Abstract
A method of making a self-sealing membrane for a prosthetic implant includes applying tension to a first layer of a cured elastomeric material to stretch the first layer, and while the first layer remains stretched, applying a second layer of an uncured elastomeric material over a first major surface of the first layer. After the second layer is cured, the tension on the first layer is released, whereupon the first layer returns to a non-stretched configuration for holding the second layer in contraction. The method includes, while the first layer remains stretched, applying a third layer of an uncured elastomeric material over a second major surface of the first layer. After curing the second and third layers, tension is released from the first layer, which returns to the non-stretched configuration for holding the second and third layers in contraction.
Claims
1-24. (canceled)
25. A self-sealing membrane for a prosthetic implant, said self-sealing membrane having a three-layer construction comprising: a middle layer of an elastomeric material having first and second major surfaces; a first outer layer of an elastomeric material overlying the first major surface of said middle layer; a second outer layer of an elastomeric material overlying the second major surface of said middle layer, wherein the middle layer is stretched prior to forming the three-layer construction such that the three-layer construction is movable from a stretched configuration to a released configuration, wherein, in said released configuration, said middle layer of said elastomeric material holds said first and second outer layers of said elastomeric material in contraction.
26. The self-sealing membrane as claimed in claim 25, wherein said self-sealing membrane is secured to an inner surface of a silicone shell of a prosthetic implant, and wherein said self-sealing membrane extends around an outer perimeter of an injection port of said prosthetic implant.
27. The self-sealing membrane as claimed in claim 25, wherein said self-sealing membrane is secured to a posterior region of a silicone shell of a prosthetic implant.
28. The self-sealing membrane as claimed in claim 27, wherein said self-sealing membrane defines a self-sealing base that covers a surface of said silicone shell at the posterior region of said silicone shell.
29. The self-sealing membrane as claimed in claim 25, wherein said self-sealing membrane is disposed within an injection port of a prosthetic implant.
30. The self-sealing membrane as claimed in claim 29, wherein said injection port includes a needle guard, and wherein self-sealing membrane covers an upper end of said needle guard.
31. A self-sealing sheet comprising two or more of said self-sealing membranes having the three-layer construction as claimed in claim 25, wherein major surfaces of adjacent ones of said self-sealing membranes having the three-layer construction are laminated together.
32. The self-sealing membrane as claimed in claim 31, wherein said self-sealing sheet is disposed within an injection port of a prosthetic implant.
33. The self-sealing membrane as claimed in claim 32, wherein said injection port of said prosthetic device includes a needle guard, and wherein self-sealing membrane covers an upper end of said needle guard.
34. The self-sealing sheet as claimed in claim 31, further comprising: a first self-sealing membrane having the three-layer construction; a second self-sealing membrane having the three-layer construction being laminated to an exposed major surface of said first self-sealing membrane; a third self-sealing membrane having the three-layer construction being laminated to an exposed major surface of said second self-sealing membrane.
35. A breast tissue expander comprising: an outer shell having an injection port; a self-sealing membrane surrounding the injection port, the self-sealing membrane having a three-layer construction comprising: a middle layer of an elastomeric material having first and second major surfaces; a first outer layer of an elastomeric material overlying the first major surface of said middle layer; and a second outer layer of an elastomeric material overlying the second major surface of said middle layer, wherein the middle layer is stretched prior to forming the three-layer construction such that the three-layer construction is movable from a stretched configuration to a released configuration, wherein, in said released configuration, said middle layer of said elastomeric material holds said first and second outer layers of said elastomeric material in contraction.
36. The breast tissue expander as claimed in claim 35, wherein said self-sealing membrane is secured to a posterior region of the outer shell.
37. The breast tissue expander as claimed in claim 36, wherein said self-sealing membrane defines a self-sealing base that covers a surface of said outer shell at the posterior region of said silicone shell.
38. The breast tissue expander as claimed in claim 35, wherein said injection port includes a needle guard, and wherein self-sealing membrane covers an upper end of said needle guard.
39. A method of making a self-sealing membrane for a prosthetic device comprising: applying tension to a first layer of a cured elastomeric material to stretch said first layer; applying tension to a second layer of a cured elastomeric material to stretch said second layer; while said first layer and the second layer remains stretched, positioning a third layer of an uncured elastomeric material between the first layer and the second layer by applying the third layer over a first major surface of said first layer and over a first major surface of said second layer; at least partially curing said third layer of said elastomeric material; and after said third layer is at least partially cured, releasing the tension from said first layer and said second layer, wherein said first layer and said second layer each returns to a released configuration for holding said middle layer in contraction.
