Sleeve retraction mechanism

Abstract

To provide a good delivery system and the like.SOLUTION: Through observation it has been determined that deployment of delivery sleeves may result in one or more portions of the delivery sleeve extending beyond one end of an endoluminal device resulting in overhang of material. The overhang may affect a blood flow through an endoprosthesis or otherwise impact performance, including facilitating unwanted tissue growth. Various inventive concepts are provided for addressing (reducing or removing) constraining sheath overhang.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates generally to medical device deployment systems or other delivery systems that include an intraluminal device having a delivery sleeve, and particularly to medical device deployment systems configured to reduce delivery sleeve overhang during deployment of the intraluminal device. [Background technology]

[0002] Intraluminal devices are often used to treat vessels in human patients. Generally, it is known to utilize a flexible sleeve to constrain the device toward a circumferential size or delivery configuration suitable for intraluminal delivery toward a vascular treatment site. It may be desirable to at least partially retract such sleeves, such as those configured to remain in place after deployment of a base intraluminal device, to prevent, for example, inadvertent occlusion of a branch vessel by the sleeve. Clinicians may not be able to rely solely on conventional imaging technology to avoid such inadvertent occlusion, particularly because (1) imaging technology cannot detect the sleeve itself, (2) the sleeve may not include radiopaque markers, and (3) radiopaque bands or other markers on the intraluminal device may not necessarily correlate with the ends of the sleeve.

[0003] U.S. Patent No. 10,219,929, issued March 5, 2019, entitled "Sleeve Retraction System," describes a system for an intraluminal device that utilizes a sleeve and a mechanism for retracting at least a portion of the sleeve to restrain the expandable device toward a restraining structure suitable for intraluminal delivery along a vessel to a treatment site. Summary of the Invention [Problem to be solved by the invention]

[0004] It has been observed that deployment of the delivery sleeve results in one or more portions of the delivery sleeve extending beyond the end of the endoluminal device, overhanging material. Overhang can affect performance, including affecting blood flow through the endoprosthesis or otherwise encouraging undesirable tissue growth. Various inventive concepts are presented to address (reduce or eliminate) constraining sheath overhang. [Means for solving the problem]

[0005] A delivery system according to an embodiment ("Example 1") of the present disclosure is disclosed. The delivery system includes a delivery sleeve releasably secured within a tubular shape configured to constrain a medical device in a delivery configuration. The delivery sleeve has a predetermined length, an upstream edge, a downstream edge, an intermediate region between the upstream and downstream edges, a first margin extending along the length of the delivery sleeve, a second margin extending along the length of the delivery sleeve, and a first corner region proximate the upstream edge. The delivery system also includes a first deployment line segment releasably connecting the first and second margins of the delivery sleeve such that the delivery sleeve is releasably secured in the tubular shape, and a second deployment line segment secured to the first corner region and extending from the first corner region to a first secured point in the intermediate region. The second deployment line segment is configured such that actuation of the second deployment line segment translates at least a portion of the upstream edge toward the intermediate region.

[0006] Referring to Example 1, the second deployment line segment can extend from the first deployment line segment. The delivery sleeve can have a second corner region proximate the upstream edge, and the second deployment line segment can be secured to the second corner region and advanced to a first secured point in the intermediate region. The second deployment line segment is configured such that, upon actuation of the second deployment line segment, both corner regions translate toward the intermediate region. The second deployment line segment can advance outside the delivery sleeve.

[0007]

[0023] Still referring to Example 1, the first corner region can include an opening, and the second deployment line segment passes through the opening to secure the second deployment line segment to the first corner region. The deployment system can include an auxiliary sleeve. When the deployment system includes an auxiliary sleeve, the auxiliary sleeve can be positioned around the medical device and the delivery sleeve.

[0008] A delivery system according to another embodiment ("Embodiment 2") of the present disclosure is disclosed. The delivery system includes a delivery sleeve configured to constrain a medical device in a delivery configuration. The delivery sleeve has a predetermined length, an upstream edge, a downstream edge, an intermediate region, and a first corner region. The delivery system further includes a first deployment line segment extending along the length of the delivery sleeve from the downstream edge to the upstream edge for releasably coupling the delivery sleeve to the tubular configuration, and a second deployment line segment coupled from the first deployment line segment. The second deployment line segment is secured to the first corner region and extends from the first corner region to the intermediate region, where it is secured to a first securing point.

[0009] Referring to Example 2, the second deployment line section can be configured such that actuation of the second deployment line section causes the first corner region to translate back toward the middle region. The first and second deployment line sections can be releasable from the delivery sleeve.

[0010] Still referring to Example 2, the delivery sleeve can have a second corner region. In such an example, a second deployment line section can be coupled to the second corner region, extend from the second corner region to the intermediate region, and be secured at a first securing point. The second deployment line section is configured such that actuation of the second deployment line section causes the first corner region and the second corner region to translate back toward the intermediate region.

