AU2012216515A1 - Pleated deployment sheath - Google Patents

Abstract

A deployment sheath for medical devices is provided that includes one or more pleats in its pre-deployment state 5 that are allowed to open during deployment so as to facilitate easier device deployment and sheath removal. Preferably, the sheath is removed by everting it over itself during the delivery process. By orienting the pleats along the length of the sheath, preferably 10 helically around the sheath, the sheath undergoes a predictable enlargement during deployment so as to relive friction of the everted sheath sliding along itself during deployment. This allows the sheath to be removed with less tension than previous everting sheath constructions is and assures more accurate device placement in a patient. 3642672_1 (GHMatters) P84555.AU.1 29/0812 362 20 24 28 FIG. 1 -8

Description

AUSTRALIA Patents Act 1990 COMPLETE SPECIFICATION Standard Patent Applicant(s) GORE ENTERPRISE HOLDINGS, INC. Invention Title: Pleated deployment sheath The following statement is a full description of this invention, including the best method for performing it known to me/us: - 2 PLEATED DEPLOYMENT SHEATH BACKGROUND OF THE INVENTION 5 Field of the Invention The present invention relates to apparatus used to position and deploy medical diagnostic and treatment 10 devices in a body. Discussion of the Related Art A growing number of medical diagnostic and treatment 15 devices are being developed that are remotely used to assess and/or treat patients, typically being guided to a target site using imagining technology such as fluoroscopes or ultrasound. Such devices include stents, stent-grafts, balloons, blood filters. occluders, probes, 20 valves, electronic leads, orthopedic devices, etc. Usually these devices are mounted near the end of a catheter or guidewire and are remotely steered to the targeted site. Radiopaque markers or similar indicia are often used to allow the medical staff to exactly position the medical 25 device using the imagining technology. Once properly positioned, the medical staff will then carry out the procedure and/or deploy the necessary device or devices. Since most of these procedures, such as 30 interventional treatment of occlusions or aneurysms, require exact placement of a treatment device, it is important that the device deploys in the same position where it had been initially placed. For instance, in treating aortic aneurysms with a stent-graft, physicians 35 expect displacement of the device of less than 5 mm following deployment. Any greater displacement may result in endoleaks, blocked side vessels, or other complications 3642672_1 (GHMatters) P84555.AU.1 29/08/12 - 3 requiring otherwise unnecessary further treatments or even risky conversion to open surgery. Not surprisingly, numerous apparatus have been 5 proposed to facilitate the placement of such devices. Originally self-expanding devices were simply drawn or stuffed into a catheter tube and then pushed out at the treatment site. Exact placement using this method can prove somewhat elusive, with the medical staff often 10 required to deploy and retract the device repeatedly before the correct orientation is achieved. More exacting deployment methods have since been developed, such as employing various constraining cords, is e.g., those described in U.S. Patent 6,042,605 to Martin et al., or implantable constraining sheaths, e.g., those described in U.S. Patent 6,352,561 to Leopold et al. A similar concept to the original catheter tube 20 constraint is to use a thin sheath of material that is pulled back over the treatment device while holding the device in place. One advantage of this concept is that the device and thin sheath can take up considerably less space than housing a device within a relatively bulky catheter 25 tube. The thin sheaths also can provide greater flexibility over much stiffer catheter tube materials. Such compactness and flexibility are highly desirable as physicians try to reach tighter treatment sites through smaller and more tortuous vessels. Unfortunately, this 30 method can put considerable strain on a self-expanding device, which is exerting pressure against the constraining sheath throughout the deployment process. The resulting friction between the device and the sheath often requires application of considerable tensile force to 35 remove the sheath, making ultimate exact positioning much more difficult, as well as possibly damaging the treatment device in the process of sheath removal. 3642672_ 1 (GHMatters) P84555.AU.1 2910&12 -4 One deployment method to limit such effects is to employ a thin sheath of material that is everted over itself, so that the constraining sheath rubs only against 5 itself while it is being pulled back over a self-expanding device. In other words, a sheath of a given diameter is everted back over itself and then pulled down the length of the sheath through the deployment procedure. Variations on this concept are described in, for instance, US Patent 10 4,732,152 to Wallsten, US Patent 5,571,135 to Fraser et al., US Patent 6,942,682 to Vrba et al., and US Application 2006/0025844 to Majercak et al., and US Patent Application 2006/0030923 to Gunderson. With sufficiently thin and strong sheath materials, these methods offer the 15 prospect of compactness with less strain placed on the treatment device and perhaps more precise device placement. While everting sheaths address some of the 20 complications seen with non-everting sheaths, they still can require considerable tension in order to pull the sheath over itself and the self-expanding device during deployment, resulting mainly from the friction of everted portion of the sheath rubbing against the non-everted 25 portion of the sheath while the sheath is being removed. These concerns are compounded with longer device lengths and more robust self-expanding devices that exert greater outward pressures. The greater the tension needed to evert and remove the sheath, the more demanding it is for the 30 medical staff to remove the sheath while trying to hold the apparatus in its exact position during deployment. Increased deployment tensions also require more substantial sheath constructions so as to avoid sheath and deployment line breakage during deployment. It is believed 35 that these deficiencies of everting sheaths may have limited practical applications for such deployment methods. 