Soft tissue repair prosthesis with handling aids and method of use - Patents.com

Abstract

The implantable prosthesis may include a substantially planar body (10) and at least one handling aid (55). The handling aid may act as a gripping point and allow an operator (e.g., surgeon) to manipulate the planar body, reducing the risk of applying an undesirable amount of stress or strain to the underlying body. The handling aid may be an embroidered jump stitch and may be attached to the planar body at at least two points, but with a central portion not attached to the surface of the body, providing sufficient clearance for the operator to grip and handle the aid. In some embodiments, the handling aid may be in the form factor of a thread-like material, strip, tube, and / or pocket. The handling aid may be used in minimally invasive procedures, such as laparoscopic and / or robotic surgery.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS)

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 289,039, filed December 13, 2021, which is incorporated herein by reference in its entirety.

[0002]

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

[0003]

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

[0004]

[0004] A hernia defect is an opening or weakening in a tissue or muscle wall, such as the abdominal wall. One approach to repairing a hernia is to insert a soft tissue prosthesis into the intraperitoneal space, position the prosthesis to cover the abdominal wall defect, and then, if desired, secure the prosthesis to the abdominal wall with tacks, sutures, and / or adhesives.

[0005]

[0005] To repair various soft tissue defects, prostheses can be delivered by minimally invasive techniques, such as laparoscopic procedures. For example, to deliver the prosthesis into the abdominal cavity, the prosthesis can be rolled, folded, or otherwise collapsed into a small shape and then inserted into the intraperitoneal space through a small incision or trocar. The prosthesis is then unfolded and positioned relative to the defect. Summary of the Invention

[0006] In some embodiments, a surgical prosthesis is provided. The surgical prosthesis may include a mesh having a first side and a second side, and a loop separate from the mesh. The loop may be attached to at least two locations on the mesh. The loop may have a central portion disposed on a first side of the first side between the at least two locations.

[0007] In some embodiments, a method of manipulating a surgical prosthesis is provided. The method of manipulating a surgical prosthesis can include grasping a central portion of a first loop that can be attached to two locations on a mesh of the prosthesis and manipulating the location of the central portion relative to the defect of the patient. The mesh can include a first side and a second side. The first loop can be separate from the mesh.

[0008]

[0008] It will be appreciated that the foregoing concepts and additional concepts discussed below may be arranged in any suitable combination, and that the disclosure is not limited in this respect. Furthermore, 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]

[0009] The accompanying drawings are not intended to be to scale. In the drawings, identical or nearly identical components shown in various figures may each be represented by a similar number. For clarity, not every component is named in every figure.

[0010] [Figure 1] 1 illustrates a schematic diagram of a mesh prosthesis with handling aids according to some embodiments. [Figure 2A]

[0011] 1A-1C are schematic diagrams illustrating a mesh prosthesis with handling aids, according to some embodiments. [Figure 2B] 1 illustrates a schematic diagram of a mesh prosthesis with handling aids according to some embodiments. [Diagram 3]

[0012] 1A-1C are schematic diagrams illustrating a portion of a mesh prosthesis with handling aids, according to some embodiments. [Figure 4]

[0013] 1 illustrates a top perspective view of a mesh prosthesis with handling aids, according to some embodiments. [Diagram 5]

[0014] 1 illustrates a top perspective view of a mesh prosthesis with handling aids during operation, according to some embodiments. [Figure 6]

[0015] 1 illustrates a top view of a mesh prosthesis with handling aids, according to some embodiments. [Figure 7]

[0016] 1A-1C are schematic diagrams illustrating a top perspective view of a mesh prosthesis with handling aids, according to some embodiments. [Figure 8]

[0017] 1 illustrates a mesh prosthesis with handling aids during operation, according to some embodiments. [Figure 9A]

[0018] 1A-1C are schematic diagrams illustrating a mesh prosthesis with handling aids, according to some embodiments. [Figure 9B] 1 illustrates a schematic representation of a mesh prosthesis with handling aids according to some embodiments. [Figure 10]

[0019] 1A-1C are schematic diagrams illustrating a mesh prosthesis with handling aids, according to some embodiments. [Figure 11A]

[0020] 13 illustrates a mesh prosthesis preparation process with handling aids, according to some embodiments. [Figure 11B] 1 illustrates a process for preparing a mesh prosthesis with handling aids according to some embodiments. [Figure 11C] 1 illustrates a process for preparing a mesh prosthesis with handling aids according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011]

[0021] In conventional laparoscopic soft tissue repair procedures, surgeons often place an implantable prosthesis into a subject's (e.g., patient's) internal biological space or pocket to provide support and / or strength to weakened tissue and facilitate the repair process. For example, in a hernia repair procedure, the surgeon places the prosthesis on the extraperitoneal surface. The prosthesis can be formed of a mesh-like sheet that is slightly larger than the defect. The high 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, reducing the risk of discomfort.

[0012]

[0022] The surgeon and / or operator can manipulate the prosthesis within the biological interior space or pocket with one or more surgical tools and / or by directing a robotic end effector inserted into the surgical site. The prosthesis can be grasped and moved or oriented relative to the defect. The inventors have recognized that grasping and manipulating the prosthesis may result in damage to the prosthesis. If the prosthesis is formed from a mesh-like structure, excessive strain from grasping or redirection may result in undesirable changes to the underlying mesh structure, reducing the effectiveness of the mesh for defect repair.