[0011] A method of actuating a delivery sleeve of a delivery system according to yet another embodiment ("Embodiment 3") of the present disclosure is disclosed. The method includes positioning the delivery sleeve at a desired location. The delivery sleeve is part of a delivery system including a medical device with which the delivery sleeve is associated. The delivery sleeve has an upstream edge, a downstream edge, a middle region, and at least one corner. The delivery system further includes a first deployment line attached to the delivery sleeve and a second deployment line segment attached to the at least one corner and passing through the middle region. The method further includes applying tension to the first deployment line segment such that the first deployment line segment actuates the delivery sleeve to effect delivery of the medical device, and applying tension to the second deployment line segment such that the second deployment line segment translates the at least one corner back toward the middle region.

[0012] According to Example 3, the first and second deployment line segments can be part of a single fluid line. The method can further include applying tension to the second deployment line segment to release the first and second deployment line segments from the delivery sleeve.

[0013] According to another embodiment ("Embodiment 4") of the present disclosure, a method of delivering a medical device is disclosed. The method involves positioning a delivery system at a desired location within a patient's body. The delivery system includes a delivery sleeve associated with the medical device. The delivery sleeve has an upstream edge, a downstream edge, a middle region, and at least one corner. The delivery system further includes a secondary sleeve positioned around the medical device and the delivery sleeve, the secondary sleeve having an upstream edge. The delivery system further includes a deployment line including a first deployment line segment coupled to the first delivery sleeve and a second deployment line segment coupled to the secondary sleeve, the deployment line attached to at least one corner of the delivery sleeve and passing through the middle region of the delivery sleeve.

[0014] The method of Example 4 further includes releasing the auxiliary sleeve from around the medical device and the delivery sleeve, applying tension to the first deployment line segment to release the delivery sleeve, and applying tension to the second deployment line segment to translate the upstream edges of each of the first and second delivery sleeves toward the intermediate region of the first delivery sleeve.

[0015] Further referring to Example 4, the delivery system can be coupled to a catheter. In such an example, the method can further include applying tension to the first and second deployment line segments such that the first and second deployment line segments are released from the delivery sleeve and the auxiliary sleeve into the catheter. [Brief explanation of the drawings]

[0016] The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated into and constitute a part of this specification, illustrating embodiments and, together with the description, serve to explain the principles of the disclosure.

[0017] [Figure 1] FIG. 1 illustrates a catheter including at least one sleeve configured to constrain a medical device, according to some embodiments.

[0018] [Figure 2A] FIG. 2A shows a catheter including at least two sleeves configured to constrain a medical device, according to some embodiments.

[0019] [Figure 2B] FIG. 2B shows the angular designation of a cylindrical instrument.

[0020] [Figure 3A] FIG. 3A shows a sleeve with a first deployment line segment route pattern prior to deployment, according to some embodiments.

[0021] [Figure 3B]FIG. 3B illustrates the sleeve with the first deployment line segment route pattern of FIG. 3B after deployment, according to some embodiments.

[0022] [Figure 4A] FIG. 4A shows a sleeve with a second deployment line segment route pattern, according to some embodiments.

[0023] [Figure 4B] FIG. 4B illustrates another sleeve having a second deployment line segment route pattern, according to some embodiments.

[0024] [Figure 5A] FIG. 5A shows a first configuration of the sleeve upon activation of the second deployment line segment of FIG. 4A.

[0025] [Figure 5B] FIG. 5B shows the second configuration of FIG. 5A upon continued actuation of the second deployment line segment.

[0026] [Figure 5C] FIG. 5C shows a third configuration of the sleeve of 5B upon continued actuation of the second deployment line segment.

[0027] [Figure 6] FIG. 6 illustrates another configuration of the sleeve according to some embodiments after the deployment line has been removed from the sleeve.

[0028] [Figure 7A] FIG. 7A shows the aortic arch of a patient, including the ascending and descending portions of the aorta.

[0029] [Figure 7B] FIG. 7B is a schematic cross-sectional view of a patient's aorta illustrating the coronary and non-coronary regions of the aortic cross-section. DETAILED DESCRIPTION OF THE INVENTION

[0030] Those skilled in the art will readily appreciate that various aspects of the present disclosure can be implemented by a variety of methods and apparatus configured to perform the intended functions. Also, the accompanying drawings referred to herein are not necessarily to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that sense the drawings should not be construed as limiting.

[0031] [Definition] With respect to uncertainty terms, "approximately" and "about" can be used interchangeably to mean a value that includes the specified value and any value that is reasonably close to the specified value. A value that is reasonably close to the specified value deviates from the specified value by a reasonably small amount that one of ordinary skill in the art would understand and readily ascertain. Reasonable deviations can result from measurement errors, variations in measurement and / or manufacturing equipment calibration, human error in reading and / or setting measurements, adjustments made to optimize performance and / or structural parameters to account for variations in measurements associated with other components, specific implementation scenarios, imprecise adjustments and / or manipulation of objects by humans or machines, etc. Where it is determined that one of ordinary skill in the art would not readily ascertain a value for such reasonably small variations, "approximately" and "about" can be interpreted to mean plus or minus 10% of the specified value.