3642672_ 1 (GHMatters) P84555.AU.I 29108M12 - 5 Accordingly, it would be desirable to develop a deployment apparatus that retains many of the benefits of everting sheath deployment while allowing for lower 5 deployment tensions and more exact device placement. SUMMARY OF THE INVENTION According to one embodiment of the present invention 10 there is provided a medical device delivery system comprising: a constraining sheath, having a length, mounted about and containing a medical device; wherein said constraining sheath includes two pleats, wherein both pleats are oriented along at least a portion of the is length, and wherein both pleats are stable when constraining a medical device. According to a further embodiment of the present invention there is provided a medical device deployment 20 system comprising: a medical device having a length; a constraining sheath mounted around the medical device along at least a portion of its length, wherein prior to deployment the sheath is at least partially everted over itself to form an interior segment and an exterior 25 segment; wherein at least a portion of the interior segment of the constraining sheath includes two helically oriented pleats, wherein said pleats are stable when constraining said medical device. 30 Additional features and advantages of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention will be realized and 35 attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings. 3642672_1 (GHMatters) P84555.AU. 1 29/0812 - 6 It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide 5 further explanation of the invention as claimed. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are included to io provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention. 15 In the drawings: Figure 1 is a plan view of one embodiment of a medical device deployment system employing a pleated sheath of the present invention mounted near a distal end 20 of a delivery catheter; Figure 2 is an enlarged perspective view of a distal end of a delivery catheter showing an everting pleated sheath of the present invention being withdrawn, progressively releasing a self-expanding stent contained 25 therein; Figure 3 is a cross-section view along line 3-3 of Figure 2, showing only the pleated sheath component of the present invention; Figure 4 is a perspective view of a portion of an everting 30 pleated sheath of the present invention, showing the pleat unfolding during eversion of the sheath, the sheath being actuated by a deployment line; Figure 5 is a perspective view of another embodiment of a pleated sheath of the present invention comprising a 35 single layer; Figure 6 is a cross-section view along line 6-6 of the sheath of Figure 5; 3642672_1 (GHMatters) P84555.AU.1 290812 - 7 Figure 7 is a cross-section view of the sheath of Figure 5 following opening of the pleat, the sheath being of a greater effective diameter than the pleated orientation shown in Figure 6; 5 Figure 8 is a perspective view of still another embodiment of a pleated sheath of the present invention comprising a single layer and having two pleats provided therein; Figure 9 is a cross-section view along line 9-9 of 10 Figure 8; Figure 10 is a perspective view of another embodiment of a sheath of the present invention wherein the spacing and pitch of the element that will define the pleat is changed along the length of the sheath in order to provide 15 a variable diameter along the sheath length after the pleat is formed; Figure 11 is a perspective view of the sheath of Figure 10 after it has been pleated; Figure 12 is a perspective view of another embodiment 20 of a sheath of the present invention wherein the width of the element that will define the pleat is changed along the length of the sheath; Figure 13 is a perspective view of the sheath of Figure 12 after it has been pleated; 25 Figure 14 is a longitudinal cross-section view of a delivery catheter incorporating a pair of sheaths of the present invention and containing a compacted device, the pair of sheaths being oriented to withdraw from the device in opposite directions from a point midway along the 30 device; Figure 15 is an enlarged perspective view showing a stent-graft device being deployed from a midpoint by removing two sheaths of the present invention in opposite directions; 35 Figure 16A is a longitudinal cross-section view of a distal portion of a catheter utilizing a sheath of the present invention, showing another embodiment of apparatus 3642672_1 (GHMatters) P84555.AU.1 29/08/12 -8 to remove the sheath; Figure 16B is a longitudinal cross-section view of a proximal portion the catheter shaft of Figure 16A; Figure 17A is a partially cut-way perspective view of 5 a distal portion of a catheter utilizing a sheath of the present