• 专利附录
  • 专利说明
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    • 专利摘要:
    IMPROVED SUTURE. A medical device (10) that includes a surgical needle (12) attached to a hollow tubular suture (14). The suture is built from the macroporous hollow tubular wall (16) facilitating and enabling the integration of tissue close to the suture core (18) after introduction into the body, thus preventing suture removal and improving biocompatibility.
    公开号:BR112014020564B1
    申请号:R112014020564-7
    申请日:2012-12-13
    公开日:2021-05-11
    发明作者:Gregory Dumanian；Anandev Gurjala
    申请人:Northwestern University；
    IPC主号:
    专利说明:

    RELATED REFERENCE TO RELATED REQUEST
    [001] This document claims the benefit arising from the priority of US Provisional Patent Application No. 61/602183m, filed on February 23, 2013, the entire contents of which are now incorporated by reference. DESCRIPTIVE FIELD
    [002] This descriptive report provides with sutures and an expanded surface area and/or methods of use and integral tissue properties and fabrication. In particular, the sutures are available with cross-sectional profiles that reinforce closure, preventing suture removal, and/or resistance to infection, and the methods of their use. FUNDAMENTALS
    [003] One of the bases of surgery is the use of suture for tissue repositioning, that is, preserving the tissue in a desired configuration until it comes to heat up. In principle, suturing is the introduction of a foreign unit under high tension (wrapped suture) in separate pieces of tissue in order to keep those pieces in close proximity until scar formation can occur, establishing continuity and resistance between the fabrics. Initially, the sutures provide a full repair reinforcement, becoming, however, a secondary or redundant reinforcement as the tissue heats up. The time until tissue heating reaches its maximum resistance and is dependent on the suture approximation, comprises a period characterized by the susceptibility to repair failure due to forces acting naturally for tissue separation.
    [004] Conventional sutures provide a single or circular stitch cross-sectional profile extended over the length of the suture material. This type of suture has the great benefit of having radial symmetry, eliminating the directional orientation, enabling the user (for example, the surgical professional, physician, etc.) not to have to worry about the orientation of the suture during use. However, a considerable disadvantage of the currently employed single point cross section is that it does not effectively distribute the force, and actively concentrates the force along a geometric point (eg, the point near the leading edge of the circle) creating a sharp edge on the axial dimension. Under these conditions, the fabric is continually exposed to stress, increasing the viability that the fatigue concentration near a geometric point or sharp edge continues to injure through the fabric.
    [005] In fact, studies of surgical closures, the most prominent example being hernia repairs, demonstrate that most failures or dehiscence occur in the early postoperative period, in the days, weeks, or months immediately following the operation , before full heating can occur. The sutures used to close the abdominal wall have high failure rates as demonstrated by the formation resulting from the hernia. After a first standard time interval laparotomy, the post-operative occurrence rate of hernia is between 11-23%. The suture failure rate after hernia repair is as high as 54%. This comprises of a large and costly clinical problem, with approximately 90,000 post-operative hernia repairs performed annually in the United States. Surgical failures were blamed on poor suture placement, suture composition, patient habits such as smoking and obesity, and defects in cellular and extracellular matrices. Clinical experience in examining the cause of these surgical failures reveals that it does not deal with the rupture of the suture, according to common thinking, in most cases the cause is the opening of the tissue around the suture, or putting it under another perspective, the part more reinforced suture by injuring the weakened tissue. Mechanical analysis of the suture unit holding the tissue together indicates that a fundamental problem with the current suture model is the concentration of fatigue at the points where the suture pierces through the tissue. That is, as the forces continue to act to lead to tissue separation, instead of fatigue being distributed more evenly along the repair region, it is concentrated, on the contrary, at each point where the suture continues to perforate the fabric. The results are of two consequences: (1) constant fatigue at the suture perforation points due to tissue slip around the suture and the widening of the holes, leading to laxity of the repair and an impossibility of wound healing, and ( 2) at each perforated point where the concentration of fatigue exceeds the mechanical strength of the tissue, the suture breaks through the tissue causing a surgical dehiscence. In addition, the high tissue pressure arising during surgical knot tightening can lead to local tissue tissue dysfunction, irritation, inflammation, infection, and in the worst case tissue necrosis. This tissue necrosis found in the suture loop is an additional factor for eventual surgical failure.
    [006] There has been no commercial solution for the problems mentioned above. On the contrary, thinner sutures continue to be the preferred ones due to the common thought that a smaller diameter can minimize tissue injury. However, the small diameter of the cross section actually increases the action of local forces applied to the tissue, increasing the action of suture removal and eventual surgical failure.
    [007] An alternative is the conventional suture described by Calvin H. Frazier in U.S. Patent No. 4034763. The Frazier patent describes a tubular suture manufactured from loose web or expanded plastic material that has sufficient microporosity to be penetrated by the newly formed tissue after insertion into the body. Frazier's patent does not necessarily describe which pore sizes fall within the definition of “microporosity” and, furthermore, it is not very clear what a tissue “penetration” mechanism means. However, the Frazier patent states that the suture promotes the formation of ligamentous tissue for initial supplementation and ultimately the replacement of suture structure and function. In addition, the Frazier patent describes that the suture is formed from Dacron or from polytetrafluoroethylene (that is, Teflon), both commonly used in vascular grafts. From this description, an expert with ordinary knowledge in the art can understand that the suture described by the Frazier patent must present pore sizes similar to those found in vascular grafts constructed using Dacron or Teflon. It should be understood that vascular grafts constructed from these materials serve to promote generally fluid-fitting conduit for accommodation of blood flow. Furthermore, it should be understood that such materials have a microporosity that enables the formation of fibrous scar tissue concisely adjacent to the tissue wall so that the graft itself becomes embedded in the scar tissue. The tissue does not grow through the graft wall, but grows around the graft wall in a concise manner. Enabling tissue ingrowth through the wall of a vascular graft should not be unexpected because vascular grafts are designed to conduct blood; however, the porosity being large enough to actually allow both leakage and tissue ingrowth to occur would restrict or block blood flow would be unexpected and not something to be contemplated. To this end, these vascular grafts, and therefore the small pore sizes of the microporous suture described in the Frazier patent, function to discourage and prevent normal neovascularization and tissue ingrowth in the suture. Pore sizes smaller than approximately 200 microns are known to be watertight and unfavorable to neovascularization. See, for example, the article by Muhl et al., New Objective Measurement to Characterize the Porosity of Textile Implants, Journal of Biomedical Materials Research Part B: Applied Biomaterials DOI 10, 1002/jbmb, Page 5 (Wiley Periodicals, Inc. 2007). Consequently, one skilled in the art can understand that the suture described in the Frazier patent has a pore size that is less than approximately 200 microns. So, in summary, Frazier's patent seeks to take advantage of the fact that microporosity encourages the “natural foreign body response” of inflammation and scar tissue formation to create a fibrous scar around the suture. GENERAL DESCRIPTION
    [008] Rather, this descriptive report is directed to sutures designed to discourage the "foreign body response" of inflammation and fibrotic tissue formation around the suture through the employment of a macroporous structure. The macroporous structure seeks to minimize the response of the foreign body to the suture. In direct contrast to the microporous structure, the macroporous structure is optimized to achieve maximum biocompatibility allowing for neovascularization and ingrowth of the normal/local tissue around the suture itself.
    [009] In some modalities, this descriptive report provides with surgical sutures comprising a profile for the cross section lacking radial symmetry. In some modalities, the surgical suture consists of a ribbon-shaped geometry. In some modalities, the suture is between 0.1 mm and 1 cm in width (eg, > 0.1 mm, > 0.2 mm, > 0.3 mm, :0.4 mm, > 0.5 mm , >0.6mm, >0.7mm, >0.8mm, >0.9mm. >1mm, >2mm, >3mm, >4mm, >5mm, >6mm, >7mm, > 8 mm, > 9 mm), although other modalities may be used, the suture is around 3.75 mm in width (eg, 3 mm, 3.1 mm, 3.2 mm, 3.3 mm , 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4.0mm, 4.1mm, 4.2mm, 4.3mm , 4.4mm, 4.5mm). In some embodiments, the two-dimensional cross-sectional profile comprises an ellipse, half ellipse, convex, half circle, crescent, concave ribbon, or rectangle; although other formats can be used. In some embodiments, the suture consists of polyethylene terephthalate, nylon, polyolefin, polypropylene, silk, polymeric p-dioxanones, p-dioxanone copolymers, e-caprolactone, glycolide, L(-)-lactide, D(+) -lactide, meso-lactide, trimethylene carbonate, polydioxanone homopolymer and combinations thereof, although other materials may be used. In some embodiments, the suture consists of polypropylene. In some modalities the suture is sterile, surgically graded, medically graded, etc.
