Patent Application
20210093444
The present patent application is generally related to medical devices, and is more specifically related to implantable prostheses such as mammary implants and tissue expanders.
Implantable prostheses, such as breast implants, are commonly used to replace or augment body tissue. In the case of the female breast, it may become necessary to remove some or all of the mammary gland and surrounding tissue in order to treat breast cancer. This surgery typically leaves a void that may be filled with an implantable prosthesis that supports surrounding tissue and provides a normal body appearance, eliminating much of the shock and depression that often follows breast cancer surgeries. Implantable prostheses are also used for breast augmentation procedures.
Tissue expanders, another form of implantable prostheses, are implantable devices that are placed beneath the skin and then gradually inflated to stretch the overlying tissue. A common breast reconstruction technique is tissue expansion, which involves expansion of the breast skin and muscle using a temporary tissue expander. After implantation, a solution, such as saline, is periodically injected into the tissue expander to increase the volume of the expander. Between injections, the surrounding skin is permitted to stretch and grow to create the increased skin surface. The solution may also be withdrawn from the tissue expander to reduce its volume.
Implantable prostheses and tissue expanders usually include a shell made of silicone or a biocompatible polymer. Such devices are typically manufactured by dipping an appropriately sized and shaped mandrel into silicone. The mandrel may be solid or hollow. In other methodologies, a silicone solution may be sprayed onto the mandrel and allowed to cure. Hollow molds may also be used for forming the shells of implantable prostheses.
When a mandrel is used for making an implant, the process results in the formation of a shell having a mandrel opening, e.g., a circular hole, in one of its faces. After the shell has been formed, it must be removed from the mandrel. The mandrel opening is subsequently covered with a patch that seals the hole to form a fluid impervious implant shell. The completed shell can remain unfilled, be pre-filled, or intraoperatively filled through a small fill port or valve with a solution such as gel, saline, foam, or combinations of these materials.
In some instances, silicone breast implants are not completely filled with solution. This situation may result in the formation of a crater or concavity at the apex of the implant, which is commonly referred to as the ashtray effect. The ashtray effect is generally most evident when the implant is positioned atop a flat surface,
Breast implants are generally designed to be relatively soft and pliable, which make breast implants susceptible to rippling or wrinkling, One of the primary clinical complications with breast implants is rippling, which may be discernible through the skin as ripples, of which smaller framed women with larger implants are more susceptible.
Another problem that occurs with mammary implants is the formation of wrinkles along one or more edges of the implant, which is commonly referred to as scalloping. Referring to
In many instances it is desirable to create implant devices that maintain or increase the projection of implants without requiring an increase in the amount of gel or the gel/shell ratio. Increasing gel adds additional weight, and increases the tension on the shell.
Referring to
The fatigue strength of a shell and/or implant is an important characteristic for providing for a long product life. One way to increase fatigue strength is to increase shell thickness, however, this may adversely affect the natural feel of the implant as thinner shells typically feel more natural. There is a continuing need for implant shells having improved fatigue strength while maintaining normal shell thickness and a more natural feel.
The form stability or ability to maintain the shape of the implant is an important consideration. Current means to afford improved form stability are directed toward increasing the cohesiveness of the gel. Increased gel cohesiveness changes the feel of the implant to less soft, while also increasing the risk of gel fracture as there are known incidences of highly cohesive gel implants exhibiting gel fracture.
In view of the above state of the art, there remains a need for mammary implants and tissue expanders that minimize the occurrence of the ashtray effect, rippling, wrinkling, and scalloping, while providing improved projection at the apex of the shell. In addition, there remains a need for systems, devices and methods that minimize the weight of implants. There also remains a need for implants having enhanced structural integrity, improved fatigue strength, and that maintain a soft feel to the touch.
The systems, devices, and methods disclosed herein are directed to overcoming the above-identified challenges that are confronted when designing and making implantable devices having shells such as mammary implants and tissue expanders.
In one embodiment, implant shells are made by dipping or spraying a mandrel with a biocompatible, curable material such as silicone, polymers, polyurethane, silicone-polyurethane co-polymers, elastomers or combinations thereof. After application of the biocompatible, curable material to the mandrel, the curable material is allowed to cure and the cured shell is removed from the mandrel.
In one embodiment, the mandrel may be made of a variety of materials including metals, metallic alloys, one or more polymers or copolymers, ceramic materials, wood, stone, or any combination thereof. In one embodiment, the mandrel may be made of a metal such as stainless steel. In one embodiment, the mandrel may be made of stainless steel and be coated with a polymer. In one embodiment, the mandrel may be made of polymers. Metals and certain polymers are preferably used for making mandrels because they are amenable to traditional machining techniques yet hold their dimensions at high temperatures.
In one embodiment, grooves having a known geometry are formed on the mandrel. The grooves may be created using well-known techniques including machining, molding, or three-dimensional printing, and hollow molding. The grooves may extend radially between an apex and a base of the mandrel, circumferentially around the sides of the mandrel, obliquely relative to the radial and circumferential directions, or in patterns involving radial, circumferential, and/or oblique directions. The grooves themselves need not be unidirectional and may be multi-directional as in a wave pattern. Those skilled in the art may discern that the grooves may be provided in select or different regions of the shell to affect the shell properties in that region.
In one embodiment, the grooves are amenable to being filled with a biocompatible, curable material used to make implant shells, such as silicone. In one embodiment, the grooves may have concave curved surfaces (rounds and fillets) that minimize the presence of sharp edges on the mandrel. In one embodiment, when a curable material (e.g., silicone) is applied to the mandrel through known methods the grooves create ribs that are integral with the shell.
In one embodiment, the mandrel preferably has an inverse of a shape and topography of a desired mammary implant or tissue expander.
In one embodiment, at least one groove has a geometry that results in the formation of a rib having a cross section to resist bending of the shell wall, yet be amenable to manual release of the shell. As such, the grooves preferably have a depth and a shape that enhances the structural integrity of the ribs while facilitating removal of the shell from the mandrel without damaging (e.g., tearing) the shell.
In one embodiment, the ribs are provided on an inner surface of the shell that does not contact the patient. The ribs preferably act as shell stiffeners to allow the shell to better resist folding onto itself, which minimizes the likelihood of wrinkles or ripples. In one embodiment, ribs may project from the outer surface of the shell. In one embodiment, ribs may project from both the inner surface and the outer surface of the shell.
In one embodiment, a shell has a least one rib. In one embodiment, the at least one rib is a circumferential rib. In one embodiment, the shell preferably includes two or more ribs that are circumferential ribs that are located in the radius region of the shell to increase the hoop stiffness of the shell. In one embodiment, the ribs are radially extending ribs (i.e., ribs that extend from the apex to the base of the shell). In one embodiment, the ribs are oblique ribs (i.e., angled relative to the radial and circumferential directions).
In one embodiment, the ribs resist bending of the shell while not significantly affecting the external compressibility or feel of the implant. A preferred cross-section may provide bending stiffness yet be releasable from the grooves of the mandrel during manufacturing. Preferred cross-sectional rib geometries may include tapered or rounded trapezoidal, rectangular, hemispherical, or triangular shaped ribs.
In one embodiment, the one or more ribs may be provided in at least the radial region of the implant. In one embodiment, the one or more ribs may be provided in the apex and/or dome region of the shell. The one or more ribs may run in the circumferential direction, radial direction, or both radial and circumferential directions.