[0013]

[0023] Based on the foregoing, the inventors have recognized advantages associated with an implantable prosthesis comprising one or more features for improving handling (e.g., transporting, positioning, orienting, etc.) of the prosthesis during a procedure (e.g., within a surgical pocket such as the extraperitoneal surface for a hernia repair procedure). The one or more features are coupled to a body of the prosthesis, which may serve as a structural support for the soft tissue defect, such that the prosthesis may be manipulated by handling the one or more features. Thus, the features serve as gripping points for the prosthesis, allowing an operator to manipulate the prosthesis body by handling the features rather than the prosthesis body (e.g., faces or corners of the prosthesis). In this manner, the risk of compromising the structural integrity of the prosthesis body may be reduced. The inventors have also recognized advantages associated with one or more handling features that do not significantly change the structure (e.g., shape, size, strength) of the prosthesis body, such that a prosthesis comprising the handling features may be used in conventional laparoscopic and / or robotic surgery.

[0014]

[0024] In some embodiments, an implantable prosthesis can include a prosthesis body and one or more handling aids. The body can be substantially planar and flexible to conform to one or more soft tissue sites. In some embodiments, the flexibility of the body allows an operator (e.g., a surgeon and / or surgical tools) to roll the prosthesis and deliver it to a surgical site (e.g., via a port and / or trocar) without significantly compromising structural integrity.

[0015]

[0025] The handling aid can be attached to the prosthesis body such that the prosthesis body can be manipulated by handling (e.g., grasping, moving, orienting, etc.) the handling aid. The handling aid includes one or more portions that are not attached to the prosthesis body, providing clearance for an operator to grasp the handling aid and manipulate the prosthesis. The structure and arrangement of the handling aid can be designed such that the presence of the handling aid does not substantially change the overall footprint and mechanical properties of the prosthesis. In other words, a prosthesis with a handling aid of the present disclosure can be integrated into conventional laparoscopic and / or robotic surgery and associated tools. For example, a prosthesis with a handling aid can be delivered to a surgical site through a conventional 8 mm port using similar insertion forces as a prosthesis without a handling aid.

[0016]

[0026] The substantially planar prosthetic body may have a first side that may be positioned against a tissue or muscle wall (e.g., abdominal wall) containing the defect, and may further have a second side that may be positioned adjacent to sensitive surrounding organs (e.g., intestines and / or other visceral organs). Thus, the first side, which may be referred to in some embodiments as the anterior side, may be configured for tissue ingrowth. In some embodiments, the anterior side may be rough and macroporous, and the increased surface area may induce tissue ingrowth during soft tissue repair procedures (e.g., hernia repair), thus facilitating the repair process. The second side, which may be referred to in some embodiments as the visceral side, may be configured to reduce the risk of adhesion formation with visceral organs. Thus, the visceral side may be smoother than the anterior side and may include one or more anti-adhesion barrier layers.

[0017]

[0027] In minimally invasive techniques and certain open procedures, the implantable prosthesis may be reduced in size to fit into the defect and / or facilitate delivery of the prosthesis to the surgical site. For example, in laparoscopic procedures, the implantable prosthesis may be rolled or otherwise folded into a small shape into an elongated cylindrical shape suitable for passing through a narrow cannula, which may have an inner diameter of about 10 mm, or about 5 mm, or smaller. To aid in unfolding the prosthesis to its expanded shape after placement through the cannula, the operator grasps one or more handling aids and guides the prosthesis (which may have a tendency to return to a planar configuration) toward the pocket at the surgical site. The handling aids may be grasped to manipulate, orient, and / or position the body at the defect site, while reducing the risk of damaging the underlying prosthesis by grasping. The prosthesis may then be secured to the soft tissue repair site using any suitable means (e.g., barbs, sutures, tacks, staples, etc.).

[0018]

[0028] In some embodiments, the handling aid can be a thread of material that spans two or more holes in the prosthetic body. The thread of material is fixed to at least one point on the prosthetic body such that an operator can grasp the unattached portion of the handling aid to manipulate the prosthetic body. In some embodiments, the handling aid can be fixed to the prosthetic body at two points, with the thread of material between the two points not attached to the face of the body. In some embodiments, the thread of material between the two points can be sufficiently spaced from the face of the body so that an operator and / or tool can grasp the handling aid. In some embodiments, the handling aid can be formed as a closed loop perpendicular to the face of the prosthetic body. In some embodiments, the thread of material can be attached to the lower prosthetic body (e.g., mesh) such that it is separate from the prosthesis.

[0019]

[0029] The filamentary material 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 is low profile and may not significantly affect the insertion force required to deliver the prosthesis through one or more ports and / or trocars.

[0020]

[0030] In some embodiments, the handling aid can be embroidered or sewn to the prosthetic body. In some embodiments, a closed loop form factor of the handling aid that can serve as a gripping point for the prosthetic body can be achieved by a jump stitch. A jump stitch is a stitch that connects between two stitches. A jump stitch can have a stitch length (measured along the stitch line) that is longer than the two stitches connected by the jump stitch. This can result in a gap being formed between the jump stitch and the underlying substrate. In other words, the jump stitch can have a portion that is not attached to the underlying substrate between the two stitches connected by the jump stitch. Of course, jump stitch embodiments without adjacent stitch lines are also contemplated and will be described in more detail below.

[0021]

[0031] The handling aids are accessible from one or more sides of the prosthesis body, allowing the operator to grasp the prosthesis from a first side (e.g., the visceral side, e.g., during unfolding the prosthesis) and / or a second side (e.g., the anterior side, e.g., during orientation and positioning of the prosthesis relative to the defect).

[0022]

[0032] In some embodiments, the handling aid can be aligned with one or more embroidered and / or sewn lines on the prosthetic body that can serve as visual and / or tactile indicators for the operator. The indicators can facilitate sizing, positioning, and / or orientation of the handling aid during operation and can include one or more axes, spatial markers, and / or spatial identifiers, as described in more detail below. In some embodiments, the handling aid can be positioned separately from the indicators, with the handling aid itself being formed of a separate material from the underlying prosthetic body. In some embodiments, the handling aid itself can function as an indicator.

