fibrillated mesh for medical implants and medical implants including such mesh

Abstract

The present invention provides a fibrillated mesh (100) for a medical implant (300) including at least one medical support structure (200), the fibrillated mesh (100) being configured to at least partially cover the medical support structure (200) to facilitate integration of the medical implant (300) with the patient's autologous tissue (T) and promote tissue formation. The present invention also provides a medical implant (300) including at least one fibrillated mesh (100) as defined above and at least one medical support structure.

Description

[0001] This invention belongs to the technical field of medical devices, implants, and techniques for providing structural support and facilitating tissue formation in a patient's bodily lumen.

[0002] Medical implants can be used in minimally invasive endovascular surgery.

[0003] As a non-limiting example, such medical implants may include medical support structures such as stents, absorbable stents, intravascular grafts, stent grafts, covered stents, transcatheter aortic valve implants (TAVI), left atrial appendage occlusion (LAAC), or right atrial appendage occlusion devices.

[0004] When performing minimally invasive endovascular surgery, especially when treating calcified lesions, complications may occur due to poor attachment of medical support structures (e.g., grafts, stents, absorbable stents, or valves), which may result in cavities on the surface of body cavities.

[0005] This could cause blood to leak around the medical implant instead of flowing through it.

[0006] Specifically, poor attachment of medical support structures can lead to complications such as endoleak, perivalvular regurgitation, and / or device leakage.

[0007] Endoleak refers to the continuous flow of blood into the aortic sac during treatment of aortic aneurysms, such as after the placement of an intravascular graft.

[0008] Specifically, endoleaks may occur due to incomplete sealing or adhesion of medical support structures, such as intravascular grafts, to the vessel wall.

[0009] Endoleaks are classified into different types, particularly types I to V, such as Figure 1 It is shown schematically in the diagram.

[0010] The aforementioned complications mainly involve type I endoleaks, which occur when a gap appears between a medical support structure (such as an intravascular graft) and an autologous artery at the proximal (type Ia) or distal (type Ib) end of the medical implant, allowing blood to flow into the aneurysm sac through this gap.

[0011] This flow of blood to the aneurysm sac can cause continuous pressure, which can lead to the risk of the aneurysm enlarging or rupturing.

[0012] Therefore, addressing type 1 endoleaks is essential to ensure the long-term success of intravascular aneurysm repair (EVAR).

[0013] Other types of endoleaks may be associated with reflux into the aneurysm sac via collaterals (Type II), graft defects (Type III), graft porosity (Type IV), and enlarged aneurysms with no identifiable endoleaks (Type V). Figure 1 ).

[0014] Perivalvular regurgitation represents a similar complication, which is associated with transcatheter aortic valve implantation (TAVI) or other procedures involving the placement of artificial heart valves.

[0015] The risk of perivalvular regurgitation increases when calcified lesions are present, such as in the case of aortic stenosis.

[0016] Specifically, perivalvular regurgitation refers to blood leakage around the prosthetic valve, usually at the level of the valve annulus, rather than through the valve leaflets themselves.

[0017] Specifically, when calcification is involved, the autologous aortic valve may be severely calcified, making it difficult for the prosthetic valve to achieve a proper seal with the patient's own tissue.

[0018] This lack of seal can lead to perivalvular regurgitation, in which blood leaks between the prosthetic valve and the surrounding autologous tissue.

[0019] This reflux can lead to a variety of, and potentially serious, complications, including heart failure, hemodynamic instability, and / or the need for surgical intervention.

[0020] Instrument leakage may occur after occlusion of the left atrial appendage.

[0021] Left atrial appendage occlusion is becoming an increasingly common method for preventing stroke in individuals with atrial fibrillation.

[0022] However, significant leakage occurs around the instruments after this surgical procedure.

[0023] Recently, this situation has increased the likelihood of future ischemia events.