40. A breast tissue expander comprising: an outer shell having an injection port; a first self-sealing membrane surrounding the injection port, the first self-sealing membrane having a three-layer construction comprising: a middle layer of an elastomeric material having first and second major surfaces; a first outer layer of an elastomeric material overlying the first major surface of said middle layer; and a second outer layer of an elastomeric material overlying the second major surface of said middle layer, wherein the first outer layer and the second outer layer are stretched prior to forming the three-layer construction such that the three-layer construction is movable from a stretched configuration to a released configuration, wherein, in the released configuration, said first and second outer layers of the elastomeric material holds the middle layer of the elastomeric material in contraction.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0087] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
[0088] FIG. 1 is a schematic view of a system used for making a self-sealing membrane for an implant, in accordance with one embodiment of the present patent application.
[0089] FIG. 2 is a schematic cross-sectional view of a self-sealing membrane having a two-layer construction with a first zone of the self-sealing membrane held in contraction by a second zone of the self-sealing membrane, in accordance with one embodiment of the present patent applications.
[0090] FIG. 3 is a cross-sectional view of a mammary implant shell including a self-sealing membrane having a two-layer construction with a first zone that is held in contraction by a second zone of the self-sealing membrane, in accordance with one embodiment of the present patent application.
[0091] FIG. 4 is a schematic view of a system utilized for making a self-sealing membrane having a three-layer construction with first and second outer zones of the self-sealing membrane being held in contraction by an intermediate zone of the self-sealing membrane, in accordance with one embodiment of the present patent application.
[0092] FIG. 5A shows a first step of making a self-sealing membrane having a three-layer construction, in accordance with one embodiment of the present patent application.
[0093] FIG. 5B shows another step of a method of making a self-sealing membrane having a three-layer construction, in accordance with one embodiment of the present patent application.
[0094] FIG. 5C shows another step of a method of making a self-sealing membrane having a three-layer construction, in accordance with one embodiment of the present patent application.
[0095] FIG. 5D shows another step of a method of making a self-sealing membrane having a three-layer construction, in accordance with one embodiment of the present patent application.
[0096] FIG. 5E shows another step of a method of making a self-sealing membrane having a three-layer construction, in accordance with one embodiment of the present patent application.
[0097] FIG. 5F shows another step of a method of making a self-sealing membrane having a three-layer construction, in accordance with one embodiment of the present patent application.
[0098] FIG. 5G shows another step of a method of making a self-sealing membrane having a three-layer construction, in accordance with one embodiment of the present patent application.
[0099] FIG. 5H shows another step of a method of making a self-sealing membrane having a three-layer construction, in accordance with one embodiment of the present patent application.
[0100] FIG. 5I shows another step of a method of making a self-sealing membrane having a three-layer construction, in accordance with one embodiment of the present patent application.
[0101] FIG. 5J shows another step of a method of making a self-sealing membrane having a three-layer construction, in accordance with one embodiment of the present patent application.
[0102] FIG. 5K shows another step of a method of making a self-sealing membrane having a three-layer construction, in accordance with one embodiment of the present patent application.
[0103] FIG. 5L shows another step of a method of making a self-sealing membrane having a three-layer construction, in accordance with one embodiment of the present patent application.
[0104] FIG. 6 is a schematic cross-sectional view of a self-sealing membrane for an implant having a three-layer construction including first and second outer zones that are held in contraction by an intermediate zone, in accordance with one embodiment of the present patent application.
[0105] FIG. 7A is a perspective view of a breast tissue expander having an injection port assembly and a self-sealing membrane that surrounds the injection port assembly, in accordance with one embodiment of the present patent application.
[0106] FIG. 7B is a side view of the breast tissue expander shown in FIG. 7A.
[0107] FIG. 8A is an exploded view of the breast tissue expander shown in FIGS. 7A and 7B.
[0108] FIG. 8B is another exploded view of the breast tissue expander shown in FIGS. 7A and 7B.
[0109] FIG. 9 is an exploded view of a shell having an injection port opening, and an injection port assembly that is assembled with the injection port opening, the injection port assembly including an injection dome, an injection dome sealing washer, a needle guard with magnet, and a self-sealing membrane, in accordance with one embodiment of the present patent application.
