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    • 专利摘要:
    surgically implantable prosthetic device. a surgically implantable prosthetic device, filled with fluid, encloses one or more adjusted, non-enclosed shells arranged adjacent and in graduated relation to each other. the invention relates specifically to implantable breast prostheses with a low coefficient of friction between two or more elastomeric shells that interact in an aqueous fluid environment, without the addition of a lubricating agent to the fluid.
    公开号:BR112014011002B1
    申请号:R112014011002-6
    申请日:2012-08-08
    公开日:2021-03-30
    发明作者:Robert S. Hamas；Dwight D. Back；Kevin Yacoub
    申请人:Ideal Implant Incorporated；
    IPC主号:
    专利说明:

    BACKGROUND OF THE INVENTION FIELD OF THE INVENTION
    [001] This invention refers, in general, to surgically implantable prophetic devices and, more specifically, breast prostheses. The invention relates specifically to implantable breast prostheses with a low coefficient of friction between two or more elastomeric shells that interact in an aqueous fluid environment, without the addition of a lubricating agent to the fluid. DESCRIPTION OF RELATED TECHNIQUE
    [002] It has become a practice in the field of surgery to place a prophetic implant in different areas of the body, under any of several conditions. In cases where neoplastic, pre-neoplastic or other abnormal or damaged tissue has been removed, the prophetic implant is generally used as a replacement for the removed tissue. Its goal is to restore the contour of the original body. Such an implant provides physical support for the surrounding body tissue. By filling in any gaps that are created by removing body tissue, it preserves the normal outer appearance and feeling of the body. Prophetic devices were used to enhance or enhance the appearance of body parts.
    [003] Breast prostheses have been widely used for breast augmentation and for reconstructive surgery after a mastectomy. The prostheses are available in several sizes and shapes, including drop shape, rounded, low profile and high profile. Commonly, breast prostheses are implanted through a small inframammary or periaerolar incision in a pocket dissected depth to the patient's breast tissue in front of the pectoral muscle. In certain situations, the prosthesis can be placed behind the various muscles of the chest.
    [004] Some prophetic devices used a single shell or casing, which is filled with a silicone gel, saline or other liquid, such as oil or polymer. Other prophetic breast devices contained a combination of silicone gel and saline in separate compartments or lumens. Previous silicone gel devices have tactile properties similar to normal tissue, but suffer from certain disadvantages. First, a little bit of silicone can leak through the envelope and migrate out of the implant into the tissue or into a physiologic-filled compartment adjacent to the implant. Second, the rupture of the wrapping of a silicone gel implant is difficult for a patient to detect and may require a Magnetic Resonance Imaging (MRI) examination for diagnosis.
    [005] Some prophetic breast devices used a single shell or wrapper, which is filled with a physiological solution. Prophetic devices filled with prior art physiological solution suffer from certain disadvantages and lose their proper appearance and tactile properties due to several factors. First, the saline solution moves very quickly to give the proper tactile properties. Second, the ease of displacement of the physiological solution can create a "fluid wave" in the implant, presenting an unnatural appearance of the prophetic device. Third, when the saline solution moves from an area of the implant, the lack of volume in that area can result in visible wrinkling of the shell. Fourth, the outer shell can bend, causing an area of wear (for example, bending error), leading to failure and deflation.
    [006] There are also prophetic breast devices that use a single shell or shell, in which the shell contains deflection-forming material. Deflection forming material fills at least part of the casing, while the rest of the casing is filled with a fluid, such as saline. Deflection forming material may or may not be included in the enclosure. The disadvantage of this deflection forming material of the prior art is that this material may not correspond to the single layer structure, geometry, proportions, etc. of the casing, thereby resulting in wrinkling and folding of the implant due to the uncontrolled position of the deflection forming material. In addition, some of the deflection material from the prior art can accumulate in a part of it and be felt through the shell, resulting in an unnatural sensation to the implant. As described in U.S. Patent No. 6,802,861, the position of the deflection-forming material within a breast implant can be controlled by a structure consisting of an inner shell that defines an internal fluid-containing lumen, surrounded by a outer shell that defines an outer lumen containing fluid and with one or more fitted shells, not enclosed in the outer lumen comprising the deflection forming material. This arrangement of lumens, adjusted, non-enclosed shells, inner shell and outer shell reduces the rate of fluid displacement, thereby improving tactile characteristics and reducing the "fluid wave" effect compared to devices filled with saline solution, single shell of the prior art. In addition, this adjusted, non-enclosed shell arrangement prevents wrinkling, folding and build-up with the deflection material within the implant. In addition, the outer shell is supported, it is smooth externally and does not bend by itself to create points of wear. US Patent No. 6,802,861 teaches that a physiological solution would be a suitable choice for use as the fluid, however, other fluids can be used, such as organic polymer or protein fluids. In addition, U.S. Patent No. 6,802,861 teaches that lubricating agents can be added to the physiological solution. Although organic polymers, protein fluids and added lubricating agents can provide a consistent lubrication layer between the various shells that interact within the implant, in the event of disruption, they can cause an unwanted tissue response. The saline solution is the most desirable fluid to use to fill the implant, since, in the event of rupture, the saline solution does not cause a tissue response and is safely absorbed into the body tissue. However, the saline solution may not provide a consistent lubricating layer between the various shells that interact within the implant, which may allow the shells, in some areas of the implant, to attach intermittently together and give the implant an undesirable tactile sensation. .
