EP2677941A2 - Maille de suture et son procédé d'utilisation - Google Patents

Maille de suture et son procédé d'utilisation

Info

Publication number
EP2677941A2
EP2677941A2 EP12749047.2A EP12749047A EP2677941A2 EP 2677941 A2 EP2677941 A2 EP 2677941A2 EP 12749047 A EP12749047 A EP 12749047A EP 2677941 A2 EP2677941 A2 EP 2677941A2
Authority
EP
European Patent Office
Prior art keywords
suture
mesh
net
raised portions
clip
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP12749047.2A
Other languages
German (de)
English (en)
Inventor
Avinash Kumar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP2677941A2 publication Critical patent/EP2677941A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0461—Means for attaching and blocking the suture in the suture anchor with features cooperating with special features on the suture, e.g. protrusions on the suture
    • A61B2017/0462—One way system, i.e. also tensioning the suture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A61B2017/0488—Instruments for applying suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A61B2017/06176—Sutures with protrusions, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A61B2017/06185—Sutures hollow or tubular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament
    • A61F2002/0858—Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0876—Position of anchor in respect to the bone
    • A61F2002/0882—Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone

Definitions

  • the field relates to affixing sutures using a transosseous tunnel.
  • Surgical procedures and devices are known for creating transosseous tunnels for attachment of soft tissues, such as tendon and ligaments to bone. Both artificial and natural materials are attached to these soft tissues to repair them, and surgical procedures may move soft tissues from one location to another to repair a damaged, torn or severed tendons or ligaments.
  • U.S. Pat. Pub. 2008/0188936 and WO 2008/097901 disclose details of rotator cuff repair.
  • the human shoulder is a complex system of hard and soft tissues that exhibits extraordinary mobility using coordinated activation of a variety of muscles, simultaneously.
  • a conventional arthroscopic repair of a torn supraspinatus tendon is disclosed in the background of the publication, reporting that 20-60% of rotator cuff repairs fail.
  • the publication discloses the dilemma with surgery of this type. Any artificial addition to the tissues that takes up too much stress on living tissues can lead to atrophy of the living tissues. In order to heal properly, living tissues must be exposed to a certain level of stress that is within a nominal range for healing.
  • Bioabsorbable materials are disclosed both in the background and as an embodiment of the publication's invention.
  • the publication teaches away from making tension members from non-absorbable materials; however, the absorbable materials of the patch and tension members may be reinforced by non-absorbable materials, such as by including nonabsorbable fibers in a patch material or tension members, and may be attached by bone anchors.
  • the publication teaches providing coatings on its medical devices, providing biologically active [0005]
  • U.S. Pat. No. 5,268,001 discloses a bone fastener for fixing either a suture or a rivet within a predrilled bone hole.
  • the background of this issued patent summarizes the variety of materials and types of bone anchors historically available for using in anchoring soft tissues to bones, either as a rivet or as a suture anchor.
  • the patent discloses a hand held means 70, in Figures 3.1 and 3.2 of the patent, which is useful in setting an anchor within an annular portion, fixing the anchor and annular portion within a pre-drilled hole in a bone.
  • U.S. Pat. No. 7,651,495 discloses a method and apparatus for preventing migration of sutures through transosseous tunnels. Its improved method for attaching soft tissues to bone passes a suture through a transosseous tunnel and uses the suture to affix the soft tissue to the bone.
  • the improved apparatus is an eyelet, which is placed into an end of the bone opposite of the soft tissue and through which the suture passes.
  • the eyelet may be threaded, interference fit or pressure fit using a two piece insertion/expandable member, with the expandable member anchoring the insertion member within the pre-drilled hole through the bone.
  • transosseous tunnels are the gold standard of rotator cuff repair, but migration of sutures through the bone itself is a significant complication, particularly in older patients.
  • U.S. Pat. No. 5,725,529 discloses another bone fastener having similar characteristics to other disclosed bone fasteners.