[0024] Type I endoleaks mainly occur when the distal and proximal ends of a medical support structure (such as a valve) are not fixed against the lumen of an autologous artery, leaving space for blood to flow around the valve into the aneurysm sac.

[0025] Another possibility for failure is that after the implantation of the intracavitary graft, the aneurysm neck gradually expands, causing the anchor point of the medical device to separate from the body wall, resulting in endoleak.

[0026] This can happen at the inflow and outflow paths.

[0027] Similarly, in perivalvular regurgitation, the valve is not positioned well against the aortic wall, thus leaving space for blood to flow around the valve.

[0028] This is especially likely to occur in cases of severe aortic calcification.

[0029] In addition, when the LAAC device is implanted, insufficient occlusion may cause blood to leak into the left atrial appendage, leading to further ischemic events.

[0030] The reasons for these leaks are twofold.

[0031] The first cause of these leaks is related to rough and uneven lumen surfaces (e.g., characterizing calcified lesions), which creates gaps between the medical implant and the patient's own tissue through which blood can flow.

[0032] The second reason for these leaks is related to the medical implant not being properly integrated with and thus reliably attached to the surrounding patient's own tissue.

[0033] JP7322115B2 discloses a polyurethane thermosetting shape memory polymer (SMP) foam for sealing the space around an implanted valve.

[0034] However, the SMP foam used cannot actively regenerate vascular tissue.

[0035] Instead, the foam only seals the valve, preventing blood from leaking around it.

[0036] US20220273852A1 discloses a method for treating abdominal aortic aneurysm (AAA) endoleaks using a shape memory polymer (SMP) foam device.

[0037] Here, the embolized SMPO foam expands and adheres to the aneurysm wall to prevent blood leakage around the graft.

[0038] However, similar to the above, this known solution only allows for the prevention of blood leakage, but cannot facilitate the integration of the medical implant with the patient's own tissue.

[0039] US11141273B2 discloses an occluder device for sealing the gap between a prosthetic heart valve and adjacent body tissue, the occluder device comprising a conformal body having a hollow interior, a front end and a rear end, and a port disposed at the rear end of the body and in fluid communication with the interior of the body.

[0040] A fixation feature is provided to connect an occluder device to a prosthetic heart valve and adjacent body tissue, the fixation feature being based on a fillable chamber having a delivery pre-deployment configuration and a final post-deployment configuration.

[0041] Similar to the above, this known solution can only prevent blood flow around the valve.

[0042] However, according to US11141273B2, the occlusion device is not suitable for promoting the integration of medical implants with the patient's own tissues.

[0043] EP3777770A1 discloses a solution that includes a stent, multiple leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a perivalve seal designed for sealing against surrounding tissue.

[0044] In some examples, the perivalvular seal includes a material that expands in response to contact with blood. Additionally, the perivalvular seal may include flaps or recesses that expand in response to back pressure and / or perivalvular blood return.

[0045] Similarly, this known solution only provides a sealing mechanism, rather than a solution that further facilitates the integration of the medical implant with the patient's own tissue.

[0046] US20220088273A1 discloses a medical implant for enhancing durability and reducing wear, the medical implant comprising a medical implant support structure, an electrospun capping layer covering at least a portion of the medical implant support structure, and an electrospun medical implant layer covering the electrospun capping layer. The electrospun capping layer constitutes an intermediate layer disposed between the portion of the medical implant support structure and the electrospun medical implant layer.

[0047] However, this known solution is designed to provide protection for the electrospun layer, rather than to facilitate the integration of the medical support structure with the patient's own tissue.

[0048] Therefore, there is a need for an improved solution that allows for the integration of medical implants (especially endovascular medical implants) with the surrounding patient's own tissues, thereby preventing complications such as endoleak, perivalvular regurgitation, and / or device leakage, even in cases of calcified or highly calcified lesions.

