CN-116056663-B - Microstructure soft tissue transplantation

Abstract

The present disclosure includes micropatterned fabrics, webs, textiles, and implantable devices (300), the implantable devices (300) may include one substrate having a web (302), a second substrate having a microstructured surface (304), and a fibrous layer (308) disposed therebetween. The fibrous layer includes a plurality of randomly oriented fibers. A device having a microstructured surface can include a plurality of first level micro features and a plurality of second level micro features, where the plurality of second level micro features are layered with the first level micro features. Methods of making such micropatterned fabrics, webs, textiles, and implantable devices are also disclosed.

Inventors

• L. Blucher
• M. Milbok

Assignees

• BVW控股公司

Dates

Publication Date

20260508

Application Date

20210803

Priority Date

20200804

Claims (9)

1. 1. An implantable device for repairing soft tissue, comprising: A first substrate comprising a web; a second substrate having a microstructured surface comprising a plurality of first level microfeatures and a plurality of second level microfeatures, wherein at least a portion of the plurality of second level microfeatures is layered on at least a portion of the first level microfeatures, wherein the microstructured surface is capable of generating Wenzel-Cassie adhesion to secure an implantable device to a target tissue surface, and A fibrous layer disposed between the first substrate and the second substrate, wherein the fibrous layer comprises a plurality of randomly oriented fibers, the fibrous layer having a first side and an opposing second side, a first bonding material disposed on the first side and penetrating the fibrous layer, and a second bonding material disposed on the opposing second side and penetrating the fibrous layer, the first bonding material and the second bonding material bonding the first substrate and the second substrate together via the fibrous layer, wherein the first bonding material and the second bonding material do not contact each other within the fibrous layer.
2. 2. The implantable device of claim 1, wherein the plurality of first level micro-features have a height of 10 to 1000 microns, a diameter of 10 to 1000 microns, and a center-to-center spacing of adjacent micro-features of 25 to 10000 microns.
3. 3. The implantable device of claim 1, wherein the plurality of second level micro-features have a height of 5 to 200 microns, a diameter of 5 to 200 microns, and a center-to-center spacing of 10 to 1000 microns of adjacent micro-features.
4. 4. The implantable device of claim 2, wherein the plurality of first stage microfeatures comprises a sinusoidal waveform.
5. 5. The implantable device of claim 1, wherein the microstructured surface further comprises a plurality of third level microfeatures, wherein at least a portion of the plurality of third level microfeatures are layered on at least a portion of the second level microfeatures.
6. 6. The implantable device of claim 5, wherein the plurality of third level microfeatures comprises a height of 1 to 5 microns, a diameter of 5 to 200 microns, and a center-to-center spacing of 10 to 1000 microns.
7. 7. The implantable device of claim 1, wherein the second substrate is bioabsorbable and the first substrate is non-absorbable.
8. 8. The implantable device of claim 7, wherein the mesh of the first substrate comprises polypropylene.
9. 9. The implantable device of claim 1, wherein the first bonding material penetrates the fibrous layer 10 to 60 microns from a first side and the second bonding material penetrates the fibrous layer 10 to 60 microns from an opposite second side.

Description

Microstructure soft tissue transplantation Technical Field The present invention relates generally to micropatterned fabrics, webs, textiles, and the like. More particularly, the present disclosure relates to an apparatus and method for producing a substrate having micropatterns disposed thereon, wherein the substrate is capable of producing adhesion to a target surface. Background Implantable devices for repairing soft tissue defects typically suffer from migration problems. Thus, such devices (such as prostheses) are typically sutured or stapled to tissue surrounding the defect to limit movement of the device from the target site. While the mechanical means of the suture or staple are effective in limiting movement of the device from the target location, attaching the prosthesis to healthy tissue can result in tissue trauma. The cascade effect from such trauma may lead to post-operative adhesions, which may lead to further complications and pain for the patient. The time required to position and attach the prosthesis significantly increases the time required to complete the procedure. Such prostheses typically do not have adhesive properties, and thus the prosthesis may move during the time interval between initial positioning of the prosthesis and fixation of the prosthesis to tissue. As an even further disadvantage, the lack of adhesive properties of these prostheses makes their implantation by minimally invasive surgery (such as laparoscopic surgery) particularly difficult, making them practically unusable for such surgery. There is thus a need for a soft tissue repair device that has adhesive properties, can be secured without the need for sutures or other trauma causing mechanical devices, and provides post-operative prevention of complications such as adhesions or other trauma related problems. Disclosure of Invention In certain embodiments disclosed herein, an adhesive component may be added to the soft tissue repair fabric. In some embodiments, the soft tissue repair fabric may be a surgical mesh. The adhesive component may comprise an interwoven absorbable matrix applied to the web, wherein the fibers protrude from the plane of the web. The added fibers can significantly increase the quality and rigidity of the implantable fabric. In some embodiments, implantable surgical meshes may generally rely on fibers to provide mesh strength. In certain embodiments, the fibers may also be interspersed with adhesive microstructures, which provide significant clinical advantages over composite structures. The composite soft tissue repair fabric comprises a first reinforcing component and a second non-slip component. For example, one of the composite soft tissue repair fabrics may be an adhesive microstructured sheet bonded to a standard polypropylene mesh. The sheet component is typically quite rigid and disrupts the flexible aspect of the woven mesh, making the tissue repair fabric stiffer and less flexible. Thus, there is a need for a soft tissue repair fabric that is soft, strong, and contains minimal material weight. There is also a need for a soft tissue repair fabric that self-adheres to the target tissue surface and is flexible enough to avoid creating gaps between the implantable fabric and the target tissue surface. The self-adhesive aspects of the present disclosure may be described by capillary action or may be described by establishing a Wenzel-Cassie interface between the implantable fabric and the target tissue surface. What is needed is an implant with a micro-surface texture that is capable of producing instant Wenzel-Cassie adhesion of the immobilized implant. In some embodiments, this same micro-surface texture may further promote healthy bonding of the implant to surrounding tissue. Wenzel-Cassie adhesion can occur by forming phase domains in the interface between the implant surface and the tissue surface. This type of adhesion may form an interfacial layer between the tissue and the implant. Unexpectedly, applicants have found that the formation of Wenzel-Cassie adhesion zone is stronger than the frictional interface. In some embodiments, the layered structures disclosed herein may include components having a multi-scale morphology and having large and accessible surface areas. Recent advances in nanomaterial science have made the design of layered microstructured surfaces with specific properties increasingly possible. Much of this work has focused on layered single-walled carbon nanotube membranes from aqueous dispersions by simple, fast, reproducible and inexpensive filtration methods. By varying the thickness of the random network of carbon nanotubes, their wettability can be accommodated due to capillary phenomena in the porous membrane. In some embodiments, the layered microstructured surface may be a surface microstructure comprising high surface energy regions juxtaposed with lower surface energy regions. These high and low surface energy regions need not be stacked, but rather a