In one embodiment, an implant preferably includes a shell enclosure having an inside surface, an outside surface, an apex, a radius section, and a dome section located between the apex and the radius section. In one embodiment, the shell is filled with a biocompatible material including but not limited to a gel, a silicone gel, saline, water, air, a biocompatible gas (e.g., nitrogen), or combinations thereof. In one embodiment, the shell has at least one elongated section that has a greater stiffness than the adjacent sections of the shell.
In one embodiment, the at least one elongated section extends from the inside surface of the shell and has a geometry that resembles one or more of the following shapes: rectangular, triangular, tapered or rounded trapezoidal, or hemispherical.
In one embodiment, the at least one elongated section extends circumferentially, radially, and/or at an oblique angle relative to the circumferential or radial directions.
In one embodiment, the at least one elongated section may be continuous or discontinuous.
In one embodiment, the at least one elongated section may be formed from the same material as the shell.
In one embodiment, the at least one elongated section may be formed integral with the shell during shell creation (e.g., spraying, dipping, molding, stenciling, injection molding, 3D printing, etc.).
In one embodiment, the at least one elongated section may be a separate piece that is assembled to the shell (e.g., insert molding, pre-cut sheeting).
In one embodiment, the at least one elongated section may be formed from a different material than that of the adjacent sections (e.g., a different silicone or the same silicone further cross-linked).
In one embodiment, the at least one elongated section may be further cross-linked to the shell as a result of selective strip-line exposure to a radiation source.
In one embodiment, the at least one elongated section may be a composite of a second material that is embedded within the shell wall (e.g., a monofilament or multifilament structure that is either polymeric (e.g., suture material) or metallic (e.g., a thin wire).
In one embodiment, the second material may be embedded during a layering or molding process used to form the shell.
In one embodiment, the embedded second material may include a portion that is adapted to extend outside the shell wall. In one embodiment, the portion that extends outside the shell wall may be in the form of a suturing tab used for fixation or anti-rotation especially for smooth implants.
In one embodiment, the embedded second material may provide surface texture, patterns, and/or barbs that will assist in resisting implant rotation after implantation.
In one embodiment, an implantable prosthesis includes a shell having an apex, a base, a radius located between the apex and the base, and a dome extending between the apex and the radius. In one embodiment, the shell has an outer surface that is smooth and an inner surface that surrounds an interior volume of the shell. In one embodiment, a biocompatible filler material (e.g., gel) is disposed within the interior volume of the shell. In one embodiment, the shell may be filled with 100 cc 1,445 cc of biocompatible filler material. In one embodiment, at least one rib is integrally formed with the shell and projects inwardly from the inner surface of the shell and into the interior volume of the shell.
In one embodiment, the at least one rib includes a plurality of circumferential ribs that project inwardly from the inner surface of the shell. In one embodiment, the circumferential ribs are evenly spaced from one another.
In one embodiment, each circumferential rib has a constant depth relative to the inner surface of the shell. In one embodiment, each circumferential rib has a depth of about 0.015-0.50 inches.
In one embodiment, each circumferential rib may have a variable depth relative to the inner surface of the shell. In one embodiment, the depth of each rib may vary, or some of the ribs may have different depths than other ribs on the shell.
In one embodiment, each circumferential rib has a height associated therewith that increases in size sequentially between the apex and the base of the shell.
In one embodiment, each circumferential rib has height that is constant.
In one embodiment, each circumferential rib has a variable depth relative to the inner surface of the shell that decreases in size sequentially between the apex and the base of the shell.
In one embodiment, the at least one rib integrally formed with the shell includes a mesh shaped rib pattern projecting inwardly from the inner surface of the shell and into the interior volume of the shell. In one embodiment, a mesh shaped rib pattern may include a combination of at least one circumferential rib and at least one radial rib that is orthogonal to the at least one circumferential rib.
In one embodiment, the mesh shaped rib pattern includes an upper circumferential rib projecting from the inner surface of the shell and aligned with the radius of the shell, an intermediate circumferential rib spaced from the upper circumferential rib, projecting from the inner surface of the shell, and aligned with the radius of the shell, and a lower circumferential rib spaced from the intermediate circumferential rib, projecting from the inner surface of the shell, and aligned with the radius of the shell. The intermediate circumferential rib is preferably located between the upper circumferential rib and the lower circumferential rib.
In one embodiment, the mesh shaped rib pattern includes a series of radially extending ribs that are spaced from one another around the radius of the shell and that project from the inner surface of the shell. In one embodiment, each radially extending rib intersects with the upper, intermediate, and lower circumferential ribs to form a lattice structure.
In one embodiment, the mesh shaped rib pattern includes a series of upper islands located between the upper circumferential rib and the intermediate circumferential rib, whereby each upper island is surrounded by the upper circumferential rib, the lower circumferential rib, and two of the radially extending ribs.
In one embodiment, the mesh shaped rib pattern also includes a series of lower islands located between the intermediate circumferential rib and the lower circumferential rib, whereby each lower island is surrounded by the intermediate circumferential rib, the lower circumferential rib, and two of the radially extending ribs.
The rib patterns disclosed in the present patent application preferably improve form stability or the ability of an implant to maintain its shape. The rib patterns disclosed herein preferably increase strength and rigidity without increasing the shell wall thickness, thus maintaining softness while improving form stability. Increasing the coverage and depth of the ribs greatly influence the form stability. Ribs may extend radially between the implant radius and apex, and circumferentially around the sides of the implant.
In one embodiment, the at least one rib integrally formed with the shell includes a star-shaped rib projecting inwardly from the inner surface of the shell. In one embodiment, the star-shaped rib pattern is aligned with the apex of the shell.
In one embodiment, the shell includes a biocompatible polymer material (e.g., silicone, a polymer), and the biocompatible filler material may be gel, silicone gel, saline, foam, air, gas, and combinations thereof.
In one embodiment, a method of making an implantable prosthesis such as a silicone shell may include obtaining a shell having a first major surface and a second major surface, applying at least one rib to the first major surface of the shell so that the at least one rib projects from the first major surface of the shell, and configuring the shell so that the second major surface of the shell defines a convexly curved smooth outer surface of the shell and the first major surface defines a concave inner surface of the shell. The at least one rib desirably projects inwardly from the concave inner surface of the shell and into an interior volume of the shell.
In one embodiment, the obtaining the shell step may include depositing a curable shell forming material over a convexly curved surface of a mandrel and at least partially curing the curable shell forming material to form the shell. In one embodiment, during the depositing step the second major surface of the shell is in contact with the convexly curved surface of the mandrel and the first major surface of the shell faces away from the convexly curved surface of the mandrel.
In one embodiment, the applying step may include juxtaposing the mandrel with a mold having a concave recess including one or more grooves formed in the concave recess so that the first major surface of the shell opposes the one or more grooves. In one embodiment, the applying step may include introducing a curable rib forming material into the one or more grooves of the mold and aligning the convexly curved surface of the mandrel with the concave recess so that the curable rib forming material contacts the first major surface of the shell.
In one embodiment, the configuring the shell step desirably includes, after the applying step, removing the shell from the mandrel and inverting the shell so that the second major surface of the shell defines a smooth outer surface of the shell and the first major surface of the shell defines an inner surface of the shell having the at least one rib projecting inwardly from the inner surface of the shell.