[0049] In view of the above, the object of the present invention is to provide a fibrillated mesh for medical implants, the medical implants including medical support structures such as grafts, scaffolds, absorbable scaffolds or valves, the fibrillated mesh facilitating optimized integration of the medical implant with the patient's own tissues and tissue formation, thereby preventing complications such as endoleak, perivalvular regurgitation and / or device leakage even in the case of calcified or highly calcified lesions.

[0050] Another object of the present invention is to provide a medical implant comprising at least one fibrillated mesh and at least one medical support structure as described above.

[0051] These objectives are achieved by providing the fibrillated mesh as defined in claim 1.

[0052] Therefore, a fibrillated mesh is provided for a medical implant, the medical implant including at least one medical support structure, the fibrillated mesh being configured to at least partially cover the medical support structure to facilitate integration of the medical implant with the patient's autologous tissue and promote tissue formation.

[0053] A medical implant is also provided, comprising at least one fibrillated mesh as defined above and at least one medical support structure, as described in more detail below.

[0054] This invention provides a fibrillated mesh for use in medical implants.

[0055] The medical implant includes a medical support structure.

[0056] The fibrillated mesh is configured to at least partially cover the medical support structure.

[0057] This can facilitate the integration of medical implants with the patient's own tissues and promote tissue formation.

[0058] This invention is based on the following basic concept: by providing a fibrillated mesh as defined above, the integration of medical implants with the surrounding patient's own tissues can be enhanced, thereby preventing poor adhesion, even in the case of calcified or highly calcified lesions.

[0059] Therefore, it can largely prevent complications such as endoleak, perivalvular regurgitation and / or periumbilical leakage.

[0060] Furthermore, fibrillated meshes can expose leaks to medical support structures, such as microfiber meshes, thereby triggering a natural healing response that promotes the integration of the medical implant with the surrounding patient's own tissue and facilitates tissue formation.

[0061] Suitable, fibrillated mesh can be made of interlaced fibers.

[0062] Suitable, fibrillated mesh can have a sponge-like structure.

[0063] Specifically, the sponge-like structure of the fibrillated mesh allows for efficient filling of cavities and / or adaptation to and adhesion to protrusions that may exist on the surface of the body cavity.

[0064] The presence of cavities and / or protrusions may create gaps between the medical implant and the patient's own tissue, potentially hindering the implant from adhering to the tissue.

[0065] By using sponge-like fibrillated mesh, integration of medical implants with surrounding autologous tissue is facilitated.

[0066] For example, surface cavities may originate from surface roughness and inhomogeneity characteristic of calcified lesions. Protrusions are also a common consequence of calcified damage. Advantageously, the fibrillated mesh may be absorbable.

[0067] Advantageously, the fibrillated mesh may be a fibrillated skirt.

[0068] In this context, the term "skirt" is defined as an element suitable for fully or partially covering the periphery of a medical implant.

[0069] Preferably, the fibrillated hem is an absorbable fibrillated hem.

[0070] Suitablely, the fibrillated mesh can be obtained by electrospinning.

[0071] Alternatively, the fibrillated mesh can be obtained by electrostatic spraying.

[0072] Alternatively, the fibrillated mesh can be obtained by electrostatic direct writing.

[0073] Alternatively, the fibrillated mesh can be obtained by melt electrospinning.

[0074] Alternatively, the fibrillated mesh can be obtained by 3D printing.

[0075] The techniques described above, as known in the art, allow for the easy manufacture of fibrillated mesh.

[0076] Furthermore, the technology can produce fibrillated mesh that can be easily applied to any shape, even to existing medical implants.

[0077] The present invention also provides a medical implant.

[0078] The medical implant can be implanted in a minimally invasive manner.

[0079] For example, the medical implant can be used in minimally invasive endovascular surgery.

[0080] The medical implant includes at least one fibrillated mesh as defined above.

[0081] For example, the medical implant may include a single fibrillated mesh.

