Patent Application
20240245398
The disclosure relates to the field of surgery and, more specifically, to tensionable knotless surgical constructs and associated knotless surgical techniques.
Surgical constructs and tissue repairs are disclosed. A surgical construct can create a knotless, tensionable, self-locking repair without the need to tie any knots. A surgical construct can include (i) a loop; (ii) a loop interconnection; and (iii) a locking mechanism. A surgical construct can be a suturing construct. A surgical construct can be a cerclage construct.
A loop of a surgical construct can be a closed, flexible, continuous suture loop. A loop of a surgical construct can be a cerclage loop. A loop interconnection can be in the form of an interconnecting loop link such as a racking hitch or half hitch. A loop interconnection can be located between a loop and a locking mechanism. A locking mechanism can be a stopper. A stopper can be a suture bulge or deformation formed by applying mechanical pressure to a suture construct. A stopper can be a ferrule with internal features that allow one way tensioning of a cerclage construct.
A surgical construct can be employed to re-attach anatomical structures, for example, a first tissue to a second tissue, such as bone to bone, soft tissue, tendon, ligament, and/or bone, to each other and/or any combination of one another, by employing a self-locking, knotless, tensionable mechanism. A self-locking construct can be employed as a stand-alone construct or with additional fixation devices, for example, attached to one or more fixation devices.
Methods of knotless, tensionable surgical repairs are also disclosed. In an embodiment, a portion of a flexible strand can be deformed by applying mechanical pressure and/or compression to form at least one bulge or deformation adjacent a racking hitch. The at least one bulge or deformation creates obstruction of sutures loosening through a racking hitch type of knot. The suturing technique eliminates tying knots.
In another embodiment, a ferrule with internal features is attached to a cerclage repair adjacent a cerclage locking mechanism, to tension the cerclage repair and lock down the cerclage material. A cerclage locking mechanism can be an interconnecting cerclage loop link such as a racking hitch or half hitch.
Surgical constructs, assemblies and methods for knotless fixation of tissue are disclosed.
A surgical construct can create a knotless, tensionable, self-locking repair. A surgical construct can include (i) a loop; (ii) a loop interconnection; and (iii) a locking mechanism. A surgical construct can be a suturing construct. A surgical construct can be a cerclage construct.
A suturing construct can include: (i) a closed, flexible, adjustable, continuous suture loop; (ii) an interconnecting loop link such as a racking hitch or half hitch; and (iii) a locking mechanism (a stopper). A stopper can be a suture bulge or deformation formed by applying mechanical pressure to the suturing construct. A suturing construct can consist essentially of suture. A suturing construct can consist essentially of a braid with a monofilament core. A suturing construct can be employed to attach or re-attach anatomical structures, for example, a first tissue to a second tissue, such as soft tissue, tendon, ligament, and/or bone, to each other and/or any combination of one another, by employing a self-locking, knotless mechanism. A suturing construct can be employed as a stand-alone construct or with additional fixation devices, for example, attached to one or more knotted or knotless suture anchors.
A cerclage construct can include: (i) a cerclage loop; (ii) an interconnecting cerclage loop link such as a racking hitch or half hitch; and (iii) a locking mechanism (a stopper). A stopper can be a ferrule with internal features that allow one way tensioning of the cerclage construct. A cerclage construct can consist essentially of cerclage suture. A cerclage construct can consist essentially of cerclage suture tape. A cerclage construct can be employed to re-attach anatomical structures, for example, bone to bone. A cerclage construct can be employed as a stand-alone construct or with additional fixation devices, for example, attached to one or more fixation devices such as bone plates, screws and/or implants.
Methods of surgical repairs are also disclosed. An exemplary method includes inter alia the steps of (i) passing a flexible construct through and/or around tissue to be repaired; (ii) passing a tail of the flexible construct through a loop of the flexible construct to form a cinch; and (iii) stopping the flexible construct from loosening by forming a locking mechanism adjacent the cinch. The flexible construct can be a suturing construct. The flexible construct can be a bone cerclage construct.
