Detailed Description
The present disclosure relates to the following implantable prostheses: the implantable prosthesis is useful for repairing anatomical defects and is particularly useful for repairing defects and weaknesses in soft tissue and muscle walls or other anatomical areas. The phrase "repairing a defect" includes the act of repairing, enlarging, and/or reconstructing the defect and/or potential defects. For ease of understanding, and without limiting the scope of the present disclosure, the prosthesis is described below in particular in connection with repairing inguinal defects including, but not limited to, one or more of indirect inguinal hernias, direct inguinal hernias, femoral hernias, and/or other weaknesses or hernias of the inguinal anatomy. However, it should be understood that the prosthesis is not so limited and may be used in other anatomical procedures, as will be apparent to those skilled in the art. For example, but not limited to, the prosthesis may be used for abdominal hernias, chest or abdominal wall reconstruction, or large defects, such as those that may occur in obese patients. The prosthesis may include one or more features, each independently or in combination, to facilitate these properties.
The present disclosure more particularly relates to the following prostheses: the prosthesis includes a repair fabric having a body portion configured to cover or extend across a defect opening or weakness when the body portion is positioned against the defect. The prosthesis may be in the form of a patch, although the prosthesis may take other configurations that should be apparent to those skilled in the art. The patch may have a planar or non-planar configuration suitable for the particular procedure used to repair the defect.
The prosthesis may be configured with a self-grasping device having features that help maintain the position of the prosthesis relative to the defect. The self-grasping device may reduce, if not eliminate, separation, sliding, twisting, folding, and/or other movement between the prosthesis and adjacent tissue, which may be desirable. Such a device may also reduce, if not eliminate, the need for the surgeon to suture, staple, or otherwise temporarily anchor the prosthesis in place awaiting tissue integration.
The prosthesis may include one or more gripping sections that are bonded to the prosthetic fabric layer of the prosthesis. In some embodiments, the gripping section may be bonded to the repair fabric by mounting the gripping section to a surface of the body portion that engages adjacent tissue. In some embodiments, the grip section may be formed from film patches of various shapes and sizes. More specifically, the gripping section may include a microstructure arrangement on the gripping surface that is capable of fixedly gripping a low coefficient of friction material without damaging the material. The grasping section may be configured to grasp tissue by placing and/or pressing the prosthesis against the tissue without employing sutures. In some embodiments, the microtextured film may be configured to grasp tissue using fluid mechanics. For example, the microstructure texture of the grip may allow fluid penetration into the microstructure, providing high solid-fluid adhesion and high contact angle hysteresis.
The gripping sections may be arranged on the body portion in any suitable configuration to provide the desired amount of grip, as will be apparent to those skilled in the art. For example, but not limited to, the gripping sections may be distributed on the body portion in a uniform, non-uniform, or random array and/or any suitable combination of arrays. The gripping sections may be distributed throughout the body portion or positioned at one or more selected areas of the body portion. For example, but not limited to, the gripping section may be positioned at one or more selected areas adjacent to one or more sections of the outer periphery of the body portion and/or at one or more selected areas within an interior region of the body portion that is inwardly remote from the outer periphery. Each selected region may include one or more gripping sections arranged in any suitable pattern within the region.
According to one aspect, the gripping section may be manufactured separately from and mounted to the body portion of the prosthesis. In this way, the grip section may be formed from a different material than the body portion. For example, but not limited to, the gripping section may be formed of a bioabsorbable material, while the body portion may be formed of a non-absorbable material. This arrangement may provide temporary gripping characteristics to the prosthesis during tissue integration while reducing the amount of foreign matter remaining in the patient and maintaining the long term strength of the prosthesis. If desired, the body portion may also be made of a bioabsorbable material that can be absorbed at a slower rate than the material of the gripping section.
The independent manufacture of the gripping sections may also provide flexibility in constructing the prosthesis. For example, but not limited to, depending on the particular application of the prosthesis, the prosthesis may include gripping sections having the same or different gripping section configurations and/or arrangements. For example, but not limited to, the prosthesis may include gripping sections having the same shape but mounted on the body portion in different orientations relative to one another. The prosthesis may include gripping sections having one or more different shapes in one or more regions of the body portion. In this way, the prosthesis may be provided with various gripping characteristics based on the particular orientation and/or shape of the gripping sections alone and as a whole.
In some embodiments, the grasping section can include a plurality of perforations to allow tissue ingrowth into and through the grasping section. The perforations may be configured in a variety of patterns, sizes, and shapes depending on the amount of tissue ingrowth desired, while maintaining the structural integrity of the gripping section. For example, the perforations may be distributed over the gripping section in a uniform, non-uniform, or random array and/or any suitable combination of arrays. The perforations may be distributed throughout the grip section or positioned at one or more selected areas of the grip section. Each selected region may include one or more perforations arranged in any suitable pattern within the region.
