Scaffold sheet for promoting tissue formation

Abstract

A device can include a medical treatment system including an implantable scaffold and components that can be configured to be coupled with a target site. The implantable scaffold can include one or more surfaces having a surface architecture with a texture that can promote formation and regeneration of tissue at a target site. The formed tissue can have a similar texture to a corresponding surface of the implantable scaffold.

Description

SCAFFOLD SHEET FOR PROMOTING TISSUE FORMATIONCLAIM OF PRIORITY

[0001] This patent application claims the benefit of priority to U.S. Application Serial No. 63 / 714,058, filed October 30, 2024, which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] The present disclosure pertains to medical devices and tissue engineering such as implantable scaffolds having surface characteristics designed to promote tissue formation and provide a spacer between tissues layers for tissue reconstruction and augmentation procedures.BACKGROUND

[0003] Reconstruction procedures can include medical interventions aimed at restoring or enhancing the form and function of anatomical structures. Such procedures can be performed in various regions of the body, including but not limited to the breast, gluteal, and calf areas. Reconstruction procedures can be performed following trauma, surgical removal of tissue, congenital anomalies, or for aesthetic purposes.

[0004] A range of implantable materials and devices can be utilized in reconstruction procedures. Implantable materials and devices can include synthetic implants, such as those made from silicone or saline, as well as biologically derived materials like acellular dermal matrices. Optionally, synthetic meshes can provide tissue coverage or support for implants. Implants can vary in shape, size, and composition to accommodate the specific requirements of the reconstruction site and the preferences of the patient and clinician.

[0005] Anatomical reconstruction and augmentation procedures can employ implants, such as synthetic implants, to alter a current anatomical appearance. The selected material can assist with formation of the desired anatomical shape or structure. For example, silicone implants represent a class of synthetic devices that can be utilized in medical procedures, including those for augmentation andreconstruction. Synthetic devices, such as silicone implants, can be designed to restore or enhance the form and function of anatomical regions by providing durable and biocompatible support within the body.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Figure 1 illustrates an example of a scaffold according to at least one example of the present disclosure.

[0007] Figure 2 illustrates a schematic of examples of different shapes of a scaffold according to at least one example of the present disclosure.

[0008] Figure 3 A illustrates a schematic of a top view of a scaffold enveloped in tissue according to at least one example or the present disclosure.

[0009] Figure 3B illustrates an example of a schematic of a perspective view of a scaffold enveloped in tissue according to at least one example of the present disclosure.

[0010] Figure 4A illustrates an example of a magnified view of a surface architecture of a scaffold according to at least one example of the present disclosure.

[0011] Figure 4B illustrates a texture characteristic chart of the surface architecture of a scaffold according to at least one example of the present disclosure.

[0012] Figure 5 illustrates a schematic of a scaffold including more than one layer according to at least one example of the present disclosure

[0013] Figure 6 illustrates a schematic of a four different scaffold profiles including a plurality of anchors according to at least one example of the present disclosure.

[0014] Figure 7 illustrates an example of a scaffold according to at least one example of the present disclosure.

[0015] Figure 8 illustrates a method of regenerating tissue at an implantation site according to at least one example of the present disclosure.SUMMARY

[0016] A scaffold can be designed for use in an implant site within a desired part of the anatomy, including but not limited to the gluteal area, calf, breast or other body contouring location. In an example, the scaffold can be a sheet of abiocompatible material including at least one side having a surface architecture. The scaffold can have a form that can assume the contours of the tissue at or proximate to the implant site. The scaffold can stimulate the patient’s body to initiate and the support regeneration of tissue in the implant site.DETAILED DESCRIPTION

[0017] Implantable medical devices can be used for reconstruction or aesthetics. For example, a silicone implant can be inserted or implanted to simulate natural tissue in a specified anatomical area. For instance, a breast implant can include a silicone implant that when implanted simulates an external appearance of a natural breast. Some medical implants can present significant or disruptive physiological effects in the surrounding tissues, including effects detectable from outside of the body. For instance, due to the relatively high volume, mass, and surface area of breast implants, the location of breast implants proximate to the chest cavity, and the potential for incompatibility with living human tissue, satisfactory long-term implantation of breast implants can present challenges. For example, improper implantation or placement of the implant can result in deformation, stress, or fracture of the implant.

[0018] Some implants, such as those formed from a silicon-based material, can be designed for long-term retention within the body. Implants retained within the body for an extended amount of time can, at times, require removal or adjustment to maintain a natural appearance. For example, implants can move out of position during and / or after surgery. To maintain a natural appearance the implant can be removed, adjusted or the like. In other instances, the implant can become encapsulated by the surrounding tissue. Due to the properties of the implant material, the patient can experience a reduced level of biocompatibility with the device.

[0019] Certain implants can be formed with a surface architecture featuring a coarse or uneven texture to enhance attachment to tissue at the implantation site and help maintain the position of the implant. Implants including a coarse surface can present excessive friction between the coarse-surfaced exterior surface architecture and the surrounding tissue. In some instances, a reaction can occur between the coarse surface and the surrounding tissue. The reaction cancause tissue encapsulation or capsular contraction due to friction induced tissue irritation. In some examples, uncontrolled implant surfaces can also be susceptible to bacterial colonization, such as in the form of biofilms that can develop over and within crevices in a surface architecture. In other examples uncontrolled implant surfaces can also be susceptible to bacterial colonization due to debris on the implant surface remaining from the manufacturing process.