[0110] FIG. 10 is a cross-sectional view of a breast tissue expander including a shell, and an injection port assembly that is assembled with the shell, the injection port assembly including an injection dome, an injection dome sealing washer, a needle guard with magnet, and a self-sealing membrane, in accordance with one embodiment of the present patent application.
[0111] FIG. 11A is a perspective view of a top side of the self-sealing membrane shown in FIG. 9.
[0112] FIG. 11B is a magnified view of an outer edge of the self-sealing membrane shown in FIG. 11A.
[0113] FIG. 12A is a perspective view of a breast tissue expander including a shell having an anterior region with a first self-sealing membrane that surrounds an injection port assembly, and a posterior region with a second self-sealing membrane that surrounds a base and radius of the posterior region, in accordance with one embodiment of the present patent application.
[0114] FIG. 12B is a side view of the breast tissue expander shown in FIG. 12A.
[0115] FIG. 13 is an exploded view of the injection port assembly of the breast tissue expander shown in FIGS. 12A and 12B including an injection dome, a needle guard with magnet, an injection dome sealing washer, and a self-sealing membrane that surrounds the injection dome, in accordance with one embodiment of the present patent application.
[0116] FIG. 14A is a side view of a self-sealing sheet for an injection port assembly, the self-sealing sheet including a plurality of self-sealing membranes that are joined together, each self-sealing membrane having a three-layer construction with first and second outer zones held in contraction by an intermediate zone, in accordance with one embodiment of the present patent application.
[0117] FIG. 14B is a magnified view of a section of the self-sealing sheet shown in FIG. 14A.
[0118] FIG. 15A is an exploded view of an injection port assembly for a breast tissue expander including an injection dome, a self-sealing sheet, and a needle guard with magnet, in accordance with one embodiment of the present patent application.
[0119] FIG. 15B is a cross-sectional view of the injection port assembly shown in FIG. 15A.
[0120] FIG. 16 is a cross-sectional view of the needle guard with magnet and the self-sealing sheet of FIGS. 15A and 15B after the needle guard with magnet and the self-sealing sheet have been assembled together, in accordance with one embodiment of the present patent application.
[0121] FIG. 17 is a cross-sectional view of an injection port assembly including an injection dome, a needle guard with magnet, and a self-sealing sheet, in accordance with one embodiment of the present patent application.
DETAILED DESCRIPTION
[0122] Referring to FIG. 1, in one embodiment, a system 100 for making a self-sealing membrane for a shell (e.g., a mammary implant) preferably includes a press 102 having a top platen 104 and a bottom platen 106 that opposes one another. In one embodiment, the system 100 preferably includes a disk 108 (i.e., a stretching disk) having a flat major surface and an outer edge 110 that extends around an outer periphery of the disk. In one embodiment, a shell 112 (e.g., a cured silicone shell) is stretched over the disk 108 to expose a flat major surface 114 of the shell 112 that overlies the flat major surface of the disk 108.
[0123] In one embodiment, the shell 112 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., U.S. Pat. No. 5,022,942 to Yan et al., or U.S. Patent Application Publication No. US 2014/0088703 to Schuessler, the disclosures of which are hereby incorporated by reference herein.
[0124] In one embodiment, the shell 112 may be 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.
[0125] In one embodiment, the disk 108 may be made of materials such as polymers, metal, wood, stone, and ceramic.
[0126] In one embodiment, a layer 116 of an uncured material (e.g., an uncured elastomer; an unvulcanized polysiloxane elastomer; an uncured silicone layer) is preferably placed onto the exposed flat surface 114 of the stretched shell 112 and trimmed to the outer edge 110 of the stretching disk 108. While the shell remains stretched over the stretching disk 108, the uncured layer 116 is desirably cured.
[0127] In one embodiment, the combination of the shell 112 and the uncured layer 116 may be placed into the press 102 of the system 100 so that pressing forces may be applied to the subassembly of the shell 112 and the uncured layer 116. The pressing forces are desirably applied by closing the press 102 by moving the top and bottom platens 104, 106 toward one another to compress the combination of the shell 112 and the uncured layer 116.
[0128] In one embodiment, during the pressing step, the top and bottom platens 104, 106 may be heated for applying heat to the combination of the shell 112 and the uncured layer 116. The heat preferably cures the uncured layer 116 for adhering the uncured layer to the expose flat surface 114 of the shell 112.
[0129] In one embodiment, the stretching disk 108, the stretched shell 112, and the uncured layer 116 may be placed into an oven at an elevated temperature for curing the uncured layer 116 while the stretched shell 112 remains on the stretching disk 108.