[0082] Alternatively, the medical implant may include two or more fibrillated meshes. The medical implant may also include at least one medical support structure.

[0083] For example, the medical implant may include a single medical support structure.

[0084] Alternatively, the medical implant may include two or more medical support structures.

[0085] The fibrillated mesh is configured to at least partially cover the at least one medical support structure to facilitate integration of the medical implant with the patient's own tissue and promote tissue formation.

[0086] In one configuration, the at least one fibrillated mesh can be configured to completely cover the medical support structure.

[0087] In an alternative construction, the at least one fibrillated mesh may be configured to partially cover the medical support structure.

[0088] Here, the at least one fibrillated mesh can be configured to cover the proximal and / or distal ends of the medical support structure.

[0089] According to the present invention, different arrangements of the at least one fibrillated mesh and the at least one medical support structure are possible.

[0090] Specifically, the fibrillated mesh can be inserted between the medical support structure and the patient's own tissue.

[0091] Alternatively, the medical support structure can be inserted between the fibrillated mesh and the patient's own tissue.

[0092] According to another alternative, the medical support structure can be sandwiched between the first fibrillated mesh and the second fibrillated mesh.

[0093] Here, the first fibrillated mesh is placed between one side of the medical support structure and the patient's own tissue, while the second fibrillated mesh is placed on the opposite side of the medical support structure.

[0094] According to another alternative, fibrillated mesh can be interwoven with medical support structures.

[0095] Suitablely, in view of the medical implant and its use in anatomical locations, different arrangements of the at least one fibrillated mesh and the at least one medical support structure are selected on a case-by-case basis.

[0096] Medical support structures can be intravascular grafts.

[0097] Specifically, this helps prevent internal leaks, especially type I internal leaks.

[0098] Alternatively, the medical support structure may be a valve replacement, such as a pulmonary valve replacement, aortic valve replacement, mitral valve replacement, or tricuspid valve replacement.

[0099] As an alternative, the medical support structure can be a transcatheter aortic valve implant (TAVI).

[0100] Specifically, this helps prevent perivalvular regurgitation.

[0101] According to another alternative, the medical support structure can be a left atrial appendage occlusion (LAAC) device. Specifically, this facilitates the prevention of device leakage.

[0102] Alternatively, the medical support structure may be a right atrial appendage occlusion device.

[0103] According to another alternative, the medical support structure may be a scaffold, absorbable scaffold, scaffold graft, or covered scaffold.

[0104] Additionally, the medical support structure may be an occlusion device, such as a septal occlusion device or a vascular occlusion device, or an occluder, such as a ventricular septal defect (VSD) occluder, a septal occluder, a patent foramen ovale (PFO) occluder, and a left atrial appendage (LAA) occluder.