In one embodiment, a mandrel for making a prosthesis implant shell includes an apex defining an upper end of the mandrel, a base defining a lower end of the mandrel, a radius that is located between the apex and the base and that defines a side region of the mandrel, and a dome located between the apex and the radius. In one embodiment, the mandrel has a convexly curved outer surface that extends from the apex to the base of the mandrel. In one embodiment, the mandrel includes at least one groove formed in the convexly curved outer surface of the mandrel.
In one embodiment, the at least one groove preferably includes a plurality of circumferential grooves formed in the convexly curved outer surface of the mandrel. In one embodiment, the circumferential grooves are evenly spaced from one another between the apex and the base of the mandrel.
In one embodiment, each circumferential groove has a constant depth relative to the convexly curved outer surface of the mandrel. In one embodiment, the constant depth of each circumferential groove is about 0.015-0.50 inches.
In one embodiment, each circumferential groove in the mandrel has a height associated therewith that increases in size sequentially between the apex and the base of the mandrel.
In one embodiment, each circumferential groove of the mandrel has height that is constant.
In one embodiment, each circumferential groove of the mandrel has a different depth relative to the convexly curved outer surface of the mandrel that decreases in size sequentially between the apex and the base of the mandrel.
In one embodiment, the at least one groove comprises a mesh shaped groove pattern formed in the convexly curved outer surface of the mandrel.
In one embodiment, the mesh shaped groove pattern in the mandrel may include an upper circumferential groove formed in the convexly curved outer surface of the mandrel and aligned with the radius of the mandrel, an intermediate circumferential groove spaced from the upper circumferential groove, formed in the convexly curved outer surface of the mandrel, and aligned with the radius of the mandrel, and a lower circumferential groove spaced from the intermediate circumferential groove, formed in the convexly curved outer surfaced of the mandrel, and aligned with the radius of the mandrel. The intermediate circumferential groove may be located between the upper circumferential groove and the lower circumferential groove.
In one embodiment, the mandrel has a series of radially extending grooves that are spaced from one another around the radius of the mandrel and that are formed in the convexly curved outer surface of the mandrel. In one embodiment, each radially extending groove intersects with the upper, intermediate, and lower circumferential grooves to form a lattice structure.
In one embodiment, the mesh shaped groove pattern of the mandrel may include a series of upper islands located between the upper circumferential groove and the intermediate circumferential groove and formed in the convexly curved outer surface of the mandrel, whereby each of the upper islands is bounded by two of the radially extending grooves.
In one embodiment, the mesh shaped groove pattern preferably includes a series of lower islands located between the intermediate circumferential rib and the lower circumferential rib and formed in the convexly curved outer surface of the mandrel, whereby each of the lower islands is bounded by two of the radially extending grooves.
In one embodiment, a mandrel for making a ribbed shell for use as a mammary implant or tissue expander preferably includes an apex at an upper end of the mandrel, a base at a lower end of the mandrel, a radius that extends around the circumference of the mandrel, and a dome having a convexly curved shape that extends between the apex and the base. In one embodiment, the mandrel desirably has a convexly curved outer surface that extends between the apex and the base.
In one embodiment, a plurality of spaced grooves is formed in the outer surface of the mandrel. In one embodiment, the grooves extend around the circumference of the mandrel. In one embodiment, the grooves are evenly spaced from one another (e.g., 0.115 inches) between the apex and the base of the mandrel. In one embodiment, the grooves may be formed by removing material from the outer surface of the mandrel. In one embodiment, the grooves may be formed by adding material to the outer surface of the mandrel, such as by using three dimensional printing techniques.
In one embodiment, each of the grooves has a constant depth. In one embodiment, the constant depth of the grooves may be between about 0.025-0.050 inches. In other embodiments, the constant depth grooves may have a depth that is less than 0.025 inches or greater than 0.050 inches. In one embodiment, each of the respective grooves has a constant depth, but a different height. The heights of the respective grooves preferably increase sequentially between the apex and the base of the mandrel.
In one embodiment, a mandrel utilized for making shells for mammary implants and tissue expanders preferably has circumferential grooves that are evenly spaced from one another, whereby each of the grooves has a constant height but a different depth. In one embodiment, the depths of the circumferential grooves become shallower or decrease sequentially between the apex and the base of the mandrel. For example, a groove closer to the apex has a greater depth than a groove further away from the apex. In one embodiment, each of the circumferential grooves has a height of about 0.025 inches. In one embodiment, the circumferential grooves are evenly spaced from one another by a distance of about 0.150 inches.
In one embodiment, a mandrel for making shells used for mammary implants and tissue expanders preferably includes a mesh shaped groove pattern formed in the outer surface of the mandrel. The mesh shaped groove pattern may be formed by removing material from the mandrel, adding material to the outer surface of the mandrel (e.g., 3D printing), or using a mold to form the mandrel. In one embodiment, the mesh shaped groove pattern preferably extends around the circumference of the mandrel (i.e., in the region of the radius of the mandrel).
In one embodiment, the mesh shaped groove pattern preferably includes an upper circumferential groove that extends around the circumference of the mandrel, an intermediate circumferential groove that extends around the circumference of the mandrel, and a lower circumferential groove that extends around the circumference of the mandrel. In one embodiment, the intermediate circumferential groove is preferably located between the upper circumferential groove and the lower circumferential groove. In one embodiment, the circumferential grooves may lie in respective planes that are parallel with one another. In one embodiment, the circumferential grooves desirably define bands that extend around the circumference of the mandrel. The bands may extend completely or partially around the circumference of the mandrel.
In one embodiment, the mesh shaped groove pattern preferably includes radial grooves that extend from the upper circumferential groove, through the intermediate circumferential groove, and to the lower circumferential groove. The radial grooves preferably extend in a radial direction that runs from the apex to the base of the mandrel. In one embodiment, the radial grooves may be vertical grooves that are evenly spaced from one another around the circumference of the mandrel. The radial grooves preferably intersect the circumferential grooves and cooperatively divide the mesh shaped groove pattern into upper islands located above the intermediate circumferential groove and lower islands located below the intermediate circumferential groove. The respective upper and lower islands preferably extend around the circumference of the mandrel. The upper and lower islands may extend partially or completely around the circumference of the mandrel. In one embodiment, the radial grooves are spaced from one another. In one embodiment, the radial grooves are spaced from one another by a distance of about 0.010-0.50 inches. In one embodiment, the radial grooves are spaced from one another by a distance of about 0.10-0.25 and more preferably about 0.17 inches.
In one embodiment, the grooves preferably have rounded or concave surfaces to avoid the presence of sharp edges, which will facilitate the removal of cured shells from the mandrel without damaging (e.g., tearing) the shells.
In one embodiment, a mandrel utilized to make a shell for a mammary implant or tissue expander preferably includes a star-shaped groove pattern formed in an apex of the mandrel. In one embodiment, the star-shaped groove pattern preferably has a center and six radially extending grooves that extend outwardly from the center. In one embodiment, a circular groove is preferably formed in the outer surface of the mandrel and surrounds the outer ends of the radially extending grooves of the star-shaped groove pattern. In one embodiment, the circular groove has a height of about 0.010-0.050 inches and more preferably about 0.025 inches, and a depth of about 0.010-0.50 inches and more preferably about 0.070 inches, which is measured from the convexly curved outer surface of the mandrel.
In one embodiment, the grooved mandrels disclosed herein are used for making shells having ribs that project inwardly from the inner walls of the shells. The mandrels may be dipped in a solution containing shell forming material, or the shell forming material may be sprayed onto the mandrels whereupon the material preferably flows into the grooves. The ribs that are formed on the shells preferably have a size, shape, orientation, and dimension that mirror the size, shape, orientation, and dimension of the grooves.
