System and method of arthroscopic insertion of a graft
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- SEAMLESS BIOLOGICS LLC
- Filing Date
- 2024-07-26
- Publication Date
- 2026-06-03
AI Technical Summary
Traditional grafts used in arthroscopic procedures face challenges in being introduced into the body without additional components and in withstanding tension forces during implantation, leading to complications and poor patient outcomes.
The development of a graft with a specific lumen geometry that allows it to be compressed for introduction through a cannula and unfurls for secure implantation, using the same suture for both introduction and fixation, eliminating the need for additional introducers and foreign fixation devices.
This solution enables the graft to be introduced arthroscopically in a simplified manner, withstands multidirectional tension forces, and ensures durable implantation, thereby improving patient outcomes and simplifying the surgical process.
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Abstract
Description
SYSTEM AND METHOD OF ARTHROSCOPIC INSERTION OF A GRAFTCROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 515,775, filed July 26, 2023, the contents of which are hereby incorporated by reference herein.TECHNICAL FIELD
[0002] The present application relates to systems and methods for arthroscopic insertion of a graft. More specifically, the present application relates to systems and methods arthroscopic insertion of a graft that can be introduced into a patient using a suture and secured to an implantation site using the same suture.BACKGROUND
[0003] Grafts delivered arthroscopically via suture (“grafts”) are used procedures including tendon and ligament repair to facilitate growth of, e.g., a torn tendon onto a bone. Such grafts are introduced into a patient in a compressed state and, once in vitro, are unfurled and attached to an implantation site.
[0004] Forces exerted on the graft by the suture must be controlled during both introduction of the graft into the patient and implantation of the graft at the implantation site. A graft must remain in a compressed state during introduction and must unfurl over the implantation site. Further, grafts must be able to withstand the tension forces acting thereon in multiple directions during implantation to ensure that the graft remains durable during its lifetime and to ensure that the tendon is repaired.
[0005] Traditional grafts have geometries that require additional components (e.g., introducers) for introduction of the graft into the body of a patient, which can complicate the introduction of a graft into a patient. Such conventional graft geometries also can render grafts incapable of withstanding tension forces upon implantation, leading to poor patient outcomes.SUMMARY
[0006] The present application discloses various embodiments of a graft configured for arthroscopic insertion to an implantation site within a body of a patient. Related methods of use and an embodiment of a kit for arthroscopic insertion of a graft to an implantation site within a body of a patient are disclosed.
[0007] In an aspect of the disclosure, the graft can include a substantially flat portion defined by at least a first edge, a second edge, and a third edge. The graft can further include a first guiding lumen disposed along a portion of the first edge, a second guiding lumen disposed along a portion of the second edge, and a leading lumen disposed along a portion of the third edge. Each of the first guiding lumen, the second guiding lumen, and the leading lumen can be configured to receive a suture. The third edge can be substantially perpendicular to the first edge and the second edge such that the leading lumen can be substantially perpendicular to the first guiding lumen and the second guiding lumen.
[0008] In some implementations, the third edge is a distal edge of the graft such that the leading lumen is disposed along a portion of the distal edge of the graft. In further implementations, the third edge can include a proximal edge of the graft such that the leading lumen is disposed along a portion of the proximal edge of the graft.
[0009] In some implementations, the graft is configured to move from a first flat configuration to a compressed configuration when the suture is pulled a first amount, and the graft is configured to move from the compressed configuration to a second flat configuration when the suture is pulled a second amount.
[0010] In some implementations, the graft includes an electrospun material. In further implementations, the first edge and the second edge can be approximately twenty millimeters long and the third edge can be approximately thirty millimeters long.
[0011] In some implementations, in the compressed configuration, the graft is sized to fit through a cannula and through an incision having a length between approximately five millimeters and approximately eight millimeters.
[0012] In some implementations, the graft includes a biocompatible material. In further implementations, the portion of the first edge is less than a length of the first edge, the portion of the second edge is less than a length of the second edge, and the portion of the third edge is less than a length of the third edge.
[0013] In some implementations, the graft further includes a fourth edge and a backout lumen disposed along a portion of the fourth edge. In some implementations, a length of the leading lumen is at least eighty percent of a length of the first guiding lumen and a length of the second guiding lumen. In further implementations, the leading lumen has a length of at least approximately eighteen millimeters.
[0014] In some implementations, the suture can include a continuous suture affixed to the implantation site at at least a first location along a length of the suture and a second location along the length of the suture. In some implementations, the suture can include a first piece ofmaterial and a second piece of material, the first piece of material affixed to the implantation site at a first location and the second piece of material affixed to the implantation site at the second location. In further implementations, the first piece of material and the second piece of material are configured to be tied together. In some implementations, the graft is configured to be affixed to the implantation site at the first and second locations.
[0015] In some implementations, at least one of the first guiding lumen and the second guiding lumen includes a first lumen segment and a second lumen segment. In further implementations, the suture is a sliding suture.
[0016] In another aspect, a method of arthroscopic insertion of a graft to an implantation site within a body of a patient is disclosed. In some embodiments, the graft can include a substantially flat portion defined by at least a first edge, a second edge, and a third edge, a first guiding lumen disposed along the first edge, a second guiding lumen disposed along the second edge, and a leading lumen disposed along the third edge, each of the first guiding lumen, the second guiding lumen, and the leading lumen can be configured to receive a suture wherein the third edge is substantially perpendicular to the first edge and the second edge such that the leading lumen is substantially perpendicular to the first guiding lumen and the second guiding lumen. The method can further include placing a suture into the first guiding lumen, the second guiding lumen, and the leading lumen of a graft, the suture being affixed to the implantation site at at least a first location along a length of the suture and a second location along the length of the suture. The method can further include pulling on the suture such that the graft travels along the suture and through an incision to the implantation site.
[0017] In some implementations, the third edge is a distal edge of the graft such that the leading lumen is disposed along a portion of the distal edge of the graft. In further implementations, the third edge is a proximal edge of the graft such that the leading lumen is disposed along a portion of the proximal edge of the graft.
[0018] In some implementations, the method further includes pulling the suture a first amount such that the graft moves from a first flat configuration to a compressed configuration, and pulling the suture a second amount such that the graft moves from the compressed configuration to a second flat configuration.
[0019] In some implementations, the graft includes an electrospun material. In further implementations, the first edge and the second edge are approximately twenty millimeters long and the third edge is approximately thirty millimeters long. In further implementations, in the compressed configuration, the graft is sized to fit through a cannula and through an incision having a length between approximately five millimeters and approximately eight millimeters.
[0020] In some implementations, the graft includes a biocompatible material. In some implementations, the portion of the first edge is less than a length of the first edge, the portion of the second edge is less than a length of the second edge, and the portion of the third edge is less than a length of the third edge.