In some embodiments, the gripping section may be joined with the body portion of the prosthesis by securing the gripping section to the body portion using one or more sutures. In some embodiments, attaching the grip section to the body portion may include a suturing application with a non-resorbable material, such as polypropylene or ePTFE or resorbable monofilaments, along the periphery of the grip section. In some embodiments, the gripping section may be attached to the body portion using an adhesive, bonding, ultrasonic or thermal welding or over-molding. In some embodiments, the gripping section may include one or more protrusions extending from a surface of the gripping section adjacent to the body portion. In a non-limiting example, the protrusion may include a hook structure or other barbed structure configured to be at least partially inserted into a surface of the body portion when the grip is pressed against the body portion to secure the grip section to the body portion.
The prosthesis may be used to repair soft tissue and muscle wall defects using a variety of surgical techniques, including open surgery, laparoscopic surgery, hybrid surgery (e.g., kugel surgery), and robotic techniques. During open surgery, the prosthesis may be placed through a relatively large incision made in the abdominal wall and tissue layers, and then the defect filled or covered by the prosthetic fabric. During laparoscopic and hybrid procedures, the prosthesis may be contracted into a contracted configuration, such as by rolling or folding, to access the subject directly through a relatively small incision or through an elongated laparoscopic cannula disposed through the incision. The prosthesis may be particularly suitable for robotic surgery in which placement of the prosthesis is achieved using surgical robotic tools, which may involve passing the prosthesis through a relatively small cannula (e.g. 8 mm) compared to cannulas (e.g. 10mm to 12 mm) typically used in more conventional laparoscopic techniques.
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 the specific embodiments described herein.
FIG. 1 illustrates one embodiment of a prosthesis for repairing tissue and muscle wall defects, such as hernia defects. The prosthesis includes a prosthetic fabric made of an implantable biocompatible material. In one embodiment, the repair fabric may comprise a mesh fabric that is relatively flexible, lightweight, and meets the performance and physical characteristics for repairing soft tissue and muscle wall defects. The prosthesis 10 may include a body portion 100, the body portion 100 being configured to have a size and/or shape suitable to cover or extend across a defect opening or weakness when the body portion is placed against a defect. The body portion 100 may be a preformed non-planar patch having a three-dimensional curved shape. The body portion may include a first region 101 and a second region 103, the first region 101 and the second region 103 being joined at a rounded ridge 107 extending from a first outer edge 109 and a second outer edge 111 of the body portion. The rounded ridge 107 may extend from the first outer edge 109 and the second outer edge 111 in a direction towards the first region 101 and intersect at an angle at an apex 113, which apex 113 is arranged near a central region 105 of the body portion between the first region 101 and the second region 103. The apex 113 may be formed as the highest point of the body portion relative to the plane formed by the peripheral edge 112 (see also fig. 12). In one embodiment, the height H of the prosthesis from the plane defined by the peripheral edge 112 to the apex 113 is about 21mm. In some embodiments, the height H of the prosthesis defined by the peripheral edge 112 and the apex 113 is about 0.5 inches, 0.7 inches, 0.9 inches, or 1.1 inches. In some embodiments, the vertex 113 may be positioned at a distance of approximately 2.75 inches, 2.8 inches, 3.0 inches, 3.15 inches, 2.25 inches, or 3.33 inches from the left peripheral edge. In some embodiments, the apex 113 may be positioned at a distance of about 1.25 inches, 1.42 inches, 1.5 inches, 1.69 inches, 1.72 inches, 1.75 inches, or 2 inches from the bottom peripheral edge defining the second region of the body portion.
As shown in fig. 12, the first region 101 and the second region 103 may have a generally spherical shape to enhance conformity with a particular anatomical shape. In one illustrative embodiment, the radius of curvature of the first region is smaller than the radius of curvature of the second region to form a surface in the second region having a steeper slope relative to the first region. Returning to fig. 1, the second region may be shaped to form a recess 115 in the surface of the body portion, the recess 115 being configured to receive an external iliac blood vessel, for example, when the prosthesis is used for inguinal hernia repair. The recess extends inwardly from the peripheral edge 112 between the first outer edge 109 and the second outer edge 111 towards the apex 113.
As shown in fig. 1, the prosthesis 10 may further include one or more gripping sections 102, 104, 106, the one or more gripping sections 102, 104, 106 being mounted to the surface 110 of the body portion 100 to provide a self-gripping arrangement for maintaining the position of the prosthesis relative to the defect. The grasping section may be configured to utilize hydrodynamic grasping and engaging adjacent tissue when the prosthesis is positioned and/or pressed against the adjacent tissue. For example, the grip section may include a substrate having a plurality of microstructures (i.e., grips) extending from the substrate in a micropattern design, thereby forming a microstructured surface (see fig. 5A-5F). The microtextured surface of the gripping sections may allow fluid penetration between the microstructured grips, providing high solid-fluid adhesion and high contact angle hysteresis. Thus, the gripping section is capable of gripping wet tissue while reducing damage to the tissue.