In one embodiment, any of the shells disclosed herein may also include at least one external rib that projects from an external surface of a shell. Thus, a shell may have at least one internally projecting rib and at least one externally projecting rib. When a shell is implanted in tissue, the at least one external rib preferably holds the shell in place within the tissue. In one embodiment, the at least one external rib may be a circumferential rib, a radial rib, or a rib angled between the circumferential and radial configurations. In one embodiment, the at least one external rib may include a plurality of externally projecting ribs that are spaced from one another.
In one embodiment, a three-dimensional mold may be used for stamping a layer of viscous silicone to provide structural features (e.g., ribs) on an implant shell. In one embodiment, the mandrel has a concave recess having one or more grooves formed in a concave surface thereof. In one embodiment, an implant shell is pre-formed on a mandrel (i.e., a shell precursor), whereupon the pre-formed shell has smooth outer and inner surfaces. The mandrel and pre-formed shell combination is preferably dipped into an uncured silicone gel to apply a flowable silicone gel material over the exposed surface of the pre-formed shell. In one embodiment, the mandrel may be inserted into the three-dimensional mold whereupon the flowable silicone gel extrudes into the grooves of the three-dimensional mold to form ribs made of uncured silicone gel that are adhered to the exposed surface of the shell. The mold and mandrel assembly may be placed into an oven to apply heat to the shell for curing the ribs adhered to the pre-formed shell, whereby the ribs are integrally secured to the exposed surface of the pre-formed shell. After curing the ribs, the mold and the mandrel may be removed from the oven and the shell detached from the mandrel. In one embodiment, a room temperature vulcanizing silicone (RTV) may be used, which may eliminate the need for oven curing. After the shell is removed from the mandrel, the shell may be inverted so that the ribs secured to the shell project inwardly from the inner surface of the shell and are located on the inside of the shell. After inversion, the outer surface of the shell is preferably smooth and the inner surface of the shell preferably has the ribs that are integral with the shell and that project inwardly from the inner surface of the shell.
In one embodiment, rather than using a three-dimensional stamping of a viscous fluid to form integral ribs on a shell, a silicone sheet or a semi-cured silicone sheet may be used to form the ribs on a pre-formed shell or a shell precursor. The silicone sheet or the semi-cured silicone sheet may be placed on either a male surface with ribs or a female surface with grooves and be compressed between two opposing surfaces for forming the ribs for the shell.
In one embodiment, an injection mold may include a female mold having a smooth concave surface and a male mold including a mandrel having a grooved convex surface that opposes the smooth concave surface of the female mold. In one embodiment, an injection molding process preferably includes injecting an uncured fluid material (e.g., uncured silicone) under pressure into the injection mold. The uncured fluid material is preferably forced into the grooves on the grooved convex surface of the mandrel to form ribs. Additional uncured fluid material preferably flows between the convex surface of the mandrel and the smooth concave surface of the female mold to form a shell having a wall thickness with integral ribs projecting inwardly from an inner surface of the shell. In one embodiment, after the ribs and the shell having been formed by injection molding, the mandrel and the shell/rib structure may be fully cured and removed from the mold. Additional layers of shell formed material may be deposited onto a smooth outer surface of the shell by spraying and/or dipping. Applying additional layers will desirably increase the wall thickness of the shell. Different layers may have different materials incorporated therein. The curable material is preferably fully cured to provide a cured implant shell having ribs integral with the shell, whereby the ribs are secured to an inner surface of the shell and project inwardly.
In one embodiment, an injection mold preferably includes a male mold part including a convex mandrel having a smooth surface and a female mold part including a concave surface having grooves. In one embodiment, prior to inserting the mandrel into the injection mold, an implant shell may be formed on the smooth convex surface of the mandrel. In one embodiment, with the mandrel opposing the grooved concave surface of the female mold, a rib forming material (e.g., uncured silicone) is injected under pressure in liquid form whereupon it flows into the grooves of the grooved concave surface of the female mold for forming ribs. In one embodiment, after the ribs have been injection molded onto a shell, the shell and ribs are cured so that the ribs are integral with the shell. In one embodiment, the cured shell and rib assembly is removed from the mandrel and the shell is inverted so that the ribs are disposed inside the shell and project inwardly from an inner surface of the shell.
In one embodiment, a flat stencil may be used as a two dimensional compression mold for forming one or more ribs on an implant shell. In one embodiment, the implant shell may be fully or partially cured. The shell may be inverted and applied (e.g., stretched) over a disk or plate so that the shell overlies a top surface of the disk/plate with an inner surface of the shell exposed. The disk/plate may have a top surface that is flat or curved.
In one embodiment, a stencil having grooves may be applied over the exposed inner surface of the shell for forming ribs on the shell. The stencil may be made of metal, metal with a lubricious coating, or made of a polymer such as TEFLON. In one embodiment, the stencil may be rigid or flexible.
In one embodiment, a curable rib forming material may be applied to the grooves of the stencil, whereby the curable rib forming material is not under pressure. In one embodiment, the curable rib forming material may be sprayed into the grooves of the stencil. In one embodiment, the curable rib forming material may be poured into the grooves of the stencil. In one embodiment, heat may be applied to cure the rib forming material to provide an implant shell having integral ribs projecting from the exposed inner surface. After curing, the shell may be inverted so that the ribs are located on the inside of shell and project inwardly from the inner surface of the shell wall.
In one embodiment, ribs may be formed on an implant shell using compression molding. In one embodiment, a compression mold preferably includes a female mold part having a concave surface with grooves and a male mold part including a mandrel having a smooth convex surface. In one embodiment, a rib forming material in fluid form (e.g., fluid silicone) is introduced into the mold. In one embodiment, the curable rib forming material that is introduced into the mold is not under pressure. In one embodiment, pressure may be applied by the two opposing mold parts for forming ribs integral with the shell. The shell and the ribs are preferably cured such as by using heat. The shell may be removed from the mandrel and inverted so that the ribs are inside the shell and project inwardly from an inner surface of a shell wall.
In one embodiment, a compression mold preferably includes a female mold part having a smooth concave surface and a male mold part including a mandrel having a grooved convex surface. In one embodiment, a curable material in fluid form is introduced into the mold. The curable material is not under pressure. In one embodiment, pressure may be applied by the two opposing mold parts for forming ribs integral with the shell. The shell and the ribs are preferably cured such as by using heat. After the ribs have been formed, a shell precursor may overlie the mandrel. The mandrel may be removed from the mold for applying additional layers of curable shell forming material over the shell precursor. The additional layers may be applied using spraying and/or dipping techniques. The shell may be removed from the mandrel to provide an implant shell having a smooth outer surface and an inner surface having ribs that project inwardly.
In one embodiment, a compression molding process forms ribs on a shell by positioning a sheet of rib forming material (e.g., a partially cured or fully cured silicone sheet) between two mold halves. In one embodiment, a compression mold preferably includes a female mold part having a concave surface with grooves and a male mold part including a mandrel having a smooth convex surface. In one embodiment, a fully cured or partially cured shell is provided on the mandrel. The sheeting to form the ribs is placed between the shell on the mandrel and the grooved concave surface of the female mold part. Pressure may be applied by the two opposing mold parts to compress the sheeting to form ribs that are integrally connected with the shell. The shell and the ribs may be cured using heat and pressure. The shell may be removed from the mandrel and inverted so that the ribs are located inside the shell and project inwardly from an inner surface of the shell.
