Silicone Prosthesis Delivery Apparatus and Methods of Use

Abstract

A silicone prosthesis delivery apparatus and associated methods are disclosed for facilitating the transport and subsequent insertion of a silicone prosthesis into a surgically developed pocket of a patient. In at least one embodiment, a flexible, substantially funnel-shaped delivery sleeve is constructed out of a material having a lubricating additive that forms a textured inner surface within the delivery sleeve. An entry portion of the delivery sleeve defines a stretchable entry opening configured for allowing the prosthesis to pass therethrough to a position inside the delivery sleeve. An opposing exit portion defines a stretchable exit opening configured for allowing the prosthesis to pass therethrough when the prosthesis is subsequently expelled from the delivery sleeve. A volume of surgical lubricating fluid coats the textured inner surface of the delivery sleeve so as to reduce the coefficient of friction between the inner surface of the delivery sleeve and the prosthesis.

Claims

1. A silicone prosthesis delivery apparatus for facilitating the transport and subsequent insertion of a silicone prosthesis into a surgically developed pocket of a patient, the apparatus comprising: a flexible, substantially funnel-shaped delivery sleeve constructed out of a material having a lubricating additive that forms a textured inner surface within the delivery sleeve, the delivery sleeve comprising: an entry portion defining a stretchable entry opening configured for allowing the prosthesis to pass therethrough to a position inside the delivery sleeve; an opposing exit portion defining a stretchable exit opening configured for allowing the prosthesis to pass therethrough when the prosthesis is expelled from the delivery sleeve, the exit opening having a diameter that is less than a diameter of the entry opening; and a volume of surgical lubricating fluid coating the textured inner surface of the delivery sleeve so as to reduce the coefficient of friction between the inner surface of the delivery sleeve and the prosthesis, the surgical lubricating fluid having a viscosity in the range of approximately 20 to 25,000 centipoise; whereby, with the prosthesis positioned within the delivery sleeve, the delivery sleeve is capable of being manipulated to apply pressure to direct the prosthesis along a length of the delivery sleeve and toward the exit opening, such that the prosthesis may be expelled from the delivery sleeve through the exit opening.

2. The silicone prosthesis delivery apparatus of claim 1, wherein the lubricating additive is an anti-block agent.

3. The silicone prosthesis delivery apparatus of claim 2, wherein the textured inner surface of the delivery sleeve has a Sa—as measured using an optical profiler having an S-filter setting of 0.0025 mm and an L-filter setting of 0.25 mm—of between approximately 0.05 μm and 1.5 μm.

4. The silicone prosthesis delivery apparatus of claim 1, wherein the lubricating additive is a combination of a slip agent and an anti-block agent.

5. The silicone prosthesis delivery apparatus of claim 1, wherein the delivery sleeve material has a hardness of between approximately 80 Shore A and 65 Shore D.

6. The silicone prosthesis delivery apparatus of claim 5, wherein the delivery sleeve material is polyurethane.

7. The silicone prosthesis delivery apparatus of claim 1, wherein the delivery sleeve material is a flexible material.

8. The silicone prosthesis delivery apparatus of claim 7, wherein one or both of the entry portion and exit portion are constructed out of a flexible material having elastic properties.

9. The silicone prosthesis delivery apparatus of claim 8, wherein the entry portion is relatively more elastic than the exit portion.

10. The silicone prosthesis delivery apparatus of claim 1, wherein the surgical lubricant consists of a water-soluble gel mixed with a lower viscosity solution.

11. The silicone prosthesis delivery apparatus of claim 1, wherein the delivery sleeve provides a plurality of spaced apart, longitudinally arranged indicia positioned proximal to one or both of the entry opening and exit opening for assisting with the selective cutting of the delivery sleeve, the indicia configured as integral, structural features of the delivery sleeve.

12. The silicone prosthesis delivery apparatus of claim 11, wherein the indicia are notches positioned longitudinally along opposing lateral edges of the delivery sleeve.

13. The silicone prosthesis delivery apparatus of claim 11, wherein the indicia are thermally produced markings positioned longitudinally across opposing lateral edges of the delivery sleeve.

14. A silicone prosthesis delivery apparatus comprising: a silicone prosthesis; and a flexible, substantially funnel-shaped delivery sleeve constructed out of a material having a lubricating additive that forms a textured inner surface within the delivery sleeve, the delivery sleeve comprising: an entry portion defining a stretchable entry opening configured for allowing the prosthesis to pass therethrough to a position inside the delivery sleeve; an opposing exit portion defining a stretchable exit opening configured for allowing the prosthesis to pass therethrough when the prosthesis is expelled from the delivery sleeve, the exit opening having a diameter that is less than a diameter of the entry opening; and a volume of surgical lubricating fluid coating the textured inner surface of the delivery sleeve so as to reduce the coefficient of friction between the inner surface of the delivery sleeve and the prosthesis, the surgical lubricating fluid having a viscosity in the range of approximately 20 to 25,000 centipoise; whereby, with the prosthesis positioned within the delivery sleeve, the delivery sleeve is capable of being manipulated to apply pressure to direct the prosthesis along a length of the delivery sleeve and toward the exit opening, such that the prosthesis may be expelled from the delivery sleeve through the exit opening.

15. A silicone prosthesis delivery apparatus for facilitating the transport and subsequent insertion of a silicone prosthesis into a surgically developed pocket of a patient, the apparatus comprising: a flexible, substantially funnel-shaped delivery sleeve constructed out of a material having a textured inner surface within the delivery sleeve, the textured inner surface of the delivery sleeve having a Sa—as measured using an optical profiler having an S-filter setting of 0.0025 mm and an L-filter setting of 0.25 mm—of between approximately 0.05 μm and 1.5 μm, the delivery sleeve comprising: an entry portion defining a stretchable entry opening configured for allowing the prosthesis to pass therethrough to a position inside the delivery sleeve; an opposing exit portion defining a stretchable exit opening configured for allowing the prosthesis to pass therethrough when the prosthesis is expelled from the delivery sleeve, the exit opening having a diameter that is less than a diameter of the entry opening; and a volume of surgical lubricating fluid coating the textured inner surface of the delivery sleeve so as to reduce the coefficient of friction between the inner surface of the delivery sleeve and the prosthesis, the surgical lubricating fluid having a viscosity in the range of approximately 20 to 25,000 centipoise; whereby, with the prosthesis positioned within the delivery sleeve, the delivery sleeve is capable of being manipulated to apply pressure to direct the prosthesis along a length of the delivery sleeve and toward the exit opening, such that the prosthesis may be expelled from the delivery sleeve through the exit opening.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The accompanying drawings illustrate aspects of the present invention. In such drawings:

[0021] FIG. 1 is a perspective view of an exemplary silicone prosthesis delivery apparatus along with an exemplary silicone prosthesis, in accordance with at least one embodiment;

[0022] FIGS. 2 and 3 are further perspective views thereof, illustrating the prosthesis positioned within a delivery sleeve of the apparatus, along with hand manipulation of the prosthesis via the delivery sleeve, in accordance with at least one embodiment;

[0023] FIG. 4 is a perspective view of a further exemplary silicone prosthesis delivery apparatus along with an exemplary silicone prosthesis, in accordance with at least one embodiment;

[0024] FIGS. 5 and 6 are further perspective views thereof, illustrating the prosthesis positioned within a delivery sleeve of the apparatus, along with hand manipulation of the prosthesis via the delivery sleeve, in accordance with at least one embodiment;

[0025] FIGS. 7 and 8 are perspective views of a further exemplary silicone prosthesis delivery apparatus, in accordance with at least one embodiment;

[0026] FIG. 9 is a further perspective view thereof, illustrating the prosthesis positioned within a delivery sleeve of the apparatus, along with the apparatus being positionable within a transport container, in accordance with at least one embodiment;

[0027] FIG. 10 is a diagram illustrating a prior art method for utilizing a prior art delivery sleeve to insert a silicone implant into a surgically developed pocket of a patient;

[0028] FIG. 11 is a diagram illustrating an exemplary method of utilizing the exemplary silicone prosthesis delivery apparatus to insert a silicone implant into a surgically developed pocket of a patient, in accordance with at least one embodiment; and

[0029] FIG. 12 is a partial top plan view of an exemplary exit portion of an exemplary delivery sleeve, in accordance with at least one embodiment.

[0030] The above-described drawing figures illustrate aspects of the invention in at least one of its exemplary embodiments, which are further defined in detail in the following description. Features, elements, and aspects of the invention that are referenced by the same numerals in different figures represent the same, equivalent, or similar features, elements, or aspects, in accordance with one or more embodiments.

DETAILED DESCRIPTION

[0031] Turning now to FIGS. 1-3, there are shown perspective views of an exemplary embodiment of a silicone prosthesis delivery apparatus configured for facilitating the transport and subsequent insertion of a silicone prosthesis 10 into a surgically developed pocket of a patient. In at least one embodiment, the apparatus comprises a flexible, substantially funnel-shaped delivery sleeve 20 able to receive and expel the prosthesis 10, as illustrated in FIGS. 1-3.

[0032] In at least one embodiment, the delivery sleeve 20 has a generally conical shape which defines an entry opening 22 at one end of the delivery sleeve 20 and a relatively smaller exit opening 24 at an opposing, tapered terminal tip of the delivery sleeve 20. In at least one embodiment, as best illustrated in FIG. 1, the delivery sleeve 20 is constructed of a sufficiently flexible material, as discussed further below, which enables the delivery sleeve 20 to assume a flattened configuration for storage and shipping. In further embodiments, the exit opening 24 could be temporally sealed to improve the process when loading the prosthesis 10, so as to retain fluids in the delivery sleeve 20 during preparation for expulsion of the prosthesis 10, at which time the exit opening 24 would be trimmed to the desired opening size, as discussed further below. In still further embodiments, any other material or combination of materials—now known or later developed—may be substituted, so long as the apparatus is capable of substantially carrying out the functionality described herein. Additionally, in at least one embodiment, the delivery sleeve 20 is constructed of a film material with a lubricious additive (or additives) dispersed within the film during the processing of the film sheet (commonly referred to as “internal lubricants”). Slip is an additive that could be utilized in the film in at least one embodiment. Slip agents have a part that is soluble in the substrate and a part that is insoluble. During processing (in the molten phase), slip additives (as overall effect) are soluble and homogeneously dispersed in the substrate. Upon crystallization, the solubility limit is exceeded and the slip additive migrates from the matrix toward the surface, thus significantly reducing the coefficient of friction at the film surface. Some slip agents are produced by the amidization of long chain fatty acids. Examples of the most commonly used of these are steramides, erucamides, and oleamides. Waxes can also be used as slip agents. Waxes are similar to oils except they are solid at ambient temperature and generally have a melting point in excess of 40° C. An evaluation study with microcrystalline waxes clearly demonstrated that the harder the wax, the better the slip properties.

[0033] An anti-blocking additive, such as talc, calcined kaolin, cristobalite, precipitated silica, diatomaceous earth, mica, calcium carbonates, calcium sulfate (anhydrite), magnesium carbonate, magnesium sulfate, or feldspars could be dispersed in the base material in at least one embodiment. The anti-block particles act to reduce the coefficient of friction by physically protruding from the film surface. The particle protrusions or asperities help to decrease the contact area between the adjacent film layers to reduce the overall friction, in addition to providing a well or reservoir for external lubricants to maintain a lubricious film layer between the interacting substrate films. The particle size, hardness and geometric shape of the particles may impact the lubricous performance. Particles with a mean particle size of less than 10 microns may be preferred. Particle hardness of 3 Mohs or greater may be preferred. Particle shape of flat or platy may be advantageous. Particle shape of smooth, round spheres may be advantageous. In at least one embodiment, the sleeve film surface that comes in contact with the prosthesis has a Sa (average areal roughness, measured with optical profiler, S-filter=0.0025 mm, L-filter=0.25 mm) between approximately 0.05 μm and 2 μm. Additionally, in at least one embodiment, the asperities population (measured with a height threshold of approximately 0.5 μm above the mean plane) is between approximately 200 and 8000 asperities per square mm. In at least one embodiment, the maximum asperities height is approximately 8 μm. Anti-blocking helps prevent adjacent film layers from sticking to each other due to electrostatic charge or Van der Waals forces (attractive forces between polymer chains). Incorporating anti-blocking properties creates a micro-rough surface that reduces adhesion between adjacent film layers and could help prevent damage to the film.