In some embodiments, the grip sections 102, 104, 106 may be positioned at one or more grip areas of the body portion 100. Such an arrangement may be suitable for positioning the gripping section in a selected region of the body portion 100 to accommodate a particular anatomical region. For example, it may be desirable to avoid providing a gripping section on the following areas of the body portion 100: these regions may potentially contact blood vessels, nerves, or other portions of the anatomy at the defect site, as will be apparent to those skilled in the art. The location of the gripping section may facilitate rolling and/or folding of the prosthesis for delivery to the soft tissue repair site. In some embodiments, the gripping section may include one or more perforations 108 to allow tissue ingrowth into the gripping section and after implantation into and through the gripping section and into the body portion 100.
As shown in fig. 1, according to some embodiments, the prosthesis 10 includes a first gripping section 102 and a second gripping section 104 positioned proximate to the peripheral edge 112 on the first region 101 of the body portion 100. The grip sections 102, 104 may be arranged such that each section is positioned on either side of the vertex 113. The gripping sections 102, 104 may be configured to have an oval shape and may or may not be the same shape or size. The third gripping section 106 may be positioned generally adjacent to the peripheral edge 112 on the second region 103 of the body portion 100. The third gripping section 106 may have an L-shaped configuration and the first portion 130 of the gripping section may extend at least partially along the peripheral edge 112 of the second region 103 and beyond the rounded ridge 107 into the first region. The second portion 132 of the gripping section 106 may extend upwardly along the peripheral edge 112 past the rounded ridge 107 into the first region 101.
As shown in fig. 1, the gripping section may be positioned on the body portion 100 near the peripheral edge 112 such that the central region 105 of the prosthesis is free of gripping sections. The gripping sections 102, 104, 106 may be positioned near the peripheral edge 112 so that a user (e.g., surgeon, physician, etc.) may see through the prosthesis when the prosthesis is implanted over a defect in the patient. In addition, such placement may reduce or prevent the gripping section from contacting nerves or other potentially sensitive areas that may cause pain to the patient when implanted. For example, the third gripping section 106 may be positioned such that it avoids nerves, blood vessels, or other tissue when implanted at the defect site.
The size, shape and location of the gripping section may be constructed and arranged to balance the gripping force, potential for tissue ingrowth, and flexibility of the prosthesis. For example, the gripping section may increase grip while reducing the exposed mesh surface required for rapid tissue ingrowth. In this way, the gripping section may act as a barrier to rapid tissue ingrowth until the gripping section breaks. Providing one or more perforations in the grasping section can allow for rapid ingrowth of tissue before the grasping section breaks. The gripping section may also reduce the flexibility of the prosthesis, which may need to be rolled up during surgery to accommodate a narrow cannula or trocar to reach the target site. The configuration and arrangement of the gripping sections 102, 104, 106 illustrated in fig. 1 may allow the prosthesis to maintain sufficient flexibility while still providing sufficient surface area with the gripping portions to securely adhere to tissue.
The number, shape, size, and location of the grip sections 102, 104, 106 may vary depending on the particular procedure, and those shown in the figures are merely non-limiting examples, as the present disclosure is not limited thereto. For example, the gripping section may take on any symmetrical or asymmetrical shape, including but not limited to a circle, polygon, arch, oval, or any free shape. In some embodiments, the gripping section may be positioned along the circumference of the prosthesis, but in some embodiments, the gripping section may be positioned near a central region of the prosthesis, or may be arranged to cover the critical surface 110 of the prosthesis, as desired. Alternatively, fewer or more than three gripping sections may be used. For example, four oval gripping sections may be positioned around the circumference of the body portion, or two L-shaped gripping sections may be positioned opposite each other in the first and second regions 101, 103. Any suitable number of gripping sections may be used to achieve the desired gripping force and flexibility.
In some embodiments, the body portion 100 may be a preformed non-planar patch having a three-dimensional curved shape. In one embodiment, the body portion 100 may have a shape corresponding to 3DMAX MID, 3DMAX Light Mesh, or 3DMAX Mesh available from Davol, and is described in one or more of U.S. patent nos. 6,723,133, 6,740,122, and 6,740,122. In this way, the prosthesis may be particularly suitable for repairing and repairing defects of the inguinal anatomy. However, it should be understood that the prosthesis may take other configurations, as should be apparent to those skilled in the art. For example, but not limited to, the body portion may have a planar or other non-planar configuration suitable for the particular procedure used to repair the defect. In addition, the prosthesis may be provided as a planar sheet with self-grasping prosthetic fabric that may be selectively trimmed to any desired size and shape for the particular procedure by the surgeon.