[0020] Some implants can be described or characterized by various parameters. For example, the surface of an implantable medical device can have a specified texture, hydrophobicity or hydrophilicity, and elasticity, among other physical and chemical properties. With respect to texture, for example, texture characteristics of a surface architecture can be described by roughness, kurtosis, and / or skewness values, e.g., based on the shapes, sizes, and / or distribution of topographical projections (peaks) and recesses (valleys), discussed below. Implants can include controlled surface features that can improve implant biocompatibility, and can improve clinical outcomes.

[0021] The implants discussed herein can include a breast implant, a gluteal implant, a calf implant, or any other implant that can benefit from the subject matter discussed herein. The surfaces discussed herein can be located on at least one of an anterior side or a posterior side of the implant. For example, a first surface can be on the anterior side, and a second surface can be on the posterior side of the implant. In other examples, the first surface can be on the posterior side and the second surface can be on the anterior side. The first surface and the second surface can be oriented in any desired arrangement as is suitable for the purpose. In examples, the surface architecture on the first side can be different from the second side. Optionally, the surface architecture on the first side can be the same as the second side, or the surface architecture can change along the first or second side.

[0022] Illustrated in Figure 1 is an example of a scaffold 100 (e.g., sheet, strip, stencil, mold or the like) as an example of implantable medical device. The scaffold 100 can be retained within an implant site (e.g., pocket, cavity, recess, or the like), as will be discussed further. The scaffold 100, in some situations is permanently (e.g., for several years, for more than ten years, for the lifetime of the patient, or the like) retained within an implant site. In another example, the scaffold includes a resorbable material. The resorbable material of the scaffold100 can be incorporated into the tissue of the implant site after a period of time has passed. Optionally, the scaffold can be a material that can be temporarily retained or arranged within the implantation site, as discussed further.

[0023] The scaffold 100 can be dimensioned and contoured to conform to the implantation site. Scaffold can include an implantable medical device, in the form of a sheet, strip, membrane, mold, or the like that is constructed from a biocompatible material. The scaffold 100 can include a pliable, or flexible, sheet. The scaffold 100 can be constructed to conform to the dimensions of the implantation site. The scaffold 100 can be constructed to conform to the profile of the tissue at the implantation site. For example, the scaffold 100 can be formed from a pliable material that can assume one or more contours that correspond to the implantation site. The scaffold 100 can be formed with a rounded shape (e.g., circle, ellipse, oval or the like), or a polygonal shape (e.g., square, rectangle, pentagon or the like). In an example, the scaffold 100 can have rounded edge portions and angular edge portions.

[0024] As illustrated in Figure 2, the scaffold 100 can include a first side 110 and a second side 112. The first side 110 or the second side 112 can be formed for orientation within the body to face in a posterior or anterior direction, a superior or inferior direction, or a lateral or medial direction, as appropriate for the intended anatomical placement. The scaffold 100 can be a thin sheet (e.g., strip, length, membrane, film or the like), as compared to a traditional implant.

[0025] As illustrated in Figure, 2, the scaffold 100 can have a thickness 120 between the first side 110 and the second side 112. The thickness 120 can be uniform throughout the scaffold 100 or the thickness 120 can vary within the scaffold 100. For example, the thickness 120 can be thicker along more central portions 105 of the scaffold 100 and thinner proximate to the periphery 102 of the scaffold 100. The thickness 120 can be varied across different regions of the scaffold 100 to accommodate the specific anatomical structure or intended function of the scaffold 100.

[0026] The scaffold 100 can have a thickness of fewer than approximately 1.0 centimeter (cm). The scaffold 100 can have a thickness of fewer than approximately 5.0 millimeters (mm). The thickness of the scaffold 100 can have thicknesses greater than approximately 1.0 cm according to the desired or specified use. In an example, the scaffold 100 can have a substantially uniformthickness of 5.0 mm or less throughout the scaffold 100. Optionally, the scaffold 100 can have a thickness of approximately 1.0 cm or less proximate to the more central portions 105 and a thickness of approximately 5.0 mm or less proximate to the periphery 102. The thickness of the scaffold 100 can be selected or adjusted as needed to suit a wide range of clinical applications and patientspecific anatomical considerations.

[0027] In an example, the scaffold 100 can be formed from an elastomer or similar material. The scaffold 100 can be formed to be pliable (e.g., flexible, malleable, elastic or the like). The scaffold 100 can be formed to move with the anatomical structure of the implantation site. The scaffold 100 can be formed from a silicone, or a silicone-based material, polydimethylsiloxane (PDMS), or another biocompatible material, such as an elastomer. The scaffold 100 can be formed from a combination of materials according to the purpose. For instance, a combination of materials can be included in the scaffold 100 to enhance structural characteristics of the scaffold 100.