    [010] In some modalities, this descriptive report provides with surgical sutures consisting of a flexible material containing one or more internal void spaces (for example, hollow core, alveolar, single or multiple lumen, etc.) that extend along the suture length. In some modalities, the surgical suture adopts a first cross-sectional profile in the absence of lateral fatigue, and a second cross-sectional profile in the presence of lateral fatigue. In some embodiments the profile of the first cross section exhibits substantial radial symmetry. In some embodiments, the second cross-sectional profile partially or fully exhibits the fragmented conformation.
    [011] In some modalities, this descriptive report provides with surgical sutures containing material and structure configured to enable the internal growth of tissue by disposing the suture within the tissue of a target. In some embodiments, the material consists of pores that allow tissue ingrowth. In some embodiments, the pores comprise of macropores (eg, pores having a diameter > 200 µm, > 300 µm, > 400 µm, > 500 µm, > 600 µm, > 700 µm, > 800 µm, > 900 µm, > 1mm, >2mm, or larger). In some embodiments, the pores consist of micropores (eg, pores having a diameter < 200 µm, < 150 µm, 75 µm, < 70 µm, < 50 µm, < 25 µm, < 10 µm, < 1 µm, < 0 .5 µm, < 0.1 µm, or less). In some embodiments, the pores can include a combination of macropores and micropores. In some embodiments, the pores can take on any type of convenient shape (eg, circular, diamond, amorphous, etc.). In some embodiments, the material consists of a concise surface (eg grooves, wefts, meshes, ribs, etc.). In some modalities, the suture consists of a cross-sectional profile lacking radial symmetry. In some embodiments, the suture has a cross-sectional profile substantially lacking radial symmetry. In some modalities, the suture has a ribbon-shaped geometry. In some modalities, the suture is between 1 mm and 1 cm in width. In some modalities, the suture has a two-dimensional profile for the cross section. In some embodiments, the two-dimensional cross-sectional profile consists of an ellipse, semi-ellipse, concave, half-circle, crescent, concave ribbon, or rectangle. In some embodiments, the suture consists of polypropylene. In some modalities, the suture is sterile, surgically graded, medically graded, etc.
    [012] In some modalities, this descriptive report provides suturing needles having a far end and a near end, the near end being configured for attachment to a suture material, the far end being configured for insertion into the fabric, and whereas needle transitions from a radially symmetrical (or substantially radially symmetrical) cross-sectional profile, or so-called triangular "notch" configurations at the far end to a cross-sectional profile lack radial symmetry at the near end. In some embodiments, the needle produces a puncture lacking radial symmetry when inserted through tissue. In some embodiments, the cross-sectional profile lacking radial symmetry has a ribbon-shaped geometry. In some modalities, the ribbon-shaped geometry has a width between 1 mm and 1 cm. In some embodiments, the cross-sectional profile lacking radial symmetry presents a two-dimensional cross-sectional profile. In some modalities, the two-dimensional cross-section profile is presented as an ellipse, half-ellipse, concave, half-circle, crescent, concave ribbon, or rectangle. In some embodiments, a suturing needle is sterilized, surgically graded, medically graded, etc.
    [013] In some modalities, this descriptive report consists of a suturing system incorporating: (a) a suturing needle (for example, as described above), having a far end and a close end, with the near end is configured for the fixation of the suture material, with the far end configured for insertion into the tissue, and the needle consists of a cross-sectional profile lacking radial symmetry at the near end of the needle, and (b) a surgical suture (eg as per the above description) having a cross-sectional profile lacking radial symmetry.
    [014] In some modalities, this descriptive report provides with methods of employing any of the above sutures, suturing needles, and/or systems for suturing a tissue and/or closing an opening in a tissue (for example , epidermal tissue, peritoneum, adipose tissue, cardiac tissue, or any other tissue in need of suturing).
    [015] In some modalities, this descriptive report provides with methods of suturing an opening in a tissue comprising (a) the provision of a suture with close and distant ends, said close end being attached to a needle, and said distal end comprising an integrated loop structure. (b) inserting said needle through said fabric adjacent a first end of said opening; (c) pulling said suture through said tissue until said distal end of said suture is adjacent to said tissue; (d) positioning said needle and said suture through said loop to create a loop at the distal end of said suture; (e) closing the suture in said opening from said first end to a second end; (f) stapling said suture along the second end; and (g) cutting the remaining suture material and withdrawing the needle close to the staple. BRIEF DESCRIPTION OF THE DRAWINGS
    [016] Figure 1 shows a schematic of the incision and suture geometry.
    [017] Figure 2 presents a scheme demonstrating the effect of tension between the suture and the surrounding tissue.
    [018] Figure 3 shows finite element analysis of the suture/tissue interface.
    [019] Figure 4 presents finite element analysis demonstrating that increasing the size of the suture decreases the forces acting on the suture/tissue interface.
    [020] Figure 5 presents finite element analysis demonstrating the shape of the suture impacting the local forces applied to the tissue by the suture.
    [021] Figures 6 and 7 show graphs showing the relative equivalence of tensile stress of a polypropylene O suture and a symmetrically non-radial suture of 2 mm wide (in ribbon format).
    [022] Figure 8 presents images of the tensiometry experiments conducted using 2D sutures and traditional sutures and porcine linea alba.
    [023] Figure 9 presents an illustration of an exemplary integrated needle and suture consisting of: (1) a precise needle stitch; (2) needle body; (c) transition area, (4) flattened profile, (5) porous suture wall, and (6) hollow core.
    [024] Figure 9A is a detailed view of a portion of the porous suture wall of Figure 9.
    [025] Figure 10 presents an illustration of an example of an anchoring end consisting of a pleated loop; (1) pleated joint. (2) circular profile.
    [026] Figure 11 shows an illustration of an example of an anchoring end comprising a flattened link: (1) flattened link, (2) transition area, (3) circular profile.
    [027] Figure 12 presents an illustration of an example of an anchoring end consisting of a formed link: (1) formed joint, (2) circular profile.
    [028] Figure 13 presents a diagram showing a cross-sectional profile altered by applying a non-axial force along a hollow core suture.
    [029] Figure 14 presents a graph of the effect of suture width for maximum suture load with a live specimen of porcine linea alba.
    [030] Figure 15 presents a graph of the effect of suture width for maximum suture load in synthetic foam plate.
    [031] Figures 16 and 17 show comparative images of tissue integration that comes to be achieved from the macroporous suture of this descriptive report in function of the failure suffered via a conventional suture when used to repair a hernia in a rat.
    [032] Figure 18 presents a graph comparing the mean defective area of thirty repaired rat hernias in Figures 16 and 17 considered randomly to repair either a macroporous suture of this descriptive report or a conventional suture. Data analyzes defective size one month after repair. DETAILED DESCRIPTION
    [033] This descriptive report provides with a medical suture featuring a macroporous tubular unit that advantageously promotes neovascularization and normal tissue ingrowth and subsequent integration with its introduction into the body. In addition, this descriptive report provides with several sutures that will increase the surface area and/or tissue integration properties and methods of fabrication and use thereof. In particular, this document has the provision of sutures with cross-sectional profiles and other structural features that reinforce closure, prevent the suture from being pulled, and/or resist infection, and methods of using them. In some modalities, sutures are provided with reinforced closure preventing suture removal, and/or resisting infection, for example: (1) featuring a cross-sectional profile that reduces pressure along the suture points, (2) featuring a structural composition that allows for tissue ingrowth in the suture, or both items (1) and (2). This descriptive report is not restricted by any mechanisms to meet the desired objectives.
    [034] In some embodiments, conventional sutures exhibit a cross-sectional profile containing radial symmetry or substantial radial symmetry. As used in this report, the term “substantial radial symmetry” is meant to refer to a shape (eg cross-sectional profile) that approximates radial symmetry. A shape that has dimensions that are within the 10% margin of error of a shape exhibiting accurate radial symmetry is said to have substantially radial symmetry. For example, an oval that is 1.1 mm high and 1.0 mm wide is substantially radially symmetric. In some modalities, this descriptive report provides with sutures that lack radial symmetry or/and substantial radial symmetry.