[0021] In further implementations, the graft of the method further includes a fourth edge and a backout lumen disposed along a portion of the fourth edge. In some implementations, a length of the leading lumen is at least eighty percent of a length of the first guiding lumen and a length of the second guiding lumen. In some implementations, the leading lumen has a length of at least approximately eighteen millimeters.
[0022] In further implementations, the suture includes a continuous suture affixed to the implantation site at at least a first location along a length of the suture and a second location along the length of the suture. In some implementations, the suture includes a first piece of material and a second piece of material, the first piece of material affixed to the implantation site at a first location and the second piece of material affixed to the implantation site at the second location. In some implementations, the method further includes tying the first piece of material and the second piece of material together.
[0023] In further implementations, the graft is configured to be affixed to the implantation site at the first and second locations. In some implementations, at least one of the first guiding lumen and the second guiding lumen includes a first lumen segment and a second lumen segment. In some implementations, the suture includes a sliding suture.
[0024] In another aspect, a kit for arthroscopic insertion of a graft to an implantation site within a body of a patient is disclosed. In some embodiments, the kit includes a suture, a cannula, and a graft, the graft comprising a substantially flat portion defined by at least a first edge, a second edge, and a third edge, a first guiding lumen disposed along the first edge, a second guiding lumen disposed along the second edge, and a leading lumen disposed along the third edge. Each off the first guiding lumen, the second guiding lumen, and the leading lumen can be configured to receive the suture. The third edge can be substantially perpendicular to the first edge and the second edge such that the leading lumen is substantially perpendicular to the first guiding lumen and the second guiding lumen, and the graft is configured to travel along the suture through the cannula to the implantation site.
[0025] In an embodiment, a graft configured for arthroscopic insertion to an implantation site within a body of a patient can include a substantially tubular body defined by at least a distal end and a proximal end along a longitudinal axis. At least a first guiding lumen can be disposed along the tubular body, and a first leading lumen can be disposed along acircumference of the distal end. Each of the first guiding lumen and the first leading lumen can be configured to receive a suture. The circumference of the distal end lies in a plane that can be substantially perpendicular to the longitudinal axis such that the first leading lumen is substantially perpendicular to the first guiding lumen.
[0026] In some implementations, the graft further includes a second guiding lumen disposed along the tubular body. In some implementations, at least the first guiding lumen is disposed within the tubular body. In further implementations, the graft includes an electrospun material.
[0027] In some implementations, the circumference of the distal end of the substantially tubular body has a length of between about 15 millimeters and about 30 millimeters. In some implementations, the graft is sized to fit through a cannula and through an incision having a length between approximately five millimeters and approximately eight millimeters. In further implementations, the graft includes a biocompatible material.
[0028] In some implementations, the graft further includes a second leading lumen disposed along the circumference of the distal end of the tubular body. In some implementations, the first leading lumen extends along a first segment of the circumference of the distal end of the tubular body, and the second leading lumen extends along a second segment of the circumference of the distal end of the tubular body.
[0029] In further implementations, the graft further includes a backout lumen disposed along a circumference of the proximal end of the tubular body. In some implementations, the suture includes a continuous suture affixed to the implantation site at at least a first location along a length of the suture and a second location along the length of the suture. In some implementations, the suture includes a first piece of material and a second piece of material, the first piece of material affixed to the implantation site at a first location and the second piece of material affixed to the implantation site at the second location. In further implementations, the first piece of material and the second piece of material are configured to be tied together. In some implementations, the graft is configured to be affixed to the implantation site at the first and second locations. In some implementations the suture is a sliding suture.
[0030] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS
[0031] The accompanying drawings, which are incorporated in and constitute a part of this specification, show certain aspects of the subject matter disclosed herein and, together with the description, help explain some of the principles associated with the disclosed implementations. In the drawings,
[0032] FIGs. 1A and IB show illustrative embodiments of grafts having four sides for arthroscopic insertion to an implantation site within a body of a patient;
[0033] FIG. 1C shows illustrative embodiments of grafts having three sides for arthroscopic insertion to an implantation site within a body of a patient;
[0034] FIGs. 2A-2D show the insertion of a graft into an implantation site within a body of a patient;
[0035] FIG. 3 describes an exemplary method of insertion of a graft in accordance with embodiments described herein;
[0036] FIGs. 4A and 4B show additional exemplary embodiments of grafts for insertion into an implantation site within a body of a patient;
[0037] FIG. 5 shows an exemplary device used in loading a lumen through an exemplary graft;
[0038] FIGs. 6A-6L show insertion of an exemplary graft to an anatomical site within a patient in accordance with embodiments described herein; and
[0039] FIGs. 7A-7C show removal of an exemplary graft having a fourth lumen from an anatomical site.
[0040] When practical, similar reference numbers denote similar structures, features, or elements.DETAILED DESCRIPTION
[0041] Described herein are various embodiments and related methods of grafts configured for arthroscopic insertion into a patient. Such grafts can be used to facilitate tendon ingrowth onto bone in, for example, repair of a rotator cuff.
[0042] The present disclosure describes various embodiments of grafts having lumen geometries that are configured to facilitate compression of the graft during introduction of the graft into a patient by directing tension forces exerted on the grafts by the sutures. The lumen geometries described herein further obviate the need for additional introducers, as they allow grafts to be introduced directly to an implantation site within a patient by travelling along the sutures when the sutures are pulled by a physician. Grafts as described herein thus have geometries that simplify introduction thereof into the patient. As used herein, the term “lumen”describes an aperture or looped aperture that may be configured to receive a suture or any mechanism for introducing, advancing / shuttling, removing, fixing, and compression a graft to / from / at an implantation site. Further, the term “graft” describes any device, including, but not limited to, sponges, scaffolds, and meshes that may be configured for implantation with a body of a patient and that may augment the strength, healing, and / or regeneration of native tissue once implanted. Grafts as described herein may be configured to deliver a healing agent to an implantation site to augment the strength, healing, and / or regeneration of native tissue once implanted.
[0043] The lumen geometries also facilitate the affixation and implantation of the graft at the implantation site. Once implanted, the geometries described herein ensure that the tensional forces exerted on the graft by the sutures once the graft is in vitro spread the graft over the implantation site in the desired manner. Further, the described geometries help to compress the graft onto the native tissue of the implantation site and facilitate this compression while avoiding point fixation and bunching of an implanted graft. By ensuring that the multidimensional tensional forces are distributed across the graft upon implantation, the described lumen and graft geometries help to ensure longevity of the graft.
[0044] The lumen and graft geometries described herein allow the same sutures to be used both for introduction of the graft to an implantation site and for affixation of the graft to the implantation site. The geometries described thus obviate the need to introduce the graft with an additional introducer, and eliminate any potential foreign bodies (e.g., staples) that would otherwise be used to fixation of the graft to the implantation site. The grafts described herein thus lead to improved ease of introduction and implantation while improving patient outcomes.