[0028] The scaffold 100 can be formed as a sheet of an elastomer (or other pliable material) that includes the first side 110 and the second side 112. Each side of the scaffold 100 can have a surface architecture 130. The surface architecture 130 of the first side 110 and the second side 112 can include a texture characteristic 132. For example, the first side 110 can include a first surface architecture 133 and the second side 112 can include a second surface architecture 135. The first surface architecture 133 and the second surface architecture 135 can extend along an entire surface of the first side 110 or the second side 112, or partially along the first side 110 or the second side 112. In an example the first surface architecture 133 is different from the second surface architecture 135. Optionally, the first surface architecture 133 is similar or the same to the second surface architecture 135. In an example, the first surface architecture 133 of the first side 110 can include a texture characteristic 132 that is rougher or more irregular than the second surface architecture 135 of the second side 112. Optionally, at least one of the first surface architecture 133 and the second surface architecture 135 can be a substantially smooth texture.

[0029] The scaffold 200 illustrated in Figure 3 A is an example of a scaffold implanted in an implantation site 201. The implantation site 201 can include a pocket, cavity, recess, or other anatomical space within a patient’s body. Theimplantation site 201 can include internal structures of a body that can be prepared or selected to receive the scaffold 200. The implantation site 201 can be formed by surgical dissection, natural anatomical spaces, or areas of tissue loss or reconstruction. The implantation site 201 can include an anatomical area of the body that can benefit from tissue regeneration (e.g., regrowth, formation, or the like).

[0030] The scaffold 200 can be arranged within the implantation site 201 with at least one of a first side 210 or second side 212 in contact with tissue 205. At least one of the first side 210 or the second side 212 can be formed with a surface architecture 230 that can induce a controlled immune response to promote tissue regeneration (e.g., regrowth, formation, or the like). The controlled immune response for tissue regeneration can include a carefully regulated, multi-stage process involving immune cells that can facilitate healing of injured tissue rather than the formation of scar tissue. The controlled immune response can initiate and promote tissue cells forming to regenerate lost tissue within the implantation site 201.

[0031] The scaffold 200 can be positioned within the implantation site 201 at a location selected to promote tissue regeneration. The scaffold 200 can include a surface architecture 230 specifically engineered to promote regeneration of the tissue. The scaffold 200 can include a surface architecture 230 specifically engineered on at least one of the first side 210 or the second side 212. The surface architecture 230 can function as a stencil to assist in guiding the immune response and promote regeneration or formation of tissue near the first side 210 or the second side 212. The surface architecture 230 of the scaffold 200 can include texture characteristics. The textured surface can be a readily identifiable texture, or the texture can be a microscopic texture and only visible through additional equipment.

[0032] Figure 4A illustrates an example of a magnified view of a portion of a scaffold 200. The scaffold 200 can include a surface architecture 330 including a plurality of peaks 331 and a plurality of troughs 333, as texture characteristics. The plurality of peaks 331 and the troughs 333 can be regularly formed along the scaffold 200. For example, the regularly formed plurality of peaks 331 and the regularly formed plurality of troughs 333 can be substantially similar heights or valleys, respectively. The plurality of peaks 331 and the plurality of troughs 333can be irregularly formed. For example, the irregularly formed plurality of peaks 331 and the plurality of troughs 333 can have different heights or valleys.

[0033] The surface architecture 330 can include one or more texture characteristics 350 that, when presented alone or together on a scaffold 200, can act as a stencil to form a biological scaffold to assist in guiding the body’s immune response. One texture characteristic of one or more texture characteristics 350 can include a mean surface roughness (Sa) between approximately 0.70 micrometers (pm) with a standard deviation of approximately ± 0.40 and approximately 17.00 pm with a standard deviation of approximately ±3.50 at a scale area of 2 millimeters by 2 millimeters (2 mm x 2 mm). For example, the mean surface roughness (Sa) can be between approximately 0.66 ± 0.38 micrometers and approximately 16.71 ± 3.30 micrometers. Another texture characteristic of the one or more texture characteristics 350 can include a mean surface skewness (Ssk) of between approximately -0.10 with a standard deviation of approximately ±0.30 and approximately 0.20 with a standard deviation of approximately ±0.40 and a scale area of 2 mm x 2 mm. For example, the mean surface skewness can be between approximately 0.16 ± 0.40 and approximately -0.10 ± 0.31. Another texture characteristic of the one or more texture characteristics 350 can include a mean kurtosis (Sku) between approximately -0.05 with a standard deviation of approximately ±0.50 and approximately 3.00 with a standard deviation of approximately ±3.00 at a scale area of 2 mm x 2 mm. For example, a mean kurtosis can be between approximately 2.68 ± 2.77 and approximately -0.04 ± 0.49. Another texture characteristic of the one or more texture characteristics 350 can include a mean maximum height (Sz) between approximately 10.50 pm with a standard deviation of approximately ± 4.50 and approximately 126.50 pm with a standard deviation of approximately ± 55.00 at a scale area of 2 mm x 2 mm. For example, the mean maximum height can be between approximately 10.41 ± 4.36 micrometers and 126.34 ± 54.04 micrometers. Another texture characteristic of the one or more texture characteristics 350 can include a mean density of peaks (peaks / cm2) between approximately 1720 peaks / cm2with a standard deviation of approximately ± 575 and approximately 22000 peaks / cm2with a standard deviation of approximately ± 3700 at a scale area of 2 mm x 2mm. For example, the mean density of peaks can be between approximately 1915 ± 1836 peak / cm2and approximately 1716 ± 572 peak / cm2

[0034] Example texture characteristic parameters 435 for three different scaffolds 451, 452 and 453 is illustrated in the chart 430 in Figure 4B. The characteristic parameters 450 are examples of texture characteristics that when formed on at least one side of a scaffold can form a surface that can promote the formation of tissue within an implantation site. Each of the scaffolds 451, 452, 453 can be similar to at least one of the scaffold 100 or 200 as discussed related to Figures 1-2 and can be formed from a material having a surface architecture, such as the surface architecture 330 as discussed related to Figure 3A, to induce a controlled immune response to regenerate tissue on and around the scaffold.