[0034] In another embodiment, a hydrophilic additive could be added to the film for enhanced lubricity at the film surface. One such hydrophilic additive could be an anti-fog agent. Internal anti-fog additives are non-ionic surfactants, or compounds that lower the surface tension between two liquids or a solid and a liquid. These additives can be added to the plastic film at the extrusion level in the form of concentrates or master batches. A degree of incompatibility exists between the polymer and the additive, and as a result, the additive migrates to the surface. These additives work to decrease the surface tension of the fluid droplets, thus reducing the surface tension between the fluid and the surface of the plastic film. Another hydrophilic additive is antimicrobial agents, which are made of hydrophilic materials or polyzwitterions capable of minimizing the formation of conditioning films via the formation of a hydration layer. The hydration layer, formed through hydrogen bonding and/or ionic solvation, is responsible for steric repulsion, electrostatic repulsion, and low surface energy. Other possible additives include antioxidants, chill roll releases, and antistat agents. In at least one embodiment, synergy of action of two or more lubricant components provides a better combined result than can be expected from a sum of actions of each component acting alone. In at least one embodiment, lubricious additives could be dispersed in the base material, such as polyurethane, to modify the surface appearance, feel, slip, abrasion resistance and overall durability of the film. In at least one embodiment, the base material of the sleeve is between approximately 0.003 inches and 0.012 inches in thickness, with a hardness between approximately 80 Shore A and 65 Shore D.

[0035] In at least one alternate embodiment, a polymer composition could incorporate constituents that promote inherent hydrophilic properties, such as or similar to commercially produced breathable films. These breathable films are permeable to gases (such as water vapors). Breathable films are categorized into two technology groups. One technology group is perforated or microporous films. These films rely on vapor transport through holes or voids, which enables physical transport in both directions. Cost-effective microporous films and composites can be made by using polyolefinic material and inorganic fillers. These microporous films and their composites can be designed and manufactured at high speed using commercial equipment for applications where air and moisture breathability is needed. One general characteristic of a water barrier microporous breathable film is that the film contains billions of micropores, and many of these micropores are connected. The inorganic filler can be calcium carbonate (CaCO3), barium sulfate, or other finely powdered inorganic materials. The second technology group of breathable films are termed monolithic films. These nonporous, solid polymer membranes are made of polymer resins that allow the passage of water vapor because of the hydrophilic character of the resin itself. Polymers such as thermoplastic polyurethanes, polyether block ester elastomers, and polyether block amide elastomers are resins that can be fabricated into monolithic films. GORE-TEX film is expanded microporous PTFE, which is an expensive polymeric material. Specialty formulations of hydrophilic aliphatic polyether-based thermoplastic polyurethanes with very high moisture absorption rates, although expensive, could be utilized as a monolithic film or as a thin film laminated to a structural film. Although these breathable film technologies are formulated to allow water vapor transmission while simultaneously blocking any transport of liquid water, it is presumed the affinity for water acts to promote the water-soluble surgical lubricant to diffuse along the film surface, thus mitigating the “squeegee” effect of the silicone implant to vacate the lubricant when being forcefully manipulated through the sleeve.

[0036] A frequently asked question arises from the term “hydrophilic polymer” as there are several ways to define it. Notably, there is a broad variety of hydrophobic polymers that are not considered to be hydrophilic at all, e.g., poly(styrene) or poly(methyl methacrylate). Contrarily, there are various polymers considered to be hydrophilic, e.g., poly(acrylamide) or poly(ethylene glycol) (PEG). Nevertheless, the boundaries are not defined. Some polymers are hydrophilic but not water-soluble and rather water-swellable, e.g., poly(2-hydroxyethyl methacrylate). Even hydrophilic polymers solubility in water will be different depending on the polymer type, molecular weight and concentration. Thus, a classification on solubility alone is not sufficient. As such, a hydrophilic polymer might be considered as a polymer with favorable interactions with water leading to solubility, swellability, or water vapor transmission. For purposes of the present silicone prosthesis delivery apparatus described herein, hydrophilic polymers will refer to those that have a water absorption characteristic as defined in ASTM D471 (Volume Swell in Water 24 hr/23 C) of equal to or greater than 2%. The water absorption characteristic pertains to the polymer material at the surface of the film, thus for a film with a hydrophilic agent additive that migrates to the surface, the primary base substrate would not be included in the volume swell calculation.

[0037] The expense of hydrophilic polymer compositions and/or additives integrated during the film manufacturing process is relatively low, especially compared to hydrophilic coatings applied to finished film. In at least one embodiment, the film could also be processed where the mechanical roller has a surface finish that results in a textured surface on the film to enhance lubricity. The textured surface could be described as asperities that protrude from the film surface. In at least one embodiment, the textured surface has as Sa (average areal roughness, measured with optical profiler, S-filter=0.0025 mm, L-filter=0.25 mm) between approximately 0.05 μm and 1.5 μm. Additionally, in at least one embodiment, the asperities population (measured with a height threshold of approximately 0.5 μm above the mean plane) is between approximately 200 and 8000 asperities per square mm. In at least one embodiment, the maximum asperities height is approximately 8 μm. In at least one embodiment, the textured surface could also be oriented in a particular direction to aid in improving lubricious contact with the prosthesis 10. The texture direction may run in the longitudinal direction in line with the direction of prosthesis 10 delivery (as opposed to lateral). In another embodiment, the surface could be extremely smooth, in the range of approximately 5-100 nanometers Sa (average roughness). In still further embodiments, any other lubricant (or any other material or composition having sufficient lubricious properties), now known or later developed, may be substituted.

[0038] In at least one further embodiment, the funnel-shaped delivery sleeve 20, produced from film processed with additives for enhanced lubricity, could be augmented with an additional, separate, external, surgical lubricant applied to the prosthesis 10 and/or an inner wall of the delivery sleeve 20 at the time of clinical use (i.e. not at the factory). By way of a non-limiting example, common surgical lubricant such as SURGILUBE (H.R. Chemicals) is provided in a foil pack, syringe, or tube. In at least one embodiment, the lubricant could be a water-soluble, high viscosity gel. The gel lubricant could be mixed with a lower viscosity solution, such as saline, triple antibiotic solution, betadine, or other solution to create a preferred viscosity in the range of approximately 20 to 25,000 centipoise, enabling the lubricant to effectively coat the inner surfaces of the delivery sleeve 20 and/or an outer surface of the prosthesis 10. The breast pocket could be irrigated and flushed to remove residual lubricant that is transferred to the surgical breast pocket during prosthesis 10 insertion. In at least one embodiment, the surgical lubricant could be inexpensive, thereby resulting in a relatively more economically appealing apparatus. In other embodiments, the gel lubricant could be mixed with a variety of combinations of saline and antibiotic solutions such as povidone-iodine (Betadine), bacitracin, cefazolin, and/or gentamicin, with a resulting preferred viscosity in the range of approximately 20 to 25,000 centipoise.