    [035] In some modalities, sutures are provided with cross-sectional shapes (eg, flat, elliptical, etc.) reducing tension against the tissue near the puncture site and reducing the possibility of tissue tear. In some embodiments, the devices (eg, sutures) and methods provided in this document reduce the concentration of suture fatigue at the suture piercing points. In some embodiments, sutures with profiles configured for cross-section distribute forces more evenly (eg, along the inner surface of the suture punch hole) than traditional suture configuration/shapes. In some modalities, the sutures configured in their cross sections distribute the tension around the puncture points of the suture. In some modalities, instead of presenting a precise stitch or line close to the tissue, as is the case with traditional sutures, the sutures described in this document present a flat or smooth rounded plane along the front edge of the tissue, increasing the surface area where the force can be distributed. In some modalities, the suture cross-sectional dimension is greater than the orthogonal cross-sectional dimension (eg, 1.1x larger, 1.2x larger, 1.3x larger, 1.4x larger, 1 .5x larger, 1.6x larger, 1.7x larger, 1.8x larger, 1.9x larger, 2.0x larger, 2.1x larger, 2.2x larger, 2.3 x larger, 2.4x larger, 2.5x larger, 2.6x larger, 2.7x larger, 2.8x larger, 2x9 x larger, 3.0x larger, >3.0x larger, 3.1x larger, 3.2x larger, 3.3x larger, 3.4x larger, 3.5x larger, 3.6x larger, 3.7x larger, 3.8x larger, 3, 9x greater, 4.0x greater, >4.0x greater,..., >5.0x greater,..., >6.0x greater,... > 7.0x greater,. .. , > 8.0 x greater,... > 9.0 x greater,... > 10.0 x greater). In some modalities, the sutures provided in this descriptive report are flat or ellipsoidal in cross section, forming a ribbon-shaped conformation. In some embodiments, sutures are provided with a pointed leading edge not present in the tissue. In some modalities, the use of the sutures described in this document reduces the rates of surgical dehiscence in all tissues (eg, hernia repairs, etc.). In some modalities, sutures are provided with cross-section profiles that provide optimized levels of reinforcement, flexibility, service, macroporosity, and/or durability while reducing the feasibility of suture removal. In some modalities, sutures are made available with sizes or shapes to expand the suture/tissue interface of each suture/tissue contact point, distributing the force over a much larger area.
    [036] In some modalities, the sutures in this descriptive report provide with several improvements over conventional sutures. In some modalities, sutures provide: with a reduction in the feasibility of removing the suture, increased closure strength, reduced number of stitches for a closure, faster healing time, and/or reduced closure failure in relation to a traditional suture. In some modalities, the relative improvements in suture performance (eg, initial closure reinforcement, rate of tissue reinforcement attainment, final closure reinforcement, infection rate, etc.) are accessed in a tissue test template, animal test model, simulated test model, in silico test, etc. In some modalities, the sutures in this descriptive report provide with initial intensified reinforcement of the closure (eg, > 10%, > 25%, > 50%, > 75%, > 2-fold, > 3-fold, > 4- folds, > 5-folds, > 10-folds, or more). As used in this report, the term “initial closure reinforcement” refers to the reinforcement of the closure (eg, resistance to opening) before the closure is reinforced through healing or healing processes. In some embodiments, the increased initial closure strength is due to mechanical distribution of forces across a larger load-carrying surface area reducing micromovement and withdrawal susceptibility. In some modalities, the sutures in this descriptive report provide an increased rate of achieving tissue reinforcement (for example, from tissue healing through the opening, from tissue ingrowth in the (porous) integration model of the suture, etc.). In some embodiments, the sutures in this specification provide at least a 10% increase in the rate of tissue reinforcement (eg :10%, 25%, > 50%, > 75%, > 2-ply, > 3-fold, > 4-fold, > 5-fold, > 10-fold, or more). In some embodiments, the increased rate of return of tissue reinforcement across the opening further increases the load-bearing surface area, promoting tissue stability and decreasing the susceptibility of withdrawal. In some modalities, the sutures in this descriptive report establish premature closure reinforcement in the healing process (for example, due to greater initial closure reinforcement and/or a higher rate of obtaining tissue reinforcement) when the closure is more susceptible to rupture (eg, at least a 10% reduction in closure reinforcement establishment time (eg, > 10% reduction, > 25% reduction, > 50% reduction, > 75% reduction , > 2-fold reduction, > 3-fold reduction, > 4-fold reduction, > 5-fold reduction, > 10-fold reduction, or more)). In some modalities, the sutures in this descriptive report provide increased closing reinforcement (eg, at least a 10% increase in final closing reinforcement (eg, > 105, > 25%, > 50%, > 75 %, > 2-fold, > 3-fold, > 4-fold, > 5-fold, > 10-fold, or more)). In some embodiments, the reinforcement of the fully cured closure is created not only by the presence of the interface between the two opposing tissue surfaces, as is the case with conventional suture closures, but also over the entire surface area of the integrated suture. In some modalities, tissue integration into the suture decreases the rate of suture abscesses and/or infections that may otherwise occur with the presence of solid foreign materials of the same size (eg, at least a 10% reduction in suture and/or infection abscesses (eg, > 10% reduction, > 25% reduction, > 50% reduction, > 75% reduction, > 2-fold reduction, > 3-fold reduction , > 4-fold reduction, > 5-fold reduction, > 10-fold reduction, or more)). In some modalities, sutures provide at least 10% reduction (eg, > 10%, > 20%, > 30%, > 40%, > 50%, > 60%, > 70%, > 80%, or more) when removing the suture (eg through tissue (eg, epidermal tissue, peritoneum, adipose tissue, cardiac tissue, or any other tissue in need of suturing), or through control substances (eg, ballistic gel )).
    [037] In some modalities, the sutures are provided containing a profile or any shape suitable for the cross section providing reduced fatigue at the tissue puncture site, tissue contact point, and/or closure site. In some modalities, the sutures have cross-sectional dimensions (eg width and/or depth) or between 0.1 mm and 1 cm (eg 0.1 mm...0.2 mm....0 .5mm...1.0mm...2.0mm...5.0mm...1cm). In some modalities, the suture dimensions are used (for example, width and/or depth) that minimize removal and/or provide maximum load. In some embodiments, the optimal suture dimensions are determined empirically for a given tissue and suture material. In some embodiments, one or both of the cross-sectional dimensions of a suture have the same cross-sectional dimensions of a traditional suture. In some modalities, a suture consists of the same cross-sectional area as a traditional suture, but differing in shape and/or dimensions. In some modalities, a suture has a larger cross-sectional area than a traditional suture. In some embodiments, a cross section of a suture provides a wider leading edge to disperse pressure over a broader portion of tissue. In some embodiments, a cross section of the suture provides a shaped leading edge (eg, convex) for evenly distributing force across a segment of tissue rather than focusing it on a single point. In some modalities, the outlined sutures prevent the load by distributing forces through the tissue instead of concentrating them in a single point. In some modalities, sutures prevent solicitation by providing a wider cross section where it is more difficult to have tissue solicitation.
    [038] In some modalities, there is provision of sutures in tape format or flat sutures. In some modalities, the sutures provided in this descriptive report consist of any suitable cross-sectional shape providing the desired qualities and characteristics. In some embodiments, the cross-sectional shape of the suture provides with an accentuated and/or enlarged leading edge distance and/or surface area (eg to reduce localized pressure on tissue). In some modalities, the cross-sectional shape of the suture comprises an ellipse, half ellipse, half circle, concavity, rectangle, square, crescent pentagon, hexagon, concave tape, convex tape, H-beam, I-beam, etc. In some embodiments, a suture cross-sectional profile comprises any combination of curves, lines, corners, twists, etc. to arrive at a desired format. In some embodiments, the edges of sutures configured to contact the tissue and/or impose pressures against the tissue become wider than one or more of the dimensions of the suture. In some embodiments, the edge of sutures configured to contact tissue and/or put pressure against tissue are configured to distribute force evenly across the contact region.