[0035] Returning to Figure 3B, the surface architecture 230 can cause additional tissue 215 to grow (such as regenerated) on the scaffold. The additional tissue 215 can envelop (e.g., cover, encase, surround, or the like) the scaffold 200. The controlled immune response caused by surface architecture 230 can initiate or induce a patient’s body to become a “bio-printer” of its own autologous tissue, such as the additional tissue 215. The additional tissue 215, as “bio-printed tissue,” can include tissue that is a copy, such as entirely similar, 95% similar, 90% similar or the like (e.g., simulate, mimic or the like) to at least one of the first side 210 or second side 212 of the scaffold 200. For example, the “bio-printed” tissue can form as an approximate copy of the surface architecture 230 including the texture characteristics, such as one or more texture characteristics 350 discussed related to Figures 4A or 4B, of the surface of the temporary implantable scaffold. The surface architecture 230 of the scaffold 200 can encourage subsequent layers of tissue to continuously be regenerated until a desired amount of tissue is formed at the implantation site.

[0036] Regeneration or growth of the patient’s own tissue can minimize scar formation while providing structural support for reconstruction of the body’s own tissue around the implant site. The scaffold 200 can promote the formation of a tissue to provide one or more of support or structure to the implant site. For example, the regenerated tissued can support an additional implant, such as a traditional breast implant. The use of the scaffold 200 can offer flexibility in the regeneration of tissue according to various surgical scenarios. For example, the scaffold 200 can also support the natural development of soft tissue, which canbe used to cover and integrate the reconstructed tissue, flaps or autologous grafts.

[0037] In an example, the scaffold 200 can be formed to retain or maintain an implantable device, such as a breast implant, in position a within a target site, such as a breast pocket. The scaffold 200 can optionally support soft tissue support devices. The scaffold 200 can be positioned within the target site, such as the breast pocket, during reconstructive or aesthetic procedures to provide a permanent or temporary structural support and maintain the desired orientation of the implantable device, such as a breast implant. The scaffold 200 can be secured or maintained in place, for example with sutures or bioadhesives, to help stabilize the implant and minimize malposition during tissue healing and integration. At least one of the first side 210 or the second side 212 including a surface architecture 230 of the scaffold 200 can promote the formation of a healthy tissue capsule around both the scaffold 200 and the implant, enhancing soft tissue support. Once sufficient tissue regeneration has occurred and the capsule is formed, the scaffold 200 can be removed, leaving behind a stable, autologous tissue structure that continues to support the breast implant, thereby reducing the risk of implant displacement and improving long-term surgical outcomes.

[0038] The scaffold 200 can be formed including medical treatments such as pharmaceuticals, antibacterial agents, or antiseptic components. These therapeutic agents can be incorporated with controlled characteristics regarding dosage and timing of release, either immediately following implantation or over a sustained period within the body. For example, a dosage or timing of release of the one or more of the pharmaceutical, antibacterial, and antiseptic components can be specified according to the procedure. The medical treatments can allow the scaffold 200 to not only provide structural support but can also deliver localized treatment to enhance healing and reduce the risk of infection or other complications.

[0039] The scaffold 200 can be formed from an elastomer. For example, a scaffold 200 can present an increased biocompatibility as compared with other implantable materials. Optionally, the scaffold 200 can include one or more of carbone-backbone, graphene, goretex, hydrogels, alginates, foams (polyurethanes, urethanes), hydroxyapatite. The scaffold 200 can include acombination of materials. The scaffold 200 can include of any one or combination of materials according to the purpose. In some examples, the scaffold 200 can be formed from multiple materials to reinforce the scaffold 200.

[0040] The scaffold 200 can be designed for permanent or temporary use within an implantation site. Optionally, the scaffold 200 can be resorbable. The scaffold 200 can be intended to be permanent and remain in place for an extended period, providing ongoing structural support and, in some instances, promote continuous tissue integration.

[0041] Alternatively, the scaffold 200 can be a temporary device, remaining in the body until sufficient tissue regeneration has occurred, after which the scaffold 200 can be removed through a minimally invasive procedure. For instance, the scaffold 200 can be formed from a silicone-based material. The silicone-base material can be engineered to include hydrophobic characteristics that can discourage, inhibit, prohibit, or the like, newly formed tissue from bonding, adhering or the like to at least one of the first side 210 or the second side 212. The scaffold 200 can be constructed as a temporary device, allowing for its removal from the implantation site once the desired tissue has developed around the implantable scaffold. For example, a small cut can be made in the tissue that has formed around the temporary implantable scaffold. A medical professional can then remove the temporary implantable scaffold through the small cut while the regenerated tissue remains at the implantation site.