[0039] In at least one further embodiment, the funnel-shaped delivery sleeve 20, produced from film processed with additives for enhanced lubricity, could be augmented with a hydrophilic coating. Due to the inherently lubricious nature of the film, the hydrophilic coating could require less demanding performance, and thus lower cost, thereby resulting in a relatively more economically appealing apparatus. The film could be of sufficient flexibility to be initially heat sealed or welded to create a conical shape and then be inverted in preparation to facilitate the dip coating process for effectively applying the hydrophilic coating to the select inner wall surfaces of the funnel, namely the approximate 60% length of the inner funnel surface from the exit opening. The wider portion of the conical area could remain free of coating for the means of reduced cost plus allowing for subsequent heat sealing or welding at that area (i.e. as in welding a “valve/entry” portion as described below to the primary delivery sleeve). The exit opening 24 could be sealed to prevent coating material from flowing to the undesired surface of the funnel. After coating has been applied, the conical shaped funnel could be reverted back to its original orientation.

[0040] In at least one alternate embodiment, as illustrated best in FIGS. 4-8, the delivery sleeve 20 provides two opposingly joined, generally conical-shaped portions (hereinafter referred to as an entry portion 27 and an exit portion 23, respectively) which cooperate to define a entry opening 28 at one end of the delivery sleeve 20 (i.e., at a free end of the entry portion 27), an exit opening 24 at the opposing end of the delivery sleeve 20 (i.e., at a free end of the exit portion 23), and a relatively larger middle section 26 positioned therebetween (i.e., where the entry portion 27 is joined with the exit portion 23). As best illustrated in FIGS. 7 and 8, the entry portion 27 and exit portion 23 may be of differing shapes, sizes and/or materials. In at least one embodiment, the entry opening 28 and the exit opening 24 have a similar diameter. In at least one alternate embodiment, the entry opening 28 and exit opening 24 have different diameters. Additionally, in at least one embodiment, the entry portion 27 could be flexible and of relatively greater elasticity as compared to the exit portion 23, thus reducing the expansion pressure required for entry of the prosthesis 10 into the delivery sleeve 20. Similarly, in at least one embodiment, the exit segment 23 could be sufficiently flexible and of relatively lesser elasticity as compared to the entry portion 27, thus providing sufficient pressure to expel the prosthesis 10 from the delivery sleeve 20 with minimal expansion through the exit opening 24.

[0041] In at least one embodiment, as best illustrated in FIGS. 5 and 6, when a prosthesis 10, such as a silicone implant, is placed through the entry opening 28 into the interior of delivery sleeve 20, the delivery sleeve 20 is capable of being manipulated to conform to the shape of the prosthesis 10 as well as to apply pressure to direct the prosthesis 10 along a length of the delivery sleeve 20 and toward the exit opening 24.

[0042] In at least one embodiment, both the entry portion 27 and exit portion 23 are constructed of flexible materials. The materials could be compatible for joining the entry portion 27 and exit portion 23 by means of heat seal bonding, RF welding, adhesive bonding, or other appropriate means—now known or later developed. In at least one alternate embodiment, the entry portion 27 and exit portion 23 are of a single, unitary construction. In at least one embodiment, the exit portion 23 is constructed out of a fabric material such as a plastic-containing fabric, which is pliable yet resistant to stretching. In at least one further embodiment, the exit portion 23 may be constructed out of a transparent plastic or other suitable polymer material having sufficient properties including flexibility and low elasticity. It is believed that there are advantages to using a transparent or semitransparent material to assist the surgeon in proper orientation of the prosthesis 10 within the delivery sleeve 20. Suitable transparent materials may include vinyl, LDPE, polyurethane, and other similar materials—now known or later developed. As disclosed therein, suitable films heat sealed to form suitable containers, are transparent with minimal hazing, and can be sterilized using gas sterilization, irradiation sterilization, or heat with intact seals and remain sufficiently flexible and pliable for the necessary handling described herein.

[0043] In at least one embodiment, the entry portion 27 is flexible and elastic, could be made of a latex or other material with similar elastic properties—now known or later developed—to enable low pressure expansion of the entry opening 28 when inserting the prosthesis 10 through the entry opening 28. In at least one embodiment, the material of the entry portion 27 may be thin and have lattice structure to further enhance low pressure expansion.

[0044] Other attributes of the delivery sleeve 20, in at least one embodiment, include the ability for the delivery sleeve 20 to be a sterile component. Additionally, in at least one embodiment, an outer surface of the entry portion 27 and the interior surface of the exit portion 23 may have a low coefficient of friction to facilitate passage of the prosthesis 10 through the entry opening 28 and exit opening 24 respectfully. In at least one embodiment, the outer surface of the entry portion 27 and/or an outer surface of the exit portion 23 may be provided with a low coefficient of friction coating or lubricant. It has been found that using a surgically appropriate lubricant will facilitate passage of the prosthesis 10 through the interior of delivery sleeve 20. Such lubricants may be applied directly to the prosthesis 10 or the delivery sleeve 20 by the user, or the delivery sleeve 20 may be supplied pre-coated with a lubricant that is already present on the appropriate surfaces of the delivery sleeve 20.

[0045] In at least one embodiment, the entry portion 27 may have a tacky or high coefficient of friction inner surface 29 to improve the retention of the prosthesis 10 within the delivery sleeve 20. In this manner, the entry portion 27 acts as a one-way valve to releasably capture the prosthesis 10 within the delivery sleeve.

[0046] Since the size of the prosthesis 10 may vary in a range from about 150 cc to approximately 800 cc, the dimensions of each of the entry opening 28 and exit opening 24 may vary in order to accommodate various sizes for the prosthesis 10. In at least one embodiment, one or both of the exit opening 24 and entry opening 28 may be selectively enlarged by cutting portions of the delivery sleeve 20, proximal the corresponding end of the delivery sleeve 20, to provide for larger openings. In at least one embodiment, the outer surface of the delivery sleeve 20 provides markings or other indicia 40 positioned and configured for assisting with the cutting of the delivery sleeve 20 to the appropriate dimensions for the size of the prosthesis 10.

