D PETER HOCHBERG CO LPA ~ 2167713804 06/28/00 14:08 ~ :04 N0:169 . , .-_ T~RAPEUTiC APPLICATOR AND COSMETIC REMOVER DEVICE
AND METHOD OF MAKING SAME :. , ..
~a he_Iav~ution ~ .
Under Title 35, United States Code ~ 119(e), this application claims the benefit of United States Provisional Application Serial Nos. 60/091,898 filed July 7, 1998 and 60/110,184 filed November 30, 1998.
The present invention is concerned with disposable, single use, unitary devices combining ffex~bk packaging material and a coated treatment surface having a therapeutic composition for application to the skin. , r Skin treatment, cosmeric removal, and drug therapy sometimes involve a time dependent application or removal proceedure involving the skin surface. An example of skin treatment is the removal of superficial or dead cells, od, sebaceous material, or keratotic phxgs from the skin- Another example is the application of a thrombogeaic or blood clotting composition. Cosmetic removal is applicable to eye shadow or other facial makeup. Drug therapy uses include treatments for skin conditions, chronic cardiac conditions, metabolic or endrinologic diseases, insect bite, or plant sting.
There are many uses for a remover or applicator device which is quick and easy to open a~
apply to the skin. Convenience for the user and high speed automated manufacturing for the producer can be achieved by a device in which an outer wrapper material and an inner therapeutic surface layer are combined in a unitary structure. These advantages are not provided by prior art devices where the applicator and its package are separate structures.
Fig. 1 is a perspective view of the device when open showing the inner surface of the wrapper material and the treatment containing surface.
Fig. 2 is a side, section view of the device in the closed condition showing the outer wrapper Layer and the inner treatment containing surface.
Fig. 3 is a side, section view of the device in the closed condition showing two separable wrapper layers, each having an inner treatment containing surface.
Fig. 4 is a side, section view of the device in the closed condition showing two separable wrapper layers, each having a treatment surface with the treatment surfaces separated by an internal dividing layer.
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Fig. 5 is a side, section view of the device is the closed condition showing two separable wrapper layers, each having a treatment surface with treatmeat~,surfaces separated by two internal separable layers of wrapper material.
Fig. 6 is a perspective view of a machine for making a therapeutic applicator device and having rotary and non rotary swab feeders and having rotary and non-rotary fluid injectors. ... .
The invention comprises a device having a layer of ffeuble and relatively impermeable material which functions"as an outer wrapper is the closed condition and as a supporting surface for a therapeutic composition in the open condition as shown in Fig.
1.
The outer wrapper 1 can be made of any suitable material but typically is comprised of one or more or a combination of layers .of plastic, metallic foil, or paper. The wrapper layer can be relatively transparent or opaque and can be printed on its outer surface. Fig. 1 shows a rectangular shape after opening and shows the fold line 2 when previously closed.
The outer wrapper can be of any size and shape. In particular curved or coloured edges may be advantageous for use on the nose, eyes, or other parts of the face. The treatment containing surface 3 can also be of any shape but typically conforms to the shape of the wrapper. The treatment containing area can be equal to but is usually less than the area of the wrapper. Depending on it's composition the treatment substance can be contained directly on the inner surface of the wrapper material or within or on a fibrous pad, sponge, hydrophilic sponge, gel, foam or any other material that can be adhered to the inner wrapper surface and that provides for absorption or better surface adsorption.
For some uses an unadhered pad or a pad with very weak adherence produced by the pad 'itself or the therapeutic substance may be sufficient. In certain cases it may be advantageous to have a pad or sponge material that can simultaneously apply pressure, and absorb or adhere blood, platelets, serum, or secretions from skin or a tissue surface and deliver a therapeutic composition to the same surface. This could be helpful in a device to control bleeding and promote blood clot formation. In particular such a device could contain one or more of gelfoam, cellulose, collagen, fibrinogen, thrombin, calcium ion, calcium salt, epsilon amino caproic acid, styptic agent, or vasoconstrictor substance in solid, powder, gel, or liquid form. The device works by providing an interface surface where blood constituents and therapeutic substances can mix and react on skin or an internal body surface. For some uses a particular color may be advantageous for the treatment surface such as a relatively light color to help visualize particulate matter removed from the skin.
