Surgical prosthesis

Abstract

The utility model relates to a surgical prosthesis. In some embodiments, an implantable prosthesis may comprise: a mesh comprising a first face and a second face; at least one suture having an average stitch length greater than an average pore size of the mesh; and a loop distinct from the mesh formed by skipping on at least one suture and attached to at least two locations on the mesh with a span length therebetween greater than the average stitch length, the loop having a central portion between the at least two locations, the central portion is not attached to the mesh and is disposed on a first side of the first face. The ring of the prosthesis provides at least one operational aid. The operating aid may serve as a grip point to allow an operator (e.g., a surgeon) to manipulate the planar body to reduce the risk of exerting an undesired stress or strain on the underlying body. The manipulation aid may be used in minimally invasive surgery, such as laparoscopic surgery and / or robotic surgery.

Description

[0001] This application is a divisional application of the utility model patent application with the application date of December 12, 2022, application number 202223327939.8, and invention name “Surgical Prosthesis”. Technical Field

[0002] The disclosed embodiments relate to implantable mesh prostheses and related methods of use. More specifically, methods and apparatus related to mesh prostheses with handling aids are disclosed. Background Art

[0003] A technique for repairing a soft tissue defect includes positioning an implantable soft tissue prosthesis, such as a mesh prosthesis, to cover the tissue defect. The prosthesis may be fixed in place relative to the defect using tacks, sutures, and / or adhesives.

[0004] A hernia defect is an opening or weakness in a tissue or muscle wall such as the abdominal wall. One method for repairing a hernia is to insert a soft tissue prosthesis into the intra-abdominal space, positioning the prosthesis to cover the wall defect, and then securing the prosthesis to the abdominal wall using tacks, sutures, and / or adhesives, if necessary.

[0005] To repair a variety of soft tissue defects, prostheses can be delivered through minimally invasive techniques, such as laparoscopic surgery. For example, to deliver a prosthesis intra-abdominally, the prosthesis can be rolled, folded, or otherwise collapsed into a reduced configuration and then inserted through a small incision or trocar into the intra-abdominal space. The prosthesis is then unfolded and positioned relative to the defect. Utility Model Content

[0006] In some embodiments, a surgical prosthesis is provided. The surgical prosthesis may include: a mesh, the mesh including a first face and a second face; at least one suture, the average stitch length of the at least one suture being greater than the average hole size of the mesh; and a ring, the ring being different from the mesh. The ring is formed by skipping stitches on the at least one suture, the ring is attached to at least two locations on the mesh, the span length between the at least two locations is greater than the average stitch length, and the ring has a central portion between the at least two locations, the central portion is not attached to the mesh and is disposed on a first side of the first face.

[0007] In some embodiments, a surgical prosthesis is provided, which includes: a mesh, the mesh including a first surface and a second surface; and at least one operating aid, the at least one operating aid is different from the mesh, the at least one operating aid includes a fixed portion attached to one of the first surface and the second surface, the at least one operating aid includes one or more protrusions extending from the fixed portion or one or more protrusions extending from the fixed portion, each of the one or more protrusions or one or more protrusions deviates from the plane of the mesh so as to be grasped by a surgical tool to facilitate manipulation of the mesh.

[0008] It should be understood that the above concepts and the additional concepts discussed below can be arranged in any suitable combination, as the present disclosure is not limited in this respect. In addition, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component illustrated in various figures may be represented by a like numeral. For purposes of clarity, not every component is labeled in every drawing. In the drawings:

[0010] Figure 1 schematically illustrates a mesh prosthesis with a manipulation aid according to some embodiments;

[0011] FIG. 2A to FIG. 2B schematically illustrates a mesh prosthesis with a manipulation aid according to some embodiments;

[0012] Figure 3 schematically illustrates a portion of a mesh prosthesis with a manipulation aid according to some embodiments;

[0013] Figure 4 shows a perspective top view of a mesh prosthesis with a manipulation aid according to some embodiments;

[0014] Figure 5 shows a perspective top view of a mesh prosthesis with an operation aid according to some embodiments in operation;

[0015] Figure 6 shows a top plan view of a mesh prosthesis with a manipulation aid according to some embodiments;

[0016] Figure 7 schematically illustrates a perspective top view of a mesh prosthesis with a manipulation aid according to some embodiments;

[0017] Figure 8A mesh prosthesis with an operation aid according to some embodiments is shown in operation;

[0018] FIG. 9A to FIG. 9B schematically illustrates a mesh prosthesis with a manipulation aid according to some embodiments;

[0019] Fig.10 schematically illustrates a mesh prosthesis with a manipulation aid according to some embodiments; and

[0020] FIG. 11A to FIG. 11C A process for preparing a mesh prosthesis with a handling aid according to some embodiments is shown. DETAILED DESCRIPTION

[0021] In conventional laparoscopic soft tissue repair surgery, surgeons typically place implantable prostheses in the internal biological space or pocket area of ​​a subject (e.g., a patient) to provide support and / or strength for weak tissue and to speed up the repair process. For example, in hernia repair surgery, surgeons can place the prosthesis in a plane outside the peritoneum. The prosthesis can be formed by a mesh sheet slightly larger than the defect. The higher surface area of ​​the porous prosthesis can induce tissue ingrowth during the repair process. The prosthesis is usually flexible enough to conform to the curved surface of the soft tissue and move with the subject, thereby reducing the risk of discomfort.

[0022] The surgeon and / or operator may manipulate the prosthesis within the internal biological space or pocket using one or more surgical tools and / or by directing a mechanical end effector into the surgical site. The prosthesis may be grasped and moved or oriented relative to the defect. The inventors have recognized that grasping the prosthesis to manipulate the prosthesis may result in damage to the prosthesis. Where the prosthesis is formed of a mesh structure, excessive strain resulting from grasping or redirecting may result in undesirable changes to the underlying mesh structure, which may reduce the effectiveness of the mesh used to repair the defect.

