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    • 专利摘要:
    composite implants with anisotropic tissue reinforcement that have alignment markers and methods of manufacturing them. the present invention relates to a composite implant that includes anisotropic surgical mesh that has more stretch along a first axis and less stretch along a second axis that crosses the first axis, and an alignment marker overlying the first main surface anisotropic network and extending along the first axis. the implant includes a first absorbable anti-adhesion film overlying the alignment marker and the first main surface of the anisotropic mesh, and a second absorbable anti-adhesion film overlying the second main surface of the biocompatible mesh. the alignment marker is arranged between the first and second absorbable films and the first and second absorbable films are laminated on the anisotropic mesh.
    公开号:BR112012031739B1
    申请号:R112012031739-3
    申请日:2011-06-14
    公开日:2020-08-04
    发明作者:Ruth Pfeiffer；Jorg Priewe；Barbara Schuldt-Hempe；Christoph Walther
    申请人:Ethicon, Inc；
    IPC主号:
    专利说明:

    Cross Reference to Related Orders
    [0001] The present application relates to US patent application for serial number 29 / 363,759, assigned to the same applicant and deposited on the same date as this application, its description being incorporated by reference. Background of the Invention Field of the Invention The present invention relates, in general, to medical implants, and more specifically, relates to implants with tissue reinforcement. Description of the Related Art
    [0002] The use of tissue-reinforced implants, such as polymer networks, is widespread. In 1995, a procedure was developed by F. Ugahary that combines the advantages of fixing the preperitoneal network with the convenience of using small incisions to form access openings.
    [0003] Laparoscopic techniques were developed to repair inguinal hernias. One technique uses a transabdominal preperitoneal network (TAPP), through which an implant network is positioned peritoneally through a transabdominal laparoscopic access opening. Another technique is to place a totally extraperitoneal pre-peritoneal mesh (TEP), in which a large mesh is applied laparoscopically through an extraperitoneal access opening. The implanted network covers all three potential openings of the hernia. Often, after the intraperitoenal implantation of polymeric networks, adhesions of internal structures occur, such as intestine, omentum, etc. Thus, there have been many efforts aimed at providing implants that prevent, reduce the intensity of and / or minimize adhesions in the implant area, both in the center and on the periphery.
    [0004] Implants with tissue reinforcement, commonly called area transplantation, were developed in order to combine or complement the mechanical properties of the underlying tissue. The orientation of the area implant in relation to the underlying tissue can be important because the target tissue and the implant have mechanical properties that are anisotropic. An example of an implant that has anisotropic properties is a mesh with reinforcement fibers going in only one direction.
    [0005] There are several problems associated with conventional implants. For example, conventional implants may require surgeons to place alignment marks on the networks to align the networks on patients. Alignment marks are made using a skin marker that can be easily removed when being washed. In addition, after implantation of polymeric networks, adhesions of the internal structure occur frequently (for example, intestine, omentum, etc.).
    [0006] US patent No. 7,615,065, assigned to the same applicant, Priewe et al., Presents an area implant that has a stable, long-lasting base structure with pores with sizes in the range of 1 , 5 mm to 8 mm and is supplied, at least in part, on both sides, with a synthetic and resorbable polymeric film. The two polymeric films are glued or welded together in the pores of the base structure. The implant presented in Priewe reduces the formation of adhesions of internal structures in human or animal organisms and, after a period of time, facilitates tissue growth.
    [0007] WO 2003/037215 presents an area implant that has a network-like base structure and an alignment mark in a central region that indicates the center of the implant. A marking line passes through the central marking. The central marking and the marking line that passes through the central marking are used to align the implant with respect to a surgical opening to reinforce the tissue.
    [0008] Despite the advances above, there is a need for tissue-reinforced implants that have anisotropic properties (eg, stretching behavior) to simulate the anisotropic properties of the supported tissue (eg, abdominal tissue). There is also a need for tissue-reinforced implants that minimize or eliminate adhesions. In addition, there is a need for tissue-reinforced implants that have durable alignment markers. There is also a need for tissue-reinforced implants that can be used for intraperitoneal or laparoscopic applications, that adapt through a trocar, that are simple to position, that can be fixed with sutures, adhesions or glues and that have a network construction . Summary of the Invention
    [0009] In one embodiment, an implant with reinforcement of composite tissue preferably includes a base component, such as a surgical mesh. In one embodiment, the surgical mesh preferably has anisotropic mechanical properties so that the mesh is more extensible in the first direction and less extensible in the second direction. In one embodiment, the composite implant preferably includes at least two transparent absorbable films having a thickness of approximately 5-100 µm. The two transparent absorbable films are preferably laminated on the respective main faces of the surgical net. Absorbable films desirably have anti-adhesion properties. In one embodiment, the composite implant preferably includes an absorbable polymeric marker including a central disposable region in relation to the center of the implant, and two marking lines projecting from the central region. In one embodiment, the absorbable alignment marker is preferably lined with absorbable films and the surgical mesh so that the alignment marker remains stable during handling and surgery.
    [00010] In one embodiment, the alignment marker is asymmetrical and is desirably adapted to clearly show the center of the implant and the preferred placement direction for the implant. In one embodiment, the asymmetric alignment marker preferably includes two different marker lines passing from a central region of the marker. The two marking lines are preferably of different widths indicating the anisotropic stretching behavior of the surgical network. Outside the region of the alignment marker, the implant device is preferably transparent, thus allowing surgical personnel to see through the implant and observe critical structures such as underlying tissue, nerves and / or vessels.
