This present disclosure relates to a method of tissue repair, in particular to a method of anterior cruciate ligament (ACL) repair and reconstruction using a biologically active suture.
Arthroscopic surgery is a minimally-invasive surgery that involves the repair of tissue inside or around a joint. In the knee, for example, a common injury is a tear in the anterior cruciate ligament (ACL) extending between the femur and the tibia, which may be a partial or a complete thickness tear. Currently, there are no universally accepted therapies for partial ACL tears that do not respond to conservative treatment. Unfortunately, untreated partial tears can progress to complete thickness tears, which require ACL reconstruction surgery to rebuild the ligament in the knee. Current methods of ACL reconstruction often require the stabilization of the entire knee and/or the use of a graft, which adds additional time during the surgical procedure and subsequent recovery, as well as problems associated with graft morbidity.
One aim of medical practitioners following ACL repair is to incite rapid healing and tissue repair throughout the treatment site. A factor in the promotion of tissue repair is the extent to which reparative cells and other factors can permeate through to the tissue in question. This, in turn, is dependent upon the extent to which blood vessels can form in and around the site. The growth of new blood vessels from existing ones is known as “angiogenesis.”
Described herein are methods of repairing a partial or complete ACL tear using a biologically active suture combined with a knotted or knotless suture anchor. The biologically active suture provides a biological stimulus (such as angiogenesis) to initiate the repair cascade throughout the tear in moderately avascular tissue. Advantageously, some of the methods described herein provide mechanical stability to the repair site rather than to the entire knee, and may be used with or without a graft. Additionally, the methods described herein are quicker than conventional ACL reconstruction and may reduce rehabilitation time for the patient. Some methods described herein may reduce rehabilitation time for the patient in an ACL reconstruction involving a tissue graft.
In one example, a method of repairing an ACL tear may include, using a surgical technique, placing a first fixation device in one of a tibia or a femur near a first ACL insertion site. The first fixation device is attached to a second fixation device by a suture material. The method may also include, using the surgical technique, placing the second fixation device in the other of the tibia or the femur near a second ACL insertion site, such that the suture material is passed through the ACL and woven within a tear. The suture material may be comprised of a water soluble or water miscible, biologically active material or precursor thereof in admixture with a non-absorbable hydrophobic polymer which may stimulate tissue repair in the surrounding tissue.
In further examples, the biologically active material may be at least one of angiogenic material or angiogenic precursor material which is capable of breaking down in vivo to form angiogenic material, wherein the angiogenic material is in admixture with polypropylene. The angiogenic material may be one or more of butyric acid, butyric acid salt, α-monobutyrin; α-dibutyrin, β-dibutyrin, tributyrin, or hydroxybutyrate. The butyric acid salt may be selected from sodium, potassium, calcium, ammonium, and lithium salts. In other examples, the angiogenic material may be one or more of the following angiogenic factors: angiogenic peptide growth factors, including autologous, xenogenic, recombinant, and synthetic forms of these, including the vascular endothelial growth factors VEGF 121, 165, 189 and 206; fibroblast growth factors FGF-1, FGF-2, FGF-7 (keratinocyte growth factor); transforming growth factor family (TGF-α, -β, platelet derived growth factors PDGF-AA, PDGF-BB, and PDGF-AB; platelet derived endothelial cell growth factor (PD-ECGF); hypoxia inducible factor-1 (HIF-1); scatter factor (SF, also known as hepatocyte growth factor or HGF); placenta growth factor (PIGF)-1, -2; tumor necrosis factor a (TNF-α); midkine; pleiotrophin; insulin-like growth factor-1; epidermal growth factor (EGF); endothelial cell growth factor (ECGF); endothelial stimulating angiogenic factor (ESAF); connective tissue growth factor (CTGF); CYR61; Angiogenin; or Angiotrophin. The angiogenic material may be one or more blood clot breakdown products, including thrombin, heparin, and autologous, allogeneic, xenogeneic, recombinant, and synthetic forms of these materials. The angiogenic material may be one or more of hyaluronan, para-thyroid hormone, angiopoietin 1, del-1, erythropoietin, fas (CD95), follistatin, macrophage migration inhibitory factor, monocyte chemoattractant protein-1, and nicotinamide. The angiogenic precursor material may be one or more of fibrin, including autologous, allogeneic, xenogeneic, recombinant and synthetic forms thereof, and hyaluronic acid.
In still further examples, the suture may be coated on at least one external surface with the biologically active material or the suture has the biologically active material impregnated into at least one region of the suture. Either one of the first and second fixation devices may be a suture, a surgical arrow, a staple, a dart, a bolt, a screw, a button, an anchor, a nail or a rivet, or a barbed surgical device. The surgical technique may be one of an “all-inside” technique, a trans-tibial technique, a medial port technique or an “outside-in” technique. In some examples, a graft may be attached to the suture material.
