Human implantable tissue expander

<u style="single">References to related applications</u> References have been made to US Provisional Patent Application No. 60 / 878,564 entitled "Human Implantable Tissue Expander" filed January 3, 2007, the disclosure of which is incorporated herein by reference. In addition, the priority is claimed in this application in accordance with 37 CFR 1.78 (a) (4) and (5) (i).

<u style="single">Technical field</u> The present invention generally relates to implantable tissue expanders.

<u style="single">Background technology</u> The following published patent documents appear to represent the current status of the technology: U.S. Pat. Nos. 6,315,796 and U.S. Pat. No. 6,605,116, as well as U.S. Patent Application Publications 2001/0010024; 2003/0074084 and 2004/0148024.

<p><u style="single">Outline of the invention</u> The present invention relates to implantable tissue expanders.</p>

<p> That is, according to a preferred embodiment of the present invention, an implantable tissue expander is provided, the implantable tissue expander comprising an integrally formed internal skeletal element, the integrally formed internal skeleton. The element extends between the bottom surface and the outer surface and comprises a plurality of elongated cells of at least one type, the elongated cells extending from the bottom surface to the outer surface along axes generally parallel to each other and. The implantable tissue expanders, defined by the walls of elongated cells formed of elastic material, contain a blocked enclosure that blocks the internal skeletal elements and fluids. Is suitable for preventing the plurality of elongated cells from being filled.</p><p> Preferably, the at least one elongated cell comprises at least the first and second elongated cells extending from the bottom surface to the outer surface along corresponding different axes that are generally parallel to each other. Alternatively, the at least one elongated cell comprises a single elongated cell extending from the bottom surface to the outer surface along an axis generally parallel to each other.</p><p> Preferably, the bottom surface is generally flat. Additional or alternative, the outer surface is generally convex.</p><p> Preferably, the wall of the elongated cell defines a passage of liquid connecting between adjacent cells in the elongated cell of at least one type. Additional or alternative, the at least one elongated cell comprises a central columnar cell.</p><p> Preferably, the walls of the elongated cell are generally of uniform thickness. Additional or alternative, the at least one elongated cell comprises a partial cell that exists along its perimeter. Preferably, the subcells are identical. Preferably, the elongated cell has a hexagonal cross section.</p><p> Preferably, the implantable tissue expander comprises at least one mesh. In addition, the at least one mesh is formed from a material that is highly deformable and has low elasticity. Additional or alternative, the at least one mesh is at least partially integrated with the blocked enclosure.</p><p> Preferably, the at least one mesh comprises layers of multiple meshes. In addition, at least two layers of mesh are located opposite the blocked enclosure of at least one layer.</p><p> Preferably, the closed enclosure generally includes a convex portion and a bottom portion. Additional or alternative, the blocked enclosure comprises multiple layers of enclosure.</p><p> Preferably, the implantable tissue expander also includes a tube leading to the interior of the closed enclosure. Additional or alternative, the blocked enclosure has a non-uniform wall thickness.</p><p> Also, according to another preferred embodiment of the present invention, a method for producing an implantable tissue expander is provided, wherein the method for producing an implantable tissue expander comprises forming an internal skeletal element, the internal skeleton. The element extends between the bottom surface and the outer surface and comprises a plurality of elongated cells of at least one type, the elongated cells extending from the bottom surface to the outer surface along axes generally parallel to each other and elastic. The method of making the implantable tissue expander, defined by the walls of elongated cells formed from the material, comprises forming a perimeter enclosure on the internal skeletal element, the perimeter enclosure. It functions to block the internal skeletal elements and is suitable to prevent body fluids from filling the plurality of elongated cells.</p><p> Preferably, forming the perimeter enclosure forms a bottom portion of the enclosure and a generally convex portion of the enclosure, and the bottom portion around the generally convex portion and the elongated portion. Includes polymerizing with the edge of the cell wall.</p><p> Preferably, the method also includes forming an outer enclosure on the surrounding enclosure. Additional or alternative, the forming step comprises forming the internal skeletal element and the generally convex portion of the surrounding enclosure integrally on the mesh.</p><p> Preferably, the method also includes providing a tube that leads to the interior of the surrounding enclosure.</p><p><u style="single">A brief description of the drawing</u> The present invention will be more fully understood from the following detailed description, which will be understood in combination with the drawings.</p>

