Sleeve pullback mechanism

Abstract

Through observation, it has been determined that deployment of the delivery sleeve can cause one or more portions of the delivery sleeve to extend beyond one end of the endoluminal device, resulting in material overhang. The overhang can affect blood flow through the endoluminal prosthesis or otherwise affect performance, including promoting unwanted tissue growth. Various inventive concepts are provided to address (reduce or remove) overhang of the restraining sheath.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to medical device deployment systems or other delivery systems including an endoluminal device having a delivery sleeve, and more particularly to medical device deployment systems configured to reduce overhang of the delivery sleeve upon deployment of the endoluminal device. BACKGROUND

[0002] Endoluminal devices are often used to treat the vasculature of human patients. It is known to utilize a flexible sleeve to constrain a device toward a peripheral size or delivery configuration suitable for endoluminal delivery toward a treatment site of a blood vessel. It can be desirable to at least partially retract such a sleeve, for example configured to maintain the sleeve in place after deployment of an underlying endoluminal device, for example to prevent inadvertent occlusion of a branch vessel by the sleeve. A clinician can not be able to rely entirely on traditional imaging techniques to avoid such inadvertent occlusion, because primarily (i) such imaging techniques can not be able to detect the sleeve itself, (ii) the sleeve can not contain radiopaque markers, and (iii) radiopaque bands or other markers on the endoluminal device can not necessarily correlate to the end of the sleeve.

[0003] U.S. Patent 10219929, entitled “Sleeve Retraction System,” issued March 5, 2019, describes a system for an endoluminal device that utilizes a sleeve to constrain an expandable device toward a constrained configuration suitable for endoluminal delivery along a vasculature toward a treatment site, and a mechanism for retracting at least a portion of the sleeve. SUMMARY

[0004] By observation, it has been determined that deployment of a delivery sleeve can result in one or more portions of the delivery sleeve extending beyond an end of the endoluminal device, resulting in overhang of material. The overhang can affect blood flow through the endoluminal prosthesis or otherwise affect performance, including promoting unwanted tissue growth. Various inventive concepts are provided to address (reduce or remove) overhang of the constraining sheath.

[0005] According to one example of the present disclosure (“Example 1”), a delivery system is disclosed. The delivery system includes a delivery sleeve releasably secured into a tubular shape, the delivery sleeve configured to constrain a medical device in a delivery configuration. The delivery sleeve has a length, an upstream edge, a downstream edge, a middle region between the upstream edge and the downstream edge, a first rim extending along the length of the delivery sleeve, a second rim extending along the length of the delivery sleeve, and a first corner region proximate the upstream edge. The delivery system further includes a first deployment line segment and a second deployment line segment, the first deployment line segment releasably coupling the first rim and the second rim of the delivery sleeve such that the delivery sleeve is releasably secured into the tubular shape, and the second deployment line segment is anchored to and directed from the first corner region to a first anchor point at the middle region. The second deployment line segment is configured such that upon actuation of the second deployment line segment, a last portion of the upstream edge translates toward the middle region.

[0006] With reference 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 anchored to the second corner region and directed to the first anchor point at the middle region, wherein the second deployment line segment is configured such that upon actuation of the second deployment line segment, both corner regions translate toward the middle region. The second deployment line segment can be directed external to the delivery sleeve.

[0007] Still with reference to Example 1, the first corner region can include a hole through which the second deployment line segment is directed to anchor the second deployment line segment to the first corner region. The deployment system can include a secondary sleeve. Where the deployment system includes the secondary sleeve, the secondary sleeve can be positioned around the medical device and the delivery sleeve.

[0008] According to another example of the present disclosure (“Example 2”), a delivery system is disclosed. The delivery system includes a delivery sleeve configured to constrain a medical device in a delivery configuration. The delivery sleeve has a length, an upstream edge, a downstream edge, a middle region, and a first corner region. The delivery system further includes a first deployment line segment and a second deployment line segment, the 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, and the second deployment line segment is coupled from the first deployment line segment. The second deployment line segment is coupled to the first corner region and directed from the first corner region to the middle region and anchored at a first anchor point at the middle region.

