Patent Application
20230310341
The invention is directed to adhesive patch systems that are attached to a wearer’s skin.
Adhesive patches are commonly used to attach medical components such as glucose sensors and/or infusion sets to the skin of a user. For example, glucose sensors and/or infusion sets are typically attached to a diabetic wearer’s body to monitor glucose levels and/or deliver insulin from an infusion pump to a subcutaneous site on the wearer’s body. Medical components such as glucose sensors typically comprise a base and a sensor or cannula inserted into an in vivo site on the wearer’s body. In such apparatuses, the base is typically attached to a patch which is attached to the wearer’s body with an adhesive system so that glucose sensors and/or other medical components can be removed and replaced periodically.
Many variations on the adhesive patch are practiced in the art, but in general, the adhesive patch comprises a backing layer, a layer of adhesive adjacent the backing layer which faces the wearer, and a release liner over the adhesive to prevent the adhesive from becoming contaminated before use. Adhesives for this purpose are typically provided commercially already applied to a backing layer, with a release liner covering the adhesive.
As continuous glucose monitoring (CGM) devices move to longer and longer wear durations (e.g., 14-16 days) the probability that a user will experience skin irritation due to the skin adhesive will increase. This skin irritation results in significant patient discomfort and a poor user experience.
In view of the above, new systems and methods designed to minimize skin irritation that occurs due to adhesive patches are desirable.
As noted above, as continuous glucose monitoring devices move to longer and longer wear durations the probability that a user will experience skin irritation due to the skin adhesive increases significantly. The invention disclosed herein provides a skin adhesive patch that inhibits skin irritation by releasing an anti-inflammatory agent such as a corticosteroid topically on the skin surface. Embodiments of the invention can be adapted for use with a wide variety of adhesive patches that are used to couple medical components to the skin of patients such as the devices that diabetic patients typically use including glucose sensors, insulin infusion sets, patch pumps, and all-in-one patch (i.e., glucose sensor +insulin pump) sets.
The invention disclosed herein has a number of embodiments. Embodiments of the invention include, for example, an adhesive patch comprising a first flexible layer of material adapted to contact skin, an adhesive composition operatively coupled to the first flexible layer of material, and a therapeutic composition such as a corticosteroid operatively coupled to this first flexible layer of material. In such embodiments, the adhesive composition is adapted to couple the first flexible layer of material to skin; and the therapeutic compound is operatively coupled to the adhesive patch such that when the first flexible layer of material is coupled to skin, the therapeutic compound is exposed to the skin such that inflammation is inhibited at a site on skin where the adhesive patch is adhered. While a wide variety of therapeutic agents can be used in such patches, typically in these embodiments, the therapeutic compound comprises an anti-inflammatory agent such as a corticosteroid.
In typical embodiments of the invention, the adhesive patch is designed to have elements and/or a three-dimensional architecture that facilitates the therapeutic agent diffusing away from the site at which it is disposed and to the skin of a patient (e.g., via conduits or vias that operably connect the therapeutic compound to skin). In some embodiments of the invention, the adhesive composition and/or the therapeutic composition is disposed in the adhesive patch in a selective pattern (e.g, one comprising alternating deposits of adhesive and therapeutic agent). In some embodiments of the invention, the adhesive patch comprises additional elements such as at least one second flexible layer of material (e.g., a second flexible layer also comprising an adhesive composition and which is adapted to adhere the first flexible layer of material to a medical device). Optionally, the therapeutic agent is disposed between the flexible layer of material and the adhesive composition such that the therapeutic agent diffuses through the adhesive composition and to skin; and/or the therapeutic agent is disposed on the adhesive composition such that the therapeutic agent diffuses through the adhesive composition and to skin. In certain embodiments of the invention, the therapeutic compound is disposed on a discrete substrate layer. In typical embodiments of the invention, the adhesive patch is coupled to a medical device such as a glucose sensor or an insulin infusion pump.
Embodiments of the invention include methods of making an adhesive patch as disclosed herein. Typically these methods include operably coupling an adhesive composition to a first flexible layer of material; and also operatively coupling a therapeutic composition to this first flexible layer of material. In such methods, the adhesive composition is adapted to adhere the first flexible layer of material to skin; and the therapeutic compound is operatively coupled to the adhesive patch such that when the first flexible layer of material is adhered to skin, the therapeutic compound is exposed to the skin in a manner such that inflammation is inhibited at a site on skin where the adhesive patch is adhered. In illustrative methods of the invention, the therapeutic compound comprises an anti-inflammatory agent such as a corticosteroid. Certain methods of the invention include the step of coupling the adhesive patch to a medical device.
Embodiments of the invention further include methods for estimating the concentrations of glucose in vivo, the methods comprising disposing an adhesive patch disclosed herein coupled to a glucose sensor on a diabetic patient; and estimating concentrations of glucose using the glucose sensor. Typically in these methods, the adhesive patch is worn by the patient for at least 10 days, at least 15 days, or at least 20 days. Optionally in these methods, the patch is coupled to an insulin infusion set and/or an infusion pump.
Other objects, features and advantages of the present invention will become apparent to those skilled in the art from the following detailed description. It is to be understood, however, that the detailed description and specific examples, while indicating some embodiments of the present invention are given by way of illustration and not limitation. Many changes and modifications within the scope of the present invention may be made without departing from the spirit thereof, and the invention includes all such modifications.