The treatment composition can be solid, semisolid, or liquid or a combination of these. A
sticky or tacky surface may be useful for adherence to the skin and for removal of superficial cells or secretions. An absorbant surface may be useful for removal of cosmetics. For some therapeutic treatments a sticky area for skin adherence can surround a more central area containing a liquid or ointment. For other treatment substances it may be possible to have the therapeutic and skin adherence compositions combined or covering the same area of the applicator surface_ The treatment substances can petform more than one function such as removal of secretory material and application of a nutrient or drug.
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D PETER HOCHBERG CO LPA ~ 2167713804 06/28/00 14:08 ~ :06 N0:169 For some treatments et may be appropriate to remove the device immediately after applied while for other treatments it may need to be left on the skin for a number of minutes, hours, or days before removal. An attached elastic band or tape segment can help hold it in place. Depending on the particular use the device provides a surface for a physical or chemical reaction between the constituents of the applicator surface and the skin surface.
This reaction can occur at least in part on the absorbent pad surface of the device.
The hemostatic device described above is of particular use in emergency situations as may occur in a military, athletic, or industrial setting. When someone experiences a serious puncture wound, laceration, or abrasion due to a weapon, projectile, machinery, or equipment, stopping bleeding is a primary consideration. For military situations, first aid kits, or emergency vehicles compactness, convenience, light weight, and flexibility are important advantages offered by this invention. It provides a means for simultaneously applying pressure and blood coagulation promoting substances to stop bleeding until more difmitive treatment is available. The present invention has an advantage in providing the most rapid treatment of a bleeding wound. Typical bandages or bandaids require relatively more time to unwrap, open, and expose the treatment surface. Blood clotting substances must usually be applied by a separate means which requires an additional step.
The present invention pulls open to expose the treatment surface already containing blood clotting substances and is placeable over a wound site in one quick continuous motion.
In Fig 2 a side, section view of the device is shown in the closed condition with the outer' wrapper 4 and the treatment surface S. The outer wrapper sheet is folded along a fold line 7 and the peripheral edges of the two overlying, opposing sheets are sealed or adhered to each othtr except for the two opening tabs 6. For some treatment compositions that can be contained without an airtight seal the,opposing sheets can be adhered at only one or several perimeter points or the sheets can be folded against each other but not adhered.
A variation of the device is shown in Fig 3. Two separate treatment areas 8 and 9 are present, each on an iener surface of one side of the wrapper layer 10. The device is opened using pull tabs 11, and the two wrapper layers are separated along all peripheral seal lines including a bottom seal line 12. This results in two separate applicators aad allows for two treatment applications. For a bleeding control device it may be useful to have blood clot promoting substances as one applicator and an attached, separable, or removable adhesive or non-adhesive bandage or bandaid as the other applicator.
Alternatively the inner surface of only one side has a treatment area and the other side forms a Covering layer. In this case the device can be used as a unitary structure after opening or the two sides can be completely separated. A one sided applicator structure can also be covered by two or more peelable wrapper layers 1 U as shown in Fig. 3A.
Another variation is shown in Fig 4. In this embodiment the two treatment areas 14 and 1 S are on opposing inner surfaces of the wrapper layer I 3 and are separated by a dividing impermeable material Iayer 16. The device is opened by tearing the outer wrapper along a sealed peripheral edge 17. The two portions are pulled apart along the ~1 06/28/00 WED 12:06 [TX/RX NO 9137]
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pe'tiphaal seal Lines inchiding a bottom seal Line 18. This results in two separate applicators each ofwhich can have a differtnt treatment composition An alfernative method of using this device is by tearing off one sealed peripheral edge I y and inserting a finger or other object into the pouch that is formed by the other three sealed peripheral edges. A finger or fingernail can then be treated with a therapeutic substance located oa one or both sides of the pouch. For application of nail polish remover it is useful to have the fluid absorbed in a single pad that is adhered to one side of the pouch-For some sticky compositions it may be necessary to use a dividing layer 16 to separate and permit opening up a treatment surface folded on itself in overlying position as shown is Fig. 2.
An additional variation is shown in Fig. 5. The device is opened by tearing across one or more seal or attachment lines 19 and 20 and pulling the two portions apart.