[0009] With reference to Example 2, the second deployment line segment can be configured such that upon actuation of the second deployment line segment, the first corner region moves back (translates back) toward the middle region. The first deployment line segment and the second deployment line segment can be released 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 segment can be coupled to and directed from the second corner region to the intermediate region and anchored at the first anchor point, where 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 move back (translate back) toward the intermediate region.

[0011] According to yet another example of the disclosure (“Example 3”), a method for actuating a delivery sleeve of a delivery system is disclosed. The method includes positioning the delivery sleeve at a desired location. The delivery sleeve forms a portion of the delivery system, which includes a medical device associated with the delivery sleeve, where the delivery sleeve has an upstream edge, a downstream edge, an intermediate 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 directed through the intermediate 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 moves the at least one corner back toward the intermediate region.

[0012] Referring to Example 3, the first deployment line segment and the second deployment line segment can be portions of a single deployment line. The method can further include the step of applying tension to the second deployment line segment to cause the first deployment line segment and the second deployment line segment to release from the delivery sleeve.

[0013] According to yet another example of the disclosure (“Example 3”), a method for actuating a delivery sleeve of a delivery system is disclosed. The method includes positioning the delivery sleeve at a desired location. The delivery sleeve forms a portion of the delivery system, which includes a medical device associated with the delivery sleeve, where the delivery sleeve has an upstream edge, a downstream edge, an intermediate 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 directed through the intermediate 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 moves the at least one corner back toward the intermediate region.

[0014] The method of Example 4 further includes releasing the secondary 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 edge of each of the first delivery sleeve and the second delivery sleeve toward the intermediate region of the first delivery sleeve.

[0015] Referring again to Example 4, the delivery system may be coupled to the catheter. In such an example, the method may further include applying tension to the second unfolding section, such that the first and second unfolding sections are released from the delivery sleeve and the auxiliary sleeve into the catheter. Attached Figure Description

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

[0017] Figure 1 A catheter according to some embodiments is shown, the catheter including at least one sleeve configured to restrain a medical device;

[0018] Figure 2A A catheter according to some embodiments is shown, the catheter comprising at least two sleeves configured to restrain a medical device;

[0019] Figure 2B The degree markings of the cylindrical device are shown;

[0020] Figure 3A A sleeve having a first unfolding line segment guide pattern before unfolding is shown according to some embodiments;

[0021] Figure 3B The following is illustrated according to some embodiments: after unfolding, it has Figure 3B The sleeve of the first unfolded line section guiding the pattern;

[0022] Figure 4A A sleeve with a second unfolded line segment guide pattern is shown according to some embodiments;

[0023] Figure 4B Another sleeve with a second unfolded line segment guide pattern is shown according to some embodiments;

[0024] Figure 5A It shows in Figure 4A The first structure of the sleeve during the actuation period of the second unfolding section;

[0025] Figure 5B This shows the continuous actuation period in the second unfolding section. Figure 5A The second construction of the sleeve;

[0026] Figure 5C This shows the continuous actuation period in the second unfolding section. Figure 5B The third construction of the sleeve;

[0027] Figure 6 Another configuration of the sleeve is shown according to some embodiments after the unfolded lines have been removed from the sleeve;

[0028] Figure 7A The aortic arch of a patient is shown, including the ascending portion of the aorta and the descending portion of the aorta; and

[0029] Figure 7B is a diagrammatic anatomical view of a patient's aorta, showing a coronal region and a non-coronal region of the aortic cross-section. DETAILED DESCRIPTION

[0030] Those skilled in the art will readily understand that the various aspects of the present disclosure can be implemented by any number of methods and devices constructed to perform the intended functions. It should also be noted that the figures referred to herein are not necessarily drawn to scale, but that certain aspects of the present disclosure can be shown exaggerated or enlarged to facilitate an understanding of such aspects, and as such, the figures should not be considered to limiting in nature.