[0032] Intraluminal devices are often used to treat the vessels of a human patient. Such treatments or procedures are commonly referred to as intraluminal or intravascular procedures. Such devices often include a sleeve. As used herein, "sleeve" refers to a primary, secondary, tertiary, etc., sleeve, sheath, or the like that constrains the intraluminal device toward a collapsed configuration or peripheral dimension suitable for intraluminal delivery of the device to a treatment portion of the patient's vessel.

[0033] In this disclosure, "constraining" means (1) limiting expansion, whether by self-expansion or with the aid of a device (e.g., a balloon), or (2) covering or surrounding at least a portion of a medical device but not otherwise restraining it (e.g., for storage or biocompatibility reasons and / or to protect the medical device and / or vessel). For reference, "diameter" is not meant to require a circular cross-section, but is understood broadly to mean the largest cross-sectional dimension of a medical device.

[0034] As used herein, "endoluminal device" or "device" means stents, grafts, filters, valves, anchors, occluders and other implantable devices, including all of the above constrained within one or more sleeves.

[0035] As used herein, "line" means any type of string, cord, thread, fiber, or wire and can be constructed from metallic, polymeric, or natural materials, including conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric organosilicon polymers, metals such as stainless steel, cobalt chromium alloys, and nitinol, and high strength polymers such as ultra-high molecular weight polyethylene fiber or aramid fiber.

[0036] Throughout this specification and claims, "distal" or "leading end" can refer to a relative location on a device that is closer to the end of the device that is inserted into and advanced through a patient's vessel. "Proximal" or "trailing end" can refer to a relative location on a device that is closer to the end of the device that is located outside the patient's vessel. In this context, "distal end" can be interpreted as "far end," and "proximal end" can be interpreted as "near end."

[0037] The present disclosure is not intended to be limiting. For example, the terms used in this application should be interpreted broadly in the context of the art to which they pertain. DESCRIPTION OF THE DISCLOSED EMBODIMENTS

[0038] The medical device can include various deployment stages for implantation within a patient's body. For example, the medical device can include an undeployed delivery configuration in which at least a portion of the medical device is contained within at least one restraint or sleeve that restrains the device for delivery into the patient's vasculature. When the device is delivered into the patient's vasculature, the restraint is removed to allow the device to deploy and expand complementary to the vasculature. For reference, when used in connection with a delivery sleeve, "detach" is synonymous with "release" and does not require physical removal from the body.

[0039] The delivery sleeve can be constructed from, for example, expanded polytetrafluoroethylene (expanded PTFE), polyester, fluoropolymers such as perfluoroelastomers, polytetrafluoroethylene, silicone, urethane, ultra-high molecular weight polyethylene, aramid fibers, and combinations thereof. Other examples of sleeve materials include high-strength polymer fibers such as ultra-high molecular weight polyethylene fibers or aramid fibers. The sleeve can include a bioactive agent. Any sleeve that can be used to constrain an endoluminal device is in accordance with the present disclosure.

[0040] For example, FIG. 1 illustrates a delivery system including a catheter 100 with a sleeve 102 according to some embodiments. As shown in FIG. 1 , the sleeve 102 can be a primary sleeve, such as a delivery sleeve 116, or a secondary sleeve, such as an auxiliary sleeve 118, as discussed further herein. The sleeve 102 is configured to cover and / or restrain a medical device 104 in a delivery configuration. The sleeve 102 includes a body 108 that is maintained in a tubular shape, the body 108 including opposing edges 110, 112 releasably secured to at least one fiber or deployment line 106. The body 108 can be formed from a sheet or layer of material that is rolled into a tubular shape (e.g., like a cigarette). For example, the opposing edges 110 and 112 can be defined by a first margin 110 extending along the sleeve 102 and a second margin 112 extending along the length of the sleeve 102. The sleeve 102 is configured to be disposed around the medical device 104 and can cover and / or maintain the medical device 104 in a delivery configuration. At a desired time, the sleeve 102 can be released by using the deployment line 106 to release the sleeve's edges 110, 112. The sleeve 102 can optionally be secured to the medical device 104 so that the sleeve 102 remains in the body after release. Alternatively, the sleeve 102, or a portion of the sleeve 102, can be detached. For example, a portion of the body 108 of the sleeve 102 can be secured (e.g., using sutures or fibers) to the medical device 104 so that the sleeve 102, along with the medical device 104, remains in the patient's body.

[0041] As shown, the sleeve 102 is arranged along the length and circumference of the medical device 104 so that at least a portion of the medical device 104 (e.g., part or all of its length) is covered and / or restrained for delivery. The deployment line 106 can be disposed within a lumen (not shown) of the catheter 100 and extend toward a proximal end of the catheter 100 that is disposed outside the patient's body during delivery of the medical device 104. The deployment line 106 includes a proximally extending portion 114, i.e., an end 114 at which a user can apply tension to release the sleeve 102 and deploy the medical device 104. The medical device 104 can be a stent, stent-graft, balloon, filter, heart valve, or similar device as desired.