In a further example, a method of anterior cruciate ligament (ACL) reconstruction is disclosed and may include passing a suture material through and along a length of a tissue graft, the suture material comprising a water soluble or water miscible, biologically active material or precursor thereof in admixture with a non-absorbable hydrophobic polymer. Passing may be achieved with a needle and/or utilizing a suture passing device. The tissue graft and suture material may then be placed within a first prepared tunnel within the tibia and a second prepared tunnel within the femur. The tissue graft may be coupled or fixed in place within the first and second tunnel using a first and second fixation device respectively. At least one of these fixation devices may include a loop of flexible material that is coupled to both a portion of the tissue graft and a button-type device that is configured to lie on an outer cortex of the tibia and/or femur. At least one of the fixation devices may be a screw-type anchor that is inserted into one of the tunnels and directly couples a portion of the tissue graft with the bone tunnel. The biologically active material may stimulate tissue graft remodeling.
In a further example, a method of anterior cruciate ligament (ACL) reconstruction is disclosed, including the steps of drilling a first tunnel within one of a tibia or a femur near a first end of an ACL insertion site, and also drilling a second tunnel within the other of the tibia or the femur near a second end of the ACL insertion site. The first and second tunnel may be coaxial with each other. A suture material is passed through and along a length of a tissue graft and then both the suture material and tissue graft placed within and along both tunnels. The suture material is comprised of a water soluble or water miscible, biologically active material or precursor thereof in admixture with a non-absorbable hydrophobic polymer; the biologically active material stimulating tissue repair and remodeling of the tissue graft.
In a further example, a kit for improved ligament reconstruction is disclosed, including a drill for preparing a first tunnel within a femur, a first fixation device and a suture material. The suture material is configured to be passed through and along a length of a tissue graft and the first fixation is configured to secure the tissue graft and thereby the suture material within and along the first tunnel. The suture material includes an angiogenic material that stimulates tissue graft repair and remodeling.
These and other features and advantages will be apparent from a reading of the following detailed description and a review of the associated drawings. It is to be understood that both the foregoing general description and the following detailed description are explanatory only and are not restrictive of aspects as claimed.
The disclosure will be more fully understood by reference to the detailed description, in conjunction with the following figures, wherein:
In the description that follows, like components have been given the same reference numerals, regardless of whether they are shown in different examples. To illustrate example(s) in a clear and concise manner, the drawings may not necessarily be to scale and certain features may be shown in somewhat schematic form. Features that are described and/or illustrated with respect to one example may be used in the same way or in a similar way in one or more other examples and/or in combination with or instead of the features of the other examples.
Comprise, include, and/or plural forms of each are open ended and include the listed parts and can include additional parts that are not listed. And/or is open ended and includes one or more of the listed parts and combinations of the listed parts.
Referring now to
Either of the first and second fixation devices 106, 110 may include any devices used to rejoin, re-affix, hold or otherwise partake in the repair of tissue. A non-exhaustive list of such devices includes sutures, surgical arrows, staples, darts, bolts, screws, buttons, anchors, nails, rivets or barbed devices. Either of the first and second fixation devices may be an “all-suture” anchor, in which the anchor construct is formed by the suture itself. The fixation devices 106, 110 may have various shapes, diameters or lengths, and may be comprised of a variety of materials. For example, the fixation devices may be completely, or portions thereof, made from a formulation of poly(lactic-co-glycolic) acid (PLGA), β-Tricalcium phosphate (β-TCP) and calcium sulfate, poly-L-lactic acid-hydroxyapatite (PLLA-HA), poly-D-lactide (PDLA), polyether ether ketone (PEEK) or variants thereof. Biocomposite embodiments of the fixation device made from a combination of PLGA, β-TCP, and calcium sulfate are absorbable by the body, which is beneficial to natural healing. An example formulation of PLGA, β-TCP, and calcium sulfate is described in U.S. Pat. No. 8,545,866, the entirety of which is herein incorporated by reference. Other commonly used material for fixation devices, such as titanium, stainless steel, or combinations thereof, are also contemplated by this disclosure. Fixation devices comprising an angiogenic material, such as those described in U.S. Pat. No. 8,541,027, the entirety of which is herein incorporated by reference, are also contemplated by this disclosure.
As shown in
The biologically active material of the suture 112 may be comprised of a water soluble or water miscible angiogenic material or precursor thereof in admixture with a non-absorbable hydrophobic polymer. For example, the biologically active material may be an angiogenic material as described in U.S. Pat. No. 8,541,027 and U.S. Publication No. 2010/0040662, the disclosures of which are incorporated by reference herein in their entirety. The angiogenic material so described may advantageously stimulate tissue repair in the area surrounding the ACL tear and release factors that promote angiogenesis. In the case of an all-suture anchor, the suture anchor construct may be comprised of the same biologically-active material as the portion of the suture woven through the tear.