[0023] Based on the foregoing, the inventors have recognized that the benefit associated with an implantable prosthesis having one or more features is to improve the manipulation of the prosthesis (e.g., transport, positioning, orientation, etc. of the prosthesis) during surgery (e.g., in a surgical bag area, such as an extraperitoneal plane for hernia repair surgery). The one or more features can be connected to the body of the prosthesis, which can serve as a structural support for a soft tissue defect, so that the prosthesis can be manipulated by manipulating the one or more features. Therefore, these features can be used as gripping points for the prosthesis, allowing the operator to manipulate the prosthesis body by manipulating these features rather than the prosthesis body (e.g., a face or corner of the prosthesis). In this way, the risk of damaging the structural integrity of the prosthesis body can be reduced. The inventors have also recognized the benefits associated with one or more operating features, which do not significantly change the structure (e.g., shape, size, strength) of the prosthesis body, so that the prosthesis with operating features can be used in conventional laparoscopic surgery and / or robotic surgery.

[0024] In some embodiments, an implantable prosthesis may include a prosthesis body and one or more operating aids. The body may be substantially planar and flexible so as to conform to one or more soft tissue sites. In some embodiments, the flexibility of the body may allow an operator (e.g., a surgeon and / or surgical tools) to roll the prosthesis without significant loss of structural integrity and deliver the prosthesis to the surgical site (e.g., via a port and / or trocar).

[0025] An operating aid can be attached to the prosthesis body so that the body can be manipulated by operation of the operating aid (e.g., grasping, moving, orienting, etc.). The operating aid may include one or more parts that are not attached to the prosthesis body, thereby providing the following gap: the operator can grasp these operating aids and manipulate the prosthesis under the gap. The structure and arrangement of the operating aid can be designed so that the total coverage area and mechanical properties of the prosthesis are not substantially changed due to the presence of the operating aid. In other words, the prosthesis with an operating aid of the present disclosure can be incorporated into conventional laparoscopic surgery and / or robotic surgery and related tools. For example, a prosthesis with an operating aid can be delivered to the surgical site through a conventional 8mm port with an insertion force similar to that of a prosthesis without an operating aid.

[0026] A substantially planar prosthesis body can have: a first side, which can be positioned against a tissue or muscle wall (e.g., an abdominal wall) comprising a defect; and a second side, which can be positioned adjacent to a sensitive nearby organ (e.g., intestines and / or other viscera). Therefore, the first side, which may be referred to as the front side in some embodiments, can be configured for tissue ingrowth. In some embodiments, the front side can be rough and macroporous and have an increased surface area, which can induce tissue ingrowth during soft tissue repair surgery (e.g., hernia repair), thereby accelerating the repair process. The second side, which may be referred to as the visceral side in some embodiments, can be configured to reduce the risk of adhesions formed with visceral organs. Therefore, the visceral side can be smoother than the front side and can include one or more anti-adhesion barrier layers.

[0027] In minimally invasive techniques and in some open surgeries, the size of the implantable prosthesis can be reduced to fit the defect and / or facilitate the delivery of the prosthesis to the surgical site. For example, in laparoscopic surgery, the implantable prosthesis can be rolled into an elongated cylindrical shape or otherwise collapsed into a smaller configuration suitable for passing through the following narrow cannula: the cannula can have a size of about 10mm, about 5mm or even finer. In order to help the prosthesis to be deployed after being deployed through the cannula, the operator can grasp one or more operating aids and guide the prosthesis (which may have a tendency to restore its planar structure) toward the pocket area in the surgical site. The operating aid can be grasped to manipulate, orient and / or position the body at the defect site while reducing the risk of damage to the prosthesis below due to grasping. The prosthesis can then be fixed against the soft tissue repair site using any suitable means (e.g., barbs, sutures, tacks, U-shaped staples, etc.).

[0028] In some embodiments, the operation aid can be a linear material piece that spans more than one hole of the prosthesis body. The linear material piece can be fixed to at least one point on the prosthesis body so that the operator can grasp the unattached portion of the operation aid to manipulate the prosthesis body. In some embodiments, the operation aid can be fixed to the prosthesis body at two points, and the linear material piece between the two points may not be attached to the plane of the body. In some embodiments, the linear material piece between the two points can be sufficiently spaced apart from the plane of the body to allow the operator and / or tool to grasp the operation aid. In some embodiments, the operation aid can be formed as a closed ring piece perpendicular to the plane of the prosthesis body. In some embodiments, the linear operation aid can be attached to the prosthesis body below (e.g., a mesh piece) so that the operation aid can be different from the prosthesis.

[0029] The thread-like material piece of the handling aid does not significantly change the strength, weight and / or volumetric footprint of the prosthesis body, allowing the prosthesis to be used with conventional tissue repair techniques. In some embodiments, the handling aid can be low profile and have no significant effect on the insertion force required to deliver the prosthesis through one or more ports and / or trocars.

[0030] In some embodiments, the operating aid can be embroidered or sewn to the prosthesis body. In some embodiments, the closed-loop form factor of the operating aid, which can be used as a gripping point for the prosthesis body, can be achieved by skipping stitches. The surgical prosthesis may also include at least one suture, the average stitch length of the at least one suture being greater than the average hole size of the mesh. The annular member may have a span length greater than the average stitch length. A skipping stitch is a connecting stitch between two stitches. A skipping stitch may have a longer stitch length (measured along the suture) than the two stitches connected by the skipping stitch. Therefore, a gap may be formed between the skipping stitch and the underlying substrate. In other words, a skipping stitch may have a portion that is not attached to the underlying substrate between the two stitches connected by the skipping stitch. Of course, embodiments of skipping stitches without any adjacent sutures are also conceivable, as described in further detail below.

[0031] The handling aid can be accessed from one or more sides of the prosthesis body, allowing the operator to grasp the prosthesis from a first side (e.g., from the visceral side during prosthesis deployment) and / or from a second side (e.g., from the anterior side during orienting and positioning the prosthesis relative to the defect).

[0032] In some embodiments, the operation aid can be consistent with one or more embroidery threads and / or sutures on the prosthesis body, which can serve as visual and / or tactile markers for the operator. Markings that can facilitate sizing, positioning and / or orienting the operation aid during operation can include one or more axial lines, spatial markings and / or spatial markers, as will be described in further detail below. In some embodiments, the operation aid can be positioned independently of any markings, so that the operation aid itself is formed of a material different from the prosthesis body below. In some embodiments, the operation aid itself can be used as an indicator.