  • U.S. Pat. Pub. 2010/0191248 discloses an arthroscopic tunnel guide for rotator cuff repair. Its tunnel guide provides a transosseous tunnel having a fixed, non-zero radius of curvature using a bone cutting instrument. This disclosure provides a tool and drill guide that provides a curvature to a transosseous tunnel drilled arthroscopically, allowing arthroscopic surgeons use of a portion of the humeral head that was previously only available by open surgery.
  • U.S. Pat. Pub. 2010/0191247 discloses another apparatus for drilling a transosseous tunnel.
  • the reference teaches that the drill bit tip acts as an anchor at the far cortex distal from the surface of the humeral head adjacent to the soft tissues, when the anchor is detached from the drill bit, at the distal end of the transosseous tunnel formed by the drill bit tip.
  • the applicant believes that there is a concern with the use of this device in the way described in the publication, which introduces a risk of possible axillary nerve injury during the described procedure, which drills to the inferior-medial aspect of the humeral head.
  • a suture or sutures is defined as any linear material, traditionally cat gut, silk, polymer thread, metal wire or combinations thereof, that is used to stitch or secure together tissues, whether or not permanent or bioabsorbable, unless otherwise indicated.
  • a suture mesh may comprise a tape or a net and may be combined with a suture having raised portion along at least a portion of the length of the suture.
  • the raised portions may take the form of a bead, ball, ratchet surface, oblong spheroid and/or disk, for example.
  • a transosseous suture net comprises, on a retention end, a retainer and, on an opposite end of the net, one or more sutures extending from the net.
  • the opposite end and/or body of the net may be sized in diameter and length to extend entirely through a transosseous tunnel such that the suture or sutures extending from the opposite end extend from a portion of the net outside of the transosseous tunnel.
  • one or more sutures may extend from a suture net and may include the raised portions on a portion of the suture that extends through the transosseous tunnel, preventing or reducing suture migration by keeping the sutures from cutting, abrading or pulling through surrounding bone, and the suture net may extend over a portion of the bone preventing or reducing cutting, abrading or pulling through of the suture net through the underlying bone material.
  • the net and suture materials may be made of a variety of
  • the net may be made of a sheet and may have holes formed or punched in the sheet or may be a weave or mat.
  • the interstitial holes in the net are sized to encourage bone in-growth, and the net acts as a scaffold structure for the formation of living tissues, aiding in the healing process.
  • the net may include one or more agents intended to improve healing or ingrowth of living tissue, such as disclosed in the references disclosed in the background section.
  • a mesh tape may comprise a mesh having sutures extending from one or both ends of the tape and/or may provide anchors or attachment points for attaching one or more sutures to mesh.
  • a mesh may be dimensioned and used as a suture net or may be used as a reinforcing mesh for a tendon or the like.
  • a retention clip may be combined with a suture having raised portions, such that the clip may be secured on one of the raised portions and fixing the raised portions in relation to tissues of a patient, a mesh or a net, for example.
  • the net and mesh are not a plug or anchor. Instead, both are pliable or flexible materials.
  • the net, mesh or a suture extending from the net or mesh may be inserted through a transosseous tunnel, such as by using an insertion device, a probe or a snare.
  • a net or mesh may be used as a support for a tendon or other patient tissues during the process of healing and/or thereafter.
  • An insertion device may have a handle, as disclosed in the references cited in the background section.
  • a tool may not be necessary.
  • a tool may be used merely to push the net or mesh or a suture through the transosseous tunnel or a snare may be used to pull a net or mesh or suture through the transosseous tunnel.
  • Figure 1 A illustrates a retention end of one example of a transosseous suture net.
  • Figure IB illustrates a detail view and partial cross section of a portion of the retention end of Figure 1A.
  • Figure 1 C illustrates an example of a suture end of a transosseous suture net, disposed at an opposite end of the net from the retention end illustrated in Figures 1 A and IB, for example.
  • Figure ID illustrates another example of a suture end.