[0042] While other configurations of the sleeve 102 can be used, a preferred configuration is a generally rectangular configuration having a constant width. However, tapered or stepped configurations, for example, are also contemplated. The sleeve 102 can be described as having side margins extending between opposite ends of the sleeve 102. Eyelets, which can also be described as openings or apertures, are optionally located along the side margins to allow for the tying or threading of connecting members, such as the deployment line 106. The eyelets can be in the form of through-holes and can be formed by a uniform diameter drilling tool or by other means, such as a laser drill. Alternatively, the eyelets can be formed by loops of material (e.g., fiber) that can be attached to the side margins or formed by other means.

[0043] The device 104 includes a delivery diameter and a deployed diameter that is larger than the delivery diameter. A removable sleeve 102 is attached to the device 104 at the delivery diameter. As described above, the removable sleeve includes a deployment line 106 configured to release the sleeve 102 and transition the medical device 104 from the delivery diameter to the deployed diameter in response to a force applied to the deployment line 106. The device 104 further includes an upstream proximal edge 1041 and a downstream distal edge 1042 that correspond to the upstream and downstream edges of the removable sleeve 102, as discussed further herein.

[0044] The medical device 104 can have any desired variety of deployed diameters (e.g., about 5 mm to about 15 mm, about 6 mm to about 9 mm, about 6 mm to about 12 mm, about 10 mm to about 20 mm, about 15 mm to about 30 mm, or about 25 mm to about 45 mm) and any desired delivery diameter that is less than the deployed diameter. For example, in some instances, the ratio of the delivery diameter of the medical device 104 to the deployed diameter of the device 104 is, e.g., less than about 0.3, less than about 0.29, less than about 0.28, less than about 0.27, or less than about 0.26. For reference, "diameter" is not intended to require a circular cross-section and is understood broadly to mean the largest cross-sectional dimension of the medical device 104.

[0045] 2A, in some embodiments, the medical device 104 includes both a primary or delivery sleeve 116 and a secondary or auxiliary sleeve 118. The use of multiple overlapping (partially or fully overlapping) sleeves (i.e., more than two) can allow the device to be deployable between multiple diameters (i.e., more than two). For example, the medical device 104 can be deployable from a delivery diameter to an intermediate deployed diameter and then to a final deployed diameter.

[0046] In some examples, the auxiliary sleeve 118 is configured to constrain the device 104 at the intermediate diameter during delivery, while the delivery sleeve 116 is configured to be positioned around the auxiliary sleeve 118 to constrain the device at the delivery diameter before delivery. In such embodiments, the delivery sleeve 116 must be deployed simultaneously with or before the auxiliary sleeve 118 is deployed. The delivery sleeve 116 can include a first deployment line segment 106a that allows a user to deploy the delivery sleeve 116. For example, actuation of the first deployment line segment 106a releases the device from the delivery diameter to the device's intermediate diameter.

[0047] 2A , the auxiliary sleeve 118 includes an upstream proximal edge 1181, a downstream distal edge 1182, and an intermediate region 1185 located between the proximal edge 1181 and the distal edge 1182. The second deployment line segment 106b of the auxiliary sleeve 118 allows a user to deploy the auxiliary sleeve 118. For example, actuating the second deployment line segment 106b releases the device 104 to an expanded diameter greater than the intermediate diameter. In some embodiments, the deployment line segments 106a, 106b comprise at least two separate lines that are separately actuated to effect deployment of the respective delivery sleeve 116 and auxiliary sleeve 118. In other embodiments, the deployment line segments 106a and 106b comprise a single deployment line 106 that can be actuated to deploy the delivery sleeve 116 and then further actuated to deploy the auxiliary sleeve 118. In any embodiment, the auxiliary sleeve 118 can be deployed immediately after the delivery sleeve 116 is deployed or a predetermined time after the delivery sleeve 116 is deployed. For example, the user may deploy the secondary sleeve 118 immediately after deploying the delivery sleeve 116. Alternatively, any amount of time may elapse between the deployment of the delivery sleeve 116 and the deployment of the secondary sleeve 118.

[0048] 2B, since the sleeve 1118 (FIG. 3B) generally covers the cylindrical instrument 104 (FIG. 1), one edge of the sleeve between the proximal edge 1181 (FIG. 2A) and the distal edge 1182 (FIG. 2A) can be designated a 0° region of the circumference of the cylindrical instrument, and the other edge of the sleeve between the proximal edge 1181 (FIG. 2A) and the distal edge 1182 (FIG. 2A) can be designated a 360° region of the circumference. Key "K1" is provided with each of the plan views of the sleeve discussed further herein to illustrate the angular regions of the sleeve through which the deployment line 106 (FIG. 1) passes, as described above.

[0049] Additionally, the deployment line 106 (FIG. 1) can travel at various angles from one fixed point to another. These angles are described herein and are distinct from the angular range designations of 0° to 360° around the circumference of a cylindrical instrument. A key "K2" is provided with each of the plan views of the sleeve discussed further herein to illustrate the angle of the route traveled by the deployment line, with each angle designated as an "A."

