WO2019069340A2

WO2019069340A2 - Substance applicator device for application of a product and for control of scratching

Info

Publication number: WO2019069340A2
Application number: PCT/JO2017/050001
Authority: WO
Inventors: Saif Aldeen ALRYALAT; Lna MALKAWI
Original assignee: Alryalat Saif Aldeen
Priority date: 2017-10-06
Filing date: 2017-10-06
Publication date: 2019-04-11
Also published as: WO2019069340A3

Abstract

A substance applicator device for application of a product to the skin. The applicator is embodied in smooth, disposable and non-allergenic material and is comprised of multiple bubble-like projections where the product is contained. The applicator can deliver more than one product in a single use and can control the amount of the product released. The applicator takes the advantage of scratching and transforms it from a major pathophysiological contributor of many diseases; particularly atopic dermatitis, into a route for treatment delivery and for impedance of disease pathology. The applicator can also aid in delivering a product not only locally to the skin, but also to systemic circulation. The invention can be embodied in different models such as: a full-glove, a half-glove, and a finger cap.

Description

Substance Applicator Device for Application of a Product and for Control of

Scratching

Description

Background of the invention

1- Field of the invention:

The present invention relates to a substance applicator. More specifically, it relates to an applicator that delivers a product to the skin mainly upon scratching, so that it aids to precisely restrict the product to the target site and to minimize the

destruction of the skin layers.

2- Description of prior art:

Atopic dermatitis is a chronic inflammatory skin disease caused by hyperreactivity of skin to various invironmental trigers. It affects both the patient's skin topically and his/her quality of life as well. Children and adults having atopic dermatitis commonly complain of itching and scratching that increases during night time and frequent awakenings at night due to itchiness and urge to scratch. The mainstay of treatment regimens rely mainly on topical medications, particularly skin

moisturizers and steroids.

So far, 3 generations were designed for topical administration through the skin: The first generation; which is represented by skin patches, it has a main drawback that is the outermost layer of the skin; i.e. stratum corneum, can impede its absorption. The second generation of drug delivery systems are the skin- permeability enhancers, particularly by manipulating drug manufacturing. These have several disadvantages regarding their cost, toxicity, and being used only for small molecular-weight drugs. The most advanced are the third generation drug delivery systems which are poised to make significant impact on drug delivery, because they directly target their effects to the stratum corneum. This targeting enables stronger disruption of the barrier effect of stratum corneum, and thereby more effective transdermal delivery, while still protecting the deeper tissues.

The presence of a strong barrier called Stratum Corneum, which is the outermost layer of the epidermis, will lead to only minute amount of the topically applied drug to be absorbed to either deeper tissues or the systemic circulation. Bypassing stratum corneum will enhance the topical penetration through the skin, and can also increase its bioavailability making the skin an efficient route to deliver systemic treatments. The present invention aims to take the advantage of the scratching itself and its resulting increase in skin permeability to deliver the appropriate treatment topically and systemically via the skin, thus making scratching one of the third-generation drug delivery systems.

Scratching is a mechanical way to disrupt stratum corneum, and thus to enhance the permeability of the skin barrier. It can also help to localize the specific targets to where we need to deliver the topical treatment. On the other hand, the patient's strong desire for scratching in diseases where itching is a main symptom e.g.

Atopic dermatitis, along with the sharp nature of the nails, will lead to devastating effects on the skin by not only disrupting the protective barrier, but also the deeper tissues including blood vessels within the dermis. As a result, several allergens and pathogens will gain entry to the deeper structures and will exacerbate the itching leading to a vicious cycle.

In somewhat related prior art, product applicators were described. A glove or a finger applicator where a product is discharged by the effect of one or more finger manipulation by the wearer.

U.S. Pat. No. 2011/0306942 issued to Thorpe sets forth a finger applicator that can be affixed or provided integral to a glove for application of a product to a patient. It has a dosage pad at the distal end of the finger that has an absorbent matrix to retain the product to be applied.

U.S. Pat. No. 5,169,251 issued to Davis sets forth a glove which has a self- contained palmar reservoir for storing materials to be dispensed at the fingertips, by the effect of the wearer's compressing the reseroir, via conduits extending from the reservoir and terminating at the fingertips.

U.S. Pat. No. 4,903,864 issued to Sirhan sets forth a glove amusement device. The glove comprises a liquid storage apparatus, a glove and an umbilical cord

connecting them and terminating at the fingertip. The glove produces a hard stream of liquid upon activation by a trigger mechanism also found on the glove.

US. Pat. No. 6,409,688 issued to Hennenfent sets forth a glove device for employment in the communication of different substances, Which is particularly useful in communicating such substances to in vivo treatment areas, such as the prostate or rectum. The substance communication pathway is embedded within the glove body and primarily acts as a conduit between the substance reservoir and the channel termination point at the distal end of the finger.

