EXTERNAL VACUUM TISSUE EXPANDER WITH SLIDABLE RIM

Abstract

A tissue expander configured to be worn by a user having a shell having an aperture formed within the shell to receive tissue expanded by a distracting force. The shell has a skirt providing a skin contact surface area against the skin of the patient, the aperture defining an aperture surface area, wherein the skin contact surface area is greater than the aperture surface area, and wherein the skirt is non-fixedly attached to the skin of the patient and slides laterally outwardly.

Claims

1. A tissue expander configured to be worn by a user comprising a shell, the shell having an aperture formed within the shell to receive tissue expanded by a distracting force, the shell having a skirt extending therefrom providing a skin contact surface area against a skin of a patient, the aperture defining an aperture surface area, wherein the skin contact surface area of the skirt is greater than the aperture surface area of the shell, and wherein the skirt is non-fixedly attached to the skin of the patient and slides laterally outwardly during application of the distracting force while worn by the user.

2. The tissue expander of claim 1, wherein the shell has an opening in communication with an external vacuum source to apply a vacuum within the shell and impart the distracting force to expand the tissue and the skirt increasingly spreads under increasing pressure in the shell.

3. The tissue expander of claim 2, wherein the opening receives a flexible tubing connected at one end to the external vacuum source and connected at an other end to the shell.

4. The tissue expander of claim 1, wherein the skirt is composed of synthetic rubber and has a lubricating layer on a bottom surface to glide over the skin, thereby reducing shear stress between the skirt and skin contact surface.

5. The tissue expander of claim 1, wherein the skirt is composed of rubber of low durometer and in the Shore OO range less than 10-15 in the shore AA.

6. The tissue expander of claim 1, wherein the skirt is less hard than the shell.

7. The tissue expander of claim 1, wherein the skirt increases the tissue contact surface area by at least a multiple of three as pressure increases.

8. The tissue expander of claim 1, wherein the skirt under pressure deflects outwardly to increase the skin contact surface area to approximately three times the aperture surface area.

9. The tissue expander of claim 2, wherein vacuum pressure can be applied for bursts over 60 mmHg.

10. The tissue expander of claim 2, wherein the increased skin contacting surface area reduces the counter pressure on the skin from a pressure above 20 mmHg to a pressure about 20 mmHG.

11. The tissue expander of claim 1, wherein an angle of the skirt shifts under increasing pressure from an inward oblique angle to an outward obtuse angle.

12. The tissue expander of claim 1, wherein the skirt angles inwardly with respect to the shell.

13. The tissue expander of claim 1, wherein a perimeter of the skirt adjacent the tissue contacting surface is shorter than a perimeter of the skirt adjacent the shell.

14. The tissue expander of claim 1, wherein the skirt has a lateral side longer than a medial side.

15. The tissue expander of claim 1, wherein the shell is removably connectable to the skirt such that shells of varying size can be selectively connected to the rim.

16. The tissue expander of claim 1, wherein the shell has a circumferential groove to receive a band to secure the skirt and shell.

17. The tissue expander of claim 1, wherein the sell and skirt are attached in a tongue and groove fashion, and a circumferential band provides an air-tight securement.

18. The tissue expander of claim 1, wherein the tissue expander maintains the tissue in an expanded state.

19. The tissue expander of claim 1, wherein the tissue expander temporarily stretches the tissue to generate a scaffold for grafting materials.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0056] So that those having ordinary skill in the art to which the subject invention appertains will more readily understand how to make and use the surgical apparatus disclosed herein, preferred embodiments thereof will be described in detail hereinbelow with reference to the drawings, wherein:

[0057] FIGS. 1A and 1B are schematic views of the forces encountered (biophysics) with an external vacuum expander with FIG. 1A showing a cross-sectional view and FIG. 1B showing a front view;

[0058] FIG. 1C is a schematic view of the shear effect during use of an external vacuum expander of the prior art;

[0059] FIGS. 2A and 2B show how the vacuum applied to the device of the prior art with an adhesive gel rim squeezes the breast like a vise as the rim deflects inwardly to dissipate the shear stress with FIG. 2A showing no vacuum and FIG. 2B showing applied vacuum;

[0060] FIG. 2C shows how limited inward deflection of the adhesive rim of the prior art such as the device of FIG. 2A causes skin damage from shear forces;

[0061] FIGS. 3A and 3B provide illustrative examples of the shear effect of an embodiment of small and large vacuum expander domes (shells) of the prior art;

[0062] FIG. 4 is a schematic side view of the external vacuum expander of an embodiment the present invention shown in contact with breast tissue, the arrows indicating the shear forces that are dissipated due to gliding of the dome;

[0063] FIGS. 5A, 5B and 5C are schematic side views of the vacuum expander of an embodiment of the present invention showing its adaptation from no contact (FIG. 5A) to mild pressure (FIG. 5B) to full pressure (FIG. 5C);

[0064] FIGS. 6A and 6B are perspective views of an embodiment of the vacuum expander of the present invention illustrating the rim skirt of the dome (shell) widening for adaptation to the complex convex contour of the torso;

[0065] FIG. 6C illustrates the wrapping of the skirt of FIG. 6B when applied to the convexity of the torso;

[0066] FIGS. 6D and 6E show how when the dome of the present invention is forced down on a flat surface (FIG. 6D), the rim skirt widens and its periphery is stretched (FIG. 6E);

[0067] FIGS. 6F-6J show various views of an embodiment of the vacuum expander of the present invention;

[0068] FIG. 6K is a perspective view of an asymmetric skirt with a groove to facilitate attachment to the dome;

[0069] FIG. 6L is a perspective view of an asymmetric skirt of FIG. 6K showing the circumferential band to attach the skirt to the dome;

[0070] FIG. 6M shows the skirt of FIG. 6K opening under vacuum;

[0071] FIG. 6N shows the inward camber of the skirt with respect to the vertical plane;

[0072] FIGS. 7A-7C are schematic side views illustrating the adaptation of the skirt of the vacuum expander of an embodiment of the present invention from no contact (FIG. 7A) where the skirt has a concave cambered inward curvature, to low pressure (FIG. 7B) as it gradually opens up, to high pressure where it is fully opens (FIG. 7C), the dome shown attached to the rim/skirt;

[0073] FIG. 8 is a view similar to FIG. 7A showing other depths of the dome shell attached to the skirt and also showing an alternative design with an additional inner thin and compliant deflecting rim that increases the contact area against the skin to improve the vacuum seal;