[0105] Other details and advantages of the invention will now be disclosed in conjunction with the accompanying drawings, in which: Figure 1 It is a diagram that schematically illustrates the different types of internal leakage (i.e., internal leakage type I to type V); Figure 2 This is a schematic diagram illustrating a fibrillated mesh (right side) according to an embodiment of the present invention. The fibrillated mesh can be arranged to at least partially cover a medical support structure (left side). According to an embodiment of the present invention, a medical implant includes at least one fibrillated mesh and at least one medical support structure; Figure 3 ab is a schematic diagram illustrating how to achieve inward tissue growth using the medical implant of the present invention. For simplicity, the medical support structure is omitted here. Figure 4 ab are schematic diagrams illustrating the spongy structure of the fibrillated mesh (a) filling cavities present on the surface of body cavities or (b) adapting to and adhering to protrusions in the tissue. Surface cavities and protrusions are common outcomes of calcified lesions; Figure 5 This is a schematic diagram showing details of a first construction of a medical implant according to the invention. Here, the fibrillated mesh is configured to completely cover the medical support structure; Figure 6 It is shown Figure 5 A schematic diagram of the first arrangement of the fibrillated mesh and medical support structure in the construction; Figure 7 It is shown Figure 5A schematic diagram of the second arrangement of the fibrillated mesh and medical support structure; Figure 8 It is shown Figure 5 A schematic diagram of a third arrangement of at least one fibrillated mesh and a medical support structure in the construction. Here, a first fibrillated mesh and a second fibrillated mesh are provided, thereby sandwiching the medical support structure in between; Figure 9 It is shown Figure 5 A schematic diagram of the fourth arrangement of the fibrillated mesh and medical support structure in the construction; Figure 10 This is a schematic diagram illustrating details of another construction of the medical implant according to the invention. Here, the fibrillated mesh is configured to partially cover the medical support structure. Specifically, the fibrillated mesh is shown covering the proximal and distal ends of the medical support structure; Figure 11 It is shown that... Figure 6 The layout is similar but referenced. Figure 10 The constructed view; Figure 12 It is shown that... Figure 7 The layout is similar but referenced. Figure 10 The constructed view; Figure 13 It is shown that... Figure 8 The layout is similar but referenced. Figure 10 The constructed view; Figure 14 It is shown that... Figure 9 The layout is similar but referenced. Figure 10 The constructed view.

[0106] Figure 2 A fibrillated mesh 100 according to an embodiment of the present invention is shown (right side of the figure).

[0107] The fibrillated mesh 100 is suitable for a medical implant 300, which includes at least one medical support structure 200, for example... Figure 2 The medical support structure 200 shown is on the left side of the figure.

[0108] The fibrillated mesh 100 is configured to at least partially cover the medical support structure 200.

[0109] This will facilitate the integration of the medical implant 300 with the patient's own tissue T and promote tissue formation.

[0110] In an embodiment of the present invention, the fibrillated mesh 100 is made of interlaced fibers.

[0111] Not shown, other configurations are also possible according to the present invention.

[0112] Figure 3 The diagram schematically illustrates how the fibrillated mesh 100 of the present invention promotes inward tissue growth. For simplicity, the medical support structure 200 is omitted here.

[0113] First, the fibrillated mesh 100 is arranged to at least partially cover the target portion of the patient's autologous tissue T, such as... Figure 3 As shown in (a).

[0114] Then, the tissue begins to grow naturally within the fibrillated mesh 100, as... Figure 3 As shown in b.

[0115] In this embodiment, the fibrillated mesh 100 has a sponge-like structure 10 ( Figure 2 ).

[0116] This sponge-like structure 10 can effectively fill cavities C that may exist on the surface of the body cavity, such as... Figure 4 As shown in (a).

[0117] The sponge-like structure 10 can also adapt to and adhere to protrusions B that may exist on the surface of the body cavity, such as... Figure 4 As shown in (b).

[0118] The presence of surface cavities C and / or protrusions B forming on the surface of body cavities is a common consequence of calcified lesions. For example, surface cavities C and / or protrusions B can arise due to surface inhomogeneities and roughness that characterize calcified lesions.

[0119] The spongy structure 10 allows for improved integration of the medical implant 300 with the surrounding patient autologous tissue T, thereby avoiding poor adhesion and preventing complications such as endoleaks, especially type I endoleaks, perivalvular regurgitation, and / or device perivalvular leaks.

[0120] In addition, it can enhance tissue formation.

[0121] In an embodiment of the present invention, the fibrillated mesh 100 is absorbable.

[0122] Alternatively, the fibrillated mesh 100 may be non-absorbable.

[0123] Suitablely, the fibrillated mesh 100 can be a skirt, preferably an absorbent skirt.

[0124] As mentioned, in this context, the term "skirt" is defined as an element suitable for fully or partially covering the periphery of a medical implant.

[0125] fibrillated mesh 100 can be obtained by one of the following methods: Electrospinning; Electrostatic spraying; Electrostatic direct writing; Melt electrospinning, or 3D printing.