[0050] The proximal edge 1181 includes the designations 1P, 2P, 3P, 4P, 5P, 6P, 7P, 8P, and 9P to correspond with the proximal stent apexes. For example, as described herein, a stent apex can include the designation 1PX, where "1P" indicates the column of the apex on the proximal edge 1181 of the sleeve 1118 and "X" indicates the number of rows distal from the proximal edge 1181 in which the corresponding stent apex is found. Similarly, the distal edge 1182 includes the designations 1D, 2D, 3D, 4D, 5D, 6D, 7D, 8D, and 9D to correspond with the distal stent apexes. For example, as described herein, a stent apex can include the designation 1DX, where "1D" designates the column of the apex on the distal edge 1182 of the sleeve 1118 as labeled and "X" designates the number of rows proximal from the distal edge 1182 in which the corresponding stent apex is found.

[0051] The designation of each stent apex may also be interchangeably referred to as a "fixation point," and each fixation point or stent apex may or may not be used to secure a deployment line as further described herein. "Stent apex(s)" may also be used interchangeably with "fixation point(s)" or "reference point(s)," where each reference point refers to the point on the device 104 that corresponds to the fixation point and / or stent apex closest to the given designation. This reference point corresponds only to the device 104 shown. The route patterns presented herein can be applied to a variable number of devices having various sizes. In other words, the route patterns can be scaled to fit any device, and the designations herein refer to the reference point, fixation point, or stent apex that is closest to the designation after the pattern is scaled.

[0052] 3A-3B show a plan view of a sleeve 1118 (e.g., a delivery sleeve 116 or an auxiliary sleeve 118). As shown, the sleeve 1118 is optionally transparent to allow underlying features (e.g., the medical device 104) to be visible underneath the sleeve 1118. In some examples, the medical device 104 can include a radiopaque element 1049 to allow visualization of the medical device 104 when positioned within a patient. In other examples, the medical device 104 does not include a radiopaque element. In some examples, the medical device 104 can further include steering lines 1048, 1047 to facilitate bending and steering of the medical device 104 through the patient's vasculature. In other examples, the medical device 104 does not include steering lines 1048, 1047. Examples of suitable steering lines and steering line arrangements can be found in U.S. Patent No. 9,375,308 to Norris, issued June 28, 2016 to W.L. Gore & Associates, Inc.

[0053] The deployment line 106 forms a primary or first deployment line segment 1061 and a secondary or second deployment line segment 1062 ( FIG. 4 ). As shown in FIG. 3A , the first deployment line segment 1061 travels below the sleeve 1118 before deployment. For example, the first deployment line segment 1061 travels between the sleeve 1118 and the medical device 104 near the downstream edge 1182 of the sleeve 1118 between approximately the 160° region and the 200° region of the sleeve 1118 to a first anchor point (e.g., a first stent apex) 3P4 located proximal to the downstream edge 1182, below the first anchor point 3P4, and then to the beginning of the seam line 120 near a second anchor point 6D0 (e.g., a second stent apex) located distally at an angle between approximately A110° and A160° from the first anchor point 3P4, thereby initiating deployment in the 360° region of the sleeve 1118. When the first deployment line segment 1061 is actuated, the sleeve 1118 (e.g., corresponding to the delivery sleeve 116 or the auxiliary sleeve 118) is deployed generally proximally along the seam line 120 along a 360° region of the sleeve 1118. After deployment of the sleeve 1118 is complete, the first deployment line segment 1061 has completed deployment and changed position, as shown in FIG.

[0054] When the sleeve 1118 is deployed, at least a portion of the sleeve 1118 overhangs at least a portion of the proximal end 1041 of the medical device 104, which may block or obstruct blood flow in the patient. To allow effective and unobstructed blood flow through the patient and the medical device, the overhanging portion of the sleeve can be pulled, peeled, retracted, bunched, pleated, inverted, folded, translated, or otherwise moved back from the proximal end 1041 of the medical device 104, as described further herein.

[0055] 4A , the sleeve 1118 includes at least a first corner region 1183. In some instances, the sleeve 1118 further includes a second corner region 1184. The first corner region 1183 and the second corner region 1184 are each further formed upon deployment. The first corner region 1183 includes an opening 122 through which the second deployment line segment 1062 advances. The second deployment line segment 1062 then advances beneath a third anchor point (e.g., a third stent apex) 3P5 located proximally at an angle of approximately A200° to A250° from the first corner region 1183 between approximately the 160° and 200° regions of the sleeve 1118. This anchor point serves as the origin 128. In other instances, multiple origins can be utilized. In either embodiment, the origin 128 can be located at any fixed point corresponding to the intermediate region 1185 of the sleeve 1118 and can vary depending on the nature of the medical device 104, the diameter of the medical device 104, and other factors.

[0056] 4B discloses sleeve 2118 (e.g., corresponding to delivery sleeve 116 or auxiliary sleeve 118). The structure and function of sleeve 2118 are substantially similar to sleeve 1118. For example, in some embodiments, sleeve 2118 has a larger diameter than sleeve 1118. Similar elements of sleeve 2118 are identified by changing the initial "1" to a "2" in the corresponding reference numeral of sleeve 1118. As shown, origin 228 can be positioned at a third fixation point 4P5 (e.g., a third stent apex) between approximately the 140° region and approximately the 180° region of sleeve 2118, and first deployment line segment 2061 can initially pass below a first fixation point 3P4 positioned distally from third fixation point 4P5 between approximately the 180° region and approximately the 220° region of sleeve 2118. Although other route changes may be made, the substantial direction of the route pattern of the development lines 106, 206 may remain substantially the same.