[0074] FIGS. 9A and 9B show how the skirt of the vacuum expander of an embodiment of the present invention is shaped to wrap around the chest and hug the skin surface contour due to its tapered fins while FIGS. 9C and 9D show how the thin feathered edges might tend to roll up from tension around the periphery and the edges do not wrap around to follow the chest contour in the absence of the fins of the device of FIG. 9A;

[0075] FIG. 10 is a schematic view of an alternate embodiment of the vacuum expander of the present invention having one embodiment of a tightening mechanism to secure the flexible rim/skirt to interchangeable harder shells;

[0076] FIG. 11 is a schematic view of an alternate embodiment of the vacuum expander of the present invention having an inner feathered lip and pockets/slits to insert reshapeable fins to follow the convexity of the chest contour;

[0077] FIG. 12 is a schematic view of an alternate embodiment of the vacuum expander of the present invention having thin tapered fins with arcuate notches between the fins to prevent roll up eversion;

[0078] FIG. 13 is a side view showing an alternate embodiment of the expander of the present invention having different depths shell domes with a constant base to interface with the rim skirt;

[0079] FIGS. 14A and 14B illustrate a mastectomy patient wearing a bra incorporating an embodiment of the vacuum expander of the present invention and holding a small pump; and

[0080] FIGS. 14C and 14D illustrate a cosmetic augmentation patient wearing a bra incorporating an embodiment of the vacuum expander of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0081] The current invention utilizes advances in materials technology such as in silicone rubber and in urethane and in other synthetic rubber materials technology to provide a solution to all three problems/challenges enumerated in the Background section above: [0082] 1) Preserving the vacuum within the dome (shell) by avoiding air leaks despite the complex surface contour of the torso, its wide individual variation, and the significant surface topography changes caused by movement of the torso and shoulders. [0083] 2) Balancing the distractive force applied to the breast with the counter-force exerted by the rim of the external vacuum expander in contact with the surrounding skin to prevent excessive pressure that would collapse capillary circulation and lead to pressure ulcerations. (The arrows show in FIG. 1A the distractive force by the vacuum vs the counter force and its relation to the area under the dome and pressure). [0084] 3) Reducing the shear stresses that develop at the junction between the tensed skin inside the vacuum shell and the skin firmly held down and anchored by the inner lip of the rim. This reduces skin irritation, blistering and ulceration caused by shear forces concentrated at the inner lip of the rim.

[0085] The solutions to each of these problems/challenges (referred to below as #1, #2 and #3) are discussed in detail below. This is achieved by a vacuum expander with a dome (shell) or other shaped device attached to a uniquely designed and configured rim (also referred to herein as a skirt) which interacts with the skin in a unique fashion and functions in ways different from prior and current vacuum expanders. Note solutions to address any one of the aforementioned three problems/challenges provide an improvement over prior and current devices so that the present invention in some embodiments can address only one or only two as well as all three of the problems/challenges.

[0086] The tissue expanders of the present invention use pressure from an external vacuum source or from recoil of its rubber rim or semi-rigid shell to impart a distracting force that can expand tissue. The device is composed of a shell (also referred to herein as a dome when dome shaped) which forms a more rigid section for the tissue to expand into and a softer rim which is in contact with the tissue to serve as an interface between the dome and tissue. The rim can have a connection mechanism, for permanent or releasable attachment to the dome. A pump, sensor and servomechanism control vacuum pressure within the dome and the pump communicates with the interior of the dome via a tube(s) from the pump extending to or into an opening in the dome. Alternatively, if the recoil of the rubber rim is used to generate the vacuum, an adjustable pressure release/relief valve can be included to prevent the accumulation of higher vacuum pressures that can be damaging to the tissues.

[0087] The prior art teaches the use of adhesive to secure the vacuum expander to the skin. However, the present inventors, after years of study, discovered that the use of adhesive caused various problems, such as those enumerated above. The inventors discovered that providing an opposite effect, that is, to allow the skin under the vacuum expander to glide or slide, rather than be adhesively secured to lock movement, actually provided significant reduction in shear stresses and significantly reduced skin damage from excessive shear forces. Thus, the expanders of the present invention developed by the inventors, which are non-fixedly/non-adhesively attached to the skin, operate in a way not contemplated, and in fact opposite to, the teachings of the prior art. The present inventors also recognized the limitations of current rim configurations and discovered unique features for the rim to improve its adaptation to the wearer's body.

[0088] The present invention provides superior results in tissue expansion via vacuum. Such tissue expansion is described below for breast expansion/augmentation, but could also be used for expansion/augmentation of other body tissue.

[0089] To maintain an air-tight seal (challenge #1) and balance the distractive force with the counterforce (challenge #2), the devices of some embodiments of the present invention replace the adhesive gel bladder of the prior art with a deeply concave, wide, tapered, soft low durometer rubber rim forming a skirt that deflects to open and spreads out under the effect of the downward vacuum force. This increases the surface contact area and improves the seal. This can be appreciated with reference to FIGS. 5A-5C. FIG. 5A shows the vacuum expander when not in contact with tissue (the skirt (rim) 102 is spaced from the tissue). When pressure is applied, the expander adapts/conforms to the complex surface contour of the body, absorbs to body movement by bending and deflects with increasing force to increase surface contact. This conformance can be seen when partial (mild) pressure is applied to expander 100 as skirt 102 spreads laterally outwardly and conforms to the skin surface S (FIG. 5B) and when full pressure is applied as shown in FIG. 5C, with increased surface area contact. The undersurface 102a of the rim (skirt) 102 better engages the skin as its shape changes as shown in FIG. 5C. Thus, with increasing downward force, the rim of the device deflects (i.e., moves laterally outwardly) to increase the surface contact and prevent an increase in counter pressure against the peripheral skin, i.e., keep pressure against the skin at safe levels. (Note the rubber rim is not adhesive and glides over the skin due to a lubricating layer as described in detail below). Furthermore, the deeply concave design/configuration of the skirt/rim forces its feathered-out periphery to grip down and espouse the complex convex surface contour of the torso to maintain the air-tight seal. This deflective conforming soft rubber skirt can also accommodate a significant amount of body motion without losing the vacuum seal.