<figref num="1A">1A, 1B, 1C and 1D are top, bottom and bottom views of the integrally formed internal skeletal elements used in an implantable tissue expander according to a preferred embodiment of the invention, respectively. It is one sectional view and the second sectional view.</figref><figref num="1B">1A, 1B, 1C and 1D are top, bottom and bottom views of the integrally formed internal skeletal elements used in an implantable tissue expander according to a preferred embodiment of the invention, respectively. It is one sectional view and the second sectional view.</figref><figref num="1C">1A, 1B, 1C and 1D are top, bottom and bottom views of the integrally formed internal skeletal elements used in an implantable tissue expander according to a preferred embodiment of the invention, respectively. It is one sectional view and the second sectional view.</figref><figref num="1D">1A, 1B, 1C and 1D are top, bottom and bottom views of the integrally formed internal skeletal elements used in an implantable tissue expander according to a preferred embodiment of the invention, respectively. It is one sectional view and the second sectional view.</figref><figref num="2A">2A, 2B, 2C and 2D are top and bottom views of the integrally formed internal skeletal elements used in implantable tissue expanders according to another preferred embodiment of the invention, respectively. , A first sectional view and a second sectional view.</figref><figref num="2B">2A, 2B, 2C and 2D are top and bottom views of the integrally formed internal skeletal elements used in implantable tissue expanders according to another preferred embodiment of the invention, respectively. , A first sectional view and a second sectional view.</figref><figref num="2C">2A, 2B, 2C and 2D are top and bottom views of the integrally formed internal skeletal elements used in implantable tissue expanders according to another preferred embodiment of the invention, respectively. , A first sectional view and a second sectional view.</figref><figref num="2D">2A, 2B, 2C and 2D are top and bottom views of the integrally formed internal skeletal elements used in implantable tissue expanders according to another preferred embodiment of the invention, respectively. , A first sectional view and a second sectional view.</figref><figref num="3A">Figures 3A, 3B, 3C and 3D show the top view and bottom view of the integrally formed internal skeletal elements used in implantable tissue expanders according to yet another preferred embodiment of the invention, respectively. It is a drawing, a first sectional view and a second sectional view.</figref><figref num="3B">Figures 3A, 3B, 3C and 3D show the top view and bottom view of the integrally formed internal skeletal elements used in implantable tissue expanders according to yet another preferred embodiment of the invention, respectively. It is a drawing, a first sectional view and a second sectional view.</figref><figref num="3C">Figures 3A, 3B, 3C and 3D show the top view and bottom view of the integrally formed internal skeletal elements used in implantable tissue expanders according to yet another preferred embodiment of the invention, respectively. It is a drawing, a first sectional view and a second sectional view.</figref><figref num="3D">Figures 3A, 3B, 3C and 3D show the top view and bottom view of the integrally formed internal skeletal elements used in implantable tissue expanders according to yet another preferred embodiment of the invention, respectively. It is a drawing, a first sectional view and a second sectional view.</figref><figref num="4">FIG. 4 is a cross-sectional view of an implantable tissue expander that uses internal skeletal elements and is constructed and functions according to one embodiment of the invention.</figref><figref num="5">FIG. 5 is a cross-sectional view of an implantable tissue expander that uses internal skeletal elements and is constructed and functions according to another embodiment of the invention.</figref><figref num="6">FIG. 6 is a cross-sectional view of an implantable tissue expander that uses internal skeletal elements and is constructed and functions according to yet another embodiment of the present invention.</figref><figref num="7">FIG. 7 is a cross-sectional view of an implantable tissue expander that uses internal skeletal elements and is constructed and functions according to yet another embodiment of the present invention.</figref><figref num="8">FIG. 8 is a cross-sectional view of an implantable tissue expander that uses internal skeletal elements and is constructed and functions according to yet another embodiment of the invention.</figref><figref num="9">FIG. 9 is a cross-sectional view of an implantable tissue expander that uses internal skeletal elements and is constructed and functions according to yet another embodiment of the present invention.</figref><figref num="10">FIG. 10 is a cross-sectional view of an implantable tissue expander that uses internal skeletal elements and is constructed and functions according to yet another embodiment of the invention.</figref><figref num="11">FIG. 11 is a cross-sectional view of an implantable tissue expander that uses internal skeletal elements and is constructed and functions according to yet another embodiment of the present invention.</figref><figref num="12">FIG. 12 is a simplified diagram of the method for producing the implantable tissue expander of FIG. 4 according to the embodiment of the present invention.</figref><figref num="13A">13A and 13B are both simplified views of the method for producing the implantable tissue expander of FIG. 5 according to another embodiment of the present invention.</figref><figref num="13B">13A and 13B are both simplified views of the method for producing the implantable tissue expander of FIG. 5 according to another embodiment of the present invention.</figref><figref num="14A">14A and 14B are both simplified views of the method for producing the implantable tissue expander of FIG. 6 according to yet another embodiment of the present invention.</figref><figref num="14B">14A and 14B are both simplified views of the method for producing the implantable tissue expander of FIG. 6 according to yet another embodiment of the present invention.</figref><figref num="15A">15A and 15B are both simplified views of the method for producing the implantable tissue expander of FIG. 7 according to another embodiment of the present invention.</figref><figref num="15B">15A and 15B are both simplified views of the method for producing the implantable tissue expander of FIG. 7 according to another embodiment of the present invention.</figref><figref num="16">FIG. 16 is a simplified diagram of the method for producing the implantable tissue expander of FIG. 8 according to a further embodiment of the present invention.</figref><figref num="17">FIG. 17 is a simplified diagram of the method for producing the implantable tissue expander of FIG. 9 according to a further embodiment of the present invention.</figref><figref num="18">FIG. 18 is a simplified diagram of the method for producing the implantable tissue expander of FIG. 10 according to a further embodiment of the present invention.</figref><figref num="19">FIG. 19 is a simplified diagram of the method for producing the implantable tissue expander of FIG. 11 according to another embodiment of the present invention.</figref>