invention, showing still another embodiment of apparatus to remove the sheath; Figure 17B is a partially cut-way perspective view of a proximal portion the catheter shaft of Figure 17A; 10 Figure 18 is a three-quarter isometric view of another single-layer sheath of the present invention including additional thickness of material along a portion of a monolithic structure to provide pleat reinforcement; Figure 19 is a three-quarter isometric view of still 15 another single-layer sheath of the present invention including surface treatment of the sheath in order provide a defined pleat hinge line; and Figure 20 is a cross-section view of another embodiment of a sheath of the present invention comprising 20 a sheet of material that is formed into a tubular construct by interlocking pleats formed on edges of the sheet. DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS 25 Reference will now be made in detail to an embodiment of the present invention, example of which is illustrated in the accompanying drawings. 30 The present invention employs a pleated deployment sheath for medical device containment and delivery, preferably for use with everting sheath delivery. One or more pleats are pre-formed into the sheath in its pre deployment state and are allowed to open during deployment 35 so as to facilitate easier sheath removal. By orienting the pleats longitudinally along the length of the sheath, preferably helically around the sheath, the sheath 3642672_1 (GHMatters) P84555.AU. 29/08/12 -9 undergoes a predictable enlargement during deployment and thus relieves friction of the everted sheath sliding along itself during deployment. This allows the sheath to be removed with considerably less tension than previous 5 everting sheath constructions and assures more accurate device placement in a patient. Shown in Figure 1 is one embodiment of a pleated sheath 10 of the present invention mounted near the end of io a medical device deployment system 12. The deployment system comprises a catheter shaft 14 extending from a distal olive 16 to a control hub 18. A medical device, such as a stent, stent-graft, balloon, blood filter, occluder, probe, valves, etc., may be contained in the is sheath 10 to be deployed at a treatment site within a patient's body. In the embodiment shown, the sheath 10 is everted over itself to form two layers, an exterior segment 20 which, in this embodiment, completely covers an interior segment 22. The exterior segment is split at its 20 proximal end 24 to form a deployment line 26 that is fed into the catheter shaft through opening 28. The deployment line 26 is operatively connected to a deployment knob 30 on the hub 18. 25 The sheath 10 may be formed from any material that is sufficiently strong both to constrain the device to be delivered and to withstand the tension of the removal process. It is desirable that the sheath 10 also be as thin and lubricious as possible so as to maintain a small 30 device delivery profile and to facilitate the removal process. Since the sheath 10 is placed temporarily deep within a patient during delivery and deployment, it is likewise desirable that the sheath be formed from a biocompatible material. As is explained in greater detail 35 below, suitable sheath materials may include: polytetrafluoroethylene (PTFE); expanded PTFE (ePTFE); fluorinated ethylene propylene (FEP), polyethylene 3642672_1 (GHMatters) P84555.AU.1 2910812 - 10 teraphthalate (PET), nylon, polyurethane, polypropylene, polyester, etc. In this embodiment of the present invention, the 5 interior segment 22 includes a helical pleat 32 extending fully along its length. The pleat 32 comprises a fold in the material of the sheath that reduces the interior segment 22 of the sheath to a diameter smaller than the diameter of the exterior segment 20. In order to aid in 10 forming and maintaining the pleat 32, a reinforcing material 34 may be layered over or otherwise attached to the sheath. Preferably such material is fold-resistant so that the pleat more readily holds its correct orientation along its entire length during the folding process and 15 through sheath deployment. Suitable reinforcing materials may include: one or more strips of polymer material, such as polyimide, polyethylene teraphthalate (PET), nylon, polyurethane, or similar material, adhered to the sheath; a coating applied to the strip that hardens to provide the 20 desired properties, such as providing sufficient stiffness/Young's Modulus and thickness to resist folding for a given helical pitch, pleat width, and effective diameter. 25 As the term "pleat" is used with respect the present invention, it refers to any fold or multiple folds in the sheath material that reduces the effective diameter of the sheath. In the preferred embodiment, each pleat comprises two folds that cause the sheath material to double back on 30 itself. Alternatively, as is explained below, the pleat may comprise a single fold or multiple folds along an edge of a sheet of material, which may be interlocked, for instance as shown in Figure 20. A pleat may also be formed through a rolling, twisting, or accordion folding of a 35 section of material or similarly storing material for later un-pleating during deployment. 