    [00011] In one embodiment, the composite implant disclosed in the present invention can be used to repair hernias, specifically incisional hernias, particularly for intraperitoneal applications. In one embodiment, the composite implant can be positioned using laparoscopic techniques such as pelvic floor repair and incontinence treatment.
    [00012] In one embodiment, a composite implant preferably includes a film with tissue reinforcement that has a first main surface and a second main surface, an alignment marker overlying the first main surface of the film with tissue reinforcement and an absorbable film overlying the alignment marker and the first main surface of the fabric-reinforced film. In one embodiment, the alignment marker is preferably laminated between the absorbable film and the first main surface of the fabric-reinforced film.
    [00013] In one embodiment, the film with tissue reinforcement desirably includes a surgical mesh that has pores extending between the first and second main surfaces of the same. In one embodiment, the surgical mesh preferably includes an anisotropic material adapted to have more stretching along a first axis and less stretching along a second axis that crosses the first axis. In one embodiment, the alignment marker desirably extends along the first axis of the implant to indicate the direction of the implant that has the most stretch.
    [00014] In one embodiment, the composite implant desirably includes a second absorbable film overlying the second main surface of the fabric-reinforced film. The second absorbable film is preferably laminated to the fabric reinforced film and the first absorbable film. In one embodiment, the first and second absorbable films preferably have anti-adhesion properties and at least one of the first and second absorbable films is transparent, so that medical personnel can see the alignment marker and / or through implant.
    [00015] In one embodiment, the composite implant may include an adhesive film, such as a film produced from polydioxanone (for example PDS film), disposed between the second absorbable film and the second main surface of the film with laminated fabric reinforcement - tion of the first and second absorbable films for the surgical net.
    [00016] In one embodiment, the alignment marker preferably includes a central region adapted to be positioned at the center of the fabric-reinforced film, a first marking line extending from a first side of the central region of the alignment marker, and a second marker line aligned with the first marker line and extending from a second side of the central region of the alignment marker. The first and second marking lines are preferably aligned with the first axis of the anisotropic network.
    [00017] In one embodiment, the first marking line preferably extends to a first end of the composite implant and the second marking line preferably extends to a second end of the composite implant. In one embodiment, the first and second marking lines have different widths, which can be used to distinguish the different sectors of the implant to orient the implant in relation to the tissue.
    [00018] In one embodiment, a composite implant preferably includes an anisotropic mesh, such as a biocompatible polymeric material, which has more stretching along a first axis and less stretching along a second axis that crosses the first axis. The composite implant desirably includes an alignment marker overlying a first major surface of the anisotropic network and extending along the first axis. The implant preferably has a first absorbable anti-adhesion film overlying the alignment marker and the first main surface of the anisotropic network, and a second absorbable anti-adhesion film overlying the second main surface of the biocompatible network. The alignment marker is preferably arranged between the first and the second absorbable films and the first and the second absorbable films are laminated on the anisotropic mesh.
    [00019] In one embodiment, the alignment marker preferably includes a polymeric film that has a central region adapted to be positioned in the center of the anisotropic network, a first marking line extending from the first side of the region center of the alignment marker, and a second marking line extending from a second side of the central region of the alignment marker. The first and second marking lines are preferably aligned with the first axis of the implant. The first and second marking lines can have different widths.
    [00020] In one embodiment, at least one of the absorbable anti-adhesion films is transparent. In one embodiment, a PDS film can be arranged between the second absorbable anti-adhesion film and the anisotropic mesh to facilitate lamination of the first and second absorbable anti-adhesion films with the anisotropic mesh. In one embodiment, the anisotropic network desirably includes a polymeric network, the first and second absorbable anti-adhesion films desirably include a MONOCRYL film, and the alignment marker preferably includes a PDS film.
    [00021] In one embodiment, a method for manufacturing a composite implant includes assembling a pre-laminated structure that has a surgical mesh with a first main surface and a second main surface, an alignment marker overlying the first main surface of the surgical network , a first absorbable anti-adhesion film overlying the alignment marker and the first main surface of the surgical mesh, and a second absorbable anti-adhesion film overlying the second main surface of the surgical mesh, so that the alignment marker is disposed between the first and the second absorbable films. In one embodiment, the method desirably includes applying pressure and heat to the pre-laminated structure to laminate the first and second absorbable films and the alignment marker on the surgical mesh.
    [00022] In one embodiment, the pressure and heat application step preferably includes the application of a pressure of about 4 N / cm2 - 6.5 N / cm2 to the pre-laminated structure assembled at a temperature of about 110-130 ° C. In one embodiment, the surgical net is desirably an anisotropic net that has more stretch along a first axis and less stretch along a second axis that crosses the first axis. The alignment marker is preferably positioned over the surgical mesh so that it extends along the first axis.
    [00023] In one embodiment, the composite implant includes a surgical mesh that has anisotropic mechanical properties with stretching behavior. In one embodiment, after resorption of the resorbable parts of the implant (for example, a resorbable film), the rest of the mesh preferably has a greater degree of stretching in a cranial to caudal direction (that is, upper to lower) than that in a horizontal (ie, lateral) direction in order to simulate the anisotropic behavior of abdominal structures.