In some embodiments, the length of the body portion may be greater than or equal to 5.25 inches, 5.5 inches, 5.75 inches, 6.0 inches, 6.25 inches, and/or any other suitable length. In some embodiments, the length may be less than or equal to 6.25 inches, 6.5 inches, 6.75 inches, 7 inches, and/or any other suitable width. Combinations of the foregoing are contemplated to include lengths of, for example, between 5.5 inches and 6.65 inches or equal to 5.5 inches and 6.65 inches, and/or any other suitable combination of the foregoing. In some embodiments, the width of the body portion may be greater than or equal to 3.25 inches, 3.5 inches, 3.75 inches, 4.0 inches, 4.25 inches, and/or any other suitable width. In some embodiments, the width may be less than or equal to 4.5 inches, 4.75 inches, 5.0 inches, 5.25 inches, and/or any other suitable width. Combinations of the foregoing are contemplated to include widths of, for example, between 3.5 inches and 4.85 inches or equal to 3.5 inches and 4.85 inches, and/or any other suitable combination of the foregoing. Although specific ranges of lengths and widths are provided above, it should be understood that ranges greater and less than the above ranges are also contemplated, as the present disclosure is not so limited.
Fig. 2 illustrates an embodiment of a prosthetic fabric layer that may be preformed into a configuration for use as a prosthesis, or may be selectively trimmed to a desired configuration for use as a prosthesis or a portion of a prosthesis. The prosthetic fabric may employ a knitted construction that provides openings or holes to allow tissue infiltration into the bonded prosthesis. When implanted, the mesh promotes rapid ingrowth of tissue or muscle into and around the mesh. Examples of surgical materials that may be used for these layers and that are suitable for tissue or muscle enhancement and defect correction include, but are not limited to: BARD Mesh (available from dav corporation), BARD Soft Mesh (available from dav corporation), soft tissue patch (microporous ePTFE-available from w.l.gore & Associates corporation), SURGIPRO (available from US surgic corporation); TRELEX (available from Meadox Medical); PROLENE and MERSILENE (available from Ethicon Inc.) and other mesh materials (available, for example, from Atrium Medical Corporation). Absorbable or resorbable materials including PHASIX Mesh (available from davo corporation), polylactic acid (VICRYL-available from Ethicon corporation) and polyglycolic acid (DEXON-available from US surgic corporation) may be suitable for applications involving temporary correction of tissue or muscle defects. Collagen materials available from the company Cook biomedica, such as COOK SURGISIS, may also be used. It is also contemplated that the mesh fabric may be formed from multifilament yarns and that any suitable method such as knitting, weaving, braiding, molding, etc. may be employed to form the mesh material.
The prosthetic fabric may also be flexible enough to allow for easy size reduction into the subject. In this way, the flexible fabric may be folded into an elongated configuration, such as a roll, which may be supported in and advanced through a narrow laparoscopic cannula for laparoscopic or robotic surgery.
Fig. 3A-3B illustrate embodiments of an L-shaped gripping section 120 and an oval-shaped gripping section 124, respectively. One or more of the L-shaped gripping section 120 and/or the oval-shaped gripping section 124 may be positioned on a surface of the body portion of the prosthesis.
In some embodiments, the length L of the L-shaped grip section 120 may be about 5.0 inches, 5.25 inches, 5.5 inches, 5.75 inches, 6.0 inches, and/or any other suitable length. In some embodiments, the length L of the shaped grip section 120 is about 5.4 inches. In some embodiments, the width W of the shaped grip section 120 may be about 1.5 inches, 1.75 inches, 2.0 inches, 2.25 inches, and/or any other suitable width. In some embodiments, the width W is 2.1 inches. In some embodiments, the thickness of the shaped grip section 120 may be about 155 μm, 165 μm, 175 μm, and/or any other suitable thickness. Combinations of the foregoing are contemplated to include, for example, lengths between 5.25 inches and 5.5 inches or equal to 5.25 inches and 5.5 inches, widths between 2.0 inches and 2.2 inches, and/or any other suitable combination of the foregoing.
In some embodiments, the length L of the oval grip section 124 may be about 2.25 inches, 2.5 inches, 2.75 inches, 3.0 inches, and/or any other suitable length. In some embodiments, the length L of the oval gripping section 124 is about 2.7 inches. In some embodiments, the width W of the oval grip section 124 may be about 0.5 inches, 0.75 inches, 1.0 inches, 1.25 inches, and/or any other suitable width. In some embodiments, the width W of the oval gripping section 124 is 1.0 inch. In some embodiments, the thickness of the oval gripping section 124 may be about 150 μm, 155 μm, 165 μm, 175 μm, and/or any other suitable thickness. Combinations of the foregoing are contemplated to include, for example, lengths between 2.5 inches and 2.7 inches or equal to 2.5 inches and 2.7 inches, widths between 1.8 inches and 1.1 inches, and/or any other suitable combination of the foregoing. While specific ranges of sizes for the gripping sections are provided above, it should be understood that ranges greater and less than the above-described sizes are also contemplated, as the present disclosure is not so limited.