[0090] A comparison of FIGS. 6A and 6B shows for illustrative purposes the widening (lateral outward spreading) of the skirt 102 when the dome 104 of the device 100 is forced downward on a flat surface by increased vacuum pressure. The widening/spreading can also be seen by comparing FIGS. 6k and 6M. It is designed to bend and widen (deflect out) in order to increase the surface contact as the vacuum pressure increases (more downward force is applied). That is, when applied to the convexity of the chest, the peripheral rubber rim is under two forces: inwardly pulling from circumferential stretch and downward flexion arc from resistance to bending (see arrows of FIG. 6C). These forces combine to make the skirt edge 102b wrap around the chest, grip the torso and tightly espouse its complex surface contour. The inward camber 102b of the skirt periphery (see FIGS. 5C and 6B) improves the grip as the circumference stretches. FIG. 6A shows the skirt 102 extending from the dome 104 of the expander 100 prior to application of pressure; FIG. 6B shows the skirt 102 expanded upon application of pressure as the diameter/or transverse dimension D2 of the skirt 102 is greater than the diameter/transverse dimension D1 of FIG. 6A. A comparison of FIGS. 6D and 6E and of FIGS. 6K and 6M also show that when the dome is forced down on a flat surface, the rim skirt widens and its periphery is stretched. As shown, the skirt moves to a substantially flattened form. The inward camber (angling inwardly from the vertical plane improves gripping of tissue as it creates additional stress on the rubber rim as it opens up, i.e., tangential tension (stress) becomes stronger if the perimeter is smaller. Thus, the periphery is under greater tension as compared to an obtuse angle which is not under increased tension as it opens up. The rim has an inward angle I beyond the vertical plane P as shown in FIG. 6N and has an additional concavity along the skin contact area. The inward folding accentuates the concavity. The circumference at the periphery of the rim is shorter than the base. Therefore, as the rim flattens and its tip spreads wider with increasing pressure, the shorter circumference of the peripheral rim edges creates a higher tangential elastic stress on the outermost rim forcing it to better inward grip the tissue. If the skirt comes down at an obtuse angle to the vertical, it does not achieve as good a seal around the chest.

[0091] Taking into account the elasticity of the rubber material, its thickness and taper angle, the mechanical properties of the rim are engineered such that by spreading and widening with increasing downward force it increases the skin contact area to maintain the surface counter pressure below damaging levels. Furthermore, the design also prevents pressure points and ensures an even pressure distribution along the contact area. That is, because the thinner more malleable edge deflects more while the thicker proximal part deflects less, a relatively constant downward force is maintained on the tissues along the width of the rim.

[0092] FIGS. 6F-6J illustrate the configuration of the device 100, with aperture 124 within the dome, shown from various angles—side, bottom, top, etc. The shape of the preferred configuration of the rim interface is a skirt as shown in FIGS. 5A-5C and 7A-7C. It is long (e.g., about 2 cm to about 5 cm medially to about 4 cm to about 9 cm laterally), although other dimensions are also contemplated, tapers down, cambers inwardly and is deeply concave, (e.g., its axis is less than 15° from the vertical axis X, although other angles are also contemplated). It has a non-adhesive, non-adherent, very low durometer rubber sole that espouses the body contour and is designed to increase surface contact with increasing pressure by deflecting out and spreading. The very soft concave, inward cambered, rubber skirt with thin tapered edges is designed for prolonged atraumatic and comfortable contact against the skin as it can be worn by the user for an extended period of time, e.g., for days, weeks or even months.

[0093] As shown in the Figures, the rim tapers in thickness with a maximum thickness at the top 107 (closer to the dome 104 where it is connected at region 108), e.g., approximately 1 inch, tapering to a maximum of a few millimeters for example at the periphery 109. In some embodiments, it tapers (narrows) down at region 114 (see e.g., FIG. 7A) to a thinner feather thickness having a feathered edge 116 at a distalmost edge. An inner thin and very compliant feather 112 can be provided for additional seal. This thin feathered inner lip 112 provides a wider and better seal. Other thicknesses along the various regions of the rim are also contemplated to absorb movements, prevent pressure points, and more evenly distribute the counter pressure against the skin.

[0094] The rim is also in preferred embodiments an asymmetric design (see e.g., FIGS. 6A, 6B and 6F-6N), with a narrower (shorter) skirt 121 medially over the sternum and longer, more curved inward skirt laterally to wrap around the torso. By way of example, it can have a long flange with a maximal length of about 3 inches on the lateral side, and minimal length of about 1 inch medially, although other dimensions are also contemplated. This asymmetric design provides the lateral side 121 with a deeper concavity and longer than the medial side 123 to wrap around the body contour. Thus, the skirt wraps around the right or left side of the chest with less contact surface in the midline. Note the thickness and length do not need to be uniform along the circumference as there is typically a left and a right side. The skirt rim 102 at rest (FIG. 7A), i.e., no contact of inner surface 102a with the skin, has a concave or straight down curve (see concave surface 103) in cross section with an inward camber 114 (accentuating the concavity) to force it further inward and grip the curvature of the torso as the periphery stretches out. The concavity becomes a convexity (see convex surface 105) where the downward force is highest under the harder rim and then feathers out as needed to even maintain some concavity at the very edge if needed to espouse the body contour. It angles significantly downward from the horizontal plane to form a long skirt-like rim. The downward angle could be constant or could vary. It typically can vary along the periphery. In preferred embodiments, the angle X from the horizontal is 45-85 degrees (or 45-5 degrees from the vertical), although other angles are also contemplated, thereby providing a large concavity depth. The skirt and its connection to the more rigid dome are designed such as when the vacuum pressure increases and the downward force increases, the angle X opens up and increases from near vertical to become more horizontal, and to keep the pressure even all around the periphery, it increase more on the shorter (narrower) medial side. The segment under the rim will change from concave to convex while the periphery, especially the lateral side, might need to remain concave to preserve seal as seen in FIG. 6C. Stated another way, the angle X varies from near vertical to 60 or near horizontal with application of pressure. Thus, when downward pressure is applied, a downward force from the dome is counteracted by the skin and the rim can stretch out to from a concave to a convex or near flat configuration at its highest pressure point while remaining concave at the lateral peripheral edge, and the counterforce between the skirt and tissue is evenly distributed over a contact area of the skin to avoid pressure points with increasing pressures.

[0095] FIG. 6N illustrates the concave skin contact surface f of the right-left asymmetric rubber skirt and the inner lip b of the rubber skirt for additional skin contact and better air tight seal. The entire concave skin area flattens under increasing vacuum pressure. Reference letter e designates the pivot point of the rubber skirt as the skin contact surface area can pivot under increasing vacuum pressure from an inward oblique direction/angle to an obtuse outward direction/angle around area e of the rubber skirt when applied over the torso. The soft rubber skirt wraps around the chest and the tangential tension resulting from the very wide stretching grips the tissue for a better seal. As discussed in detail herein, the low friction/lubricated base allows the rubber to slide over the skin for a large distance as it spreads open A cane handle recess C of the skirt receives a cane handle shaped part a, i.e., the cane handle a fits within the cane handle recess c in a tongue and groove fashion.

