IMPLANTS

FIELD OF THE INVENTION

This invention relates to devices and methods to cover medical implants for enhanced durability and wear reduction.

BACKGROUND OF THE INVENTION

The durability of bioprosthetic heart valves is unfortunately limited due to abrasion and stress on the valves. An important aspect in maximizing the durability of bioprosthetic heart valves is the reduction of areas with abrasion and stress concentrations.

Nowadays, heart valve struts are often covered with additional synthetic fabric, usually PTFE or polyester (one or more layers) to reduce abrasion-related wear from direct contact to bare metal or other hard parts. The synthetic fabric then serves as an anchor point for porcine or pericardial tissue attachment. This solution is not ideal since durability problems are only reduced and the materials used can lead to infections in the valve prosthesis.

The present invention focuses on a different technique to cover medical implants for enhanced durability and wear reduction. SUMMARY OF THE INVENTION

The present invention provides a medical implant that distinguishes a medical implant support structure, an electrospun cover layer covering at least a portion of the medical implant support structure, and an electrospun medical implant layer covering the electrospun cover layer such that the electrospun cover layer is an in-between layer in between the portion of the medical implant support structure and the electrospun medical implant layer and therewith preventing direct contact for the medical implant support structure with the electrospun medical implant layer and ensuring that the electrospun cover layer is in direct contact with the electrospun medical implant layer.

In one embodiment, the electrospun cover layer is a bioabsorbable porous electrospun cover layer. The bioabsorbable porous electrospun cover layer is capable of being absorbed and replaced by natural tissue due to ingrowth of cells and nutrient into the pores of the bioabsorbable porous electrospun cover layer. The porous electrospun cover layer has a pore size distribution of 5 to 50 micrometers.

In one embodiment, the electrospun medical implant layer is a bioabsorbable porous electrospun medical implant layer. The bioabsorbable porous electrospun medical implant layer is also capable of being absorbed and replaced by natural tissue due to ingrowth of cells and nutrient into the pores of the bioabsorbable porous electrospun medical implant layer. The porous electrospun medical implant layer has a pore size distribution of 5 to 50 micrometers.

In one example, the electrospun medical implant layer is a heart valve or leaflet.

In one example, the medical implant support structure is a metal wire support structure with posts for a heart valve. The electrospun cover layer could cover one or more posts. The electrospun cover layer could be directly electrospun onto or over the portion of the medical implant support structure. The electrospun cover layer could also be a tube and slid over the portion of the medical implant support structure. The electrospun cover layer could be stitched onto the portion of the medical implant support structure. The electrospun cover layer could also be glued to the portion of the medical implant support structure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a metallic wire (support structure) for a heart valve with three posts.

FIG. 2 shows according to the present invention the metallic wire of FIG. 1

with added, over a portion of the metallic wire, an electrospun cover layer 210. It is noted that the figure only shows a portion of the metal wire frame being covered with the electrospun cover layer for clarity purposes. The invention is not limited to embodiments where only a portion is being covered by the electrospun cover layer as the objective of the invention is to cover the metallic wire at locations of the metallic wire where abrasion is a problem. In one embodiment, only the struts/posts could be covered, where in another embodiment most if not all of the metallic wire could be covered with the electrospun cover layer/material.

FIG. 3 shows the metallic wire of FIG. 1 with electrospun cover layer 210

according to the present invention. In addition to the electrospun cover layer 210 covering the portion of the metal wire frame and according to the present invention, the covered post of the metal wire frame is further covered with electrospun layer 310 (which is shown by the additional dashed curvature over the post). It is noted that the figure only shows one post being covered with the second electrospun layer. It is further noted that each post could have such an additional electrospun layer in addition to the electrospun covered layer. In one example (not shown), the electrospun layer could be an electrospun leaflet or heart valve that is placed over the metallic wire and therewith also placed over the electrospun cover layer 210, whereby the electrospun cover layer 210 serves as the in-between layer, in between the metallic wire and the electrospun leaflet or heart valve.