As shown in fig. 3A-3B, in some embodiments, the gripping sections 120, 124 may include a plurality of perforations to allow tissue penetration in combination with the prosthesis. When implanted, the porous gripping section promotes rapid ingrowth of tissue or muscle into and around the gripping section and body portion. The perforations 122 may extend through the entire thickness of the gripping section or may extend only partially through the gripping section. Perforations may be included on the gripping section in various patterns. For example, in the embodiment of fig. 3A, the L-shaped grip section 120 includes a single array of 18 perforations along the length of the grip section. In the embodiment of fig. 3B, the oval gripping section 124 includes a single array of 5 perforations along its length. The perforations may be arranged in a uniform, non-uniform or random array and/or any suitable combination of arrays. Perforations may also be distributed throughout the grip section.
The perforations provided in the gripping section may be of various shapes and sizes to optimize tissue ingrowth and maintain the integrity of the components used to insert the prosthesis. In some embodiments, the perforations may occupy greater than or equal to about 4%, 6%, 8%, 10%, or 12% of the surface of the gripping section. In some embodiments, the perforations may occupy less than or equal to about 25%, 22%, 20%, or 17% of the surface of the gripping section. Any suitable combination of the above ranges is also possible. In one embodiment, the perforations may occupy greater than or equal to 6% and less than or equal to 20% of the surface of the gripping section.
Fig. 4A to 4B show enlarged views of perforations from the sections 4A and 4B in fig. 3A to 3B. As shown in fig. 4A, the perforations 126 may be configured in a circular shape. Perforations 126 may have a diameter D1 of approximately 0.003 inches, 0.05 inches, 0.075 inches, 0.100 inches, 0.125 inches, and/or any other suitable diameter. As shown in fig. 4B, the perforations 128 may be configured in a hexagonal shape. The perforations 128 may have a section diameter D2 of approximately 0.025 inches, 0.050 inches, 0.075 inches, and/or any other suitable section distance. Although only two perforations are described, it should be noted that any perforation on the gripping section may be of any shape or size according to particular needs. It should also be appreciated that the grip section may employ a combination of perforations having different configurations including, but not limited to, different shapes and/or sizes.
It should be appreciated that any suitable arrangement of gripping sections may be provided on the prosthesis to provide the desired amount of grip, as should be apparent to those skilled in the art. In some embodiments, depending on the particular application of the prosthesis, the prosthesis may include gripping sections having the same or different gripping configurations and/or arrangements. For example, but not limited to, the prosthesis may include gripping sections having the same shape but mounted on the body portion in different orientations relative to one another. The prosthesis may include gripping sections having one or more different shapes in one or more regions of the body portion. The gripping section may include various patterns of perforations to promote a desired level of tissue ingrowth while maintaining structural integrity. In this way, the prosthesis may have various gripping characteristics for a particular application of the prosthesis based on the configuration and/or arrangement of the gripping sections.
The gripping section may be manufactured separately from the body portion of the prosthesis and mounted thereto (e.g., via adhesive, molding, bonding, stitching, etc.). Independent manufacture of the gripping sections may provide flexibility in constructing the prosthesis. In one embodiment, the gripping section may be formed of a bioabsorbable material, while the body portion may be formed of a non-absorbable material. If desired, the body portion may also be made of a bioabsorbable material that can be absorbed at a slower rate than the material of the gripping section. This arrangement may provide temporary gripping characteristics to the prosthesis during tissue integration while reducing the amount of foreign matter remaining in the patient and maintaining the long term strength of the prosthesis.
In some embodiments, the gripping section may comprise one or more films. Fig. 5A-5E illustrate embodiments of a gripping section formed from a microtextured film. The microtextured film may be cut to form gripping sections of different shapes, including but not limited to L-shaped and oval-shaped gripping sections. The microtextured film comprises a film having a microtextured micropattern on a surface. As shown in fig. 5A, the microstructured film 20 includes a substrate 200 and a plurality of microstructured grips 201 on the surface of the substrate. In one embodiment, the film 20 may be a single-sided film having a grip 201 on one surface of the substrate as shown, but the present disclosure is not limited thereto. In one embodiment, the film 20 may be a double-sided film having grips disposed on and protruding from two opposite surfaces of the substrate. Such an arrangement may allow either side of the gripping section to be positioned towards the body portion, while the opposite side faces away from the body portion, which may facilitate the manufacture of the prosthesis. In a non-limiting example, an asymmetric gripping section (e.g., an L-shaped gripping section) made of a double-sided film may be attached to a left-hand or right-hand prosthesis by flipping the gripping section over (i.e., attaching a first surface of the gripping section to the right-hand prosthesis and an opposite second surface to the left-hand prosthesis).
In some embodiments, the grip 201 may be arranged on the substrate 200 in a pattern such as a triangular mesh as shown in fig. 5A-5B, but the present disclosure is not limited thereto, and the grip 201 may be arranged on the substrate in any pattern including, but not limited to, a hexagonal, honeycomb, or square mesh. In some embodiments, the grip 201 may be positioned on the substrate in a random array.
