Lock belt for aortic diameter reduction & reinforcement

Abstract

A method for placing a stent graft in a vessel includes surgically accessing an exterior of the vessel, establishing a landing zone for the stent graft by wrapping the vessel with a belt and reducing a diameter of the vessel to a target diameter by tightening the belt, and implanting the stent graft in the vessel at the landing zone while the diameter of the vessel is held at the target diameter by the belt.

Description

Atty. Dkt. No.: 143905-0104LOCK BELT FOR AORTIC DIAMETER REDUCTION & REINFORCEMENT CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 791,185, filed April 18, 2025, the entire disclosure of which is incorporated by reference herein.BACKGROUND[0002 J The present disclosure relates generally to systems and methods for treating diseased blood vessels, and more particularly to surgical devices and techniques for treating diseased vessels. Endovascular stent grafting or endovascular aneurysm repair, which may be referred to as stent grafting, is widely used to treat a weakened or diseased section of a blood vessel by inserting a stent graft into the vessel to reinforce the vessel wall. Stent grafting may be performed laparoscopically.SUMMARY[0003 J In various embodiments, a method for placing a stent graft in a vessel includes surgically accessing an exterior of the vessel, establishing a landing zone for the stent graft by wrapping the vessel with a belt and reducing a diameter of the vessel to a target diameter by tightening the belt, and implanting the stent graft in the vessel at the landing zone while the diameter of the vessel is held at the target diameter by the belt.

[0004] In various embodiments, a lock belt for reducing a diameter of a vessel includes a first panel including a plurality of slits spaced along a longitudinal direction of the first panel, one or more second panels coupled to a first side of the first panel between the plurality of slits, and a fastener extending along the longitudinal direction and through the slits such that the fastener is positioned on the first side of the first panel with sections of the second panels positioned between the fastener and the first panel.

[0005] In various embodiments, a lock belt for reducing a diameter of a vessel includes a panel configured to radially surround the vessel and a shape-memory cable coupled to and extending along an external surface of the panel. The shape-memory cable is deformable for wrapping around the vessel and configured to resiliently return to a shape which provides aAtty. Dkt. No.: 143905-0104restrictive radial force on the vessel so as to provide a landing zone for implanting a stent graft in the vessel.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. l is a front view of a lock belt, according to an example embodiment.

[0007] FIG. 2 is a rear view of the lock belt of FIG. 1, according to some embodiments.

[0008] FIG. 3 is a side view of the lock belt of FIG. 1 in an in-use configuration, according to some embodiments.

[0009] FIG. 4 is a first perspective view illustrating the lock belt of FIG. 1 in the in-use configuration, according to some embodiments.

[0010] FIG. 5 is a second perspective view illustrating the lock belt of FIG. 1 in the in-use configuration, according to some embodiments.

[0011] FIG. 6 is a perspective view illustrating options for placement of the lock belt of FIG. 1, according to some embodiments.

[0012] FIG. 7 is a front view of a lock belt, according to another example embodiment.

[0013] FIG. 8 is a first perspective view illustrating the lock belt of FIG. 7 in an in-use configuration and including a cover, according to some embodiments.

[0014] FIG. 9 is a second perspective view illustrating the lock belt of FIG. 7 and the cover of FIG. 8, according to some embodiments.

[0015] FIG. 10 is a perspective view illustrating a lock belt in an in-use configuration, according to another example embodiment.

[0016] FIG. 11 is a perspective view illustrating a lock belt in an in-use configuration, according to yet another example embodiment.

[0017] FIG. 12 is a flowchart of a process for using the lock belt of FIG. 1, according to some embodiments.Atty. Dkt. No.: 143905-0104

[0018] FIG. 13 is a flowchart of a process for securing a cover to the lock belt of FIG. 1, according to some embodiments.DETAILED DESCRIPTION

[0019] Presently preferred embodiments of the invention are illustrated in the drawings. An effort has been made to use the same or like reference numbers throughout the drawings to refer to the same or like parts. Although this specification refers primarily to a lock belt for aortic diameter reduction, it should be understood that the subject matter described herein is applicable to other vessels of the body, and / or to other types of medical systems, including those used for surgical and non-surgical applications.[0020} Referring to the Figures generally, various embodiments disclosed herein relate to systems and methods for reducing an arterial diameter using a lock belt, for example for providing a landing site for a stent graft. The lock belt as described herein is capable of providing at least one of a surgical anastomotic site. Specifically, the lock belt may rely on reducing a diameter of a blood vessel, such as an aorta, by wrapping and tightening a lock belt around the blood vessel. The aorta is the main artery that provides oxygenated blood from the heart to the rest of the body and primarily functions to distribute the oxygenated blood to various organs and tissues. The lock belt as described herein may provide a practitioner with a secure, structurally sound landing location to secure a stent graft to a wall of a blood vessel. The lock belt as described herein may be used as within various systems (e.g., therapeutic medical systems), such as to treat particular arterial conditions or patient conditions associated with the vascular system. These systems may include other devices, systems, equipment, etc., such as stent grafts and devices for placing stent grafts, devices for placing the lock belt (e.g., a laparoscopic robot), in addition to the lock belt.