  • Figure IE illustrates a detail view of an example of a portion of a suture extending from a suture end, presenting a suture with retention balls made of a material that is crosslinkable in situ.
  • Figure IF illustrates a detail view of another example of a portion of a suture extending from a suture end, providing a ratcheted surface
  • Figure 1G illustrates a detail view of yet another example of a suture end providing a ratcheted surface.
  • Figure 2A illustrates an example of the use of sutures in one example of a suture end in combination with features of a retention end.
  • Figure 2B illustrates another example of the use of sutures in one example of a suture end in combination with an alternative feature of a retention end.
  • Figure 3 A illustrates an example of a cross section of the features shown in Figures 2A and 2B, for example.
  • Figure 3B illustrates an example of a suture engaging the feature illustrated in Figure 3 A.
  • Figure 4A illustrates another example of a cross section of the features shown in Figures 2A and 2B, for example.
  • Figure 4B illustrates an example of a suture engaging the feature illustrated in Figure 4A.
  • Figure 5 illustrates a detail view of a woven structure that may be used for the body in one example of a net.
  • Figure 6 illustrates a detail view of a non-woven structure that may be used for the body in another example of a net.
  • Figure 7 illustrates an example of a retention feature that is retainable on a retainer.
  • Figure 8 illustrates an example of a suture feature that is retainable on a retainer.
  • Figure 9 illustrates an example of a transosseous suture net being used to repair damage to a tendon or ligament in an exemplary method.
  • Figure 10 illustrates one example of a mesh having a reinforced region to which one or more sutures may be attached by a user or may be pre-attached.
  • Figures 11 A-C illustrate views of an example of a suture clip engaged on a raised portion of a suture with Figure 11C illustrating how such a suture clip may be used with a mesh or net.
  • Figures 12A-B illustrate alternative forms for raised portions on a suture.
  • Figure 13 illustrates a portion of a humerus bone that displays a torn tendon, as an example of a repair that may be benefited using a process including a mesh or net according to the examples.
  • Figure 14 illustrates a step in an exemplary process.
  • Figure 15 illustrates a subsequent step in the exemplary process.
  • Figure 16 illustrates another subsequent step in the exemplary process.
  • Figure 17 illustrates yet another subsequent step in the exemplary process.
  • Figure 18 illustrates a process for engaging a retention clip on a raised portion of a suture attached at one end to a reinforced portion of a mesh and on an opposite end by the raised portions extending through and engaging the mesh.
  • Figures 19A-B illustrate a humeral bone before and after a tear of a ligament.
  • Figure 20 illustrates the use of sutures in the prior art to repair a tendon with bone anchors inserted into a surface of the humeral head.
  • Figure 21 illustrates a subsequent step for applying a net to reinforce the tendon using sutures to reinforce a tear in the tendon illustrated in Figure 20.
  • Figure 1 A illustrates a retention end of one example of a transosseous suture net.
  • a transosseous suture net may be used to prevent the suture net from pulling through the transosseous channel drilled into a bone, for example.
  • the net 61 may be comprised of a woven fabric, such as the fabric illustrated in Figure 5, which shows a fabric 51 comprises of strands, which may be a solid or spun strands, for example.
  • the mesh 61 may be comprised of a material having holes 69, which may be formed as part of the process of fabrication of the mesh, such as by a die injection, hot forming, forging, machining, stamping, etching or other processes that result in a continuous material with holes 69 in the mesh 61, as illustrated in Figure 6, for example.
  • the mesh 61 is a seamless tubular mesh.
  • the mesh 61 may be formed as a tape or sheet, for example.
  • Figure IB illustrates a detail view and partial cross section of a portion of the retention end of Figure 1 A, for example.
  • the retention end 11 comprises a portion of the mesh 61, which does not comprise holes 69, that is wrapped and fused about a retention ring 14, which may be made of a metal, a more rigid polymer, a ceramic or another material that tends to prevent the retention end 11 from being drawn through a transosseous channel drilled through a bone.