U.S. Pat. No. 3,883,897 issued to LefkoWitZ et al. sets forth a painting glove that may be used as a surrogate for a painting brush. The glove may be dipped into a paint reservoir and then used to spread paint on a surface. The glove may also includes a paint reservoir that allows paint to be slowly discharged onto the target site via conduits that terminate at each fissure between the fingers.

US. Pat. No. 3,701,604 issued to Holroyd sets forth a glove for the manual application of a liquid over a treatment surface. It comprises a liquid reservoir which is connected to an absorbent material via a passage means that controls the flow of liquid. The liquid is absorbed by the absorbent material and is discharged through the material to its outer surface by manual pressure.

Brief summary of the invention

A substance applicator device for product application to the skin, which is particularly useful for atopic dermatitis patients to deliver medications and skin moisturizers upon scratching. It also comprises a mean to prevent skin damage by vigorous scratching encountered in many other diseases such as: scabies, urticaria, skin rash,..etc. The invention is embodied in smooth, disposable and non-allergenic material, and is comprised of at least one finger pocket, with the distal end of at least one finger is comprised of at least one small bubble-like projection (bleb) that is pre-filled with the product of interest. The product will be released after the rupture of the described projection by the effect of scratching or finger

manipulation.

Accordingly, one of the objects of the present invention is to take control of scratching and to transform it from a major patho-physiological contributor for atopic dermatitis into a mean for treatment delivery.

It also comprises a mean for breaking the vicious cycle of atopic dermatitis; by working to relieve the urge for itching without causing undesired damage to the skin and the subsequent entry of allergens and pathogens.

One more object is to cover the nails; which are the most contaminated parts of the hand where most pathogens reside. The present invention also takes the advantage of the "night scratching", that patients with atopic dermatitis frequently suffer from, to deliver the medication at the optimal time and site.

The present invention is painless and non-invasive. It also aims to preferably break the skin barrier, formed particularly by stratum corneum layer; the outer most layer of the skin, as well as to apply the treatment in one step, so that users of different ages can easily and properly use it.

Detailed description of the invention

While the present invention can be in many different forms, what is shown in the drawings and will be described herein in details, is the preferred embodiments of the present invention. It should be understood, however, that the present disclosure is to be considered an exemplification of the principles of the invention and is not intended to limit the scope of the invention and/or claims of the illustrated embodiments.

Referring now to the drawings in detail, Figure 1 illustrates a substance applicator device in one embodiment. It is a hand-receiving glove, that has a substance- containing bubble-like projections/blebs (a) on the distal end of at least one finger. The glove body is constructed in a convenient way so that it has finger pockets (b), a thumb pocket (c), the palm (d) and the wrist portion (e).

The applicator is conventionally comprised of latex-free rubber. It can alternatively be comprised of any convenient disposable material such as : silicon, vinyl, nitrile or any other suitable material known by one of ordinary skill in the art.

The applicator is constructed from a light, smooth, and non-irritative material so that it is convenient to be worn for several hours, for example during nighttime.

The substance that is intended to be applied to the skin is embedded in small bubble-like projections (a) that are allocated at the distal ends of the fingers. The described projections are prefilled with the substance of interest. The substance is discharged from the projections after the rupture of the described projections by the effect of the pressure applied by the wearer while scratching the site of the skin disease or by finger manipulation over the target site. The projections (a) are constructed to be in different sizes and different wall-thicknesses so that the number of ruptured projections and subsequently the amount of the substance is controlled and gradually-released according to the force of scratching/finger manipulation; i.e. severity of symptoms. Furthermore, the projections (a) are designed in different wall-thicknesses so that they can accommodate the increasing force of scratching and thus can help to relieve the different severities of itching that patients might suffer from specially and more-severely during nighttime.

In one embodiment, the projections can be grouped into clusters, with each cluster is comprised of at least one projection, and is connected to a single reservoir that is filled with the substance of interest. This allows the content of the whole cluster to be released even if only one or some of them were ruptured.

The presence of the described projections (a) makes the surface of the fingertips of the applicator slightly roughened, thus allowing for bypassing the barrier effect of skin; by breaching the stratum corneum layer. This will aid in accomplishing a better penetration of the substance into the skin and to relieve the urge for itching, however, without causing any trauma or undesired damage to the skin.

Although it is illustrated that the projections only cover the distal end of the finger, it is to be understood that it is only one embodiment of the present invention. As it can be also constructed in various embodiments, for example: the projections can be allocated on the palm and/or on the proximal part of the finger.