Each .
portion then consists of a wrapper layer 21 or 22 with an applicator surface 23 or 24 .
folded on itself along a fold line 25 or 26. This variation_also allows for two different types of treatment application. With this embodiment as yvell as that shown in Fig. 4 any number of wrapper layers with separate applicator surfaces and treatment compositions ' can be provided in one device.
It may be convenie~ to dispense multiple applicators in the form of a roll such as a roll of tape. Such a roll having a series of folded applicators of the type shown in Fig. 2 or 3 could be separated from each other along a perforated tear line. A series of applicators in the unfolded condition as shown in Fig. 1 could also be dispensed in roll form. If a pressure sensitive adhesive applicator surface is used then the surfaces are covered in the roll by adhering them to the outer wrapper material of the underlying layer.
With this embodiment an outer wrapper of one layer of devices functions as one of the two opposing impermeable portions for the next outer layer of applicators. 'file applicators can be separated from each other along perforated tear lines or at any random point resulting in an applicator length of the user's choice.
The device is typically used by pressing the therapeutic surface with overlying wrapper Layer on the skis surface. An akernative method of use as shows in Fig. l A is to tear off an end segment of wrapper material 1 and use an exposed end portion of a co~ained relatively thick (at least 2 mm) pad or towiette 3 to apply the therapeutic substance. Yet another method of use as shown in Fig. 1 B is to tear away a portion of wrapper material 1 and fold it under an unattached or partially attached pad 3 as a support for application to the skin. This method may be useful for certain applications or for fingerprinting.
In the manufacture of this device new methods may be useful for adhering or attaching the therapeutic substance or absorptive material layer to the wrapper material as shovtrn in Fig. 6. One method involves bending the wrapper material 22 around the convex aspect of a rotating curved surface 28. This can help produce better contact for adhering the adsorptive material 29. Heat or pressure can also be applied 'by the rotating curved surface or against it 30 to help attachment. With a firm attachment an absorptive material will stay adhered to the wrapper material after opening of the device and during use. With a Loose attachment an absorptive material segment or folded towlette can be removed 06/28/00 WED 12:06 [TX/RX NO 9137]
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from the device after opening and used separate from the wrapper. Where an absorptive , fibrous pad is loosely adhered the subsequent addition Qf a therapeutic yance or fluuid such as an alcohol can weaken adhering forces and allow removal of the pad from the wrapper. The therapeutic substance or absorptive material can be placed folded, or unfolded on the curved surface of a second rotary element 31 for bringing into contact with the wrapper material. Contact points can be de&ned by a series of molded elevations or depressions on a rotating drum so as to correspond to the perimeter seal zones of a swab or folded towlette device. The second rotary element can have a series of small holes through its surface and through which suction can be applied to help hold the therapeutic substance or segments of absorptive material 32 in place.
Absorptive material segments or towleites can also be held in place by use of electrostatic forces, heat, positive air pressure, or surface tension as when the absorptive segment has akeady been soaked with therapeutic fluid_ The attachment process can be done before or after the wrapper material is cut into individual applicator devices. A rotary element 33 can also be used to apply a second covering layer of wrapper material 34. The method can provide for using one temperature or pressure for attaching the therapeutic or absorptive material and a different temperature or pressure for sealing the perimeter edges of the device.
Alternatively absorptive material segments 35 cari be inserted using a non-rotating swab feeder 36 positioned above fluid impermeable wrapper pouches formed on a rotating drum The addition of a therapeutic composition or fluid to the device can be done using one or more pistons, valves, nozzles or spray aperatures 37 that are held stationary for injection into a pouch formed by the wrapper material Alternatively, the series of valves or nozzles can be fined to a rotating element 3 8 that beings each valve or nozzle into contact or close proximity to segments of wrapper or absorptive material for addition of a therapeutic composition or other skin treatment substance such as a fingerprint fluid. The rotary elements can be arranged with the axis of rotation horizontal or vertical relative to the ground. The process can be carried out using intermittent or continuous motion. The finished applicator 39 having an attached or unattached pad or towlette can have one seal line of a peel-open type with unadhered edges to facilitate opening or can have all edges completely sealed and of the tear-open type.
This invention is useful for various types oftreatments applied to the skin and in particular for those involving a time dependent application_ The device can be used to remove umwanted cellular or non-celtular material from the skin surface and to apply fluid, solid, or semi-solid substances to the skin Multiple treatment proceedures can be carried out simultaneously or m succession.