[0096] The rim, with its deep concave shape, is preferably made of a low durometer synthetic rubber material such as silicone or newer formulations of urethane. Thus, it is the soft rubber that contacts the skin. With increasing pressure, the rim increases its deflection to increase the contact area and reduce the counter-pressure exerted on the skin. Furthermore, it is designed such that the applied vacuum does not cause it to buckle inward and get sucked into the dome section. (This would reduce the aperture of the expansion surface). In preferred embodiments, a low durometer (anywhere on the entire Shore OO scale), or on the low shore A scale (less than 25 Shore A, and preferably less than 15 Shore A) rubber, preferably silicone or medical grade urethane is utilized. Such materials have the required softness (close to gel like) to be comfortable and elastic rigidity to properly deflect and evenly distribute the pressure as the rim which contours to the skin surface deflects with pressure. (While there are different overlapping shore scales, it is understood that any scale used would be specifying materials of similar and crucial mechanical property as the ones mentioned above. It should also be noted that these are novel materials not widely available until recently for medical use). However, different materials, and combination of materials of different durometers, are also contemplated. The rim material is stretchy enough (very low durometer rubber) so that when pressure is applied and the downward force from the dome is counteracted by the skin, the skirt can stretch out to a flat or near flattened shape as it glides open and allows skin recruitment. Though more complicated to manufacture, it is also contemplated in alternate embodiments to have the skirt made of varying durometers along its thickness and circumference in order to reduce bulk weight and make it more comfortable and concealable, provided the concavity, the taper angle, the width and the deflection property under downward pressure preserve adequate deflection under the physiologic pressures used to evenly distribute the pressure avoiding pressure points. That is, the softer durometer material is more comfortable and conforming against the skin, but is bulkier (thicker). (In some embodiments, the softer durometer can be like a gel). The higher durometer is thinner but less comfortable. Thus, in some embodiments, the durometer can vary so it is harder adjacent the center of the dome to provide reinforcement to hold it together and softer at the periphery for comfort and conformance. In some embodiments, the variable durometer concept can be utilized so that it progressively decreases in durometer toward the periphery. In such variable durometer embodiments, the delicate balance needs to be achieved between comfort/conformance and reinforcement.

[0097] The rim/skirt design variables include durometer of the material (e.g.,) rubber, its mechanical properties, its thickness, its rate (angle) of taper, its concavity, its length and its shape, and these variables are design engineered/optimized in order to increase surface contact with increases in vacuum pressure to decrease the counter pressure on the skin—as the skirt flattens with downward pressure, the counter force between the skirt and the tissue is evenly distributed all over and around the contact area. The above variables are design engineered such that there are no concentrated pressure points, but rather a distribution, preferably an even distribution, all over the skin contact area. The taper angle and concavity are also designed to evenly distribute pressure under the spread out skirt such to avoid pressure points. With increasing pressure, the rim increases its deflection, i.e., deflects out and widens, to increase the contact area and thereby reduce the counter-pressure exerted on the skin. The design leads to a near linear relation between vacuum pressure increases and surface contact area increase. To illustrate, when the vacuum pressure doubles, the rim flattens and spreads out to double the contact surface against the skin and keep the pressure it exerts against the skin low and even all around its circumference. This property of the concave tapered deflecting rubber sole that increases surface contact with increases in the downward force balances the forces to keep the skin pressure below damaging levels.

[0098] Thus, the devices of the present invention are designed to decrease the frictional shear forces as the smooth (and lubricated in some embodiments) rim/skirt slides and deflects with minimal force (lowest durometer rubber) thereby allowing the dome to push down and the rim to slide without skin damage.

[0099] FIG. 8 is a view similar to FIG. 7A schematically showing other depths of the dome shell 124 attached to the rim 122 of expander 120 and also showing an alternative rim design with an additional inner thin and compliant deflecting rim 122 extending inside the dome aperture that increases the contact area against the skin to improve the vacuum seal. This thin inner rim is very soft and compliant, it is not designed to distribute the pressure but to improve the surface contact against the skin and therefore the seal. The rim can include a feathered region 129 similar to feathered region 112 of FIG. 7A. The domes 124 can be permanently attached or interchangeable as described below.

[0100] FIGS. 7A-7C illustrate the increased contact area as pressure increases. In FIG. 7A, the vacuum expander 100 of the present invention is shown with inner/lower surface 102a of rim 102 not in contact with tissue. The long, tapered low durometer rubber rim and the near vertical axis of the rim skirt in this no-contact position are illustrated. As shown, the concave configuration 114 cambers inwardly to hug the chest contour and prevents the edges from flipping up under elastic recoil as the perimeter increases with increasing elastic stretch. The cambered inward curvature forces the periphery to hug tissues down with increasing stretch. Under low pressure (arrow C of FIG. 7B), as it gradually opens up, the rim 102 deflects (see region 118) and conforms to the skin surface (breast edge and curved chest contour). As the downward force increases under higher pressure (arrow D of Figure C), it fully opens as the rubber rim 102 bends outward and spreads out to increase surface contact (FIG. 7C) and keep the pressure against the skin at safe levels. The edge wraps at periphery 109 around to conform to the body contour.

[0101] A thin feathered inner rim (feathered lip) to increase contact area and improve the seal could be provided, as illustrated in FIGS. 7A-7C and 11. In some embodiments, as shown in the expander 140 of FIG. 11, a fin pocket 142 or slit can be provided to insert fins 144 to follow the convexity of the chest contour. The fin 144 can be reshapeable and repositioned along the perimeter of the rim to best follow the chest surface contour. The fin pocket 142 in some embodiments could address the issue of the skirt folding up and out under the effect of the peripheral tension and not adequately wrapping around the torso at the lateral chest border as shown in FIGS. 9C and 9D. By providing the fins that curve inwardly and are feathered in configuration, there is less inward force at the tip (see FIGS. 9A and 9B). Expander 140 can also have an inner feathered lip 143 for an additional seal. The concave shape 148 and feathered edge 150 of rim 146 better conform to the torso as described herein. The non-adhesive tapered soft rubber sole 146 deflects outward with pressure as in the embodiment of FIG. 7A-7C. The dome 134 is attached to rim 146, and has peripheral edge 136. Furthermore, in some embodiments the fins can be a permanent component of the skirt. The dome shell might include a thickened rim or a cane handle design at its periphery to increase surface contact against the soft skirt and prevent it from cutting into it.