In one embodiment, ribs may be formed on a shell using stamps, stencils, and embossing tools. In one embodiment, a shell is premade using any known means. The shell may be fully or partially cured. In one embodiment, the shell is inverted and applied over disk so that an inner surface of the shell is exposed over the top surface of the disk. The shell may be stretched for being applied over the disk. The shell may be secured over a peripheral edge of the disk for holding the shell in the stretched configuration. In one embodiment, the top surface of the disk may be flat or have some curvature.
In one embodiment, an intervening sheet layer of rib forming material may be applied over the exposed inner surface of shell that is stretched over the disk. The intervening sheet layer may be uncured or partially cured. The intervening sheet layer may include a removable barrier layer to facilitate assembly with the exposed inner surface of the shell. The intervening sheet layer may have one or more layers that define the thickness of the sheet layer. The intervening layer, such as a release liner, may be applied between stencil and the sheet material to facilitate ease of separation and removal of the stencil from the sheet material.
In one embodiment, a stencil with grooves is applied over the intervening sheet layer for cutting ribs in the sheet layer. The stencil may be flat. In one embodiment, the stencil may be curved to facilitate flow of material into stencil grooves when flattened under pressure. In one embodiment, the stencil may be pliable or rigid. The stencil is preferably able to withstand pressure without distortion. The stencil may be made of metal. In one embodiment, the stencil may be made of metal with a lubricious coating. In one embodiment, the stencil may be made of a polymer material such as TEFLON®.
In one embodiment, the stencil grooves may include through grooves and/or blind grooves. In one embodiment, the stencil grooves may have chamfers on the sheet contact side of the stencil to facilitate the flow of the sheet material into the stencil grooves when the sheet material is under pressure.
In one embodiment, heat, pressure and/or time may be applied to the sheet and the shell to force the sheet material into the stencil grooves for forming the ribs on the exposed surface of the shell.
In one embodiment, an embossing roller may be used for embossing a rib pattern onto a shell. In one embodiment, a shell may be fully or partially cured. The shell may be applied (e.g., stretched) over a disk (e.g., a flat plate, a curved plate) so that the shell overlies a top surface of the disk with an inner surface of the shell exposed.
In one embodiment, an intervening sheet layer may be applied over the exposed inner surface of the shell. The sheet layer may include one or more layers. The sheet layer may be uncured or partially cured, and may have a removable barrier layer to facilitate assembly with the shell.
In one embodiment, an embossing roller (e.g., a cylindrical roller, a rolling pin) with grooves or a pattern may be rolled over the sheet layer to apply pressure to the sheet layer to improve and/or form a rib pattern on the sheet layer. In one embodiment, heat may be applied to the sheet material to force the sheet material into stencil grooves.
In one embodiment, three-dimensional (3D) printing equipment may be used for forming one or more ribs on an implant shell. In one embodiment, the implant shell may be fully or partially cured. The shell may be applied (e.g., stretched) over a disk so that the shell overlies a top surface of the disk with an inner surface of the shell exposed. The disk may be flat or slightly curved with the shell conforming to the shape of the disk. The 3D printer may be used to form one of more ribs that are integrally secured to the exposed inner surface of the shell. The shell and the ribs may be cured. The shell may be removed from the disk and inverted so that the 3D printed ribs are located inside the shell and project inwardly from the inner surface of the shell.
In one embodiment, a pre-cut rib pattern may be adhered to an exposed inner surface of an implant shell. The pre-cut rib pattern may be formed using conventional methodologies such as stamping, laser cutting, etc. In one embodiment, the pre-cut rib pattern may include a combination of a sheeting and a release liner, which are cut together to form a rib pattern in the sheeting.
In one embodiment, an implant shell may be fully or partially cured. The shell may be inverted and applied (e.g., stretched) over a disk so that the shell overlies a top surface of the disk with an inner surface of the shell exposed. The top surface of the disk may be flat or slightly curved with the shell conforming to the shape of the top surface of the disk.
In one embodiment, the release liner may be removed to expose a surface of the cut sheet that contains the rib pattern, and the exposed surface of the rib pattern is laid over the exposed inner surface of the implant shell. Heat is preferably applied to secure the ribs to the exposed inner surface of the implant shell.
In one embodiment, the rib pattern laid over the exposed inner surface of the implant shell may be made from molding, by cutting the rib pattern from a sheet, from 3D printing, extrusion, and/or any known methodology to form and apply a desired rib pattern to the inside surface of an implant shell.
In one embodiment, the rib pattern is applied over the exposed inner surface of the shell that is stretched out. In one embodiment, heat may be applied to the implant shell and the rib pattern to vulcanize the components together. In one embodiment, pressure may be used for joining the rib pattern and the shell together. In one embodiment, pressure is not required for joining the rib pattern and the shell together.
In one embodiment, the pre-cut rib pattern may be laid over the exposed inner surface of the shell in 3D form (e.g., an inverted shell over a mandrel). In one embodiment, the pre-cut rib pattern may be laid over the exposed inner surface of the shell in 2D form (e.g., stretching the shell over a flat or slightly curved disk). In one embodiment, the pre-cut rib pattern may be dyed a different color to facilitate inspection of the implant shell to confirm that all of the components are intact (e.g., that the rib pattern is properly aligned with and secured over the inner surface of the implant shell).
In one embodiment, the releasable backing liner preferably keeps the pre-cut rib pattern in proper alignment during transportation to the shell. In one embodiment, the inner surface of the shell may be applied to a pre-cut rib pattern to minimize travel of the pre-cut rib pattern with the shell stretched over a flat disk. In one embodiment, the rib pattern is continuous and has one integral pattern, which may be termed a snowflake pattern.
The rib pattern preferably includes the actual ribs that are attached to the inner surface of the implant shell, and not the grooves that are used to create the ribs. The “backing sheet” may be temporary (e.g., a removable polymer film that is removed and discarded), or permanent (e.g., a thin silicone layer substrate), whereby the permanent layer serves as a thin bonding layer that enables the ribs to be bonded directly to the inner surface of the shell.
These and other preferred embodiments of the systems, devices and methods disclosed herein will be described in more detail below.
In one embodiment, the elements of the mammary implants and/or tissue expanders disclosed herein may be defined as set forth below.
Device. A mammary implant or tissue expander, which is filled with gel or saline. A device may be pre-filled, filled intraoperatively, or may be filled in situ. Breast implants are typically pre-filled. Tissue expanders are typically filled in situ.
Shell. The outer envelope of the device, which contains the gel or saline. The shell is typically made of biocompatible polymers such as silicone, however, other materials may be used.
Shell precursor. A shell subassembly from which a fully formed implantable shell is derived. A shell precursor may have a wall thickness that is thinner than the wall thickness of a shell and one or more layers of a shell forming material may be added to the shell precursor to form a shell.
Ribs. Male protrusions provided on the shell, which are integral with the shell. The ribs may be internal ribs projecting from the inner, non patient contacting surface of the shell. The ribs may be external ribs that project from the outer surface of the shell. A device may have a single rib or multiple ribs referred to herein as ribs.
Radius. The side region of the device where the dome of the shell comes down to intersect with the base of the shell.
Dome. The rounded region of the shell running from the apex to the radius region.
Apex. The top of the dome of the shell.
Integral. Manufactured in such a way such that one piece is created (e.g., the ribs are integral with the shell).