    [039] In some embodiments, hollow core sutures are provided in the manner as described in Figure 9. More specifically, Figure 9 depicts a medical device 10 that includes a surgical needle 12 and an elongated suture 14. In Figure 9, a needle 12 includes a curved or contoured needle having a flattened cross-sectional profile, however, needles having any generic type of geometry may be used. Suture 14 may be a hollow core suture with a first end 14 secured to needle 12 and a second end 14b located a distance away from needle 12. As shown, the entire length of suture 14 between first and second ends 14a 14b may include a tubular wall 16 defining a hollow core 18. In other versions, however, a lesser portion the full length of suture 14 may be tubular. For example, it can be seen that either or both of the first and second ends 14a, 14b may have a non-tubular portion or portion having another geometry. Such non-tubular portions may be attached to the first end 14a of the suture 14 close to the needle 12 or for securing the second end 14b, for example, in versions where the entire length of the suture 14 is tubular, as shown, this entire length of the suture 14 including the ends and also the central portion generally has a constant or uniform diameter or thickness in the absence of fatigue. That is, no portion of suture 14 is significantly larger in diameter than any other portion or suture 14. Furthermore, no feature, end, or other portion of suture 14 is intended to be or will actually pass through, be positioned , admitted, or otherwise disposed within the hollow core 18. The hollow core 18 is adapted solely to receive tissue ingrowth.
    [040] In some embodiments, the tubular wall 16 may have a diameter in the range of approximately 1mm to approximately 10mm and may be constructed of a material such as polyethylene terephthalate, nylon, polyolefin, polypropylene, silk, p- polymeric dioxanone, p-dioxanone copolymer, e-caprolactone, glycolide, L(-)-lactide, D(+)-lactide, mesa-lactide, trimethylene carbonate, polydioxanone homopolymer, and combinations thereof. Constructed in this way, the tubular wall 16 of the suture 14 can be radially deformable so that it assumes a first cross-sectional profile in the absence of lateral stresses and a second cross-sectional profile in the presence of lateral stresses. For example, in the absence of lateral stresses, the tubular wall 16 and therefore the suture 14 described in Figure 9, for example, can have a profile with a circular cross section, exhibiting radial symmetry. In the presence of lateral fatigue, such suture 14 may exhibit a completely or partially collapsed conformation.
    [041] In at least one version of the medical device 10, at least part of the tubular wall 16 may be macroporous defining a plurality of pores 20 (e.g., openings, orifices, etc.), with only a handful of them becoming expressly identified with reference numbers and by relevant lines in Figure 9 for clarification. Pores 20 extend completely through mesh wall 16 adjoining hollow core 18. In some versions, tubular wall 16 may be constructed from a fabricated or woven mesh material. In one version, wall 16 can be constructed from a meshed polypropylene mesh material similar or identical to the product available under the Prolene Soft Mesh trademark and marketed by Ethicon. Other similarly constructed mesh materials may be equally suitable.
    [042] According to the use given by this report, the expression "macroporous" can include pore sizes that are at least greater than or equal to approximately 200 microns and, preferably, greater than or equal to 500 microns. In some versions of medical device 10, the size of at least some of the pores 20 in suture 14 can be in the range of approximately 500 microns to approximately 4 millimeters. In another version, at least some of the pores 20 may have a pore size in the range of approximately 500 microns to approximately 2.5 millimeters. In another version, at least part of the pores 20 may have a pore size in the range of approximately 1 millimeter to approximately 2.5 millimeters. In another version, the size of at least some of the pores 20 may be approximately 2 millimeters. Also, in some versions, pores 20 may vary in size. For example, as mentioned above and as also illustrated in Figure 9A, in some versions, part of the pores 20a may appear macroporous (eg larger than approximately 200 microns), and part of the pores 20b may be microporous (eg. , smaller than approximately 200 microns). The presence of microporosity (ie, the pores being smaller than approximately 200 microns) in such versions described for the suture may comprise an only incidental factor in the manufacturing process, which may include sewing, sewing, extrusion, blow molding or some other type of process, without necessarily addressing any other functional reason with respect to biocompatibility or tissue integration. The presence of microporosity (i.e., some pores being smaller than approximately 200 microns in size), such as a by-product or incidental result from fabrication does not change the character of the macroporous suture described (for example, having pores larger than approximately 200 microns, and preferably larger than approximately 500 microns, for example), which facilitates tissue ingrowth by aiding biocompatibility, reducing tissue inflammation, and decreasing suture demand.
    [043] In the versions relevant to the described suture, presenting both macroporosity and microporosity, the amount of pores 20 that present as macroporous can be found in the range ranging from approximately 1% of the pores to approximately 99% of the pores (when measured by pore cross-sectional area), in a range from approximately 5% of the pores to approximately 99% of the pores (when measured by pore cross-sectional area), in a range from approximately 10% of the pores for approximately 99% of the pores (when measured by pore cross-sectional area), in a range of approximately 30% of the pores to approximately 99% of the pores (when measured by pore cross-sectional area), in a range of approximately 50% of pores to approximately 99% of pores (when measured by pore cross-sectional area), in a range from approximately 60% of pores to approximately 99% of pores (when measured by cross-sectional area). pore section), in a range from approximately 80% of the pores to approximately 99% of the pores (when measured by pore cross-sectional area), or in a range from approximately 90% of the pores to approximately 99% of the pores (when measured by pore cross-sectional area).
    [044] Configured in this way, the pores 20 in the suture 14 are arranged and configured so that the suture 14 is adapted to facilitate and enable tissue ingrowth and integration through the pores 20 in the weft wall 16 and entry into the hollow core 18 when introduced into a body. In other words, pores 20 are adequately sized to have maximum biocompatibility by promoting neovascularization and normal/local tissue ingrowth through pores 20 and into hollow core 18 of the suture 14. of tissue through pores 16 and into hollow core 20 enables suture 14 and resulting tissue to combine and cooperatively increase the strength and effectiveness of medical device 10, while also reducing irritation, inflammation, necrosis. of the local tissue, and the viability of the rupture. In contrast, suture 14 promotes the production of new healthy tissue along the constructed suture including the inner portion of pores 20 and hollow core 18.
    [045] While suture 14 in Figure 9 has come to be described as including an elongated hollow core 18, in some embodiments, a suture in accordance with the present specification may consist of a tubular wall defining a hollow core including one or more empty spaces (eg, extending the length of the suture). In some versions, at least part of the internal voids may have a size or diameter > than approximately 200 microns, > than approximately 300 microns, > than approximately 400 microns, > than approximately 500 microns, > than approximately 600 microns, > than about 700 microns, > than about 800 microns, > than about 900 microns, > than about 1 mm, or > than about 2 mm. In some embodiments, a suture and in accordance with the present description may consist of a tubular wall defining a hollow core including one or more lumens (e.g., 1, 2, 3, 4, 5, 6, 7, 8, or more) (eg, acting along the length of the suture). In some embodiments, a suture in accordance with the present description may consist of a tubular wall defining a hollow core including a honeycomb shaped structure, 3D lattice structure, or any other suitable type of internal matrix defining one or more internal void spaces. In some versions, at least part of the internal voids in the honeycomb structure, 3D lattice structure, or any other suitable matrix type may have a size or diameter > than approximately 200 microns, > than approximately 300 microns, > than approximately than approximately 400 microns, > than approximately 500 microns, > than approximately 600 microns, > than approximately 700 microns, > than approximately 800 microns, > than approximately 900 microns, > than approximately 1 millimeter, or > than approximately that approximately 2 millimeters. In some embodiments, the empty space consists of a hollow core. In some embodiments, a hollow core may include a hollow cylindrical space in the tubular wall, but as described the expression "hollow core" is not limited to the definition of a cylindrical space, it may include a labyrinth of internal void spaces defined by a structure alveolar, a 3D lattice structure, or some other suitable matrix type. In some modalities, sutures consist of a flexible, hollow structure presenting a circular cross-section profile in its fatigue-free condition, being fragmented into a flatter cross-sectional shape when requested in its direction outside the geometric axis. In some embodiments, sutures are made available exhibiting radial symmetry under a fatigue-free condition. In some embodiments, radial symmetry under a no-fatigue condition eliminates the need for directional guidance while suturing. In some modalities the sutures are available showing a flattened cross-section profile when the decentralized force (longitudinal axis) is applied (for example, pressing the suture against the tissue) (See Figure 13), with a more uniform distribution of the force applied by the suture to the tissue. In some embodiments, sutures are provided exhibiting a flattened cross-sectional profile when applying axial force. In some modalities, the sutures consist of a flexible structure adopting a first cross-sectional profile in its fatigue-free condition (for example, suturing profile), however, adopting a second cross-sectional shape when requested in a direction displaced from the axis geometric (eg clamping profile). In some embodiments, a suture is hollow and/or comprises one or more internal voids (eg, acting along the length of the suture). In some embodiments, the internal voids are configured to encourage the suture to provide a preferred conformation (eg, enlarging the leading edge to shift pressures through contacted tissue) when under fatigue conditions (eg, tightening profile) . In some embodiments, the internal voids are configured to enable a suture to adopt radial external symmetry (eg, a circular external cross-sectional profile) when under a non-fatigue condition. In some modalities, varying the size, shape, and/or arrangement of the internal void spaces changes one or both profiles, the first cross-sectional profile (eg, suture profile, non-fatigue profile) and the second profile of cross section (eg off-center profile, fatigued profile, clamp profile).