[0021] FIGS. 1 and 2 depict an example of a device (e.g., an adaptive device, a medical device), shown as lock belt 100, that can reinforce and / or reduce a diameter of a blood vessel, in accordance with some implementations of the present disclosure. FIG. 1 depicts a front view of the lock belt 100, and FIG. 2 depicts a rear view of the lock belt 100. It should be understood that this and other arrangements described herein are set forth only as examples.Atty. Dkt. No.: 143905-0104

[0022] The lock belt 100 includes a first panel 102 (e.g., a strip of a first material, a biocompatible portion). The first panel 102 includes a first end 101 and a second end 103, opposite the first end 101. A longitudinal direction of the first panel 102 is defined between the first end 101 and the second end 103. In some embodiments, as shown in FIGS. 1 and 2, the first panel 102 is generally rectangular. In other embodiments, the first panel 102 defines an alternative shape (e.g., square, oval, etc.). The first panel 102 includes one or more slits 108 spaced along the longitudinal direction of the lock belt 100. The lock belt 100 includes one or more second panels 104 (e.g., strips of a second material, biocompatible portions) positioned between the one or more slits 108. The second panels 104 are shown as extending from a first longitudinal edge of the lock belt 100 to a second longitudinal edge of the lock belt 100.

[0023] In some embodiments, the first panel 102 is composed of a first material and the second panels 104 are composed from a second material, for example with the second material being more rigid (e.g., more firm, dense, solid, harder, etc.) than the first material. The first material and / or the second material may be composed of biocompatible materials, such as polytetrafluoroethylene (PTFE) or felt.

[0024] The second panels 104 are coupled to the first panel 102. In some cases, the lock belt 100 may include an attachment mechanism in order to couple (e.g., fasten, secure, connect, etc.) the second panels 104 to the first panel 102. For example, an attachment member, such as a fastener, a hook and loop fastener, or an engagement member, may be disposed on an external surface of the first panel 102. One or more receiving portions that are compatible for attachment to the attachment member of the first panel 102 may be disposed on one or more internal surfaces of the second panels 104. Specifically, the attachment member of the first panel 102 and the one or more receiving portions of the second panels 104 are configured such that the attachment member and the one or more receiving portions are attached responsive to being interfaced (e.g., pushed together, coupled, etc.). In some implementations, the second panels 104 may include the attachment member and the first panel 102 may include the one or more receiving portions. In some cases, the first panel 102 and / or the second panels 104 may be coupled via an adhesive. In some cases, the first panel 102 and the second panels 104 may be stitched together or joined in any other manner. In some cases, the first panel 102 and the second panels 104 may be formed as a single unitary body.Atty. Dkt. No.: 143905-0104

[0025] The lock belt 100 includes a fastener 106 (e.g., a self-locking fastener, a cable tie, a zip tie, a hook-and-loop fastener, a zipper, etc.) extending along the longitudinal direction of the lock belt 100. The fastener 106 may be inserted and threaded through the one or more slits 108, such that the fastener 106 extends through the slits 108 as shown in FIGS. 1 and 2. Because the slits 108 are placed along the first panel 102 between the second panels 104, the slits 108 are arranged to receive the fastener 106 and allow the fastener 106 to pass through the slits 108 while also being disposed along an external surface of the second panels 104. At positions of the lock belt 100 where the fastener 106 is disposed at an external surface of the lock belt 100, the second panels 104 are disposed in between the fastener 106 and the first panel 102.

[0026] The fastener 106 includes a first end, shown as first fastener end 116, and a second end, opposite the first fastener end 116, shown as second fastener end 118. The fastener 106 is configured to be fixed to itself. The first fastener end 116 may include an engagement portion 110 (e.g., a channel, a slot, an opening, receiver, etc.) configured to receive and retain the second fastener end 118. The engagement portion 110 may include one or more notches (e.g., receiving portions) configured to receive a set of grooves (e.g., protrusions) disposed along an external surface of the fastener 106. In some embodiments, responsive to the second fastener end 118 being inserted into the engagement portion 110, the engagement portion 110 may engage at least a groove of the one or more grooves disposed along at least a portion of the fastener 106 (e.g., along one or more sides of the fastener 106). By way of example, one or more external surfaces (e.g., side surfaces) of the fastener 106 may include grooves that are configured to engage an internal mechanism of the engagement portion 110 (e.g., a ratcheting system). The engagement portion 110 can thereby receive and retain the second fastener end 118 of the fastener 106 such that the fastener 106 can be formed into a loop having a circumference defined by the distance along a length of the fastener 106 from the engagement portion 110 and a point along the fastener extending through the engagement portion 110.

[0027] In some implementations, a width of the lock belt 100 may be 15-20mm wide. In other implementations, the lock belt 100 may be one of a plurality of sizes, such that a width, height, thickness, shape, etc. of the lock belt 100 may be provided to meet the requirements (e.g., specifications, dimensions) of a blood vessel of a patient.Atty. Dkt. No.: 143905-0104

[0028] Referring now to FIG. 3, a side view of the lock belt 100 in an in-use configuration is shown, according to some implementations of the present disclosure. As shown in FIG.3, in the in-use configuration, the lock belt 100 is radially surrounding a blood vessel, such as the aorta, shown as vessel 150. Specifically, a surgeon or other user may access an exterior of the vessel 150 in order to wrap the lock belt 100 around the vessel 150. An inner surface of the second panels 104 is configured to interface (e.g., abut, engage) with an exterior wall of the vessel 150 when the lock belt 100 surrounds the vessel 150.