In an exemplary embodiment, a portion of a suturing construct can be deformed by applying mechanical pressure and/or compression to form at least one bulge, enlargement, or deformation in the suture adjacent a racking hitch knot. The at least one bulge enlargement, or deformation creates obstruction of the sutures loosening through the racking hitch type of knot. The suturing technique eliminates tying knots. Tension is applied to the racking hitch and subsequently, mechanical pressure is applied to the suture. The mechanical pressure creates one or more monofilament bulges out and through the braid, which act as a stopper.
In another exemplary embodiment, a cerclage repair can be conducted with cerclage material (such as cerclage tape) secured by a racking hitch type of knot. A ferrule with internal features is slipped over ends of the cerclage tape and tensioned down to the hitch where it locks in a one-way manner. The hitch holds much of the tension of the repair, while the ferrule acts as a stopper.
Referring now to the drawings, where like elements are designated by like reference numerals,
Suturing construct 100 (surgical construct 100; suture 100; self-locking construct 100; knotless, tensionable construct 100; knotless closure suture 100; flexible construct 100; side-to-side knotless suture 100) is formed of a flexible strand 50 (flexible material 50, suture construct 50, suturing construct 50) employed for fixation of first tissue to second tissue. In an exemplary embodiment, suturing construct 100 is formed of flexible strand 50 which includes a central strand of core suture 10 (first strand or filament; inner strand) and an outer strand of suture 11 (second strand or filament; outer strand; coreless suture) covering the central strand. The central strand 10 can be a monofilament core. In an embodiment, the outer strand 11 covers completely the central strand 10 in at least two directions, a longitudinal direction and a transversal direction. Additional details of flexible strand 50 are shown in
Suturing construct 100 also includes one or more loop interconnections 66 and one or more locking mechanisms 77 (stopping mechanism 77). In an embodiment, and as shown in
Reference is now made to
While bulge 77 locks the construct 100, it is important to note that bulge 77 acts primarily as a stopper for the suture, creating an obstruction of the suture loosening through the racking hitch type of knot 66. In this manner, without using any electrically powered sources of welding/deformation of the suture, the mechanical pressure alone eliminates tying of knots while providing a secure, reinforced locking of the suture 50.
Reference is now made to
Final repair 101 includes suturing construct 100 with bulge or enlargement 77 formed in the flexible strand 50 by applying mechanical pressure and locked into place by racking hitch 66, unable to slip or slide out of the loop formed around first tissue 90 (for example, soft tissue 90) attached to second tissue 80 (for example, bone 80).
Flexible strand 50 (suturing construct 50) can include a single filament, or fiber, or can include multiple continuous filaments, segments or regions of filaments that have different configurations (for example, different diameters and/or different compositions) and allow formation of at least one bugle 77 by application of mechanical pressure and/or compression.
Flexible strand 50 can be made of any known suture construct, such as multifilament, braided, knitted, woven suture, or including fibers of ultrahigh molecular weight polyethylene (UHMWPE) or the FiberWire® suture (disclosed in U.S. Pat. No. 6,716,234, the disclosure of which is hereby incorporated by reference in its entirety herein). The flexible strand can be also formed of suture tape, for example, Arthrex FiberTape®, which is a high strength suture tape that is braided and rectangular-like in cross section and as disclosed in U.S. Pat. No. 7,892,256, the disclosure of which is incorporated by reference in its entirety herein.
A cerclage repair with cinch 166 (racking hitch 166) is created around bone 80 and/or tissue 90. Ferrule 177 has internal features 178 that permit one way tensioning and one way suture direction and movement. Ferrule 177 slipped over the ends of the flexible strand 150 (cerclage tape 150) is tensioned down to the hitch 166 where it locks in a one-way manner. The hitch 166 holds much of the tension of the cerclage repair while the ferrule 166 acts as a stopper. The cerclage repair of the present disclosure is tensionable and knotless in that it eliminates tying knots from suturing techniques such as cerclage and side-to-side repairs. With the racking hitch geometry of the cerclage technique disclosed above, the ferrule 177 no longer needs to hold the entire force of the repair, but instead acts as a stopper. This aspect alone provides additional strength to the overall cerclage repair.