    [007] Typically, implantable breast prosthesis shells are formed from silicone solvent dispersions of high temperature vulcanization (HTV) or room temperature vulcanization (RTV). Aqueous fluids, as a saline solution, do not appreciably moisten the silicone surface and are viscous. In addition, a thin fluid film between two silicone surfaces can be easily displaced from an area, for example, when the shell surfaces are compressed together, as can occur when a breast implant with two or more shells is manipulated or palpated with your fingertips. The displacement of the aqueous fluid from an area between the shells removes the aqueous fluid that was providing a consistent lubrication layer in that area, allowing the two silicone surfaces in that area to interact and "stick" as described above.
    [008] Silicone surfaces can be joined together, as they have high coefficients of friction (static or kinetic), making it difficult for a silicone surface to slide while in contact with another silicone surface (ASTM D1894 standard is a means to measure the friction coefficients of plastic film and coating). "Static friction", a contraction of static friction, also a term sometimes used to describe the interaction of these surfaces and their tendency to form cohesive or adhesive bonds, which cause them to come together. This type of bond can have a chemical base (for example, hydrogen bonding, Van der Waals forces or electrostatic forces), or a mechanical base (for example, interlocking roughness), or a combination of both.
    [009] Several chemical surface modifications, applied coatings, lubricating fluids, such as organic polymers and the addition of lubricants to aqueous fluids, as a physiological solution, have been proposed to reduce the coefficient of friction and enhance how two elastomeric surfaces interact and slide one through on the other ("sliding ability"), thereby reducing the bonding and abrasion of surfaces. See, for example, U.S. Patent No. 5,736,251. Chemical modifications of the surface (for example, plasma) and application of coatings to the surface can change the surface of the silicone, changing how the two surfaces interact. Lubricating fluids, such as organic polymers and the addition of lubricants to aqueous fluids, as a physiological solution, provide a physical layer that separates the two silicone surfaces, so that the surfaces do not interact and bond directly. US Patent No. 4,731,081 describes the addition of a lubricant to the saline solution in a breast implant to increase the ability of the inner surfaces of the shell to slip when folded.
    [010] Instead of directly adding a lubricant to the fluid in a lumen to separate the surfaces between interacting silicone shells from a breast implant, a lubricant can be indirectly added to the fluid in a lumen by diffusion through the shell of a breast implant. lumen filled with adjacent gel. For example, double-shell / double-lumen breast implants are marketed, which are a combination of lumen filled with silicone gel and filled with saline. Considering an implant that has an internal lumen of silicone gel and external lumen filled with physiological solution, chemical species of lubrication can diffuse through the inner lumen shell to the outer lumen providing a lubrication layer, if contacted by the inner surface of the outer shell and / or the outer surface of the inner shell. As an additional example, a double-shell / double-lumen implant with an external lumen filled with silicone gel and an internal lumen filled with physiological solution may have chemical lubrication species that diffuse through the inner lumen shell to the internal lumen, providing a lubrication layer, if contacted by the inner surface of the inner shell.
    [011] It is an objective of the present invention to provide a surgically implantable prophetic device, filled only with saline and / or other aqueous fluids and which has the tactile sensation, appearance and other suitable characteristics found in the human breast. The present invention provides a low coefficient of friction and high sliding capacity between two or more elastomeric shells that interact in an aqueous fluid environment, without the addition of a lubricating agent to the fluid, thereby providing the implant with a tactile sensation. natural that is similar to human breast tissue.
    [012] Another objective of this invention is to provide a low coefficient of friction (for example, static and / or kinetic friction coefficient) and high sliding capacity between two or more silicone shells that interact in an aqueous fluid environment within a prophetic device with two or more shells, by applying a surface texture to at least one of the two interacting shells to maintain a sufficient amount or volume of fluid in reservoirs on the surfaces to provide a consistent lubrication layer between the two interacting shells.
    [013] Yet another objective of this invention is to provide a consistent lubricating layer of aqueous fluid between two or more shells that interact within an implant with two or more shells, to reduce or prevent the intermittent union of shells in one or more areas , thereby giving the implant a natural and more desirable tactile sensation. SUMMARY OF THE INVENTION
    [014] Briefly, according to the present invention, a surgically implantable prophetic device is provided, comprising an external clamping shell having an external surface, an internal surface, and which encloses an external lumen or compartment, in which the external lumen is able to accommodate a first fluid in it. The prophetic device further comprises an inner enclosure shell having an outer surface, an inner surface, and encloses an inner lumen or compartment, in which the inner lumen is capable of accommodating a second fluid in it. Additionally, the prophetic device has one or more adjusted, non-enclosed shells, located between the outer surface of the inner shell and the inner surface of the outer shell. The adjusted, non-enclosed shells are adjacent to each other, so that all surfaces of the adjusted, non-enclosed shells are in communication with the external fluid.
    [015] Both the outer shell and the inner shell are at least partially filled with an aqueous fluid. The fluid is able to move within the outer lumen and involve the adjusted, non-enclosed shells. A saline solution would be a suitable choice for use as the fluid. Saline solution refers to any combination of electrolytes to water; however, the invention is not limited to the use of saline solution only. Other fluids that are substantially aqueous can also be used. For example, implants of multiple shells, filled with aqueous solutions that contain water-soluble species, non-lubricants, including, among others, surfactants, antibiotics, and polymers that are contemplated, and will also benefit from the invention.