[0130] In one embodiment, heat may be applied directly to the assembly of the stretching disk 108, the shell 112, and the uncured layer 116 using heating elements such as one or more heat guns.
[0131] In one embodiment, once the uncured silicone layer 116 is fully cured for being adhered to the shell 112, the shell 112 and the cured layer 116 form a seal-sealing membrane that may be removed from the stretching disk 108. In one embodiment, due to the stretched state of the shell 112 on the stretching disk 108, upon removal from the stretching disk 108, the shell 112 portion of the self-sealing membrane contracts back into its original shape and the cured layer 116 is under contraction.
[0132] Referring to FIG. 2, in one embodiment, a self-sealing membrane 120 has a two-layer construction including a second layer 116 (i.e., a second zone) that is held in contraction by a first layer 112 (i.e., a first zone). Thus, after being removed from the disk 108 (FIG. 1), the shell layer 112 holds the added layer 116 in contraction.
[0133] Referring to FIG. 3, in one embodiment, a mammary implant 122 may include the self-sealing membrane 120 shown and described above in FIG. 2. The self-sealing membrane 120 may be made utilizing the system 100 shown and described above in FIG. 1. In one embodiment, the self-sealing membrane 120 may cover the entire area of the mammary implant 122 or a portion of the mammary implant 122 (e.g., an area surrounding an injection port). In one embodiment, the self-sealing membrane 120 includes the initial silicone shell layer 112 that is in its normal, non-stretched state and the added elastomeric layer 116 that is under contraction.
[0134] Referring to FIG. 4, in one embodiment, a self-sealing membrane may have a three-layer construction whereby first and second outer layers are held in contraction by an intermediate layer. In one embodiment, a system 200 for making a self-sealing membrane having first and second outer layers held in contraction by an intermediate, middle layer preferably includes two or more grips 208A, 208B that are adapted to grip the outer periphery of a vulcanized silicone sheet 212 for stretching the sheet 212. In one embodiment, a first layer 216A of an unvulcanized polysiloxane elastomer 216A is applied over a first major face of the vulcanized, intermediate layer 212, and a second layer 216B of an unvulcanized polysiloxane elastomer is applied over a second major face of the vulcanized, intermediate layer 212. In one embodiment, while the intermediate layer 212 is stretched by the grips 208A, 208B, the first and second outer layers 216A, 216B are pressed together to form a three-layer construction and the first and second outer layers 216A, 216B are cured by using heat. Once the three-layer construction is fully cured, the grips 208A and 208B may be loosened for releasing the self-sealing membrane from the grips 208A, 208B. Once the self-sealing membrane is released from the grips, the intermediate layer 212 returns to its normal, non-stretched state and the first and second outer layers 216A and 216B are contracted by the intermediate layer 212.
[0135] Referring to FIG. 5A, in one embodiment, a system 200 for making a self-sealing membrane having three layers preferably includes a frame 230 having four rails 232, 234, 236, and 238 that are adapted to slide relative to one another for selectively modifying the size or area of the frame 230. In one embodiment, each sliding rail preferably supports one or more grips 208 that are adapted to engage the outer perimeter of a vulcanized silicone layer 212. In the particular embodiment shown in FIG. 5A, the system 200 includes a pair of grips 208 attached to each sliding rail 232, 2343, 236, and 238. In one embodiment, the grips 208 desirably project inwardly toward one another from the outer perimeter of the frame 230.
[0136] Referring to FIG. 5B, in one embodiment, the respective grips 208 include clamps 240 that are configured for clamping down onto the outer perimeter (e.g., outer edge) of the vulcanized silicone sheet 212.
[0137] Referring to FIG. 5C, in one embodiment, the vulcanized silicone sheet 212 has a square or rectangular shape, and the sheet 212 may be stretched within a plane along X and Y axes. In one embodiment, the frame 230 is loosened so that the fourth sliding rail 238 may be moved along the X axis in the direction DIR1 for moving the fourth rail 238 away from the second rail 234 to stretch the vulcanized silicone layer 212 along the X axis. After the fourth rail 238 has been moved into the position shown in FIG. 5C, the frame 230 may be tightened to prevent the rails from shifting along the X axis, thereby maintaining the silicone layer 212 in the stretched configuration shown in FIG. 5C.