[0033] In some embodiments, the markings may be visually and / or optically apparent to the operator before installation, so that the operator may size, shape and / or manipulate the body in an appropriate manner. In some embodiments, the markings and / or manipulation aids are visible to a laparoscopic camera or any other suitable surgical tool. Thus, the markings and / or manipulation aids may include one or more properties that are different from the prosthesis body. For example, the markings and / or manipulation aids may be embroidered on the body using a piece of thread-like material. In some embodiments, the markings and / or manipulation aids may be colored differently from the prosthesis body. The markings and / or manipulation aids may also include one or more directional features that may help the operator orient the body. For example, the spatial marker may include letters or numbers visible from both sides of the body, which may distinguish one side of the body from the other. If the body is oriented with one side facing the operator, the operator may be able to determine which side of the prosthesis body he or she is facing based on the rotation or orientation of the spatial marker. Such functionality may be useful for embodiments of the prosthesis in which the body may include one or more features (e.g., roughness, anti-adhesion coating, etc.) on at least one side (e.g., visceral side, anterior side) designed to induce a specific biological response at the installation site.

[0034] In some embodiments, the marking and / or operation aid can be colored so that the marking and / or operation aid can be visually distinguished from the prosthesis body below. The marking and / or operation aid can be colored with any suitable biocompatible color so that the marking and / or operation aid has any suitable color, including but not limited to blue, green, black, purple, indigo and / or any other color. The prosthesis may include multiple markings and / or operation aids, and the multiple markings and / or operation aids are provided with more than one color to distinguish these markings and / or operation aids from each other. In some embodiments, one or more markings and / or operation aids may be transparent in color. In some embodiments, the color of the marking and / or operation aid may contrast with the color of the body below. The marking and / or operation aid may also be the same color as the prosthesis body below. In some embodiments, the marking and / or operation aid may include one or more pigments that are visible only through special imaging tools. For example, the marking and / or operation aid may be opaque so that the marking and / or operation aid can show X-ray contrast relative to the wound.

[0035] In some embodiments, the marking may include an arrow, an arrow portion, a bull's eye, a circle, and / or any other suitable shape or combination of shapes, as the present disclosure is not limited thereto. The marking may indicate a direction and / or rotation (e.g., orientation) to the operator. For example, the marking may include an arrow pointing in one or more axial directions toward the operator. In some embodiments, the marking may be printed and / or written on the prosthesis body below. For example, a surgical marker may be used to provide a marking along the prosthesis. In some embodiments, a combination of ink and embroidery may be used to mark the prosthesis. In some embodiments, the marking may be distinguished from the prosthesis in a tactile manner so that the operator may perceive the marking by touch and / or force feedback.

[0036] In some embodiments, the marking and / or handling aid can be formed of a linear structure formed of a material similar to the underlying prosthesis (e.g., polypropylene sutures on a woven polypropylene mesh). In other embodiments, the marking and / or handling aid can be formed of a different material than the underlying prosthesis. It should be understood that a combination of materials (similar or different than the underlying prosthesis material) can be used, as the present disclosure is not limited in this regard.

[0037] It should be understood that any suitable markings and / or handling aids located at any suitable location of the prosthesis may be employed, as the implantable prostheses of the present disclosure are not limited by the placement, location, distribution, number, type, shape, color, material and / or composition, bioabsorbability and / or any other parameters of the markings and / or handling aids. In some embodiments, the implantable prosthesis may not include any markings.

[0038] In some embodiments, the handling aid may be made of a strip of flexible material that may be secured to the underlying prosthesis body at least at one point. The strip may provide similar benefits to the body as a linear material piece, namely serving as a gripping point for the body and limiting the risk of damage to the prosthesis body or transfer of undesirable strain to the prosthesis body during handling and operation. As will be described in further detail below, the strip may be secured to the prosthesis body in a variety of ways to provide the operator with sufficient clearance to grip the handling aid strip and manipulate the prosthesis body.

[0039] It should be understood that the prosthesis body can be formed of any suitable biocompatible material and / or material combination. In some embodiments, the prosthesis body can be formed of a woven polypropylene mesh material. It should be understood that the present disclosure is not limited by the material and / or structure (e.g., size, shape, arrangement structure) of the prosthesis body to which the operation aid is attached. Therefore, any suitable prosthesis body material and / or structure known in the art can be used together with the operation aid of the present disclosure.

[0040] Term used herein " linear " refers to any usually flexible one-dimensional structure formed by the arrangement structure and / or assembly of yarn, fiber, rope, strand, line, monofilament and / or multifilament.Such structure can comprise knitted fabric, woven fabric, braid, nonwoven material, its combination and / or any other suitable form factor.The linear material piece that is used to form one or more operation auxiliary parts and / or marking of the present disclosure can be formed by the combination of any suitable biocompatible material or bioabsorbable material and / or non-bioabsorbable material.

[0041] As used herein, the term "biocompatible material" refers to a material that is capable of producing an appropriate host response in a particular application. A biocompatible material has the property of not being toxic or harmful to biological systems.

[0042] As used herein, the term "bioabsorbable material" or "biodegradable material" refers to a material that is degraded by the body's enzymatic and / or hydrolytic pathways by reacting against "foreign" substances. Depending on the chemical nature of the material, a bioabsorbable material may disappear from the body environment after a defined period of time, which may vary, for example, from a few hours to several months.

[0043] Examples of bioresorbable materials include, but are not limited to, polylactic acid (PLA), polyglycolic acid (PGA), oxidized cellulose, polycaprolactone (PCL), polydioxanone (PDO), trimethylene carbonate (TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoates (PHAs), polyamides, polyethers, copolymers thereof and / or mixtures thereof.

[0044] Examples of non-bioresorbable materials include, but are not limited to, polyethylene terephthalate (PET), polyamide, aramid, expanded polytetrafluoroethylene, polyurethane, polyvinylidene fluoride (PVDF), polybutyrate, polyetheretherketone (PEEK), polyolefins (such as polyethylene or polypropylene), copper alloys, silver alloys, platinum, medical grade steel such as medical grade stainless steel, and / or combinations thereof.