[0126] The above-mentioned techniques are well known in the field, and therefore will not be described further for the sake of brevity.

[0127] According to an embodiment of the present invention, the medical implant 300 includes at least one fibrillated mesh 100, such as the fibrillated mesh 100 described above. Figure 2 (left side), and at least one medical support structure 200.

[0128] exist Figure 2 An exemplary medical support structure 200 (left side) for a medical implant 300 is schematically shown in the figure.

[0129] The fibrillated mesh 100 is configured to at least partially cover the at least one medical support structure 200 to facilitate the integration of the medical implant 300 with the patient's autologous tissue T and to promote tissue formation.

[0130] The medical implant 300 may include a single fibrillated mesh 100.

[0131] Alternatively, the medical implant 300 may include two or more fibrillated meshes 100.

[0132] In the described construction, the medical implant 300 includes a single medical support structure 200.

[0133] It is not shown, or, the medical implant 300 may include multiple (e.g., two) medical support structures 200.

[0134] Medical implant 300 is suitable for minimally invasive implantation. Specifically, medical implant 300 is suitable for minimally invasive endovascular surgery.

[0135] The fibrillated mesh 100 can be absorbable.

[0136] Alternatively, the fibrillated mesh 100 may be non-absorbable.

[0137] Figure 5 A first construction of a medical implant 300 according to the present invention is shown.

[0138] Here, the fibrillated mesh 100 is constructed to completely cover the medical support structure 200.

[0139] Figure 6-7 schematically shown Figure 5 The corresponding arrangement of at least one fibrillated mesh 100 and medical support structure 200 in the construction.

[0140] Specifically, such as Figure 6 As shown, the fibrillated mesh 100 can be inserted between the medical support structure 200 and the patient's autologous tissue T.

[0141] Or, such as Figure 7 As shown, the medical support structure 200 can be inserted between the fibrillated mesh 100 and the patient's autologous tissue T.

[0142] As another alternative, such as Figure 8 As shown, a first fibrillated mesh 100 and a second fibrillated mesh 100 can be provided to sandwich the medical support structure 200 in the middle.

[0143] Specifically, in this configuration, the first fibrillated mesh 100 is positioned between one side of the medical support structure 200 and the patient's autologous tissue T, while the second fibrillated mesh 100 is positioned on the opposite side of the medical support structure 200. Figure 8 ).

[0144] According to another alternative, such as Figure 9 As shown, the fibrillated mesh 100 can be interwoven with the medical support structure 200.

[0145] Suitablely, depending on the patient's surgical condition, the at least one fibrillated mesh 100 and the medical support structure 200 are arranged differently for each case. Figure 6-9 The choice between )

[0146] Figure 10 Another configuration of the medical implant 300 according to the present invention is shown.

[0147] Here, the fibrillated mesh 100 is configured to partially cover the medical support structure 200.

[0148] Specifically, the fibrillated mesh 100 can be adapted to cover the proximal and / or distal ends of the medical support structure 200.

[0149] Specifically, in the illustrated configuration, the fibrillated mesh 100 is adapted to cover the proximal and distal ends of the medical support structure 200. Figure 10 ).

[0150] Figure 11-14 schematically shown Figure 10 The corresponding arrangement of at least one fibrillated mesh 100 and medical support structure 200 in the construction.

[0151] It can be noted that, Figure 11-14 The arrangements shown are respectively basically corresponding to Figure 6-9 The only difference in the arrangement is that the original fiberized mesh 100 only partially covers the medical support structure 200.

[0152] Therefore, for the sake of brevity, the details of the previous section have been omitted. Figure 11-14 Further description of the arrangement shown. The medical support structure 200 may include a fiber mesh 20, such as Figure 2 As shown.

[0153] In the illustrated embodiment, the medical support structure 200 is an intravascular graft ( Figure 2 ).

[0154] This helps prevent internal leakage, especially type I internal leakage.