    [016] The prophetic device that uses saline solution or similar provides a safe and harmless prophetic implant. If the outer shell is ruptured or compromised in any way, the saline solution is safely absorbed into the body tissue. In addition, the patient would observe the reduction in the volume of the implant and make the diagnosis of rupture of the shell, without the need for diagnostic tests, such as an Magnetic Resonance Imaging (MRI) test.
    [017] The outer lumen and / or the inner lumen can be pre-filled before implantation or, alternatively, it can be first implanted and then filled with fluid. One or more valves can be provided for filling the outer lumen, which includes the spaces between the adjusted, non-enclosed shells, and for filling the inner lumen.
    [018] The arrangement of the lumens, the adjusted shells, not enclosed, and the internal and external shells decreases the rate of fluid displacement. This restriction of the fluid's ability to move within the outer lumen improves the tactile characteristics of the implant compared to prior art single-lumen implants filled with an aqueous fluid and reduces the "fluid wave" effect of the fluid within the implant. In addition, this adjusted, non-enclosed shell arrangement prevents wrinkling, folding or build-up of the deflection material within the implant. In addition, the outer shell is supported, has a smooth appearance on the outside and does not bend.
    [019] The implant architecture consists of a series of shells with interacting surfaces that are in an aqueous fluid environment. Starting with the inner surface of the outer shell and continuing to the outer surface of the inner shell, there will be a total of two surfaces that interact when an adjusted, non-enclosed shell is present, three surfaces that interact, when two adjusted, non-enclosed shells are present. four interacting surfaces are present, when three adjusted, non-enclosed shells are present, and so on.
    [020] According to the present invention, the surface of at least one of the interacting shells is textured to provide a low coefficient of friction, preferably less than 2, as measured by a standard method, such as ASTM D1894, and high capacity of sliding over an adjacent shell in an aqueous fluid environment, without the need for the addition of a lubricating agent. This avoids intermittent union and friction between the shells that interact in an aqueous fluid environment, without the need for the addition of a lubricating agent, thereby providing the desired tactile sensation of the implant, which is similar to natural breast tissue. Only one of the surfaces on each pair of surfaces that interact needs to be textured to benefit from this invention, although it is contemplated that both surfaces, on each pair of surfaces that interact, can be textured.
    [021] These and other advantages of the present invention will be understood from the description of the desirable achievements, considered with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS
    [022] Figure 1 is a side view in cross section of an implant, according to the present invention;
    [023] Figure 2 is a side view in cross section of an implant, according to an alternative embodiment;
    [024] Figure 3 is a schematic illustration of two adjacent surfaces to explain the sliding contact, not in accordance with this invention; and
    [025] Figures 4 and 5 are schematic illustrations of two adjacent surfaces, one of which is textured to explain the sliding contact, according to this invention. DESCRIPTION OF THE PREFERRED ACHIEVEMENTS
    [026] Referring to Figures 1 and 2, implants 10a and 10b are particularly adapted for use as a surgically implantable breast prosthesis. The implant 10a of Figure 1 includes an outer shell 12 that encloses a lumen or compartment, an inner shell 14 that encloses a lumen or compartment, and one or more fitted shells, usually not enclosed in a dome shape, for example, a first adjusted, non-enclosed shell 16a, a second adjusted, non-enclosed shell 16b, a third adjusted, non-enclosed shell 16c and a fourth adjusted, non-enclosed shell 16d. The inner shell 14 and outer shell 12 are typically sealed with silicone "segments", by means known to those skilled in the art. In a particularly desirable embodiment, with reference to the implant 10a, as directed in the drawing, the dimensions of the outer shell 12 and the inner shell 14 are defined by a diameter measurement and a projection measurement. The diameter measurement is representative of the width of the implant 10a, at its widest point, and the projection measurement is representative of the height of the implant 10a, at its highest point. In this desirable embodiment, the measurement of implant diameter 10a is greater than the projection measurement of implant 10a. Thus, implant 10a is substantially oval, elliptical or parabolic. The implant 10b of the first alternative embodiment of Figure 2 is similar in shape and function to the implant 10a, except for the differences explicitly discussed here.
    [027] With reference to Figure 1, the outer shell 12 defines an outer lumen 20 and includes an outer surface 22 and an inner surface 24. The outer shell 12 may include a valve 26 that opens up a part between an outer surface 22 and the inner surface 24 of the outer shell 12. Valve 26 can be placed along several areas of outer shell 12. (As shown in Figure 2, valve 27 is at the rear of outer shell 12.) Valves 26 and 27 allow the external lumen 20 of the external shell 12 to be filled with a fluid after the manufacture of the implant 10a, before or after the implant in a patient. The fluid is preferably a physiological solution, yet it must be understood that the term fluid can refer to other aqueous solutions. Valve 26 also allows for controlled removal of the fluid without damaging or destroying the implant 10a. Alternatively, the outer lumen 20 can be manufactured as a pre-filled and completely sealed member (not shown) and therefore does not need a valve 26 for the outer lumen 20.
