Degradable breast prosthesis shaping net bag with heterogeneous hierarchical porous structure

Abstract

The degradable breast prosthesis shaping net bag with the heterogeneous hierarchical porous structure is composed of the large-aperture structure layer and the micro-aperture structure layer, the large-aperture structure layer and the micro-aperture structure layer are formed by combining degradable fibers in a staggered mode, the degradable breast prosthesis shaping net bag and the breast prosthesis are perfectly conformal, and the mechanical property and the tissue adhesion property needed by the net bag are provided; the two cooperate to realize the integration function of the prosthesis and the tissue, and an additional suture fixing device is not needed; the overall shape of the net bag is designed to be the hemispherical upper cover and the lower end cover edge, the process of adding the net bag and a prosthesis is simplified, the operation efficiency is improved, the net bag has excellent mechanical performance and shaping capacity, the micropore structure is beneficial to adhesion and immigration of cells, rejection reaction of a body is reduced, the incidence rate of capsular contracture is remarkably reduced, and the net bag is suitable for popularization and application. The invention has the characteristics of hierarchical porous structure design, mechanical shaping capability customization and capsule contracture prevention, and provides an innovative breast prosthesis shaping and biological performance improvement scheme for breast cancer patients.

Description

Technical Field

[0001] The invention relates to the technical field of plastic surgery and breast tissue engineering, and in particular to a degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure. Background Art

[0002] Breast cancer ranks first among female malignant tumors. Surgical removal of breast tumors is still the most effective treatment strategy, but the permanent loss of breast tissue after tumor resection seriously affects the patient's physical and mental health. As patients who have undergone breast tumor resection have increasing requirements for their quality of life and body aesthetics, more and more patients will choose breast reconstruction. At present, prosthetic implant reconstruction has become the main means of breast reconstruction after breast tumor resection due to its advantages such as simple surgery and rapid recovery. However, traditional silicone implants lack effective fixation with autologous tissue, leading to complications such as prosthesis displacement and fibrous capsule contracture. In severe cases, a second operation may even be required to remove the prosthesis, causing significant harm to the patient's physical and mental health.

[0003] To solve this problem, the method of adding breast prosthesis coating sheets to the surface of silicone prostheses is widely used in clinics to enhance the integration ability of silicone prostheses with autologous tissues. The existing breast prosthesis coating sheets in clinics are mainly titanium-coated polypropylene sheets, which have excellent mechanical properties and can provide good fixation and support for silicone prosthesis implants. However, they are relatively rigid, and patients report obvious foreign body sensations. At the same time, the coating sheets are non-degradable, and long-term presence in the patient's body is a time bomb. As alternative materials, natural biomaterials such as coating sheets of bovine pericardium and acellular dermal matrix are also often used as coating sheets to coat silicone prostheses. Although natural biomaterials have good biocompatibility and degradability, and their mechanical properties are close to those of autologous tissues, they have the potential risk of virus carrying from animal sources, and the product consistency is poor. More importantly, the existing breast prosthesis coating sheet materials are all flat designs, and they need to be folded before the prosthesis can be coated, which is prone to produce a large number of wrinkles, affecting the fit and integration effect.

[0004] In order to improve the fit of the breast prosthesis covering sheet, U.S. Patent US 2024 / 0041584A1 discloses a fixing device for a breast reconstruction implant, which folds the designed covering sheet shape in a specific path, wraps it around the prosthesis, limits the relative movement between the breast prosthesis covering sheet and the prosthesis, increases the fit of the breast prosthesis covering sheet and the prosthesis, and reduces wrinkles. However, the method of folding the breast prosthesis covering sheet using a specific path in the invention is only suitable for breast prosthesis covering sheets with weaker mechanical properties. The harder covering sheet will warp due to its greater rigidity after folding. There is also a patent (CN116211539A) that proposes to cancel the covering sheet and coat a degradable protective layer with good biocompatibility on the surface of the prosthesis body to avoid the formation of the prosthesis capsule, and at the same time fix the entire prosthesis to the patient's chest wall through a specific fixing seat. However, the surface coating gel material generally has poor mechanical properties and is difficult to form a stable tissue-gel-prosthesis interface, which can easily cause problems such as deformation of the breast and prosthesis contours and prosthesis displacement. At the same time, an additional base is still required to fix the prosthesis, which increases the complexity of the entire device. In addition, the above studies are all homogeneous sheets, and do not take into account the phenomenon that the sagging breasts due to gravity squeeze the softer silicone prosthesis, resulting in uneven force at different positions of the prosthesis sheet, which cannot produce effective prosthesis fixation and breast shaping after implantation. Summary of the invention

