches a predetermined amount, it breaks, allowing the sleeve 122 to unwind under its own force or remain twisted and, therefore, move with the outer tubular member 124. In any scenario , the stability sheath 122 is prevented from inhibiting the movement of the outer tubular member 124 and, therefore, the supply of the prosthesis. Although the invention has been described in terms of particular modalities and applications, one skilled in the art, in view of this teaching, may generate additional modalities and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it should be understood that the drawings and descriptions herein are offered by way of example to facilitate understanding of the invention and should not be construed to limit its scope.

Claims (1)

1. - A stent delivery system comprising: a first tubular member having a distal end dimensioned and shaped to receive a stent; a second tubular member being longitudinally slidable on the first tubular member; a third member being partially disposed on the second tubular member, said third tubular member being rotatable relative to said first tubular member and said second tubular member; a handle body coupled to the second tubular member for retracting the second tubular member relative to the first tubular member. 2 - A stent delivery system, comprising: a first tubular member having a distal end dimensioned and shaped to receive a stent; a second tubular member being longitudinally slidable on the first tubular member; a third member being partially disposed on the second tubular member, said third tubular member being longitudinally compressible relative to said first tubular member and said second tubular member; a handle body coupled to the second tubular member for retracting the second tubular member relative to the first tubular member. 3. A stent delivery system comprising: a first tubular member having a distal end dimensioned and shaped to receive a stent; a second tubular member being longitudinally slidable on the first tubular member; a third member being at least partially disposed on the second tubular member; a handle body coupled to the second tubular member for retracting the second tubular member relative to the first tubular member; said third tubular member being releasably attached to said handle body.