[0102] With respect to shear stresses (challenge #3), the above vacuum expanders of the present invention completely solve the shear stress problem. The forces and shear effect can be appreciated with reference to FIG. 1C and are also described in U.S. Pat. No. 6,500,112 (same inventor as the present invention). (The entire contents of U.S. Pat. No. 6,500,112 are incorporated herein by reference). The objective is balancing counter pressure and reducing skin shear stress as described in the '112 patent. FIG. 1C shows the inward deflection of the adhesive gel rim of the prior art Brava device to dissipate shear forces with the drawing on the left showing the shear effect and the drawing on the right showing the reduction of shear stresses due to the inwardly deflecting adhesive rim (sole).

[0103] In the present invention, a soft rubber rim (skirt) instead of an adhesive rim is provided. The soft rubber rim maintains a vacuum seal by faithfully espousing the body contour so there is no need for an adhesive layer (or other skin-adherent layer) so the rim is thus non-fixedly/non-adherently/non-adheredly positionable on the skin of the patient to enable sliding outwardly. The device rim (skirt) can have a lubricant or other material to provide near friction free gliding between the skin and the skirt that opens to wrap around the body. With the contact surface no longer glued and anchored to the rim as in devices using adhesive (or other adherent material or structure) which fix the position of the rim and device, the skin is free to move, and the tension can recruit as much peripheral skin as necessary to dissipate the damaging shear stress. With this near free tissue recruitment there is lower strain, lower force, and lower shear stress.

[0104] Thus, the vacuum expanders of certain embodiments of the present invention have a lubricated skin-to-rim sole contact area to allow a friction free skin recruitment (and sliding/gliding) that dissipates the shear forces. The lubrication reduces shear stress between the contact surfaces of the skin and the device. In the prior art, the skin is anchored to the contact surface via high friction interfaces or more frequently via adhesives. Lubrication of the present invention takes away this anchoring and thus removes or reduces the shear force.

[0105] The lubricant or a low friction film can be applied in one or more of the following ways: a) applied to the skin before placing the device on the skin; b) applied to the bottom (lower) surface (sole) of the rim itself before placing it on the skin and/or c) be in the material of the rim so that it continually lubricates. (The bottom (lower) surface refers to the surface closer to the tissue, e.g., breast tissue, and is also referred to herein as the sole or base). The lubricant or low friction film can be added separately, or alternatively, the rim sole material can have an inherently low friction coefficient thus removing the need for lubricant or film. Thus, the device is non-adhesive/non-adherent to the skin and has a low friction smooth contact skin surface either inherent or by the addition of a lubricant or film interface. Such lubricants which can be utilized to remove or reduce the shear forces between the skin and the device contact surface (rim) include by way of example, grease, petroleum jelly, oils, waxes, KY Jelly, glycerin, hydroxyethyl cellulose, water, liquid, jell, cream, or wax of any type, an Allergen free lubricating material with excellent skin tolerance such as cocoa butter, petrolatum gel, Vaseline, Nivea, Aloe Vera, mineral oil, etc., or a combination of these.

[0106] FIG. 4 illustrates damaging shear forces (arrow A) created when the vacuum inside the dome pulls inward the skin held under the rim. The rubber rim of the present invention is non-sticky and allows free skin gliding and has a low friction coefficient against the skin (either inherent in the material or via application of lubricant on the skin or rim sole). As shown by arrow B in FIG. 4, the shear forces are dissipated due to the gliding of the lubricating layer that allows inward skin recruitment.

[0107] The limited deflection under higher pressure of the adhesive rim of the prior art can be appreciated by the photographs in FIGS. 2A and 2B showing no vacuum in FIG. 2A and application of vacuum in FIG. 2B. With higher pressure, the adhesive rim deflects inwardly and fails to dissipate additional shear forces, reduces the aperture expansion area and squeezes the breast like a vise. The high pressure can also delaminate and destroy the silicone gel rim. FIG. 2C illustrates an example of how limited inward deflection of the adhesive rim of the prior art can cause skin damage from the shear forces.

[0108] Examples of the shear effect in a small and large dome (shell) of the prior art, illustrating how a larger aperture pulling on a larger surface will tend to create more inward pull and therefore more shear force concentrated at the rim that can damage the skin are depicted in FIGS. 3A and 3B. As shown, rims 11a, 11b are attached to domes 10a, 10b, respectively, positioned on skin S. When suction (vacuum) is applied to a small dome 10a (FIG. 3A), the shell (dome) moves from a flat to a dome shape, and 3 cm of skin (breast width) will elongate 10% (3 mm). When suction (vacuum) is applied to a large dome 11b (FIG. 3B), the shell (dome) moves from a flat shape to a dome shape, and 12 cm of skin (breast width) will elongate 10% (1.2 cm). If the rim is held firmly at the edges, i.e., by the adhesive of the prior art, the 1.2 cm causes higher shear that cannot be accommodated and the skin will tear. The devices of the present invention prevent this by, as discussed above, 1) enabling the rim to deflect inwardly; 2) having a lubricated interface to freely recruit peripheral skin; and/or 3) having a friction fee recruitment of the non-adherent rim base.

[0109] Vacuum Pressure (P) generates a downward force (F) on the skin that is a function of the aperture surface area (S) (F=P×S). That force is balanced by a counter-force against the skin. The force F in the devices of the present invention has to be gently dissipated against the skin as opposed to other suction devices that are designed to pull out and extract. Thus, the rim contact surface area needs to increase in order to diminish the pressure on the skin.

[0110] A sustained high pressure cannot be tolerated because after more than a few minutes the skin breaks down. Therefore, the soft rubber rim/skirt (sole) of the device is designed to significantly enlarge its surface contact area in order to reduce the pressure on the skin with increasing vacuum pressure. The Forces are balanced according to the following formula: F(in)=Aperture Surface area×Vacuum Pressure. This is balanced by F(out)=Skin contact Surface area×Pressure applied to the skin. According to Newton, F(in)=F(out). In devices unlike the present invention which are designed to grip and pull out, e.g., a vacuum applier for a fetus, a high pressure needs to be applied to the skin in order to grip and pull out. Therefore, the skin contact surface area has to be small compared to the aperture area. The devices of the present invention are designed for prolonged contact, e.g., several continuous hours at a time (over a span of days, weeks or months), and cannot afford high pressure against the skin. Therefore, the skin contact surface area needs to be much larger. That is, the ratio of aperture surface area to skin contact surface area needs to be greater. (A large aperture and small contact area in contrast is designed for higher gripping pressures against the skin for gripping and extraction; the devices of the present invention have a large contact area relative to the smaller aperture area). Stated another way, for a given aperture surface area and vacuum pressure, the devices of the present provide a much larger skin contact surface area.