[0138] Referring to FIG. 5D, in one embodiment, the frame 230 may be loosened so that the cured silicone layer 212 may be stretched along the Y axis in the direction DIR2. In one embodiment, the frame 230 is desirably loosened so that the first rail 232 may be slid away from the third rail 236 for stretching the cured silicone layer 212 along the Y axis. The frame 230 may then be tightened to prevent the rails from shifting along the Y axis, thereby maintaining the silicone layer 212 in the stretched configuration shown in FIG. 5D in which the cured silicone layer 212 is stretched along both the X and Y axes. In one embodiment, the frame 230 is desirably loosened so that the rails 232, 234, 236 and 238 can be moved in combination and simultaneously, after which the frame 230 is tightened thereby maintaining the silicone layer 212 in the stretched configuration shown in FIG. 5D, whereby the cured silicone layer 212 is stretched along both the X and Y axes. In one embodiment, the amount of stretching in the X and Y axes is the same to create a uniformly stretched silicone layer 212. In one embodiment, the amount of stretching in the X and Y axes differs to achieve a non-uniform stretched layer having differing self-sealing properties, or different tensile properties along different directions. In one embodiment, rather than using a fixed frame 230, a continuous calendaring process may be used to apply tension to a silicone layer 212, while unvulcanized silicone layers 216A and 2168 are applied to the major faces of the silicone layer 212, and subsequently cured through an oven or conveyor belt heating system.
[0139] Referring to FIG. 5E, in one embodiment, a first unvulcanized silicone layer 216A may be applied over a first major surface of the stretched silicone layer 212 (FIG. 5D). The frame 230 may then be reversed to expose a second major surface of the stretched silicone layer. A second unvulcanized silicon layer 2166 (FIG. 4) may be applied over the exposed second major surface of the stretched silicone layer 212 (FIG. 5D).
[0140] Referring to FIG. 5F, in one embodiment, the first unvulcanized layer 216A may be applied over a first exposed major surface of the vulcanized layer 212 by gradually laying the first unvulcanized layer 216A onto the exposed, first major surface of the vulcanized layer 212. The unvulcanized layer 216A is applied by gradually laying the layer 216A onto the exposed, first major surface of the vulcanized layer 212 in the direction indicated by the first arrow 215, while concurrently pressing the layer 216A with fingers or blunt tooling aids toward the sides, in the lateral directions indicated by the second arrows 217 to remove air bubbles.
[0141] In one embodiment, after the first unvulcanized layer 216A has been applied over the vulcanized layer 212, the frame 230 may be reversed to expose the second major surface of the vulcanized layer, whereupon the second unvulcanized layer 216B may be applied over the second major surface of the vulcanized layer 212.
[0142] Referring to FIG. 5G, in one embodiment, a three-layer structure of the stretched vulcanized layer 212 and the two outer unvulcanized layers 216A, 216B may be placed onto a first polyurethane foam layer 242A that underlies the three-layer structure.
[0143] Referring to FIG. 5H, in one embodiment, a second polyurethane foam layer 242B may be placed on top of the three-layer structure shown in FIG. 5G. In one embodiment, the three-layer structure including the two foam layers 242A (FIG. 5G) and 242B may be placed into a press, such as the press 102 shown and described above in FIG. 1. In one embodiment, the polyurethane foams may be used to apply a desired textured surface to the unvulcanized layers 216A, 2166. In one embodiment, the two polyurethane foams are used as buffering materials to apply more even distribution f compression forces during pressing.
[0144] Referring to FIG. 5I, in one embodiment, a metal roller 244 may be used as a tooling aide for pressing against the foam layers 242A (FIG. 5G) and 242B (FIG. 5H) for compressing the unvulcanized layers 216A, 2166 (FIG. 4) onto the stretched silicone layer 212 (FIG. 5F). The platens 104, 106 shown and described above in FIG. 1 may also be used.
[0145] Referring to FIG. 5J, in one embodiment, after the second foam layer 242B has been pressed into the second unvulcanized layer 216B, the second foam layer 242B may be slowly peeled away to expose the second unvulcanized layer 2166. The frame 230 may be reversed so that the first foam layer 242A may be slowly peeled away to expose the first unvulcanized layer 216A.
[0146] Referring to FIG. 5K, in one embodiment, the second unvulcanized layer 216B is preferably cured while it remains on the second major surface of the stretched silicone layer 212. In one embodiment, heat guns 250 may be utilized for curing the second unvulcanized layer 216B. In one embodiment, after the second unvulcanized layer 216B has been cured, the frame 230 may be flipped over for curing the first unvulcanized layer 216A that has been applied over the first major surface of the stretched silicone layer 212.