[0023]

[0033] In some embodiments, the indicia are visually and / or optically apparent to the operator prior to installation so that the operator can size, shape, and / or handle the body appropriately. In some embodiments, the indicia and / or handling aids can be viewed by a laparoscopic camera or any other suitable surgical tool. As such, the indicia and / or handling aids can include one or more characteristics that are distinct from the prosthetic body. For example, the indicia and / or handling aids can be embroidered on the body using a thread-like material. In some embodiments, the indicia and / or handling aids can be a different color than the prosthetic body. The indicia and / or handling aids can also include one or more orientation features that help the operator orient the body. For example, the spatial identifiers can include letters or numbers that are visible from both sides of the body, allowing one side of the body to be distinguished from the other side. When the body is oriented with one side facing the operator, the operator can determine which side of the prosthetic body he or she is facing based on the handedness or orientation of the spatial identifiers. Such features may be useful in prosthetic embodiments 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 elicit a specific biological response at the implantation site.

[0024]

[0034] In some embodiments, the indicators and / or handling aids can be colored to be visually different from the underlying prosthetic body. The indicators and / or handling aids can be colored in any suitable biocompatible color to be any suitable color, including, but not limited to, blue, green, black, purple, indigo, and / or any other color. The prosthesis can include multiple indicators and / or handling aids colored in two or more colors to distinguish the indicators and / or handling aids from one another. In some embodiments, one or more indicators and / or handling aids can be transparent. In some embodiments, the indicators and / or handling aids can be colored in a color that contrasts with the color of the underlying body. Also, the indicators and / or handling aids can be the same color as the color of the underlying prosthetic body. In some embodiments, the indicators and / or handling aids can include one or more pigments that are only visible with special imaging tools. For example, the indicators and / or handling aids can be radiopaque to provide x-ray contrast for trauma.

[0025]

[0035] In some embodiments, the indicia may include an arrow, an arrowhead, a target center circle, a circle, and / or any other suitable shape or combination of shapes, and the disclosure is not limited in this respect. The indicia may indicate directionality and / or handedness (e.g., orientation) to the operator. For example, the indicia may include an arrow pointing in one or more axial directions to orient the operator. In some embodiments, the indicia may be printed and / or written on the underlying prosthesis body. For example, a surgical marker may be used to provide the indicia along the prosthesis. In some embodiments, a combination of ink and embroidery may be used to mark the prosthesis. In some embodiments, the indicia is tactilely distinct from the prosthesis, allowing the operator to sense the indicia by touch and / or force feedback.

[0026]

[0036] In some embodiments, the indicators and / or handling aids may be formed of thread-like structures formed of a similar material to the underlying prosthesis (e.g., polypropylene sutures on a woven polypropylene mesh). In other embodiments, the indicators and / or handling aids may be formed of a different material than the underlying prosthesis. It will be appreciated that combinations of materials (similar or different to the underlying prosthesis material) can be used and the disclosure is not limited in this respect.

[0027]

[0037] It will be appreciated that 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 indicia and / or handling aids, and thus any suitable indicia and / or handling aids located at any suitable location on the prosthesis may be used. In some embodiments, the implantable prosthesis may not include indicia.

[0028]

[0038] In some embodiments, the handling aid can be formed of a flexible piece of material that can be fixed at least one point to the underlying prosthetic body. This piece of material can provide the body with similar advantages as a thread-like material, i.e., it acts as a gripping point for the body, limiting the risk of damaging the prosthetic body or transmitting undesirable strains to the prosthetic body during manipulation and handling. As described in more detail below, the piece of material can be fixed to the prosthetic body in a variety of ways to provide the operator with sufficient clearance to grip the handling aid piece and manipulate the prosthetic body.

[0029]

[0039] It will be appreciated that the prosthetic body may be formed of any suitable biocompatible material and / or combination of materials. In some embodiments, the prosthetic body may be formed of a woven polypropylene mesh material. It will be appreciated that the present disclosure is not limited by the material and / or configuration (e.g., size, shape, arrangement) of the prosthetic body to which the handling aid is attached. Thus, any suitable prosthetic body material and / or configuration known in the art may be used with the handling aids of the present disclosure.

[0030]

[0040] The term "filamentous" as used herein refers to any generally flexible one-dimensional structure formed from an arrangement and / or assembly of yarns, fibers, cords, threads, threads, monofilaments, and / or multifilaments. Such structures may include knits, wovens, braids, nonwoven materials, combinations thereof, and / or any other suitable form factor. The filar materials used to form one or more handling aids and / or indicators of the present disclosure may be formed of any suitable biocompatible material or combination of bioabsorbable and / or non-bioabsorbable materials.

[0031]

[0041] As used herein, the term "biocompatible material" refers to a material that has the ability to function in an appropriate host response in a particular application. A biocompatible material has the quality of not having a toxic or deleterious effect on a living system.

[0032]

[0042] As used herein, the terms "bioabsorbable" or "biodegradable" refer to materials that are broken down by the body's enzymes and / or hydrolytic pathways through a reaction to "foreign" substances. Depending on the chemical nature of the material, bioabsorbable materials may disappear into the ecological environment after a period of time that may vary, for example, from a few hours to several months.

[0033]

[0043] Examples of bioabsorbable 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.

[0034]

[0044] Examples of non-bioabsorbable materials include, but are not limited to, polyethylene terephthalate (PET), polyamide, aramid, expanded polytetrafluoroethylene, polyurethane, polyvinylidene difluoride (PVDF), polybutyl ester, polyether ether ketone (PEEK), polyolefins (such as polyethylene or polypropylene), copper alloys, silver alloys, platinum, medical grade steels such as medical grade stainless steel, and / or combinations thereof.