[0029] The lock belt 100 may be fastened to itself responsive to surrounding the vessel 150 (e.g., via the engagement portion 110 of the fastener 106 receiving the second fastener end 118 of the fastener 106) such that the lock belt 100 is fixed relative to the vessel 150.Responsive to the lock belt 100 securably surrounding the vessel 150, a diameter of the vessel 150 may be reduced by tightening the lock belt 100. Specifically, drawing on the second fastener end 118 in a direction away from the engagement portion 110 (i.e., pulling more of the fastener 106 through the engagement portion 110), provides a tightening force to reduce a diameter of the fastener 106, and thus the lock belt 100. For example, drawing the second fastener end 118 through the engagement portion 110 may engage at least a groove of the set of grooves disposed on the fastener 106 such that the fastener 106 is securably attached to itself. In some instances, the internal mechanism of the engagement portion 110 prevents the second fastener end 118 from being withdrawn from the engagement portion 110, such that the fastener 106 is in a locked position. The second fastener end 118 of the fastener 106 may extend past the engagement portion 110 responsive to being drawn through the engagement portion 110. Drawing the second fastener end 118 further through the engagement portion 110 reduces the circumference (and radius, diameter, etc.) of a loop formed by the fastener 106, and thus also the circumference (and radius, diameter, etc.) of the first panel 102 and of the lock belt 100. In some embodiments, additional or alternative tightening mechanisms can be provided with the fastener 106 (e.g., dials, knobs, etc.).

[0030] As shown in FIG. 3, when the lock belt 100 is tightened around the vessel 150, the first panel 102 faces outwardly (e.g., away from the vessel 150). Sections of the second panels 104 extend past the first panel 102 (e.g., in an outwards direction), for example, the sections of the second panels 104 positioned between the slits 108. The fastener 106 can be threaded through the slits 108 of the first panel 102. The fastener 106 can be securablyAtty. Dkt. No.: 143905-0104fastened to itself and tightened such that portions of the second panels 104 protrude externally through the slits 108. Specifically, drawing the second fastener end 118 further through the engagement portion 110 causes the second panels 104 to be compressed, such that neighboring slits 108 are drawn closer together. The lock belt 100 compresses such that a diameter (and circumference, radius, etc.) of the lock belt 100 is reduced. Portions of the second panel 104 protruding through of the slits 108 may be folded, such that two internal surfaces of the second panels 104 are in contact. A length of the slits 108 across a lateral direction of the lock belt 100 provides space (e.g., slack) for portions of the second panels 104 to protrude through. The tightening force of the lock belt 100 around the vessel 150 compresses and decreases a diameter of the vessel 150.

[0031] Referring now to FIGS. 4 and 5, FIGS. 4 and 5 illustrate the lock belt 100 in use for treating a vessel 150. The vessel 150 includes a vessel wall 152 that surrounds the length of the vessel 150 and provides structural support. The vessel wall 152 may be composed of various types of tissue.

[0032] Overtime, the vessel 150 and / or the vessel wall 152 may become diseased (for example, due to aortic aneurysm, dissection, traumatic injury, etc.) resulting in degeneration and diminished functionality. As a result, a stent graft 160 may be necessary to treat the diseased vessel 150. A surgeon may access the diseased vessel wall 152 in order to place the stent graft 160 around the vessel 150. The stent graft 160 can cover one or more sections of the vessel wall 152 to control and restore normal blood flow through the vessel 150. In order to effectively place and ensure proper sealing of the stent graft 160, at least a portion of the stent graft 160 preferably lands at (is contacted to, is positioned on, is engaged with, etc.) a healthy section (e.g., not diseased) of the vessel wall 152. When the stent graft 160 is positioned and / or placed at a position of the vessel wall 152 including diseased tissue, the stent graft 160 may drive the tissue away, rather than engage the tissue, which can result in difficulty in securing the stent graft 160 in position and / or otherwise diminish the ability of the stent graft 160 to provide its intended clinical benefit.

[0033] The lock belt 100 (and methods of use thereof) advantageously provides for creation of a landing zone, or a viable location along the vessel wall 152 wherein a stent graft 160 may be placed. This may be advantageous in a case where no suitable landing zone exists (e.g., due to diseased tissue disposed along the vessel 150). The stent graft 160 may be anyAtty. Dkt. No.: 143905-0104type of device used by surgeons that requires a landing zone in order to be placed (e.g., around a vessel wall 152). Examples of the stent graft 160 may include, but are not limited to, a chimney snorkel stent, a branched stent graft, and a fenestrated stent graft.

[0034] Referring now to FIG. 6, an illustration of the vessel 150 showing options for placement of the lock belt 100 is shown, according to some embodiments. As shown in FIG. 6, the lock belt 100 may be placed at various positions along the vessel wall 152. For example, one or more lock belts 100 may be placed along the vessel wall 152 based on patient disease state. The lock belt 100 may be placed at any position along the vessel wall 152 where one or more stent grafts 160 need to be positioned. Any surgical tools and methods may be used to facilitate placing the lock belt 100 (and / or the stent graft 160), including but not limited to, imaging systems (e.g., for guiding a placement of the lock belt and / or the stent graft 160); manual or robotic laparoscopic grippers, scissors, endoscopes, or other minimally-invasive tools; guidewires, catheters, and blood flow and / or pressure monitors; or other surgical devices as may be clinically appropriate.

[0035] Referring now to FIG. 7, an example of the lock belt 100 is shown according to another embodiment as lock belt 200. The lock belt 200 can operate similarly to the lock belt 100 and / or can have similar structure / elements as the lock belt 100.