[0045] The term "implantable prosthesis" as used herein refers in a non-limiting manner to a flexible planar member (e.g., a mesh or patch) having a desired contour, selected in a non-limiting manner from a biocompatible composition selected from: a polymer composition; a glass article; a titanium-containing article, stainless steel, nitinol (nickel-titanium alloy) and / or other metal articles; a composite material; paperboard, natural fibers, silicone, rubber or a rubber-like composition or any mixture thereof. In some embodiments, the implantable prosthesis can be formed from polypropylene.

[0046] As used herein, the term "trocar" refers to a surgical instrument that is passed through the body or abdominal wall to allow easy replacement of endoscopic instruments during endoscopic or other minimally invasive procedures.

[0047] The term "hernia" as used herein refers to abdominal hernia or preperitoneal hernia. In addition, the term "hernia" can be considered as umbilical hernia, hiatal hernia, ventral hernia, postoperative hernia, epigastric hernia, semilunar hernia, inguinal hernia and femoral hernia, which is normally the hernia associated with any abdominal wall.

[0048] It should be understood that the implantable prosthesis of the present disclosure can be used in any suitable repair application, including but not limited to hernia repair, pelvic reconstruction, breast implant support, repair patch for dura mater, inguinal hernia repair, combinations thereof, and / or any other suitable application. In some embodiments, the implantable prosthesis can be used in the process of repairing a defect formed in soft tissue.

[0049] Turning to the drawings, specific non-limiting embodiments are described in further detail. It should be understood that the various systems, components, features, and methods described with respect to these embodiments may be used alone and / or in any desired combination, as the present disclosure is not limited to only the specific embodiments described herein.

[0050] Figure 1 An implantable prosthesis 100 is shown according to some embodiments. The prosthesis 100 can include a substantially planar body 10 that can be formed of a flexible fabric to conform to a surgical site. The prosthesis 100 can include one or more markings to facilitate sizing, positioning, orientation, and general handling of the body 10 during operation. In some embodiments, the markings can include an axial line 20, a spatial marker 30, and / or a spatial marker 40.

[0051] The body 10 can extend along at least two axial axes A1, A2 and have at least a first dimension D1 along a first axial direction A1 and a second dimension D2 along a second axial direction A2. It should be understood that the body can be any suitable size for a given application and defect size. It should also be understood that the body can be formed (e.g., cut) into any suitable shape prior to installation to appropriately fit the intended implantation location. Although the body 10 is Figure 110 is shown as a square, but it should be understood that the body 10 can be any suitable shape (e.g., circular, oval, triangular) with any suitable contour shape. Therefore, the present disclosure is not limited by the size or shape of the prosthesis body. For example, the prosthesis body can be a rectangular shape with a first dimension D1 of 8 cm and a second dimension D2 of 6 cm. In some embodiments, at least one dimension (e.g., dimension D1 and / or D2) can be greater than or equal to 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 10 cm, 12 cm, 15 cm, 20 cm, 30 cm and / or any other suitable size. In some embodiments, at least one dimension (e.g., D1 and / or D2) of the prosthesis body can be less than or equal to 30 cm, 20 cm, 15 cm, 12 cm, 10 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm and / or any other suitable size. Combinations of the above ranges are also contemplated, including, for example, at least one dimension (e.g., D1 and / or D2) between 1 cm and 30 cm, 2 cm and 10 cm, and / or any other suitable range. Of course, other ranges are also contemplated, including ranges greater than or less than the above ranges, as the present disclosure is not limited thereto.

[0052] In some embodiments, Figure 1 As shown in , the prosthesis body 10 may include an operating aid at one or more locations 50. The operating aid may allow an operator to grasp and manipulate the body 10 without applying excessive stress to the body itself. The operator may operate the body 10 by grasping the operating aid, thereby reducing the risk of causing undesirable strain and / or tearing to the body 10 during operation. It should be understood that although the location 50 of the operating aid is shown as following the path of one or more markings (e.g., the axial line 20), the operating aid may be located at any suitable location, which may allow the operator to easily operate the prosthesis body.

[0053] Therefore, it should be understood that the present disclosure is not limited by the arrangement, number and / or spacing of the operating aids. Figure 1 In the figure, the operating aids are shown as being axisymmetric, but in some exemplary embodiments, the operating aids may be distributed asymmetrically around the axes A1, A2 of the body. Figure 1 In contrast, the handling aids may not be evenly distributed along one or more markings (eg, the axial line 20 ).

[0054] Figure 2A and Figure 2B An operation aid 55 according to some embodiments is shown. The operation aid 55 (eg Figure 1As shown in , the operation aid 55 can be installed in one or more operation aid positions 50) and can extend from the plane of the prosthesis body 10. The planar body 10 may include: a first face 10A, which is used to position against a soft tissue surface with a defect (e.g., an abdominal wall); and a second face 10B, which is used to position against adjacent organs and / or soft tissues. In some embodiments, the first face 10A may include a larger surface texture than the second face, so that the first face 10A can induce tissue ingrowth and accelerate healing. In some embodiments, the second face 10B may include a barrier portion, such as a barrier material layer or a barrier coating, to prevent adhesion to nearby organs and / or soft tissues.

[0055] Thus, the operation aid 55 can extend from at least one side of the planar body 10. In some embodiments, the operation aid 55 can form a ring-like structure extending from both the first side 10A and the second side 10B. In this way, the operation aid 55 can be approached from both sides of the body 10, so that the operator can grasp and / or operate the prosthesis from either side. FIG. 2A to FIG. 2B As shown in FIG. 1 , the operation aid 55 may include a first portion 55A extending from the first face 10A of the body 10 and a second portion 55B extending from the second face 10B of the body.