DETAILED DESCRIPTION

The present invention provides a medical implant with an electrospun cover layer in between a support structure of the medial implant and an electrospun layer, whereby the electrospun cover layer is intended for enhanced durability and wear reduction. Specifically, in one embodiment, the invention provides a heart valve metallic wire structure (support structure, FIG. 1) with the electrospun cover layer (210, FIG. 2) covering at least a portion of the metallic wire structure and situated in between the heart valve metallic wire structure and an electrospun heart valve or leaflet (310, FIG. 3). For clarity reasons the electrospun heart valve or leaflet is not shown and, in this example, is only shown or represented by 310. At stated supra , the electrospun cover layer covers at least a portion of the support structure. In the example of the heart valve, would be the heart valve strut being a typical area where abrasion occurs. As a result of the electrospun cover layer over the support structure, the electrospun heart valve is then no longer in direct contact with the support structure. Instead, the electrospun heart valve is now in direct contact with the electrospun cover layer. The inventors have found that the abrasion between two electrospun layers is significantly less than the abrasion between other non-electrospun structures and the electrospun polymer according to this invention. It was therefore concluded that the electrospun cover layer helps to reduce abrasion-related wear of an electrospun leaflet or heart valve, resulting in increased durability.

More generally speaking the electrospun cover layer could be a cover layer over a metal support structure or even over a synthetic layer to the effect that the electrospun cover layer becomes the in-between layer between a (metal) support structure and an electrospun layer such as the heart valve or leaflet, or even a synthetic layer or animal-derived tissue layer positioned over the electrospun cover layer.

Support structures could be directly covered or encapsulated into layer(s) of electrospun material, in particular from bioabsorbable polymers. This would stimulate the Endogenous Tissue Restoration (ETR) process and prevent leaflet wear at the same time. The electrospun cover layer is then of porous nature which is important as it makes the electrospun cover layer bioabsorbable and therewith capable of being absorbed and replaced by natural tissue due to ingrowth of cells and nutrients into pores of the electrospun cover layer. The pore size distribution of the pores is 5 to 50 micrometers. The electrospun cover layer could therewith also referred to as bioabsorbable porous electrospun cover layer.

The design of the electrospun cover layer varies per application and could be provided as small tubes that fit over a strut/post of a metallic wire support structure for a heart valve. Since closed tubes are used they do not have any wear, abrasion or breaking points and would cover the struts in a perfect way. In addition, electrospun material is less bulky and reduces the overall size of the final device. Another design option is in sheets.

In the embodiment of a tube, electrospinning could be performed directly onto a wire instead of a bigger mandrel. This technique produces very fine tubes with a very small inner diameter.

Useful embodiments could be directly electrospun on top of the struts, sliding of the electrospun cover material, for example, tubes on top of the struts or over the struts, gluing of the material to the struts, stitching (with suture wires) of the material (e.g. sheets or tubes) directly on the struts.

The electrospun material referenced in this invention may include the ureido- pyrimidinone (UPy) quadruple hydrogen-bonding motif (pioneered by Sijbesma (1997), Science 278, 1601-1604) and a polymer backbone, for example selected from the group of biodegradable polyesters, polyurethanes, polycarbonates, poly(orthoesters), polyphosphoesters, polyanhydrides, polyphosphazenes, polyhydroxyalkanoates, polyvinylalcohol, polypropylenefumarate. Examples of polyesters are polycaprolactone, poly(L- lactide), poly(DL-lactide), poly(valerolactone), polyglycolide, polydioxanone, and their copolyesters. Examples of polycarbonates are poly(trimethylenecarbonate), poly(dimethyltrimethylenecarbonate), poly(hexamethylene carbonate).

The same result may be obtained with alternative, non-supramolecular polymers, if properties are carefully selected and material processed to ensure required surface characteristics. These polymers may comprise biodegradable or non-biodegradable polyesters, polyurethanes, polycarbonates, poly(orthoesters), polyphosphoesters, polyanhydrides, polyphosphazenes, polyhydroxyalkanoates, polyvinylalcohol, polypropylenefumarate. Examples of polyesters are polycaprolactone, poly(L-lactide), poly(DL-lactide), poly(valerolactone), polyglycolide, polydioxanone, and their copolyesters. Examples of polycarbonates are poly(trimethylenecarbonate), poly(dimethyltrimethylenecarbonate), poly(hexamethylene carbonate). Experimental Data

The inventors studied ePTFE fabric and an electrospun cover layer which are both polymeric fibrous structures, for which one would expect similar abrasive characteristics. However, and surprisingly, the inventors found that the electrospun cover layer showed significantly improved results when compared to ePTFE fabric as shown below in Table 1.

Table 1

Valves with ePTFE fabric covered frame (XSAV-158 and XSAV-159) failed very early in an Accelerated Wear Test (AWT), while valves with the electrospun cover layer covering the synthetic fabric frame (XSAV-162 and XSAV-163) are running much longer. This showed a great and unexpected increase in durability when covering the frame with electrospun cover layer.