    [046] Sutures that have a substantially linear geometry have two distinct ends, as described above with reference to Figure 9, for example. In some embodiments, both ends are identical. In some modalities, each end is differentiated. In some embodiments, one or both ends are structurally unadorned. In some embodiments, one or both ends are attached or at least configured for clamping, sonic welding, tackling, clamping, or some other type of mechanism to a needle (as shown in Figure 9). In some embodiments, the second end 14b of suture 14 is configured to include an anchor 22 (e.g., Figures 10, 11, 12) for anchoring suture 14 against tissue through which suture 14 comes to. be inserted. In some embodiments, the second end 14b of suture 14 is configured to anchor the suture at the start of closure. In some embodiments, the second end 14b of suture 14 includes an anchor 22 which is a structure preventing complete release of suture 14 through tissue. In some modalities, anchor 22 has a larger dimension than the rest of suture 14 (at least 10% larger, at least 25% larger, at least 50% larger, at least 2 folds larger, at least 3 folds larger, at least minus 4 folds larger, at least 5 folds larger, at least 6 folds larger, at least 10 folds larger, etc.). In some embodiments, anchor 22 consists of a structure having any suitable shape to prevent the loosening of suture 14 through the hole (e.g., spherical, disk, plate, cylindrical), thus preventing suture 14 from being pulled through. the insertion hole. In some embodiments, anchor 2 of suture 14 consists, for example, of a closed loop, described in accordance with Figure 10. In some embodiments, the closed loop has any suitable type of structure including, without restriction, a loop. pleated (Figure 10), flattened link (Figure 11) or a formatted link (Figure 12). In some embodiments, a loop may be integrated near the end of the suture 14. In some embodiments, a separate loop structure may be attached to the suture 14. In some embodiments, the needle 12 may be passed through the closed loop anchor. 22 to create a seam grip for anchoring suture 14 at that point. In some embodiments, anchor 22 can consist of one or more structures (e.g., barb, hook, etc.) for retaining the end of suture 14 in position. In some embodiments, one or more anchor structures 22 (e.g., barbs, hook, etc.) are employed in conjunction with a closed loop to retain the seam grip and retain it in position. In some embodiments, a nodeless anchoring system may be provided.
    [047] In some modalities, and as succinctly indicated in relation to Figure 9, this descriptive report provides suturing needles with cross-sectional profiles configured to prevent suture request and the methods of using them. In some modalities, suturing needles are provided with cross-sectional shapes (eg, flat, elliptical, transiting over the length of the needle, etc.) reducing tension against the tissue close to the site and reducing the possibility of breakage of the fabric. In some embodiments, a needle cross-sectional dimension is greater than the orthogonal cross-sectional dimension (eg, 1.1x larger, 1.2x larger, 1.3x larger, 1.4x larger, 1 .5x larger, 1.6x larger, 1.7x larger, 1.8x larger, 1.9x larger, >2x larger, 2.0x larger, 2.1x larger, 2.2x larger, 2 .3x larger, 2.4x larger, 2.5x larger, 2.6x larger, 2.7x larger, 2.8x larger, 2.9x larger, 3.0x larger, > 3, 0 larger, 3.1x larger, 3.2x larger, 3.3x larger, 3.4x larger, 3.5x larger, 3.6x larger, 3.7x larger, 3.8x larger, 3.9x larger, 4.0x larger, >4.0x larger... > 5.0 larger...> 6.0 larger...> 7.0x larger...> 8.0 major...> 9.0 major...>10.0 major). In some modalities, suturing needles are provided with a circular shape near this point (for example, the far end), but the transition along a flattened profile (for example, in a tape shape) near the back (for example the near end). In some modalities, the face of the flattened area appears orthogonal to the radius of curvature of the needle. In some embodiments, suturing needles create a slit (or flat puncture) in the tissue as they pass, rather than creating a circle or puncture puncture. In some modalities, suturing needles are provided in circular shapes along that point (for example, at the far end), but the transition to a 2D cross-sectional profile (for example, ellipse, crescent, half moon, concave, etc. .) near the back (for example, near end). In some modalities, the suturing needles provided in this descriptive report find use with sutures of the same shape and/or size. In some embodiments, suturing needles and sutures are not the same size and/or shape. In some modalities, the suturing needles provided in this descriptive report find use with traditional sutures. Several types of suturing needles are well known in the art. In some embodiments, the suturing needles provided in this specification incorporate any of the suitable suturing needle characteristics known in the field, but modified by the dimensions described in this document.
    [048] In some modalities, this descriptive report also provides with compositions, methods, and devices for anchoring the suture at the end of the closure (for example, without properly tightening the suture). In some embodiments, one or more retaining elements (eg, staples) are positioned over the terminal end of the suture to secure the end of the closure. In some embodiments, one or more retaining elements (eg, staples) are attached to the last “ring” of the suture closure (eg, to hold the suture tightly along the closure). In some embodiments, a retaining element consists of a clip. In some embodiments, a staple comprises a plurality of pins that can pass through the entire thickness of the two layers of suture. In some embodiments, the staple pins are configured to secure the end of the suture without loosening and/or weakening the suture filament. In some embodiments a staple forms a strong junction with the suture. In some modalities, a staple is made available after the needle has acted with the suture. In some embodiments, a clamp is provided with simultaneous needle removal.
    [049] In some embodiments, the present specification provides with devices (eg, staple guns) for delivering a staple close to tissue to secure the end of the suture. In some embodiments, a simultaneous or close to simultaneous staple actuation device triggers the staple and removes the needle from the suture. In some embodiments, a device a staple drive device consists of a lip or base shelf for passing the last suture ring (e.g., between the suture and tissue surface) against which the staple pins can be pushed. deformed in their locking position. In some embodiments, the base lip of the staple drive device is placed under the last ring of the suture, the released suture tail is positioned within the stapling mechanism, and the suture is firmly pulled. In some embodiments, while retaining tension, the staple drive mechanism is activated, binding the two layers of suture together. In some embodiments, the device also cuts off the excess length of tail released from the suture. In some embodiments, the staple drive device terminates the ongoing suture and pleats the excess suture in one step. In some embodiments, only one clip is required per closure. In some embodiments, a standard stapler is used for applying the staples and securing the end of the suture. In some modalities, a staple is applied to the end of the suture manually.
    [050] In some modalities, the sutures provided in this document provide an increase in the integrative properties of the tissue regarding the overall length of the repair (for example, at a earlier time point than traditional sutures). In some embodiments, sutures are provided that have enhanced tissue-adhering properties. In some modalities, sutures are provided integrated with the surrounding tissue. In some modalities, the integrative properties of the tissue find use with any of the other suture characteristics described in this document. In some modalities, sutures allow the healing tissue to integrate with the suture. In some modalities, tissue growth in the suture is promoted (eg, through the composition of the suture surface). In some embodiments, tissue growth in the suture prevents tissue from slipping around the suture, and/or minimizes micromovement between the suture and tissue. In some modalities, tissue ingrowth in the suture increases the overall size of the repair by multiplying the surface area for the scar in establishing tissue continuity. Conventionally, the strength of a repair depends only on the interface between the two tissue surfaces being approximated. In some modalities, tissue ingrowth in the suture is added to the surface area of the repair, accentuating its strength. In some modalities, increasing the surface area for scar formation causes the closure to achieve significant strength more quickly, shortening the relevant dehiscence risk window.