[0035]

[0045] The term "implantable prosthesis" as used herein refers to a flexible planar member (e.g., mesh or patch) of a desired geometry selected from, but not limited to, a biocompatible composition selected from, but not limited to, polymeric compositions; glassware; titanium-containing, stainless steel, nitinol (nickel-titanium alloy), and / or other metal products; composite materials; cardboard, natural fibers, silicone, rubber or rubber-like compositions, or any mixture thereof. In some embodiments, the implantable prosthesis can be formed of polypropylene.

[0036]

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

[0037]

[0047] The term "hernia" as used herein refers to a peritoneal or preperitoneal hernia. Furthermore, the term hernia may be considered to be an umbilical hernia, a hiatal hernia, a ventral hernia, a incisional hernia, an epigastric hernia, a semilunar hernia, an inguinal hernia, and a femoral hernia, generally any abdominal wall-related hernia.

[0038]

[0048] It will be appreciated that the implantable prosthesis of the present disclosure may be utilized in any suitable repair application, including, but not limited to, hernia repair, pelvic mesh, breast implant support, repair patches for the dura, inguinal hernia repair, combinations thereof, and / or any other suitable application. In some embodiments, the implantable prosthesis may be used in the process of repairing defects formed in soft tissue.

[0039]

[0049] Turning now to the drawings, certain non-limiting embodiments will be described in further detail. It will be understood that the disclosure is not limited to only the specific embodiments described herein, and that the various systems, components, features, and methods described in connection with these embodiments can be used individually and / or in any desired combination.

[0040]

[0050] 1 illustrates an implantable prosthesis 100 according to some embodiments. The prosthesis 100 may include a substantially planar body 10 that may be formed of a flexible fabric to conform to a surgical site. The prosthesis 100 may include one or more indicia to facilitate sizing, positioning, orientation, and overall handling of the body 10 during operation. In some embodiments, the indicia may include an axis 20, a spatial marker 30, and / or a spatial identifier 40.

[0041]

[0051] The body 10 may extend along at least two directional axes A1, A2. At least, a first dimension D1 is along the first axial direction A1 and a second dimension D2 is along the second axial direction A2. It will be appreciated that the body may be any suitable size for a given application and defect size. It will also be appreciated that the body may be formed (e.g., cut) into any suitable shape prior to installation to properly fit the intended implantation location. Although the body 10 is shown in FIG. 1 as being rectangular in shape, it will be appreciated that the body 10 may be any suitable shape (e.g., circular, oval, triangular) having a suitable exterior shape. As such, the present disclosure is not limited by the size or shape of the prosthetic body. For example, the prosthetic body may be rectangular in 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) may be 1 cm or more, 2 cm or more, 3 cm or more, 4 cm or more, 5 cm or more, 6 cm or more, 7 cm or more, 8 cm or more, 10 cm or more, 12 cm or more, 15 cm or more, 20 cm or more, 30 cm or more, and / or any other suitable size. In some embodiments, at least one dimension (e.g., dimension D1 and / or D2) of the prosthetic body may be 30 cm or less, 20 cm or less, 15 cm or less, 12 cm or less, 10 cm or less, 8 cm or less, 7 cm or less, 6 cm or less, 5 cm or less, 4 cm or less, 3 cm or less, 2 cm or less, 1 cm or less, and / or any other suitable size. Combinations of the foregoing ranges are also contemplated, including, for example, at least one dimension (e.g., dimension D1 and / or D2) within a range between 1 cm and 30 cm, between 2 cm and 10 cm, and / or any other suitable range. Of course, other ranges, including both larger and smaller ranges than those stated above, are contemplated and the disclosure is not limited in this respect.

[0042]

[0052] In some embodiments, as shown in FIG. 1, the prosthetic body 10 may include handling aids at one or more locations 50. The handling aids allow an operator to grasp and handle the body 10 without placing undue stress on the body itself. The operator manipulates the body 10 by grasping the handling aid, thereby reducing the risk of undesirably distorting and / or tearing the body 10 during handling. Although the handling aid locations 50 are shown along the path (e.g., axis 20) of one or more indicia, it will be appreciated that the handling aids may be located in any suitable location that allows the operator to easily handle the prosthetic body.

[0043]

[0053] It will be appreciated, therefore, that the present disclosure is not limited by the placement, number, and / or spacing of the handling aids. For example, while the location of the handling aids is axisymmetric in Figure 1, in some exemplary embodiments the handling aids may be distributed asymmetrically with respect to the body's axes A1, A2. In other exemplary embodiments, unlike Figure 1, the handling aids may not be uniformly distributed along one or more indices (e.g., axis 20).

[0044]

[0054] 2A and 2B show a handling aid 55 according to some embodiments. The handling aid 55 (which may be mounted to one or more handling aid positions 50 as shown in FIG. 1) may extend outside the plane of the prosthetic body 10. The planar body 10 may include a first side 10A for positioning against a defective soft tissue surface (e.g., abdominal wall) and a second side 10B for positioning against adjacent organs and / or soft tissues. In some embodiments, the first side 10A includes a greater surface texture than the second side, such that the first side 10A can induce tissue ingrowth to promote healing. The second side 10B may include a barrier, such as a barrier material layer or barrier coating, to prevent adhesions with adjacent organs and / or soft tissues in some embodiments.

[0045]

[0055] Thus, the handling aid 55 may extend from at least one side of the planar body 10. In some embodiments, the handling aid 55 may form a loop-like structure and extend out of both the first side 10A and the second side 10B. Thus, the handling aid 55 is accessible from both sides of the body 10, allowing an operator to grasp and / or handle the prosthesis from either side. As shown in Figures 2A-2B, the handling aid 55 may include a first portion 55A that extends out of the first side 10A of the body 10 and a second portion 55B that extends out of the second side 10B of the body.