    [028] The outer shell 12 is preferably constructed of a non-porous, flexible and biocompatible material, such as silicone elastomer. A preferred silicone is MED-6605, an RTV silicone curing acetoxy, manufactured by NuSil Technology, LLC. Any other silicone from which non-porous shells can be molded is also contemplated by this invention. It is understood by the person skilled in the art and by this invention that a reference to silicone includes, among others, the following classifications of silicones: RTV, HTV, liquid silicone rubbers, 1-part, 2-part, curing acetoxy, curing alkoxy, oxime curing, peroxide curing, moderate and high temperature curing, platinum catalyzed curing and tin catalyzed curing. Other elastomeric materials contemplated by this invention include, but are not limited to, silicone copolymers and biocompatible elastomers, from which non-porous shells can be shaped. The outer shell 12 has a wall of sufficient thickness to provide structural integrity to retain fluids, while achieving the desired flexibility and malleability of the implant 10a. The outer shell 12 is substantially oval in shape, with the top of the implant 10a having a convex shape, as directed in the drawing. Thus, the shape of the implant 10a is defined by the overall external shape of the outer shell 12. In an exemplary embodiment, the volume enclosed within the outer shell 12 is 575 cc. Therefore, the outer shell 12 can accommodate, say 575 cc, of volume displacement material, for example, fluid, inner shell and adjusted, non-enclosed shells. It is to be understood that the various other shell volumes 12 can be used. According to a preferred embodiment of this invention, a textured inner surface 24 of the outer shell 12 is provided.
    [029] The inner shell 14 defines an inner lumen 30, and includes an outer surface 32 and an inner surface 34. The inner shell 14 is smaller than the outer shell 12, in which the diameter measurement and / or the projection measurement are smaller than those of implant 10a. The inner shell 14 is also substantially oval in shape. In an exemplary embodiment, the enclosed volume of the inner shell 14 is 345 cc. The inner shell 14 is located within the outer lumen 20 of the outer shell 12, in a relatively central position with respect to the inner surface 24 of the outer lumen 20. Similar to the outer shell 12, the inner shell 14 may include a valve 36. The valve 36 bridges the outer surface 32 and the inner surface 34 of the inner shell 14, as well as the outer surface 22 and the inner surface 24 of the outer shell 12, or the valve bridges with a segment (not shown) that seals the inner shell and external shell. The valve 36 allows the filling of the inner lumen 30 of the inner shell 14 with the fluid after the manufacture of the implant 10a, before or after the implant in a patient. Valve 36 also allows for controlled fluid removal without damaging or destroying the implant 10a. The inner shell 14 is preferably constructed of a non-porous, flexible, biocompatible material, such as silicone elastomer. A preferred silicone is MED-6605, an RTV silicone curing acetoxy, manufactured by NuSil Technology, LLC. In addition to this elastomer, materials contemplated by this invention include, but are not limited to, any other silicone, silicone copolymers and biocompatible elastomers from which non-porous shells can be shaped.
    [030] Referring to Figure 1, once implanted, the top of implant 10a faces away from a patient's chest wall. Thus, if implant 10a is not pre-filled, it is desirable to have valve 26 for external lumen 20, located on top of implant 10a and valve 36 for internal lumen 30 located at the rear of the implant. This allows the implant 10a to be easily filled after it has been implanted in the patient. Valves 26, 36 can be located along other areas of the outer surface 22 of the outer shell 12 or the segment.
    [031] One or more adjusted, non-enclosed shells are located within the outer lumen 20 of the external shell 12. It should be appreciated that there is an ideal number of adjusted, non-enclosed shells to effectively achieve the objectives of the present invention. The ideal number of shells is based on the characteristics of the implant, for example, the patient's needs, the dimensions of the implant, the type of fluid used, etc. Each adjusted shell, not enclosed, is preferably constructed of a porous or non-porous, flexible, biocompatible material, such as silicone elastomer, having a similar construction in the form of that of the inner shell 14 or the outer shell 12. A preferred silicone is MED- 6605, an RTV silicone curing acetoxy, manufactured by NuSil Technology, LLC. In addition to this elastomer, materials contemplated by this invention include, but are not limited to, any other silicone, silicone copolymers and biocompatible elastomers from which porous and non-porous shells can be shaped. It should be understood that the adjusted shells, not enclosed, can be of varying thickness in different areas, one in relation to the other and in relation to the inner shell 14 and the outer shell 12. Desirably, the adjusted shells, not enclosed should be as thin as possible, in order to minimize any build-up within the implant 10a. In addition, the adjusted, non-enclosed shells can be porous or non-porous. Examples of porosity introduced into an adjusted, non-enclosed shell include, among others, features such as holes, cracks, flaps and any other openings in the adjusted, non-enclosed shell that allow free flow of fluid between volumes on both sides of the adjusted shell. , not cloistered. A preferred embodiment of this invention is to provide a textured inner surface in the fitted shells, not enclosed in an assembled breast prosthesis.