    [051] In some embodiments, the surface and/or internal composition of a suture promotes tissue adhesion and/or ingrowth. In some embodiments, as discussed above, specifically with reference to Figure 9, a suture in this specification may consist of a composite and/or porous material (eg, macroporous). In some modalities, a suture consists of a composite and/or porous (eg, macroporous) outer part. In some modalities, the pores in the suture allow for tissue ingrowth and/or integration. In some modalities, the suture consists of a porous girdle-shaped structure rather than a tubular-shaped structure. In some embodiments, a porous suture consists of a 2D cross-sectional profile (eg, elliptical, circular (eg, a fragmentable circle), crescent, crescent, concave, etc.). In some embodiments, a porous suture comprises polypropylene or any other suitable suture material. In some embodiments, the pores are between 500 µm and 3.5 mm or larger in diameter (eg, > 500 µm in diameter, > 600 µm, > 700 µm, > 800 µm, > 900 µm, > 1mm, or more). In some modalities, pores have variable sizes. In some of the embodiments, the suture is any surface composition suitable for promoting tissue ingrowth and/or adhesion. In some embodiments, suitable surface compositions include, without restriction, rib, weft, weave, groove, etc. In some embodiments, the suture may include filaments or other structures (e.g., to provide with increased surface area and/or increased stability of the suture within tissue). In some embodiments, interconnected porous architecture is provided where pore size porosity, pore shape and/or pore alignment facilitate tissue ingrowth.
    [052] In some embodiments, a suture consists of a mesh and/or a mesh-shaped outer part. In some modalities, a mesh outer part provides a flexible suture that disperses pressure across the closure site, and allows for significant tissue ingrowth. In some embodiments, mesh density is refined to obtain the desired flexibility, elasticity, and ingrowth characteristics.
    [053] In some modalities, a suture is coated and/or embedded with materials promoting tissue ingrowth. Examples of biologically active compounds that can be used in sutures to promote tissue ingrowth, without any restriction, comprise cell attachment mediators, such as peptides containing "RGD" integrin agglutination sequence variations known to influence attachment cell, biologically active ligands, and substances that enhance or exclude particular varieties of cellular or tissue ingrowth. Such substances include, for example, osteoinductive substances such as bone morphogenic proteins (BMP), epidermal growth factor (EGF), fibroblast growth factor (FGF), platelet-derived growth factor (PDGF), growth factor in insulin form (IGF-I and II), TGF-B, etc. Examples of active pharmaceutical compounds that can be used in sutures to promote tissue growth include, without restriction, acyclovir, cephradine, malphaline, procaine, ephedrine, adriomycin, claunomycin, plumbagine, atropine, quinine, digoxin, quinidine, peptides biologically active, chlorine and, sub. 6, cefatoquine, proline and proline analogues such as cis-hydroxy-L-proline, penicillin V, aspirin, ibuprofen, steroids, nicotinic acid, chemodeoxycholic acid, chlorambucil, and the like. Effective therapeutic dosages can be determined either by in vitro methods or by in vivo methods.
    [054] Sutures consist of medical devices well known in the art. In some modalities, the sutures have monofilament or woven constructions. In some embodiments, sutures are provided in single- or double-armed configurations containing a surgical needle installed at one or both ends of the suture, or may be made available without the installation of surgical needles. In some embodiments, the end of the suture away from the needle comprises one or more structures adjacent to the needle anchor. In some embodiments, the distal end of the suture consists of one or more closed loop, open loop, anchor point, barb, hook, etc. In some embodiments, sutures consist of one or more biocompatible materials. In some embodiments, sutures consist of one or more varieties of bioabsorbable and non-absorbable materials. For example, in some embodiments, the sutures consist of one or more aromatic polyesters such as polyethylene terephthalate, nylons such as nylon 6 and nylon 66, polyolefins such as polypropylene, silk, and other non-absorbable polymers . In some embodiments, the sutures consist of one or more polymers and/or copolymers of p-dioxanone (also known as 1,4-dioxanone-2-um), e-caprolactone, glycotide, L(-)-lactide, D( +)-lactide, meso-lactide, trimethylene carbonate, and combinations thereof. In some embodiments, the sutures consist of polydioxanone homopolymer. The above listing pertaining to suture materials should not be viewed as restrictive. Suture materials and their characteristics are known in the art. Any suitable types of suture material and combinations thereof are within the scope of this report. In some embodiments, the sutures are sterilized, medically graded, surgically graded, and/or are biodegradable materials. In some embodiments, the suture is coated, contains, and/or purifies one or more bioactive substances (eg, antiseptics, antibiotics, anesthetics, healing promoters, etc.).
    [055] In some modalities, the structure and material of the suture provides physiologically tuned elasticity. In some embodiments, a suture with appropriate elasticity is selected for a tissue. In some modalities, the elasticity of the suture is combined with tissue. For example, in some modalities, sutures for use in closing the abdominal wall have an elasticity similar to the abdominal wall, so as to reversibly deform together with the abdominal wall, rather than acting as a relatively rigid structure that would eventually carry a higher risk of the request. In some embodiments, the elasticity should not be so great that it forms a loose closure that can be easily removed. In some embodiments, the initial deformation of the suture would occur just before the elastic limit of the surrounding tissue, for example, before the tissue begins to break or deform irreversibly.
    [056] In some modalities, the sutures described in the report provide an adequate replacement or alternative to surgical repair meshes (eg, those employed in hernia repair). In some modalities, the use of sutures in place of the mesh reduces the amount of foreign material placed in the location in question (eg, 50 cm2 (suture) by 240 cm2 (mesh). enables the use of sutures to close tissue that is not possible with traditional sutures (eg, in areas of poor tissue quality (eg, weak or friable tissue) given conditions such as inflammation, fibrosis, atrophy, denervation , congenital disorders, age-related attenuation, or other chronic or acute diseases). As a surgical mesh, the sutures described in the report allow for a distribution of forces over a larger area by displacing the forces felt by the tissue and reducing the chance of suturing be withdrawn and failure to close.
    [057] In some modalities, sutures are permanent, removable, or absorbable. In some modalities, permanent sutures provide added strength along a closure or other region of the body, without the expectation that the sutures will be removed from the tissue and meet enough strength. In such modalities, materials are selected imposing little risk of long-term residence with the tissue or body. In some modalities, the removable sutures are stable (eg, do not degrade immediately in a physiological environment), and are intended to be removed when the surrounding tissue reaches full closure resistance. In some modalities, absorbable sutures integrate with tissue in the same manner as permanent or removable sutures but eventually degrade (eg > 1 week, > 2 weeks, > 3 weeks, > 4 weeks, > 10 weeks, > than 25 weeks, > than 1 year) and/or being absorbed by tissue after they have been helpful in keeping tissue together during the post-operative and/or healing period. In some modalities, absorbable sutures have a reduced risk of the presence of foreign bodies.
    [058] Although the prevention of dehiscence of abdominal closures (eg, hernia formation) is specifically described along with an application of the modalities in this report, the sutures described here are useful for joining any tissue types throughout the body. . In some embodiments, the sutures described in this report are of particular use for closures that are subject to top tension and/or for which a round seam is a concern. Example tissues pertinent to this specification find use including, without limitation, connective tissue, muscle, dermal tissue, cartilage, tendon, or any other soft tissue. Specific applications of the sutures described in this report include conciliation, suspensions, bandages, etc. The sutures described in this report find use in surgical procedures, non-surgical medical procedures, veterinary procedures, field medical procedures, etc. The scope of this descriptive report is not restricted to the potential applications of the sutures described by it.
    [059] Furthermore, from the foregoing, it should be understood that this descriptive report additionally provides both an innovative method of repositioning soft tissue and an innovative method of manufacturing a medical device.
    [060] Based on this specification, a method of repositioning the soft tissue may first include a portion of the soft tissue with the surgical needle 12 (as shown in Figure 9, for example) attached to a first end 14a of a suture tubular 14. A practitioner can then thread tubular suture 14 openings through the soft tissue and perform one or more stitches, as generally indicated. Finally, the practitioner can anchor the tubular suture 14 in place in the soft tissue. As previously described, the tubular suture 14 consists of a tubular mesh wall 16 defining a hollow core 18. The tubular mesh wall 16 defines a plurality of pores 20, each of which contains a pore size that is greater than or equal to approximately 500 microns. Thus configured, tubular suture 14 is adapted to accommodate soft tissue growing through tubular mesh wall 16 and into hollow core 18, thus integrating with the suture. In some versions, the method may further and finally include anchoring the tubular suture 14 in position by passing the surgical needle 12 through a closed loop anchor 22 (as seen in Figure 10, for example) along the second end 14b to the soft fabric. Once anchored, suture 14 can be cut off near anchor 22 and any remaining unused portion of suture 14 can be discarded.