[0047] Due to the lubricious nature of the film material, obtaining satisfactory ink adhesion during printing may be a challenge. Polyurethanes are polymers known for their good mechanical properties, abrasion resistance, durability, flexibility, and biocompatibility, along with ease of finishing and low weight. Therefore, polyurethanes are commonly used for medical applications as bladders and bags. However, despite its excellent properties, for some applications where good wettability and adhesion are required, the use of polyurethanes can be restrictive. Most polyurethanes are characterized by low surface energy values resulting in inherently poor adhesion. The poor adhesion is mainly attributed to its chemical inertness due to a lack of polar functional groups on its surface. It may not be technically or economically feasible to print indicators directly on a film substrate with a low surface energy. Accordingly, in at least one embodiment, as illustrated in FIG. 12, the indicia 40 for assisting with the cutting of the delivery sleeve 20 are integral, structural features of the delivery sleeve 20. In at least one such embodiment, the indicia 40 are notches 42 positioned along opposing lateral edges 44 of the delivery sleeve 20 so as to indicate cutting locations for creating an exit opening 24 or entry opening 28 of a desired diameter (e.g., 5.0 cm, 5.5 cm, 6.0 cm, 6.5 cm, etc.). It should be noted that the specific sizes, shapes, dimensions, quantities and relative positions of the notches 42 depicted in the drawings are merely exemplary and shown for illustrative purposes. Thus, in further such embodiments, the notches 42 may take on any other sizes, shapes, dimensions, quantities and/or relative positions now known or later developed, so long as the delivery sleeve 20 is capable of substantially carrying out the functionality described herein. Furthermore, while the indicia 40 are shown and described herein as being notches 42, in further embodiments, the indicia 40 may take on any other type of integral, structural features now known or later developed, so long as the delivery sleeve 20 is capable of substantially carrying out the functionality described herein. In at least one embodiment, the indicia 40 further includes corresponding markings printed or formed directly on the delivery sleeve 20. In yet a similar embodiment, the indicia 40 could be thermally produced markings on the delivery sleeve 20 that create a different refractory index to produce differentiating markings. In yet a similar embodiment, the indicia 40 could be a label with markings which is releasably or permanently adhered to the delivery sleeve 20 in the appropriate location. In at least one alternate embodiment, the delivery sleeve 20 is accompanied by a printed instruction sheet on which the corresponding markings are displayed.

[0048] In at least one embodiment, the polymer film constructing the delivery sleeve 20 can be subjected to micro-surface modification through inserting new functional groups, including carboxyls, hydroxyls, and amines, into the polymer surface to immensely enhance the inert surface properties of polymers. Various modification procedures could be utilized for this purpose. Chemical wetting with reagents such as acids and oxidizers as well as plasma treatment can be utilized to increase the surface energy by introducing new functional groups at the interface and thus increase wettability of the external lubricant applied to the delivery device. In at least one such embodiment, the micro-surface could have an untreated surface roughness in the range of approximately 2-10 nm RMS, while the treatment can increase the roughness to approximately 15-30 nm RMS.

[0049] In at least one embodiment, the entry portion 27 is configured for being selectively inverted, as illustrated in FIG. 8. Accordingly, in such embodiments, when the prosthesis 10 is positioned within the entry portion 27, the entry opening 28 may expand in a similar manner as the exit opening 24 to enable the prosthesis 10 to traverse though the entry opening 28. After the prosthesis 10 is within the delivery sleeve 20, the entry opening 28 contracts back to a smaller size. Thereafter, the clinician is able to transport or manipulate the delivery sleeve 20 without the prosthesis 10 unintentionally escaping from the delivery sleeve 20. The clinician is thus able to apply pressure to the prosthesis 10, forcing the prosthesis 10 toward the exit opening 24. As illustrated in FIGS. 5 and 6, the prosthesis 10 can be forced through the exit opening 24.

[0050] Another aspect of the invention involves an exemplary method of placing the prosthesis 10 within the delivery sleeve 20, and placing the assembly within the appropriate sterile barrier packaging 30 (FIG. 9) prior to sterilization and shipment to the customer. In at least one embodiment, the sterile barrier packaging 30 could be a similar tray 32 and lid 34 commonly used for sterilization and shipment of implants. In at least one embodiment, the tray 32 could contain saline solution or other fluids to hydrate the prosthesis 10 and delivery sleeve 20. In at least one embodiment, the exemplary method would eliminate the concern of contamination in the operating room when the prosthesis 10 is being transferred and loaded into the delivery sleeve 20. In at least one embodiment, the entry opening 28 would aid in containing and maintaining the prosthesis 10 within the delivery sleeve 20 during transport. To further aid in containing and maintaining the prosthesis 10 within the delivery sleeve 20 during transport, one or both ends of the delivery sleeve 20 could be folded in a manner to obstruct the corresponding entry opening 28 and/or exit opening 24 so as to maintain the prosthesis 10 within the delivery sleeve 20. A manner of folding in at least one embodiment could be one or both ends folded down approximately 180 degrees and placed under the remainder of the delivery sleeve 20. Another manner of folding in at least one alternate embodiment could be one or both ends folded up 90 degrees, where a length of the tray 32 is such that the folded ends of the delivery sleeve 20 are in close proximity to opposing side walls of the tray 32.

[0051] FIG. 10 provides a diagram that illustrates the known prior art funnel delivery method and handling of the prosthesis 10. Four steps are involved, three of which can expose the prosthesis 10 to contamination. By comparison, FIG. 11 provides a diagram that illustrates the exemplary method of utilizing the apparatus, where the prosthesis 10 is placed within the delivery sleeve 20 prior to being placed in the sterile barrier packaging 30. The three steps which can expose the prosthesis 10 to contamination are eliminated, thus providing improved sterile integrity and cleanliness to the prosthesis 10.

[0052] Aspects of the present specification may also be described as the following embodiments:

[0053] 1. A silicone prosthesis delivery apparatus for facilitating the transport and subsequent insertion of a silicone prosthesis into a surgically developed pocket of a patient, the apparatus comprising: a flexible, substantially funnel-shaped delivery sleeve for receiving and subsequently expelling the prosthesis therefrom, the delivery sleeve comprising: a substantially conical-shaped entry portion and a substantially conical-shaped exit portion, the entry portion and exit portion opposingly positioned and joined with one another so as to form a relatively larger diameter middle section; a tapered free end of the entry portion providing an entry opening configured for allowing the prosthesis to selectively pass therethrough when the prosthesis is inserted into the delivery sleeve; and a tapered free end of the exit portion providing an exit opening configured for allowing the prosthesis to selectively pass therethrough when the prosthesis is expelled from the delivery sleeve; whereby, with the prosthesis positioned within the delivery sleeve, the delivery sleeve is capable of being manipulated to conform to the shape of the prosthesis as well as to apply pressure to direct the prosthesis along a length of the delivery sleeve and toward the exit opening, such that the prosthesis may be expelled from the delivery sleeve through the exit opening.