  • Figure 9 illustrates use of such a device with the retention end 11 being used to place the end of a transosseus suture net fabric 51 at a surface of a patient's bone.
  • FIG. 1 A Several attachment points 70, 82 are illustrated in Figure 1 A, such as a tab 70 having a fastening hole 75 or holes or an attached suture 80 with a retention end 82 and a suture end 81 having an optionally integrated suture needle, for example.
  • the tabs 70 or sutures 82 may be attached to the retention end 11, such as by a retention mechanism 73, 83 having a hole 74, 84 through which the retention ring 14 passes, as illustrated in the detailed views of Figures 7 and 8, for example.
  • Figure 1C illustrates an example of a suture end 81 on an opposite end of a transosseous suture net 61, for example.
  • This suture end 81 may be inserted through a transosseous tunnel from either end of the tunnel and may be used for fixing tissues to a patient's bone, for example.
  • a suture 63 incorporating a suture end 81 may be integrally formed with and/or from a material of the mesh 61 as illustrated in Figure 1C.
  • examples of suture ends 81, 45 are illustrated, one having a suture needle 81 and the other having a hole 45 formed in the end.
  • the suture 63 may have raised portions 43 formed along the length of the suture 63, which allows the suture to be adjustably retained, for example.
  • Figures IE- IF illustrate alternative examples of an end portion of a suture 473, 263, 471, presenting a suture with an adjustable ratchet mechanism as part of a suture.
  • retention balls 43 are connected by ligands 41 to each other and to a suture 47, 471, and the retention balls 43 may be made of a material that is crosslinkable in situ with a retention tab 70, for example.
  • Figure IF illustrates a detail view of another example of a portion of a suture extending from a suture end, providing a ratchet surface 140 extending from a suture 163 and a tapered surface 141 preferably for a one-way ratcheting mechanism that resists or prevents a suture from pulling back through a retention tab 70 or a hole in a tissue, for example, while allowing the suture to pull through the tab 70 in order to tighten the suture and/or to fix a tissue in place.
  • Figure 1G illustrates an alternative ratchet mechanism the presents a flat form factor with a raised portion 240 and a tapered portion 243 extending between a slot, slit or hole 245 and a tape-like suture 263. Any number or length of raised portions may be provided at or before and end of a suture to allow for adjustable retention of the suture in a tab or tissue, for example.
  • Figure 2A illustrates an example of a monolithic retention end 20 and the use of sutures in one example of a suture end 33, 43 in combination with features of the retention end 20, such as tabs 32, 42.
  • Figure 2B illustrates an alternative example of the use of sutures in one example of a suture end 23 in combination with an alternative feature of a retention end, having a pair of holes in each tab 22.
  • Figures 3 A and 3B illustrate an example of a cross section of a tab 32 and a suture 33 as illustrated in Figures 2A and 2B
  • Figures 4A and 4B illustrate an alternative example of a suture tab 42 engaging a ball in a suture 43, which may be made of a polymer crosslinkable with the material of the tab 42, for example, such as using a chemical reaction or an ultraviolet reaction to initiate or increase the rate of a crosslinking reaction, for example.
  • Figure 9 illustrates an example of a transosseous suture net being used to repair damage to a tendon or ligament in an exemplary method.
  • a tendon In this example, a tendon
  • suture net 51 passes through a transosseus channel formed through the humeral head.
  • the structure of the suture net 51 allows the surgeon to pull the suture net 51 through the channel from the lower portion of the channel to the upper portion of the channel.
  • the suture needles 81 may be used to draw the sutures 47 through the tendon and through a retention mechanism, such as the tabs 70 located in the retention end 11 of the suture net 51, for example.
  • balls 43 assist the surgeon to adjust the tension on the sutures in discreet increments by pulling the balls 43 through holes in the tabs 70.
  • one or more of these devices provides for rapid attachment and adjustment of the fixation devices and substantially prevent suture pull through, which can lead to normal sutures working or cutting their way through the a portion of the bone that defines the transosseus channel.