[0045] The present disclosure further describes various embodiments of a method of arthroscopic introduction of a graft into an implantation site within a patient. The methods describe herein allow for introduction of a graft using only the suture or sutures that are also used to affix the graft to the implantation site, without the need of an additional introducer.
[0046] Referring now to FIG. 1A, there is illustrated a graft 100 in accordance with embodiments described herein. The graft 100 includes a substantially flat portion 102 defined by at least a first edge 104, a second edge 106, and a third edge 108. A first guiding lumen 110 is disposed along a portion of the first edge 104. A second guiding lumen 112 is disposed along at least a portion of the second edge 106. A leading lumen 114 is disposed along at least a portion of the third edge 108. Each of the first guiding lumen 110, the second guiding lumen 112, and the leading lumen 114 is configured to receive a suture 116. As described further below with respect to FIGs. 6A-6L, suture 116 may comprise a single suture or at least twosutures. The third edge 108 is substantially perpendicular to the first edge 104 and the second edge 106 such that the leading lumen 114 is substantially perpendicular to the first guiding lumen 110 and the second guiding lumen 112. As described herein, each of the first guiding lumen 110, the second guiding lumen 112, and the leading lumen 114 facilitates the introduction of the graft 100 into the implantation site by guiding the graft 100 to the appropriate location in the patient’s body. Further, each of the first guiding lumen 110, the second guiding lumen 112, and the leading lumen 114 is configured to help spread the graft 100 out over an implantation site once the graft 100 is introduced into the implantation site. As also described herein, each of the first guiding lumen 110, the second guiding lumen 112, and the leading lumen 114 is configured to compress the graft 100 against the implantation site upon implantation.
[0047] As shown in FIG. 1A, in certain embodiments, the first guiding lumen 110 is disposed along an entire length LI of the first edge 104, the second guiding lumen 112 is disposed along an entire length L2 of the second edge 106, and the leading lumen 114 is disposed along an entire length L3 of the third edge 108.
[0048] In some implementations, the graft 100 of FIG. 1A further includes a fourth edge 113 along a portion of which there may be disposed a backout lumen 115. The backout lumen 115 can be used to remove the graft 100 from an implantation site, as described further below with respect to FIG. 2 and FIGs. 6A-6L. Further, when the graft 100 is fixated at an implantation site, each of the lumens 110, 112, 114, and 115 can provide compression of the graft onto the native tissue at the implantation site.
[0049] Referring now to FIG. IB, there is illustrated a graft 130 in accordance with embodiments described herein. The graft 130 includes a substantially flat portion 102 defined by at least a first edge 104, a second edge 106, and a third edge 108. A first guiding lumen 110 is disposed along a portion of the first edge 104. A second guiding lumen 112 is disposed along at least a portion of the second edge 106. A leading lumen 114 is disposed along at least a portion of the third edge 108. Each of the first guiding lumen 110, the second guiding lumen 112, and the leading lumen 114 is configured to receive a suture 116. The third edge 108 is substantially perpendicular to the first edge 104 and the second edge 106 such that the leading lumen 114 is substantially perpendicular to the first guiding lumen 110 and the second guiding lumen 112. The graft 130 further includes fourth edge 113.
[0050] As shown in FIG. IB, in certain embodiments, the first guiding lumen 110 is disposed along a portion of length LI of first edge 104, the second guiding lumen 112 is disposed along a portion of length L2 of second edge 106, and the leading lumen 114 isdisposed along a portion of length L3 of third edge 108. In some implementations, the portion of length LI of the first edge 104 along which the first guiding lumen 110 is disposed may be between approximately fifty percent of the length LI of the first edge 104 and one hundred percent of the length LI of the first edge 104. In further implementations, the portion of length L2 of the second edge 106 along which the second guiding lumen 112 is disposed may be between approximately fifty percent of the length L2 of the second edge 106 and one hundred percent of the length L2 of the second edge 106. In further implementations, the portion of length L3 of the third edge 108 along which the leading lumen 114 is disposed may be between approximately fifty percent of the length L3 of the third edge 108 and one hundred percent of the length of L3 of the third edge 108.
[0051] In the embodiments described in FIGs. 1A and IB, the third edge 108 is a distal edge of graft 100 and graft 130 such that the leading lumen 114 is disposed along the distal edge 108 of graft 100 (e.g., disposed along the entire length L3) and graft 130 (e.g., disposed along a portion of length L3).
[0052] Each of the first guiding lumen 110, the second guiding lumen 112, and the leading lumen 114 (“the lumens 110, 112, 114”) may, in general, be disposed along any suitable portion of the lengths LI, L2, and L3 of the first edge 104, the second edge 106, and the third edge 108 (“the edges 104, 106, 108”), respectively. The portion of the lengths LI, L2, and L3 of the respective first edge 104, second edge 106, and third edge 108 along which the lumens 110, 112, 114 are disposed may be selected based on the procedure for which graft 100 or graft 130 is intended to be used.
[0053] By configuring each of the lumens 110, 112, 114 so as to be disposed along a particular portion of the lengths LI, L2, and L3 of the respective edges 104, 106, 108, the forces exerted by the suture 116 on the graft 100 or the graft 130 can be controlled during introduction of the graft 100 or the graft 130 to an implantation site within a patient. By controlling these forces, the graft 100 or the graft 130 can be configured to move from a first unfurled or flat configuration to a compressed (i.e., rolled-up or substantially cylindrical) configuration for passage through a cannula and an incision, and from the compressed configuration to a second unfurled or flat configuration for affixation at the implantation site when the suture 116 is pulled, as described further below with respect to FIGs. 2A-2D. The first unfurled or flat configuration of graft 100 or graft 130 may resemble the second unfurled or flat configuration of graft 100 or graft 130. Factors such as the implantation site, the material (i.e., tissue type) of the implantation site, the incision size, and the severity of the injury being treated byinsertion of the graft 100 or the graft 130 may necessitate a graft with lumens of particular length, relative to the lengths LI, L2, and L3 of the edges 104, 106, and 108.
[0054] In some implementations, the length LI of the first edge 104 and the length L2 of the second edge 106 are between about five millimeters and about ninety millimeters. In certain implementations, the length LI of the first edge 104 and the length L2 of the second edge 106 are between about five millimeters and about sixty millimeters. In further implementations, the length LI of the first edge 104 and the length L2 of the second edge 106 are between about fifty millimeters and about ninety millimeters. In further implementations, the length LI of the first edge 104 and the length L2 of the second edge 106 are between about twenty millimeters and about fifty millimeters. In certain implementations, the length LI of the first edge 104 and length L2 of the second edge 106 are between approximately seventeen millimeters long and approximately twenty-three millimeters long. In some implementations, the length LI of the first edge 104 and the length L2 of the second edge are approximately twenty millimeters long. In further implementations, the length L3 of the third edge 108 is between approximately twenty-seven millimeters and approximately thirty-three millimeters. In certain implementations, the length L3 of the third edge 108 is approximately thirty millimeters. In general, the dimensions of the grafts described herein may be selected in accordance with the procedure for which the graft is intended (e.g., rotator cuff repair, Achilles tendon repair, ACL repair, or the like). In some implementations, any of the edges 104, 106, and 108 may have a length of between about 5 millimeters and about 90 millimeters.