[0046]

[0056] In some embodiments, as shown in FIG. 2A, the handling aid 55 can follow the line of the embroidered indicia (e.g., axis 20, spatial marker 30). As previously described, the handling aid 55 is a jump stitch of the embroidery line, and the length S1 of the handling aid (measured along the axial direction A1 of the body 10) can be greater than the length S2 of the adjacent stitch. In some embodiments, the length of the handling aid is equal to the length of the adjacent stitch, but the span length of the handling aid (see length S3 in FIG. 2A) can be greater than the span length of the neighboring stitch. In any embodiment, at least a portion of the handling aid 55 floats above the body or is otherwise not attached to the body, providing sufficient clearance between the body 10 and the handling aid 55 to allow a tool to grasp the handling aid. In some embodiments, at least a portion of the handling aid 55 (first portion 55A, which may be the center of the handling aid) can be positioned offset from the plane of the first surface 10A.

[0047]

[0057] It will be appreciated that the handling aid 55 may follow one or more indicator lines, as shown in FIG. 2A. In some embodiments, positioning of the handling aid 55 along the indicators (e.g., axis 20, spatial marker 30) allows the operator to easily position the aid 55. In other embodiments, the handling aid 55 may be positioned separately from the indicators on the prosthesis, which allows for visual differentiation between the handling aid and the indicators. In other embodiments, the handling aid 55 may include a separate indicator (e.g., an arrow, circle, etc.) to guide the operator's eye and / or tools to the handling aid. It will be appreciated that the handling aid may be positioned in any suitable location relative to the adjacent indicators, and the disclosure is not limited in this respect. In some embodiments, the prosthesis may not include indicators, and the handling aid may be the only feature on the prosthesis.

[0048]

[0058] 2B shows a side view of a handling aid 55 mounted on the prosthesis body 10. In some embodiments, the handling aid 55 can include a first portion 55A that extends out of the first side 10A of the body 10 and a second portion 55B that extends out of the second side 10B of the body 10. The handling aid 55 is thus accessible from both sides of the planar body 10, allowing an operator (e.g., a surgeon and / or surgical tools) to grasp the handling aid 55 from either side of the body to manipulate the prosthesis.

[0049]

[0059] It will be appreciated that in some embodiments, the handling aid 55 may include only one portion (e.g., portion 55A or 55B) that extends out of only one side (e.g., side 10A or 10B) of the body 10. In this manner, the handling aid may be accessible from only one side of the prosthesis. In some embodiments, limiting the handling aid to only one side of the prosthesis serves as an indicator of the orientation of the prosthesis, so that if the handling aid is inaccessible, it may indicate to the operator that the prosthesis is oriented on either side. In some embodiments, a combination of handling aids positioned on one side of the prosthesis and handling aids accessible from both sides of the prosthesis may be employed, and the disclosure is not limited in this respect.

[0050]

[0060] FIG. 3 illustrates a portion of a prosthesis 100 according to some embodiments. The prosthesis may be formed with a substantially planar body 10 and may include one or more handling aids 55E, 55F, 550 to allow an operator to handle the prosthesis. As shown, the handling aids may be oriented along an axial direction of the body 10 (e.g., axis A1). Thus, the handling aids may be oriented perpendicular to a secondary axis of the body 10 (e.g., axis A2). In some embodiments, the orientation of the handling aids may be determined by an angle measured between the aid and at least one axial direction of the body 10. For example, FIG. 3 illustrates the handling aid 55E at an angle N11 of 90 degrees relative to the axial direction A2. In another example, FIG. 3 illustrates the handling aid 55F at an angle N12 of 45 degrees relative to the axial direction A1.

[0051]

[0061] It will be appreciated that in some embodiments, the handling aid may be oriented at any suitable angle relative to an axial direction of the body. In some embodiments, the handling aid may be oriented at an angle of 0 degrees or more, 10 degrees or more, 20 degrees or more, 30 degrees or more, 40 degrees or more, 45 degrees or more, 50 degrees or more, 60 degrees or more, 70 degrees or more, 75 degrees or more, 80 degrees or more, 90 degrees or more, and / or any other suitable angle relative to at least one axial direction of the prosthesis. The handling aid may also be oriented at an angle of 90 degrees or less, 80 degrees or less, 70 degrees or less, 75 degrees or less, 60 degrees or less, 50 degrees or less, 45 degrees or less, 40 degrees or less, 30 degrees or less, 20 degrees or less, 10 degrees or less, 0 degrees or less, and / or any other suitable angle. Combinations of the foregoing ranges are also contemplated, including, for example, handling aids oriented at angles between 0 degrees and 90 degrees, between 0 degrees and 45 degrees, and / or any other suitable angle range. Of course, other ranges, including both larger and smaller ranges than those stated above, are contemplated and the disclosure is not limited in this respect.

[0052]

[0062] It will be appreciated that the orientation of one or more handling aids may be selected to facilitate manufacturing and / or to improve the functionality and visibility of the handling aid. In some embodiments, positioning at least one handling aid along an indicator line can streamline the overall embroidery process of the prosthesis. In some embodiments, positioning the handling aid at an angle to the indicator, as previously described, can enhance the visibility of the handling aid. In some embodiments, the prosthesis may include at least one handling aid oriented in a first direction relative to the axial direction of the prosthesis and at least one handling aid oriented in a second direction. In this manner, the prosthesis may include two or more handling aids positioned in a variety of different orientations to facilitate manipulation of the prosthesis by the handling aids. In some embodiments, the prosthesis may include multiple handling aids all oriented in the same direction relative to the axial direction of the prosthesis. It will be appreciated, therefore, that the present disclosure is not limited by any one or combination of orientations of the handling aids relative to the axial direction of the prosthesis.