[0031] Definitions and Terminology

[0032] With respect to inexact terms, the terms "about" and "approximately" can be used interchangeably to refer to a measurement that includes the stated measurement value and also includes any measurement value that is reasonably (substantially) close to the stated measurement value. As understood and readily determined by one of ordinary skill in the relevant art, a measurement value that is reasonably close to the stated measurement value deviates from the stated measurement value by an amount that is reasonably small. Such a deviation can be attributable to, for example, measurement error, differences in measurement values and / or manufacturing equipment calibration, human error in reading and / or setting measurement values, adjustments made to optimize performance and / or structural parameters taking into account differences in measurement values related to other components, particular implementation scenarios, imprecise adjustments and / or manipulations of objects by humans or machines, and / or the like. In instances where it is determined that one of ordinary skill in the relevant art would not readily determine such a reasonably small difference value, then the terms "about" and "approximately" can be understood to be the stated value plus or minus 10%.

[0033] Endoluminal devices are often used to treat the vasculature of human patients. These treatments or procedures are often referred to as endoluminal or intravascular procedures (surgery). Such devices often include a sleeve. As used herein, the term "sleeve" refers to a primary sleeve, a secondary sleeve, a tertiary sleeve, a primary sheath, a secondary sheath, a tertiary sheath, and the like, which constrains an endoluminal device toward a collapsed configuration or peripheral dimension suitable for endoluminal delivery of the device to a treatment portion of a patient's vasculature.

[0034] For purposes of this disclosure, the term "constrained" can mean (i) limiting the expansion of the diameter of at least a portion of a medical device by self-expansion or with the aid of a device (e.g., a capsule / sac), or (ii) covering or surrounding a medical device without otherwise limiting at least a portion of the medical device (e.g., for storage or biocompatibility reasons and / or to provide protection to the medical device and / or vasculature). By way of reference, the term "diameter" does not imply a requirement for a circular cross-section, but is broadly understood to refer to the dimension of the largest lateral cross-section of the medical device.

[0035] As used herein, the term "endoluminal device" or "device" refers to stents, grafts, filters, valves, anchors, occlusions, and other implantable devices, and also includes all of the foregoing constrained in one or more sleeves.

[0036] As used herein, the term "wire" refers to any type of cord, string, thread, fiber, or wire, and can be composed of metals, polymers, or natural materials, including traditional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethyl methacrylate, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric silicone polymers; metals such as stainless steel, cobalt-chrome alloy, and nitinol; and high-strength polymeric fibers such as ultra-high molecular weight polyethylene fibers or aramid fibers.

[0037] Throughout this specification and claims, the terms "distal" or "forward" can refer to the relative position on a device closer to the end of the device that is inserted into and travels through the patient's vasculature. The terms "proximal" or "rear (aft)" refer to the relative position on a device closer to the end of the device that is outside the patient's vasculature. In related terminology, the term "distal end" can be interpreted as "distal end," and "proximal end" can be interpreted as "proximal end."

[0038] The present disclosure is not intended to be read in a limiting sense. For example, the terms used in this application should be read broadly as would be understood by one of ordinary skill in the art to whom this type of terminology would be meaningfully attributed. DETAILED DESCRIPTION

[0040] A medical device can include different stages of deployment for implantation into a patient. For example, a medical device can include an undeployed delivery configuration in which at least a portion of the medical device is contained within at least one constraining member or sleeve that constrains the device for delivery into the vasculature of a patient. When the device has been delivered into the vasculature of a patient, the constraint is removed, allowing the device to deploy and expand in a manner complementary to the vasculature. By way of reference, the term "removed" used in relation to a delivery sleeve is synonymous with "released," and does not require physical removal from the body.

[0041] The delivery sleeve can be constructed of, for example, expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane (polyurethane), fluoropolymers such as perfluoroelastomers, polytetrafluoroethylene, silicone, polyurethane, ultra-high molecular weight polyethylene, aramid fibers, and combinations thereof. Other examples of sleeve materials can include high-strength polymeric 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 a device within a cavity is consistent with the present disclosure.