Radial direction. Running in general direction from the apex to the base of the shell and/or running in a plane that is perpendicular to the base.
Circumferential direction. A direction that extends around the sides of an implant and/or in a plane that is parallel with the base, such as the radius region of a mammary implant or tissue expander.
Referring to
In one embodiment, a plurality of spaced grooves 112A-112H is formed in the outer surface 110 of the mandrel 100. In one embodiment, the grooves 112A-112H extends around the circumference of the mandrel. In one embodiment, the grooves 112A-112H are evenly spaced from one another between the apex 102 and the base 104 of the mandrel. In one embodiment, the grooves 112A-112H may be formed by removing material from the outer surface 110 of the mandrel 100. In one embodiment, the grooves 112A-112H may be formed by adding material to the outer surface of the mandrel, such as by using 3D printing techniques.
Referring to
In one embodiment, each of the respective grooves 112A-112H has a constant depth, but a different height. In one embodiment, the heights of the respective grooves 112A-112H increase sequentially between the first groove 112A adjacent the apex 102 and the seventh groove 112H adjacent the base 102. For example, in one embodiment, the second groove 112B has a height H2 that is greater than the height H1 of the first groove 112A, the third groove has a height H3 that is greater than the height H2 of the second groove 112B, the fourth groove 112D has a height H4 that is greater than the height H3 of the third groove 112C, etc. In one embodiment, the first groove 112A has a height H1 of about 0.009 inches, the second groove 112B has a height H2 of about 0.027 inches, the third groove 1120 has a height H3 of about 0.037 inches, and the fourth groove 112D has a height H4 of about 0.051 inches. In addition, in one embodiment, the fifth groove 112E has a height H5 of about 0.069 inches, the sixth groove 112F has a height H6 of about 0.073 inches, the seventh groove 112G has a height H7 of about 0.107 inches, and the eighth groove 112H has a height H7 of about 0.163 inches. In one embodiment, a mandrel may have less than seven grooves or more than seven grooves. In one embodiment, the grooves may extend circumferentially around the radius 106 (
In one embodiment, the mandrel 100 shown and described above in
Referring to
In one embodiment, the shell has a convexly curved outer surface 130 and a concavely curved inner surface 135 that surrounds an interior volume of the shell 120. In one embodiment, the interior volume of the shell 120 is preferably filled with a gel or saline solution. The shell 120 desirably includes ribs 132A-132H that project inwardly from the inner surface 135 of the shell 120. In one embodiment, the ribs are desirably mirror images of the grooves 112A-112H provided on the mandrel shown and described above in
In one embodiment, each of the ribs 132A-132H projects inwardly from the inner surface 135 of the shell 120. In one embodiment, each rib projects inwardly a depth D1 of about 0.050 inches. In one embodiment, the spacing between each of the ribs 132A-132H may be constant. In one embodiment, the spacing S1 between each of the ribs 132A-132H may be about 0.150 inches. In one embodiment, the shell 120 may be filled with a filling material such as a gel, saline, a gas, or a combination of two or more of the above-listed filler materials. In one embodiment, the shell may include a patch secured over a mandrel opening, which is typically located at a posterior face of the shell.
Referring to
In one embodiment, the mandrel 200 desirably includes a plurality of grooves 212A-212I that are formed in the outer surface 210 of the mandrel. The grooves may be circumferential grooves. The grooves may have a depth that is less than the depth of the grooves shown and described above for the embodiment of
Referring to
In one embodiment, the mandrel 200 (
In one embodiment, the grooves may extend circumferentially around the side of the mandrel, radially between the apex and the base of the mandrel, or at an angle or slope that is between a circumferential orientation and a radial orientation.
Referring to
In one embodiment, the shell 220 desirably includes a plurality of ribs 232A-232I that project inwardly from the interior surface 235 of the shell 220. The inwardly projecting ribs 232A-232I preferably mirror the shape and dimension of the circumferential grooves 212A-212I of the mandrel 200 shown and described above in
In one embodiment, the shell 220 desirably includes a first rib 232A having a height H11 of about 0.009 inches, a second rib 232B having a height H12 of about 0.014 inches, a third rib 232C having a height H13 of about 0.019 inches, a fourth rib 232D having a height H14 of about 0.024 inches, and a fifth rib 232E having a height H15 of about 0.029 inches. In one embodiment, the shell 220 desirably includes a sixth rib 232F having a height H15 of about 0.036 inches, a seventh rib 232G having a height H17 of about 0.045 inches, an eighth rib 232H having a height H18 of about 0.061 inches, and a ninth rib 232I having a height H19 of about 0.094 inches. In one embodiment, the ribs 232A-232I are circumferential ribs that lie in planes that are parallel to one another.
In one embodiment, each of the ribs 232A-232I desirably projects inwardly from the inner surface 232 of the shell 220 by a constant distance D2 of about 0.025 inches. In one embodiment, each of the ribs 232A-232I are evenly spaced from one another by a constant distance S2 of about 0.150 inches. For example, in one embodiment, the distance S2 between a lower end of the first rib 232A and an upper end of the second rib 232B is about 0.150 inches.
Referring to
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In one embodiment, each respective circumferential groove 312A-312J has a different depth relative to the outer surface 310 of the mandrel 300. In one embodiment, the respective depths of the grooves increase in size sequentially between the apex and the base of the mandrel 300. In one embodiment, a first groove 312A has a depth D11 of about 0.094 inches, a second groove 312E has a depth D12 of about 0.049 inches, a third groove 312C has a depth D13 of about 0.035 inches, a fourth groove 312D has a depth D14 of about 0.027 inches, and a fifth groove 312E has a depth D15 of about 0.022 inches. In one embodiment, the mandrel desirably includes a sixth groove 312F having a depth D16 of about 0.018 inches, a seventh groove 312G having a depth D17 of about 0.015 inches, an eighth groove 312H having a depth D13 of about 0.012 inches, a ninth groove 312I having a depth D19 of about 0.009 inches, and a tenth 312J having a depth D20 of about 0.006 inches. In one embodiment, the mandrel 300 may have fewer than ten grooves or more than ten grooves.
Referring to
In one embodiment, each of the ribs 332A-332J desirably has a constant height designated H20 of about 0.025 inches. In one embodiment, the ribs 332A-332J are evenly spaced from one another between the apex 322 and the base 324 by a distance S3 of about 0.150 inches.
In one embodiment, each of the respective ribs 332A-332J projects inwardly from the inner surface 335 of the shell 320 by different distances. In one embodiment, a first rib 332A has a depth D11 of about 0.094 inches, a second rib 332B has a depth D12 of about 0.049 inches, a third rib 312C has a depth D13 of about 0.035 inches, a fourth rib 332D has a depth D14 of about 0.027 inches, and a fifth rib 332E has a depth D15 of about 0.022 inches. In one embodiment, the shell 320 preferably includes a sixth rib 332F having a depth D15 of about 0.018 inches, a seventh rib 332G having a depth D17 of about 0.015 inches, an eighth circumferential rib 332H having a depth D13 of about 0.012 inches, a ninth rib 332I having a depth D19 of about 0.009 inches, and a tenth rib 332J having a depth D20 of about 0.006 inches. In one embodiment, the ribs are circumferential ribs that extend in planes that are parallel to one another. In one embodiment, the ribs extend radially between the apex and the base of the shell. In one embodiment, the ribs slope between the apex and the base.