As shown in fig. 5B to 5F, each of the plurality of grip portions 201 may include a first pillar 202 extending from a surface of the base plate 200 and a plurality of second pillars 204 extending from a surface of the first pillar 202. The second pillar 204 may be positioned on the top surface of the first pillar 202 as shown in fig. 5B-5D, or the second pillar 204 may be positioned on the top surface and/or side surface of the first pillar 202 (see fig. 5F). The second struts 204 may be arranged on the first struts 202 in any pattern, including but not limited to a triangular mesh, as shown in fig. 5C.
In some embodiments, the shape of the first leg 202 may be cylindrical. In some embodiments, the first struts 202 may have a diameter D3 of about 0.09 inches to 0.11 inches and may be spaced apart in rows at a spacing D4 of about 0.18 inches to 0.22 inches. The first leg 202 may have a height D7 of about 0.045 inch to 0.055 inch. The first leg 202 may have an axis angle of about 3 ° to 7 °.
In some embodiments, the second leg 204 may be cylindrical in shape and extend in a generally perpendicular direction from the surface of the first leg 202. In some embodiments, the second struts 204 may have a diameter D5 of about 0.009 inches to 0.011 inches and may be spaced apart in rows at a spacing D6 of about 0.018 inches to 0.022 inches. The second leg 204 may have a height D8 of about 0.018 inch to 0.022 inch. Other cross-sectional shapes (e.g., square, oval, orthogonal, etc.), sizes, and patterns for the first and second struts are also contemplated, as the present disclosure is not limited thereto. It should be noted that the second leg 204 may not always extend at an angle perpendicular to the surface of the leg 202, wherein the second leg 204 extends from the surface of the leg 202.
In some embodiments, the gripping section may be formed ofPLDL 7038-GMP grade copolymer of L-lactide and DL-lactide,PLDL 7038 has a molar ratio of 70/30 and an intrinsic viscosity midpoint of 3.8 dl/g.
Fig. 5F is a schematic illustration of a portion of the microstructured film 20 contacting the fluid 206. In some embodiments, the second struts 204 may draw in fluid between the first struts of the membrane 20 such that the fluid penetrates into the gripping microstructure between the first struts 202. This can create superhydrophobic and hydrophilic surfaces, resulting in solid-fluid adhesion and thus high contact angle hysteresis. Thus, the grip portion 201 of the microtextured film 20 can grip wet substrates including tissue without damaging the tissue.
Fig. 6-10 illustrate embodiments of a prosthesis having various gripping sections and perforation configurations and arrangements. The number, size, shape and configuration of the gripping sections may be adjusted depending on the application and the desired use.
Fig. 6 shows an embodiment of the prosthesis 30, the prosthesis 30 having three gripping sections arranged on the surface 310 of the body portion 300. The body portion 300 comprises a first grip section 302 and a second grip section 304, the first grip section 302 and the second grip section 304 having an oval configuration arranged in the first region 301 of the body portion 300 near the peripheral edge 312. The body portion 300 further comprises a third grip section 306 having an L-shaped configuration, which third grip section 306 is arranged close to the peripheral edge 312 of the second region 303 and extends beyond the rounded ridge 307 into the first region 301. The gripping section may be arranged below the apex 313 of the body part such that the gripping section does not cover the apex. In some embodiments, the gripping section may be arranged to cover the roof point.
Each of the grip sections 302, 304, 306 may include a plurality of perforations 308. As illustrated, perforations 308 for the first and second grip sections 302, 304 may be provided in a linear arrangement along the length of the grip sections. The pattern of perforations of the third gripping section may include multiple rows of perforations 308 along the length of the gripping section. The pattern may include a row of perforations at the bottom and a continuous row of perforations stepped outwardly in a chevron shape such that the perforations extend in a grid-like manner along each end of the gripping section. The rows of perforations may be arranged at an angle to a direction along the length of the gripping section. Such a grid-like pattern may facilitate manufacturing or may promote tissue ingrowth at desired locations while maintaining the structural integrity of the gripping section and adequate grip. However, it should be understood that the gripping section may employ any suitable perforation arrangement, as will be apparent to those skilled in the art.
Fig. 7 shows an embodiment of the prosthesis 30, the prosthesis 30 having three gripping sections arranged on a surface 410 of the body portion 300. The body portion 400 comprises a first grip section 402 and a second grip section 404 arranged in a first region 401 of the body portion 400 near a peripheral edge 412. The body portion further comprises an L-shaped third gripping section 406, the third gripping section 406 being arranged close to the peripheral edge 412 of the second region 403 and extending beyond the rounded ridge 407 into the first region 401. The first and second grip sections 402, 404 may have an asymmetric oval shape and the third grip section 406 may have a larger surface area and a greater number of perforations 408 than the grip section 306, as compared to the grip sections 302, 303 of fig. 6. The grip section 404 may be positioned such that it rotates slightly clockwise about the peripheral edge 412, closer to the grip section 406 than to the grip section 402. Grip 406 may be positioned such that it covers apex 413.