[0057] 4A , after arriving at the fixed point 3P5 from the first corner region 1183, the second deployment line section 1062 travels below the third fixed point 3P5 and then travels to an opening 125 near the fixed point 3P8, which is positioned, e.g., proximally and generally longitudinally to the third fixed point 3P5, near the upstream edge 1181 of the sleeve 1118. The second deployment line section 1062 can then be attached to a tip attachment fiber 124. For example, in an example including a delivery sleeve 116 (also described as a primary sleeve in FIG. 2 ) and a secondary sleeve 118 (also described as a secondary sleeve), the sleeve 1118 can be either the delivery sleeve 116 or the secondary sleeve 118. In one example, when the sleeve 1118 is the secondary sleeve 118, the tip attachment fiber 124 can be attached to both the delivery sleeve 116 ( FIG. 2 ) and the secondary sleeve 118 to facilitate attachment of the secondary deployment line section 1062 to the delivery sleeve 116 ( FIG. 2 ).

[0058] In some embodiments, the second deployment line segment 1062 passes through a laterally located opening 125 between the openings 122, 126 that form the point of attachment to the tip attachment fiber 124, and returns distally to a third fixed point 3P5 positioned generally longitudinally of the point of attachment to the tip attachment fiber 124. The second line segment 1062 again passes below or past the third fixed point 3P5, and then passes proximally from the fixed point 3P5 to a second corner region 1184 located laterally from the first corner 1183. The second corner region 1184 includes a second opening 126 through which the second deployment line segment 1062 passes. The second deployment line segment 1062 then returns to the third fixed point 3P5 and passes below, past, or is slidably attached to the third fixed point 3P5. The second deployment line segment 1062 passes from the third fixation point 3P5 to and below a fourth fixation point 4P4 (e.g., the fourth stent apex), which is positioned distally from the third fixation point 3P5 between approximately the 110° and 160° regions of the sleeve 1118 and at an angle of approximately A200° to A250° from the third fixation point 3P5. The fourth fixation point acts as a friction point 130 to provide friction to the deployment line 106 to facilitate actuation of the deployment line 106. The friction point 130 helps prevent the deployment line 106 from slipping or becoming dislodged from its position before both the first deployment line segment 1061 and the second deployment line segment 1062 have been deployed. In the illustrated embodiment, only one friction point 130 is used, which helps prevent the medical device 104 from slipping when the deployment line 106 is actuated. However, in various examples, multiple friction points 130 may be utilized and positioned at various locations on the medical device 104 .

[0059] 5A-5C, when the deployment line 106 is actuated, after deployment of the first deployment line section 1061 and resulting deployment of the sleeve 1118, subsequent actuation of the second deployment line section 1062 moves (e.g., pulls, retracts, bunches, pleats, inverts, or folds) the sleeve 1118 according to the route pattern of the second deployment line section 1062. For example, after deployment of the first deployment line section 1061, actuation of the second deployment line section 1062 causes the first corner region 1183 to be pulled, peeled, retracted, bunched, pleated, inverts, folds, translated, or otherwise moved back from the proximal edge 1041 of the medical device 104, as shown in FIG. 5A, to gather toward the origin 128.

[0060] As the second deployment line segment 1062 continues to be actuated by actuation of the deployment line 106, the upstream proximal edge 1181 of the sleeve 1118 is pulled, peeled, retracted, bunched, pleated, inverted, folded, translated, or otherwise moved back from the proximal edge 1041 of the device 104 to converge toward the origin 128, as shown in FIG. 5B. In the embodiment described above having a delivery sleeve 116 (FIG. 2) and an auxiliary sleeve 118, if the sleeve 1118 is the auxiliary sleeve 118, the delivery sleeve 116 (FIG. 2) can also be pulled, peeled, retracted, bunched, pleated, inverted, folded, translated, or otherwise moved back from the proximal edge 1041 of the medical device 104 to converge toward the origin 128.

[0061] After actuating the upstream proximal edge 1181 of the sleeve 1118, when the second deployment line section 1062 is subsequently actuated by the deployment line 106, the second corner region 1184 is pulled, peeled back, retracted, bunched, pleated, inverted, folded, translated or pulled back from the proximal edge 1041 of the medical device 104 as shown in FIG. 5C to gather at the base point 128.

[0062] 6 , in some examples, after the corner regions 1183, 1184 and proximal edge 1181 of the sleeve 1118 are returned to the origin 128, the user can continue to apply tension to the second deployment line segment 1062. As tension continues to be applied, the deployment line 106 releases from the sleeve 1118 (and, optionally, any additional sleeves, such as the delivery sleeve 116) and from the anchor point 3P5 or other anchor point located at the origin 128, and can then be retracted or withdrawn through the catheter 100 ( FIG. 1 ). In other examples, the deployment line 106 may not release from the sleeve 1118, other sleeves, and / or the origin 128.