[0053]

[0063] FIG. 3 also shows a handling aid 550 having multiple legs, such as 550C, 550D, according to some embodiments. The additional leg or legs may increase the strength of the handling aid, allowing greater tension to be applied to the handling aid while still allowing the prosthesis to be manipulated without risk of tearing. In some embodiments, the additional leg or legs may increase the visibility of the handling aid. As shown in the figure, in some embodiments, the handling aid 550 may include two legs 550C, 550D that form a cross shape. In some embodiments, as shown in FIG. 3, the legs 550C, 550D are substantially equal in length, while in other embodiments, each leg of the handling aid 550 may have a different length.

[0054]

[0064] As discussed with respect to the handling aid 55, each leg of the handling aid 550 can be oriented at an angle relative to at least one axial direction of the body 10. For example, FIG. 3 shows a handling aid 550 with a first leg 550C oriented at an angle N2 and a second leg 550D oriented at an angle N3 relative to an axial direction A1 of the prosthesis. It will be appreciated that in some embodiments, each of the legs 550C, 550D of the handling aid 550 can be oriented at any suitable angle relative to an axial direction of the body (e.g., axes A1 and A2 in FIG. 3). In some embodiments, at least one leg of the handling aid can be oriented at 0 degrees or more, 10 degrees or more, 20 degrees or more, 30 degrees or more, 40 degrees or more, 45 degrees or more, 50 degrees or more, 60 degrees or more, 70 degrees or more, 75 degrees or more, 80 degrees or more, 90 degrees or more, and / or any other suitable angle relative to at least one axial direction of the prosthesis. Additionally, at least one leg of the handling aid may be oriented at an angle of 90 degrees or less, 80 degrees or less, 75 degrees or less, 70 degrees or less, 60 degrees or less, 50 degrees or less, 45 degrees or less, 40 degrees or less, 30 degrees or less, 20 degrees or less, 10 degrees or less, 0 degrees or less, and / or any other suitable angle. Combinations of the foregoing ranges are also contemplated, including, for example, at least one leg of the handling aid oriented at an angle between 0 degrees and 90 degrees, between 0 degrees and 45 degrees, and / or any other suitable angle range. Of course, other ranges, including both larger and smaller ranges than those recited above, are also contemplated, and the disclosure is not limited in this respect.

[0055]

[0065] In FIG. 3, the legs 550C, 550D are shown as being orthogonal to each other, but it will be appreciated that embodiments are envisioned in which the legs are not orthogonal to each other. Also, in at least one handling aid 550 in FIG. 3, the legs 550C, 550D are shown symmetrically to the prosthesis body 10, but embodiments are envisioned in which the legs are asymmetrical to the prosthesis. Furthermore, in FIG. 3, the legs 550C, 550D are shown symmetrically to each other, but embodiments are envisioned in which the legs are asymmetrical to each other. Also, while the handling aid 550 is shown to have a pair of legs, it will be appreciated that a handling aid according to the present disclosure may include three or more legs (e.g., three, four, five, six), each of which may be disposed at a respective angle relative to the axial direction of the prosthesis. As previously mentioned, increasing the number of legs may increase the strength of the handling aid during operation.

[0056]

[0066] 4 illustrates a handling aid 550 according to some embodiments mounted on the prosthetic body 10. The handling aid 550 is separate from the prosthetic body 10. The handling 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 handling aid 550 is illustrated extending along an index path such as axis 20. As illustrated, the legs 550C, 550D can cross each other to form the handling aid 550.

[0057]

[0067] In some embodiments, as shown in Figure 4, the prosthesis body 10 may have a mesh-like form factor and include one or more holes 101 distributed throughout the body. The inclusion of holes significantly increases the surface area of ​​the prosthesis while reducing the overall volume of installed material, which may be beneficial for the implanted prosthesis. As previously mentioned, the legs 550C, 550D of the handling aid 550 span two or more holes 101 to provide ample space for the operator to grasp and manipulate the aid.

[0058]

[0068] FIG. 5 shows a handling aid 550 according to some embodiments mounted on the prosthetic body 10. The handling aid 550 may include one or more legs 550C, 550D that span two or more holes 101 in the body 10. In some embodiments, at least one leg of the handling aid 550 (e.g., leg 550C) may have a length S1 that may be greater than the length S2 of the adjacent stitches. As shown, one or more legs of the handling aid 550 may be grasped with a tool 2 to manipulate the body 10. In other words, the length S1 of the legs may be greater than the average hole diameter of the body. The tool may fit within a gap formed between the legs 550C, 550D (shown crossed with each other in FIG. 5) and the body 10. The handling aid 550 may be positioned in a location near an indicator (e.g., identifier 40) that allows an operator to locate and grasp the aid 55.

[0059]

[0069] FIG. 6 illustrates an implantable prosthesis 100 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. In the embodiment illustrated in FIG. 6, the prosthesis 100 may include one or more handling aids 56 coupled to the body 10. In some embodiments, the handling aid 56 is a piece of material (e.g., a mesh similar to the body 10) attached to the body 10 at two ends such that the piece of material can act as a handle for the body during operation.

[0060]

[0070] 7 illustrates a handling aid 56 according to some embodiments. As shown, the handling aid 56 can include one or more fasteners 56A that can be attached to the prosthetic body 10. In some embodiments, the fasteners 56A are sewn directly to the body 10, while in other embodiments, the fasteners 56A can be fastened to the body 10 using one or more adhesive materials. It will be appreciated that the handling aid 56 of the present disclosure is not limited by the means of fastening and / or attachment to the prosthetic body.

[0061]

[0071] The handling aid 56 may also include a free portion 56B that floats between the fixed portions 56A. The free portion 56B serves a similar purpose to the handling aid previously described (handling aid 55 in Figs. 2A-2B) and provides a clearance that allows an operator to grasp and manipulate the prosthetic body 10. As shown in Fig. 7, the handling aid 56 may be formed from one or more pieces of material (e.g., rectangular pieces). In some embodiments, the handling aid may be formed from a flattened tube of material. The extra material may increase the strength of the handling aid and reduce the risk of tearing / breakage during handling.