Each gripping section 402, 404, 406 includes multiple rows of perforations 408. In some embodiments, the first and second grip sections 402, 404 include fifteen (15) perforations aligned in three (3) rows along the length of the grip sections. The larger grip section 406 includes three (3) sets of separate perforations 408: a central region 420 and two end regions 422, 424. The perforations of each set may be arranged in a grid-like fashion as shown with equal size and spacing. The distance between adjacent perforations of different groups may be smaller or larger than the distance between perforations of the same group. Alternatively, the perforations may be arranged in a less structured manner within each group, and may include unequal or random spacing and/or sizes.
Fig. 8 shows an embodiment of the prosthesis 50, the prosthesis 50 having three gripping sections arranged on a surface 510 of the body portion 500. The body portion 300 includes a first grip section 502 and a second grip section 504 disposed proximate to the peripheral edge 512 in a first region 501 of the body portion 300. The second grip 504 may be disposed proximate a side of the peripheral edge 512 proximate the rounded ridge 507. The first and second grip sections 502, 504 may be larger than the first and second grip sections in fig. 2-7. The first grip section 502 and the second grip section 504 may include a pattern of perforations 508 that occupy a majority of the surface area of the grip section. The perforations 508 may be arranged in a grid-like fashion with equal spacing as shown.
The body portion 500 further comprises a third grip section 506, which third grip section 506 is arranged close to the peripheral edge 512 of the second region 503 and extends upwards over the rounded ridge 507 into the first region 501. The third gripping section 506 may be shaped such that one end has a greater width than the opposite end. The third grip section 506 may have equally spaced and sized perforations 508 positioned in three (3) separate areas on the grip section.
Fig. 9 shows an embodiment of a prosthesis 60 having three gripping sections 602, 604, 606, the three gripping sections 602, 604, 606 comprising a plurality of perforations 608 arranged on a surface 610 of the body portion 600. The body portion 600 includes a first grip section 602 and a second grip section 604 disposed proximate to the peripheral edge 612 in a first region 601 of the body portion 600. The body portion 600 further comprises a third grip section 606, which third grip section 606 is arranged close to the peripheral edge 612 of the second region 603 and extends upwards over the rounded ridge 607 into the first region 601. The third gripping section 606 may be sized to have a shorter length relative to the third gripping section of fig. 8. Comparing fig. 8 and 9, the grip section 506 of fig. 8 includes a relatively longer end portion 509 extending to the peripheral edge 512 of the body portion, while the grip section 606 of fig. 9 has a relatively shorter end portion 609 terminating before the peripheral edge.
As shown in fig. 10, the prosthesis 70 includes three gripping sections disposed on the surface 710 of the body portion 700. The body portion 700 includes a first grip section and a second grip section having twelve (12) perforations 708, the perforations 708 being arranged in two offset rows of six perforations each. The body portion 700 also includes a third gripping section 706 having an L-shape with two (2) sets 720, 722 of perforations 708, the perforations 708 being separated by a non-perforated middle portion 724 of the gripping section. The third gripping portion 706 of the L-shape may be disposed proximate to the peripheral edge 712 in the second region 703 of the body portion, and a portion of the gripping portion 706 may extend beyond the rounded ridge 707 into the first region 701.
In some embodiments, the prosthesis may include any number of gripping sections. For example, as shown in fig. 11, the prosthesis 80 may include four (4) grip sections 802, 804, 806, 814, the four grip sections 802, 804, 806, 814 being disposed on the surface 810 of the body portion 800 proximate the peripheral edge 812 in the first region 801. The body portion may also include two (2) grip sections 816, 818, the two grip sections 816, 818 being arranged near the periphery in the second region 803 of the body portion. A portion of one of the gripping sections 816, 818 may extend beyond the rounded ridge 807 into the first region 801. The gripping sections may be positioned in pairs, with a small amount of mesh of the body portion 800 exposed between the length of each gripping section pair. This may provide greater flexibility to the prosthesis and minimize the volume of the prosthesis to allow insertion into the trocar. In some embodiments, the prosthesis may be folded to fit within an 8mm trocar.