    [00024] In one embodiment, the composite implant is preferably adapted to be folded by passing the implant through a trocar and then unfolded after passing from a distal end of the trocar. In one embodiment, prior to insertion through the trocar, the composite implant is preferably rolled up, so that the alignment marker marking lines form a medium axis of the implant. In one embodiment, the composite implant can be inserted through a trocar and, after positioning the implant, the alignment marker including the marking lines is used to align the implant. In one embodiment, by positioning the implant, the marking lines preferably pass from the cranial to the caudal position. Thus, after absorbing the absorbable films, there is a tension behavior in the implant in the desired orientation. As a result, the difficult process of deploying the 90-degree rotation intraoperatively is avoided.
    [00025] In one embodiment, the composite implant is preferably coated on both sides with an absorbable film. Thus, it does not matter which side of the implant is positioned against an abdominal wall or intestine. This provides a clear advantage over other implants with only one side coated with a non-absorbable collagen mesh such as Paritex or Parietene, or mesh structures with two different surface structures. An example of a commercial product that has two different surface structures is commercially available under the trademark Dyna Mesh, which combines polypropylene (PP) monofilaments and polyvinylidene fluoride (PVDF).
    [00026] In one embodiment, a composite implant includes a stable long-lasting monofilament basically flat and a mesh repair that has anisotropic stretching behavior. The composite implant preferably includes at least two transparent synthetic absorbable films having a thickness of about 5-100 micrometers laminated on both sides of the surgical mesh. The composite implant preferably includes a colored and asymmetric polymeric marker that has a central region indicating the center of the implant, and two lines of marking extending from the central region. The two marking lines desirably have different widths indicating the anisotropic stretching behavior of the implant. In one embodiment, the alignment markers are preferably oriented between at least two synthetic absorbable films.
    [00027] In one embodiment, one of the external resorbable films is coated with a second, or supplementary, resorbable film, such as a PDS film. The second resorbable film desirably has the function of laminating the first and the second external resorbable films with the base component. The implant preferably includes an alignment marker which is laminated to the base component and which is covered by two external absorbable films. In one embodiment, the alignment marker is preferably an absorbable color film that is laminated between the first and the second external absorbable films. In one embodiment, gold or silver can be sprayed onto the surface of the surgical mesh before lamination.
    [00028] These and other preferred embodiments of the present invention will be described in detail later in this document. Brief Description of Drawings
    [00029] Figure 1 shows a plan view of a composite implant that has an alignment marker, according to an embodiment of the present invention.
    [00030] Figure 2 shows an exploded view of the composite implant in Figure 1.
    [00031] Figure 3 shows a perspective view of a composite implant including an alignment marker, according to an embodiment of the present invention.
    [00032] Figure 4 shows a plan view of the alignment marker shown in figure 3.
    [00033] Figure 5 shows a plan view of a composite implant including an alignment marker, according to an embodiment of the present invention.
    [00034] Figure 6 shows a plan view of a composite implant that has an alignment marker, according to an embodiment of the present invention.
    [00035] Figure 7 shows a plan view of a composite implant that has an alignment marker, according to an embodiment of the present invention.
    [00036] Figure 8 shows a plan view of a composite implant that has an alignment marker, according to an embodiment of the present invention.
    [00037] Figure 9 shows a plan view of an alignment marker for a tissue-reinforced implant, according to an embodiment of the present invention.
    [00038] Figure 10 shows a plan view of an alignment marker for a tissue-reinforced implant, according to an embodiment of the present invention.
    [00039] Figure 11 shows a plan view of an alignment marker for a tissue-reinforced implant, according to an embodiment of the present invention.
    [00040] Figure 12 shows alignment markers for tissue-reinforced implants, according to the modalities of the present invention. Detailed Description
    [00041] With reference to figure 1, in one embodiment, a composite tissue reinforcement implant 20 preferably includes a first end 22, a second end 24, a first side side 26, and a second side side 28. O tissue-reinforced implant 20 desirably has an alignment marker 30 including a central region 32 which preferably indicates a center of the implant 20, a first marking line 34 extending from the central region 32 of the alignment marker to the first end 22 of the implant 20, and a second marking line 36 that extends between the central region 32 of the alignment marker and the second ex-tremor 24 of the implant 20. In one embodiment, the alignment marker preferably assists medical personnel in the orientation and proper alignment of the composite implant 20 in relation to the patient's tissue in order to combine the anisotropic properties of the implant with the anisotropic properties of the tissue.
    [00042] With reference to figures 1 and 2, in one embodiment, the tissue-reinforced implant is preferably a composite implant with layers or films that are laminated together. In one embodiment, the composite implant 20 preferably includes a surgical mesh 40 that has an upper main surface 42 and a lower main surface 44. In one embodiment, the surgical mesh 40 has anisotropic properties so that the implant has more stretch along a longitudinal axis Ai extending between the first and second ends 22, 24 of the implant 20, and less stretching along a transverse axis A2 extending between 0 first and 0 second lateral sides 26, 28 (see figure 1).
    [00043] In one embodiment, surgical net 40 is preferably a stable, long-lasting component that may be non-absorbable or slowly absorbable. For use in the present invention, the long-term stable base component terminology means a non-absorbable polymer or a very slowly absorbable polymer that desirably has at least 50 percent of its original tear strength 60 days after implantation. In one embodiment, the long-lasting stable base component preferably includes substances such as polyamides, which are generally considered to be resistant and non-resorbable materials, and which may be exposed over time to body tissue and tissue fluids.
    [00044] In one embodiment, surgical net 40 may be produced from one or more materials, including polypropylene, mixtures of polyvinylidene fluoride and / or copolymers of vinylidene fluoride, hexafluoropropene, polyglycolide-polylactide or polyglecaprone (i.e., MONOCRYL film). In one embodiment, surgical net 40 can be produced from monofilaments, multifilaments and / or threads that have different diameters / sizes. In one embodiment, surgical net 40 is desirably woven.