[0056] In some embodiments, the manipulation aid 55 can follow the lines of the embroidery markings (eg, axial lines 20, spatial markings 30), such as Figure 2A As described above, the operation aid 55 may be a skipped stitch in the embroidery circuit, so that the length S1 of the operation aid (measured along the axial direction A1 of the body 10) may be greater than the length S2 of the adjacent stitches. In some embodiments, the length of the operation aid may be equal to the length of the adjacent stitches, but the operation aid may have a span length greater than the span length of the adjacent stitches (see Figure 2A In any embodiment, at least a portion of the operating aid 55 can be suspended above the body, or otherwise not attached to the body, thereby providing sufficient clearance between the body 10 and the aid 55 to allow a tool to grasp the aid. In some embodiments, at least a portion of the operating aid 55 (the first portion 55A, which can be the central portion of the operating aid) can be positioned offset from the plane of the first face 10A.

[0057] It should be understood that the operating aid 55 may follow one or more marked lines, such as Figure 2AAs shown in . In some embodiments, the positioning of the operating aid 55 along the markings (e.g., the axial line 20, the spatial marking 30) can allow the operator to easily position the aid 55. In other embodiments, the operating aid 55 can be positioned independently of the markings of the prosthesis, which can visually distinguish the operating aid from the markings. In still other embodiments, the operating aid 55 may include separate markings (such as arrows, circles, etc.) to guide the operator's eyes and / or tools to the aid. It should be understood that the operating aid can be located in any suitable position relative to nearby markings, as the present disclosure is not limited to this. In some embodiments, the prosthesis may not include any markings, so that the features on the prosthesis can only be operating aids.

[0058] Figure 2B A side view of an operating aid 55 mounted on a prosthesis body 10 is shown. In some embodiments, the operating aid 55 can include a first portion 55A extending from a first face 10A of the body 10 and a second portion 55B extending from a second face 10B of the body 10. Thus, the operating aid 55 can be approached from both faces of the planar body 10, so that an operator (e.g., a surgeon and / or surgical tools) can grasp the operating aid 55 from either side of the body to manipulate the prosthesis.

[0059] It should be understood that in some embodiments, the operating aid 55 may include only a portion (e.g., portion 55A or portion 55B) extending from only one face of the body 10 (e.g., face 10A or face 10B). In this way, the operating aid can be accessed from only one face of the prosthesis. In some embodiments, limiting the operating aid to only one face of the prosthesis can serve as a marker for the orientation of the prosthesis, such that lack of access to the operating aid can indicate to the operator that the prosthesis is oriented toward one face or the other. In some embodiments, a combination of operating aids positioned on one face of the prosthesis and operating aids accessible from both faces of the prosthesis may be employed, as the present disclosure is not limited in this regard.

[0060] Figure 3 A partial prosthesis 100 according to some embodiments is shown. The prosthesis can be composed of a substantially planar body 10 having one or more operating aids 55E, 55F, 550 for allowing an operator to operate the prosthesis. As shown in the figure, the operating aid can be oriented along an axial direction of the body 10 (e.g., axis A1). Therefore, the operating aid can be oriented perpendicular to a second axis of the body 10 (e.g., axis A2). In some embodiments, the orientation of the operating aid can be determined by an angle measured between the aid and at least one axial direction of the body 10. For example, Figure 3An operating aid 55E is shown, which has an angle N11 of 90° relative to the axial direction A2. In another example, Figure 3 An operating aid 55F is shown which has an angle N12 of 45° with respect to the axial direction A1 .

[0061] It should be understood that in some embodiments, the operation aid can be oriented at any suitable angle relative to the axial direction of the body. In some embodiments, the operation aid can be oriented at an angle greater than or equal to 0°, 10°, 20°, 30°, 40°, 45°, 50°, 60°, 70°, 75°, 80°, 90° and / or any other suitable angle relative to at least one axial direction of the prosthesis. The auxiliary piece can also be oriented at an angle less than or equal to 90°, 80°, 70°, 75°, 60°, 50°, 45°, 40°, 30°, 20°, 10°, 0° and / or any other suitable angle. It is also contemplated that the combination of the aforementioned ranges, including, for example, the operation aid is oriented at an angle between 0° and 90°, between 0° and 45°, and / or in any other suitable range. Of course, other ranges are also contemplated, including ranges greater than and less than the above ranges, because the present disclosure is not limited thereto.

[0062] It should be understood that the orientation of one or more operating aids can be selected to facilitate manufacturing and / or improve the functionality and visibility of the operating aids. In some embodiments, positioning at least one operating aid along the line of the mark can simplify the overall embroidery process of the prosthesis. In some embodiments, as described above, positioning the operating aid at a certain angle relative to the mark can enhance the visibility of the operating aid. In some embodiments, the prosthesis may include at least one operating aid oriented in a first direction relative to the axial direction of the prosthesis and at least one operating aid oriented in a second direction relative to the axial direction of the prosthesis. Therefore, the prosthesis may include more than one operating aid positioned in various different orientations to facilitate the use of the operating aid to manipulate the prosthesis. In some embodiments, the prosthesis may include multiple operating aids, all of which are oriented in the same direction relative to the axial direction of the prosthesis. Therefore, it should be understood that the present disclosure is not limited by the orientation of any one or combination of operating aids in the operating aids relative to the axial direction of the prosthesis.

[0063] According to some embodiments, Figure 3Also shown is a handling aid 550 having multiple legs, such as 550C, 550D. The additional legs can improve the strength of the handling aid so that more tension can be applied to the handling aid while manipulating the prosthesis without the risk of tearing. In some embodiments, the additional legs can improve the visibility of the handling aid. As shown in the figure, in some embodiments, the handling aid 550 can include two legs 550C, 550D so that the handling aid can form a cross shape. In some embodiments, such as Figure 3 As shown in FIG. 5 , the legs 550C, 550D may be substantially equal in length, however in other embodiments, each leg of the handling aid 550 may have a different length.

