CN-115734768-B - Microstructure soft tissue graft

Abstract

A soft tissue repair graft (500) is described that includes an anti-adhesion layer (502), a structural layer, and a positioning layer. The layers may be different or integrated into one substrate. The term "layer" is used to distinguish the function of a tissue repair graft, rather than to distinguish different layers of material. The different functional layers may comprise a single plane of matter.

Inventors

• L. Blucher
• M. Milbok

Assignees

• BVW控股公司

Dates

Publication Date

20260508

Application Date

20210422

Priority Date

20200429

Claims (15)

1. 1.A soft tissue repair graft comprising: A first layer comprising a biocompatible, non-bioabsorbable polymeric mesh; a second layer comprising an antiblocking forming polymeric material; A third layer comprising a microstructured surface, wherein the microstructured surface comprises a first microstructured pattern and a second microstructured pattern, the first microstructured pattern being a hierarchical microstructure having at least a first and second micro features, wherein the second micro features are disposed about the first micro features, the second microstructured pattern having tissue engagement structures configured to invasively engage a target surface, wherein the hierarchical microstructure and the tissue engagement structures are located at different locations of the microstructured surface; Wherein the second microstructured pattern is configured to distribute a force on a contact area of the target surface when the force is applied to the soft tissue repair graft to invasively engage the second microstructured pattern, and wherein individual microfeatures of the second microstructured pattern do not apply a force greater than 0.025 kg/cm 3 when the soft tissue repair graft is detached from the target surface, wherein volume cm 3 is the volume of the microstructure, and wherein the detachment force is greater than 25 kg/cm 2 , wherein surface area cm 2 is the contact area between the soft tissue repair graft and the target surface, and Wherein the second layer is disposed about the first layer and the third layer is disposed about the second layer.
2. 2. The soft tissue repair graft of claim 1, wherein said anti-adhesion forming polymeric material comprises a bioabsorbable material and said microstructured surface comprises a non-bioabsorbable polymeric material.
3. 3. The soft tissue repair graft of claim 1, wherein said anti-adhesion forming polymeric material comprises a bioabsorbable polymeric material and said microstructured surface comprises a bioabsorbable polymeric material.
4. 4. The soft tissue repair graft of claim 1, wherein said anti-adhesion forming polymeric material comprises a non-bioabsorbable polymeric material and said microstructured surface comprises a non-bioabsorbable polymeric material.
5. 5. The soft tissue repair graft of claim 1, wherein said anti-adhesion forming polymeric material comprises a non-bioabsorbable polymeric material and said microstructured surface comprises a bioabsorbable polymeric material.
6. 6. The soft tissue repair graft of claim 1, wherein said microstructured surface comprises a first bioabsorbable polymeric material, and wherein said first microstructured pattern comprises a second bioabsorbable polymeric material, and said second microstructured pattern comprises said first bioabsorbable polymeric material.
7. 7. The soft tissue repair graft of claim 1, wherein said microstructured surface comprises a non-bioabsorbable polymeric material, and wherein said first microstructured pattern comprises a bioabsorbable polymeric material and said second microstructured pattern comprises said non-bioabsorbable polymeric material.
8. 8. The soft tissue repair graft of claim 1, wherein said third layer comprises fenestrations such that tissue growing from said target surface penetrates said third layer fenestrations and into said first layer.
9. 9. The soft tissue repair graft of claim 1, wherein said polymeric mesh comprises pores having a diameter between 0.5mm and 6 mm.
10. 10. The soft tissue repair graft of claim 1, wherein said polymeric mesh comprises warp knit filaments having a diameter between 5 microns and 100 microns.
11. 11. The soft tissue repair graft of claim 1, wherein said graft has a mass per unit area of less than 300 g/m 2 .
12. 12. The soft tissue repair graft of claim 1, wherein said first layer further comprises a first surface and a second surface, and wherein said second layer is attached to at least a portion of said first surface of said first layer and said third layer is attached to at least a portion of said second surface of said first layer.
13. 13. The soft tissue repair graft of claim 12, wherein said second layer is attached to at least a portion of said first surface of said first layer at an attachment site comprising first filaments for attaching said first layer and said second layer together, and wherein adjacent attachment sites are spaced apart by a distance between 1mm and 20 mm.
14. 14. The soft tissue repair graft of claim 13, wherein said third layer is attached to at least a portion of said second surface of said first layer at an attachment site comprising a second filament for attaching said first layer and said third layer together, and wherein adjacent attachment sites are spaced apart by a distance of between 0.1 mm and 10 mm.
15. 15. The soft tissue repair graft of claim 14, wherein said filaments are bioabsorbable.