In one embodiment as shown in fig. 13A-13B, the prosthesis 90 may include four gripping sections 902, 904, 906, 914 disposed on the surface 910 of the body portion 900. Each gripping section may include a plurality of perforations 908. The body portion includes three grip sections 902, 904, 906 that may have an oval shape and may be disposed proximate a first peripheral edge 912 in a first region 901 of the body portion 900. As illustrated, the first region may be located on a first side of the rounded ridge 907. The first grip section 902 may have a smaller size, such as a shorter length and/or width, relative to the second grip section 904 and the third grip section 906. The first gripping section 902 may be disposed along a section of the first peripheral edge, and the second gripping section 904 and the third gripping section 906 may be disposed along adjacent sections of the first peripheral edge. The fourth grip section 914 may be disposed in a second region 903 of the body portion 900, the second region 903 being located on a second side of the rounded ridge 907 and extending along the second peripheral edge 912. In some embodiments, the fourth gripping section 914 may be disposed entirely in the second region 903, or a portion of the fourth section 914 may contact or extend partially beyond the rounded ridge 907 into the first region 901. As shown in fig. 13A, the fourth gripping section 914 may contact the rounded ridge 907 at one side of the gripping section, but does not extend beyond the vertex 913. As shown in fig. 13B, the fourth gripping section 914 may extend over the rounded ridge 907 and the vertex 913 on one side of the gripping section. The fourth grip section 914 may be oval in shape and may be larger, such as sized to have a longer length and/or width relative to the second grip section 904 and the third grip section 906.
In some embodiments, the first grip section 902 may have a length of about 1.25 inches, 1.50 inches, 1.75 inches, 1.90 inches, or 2.0 inches and a width of about 0.50 inches, 0.70 inches, or 0.80 inches. In some embodiments, the first grip section 902 may have a length of about 1.89 inches and a width of about 0.689 inches. In some embodiments, the first grip section 902 may have a length of about 1.51 inches and a width of about 0.614 inches. In some embodiments, the second grip section 904 and the third grip section 906 may have a length of about 1.75 inches, 2.0 inches, 2.25 inches, or 2.5 inches and a width of about 0.50 inches, 0.60 inches, 0.70 inches, 0.80 inches, or 0.90 inches. In some embodiments, the second grip section 904 and the third grip section 906 may have a length of about 2.362 inches and a width of about 0.787 inches. In some embodiments, the second grip section 904 and the third grip section 906 may have a length of about 2.047 inches and a width of about 0.632 inches. In some embodiments, the fourth grip section 914 may have a length of about 3.75 inches, 4.0 inches, 4.50 inches, 4.75 inches, or 5.0 inches and a width of about 0.75 inches, 1.0 inches, or 1.25 inches. In some embodiments, the fourth grip section 914 may have a length of about 4.762 inches and a width of about 1.00 inches. In some embodiments, the fourth grip section 914 may have a length of about 4.055 inches and a width of about 0.787 inches.
In some embodiments, the grip segments 902, 904, 906, and 914 may each include a plurality of perforations. The perforations 908 may have a diameter of about 0.10 inches and may be linearly arranged along the longitudinal direction of the gripping section. The perforations may be spaced apart at a pitch of about 0.25 inches to about 0.30 inches. In some embodiments, the perforations 908 may be spaced apart at a pitch of about 0.28 inches. In some embodiments, the first grip section 902 may include four perforations, the second grip section 904 and the third grip section 906 may include six perforations, and the fourth grip section may include fifteen perforations. It should be noted that the sizes and spacing of the grip sections and perforations described with reference to fig. 13A-13B may be included in any of the embodiments described herein.
The grasping section may be disposed on a layer made of repair fabric to cover a portion of the surface of the body portion to maximize tissue grasping. In some embodiments, the grip section may be disposed on the body portion to cover greater than or equal to about 10%, 15%, 20%, or 25% of the surface area of the body portion 100. In some embodiments, the gripping section may be disposed on the body portion to cover less than or equal to about 45%, 40%, 35%, 30%, or 25% of the surface area of all dimensions of the body portion 100. Any suitable combination of the above ranges is also possible. In one embodiment, the grip section may be disposed on the body portion to cover greater than or equal to about 20% and less than or equal to 30% of the surface area of the body portion.
In some embodiments, the gripping section may be made of polylactide acid (PLA), but the present disclosure is not so limited, and the gripping section may be made of other suitable resorbable materials (e.g., P4HB, etc.). In some embodiments, the prosthesis may include four gripping sections (see fig. 13A and 13B). In such embodiments, the total surface area of the gripping sections on the prosthesis may be from about 5.3 square inches to about 7.6 square inches, depending on the size of the prosthesis. The total surface area of the exposed layer of prosthetic fabric of the body portion may be from about 17.5 square inches to about 28.4 square inches depending on the size of the prosthesis. In some embodiments, the grip section may occupy about 26% to about 30.2% of the surface area of the body portion.
It should be understood that all of the gripping sections, perforations and patterns described in each embodiment are non-limiting examples and that any configuration may be used as desired. It should also be noted that any gripping section and configuration from each of the embodiments described above may be used in any prosthesis.
Although several embodiments of the utility model have been described and illustrated herein, a variety of other features and/or structures for performing the function and/or achieving one or more of the results and/or advantages described herein will be apparent to those of ordinary skill in the art and it is intended that each such variation and/or modification be contemplated as being within the scope of the utility model. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present utility model 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 utility model described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the utility model may be practiced otherwise than as specifically described and claimed. The present utility model is directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, if two or more such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, any combination of such features, systems, articles, materials, kits, and/or methods is included within the scope of the present utility model.