[0055] The relative lengths of the lumens 110, 112, and 114 (i.e., the relative lengths of the portions of LI, L2, and L3 along which the lumens 110, 112, and 114 are respectively disposed) may similarly be selected in order to control the forces that the suture 116 exerts on the graft 100 or 130 upon the introduction and implantation of such a graft into a body of a patient. By controlling the forces that the suture 116 exerts on the graft 100 or 130 during introduction and implantation, graft 100 or 130 can be brought from a first unfurled or flat configuration to a compressed (i.e., rolled-up or substantially cylindrical) configuration for passage through a cannula and an incision, and from the compressed configuration to a second unfurled or flat configuration for affixation at the implantation site.
[0056] In certain implementations, a length of the leading lumen 114 may be at least eighty percent of a length of the first guiding lumen 110 and a length of the second guiding lumen 112. In some embodiments, a length of the leading lumen 114 may be at least fifty percent of a length of the first guiding lumen 110 and a length of the second guiding lumen 112. Ingeneral, the leading lumen 114 may be configured to have a length of approximately eighteen millimeters.
[0057] FIG. 1C shows graft 150 comprising first edge 104 and second edge 106 bounding substantially flat portion 102. Similar to the grafts described in FIGs. 1A and IB, graft 150 includes a first guiding lumen 110 disposed along a portion of the length LI of first edge 104 and a second guiding lumen 112 disposed along a portion of the length L2 of second edge 106. As shown in FIG. 1C, graft 150 includes a third edge 118. A leading lumen 120 may be disposed along a portion of length L3 of third edge 118. In the embodiment of FIG. 1C, third edge 118 is aproximal edge of graft 150 such that leading lumen 120 is disposed along a portion of the length L3 of the proximal edge 118 of graft 150. In general, each of the lumens 110, 112, 114, and 120 may be disposed along any suitable portions of their respective edges and may be configured to at least be disposed against the comers of their respective edges. By disposing each of the lumens 110, 112, 114, and 120 against the comers of their respective edges, the grafts described herein are configured to unfurl upon implantation in a patient and to be anchored in place by their comers, as described further herein. In this way, each of the lumens 110, 112, 114, and 120 aid in the guiding of the graft 100 to the implantation site, the spreading out of the graft 100 at the implantation site, and the compression of the graft 100 against the implantation site once spread out.
[0058] FIGs. 2A-2D show an example insertion of graft 100 into an implantation site 101 within the body of a patient. The graft 100 may be, for example, any of the grafts 100, 130, or 150 of FIGs. 1A-1C, or grafts 170 and 180 of FIGs. 4A-4B, described further below.
[0059] As shown in FIG. 2A, the suture 116 is affixed to the implantation site 101 at a first location 127 and at a second location 128. The suture 116 may have, as shown in the illustrative embodiment of FIGs. 2A-2D, segments 122, 123, 124, and 125. The dashed lines at locations 127 and 128 represent that suture 116 is disposed at least in part along the underside of the tissue of implantation site 101. Suture 116 is configured as a sliding suture, such that it can move relative to the implantation site 101 to which it is affixed when pulled on by a physician, as described herein.
[0060] In certain implementations, the suture 116 includes at least two pieces of material (e.g., the segments 122 and 123 of the suture 116 are formed of a first continuous piece of material and the segments 124 and 125 of suture 116 are formed of a second continuous piece of material). In some implementations, the suture 116 is a continuous suture (i.e., each of the segments 122, 123, 124, and 125 of the suture 116 is formed of the same, continuous piece of material. As described further below with respect to FIG. 6, in implementations in which thesuture 116 is a continuous suture, the graft 100 may still be configured to receive at least two pieces of suture material during introduction of the graft 100 to implantation site 101, and the two pieces of suture material may then be tied together and drawn through the lumens 110, 112, and 114 of graft 100 such that a continuous piece of material comprising segments 122 and 123 of suture 116 runs through the lumens of graft 100 during implantation.
[0061] As shown in FIG. 2B, the graft 100 having a substantially flat portion 102 is configured to receive the suture 116. Each of the segments 122, 123, 124, and 125 of suture 116 are configured to help introduce and affix graft 100 to the implantation site 101. As described further below, shuttling the appropriate segments 122, 123, 124, and 125 through lumens 110, 112, 114, and 115 allows a physician to introduce graft 100 to implantation site 101.
[0062] In implementations in which the suture 116 includes a first piece of material and a second piece of material, the first piece of material comprising the segments 122 and 123 of the suture 116 is configured to be affixed to the implantation site 101 at the first location 127, and the second piece of material comprising the segments 124 and 125 of the suture 116 is configured to be affixed to the implantation site 101 at the second location 128. When the segments 122 and 125 of the suture 116 are pulled proximally to a practitioner, the affixation of the suture 116 to the first location 127 and the second location 128 provides resistance to the pulling. This resistance causes the graft 100 to travel in a direction distal to the practitioner, into the patient to implantation site 101 upon the pulling of the suture 116.
[0063] As further shown in FIG. 2C, the graft 100 is configured to move from a first flat configuration to a compressed configuration when the suture 116 is pulled a first amount proximally towards a practitioner (as indicated by arrows). As shown in FIG. 2C, a compressed configuration may be one in which each of the sides of the graft 100 curves inwards towards a center of the flat portion 102 in a plane defined by flat portion 102. A compressed configuration of the graft 100 may be one, for example, in which the graft 100 is rolled into a cylindrical shape along a longitudinal or central axis of the flat portion 102. A compressed configuration of the graft 100 may be one, for example, in which the graft 100 is rolled into a C- shape along a longitudinal or central axis of the flat portion 102. A compressed configuration of the graft 100 may be one, for example, in which the graft 100 rolls into a C- shape while each of the sides of the graft 100 also curves inwards towards the center of the flat portion 102 in a plane defined by the flat portion 102. As further shown in FIG. 2C, in the compressed configuration, the graft 100 is sized to fit through a cannula 126. The cannula 126 is disposed within an incision in the patient’s body. In some embodiments, the graft 100 is sized to fit in a cannula126 disposed within an incision having a length between about five millimeters and about eight millimeters. In general, any appropriate arthroscopic portal to implantation site 101 may be used. In some implementations, the graft 100 may be sized to fit in a cannula 126 having a diameter of between about 2.5 millimeters and about 15 millimeters. In certain implementations, the graft 100 may be sized to fit in a cannula 126 having a diameter of between about 5 millimeters and about 10 millimeters. The cannula 126 may comprise a retractable fluid dam to prevent leakage of fluid from a patient’s body upon insertion of graft 100 into implantation site 101. In certain implementations, the cannula 126 may be used in conjunction with a graft compressor to introduce graft 100 to an implantation site 101. A graft compressor can help compress graft 100 for passage through a fluid dam of a cannula such as cannula 126.