<u style="single">Detailed description of preferred embodiments</u> See FIGS. 1A, 1B, 1C and 1D here. These are a top view, a bottom view, a first cross section and a second cross section of the integrally formed internal skeletal elements 100 used in the implantable tissue expander according to a preferred embodiment of the present invention. Is.

As seen in FIGS. 1A-1D, the integrally formed internal skeleton element 100 comprises an array of elongated cells 102, which elongated cells 102 are typically planar, as in the illustrated embodiment. From the virtual bottom surface 106, which is preferably generally convex, and to the virtual outer surface 108, which is folded into the adjacent virtual bottom surface 106, as clearly seen in FIG. 1A-1C. Extends along an axis 104 that is generally parallel to each other. The elongated cells 102 are defined with each other by the elongated cell walls 110 formed from an elastic material. The elongated cell wall 110 is preferably formed to define a liquid passage 111 connecting between adjacent cells 102.

In the illustrated embodiment, the array of elongated cells 102 is preferably characterized by including a central columnar cell 112 and the elongated cell wall 110 having a generally uniform thickness. It is also characterized in that a regular pattern of subcells 114 exists along the perimeter of the array. In the embodiment illustrated in FIG. 1A-1D, the subcells 114 are all equivalent. In other embodiments, this is not always the case. Alternatively, the walls 110 of the elongated wells do not have to be generally uniform in thickness and may be of different and / or varying thicknesses.

Then refer to Figures 2A, 2B, 2C and 2D. These are the top, bottom, first and second cross-sectional views of the integrally formed internal skeletal element 200 used in the implantable tissue expander according to a preferred embodiment of the present invention. is there.

As seen in FIGS. 2A-2D, the integrally formed internal skeleton element 200 contains an array of elongated cells containing the first plurality of elongated cells 202 in the center of the array, the cells 202 generally each other. An internal skeletal element 200 extending and integrally formed along a parallel axis 204 comprises a second plurality of elongated cells 206, each of which the second plurality of elongated cells 206 are along an axis 208. The shaft 208 extends outward with respect to the shaft 204. Cells 202 and 206 are preferably generally convex from a virtual bottom surface 210, which is typically planar, as in the illustrated embodiment, and adjacent, as seen in FIGS. 2A-2D. It extends to a virtual outer surface 212 that is folded into a matching virtual bottom surface 210. The elongated cells 202 and 206 are defined by the elongated cell wall 214 formed of an elastic material. The elongated cell wall 214 is preferably formed to define a liquid passage 215 connecting between adjacent cells 202 and 206.