3642672_1 (GHMatters) P84555.AU. 129/08/12 - 11 The sheath 10 everts over itself at a fold 36 at one end, in this embodiment at the distal end. As is explained below, the fold 36 may be oriented at either the distal end or the proximal end of the device, or anywhere in 5 between. In order to actuate the deployment line 26, medical personnel will unscrew the deployment knob 30 and pull on the knob and connected deployment line to cause the sheath 10 to progressively withdraw off of the contained device. As the exterior segment of the sheath is withdrawn, the fold 36 will progress down the length of the contained device, steadily everting the interior segment 22 so that it becomes the exterior segment 20. In the process of 15 everting, the pleat 32 will wrap around the fold 36 and open up. In this manner, the un-pleated exterior segment 20 will always remain at a larger effective diameter than the pleated interior segment 22 of the sheath. As a result, the larger diameter exterior segment 20 slides 20 easily over the interior segment 22 and is readily removed with minimal friction between the two layers. The process of device delivery can be better seen in Figure 2. In this embodiment, the interior segment 22 with 25 its reinforced pleats 32 is shown exposed in cut-away. As the larger diameter exterior segment 20 is withdrawn, the pleats 32 open up along fold 36. Seen along the length of the exterior segment 20 are the strips of reinforcement material 34, now merely attached to the sheath 10 and no 30 longer defining a pleat. As the sheath 10 is withdrawn in this manner, a constrained self-expanding stent 38 is progressively deployed from this embodiment. As can be seen in the cross-section illustration of 35 Figure 3, the coaxial interior segment 22 and pleat 32 and reinforcement material 34 are shown within the larger diameter exterior segment 20 having only un-pleated 3642672_ 1 (GHMatters) P84555.AU. 129/08/12 - 12 reinforcement material 34. Figure 4 shows the process of un-pleating with the contained pleats 32 shown in phantom and the un-pleated 5 reinforcement material 34 shown exposed along the exterior segment 20. Again, transition occurs along fold 36. In this embodiment a deployment line 40 is connected to one end 42 of the exterior segment 20. Tension on the deployment line 42 actuates the sheath 10. 10 Figure 5 illustrates another embodiment of the present invention comprising a single layer sheath 10. The helically formed pleat 32 again includes a strip of reinforcement material 34. As can be seen in the cross 15 section of Figure 6, the pleat 32 causes the sheath 10 to have a given diameter of x. Once the pleat 32 is released, as is shown in Figure 7, the diameter of the sheath 10 enlarges to increased diameter of y. 20 With respect to single layer embodiments of the present invention, there are a variety of methods through which the sheath can be used. First, the pleats of the present invention are preferably stable without a constraining force. For instance, a sufficiently rigid 25 pleat with sufficient helical angle will be inherently stable and will remain in place even without an external constraint. Alternatively, a variety of constraints can be provided to help retain the pleats in position. For instance, the single layer sheath may be formed and then 30 everted over itself, either partially or entirely, and then employed in the manner described above. The everted portion of the sheath will maintain the pleats in their folded configuration until the device is ready for deployment. In another embodiment, the single layer sheath 35 may be contained in another tubular structure to maintain the pleats in a folded configuration, such as through use of another sheath, a closely fitted catheter tube, or 3642672 1 (GHMatters) P84555.AU.129/08112 - 13 similar structure. In still another embodiment, the pleats can be joined to the sheath, such as through use of an adhesive, an adhered tape, a wrapped tape, a wrapped thread, or similar means, that will hold the pleats in 5 position until the device is ready for deployment. A further method of deployment of a single layer sheath may include tensioning from the proximal end of.the pleated tube (that is, the end closest to the clinician). When sufficient tension is applied, the pleat will unfold and io the tube will increase diametrically allowing it to be translated relative to the device. Illustrated in Figures 8 and 9 is a still another embodiment of a pleated sheath 10 of the present 15 invention. In this embodiment, the sheath 10 comprises a single layer and includes two pleats 32a, 32b therein. The pleats may be evenly aligned on opposite sides of the sheath 10, as shown, or may be placed in other orientations. It should be understood that depending on 20 desired deployment specifications, the present invention can be practiced with one, two, three, four, five or more pleats along part or all of the sheath length. Figure 10 illustrates another embodiment of a sheath 25 10 of the present invention wherein the spacing 44a, 44b, 44c, 44d between pleating elements 32 varies along the length of the sheath 10. Likewise, the pitch 46a, 46b, 46c, 46d, 46e of the helical wraps of the pleating elements 32 also varies along the length of the sheath 10. 