[0064] As then shown in FIG. 2D, the graft 100 is configured to move from the compressed configuration to a second flat configuration when the suture 116 is pulled a second amount proximally towards a practitioner (as indicated by arrows). The first flat configuration may resemble the second flat configuration. As discussed above, the relative lengths of the lumens 110, 112, and 114 can be configured to ensure that, once implanted, the graft 100 can withstand multidirectional tension forces exerted on the graft 100 by the suture 116. In general, increasing the lengths of the lumens 110, 112, and 114 facilitates both the movement of the graft 100 from the compressed configuration to the second flat configuration, and the subsequent affixation of the graft 100 at implantation site 101. While FIG. 2D shows that graft 100 is affixed to the implantation site 101 at two corners, in general, the locations 127 and 128, as well as the lumen geometry of the graft 100, can be selected to affix graft 100 to the implantation site 101 via any suitable part of the graft 100.
[0065] FIG. 3 illustrates an exemplary method 300 of arthroscopic insertion of a graft to an implantation site within a body of a patient. The graft inserted into the body of the patient according to the method 300 may be graft 100, 130, 150, 170, or 180 of any of FIGs. 1A-1C, 2A-2D, and 4A-4B. The graft of the method 300 includes a substantially flat portion defined by at least a first edge, a second edge, and a third edge. The graft of the method 300 further includes a first guiding lumen disposed along the first edge, a second guiding lumen disposed along the second edge, and a leading lumen disposed along the third edge, each of the first guiding lumen, the second guiding lumen, and the leading lumen configured to receive a suture. In some embodiments, the third edge of the graft of method 300 is substantially perpendicular to the first edge and the second edge of the graft of method 300 such that the leading lumen is substantially perpendicular to the first guiding lumen and the second guiding lumen. The sutureof the method 300 may be, for example suture 116 of any of FIGs. 1A-1C and 2A-2D. The suture of the method 300 may be a sliding suture, as described above, such that the suture of the method 300 can move relative to the implantation site when segments of the suture are pulled by a physician, as described herein.
[0066] In some embodiments, the method includes step 302 of placing a suture into the first guiding lumen, the second guiding lumen, and the leading lumen of a graft, the suture being affixed to the implantation site at at least a first location along a length of the suture and a second location along the length of the suture.
[0067] In certain embodiments, the method further includes step 304 of pulling on the suture such that the graft travels along the suture and through an incision to the implantation site. As described above with respect to FIGs. 2A-2D, as an exemplary graft in accordance with the embodiments described herein travels along the suture and through an incision to the implantation site, the graft is configured to move from a first flat configuration into a compressed configuration for passage through a cannula and an incision. Thereafter, the graft is configured to unfurl from the compressed configuration into a second flat configuration for implantation at the implantation site. Once in the second flat configuration, the lumen geometries facilitate compression of the graft against the native tissue at the implantation site. The lumen geometries provide this compression while avoiding point fixation of the graft at the implantation site and preventing scrunching or bunching of the graft once implanted. The embodiments described herein this improve graft longevity and patient outcomes.
[0068] As described above, performing method 300 with any of the exemplary grafts 100, 130, and 150 facilitates introduction of the graft into the patient without the need for an additional introducer. The graft 100, 130, and 150 has lumen geometries configured to direct the forces caused by the pulling of suture 116 onto the graft such that the graft moves from the first flat configuration into the compressed configuration for passage through a cannula and an incision, and thereafter into a second flat configuration for implantation at the implantation site. The lumen geometries as described herein also ensure that the graft, once delivered to the implantation site via method 300, is able to withstand the tensional forces exerted on the graft by the suture to which the graft is subject during its implantation and use.
[0069] FIG. 4A shows an exemplary graft 170 in accordance with embodiments as described herein. FIG. 4A shows the graft 170 having guiding lumens 110 and 112, as described above with respect to FIGs. 1A-1C. As shown in FIG. 4A, the first guiding lumen 110 can include a first lumen segment 110a separated from a second lumen segment 110b by a first spacing distance and / or the second guiding lumen 112 can include a third lumen segment112a separated from a fourth lumen segment 112b by a second spacing distance. For example, the first spacing distance and the second spacing distance can be the same or different in length, and such length can be approximately 1 millimeter (mm) to approximately 5 mm. Other lengths are within the scope of this disclosure. In general, any of the guiding lumens 110 and 112 and the leading lumen 114 can be divided into any suitable number of segments and can be separated by a spacing distance of any appropriate size. Each of the lumen segments of each of the guiding lumens 110 and 112 and leading lumen 114 can be disposed against a corner of the graft 170 so that the graft 170 can unfold and be anchored to an implantation site at its comers, as described further with respect to FIGs. 6A-6L.
[0070] FIG. 4B shows an exemplary graft 180 in accordance with embodiments described herein. The graft 180 of FIG. 4B includes a tubular body 182 having distal end 184 and proximal end 185. The distal end 184 of the tubular body 182 of the graft 180 includes a circumference 186 having a leading lumen 188 configured to receive a suture, such as suture 116 of FIGs. 1A-1C. Suture 116 can be used to introduce the graft 180 into the implantation site 101, as described with respect to FIGs. 1A-1C, 2A-2D, and 6A-6L.
[0071] The circumference 186 of tubular body 182 may comprise any number of leading lumens 188 disposed circumferentially thereon. Each of the leading lumens 188 may be separated by any suitable spacing along the circumference 186 of tubular body 182 of graft 180. The graft 180 of FIG. 4B also includes at least a first guiding lumen 110, but may comprise two guiding lumens 110 and 112, as described above with respect to FIGs. 1A-1C. Each of the first and second leading lumens 188 may extend along a respective segment of the circumference 186 of the distal end 184 of the tubular body 182 of the graft 180. For example, the first leading lumen 188 may extend along a first segment of the circumference 186 of the distal end 184 of the tubular body 182 of the graft 180, and the second leading lumen 188 may extend along a second segment of the circumference 186 of the distal end 184 of the tubular body 182 of the graft 180. The circumference 186 of tubular body 182 may have a length between about 15 millimeters and about 30 millimeters. In some implementations, tubular body 182 may have a length of between about 5 millimeters and 150 millimeters. In some implementations, tubular body 182 may have a length of between about 20 millimeters and 130 millimeters. In some implementations, tubular body 182 may have a length of between about 40 millimeters and 110 millimeters. In some implementations, tubular body 182 may have a length of between about 60 millimeters and 90 millimeters. In some implementations, tubular body 182 may have a length of about 75 millimeters.