[0147] Referring to FIG. 5L, in one embodiment, after the first and second outer layers 216A and 216B (FIG. 5K) have been cured (e.g., by using heat) over the respective first and second major surfaces of the stretched silicone layer 212, the clamps 240 may be loosened for releasing the outer edges of the silicone sheet 212 from the grips 208 of the system 200.
[0148] Referring to FIG. 6, in one embodiment, the system 200 shown and described above in FIGS. 5A-5L may be utilized for making a self-sealing membrane 220 having three layers including an intermediate layer 212 of a silicone elastomer, and first and second outer layers 216A, 216B of a silicone elastomer that are held in contraction by the intermediate layer 212.
[0149] Referring to FIGS. 7A and 7B, in one embodiment, a breast tissue expander 300 may be similar to or include one or more of the structural elements disclosed in assigned U.S. Pat. No. 9,700,404 to Martin et al., assigned to Ethicon, Inc. of Somerville, New Jersey, the disclosure of which is hereby incorporated by reference herein. In one embodiment, the breast tissue expander 300 preferably includes a shell 350 (e.g., a silicone shell) having an injection port assembly 352 with a self-sealing membrane that surrounds the injection port assembly. The self-sealing membrane may be similar to that shown and described above in FIG. 2 or 6.
[0150] Referring to FIGS. 8A and 8B, in one embodiment, the breast tissue expander 300 preferably includes a base patch 354 having one or more suture tabs 356 that may be utilized for suturing the breast tissue expander 300 to tissue. In one embodiment, the base patch 354 preferably covers a posterior region of the breast tissue expander 300.
[0151] In one embodiment, the breast tissue expander 300 preferably includes a self-sealing base 358 having a raised rim 360 that is preferably secured to the inside of the shell 350.
[0152] In one embodiment, the breast tissue expander 300 preferably includes the shell 350 (e.g., a silicone shell) having a mandrel opening 364 that is covered by the base patch 354, and an injection port opening 366 that is adapted to receive an injection port assembly 352.
[0153] In one embodiment, a posterior region of the shell 350 that surrounds the mandrel opening 364 is desirably covered by the self-sealing base 358 to protect the posterior face and the posterior radius of the shell. In one embodiment, the raised rim 360 of the self-sealing base 358 preferably surrounds the posterior radius of the shell 350. In one embodiment, a sealing washer similar to the base patch sealing washer 362 may be utilized for sealing and/or adhering the posterior face 361 of the self-sealing base 358 to the inner surface of the posterior face 355 of the shell 350.
[0154] In one embodiment, the injection port assembly 352 preferably includes an injection dome 368 having a port base 335 and a sealing flange 385, an injection dome sealing washer 370 having a central opening 375, a needle guard 372 having a magnet 374, and a self-sealing membrane 320 having a three-layer self-sealing construction as shown and described above in FIG. 6. In one embodiment, the self-sealing membrane 320 desirably has a central opening 325 that is aligned with the injection port opening 366 of the shell 350. In one embodiment, the central opening 325 of the self-sealing membrane 320 is adapted to receive the needle guard 372 and the port base 335 of the injection dome 368.
[0155] Referring to FIG. 9, the injection port assembly 352 is preferably adapted to be aligned with the injection port opening 366 of the shell 350. In one embodiment, the self-sealing membrane 320 is preferably disposed inside the shell 350 and is secured to an inner surface of the shell 350 so that the opening 325 of the self-sealing membrane 320 is aligned with the injection port opening 366 of the shell 350. In one embodiment, the needle guard 372 is preferably disposed within the central opening 325 of the self-sealing membrane 320 and the injection port opening 366 of the shell 350.
[0156] In one embodiment, injection dome sealing washer 370 is preferably secured to the outer surface of the shell 350 with the central opening 375 of the injection dome sealing washer 370 aligned with the central opening 325 of the self-sealing membrane 320 and the injection port opening 366 of the shell 350.
[0157] In one embodiment, after the self-sealing membrane 320 and the injection dome sealing washer 370 have been secured to the shell 350, the shell material that surrounds the injection port opening 366 is preferably sandwiched between the self-sealing membrane 320 and the injection dome sealing washer 370.
