Implantable Prosthesis With Open Cell Textured Surface and Method for Forming Same

There has been much concern in the prior art with the external surfaces of medically implantable prostheses, including breast implants. One such concern with these implantable prostheses is the natural tendency for the human body to surround an implanted foreign substance with fibrous tissue to thereby isolate them from surrounding normal tissues. This encapsulation, called capsular contracture when involving mammary prostheses, is not desirable as there is a tendency for the scar tissue or capsule to contract. Ultimately, the capsule has been found to contract to assume a nearly spherical shape thereby detracting from the desired aesthetic appearance of a human breast. Furthermore, this can cause discomfort and may require correction through a surgical procedure which is not desired.

In the prior art, some attention has been paid to this problem and one of the approaches to partially solving this problem has been to texture the external surface of these implants. Various kinds of texturing have been tried in the prior art including open cell structure texturing as disclosed in U.S. Pat. Nos. 4,889,744 and 5,007,929, the disclosures of which are incorporated herein by reference. As described therein, a method may be used as a silicone elastomer surface is formed to create an open cell structure in the external surface thereof. This method generally comprises the steps of partially curing the external surface, applying a layer of solid particles to the surface before the layer is fully cured, fully curing the layer, and then dissolving the solid particles from the surface by dipping the surface into a solvent. The solvent must be chosen so as to dissolve only the solid particles and not affect the silicone elastomer surface. One example given is crystalline sodium chloride (salt) for the particles and water as the solvent. As disclosed therein, the method requires fully curing the layer with the solid particles being intact within the layer prior to dipping the layer into the solvent. However, the inventors believe that, in actual practice, the implant is first scrubbed with a stiff brush to perforate the encapsulated salt to speed up the dissolving process.

This prior art method is successful in forming a textured surface, but the texturing is limited by the nature of the method itself. First of all, the solid particles must be on the edge of the surface, or so closely adjacent as to be touching particles which are on the edge of the surface so that the solvent may reach the particles and dissolve them. As can be appreciated, water has no affect upon an elastomer so that any particles which are not so oriented will not be reached by the water as the water does not penetrate the silicone elastomeric material. Thus, the texturing is shallow and does not penetrate to any appreciable extent the surface of the layer. Furthermore, there is no interaction between the particles and the silicone elastomer as the particles are dissolved by the solvent. This is because the silicone elastomer has been fixed in shape in the curing step and the step of dissolving the particles takes place after the curing step. Again, this tends to limit the "roughness" of the surface whose shape is determined as the elastomer is cured and prior to the dissolving step. Thus, while there is some texturing achieved with the prior art method, it is limited in depth and "roughness".

In order to improve upon this prior art method of texturing silicone elastomeric surfaces which cover medically implantable prostheses and other devices, the inventors herein have succeeded in developing a method which not only increases the depth of the texturing and the "roughness" of the texturing, it also eliminates a separate dissolving step for the solid particles. Thus, not only is the surface better "texturized", so that it should experience greater physiological compatibility by optimizing tissue ingrowth with blood vessel proliferation (vascularity), this improved method may be performed faster and at less expense in manufacturing. Briefly, the method of the present invention includes the step of first forming a silicone elastomer laminate base and then adding a layer of silicone elastomer by dipping the mandrel and laminate base layer into a silicone rubber dispersion, thereby creating a silicone elastomer top layer with a tacky surface, applying a coating of volatilizable particles to the tacky surface, and then finish curing the surface by heating it at an elevated temperature for a prescribed time period which also volatilizes the particles. Thus, the particles decompose and volatilize into constituent gases which interact with the layer of silicone elastomer as it is being cured to dramatically increase the "roughing" of the surface. The volatilizing during the curing step can be likened to a "boiling" action which is much more active than merely dissolving the particles in a solvent as in the prior art. Furthermore, particles which are completely covered with the silicone elastomer layer will still volatilize and force their way to the surface. Thus, the depth of the texturing achieved can be much greater than in the prior art method.

While the principal advantages and features of the present invention have been described above, a more complete and thorough understanding of the invention may be attained by referring to the drawings and description of the preferred embodiment which follow.