    [032] In the realization of Figure 1, the implant 10a includes four adjusted shells, not enclosed and, in the realization of Figure 2, the implant 10b includes only three adjusted shells, not enclosed: the first adjusted shell, not enclosed 16a, the second adjusted, non-enclosed shell 16b, the third, non-enclosed adjusted shell 16c, (and the fourth, non-enclosed shell 16d, in the case of implant 10a), although it is understood that any number of adjusted, non-enclosed shells can be used. Each fitted, non-enclosed shell 16a-16d includes an outer surface 38a-38d and an inner surface 40a-40d, respectively. Each adjusted, non-enclosed shell 16a-16d may have a perforated and / or incised part as in the case of implant 10a, thereby forming adjusted, un-enclosed shell openings 42a-42d in the adjusted, non-enclosed shells 16a-16d, respectively, that allow space for the passage of a valve from the outer shell 12 to the inner shell 14 and / or to a segment that connects the outer shell 12 to the inner shell 14. The dimensions of each adjusted, non-enclosed shell are also defined by a diameter measurement and a projection measurement. The diameter measurement is representative of the length of the adjusted shell, not enclosed at its widest point, and the projection measurement is representative of the height of the adjusted shell, not enclosed at its highest point.
    [033] If more than one adjusted, non-enclosed shell is used, as depicted in Figure 1, then the adjusted, non-enclosed shells 16a-16d are contained within each other. Thus, it is preferable that the sizes of the adjusted, non-enclosed shells 16a-16d are graduated, in which the diameter measurement, the projection measurement or both the diameter and projection measurements of each adjusted, non-enclosed shell are incrementally larger or smaller than the adjusted shells, not previously or successively enclosed, respectively. For example, in an exemplary embodiment, the measurements of uncloistered volume of the adjusted, non-enclosed shells 16a-16d are 555 cc, 515 cc, 475 cc, and 440 cc, respectively, with the adjusted, non-enclosed shells 16a-16d spaced between 0 cm and 1.0 cm from each other. The resulting graduated arrangement occupies the outer lumen 20 of the outer shell 12 with the inner shell 14 enveloped by the adjusted, non-enclosed shells 16a-16d. It should be understood that some of the fitted, non-enclosed shells 16a-16d may be the same size as the other and therefore do not necessarily incorporate a graduated arrangement. The fitted, unshielded shell openings 42a-42d are dimensioned so that the inner shell 14 does not fit through the adjusted, unshielded shell openings 42a-42d. Thus, the fourth adjusted, non-enclosed shell 16d, having the smallest volume measurement is adjacent to the outer surface 32 of the inner shell 14 and the first adjusted, non-enclosed shell 16a, having the largest volume measurement is adjacent to the inner surface 24 of the outer shell 12. The second adjusted, non-enclosed shell 16b and the third adjusted, non-enclosed shell 16c are located between the first adjusted, non-enclosed shell 16a and the fourth adjusted, non-enclosed shell 16d, according to their volume measurements. Specifically, the second adjusted, non-enclosed shell 16b is adjacent to the first adjusted, non-enclosed shell 16a and the third adjusted, non-enclosed shell 16c is adjacent to the fourth adjusted, non-enclosed shell 16d. This graduated arrangement creates a space between each of the adjusted, non-enclosed shells and a space between both the inner and outer shells and the adjusted, non-enclosed shells. Thus, a space 44 is between the first adjusted, non-enclosed shell 16a and the second adjusted, non-enclosed shell 16b, a space 46 is between the second adjusted, non-enclosed shell 16b and the third adjusted, non-enclosed shell 16c, and a space 48 is between the third adjusted, non-enclosed shell 16c and the fourth adjusted, non-enclosed shell 16d. Similarly, a space 50 is between the outer shell 12 and the first fitted, non-enclosed shell 16a and a space 52 is between the inner shell 14 and the adjusted, non-enclosed shell 16d.
    [034] Beginning with the outer surface of the outer shell, and continuing to the inner surface of the inner shell, there will be a total of two surfaces that interact when an adjusted, non-enclosed shell is present, three surfaces that interact when two adjusted shells do not. cloistered are present, four surfaces that interact when three adjusted, non-cloistered shells are present, and so on. At least one of the surfaces on each pair of interacting surfaces needs to be physically textured to provide a low coefficient of friction and high sliding ability between the pair of shells in an aqueous fluid environment, without the addition of a lubricating agent. Accordingly, according to an embodiment of the present invention, a textured outer surface is provided in one or more fitted, non-enclosed shells and a textured outer surface is provided in the inner shell in an assembled breast prosthesis.
    [035] The insertion of fluid into the outer lumen 20 of the outer shell 12 causes the fluid to fill the outer lumen 20 and also to wrap the adjusted, non-enclosed shells 16a-16d when flowing into spaces 44, 46, 48, 50, and 52. The shape, size and graduated arrangement of the adjusted, non-enclosed shells 16a-16d result in the adjusted, non-enclosed shells 16a-16d maintaining their relative positions within the outer shell 12 and preventing the adjusted, non-enclosed shells 16a-16d crinkle, bend or accumulate, which would otherwise be felt as a lump through the outer shell 12. In conjunction with the inner shell 14 filled with fluid, this combination provides implant 10a with static and kinetic characteristics (or dynamics) of natural breast tissue by supporting the outer shell to maintain volume in an area and by reducing the rate of fluid displacement in an area when the implant is manipulated or when the patient changes position. In addition, spreading, "fluid wave" and reverberation are reduced or avoided. Consequently, a reconstructed or enhanced breast with the 10a implant or alternatively realized implants will look like a natural breast and will approach the movement and sensation of the natural breast.