  • FIG 10 illustrates a mesh 2101 having one or more sutures 2107 attached to a reinforced portion 2103 at an anchor point 2109.
  • Each of the sutures 2107 may include a portion comprising raised portions 2143, such as beads, balls or the like.
  • a lead 2145 may extend from the portion comprising raised portions.
  • the mesh may comprise a tape that includes one end 2103 that may be folded-over and joined together, such as by fusing, welding, stitching or the like.
  • the material may be a heat-processable material that can be fused together by heating, such as with the application of pressure during the heating process or, alternatively, without the application of such pressure.
  • the mesh may be made of a polyester, ultrahigh molecular weight polyethylene or the like.
  • ultrahigh molecular weight is defined as a molecular weight greater than 300,000.
  • the ultrahigh molecular weight polyethylene is covalently crosslinked.
  • the additional stiffness and strength may provide a material that requires no tabs for retaining devices 2043, such as beads, balls or ratchet surfaces, formed or added to the ends of the sutures for temporarily or permanently fixing the sutures to a mesh tape 2001, such as with crosslinking caused by a chemical reaction or radiation or without such crosslinking.
  • the sutures 2107 extending from a mesh may be made of the same material as the mesh or may be made of a different material and may be joined to the mesh by a surgeon or a technician or may be pre-affixed at one or more anchor points.
  • an anchor point may comprise one or more holes formed in the reinforced end, allowing a suture to be tied to the reinforced region by knotting one end of a suture through one or more of the holes.
  • Beads, balls, ratchet surfaces and the like may be made integrally with the sutures or may be added, such as by fusing these features onto a length of suture, for example. Welding, bonding, adhering or press fitting may be used to add these retention or ratchet structures to the line of a suture, for example.
  • a clip 2041 such as illustrated in Figures 11A-C, may be added to aid in retention of a retaining device 2043, such as illustrated in Figures 10, 12A and IB, for example.
  • a tape 2101 may be disposed during surgery between a rotator cuff tendon and the skin, as illustrated in the process shown in Figures 14-18, for example.
  • Sutures 2107 may be joined at one end to an end 2103 of the mesh tape and at an opposite end of the sutures 2107 to a different location of the mesh after passing the sutures through a bone anchor and/or the patients tissues, such as a bone tunnel, muscle and tendons, for example.
  • a clip 2041 may be disposed between a mesh 2001 and the skin, as illustrated in the detailed view of Figure 11C, for example.
  • a low-profile clip may be used for a retaining device 2043 that is reduced in diameter or shaped as an oblate sphere 2045, disk 2047 or the like, as illustrated in Figures 12A-B, for example.
  • a clip 2041 engages a retention portion 2043 of a suture, which retention portion 2043 is inserted into a conformingly-shaped recess of the clip 2041 defined by a plurality of prongs 2042.
  • a tapered portion 2048 of each prong 2042 of a clip 2041 helps to spread the prongs as a force is applied to insert a spherically-shaped retaining device within the clip.
  • a tool 2500 includes a handle 2501 removably attachable at one end 2505 to a hole 2042.
  • the hole 2042 may comprise threads 2044, and the tool 2500 may be threadingly engaged to the clip 2041.
  • the retention portion of the suture may be inserted through a tension by pressure of a stiff end of the suture or using a needle, a punch or the like to provide a hole in the tendon through which the retention portion is passed, reversibly or irreversibly, depending on the shape of the retention portion.
  • the retention portion may adjustably retain the suture in the tendon, allowing the user to apply a desired tension on the mesh or net.
  • a clip may prevent the raised retention portion from being pulled back through the mesh, tape, net and / or tendon, as illustrated in Figures 11C and 18, for example.
  • the clip may be engaged onto the retention portion, when the retention portion is properly tensioned, and the tool may be withdrawn by unthreading the tool from the threaded hole in the clip.
  • the process for using a tape 2101 may be combined with a suture mesh 61 used as an anchor or with other anchors. If used with a suture mesh 61, the sutures of the suture mesh 61 may be inserted through the patient's tissue and through the tape 2101 to secure the patient's tissue between the bone and the tape 2101, for example.