[0062]

[0072] 8 shows several handling aids 56 mounted on the implantable prosthesis body 10. The handling aids may be positioned along one or more indicia (e.g., spatial markers 30) on the body 10 as shown, and / or may be positioned in any suitable location independent of the indicia. In some embodiments, the handling aids 56 are naturally visually distinct due to the reduced transparency of the two or more prosthesis layers compared to a single layer of the body 10. The handling aids 56 extend sufficiently out of the plane of the body 10 to form a gap that allows an operator and / or tool 2 to grasp the aid and manipulate the prosthesis.

[0063]

[0073] It will be appreciated that the handling aid 56 shown in Figures 6-8 may be oriented at any suitable angle relative to the axial direction of the prosthesis body, as discussed with reference to the handling aid 55 of Figures 1-5. Additionally, the handling aid 56 may be configured with more than two legs (e.g., two crossed legs in any suitable orientation) to improve the strength of the handling aid 56.

[0064]

[0074] Figures 9A-9B show various alternative embodiments of handling aids on an implantable prosthetic body. The handling aids of Figures 9A-9B can be formed in a jump stitch form factor similar to handling aid 55 of Figures 1-5 and / or can be formed of planar or strip-like material similar to handling aid 56 of Figures 6-8.

[0065]

[0075] In FIG. 9A, the handling aid 57 may include one or more rounded projections 57B extending from a surface of the prosthesis body 10. The rounded projections 57B may be held in place on the body 10 by one or more fasteners 57A. The rounded projections 57B may be sized to allow a surgical tool to grasp the rounded projections and manipulate the prosthesis. As previously mentioned, the present disclosure is not limited by the means by which the handling aid may be mounted on the body 10. FIG. 9B illustrates an embodiment in which the handling aid 58 includes at least one fastener 58A to attach the handling aid to the prosthesis body 10. The handling aid 58 may also include one or more tabs 58B that may serve as gripping points for an operator to grasp the handling aid 58 and manipulate the prosthesis.

[0066]

[0076] It will be appreciated that any of the handling aids (e.g., aids 55, 56, 57, 58) of the present disclosure can be positioned on (e.g., extending out of or suspended above) any suitable surface of the prosthetic body, and the disclosure is not limited in this respect. Also, the handling aids can be positioned on (e.g., extending out of or suspended above) both surfaces of a substantially planar prosthetic body. In some embodiments, a combination of handling aids positioned on one surface and handling aids positioned on both surfaces can be employed, and the disclosure is not limited in this respect.

[0067]

[0077] FIG. 10 illustrates an implantable prosthesis 100 according to some embodiments. The prosthesis 100 may include a substantially planar body 10 optionally surrounded by one or more indicia (e.g., axis 20, spatial marker 30). The prosthesis 100 may include one or more pockets 60 formed in one or more locations of the body 10. The pockets 60 may be formed of a planar material that may be attached to the body 10 at one or more borders 62. At least one side and / or portion of the periphery of the planar material may be left open to form a pocket form factor. The pockets 60 may be attached to the body 10 in any suitable manner, such as stitching, welding, folding, and / or any other suitable technique. The pockets 60 allow an operator to grip the prosthesis 100 without undesirably straining the underlying body 10. In some embodiments, the pockets 60 may be located at one or more corners of the body 10, as shown in FIG. 10. Of course, embodiments in which one or more pockets are located in other locations on the body are also contemplated and the disclosure is not limited in this respect.

[0068]

[0078] It will be appreciated that an implantable prosthesis may employ combinations of the aforementioned handling aids in any suitable orientation and arrangement on the prosthesis body, and the disclosure is not limited in this respect. For example, an implantable prosthesis may include one or more jump stitch handling aids (similar to handling aid 55 of FIGS. 1-5, with one or more legs), one or more strip-like handling aids (similar to handling aid 56 of FIGS. 6-9B), and / or one or more pockets (similar to pocket 60 of FIG. 10). Combinations of handling aids and pockets oriented in any suitable direction and / or extending out of one or more faces of the prosthesis body may also be employed, and the disclosure is not limited in this respect.

[0069]

[0079] 11A-11C illustrate the process of preparing the prosthesis 100 prior to installation in a defect in a subject. First, an operator can measure the effective size of the defect and determine the size of the prosthesis needed to aid in the defect repair process. The size of the prosthesis can correspond to the size of the defect, including margins to ensure proper coverage. The operator can then select and / or cut the prosthesis to match the defect size specifications. As shown in FIG. 11A, the operator can cut the prosthesis along one or more landmarks (e.g., axis 20) for ease of use. In some embodiments, the prosthesis 100 does not include landmarks, so the prosthesis can be temporarily marked (e.g., with a surgical marker) prior to cutting.

[0070]

[0080] In some embodiments, the operator can cut or otherwise form the prosthesis to maintain symmetry with respect to at least one axial direction (e.g., directions A1, A2). The prosthesis 100 can include a central portion 10C that can be maintained centered with respect to one or more axes of the prosthesis. As shown in FIG. 11A, the central portion 10C can include one or more handling aids 55H that can be used to manipulate the prosthesis 100. The prosthesis 100 can also include one or more handling aids 55G positioned about the axial markings of the body. In some embodiments, the prosthesis can include at least one aid accessible from only one side of the prosthesis (e.g., handling aid 55G) and at least one aid accessible from both sides of the substantially planar prosthesis body (e.g., handling aid 55H).