[0042] The scaffold 200 can also include a bioresorbable material. For example, the scaffold 200 can include one or more of polycaprolactone (PCL), poly-4-hydroxybutyrate (P4HB), hyaluronic acid, collagen, polydioxanone (PDO), polyactic acid (PGA), polylatic acid (PLA) or poly(lactic-co-glycolic), or the like. The scaffold 200, as a bioresorbable material, can include any material that can gradually degrade and can be absorbed by the surrounding tissue. A bioresorbable material can reduce the need for surgical removal and can allow the regenerated tissue to maintain the desired anatomical structure.

[0043] As illustrated in Figure 5, the scaffold 400 can include one or more layers 411. Each of the one or more layers 411 can be formed from the same material or each of the one or more layers 411 can be formed from different materials. Optionally, one layer of the one or more layers 411 can be formed from a different material than the remaining layers. For example, a first layer413 of the one or more layers 411 can be formed from a first biocompatible material and a second layer 415 can be formed from a second biocompatible material. In some examples, one or more of the one or more layers 411 can include a color layer. Each of the one or more layers 411 can have a different thickness. Each of the one or more layers 411 can have the same or a similar thickness. In an example, some of the one or more layers 411 can have the same thickness and one or more other layers can have a different thickness.

[0044] Illustrated in Figure 6 are examples of four different shapes, or profiles, of scaffolds 501, 502, 503 and 504 that can be included in a medical treatment system. The scaffolds 501, 502, 503, 504 can be similar to scaffolds 100, 200 discussed previously related to Figures 1 or 2 and can include surface architectures including surface textures discussed previously. The medical treatment system can include the scaffold and the features and components used to couple the scaffold with the tissue at the implantation site. The scaffold 501 is an example of a scaffold that can include angular profile, such as rectangular, square, rhombus or the like, as discussed previously related to Figure 1. The scaffold 502 is an example of a scaffold formed as a strip with a first side 502a having a length dimension much smaller than a length of the second side 502b. The scaffold 503 is an example of a scaffold that can be formed in a substantially circular shape. The scaffold 504 is an example of a scaffold that can be formed in an oval shape.

[0045] Each of scaffolds 501, 502, 503, 504 can include one or more suture areas 540. The one or more suture areas 540 can be arranged around a perimeter portion 541 of each of the scaffolds 501, 502, 503, 504. Each of scaffolds 501, 502, 503, 504 can include one or more anchoring structures 545, such as suture areas or holes. The one or more anchoring structures 545 can be formed to receive sutures for secure fixation of each of scaffolds 501, 502, 503, 504 with the tissue at or proximate to the implantation site. The one or more anchoring structures 545 can be located around the perimeter portion 541 or at intermediary locations 543 on the scaffold. The one or more anchoring structures 545 can allow a clinician to couple the scaffold to surrounding tissue and maintain a desired orientation of the scaffold during tissue regeneration.

[0046] Figure 7 illustrates an example of a scaffold 600 featuring a surface architecture that includes recesses 608, such as openings or holes, which interactwith the overall surface architecture 630. The scaffold 600 can be a temporary implant, resorbable implant or a permanent implant. The scaffold 600 can have a surface architecture 630 that be favorable to tissue growth or regeneration. For example, as the scaffold 600 remains in an implant site, tissue cells can form along at least one of a first surface 610 or a second surface 612 of the scaffold 600. In an example, tissue cells can regenerate larger bodies of tissue that can replicate at least one of the first surface 610 or the second surface 612 of the scaffold 600. Tissue cells, or tissue, can regeneration through one or more of the recesses 608 formed within the scaffold 600.

[0047] Illustrated in Figure 8 is an example of a method of forming a scaffold 700. The method can include providing a scaffold including at least one surface architecture 710. The scaffold can be formed by poured or cast into a mold that imparts the desired overall shape and profile, as well as specific surface architecture features. For example, a biocompatible elastomeric material, such as silicone or poly dimethylsiloxane (PDMS), can be injected, poured or otherwise applied to a mold. The mold can include varying sizes and thicknesses to accommodate different anatomical requirements. Optionally, the mold can include features such as suture holes or porous regions to facilitate fixation and integration with surrounding tissue. After the biocompatible material is injected into the mold, the biocompatible material can conform to the shape and surface features of the mold. As the biocompatible material cools and sets, the shape and surface features can be imparting the desired overall profile and engineered surface architecture to the scaffold.

[0048] Optionally, the mold includes a desired or specified shape with relatively smooth surfaces. As the injected biocompatible material cools and sets, exposed surfaces of the scaffold include relatively untextured surfaces. One or more secondary processes can be applied to the cooled and set scaffold. Secondary processes can include techniques such as surface texturing, etching, or the application of coatings, which can impart texture characteristics to the scaffold.

[0049] The method of forming a scaffold 700, illustrated in Figure 8, can include forming a scaffold with additive manufacturing. For example, digital model of the desired or specified scaffold geometry and surface architecture can be generated using computer-aided design (CAD) software. The biocompatiblematerial, in the form of a liquid resin, gel, or thermoplastic filament, such as a liquid silicone, silicone-based material, PDMS or another biocompatible elastomer, can be deposited layer by layer according to the digital model. Additive printing according to a pre-designed model can allow for substantially precise control over one or more of shape, thickness, and surface architecture, including one or more texture characteristics. Additive manufacturing can aid with fabrication of complex geometries and customized surface textures that can be difficult to achieve with traditional molding methods.

[0050] Either molding or additively manufacturing the scaffold can produce a relatively thin (as compared to traditional anatomical contour forming implants), flexible scaffold.