In the illustrated embodiment, the array of elongated cells 202 is preferably characterized by including a central columnar cell 216 and a generally uniform thickness of the elongated cell wall 214. It is also characterized in that a regular pattern of subcells 218 exists along the perimeter of the array. In the embodiment illustrated in FIG. 2A-2D, the subcells 218 are all equivalent. In other embodiments, this is not always the case.

Then refer to Figures 3A, 3B, 3C and 3D. These are the top, bottom, first and second cross-sectional views of the integrally formed internal skeletal element 300 used in the implantable tissue expander according to a preferred embodiment of the present invention. is there.

As seen in FIGS. 3A-3D, the integrally formed internal skeleton element 300 contains an array of equilateral elongated cells 302, each of which elongated cells 302 have a hexagonal cross section and are illustrated. From the virtual bottom surface 306, which is typically planar as in the embodiment, to the adjacent virtual bottom surface 306, which is preferably generally convex and is apparently seen in FIG. 3A-3C. It extends to the folded virtual outer surface 308 along an axis 304, which is generally parallel to each other. The elongated cells 302 are defined with each other by the elongated cell walls 310 formed from the elastic material. The elongated cell wall 310 is preferably formed to define a liquid passage 311 connecting between adjacent cells 302.

In the illustrated embodiment, the array of elongated cells 302 is preferably characterized in that the elongated cell walls 310 are generally of uniform thickness. It is also characterized in that a regular pattern of subcells 312 exists along the perimeter of the array. In the embodiment illustrated in FIGS. 3A-3D, the subcells 312 are not equivalent.

Next, refer to FIG. This is a cross-sectional view of an implantable tissue expander constructed and functioning according to a preferred embodiment of the present invention and using the internal skeletal element 100 of FIG. 1A-1D. As can be seen in FIG. 4, the internal skeletal element 100 is surrounded by a surrounding enclosure 400, which preferably generally includes a generally convex portion 402, wherein this generally convex portion 402 is internal. Molded with the skeleton element 100 and the bottom portion 404, the bottom portion 404 is polymerized or substituted on the virtual bottom surface 106 with the perimeter of the convex portion 402 and the edge of the wall 110 of the elongated cell. Therefore, by using an appropriate adhesive, they can be joined to each other in a blocking manner.

The internal skeletal element 100 and the perimeter enclosure 400 are surrounded by an outer perimeter enclosure 406, which generally includes a generally convex portion 408, which generally contains a generally convex portion 408. Formed integrally with the bottom portion 410, these are molded together as a dress on the surrounding enclosure 400.

Preferably, the tube 412 leads to the interior of the surrounding enclosure 400. The tube is preferably closed after implanting to keep the interior of the surrounding enclosure 400 at ambient pressure.

The enclosure used in various embodiments of the present invention, such as enclosure 400, may have any suitable thickness. Such thickness may be uniform or different.

Next, refer to FIG. This is a cross-sectional view of an implantable tissue expander constructed and functioning according to another preferred embodiment of the present invention, yet using the internal skeletal element 100 of FIG. 1A-1D. In the embodiment of FIG. 5, the mesh 500 is preferably made of a highly deformable, less stretchable material, such as polyethylene or polyurethane, and surrounds the internal skeletal element 100.

As can be seen in FIG. 5, the internal skeleton element 100 and the mesh 500 are surrounded by a perimeter enclosure 502, which perimeter enclosure 502 preferably comprises a generally convex portion 504, which generally contains a convex portion 504. Is molded with the internal skeleton element 100 on the mesh 500. The perimeter enclosure 502 also includes a bottom portion 506, which is polymerized on the virtual bottom surface 106 along with the perimeter of the convex portion 504 and the edge of the elongated cell wall 110. Alternatively, they can be occluded and joined to them by using a suitable adhesive.