[0063] In some instances, after full deployment and removal of the deployment line 106, the entire proximal end 1041 of the medical device 104 is unobstructed by the sleeve overhang, as described above. However, in other embodiments, it may be more difficult or nearly impossible to ensure that the entire proximal end 1041 of the medical device 104 is unobstructed. For example, FIG. 7A illustrates the aortic arch 2 within which the medical device 104 (FIGS. 1-6) may be deployed. FIG. 7B illustrates a cross-sectional view of the ascending aorta of FIG. 7A, with the patient's anterior to the left and the patient's posterior to the right. The shaded region C of the cross-sectional view is the coronary region, and the non-shaded region NC of the cross-sectional view is referred to as the non-coronary region. If the medical device 104 (FIGS. 1-6) were to be deployed within the aortic arch 2, at least the coronary region would be unobstructed upon full deployment of the medical device 104 (FIGS. 1-6) and actuation of the deployment line 106 (FIGS. 1-6). Thus, in various embodiments, the medical device 104 and sleeve 1118 are configured such that when the sleeve 1118 is pulled, retracted, bunched, pleated, inverted, folded, or otherwise moved away from the end of the medical device 104, preferably the entire device, or at least a coronal region thereof, is not obstructed after full deployment of the medical device, as described in detail above with reference to Figures 5A-C.

[0064] The foregoing examples are merely examples and should not be construed as limiting or narrowing the scope of any of the inventive concepts presented in this disclosure. While multiple examples are disclosed, other and further embodiments will become apparent to those skilled in the art upon reading the detailed description setting forth illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative and not restrictive. (Aspect) (Aspect 1) A delivery system comprising: a delivery sleeve releasably secured to a tubular shape configured to constrain a medical device in a delivery configuration, the delivery sleeve having a predetermined length, an upstream edge, a downstream edge, an intermediate region between the upstream and downstream edges, a first margin extending along the length of the delivery sleeve, a second margin extending along the length of the delivery sleeve, and a first corner region adjacent the upstream edge; a first deployment line segment releasably joining the first and second margins of the delivery sleeve such that the delivery sleeve is releasably secured in a tubular shape; a second deployment line segment fixed to the first corner region and extending from the first corner region to a first fixed point in the intermediate region, the second deployment line segment configured such that upon actuation of the second deployment line segment, at least a portion of the upstream edge translates toward the intermediate region; and A delivery system comprising: (Aspect 2) 2. The delivery system of embodiment 1, wherein the second deployment line segment extends from the first deployment line segment. (Aspect 3) the delivery sleeve having a second corner region adjacent the upstream edge; the second deployment line segment is fixed to the second corner region and advances to the first fixed point of the intermediate region, and the second deployment line segment is configured such that upon actuation of the second deployment line segment, both of the corner regions translate toward the intermediate region. 3. The delivery system of embodiment 1 or 2. (Aspect 4) Aspect 4. The delivery system of any one of aspects 1-3, wherein the second deployment line segment travels on an outer surface of the delivery sleeve. (Aspect 5) A delivery system according to any one of aspects 1 to 4, wherein the first corner region includes an opening, and the second deployment line section passes through the opening to secure the second deployment line section to the first corner region. (Aspect 6)

[0022] A delivery system according to any one of the preceding aspects, wherein the deployment system comprises an auxiliary sleeve. (Aspect 7) 7. The delivery system of claim 6, wherein the auxiliary sleeve is disposed around the medical device and the delivery sleeve. (Aspect 8) A delivery system comprising: a delivery sleeve configured to constrain a medical device in a delivery configuration, the delivery sleeve having a length, an upstream edge, a downstream edge, an intermediate region, and a first corner region; a first deployment line segment extending along the length of the delivery sleeve from the downstream edge to the upstream edge for releasably coupling the delivery sleeve to a tubular shape; a second development line segment extending from the first development line segment, the second development line segment being connected to the first corner region, extending from the first corner region to the intermediate region, and secured to a first securing point at the intermediate region; A delivery system comprising: (Aspect 9) A delivery system as described in aspect 8, wherein the second deployment line section is configured such that, upon actuation of the second deployment line section, the first corner region translates back toward the intermediate region. (Aspect 10) A delivery system according to aspect 8 or 9, wherein the first deployment line segment and the second deployment line segment are releasable from the delivery sleeve. (Aspect 11) the delivery sleeve having a second corner region; the second development line section is coupled to the second corner region, extends from the second corner region to the intermediate region, and is fixed to the first fixing point; the second deployment line segment is configured such that, upon actuation of the second deployment line segment, the first corner region and the second corner region translate back toward the intermediate region. A delivery system according to any one of aspects 8 to 10. (Aspect 12) 1. A method of actuating a delivery sleeve of a delivery system, the method comprising: positioning the delivery sleeve at a desired location, the delivery sleeve being part of a delivery system including a medical device with which the delivery sleeve is associated, the delivery sleeve having an upstream edge, a downstream edge, a mid-region, and at least one corner, a first deployment line segment attached to the delivery sleeve, and a second deployment line segment attached to the at least one corner and passing through the mid-region; applying tension to the first deployment line segment such that the first deployment line segment actuates the delivery sleeve to effect delivery of the medical device; applying tension to the second deployment line section such that the second deployment line section translates the at least one corner back toward the intermediate region; A method comprising: (Aspect 13) 13. The method of embodiment 12, wherein the first and second deployment line segments are portions of a single deployment line. (Aspect 14) A method according to any one of aspects 12 and 13, further comprising applying tension to the second deployment line section so that the first deployment line section and the second deployment line section are released from the delivery sleeve. (Aspect 15) 1. A method of delivering a medical device, said method comprising: positioning a delivery system at a desired location within a patient, the delivery system including: a delivery sleeve associated with a medical device, the delivery sleeve having an upstream edge, a downstream edge, a middle region, and at least one corner; an auxiliary sleeve positioned around the medical device and the delivery sleeve, the auxiliary sleeve having an upstream edge; and a deployment line including a first deployment line segment secured to the first delivery sleeve and a second deployment line segment coupled to the auxiliary sleeve and attached to the at least one corner of the delivery sleeve and passing through the middle region of the delivery sleeve; releasing the auxiliary sleeve from around the medical device and the delivery sleeve; applying tension to the first deployment line section to release the delivery sleeve; applying tension to the second deployment line segment to translate the upstream edge of each of the first delivery sleeve and the second delivery sleeve toward the intermediate region of the first delivery sleeve; A method comprising: (Aspect 16) 16. The method of embodiment 15, wherein the delivery system is coupled to a catheter. (Aspect 17) A method as described in aspect 16, wherein the method further includes applying tension to the second deployment line segment so that the first deployment line segment and the second deployment line segment are released from the delivery sleeve and the auxiliary sleeve into the catheter.