[0005] In order to overcome the shortcomings of the existing technology, an innovative biodegradable breast prosthesis shaping net bag with a non-homogeneous graded porous structure is proposed. Medical biodegradable polymer is used as the material, and the design is customized according to the curved surface shape of the prosthesis to achieve a curved surface fit consistent with the silicone prosthesis. Its structural design is ingenious, and the necessary mechanical support is provided by the coarse fiber and large-pore structure layer to effectively prevent wrinkles and displacement. In addition, the mesh of the large-pore structure layer is a non-homogeneous mesh. By strengthening the mesh mechanics in the area where the net bag is subjected to greater force, the squeezing of the prosthesis caused by sagging breasts is effectively alleviated, and the breast is lifted and supported. At the same time, the larger diameter and pore size also provide a stable fixed anchor point for the prosthesis installation, ultimately achieving the prosthesis fixation and breast shaping functions. The fine fiber and micro-pore structure layer promotes tissue adhesion and growth through a fine surface microstructure, enhancing tissue-prosthesis integration while facilitating tissue ingrowth and avoiding capsular contracture.

[0006] In order to achieve the above-mentioned purpose, the technical solution of the present invention is: a degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure, which is composed of at least one layer of coarse fiber, large pore structure and one layer of fine fiber, micropore structure, the two are staggered and tightly combined and perfectly conform to the breast prosthesis, respectively providing mechanical properties for fixing the breast prosthesis and biological properties for promoting tissue adhesion and avoiding capsular contracture.

[0007] The large-aperture structural layer grid of the degradable breast prosthesis shaping net bag with a non-homogeneous graded porous structure is a non-homogeneous grid, and the structure is encrypted in the area below the net bag to avoid displacement of the prosthesis and improve the mechanical support of the net bag. An elastic structure is designed in the area above the net bag that bears the weight of the prosthesis to simulate the ligament structure in a natural human breast and produce a natural shaping effect on the breast appearance.

[0008] The biodegradable breast prosthesis shaping net bag with a non-homogeneous graded porous structure consists of two parts: a hemispherical upper cover and a lower end cover edge. The shape of the upper cover is consistent with the curved surface of the prosthesis, and the lower end cover edge is distributed in an annular array along the circumference of the bottom surface of the upper cover. The number of arrays is not less than 2, and the radial length is slightly larger than the circumferential radius by 2 to 3 cm, so as to facilitate perfect wrapping of the prosthesis after folding.

[0009] The cover edges of the degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure are connected to each other by buckles, medical suture thread suturing, medical glue bonding, mechanical pressing or reagent bonding after being folded.

[0010] The large-pore structure layer of the degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure has a thickness of 0.5-1 mm and a fiber width of 0.2-0.5 mm; the micro-pore structure layer of the degradable breast prosthesis shaping net bag with a graded porous structure has a thickness of 0.01-0.2 mm and a fiber width of 0.001-0.15 mm.

[0011] The degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure is manufactured by adopting 3D printing technology, mold remolding or layer-by-layer stacking and assembly.

[0012] The hole shape of the degradable breast prosthesis shaping net bag with a non-homogeneous graded porous structure is one or more of a polygon and a curved closed figure.

[0013] The medical biodegradable materials used in the degradable breast prosthesis shaping net bag with a heterogeneous hierarchical porous structure include but are not limited to polyhydroxyalkanoate (PHA), polycaprolactone (PCL), polyglycolide (PGA), polybutylene succinate (PBS) and its copolymers, and one or more of polyvinyl alcohol (PVA), polylactic acid (PLA) and polylactic acid-glycolic acid copolymer (PLGA).