[0064] As discussed with respect to the operating aid 55, each leg of the operating aid 550 may be oriented at an angle relative to at least one axial direction of the body 10. For example, Figure 3 The operation aid 550 is shown to have a first leg 550C oriented at an angle N2 relative to the axial direction A1 of the prosthesis and a second leg 550D oriented at an angle N3 relative to the axial direction A1 of the prosthesis. It should be understood that in some embodiments, each of the legs 550C, 550D of the operation aid 550 can be oriented at an angle N2 relative to the axial direction A1 of the body (e.g., Figure 3 The at least one leg of the operation aid can be oriented at any suitable angle of the axes A1 and A2 of the prosthesis. In some embodiments, at least one leg of the operation aid can be oriented at an angle greater than or equal to 0°, 10°, 20°, 30°, 40°, 45°, 50°, 60°, 70°, 75°, 80°, 90° and / or any other suitable angle relative to at least one axial direction of the prosthesis. At least one leg of the operation aid can also be oriented at an angle less than or equal to 90°, 80°, 70°, 75°, 60°, 50°, 45°, 40°, 30°, 20°, 10°, 0° and / or any other suitable angle. Combinations of the above ranges are also envisioned, including, for example, at least one leg of the operation aid is oriented at an angle between 0° and 90°, 0° and 45° and / or in any other suitable range. Of course, other ranges are also envisioned, including ranges greater than and less than the above ranges, as the present disclosure is not limited thereto.

[0065] It should be understood that although legs 550C and 550D are Figure 3 , but embodiments where the legs are not orthogonal to each other are also contemplated. Figure 3 In terms of at least one operating aid 550 in the embodiment, the legs 550C, 550D are shown as being symmetrical about the prosthesis body 10, but embodiments in which the legs are asymmetrical about the prosthesis are also contemplated. Figure 3 symmetrical with respect to each other, embodiments in which the legs are asymmetrical with respect to each other are also contemplated. It should also be understood that although the operation aid 550 is shown as having a pair of legs, an operation aid according to the present disclosure may include more than two legs (e.g., three, four, five, six), each leg being located at a corresponding angle relative to the axial direction of the prosthesis. As previously described, an increase in the number of legs may provide an increased strength to the operation aid during manipulation.

[0066] Figure 4 An operation aid 550 mounted on a prosthesis body 10 is shown according to some embodiments. The operation aid 550 is different from the prosthesis 10. The operation aid 550 includes a first leg 550C extending along a first axial direction A1 of the body and a second leg 550D extending along a second axial direction A2 of the body. The operation aid 550 is shown extending along a path marked such as the axial line 20. As shown in the figure, the legs 550C, 550D can cross each other to form the operation aid 550.

[0067] In some embodiments, Figure 4 As shown in , the prosthesis body 10 can have a mesh-like form factor that includes one or more holes 101 distributed around its body. Including holes can significantly increase the surface area of ​​the prosthesis while reducing the total volume of mounting material, which can be beneficial to the implanted prosthesis. As previously described, the legs 550C, 550D of the handling aid 550 can span more than one hole 101, so that this can provide sufficient space for the operator to grasp and manipulate the aid.

[0068] Figure 5 An operating aid 550 mounted on a prosthesis body 10 is shown according to some embodiments. The operating aid 550 may include one or more legs 550C, 550D that span more than one hole 101 of the body 10. In some embodiments, at least one leg of the operating aid 550 (e.g., leg 550C) may have a length S1 that may be greater than the length S2 of a nearby stitch. As shown in the figure, a tool 2 may be used to grasp one or more legs of the operating aid 550 to manipulate the body 10. In other words, the leg length S1 may be greater than the average hole size of the body. The tool may be mounted on a prosthesis body 10 formed (in Figure 5 The operating aid 550 is shown as being crossed with each other in the figure and is in a gap between the legs 550C, 550D and the body 10. The operating aid 550 can be positioned in a position near a mark (such as a marker 40), which can allow the operator to position and grasp the aid 55.

[0069] Figure 6An implantable prosthesis 100 is shown according to some embodiments. The prosthesis 100 may include a substantially planar body 10 that may be flexible to conform to one or more soft tissue and / or organ surfaces. Figure 6 In the illustrated embodiment, the prosthesis 100 can include one or more handling aids 56 coupled to the body 10. In some embodiments, the handling aid 56 can be a strip of material (e.g., a mesh similar to the body 10) that is attached to the body 10 at two ends so that the strip of material can be used as a handle for the body during operation.

[0070] Figure 7 An operation aid 56 according to some embodiments is shown. As shown in the figure, the operation aid 56 can include one or more fixing portions 56A that can be attached to the prosthesis body 10. In some embodiments, the fixing portion 56A can be sewn directly to the body 10, while in other embodiments, the fixing portion 56A can be stapled to the body 10 using one or more adhesive materials. It should be understood that the operation aid 56 of the present disclosure is not limited by the manner in which it can be fixed and / or attached to the prosthesis body.

[0071] The operation aid 56 may further include a free portion 56B that may be suspended between the fixed portions 56A. The free portion 56B may be used as a component in conjunction with the above-mentioned operation aid (e.g., FIG. 2A to FIG. 2B The free portion 56B may be provided with a similar purpose to the operation aid 55 of the embodiment of the present invention, so that the free portion 56B may provide the following gap: the operator may grasp the gap to manipulate the prosthesis body 10. The operation aid 56 may be composed of one or more components such as Figure 7 In some embodiments, the handling aid may be formed from a strip of material (e.g., a rectangular strip) as shown in FIG. In some embodiments, the handling aid may be formed from a flat tube of material. The excess material may provide increased strength to the handling aid and reduce the risk of tearing / breakage during operation.

[0072] Figure 8 Several handling aids 56 are shown mounted on an implantable prosthesis body 10. As shown in the figure, the handling aids can be positioned along one or more markings (e.g., spatial markings 30) of the body 10, and / or can be positioned at any suitable location independent of the markings. In some embodiments, the handling aids 56 themselves can be visually distinct due to the reduced transparency of two or more prosthesis layers of the body 10 compared to a single layer. The handling aids 56 can extend sufficiently from the plane 10 of the body to form a gap and allow an operator and / or tool 2 to grasp the aid to manipulate the prosthesis.

[0073] It should be understood that Figures 6 to 8The operation aid 56 shown in FIG. 1 can be oriented at any suitable angle relative to the axial direction of the prosthesis body, as shown in FIG. Figures 1 to 5 The operation aid 55 is discussed above. In addition, the operation aid 56 may be configured with more than one leg (eg, two legs that cross each other in any suitable orientation) to enhance the strength of the operation aid 56.