[0071]

[0081] As shown in FIG. 11B, after proper sizing, the prosthesis 100 is rolled so that the first side 10A is on the inside of the roll and the second side 10B is on the outside of the roll. In some embodiments, one or more indicators (e.g., spatial markers 30) can facilitate the rolling process perpendicular to at least one axis of the prosthesis. The prosthesis 100 can then be grasped by a tool 3 (e.g., a 5 mm grasper). The tool 3 can guide the rolled prosthesis 100 into a trocar inserted near the surgical site.

[0072]

[0082] Once the prosthesis is inserted into the surgical site, it can be unfolded so that the outer surface of the prosthesis (e.g., surface 10B in FIG. 11B) faces the defect. As previously described, handling aids 55G are accessible from at least the outer surface of the prosthesis. Thus, such handling aids can assist the surgical tools in unfolding, flattening, and / or positioning the prosthesis relative to the defect. The surgical tools can then center the prosthesis relative to the defect using one or more handling aids (e.g., aid 55H shown in FIG. 11A) positioned in the center of the prosthesis (e.g., located in the central portion 10C shown in FIG. 11A). The central handling aids are accessible from both sides of the prosthesis and can help align the prosthesis with the defect. Once it is determined (e.g., by visual inspection) that the prosthesis is properly seated, it can be secured to the defect site by any suitable means (e.g., sutures, staples, tacks, combinations thereof, etc.). Although exemplary repair processes using prostheses are described herein, it will be appreciated that the prostheses of the present disclosure are not limited by the technique by which the prosthesis is provided, seated, and / or secured to the defect site.

[0073]

[0083] Although several embodiments of the present disclosure have been described and illustrated herein, those skilled in the art will readily envision a wide variety of other means and / or structures for performing the functions and / or obtaining one or more of the results and / or advantages described herein. Each of such variations and / or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the particular application or applications for which the teachings of the present disclosure are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the disclosure described herein. It will thus be understood that the foregoing embodiments are offered by way of example only, and that, within the scope of the appended claims and their equivalents, the present disclosure may be practiced otherwise than as specifically described and claimed. The present disclosure is directed to each individual feature, system, article, material, kit, and / or method described herein. Furthermore, 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.

[0074]

[0084] Any terms used herein relating to, for example, the shape, orientation, alignment, and / or geometric relationships of 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 enumerated above that are amenable to characterization by such terms, should be understood not to require absolute conformance to the mathematical definitions of such terms, unless otherwise specified or indicated, but rather to indicate conformance to the mathematical definitions of such terms to the extent that the subject matter can be characterized as understood by one of ordinary skill in the art to which the subject matter is most closely related.

Claims

1. a mesh including a first surface and a second surface; a loop separate from the mesh, the loop being attached to the mesh at at least two locations and having a central portion between the at least two locations, the central portion being unattached to the mesh and disposed on a first side of the first surface; A surgical prosthesis comprising:

2. at least one stitch line having an average stitch length greater than an average pore size of the mesh; The surgical prosthesis of claim 1 , wherein the loop has a span length greater than the average stitch length.

3. The surgical prosthesis of claim 1 , wherein the central portion is offset from the plane of the first surface.

4. a secondary center portion of the loop; the secondary central portion of the loop is accessible from the second face; The surgical prosthesis of claim 1 , wherein the central portion of the loop is accessible from the first surface.

5. a mesh piece attached to the mesh at at least one location; The surgical prosthesis of claim 1 , wherein at least a portion of the mesh piece is offset from the first surface.

6. The surgical prosthesis of claim 5 , wherein the mesh pieces are formed from collapsed tubes.

7. The surgical prosthesis of claim 1 , further comprising at least one stitch line visually distinct from the mesh.

8. The surgical prosthesis of claim 7 , wherein the at least one stitch line is a different color than the mesh.

9. The surgical prosthesis of claim 1 , wherein the loops are aligned with an axial direction of the mesh.

10. The surgical prosthesis of claim 3 , wherein a gap between the first surface and the loop is configured to fit over at least a portion of a surgical tool.

11. The surgical prosthesis of claim 1 , further comprising a secondary loop oriented at an angle relative to the loop.

12. The surgical prosthesis of claim 1 , wherein the loop is centrally disposed relative to the mesh.

13. The surgical prosthesis of claim 1 , wherein the loop is disposed proximally relative to a periphery of the mesh.

14. The surgical prosthesis of claim 1 , wherein the loops and the mesh are formed of the same material.

15. 1. A method of treating a surgical prosthesis, comprising: grasping a central portion of a first loop attached at two locations on a mesh of the surgical prosthesis, the mesh including a first side and a second side, the first loop being separate from the mesh; manipulating the position of the central portion relative to the patient's defect; and A method comprising:

16. further comprising rolling the mesh; The method of claim 15, wherein gripping the central portion of the first loop unfolds the mesh.

17. rolling the mesh; Grasping a center portion of a second loop to spread the mesh; The method of claim 15 further comprising:

18. The method of claim 15, further comprising grasping a center portion of a second loop from the second side of the mesh.

19. 16. The method of claim 15, further comprising grasping the central portion of the first loop from the first side of the mesh.

20. 20. The method of claim 19, further comprising grasping a secondary center portion of the first loop from the second side of the mesh.

21. The method of claim 15, further comprising attaching the mesh around the defect.

22. further comprising gripping the mesh piece attached to the mesh at at least one location; The method of claim 15 , wherein at least a portion of the mesh piece is offset from the first surface.

23. 23. The method of claim 22, wherein the mesh pieces are formed from collapsed tubing.

24. The method of claim 15 , further comprising grasping the central portion of the first tool with a surgical tool.

25. further comprising grasping a central portion of a second loop attached to the mesh in at least two locations; The method of claim 15 , wherein the second loop is oriented at an angle relative to the first loop.

26. further comprising grasping at least one pocket of the mesh to manipulate the mesh relative to the defect; The method of claim 15 , wherein the at least one pocket is attached to the mesh at at least one boundary.

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