[0054] 2. The silicone prosthesis delivery apparatus according to embodiment 1, wherein the entry portion and exit portion have similar dimensions.

[0055] 3. The silicone prosthesis delivery apparatus according to embodiments 1-2, wherein the entry portion and exit portion have different dimensions.

[0056] 4. The silicone prosthesis delivery apparatus according to embodiments 1-3, wherein the entry portion has relatively smaller dimensions than the exit portion.

[0057] 5. The silicone prosthesis delivery apparatus according to embodiments 1-4, wherein the delivery sleeve is constructed out of a flexible material.

[0058] 6. The silicone prosthesis delivery apparatus according to embodiments 1-5, wherein the delivery sleeve is constructed out of a film material having a lubricious additive dispersed therewithin.

[0059] 7. The silicone prosthesis delivery apparatus according to embodiments 1-6, wherein the lubricious additive is a slip agent.

[0060] 8. The silicone prosthesis delivery apparatus according to embodiments 1-7, wherein the delivery sleeve provides a hydrophilic coating.

[0061] 9. The silicone prosthesis delivery apparatus according to embodiments 1-8, wherein the film material is transparent or semi-transparent.

[0062] 10. The silicone prosthesis delivery apparatus according to embodiments 1-9, wherein one or both of the entry portion and exit portion are constructed out of a flexible material having elastic properties.

[0063] 11. The silicone prosthesis delivery apparatus according to embodiments 1-10, wherein the entry portion is relatively more elastic than the exit portion.

[0064] 12. The silicone prosthesis delivery apparatus according to embodiments 1-11, wherein the delivery sleeve further provides an anti-blocking additive.

[0065] 13. The silicone prosthesis delivery apparatus according to embodiments 1-12, wherein the delivery sleeve further provides a wax additive.

[0066] 14. The silicone prosthesis delivery apparatus according to embodiments 1-13, wherein the delivery sleeve provides a textured surface for enhancing lubricity of the delivery sleeve.

[0067] 15. The silicone prosthesis delivery apparatus according to embodiments 1-14, wherein an inner surface of the delivery sleeve provides a lubricant.

[0068] 16. The silicone prosthesis delivery apparatus according to embodiments 1-15, wherein the entry portion is constructed out of a lattice structure for facilitating low pressure expansion of the entry portion when the prosthesis is inserted through the entry opening.

[0069] 17. The silicone prosthesis delivery apparatus according to embodiments 1-16, wherein an inner surface of the entry portion has a sufficient coefficient of friction for preventing the prosthesis from exiting the delivery sleeve through the entry opening.

[0070] 18. The silicone prosthesis delivery apparatus according to embodiments 1-17, wherein the delivery sleeve is capable of being cut proximal one or both of the entry opening and exit opening, thereby allowing one or both of the entry opening and exit opening to be selectively enlarged to better accommodate the prosthesis as needed.

[0071] 19. The silicone prosthesis delivery apparatus according to embodiments 1-18, wherein an outer surface of the delivery sleeve provides markings or other indicia positioned and configured for assisting with the cutting of the delivery sleeve.

[0072] 20. The silicone prosthesis delivery apparatus according to embodiments 1-19, wherein the entry portion is capable of being selectively inverted when the prosthesis is inserted through the entry opening.

[0073] 21. The silicone prosthesis delivery apparatus according to embodiments 1-20, further comprising a sterile barrier packaging configured for storing and maintaining the sterilization of the delivery sleeve and prosthesis prior to use.

[0074] 22. The silicone prosthesis delivery apparatus according to embodiments 1-21, wherein a tray of the barrier packaging contains a volume of an at least one fluid for hydrating the delivery sleeve and prosthesis.

[0075] 23. A silicone prosthesis delivery apparatus comprising: a silicone prosthesis; and a flexible, substantially funnel-shaped delivery sleeve configured for receiving and subsequently expelling the prosthesis therefrom, the delivery sleeve comprising: a substantially conical-shaped entry portion and a substantially conical-shaped exit portion, the entry portion and exit portion opposingly positioned and joined with one another so as to form a relatively larger diameter middle section; a tapered free end of the entry portion providing an entry opening configured for allowing the prosthesis to selectively pass therethrough when the prosthesis is inserted into the delivery sleeve; a tapered free end of the exit portion providing an exit opening configured for allowing the prosthesis to selectively pass therethrough when the prosthesis is expelled from the delivery sleeve; whereby, with the prosthesis positioned within the delivery sleeve, the delivery sleeve is capable of being manipulated to conform to the shape of the prosthesis as well as to apply pressure to direct the prosthesis along a length of the delivery sleeve and toward the exit opening, such that the prosthesis may be expelled from the delivery sleeve through the exit opening.

[0076] 24. A method for preparing the silicone prosthesis delivery apparatus of claim 1, the method comprising the steps of: inserting a prosthesis through the entry opening of the entry portion of the delivery sleeve, such that the prosthesis is positioned within the delivery sleeve; folding each of the opposing ends of the delivery sleeve so as to obstruct each of the entry opening and exit opening, thereby preventing the prosthesis from unintentionally exiting the delivery sleeve; and positioning the delivery sleeve within a sterile barrier packaging.

[0077] 25. The method according to embodiment 24, further comprising the step of folding each of the opposing ends of the delivery sleeve so as to obstruct each of the entry opening and exit opening, thereby preventing the prosthesis from unintentionally exiting the delivery sleeve.

[0078] 26. The method according to embodiments 24-25, further comprising the step of placing a volume of an at least one fluid into a tray of the barrier packaging for hydrating the delivery sleeve and prosthesis.

[0079] 27. The method according to embodiments 24-26, wherein the step of folding each of the opposing ends of the delivery sleeve further comprises the step of folding each of the opposing ends down approximately 180 degrees and placing the folded ends under the remainder of the delivery sleeve.

[0080] 28. The method according to embodiments 24-27, wherein the step of folding each of the opposing ends of the delivery sleeve further comprises the step of folding each of the opposing ends up approximately 90 degrees such that the folded ends are in close proximity to opposing side walls of a tray of the barrier packaging.