The internal skeleton element 100 and the mesh 500 are surrounded by an outer perimeter enclosure 508, which generally comprises a generally convex portion 510, which generally the generally convex portion 510 is a bottom portion. Formed integrally with 512, they are molded together as a dress on the perimeter enclosure 502 and mesh 500.

Preferably, the tube 514 leads to the interior of the surrounding enclosure 502. The tube is preferably closed after implanting to keep the interior of the surrounding enclosure 502 at ambient pressure.

Next, refer to FIG. This is a cross-sectional view of an implantable tissue expander constructed and functioning according to yet another preferred embodiment of the present invention, yet using the internal skeletal element 100 of FIG. 1A-1D. In the embodiment of FIG. 6, the mesh 600 is preferably made of a highly deformable, less stretchable material, such as polyethylene or polyurethane, and surrounds the internal skeleton element 100 and the surrounding enclosure 602.

As can be seen in FIG. 6, the internal skeletal element 100 is surrounded by a perimeter enclosure 602, which perimeter enclosure 602 preferably comprises a generally convex portion 604, which generally convex portion 604 is internal. Molded with the skeleton element 100 and the bottom portion 606, the bottom portion 606 is polymerized or replaced on the virtual bottom surface 106 with the perimeter of the convex portion 604 and the edge of the wall 110 of the elongated cell. Therefore, by using an appropriate adhesive, they can be joined to each other in a blocking manner.

The internal skeleton element 100 and the mesh 600 are surrounded by an outer perimeter enclosure 608, which generally comprises a generally convex portion 610, which generally the generally convex portion 610 is a bottom portion. Formed integrally with 612, they are molded together as a dress on the perimeter enclosure 602 and mesh 600.

Preferably, tube 614 leads to the interior of the surrounding enclosure 602. The tube is preferably closed after implanting to keep the interior of the surrounding enclosure 602 at ambient pressure.

Next, refer to FIG. This is a cross-sectional view of an implantable tissue expander constructed and functioning according to yet another preferred embodiment of the present invention, yet using the internal skeletal element 100 of FIG. 1A-1D. In the embodiment of FIG. 7, the mesh 700 is preferably made of a highly deformable, non-stretchable material, such as polyethylene or polyurethane, the internal skeleton element 100 and the first and second perimeter enclosures 702. And surrounds 704. The mesh 700 may be completely outside the enclosure 704 and may or may not be attached to it. Alternatively, the mesh 700 may be wholly or partially integrated within the surrounding enclosure 704.

As can be seen in FIG. 7, the internal skeletal element 100 is surrounded by a first perimeter enclosure 702, the first perimeter enclosure 702 preferably containing a generally convex portion 706, which is generally convex. The portion 706 is molded together with the internal skeleton element 100 and the bottom portion 708, which is polymerized on the virtual bottom surface 106 with the periphery of the convex portion 706 and the edge of the wall 110 of the elongated cell. Alternatively, they can be occluded and spliced to them by using the appropriate adhesive. The first perimeter enclosure 702 is preferably surrounded by a second outer perimeter enclosure 704, and this second outer perimeter enclosure 704 preferably comprises a generally convex portion 710, which is generally convex. The shaped portion 710 is formed integrally with the bottom portion 712, which are molded together as a dress on the first perimeter enclosure 702.

Preferably, the tube 714 leads to the interior of the surrounding enclosure 702. The tube is preferably closed after implanting to keep the interior of the first perimeter enclosure 702 at ambient pressure.

Next, refer to FIG. This is a cross-sectional view of an implantable tissue expander constructed and functioning according to yet another preferred embodiment of the present invention, yet using the internal skeletal element 100 of FIG. 1A-1D. In the embodiment of FIG. 8, the mesh 800 is preferably made of a highly deformable, less stretchable material, such as polyethylene or polyurethane, and surrounds the internal skeleton element 100 and the generally convex portion 802.

As can be seen in FIG. 8, the internal skeleton element 100 is generally partially surrounded by a convex portion 802, and this generally convex portion 802 is molded together with the internal skeleton element 100. The internal skeletal element 100 and the generally convex portion 802 are completely surrounded by a mesh 800. The bottom portion 806 is polymerized on the mesh 800 on the virtual bottom surface 106 with the perimeter of the convex portion 802 and the edge of the wall 110 of the elongated cell, or, instead, a suitable adhesive. By using, they are glued together in a blocking manner, thereby defining the first perimeter enclosure 807.