[0014] The present invention provides a degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure, which has the following beneficial effects compared with the prior art:

[0015] 1. Conformability to the curved surface of silicone prosthesis. The structure of the degradable breast prosthesis shaping net bag with a non-homogeneous graded porous structure of the present invention is consistent with the curved surface shape of the silicone prosthesis, which significantly improves the conformability of the coating sheet, effectively solves the problems of poor fit and wrinkles of traditional flat coating sheets, and avoids prosthesis slippage caused by shape mismatch;

[0016] 2. Simplified surgical installation process. The biodegradable breast prosthesis shaping net bag of the present invention has a hemispherical upper cover and a foldable flat cover edge design with a non-homogeneous graded porous structure, making the installation process of the prosthesis simple and fast. The porous structure provides multiple fixing anchor points for the prosthesis and tissue, eliminating the need for additional suturing and fixing devices, thus simplifying the surgical operation;

[0017] 3. Excellent mechanical / biological properties brought by the heterogeneous graded porous structure. The large-pore structure layer of the biodegradable breast prosthesis shaping net bag with a heterogeneous graded porous structure of the present invention has excellent mechanical properties and surface roughness, effectively supporting and fixing the prosthesis to prevent it from shifting, thereby shaping the breast. The fine pores and fiber size of the microporous structure layer are conducive to cell adhesion and tissue growth, inducing body regeneration, reducing rejection reactions, and reducing the incidence of capsular contracture;

[0018] 4. Biocompatibility and degradation characteristics. The biodegradable breast prosthesis shaping net bag with a heterogeneous graded porous structure of the present invention has good biocompatibility and degradation performance. As the new tissue grows, the net bag gradually degrades. At the same time, due to the larger wire diameter, the degradation time of the large-pore structure layer is slightly longer, which provides continuous restraint for the tissue growing along the micro-pore structure layer, effectively avoiding the formation of capsule. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a schematic structural diagram of the degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure of the present invention.

[0020] Figure 2 Schematic diagram of the manufacturing process of the degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure in Example 1.

[0021] Figure 3 This is a real-life picture of the degradable breast implant shaping net bag with a heterogeneous graded porous structure in Example 1.

[0022] Figure 4 Schematic diagram of the prosthesis covering effect of the biodegradable breast prosthesis shaping net bag with a heterogeneous graded porous structure.

[0023] Figure 5 This is a real-life picture of the degradable breast implant shaping net bag with a heterogeneous graded porous structure in Example 2.

[0024] Figure 6 These are the cell culture results of different regions of the degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure in Example 2. DETAILED DESCRIPTION

[0025] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0026] A biodegradable breast prosthesis shaping net bag with a heterogeneous graded porous structure is composed of a layer of coarse fiber, large pore structure and fine fiber, micropore structure. The two are staggered and tightly combined and perfectly conform to the breast prosthesis, respectively providing mechanical properties for fixing the breast prosthesis and biological properties for promoting tissue adhesion and avoiding capsular contracture.

[0027] The large-aperture structural layer grid of the degradable breast prosthesis shaping net bag with a non-homogeneous graded porous structure is a non-homogeneous grid, and the structure is encrypted in the area below the net bag that bears the weight of the prosthesis, thereby improving the mechanical support of the net bag, avoiding sagging and displacement of the prosthesis, and producing a shaping effect on the breast.

[0028] Embodiment 1:

[0029] The medical biodegradable material polycaprolactone (PCL) was selected as the manufacturing material of the net bag because of its good biocompatibility and degradation properties.

[0030] According to the predetermined size of the silicone prosthesis, a mesh bag model consistent with the curved surface shape of the prosthesis is designed using computer-aided design (CAD) software. The model includes a large-aperture structure layer and a micro-aperture structure layer, such as Figure 1 shown.

[0031] like Figure 2 As shown in FIG. 1 , the PCL material is printed layer by layer using 3D printing technology to form a net bag with a heterogeneous hierarchical porous structure. Figure 3 As shown, the aperture of the large aperture structure layer is designed to be 1 mm, and the aperture of the micro-aperture structure layer is designed to be 0.1 mm. The printed large aperture structure is a rectangular structure, and the small aperture structure layer is a diamond structure.

[0032] Assemble the hemispherical upper cover and lower end cover of the net bag together. Figure 4 Use medical sutures to connect the edges of the net bag to each other after folding, making sure that the connection is firm and there is no gap.