[0042] For example, referring to Figure 1 , a delivery system including a catheter 100 having a sleeve 102 is shown in accordance with some embodiments. As shown in Figure 1 , the sleeve 102 can be a primary sleeve such as a delivery sleeve 116, or a secondary sleeve such as a secondary sleeve 118, as discussed further herein. The sleeve 102 is configured to cover and / or constrain the medical device 104 into a delivery configuration. The sleeve 102 includes a body 108 held in a tubular shape, where the body 108 includes opposing edges 110, 112 that are releasably secured together with at least one fiber or deployment line 106. The body 108 can be formed from a sheet or layer of material wrapped into a tubular shape (e.g., a cigarette wrap). For example, the opposing edge 110 and the opposing edge 112 can be defined by a first edge 110 extending along a length of the sleeve 102 and a second edge 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 hold the medical device 104 in a delivery configuration. At a desired time, the sleeve 102 can be released by releasing the opposing edges 110, 112 of the sleeve using the deployment line 106. The sleeve 102 is optionally secured to the medical device 104 such that the sleeve 102 remains in the body after release; in other cases, the sleeve 102 or a portion of the sleeve 102 can be removed. For example, a portion of the body 108 of the sleeve 102 can be secured to the medical device 104 (e.g., using a suture or fiber) such that the sleeve 102 remains in the patient’s body with the medical device 104.

[0043] As shown, the sleeve 102 is disposed along a length of the medical device 104 and circumferentially around the medical device 104 such that at least a portion of the medical device 104 (e.g., some or all of its length) is covered and / or constrained for delivery. A deployment line 106 can be disposed within a lumen (not shown) of the catheter 100 and extends toward a proximal end of the catheter 100 disposed outside of the patient during delivery of the medical device 104. The deployment line 106 includes a proximally extending portion or end 114 to which a user can apply tension to release the sleeve 102 and deploy the implantable medical device 104. The medical device 104 can be a stent, a stent graft, a balloon, a filter, a heart valve, or a similar device as desired.

[0044] While other configurations of the sleeve 102 can be used, a preferred configuration is a generally rectangular configuration having a constant width, although tapered or stepped configurations are contemplated, for example. The sleeve 102 can be described as having a side edge extending between ends of the sleeve 102. Eyelets, which are also described as openings or holes, are optionally disposed along the side edge such that a coupling member, such as the deployment line 106, can be tied (interwoven) or threaded through the eyelets. The eyelets can be in the form of through-holes that can be formed by a uniform diameter puncture device, or can be formed by other means, such as laser drilling. Alternatively, the eyelets can be formed by or through other means from a material (e.g., fiber) loop that can be attached to the side edge.

[0045] The device 104 includes a delivery diameter and a deployed diameter that is larger than the delivery diameter. The removable sleeve 102 is attached to the device 104 in its delivery diameter. As described above, the removable sleeve illustratively includes a deployment line 106 that is 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 also includes an upstream proximal edge 1041 and a downstream distal edge 1042 that correspond to upstream and downstream edges of the removable sleeve 102, which are discussed further herein.

[0046] The medical device 104 can have any of a variety of desired deployed diameters (e.g., from 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), as well as any desired delivery diameter that is smaller than the deployed diameter. For example, in some cases, the ratio of the delivery diameter of the medical device 104 to the deployed diameter of the device 104 is 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 example. By way of reference, the term "diameter" is not meant to require a circular cross-section, but is broadly understood to refer to the largest spanning cross-sectional dimension of the medical device 104.

[0047] Referring now to Figure 2A In some embodiments, the medical device 104 includes a primary or delivery sleeve 116 and a secondary or auxiliary sleeve 118. The use of multiple overlapping (partially overlapping or fully overlapping) sleeves (i.e., more than two) can allow the device to be deployed between multiple (i.e., more than two) diameters. For example, the medical device 104 can be deployed from a delivery diameter to an intermediate deployed diameter and then to a final deployed diameter.

[0048] In some cases, the auxiliary sleeve 118 is configured to constrain the device 104 at an intermediate diameter during delivery, while the delivery sleeve 116 is configured to be positioned around the auxiliary sleeve 118 to constrain the device to a delivery diameter prior to delivery. In such embodiments, the delivery sleeve 116 must be deployed at the same time or prior to the auxiliary sleeve 118 can be 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 causes the device to release from the delivery diameter to an intermediate diameter of the device.