The first perimeter enclosure 807 is preferably surrounded by a second outer perimeter enclosure 808, and this second perimeter enclosure 808 preferably comprises a generally convex portion 810, which is generally convex. Part 810 is formed integrally with bottom part 812, which are molded together as a dress on the first perimeter enclosure 807. It is understood that the attachment of the bottom portion 806 to the convex portion 802 can be done before manufacturing the second perimeter enclosure 808, or in the same molding process. As a third alternative, either the bottom portion 806 or the bottom portion 812 may be removed.

Preferably, tube 814 leads to the interior of the first perimeter enclosure 804. The tube is preferably closed after implanting to keep the interior of the first perimeter enclosure 804 at ambient pressure.

Next, refer to FIG. This is a cross-sectional view of an implantable tissue expander constructed and functioning according to yet another preferred embodiment of the present invention, yet using the internal skeletal element 100 of FIG. 1A-1D. In the embodiment of FIG. 9, the first mesh 900 is preferably made of a highly deformable, less stretchable material, such as polyethylene or polyurethane, and surrounds the internal skeletal element 100. The term "mesh" is used in a broad sense and may be woven or non-woven, regular or irregularly shaped, and also. Includes any type of open enclosure, such as a cloth enclosure, which may have spaced openings. The mesh may be formed from a single piece or multiple pieces, or from a twist of materials, by any suitable method such as injection molding, winding, wrapping, etc.

As can be seen in FIG. 9, the internal skeleton element 100 and the first mesh 900 are surrounded by a perimeter enclosure 902, which perimeter enclosure 902 preferably comprises a generally convex portion 904, which is generally convex. Part 904 is molded with the internal skeleton element 100 on the first mesh 900. The perimeter enclosure 902 also includes a bottom portion 906, which is polymerized on a virtual bottom surface 106 with the perimeter of the convex portion 904 and the edge of the wall 110 of the elongated cell. Alternatively, they can be occluded and joined to them by using a suitable adhesive.

The internal skeleton element 100 and the first mesh 900 are surrounded by an outer perimeter enclosure 908, which generally contains a generally convex portion 910, which generally contains a generally convex portion 910. , Formed integrally with the bottom portion 912, which are molded together as a dress on the perimeter enclosure 902 and the first mesh 900.

A second mesh 914 is preferably formed or wrapped around the outer perimeter enclosure 908. Preferably, the tube 916 leads to the interior of the surrounding enclosure 902. The tube is preferably closed after implanting to keep the interior of the perimeter enclosure 902 at ambient pressure.

Next, refer to FIG. This is a cross-sectional view of an implantable tissue expander constructed and functioning according to a further preferred embodiment of the present invention, yet using the internal skeletal element 100 of FIG. 1A-1D. In the embodiment of FIG. 10, the first mesh 1000 is preferably made of a highly deformable, non-stretchable material, such as polyethylene or polyurethane, and surrounds the internal skeleton element 100 and the surrounding enclosure 1002.

As can be seen in FIG. 10, the internal skeletal element 100 is surrounded by a perimeter enclosure 1002, which perimeter enclosure 1002 preferably comprises a generally convex portion 1004, the generally convex portion 1004 being internal. Molded with the skeletal element 100 and the bottom portion 1006, the bottom portion 1006 is polymerized or replaced on the virtual bottom surface 106 with the perimeter of the convex portion 1004 and the edge of the wall 110 of the elongated cell. Therefore, by using an appropriate adhesive, they can be joined to each other in a blocking manner.

The internal skeleton element 100 and the first mesh 1000 are surrounded by an outer perimeter enclosure 1008, which generally contains a generally convex portion 1010, which generally contains a convex portion 1010. , Formed integrally with the bottom portion 1012, which are both molded as a dress on the perimeter enclosure 1002 and mesh 1000.

A second mesh 1014 is preferably formed or wrapped around the outer perimeter enclosure 1008. Preferably, tube 1016 leads to the interior of the perimeter enclosure 1002. The tube is preferably closed after implanting to keep the interior of the perimeter enclosure 1002 at ambient pressure.