[0033] During the operation, a mesh bag is wrapped around the silicone prosthesis to achieve breast shaping by utilizing the mechanical support of its heterogeneous porous structure and the fixed anchor points formed by its large pores and tissue.

[0034] Embodiment 2:

[0035] Poly(lactic-co-glycolic acid) (PLGA) was selected as the material for making the net bag.

[0036] According to the specific shape of the silicone prosthesis, a graded porous structure mesh bag with different pore sizes is designed to adapt to the mechanical and biological needs of different areas.

[0037] The mold re-molding method is used to make the PLGA material into the large-pore structure layer of the net bag, and the freeze-drying technology is used to make the micro-pore structure layer of the net bag. Ensure that the fibers of the large-pore structure layer and the micro-pore structure layer are staggered to form a stable structure. The quality of the net bag is checked to ensure that the shape and size of the holes meet the design requirements.

[0038] Taking into account the shape and size of the prosthesis, a graded porous structure of the net bag is designed. The large-pore structure layer is made by 3D printing, with a width of 0.8mm and a thickness of 2mm. The micro-pore structure layer is made by freeze-drying the electrospun PLGA membrane, with an average pore size of 0.08mm and a thickness consistent with the large-pore structure layer. Figure 5 shown.

[0039] Bone marrow mesenchymal stem cells were further inoculated on the net bag. After five days of culture, the cell death and liveness staining was as follows: Figure 6 As shown, the results prove that the net bag has good biocompatibility and cell growth promotion.

[0040] Assemble the various parts of the net bag and glue them together using medical glue to ensure that the bonding strength meets the surgical requirements.

[0041] During surgery, the mesh bag is combined with the prosthesis to promote tissue growth and adhesion due to its graded porous structure, while preventing prosthesis displacement and capsular contracture.

[0042] Meanwhile, the contents not described in detail in this specification belong to the prior art known to those skilled in the art.

[0043] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or apparatus that includes a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or apparatus.

[0044] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure, characterized in that: It is composed of at least one layer of coarse fibers and one layer of fine fibers. The pore structure formed includes a large pore structure and a micropore structure. The two are staggered and tightly combined and perfectly conform to the breast prosthesis, providing mechanical properties for fixing the breast prosthesis and biological properties for promoting tissue adhesion and avoiding capsular contracture.

2. The degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure according to claim 1, characterized in that: The coarse fiber and large-aperture structural layer grid is a non-homogeneous grid. The structure is encrypted in the area below the net bag to support the prosthesis, and an elastic structure is arranged in the area above the net bag to simulate the human breast ligament to bear the weight of the prosthesis.

3. The degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure according to claim 1, characterized in that: It consists of two parts: a hemispherical upper cover and a lower end cover edge. The shape of the upper cover is consistent with the curved surface of the prosthesis, and the lower end cover edge is distributed in a circumferential array along the bottom surface of the upper cover. The number of arrays is not less than 2, and the radial length is slightly larger than the circumferential radius of 2 to 3 cm. It is used to perfectly wrap the prosthesis after folding.

4. The degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure according to claim 3, characterized in that: After being folded, the cover edges are connected to each other by buckles, medical suture thread suturing, medical glue bonding, mechanical pressing, or reagent bonding.

5. The degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure according to claim 1, characterized in that: The thickness of the large-pore structure layer is 0.5-1 mm, and the fiber width is 0.2-0.5 mm; the thickness of the micro-pore structure layer of the degradable breast prosthesis shaping net bag with graded porous structure is 0.01-0.2 mm, and the fiber width is 0.001-0.05 mm.

6. The degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure according to claim 1, characterized in that: It is assembled and produced using 3D printing technology, mold remodeling, freeze drying, and layer-by-layer stacking.

7. The degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure according to claim 1, characterized in that: The aperture structure is in the shape of a polygon, a curved closed figure or several of them.

8. The degradable breast prosthesis shaping net bag with a heterogeneous graded porous structure according to claim 1, characterized in that: The medical biodegradable materials used include, but are not limited to, polyhydroxyalkanoate (PHA), polycaprolactone (PCL), polyglycolide (PGA), polybutylene succinate (PBS) and copolymers thereof, and one or more of polyvinyl alcohol (PVA), polylactic acid (PLA) and polylactic-glycolic acid copolymer (PLGA).

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