Referring to
In one embodiment, the mesh shaped groove pattern 415 preferably includes an upper circumferential groove 420 that extends around the circumference of the mandrel, an intermediate circumferential groove 422 that extends around the circumference of the mandrel, and a lower circumferential groove 424 that extends around the circumference of the mandrel. The intermediate circumferential groove is preferably located between the upper circumferential groove and the lower circumferential groove. In one embodiment, the circumferential grooves 420, 422 and 424 may lie in respective planes that are parallel with one another. In one embodiment, the circumferential grooves 420, 422, and 422 desirably define bands that extend around the circumference of the mandrel. The bands may extend completely or partially around the circumference of the mandrel.
In one embodiment, the mesh shaped groove pattern 415 preferably includes radial grooves 426 that extend from the upper circumferential groove 420, through the intermediate circumferential groove 422, and to the lower circumferential groove 424. The radial grooves 426 preferably extend in a radial direction that runs from the apex 402 to the base 404 of the mandrel 400. In one embodiment, the radial grooves 426 may be vertical grooves that are evenly spaced from one another around the circumference of the mandrel 400. The radial grooves 426 preferably intersect the circumferential grooves 420, 422 and 424 and cooperatively divide the mesh shaped groove pattern 415 into upper islands 428 located above the intermediate circumferential groove 422 and lower islands 430 located below the intermediate circumferential groove 422. The respective upper and lower islands 428, 430 preferably extend around the circumference of the mandrel. The upper and lower islands 428, 430 may extend partially or completely around the circumference of the mandrel. In one embodiment, the vertical grooves 426 are spaced from one another by a distance W1 of about 0.170 inches.
Referring to
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In one embodiment, the mesh shaped rib pattern 450 formed in the shell 420 preferably includes an upper circumferential rib 452, an intermediate circumferential rib 454, and a lower circumferential rib 456 that extend around the circumference of the shell 420 and that project inwardly from the inner surface 435 of the shell. The circumferential ribs 452, 454 and 456 preferably match and mirror the size, shape and dimension of the circumferential grooves 420, 422 and 424 shown and described above in the mandrel 400 of
In one embodiment, the mesh shaped rib pattern 450 desirably includes vertically extending upper ribs 458 that extend between the circumferential upper rib 452 and the circumferential intermediate rib 454, and vertically extending lower ribs 460 that extend between the circumferential intermediate rib 454 and the circumferential lower rib 456. The vertically extending upper and lower ribs 458, 460 preferably match and mirror the size, shape and dimension of the vertical grooves 426 shown and described above in the mandrel 400 of
In one embodiment, the vertically extending upper ribs 458 are evenly spaced from one another around the circumference of the shell, and upper islands 462 are located between the vertically extending upper ribs 458. In one embodiment, the spacing between adjacent vertically extending upper ribs 458 is designated W1 or about 0.170 inches. In one embodiment, the vertically extending lower ribs 460 are evenly spaced from one another around the circumference of the shell, and lower islands 464 are located between the vertically extending lower ribs 460. In one embodiment, the spacing between the vertically extending lower ribs 460 is W1 or about 0.170 inches.
The rib patterns disclosed in the present patent application preferably improve form stability or the ability of an implant to maintain its shape. The rib patterns disclosed herein preferably increase strength and rigidity without increasing the shell wall thickness, thus maintaining softness while improving form stability. Increasing the coverage and depth of the ribs greatly influence the form stability. Ribs may extend radially between the implant radius and apex, and circumferentially around the sides of the implant.
Referring to
In one embodiment, the mesh shaped groove pattern 515 preferably includes an upper circumferential groove 520 that extends around the circumference of the mandrel, an intermediate circumferential groove 522 that extends around the circumference of the mandrel, and a lower circumferential groove 524 that extends around the circumference of the mandrel. In one embodiment, the circumferential grooves 520, 522 and 524 may lie in respective planes that are parallel with one another. In one embodiment, the circumferential grooves 520, 522, and 522 desirably form bands that extend completely around the circumference of the mandrel. In one embodiment, the circumferential grooves have rounded, curved and/or concave curved surfaces to avoid the presence of sharp edges, thereby minimizing the potential for damaging a shell as a shell is removed from the mandrel.
In one embodiment, the mesh shaped groove pattern 515 preferably includes vertically extending or radial grooves 526 that extend from the upper circumferential groove 520, through the intermediate circumferential groove 522, and to the lower circumferential groove 524. The radial grooves 526 preferably extend in a radial direction that runs from the apex 502 to the base 504 of the mandrel 500. In one embodiment, the radial grooves 526 may be vertical grooves that are evenly spaced from one another around the circumference of the mandrel 500. The radial grooves 526 preferably intersect the circumferential grooves 520, 522 and 524 and cooperatively divide the mesh shaped groove pattern 515 into upper islands 528 located above the intermediate circumferential groove 522 and lower islands 530 located below the intermediate circumferential groove 522. The respective upper and lower islands 528, 530 preferably extend around the circumference of the mandrel. In one embodiment, the radial grooves 526 are spaced from one another a distance W1 of about 0.170 inches. In one embodiment, the upper islands 528 are spaced and divided from one another by the radial grooves 526. In one embodiment, the lower islands 530 are spaced and divided from one another by the radial grooves 526.
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In one embodiment, the mesh shaped groove pattern 615 preferably includes an upper circumferential groove 620 that extends around the circumference of the mandrel, an intermediate circumferential groove 622 that extends around the circumference of the mandrel, and a lower circumferential groove 624 that extends around the circumference of the mandrel. In one embodiment, the intermediate circumferential groove is located between the upper circumferential groove and the lower circumferential groove. In one embodiment, the circumferential grooves 620, 622 and 624 may lie in respective planes that are parallel with one another. In one embodiment, the circumferential grooves 620, 622, and 622 desirably form bands that extend completely around the circumference of the mandrel.
In one embodiment, the mesh shaped groove pattern 615 preferably includes radial grooves 626 that extend from the upper circumferential groove 620, through the intermediate circumferential groove 622, and to the lower circumferential groove 624. The radial grooves 626 preferably extend in a radial direction (e.g., a vertical direction) that runs from the apex 602 to the base 604 of the mandrel 600. In one embodiment, the radial grooves 626 may be vertical grooves that are evenly spaced from one another around the circumference of the mandrel 600. The radial grooves 626 preferably intersect the circumferential grooves 620, 622 and 624 and cooperatively divide the mesh shaped groove pattern 615 into upper islands 628 located above the intermediate circumferential groove 622 and lower islands 630 located below the intermediate circumferential groove 622. The respective upper and lower islands 628, 630 preferably extend around the circumference of the mandrel. In one embodiment, the vertical grooves 626 are spaced from one another a distance W1 of about 0.170 inches.
Referring to
In one embodiment, each of the circumferential grooves 620, 622, 624 is formed in the outer surface 610 of the mandrel 600. In one embodiment, the upper circumferential groove 620 has a depth D23 of about 0.04 inches. In one embodiment, the intermediate circumferential groove 622 has a depth D29 of about 0.045 inches. In one embodiment, the lower circumferential groove 624 has a depth D30 of about 0.04 inches. In one embodiment, the vertically extending groove 626 (
Referring to
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The mandrel 700 shown in
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In one embodiment, the mandrel shown and described above in
It is desirable for mammary implants to be soft and maintain a natural look and feel. Gel filled implants are generally softer than saline filled implants. Mammary implants are often tested to evaluate softness levels.