[0036] As shown in FIG. 7, the lock belt 200 includes a plurality of fasteners 106. The lock belt 200 can include one or more fasteners 106. For example, the fasteners 106 may include a first fastener 106a and a second fastener 106b. The first fastener 106a and / or the second fastener 106b extend along the longitudinal direction of the lock belt 200. The slits 108 may include a first set of slits 108a and a second set of slits 108b extending along the longitudinal direction of the first panel 102. The second set of slits 108b may be positioned proximate the first set of slits 108a. The first fastener 106a may be threaded through the first set of slits 108a and the second fastener 106b may be threaded through the second set of slits 108b. The second fastener 106b may be positioned proximate to the first fastener 106a in a lateral direction (opposite the longitudinal direction). The first fastener 106a and / or the second fastener 106b may include one or more mechanisms for fastening to itself, such as to surround the vessel 150 (e.g., a self-locking fastener, a cable tie, a zip tie, a hook-and-loop fastener, a zipper, etc.). In some implementations, the second fastener 106b may be the same (e.g., include a same fastening mechanism) as the first fastener 106a. In otherAtty. Dkt. No.: 143905-0104implementations, the first fastener 106a may include a first fastening mechanism and the second fastener 106b may include a second (different) fastening mechanism. In various cases, the lock belt 200 and / or the lock belt 100 may include any number of fasteners 106 (e.g., two, three, four, etc.) (and corresponding sets of slits 108) positioned horizontally to each other and extending along the longitudinal direction of the corresponding lock belt.[00371 Referring now to FIGS. 8 and 9, perspective views of another implementation of the lock belt 200 deployed to at least radially surround a vessel 150 is shown, according to some embodiments. In the example of FIGS. 8 and 9, the lock belt 200 includes and / or is coupled with a third panel (e.g., covering panel), shown as cover 120, configured to cover at least a portion of the fasteners 106a, 106b. An internal surface of the cover 120 is configured to surround or cover at least a portion of the fasteners 106a, 106b. By way of example, the cover may be configured to cover the engagement portion 110 and / or an end of the fastener 106a and / or an end of the fastener 106b. The cover 120 may be composed of a same material as the first panel 102 or the second panels 104, or may be composed of any other biocompatible material. It should be understood that in some embodiments, the cover 120 can be used in combination with the lock belt 100.

[0038] In some implementations, an end of the fastener 106a and / or an end of the fastener 106b (e.g., ends drawn through the engagement portions of the fastener 106a and / or the fastener 106b respectively) may be cut to remove an excess length of the fastener 106a or the fastener 106b respectively. The excess length may protrude past the engagement portions 110 of the fastener 106a and / or the fastener 106b responsive to tightening the lock belt 200 around the vessel 150. The cover 120 may be configured to sheath (e.g., cover) a cut end (e.g., the second ends drawn through the engagement portions) of the fastener 106a and / or the fastener 106b. The cover 120 may advantageously protect the walls of the vessel 150 and / or near blood vessels. The cover 120 may also provide the lock belt 200 with a smooth external surface which may provide an improved landing zone. The cover 120 may also help ensure the lock belt 200 securedly surrounds the vessel 150.

[0039] In some implementations, the lock belt 200 may include an attachment mechanism in order to couple (e.g., fasten, secure, connect, etc.) the cover 120 with the lock belt 200. For example, as shown in FIG. 8, the first panel 102 includes an attachment member 130 (e.g., a fastener, a hook and loop fastener, an engagement member, etc.). The cover 120Atty. Dkt. No.: 143905-0104includes a first end, shown as first cover end 122, and a second end, opposite the first cover end 122, shown as second cover end 124. In some embodiments, the first end 101 of the first panel 102 includes the attachment member 130, and the second cover end 124 is integrally formed or coupled with the first panel 102 at the second end 103. In other embodiments, the second end 103 of the first panel 102 includes the attachment member 130, and the first cover end 122 is integrally formed or coupled with the first panel 102 at the first end 101.10040} The cover 120 may include a receiver at or proximate the first cover end 122 that is compatible for attachment to the attachment member 130. The receiver may be positioned along a first surface of the cover 120 (e.g., an inner surface, a surface configured to abut the first panel 102). Specifically, the attachment member 130 and the receiver are configured such that the attachment member 130 and the receiver are attached responsive to the attachment member 130 and the receiver being interfaced (e.g., pushed together, coupled, etc.). For example, the attachment member 130 may be a first part of a hook and loop fastener and the receiver may be an opposing, compatible second part to the hook and loop fastener such that the first part of the hook and loop fastener and the second part of the hook and loop fastener are joined responsive to first part of the hook and loop fastener and the second part of the hook and loop fastener being interfaced. In various implementations, a portion of the cover 120 may be coupled to a portion of the lock belt 200, such that the portion of the cover 120 is fixedly connected to the lock belt 200 prior to the attachment member 130 and the receiver being joined. In other implementations, the cover 120 may be independent from the lock belt 200, such that the cover 120 is detachable from the lock belt 200.

[0041] Referring to FIG. 10 an example of the lock belt 100 is shown according to another embodiment as lock belt 300. As shown in FIG. 10, the lock belt 300 can be deployed to at least radially surround the vessel 150. The lock belt 300 can operate similarly to any of the lock belts described herein and / or can have similar structure / elements to any of the lock belts described herein.

[0042] The lock belt 300 includes a panel 302 (e.g., a strip of a material, a biocompatible portion). The panel 302 can include one or more panels. In some embodiments, the panel 302 is generally rectangular. In other embodiments, the panel 302 defines an alternativeAtty. Dkt. No.: 143905-0104shape (e.g., square, oval, etc.). In various embodiments, the panel 302 may be composed of biocompatible material, such as polytetrafluoroethylene (PTFE) or felt. The panel 302 may be similar to the first panel 102.

[0043] In some embodiments, as shown in FIG. 10, the lock belt 300 is configured to surround at least a portion of the vessel 150 (e.g., radially surround the vessel 150). An inner surface of the panel 302 may be configured to interface (e.g., abut, engage, etc.) with the vessel wall 152 when the lock belt 300 surrounds the vessel 150. An external surface of the panel 302, shown as external surface 306, may be configured to face outwards when the lock belt 300 surrounds the vessel 150. The external surface 306 is opposite the inner surface of the panel 302.