[0158] In one embodiment, prior to insertion into the central opening 325 of the self-sealing membrane 320, the needle guard 372 and the injection dome 368 are assembled together to form a subassembly. In one embodiment, the injection dome 368 preferably includes the port base 335 and the sealing flange 385 that extends outside the diameter of the port base 335. In one embodiment, when the injection dome 368/needle guard 372 subassembly is assembled with the shell 350, the needle guard 372 and the port base 335 of the injection dome 368 pass through the central opening 375 of the injection dome sealing washer 370 and the central opening 325 of the self-sealing membrane 320, as well as the injection port opening 366 of the shell 350. The sealing flange 385 of the injection dome 368 preferably overlies the outer surface of the shell 350 for engaging the injection dome sealing washer 370, which is also secured to the outer surface of the shell 350.
[0159] Referring to FIG. 10, in one embodiment, the injection port assembly 352 is assembled with the shell 350 of the breast tissue expander 300 (FIG. 7A). The injection port assembly 352 preferably passes through the injection port opening 366 (FIG. 8A) of the shell 350. In one embodiment, the self-sealing membrane 320 is secured to the inner surface of the shell 350 and surrounds the injection port opening 366 (FIG. 8A) of the shell 350. The needle guard 372 is assembled with the injection dome 368 so that the needle guard 372 and the port base 335 of the injection dome pass through the central opening 325 (FIG. 8A) of the self-sealing membrane 320 as well as the injection port opening 366 (FIG. 8A) of the shell 350. The magnet 374 is secured to an underside of the needle guard 372. The sealing flange 385 of the injection dome 368 extends outwardly beyond the outer perimeter of the injection port opening 366 (FIG. 8A) of the shell 350. The injection dome sealing washer 370 preferably secures an underside of the sealing flange 385 of the injection dome 368 to an outer surface of the shell 350.
[0160] Referring to FIG. 11A, in one embodiment, the self-sealing membrane 320 preferably includes the three-layer construction shown and described above in FIG. 6. In one embodiment, the self-sealing membrane preferably has the central opening 325 that is adapted to receive a needle guard and a base of an injection dome. As described above, the central opening 325 is preferably aligned with an injection port opening 366 (FIG. 8A) formed in a shell of a breast tissue expander. In one embodiment, the self-sealing membrane 320 preferably includes an inner washer 390 that surrounds the central opening 325 and an outer washer 392 that extends around the outer perimeter of the self-sealing membrane 320. In one embodiment, the inner and outer washers 390, 392 are preferably utilized for securing a top surface 395 of the self-sealing membrane 322 to an inner surface of a shell of a mammary implant. In one embodiment, the first and second sealing washers 390, 392 may be replaced by a single washer that extends outwardly between the outer perimeter of the central opening 325 and the outer perimeter of the self-sealing membrane, and that completely covers the top surface 395 of the self-sealing membrane 320.
[0161] Referring to FIG. 11B, in one embodiment, the self-sealing membrane 320 preferably includes a three-layer construction having an intermediate layer 312 that is sandwiched between first and second outer layers 316A and 316B. The first and second outer layers 316A and 316B are preferably held in contraction by the intermediate layer 312. The outer sealing washer 392 preferably overlies the outer perimeter of the first outer layer 316A for securing the anterior face of the self-sealing membrane 320 to an inner surface of a shell of a breast tissue expander.
[0162] Referring to FIGS. 12A and 12B, in one embodiment, a breast tissue expander 400 may be similar to or include one or more of the structural elements disclosed in U.S. Pat. No. 9,463,087 to Hristov et al., assigned to Mentor Worldwide LLC, of Irvine, California, the disclosure of which is hereby incorporated by reference herein. In one embodiment, the breast tissue expander 400 preferably includes a shell 450 with an injection port assembly 452 assembled around an injection port opening of the shell 450. In one embodiment, the breast tissue expander 400 preferably includes a self-sealing membrane 420 as shown and described herein that surrounds an injection dome 468 of the injection port assembly 452.
[0163] In one embodiment, the breast tissue expander 400 includes a seal-sealing base 458 having a raised rim 460 that extends between a posterior region of the shell 450 and a base patch 454. In one embodiment, the self-sealing base 458 preferably includes the self-sealing structure disclosed herein for minimizing the risk of a leak if the self-sealing base 458 is punctured during a suturing operation.
[0164] Referring to FIG. 13, in one embodiment, the injection port assembly 452 of the breast tissue expander 400 shown and described above in FIGS. 12A and 12B preferably includes a self-sealing membrane 420 having a central opening 425, a needle guard 472 having a magnet 474, an injection dome 468 having a base 435 and a sealing flange 485, and an injection dome sealing washer 470 having a central opening 475 that is adapted to receive the needle guard 472 and the base 435 of the injection dome 468.