[0155] Alternatively, the medical support structure 200 may be a valve replacement, such as a pulmonary valve replacement, aortic valve replacement, mitral valve replacement, or tricuspid valve replacement (not shown).

[0156] As an alternative, the medical support structure 200 may be a transcatheter aortic valve implant (TAVI) (not shown).

[0157] This helps prevent perivalvular regurgitation.

[0158] According to another alternative, the medical support structure 200 can be a left atrial appendage occlusion (LAAC) device (not shown). This facilitates the prevention of device leakage.

[0159] Alternatively, the medical support structure 200 may be a right atrial appendage occlusion device (not shown).

[0160] According to another alternative (not shown), the medical structure 200 may also be one of a stent, absorbable stent, stent graft, or covered stent.

[0161] Additionally, the medical support structure 200 may be an occlusion device, such as a septal occlusion device or a vascular occlusion device, or an occluder, such as a ventricular septal defect (VSD) occluder, a septal occluder, a patent foramen ovale (PFO) occluder, and a left atrial appendage (LAA) occluder (not shown).

[0162] This invention provides a medical implant 300 comprising a fibrillated mesh 100 specifically designed to facilitate in-situ tissue engineering. Preferably, the medical implant 300 is absorbable in a biological environment. The medical implant 300 provides an absorbable scaffold structure that promotes cell attachment, proliferation, and differentiation at the implantation site. The fibrillated architecture of the mesh mimics the natural extracellular matrix, thereby creating an environment conducive to cell infiltration. As the implant material degrades over time, it is gradually replaced by autologous tissue, thereby supporting the integration and / or formation of functional or non-functional tissues, depending on the specific requirements of the application. This approach relies on endogenous healing mechanisms to achieve inward tissue growth that meets physiological and functional requirements.

[0163] The tissue formation process induced and promoted by the medical implant 300 of the present invention is a multi-stage approach supported by the structure and biochemical properties of the implant, which is optimized for cardiovascular tissue engineering.

[0164] Specifically, the process includes the following steps: 1. Cell Recruitment and Adhesion: After implantation of the implant 300, the fibrillated mesh 100, characterized by its high surface area and porosity, promotes the infiltration of host cells, such as endothelial cells, fibroblasts, and progenitor cells. The fibrillated mesh 100 can be functionalized with biomolecules such as peptides or growth factors to enhance cell adhesion and selectively recruit the cell types required for desired tissue formation. 2. Cell proliferation and differentiation: Adhering cells proliferate and expand along the fibrillated structure. Interconnected pores and fibrous structures guide cell migration within the mesh 100, promoting cell distribution and intercellular interactions. The physiological microenvironment can promote the differentiation of progenitor cells into cardiovascular cell types, including endothelial cells for lining and smooth muscle cells that facilitate structural integrity; 3. Extracellular matrix (ECM) production: As cells proliferate and differentiate, they produce ECM proteins, such as collagen and elastin, which gradually replace the synthetic matrix of the fibrillated mesh 100. ECM deposition enhances the strength of developing tissues and improves their integration with autologous tissues; 4. Angiogenesis and Vascular Formation: The structure of the implant 300, especially the fibrillated mesh 100, can support angiogenesis by promoting blood vessel formation within the implant, thereby ensuring the nutrient and oxygen supply to developing tissues. This feature is particularly advantageous in cardiovascular applications, where robust angiogenesis may be essential for maintaining tissue viability and function. 5. Controlled Absorbable Scaffold Absorption: The implant 300 may be formed of an absorbable material specifically engineered to degrade and / or be absorbed during and / or after tissue formation. When the implant 300 dissolves, it is replaced by autologous tissue that undergoes natural remodeling and integrates into the surrounding tissue, thereby minimizing the need for subsequent implant removal surgery and reducing foreign body reactions. 6. Functional or Non-functional Tissue Integration: The end result can be integration with surrounding tissue as either functional or non-functional, depending on the desired application. This flexibility allows the implant 300 to adapt to applications requiring support from load-bearing functional or non-functional structures, thus providing durability and the ability to withstand physiological forces over time. This tissue integration ensures implant fixation and prevents and overcomes blood leakage at the interface between the medical implant 300 and the surrounding tissue.