  • suture mesh 61 anchors other bone anchors may be used or sutures with balls, beads or ratchet surfaces may be inserted directly through transosseous channels. Surprisingly, the balls, beads or ratchet surfaces may be capable of reducing or preventing undesired pull through (i.e.
  • the mesh, sutures and/or clips may be made of non-bioadsorbable materials such as a polyester, ultrahigh molecular weight polyethylene or the like or a bioabsorbable material, such as a polylactide (i.e. polylactic acid based polymers), polyglycolide (i.e. polyglycolic acid based polymers) or other biocompatible and absorbable polymers that break down and are absorbed over time (or combinations of these).
  • a polylactide i.e. polylactic acid based polymers
  • polyglycolide i.e. polyglycolic acid based polymers
  • glycolide-based copolyesters have aliphatic polyester based co-monomers or non-aliphatic polyester based co-monomers.
  • linear aliphatic polyesters such as lactices, carbonates and epsilon caprolactones may be used or poly-/?-dioxanone may be used with or without copolymerized radiostabilizers.
  • a trimethylene carbonate or a may be used.
  • a gamma sterilizable biocompatible and absorbable polymer may be used, such as a poly(ethylene 1,4-phenylene-bis-oxyacetate).
  • Polylactides such as poly-L-lactide (PLLA) may be used with or without copolymerization with aliphatic polycarbonates such as trimethylene carbonate and with or without the presence of self- eluting agents such as to manage local pH during degradation, reduce inflammatory responses or to prevent infections, for example.
  • Polymers including a cyclic diester or poly(ethylene oxide) may be used in order to modulate hydrophilicity, for example.
  • a poly(ester-amide) may be selected with film forming properties to form a mesh tape, for example, which may be degraded by enzyme and or nonenzymatic mechanisms.
  • the material is a biologic, such as a poly-4-hydroxybutyrate, i.e. is biologically-derived or harvested from bacteriological or plant processes.
  • FIGS 14-18 an example of a process for using a mesh, such as a tape, is illustrated.
  • a boring device 2110 such as drill, bores a hole through a bone, which may be bored as illustrated or may be bored in the opposite direction.
  • a curved channel is bored to provide an arcuate transosseous tunnel.
  • the end of the boring device or another device may be used to draw a snare 2230 through the tunnel formed in the bone, and the snare may be inserted through a hole formed in a tendon, as illustrated in the example of Figure 15, for example, while a gripping device 2220 pulls a portion of the tendon 2221 into position on the humerus 2200.
  • An opposite end 2231 of the snare 2230 extends out of the opposite side of the tunnel in the bone, allowing the surgeon to draw an end 2145 of one or more sutures through the tunnel in the bone using the snare 2230, as illustrated in Figures 16 and 17, for example.
  • the mesh, net or tape 2250 is rolled in order for it to fit through a trochar, endoscope or other device being used in a minimally invasive procedure.
  • the mesh, net or tape 2250 is unrolled and is pulled into position by the snares. A suture is anchored to the mesh at one end 2109.
  • the mesh, net or tape is shown conformingly fit over a portion of the tendon and a portion of the bone, with an anchor point 2255 anchoring the suture on one end to the mesh, net or tape such as by forming a knot or stitch and at the other end the raised retention portion of the suture and the clip retain the mesh, net or tape in position and adjustably apply a tension on the mesh, net or tape, in one alternative, as illustrated in Figure 17, holes 2111 may be provided as an anchor point for one or more sutures to be anchored to the mesh, net or tape. A tension may be applied up to one-half of the mean or median tensile force applied to the repaired tendon under normal conditions, for example.
  • the suture mesh, net or tape may secure the tendon to the bone without removing all of the load on the tendon.
  • a tension may be selected by the surgeon for optimal healing of the tendon repair, for example.
  • the suture net, mesh or tape may be used without bone anchors, the net, mesh or tape may extend over a portion of the tendon and over a portion of the bone where the particular tendon does not extend.