[0051] The scaffold can then be inserted into or along a previously prepared implantation site 720. For example, the implantation site can include a previously formed pocket within layers of tissue. The implantation site can be along an area of tissue. The scaffold can be arranged within the implantation site so that either the first side, the second side, or both sides are in engaged with at least a portion of the tissue 730. In some examples, only a portion of a side of the scaffold can interface with tissue.

[0052] Selective contact or engagement with the tissue at or along the target site can allow for targeted interaction between the surface architecture and the tissue to promote controlled tissue regeneration. The scaffold can be maintained at the implantation site for a desired or specified period of time 740. The scaffold can be retained within the implantation site by coupling the scaffold to tissue at the implantation site. For example, the scaffold can be coupled with sutures, staples, adhesives or the like.

[0053] The surface architecture of at least one side of the scaffold can promote tissue regeneration at the implantation site 750. As the tissue grows along one or more surfaces of the scaffold, the newly regenerated tissue can form a capsule that can at least partially envelops the scaffold. The new tissue can continue to grow around the scaffold until a desired amount of tissue has formed.

[0054] When the desired tissue has formed around the scaffold, the scaffold can, optionally be removed from the implant site. In an example, the scaffold can be formed from a resorbable material that can be absorbed into the surroundingtissue over a period of time. In another example, the scaffold can be formed from a material that does not substantially degrade and remains at the implantation site for a longer duration of time.ASPECTS

[0055] Aspect 1 can include subject matter such as an implantable medical device comprising: a flexible sheet including: a first surface having a first surface texture; and a second surface having a second surface texture; wherein at least one of the first surface texture or the second surface texture is configured to induce a controlled immune and promote tissue growth response within an implantation site.

[0056] Aspect 2 can include, or can optionally be combined with the subject matter of Aspect 1, to optionally include at least one of the first surface texture and the second surface texture is configured to promote regeneration of tissue.

[0057] Aspect 3 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 1 or 2 to optionally include the flexible sheet is formed from a biocompatible elastomer.

[0058] Aspect 4 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 1-3 to optionally include the first surface texture includes a first surface roughness, a first skewness, and a first kurtosis; wherein the second surface texture different from the first surface texture, the second surface texture includes a second surface roughness, a second skewness, and a second kurtosis.

[0059] Aspect 5 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 1-4 to optionally include the flexible sheet includes a thickness fewer than 5 millimeters.

[0060] Aspect 6 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 1-5 to optionally include the flexible sheet includes a temporary implantable scaffold.

[0061] Aspect 7 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 1-6 to optionally include the flexible sheet includes rectangular, oval or circular form.

[0062] Aspect 8 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 1-7 to optionally include the flexible sheet is formed from a bioresorbable material.

[0063] Aspect 9 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 1-8 to optionally include one or more anchoring structures configured to receive sutures.

[0064] Aspect 10 can include subject matter such as a medical treatment system configured to promote tissue regeneration comprising: a flexible scaffold configured to be received within a tissue capsule of an implantation site, the flexible scaffold including: a first side including a first surface architecture configured to promote tissue regeneration; a second side including a second surface architecture; and a thickness between the first side and the second side is fewer than 5 millimeters; wherein the flexible scaffold includes a construction configured to maintain a structure of the implantation site; and one or more sutures configured to couple the flexible scaffold to the tissue capsule.

[0065] Aspect 11 can include, or can optionally be combined with the subject matter of Aspect 10, to optionally include the flexible scaffold includes a sheet, strip, or mold.

[0066] Aspect 12 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 10 or 11 to optionally include at least one of the first side or the second side includes a surface architecture including a mean surface roughness between 0.70 micrometers (pm) with a standard deviation of ± 0.40 and 17.00 pm with a standard deviation of ±3.50 micrometers at an area scale of 2 millimeters x 2 millimeters.

[0067] Aspect 13 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 10-12 to optionally include at least one of the first side or the second side includes a surface architecture having a mean skewness of between -0.10 with a standard deviation of ±0.30 and 0.20 with a standard deviation of ±0.40 an area scale of 2 millimeters x 2 millimeters.

[0068] Aspect 14 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 10-13 to optionally include at least one of the first side or the second side includes a surface architecture having a mean surface kurtosis value of between approximately -0.05 with astandard deviation of approximately ±0.50 and approximately 3.00 with a standard deviation of approximately ±3.00 at an area scale of 2 millimeters x 2 millimeters.

[0069] Aspect 15 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 10-14 to optionally include at least one of the first side or the second side includes a surface architecture having a mean maximum peak height to trough of between 10.50 pm with a standard deviation of approximately ±4.50 and approximately 126.50 pm with a standard deviation of approximately ±55.00 micrometers at an area scale of 2 millimeters x 2 millimeters.

[0070] Aspect 16 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 10-15 to optionally include at least one of the first side or the second side includes a surface architecture having a mean surface density of peaks of between 1720 peaks / cm2 with a standard deviation of approximately ±575 and approximately 22000 peaks / cm2 with a standard deviation of approximately ±3700 at an area scale of 2 millimeters x 2 millimeters.

[0071] Aspect 17 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 10-16 to optionally include the first surface architecture is different than the second surface architecture.

[0072] Aspect 18 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 10-17 to optionally include the second surface architecture is configured to promote tissue regeneration.