[0111] Thus, the rubber rim/skirt of the devices disclosed herein spread out to significantly increase skin contact surface area to maintain a low pressure on the skin. Therefore, the deflecting rim significantly increases skin contact surface area with increasing vacuum pressures. (As it glides outward with minimal friction, the surface contact area increases as the vacuum pressure increases in order to minimize skin damage). To give illustrative numbers to aid understanding, in one example, the device has a dome aperture about 4.5 inches in diameter but its skirt can extend the surface contact diameter by another 4.5 inches. We calculate the resting surfaces at 3.14×2.25×2.25=15.8. Increasing the surface contact diameter by another 4.5 inches gives 3.14×4.5×4.5=63.6 square inches for an increase surface contact area of 63.6−15.8=47.8. inches. Thus, the device increases surface contact area by 47.8 sq inches. Clearly, other dimensions to increase the surface contact area are also contemplated.

[0112] The maximal tolerable pressure against the skin is 20 mmHg or about 0.4 PSI. Pressure on the skin above this level occludes the capillaries and with no blood flow for more than a few minutes causes tissue damage. The devices of the present invention function at vacuum pressures of 20 to 60 mmHg, and in some instances can function at vacuum pressures of 100 mmHG for short bursts. This means that they can function at about 3 to 4× (times) the tolerable pressure of 20 mmHg. However, to maintain the pressure against the skin at below 20 mmHg, the rim has to increase its surface contact area 3 to 4× (times) as the pressure increases.

[0113] Stated another way, and to give illustrative numbers to aid understanding, in one example the diameter of the device dome aperture that applies vacuum pressure on the skin is about 4.5 inches (radius of about 2.25 inches). This corresponds to an aperture area of 2.25×2.25×π=about 15.8 sq inches.

[0114] The rim is designed such that its skin surface contact area starts from minimal with no pressure applied (only the thin feathered distal end of the near vertical standing rim provides contact) to an additional approximately 2 inches to approximately 2.5 inches (about 2.25 average.). This gives a surface contact area as follows:

Contact area=Total area−Aperture area=[(2.25+2.25)×(2.25+2.25)×π]−15.8=47.8 sq inches.

[0115] This means with increasing vacuum pressure, the rim with the forgoing dimensions can deflect outward to increase its surface contact by 3× the aperture area. (Other ratios are also contemplated) This effectively reduces the counter pressure on the skin from the 60 that is not tolerable to 20 that can be tolerated long term. As can be appreciated, other dimensions are also contemplated which would still provide a surface contact area which is multiple of the aperture area, and with increased surface contact area providing larger multiples.

[0116] The vacuum expanders of the present invention in preferred embodiments have an external portable vacuum pump with a pressure control mechanism. However, in alternate embodiments, a manual pump such as a bulb can be utilized. With manual pumps, a pressure relief valve can be included to prevent vacuum pressure from reaching damaging levels. Flexible rubber tubing can be connected at one end to a separate external vacuum pump and at the other end to an opening in the dome to apply a vacuum within the dome/shell and impart a distracting force to expand tissue into the shell.

[0117] The devices of the present invention can alternatively function without a pump since surface tension is not required. In such embodiments, the vacuum source is the elastic recoil of the rubber sole. The device is placed over the breast and the air is “burped” out until the rim flattens down completely. At that point, the vacuum pressure inside the dome is a function of the elastic recoil force of the rubber and the surface aperture area of the dome. (Pressure=Force/Surface area). Given a fixed surface of the breast, the rubber sole shape design and its modulus of elasticity determine the force required to maintain the pressure within safe therapeutic range. A relief valve could also be included for added safety. Stated another way, the device would use surface tension in the dome section of the device to adhere to the skin so an active vacuum is not needed. The concept is to burp the air out of the flexible dome and rely on the natural recoil of the dome and/or dome rim to pull on the breast tissue.

[0118] In some embodiments, a special garment bra can hold the device in place. This can offer the same effect as pressing the feathered edge of the skirt to fold down and wrap around the chest contour to maintain the seal. The bra has first and second apertures or openings that hold the rubber rim and the dome. This component secures the device as the non-sticky device would otherwise fall off whenever the pressure abates. The bra can have a special design to include a series of reinforcement straps and/or padding cushions that maintain the loose feathered peripheral edges of the skirt in firm contact with the skin all around the breast in order to ensure the vacuum seal. The bra hugs the body contour to force the feathered edges to stay in contact with the skin. Reinforcing bands can connect the bra to the rim.

[0119] In some embodiments, a tapered thin additional inner rim that blends with the outer rim to increase the sealing surface without interfering with the vacuum expansion force can be provided.

[0120] In some embodiments, the rim is radially reinforced with a series of adjustable thin tapered concave fins to better hug the body contour. FIGS. 9C and 9D are photographs showing how the thin feathered edges of the rim could in certain applications roll up from tension around the periphery and the edges not wrapping around to follow the chest contour; FIGS. 9A and 9B are photographs showing how the rim of the vacuum expander of the present invention is shaped to wrap around the chest and hug the skin surface contour to avoid the pitfalls of the expander of FIG. 9C and 9D. The rubber rim, in these alternate embodiments of FIGS. 9A and 9B, has thin tapered fin-like inward cambered ribs to wrap around the chest and hug the skin surface contour. The ribs can be inserted inside pre-formed pockets at the outside surface of the skirt to provide additional inward camber if desirable. The ribs can be provided at select locations where they are needed to best espouse the patient's particular chest wall surface topography. The rim can also have arcuate notches between the fins to prevent its eversion as the periphery stretches with increasing surface contact. An example of an expander with tapered fins is shown in the embodiment of FIG. 12 wherein the fin 153 extends from the peripheral edge 156 of dome 154 to the end 155 at edge 157 of skirt 152. FIG. 11 also shows a fin 134 to reinforce the rim 146 extending to a peripheral edge 136 of the dome shell.

[0121] FIGS. 6F-6N shows the left/right asymmetry of the skirt as in the aforedescribed embodiments with more length laterally to conform to the lateral chest, a shorter medial length over the sternum to limit medial overlap and a deeper angle laterally to hug the side of the chest. The ribs/fins placement, curvature and length can be adjusted to fit individual patients, i.e., fitted with ribs/fins of different size, camber, stiffness, etc. where necessary along the circumference of the rim to achieve the best air tight fit based on the patient's torso contour. The drawings of FIG. 6F-6M show various views of an embodiment of an asymmetric dome of the present invention. Note the asymmetry in length and curvature between the medial and the lateral sides of the dome skirt. Also note the length, the near vertical design and the gently inward curved feathered edge.