[0049] Still referring to Figure 2A The auxiliary sleeve 118 includes an upstream proximal edge 1181, a downstream distal edge 1182, and an intermediate region 1185 between the proximal edge 1181 and the distal edge 1182. A second deployment line segment 106b of the auxiliary sleeve 118 allows a user to deploy the auxiliary sleeve 118. For example, actuation of the second deployment line segment 106b causes the device 104 to release to an expanded diameter that is larger than the intermediate diameter. In some embodiments, the deployment line segments 106a, 106b include at least two separate lines that are independently actuated to effect deployment of the respective delivery sleeve 116 and auxiliary sleeve 118. In other embodiments, the deployment line segments 106a and 106b include 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 either embodiment, the auxiliary sleeve 118 can be deployed immediately after the delivery sleeve 116 is deployed, or after a period of time after the delivery sleeve 116 is deployed. For example, the user can immediately deploy the auxiliary sleeve 118 after the delivery sleeve 116 is deployed. In other cases, a self-determined period of time can pass between deployment of the delivery sleeve 116 and deployment of the auxiliary sleeve 118.

[0050] Briefly referring to Figure 2B It should be noted that the sleeve 1118( Figure 3A ) substantially covers the cylindrical device 104( Figure 1 ), such that one edge of the sleeve is at the proximal edge 1181( Figure 2A ) and the distal edge 1182( Figure 2Aindicated at the 0° region of the circumference of the cylindrical device, and the other edge of the sleeve is indicated at the 360° region of the circumference between the proximal edge 1181 Figure 2A and the distal edge 1182 Figure 2A . The symbol “K1” is provided with each plan view of the sleeve discussed further herein to illustrate the degree region of the sleeve through which the deployment line 106 Figure 1 is directed as described above.

[0051] Further, the deployment line 106 Figure 1 is capable of being directed at different angles from one anchor point to another. These angles are referenced herein and are indicated in degrees of the circumference of the cylindrical device, which is different from 0°-360°. The symbol “K2” is provided with each plan view of the sleeve discussed further herein to illustrate the angle at which the deployment line is directed, the degrees of each angle being indicated with “A”. Figure 1

[0052] The proximal edge 1181 includes the designations 1P, 2P, 3P, 4P, 5P, 6P, 7P, 8P, and 9P to correspond to proximal stent vertices. For example, as described herein, a stent vertex can include the designation 1PX, where “1P” indicates the column of apices on the proximal edge 1181 of the sleeve 1118 as labeled, and “X” indicates the number of rows distal to the proximal edge 1181 in which the corresponding stent vertex can be found. Similarly, the distal edge 1182 includes the designations 1D, 2D, 3D, 4D, 5D, 6D, 7D, 8D, and 9D to correspond to distal stent apices. For example, as described herein, a stent vertex can include the designation 1DX, where “1D” indicates the column of apices on the distal edge 1182 of the sleeve 1118 as labeled, and “X” indicates the number of rows proximal to the distal edge 1182 in which the corresponding stent vertex can be found.

[0053] The designation of each stent vertex can further be interchangeably referred to as an “anchor point,” where each anchor point or stent vertex can or can not be used to anchor a deployment line, as described further herein. “The stent vertex” or “the stent vertices” can be used interchangeably with “the anchor point” or “the anchor points” or can also be used interchangeably with “the reference point” or “the reference points,” where each reference point refers to a point on the device 104 that corresponds to the anchor point and / or stent vertex closest to a given designation. Notably, such reference points correspond only to the device 104 shown. The guide patterns (travel patterns) provided herein can be applied to different numbers of devices having different sizes. In other words, the guide patterns can be scaled to be applied to any device, where the designations referenced herein refer to the reference points, anchor points, or stent vertices positioned closest to the designations after the pattern is scaled. ​