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Fixation devices (106, 110) may include a flexible member portion that does not include an angiogenic material. This flexible member portion may extend along a portion of at least one of the tunnels (124 or 126) and couple to the suture 112 at a location within the tunnel(s). Alternatively suture 112 may include a first portion comprising an angiogenic material configured to extend through the ACL 108 and proximate the tear 128, and a second portion that does not comprise angiogenic material configured to selectively couple to a fixation device. This second portion may not interweave with the ACL 108.
A knot may be tied in the suture 112 at either end of the first and final stitch through the ACL 108 or a clip or cinch used, so as to maintain the suture 112 in place around the tear 128 and within the ACL 108. The knot or clip may keep the suture 112 at a desired tension along the ACL 108, and around the tear 128. Access to the ACL tear 128 and interlacing/knot tying of the suture 112 within the tear 128 may be an arthroscopic procedure, somewhat independent of the bone tunnel formation and may use ports distinct from the bone tunnels 124 and 126.
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The biologically active material may also be at least one of angiogenic material or angiogenic precursor material which is capable of breaking down in vivo to form angiogenic material, wherein the angiogenic material is in admixture with polypropylene. The angiogenic material may comprise one or more of sodium butyrate, butyric acid, butyric acid salt, α-monobutyrin; α-dibutyrin, β-dibutyrin, tributyrin, or hydroxybutyrate, and the butyric acid salt may be one of sodium, potassium, calcium, ammonium, and lithium salts. The angiogenic material may comprise one or more of the following angiogenic factors:
angiogenic peptide growth factors, including autologous, xenogenic, recombinant, and synthetic forms of these, including the vascular endothelial growth factors VEGF 121, 165, 189 and 206; fibroblast growth factors FGF-1, FGF-2, FGF-7 (keratinocyte growth factor); transforming growth factor family (TGF-α, -β, platelet derived growth factors PDGF-AA, PDGF-BB, and PDGF-AB; platelet derived endothelial cell growth factor (PD-ECGF); hypoxia inducible factor-1 (HIF-1); scatter factor (SF, also known as hepatocyte growth factor or HGF); placenta growth factor (PIGF)-1, -2; tumor necrosis factor a (TNF-α); midkine; pleiotrophin; insulin-like growth factor-1; epidermal growth factor (EGF); endothelial cell growth factor (ECGF); endothelial stimulating angiogenic factor (ESAF); connective tissue growth factor (CTGF); CYR61; Angiogenin; or Angiotrophin. The angiogenic material may comprise one or more blood clot breakdown products, including thrombin, heparin, and autologous, allogeneic, xenogeneic, recombinant, and synthetic forms of these materials. The angiogenic material may also comprise one or more of hyaluronan, para-thyroid hormone, angiopoietin 1, del-1, erythropoietin, fas (CD95), follistatin, macrophage migration inhibitory factor, monocyte chemoattractant protein-1, and nicotinamide. The angiogenic precursor material comprises one or more of fibrin, including autologous, allogeneic, xenogeneic, recombinant and synthetic forms thereof, and hyaluronic acid.
The suture 112 may be impregnated (e.g., dipped or soaked) with the biologically active material after manufacture of the suture 112, such that the biologically active material is distributed throughout up to the whole of the suture 112. Alternatively, the biologically active material may be physically incorporated into the main fabric of the suture 112. For example, threads of biologically active material may be braided with polyethylene terephthalate fibers used to produce the suture 112. The biologically active material may be present in an amount that is therapeutically effective for humans.
It is contemplated by this disclosure that the methods of ACL repair as described herein may be used as a primary procedure (i.e., employed for the actual repair of the ACL tissue) or may be used in conjunction with other methods of ACL repair, such as ACL reconstruction.
Although the present disclosure has been described with respect to various examples, it would be apparent to one of ordinary skill in the art that various other examples are possible, without departing from the spirit and scope as defined in the appended claims.
This application claims the benefit of U.S. Provisional Application Ser. No. 62/260879 filed 30 Nov. 2015 titled “Methods of ACL Repair Using Biologically Active Suture.” and PCT Application PCT/US16/062798, filed 18 Nov. 2016. The provisional and PCT are incorporated by reference herein as if reproduced in full below.
Filing Document | Filing Date | Country | Kind |
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PCT/US16/62798 | 11/18/2016 | WO | 00 |
Number | Date | Country | |
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62260879 | Nov 2015 | US |