[0165] Figure Labels 100 fibrillated mesh 200 medical support structures 300 medical implants 10. Sponge-like structure (fibrillated mesh) 20-fiber mesh (medical support structure) T (patient's) autologous tissue C-surface cavity (tissue) B. Protruding part (tissue)

Claims

1. A fibrillated mesh (100) for a medical implant (300), the medical implant (300) including at least one medical support structure (200), the fibrillated mesh (100) being configured to at least partially cover the medical support structure (200) to facilitate integration of the medical implant (300) with a patient’s autologous tissue (T) and to promote tissue formation.

2. The fibrillated mesh (100) according to claim 1. Its features are, The fibrillated mesh (100) is made of interlaced fibers.

3. The fibrillated mesh (100) according to claim 1 or 2. Its features are, The fibrillated mesh (100) has a sponge-like structure.

4. The fibrillated mesh (100) according to any one of the preceding claims. Its features are, The fibrillated mesh (100) is absorbable.

5. The fibrillated mesh (100) according to any one of the preceding claims. Its features are, The fibrillated mesh (100) is a fibrillated skirt, preferably an absorbable fibrillated skirt.

6. The fibrillated mesh (100) according to any one of the preceding claims. Its features are, The fibrillated mesh (100) is obtained by one of the following methods: Electrospinning; Electrostatic spraying; Electrostatic direct writing; Melt electrospinning, or 3D printing.

7. A medical implant (300), comprising: At least one fibrillated mesh (100) according to claims 1 to 6, and At least one medical support structure (200).

8. The medical implant (300) according to claim 7. Its features are, The fibrillated mesh (100) is configured to completely cover the medical support structure (200).

9. The medical implant (300) according to claim 7. Its features are, The fibrillated mesh (100) is configured to partially cover the medical support structure (200). Preferably, the fibrillated mesh (100) is configured to cover the proximal and / or distal ends of the medical support structure (200).

10. The medical implant (300) according to any one of claims 7 to 9. Its features are, The fibrillated mesh (100) is inserted between the medical support structure (200) and the patient's autologous tissue (T).

11. The medical implant (300) according to any one of claims 7 to 9. Its features are, The medical support structure (200) is inserted between the fibrillated mesh (100) and the patient's autologous tissue (T).

12. The medical implant (300) according to any one of claims 7 to 9. Its features are, The medical support structure (200) is sandwiched between the following two: A first fibrillated mesh (100) is disposed on one side of the medical support structure (200) between the patient's autologous tissue (T) and... The second fibrillated mesh (100) is arranged on the opposite side of the medical support structure (200).

13. The medical implant (300) according to any one of claims 7 to 9. Its features are, The fibrillated mesh (100) is interwoven with the medical support structure (200).

14. The medical implant (300) according to any one of claims 7 to 13. Its features are, The medical support structure (200) is one of the following: Intravascular grafts; Pulmonary valve replacement material; Aortic valve replacement; Mitral valve replacement; Tricuspid valve replacement; Transcatheter aortic valve implant (TAVI); Left atrial appendage occlusion (LAAC) device; Right atrial appendage occlusion device; support; Absorbable stent; Scaffold grafts, or Covered stent; Interval sealing device; Vascular occlusion device; Catheter occluder; Ventricular septal defect (VSD) occluder; Interval plug; Patent foramen ovale (PFO) occluder, and Left atrial appendage (LAA) occluder.

15. The medical implant (300) according to any one of claims 7 to 14. Its features are, The medical implant (300) is configured for minimally invasive implantation.

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