    [00045] In one embodiment, the surgical mesh preferably includes non-resorbable polypropylene wires having a diameter of between about 0.089 - 0.13 mm, polyvinylidene fluoride copolymer wires with a diameter of about 0.069 - 0.089 mm, PVDF yarns with a diameter of about 0.089 - 0.13 mm, polyester yarns with a diameter of about 0.08 - 0.12 mm and / or polyamide yarns with a diameter of about 0.010 - 0.13 mm.
    [00046] In one embodiment, the tissue-reinforced implant may be a surgical mesh product sold under the trademark ULTRAPRO Partially Absorbable Lightweight Mesh (also known as ULTRAPRO) used for what is commonly called "open hernia repair techniques" ". In one embodiment, the tissue-reinforced implant can be a composite structure that includes a surgical mesh, such as the composite structure sold under the trademark PROCEED Surgical Mesh, which can be used for hernia repair, specifically for intraperitoneal applications and specifically for laparoscopic applications. The PROCEED Surgical Mesh composite implant can be a multi-layered implant including oxidized regenerated cellulose tissue (ORC), polydioxanone film (PDS or PDO), polypropylene monofilament mesh (PP) (eg PROLENE mesh), and polydioxanone film (PDS or PDO). During flexion tests, both types of implants show an "anisotropic" behavior that has greater flexural stiffness in the direction of texture and less flexion stiffness in the direction of travel. In one embodiment, the acronyms PDS and PDO stand for polydioxanone or a polydioxanone film. In one embodiment, the term PROLENE net means a soft PROLENE polypropylene net.
    [00047] In one embodiment, the alignment marker 30 is preferably positioned on the first main surface 42 of the surgical net 40. In one embodiment, the central region 32 of the alignment marker is preferably centered in relation to the first main surface 42 of the surgical net 40. Thus, the central region 32 is preferably equidistant between the first and second ends 22, 24 of the surgical implant 20, and is also preferably equidistant between the first and the second lateral sides 26, 28 of the implant 20. In one embodiment, the first marking line 34 preferably extends between the central region 32 of the alignment marker 30 and the first end 22 of the implant 20, and the second marking line 36 preferably extends between the central region 32 of the alignment marker 30 and a second end 24 of the implant 20. In one embodiment, the alignment marker 30 preferably extends along the longitudinal axis There is a way that differentiates between a "north-south" direction and an "east-west" direction.
    [00048] In one embodiment, the alignment marker 30 can be produced from a polymeric material. In one embodiment, the alignment marker 30 can be produced from an absorbable material. The alignment marker 30 may be colored, such as violet. In one embodiment, the alignment marker 30 may have a color differentiation to indicate the particular orientation as a "north-south" direction and / or an "east-west" direction. The alignment marker can be an absorbable polymeric material such as a PDS film.
    [00049] In one embodiment, the alignment marker 30 preferably increases the flexural stiffness of the composite implant 20 in order to facilitate deployment and to properly orient the implant in a patient (for example, orienting the implant in a "north" direction -south").
    [00050] In one embodiment, the alignment marker desirably includes a coloring agent that preferably contains a dye and a binder as a polymer. In one embodiment, printing or spraying techniques can be used to apply the alignment marker to the surgical mesh or an absorbable film. In one embodiment, the coloring agent can be prepared by dissolving dye and a polymer in a suitable solvent and spraying the alignment marker on a base frame or one of the absorbable films using an airbrush technique or a jet printer. of ink. After evaporation of the solvent, the desired markings are preferably firmly connected to the base structure or one of the absorbable films.
    [00051] In one embodiment, the alignment marker is preferably at least partially absorbable and is preferably arranged between a surgical mesh and an absorbable film. In one embodiment, the alignment marker is a polydioxanone film that is approximately 150 µm thick. In one embodiment, the alignment marker is colored, like a violet color. In one embodiment, the alignment marker can be cut from an extruded film sheet using common cutting techniques such as using a laser, a knife, a cutting die and / or ultrasound. In one embodiment, the alignment marker is preferably produced from a piece of material, which facilitates the positioning and orientation of the alignment marker on an implant.
    [00052] The composite implant 20 can be used for a wide range of surgical uses such as support for the urethra, support for the pelvic floor or hernia repair. Although the present invention is not limited by any particular operating theory, it is believed that the alignment marker 30 enables surgical personnel to visually differentiate between the first and second ends and the lateral sides of the implant 20 in order to assist in the proper orientation of the implant in relation to a patient. In a modality, the implant is anisotropic and the alignment marker enables surgical personnel to properly orient the implant to take advantage of the implant's anisotropic properties to maximize the therapeutic benefit.
    [00053] With reference to figure 2, in one embodiment, a first absorbable film 46 is attached to the first main surface 42 of the surgical net 40 with the alignment marker 30 positioned between the first absorbable film 46 and the surgical net 40. In In one embodiment, the first absorbable film 46 is preferably laminated to the surgical mesh 40. In one embodiment, the first absorbable film is transparent so that the alignment marker 30 is visible through the first absorbable film 46. In one embodiment, the first absorbable film 46 is preferably adapted to resist the formation of tissue adhesions. In one embodiment, the composite implant 20 preferably includes a second absorbable film 48 that has one or more of the properties of the first absorbable film 46. The second absorbable film 48 is preferably positioned on the second main surface 44 of the surgical network. 40 to form a laminated structure including surgical mesh 40, the alignment marker 30 and the first absorbable film 46. In one embodiment, a film to facilitate lamination of the implant structure, such as a PDS 50 film, can be arranged between the second absorbable film 48 and the second main surface 44 of the surgical net 40.