[0074] FIG. 9A to FIG. 9B Various alternative embodiments of handling aids located on an implantable prosthesis body are shown. FIG. 9A to FIG. 9B The operating aid can be formed as Figures 1 to 5 The operating aid 55 has a similar jump stitch form factor and / or can be made of Figures 6 to 8 The handling aid 56 is similarly formed of a flat or strip-shaped material.

[0075] exist Fig. 9A In the embodiment of the present invention, the operation aid 57 may include one or more protrusions 57B extending from the plane of the prosthesis body 10. The protrusions 57B may be held in place on the body 10 using one or more fixing portions 57A. The protrusions 57B may be sized to allow surgical tools to grasp the protrusions and manipulate the prosthesis. As previously mentioned, the present disclosure is not limited by the manner in which the operation aid can be mounted on the body 10. Fig. 9B 1 shows an embodiment in which the operating aid 58 comprises at least one fixing portion 58A, thereby attaching the operating aid to the prosthesis body 10. The operating aid 58 may also comprise one or more tabs 58B, which may serve as gripping points for an operator to grip the operating aid 58 and manipulate the prosthesis.

[0076] It should be understood that any of the operation aids (e.g., aids 55, 56, 57, 58) of the present disclosure may be positioned (e.g., extended out, suspended) on any suitable surface of the prosthesis body, as the present disclosure is not limited thereto. The operation aids may also be positioned (e.g., extended out, suspended) on both surfaces of a substantially planar prosthesis body. In some embodiments, a combination of an operation aid positioned on one surface and an operation aid positioned on two surfaces may be employed, as the present disclosure is not limited thereto.

[0077] Fig.10An implantable prosthesis 100 is shown according to some embodiments. The prosthesis 100 may include a substantially planar body 10 that is optionally outlined with one or more markings (e.g., an axial line 20, a spatial marker 30). The prosthesis 100 may include one or more pockets 60 formed at one or more locations on the body 10. The pocket 60 may be formed from a planar material that may be attached to the body 10 at one or more boundary lines 62. At least one side and / or portion of the periphery of the planar material may remain open to form a pocket form factor. The pocket 60 may be attached to the body 10 in any suitable manner, such as by suturing, welding, folding, and / or any other suitable technique. The pocket 60 may allow an operator to grasp the prosthesis 100 without applying undesirable strain to the underlying body 10. In some embodiments, as Fig.10 As shown in , the pockets 60 may be located at one or more corners of the body 10. Of course, embodiments are also contemplated where one or more pockets are located at other locations on the body, as the present disclosure is not limited thereto.

[0078] It should be understood that the implantable prosthesis may employ any combination of the above-described handling aids in any suitable orientation and arrangement on the prosthesis, as the present disclosure is not limited thereto. For example, the implantable prosthesis may include one or more skip needle handling aids (similar to Figures 1 to 5 A manipulation aid 55 having one or more legs), one or more strip-shaped manipulation aids (similar to Figures 6 to 9B operating aid 56) and / or one or more pocket areas (similar to Fig.10 Any suitable combination of handling aids and pockets oriented in any suitable direction and / or extending from one or more faces of the prosthesis body may be employed, as the present disclosure is not limited in this regard.

[0079] FIG. 11A to FIG. 11C The preparation process of the prosthesis 100 before installation on the defect in the subject is shown. First, the operator can measure the effective size of the defect and determine the necessary size of the prosthesis to facilitate the repair process of the defect. The size of the prosthesis can correspond to the size of the defect with a margin to ensure proper coverage. The operator can then select and / or cut the prosthesis that meets the size criteria of the defect. Fig.11A As shown in , the operator can cut the prosthesis along one or more marks (e.g., axial line 20) for ease of use. In some embodiments, the prosthesis 100 may not include any marks, so that the prosthesis can be temporarily marked before cutting (e.g., using surgical markings).

[0080] In some embodiments, an operator may cut or otherwise form the prosthesis to maintain a degree of symmetry about at least one axial direction (e.g., directions A1, A2). The prosthesis 100 may include a central portion 10C that may be centered relative to one or more axes of the prosthesis. Fig.11A As shown in , the central portion 10C may include one or more operating aids 55H that can be used to manipulate the prosthesis 100. The prosthesis 100 may also include one or more operating aids 55G positioned around the axial markings of the body. In some embodiments, the prosthesis may include at least one aid accessible through only one face of the prosthesis (e.g., operating aid 55G) and at least one aid accessible through two faces of the substantially planar prosthesis body (e.g., operating aid 55H).

[0081] like Fig. 11B As shown in , following appropriate sizing, the prosthesis 100 can be rolled so that the first face 10A can be inside the roll and the second face 10B can be outside the roll. In some embodiments, one or more markings (e.g., spatial markers 30) can facilitate the rolling process orthogonal to at least one axial direction of the prosthesis. Subsequently, the prosthesis 100 can be grasped by a tool 3 (e.g., a 5 mm grasper), which can guide the rolled prosthesis 100 into a trocar inserted near the surgical site.

[0082] Once the prosthesis has been inserted into the surgical site, the prosthesis can be deployed so that the outer surface of the prosthesis (e.g. Fig. 11B As previously described, the handling aid 55G can be accessible from at least the outer surface of the prosthesis. Thus, such a handling aid can assist the surgical tool in unfolding, smoothing and / or positioning the prosthesis relative to the defect. The surgical tool can then be positioned in the center of the prosthesis (e.g., at the Fig.11A One or more operating aids (e.g., Fig.11A The aid 55H shown in the figure centers the prosthesis relative to the defect. The central operation aid can be accessible from both sides of the prosthesis and can help align the prosthesis with the defect. Once it has been determined that the prosthesis is properly installed (for example, using visual inspection), the prosthesis can be secured to the defect site using any suitable means (for example, sutures, staples, tacks, combinations thereof, etc.). Although exemplary repair processes using prostheses are described herein, it should be understood that the prostheses of the present disclosure are not limited by the techniques used by which they can be delivered, installed and / or secured to the defect site.