A suturing construct 100 can include: (i) a closed, flexible, adjustable, continuous suture loop 55; (ii) an interconnecting loop link 66 such as a racking hitch 66 or half hitch 66 or cinch 66; and (iii) a locking mechanism 77 or stopper 77. A stopper 77 can be a suture bulge or deformation formed by applying mechanical pressure to the suturing construct. A suturing construct 100 can consist essentially of suture 50. A suturing construct 100 can consist essentially of a braid 11 with a monofilament core 10. A suturing construct 10 can be employed to attach or re-attach anatomical structures, for example, a first tissue 90 to a second tissue 80, such as soft tissue, tendon, ligament, and/or bone, to each other and/or any combination of one another, by employing a self-locking, knotless mechanism. A suturing construct 100 can be employed as a stand-alone construct or with additional fixation devices, for example, attached to one or more fixation devices.
A cerclage construct 200 can include: (i) a cerclage loop 150; (ii) an interconnecting cerclage loop link 166 such as a racking hitch 166 or half hitch 166 or cinch 166; and (iii) a locking mechanism 177 or stopper 177. A stopper 177 can be a ferrule 177 provided with internal features 178 that allow one way tensioning of a cerclage construct. A cerclage construct 200 can consist essentially of suture tape 150. A cerclage construct 200 can be employed to re-attach anatomical structures, for example, bone to bone, or bone to soft tissue. A cerclage construct 200 can be employed as a stand-alone construct or with additional fixation devices, for example, attached to one or more fixation devices such as bone plates, anchors, screws and/or implants.
Flexible strands 50, 150 may be in the form of any elongated members, fibers, or materials, or combinations thereof. Flexible strands 50, 150 may be coated (partially or totally) with wax (beeswax, petroleum wax, polyethylene wax, or others), silicone (Dow Corning silicone fluid 202A or others), silicone rubbers (Nusil Med 2245, Nusil Med 2174 with a bonding catalyst, or others) PTFE (Teflon, Hostaflon, or others), PBA (polybutylate acid), ethyl cellulose (Filodel) or other coatings, to improve lubricity of the suture, loop security, pliability, handleability or abrasion resistance, for example.
Flexible strands 50, 150 can be made of any known suture construct, such as multifilament, braided, knitted, woven suture, or including fibers of ultrahigh molecular weight polyethylene (UHMWPE) or the FiberWire® suture (disclosed in U.S. Pat. No. 6,716,234, the disclosure of which is hereby incorporated by reference in its entirety herein). Flexible strands 50, 150 can be also formed of suture tape, for example, Arthrex FiberTape®, which is a high strength suture tape that is braided and rectangular-like in cross section and as disclosed in U.S. Pat. No. 7,892,256, the disclosure of which is incorporated by reference in its entirety herein.
Flexible strands 50, 150 can be also provided with tinted tracing strands, or otherwise contrast visually with other areas/regions of the construct, which remains a plain, solid color, or displays a different tracing pattern, for example. Various structural elements of flexible strands 50, 150 such as loops 55, 155 and/or tails may be visually coded, making identification and handling of the suture loops and ends simpler. Easy identification of suture in situ is advantageous in surgical procedures.
The term “high strength suture” is defined as any elongated flexible member, the choice of material and size being dependent upon the particular application. For the purposes of illustration and without limitation, the term “suture” as used herein may be a cable, filament, tape, thread, wire, fabric, or any other flexible member suitable for tissue fixation in the body.
The term “luggage tag stitch” is defined as any cinch or loop that is formed by the luggage tag technique.