[0122] In some embodiments, the rim can have an arcuate periphery that spikes at the reinforcing rims and is concave in between (duck feet).

[0123] In some embodiments, ribs of varying curvature and length judiciously inserted inside the rubber skirt at various points within its periphery can help it better adapt to the potentially complex and variable surface contour. Edges of the rim can also have an arcuate periphery with peaks at the site of the reinforcing ribs. A variable durometer construct, such as described herein, could also produce the same effect without the additional bulk.

[0124] In some embodiments, interchangeable breast shaped dome shells can be provided. A connector mechanism such as circumferential clasping/tightening mechanism 132 can be provided to secure the rubber sole (rim) 132 to the interchangeable shells (FIG. 10) and allow for easy removal and replacement with the selected dome. FIG. 6K shows an embodiment of the skirt having a recess/groove 131 for receiving a circumferential tightening band (removable in interchangeable shell embodiments) that helps achieve an airtight seal to the tongue-groove attachment of the shell and skirt as it applies a force against the rim. The band wraps around the skirt within the groove for attachment of the rubber skirt to the base/rim of the hard dome as shown in FIG. 6L. (Note when expanded as shown in FIG. 6M, the outward rotation of the skirt around the rotation point obscures the view of the tightening band).

[0125] It should also be noted that the design and the circumference of the rubber skirt can be slightly smaller than the circumference of the harder shell dome at their connection areas and configured such that the stretch of the rubber skirt in itself already provides an intrinsic lock and seal similar to the Tupperware seal of food items. That is, using for example a thick rubber band or an elastic string or a tightening band with an easy snap-tightened or spring lock tightened connection between the silicone rim skirt and dome, domes of various depths can be provided. In use, the connector mechanism is released, one dome is removed and a larger dome is secured to the rim by the connection mechanism. This allows the wearer to use the smallest, most innocuous (most concealable) to wear dome that still provides 1-2 cm of room for expansion. Once the breast expands to fill that small dome, the user can easily switch to a slightly larger one keeping the device worn as concealed as possible which is beneficial since the device should be worn near continuously.

[0126] It is also contemplated to have markers on the dome and/or on the skirt that need to match so when the dome is removed and replaced, the patient properly connects a new dome, e.g., easily matches the top with the bottom and the left with the right to preserve the desired asymmetric configuration. This can ensure that the domes are replaced in the proper orientation (especially if the same molds are used for the right and the left domes and skirts).

[0127] The multiple depths of the dome shells, e.g., from an AA bra cup to a DDD bra cup, are shown in FIG. 13. The domes of different depths are attached to a constant base to interface with the rim skirt. Examples of various sized domes, e.g., 164a, 164b, 164c and 164d, are all shown attached to the base in FIG. 13 for illustrative purposes as it should be understood that one dome at a time (progressively increasing in size as the breast or other tissue, depending on its clinical application, expands over time) would be attached to the base/rim. Additional or fewer number of domes could be provided. The device can be sold as a kit having multiple size depth domes detached from the rim for selective attachment by the clinician or the patient as needed to best fit as the breast expands. The device can alternatively be sold as a kit with multiple size/depth domes all permanently connected to their rubber rim. With these interchangeable domes of progressively deeper sizes, it would allow the wearer to use the smallest, easiest to conceal dome, and move to the next larger size once her breasts fill that dome. Thus, the devices in this embodiment are designed to have interchangeable multiple depth hard plastic domes that snap on to the rubber skirt through a vacuum tight fastening mechanism. The patient starts with a shallow dome and as the tissues expand, the shallow dome is replaced with progressively deeper domes. The device comes as a kit with a soft rubber skirt and a number of interchangeable hard plastic domes that can be fastened to it.

[0128] The rubber skirt, is connected to the hard dome at the firm bottom base (rim) of the dome. In the embodiment of FIGS. 6K-6N by way of example, the rim of the dome has a curved cane handle shaped cross-section which fits within the corresponding cane handle shaped recess c of the skirt. Interchangeable domes of different depths can in preferred embodiments have the same base/rim configuration in order to fit with the same skirt so various dome sizes can be attached for use with brassieres as described herein or for use as a separate device, depending on the clinical application. To get an airtight seal, a circumferential tightening band can be placed in a recessed groove (e.g., groove d of FIG. 6L) of the rubber skirt. FIG. 6N also shows the asymmetry discussed above and how the skirt extends for a distance from the dome, increasing the depth/height H of the device. In some embodiments, the height of the skirt can be 50% or more of the total height of the device (see FIG. 6L)

[0129] To be effective, the device of the present invention needs to be worn nearly 24/7. Therefore, it is preferable to be as concealable as a padded bra as well as be able to be worn as easily as their regular padded bra. It preferably should not add more than 1-2 cm beyond the original breast projection. It is therefore advantageous to have the smallest dome possible that still leaves room for the vacuum expansion. Once she fills the dome, she graduates to the next incremental size, either by selecting the next dome/rim or by removing the dome and attaching a larger dome to the same base (rim) in the replaceable dome embodiments. (FIG. 13 shows different size domes to illustrate the comparison of different size domes connected to the rim).

[0130] FIGS. 14A-14D illustrate an example of the expander of the present invention incorporated into a brassiere with FIGS. 14A and 14B illustrating a mastectomy patient wearing the bra and holding the small pump of the present invention for applying vacuum for expansion and FIGS. 14C and 14D illustrating a cosmetic augmentation patient wearing a bra of the present invention which is also used in conjunction with the small pump of FIG. 14A. Two expanders are shown, although it is also contemplated that a bra with a single expander can be provided for example in cases of unilateral mastectomy. As shown, the apertures in the brassiere each receive the dome and/or rim for placement on the skin. The dome and/or rim can be attached to the bra such that the inner volume of the dome is in communication with the aperture. The tubes connect the vacuum to the interior of the dome via an opening in the dome. The bra can include the reinforcements discussed above.

[0131] The dome is one shell shape that can be used as other shaped shells can also be utilized. Note the various shell and rim materials and structures/features disclosed herein be utilized for the shells of the brassiere, including the replaceable shell versions.