[0044] The lock belt 300 includes a cable 304 (e.g., first cable, wire, elongated member, etc.) coupled to the panel 302. The cable 304 may be stitched, fastened, sutured, bonded, embedded, molded, sealed, or adhered to the panel 302 in any suitable manner. The cable 304 may be coupled with and / or abut the external surface 306. The cable 304 may extend along the external surface of the panel 302. In some cases, the cable 304 extends between first and second ends of the panel 302 in a longitudinal direction, for example, from the first end to the second end of the panel 302.

[0045] According to an example embodiment, as shown in FIG. 11, the cable 304 defines a substantially linear configuration (e.g., shape, pattern, arrangement) along the longitudinal direction. In other embodiments, the cable 404 defines an alternative configuration including, but not limited to, a sinusoidal configuration, a waved configuration, a sawtooth configuration, a zig-zag configuration, a helical configuration, a looped configuration, or a lattice configuration. The cable 304 is composed at least partly of a shape-memory material (e.g., nitinol) configured to resiliently return to a substantially-circular shape, for example as in the in-use configurations of FIGS. 10-11, while being easily deformable by a surgeon (e.g., laparoscopically, using a laparoscopic robotic assistance). The cable 304 thereby allows the lock belt 300 to be unwound, bent, twisted, and otherwise handled as needed to position the lock belt 300 around the vessel 150, while then resiliently returning to and holding the stored, substantially-circular shape in the “memory” of the cable 304. The cable 304 can thereby hold the lock belt 300 on the vessel 150 without requiring additional coupling means.Atty. Dkt. No.: 143905-0104

[0046] The cable 304 may define a landing zone configured to receive a stent graft relative to the vessel 150. The cable 304 may facilitate positioning, seating, and / or retention of the stent graft relative to the vessel 150. By way of example, a surgeon or a user may access (e.g., laparoscopically, minimally-invasively, robotically) an exterior of the vessel 150 in order to wrap the lock belt 300 around the vessel 150. The lock belt 300 may be fastened to itself responsive to surrounding the vessel 150 via the shape-memory properties of the cable 304. In some cases, a diameter of the vessel 150 may be reduced to a target diameter by tightening the lock belt 300 using the teachings for the examples above, such that the stent graft in the vessel 150 at the landing zone while the diameter of the vessel 150 is held at the target diameter by the lock belt 300. In other cases, the lock belt 300 may be preconfigured (e.g., sized) to reduce the diameter of the vessel 150 to the target diameter once wrapped around the vessel 150.

[0047] The cable 304 is configured to apply a radially inward force to the vessel 150.Accordingly, the lock belt 300 can be used to treat an expanding vessel, such as in an aneurysm, by applying a counteracting radially inward force against vessel dilation, thereby stabilizing the vessel and / or preventing further vessel dilation. In some cases, the external structural support provided by the lock belt 300 enables the lock belt 300 to function as an exovascular stent graft.

[0048] The shape-memory cable 304 can be tuned to provide different amounts of inward force at different sizes, depending on the amount of material provided in the cable 304, the geometric arrangement of the cable 304, the memorized shape of the cable 304, etc., as may be suitable for different vessels, patients, conditions, etc. (e.g., provided in a kit of multiple lock belts of different configurations to be selected between by a surgeon in a given situation).

[0049] In some embodiments, the lock belt 300 includes one or more second cables 308 (e.g., wire, elongated member, etc.) coupled to the panel 302. The second cables 308 may be coupled with / extend over the external surface 306. The second cables 308 may be spaced along the longitudinal direction of the lock belt 300. According to an example embodiment, the second cables 308 may be positioned substantially perpendicular to the cable 304. In other embodiments, the second cables 308 may be otherwise positioned relative to the cable 304 (e.g., diagonal, parallel, etc.). In some embodiments, as shown in at least FIG. 10, eachAtty. Dkt. No.: 143905-0104second cable 308 extends transversely across the cable 304. The second cables 308 may define one or more landing zones configured to receive a stent graft relative to the vessel 150. The second cables 308 may facilitate positioning, seating, and / or retention of the stent graft relative to the vessel 150. In various implementations, the cable 304 and / or the second cables 308 can be implemented within any of the lock belts described herein.

[0050] Referring to FIG. 11, an example of the lock belt 100 is shown according to another embodiment as lock belt 400. The lock belt 400 can operate similarly to any of the lock belts described herein and / or can have similar structure / elements as any of the lock belts described herein.

[0051] The lock belt 400 includes a panel 402 (e.g., a strip of a material, a biocompatible portion). The panel 402 can include one or more panels. In some embodiments, the panel 402 is generally rectangular. In other embodiments, the panel 402 defines an alternative shape (e.g., square, oval, etc.). In various embodiments, the panel 402 may be composed of biocompatible material, such as polytetrafluoroethylene (PTFE) or felt.

[0052] The lock belt 400 includes a cable 404 (e.g., wire, elongated member, etc.) coupled to the panel 402. In some embodiments, the cable 404 is integrally formed with the panel 402. In some cases, the cable 404 extends between first and second ends of the panel 402 in a longitudinal direction, for example, from the first end to the second end of the panel 402. According to an example embodiment, as shown in FIG. 11, the cable 404 defines a substantially zig-zag configuration (e.g., shape, pattern, arrangement) along the longitudinal direction. In other embodiments, the cable 404 defines an alternative configuration including, but not limited to, a sinusoidal configuration, a waved configuration, a sawtooth configuration, a substantially linear configuration, a helical configuration, a looped configuration, or a lattice configuration. In some embodiments, the cable 404 can be implemented within any of the lock belts described herein.