    [036] The textured shell surfaces of a mounted breast prosthesis, contemplated by the present invention, include a texture on one of the surfaces for each pair of surfaces that interact from a mounted breast prosthesis. The combinations of interacting surfaces contemplated by this invention include (1) an inner textured surface of the outer shell and the adjusted inner surface of the adjusted, non-enclosed shells, and (2) an outer textured surface of the adjusted, non-enclosed shells and an outer surface texture of the inner shell. A suitable method of applying this texture to the shells is to change the surface of the mandrel (or "mold") used to form the shells with an impact or abrasive medium. These surface texture aspects can be contiguous along the surface of the mandrel or different islands or other patterns distributed along the surface of the mandrel. The surface texture of the mandrel or mold is then printed on the inner surface of the silicone shell when removed from the mold. To achieve a final assembled configuration of at least one textured surface on each of the pairs of surfaces that interact, the inner surface of the inner shell, fitted, non-enclosed shells or outer shell can be textured and any particular shell could be inverted before assembly to make the textured surface the outer surface of the particular shell after assembly.
    [037] Impact medium is used in a variety of industries to perform functions, such as surface deburring and surface preparation for coating and painting. The choice of impact medium and contact medium from impact medium to the surface of an article depends on the material, geometry and size of the article. There are also variations in the size of the impact medium available and used in these industries. There are numerous types of impact medium, including, but not limited to, silica, alumina, garnet, glass beads, metal particles, nutshells, pumice, silicon carbide, plastics / polymers, zirconia and other ceramics.
    [038] The impact medium is forced to contact the surface of an article, such as a mold, thereby altering the surface characteristics (for example, the height and / or depth of texture aspects, separation distance between the aspects texture and smoothness of the texture aspects). Surface roughness is a measure of surface irregularities in a surface texture. The irregularities are the result of the manufacturing and post-processing (ie finishing) processes used to create the surface. Surface roughness Ra is defined as the arithmetic mean deviation of valleys and surface peaks, typically expressed in units of microinches or micrometers ("micra").
    [039] A currently preferred embodiment is to use an impact medium particle having the morphological aspects of an irregularly and / or non-smooth surface to texture the surface of the mold. Preferred impact medium having an irregular and / or non-smooth surface includes, among others, aluminum oxide ("alumina"), silica, silicon carbide, pumice stone, zirconium and other ceramics. The preferred mold surface is a polymer including, among others, polyoxymethylene, polytetrafluoroethylene, polyethylene, polydimethylsiloxane, polyamides and polyethylene terephthalate, although other surfaces, such as aluminum, titanium or stainless steel, are contemplated. It is also contemplated that a surface of the mold could be a polymer coating on metals, such as stainless steel, aluminum and titanium.
    [040] Referring to Figures 3, 4, and 5, friction or union of two surfaces results from the chemical interaction of the surface species or physical interaction of the interlocking roughness on the surfaces. How two surfaces interact and slide along one another is dependent on the contact area between the two surfaces, the chemical or physical properties of the surfaces and the amount or volume of aqueous fluid between the surfaces that can act as a lubricant. According to this invention, the reduction of the contact area for interaction of chemical surface species is a means to reduce the degree of chemical interaction and increase the ability to slide between surfaces. Another way is to reduce the contact area for the interaction of the physical properties of the surface, such as changing the number, shape and / or size of the surface aspects to reduce the degree of physical interaction and friction coefficient and increase the sliding capacity. between surfaces; however, a texture on the surfaces that interact may not always be beneficial, since interlocking and increased friction may occur, depending on the shape, height and / or depth of the texture aspects, separation distance between the texture aspects and the smoothness of the aspects of texture. By maintaining a sufficient amount or volume of fluid between surfaces that interact like this, it can act as a lubricant, as by using a texture on at least one of the surfaces that interact to keep enough fluid on the surface in reservoirs, is another means of decreasing the friction coefficient and increase the sliding capacity between surfaces. A sufficient amount or volume of fluid in the reservoirs between two interacting surfaces is depicted by areas 62b in Figures 4 and 5. The sufficient amount or volume of fluid in areas 62b kept on the surface in reservoirs to act as a lubricant provides a low coefficient of friction and high sliding capacity between the interacting surfaces, without the addition of any lubricating agents to the fluid.
    [041] The shells are nested in the breast implant, so that the texture transferred to the inner silicone surface by the mold surface is in contact with a relatively smooth outer silicone surface, as shown in Figures 4 and 5. For a mold of polyoxymethylene (for example, Delrin®) or polytetrafluoroethylene (for example, Teflon®), the preferred granulometry range for the alumina impact medium is about 100 to 500, and more preferably between about 200 to 400. A preferred embodiment for the surface roughness Ra in a polyoxymethylene or polytetrafluoroethylene mold forming the RTV silicone shells is about 30-150 microinches, and more preferably about 50-100 microinches. The ideal surface roughness to maintain a sufficient amount or volume of fluid between the interacting surfaces to act as a lubricant to provide a low coefficient of friction and high sliding capacity will depend on the material, grain size and grain material of the mold used to texture the mold, the specific elastomeric material formed in the mold, the thickness of the elastomeric shell and the surface chemistry of the elastomeric material.