[0081] 29. A silicone prosthesis delivery apparatus for facilitating the transport and subsequent insertion of a silicone prosthesis into a surgically developed pocket of a patient, the apparatus comprising: a flexible, substantially funnel-shaped delivery sleeve constructed out of a material having a lubricating additive that forms a textured inner surface within the delivery sleeve, the delivery sleeve comprising: an entry portion defining a stretchable entry opening configured for allowing the prosthesis to pass therethrough to a position inside the delivery sleeve; an opposing exit portion defining a stretchable exit opening configured for allowing the prosthesis to pass therethrough when the prosthesis is expelled from the delivery sleeve, the exit opening having a diameter that is less than a diameter of the entry opening; and a volume of surgical lubricating fluid coating the textured inner surface of the delivery sleeve so as to reduce the coefficient of friction between the inner surface of the delivery sleeve and the prosthesis, the surgical lubricating fluid having a viscosity in the range of approximately 20 to 25,000 centipoise; whereby, with the prosthesis positioned within the delivery sleeve, the delivery sleeve is capable of being manipulated to apply pressure to direct the prosthesis along a length of the delivery sleeve and toward the exit opening, such that the prosthesis may be expelled from the delivery sleeve through the exit opening.

[0082] 30. The silicone prosthesis delivery apparatus according to embodiment 29, wherein: each of the entry portion and exit portion of the delivery sleeve is substantially conical-shaped; the entry portion and exit portion are opposingly positioned and joined with one another so as to form a relatively larger diameter middle section, with the entry opening being positioned at a tapered free end of the entry portion, and the exit opening being positioned at a tapered free end of the exit portion; and the entry portion is further configured for being temporarily inverted so as to be positioned within the exit portion during insertion of the prosthesis through the entry opening.

[0083] 31. The silicone prosthesis delivery apparatus according to embodiments 29-30, wherein the lubricating additive is a slip agent.

[0084] 32. The silicone prosthesis delivery apparatus according to embodiments 29-31, wherein the lubricating additive is an anti-block agent.

[0085] 33. The silicone prosthesis delivery apparatus according to embodiments 29-32, wherein the textured inner surface of the delivery sleeve has a Sa—as measured using an optical profiler having an S-filter setting of 0.0025 mm and an L-filter setting of 0.25 mm—of between approximately 0.05 μm and 1.5 μm.

[0086] 34. The silicone prosthesis delivery apparatus according to embodiments 29-33, wherein the lubricating additive of is a combination of a slip agent and an anti-block agent.

[0087] 35. The silicone prosthesis delivery apparatus according to embodiments 29-34, wherein the delivery sleeve material has a hardness of between approximately 80 Shore A and 65 Shore D.

[0088] 36. The silicone prosthesis delivery apparatus according to embodiments 29-35, wherein the delivery sleeve material is polyurethane.

[0089] 37. The silicone prosthesis delivery apparatus according to embodiments 29-36, wherein the delivery sleeve material is a flexible material.

[0090] 38. The silicone prosthesis delivery apparatus according to embodiments 29-37, wherein one or both of the entry portion and exit portion are constructed out of a flexible material having elastic properties.

[0091] 39. The silicone prosthesis delivery apparatus according to embodiments 29-38, wherein the entry portion is relatively more elastic than the exit portion.

[0092] 40. The silicone prosthesis delivery apparatus according to embodiments 29-39, wherein the entry portion is constructed out of a lattice structure for facilitating low pressure expansion of the entry portion when the prosthesis is inserted through the entry opening.

[0093] 41. The silicone prosthesis delivery apparatus according to embodiments 29-40, wherein an inner surface of the entry portion has a sufficient coefficient of friction for preventing the prosthesis from exiting the delivery sleeve through the entry opening.

[0094] 42. The silicone prosthesis delivery apparatus according to embodiments 29-41, wherein the surgical lubricant consists of a water-soluble gel mixed with a lower viscosity solution.

[0095] 43. The silicone prosthesis delivery apparatus according to embodiments 29-42, wherein the delivery sleeve provides a plurality of spaced apart, longitudinally arranged indicia positioned proximal to one or both of the entry opening and exit opening for assisting with the selective cutting of the delivery sleeve, the indicia configured as integral, structural features of the delivery sleeve.

[0096] 44. The silicone prosthesis delivery apparatus according to embodiments 29-43, wherein the indicia are notches positioned longitudinally along opposing lateral edges of the delivery sleeve.

[0097] 45. The silicone prosthesis delivery apparatus according to embodiments 29-44, wherein the indicia are thermally produced markings positioned longitudinally across opposing lateral edges of the delivery sleeve.

[0098] 46. A silicone prosthesis delivery apparatus comprising: a silicone prosthesis; and a flexible, substantially funnel-shaped delivery sleeve constructed out of a material having a lubricating additive that forms a textured inner surface within the delivery sleeve, the delivery sleeve comprising: an entry portion defining a stretchable entry opening configured for allowing the prosthesis to pass therethrough to a position inside the delivery sleeve; an opposing exit portion defining a stretchable exit opening configured for allowing the prosthesis to pass therethrough when the prosthesis is expelled from the delivery sleeve, the exit opening having a diameter that is less than a diameter of the entry opening; and a volume of surgical lubricating fluid coating the textured inner surface of the delivery sleeve so as to reduce the coefficient of friction between the inner surface of the delivery sleeve and the prosthesis, the surgical lubricating fluid having a viscosity in the range of approximately 20 to 25,000 centipoise; whereby, with the prosthesis positioned within the delivery sleeve, the delivery sleeve is capable of being manipulated to apply pressure to direct the prosthesis along a length of the delivery sleeve and toward the exit opening, such that the prosthesis may be expelled from the delivery sleeve through the exit opening.

[0099] 47. A silicone prosthesis delivery apparatus for facilitating the transport and subsequent insertion of a silicone prosthesis into a surgically developed pocket of a patient, the apparatus comprising: a flexible, substantially funnel-shaped delivery sleeve constructed out of a material having a lubricating additive that forms a textured inner surface within the delivery sleeve, the textured inner surface of the delivery sleeve having a Sa—as measured using an optical profiler having an S-filter setting of 0.0025 mm and an L-filter setting of 0.25 mm—of between approximately 0.05 μm and 1.5 μm, the delivery sleeve comprising: an entry portion defining a stretchable entry opening configured for allowing the prosthesis to pass therethrough to a position inside the delivery sleeve; an opposing exit portion defining a stretchable exit opening configured for allowing the prosthesis to pass therethrough when the prosthesis is expelled from the delivery sleeve, the exit opening having a diameter that is less than a diameter of the entry opening; and a volume of surgical lubricating fluid coating the textured inner surface of the delivery sleeve so as to reduce the coefficient of friction between the inner surface of the delivery sleeve and the prosthesis, the surgical lubricating fluid having a viscosity in the range of approximately 20 to 25,000 centipoise; whereby, with the prosthesis positioned within the delivery sleeve, the delivery sleeve is capable of being manipulated to apply pressure to direct the prosthesis along a length of the delivery sleeve and toward the exit opening, such that the prosthesis may be expelled from the delivery sleeve through the exit opening.