    [00054] In one embodiment, the first and second absorbable films 46, 48 preferably have a thickness between about 5-100 µm. The first and second absorbable films 46, 48 can be produced from a synthetic absorbable material such as a laminate of MONOCRYL film and film produced from polydioxanone (i.e., PDS film).
    [00055] With reference to figure 2, in one embodiment, a process for forming a composite implant 20 preferably includes the assembly of a pre-laminated structure including surgical mesh 40, the alignment marker 30 overlying the first main surface 42 of surgical net 40, and the first and second absorbable films, 46, 48 overlying the respective first and second main surfaces 42, 44 of surgical net 40. The alignment marker 30 is preferably arranged between the first absorbable film 46 and the first main surface 42 of the surgical network 40. In one embodiment, a polydioxanone film or PDS film 50 can be disposed between the second absorbable film 48 and the second main surface 44 of the surgical network 40. The pre-structure -laminate is preferably arranged inside a press adapted to apply pressure and temperature for a preferred period of time to laminate and sufficiently temper the implant 20. In u In one embodiment, the pressure applied to the laminated structure is preferably about 5 N / cm2 to about 6.5 N / cm2. In one embodiment, the laminated structure is preferably exposed to a temperature of about 120 ° C for about 5-10 minutes. The laminated structure can be cooled while being held in position to prevent shrinkage of the implant 20.
    [00056] In one embodiment, the composite implant, 20 can be impregnated with a therapeutic agent such as a liquid-based therapeutic agent. More specifically, in one embodiment, the surgical net 40, the first absorbable film 46 and / or the second absorbable film 48 can be impregnated with a liquid-based therapeutic agent such as gentamicin, octenidine, polyhexamethylene biguanide (PHMB), etc. . The therapeutic agent can be incorporated into the surgical net 40, the first absorbable film 46, and / or the second absorbable film 48 with the use of horizontal or vertical immersion techniques.
    [00057] In one embodiment, the composite implant 20 may include an active agent such as an antimicrobial agent. In one embodiment, a composite tissue supporting the implant can include at least one biologically active agent that is preferably released locally after implantation. The biologically active agent can be applied to at least one of the layers of composite implant or only to the surgical network before the implant lamination.
    [00058] Substances that are suitable as active agents can be naturally occurring or synthetic and may include, but are not limited to, for example, antibiotics, antimicrobials, antibacterials, antiseptics, chemotherapy, cytostatics, metastasis inhibitors , antidiabetics, antimycotics, gynecological agents, urological agents, antiallergic agents, sex hormones, sex hormone inhibitors, hemostiptics, hormones, hormonal peptides, antidepressants, vitamins like vitamin C, antihistamines, naked DNA, plasmid DNA, cationic DNA complexes , RNA, cell constituents, vaccines, naturally occurring cells in the body or genetically modified cells. The active agents can be present in an encapsulated form or in an absorbed form. With such active agents, the patient's diagnosis can be improved according to the application or a therapeutic effect can be obtained (for example, better wound healing, or inhibition or reduction of inflammation).
    [00059] In one embodiment, the active agents can be antibiotics including such agents as gentamicin or antibiotic brand ZEVTERA® (ceftobiprol medocaril) (available from Basilea Pharmaceuticals Ltd., Basel, Switzerland). In one embodiment, an implant may include broad-spectrum antimicrobials used against different bacteria and yeasts (even in the presence of bodily fluids) such as octenidine, octenidine dihydrochloride (available as an active ingredient in the Octenisept® disinfectant from Schulke & Mayr, Norderstedt, Germany) , polyhexamethylene biguanide (PHMB) (available as an active ingredient in Lavasept® from Braun, Switzerland), triclosan, copper (Cu), silver (Ag), nanoparticulate silver, gold (Au), selenium (Se), gallium (Ga ), taurolidine, N-chlorotaurine, alcohol-based antiseptics such as the Listerine® mouthwash, N-lauryl-L-arginine ethyl ester (LAE), myristamido propyl dimethylamine (MAPD, available as an active ingredient in SCHERCODINE® M), propyl dimethylamine oleamide (OAPD, available as an active ingredient in SCHERCODINE® O), and propyl dimethylamine steamer (SAPD, available as an active ingredient in SCHERCODINE® S). In one embodiment, the agent can be octenidine dihydrochloride (later in this document called octenidine) and / or PHMB. The active agents can be applied together with an absorbable coating polymer to adjust the release time of the agents.
    [00060] In one embodiment, a composite implant is impregnated with an antibiotic, antiseptic or therapeutic solution prior to implantation, preferably under operating room conditions. In one embodiment, the composite implant can be impregnated with the antibiotic, antiseptic or therapeutic solution by immersing the implant in a solution for up to five (5) minutes or more in order to impregnate the external absorbable films and the internal surgical network. In one embodiment, a composite implant is 7.5 cm by 15 cm in size and includes a 150 pm thick PDS violet film for an alignment marker. The alignment marker preferably includes a center section of the marker about 10 mm high and 20 mm wide, a marking line with a north direction with a width of about 3 mm and a marking line with a south direction with a width of about 5 mm. Both marking lines preferably pass from the central section to the respective north and south edges of the implant. In one embodiment, the composite implant is preferably placed horizontally in an antiseptic solution for about five minutes. In one embodiment, the antiseptic solution is approximately 500 ml of 0.2 percent Lavasept. The implant is preferably immersed under the liquid surface of the antiseptic solution and the implant can be secured with forceps and agitated to remove any excess solution. In one embodiment, the surfaces of the absorbable film are instantly moistened and a surgical mesh between the absorbable films will be slowly moistened from the edges by moving air with the antiseptic liquid around the periphery of the implant. In one embodiment, more than 50 percent of the net area is impregnated with the antiseptic solution after five minutes.