[0073] Aspect 19 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 10-18 to optionally include the flexible scaffold is configured to be removable from the implantation site.

[0074] Aspect 20 can include subject matter such as method of regenerating tissue at an implantation site, the method comprising: providing an implantable scaffold formed from a biocompatible sheet including at least one surface architecture configured to include a controlled immune response; arranging the implantable scaffold within the implantation site with the at least one surface engaged with tissue at the implantation site; and maintaining the implantable scaffold in the implantation site; wherein the at least one surface architecture promotes new tissue formation proximate to the at least one surface.

[0075] Aspect 21 can include, or can optionally be combined with the subject matter of Aspect 20, to optionally include the biocompatible sheet includes: a first side including the at least one surface architecture; and a second surface architecture along a second side of the implantable scaffold from the at least one first surface, the method including: arranging the implantable scaffold within the implantation site with the second surface architecture proximate to the tissue at the implantation site.

[0076] Aspect 22 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 20 or 21 to optionally include at least one of the at least one surface architecture and the second surface architecture includes one or more texture characteristics having: a mean surface roughness between 0.70 micrometers (pm) with a standard deviation of ± 0.40 and 17.00 pm with a standard deviation of ±3.50 micrometers at an area scale of 2 millimeters x 2 millimeters; a mean skewness of between -0.10 with a standard deviation of ±0.30 and 0.20 with a standard deviation of ±0.40 an area scale of 2 millimeters x 2 millimeters; a mean surface kurtosis value of between -0.05 with a standard deviation of ±0.50 and 3.00 with a standard deviation of ±3.00 at an area scale of 2 millimeters x 2 millimeters; a mean maximum peak height to trough of between 10.50 pm with a standard deviation of ±4.50 and 126.50 pm with a standard deviation of ±55.00 micrometers at an area scale of 2 millimeters x 2 millimeters; and a surface architecture having a mean surface density of peaks of between 1720 peaks / cm2 with a standard deviation of ±575 and 22000 peaks / cm2 with a standard deviation of ±3700 at an area scale of 2 millimeters x 2 millimeters.

[0077] Aspect 23 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 20-22 to optionally include the implantable scaffold is formed from a bioresorbable material.

[0078] Aspect 24 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 20-23 to optionally include including removing the implantable scaffold after a desired amount of tissue has formed.

[0079] Aspect 25 can include subject matter such as a method of supporting an implant including: providing a scaffold formed from a biocompatible material including at least one surface including a surface architecture; wherein thescaffold is configured to include a controlled immune response; providing an implantable device; implanting the scaffold at a target site; maintaining the scaffold at the target site; implanting the implantable device proximate to scaffold; supporting the implantable device with the scaffold; and promoting tissue regeneration along the at least one surface and proximate to the implantable device.

[0080] Aspect 26 can include, or can optionally be combined with the subject matter of Aspect 25 to optionally include the scaffold includes a medical treatment; wherein the medical treatment includes one or more of a pharmaceutical, antibacterial, and antiseptic components.

[0081] Aspect 27 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 25 or 26 to optionally include applying a dosage or timing of release of the one or more of the pharmaceutical, antibacterial, and antiseptic.

[0082] Aspect 27 can include, or can optionally be combined with the subject matter of one or any combination of Aspects 25 or 26 to optionally include maintaining the implantable device in place with one or more of sutures or bioadhesives.

[0083] The above description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “aspects” or “examples.” Such aspects or example can include elements in addition to those shown or described. However, the present inventors also contemplate aspects or examples in which only those elements shown or described are provided.Moreover, the present inventors also contemplate aspects or examples using any combination or permutation of those elements shown or described (or one or more features thereof), either with respect to a particular aspects or examples (or one or more features thereof), or with respect to other Aspects (or one or more features thereof) shown or described herein.

[0084] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.

[0085] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0086] Geometric terms, such as “parallel”, “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “round” or “generally round,” a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description.

[0087] The above description is intended to be illustrative, and not restrictive. For example, the above-described aspects or examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as aspects, examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that suchembodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

CLAIMSWhat is claimed is:

1. An implantable medical device comprising: a flexible sheet including: a first surface having a first surface texture; and a second surface having a second surface texture; wherein at least one of the first surface texture or the second surface texture is configured to induce a controlled immune response and promote tissue growth response within an implantation site.

2. The implantable medical device of claim 1, wherein at least one of the first surface texture and the second surface texture is configured to promote regeneration of tissue.

3. The implantable medical device of claim 1, wherein the flexible sheet is formed from a biocompatible material.

4. The implantable medical device of claim 1, wherein the first surface texture includes a first surface roughness, a first skewness, and a first kurtosis; wherein the second surface texture different from the first surface texture, the second surface texture includes a second surface roughness, a second skewness, and a second kurtosis.

5. The implantable medical device of claim 1, wherein the flexible sheet includes a thickness fewer than 5 millimeters.

6. The implantable medical device of claim 1, wherein the flexible sheet includes at least one of a permanent, temporary, or bioresorbable implantable scaffold.

7. The implantable medical device of claim 1, wherein the flexible sheet includes at least one of rectangular, oval or circular profiles.