[0054] Referring now to Figure 3A-3B , a plan view of the sleeve 1118 (e.g., delivery sleeve 116 or auxiliary sleeve 118) is shown. As shown, the sleeve 1118 is optionally transparent such that the underlying feature (e.g., medical device 104) can be seen underneath the sleeve 1118. In some cases, the medical device 104 can include a radiopaque element 1049 for visibility of the medical device 104 when positioned within a patient. In other cases, the medical device 104 can not include a radiopaque element. In some cases, the medical device 104 can also include steering lines 1048, 1047 to facilitate bending and steering of the medical device 104 through a patient’s vasculature. In other cases, the medical device 104 can not include steering lines 1048, 1047. Examples of suitable steering lines and steering line arrangements can be found in U.S. Patent 9,375,308 to W. L. Gore & Associates, Inc., issued June 28, 2016.

[0055] The deployment line 106 defines a primary deployment line or first deployment line segment 1061 and a secondary deployment line or second deployment line segment 1062 (FIG. 4). As Figure 3A shown, the first deployment line segment 1061 is directed (travels) underneath the sleeve 1118 prior to deployment. For example, the first deployment line segment 1061 can be directed between the sleeve 1118 and the medical device 104 from near the downstream edge 1182 of the sleeve 1118 to a first anchor point (e.g., first stent apex) 3P4 positioned proximal to the downstream edge 1182 between about 160° and about 200° of the sleeve 1118, directed under the first anchor point 3P4, and then to a start point of the seam line 120 near the second anchor point 6D0 (e.g., second stent apex) positioned distally from the first anchor point 3P4 at an angle between about A110° and about A160° to begin deployment in the 360° 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 auxiliary sleeve 118) deploys in a proximal direction along the seam line 120 along the 360° of the sleeve 1118. After completion of the deployment of the sleeve 1118, the first deployment line segment 1061 has completed deployment and has changed position as Figure 3B shown.

[0056] After the deployment of the sleeve 1118, at least a portion of the sleeve 1118 can overhang at least a portion of the proximal end 1041 of the medical device 104, which in turn can obstruct or impede blood flow within the patient. To ensure efficient and unobstructed blood flow through the patient and the medical device, the overhanging portion of the sleeve can be pulled, peeled (shed / peeled away), retracted, bunched (tightened / creased), pleated, flipped, folded, translated, or otherwise moved back from the proximal end 1041 of the medical device 104, as further described herein.

[0057] Reference is now made to Figure 4A The sleeve 1118 includes at least a first corner region 1183. In some cases, the sleeve 1118 also includes a second corner region 1184. Each of the first corner region 1183 and the second corner region 1184 becomes further defined upon deployment. The first corner region 1183 includes an aperture 122 through which the second deployment line segment 1062 is directed. The second deployment line segment 1062 is then directed under a third anchor point 3P5 (e.g., a third stent vertex) that is positioned proximally from the first corner region 1183 at an angle between about A200° and about A250° between about 160° region and about 200° region of the sleeve 1118, which serves as a base point 128. In other cases, multiple base points can be used. In any embodiment, the base point 128 can be positioned at any anchor point corresponding to the middle 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.

[0058] For example, as shown in comparison Figure 4B A sleeve 2118 (e.g., corresponding to the delivery sleeve 116 or the auxiliary sleeve 118) is disclosed. The structure and function of the sleeve 2118 are substantially the same as the structure and function of the sleeve 1118. For example, in some examples, the sleeve 2118 has a larger diameter than the sleeve 1118. Like elements of the sleeve 2118 are identified by changing the “1” preceding the corresponding reference number of the sleeve 1118 to a “2”. As shown, the base point 228 can be positioned at a third anchor point 4P5 (e.g., a third stent vertex) between about 140° region and about 180° region of the sleeve 2118, while the first deployment line segment 2061 can initially be directed under a first anchor point 3P4 that is positioned distally from the third anchor point 4P5 between about 180° region and about 220° region of the sleeve 2118. Other directing (traveling) variations can be made, while the basic direction of the directing pattern (traveling pattern) of the deployment lines 106, 206 can be substantially the same.