    [042] A textured surface that interacts with a smoother surface can reduce the coefficient of friction between the two surfaces. In Figure 3, a smooth silicone surface 60 is brought into contact with a smooth silicone surface 61a. The entire surface of 61a can interact with surface 60. While, as in the case of Figures 4 and 5, only parts of the areas depicted by surface 61b can interact with surface 60. The total surface area for the interaction for surfaces 60- 61b is reduced, compared to 60-61a. Areas 62b also provide reservoirs to hold a sufficient amount or volume of fluid (for example, saline) between surfaces that interact to act as a lubricant to provide a low coefficient of friction and high ability to slide between surfaces when brought into contact. in an aqueous fluid environment. Depending on the size and relative geometries of the textured surface aspects, it can result in a greater or lesser coefficient of friction between the textured surface and the smooth surface. Therefore, the characteristics of the surface aspects on each of the interacting surfaces are important and must be appreciated to provide the desired low friction coefficient and high sliding capacity of interacting surfaces. Those skilled in the art will understand that the static and kinetic friction coefficient can be measured using a standard, such as ASTM D1894, "Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting". This method can be adapted for measurements in an aqueous environment. The static friction coefficient μ8 is defined by F8 <μ8Fn, where Fs is the frictional force between two surfaces tangential to the surface contact plane and Fn is the normal (or perpendicular) force between the two surfaces. The kinetic (or dynamic) friction coefficient μk is defined by Fk = PkFnz where Fk is the force necessary to maintain a tangential movement of the two surfaces along one another. Measurements using a pattern like this can then be used to select the surface texture for a given mold material that produces shells with a low coefficient of friction and high sliding capacity between them, thereby providing the means for production of tactile properties of the surgically implantable prophetic device that are similar to natural breast tissue. For example, both static and kinetic friction coefficients between two silicone surfaces in an aqueous fluid environment were measured based on ASTM D1894. For various combinations of interacting shell silicone surfaces (for example, smooth to smooth, textured to textured, smooth to textured), the measured static and kinetic friction coefficients varied between about 1 and 5. The static friction coefficient between two or more shells that interact in an aqueous fluid environment that produces the desired natural feel of the implant, similar to natural breast tissue, is preferably less than about 2, and the preferred kinetic friction coefficient is less than about 2. More preferably, the static and kinetic friction coefficients in an aqueous fluid environment are both less than about 1.5.
    [043] In addition to a surface that is textured, another surface contemplated by the present invention to provide a low coefficient of friction and a high sliding capacity can be a coating applied to at least one of the surfaces of a pair of surfaces that interact with a prosthesis mounted breast. Suitable coatings that bond chemically or mechanically to a surface include MED-6670, sold by NuSil Technology LLC, and Slick Sil LSR, sold by Solution Group, LLC. The coating must, in fact, be non-toxic and approved by the authorities having jurisdiction over implantable prostheses. These surface modifications can be contiguous along the shell surface or different islands distributed along the shell surface. To achieve at least one coated surface on each of the interacting surface pairs comprising the implant, a shell can have a coated surface and then the shell can be inverted.
    [044] Another surface contemplated by the present invention to provide a low coefficient of friction and a high sliding capacity can be a chemical modification of at least one of the surfaces of a pair of surfaces that interact with an assembled breast prosthesis. For example, a shell surface may be exposed to a plasma beam comprised of inert gases, such as helium or nitrogen, or reactive gases, such as oxygen, or excimer radiation. Plasma treatment or excimer irradiation of a silicone surface can create functional surface entities with improved wetting capacity and / or less frictional properties than the base silicone. Surface entities created by plasma or irradiation can also be further reacted with chemicals to alter the chemical and physical properties of the surface. To achieve at least one chemically modified surface on each of the pairs of interacting surfaces comprising the implant, a shell can have a chemically modified surface and then the shell can be inverted.
    [045] Another surface contemplated by the present invention to provide a low coefficient of friction and a high sliding capacity can be a physical modification of at least one of the surfaces of a pair of surfaces that interact with a mounted breast prosthesis when spraying the material of the shell or when printing the shell material before it is cured with a separate material that is textured.
    [046] Having therefore described our invention with the details and particularities required by the Patent Laws, what is desired to be protected by the Patent Letters is set out in the following claims.
    权利要求:
    Claims (14)
    [0001]
    1. SURGERY IMPLANTABLE PROSTHETIC DEVICE, characterized by comprising: an outer shell (12) having an outer surface (22), an inner surface (24), and enclosing a lumen (20), in which the lumen enclosed by the outer shell is able to accommodate a first fluid in it; an inner shell (14) having an outer surface (32), an inner surface (34), and enclosing a lumen (30), in which the lumen enclosed by the inner shell is able to accommodate a second fluid therein; one or more fitted shells (16a-16d), not enclosed, located between the outer surface (32) of the inner shell and the inner surface (24) of the outer shell, so that all the surfaces of the adjusted, non-enclosed shells are in communication with the first fluid, said adjusted shells, not enclosed, defining at least two pairs of interacting shell surfaces; and at least one shell surface on at least one pair of interacting shell surfaces being textured by printing to provide reservoirs (62b) on the surface to reduce the static coefficient of friction between the interacting shell surfaces to a coefficient value of static friction less than 2.