[0072] The circumference 186 of tubular body 182 may be configured to lie in a plane perpendicular to a central axis of tubular body 182. In this way, as described herein with respect to the remaining embodiments, leading lumens 188 of graft 180 are disposed perpendicularly to the guiding lumens 110 and 112. Tubular body 182 may comprise a sleeve that itself serves as a guiding lumen 110, or tubular body 182 may define a sleeve in which any number of guiding lumens 110 and 112 may be disposed for allowing one or more lengths of suture to extended therethrough for assisting with positioning and securing graft 180 at an implantation site within a patient. The guiding lumen 110 of tubular body 182 may be configured to receive a single length of suture 116. The guiding lumen 110 of tubular body 182 may also be configured to receive more than one (for example, two) lengths of suture 116 therethrough. The suture or sutures 116 received by guiding lumen 110 of tubular body 182 are used to introduce, advance, and position tubular body 182 of graft 180 to and at an implantation site with the body of a patient, as described herein. The suture or suture 116 received by guiding lumen 110 of tubular body 182 may be sliding sutures, as described above, such that they may move relative to an implantation site when pulled on by a physician, as described herein. In some implementations, graft 180 of FIG. 4B may have a backout lumen (e.g., backout lumen 115) disposed along a circumference of its proximal end. As described herein, a backout lumen may be configured to receive a suture and a physician may use a backout lumen to aid in both positioning a graft, such as graft 180 of FIG. 4B, at an implantation site, and removing a graft from an implantation site.
[0073] A tubular graft such as graft 180 of FIG. 4B may be particularly useful for procedures in which a physician wants to ensure a close abutment between the distal end 184 of the tubular body 182 of the graft 180 and the implantation site, such as implantation site 101 of FIGs. 2A-2D. In some embodiments, the graft 180 of FIG. 4B may be a substantially hollow cylinder packaged for use with a needle disposed down a central axis of tubular body 182. In such embodiments, the needle may have, at a distal end, a suture shuttle or device for engaging a suture, and when a physician pulls proximally on the needle, the suture may be drawn through tubular body 182 of graft 180 to create the guiding lumen 110.
[0074] The grafts 100, 130, 150, 170, and 180 of FIGs. 1A-1C and 4A-4B may comprise an electrospun material. Electrospun materials are configured to withstand the multidirectional tension forces to which the grafts are subject upon implantation within a patient, and thus provide increased graft reliability and lifetime. The grafts 100, 130, 150, 170, and 180 of FIGs. 1A-1C and 4A-4B may further comprise a biocompatible material. The grafts 100, 130, 150, 170, and 180 of FIGs. 1A-1C and 4A-4B may further comprise an allograft. The grafts 100,130, 150, 170, and 180 of FIGs. 1A-1C and 4A-4B may further comprise a scaffold, a mesh, or a sponge.
[0075] FIG. 5 shows an exemplary packaging of the grafts described in embodiments herein. The graft 100 of FIG. 5 may be any of grafts 100, 130, 150, 170, and 180 of FIGs. 1A- 1C and 4A-4B. As shown in FIG. 5, graft 100 may be packaged with fork 502 having prongs 504 and 506. Graft 100 of FIG. 5 may be packaged with prong 504 in a lumen 110 of graft 100 and with prong 506 in a lumen 112 of graft 100. Lumen 110 of graft 100 of FIG. 5 may be, for example, the first guiding lumen 110 of FIG. 1. Lumen 112 of graft 100 of FIG. 5 may be, for example, the second guiding lumen 112 of FIG. 1. Prongs 504 and 506 are slotted as shown so that a suture, such as suture 116 of FIG. 1 can be easily inserted into and removed from lumens 110 and 112. A physician may hold a proximal end of fork 502 to remove fork 502 from graft 100 once sutures are loaded into lumens 110 and 112, as described herein. The use of fork 502 in the packaging of an exemplary graft 100 is anchor and suture agnostic: it can be used to package graft 100 regardless of the anchor that is ultimately used to fix the graft 100 to an implantation site within a patient (e.g., if the graft 100 is affixed directly via the suture 116 to implantation site 101 and / or if the graft 100 is affixed to bone by a bone anchor), and can be used to insert any suture 116 through lumens 110 and 112.
[0076] FIGs. 6A-6L demonstrate the insertion of an exemplary graft 100 as described herein to an implantation site 101 within a patient. The graft 100 of FIGs. 6A-6L may be any of the exemplary grafts 100, 130, and 150 as described above. The graft of FIGs. 6A-6L comprises a substantially flat portion 102 defined by at least a first edge 104, a second edge 106, and a third edge 108. A first guiding lumen 110 is disposed along a portion of the first edge 104. A second guiding lumen 112 is disposed along at least a portion of the second edge 106. A leading lumen 114 is disposed along at least a portion of the third edge 108. Each of the first guiding lumen 110, the second guiding lumen 112, and the leading lumen 114 is configured to receive a suture 116. The third edge 108 is substantially perpendicular to the first edge 104 and the second edge 106 such that the leading lumen 114 is substantially perpendicular to the first guiding lumen 110 and the second guiding lumen 112.
[0077] In the embodiments of FIGs. 6A-6L, suture 116 comprises two sutures 116a and 116b. In FIG. 6A, sutures 116a and 116b are affixed to implantation site 101 within a patient. Suture 116a comprises segments 122 and 123. Suture 116b comprises segments 124 and 125. The sutures 116a and 116b may be affixed to implantation site 101 at respective locations at which the comers of a graft may be configured to be disposed. While a particular series of steps for insertion of the graft 100 is outlined in FIGs. 6A-6L, sutures 116a and 116b can beinserted into the lumens of graft 100 in any suitable manner, so long as graft 100 is able to slide along the sutures 116a and 116b when segments thereof are pulled by a physician, as described herein.
[0078] As shown in FIG. 6B, device 606 is configured to be inserted through the first guiding lumen 110 of the graft 100 in order to secure segment 122 of suture 116a. Device 606 of FIG. 6B may be, for example, a wire loop, or any other device or material configured to secure a suture, such as suture 116a.
[0079] FIG. 6C illustrates that device 606 can be pulled proximate a physician in order to draw the suture 116a through the first guiding lumen 110 of the graft 100. In FIG. 6D, device 606 (which may be the same device 606 of FIG. 6C) is similarly inserted through the leading lumen 114 of the graft 100. FIG. 6E shows that device 606 secures segment 123 of suture 116a, and FIG. 6F shows that by pulling the device 606 through the leading lumen 114 of the graft 100, suture 116a is drawn through the leading lumen 114.