[0100] In closing, regarding the exemplary embodiments of the present invention as shown and described herein, it will be appreciated that a silicone prosthesis delivery apparatus and configured for facilitating the transport and subsequent insertion of a silicone prosthesis into a surgically developed pocket of a patient is disclosed. Because the principles of the invention may be practiced in a number of configurations beyond those shown and described, it is to be understood that the invention is not in any way limited by the exemplary embodiments, but is generally directed to a silicone prosthesis delivery apparatus and is able to take numerous forms to do so without departing from the spirit and scope of the invention. It will also be appreciated by those skilled in the art that the present invention is not limited to the particular geometries and materials of construction disclosed, but may instead entail other functionally comparable structures or materials, now known or later developed, without departing from the spirit and scope of the invention.

[0101] Certain embodiments of the present invention are described herein, including the best mode known to the inventor(s) for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor(s) expect skilled artisans to employ such variations as appropriate, and the inventor(s) intend for the present invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described embodiments in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

[0102] Groupings of alternative embodiments, elements, or steps of the present invention are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

[0103] Unless otherwise indicated, all numbers expressing a characteristic, item, quantity, parameter, property, term, and so forth used in the present specification and claims are to be understood as being modified in all instances by the terms “about” and “approximately.” As used herein, the terms “about” and “approximately” mean that the characteristic, item, quantity, parameter, property, or term so qualified encompasses a range of plus or minus ten percent above and below the value of the stated characteristic, item, quantity, parameter, property, or term. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical indication should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0104] Notwithstanding that the numerical ranges and values setting forth the broad scope of the invention are approximations, the numerical ranges and values set forth in the specific examples are reported as precisely as possible. Any numerical range or value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Recitation of numerical ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate numerical value falling within the range. Unless otherwise indicated herein, each individual value of a numerical range is incorporated into the present specification as if it were individually recited herein. Similarly, as used herein, unless indicated to the contrary, the term “substantially” is a term of degree intended to indicate an approximation of the characteristic, item, quantity, parameter, property, or term so qualified, encompassing a range that can be understood and construed by those of ordinary skill in the art.

[0105] Use of the terms “may” or “can” in reference to an embodiment or aspect of an embodiment also carries with it the alternative meaning of “may not” or “cannot.” As such, if the present specification discloses that an embodiment or an aspect of an embodiment may be or can be included as part of the inventive subject matter, then the negative limitation or exclusionary proviso is also explicitly meant, meaning that an embodiment or an aspect of an embodiment may not be or cannot be included as part of the inventive subject matter. In a similar manner, use of the term “optionally” in reference to an embodiment or aspect of an embodiment means that such embodiment or aspect of the embodiment may be included as part of the inventive subject matter or may not be included as part of the inventive subject matter. Whether such a negative limitation or exclusionary proviso applies will be based on whether the negative limitation or exclusionary proviso is recited in the claimed subject matter.

[0106] The terms “a,” “an,” “the” and similar references used in the context of describing the present invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Further, ordinal indicators—such as “first,” “second,” “third,” etc.—for identified elements are used to distinguish between the elements, and do not indicate or imply a required or limited number of such elements, and do not indicate a particular position or order of such elements unless otherwise specifically stated. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the present invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the present specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0107] When used in the claims, whether as filed or added per amendment, the open-ended transitional term “comprising” (along with equivalent open-ended transitional phrases thereof such as “including,” “containing” and “having”) encompasses all the expressly recited elements, limitations, steps and/or features alone or in combination with un-recited subject matter; the named elements, limitations and/or features are essential, but other unnamed elements, limitations and/or features may be added and still form a construct within the scope of the claim. Specific embodiments disclosed herein may be further limited in the claims using the closed-ended transitional phrases “consisting of” or “consisting essentially of” in lieu of or as an amendment for “comprising.” When used in the claims, whether as filed or added per amendment, the closed-ended transitional phrase “consisting of” excludes any element, limitation, step, or feature not expressly recited in the claims. The closed-ended transitional phrase “consisting essentially of” limits the scope of a claim to the expressly recited elements, limitations, steps and/or features and any other elements, limitations, steps and/or features that do not materially affect the basic and novel characteristic(s) of the claimed subject matter. Thus, the meaning of the open-ended transitional phrase “comprising” is being defined as encompassing all the specifically recited elements, limitations, steps and/or features as well as any optional, additional unspecified ones. The meaning of the closed-ended transitional phrase “consisting of” is being defined as only including those elements, limitations, steps and/or features specifically recited in the claim, whereas the meaning of the closed-ended transitional phrase “consisting essentially of” is being defined as only including those elements, limitations, steps and/or features specifically recited in the claim and those elements, limitations, steps and/or features that do not materially affect the basic and novel characteristic(s) of the claimed subject matter. Therefore, the open-ended transitional phrase “comprising” (along with equivalent open-ended transitional phrases thereof) includes within its meaning, as a limiting case, claimed subject matter specified by the closed-ended transitional phrases “consisting of” or “consisting essentially of.” As such, embodiments described herein or so claimed with the phrase “comprising” are expressly or inherently unambiguously described, enabled and supported herein for the phrases “consisting essentially of” and “consisting of.”

[0108] Any claims intended to be treated under 35 U.S.C. § 112(f) will begin with the words “means for,” but use of the term “for” in any other context is not intended to invoke treatment under 35 U.S.C. § 112(f). Accordingly, Applicant reserves the right to pursue additional claims after filing this application, in either this application or in a continuing application.

[0109] It should be understood that the methods and the order in which the respective elements of each method are performed are purely exemplary. Depending on the implementation, they may be performed in any order or in parallel, unless indicated otherwise in the present disclosure.

[0110] All patents, patent publications, and other publications referenced and identified in the present specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described in such publications that might be used in connection with the present invention. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicant and does not constitute any admission as to the correctness of the dates or contents of these documents.

[0111] While aspects of the invention have been described with reference to at least one exemplary embodiment, it is to be clearly understood by those skilled in the art that the invention is not limited thereto. Rather, the scope of the invention is to be interpreted only in conjunction with the appended claims and it is made clear, here, that the inventor(s) believe that the claimed subject matter is the invention.