    [061] A method of manufacturing a medical device coming in accordance with this specification may include forming a tubular wall 16 having a plurality of pores 20 and defining a hollow core 18, with each pore 20 having a pore size that is greater than or equal to approximately 500 microns. In addition, the method of fabrication may include attaching a first end 14a of the tubular wall 14 to a surgical needle 12 in a manner as illustrated in Figure 9. Forming the tubular wall 14 may include forming a tube from mesh material. The tubular mesh wall 16 can be formed by direct weaving or stitching the fibers into a tube shape. Alternatively, forming the meshed tubular wall 16 may include weaving or stitching the fibers into a flat plate and subsequently forming a flat tube-shaped laminate. Naturally, there are other possible manufacturing formats, and the weft and weaving of fibers do not comprise the only possibilities for creating a porous tube within the scope of this report, rather, they consist of mere examples.
    [062] It is further noted that a method of manufacturing a medical device coming in accordance with the present specification may include the provision of an anchor 22 at one end of the tubular wall 16 opposite the needle 12. In some versions of the method, and just as an example, provision of the anchor may be as simple to perform as forming a link, so as to resemble the anchor 22 described in Figure 10.
    [063] To substantiate some of the characteristics of the medical device 10 described in this document, a number of experiments were conducted and the character and results of some of these experiments are presented below. EXPERIMENTAL WORK Example 1 Finite element analysis of the suture/tissue interface for sutured abdominal wall closures
    [064] Experiments were conducted during the development of modalities of this descriptive report to perform finite element analyzes of the suture/tissue interface for sutured abdominal wall closures. A theoretical basis was created through intuitive concepts and clinical observations as the first step in the model of this line of study (see Figures 1 and 2). Finite element analysis of the suture/tissue interface came to be performed (Figure 3). Experiments have shown that increasing suture size (ie diameter) decreases forces at the suture/tissue interface as suspected (Figure 4). The shape of the suture was also shown to impact along with the local forces applied to the tissue by the suture (Figure 5). Example 2 Creating an “equivalence” between conventional and macroporous sutures in this descriptive report.
    [065] An O-sized polypropylene suture is commonly employed in hernia repair for care-handling factors and enhanced reinforcement. The experiments were conducted to determine a suture configured in cross section that is relatively equivalent to this type of suture. The two-dimensional suture was compared with the standard suture commonly used for loading at a certain yield, maximum load, and Young's modulus. An Instron 5984 equipment was used for mechanical testing. The experiments demonstrated a relative equivalence between polypropylene-o and a 5mm wide two-dimensional tape suture (Figures 6 and 7). A 5-0 polypropylene suture used in experimental rat hernia repair presented an equivalence referring to a 2 mm-wide sample of a macroporous suture in this descriptive report. Example 3 Creation and validation of an acute suture removal model using biological tissue and tensiometry.
    [066] Porcino alba linea is available from local butchers to provide conditions for a realistic acute suture removal test. The standard suture and macroporous suture of this descriptive report were positioned evenly through the porcine tissue. To reduce biological variability, adjacent pieces of fascia were randomized to either the standard suture or the two-dimensional suture, with the suture bite width reproducing what is done clinically (1 cm from the edge). Tests were performed using Tensiometry using an Instron 5964 as the removal of the suture at both a fast and a slow speed to simulate both the baseline tension of the suture and high momentary tension (eg, cough, stairs , etc.). Taking into account biological variability and the availability of access to biological materials, an adequate amount of tests were carried out, both focused on the standard suture and the macroporous suture of this descriptive report. Example 4 Rat Hernia Model
    [067] Experiments were conducted during the development of the modalities of this descriptive report reproducing a rat hernia model established in order to access the standard suture request and the claimed experimental macroporous suture.
    [068] A well-established rat hernia model has been reproduced (Dubay DA, Ann Surg 2007; 245; 140-146; incorporated herein by reference in its entirety). The rats' ventral hernias were randomized to repair using two standard sutures (5-0 polypropylene), and with two integrated sutures containing equivalent fatigue reinforcement. One month after hernia repair, rats were sacrificed and analyzed for hernia recurrence, hernia size, and suture order. Abdominal wall histology for analysis of suture integration came to be accessed by random observers. In these medical experiments, none of the macroporous sutures in this descriptive report were removed from the 17 rat hernias (that is, 34 of the 34 macroporous sutures were retained in the abdominal wall without flaws, with the image on the left side of Figure 16 comprising a typical example). The macroporous suture in this descriptive report facilitated tissue integration for each suture of each rat used. On the left of Figure 17, at one point there was an 82% reduction in the area under defect one month after repair with the macroporous suture. In contrast to this, in 13 rat hernias repaired with a conventional suture, 11 of 13 rats had at least one suture completely removed from the abdominal wall. The right side of Figure 16 comprises an example of a failed hernia repair with both sutures ordered. On the right side of Figure 17, it is shown that hernia size increased by 42% one month after repair with standard suture in an animal test. Figure 18 presents a graph comparing the mean defective area of 30 rat hernias repaired according to Figures 16 and 17 randomized for repair with both macroporous sutures from this descriptive report and with conventional sutures. One month after repair, mean hernia size decreased by 54% with the experimental macroporous suture in this report, while hernia size increased by 5% with conventional suture. Some recurrent hernia element containing both conventional and macroporous sutures was to be expected - only two sutures were used in this model, while six sutures were required to arrive at a completely closed abdominal wall. Example 5 Suture Width
    [069] Experiments conducted to assess the effect of suture width demonstrated that the enlarged suture width resulted in an increase in the maximum suture load, resulting in a decrease in suture withdrawal. Flat tinned copper braided wire was used as a prototype for suturing of variable widths. In relation to the fabric, the metallic thread turns out to be essentially unsatisfactory, creating a system that isolates the effect of the variation in width when the suture placed in the fabric is requested. The threads of variable width were placed in two different substances: tissue from live animals (porcine from the abdominal wall) and synthetic foamy veneer, and an Instron 5942 tensiometer equipment used to precisely measure the rupture of the resistance of this system. The thread was tested from widths ranging from 0.36 mm (equivalent to suturing in O-prolene) to 5 mm. These experiments examined the effects of increasing suture width on both animal tissue and synthetic “tissue” to determine whether there would be any differences between a live specimen and a synthetic substrate.
    [070] Figure 14 demonstrates that the increase in suture width came to require a greater force for the removal of the porcine from the abdomen. Unexpectedly, the benefits of increasing the suture width began to peak at a width around 3 mm. At a width of 3.75 mm, the pull-out resistance (maximum system load) actually decreased; Video time lag analysis showed that this fabric width began to fragment on both sides of the yarn, tending to come out of a segment of fabric. On the contrary, for the case of smaller widths, the thread came to cut through the fabric via a simple tear line. Therefore, the fractionation pattern incorporates maximum strength support of the system.
    [071] Figure 15 demonstrates that the same relationship is preserved in a synthetic tissue. In the so-called "transparent" system, the use of foam instead of animal tissue (the load consisting of a homogeneous substance presenting a smaller amount of mechanical variables than animal tissue), presents benefits of more varied sutures in addition to conventional suture, confirming yet the increased load-capacity surface area at the tissue-suture interface decreases the strain. However, in a similar way to porcine tissue, the benefit from the increased width has been shown to be up to 3.75 mm, at which point the foam substrate begins to break up into a segment shape.
    [072] While the hypothesis that a wider suture would be less likely to break was initially considered, in some modalities the suture width was not the only factor under consideration. For example, it is clear that tissue integration (ie, ingrowth through the pores 20 of suture 14 and into hollow core 28) along suture 14 further increased repair strength and reduced and/or completely eliminated the risk of removing the suture. Furthermore, as shown above, the experiments conducted during the development of the various modalities of this descriptive report demonstrated that the increase in the surface area carrying capacity came to further reduce the occurrence of withdrawal. The experiments with the use of wire in the porcine's abdomen confirmed these findings. In some experiments with widths above 3.75 mm, the pullout strength decreased. Instead of tearing the suture through the tissue in a straight line, there was the tearing of the tissue in the form of a segment or block. This discovery was unexpected. These experiments were repeated using a synthetic/homogeneous substance to test whether the benefit of increasing width was equally weak. A rubber foam having the same thickness as the porcino linea alba was used. Unexpectedly, the force required to withdraw the suture through the foam peaked for the same suture width, and the foam was even consumed within the same pattern as porcine tissue. The suture width as a maximum load ratio was preserved in both synthetic and animal tissue.