[0080] FIG. 6G shows that segment 123 of suture 116a is tied to segment 124 of suture 116b. A physician inserting graft 100 to implantation site 101 can optionally either pull on segment 125 of suture 116b, such that suture 116b is entirely drawn out of the implantation site 101 and a knot formed by tying suture 116a and suture 116b together is drawn all the way through the insertion site of suture 116b, or the physician can keep suture 116b in vitro.
[0081] The sutures 116a and 116b of FIGs. 6A-6L may be sliding sutures, such that they may move relative to implantation site 101 when pulled on by a physician. In FIG. 6H, it is seen that by virtue of a physician pulling suture 116b entirely out of the implantation site 101, suture 116a has been pulled through the insertion sites initially occupied by suture 116b. In FIG. 61, a device 606 is inserted into second guiding lumen 112 and secures segment 125 of suture 116b. In FIG. 6J, a physician pulls on device 606 such that suture 116b is drawn through second guiding lumen 112. In FIG. 6K, a physician pulls on segment 122 of suture 116a and segment 123 of suture 116a such that graft 100 is shuttled towards the implantation site 101. As discussed above with respect to FIGs. 2A-2D, as the graft 100 is shuttled through a cannula towards implantation site 101, the graft 100 moves from a first flat configuration (as shown in FIGs. 6A-6K) to a compressed configuration (for passage through a cannula as discussed above with respect to FIGs. 2A-2D) to a second flat configuration. FIG. 6L shows graft 100 disposed at implantation site 101 in the second flat configuration. Once the graft 100 is in vitro, the tension on the lateral anchors provided by sutures 116a and 116b helps keep graft 100 spread out and implanted in a flat configuration. As described above, the tension on the lateral anchors provided by sutures 116a and 116b also help to compress the graft against native tissue onceimplanted, while avoiding point fixation of the graft to the tissue and preventing bunching or scrunching of the graft upon implantation. The lumen geometries described herein thus improve patch longevity and patient outcomes.
[0082] Segments 122 and 123 of the suture 116a can be anchored in any appropriate manner, including into tissue or into a hard bone anchor. In general, embodiments of the grafts, such as graft 180, as described herein and / or certain procedures that use the exemplary sutures grafts may not need to dispose the graft in a flattened configuration but can achieve a flattened configuration of the graft as needed.
[0083] As shown in FIG. 7A, in some embodiments, graft 100 has an optional fourth backout lumen, such as backout lumen 115 of FIG. 1A. To remove graft 100 from implantation site 101, or to aid in altering the position of graft 100 at implantation site 101, a device 606 may be inserted into lumen 115 and may be used to secure a suture for insertion into lumen 115. The suture for insertion into lumen 115 may be a new suture, not previously used in the insertion of the graft 100 to implantation site 101, or may be segment 125 of suture 116b. As shown in FIG. 7B, device 606 is drawn through lumen 115 such that segment 125 of suture 116b is drawn through lumen 115. As shown in FIG. 7C, pulling on the segment 125 of suture 116b moves the graft 100 backwards along the suture 116a (in embodiments in which a non- continuous suture is used, a new suture may be drawn through lumen 115 such that the backwards motion occurs along suture 116b).
[0084] Advantageously, described herein are systems and methods for arthroscopic insertion of grafts that allows simple introduction into a patient of a graft capable of withstanding multidimensional tensioning. Such simple introduction may be enabled by a particular configuration of leading and guiding lumens, as described herein. These lumen configurations eliminate the need to burdensome introducers, and simplify introduction and implantation of grafts into patients while easing the fixation of the graft to the ultimate implantation site by controlling the multidirectional tension applied on the graft by the sutures.
[0085] While the present disclosure is described in relation to a graft for treatment of a rotator cuff, the systems and methods described herein are usable with any medical or therapeutic devices that utilize an implantable graft.
[0086] In the descriptions above and in the claims, phrases such as “at least one of’ or “one or more of’ may occur followed by a conjunctive list of elements or features. The term “and / or” may also occur in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such a phrase is intended to mean any of the listed elements or features individually or any of the recited elements orfeatures in combination with any of the other recited elements or features. For example, the phrases “at least one of A and B;” “one or more of A and B;” and “A and / or B” are each intended to mean “A alone, B alone, or A and B together.” A similar interpretation is also intended for lists including three or more items. For example, the phrases “at least one of A, B, and C;” “one or more of A, B, and C;” and “A, B, and / or C” are each intended to mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.” Use of the term “based on,” above and in the claims is intended to mean, “based at least in part on,” such that an unrecited feature or element is also permissible.
[0087] The implementations set forth in the foregoing description do not represent all implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the described subject matter. Although a few variations have been described in detail herein, other modifications or additions are possible. In particular, further features and / or variations can be provided in addition to those set forth herein. For example, the implementations described above can be directed to various combinations and sub-combinations of the disclosed features and / or combinations and subcombinations of one or more features further to those disclosed herein. In addition, the logic flows depicted in the accompanying figures and / or described herein do not necessarily require the particular order shown, or sequential order, to achieve desirable results. The scope of the following claims may include other implementations or embodiments.
Claims
CLAIMSWhat is claimed is:
1. A graft configured for arthroscopic insertion to an implantation site within a body of a patient, the graft comprising: a substantially flat portion defined by at least a first edge, a second edge, and a third edge; a first guiding lumen disposed along a portion of the first edge, a second guiding lumen disposed along a portion of the second edge, and a leading lumen disposed along a portion of the third edge, each of the first guiding lumen, the second guiding lumen, and the leading lumen configured to receive a suture; wherein the third edge is substantially perpendicular to the first edge and the second edge such that the leading lumen is substantially perpendicular to the first guiding lumen and the second guiding lumen.
2. The graft of claim 1, wherein the third edge is a distal edge of the graft such that the leading lumen is disposed along a portion of the distal edge of the graft.
3. The graft of claim 1, wherein the third edge is a proximal edge of the graft such that the leading lumen is disposed along a portion of the proximal edge of the graft.
4. The graft of claim 1, wherein: the graft is configured to move from a first flat configuration to a compressed configuration when the suture is pulled a first amount, and the graft is configured to move from the compressed configuration to a second flat configuration when the suture is pulled a second amount.
5. The graft of claim 1, wherein the graft comprises an electrospun material.
6. The graft of claim 3, wherein the first edge and the second edge are approximately twenty millimeters long and wherein the third edge is approximately thirty millimeters long.
7. The graft of claim 4, wherein, in the compressed configuration, the graft is sized to fit through a cannula and through an incision having a length between approximately five millimeters and approximately eight millimeters.
8. The graft of claim 1, wherein the graft comprises a biocompatible material.
9. The graft of claim 1, wherein: the portion of the first edge is less than a length of the first edge, the portion of the second edge is less than a length of the second edge, and the portion of the third edge is less than a length of the third edge.