Claims

1. a delivery sleeve associated with the medical device and having an upstream edge, a downstream edge, an intermediate region, a first corner region proximate the upstream edge, and a second corner region proximate the upstream edge; an auxiliary sleeve positioned around the medical device and between the medical device and the delivery sleeve, the auxiliary sleeve having an upstream edge; a deployment line including a first deployment line segment coupled to the delivery sleeve and a second deployment line segment coupled to the auxiliary sleeve and attached to the first corner region of the delivery sleeve and passing through the intermediate region of the delivery sleeve; Including, applying tension to the first deployment line section releases the delivery sleeve from an annular shape; and applying tension to the second deployment line section translates the upstream edge of each of the delivery sleeve and the auxiliary sleeve toward the intermediate region of the delivery sleeve; the first deployment line segment extends along a length of the delivery sleeve between the upstream edge and the downstream edge and releasably secures the delivery sleeve in the annular shape; The second deployment line segment is secured to the second corner region and extends to a first securing point at the intermediate region of the delivery sleeve.

2. The delivery system of claim 1 further comprising a catheter.

3. The delivery system of claim 2 , wherein applying tension to the second deployment line segment releases the first and second deployment line segments from the delivery sleeve and the auxiliary sleeve into the catheter.

4. The delivery system of claim 1 , wherein the second deployment line segment extends from the first deployment line segment.

5. A delivery system as described in claim 1, wherein the second deployment line segment is configured such that activation of the second deployment line segment causes both of the corner regions to translate toward the intermediate region.

6. The delivery system of claim 1 , wherein the second deployment line section travels outside the delivery sleeve.

7. The delivery system of claim 1 , wherein the first corner region includes an opening through which the second deployment line section passes to secure the second deployment line section to the first corner region.

8. a delivery sleeve configured to restrain a medical device in a delivery configuration, the delivery sleeve having a length, an upstream edge, a downstream edge, an intermediate region, and a first corner region proximate the upstream edge; a first deployment line segment extending along the length of the delivery sleeve from the downstream edge to the upstream edge to releasably couple the delivery sleeve in a tubular configuration; a second deployment line section extending from the first deployment line section, the second deployment line section being coupled to the first corner region, progressing from the first corner region to the intermediate region, being secured to the intermediate region at a first securing point, and progressing from the first securing point to a second securing point proximate the upstream edge of the delivery sleeve; A delivery system comprising:

9. The delivery system of claim 8, wherein the second deployment line section is configured such that actuation of the second deployment line section causes the first corner region and the upstream edge of the delivery sleeve to translate back toward the intermediate region.

10. The delivery system of claim 8 , wherein the first and second deployment line segments are releasable from the delivery sleeve.

11. The delivery system of claim 8 , wherein the second deployment line segment extends from the second anchor point to the first anchor point and is anchored at the first anchor point.

12. the delivery sleeve has a second corner region; the second development line section is connected to the second corner region and extends from the second corner region to the intermediate region and is fixed at the first fixing point; The delivery system of claim 11, wherein the second deployment line section is configured such that actuation of the second deployment line section causes the first corner region, the second corner region, and the upstream edge of the delivery sleeve to translate back toward the intermediate region.

13. The delivery system of claim 8 further comprising a secondary sleeve.

14. The delivery system of claim 13 , wherein the delivery sleeve is positioned around the medical device and the auxiliary sleeve.

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