[0053] In some embodiments, the cable 404 is composed at least partly of a shape-memory material (e.g., nitinol) configured to resiliently return to a substantially-circular shape, for example as in the in-use configurations of FIGS. 10-11, while being easily deformable by a surgeon (e.g., laparoscopically, using laparoscopic robotic assistance). The cable 404 thereby allows the lock belt 400 to be unwound, bent, twisted, and otherwise handled as needed to position the lock belt 400 around the vessel 150, while then resiliently returningAtty. Dkt. No.: 143905-0104to and holding the stored, substantially-circular shape in the “memory” of the cable 404. The cable 404 can thereby hold the lock belt 400 on the vessel 150 without requiring additional coupling means.

[0054] The cable 404 may define a landing zone configured to receive, support, position, and / or retain a stent graft relative to the vessel 150. In some embodiments, the cable 404 may provide localized reinforcement, shape retention, and / or radial support to the panel 402 such that the lock belt 400 defines a more uniform and / or stable interface with the vessel 150. Similarly to the cable 304, the cable 404 is configured to apply a radially inward force to the vessel 150. The cable 404 may facilitate positioning, seating, and / or retention of the stent graft relative to the vessel 150 and may reduce localized deformation of the panel 402. By way of example, a surgeon or a user may access an exterior of the vessel 150 in order to wrap the lock belt 400 around the vessel 150. The lock belt 400 may be fastened to itself responsive to surrounding the vessel 150 (e.g., via a fastener, an adhesive, or the like). In some cases, a diameter of the vessel 150 may be reduced to a target diameter by tightening the lock belt 400, such that the stent graft in the vessel 150 at the landing zone while the diameter of the vessel 150 is held at the target diameter by the lock belt 400. In other cases, the lock belt 400 may be preconfigured (e.g., sized) to reduce the diameter of the vessel 150 to the target diameter once wrapped around the vessel 150. In some embodiments, as shown in FIG. 11, a plurality of lock belts may be placed at various positions along the vessel wall 152. Each of the plurality of lock belts may provide a unique landing site, for example, configured to receive, support, position, and / or retain a stent graft relative to the vessel 150. According to an example embodiment, as shown in FIG. 11, a first lock belt 400 may be positioned near a first end of the vessel 150, a lock belt 300 may be positioned near a second end of the vessel 150, opposite the first end, and a second lock belt 400 may be positioned between the first lock belt 400 and the lock belt 300. It should be understood that the positions of the first lock belt 400, the second lock belt 400, and the lock belt 300 are illustrative only, and each of the first lock belt 400, the second lock belt 400, and the lock belt 300 can be positioned at any position along the vessel 150. In some cases, fewer or greater numbers of lock belts can be positioned along the vessel wall 152. Although shown as lock belts 400 and lock belt 300 in FIG. 11, any of the lock belts described herein may be placed at various positions along the vessel wall 152.Atty. Dkt. No.: 143905-0104

[0055] The lock belt 300 and / or the lock belt 400 may also serve as a self-wrapping reinforcement member, such as a surgical felt substitute for use at a surgical anastomosis site. Felt strips (e.g., composed of PTFE or similar materials) are commonly used during surgical anastomosis to reinforce tissue and / or a suture line (e.g., a region or line where sutures are placed to join tissue portions). However, conventional felt strips typically require manual positioning, for example, by the surgeon, for each suture during suturing, which may be labor-intensive and / or time-consuming. In contrast to conventional felt systems, the lock belt 300 and / or the lock belt 400 can automatically conform to and / or remain positioned at the surgical anastomosis site without requiring repeated manual adjustment during suturing, thereby improving ease of use and positional accuracy during surgical anastomosis.

[0056] Referring now to FIG. 12, a flowchart for a method 500 for placing a stent graft around a vessel is shown, according to some embodiments. Although the method 500 may be used for placing a stent graft around an aorta, the method 500 and / or other methods as described herein may apply to any vessel of the venous system. Method 500 is described as being executed using the lock belt 100 of FIG. 1, however, method 500 can be executed using any of the lock belts described herein.

[0057] At step 502, an exterior of a vessel (e.g., vessel 150) is accessed (e.g., by a surgeon or a user). For example, a surgeon may access a vessel wall (e.g., the vessel wall 152) by minimally invasive robotic or laparoscopic surgery. For example, one or more of the locations along the aorta illustrated in FIG. 4 may be accessed from outside of the aorta in step 502.

[0058] At step 504, a lock belt (e.g., the lock belt 100) is wrapped around the vessel wall 152, such that the lock belt 100 surrounds the vessel 150. For example, the lock belt 100 may be manipulated by manual or robotic laparoscopic tools into a position where the first panel 102 of the lock belt 100 is placed in contact with the vessel wall 152 with the second panels 104 on the side of the first panel 102 facing away from the vessel 150, and with the lock belt 100 extending around a circumference of the vessel 150.

[0059] At step 506, the lock belt 100 is secured around the vessel wall 152. For example, an end (e.g., the second fastener end 118) of a fastener (e.g., the fastener 106) may be inserted to an engagement portion (e.g., the engagement portion 110) of an opposite end (e.g., theAtty. Dkt. No.: 143905-0104first fastener end 116) of the fastener 106, such that the lock belt 100 is secured to itself while surrounding the vessel 150 (thereby holding the lock belt 100 on the vessel 150). The engagement portion 110 may include an internal mechanism to receive the second fastener end 118 of the fastener 106. Step 506 can include engaging, using one or more laparoscopic manipulators, the second fastener end 118 of the fastener 106 with the engagement portion 110, such that the second fastener end 118 extends through the engagement portion 110.