30 Each of these properties can be adjusted, independently or in cooperation, in device design so as to provide varying diameters along the length of the sheath after pleating. Diameter may be varied along the length of the sheath to accommodate non-cylindrical device profiles and/or produce 35 variable sheath removal properties. Figure 11 depicts the sheath of Figure 10 after it 3642672_ I (GHMatters) P84555.AU.1 29/0/12 - 14 has been pleated. In this instance, the sheath and contained device provide a tapered profile, with the distal end 48 being a smaller diameter than the proximal end 50. s In the embodiment of Figure 12, width 52a, 52b, 52c of the pleating element is changed along the length of the sheath 10. Again, by changing pleat width, diameter can be varied along the length of the sheath to accommodate non 10 cylindrical device profiles and/or produce variable sheath removal properties. For instance, by making the pleating elements progressively narrower along the length of the device as shown, the pleated sheath can be formed with a variable diameter, producing either greater or lesser 15 friction (depending on the direction of deployment) as the sheath is deployed along its length - making it either initially easier or more difficult to deploy the sheath. Figure 13 depicts the sheath of Figure 12 after it 20 has been pleated. In this instance, the sheath and contained device provide a tapered profile, with the distal end 48 being a smaller diameter than the proximal end 50. 25 Shown in Figure 14 is a delivery catheter incorporating a pair of sheaths of the present invention and containing a compacted device 38, the pair of sheaths 10a, lob being oriented to withdraw from a compacted device 38 in opposite directions from a point midway along 30 the device. Proximal sheath 10a runs along catheter shaft 14 to an actuation mechanism 54. Distal sheath lob is withdrawn in the opposite direction (that is, towards the distal end of the catheter 14) and is inverted into the catheter shaft 14. The distal sheath lob is likewise 35 controlled by actuation mechanism 54. By actuating the two sheaths in this embodiment, the 3642672_1 (GHMatters) P84555.AU.1 29108/12 - 15 two sheaths 10a, 10b are withdrawn simultaneously from the compacted device 38 to allow it to deploy from its middle outward. Such deployment may be useful in those instances where very rapid device deployment is sought and/or where 5 it is desirable to minimize the effect of high volume of blood flow upon the device prior to full deployment (for instance, when a device is deployed in the aorta and it is desirous to have the upstream end of the device deploy last so as to avoid a "windsock" effect in the high 10 volume blood flow which may misalign device positioning). Figure 15 illustrates how a stent-graft device 38 can be deployed from its midpoint by removing two sheaths 10a, 10b. This deployment method would be preferred for placing 15 a stent-graft device in a thoracic aorta or the like. It should be understood that for some applications it may be preferred to actuate each of the sheaths 10a, 10b independently of each other so that only part of the 20 device is deployed at any given time. This can be readily accomplished by providing separate actuation mechanisms for each of the sheaths. It should be further appreciated that with respect to all of the embodiments of the present invention discussed herein it may be desirable to have 25 sheath deployment occur either from the distal end of the catheter back or from the proximal end of the catheter forward, or with two or more deployment sheaths moving in opposite directions, as illustrated in the embodiments of Figures 14 and 15. 30 Figures 16A and 16B illustrate a deployment mechanism similar to the one shown in Figure 14. In this embodiment, a single everted sheath 10 is provided constraining a device 38. The sheath 10 extends proximally within an 35 outer casing 54 of catheter shaft 14, coaxially surrounding inner catheter shaft 56. The sheath 10 extends to the proximal end 58 of the catheter 14, where it can be 3642672_ 1 (GHMatters) P84555.AU.1 29/012 - 16 actuated by a user. In this embodiment, the sheath 10 is constructed from a material that will split longitudinally, such as through a pre-formed longitudinal line of perforations or similar weakening means 60, so 5 that the sheath 10 can be removed from the inner shaft 56 by applying tension to tail 62, as is shown in Figure 16B. A strain relief 64 may be provided on the distal end of the outer casing 54 to assist in handling of the catheter 14 during placement and deployment. 10 Another deployment mechanism that may be used with the present invention is shown in Figures 17A and 17B. In this embodiment, a dual lumen catheter 14 is provided, having a lumen 66 for housing inner shaft 56 and a lumen 15 68 designed to accept a deployment line 40. The deployment line 40 is integral with or attached to the sheath 10. The line 40 is actuated to cause the sheath 10 to withdraw in the manner previously described. 20 The preferred sheath of the present invention for containing and deploying a self-expanding stent or stent graft for vascular applications will be constructed of a thin, lubricous polymer material, such as an ePTFE multi layer laminated film tube, with a thickness of 0.03 to 0.3 25 mm, and more preferably 0.05 to 0.12 mm. In light of the present description, it should be evident that the tube of the present invention is preferably as thin as possible while having strength properties that will withstand loading forces and effectively constrain the device until 30 it is deployed. Still other embodiments of pleats that may be employed in the present invention are illustrated in Figures 18 through 20. Figure 18 illustrates a pleat 35 reinforcement 70 that is formed from the same material as the sheath 10 itself. Such reinforcement 70 is achieved by providing a layer of additional material along a portion 3642672_1 (GHMatters) P84555.AU.1 29108/12 - 17 of the sheath circumference so as to provide defined fold lines 72a, 72b on either side of the raised reinforcement 70. This construct may be formed by extruding or otherwise adding additional material in the defined manner on the 5 sheath and/or removing material from, or densifying material on, the remainder of the sheath 10 in order to leave a pleat reinforcement 70 of increased dimension. A similar effect may be achieved by densifying the reinforcement area in order to establish told-resistance. 