    [00061] In one embodiment, a composite implant can be impregnated using a standard laboratory device for applying dip coating. In one embodiment, the composite implant can be immersed in a solution of octenidine dihydrochloride in acetone / water for at least five minutes and removed with an extraction speed of about three mm / second. Using the process described above, the composite implant can be completely impregnated with the solution inside and outside, except for the inner area of the bright spots of the welding of the two absorbable films in the centers of the pores.
    [00062] With reference to figures 3 and 4, in one embodiment, the alignment marker 30 has at least one feature that enables surgical personnel to properly align implant 20 in a patient. In one embodiment, the alignment marker is an asymmetric alignment marker that is laminated on the 40 mesh (figure 2) and that can be used by medical personnel to guide the implant. In one embodiment, the asymmetric alignment marker 30 desirably includes a central region 32 that is preferably centered between the first end 22 and the second end 24 of the implant 20. In one embodiment, the central region 32 of the alignment marker 30 is, preferably equidistant between the first lateral side 26 and the second lateral side 28 of the implant 20. The asymmetric alignment marker 30 desirably includes a first marking line 34 which extends between the central region 32 of the alignment marker 30 and the first end 22 of implant 20. Alignment marker 30 preferably includes a second marking line 36 which extends between the central region 32 and the second end 24 of implant 20. In one embodiment, the first marking line 34 and the second marking line 36 is preferably aligned with one another along an axis designated Ai. In one embodiment, the Ai axis desirably defines a longitudinal axis of the implant 20. In one embodiment, the first marking line 34 is preferably different in width from the second marking line 36 so that medical personnel can adequately distinguish between the two. "north" and "south" ends of the implant to properly orient the implant 20 over the tissue. In one embodiment, the first marking line 34 is desirably narrower than the second marking line 36, which enables medical personnel to properly orient and align the implant 20 in a particular direction on a patient, such as a "north" direction ".
    [00063] In one embodiment, the surgical net 40 covered by the absorbable layers preferably has anisotropic properties so that the implant has more stretching in a first direction and less stretching in a second direction. With reference to figure 3, in one embodiment, the surgical net 40 is preferably adapted to be more extensible along the longitudinal axis Ai extending between the first and second ends of the implant and less extensible along an axis cross-sectional A2 extending between 0 first and 0 second side sides 26, 28. The alignment marker 30 preferably enables surgeons to properly orient the implant 20 with respect to the tissue to maximize the anisotropic properties of the implant. For example, some regions of patient tissue tend to stretch more in one direction than in the other direction, and tissue-reinforced implants with anisotropic mechanical properties can be implanted in a particular orientation to cooperate with the stretch characteristics of the underlying tissue.
    [00064] Figures 1 and 3 show a composite implant that has a generally oval shape. It is contemplated that the particular shape of a composite implant can be modified and still remain within the scope of the present invention. In other embodiments, a composite implant may have a circular, square or rectangular shape.
    [00065] With reference to figure 5, in one embodiment, a composite implant 120 has an elongated oval shape with a Li length of approximately 100-400 mm and a Wi width of approximately 75-300 mm. An asymmetric alignment marker 130 desirably extends along a longitudinal axis of the implant, which preferably extends between a first end 122 and a second end 124 of the implant 120. The implant 120 preferably has properties anisotropic that allow the implant to have more stretching along the longitudinal axis of the implant and less stretching in the lateral directions.
    [00066] With reference to figure 6, in one embodiment, a composite implant 220 has an oval shape, the implant being wider than the implant shown in figure 5. In figure 6, implant 220 preferably has a length l_2 of approximately 200-300 mm and a width W2 of approximately 150-200 mm.
    [00067] Figure 7 shows a modality in which the implant 320 is rectangular, having an L3 length of approximately 100-500 mm and a W3 width of approximately 75-400 mm.
    [00068] Figure 8 shows a composite implant 420 which is substantially square, which has a length of approximately 100-400 mm and a width of approximately 100-400 mm. The modalities shown in figures 5-8 desirably include an asymmetric marker that enables surgical personnel to properly align the implant with respect to the tissue to reinforce the tissue. In one embodiment, the implants have anisotropic properties, and the asymmetric markers preferably extend along an axis that identifies the direction of the implant that has the most stretch and the transverse direction of the implant that has the least stretch.
    [00069] With reference to figure 9, in one embodiment, an alignment marker 530 for a tissue-reinforced implant preferably includes a central region 532 that can be centrally located on an implant, such as the implant shown in figures 1 , 3 and 5-8 above. The alignment marker 530 preferably includes a first marking line 534 that extends towards a first end of an implant and a second marking line 536 that extends towards a second end of an implant. The alignment marker 530 may have an arrow 535 printed, cut and / or formed within the central region 532 to enable medical personnel to properly orient a surgical implant. In one embodiment, the alignment marker 530 is preferably positioned on a main surface of a surgical mesh as shown in figure 2. The alignment marker 530 is preferably laminated on the surgical mesh. The first and second marking lines 534, 536 are preferably oriented with the axis of the implant that has the most stretch, which enables medical personnel to properly orient the implant.