10. The graft of claim 2, further comprising: a fourth edge; and a backout lumen disposed along a portion of the fourth edge.
11. The graft of claim 1, wherein a length of the leading lumen is at least eighty percent of a length of the first guiding lumen and a length of the second guiding lumen.
12. The graft of claim 1, wherein the leading lumen has a length of at least approximately eighteen millimeters.
13. The graft of claim 1, wherein the suture comprises a continuous suture affixed to the implantation site at at least a first location along a length of the suture and a second location along the length of the suture.
14. The graft of claim 1, wherein the suture comprises a first piece of material and a second piece of material, the first piece of material affixed to the implantation site at a first location and the second piece of material affixed to the implantation site at the second location.
15. The graft of claim 14, wherein the first piece of material and the second piece of material are configured to be tied together.
16. The graft of claim 13, wherein the graft is configured to be affixed to the implantation site at the first and second locations.
17. The graft of claim 1, where at least one of the first guiding lumen and the second guiding lumen comprises a first lumen segment and a second lumen segment.
18. The graft of claim 1, wherein the suture is a sliding suture.
19. A method of arthroscopic insertion of a graft to an implantation site within a body of a patient, the graft comprising: a substantially flat portion defined by at least a first edge, a second edge, and a third edge; a first guiding lumen disposed along the first edge, a second guiding lumen disposed along the second edge, and a leading lumen disposed along the third edge, each of the first guiding lumen, the second guiding lumen, and the leading lumen configured to receive a suture; wherein the third edge is substantially perpendicular to the first edge and the second edge such that the leading lumen is substantially perpendicular to the first guiding lumen and the second guiding lumen; the method comprising: placing a suture into the first guiding lumen, the second guiding lumen, and the leading lumen of a graft, the suture being affixed to the implantation site at at least a first location along a length of the suture and a second location along the length of the suture; pulling on the suture such that the graft travels along the suture and through an incision to the implantation site.
20. The method of claim 19, wherein the third edge is a distal edge of the graft such that the leading lumen is disposed along a portion of the distal edge of the graft.
21. The method of claim 19, wherein the third edge is a proximal edge of the graft such that the leading lumen is disposed along a portion of the proximal edge of the graft.
22. The method of claim 19, further comprising: pulling the suture a first amount such that the graft moves from a first flat configuration to a compressed configuration; andpulling the suture a second amount such that the graft moves from the compressed configuration to a second flat configuration.
23. The method of claim 19, wherein the graft comprises an electrospun material.
24. The method of claim 21, wherein the first edge and the second edge are approximately twenty millimeters long and wherein the third edge is approximately thirty millimeters long.
25. The method of claim 22, wherein, in the compressed configuration, the graft is sized to fit through a cannula and through an incision having a length between approximately five millimeters and approximately eight millimeters.
26. The method of claim 19, wherein the graft comprises a biocompatible material.
27. The method of claim 19, wherein: the portion of the first edge is less than a length of the first edge, the portion of the second edge is less than a length of the second edge, and the portion of the third edge is less than a length of the third edge.
28. The method of claim 21, wherein the graft further comprises: a fourth edge; and a backout lumen disposed along a portion of the fourth edge.
29. The method of claim 19, wherein a length of the leading lumen is at least eighty percent of a length of the first guiding lumen and a length of the second guiding lumen.
30. The method of claim 19, wherein the leading lumen has a length of at least approximately eighteen millimeters.
31. The method of claim 19, wherein the suture comprises a continuous suture affixed to the implantation site at at least a first location along a length of the suture and a second location along the length of the suture.
32. The method of claim 19, wherein the suture comprises a first piece of material and a second piece of material, the first piece of material affixed to the implantation site at afirst location and the second piece of material affixed to the implantation site at the second location.
33. The method of claim 32, further comprising tying the first piece of material and the second piece of material together.
34. The method of claim 31, wherein the graft is configured to be affixed to the implantation site at the first and second locations.
35. The method of claim 19, where at least one of the first guiding lumen and the second guiding lumen comprises a first lumen segment and a second lumen segment.
36. The method of claim 19, wherein the suture comprises a sliding suture.
37. A kit for arthroscopic insertion of a graft to an implantation site within a body of a patient, the kit comprising: a suture; a cannula; and a graft, the graft comprising: a substantially flat portion defined by at least a first edge, a second edge, and a third edge; a first guiding lumen disposed along the first edge, a second guiding lumen disposed along the second edge, and a leading lumen disposed along the third edge, each of the first guiding lumen, the second guiding lumen, and the leading lumen configured to receive the suture; wherein the third edge is substantially perpendicular to the first edge and the second edge such that the leading lumen is substantially perpendicular to the first guiding lumen and the second guiding lumen, and the graft is configured to travel along the suture through the cannula to the implantation site.
38. A graft configured for arthroscopic insertion to an implantation site within a body of a patient, the graft comprising:a substantially tubular body defined by at least a distal end and a proximal end along a longitudinal axis; at least a first guiding lumen disposed along the tubular body, and a first leading lumen disposed along a circumference of the distal end, each of the first guiding lumen and the first leading lumen configured to receive a suture; wherein the circumference of the distal end lies in a plane that is substantially perpendicular to the longitudinal axis such that the first leading lumen is substantially perpendicular to the first guiding lumen.
39. The graft of claim 38, further comprising a second guiding lumen disposed along the tubular body.
40. The graft of claim 38, wherein at least the first guiding lumen is disposed within the tubular body.
41. The graft of claim 38, wherein the graft comprises an electrospun material.
42. The graft of claim 38, wherein the circumference of the distal end of the substantially tubular body has a length of between about 15 millimeters and about 30 millimeters.
43. The graft of claim 38 wherein the graft is sized to fit through a cannula and through an incision having a length between approximately five millimeters and approximately eight millimeters.
44. The graft of claim 38, wherein the graft comprises a biocompatible material.
45. The graft of claim 38, further comprising: a second leading lumen disposed along the circumference of the distal end of the tubular body, wherein: the first leading lumen extends along a first segment of the circumference of the distal end of the tubular body, and the second leading lumen extends along a second segment of the circumference of the distal end of the tubular body.
46. The graft of claim 38, further comprising: a backout lumen disposed along a circumference of the proximal end of the tubular body.
47. The graft of claim 38, wherein the suture comprises a continuous suture affixed to the implantation site at at least a first location along a length of the suture and a second location along the length of the suture.
48. The graft of claim 38, wherein the suture comprises a first piece of material and a second piece of material, the first piece of material affixed to the implantation site at a first location and the second piece of material affixed to the implantation site at the second location.
49. The graft of claim 48, wherein the first piece of material and the second piece of material are configured to be tied together.
50. The graft of claim 48, wherein the graft is configured to be affixed to the implantation site at the first and second locations.
51. The graft of claim 38, wherein the suture is a sliding suture. 1