[0059] Reference is again made to Figure 4AAfter reaching anchor point 3P5 from first corner region 1183, second deployment line segment 1062 is directed below third anchor point 3P5 and then directed up to about the upstream edge 1181 of sleeve 1118, for example to hole 125 about anchor point 3P8, which is proximal to third anchor point 3P5 and positioned generally longitudinally. Second deployment line segment 1062 can then be attached to front attachment fiber 124. For example, in cases including a delivery sleeve 116 (FIG. 2, also referred to as a primary sleeve) and a secondary sleeve 118 (also referred to as a secondary sleeve), sleeve 1118 can be either delivery sleeve 116 or secondary sleeve 118. In an example, sleeve 1118 is secondary sleeve 118, and front attachment fiber 124 can be attached to both delivery sleeve 116 (FIG. 2) and secondary sleeve 118 to facilitate attachment of second deployment line segment 1062 to delivery sleeve 116 (FIG. 2).

[0060] In various examples, second deployment line segment 1062 is directed through hole 125, which is positioned laterally between holes 122, 126, defining a coupling point with front attachment fiber 124 (relative to front attachment fiber 124), to third anchor point 3P5, which is positioned distal to the coupling point with front attachment fiber 124 (relative to front attachment fiber 124) and generally longitudinally. Second line portion 1062 is again directed below or through third anchor point 3P5 and then directed to second corner region 1184, which is positioned proximally from anchor point 3P5 and laterally from first corner 1183. Second corner region 1184 includes second hole 126 through which second deployment line segment 1062 is directed. Second deployment line segment 1062 is then directed back to and below, through, or otherwise slidably anchored at third anchor point 3P5. Second deployment line segment 1062 is directed from third anchor point 3P5 to fourth anchor point 4P4 (e.g., fourth stent apex) between about 110° and about 160° regions of sleeve 1118, which is positioned distally from third anchor point 3P5 at an angle between about A200° and about A250°, and further directed below fourth anchor point 4P4, which serves as a friction point 130 to provide friction to deployment line 106 to facilitate actuation of deployment line 106. Friction point 130 helps to prevent deployment line 106 from slipping out of position or releasing before deployment of first deployment line segment 1061 and second deployment line segment 1062 is complete. In an example embodiment, only one friction point 130 is used, which helps to prevent medical device 104 from slipping when deployment line 106 is actuated. However, in various cases, multiple friction points 130 can be utilized and positioned in multiple locations on medical device 104.

[0061] Referring now to Figure 5A-5C When the deployment line 106 is actuated, after deployment of the first deployment line segment 1061 and consequent deployment of the sleeve 1118, continued actuation of the second deployment line segment 1062 causes movement (e.g., pulling, retracting, bunching (tightening / creasing), pleating, inverting, or folding) of the sleeve 1118 according to the guided pattern (travel pattern) of the second deployment line segment 1062. For example, as shown in Figure 5A after deployment of the first deployment line segment 1061, as the second deployment line segment 1062 is actuated, the first corner region 1183 is pulled, peeled (flaked / peeled away), retracted, bunched (tightened / creased), pleated, inverted, folded, translated, or otherwise moved back from the proximal edge 1041 of the medical device 104 to gather toward the base point 128.

[0062] As shown in Figure 5B after deployment of the first deployment line segment 1061, as the second deployment line segment 1062 is actuated, the first corner region 1183 is pulled, peeled (flaked / peeled away), retracted, bunched (tightened / creased), pleated, inverted, folded, translated, or otherwise moved back from the proximal edge 1041 of the medical device 104 to gather toward the base point 128.

[0063] After the upstream proximal edge 1181 of the sleeve 1118 is actuated, as the second deployment line segment 1062 is continuously actuated via the deployment line 106, the second corner region 1184 is pulled, peeled (flaked / peeled away), retracted, bunched (tightened / creased), pleated, inverted, folded, translated, or otherwise moved back from the proximal edge 1041 of the medical device 104, as shown in Figure 5C to gather toward the base point 128.