8. The implantable medical device of claim 1, wherein the flexible sheet is formed from a bioresorbable material.

9. The implantable medical device of claim 1, including one or more anchoring structures configured to receive sutures.

10. A medical treatment system configured to promote tissue regeneration comprising: a flexible scaffold configured to be received within an implantation site, the flexible scaffold including: a first side including a first surface architecture configured to promote tissue regeneration; a second side including a second surface architecture; and a thickness between the first side and the second side; wherein the flexible scaffold includes a construction configured to maintain a structure of the implantation site; and one or more sutures configured to couple the flexible scaffold to the implantation site.

11. The medical treatment system of claim 10, wherein the flexible scaffold includes a sheet, strip, or mold.

12. The medical treatment system of claim 10, wherein at least one of the first side or the second side includes a surface architecture including a mean surface roughness between 0.70 micrometers (pm) with a standard deviation of ± 0.40 and 17.00 pm with a standard deviation of ±3.50 micrometers at an area scale of 2 millimeters x 2 millimeters.

13. The medical treatment system of claim 10, wherein at least one of the first side or the second side includes a surface architecture having a meanskewness of between -0.10 with a standard deviation of ±0.30 and 0.20 with a standard deviation of ±0.40 an area scale of 2 millimeters x 2 millimeters.

14. The medical treatment system of claim 10, wherein at least one of the first side or the second side includes a surface architecture having a mean surface kurtosis value of between approximately -0.05 with a standard deviation of approximately ±0.50 and approximately 3.00 with a standard deviation of approximately ±3.00 at an area scale of 2 millimeters x 2 millimeters.

15. The medical treatment system of claim 10, wherein at least one of the first side or the second side includes a surface architecture having a mean maximum peak height to trough of between 10.50 pm with a standard deviation of approximately ±4.50 and approximately 126.50 pm with a standard deviation of approximately ±55.00 micrometers at an area scale of 2 millimeters x 2 millimeters.

16. The medical treatment system of claim 10, wherein at least one of the first side or the second side includes a surface architecture having a mean surface density of peaks of between 1720 peaks / cm2with a standard deviation of approximately ±575 and approximately 22000 peaks / cm2with a standard deviation of approximately ±3700 at an area scale of 2 millimeters x 2 millimeters.

17. The medical treatment system of claim 10, wherein the first surface architecture is different than the second surface architecture.

18. The medical treatment system of claim 10, wherein the second surface architecture is configured to promote tissue regeneration.

19. The medical treatment system of claim 10, wherein the flexible scaffold is configured to be removable from the implantation site.

20. A method of regenerating tissue at an implantation site, the method comprising:providing an implantable scaffold formed from a biocompatible sheet including at least one surface architecture configured to include a controlled immune response; arranging the implantable scaffold within the implantation site with the at least one surface engaged with tissue at the implantation site; and maintaining the implantable scaffold in the implantation site; wherein the at least one surface architecture promotes new tissue formation proximate to the at least one surface.

21. The method of regenerating tissue at the implantation site of claim 20, wherein the biocompatible sheet includes: a first side including the at least one surface architecture; and a second surface architecture along a second side of the implantable scaffold from the at least one first surface, the method including: arranging the implantable scaffold within the implantation site with the second surface architecture proximate to the tissue at the implantation site.

22. The method of regenerating tissue at the implantation site of claim 21, wherein at least one of the at least one surface architecture and the second surface architecture includes one or more texture characteristics having: a mean surface roughness between 0.70 micrometers (pm) with a standard deviation of ± 0.40 and 17.00 pm with a standard deviation of ±3.50 micrometers at an area scale of 2 millimeters x 2 millimeters; a mean skewness of between -0.10 with a standard deviation of ±0.30 and 0.20 with a standard deviation of ±0.40 an area scale of 2 millimeters x 2 millimeters; a mean surface kurtosis value of between -0.05 with a standard deviation of ±0.50 and 3.00 with a standard deviation of ±3.00 at an area scale of 2 millimeters x 2 millimeters; a mean maximum peak height to trough of between 10.50 pm with a standard deviation of ±4.50 and 126.50 pm with a standard deviation of ±55.00 micrometers at an area scale of 2 millimeters x 2 millimeters; anda surface architecture having a mean surface density of peaks of between 1720 peaks / cm2with a standard deviation of ±575 and 22000 peaks / cm2with a standard deviation of ±3700 at an area scale of 2 millimeters x 2 millimeters.

23. The method of regenerating tissue at the implantation site of claim 20, wherein the implantable scaffold is formed from a bioresorbable material.

24. The method of regenerating tissue at the implantation site of claim 20, including removing the implantable scaffold after a desired amount of tissue has formed.

25. A method of supporting an implant including: providing a scaffold formed from a biocompatible material including at least one surface including a surface architecture; wherein the scaffold is configured to include a controlled immune response; providing an implantable device; implanting the scaffold at a target site; maintaining the scaffold at the target site; implanting the implantable device proximate to the scaffold; supporting the implantable device with the scaffold; and promoting tissue regeneration along the at least one surface and proximate to the implantable device.

26. The method of supporting the implant of claim 25 wherein the scaffold includes a medical treatment; wherein the medical treatment includes one or more of a pharmaceutical, antibacterial, and antiseptic components.

27. The method of supporting the implant of claim 26, including applying a dosage or timing of release of the one or more of the pharmaceutical, antibacterial, and antiseptic components.

28. The method of supporting the implant of claim 25, including maintaining the implantable device in place with one or more of sutures or bioadhesives.

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