10 Figure 19 illustrates another approach to achieve predictable sheath folding. In this embodiment the sheath 10 has been treated to provide one or more defined pleat hinge lines 74a, 74b. Each hinge line 74 may be formed is through any of a variety of surface treatment means, including through mechanical methods (e.g., cutting, scoring, densification, etc.), through extrusion or other material manufacture steps, or through thermal processing (e.g., through heat or laser treatment), or some 20 combination of such various methods. The pleated configuration of the sheath 10 is folded along these hinge lines 74. It should be evident that with respect to the 25 embodiments of both Figure 18 and Figure 19, the desired result is achieved by forming a pleat region with sufficient relative stiffness and/or thickness to resist folding or otherwise to fold preferentially. Additionally, using these techniques the sheath can be provided with 30 preferential folding properties without the need to add additional material to the sheath. Figure 20 illustrates still another method of forming a pleat in accordance with the present invention. In this 35 embodiment the sheath 10 is formed from a sheet of material having two edges 76a, 76b. Each of these edges 76a, 76b can then be folded to form a pleat 78a, 78b with 3642672_1 (GHMatters) P84555.AU. 129/08/12 - 18 one or more folds. The edge pleats 76a, 76b can then be interlocked with one another, for instance as shown, to create a tubular structure that serves as the sheath 10 of the present invention. In this embodiment when the pleat 5 10 is opened, the edges 76 will separate from each other to provide the desired predictable enlargement of the present invention. One or both of the edges 76 can be provided with reinforcement 80a, 80b, such as through one of the methods previously described, in order to io facilitate the formation and retention of the pleat 78. It should be appreciated that in the everted embodiments of the present invention, in the final construct the exterior segment should have an inner 15 diameter that is sufficiently greater than the outer diameter of the interior segment in order to minimize friction between the two segments. That is, in order to minimize interference between the interior segment and the exterior segment, the un-pleated exterior segment should 20 enlarge enough so that its inner diameter comfortably clears the outer diameter of the pleated interior segment. It is preferred that the inner diameter of the exterior segment be 0.1 to 50 % larger than the outer diameter of the interior segment, and more preferably 10 to 20 % 25 larger. For example, to achieve these dimensions, a sheath with a wall thickness of about 0.08 mm and an un-pleated a inner diameter of about 2.1 mm will typically be provided 30 with one or more pleats with a pleat width of 0.8 mm to create a pleated interior segment having a outer diameter of about 1.9 mm. In the preferred embodiments of the present invention 35 for the deployment of a self-expanding stent or stent graft, pleats are provided with a width of 0.3 to 2.0 mm, and more preferably with a width range of 0.6 to 1.3 mm. 3642672_ 1 (GHMatters) P84555.AU.I 29/08/12 - 19 Pleats will typically be oriented helically around the sheath, with a typical pitch angle of 30 to 75 degrees, and more preferably a pitch of 50 to 70 degrees. 5 The pleats are preferably reinforced with a strip or strips of relatively fold-resistant material, such as polyimide film, with a thickness of 0.01 to 0.08 mm, and more preferably 0.02 to 0.05 mm. The reinforcement material is encapsulated between layers of a laminated 10 sheath, adhered using an adhesive such as FEP or similar material. While the preferred sheath of the present invention includes one or more pleats helically oriented along part 15 or all of the longitudinal length of the sheath, it should be appreciated that other pleat orientations as likewise contemplated by the present invention. For example, so long as they are adequately constrained or adhered the pleat or pleats may be arranged essentially parallel to 20 the axis of the device. Further, for some applications multiple discontinuous pleats may be provided to achieve suitable deployment properties. Additionally, for some applications it may be desirable to provide pleats along at least a portion of both the interior segment and the 25 exterior segment of the sheath. The sheath of the present invention has been determined to vastly reduce the amount of tension required to deploy a device. In this regard, deployment tensions 30 are typically on the order of 50 - 150 grams. It should be noted that the present invention may be scaled to virtually any dimensions. 35 EXAMPLE Without intending to limit the scope of the present 3642672_1 (GHMatters) P84555.AU.1 29108/12 - 20 invention, the following example illustrates one embodiment of how the present invention may be practiced. Sheath Tube Construct: 5 (1) A 1" (25.4 mm) wide strip of expanded polytetrafluoroethylene (ePTFE) film (having predominantly longitudinally oriented strength, film thickness of approximately 0006 mm and break strength of approximately io 0.8 kg I cm width) was 'cigarette" wrapped on a 0.11" (2.8 mm) diameter x 40cm long mandrel. The film structure was orientation parallel to mandrel axis so that the film was stronger parallel to the mandrel's longitudinal axis. 15 (2) A second layer of 0.4" (10 mm) wide ePTFEIFEP laminate film (predominantly longitudinally oriented strength, total film thickness of approximately 0.003 mm, FEP thickness of approximately 0.001 mm and break strength of approximately 0.7 kg / cm width) was then helically 20 overwrapped around the first film layer with a single pass at a 0.2" (5 mm) pitch, to create a double thickness of the second film layer. The oriented film structure of the second layer was aligned in the helical direction around the mandrel. 