[0132] The device can include a rigid. e.g., hard plastic, dome and firm rim, and the skirt (preferably of low durometer rubber) attaches to the dome at the rigid rim and pivots outward at this firm rim. As the skirt pivots outward, an additional inner component of the skirt increases surface contact and improves the seal.

[0133] In preferred embodiments, the dome is made of transparent plastic and is translucent enough to visualize the expansion space between the nipple and the peak of the dome. The dome section can be permanently attached to the skirt by glue, sonic welding, or can cure with the skirt in a complex mold with potentially different rubbers. In alternate embodiments, the dome section of the device can be a separate plastic or rubber component that can be attached to and removed from the rim skirt.

[0134] The rigid shell is discussed herein and illustrated as dome shaped, however, it is not limited to such shape as it can be other shapes such as a cube, cylinder, etc. for forming the vacuum chamber, since pressure is isotropic. Thus, the discussion herein of shells utilizing the term “dome” is fully applicable to shells of non-dome shapes.

[0135] The dome (shell) and rim/skirt separation/distinction should be appreciated. If the skirt/rim is composed of rubber, there could be a gradual change in durometer from the skirt to the dome. Alternatively, or in addition, the dome can be rigidified with reinforcing ribs. There could be a skin, sheet, etc. covering both the dome and the skirt. The skin, sheet, etc. could be a hard-protective durometer or a soft-cushioning durometer.

[0136] It should be appreciated that materials other than rubber could be utilized for the rim (and other components/features) and are within the scope of the present invention.

[0137] The present invention could be used in combination with the surface tension concept of U.S. Pat. No. 10,433,947 if a rubber dome is used. In this combined embodiment, the wearer would need to find the proper dome size that perfectly encloses her breast. With no vacuum space, and with the skin in complete contact with the inner surface of the dome, surface tension between the dome and the skin would maintain a friction free adhesion. The air would be burped out of the flexible dome and rely on the natural recoil of the dome and/or dome rim to pull on the breast tissue. The expansion force becomes a function of the elastic recoil properties of the rim/flexible dome construct.

[0138] The present invention also provides methods of use of the expanders. For example, one method provides reducing shear stress including positioning a device having a shell and a rim (skirt) extending from the shell configured for contact with a body of a patient, wherein the rim is non-adherently positioned on the body so that upon application of a distracting force within the shell, the rim spreads laterally outwardly with respect to the shell such that shear stress is reduced at a junction between skin inside the shell and the skin held down by the rim. The method can include providing a distractive force by elastic recoil of one or both of the shell or rim or by applying a vacuum within the shell.

[0139] The expander devices disclosed herein have several useful methods/applications such as the following three: 1) Enlargement of the expansion treated tissue based upon the principle of tension induced tissue growth. This application takes time (e.g., months of use) because tissue growth is a slow process. (This is an alternative that does not require surgery); 2) Temporary stretching (e.g., mechanical tension) of the expanded tissues to generate a vascularized, primed, and fertilized scaffold for a) grafting and/or b) for injection of materials/agents derived from allografts or xenografts or other growth stimulating factors. This application takes weeks compared to the stand alone tissue growth that takes months. The autologous fat grafting and the method of grafting materials derived from fat whether autograft, allograft, or xenograft can be utilized as disclosed in application Ser. No. 17/719,456 filed Apr. 23, 2022, the entire contents of which are incorporated by reference. This application describes acceleration and improvement of ingrowth into a graft by application of mechanical tension over the graft/host interface. 3) Preservation or Maintenance of a pre-expanded state either from surgery, grafting, injection of fluids, or other means of pre-expanding the tissues and then using the device to maintain the expanded or swollen state.

[0140] To achieve any of the three foregoing methods or applications, two possible alternatives are: 1) Continuous wear at a constant pressure of 20 mmHg for at least 10 hours/day. Note 20 mmHg is a level of pressure that does not occlude capillary circulation and can therefore be maintained for a long period of time over the tissue; or 2) for a more effective expansion, raising the pressure up to 80 mmHg for a short while during which the capillaries collapse and tissue perfusion stops. This high pressure therefore cannot be maintained for more than a few minutes before tissue damage sets in so the pressure then drops to 0-10 mmHg to allow re-circulation for a few minutes. This cycling pressure alternative is a more efficient method, but it consumes more battery and requires a more complex electronic control mechanism. Note the current protocol is to raise the pressure to 60 mmHg for about 2-6 minutes and then release it to 0-10 mmHg for 1-2 minutes. While most people can tolerate 60 mmHg, a few will be allowed to reach 80 mmHg without problems and some will need to have their pressure reduced to 40 mmHg because 60 mmHg is not tolerated.

[0141] The devices of the present invention can be used with the grafts and materials disclosed in commonly assigned pending application Ser. No. 17/719,459, filed Apr. 23, 2022. The devices enlarge the tissue, e.g., breast tissue, by mechanical force to temporarily create a scaffold for accepting allograft.

[0142] Persons skilled in the art will understand that the elements and features shown or described in connection with one embodiment may be combined with those of another embodiment without departing from the scope of the present invention and will appreciate further features and advantages of the presently disclosed subject matter based on the description provided.

[0143] While the present invention has been described with reference to the specific embodiments thereof, which constitute non-limiting examples, it should be understood by those skilled in the art that various changes and modifications may be made and equivalents may be substituted without departing from the spirit and scope of the invention as defined in the appended claims. In addition, many modifications may be made to adopt a particular situation, material, composition of matter, process, process step or steps, to the objective spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.

[0144] Where a range of values is provided, it is understood that each intervening value within the stated range is encompassed within the invention.

[0145] Throughout the present disclosure, terms such as “approximately,” “about,” “generally,” “substantially,” and the like should be understood to allow for variations in any numerical range or concept with which they are associated. For example, it is intended that the use of terms such as “approximately,” “about” and “generally” should be understood to encompass variations on the order of 25%, or to allow for manufacturing tolerances and/or deviations in design.

[0146] Although terms such as “first,” “second,” “third,” etc., may be used herein to describe various operations, elements, components, regions, and/or sections, these operations, elements, components, regions, and/or sections should not be limited by the use of these terms in that these terms are used to distinguish one operation, element, component, region, or section from another. Thus, unless expressly stated otherwise, a first operation, element, component, region, or section could be termed a second operation, element, component, region, or section without departing from the scope of the present invention.

[0147] Each and every claim is incorporated as further disclosure into the specification and represents embodiments of the present disclosure. Also, the phrases “at least one of A, B, and C” and “A and/or B and/or C” should each be interpreted to include only A, only B, only C, or any combination of A, B, and C.