Referring to
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In one embodiment, a first external rib 1058A has a topside surface that projects away from an axis A3 at an angle α5 of about 52 degrees. The first external rib 1058A preferably includes an underside surface having a concave section 1090A, extending away from the outer surface 1080 of the shell, having a length L13 of about 0.025 inches, which transforms to a convex section 1092A, adjacent a tip 1094A of the rib 1058A, having a radius R3 of about 0.018 inches. In one embodiment, a second external rib 1058B has a topside surface that projects away from an axis A3 at an angle α6 of about 41 degrees. The second external rib 1058B preferably includes an underside surface having a concave section 1090B, extending away from the outer surface 1080 of the shell, having a length L14 of about 0.030 inches that transforms to a convex section 1092B, adjacent a tip 1094B of the rib 1058B, having a radius R9 of about 0.015 inches. In one embodiment, a third external rib 1058C has a topside surface that projects away from an axis A3 at an angle α7 of about 33 degrees. The third external rib 1058C preferably includes an underside surface having a concave section 1090C, extending away from the outer surface 1080 of the shell, having a length L15 of about 0.023 inches that transforms to a convex section 1092C, adjacent a tip 1094C of the rib 1058C, having a radius R10 of about 0.016 inches. In one embodiment, the spacing L16 between the tip 1094A of the first external rib 1058A and the tip 1094B of the second external rib 1058B is about 0.253 inches. In one embodiment, the spacing L17 between the tip 1094B of the second external rib 1058B and the tip 1094C of the third external rib 1058C is about 0.20 inches.
Referring to
In one embodiment, the mandrel 1100 preferably has a plurality of spaced grooves 1112 that are formed in the convexly curved outer surface 1110 of the mandrel 1100. The grooves 1112 may extend in any direction over the convexly curved surface of the mandrel (e.g., horizontally, vertically, diagonally, radially).
In one embodiment, the grooves 1112 may include radially extending grooves 1112A that extend between the apex 1102 and the base 1104 of the mandrel 1100. In one embodiment, the grooves may include circumferential grooves 1112B that extend around the circumference of the mandrel 1100. In one embodiment, the grooves 1112 may be formed by removing material from the convexly curved outer surface 1110 of the mandrel 1100. In one embodiment, the grooves 1112 may be formed by adding material to the convexly curved outer surface 1110 of the mandrel, such as by using 3D printing techniques.
In one embodiment, the outer surface of the mandrel may be machined for forming the convexly curved outer surface 1110 and/or the grooves 1112. In one embodiment, the mandrel 1100 may be made of materials such as polymers (e.g., Ertalyte), metal, wood, stone, and ceramic.
In one embodiment, a shell for use as an implant may be formed by depositing (e.g., spraying, dipping) a biocompatible curable material over the convexly curved outer surface 1110 of the mandrel 1100. In one embodiment, the curable material that is applied over the convexly curved outer surface 1110 of the mandrel may be a curable silicone material. In one embodiment, the curable silicone material may be sprayed over the convexly curved outer surface 1110 of the mandrel 1100, whereupon the curable material flows over the convexly curved surface and into the grooves 1112 formed in the convexly curved outer surface. In one embodiment, the curable silicone material may be applied over the convexly curved outer surface 1110 by dipping the mandrel in a curable silicone solution. In one embodiment, the shell may have multiple layers that are built up over the convexly curved outer surface of the mandrel using multiple spraying and/or dipping steps, whereby multiple layers of the curable material are deposited for increasing the wall thickness of shell. In one embodiment, prior to spraying a curable solution or dipping the mandrel in a curable solution, the grooves 1112 formed in the convexly curved outer surface 1110 of the mandrel 1100 may be prefilled with a material utilized for forming ribs (e.g., uncured, partially cured or cured silicone; a web of cured silicone) followed by one or more of the spraying and/or dipping steps described herein. In one embodiment, the rib forming material that is pre-filled into the grooves of the mandrel may be made of a different material than the material utilized for making the implant shell. In one embodiment, the rib forming material that is pre-filled into the grooves may include suture or wire material.
In one embodiment, a shell may be made using one or more of the systems, devices and methods disclosed in U.S. Pat. No. 4,472,226 to Redinger et al. or U.S. Patent Application Publication No. US 2014/0088703 to Schuessler, the disclosures of which are hereby incorporated by reference herein.
Referring to
In one embodiment, the shell 1120 desirably has a convexly curved outer surface 1130 and a concave curved inner surface 1135 that surrounds an interior volume 1137 of the shell 1120. In one embodiment, the interior volume 1137 of the shell 1120 is preferably filled with a gel or saline solution. In one embodiment, the shell 1120 desirably includes integral ribs 1132 that project inwardly from the inner surface 1135 of the shell 1120. In one embodiment, the ribs 1132 are desirably mirror images of the grooves 1112 provided on the convexly curved outer surface of the mandrel 1100 shown and described above in
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In one embodiment, a shell forming material (e.g., uncured silicone, partially cured silicone) may be applied to the convexly curved outer surface of the grooved convex mandrel (
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In one embodiment, the top face 1242 of the mold 1220 desirably includes spaced alignment openings 1250A-1250C that are adapted to receive legs provided on the leveling brace 1222 (
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In one embodiment, the leveling brace 1222 desirably includes three alignment legs 1268A-1268C having respective lower ends that are adapted to be received in the spaced alignment openings 1250A-1250C provided in the top face 1242 of the mold 1220 (
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In one embodiment, prior to fully inserting the alignment legs 1268A-1268C into the alignment openings of the mold 1220, a curable shell forming material such as curable silicone may be applied over the concave recess 1246, whereupon at least a portion of the curable shell forming material flows into the grooves 1248 (
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Referring to 47A, in one embodiment, an injection molding system 1300 may be utilized for forming ribs on an implant shell (e.g., a mammary implant). In one embodiment, the injection molding system 1300 desirably includes a lower mold part 1302 and an upper mold part 1304 that may be moved between an open position for inserting a mandrel 1306 into the mold (or removing the mandrel from the mold), and a closed position for performing an injection molding process. In one embodiment, the mandrel 1306 preferably includes a convexly curved surface 1308 having one or more grooves 1310 formed on the convexly curved surface.
In one embodiment, the upper mold part 1304 preferably includes injection ports 1312 that are directed toward the convexly curved surface 1308 of the mandrel 1306 for introducing a curable material, such as curable silicone, between the upper mold part 1304 and the lower mold part 1302, whereupon the curable material flows over the convexly curved surface of the mandrel and into the grooves provided on the mandrel. The curable silicone material is preferably introduced through the injection ports 1312 for forming an implant shell over the convexly curved surface 1308 of the mandrel 1306.
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Referring to 500, in one embodiment, after the stencil is pressed into the unvulcanized silicone layer 1422 (
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While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, which is only limited by the scope of the claims that follow. For example, the present invention contemplates that any of the features shown in any of the embodiments described herein, or incorporated by reference herein, may be incorporated with any of the features shown in any of the other embodiments described herein, or incorporated by reference herein, and still fail within the scope of the present invention.
The present patent application is a continuation of U.S. patent application Ser. No. 16/528,797, filed on Aug. 1, 2019, now allowed, which claims benefit of U.S. Provisional Application Ser. No. 62/717,271, filed Aug. 10, 2018, the disclosures of which are hereby incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 62717271 | Aug 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16528797 | Aug 2019 | US |
| Child | 17121028 | US |