    [0002]
    2. PROSTHETIC DEVICE, according to claim 1, in which the outer shell (12), the inner shell (14), and one or more adjusted shells (16a-16d), not enclosed are made of a material selected from the group characterized by consisting of silicones, silicone copolymers or biocompatible elastomers.
    [0003]
    3. PROSTHETIC DEVICE, according to claim 1, characterized by the outer shell (12), the inner shell (14), and one or more adjusted shells (16-16d), all of which are enclosed in RTV silicone.
    [0004]
    4. PROSTHETIC DEVICE, according to claim 1, characterized in that the first fluid and the second fluid are substantially aqueous.
    [0005]
    5. PROSTHETIC DEVICE, according to claim 1, characterized by the coefficient of friction being the kinetic friction coefficient having a value less than 2.
    [0006]
    6. PROSTHETIC DEVICE, according to claim 1, wherein the surface texture of at least one shell surface on at least one pair of interacting shell surfaces is selected from the group characterized by being contiguous along the surface of the said shell, comprised of different islands distributed along the surface of said shell, and patterns distributed along the surface of said shell.
    [0007]
    7. PROSTHETIC DEVICE, according to claim 1, in which the one or more adjusted shells (16a-16d), not enclosed are characterized by comprising an inner shell, not closed, and an outer shell, not closed, wherein the innermost adjusted, non-enclosed shell is adjacent to the outer surface (32) of the inner shell (14) and the outermost adjusted, non-enclosed shell is adjacent to the inner surface (24) of the outer shell (12).
    [0008]
    8. PROSTHETIC DEVICE, according to claim 1, characterized in that each adjusted shell (16a-16d) is generally dome-shaped and has a diameter measurement and a projection measurement, and the projection measurement increases according to the diameter measurement increases.
    [0009]
    9. PROSTHETIC DEVICE, according to claim 1, characterized in that the diameter measurement of one of the adjusted shells (16a-16d), not enclosed is greater than the diameter measurement of any other adjusted shell, not enclosed.
    [0010]
    10. PROSTHETIC DEVICE, according to claim 1, characterized in that the adjusted shells (16a-16d), are not enclosed in a graduated way, based on the diameter measurement of each adjusted shell, not enclosed, in which the adjusted shell, non-enclosed shell having the smallest diameter measurement is adjacent to the outer surface (32) of the inner shell (14) and where the fitted shell, non-enclosed having the largest diameter is adjacent to the inner surface (24) of the outer shell (12).
    [0011]
    11. PROSTHETIC DEVICE, according to claim 1, characterized in that one or more adjusted shells (16a-16d), not enclosed, have one or more porosity characteristics that allow the free flow of said first fluid between volumes on both sides of the said adjusted shell, not cloistered.
    [0012]
    12. PROSTHETIC DEVICE, according to claim 1, characterized in that the surgically implantable prosthetic device is a breast implant (10a).
    [0013]
    13. PROSTHETIC DEVICE, according to claim 1, characterized by the texture of at least one shell surface on at least one pair of shell surfaces which interact to be printed on at least one shell surface by a texture of a mold.
    [0014]
    14. PROSTHETIC DEVICE, according to claim 1, in which the outer shell (12), the inner shell (14) and one or more adjusted shells (16a-16d), not enclosed are characterized by comprising a silicone elastomer; the first fluid and the second fluid are physiological solutions; the texture on at least one shell surface of at least one pair of interacting shell surfaces is printed on at least one shell surface by a texture of a mold surface, wherein the mold surface is comprised of a selected material the group consisting of polyoxymethylene and polytetrafluoroethylene; the surface texture of the mold is applied using aluminum oxide impact medium having a particle size between 100 and 500; and the texture of the mold surface has a surface roughness between 0.72 and 3.75 μm (30 and 150 microinches); the coefficient of static friction between the shells that interact is less than 2; and the coefficient of kinetic friction between the shells that interact is less than 2.
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    同族专利:
    公开号 | 公开日
    MX2014005622A|2014-09-15|
    HK1197011A1|2015-01-02|
    CN103997988A|2014-08-20|
    CA2854487C|2017-10-17|
    KR101632935B1|2016-06-23|
    US20130116784A1|2013-05-09|
    CN103997988B|2017-03-08|
    AU2012336353B2|2014-10-23|
    EP2775960B1|2021-12-22|
    BR112014011002A2|2017-06-06|
    RU2573048C1|2016-01-20|
    WO2013070290A1|2013-05-16|
    KR20140089425A|2014-07-14|
    JP2015502196A|2015-01-22|
    IN2014KN01155A|2015-10-16|
    US8556968B2|2013-10-15|
    AU2012336353A1|2014-05-22|
    EP2775960A1|2014-09-17|
    IL232327D0|2014-06-30|
    IL232327A|2019-01-31|
    RU2014123302A|2015-12-27|
    EP2775960A4|2015-07-22|
    CA2854487A1|2013-05-16|
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-11-12| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-09-29| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2021-02-09| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-03-30| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 08/08/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/292,303|2011-11-09|
    US13/292,303|US8556968B2|2011-11-09|2011-11-09|Breast implant with low coefficient of friction between internal shells in an aqueous fluid environment|
    PCT/US2012/049887|WO2013070290A1|2011-11-09|2012-08-08|Breast implant with low coefficient of friction between internal shells in an aqueous fluid environment|
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