Next, refer to FIG. This is a cross-sectional view of an implantable tissue expander constructed and functioning according to a further preferred embodiment of the present invention, yet using the internal skeletal element 100 of FIG. 1A-1D. In the embodiment of FIG. 11, the first mesh 1100 is preferably formed from a highly deformable, less stretchable material, such as polyethylene or polyurethane, with the internal skeleton element 100 and the generally convex portion 1102. surround.

As can be seen in FIG. 11, the internal skeleton element 100 is generally partially surrounded by a convex portion 1102, which generally convex portion 1102 is molded with the internal skeleton element 100. The internal skeletal element 100 and the generally convex portion 1102 are completely surrounded by the first mesh 1100. The bottom portion 1106 is polymerized on the mesh 1100 on the virtual bottom surface 106 with the perimeter of the convex portion 1102 and the edge of the elongated cell wall 110, or, instead, a suitable adhesive. By using, it is tethered to them in a blocking manner, thereby defining the first perimeter enclosure 1107.

The first perimeter enclosure 1107 is preferably enclosed by a second outer perimeter enclosure 1108, and this second outer perimeter enclosure 1108 preferably comprises a generally convex portion 1110, which is generally convex. The shaped portion 1110 is formed integrally with the bottom portion 1112, which are molded together as a dress on the first perimeter enclosure 1107. It is understood that the attachment of the bottom portion 1106 to the convex portion 1102 can be done before manufacturing the second perimeter enclosure 1108, or in the same molding process. As a third alternative, either the bottom portion 1106 or the bottom portion 1112 may be removed.

The second mesh 1114 is preferably formed or wrapped around the outer perimeter enclosure 1108. Preferably, tube 1116 leads to the interior of the perimeter enclosure 1102. The tube is preferably closed after implanting to keep the interior of the perimeter enclosure 1102 at ambient pressure.

Next, refer to FIG. This is a simplified diagram of the manufacturing method of the implantable tissue expander of FIG. As seen in FIG. 12, the generally convex portion 402 of the internal skeleton element 100 and the surrounding enclosure 400 is molded together as a dress, as seen in the stages shown by A, B and C. Then, in the next molding stage shown by D, the bottom portion 404 is formed and polymerized on the virtual bottom surface 106 with the periphery of the convex portion 402 and the edge of the wall 110 of the elongated cell. Will be done. Then, in another molding stage, indicated by E, an outer perimeter enclosure 406 is formed on top of the perimeter enclosure 404. Tube 412 (not shown) may be formed in this molding stage E.

Then refer to FIGS. 13A and 13B. Both of these are simplified views of the method for producing the implantable tissue expander of FIG. As seen in FIGS. 13A and 13B, the generally convex portion 504 of the internal skeleton element 100 and the surrounding enclosure 502 is dressed on the mesh 500, as seen on the stages shown by A, B and C. It is molded together as. Then, as shown in stage D, on the virtual bottom surface 106, the mesh 500 is mounted on the internal skeleton element 100, preferably fixed in an appropriate position so that the mesh does not fold. In the subsequent molding stage indicated by E, the bottom portion 506 is formed and polymerized on the virtual bottom surface 106 along with the perimeter of the convex portion 504 and the edge of the elongated cell wall 110. Tube 514 (not shown) may be formed in molding stage E.

In the subsequent molding stage, indicated by G, on the inner perimeter enclosure 502, the outer perimeter enclosure 508 is molded as a dress.

Then refer to FIGS. 14A and 14B. Both of these are simplified views of the method for producing the implantable tissue expander of FIG. As seen in FIGS. 14A and 14B, the generally convex portion 604 of the internal skeleton element 100 and the surrounding enclosure 602 is molded together as a dress, as seen on the stages shown by A, B and C. .. The bottom portion 606 is then formed in another molding stage, indicated by D, and polymerized on the virtual bottom surface 106, along with the perimeter of the convex portion 604 and the edge of the elongated cell wall 110. To. Tube 614 (not shown) may be formed in molding stage D.