25 (3) A 0.035" (0.89 mm) wide x 0.001" (0.025 mm) thick strip of polyimide was wrapped over the second film layer at a pitch of 0.375" (9.5 mm). 30 (4) A second pass of the second layer of film was wrapped over the polyimide in a direction opposing the previous pass of the second layer of film. (5) The wrapped tube was thermally processed on 35 mandrel at a temperature of 380 0 C for 8 minutes, after which the tube (approximately 25cm in length) was stripped from the mandrel. 3642672_ 1 (GHMatters) P84555.AU. 129/08/12 - 21 (6) The tube was helically pleated by manually flipping the polyimide strip 1800. Approximately 11 cm of the tube was pleated with the pleat originating at one end 5 of the tube, open side of the pleat facing away from the un-pleated section. Pleated inside diameter of the tube was approximately 0.095" (2.4 mm) with the helical pleat having a pitch of about 0.23" (5.8 mm). Approximately 14 cm of the tube was left un-pleated. 10 Loading: (1) Traction lines were attached to each of the six leading apices on an 8mm x 10 cm GORE VIABIL* 15 endoprosthesis device (available from W. L. Gore & Associates, Inc., Flagstaff, AZ). A Pebax* coated, braided stainless steel shaft (approximately 0.038" (0.97 mm) I.D., 0.045" (1.1 mm O.D.) was positioned in the lumen of the device. 20 (2) A long stainless steel nozzle (approximately 100mm length, 0.095" (2.4 mm) outer diameter, 0.088" (2.2 mm) inner diameter) was fixed to the small end of a stainless steel loading funnel. The funnel was sized with 25 a wide opening of approximately 14 mm diameter, a small funnel opening of approximately 2.2 mm diameter and a straight taper approximately 34 mm in length. (3) The pleated end of the tube was positioned on the 30 O.D. of the nozzle with the pleat extending approximately 5 mm beyond the end of the nozzle. The open side of the pleat was facing the funnel end of the nozzle. (4) The endoprosthesis was compressed by pulling it 35 through the funnel and attached nozzle, via the attached traction lines. As the device exited the nozzle, the pleated tube was fed from the O.D. of the nozzle onto the 3642672_1 (GHMatters) P84555.AU.1 29/08/12 - 22 compressed device, constraining the device at the pleated diameter. (5) With the entire device pulled through the nozzle 5 and subsequently constrained in the pleated tube, the un pleated section of the tube was everted over the device. Deployment: 10 (1) Deployment of the device was accomplished by tensioning and displacing the outer, un-pleated, section of the tube relative to the device, releasing it from its constrained state. 15 (2) As the tube is everted, the pleat opens up or unfolds at the point of eversion, allowing the un-pleated outer layer of the tube to translate relative to the pleated inner layer without interference. 20 It was determined that this delivery tube could be deployed with significantly less deployment line tension than a comparably constructed everted tube that did not include pleats. A conventional tensile test was conducted on an un-pleated everting sheath and a pleated everting 25 sheath of the present invention, the sheaths being otherwise comparable in material and construction, using an INSTRON Tensile Tester employing a crosshead speed of 400 mm/mm. 30 Tension required to deploy the pleated sheath of the present invention was consistent throughout the deployment with a peak of approximately 0.074 kg. Tension required to deploy the conventional everting sheath without pleats was approximately 2.2 kg initially, reducing to approximately 35 0.50kg midway through the deployment. These results are illustrated in the following graph, wherein the upper plot shows the load encountered by a deployment line attached 3642672_ 1 (GHMatters) P84555.AU.1 2910812 - 23 to the conventional un-pleated everting sheath during device deployment, and the lower plot shows the load encountered by a deployment line attached to the pleated everting sheath of the present invention during device 5 deployment. 2.5 2.0......... 1.5...................... 0.5. . .... .. ..... ... .. .. .. .... ... .... . 0.0 I 0 20 40 60 80 100 120 140 160 180 200 220 240 260 280 Extension (mm) 10 It will be apparent to those skilled in the art that various modifications and variation can be made in the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover the modifications and variations is of this invention provided they come within the scope of the appended claims and their equivalents. In the claims which follow and in the preceding description of the invention, except where the context 20 requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further 25 features in various embodiments of the invention. It is to be understood that, if any prior art 3642672_1 (GHMatters) P84555.AU.l 29/08/12 - 24 publication is referred to herein, such reference does not constitute an admission that the publication forms a part of the common general knowledge in the art, in Australia or any other country. 5 3642672_1 (GHMatters) P84555.AU. 1 29/08/12