Description

Microstructure soft tissue graft Technical Field The present invention relates generally to devices and methods in the field of soft tissue repair. More particularly, the present invention relates to a graft material for soft tissue repair comprising an anti-adhesion layer that inhibits post-operative adhesion formation and a fixation device that is suture-independent and advantageously self-adhering and distributes the anchoring forces over a large tissue area. Adhesions are fibrous bands of connective tissue formed between body tissue and organs that are not typically joined together or formed in a manner different from the normal connective tissue anatomy between body tissue and organs. Adhesive communication is often established after surgery in the abdominal or pelvic region. In some cases, adhesions may cause complications such as pain or blockage of the organ to which they are attached. Adhesive communication often begins to form shortly after surgery and may continue to develop thereafter. There is no known effective treatment to reverse adhesion formation. If adhesions lead to complications in the patient, a typical treatment is surgical removal of them. Thus, the best approach to adhesion management is to prevent adhesion formation, or limit adhesion formation. Background Although there are no known products for effectively reversing the formation of adhesions, there are various products which prevent the formation of adhesions and are commercially available. These products are not 100% effective, although their use is known to consistently reduce blocking formation. These products take many forms, such as gels and absorbable sheets, which are applied to surgical sites within the body and gradually resorb over the course of several days. In the repair of soft tissue defects, sheets, rather than gels, are often used in combination with reinforcing meshes. Typically, the sheet is attached to the mesh as a composite structure. The sheet may be formed on a mesh or attached by an adhesive. Typically, the mesh side of the composite structure faces the soft tissue defect site, such as a hernia. It is advantageous to leave a space between the mesh and the anti-adhesion layer to promote tissue ingrowth into the mesh and adhesion between the mesh and the soft tissue defect. Optimally, the mesh acts as a tissue scaffold, promoting healthy, rather than fibrotic, tissue growth between the mesh and the soft tissue defect. However, one disadvantage of current products is the need to use sutures or some similar mechanism to secure the device in place. In products such as gels that cannot be mechanically fixed to a tissue defect, a disadvantage is found in the poor ability to hold the gel at the point of interest for a fairly long period of time (such as hours, days or weeks). Thus, some products have good fixation by mechanical means, but have poor repositioning capabilities and damage to surrounding tissue, while others are repositionable, but have poor long term positioning capabilities. Thus, there is a need for a repositionable, self-adhering repair graft for placement at a location of interest that can maintain its positioning but does not require mechanical fixation. Furthermore, there is a need for a device with repositionable properties that has sufficient adhesive strength to temporarily hold the device in place relative to the tissue of a target tissue site during a surgical procedure and in the absence of a positioning agent that needs to be coagulated or solidified, otherwise will be unsupported relative to the tissue of the target tissue site. Disclosure of Invention In accordance with the present disclosure, various embodiments are described herein. In some embodiments, the positioning agent may be disposed on the soft tissue repair graft. The positioning agent may have an adhesive capability sufficient to temporarily hold the surgical soft tissue repair prosthesis in place relative to the target tissue site during the surgical procedure, which would otherwise be unsupported. In some embodiments, the mesh prosthesis may remain in a temporary position until the mesh prosthesis is permanently fixed in place relative to the target tissue location using the means for permanently fixing. In some embodiments, the means for permanently securing may include sutures, surgical staples, and the like. The positioning agent may exhibit sufficient adhesion capability when applied to a surgical soft tissue repair prosthesis to hold it in place against gravity, for example, without solidification or curing of the positioning agent during implantation. Embodiments of the present disclosure may include a permanent fixative disposed on the soft tissue repair graft. In some embodiments, the positioning agent may function in combination with a permanent fixation agent, and together they have sufficient adhesion capability to hold the surgical soft tissue repair prosthesis in place relative to the target tissue site duri