[0060] At step 508, the lock belt 100 is tightened, such as to decrease a diameter of the lock belt 100. The lock belt 100 may be tightened by drawing the second fastener end 118 of the fastener 106 in a direction away from the engagement portion 110 (such that more of the fastener 106 is drawn through the engagement portion 110 and less of the fastener 106 remains to define a circumference of the lock belt 100). The second fastener end 118 of the fastener 106 may extend past the engagement portion 110 responsive to the fastener 106 being tightened. Tightening the lock belt 100 via the fastener 106 reduces a diameter (and radius, circumference, etc.) of the lock belt 100, which in turn presses inwardly against and reduces a diameter (and radius, circumference, etc.) of the vessel 150 as the lock belt 100 is securely fastened around and pushes inwardly on the vessel 150. The lock belt 100 may be tightened to reduce the diameter of the vessel 150 until the diameter of the vessel 150 reaches a target diameter (e.g., a clinically-desired target, a target corresponding to a dimension of a stent graft to be implanted). In embodiments using the lock belts 300 or 400, the lock belt may be self-tightening in step 508 by virtue of shape-memory properties of materials used in the lock belt.

[0061] At step 510, a stent graft (e.g., stent graft 160) is implanted in the vessel 150. For example, a portion of the vessel wall 152 surrounded by the lock belt 100 provides a landing zone for the stent graft 160 to be placed, since the portion of the vessel 150 is reinforced by the lock belt 100. The lock belt 100 provides a viable portion of the vessel wall 152 where the stent graft 160 can land and seal.

[0062] In some implementations, responsive to step 510, the lock belt 100 may be removed to complete the surgical procedure. The lock belt 100 may be released from around the vessel wall 152. For example, the lock belt 100 may be loosened, such that less of the fastener 106 is drawn through the engagement portion 110 and more of the fastener 106 remains to define a circumference of the lock belt 100. The second fastener end 118 of theAtty. Dkt. No.: 143905-0104fastener 106 may be withdrawn from the engagement portion 110 of the first fastener end 116 of the fastener 106. This can include pulling, using one or more laparoscopic manipulators, the second fastener end 118 of the fastener 106 through the engagement portion 110 in an opposite direction as in step 508 to tighten the fastener 106. By way of another example, the lock belt 100 may be cut to unfasten the lock belt 100 from itself. This can include cutting the fastener 106 and unwrapping the lock belt 100 from around the vessel wall 152, using one or more laparoscopic manipulators. In some other implementations, the surgical procedure may end where the lock belt 100 is left around the vessel wall 152 (e.g., according to patient requirements).

[0063] Alternatively to step 510, in some embodiments the lock belt 100 (or 300) is used without an endovascular stent graft and instead provides external support to serve as a external support structure (e.g., exo-vascular stent, belt, cylinder, fabric loop, etc.) which reinforces the vessel wall from outside the vessel. In some such scenarios, the lock belt 100 (or other embodiments of the lock belt) can be used instead of (e.g., without requiring use of) a stent graft internal to the vessel.

[0064] As another alternative to step 510, in some embodiments, the lock belt 100 (or 300) is used during open surgical anastomosis, such that the process involves positioning the lock belt to self-secure at an anastomosis cite for use as support for suturing and related operation steps. The lock-belt 100, 300 can remain in place as a material supporting the vessel wall for each suture, and can be easily adjustable as need for the operation to proceed, without needing to be manually held in place throughout, thereby making the surgical anastomosis procedure significantly easier for the surgeon.[0065} Referring now to FIG. 13, a flowchart for a method 600 for securing a cover to a lock belt is shown, according to an example embodiment. In some implementations, the method 600 may be used in conjunction with method 500. Method 600 is described as being executed using the lock belt 200 of FIGS. 8 and 9, however, method 600 can be executed using any of the lock belts described herein.

[0066] At step 602, a lock belt (e.g., lock belt 200) is wrapped around a vessel (e.g., vessel 150) and tightened using one or more fasteners (e.g., fasteners 106) (e.g., as described in steps 504-508 of method 500 above).Atty. Dkt. No.: 143905-0104

[0067] At step 604, responsive to a target diameter of the vessel 150 being reached, an end of the fastener 106 may be removed. For example, an end of the fastener 106 may extend past the engagement portion 110 responsive to the fastener 106 being tightened. The end of the fastener 106 may be cut (e.g., removed, detached, shortened, severed, etc.), such that end of the fastener 106 does not protrude past the engagement portion 110.

[0068] At step 606, a cover (e.g., the cover 120) is secured to the lock belt 200. For example, the lock belt 100 may include an attachment member (e.g., attachment member 130). The attachment member 130 may be a fastener, a hook and loop fastener, or an engagement member, among others. The cover 120 may include a receiver (e.g., a receiving portion) that is compatible for attachment to the attachment member 130. In some cases, when the receiver of the cover 120 is coupled to the attachment member 130, the cover 120 is coupled to the lock belt 200. In some cases, the cover 120 may be secured to the lock belt 200 without the end of the fastener 106 being cut.[0069J At step 608, the stent graft 160 is placed at a position of the vessel 150 reinforced by the lock belt 200. The lock belt 200, and specifically the externally facing portion of the lock belt 200 (i.e., the cover 120), provides a landing zone wherein the stent graft 160 can be placed.