Claims (22)

1. A medical device delivery system comprising a constraining sheath, having a length, mounted 5 about and containing a medical device; wherein said constraining sheath includes two pleats, wherein both pleats are oriented along at least a portion of the length, and wherein both pleats are stable when constraining a medical device. 10

2. The medical device delivery system of claim 1 wherein both pleats are oriented helically along at least a portion of the length of the sheath. is

3. The medical device delivery system of claim 1 wherein the two pleats are evenly aligned on opposite sides.

4. The medical device delivery system of claim 1 wherein the two pleats are not evenly aligned. 20

5. The medical device delivery system of claim 1 wherein at least one pleat is reinforced with a reinforcing material. 25

6. The medical device delivery system of claim 5 wherein the reinforcing material comprises a polymer strip attached to the sheath.

7. The medical device delivery system of claim 2 wherein 30 at least a portion of the sheath is everted over itself prior to the medical device deployment.

8. The medical device delivery system of claim 7 wherein when tension is applied to the portion of the sheath that 35 is everted, the everted portion of the sheath slides along the length of the device and both pleats progressively opens to provide an enlarged diameter to the everted 3642672_ 1 (GHMatters) P84555.AU. 1 29/08/12 - 26 portion of the sheath.

9. The medical device delivery system of claim 1 wherein the sheath comprises expanded polytetrafluoroethylene. 5

10. The medical device delivery system of claim 9 wherein the sheath comprises a tube of multiple layers of expanded polytetrafluoroethylene film. 10

11. The medical device delivery system of claim 1 wherein the medical device is an endoprosthesis.

12. The medical device delivery system of claim 11 wherein the endoprosthesis is a self-expanding device. 15

13. A medical device deployment system comprising a medical device having a length; a constraining sheath mounted around the medical device along at least a portion of its length, 20 wherein prior to deployment the sheath is at least partially everted over itself to form an interior segment and an exterior segment; wherein at least a portion of the interior segment of the constraining sheath includes two helically 25 oriented pleats, wherein said pleats are stable when constraining said medical device.

14. The medical device deployment system of claim 13 wherein deployment occurs by applying tension to the 30 exterior segment of the sheath to evert the interior segment and progressively reorient it into the exterior segment, with both pleats progressively opening as the sheath everts, creating an unpleated exterior segment and a pleated interior segment. 35

15. The medical device deployment system of claim 14 wherein the un-pleated exterior segment is of a 3642672_ 1 (GHMatters) P84555.AU.I 2908/12 - 27 sufficiently greater diameter than the pleated interior segment so as to reduce frictional contact between the interior segment and the exterior segment during deployment. 5

16. The medical device deployment system of claim 13 wherein the helically oriented pleats are evenly aligned on opposite sides of the sheath. 10

17. The medical device deployment system of claim 13 wherein the helically oriented pleats are not evenly aligned.

18. The medical device deployment system of claim 13 15 wherein the sheath comprises expanded polytetrafluoroethylene.

19. The medical device deployment system of claim 18 wherein the sheath comprises a tube of multiple layers of 20 expanded polytetrafluoroethylene film.

20. The medical device delivery system of claim 13 wherein the medical device is an endoprosthesis. 25

21. The medical device delivery system of claim 20 wherein the endoprosthesis is a self-expanding device.

22. A medical device delivery system comprising a constraining sheath, having a length, mounted 30 about and containing a medical device; wherein said constraining sheath includes at least one pleat helically oriented along at least a portion of the length, wherein said pleat is stable when constraining a medical device. 35 3642672_ 1 (GHMatters) P84555.AU. 129/08112