[0083] Although several embodiments of the present disclosure have been described and illustrated herein, a person of ordinary skill in the art will readily envision a variety of other devices and / or structures for performing functions and / or obtaining one or more of the results and / or advantages described herein, and each of these variations and / or modifications is considered to be within the scope of the present disclosure. More generally, it will be readily understood by those skilled in the art that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that actual parameters, dimensions, materials, and / or configurations will depend on the specific application or application for which the teachings of the present disclosure are used. Those skilled in the art will recognize or be able to determine many equivalents of the specific embodiments of the disclosure described herein using only routine experiments. Therefore, it should be understood that the aforementioned embodiments are illustrated only by way of example, and within the scope of the appended claims and their equivalents, the present disclosure may be practiced in other ways than those specifically described and claimed. The present disclosure relates to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits and / or methods is included within the scope of the present disclosure if such features, systems, articles, materials, kits and / or methods are not mutually inconsistent.

[0084] Unless otherwise limited or indicated, any terms used herein relating to, for example, the shape, orientation, alignment, and / or geometric relationship of or between one or more articles, structures, forces, fields, flows, directions / trajectories, and / or subcomponents thereof and / or combinations thereof and / or any other tangible or intangible elements not listed above that can be characterized by such terms should be understood not to require absolute conformance to the mathematical definitions of such terms, but rather to conform to the mathematical definitions of such terms to the extent possible for the subject matter characterized, as understood by those skilled in the art most closely related to such subject matter.

[0085] The embodiments of the present invention can be understood by referring to the following numbered paragraphs:

[0086] 1. A method for operating a surgical prosthesis, the method comprising the following steps:

[0087] grasping a central portion of a first ring attached to two locations on a mesh of the surgical prosthesis, the mesh including a first side and a second side, the first ring being distinct from the mesh; and

[0088] The position of the central portion relative to the defect in the patient is manipulated.

[0089] 2. The method according to paragraph 1, further comprising rolling the mesh, and wherein the central portion of the first ring-shaped member is grasped to unfold the mesh.

[0090] 3. The method according to paragraph 1, further comprising:

[0091] rolling the mesh member; and

[0092] The central portion of the second ring is grasped to unfold the mesh.

[0093] 4. The method according to paragraph 1, further comprising grasping a central portion of a second annular member from the second side of the mesh member.

[0094] 5. The method of paragraph 1, further comprising grasping a central portion of the first annular member from the first side of the mesh member.

[0095] 6. The method of paragraph 5, further comprising grasping a second central portion of the first annular member from the second side of the mesh member.

[0096] 7. The method of paragraph 1 further comprising attaching the mesh around the defect.

[0097] 8. The method of paragraph 1, further comprising grasping a mesh strip attached to the mesh at least at one location, wherein at least a portion of the mesh strip is offset from the first face.

[0098] 9. The method of paragraph 8, wherein the mesh strips are formed from collapsed tubes.

[0099] 10. The method of paragraph 1, further comprising using a surgical tool to grasp a central portion of the first annular member.

[0100] 11. The method of paragraph 1, further comprising grasping a central portion of a second ring-shaped member, the second ring-shaped member being attached to the mesh at least at two locations, the second ring-shaped member being oriented at an angle relative to the first ring-shaped member.

[0101] 12. The method of paragraph 1, further comprising grasping at least one pocket of the mesh to manipulate the mesh relative to the defect, wherein the at least one pocket is attached to the mesh at least at one boundary.

Claims

1. A surgical prosthesis, characterized in that: The surgical prosthesis comprises: A mesh member, the mesh member comprising a first surface and a second surface; at least one suture having an average stitch length greater than an average pore size of the mesh; and A ring-shaped member, which is different from the mesh, the ring-shaped member is formed by skipping stitches on the at least one suture line, the ring-shaped member is attached to at least two positions on the mesh, the span length between the at least two positions is greater than the average stitch length, and the ring-shaped member has a central portion between the at least two positions, the central portion is not attached to the mesh and is arranged on the first side of the first surface.

2. The surgical prosthesis according to claim 1, characterized in that The central portion is offset from the plane of the first face.

3. The surgical prosthesis according to claim 1, characterized in that Also included is a second central portion of the annulus, the second central portion of the annulus being accessible from the second face, and the central portion of the annulus being accessible from the first face.

4. The surgical prosthesis according to claim 1, characterized in that Also included is a mesh strip attached to the mesh at least at one location, at least a portion of the mesh strip being offset from the first face.

5. The surgical prosthesis according to claim 4, characterized in that The mesh strips are formed from collapsed tubes.

6. The surgical prosthesis according to claim 1, characterized in that: Also included is at least one suture that is visually distinct from the mesh.

7. The surgical prosthesis according to claim 6, characterized in that The at least one suture is a different color than the mesh.

8. The surgical prosthesis according to claim 1, characterized in that: The annular member is aligned with the axial direction of the mesh member.

9. The surgical prosthesis according to claim 2, characterized in that: A gap between the first surface and the annular member is configured to accommodate at least a portion of a surgical tool.

10. The surgical prosthesis according to claim 1, characterized in that Also included is a second annular member oriented at an angle relative to the annular member.

11. The surgical prosthesis according to claim 1, characterized in that The annular member is disposed centrally relative to the mesh member.

12. The surgical prosthesis according to claim 1, characterized in that The annular member is disposed adjacent to a periphery of the mesh member.

13. The surgical prosthesis according to claim 1, characterized in that The ring-shaped member and the mesh-shaped member are formed of the same material.

14. A surgical prosthesis, characterized in that: The surgical prosthesis comprises: a mesh member, the mesh member comprising a first surface and a second surface; and At least one operation aid, the at least one operation aid is different from the mesh, the at least one operation aid includes a fixed portion attached to one of the first surface and the second surface, the at least one operation aid includes one or more protrusions extending from the fixed portion or one or more protrusions extending from the fixed portion, each of the one or more protrusions or one or more protrusions deviates from the plane of the mesh so as to be grasped by a surgical tool to facilitate manipulation of the mesh.

15. The surgical prosthesis according to claim 14, characterized in that The two protrusions or the two tabs extend from the fixing portion in opposite directions.

16. The surgical prosthesis according to claim 14, characterized in that The at least one handling aid is formed from a strip of material.

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