[0064] As shown in Figure 6 In some cases, after the corner regions 1183, 1184 and the proximal edge 1181 of the sleeve 1118 have moved back to the base point 128, the user can continue to apply tension to the second deployment line segment 1062. As the tension continues to be applied, the deployment line 106 is released from the sleeve 1118 (and any additional sleeves, such as the delivery sleeve 116, if present), and the anchor point 3P5 or other anchor point located at the base point 128 is then able to be passed through the catheter 100Figure 1 ) retracted or pulled out. In other cases, the deployment line 106 can not be released from the sleeve 1118, any other sleeve, and / or the base point 128.

[0065] In some cases, the entire proximal end 1041 of the medical device 104 is unobstructed by sleeve overhang (overhanging / suspended) after full deployment and removal of the deployment line 106, as described in detail above. However, in other embodiments, it can be more difficult or nearly impossible to unobstruct the entire proximal end 1041 of the medical device 104. For example, referring to Figure 7A , a diagram of an aortic arch 2 is shown in which the medical device 104 Figure 1-6 ) can be deployed. Figure 7B A cross-sectional view of the ascending aorta of Figure 7A is shown, with the patient’s anterior artery on the left and the patient’s posterior artery on the right. The shaded region C of the cross-sectional view is referred to as the coronary region, while the unshaded region NC of the cross-sectional view is referred to as the non-coronary region. If the medical device 104 Figure 1-6 is to be deployed in the aortic arch 2, then at least the coronary region should be unobstructed when the medical device 104 Figure 1-6 is fully deployed and the deployment line 106 Figure 1-6 is actuated. Thus, in various examples, the medical device 104 and the 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, but at least the coronary region of the device, is unobstructed after the medical device is fully deployed, as described in detail above and with reference to Figure 5A -C.

[0066] The foregoing examples are merely examples and should not be understood to limit or otherwise restrict the scope of any of the inventive concepts provided by the present disclosure. Although a number of examples have been disclosed, still other examples will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature rather than restrictive in nature.

Claims

1. A delivery system comprising: a delivery sleeve releasably secured into a tubular shape, the 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 between the upstream edge and the downstream edge, a first rim extending along the length of the delivery sleeve, a second rim extending along the length of the delivery sleeve, and a first corner region proximate the upstream edge; a first deployment line segment releasably coupling the first rim and the second rim of the delivery sleeve such that the delivery sleeve is releasably secured into a tubular shape; and a second deployment line segment anchored at the first corner region and directed from the first corner region to a first anchor point at 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.

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

3. The delivery system of any of the preceding claims, the delivery sleeve has a second corner region proximate the upstream edge; and the second deployment line segment is anchored at the second corner region and directed to the first anchor point at the intermediate region, the second deployment line segment configured such that upon actuation of the second deployment line segment both corner regions translate toward the intermediate region.

4. The delivery system of claim 1, wherein, The second deployment line segment is directed external to the delivery sleeve.

5. The delivery system of claim 1, wherein, The first corner region includes an aperture through which the second deployment line segment is directed to anchor the second deployment line segment to the first corner region.

6. The delivery system of claim 1, wherein, The delivery system includes a secondary sleeve.

7. The delivery system of claim 6, wherein, The secondary sleeve is positioned about the medical device and the delivery sleeve.

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 to releasably couple the delivery sleeve in a tubular configuration; a second deployment line segment extending from the first deployment line segment, the second deployment line segment coupled at the first corner region and directed from the first corner region to the intermediate region and anchored at a first anchor point at the intermediate region.

9. The delivery system of claim 8, wherein, The second deployment line segment is configured such that upon actuation of the second deployment line segment the first corner region moves back toward the intermediate region.

10. The delivery system of claim 8 or 9, wherein, The first deployment line segment and the second deployment line segment are releasable from the delivery sleeve.

11. The delivery system of claim 8, the delivery sleeve has a second corner region; and The second deployment line section is coupled to the second corner region and is directed from the second corner region to the intermediate region and is anchored at the first anchor point; wherein the second deployment line section is configurable such that upon actuation of the second deployment line section, the first corner region and the second corner region move back toward the intermediate region.

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