  • the mesh, net or tape may distribute the load on the tendon over a larger surface of the tendon, as illustrated in Figure 18 than would be the case for discrete suture knots and bone anchors as illustrated in the prior art drawing of Figure 20, for example.
  • the examples illustrate advantages over the prior art devices that fail to stimulate optimal healing and require greater time to complete a repair and potentially cause more damage to the repaired tendon.

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  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
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  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif médical qui comporte une combinaison de maille et de suture, la suture présentant des mécanismes de retenue tels que des perles, des billes, des surfaces d'encliquetage, des sphères aplaties et/ou des disques s'étendant le long d'au moins une partie de la longueur de la suture. Une agrafe ou une languette peuvent être combinées aux mécanismes de retenue pour fixer la suture en place, comme au cours d'une opération chirurgicale reconstructive. Par exemple, la combinaison de maille et de suture peut être utilisée pour fixer des tendons en place par rapport à des os en tant qu'ancre osseuse et/ou en tant que maille de support pour la réparation de tendons déchirés.
EP12749047.2A 2011-02-25 2012-02-24 Maille de suture et son procédé d'utilisation Withdrawn EP2677941A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161446540P 2011-02-25 2011-02-25
PCT/US2012/026605 WO2012116319A2 (fr) 2011-02-25 2012-02-24 Maille de suture et son procédé d'utilisation

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ITMO20120217A1 (it) * 2012-09-17 2014-03-18 Ncs Lab S R L Dispositivo per il fissaggio di tendini muscolari ad un osso.
US9585695B2 (en) 2013-03-15 2017-03-07 Woven Orthopedic Technologies, Llc Surgical screw hole liner devices and related methods
US8956394B1 (en) 2014-08-05 2015-02-17 Woven Orthopedic Technologies, Llc Woven retention devices, systems and methods
US9907593B2 (en) 2014-08-05 2018-03-06 Woven Orthopedic Technologies, Llc Woven retention devices, systems and methods
US9943351B2 (en) 2014-09-16 2018-04-17 Woven Orthopedic Technologies, Llc Woven retention devices, systems, packaging, and related methods
USD740427S1 (en) 2014-10-17 2015-10-06 Woven Orthopedic Technologies, Llc Orthopedic woven retention device
MX2017005965A (es) 2014-11-13 2017-09-13 sambusseti Antonio Dispositivo reabsorbible para la reconstruccion de manguitos rotadores.
EP3331459A4 (fr) 2015-08-05 2019-08-14 Woven Orthopedic Technologies, LLC Dispositifs, systèmes et procédés de prélèvement à utiliser dans un tissu osseux
EP3551105A4 (fr) 2016-12-09 2020-07-29 Woven Orthopedic Technologies, LLC Dispositifs de retenue, treillis et systèmes et procédés associés
US11369474B2 (en) 2017-07-17 2022-06-28 Warsaw Orthopedic, Inc. Bone implant having a mesh
BR112020006769A2 (pt) * 2017-10-06 2020-10-06 Thread & Lift fio cirúrgico

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US7641694B1 (en) * 2005-01-06 2010-01-05 IMDS, Inc. Line lock graft retention system and method
ES2664870T3 (es) * 2006-10-10 2018-04-23 Adrian Edward Park Retractores de línea y red ajustables
WO2008097901A1 (fr) * 2007-02-02 2008-08-14 Tornier, Inc. Système et procédé pour réparer les tendons et les ligaments
US8277458B2 (en) * 2009-01-23 2012-10-02 Biomet Sports Medicine, Llc Apparatus and method for arthroscopic transhumeral rotator cuff repair

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Also Published As

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WO2012116319A9 (fr) 2012-10-18
WO2012116319A3 (fr) 2012-12-06
CA2827404A1 (fr) 2012-08-30
WO2012116319A4 (fr) 2013-01-17
WO2012116319A2 (fr) 2012-08-30

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