    [00070] With reference to figure 9, in one embodiment, the alignment marker is a film having a thickness of about 100-200 pm and more preferably about 150 pm. In one embodiment, the alignment marker 530 is produced from a colored PDS film. In one embodiment, the alignment marker 530 can include connection elements 570A, 570B that have alignment openings provided at the outer ends of the respective first and second marking lines 534, 536. Connection elements 570A, 570B can be used during mounting an implant to properly orient the alignment marker 530 on the implant, and can be removed at a later stage in the assembly process to provide an implant that has a final shape (for example the implant shapes shown in figures 1, 3, and 5-8).
    [00071] With reference to figure 10, in one embodiment, an alignment marker 630 preferably includes a central region 632, a first marking line 634 extending from the first side of the central region 632 and a second line marking 636 extending from an opposite side of central region 632. In one embodiment, central region 632 of alignment marker 630 is preferably centered with respect to a first major surface of a base component as a surgical network. The first and second marking lines 634, 636 are preferably aligned with each other and can extend along an axis to indicate the anisotropic properties of the implant.
    [00072] With reference to figure 11, in one embodiment, an alignment marker 730 for a tissue-reinforced implant preferably includes a central region 732 that is adapted to be centered in relation to a first main surface of a network surgical. The central region 732 can be centrally located between a first end and a second end of an implant, and between the first and second side sides of an implant, as shown in figure 1. The alignment marker 730 desirably includes a first line of marking 734 projecting from a first side of the central region 732 and a second marking line 736 projecting from an opposite side of the central region 732. The first and second marking lines 734, 736 are preferably in alignment with each other along an axis. In one embodiment, the first marking line 734 preferably orientates the implant so that the first marking line 734 extends in a "north" or "south" direction. In one embodiment, the first marking line 734 has a wider width than the second marking line 736.
    [00073] With reference to figure 12, in one embodiment, a plurality of alignment markers having different formats and configurations can be used. The alignment markers are preferably positioned on a tissue supporting the implant and laminated on the implant. Alignment markers are preferably used to properly orient implants in a patient. In one embodiment, the implants have anisotropic mechanical properties and the alignment markers are oriented on the implants so that medical personnel can properly position the implants to take advantage of the anisotropic properties of the implants.
    [00074] Although the present invention is not limited by any particular theory of operation, it is believed that incorporating an alignment marker in a laminated composite implant increases the hardness of the implant, which improves the deployment of the implant after dispensing the implant from a trocar or laparoscopic device.
    [00075] In one embodiment, the alignment marker is arranged between an absorbable anti-adhesion film and a base component such as a surgical mesh. The absorbable film, the alignment marker and the base component are preferably laminated together. The absorbable film and the base component desirably lines the alignment marker for external forces that can dislodge the implant alignment marker.
    [00076] In one embodiment, the absorbable film is transparent so that the alignment marker is visible to medical personnel to assist medical personnel to properly orient the implant within a patient. In one embodiment, the base component and the alignment marker are laminated between a pair of transparent absorbable films that provide visibility of the alignment marker from both sides of the implant.
    [00077] In one embodiment, a tissue-reinforced implant preferably includes a base component, such as a surgical mesh, an alignment marker overlying the base component, and a pair of external absorbable films that are laminated to the component base and the alignment marker. A therapeutic agent is provided between the two external absorbable films to provide good retention of the therapeutic agent by the implant prior to implantation.
    [00078] In one embodiment, the alignment marker is asymmetric, which preferably provides visual differentiation between all four sides of an implant to assist in the proper orientation of the implant within a patient.
    [00079] In one embodiment, a process for forming a composite implant includes lamination and annealing of the implant structure in a single step, restricting the implant structure in a press during the process, providing more efficient fabrication of a composite implant.
    [00080] Although the aforementioned is directed to modalities of the present invention, other additional modalities of the invention can be invented without departing from the basic scope thereof, which is limited only by the scope of the following claims. For example, the present invention contemplates that any of the characteristics shown in any of the modalities described herein, or incorporated by reference, can be incorporated with any of the characteristics shown in any other of the modalities described herein, or incorporated by reference, and still fall within the scope of the present invention.
    权利要求:
    Claims (18)
    [0001]
    1. Composite implant (20) comprising: a surgical mesh (40) that has a first main surface (42) and a second main surface (44) and pores that extend between the first and second main surfaces (42, 44) ; an alignment marker (30) overlying the first main surface (42) of the surgical net (40); an absorbable film (46) overlying the alignment marker (30) and the first main surface (42) of the surgical net (40), where the alignment marker (30) is laminated between the absorbable film (46) and the first main surface (42) of the surgical net (40). characterized by the fact that the surgical net (40) comprises an anisotropic material adapted to have more stretching along a first axis (Ai) and less stretching along a second axis (A2) that crosses the first axis (Ai) and The alignment marker (30) extends along the first axis (Ai) of the implant (20) to indicate the direction of the implant (20) having more stretch.
    [0002]
    2. Composite implant (20) according to claim 1, characterized by the fact that it still comprises a second absorbable film (48) overlying the second main surface (44) of the surgical net (40), in which 0 second absorbable film (48) is laminated on the surgical net (40) and on the first absorbable film (46).
    [0003]
    3. Composite implant (20), according to claim 2, characterized by the fact that the first and second absorbable films (46, 48) have anti-adhesion properties, and in which at least one of the first and second absorbable films (46, 48) is transparent.