    [073] Both experiments indicated that the suture width/maximum load ratio is a function of mechanical phenomenon; although this descriptive report is not limited to any particular mechanism of action and an understanding of the mechanism at work is not necessary for the practice of this document.
    [074] Various modifications and variations to the method and system described in the report will become evident to experts in the field without deviating from the scope and spirit of the description. Although the descriptive report has been detailed in connection with the specific preferred modalities, it should be understood that the description of the form as claimed should not be unduly limited to those specific modalities. In fact, several modifications in relation to the ways described for the effective execution of the descriptive report that are obvious to technicians in the field of relevance are intended to be within the scope of this descriptive report.
    权利要求:
    Claims (19)
    [0001]
    1. Medical device, comprising: a surgical needle (12); and an elongated mesh suture (14) having a first end (14a) and a second end (14b) located remote from the first end (14a), wherein the first end (14a) is directly attached to the surgical needle (12); the elongated mesh suture (14) including a tubular wall (16), a hollow core (18) within the tubular wall (16), and a plurality of pores (20) extending through the tubular wall (16), CHARACTERIZED by the fact that at least some of the pores (20) have a pore size that is greater than or equal to approximately 500 microns, so that the pores (20) are adapted to facilitate tissue integration through the tubular wall ( 16) of the suture (14) when introduced into a body, wherein the suture (14) is uniform in diameter throughout substantially its entire length and the diameter is in a range of approximately 1 mm to approximately 5 mm.
    [0002]
    2. Medical device according to claim 1, CHARACTERIZED by the fact that the tubular wall (16) of the suture (14) extends along the entire length of the suture between the first and second ends (14a, 14b).
    [0003]
    3. Medical device, according to claim 1, CHARACTERIZED by the fact that the plurality of pores (20) varies in pore size.
    [0004]
    4. Medical device, according to claim 1, CHARACTERIZED by the fact that the suture (14) is constructed of a material selected from the group consisting of: polypropylene terephthalate, nylon, polyolefin, polypropylene, silk, polymeric p-diaxonone, p-diaxanone copolymer, ε-caprotactone, glycolide, L(-)-lactide, D(+)-lactide, meso-lactide, trimethylene carbonate, polydioxanone homopolymer, and combinations thereof.
    [0005]
    5. Medical device according to claim 1, CHARACTERIZED by the fact that the suture (14) is radially deformable so that the suture (14) adopts a first cross-sectional profile in the absence of lateral fatigue and a second profile of cross section in the presence of lateral fatigue.
    [0006]
    6. Medical device according to claim 5, CHARACTERIZED by the fact that the first cross-sectional profile exhibits radial symmetry.
    [0007]
    7. Medical device, according to claim 6, CHARACTERIZED by the fact that the second cross-sectional profile exhibits totally or partially fragmented conformation.
    [0008]
    8. Medical device, according to claim 1, CHARACTERIZED by the fact that the suture (14) has a circular cross-section profile when in a non-fatigue condition.
    [0009]
    9. Medical device, according to claim 1, CHARACTERIZED by the fact that it further comprises an anchor (22) fixed to the second end (14b) of the suture (14) to prevent the removal of the suture (14) during use, the anchor (22) having a dimension that is greater than the diameter of the suture (14).
    [0010]
    10. Medical device according to claim 9, CHARACTERIZED by the fact that the anchor (22) comprises a link, a sphere, a disk, a cylinder, a barb, and/or a hook.
    [0011]
    11. Medical device, according to claim 1, CHARACTERIZED by the fact that the tubular wall (16) comprises a fabric mesh material or sewn.
    [0012]
    12. Medical device, according to claim 1, CHARACTERIZED by the fact that the hollow core (18) is a hollow cylindrical space.
    [0013]
    13. Medical device according to claim 1, CHARACTERIZED by the fact that the hollow core (18) includes an alveolar structure or a 3D lattice structure defining one or more internal spaces.
    [0014]
    14. Medical device according to claim 1, CHARACTERIZED by the fact that the second end (14b) of the elongated mesh suture (14) is not connected to a needle.
    [0015]
    15. The medical device of claim 1, CHARACTERIZED by the fact that the second end (14b) of the elongated mesh suture (14) is selected from the group consisting of (a) a free end, (b) a end connected to an anchor (22), (c) one end having a loop, (d) one end connected to a barb and (e) one end connected to another surgical needle (12).
    [0016]
    A method of repositioning soft tissue using the medical device as defined in claim 1, the method comprising: puncturing a portion of the soft tissue with a surgical needle (12); and threading an elongated mesh suture (14) through the soft tissue, the elongated mesh suture (14) having a first end (14a) and a second end (14b) located remote from the first end (14a), at that the first end (14a) is directly attached to the surgical needle (12), wherein the elongated mesh suture (14) further comprises a tubular wall (16), a hollow core (18) inside the tubular wall (16), and a plurality of pores (20) extending through the tubular wall (16), CHARACTERIZED by the fact that at least some of the pores (20) have a pore size that is greater than or equal to approximately 500 microns so that the suture elongated mesh (14) is adapted to accommodate soft tissue growth through the tubular mesh wall (16) and into the hollow core (18), thereby integrating with the suture (14), the elongated mesh suture ( 14) still being uniform in diameter substantially along its entire length and with a diameter in a range of approximately 1 mm to approximately 5 mm.
    [0017]
    17. Method according to claim 16, CHARACTERIZED by the fact that the opening of threads in the elongated mesh suture (14) through the soft tissue comprises performing a plurality of stitches.
    [0018]
    18. Method according to claim 16, characterized in that it further comprises anchoring the elongated mesh suture (14) positioned in the soft tissue after opening threads in the elongated mesh suture (14) through the soft tissue.
    [0019]
    19. Method according to claim 18, CHARACTERIZED by the fact that the anchorage of the elongated mesh suture (14) in its position consists of passing the surgical needle (12) through a closed loop anchor (22) in the second end (14b) of the elongated mesh suture (14) and create a grip for anchoring the suture (14) to the soft tissue.
    类似技术:
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    同族专利:
    公开号 | 公开日
    JP2019084365A|2019-06-06|
    JP2015511160A|2015-04-16|
    KR101934981B1|2019-01-03|
    EP2816961A1|2014-12-31|
    KR102122998B1|2020-06-15|
    EP3305211A1|2018-04-11|
    HK1257958A1|2019-11-01|
    EP3305211B1|2021-09-22|
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    JP2019069263A|2019-05-09|
    US20180021040A1|2018-01-25|
    JP6189339B2|2017-08-30|
    KR20140127333A|2014-11-03|
    AU2017261502A1|2017-12-07|
    MX354311B|2018-02-23|
    AU2012370448B2|2017-09-07|
    IN2014DN07879A|2015-04-24|
    HK1245619A1|2018-08-31|
    AU2019275649A1|2020-01-16|
    AU2012370448A1|2015-01-22|
    US9237889B2|2016-01-19|
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    US20160106423A1|2016-04-21|
    KR102066230B1|2020-01-15|
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    KR20200006191A|2020-01-17|
    DK2816961T3|2018-01-15|
    KR20190006031A|2019-01-16|
    JP2017213397A|2017-12-07|
    WO2013126130A1|2013-08-29|
    ES2655821T3|2018-02-21|
    AU2017261502B2|2019-09-12|
    CN109602468A|2019-04-12|
    CN104168840A|2014-11-26|
    CN107661132A|2018-02-06|
    US20130226232A1|2013-08-29|
    PT2816961T|2018-02-05|
    EP3348207A1|2018-07-18|
    MX2014010180A|2015-08-06|
    NO2859175T3|2018-04-14|
    IL265173D0|2019-05-30|
    CA2865278A1|2013-08-29|
    CN107811665B|2020-09-04|
    US10881394B2|2021-01-05|
    CN104168840B|2018-10-16|
    EP2816961B1|2017-11-01|
    CN107661132B|2019-07-09|
    CA2865278C|2020-08-04|
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-11-05| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-12-01| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2021-04-13| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-05-11| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 13/12/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201261602183P| true| 2012-02-23|2012-02-23|
    US61/602,183|2012-02-23|
    PCT/US2012/069480|WO2013126130A1|2012-02-23|2012-12-13|Improved suture|
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