Figure 2 illustrates another preferred embodiment of the present invention, the "half-glove" applicator. It is constructed in a specialized design that is comprised of finger pockets (b) and a thumb pocket (c) that are comprised of the described projections (a), however, it lacks the palm and the wrist portions described in the first embodiment. This embodiment is mainly designed to serve patients whose skin symptoms and itching involve parts of the hand (e.g. The palm, dorsum of hand, wrist joint.. etc), so that these parts are kept exposed and can be targeted by the substance upon scratching/finger manipulation.

Figure 3 illustrates one more embodiment of the substance applicator; that is a finger cap that covers a single finger and is comprised of the described projections (a). In this embodiment, the user can wear at least one finger cap to apply the substance to the target skin area.

Figure 4 illustrates another embodiment of the present invention. It is embodied in a patch form, that is comprised of the described projections (a), and can be attached to the user's finger by means of an anchoring band, or can have a sticky surface to affix it to the user's hand.

The latter two embodiments are helpful in circumstances where fingers need to be targeted by the substance contained in the projections. These can also helps to restrict the applied amount of the substance in circumstances where only limited amount of the substance is allowed to be applied, for example topical steroids.

The target population of the present invention includes, but is not restricted to, patients with all skin disorders that need topical treatments particularly those diseases where itching is a frequent disturbing symptom, for example: different types of dermatitis especially atopic dermatitis, scabies, infectious skin rash, ...etc. It is to be understood that the substance contained in the projections can be liquid, powder, cream, ointment, paste, foam, gel or in any other suitable form.

Patients with Atopic Dermatitis commonly suffer from nighttime itchiness that can be severe enough to drive an unconscious, vigorous and skin-damaging scratching while the patient is sleeping, and can even awaken them from sleep. The present invention aims to help this group of patients by controlling their night scratching and taking the advantage of this forceful unconscious scratching to deliver the treatment as well as to prevent skin damage, and ultimately to break the vicious cycle of the disease.

It is to be understood that more than one substance can be contained inside the projections (a) of a single applicator, whether simultaneously in the same projection, or separately in different projections. For example, in a single applicator, at least one projection contains a therapeutic ointment, and at least one other projection contains a moisturizer cream. This is of particular use for patients who need to apply more than one medication/product to the same skin area.

It is also to be understood that the present invention is not limited for topical destination, instead it can also be used to deliver drugs to the systemic circulation through the skin, especially when other routes are contraindicated. As the transdermal route has several advantages compared to the oral route. In particular, it is used when there is a significant first-pass effect of the liver that can prematurely metabolize drugs. Trans-dermal delivery also has advantages over hypodermic injections, as the latter are painful, generate dangerous medical waste and pose the risk of disease transmission by needle re-use, especially in developing countries.

It should be understood that the terms "a" and "an" as used above and elsewhere herein refer to "one or more" of the mentioned components. It is clear to one of ordinary skill in the art that the use of the singular includes the plural unless otherwise specifically stated. Drawings

Brief description of the drawings:

Figure 1 illustrates a top perspective view of a substance applicator embodied in a hand-receiving glove.

Figure 2 illustrates a top perspective view of a half-glove embodiment of the present invention.

Figure 3 illustrates a perspective view of a finger cap embodiment of the present invention.

Figure 4 illustrates a perspective view of a patch embodiment of the present invention.

Claims

1- A substance applicator device for application of a product, comprising of:

- a pocket to contain the user's hand;

- plurality of finger pockets;

- a plurality of projections prefilled with a product.

2- The substance applicator in claim 1 wherein is composed of a basically disposable material.

3- The substance applicator in claim 1 wherein amount of the product released is controlled by force of scratching or finger manipulation.

4- The substance applicator in claim 1 wherein is embodied in a hand-receiving glove.

5- The substance applicator in claim 1 wherein is embodied in a half-glove form.

6- The substance applicator in claim 1 wherein is embodied in a patch form.

7- The substance applicator in claim 1 wherein can enhance the permeability of the skin.

8- The substance applicator in claim 1 wherein delivers to local and/or systemic destinations.

9- The substance applicator in claim 1 wherein is embodied in a finger cap design.

10- The finger cap in claim 7 wherein is comprised of at least one of the projections.

11- The product in claim 1 wherein comprising: liquid, powder, cream, ointment, paste, foam and gel.

12- The projections in claim 1 wherein are comprised of walls of different thicknesses.

13- The projections in claim 1 wherein are prefilled with greater than one product simultaneously in the same projection.

14- The projections in claim 1 wherein are prefilled with greater than one product separately in different projections.

15- The projections in claim 1 wherein are grouped into clusters, with each cluster is comprised of at least one projection, and is connected to a single reservoir of the product.

16- A method of scratching as a route to deliver a substance to the skin, comprising:

- escaping the barrier effect of superficial skin by breaching the stratum corneum layer upon scratching;

- delivering the material during scratching; and

- delivering to plurality of destinations comprising locally to the skin or to systemic circulation.