Then, as shown in stage F, on the virtual bottom surface 106, the mesh 600 is attached to the internal skeleton element 100, preferably fixed in an appropriate position so that the mesh does not fold. In the subsequent molding stage, indicated by H, on the perimeter enclosure 602 and mesh 600, the outer perimeter enclosure 608 is molded together as a dress.

Then refer to FIGS. 15A and 15B. Both of these are simplified views of the method for producing the implantable tissue expander of FIG. As seen in FIGS. 15A and 15B, the generally convex portion 706 of the internal skeleton element 100 and the first perimeter enclosure 702, together as a dress, as seen on the stages shown by A, B and C. It is molded. The bottom portion 708 is then formed in another subsequent molding stage, indicated by D, and polymerized on the virtual bottom surface 106, along with the perimeter of the convex portion 706 and the edges of the elongated cell wall 110. Will be done. Tube 714 (not shown) may be formed in molding stage D.

In the subsequent molding stage indicated by E, the outer perimeter enclosure 704 is molded as a dress on the first perimeter enclosure 702.

Then, as shown in stage G, the mesh 700 is mounted on the outer perimeter enclosure 708 and preferably fixed in an appropriate position so that the mesh 700 does not fold.

Next, refer to FIG. This is a simplified diagram of the method for producing the implantable tissue expander of FIG. 8 according to another embodiment of the present invention. The internal skeletal element 100 is generally formed integrally with the convex portion 802 to form part of the first perimeter enclosure 807, which is the stage shown in A, B and C in FIG. It can be the same method as the formation of the generally convex portion 402 of the internal skeleton element 100 and the surrounding enclosure 400, as shown in and described above.

As shown in the stage shown in B, the integrally formed internal skeleton element 100 and the generally convex portion 802 are subsequently deformed to temporarily elastically fit within the mesh 800. , Here it is molded to generally match the outer surface of the convex portion 802. The mesh 800 surrounds the integrally formed internal skeleton element 100 and the generally convex portion 802 and is held in a suitable position relative to them. The mesh 800 is attached to the internal skeleton element 100 on the virtual bottom surface 106, as shown in stage C, and is preferably fixed in an appropriate position so that the mesh 800 does not fold.

Then, on the first perimeter enclosure 807, an outer perimeter enclosure 808 is formed on another molding stage that follows, indicated by D. Tube 814 (not shown) may be formed in molding stage D.

It is understood that the attachment of the bottom portion 806 to the convex portion 802 can be done before manufacturing the second perimeter enclosure 808, or in the same molding process. As a third alternative, either the bottom portion 806 or the bottom portion 812 may be removed.

Next, refer to FIG. This is a simplified diagram of the method for producing the implantable tissue expander of FIG. 9 according to another embodiment of the present invention. The internal skeleton element 100 is shown in the stage shown by AH in FIGS. 13A and 13B, and is the first in a manner that can be identical to the formation of the internal skeleton element 100 and the surrounding enclosures 502 and 508 as described above. Formed with mesh 900, perimeter enclosure 902 and outer enclosure 908.

As shown in the stage shown in B, the internal skeleton element 100, the first mesh 900 and the surrounding enclosures 902 and 908 are then temporarily elastically fitted into the second mesh 914. Transformed into, where it is molded to roughly match the outer surface of the outer perimeter enclosure 908. The second mesh 914 surrounds the integrally formed internal skeleton element 100 and the outer perimeter enclosure 908 and is held in place with respect to them.

Next, refer to FIG. This is a simplified diagram of the method of manufacturing the implantable tissue expander of FIG. According to the Stage AH methodology of FIGS. 14A and 14B described above, the second mesh 1014 is preferably formed around the outer perimeter enclosure 1008, preferably so that the mesh does not fold. Wrapped around.

Next, refer to FIG. This is a simplified diagram of the method of manufacturing the implantable tissue expander of FIG. According to the Stage AE methodology of FIG. 16 described above, the second mesh 1114 is preferably formed or wrapped around the outer perimeter enclosure 1108 so that the mesh does not fold over.

Those skilled in the art will appreciate that the present invention is not limited to those specifically shown and described above. Rather, the scope of the invention includes both combinations and partial combinations of the various features described above, as well as those improvements and modifications not found in the prior art that will be conceived by those skilled in the art who have read the above description. ..