[0070] The systems and methods described herein with respect to the lock belts described herein provide numerous advantages over traditional methods. For example, a common procedure to treat a diseased blood vessel is endovascular stent grafting or endovascular aneurysm repair to reinforce a weakened or diseased section of the blood vessel. However, in order for a stent graft to be placed, the stent graft needs to land at a healthy section of the blood vessel. In some cases, no such viable position of the blood vessel exists. If the stent graft lands at a diseased or weakened position of the vessel, the stent graft may not seal correctly. The systems and methods as described herein reinforce the blood vessel externally to artificially create a viable landing zone for the stent graft. Regarding the aorta, the lock belt can reinforce the arterial walls, which may be weakened due to a disease (aortic aneurysm, dissection, traumatic injury, etc). Advantageously, the systems and methods as described herein enable surgeons to perform endovascular stentgrafting or endovascular aneurysm repair, which are minimally invasive procedures.Therefore, the systems and methods as described herein may lead to reduced recovery time,Atty. Dkt. No.: 143905-0104lower risk of complications, less pain, and overall improved outcomes for patients.Additionally, modifying a commonly used existing procedure, such as stent grafting, is advantageous because surgeons are familiar with the technique, allowing surgeons to easily utilize the lock belt 100.

[0071] The construction and arrangement of the systems and methods as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, use of materials, colors, orientations, etc.). For example, the position of elements may be reversed or otherwise varied and the nature or number of discrete elements or positions may be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.

Claims

Atty. Dkt. No.: 143905-0104WHAT IS CLAIMED IS1. A method for placing a stent graft in a vessel, comprising:surgically accessing an exterior of the vessel;establishing a landing zone for the stent graft by:wrapping the vessel with a belt; andreducing a diameter of the vessel to a target diameter by tightening the belt; andimplanting the stent graft in the vessel at the landing zone while the diameter of the vessel is held at the target diameter by the belt.

2. The method of Claim 1, wherein the belt comprises:a first panel including a plurality of slits spaced along a longitudinal direction of the first panel; and ;one or more second panels coupled to a first side of the first panel between the plurality of slits.

3. The method of Claim 2, wherein the first panel is comprised of a first material and the second panels are comprised of a second material, the second material more rigid than the first material.

4. The method of Claim 2, wherein the belt further comprises a fastener such that the belt is configured to fasten to itself, wherein the fastener extends along the longitudinal direction and through the slits such that the fastener is positioned on the first side of the first panel with sections of the second panels positioned between the fastener and the first panel.

5. The method of Claim 2, wherein responsive to tightening the belt, the belt compresses such that sections of the second panels protrude through the slits.

6. The method of Claim 4, further comprising fixing the fastener to itself such that the belt is fixed relative to the vessel prior to reducing the diameter of the vessel.Atty. Dkt. No.: 143905-01047. The method of Claim 4, wherein the fastener is a first fastener, and wherein the belt further comprises a second fastener, positioned proximate to the first fastener and extending along the longitudinal direction.

8. The method of Claim 6, wherein the fastener comprises an engagement portion at a first end of the fastener and a set of grooves, and wherein fixing the fastener to itself further comprises:inserting a second end of the fastener, opposite the first end, into the engagement portion; anddrawing the second end of the fastener through the engagement portion until the vessel reduces to the target diameter.

9. The method of Claim 8, further comprising cutting the second end of the fastener after reducing the diameter of the vessel to the target diameter.

10. The method of Claim 9, further comprising securing a covering panel to the belt, after cutting the second end of the fastener, such that the covering panel covers the second end of the fastener.

11. A lock belt for reducing a diameter of a vessel, comprising:a first panel including a plurality of slits spaced along a longitudinal direction of the first panel;one or more second panels coupled to a first side of the first panel between the plurality of slits; anda fastener extending along the longitudinal direction and through the slits such that the fastener is positioned on the first side of the first panel with sections of the second panels positioned between the fastener and the first panel.

12. The lock belt of Claim 11, wherein the first panel is comprised of a first material and the second panel is comprised of a second material, the second material more rigid than the first material.Atty. Dkt. No.: 143905-010413. The lock belt of Claim 11, wherein the fastener comprises:an engagement portion at a first end of the fastener configured to receive at least a second end of the fastener, opposite the first end; anda set of grooves disposed along an external surface of the fastener, wherein drawing the second end of the fastener through the engagement portion engages at least a groove of the set of grooves with the engagement portion such that the lock belt is fastened to itself.

14. The lock belt of Claim 13, wherein the lock belt establishes a landing zone for implanting a stent graft in the vessel when the lock belt is fastened to itself.

15. The lock belt of Claim 11, further comprising a covering panel configured to couple with the first panel such that at least a portion of the fastener is covered by the covering panel.

16. The lock belt of Claim 11 , wherein the fastener is a first fastener, further comprising a second fastener positioned proximate to the fastener and extending along the longitudinal direction.

17. The lock belt of Claim 16, wherein the slits are a first set of slits, wherein the first panel includes a second set of slits spaced along the longitudinal direction of the first panel and positioned proximate the first set of slits, and wherein the second fastener is configured to extend through the second set of slits.

18. A lock belt for reducing a diameter of a vessel, comprising:a panel configured to radially surround the vessel; anda shape-memory cable coupled to and extending along an external surface of the panel,wherein the shape-memory cable is deformable for wrapping around the vessel and configured to resiliently return to a shape which provides a restrictive radial force on the vessel.Atty. Dkt. No.: 143905-010419. The lock belt of claim 18, wherein the cable comprises nitinol.

20. The lock belt of claim 18, wherein the cable defines a zig-zag configuration.

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