FIG. 1 is a magnified view of the surface of a breast implant shell texturized with the method of the prior art;

FIG. 2 is a magnified view of the surface of a breast implant texturized with the method of the present invention;

FIG. 3 is an enlarged cross-sectional view of the shell of the present invention having the discrete particles coated thereon;

FIG. 4 is an enlarged cross-sectional view of the shell for a breast implant which has been texturized using the method of the present invention; and

FIG. 5 is a top view of a shell for a breast implant texturized using the method of the present invention.

As shown in FIG. 1, the method of the prior art creates a textured surface which is characterized by a number of discrete particles which are randomly arranged and some of which are deformed. Thus, while there are interstices and deformations formed in the surface, they are of limited depth and are regularly shaped.

Referring to FIG. 2, a magnified view of a silicone elastomer surface which has been texturized using the method of the present invention is shown and which clearly demonstrates a textured surface having dramatically increased "roughness" as well as irregularities and depth. There is no appearance of regularity with regard to the surface and, instead, the surface gives the appearance of Swiss cheese, a sponge, or some such other surface with a large density of irregularly shaped caverns and caves extending therethrough. This dramatically roughened, textured, and porous surface provides what is believed to be a much greater opportunity for tissue ingrowth so as to dramatically improve the physiological compatibility of any implant having such a surface.

As and for their preferred embodiment, the inventors have chosen a laminate structure for the silicone elastomer surface. This laminate structure is typically used in forming a shell for a breast implant. However, the laminate surface, or other silicone elastomeric surface may be used to coat any medical device desired to be surgically implanted in order to increase its physiological compatibility. Such devices might include pacemakers, for example. As shown in FIG. 3, the laminate structure 20 includes a fluorosilicone barrier layer 22 which may be approximately 0.002 inches thick, and a polydimethylsiloxane base layer 24 approximately 0.012 inches thick. This base layer 24 may be partially cross-linked for structural integrity by curing at 150.degree. C. for approximately 30 minutes. This creates a solid, consistent base layer 24 for the subsequent texturing process thereby minimizing the possibility of potentially thin or weak spots in the finished, texturized shell.

The texturing process begins with the smooth shell laminate 20 as the laminate remains on a mandrel (not shown) as is well known in the art for manufacturing breast implant shells. The laminate 20 and mandrel is then dipped into a polydimethylsiloxane dispersion comprised of the polydimethylsiloxane along with a solvent. The shell and mandrel are then removed to drain the excess dispersion and to permit any excess solvent to volatilize or evaporate therefrom. After evaporation, the resulting laminate 20 has a thin top layer or tacky surface 25. This tacky surface 25 is then liberally coated with ammonium carbonate particles 26 in the size range of about 350 to about 800 microns in diameter. The coated mandrel/shell is then heated for final curing at a temperature of about 150.degree. C. for about 120 minutes. As ammonium carbonate decomposes at a temperature of about 60.degree. C., the solid particles decompose into their constituent gases and volatilize from within the tacky surface 25 in a "boiling" action. As shown in FIG. 4, this volatilization as the laminate 20 is cured creates a highly texturized surface 28 and as depicted in greater detail in FIG. 2 is dramatically less regular to create a truly open cell structure. After the curing step, the textured surface 28 has been formed and there are no additional steps required as in the prior art such as dipping the surface into a solvent. A finished breast implant shell 30 is shown in FIG. 5 which includes a highly texturized surface 32 which demonstrates the improved physiological compatibility of the present invention.

In prototypes formed with the method of the present invention, pore openings for breast implant shells have been formed ranging from approximately 300 to 900 microns in diameter with a pore depth ranging from approximately 250 to 900 microns. Ammonium carbonate particles which range in size from about 50 microns to about 1500 microns, with a desired target range of between about 350 to 800 microns is believed to be optimal for use in the method of the present invention.

Although ammonium carbonate has been chosen for use in the preferred embodiment, it is believed only to be necessary that the particles chosen decompose and volatilize at a temperature less than the curing temperature used for the surface being texturized. By achieving volatilization as part of the curing step, it is believed that the highly roughened, textured, surface of increased depth in the present invention is formed.

There are various changes and modifications which may be made to the invention as would be apparent to those skilled in the art. However, these changes or modifications are included in the teaching of the disclosure, and it is intended that the invention be limited only by the scope of the claims appended hereto.