[0165] In one embodiment, when the self-sealing membrane 420 is assembled with an inner surface of a shell of a breast tissue expander, the anterior face 495 of the self-sealing membrane 420 is desirably secured to the inner surface of the shell. The injection dome sealing washer 470 is preferably secured to an outer surface of the shell and surrounds the central opening 425 of the self-sealing membrane 420. The needle guard 472 passes through the central opening 475 of the injection dome sealing washer 470 and the central opening 425 of the self-sealing membrane 420. The injection dome 468 is assembled with the shell by abutting a posterior face of the injection dome sealing flange 485 with the anterior face of the injection dome sealing washer 470, whereupon the injection dome sealing flange 485 of the injection dome 468 overlies the outer surface of the shell of the breast tissue expander.
[0166] Referring to FIG. 14A, in one embodiment, a self-sealing sheet 520 for an implant may include two or more of the three-layer self-sealing membranes 220 shown and described above in FIG. 6. In one embodiment, the self-sealing sheet 520 preferably includes three different self-sealing membranes 220A, 220B, and 220C that are joined together by unvulcanized sealing layers 595A and 595B that may be cured for adhering the three self-sealing membranes 220A, 220B, and 220C to one another.
[0167] Referring to FIG. 14B, in one embodiment, the self-sealing sheet 520 preferably includes a first self-sealing membrane 220A having first and second outer layers 516A and 516B that are held in contraction by an intermediate layer 512. The self-sealing sheet 520 preferably includes a second self-sealing membrane 220B including first and second outer layers 516A and 516B that are held in contraction by intermediate layer 512. In one embodiment, the seal-sealing sheet 520 preferably includes a third self-sealing membrane having first and second outer layers 516A and 516B that are held in contraction by intermediate layer 512. In one embodiment, the first and second self-sealing members 220A and 220B are joined together by an unvulcanized layer 595A that may be cured. In one embodiment, the second the third self-sealing membranes 220B and 220C are joined together by a second unvulcanized layer 595B that may be cured.
[0168] In one embodiment, the self-sealing sheet 520 shown in FIGS. 14A and 14B may be incorporated anywhere on a mammary implant to close needle openings after the self-sealing sheet 520 has been punctured by a needle. In one embodiment, unvulcanized layers 595 are not required and a plurality of alternating layers of 120 may be constructed by stacking multiple alternating layers of cured silicone shells 112 and unvulcanized layers 116 (FIG. 1). In one embodiment, unvulcanized layers 595 are not required and a plurality of alternating layers of 120 may be constructed by stacking multiple alternating layers of cured silicone shells 112 and unvulcanized layers 116 as in the process shown in FIG. 1, or by stretching multiple layers of vulcanized silicone sheets 212 with alternating layers of unvulcanized silicone 216 as in the process shown in FIG. 4.
[0169] Referring to FIGS. 15A and 15B, in one embodiment, the self-sealing structure 520 shown and described above in FIGS. 14A and 14B may be incorporated into an injection port assembly 552 that includes an injection dome 568 and a needle guard 572 having a magnet 574.
[0170] Referring to FIG. 16, in one embodiment, the self-sealing structure 520 is preferably secured to the upper end 545 of an outer wall 555 of the needle guard 572. The self-sealing structure 520 preferably completely covers the opening at the upper end 545 of the outer wall 555 to completely seal an enclosed chamber 565 disposed between a bottom surface of the implant shell sealing structures 520 and a bottom wall 567 of the needle guard 572.
[0171] FIG. 17 shows an injection port assembly 552 including the self-sealing sheet 520 and the needle guard 572 of FIG. 16 assembled with the injection dome 568 shown in FIGS. 15A and 15B. The injection port assembly 552 may be inserted into an injection port opening of a shell of a breast tissue expander so that the sealing flange 585 of the injection dome 552 overlies the outer surface of the shell and the base 535 of the injection dome 568 passes through the injection port opening of the shell. In one embodiment, the base 535 of the injection dome 568 may also pass through the central opening of a self-sealing membrane as shown and described herein. In one embodiment, the anterior surface of the self-sealing structure 520 and the needle guard 572 of FIG. 16 may be attached directly to the inner surface of the shell without requiring an opening through the shell nor an opening through the self-sealing membrane.
[0172] 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 fall within the scope of the present invention.