    [0004]
    4. Composite implant (20), according to claim 3, characterized by the fact that it still comprises an adhesive film (50) disposed between the second absorbable film (48) and the second main surface (44) of the surgical net (40 ) to laminate the first and second absorbable films (46, 48) together.
    [0005]
    5. Composite implant (20), according to claim 4, characterized in that the adhesive film (50) comprises a film produced from polydioxanono.
    [0006]
    6. Composite implant (20), according to claim 1, characterized by the fact that the alignment marker (30) comprises: a central region (32) adapted to be positioned in a center of the surgical network (40); a first marking line (34) extending from a first side of the central region (32) of the alignment marker (30); and a second marking line (36) aligned with the first marking line (34) and extending from a second side of the central region (32) of the alignment marker (30), where the first and second lines marking lines (34, 36) are aligned with the first axis (Ai) of the anisotropic material.
    [0007]
    7. Composite implant (20) according to claim 6, characterized in that the first marking line (34) extends to a first end (22) of the composite implant (20) and the second marking line (36) extends to a second end (24) of the composite implant (20), and the first and second marking lines (34, 36) have different widths.
    [0008]
    8. Composite implant (20), according to claim 1, characterized by the fact that the surgical network (40) comprises a biocompatible and flat polymeric network.
    [0009]
    9. Composite implant (20), according to claim 1, characterized by the fact that it comprises absorbable film (46) is a first absorbable anti-adhesion film overlying the alignment marker (30) and the first main surface (42) of the network anisotropic surgery (40); and the implant (20) still comprises a second absorbable anti-adhesion film (48) overlying the second main surface (44) of the anisotropic surgical network (40), in which the alignment marker (30) is disposed between the first and second absorbable films (46, 48) and the first and second absorbable films (46, 48) are laminated in the anisotropic surgical mesh (40).
    [0010]
    10. Composite implant (20), according to claim 9, characterized by the fact that the anisotropic surgical network (40) comprises a biocompatible and flat polymeric network.
    [0011]
    11. Composite implant (20), according to claim 10, characterized by the fact that the alignment marker (30) comprises a polymeric film including a central region (32) adapted to be positioned in a center of the anisotropic surgical network ( 40), a first marking line (34) extending from a first side of the central region (32) of the alignment marker (30), and a second marking line (36) extending from a second side of the central region (32) of the alignment marker (30), where the first and second marking lines (34, 36) are aligned with the first axis (Ai).
    [0012]
    12. Composite implant (20) according to claim 11, characterized in that the first and second marking lines (34, 36) have different widths.
    [0013]
    13. Composite implant, according to claim 9, characterized by the fact that at least one of the absorbable anti-adhesion films (46, 48) is transparent.
    [0014]
    14. Composite implant (20) according to claim 9, characterized by the fact that it still comprises a film 950) produced from polydioxanone disposed between the second absorbable anti-adhesion film (48) and the anisotropic surgical mesh (40) for facilitate the lamination of the first and second absorbable anti-adhesion films (46, 48) with the anisotropic surgical mesh (40).
    [0015]
    15. Composite implant (20) according to claim 9, characterized by the fact that the anisotropic surgical mesh (40) comprises a polymeric mesh, the first and second absorbable anti-adhesion films (46, 48) comprise the MONOCRYL film, and the alignment marker (30) comprises colored PDS film.
    [0016]
    16. Method for manufacturing a composite implant (20) characterized by the fact that it comprises the steps of: assembling a pre-laminated structure that includes: a surgical mesh (40) that has a first main surface (42) and a second surface main (44) and pores extending between the first and second main surfaces (42, 44), comprising an anisotropic material adapted to have more stretching along a first axis (Ai) and less stretching along a second axis ( A2) that crosses the first axis (Ai), an alignment marker (30) on the first main surface (42) of the surgical net (40) whose alignment marker (30) extends along the first axis (Ai) of the implant (20) to indicate the direction of the implant (20) having more stretch, a first absorbable anti-adhesion film (46) overlying the alignment marker (30) and the first main surface (42) of the surgical net (40); a second absorbable anti-adhesion film (48) overlying the second main surface (44) of the surgical net (40), in which the alignment marker (30) is disposed between the first and second absorbable films (46, 48); apply pressure and heat to the pre-laminated structure to laminate the first and second absorbable films (46, 48) and the alignment marker (30) to the surgical mesh (40).
    [0017]
    17. Method, according to claim 16, characterized by the fact that the step of applying pressure and heat comprises the application of pressure of 4 N / cm2 - 6.5 N / cm2 to the pre-laminated structure assembled at a temperature 110-130 ° C.
    [0018]
    18. Method, according to claim 16, characterized by the fact that the surgical net (40) comprises an anisotropic net that has more stretching along a first axis (Ai) and less stretching along a second axis (A2 ) which crosses the first axis (Ai), and where the alignment marker (30) extends along the first axis (Ai).
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    JP2013532028A|2013-08-15|
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    BR112012031739A2|2017-03-14|
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    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-09-03| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-06-02| B09A| Decision: intention to grant|
    2020-08-04| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 14/06/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US12/815,275|2010-06-14|
    US12/815,275|US8821585B2|2010-06-14|2010-06-14|Composite anisotropic tissue reinforcing implants having alignment markers and methods of manufacturing same|
    PCT/US2011/040355|WO2011159700A1|2010-06-14|2011-06-14|Composite anisotropic tissue reinforcing implants having alignment markers and methods of manufacturing same|
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