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Unless otherwise defined, all terms of art, notations, and other scientific terms or terminology used herein are intended to have the meanings commonly understood by those of skill in the art to which this invention pertains. In some cases, terms with commonly understood meanings may be defined herein for clarity and/or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art. Many of the techniques and procedures described or referenced herein are well understood and commonly employed using conventional methodology by those skilled in the art. As appropriate, procedures involving the use of commercially available kits and reagents are generally carried out in accordance with manufacturer defined protocols and/or parameters unless otherwise noted.
Embodiments of the invention comprise adhesive patches that are adapted to couple medical components (e.g., glucose sensors, infusion sets, infusion pumps and the like) to the skin of patients. Embodiments of the invention can be used with a wide variety of medical components/devices such as glucose sensors and/or insulin infusion sets and insulin pumps that are commonly worn by diabetic patients. In the text below, a continuous glucose monitor comprising a glucose sensor is used as an example of medical components/devices in illustrative embodiments of the invention discussed herein.
The invention disclosed herein has a number of embodiments. Embodiments of the invention include, for example, an adhesive patch comprising a first flexible layer of material adapted to contact skin, an adhesive composition operatively coupled to the first flexible layer of material, and a therapeutic composition such as a corticosteroid operatively coupled to this first flexible layer of material. In such embodiments, the adhesive composition is adapted to adhere the first flexible layer of material to skin; and the therapeutic compound is operatively coupled to the adhesive patch such that when the first flexible layer of material is adhered to skin, the therapeutic compound is exposed to the skin such that inflammation is inhibited at a site on skin where the adhesive patch is adhered.
While a wide variety of therapeutic agents can be used with embodiments of the invention, in typical embodiments a corticosteroid is used as the agent (e.g., dexamethasone, dexacetate, prednisone, etc.) and is disposed in the patch so that it is released topically on the skin surface (see, e.g.,
In typical embodiments of the adhesive patch is designed to have elements and/or a three-dimensional architecture that facilitates the therapeutic agent diffusing away from the site at which it is disposed and to the skin of a patient (e.g., via conduits or vias that operably connect the therapeutic compound to skin). Schematics of illustrative embodiments of this are shown in
Embodiments of the invention include methods of making an adhesive patch as disclosed herein. Typically these methods include operably coupling an adhesive composition operatively coupled to a first flexible layer of material; and operatively coupling a therapeutic composition to the first flexible layer of material. The components of the adhesive patches can be formed using art accepted methods. For example, in methods where the therapeutic agent in dexamethasone, a solution of dexacetate (DXAC) and polyurethane (PU) can be prepared (e.g. 60% PU & 40% DXAC) using with isopropyl alcohol (IPA) + tetrahydrofuran (THF). Dimethylacetamide (DMAC) can also be used as an alternative to IPA + THC. This composition can spray coated on to the desired location/substrate. In such methods, an amount of drug loaded is dependent on the number of spray passes. A mask can be used during the spray coating process to ensure that the agent such as DXAC is deposited only in the desired location (i.e., selective deposition). In typical methods, the adhesive composition is adapted to adhere the first flexible layer of material to skin; and the therapeutic compound is operatively coupled to the adhesive patch such that when the first flexible layer of material is adhered to skin, the therapeutic compound is exposed to the skin such that inflammation is inhibited at a site on skin where the adhesive patch is adhered. In illustrative embodiments of the invention, the therapeutic compound comprises an anti-inflammatory agent such as a corticosteroid and/or the adhesive composition comprises an acrylate. Certain embodiments of the invention include the step of coupling the adhesive patch to a medical device.
The dimensions of the adhesive patch are not critical and may be adapted according to conventional configurations practiced in the art. The patches may be sized as known in the art, with a typical diameter of the patch at the widest point being 1.5 to 2.5 inches, although this dimension likewise is not critical. Apertures, vias and the like through one or more of the layers may be of any shape such as circular, depending on the requirements of receiving a sensor or a cannula, hub or other medical component. The adhesive patches disclosed herein can have additional elements such as tabs adapted to be grasped by the user to manipulate the patch.
Embodiments of the invention further include methods for estimating the concentrations of glucose in vivo, the methods comprising disposing an adhesive patch disclosed herein coupled to a glucose sensor on a diabetic patient; and estimating concentrations of glucose using the glucose sensor. Typically in these methods, the adhesive patch is worn by the patient for at least 10 days, at least 15 days, or at least 20 days. Optionally in these methods, the patch is coupled to an insulin infusion set and/or an infusion pump.
Embodiments of the invention can use pressure sensitive adhesive compositions. Pressure sensitive adhesives (“PSAs”) based on polymers having acrylic or acrylate moieties are well known in the art and have been used for many years in the medical device arts. Pressure-sensitive acrylic adhesives for application to skin are typically made from compounds such as: 2-ethylhexyl acrylate, isooctyl acrylate or n-butyl acrylate. Polymers in such adhesives can be copolymerized with polar functional monomers such as: acrylic acid, methacrylic acid, vinyl acetate, methyl acrylate, N-vinylcaprolactam, or hydroxyethyl methacrylate (see, e.g., Kenney, J. F., et al. “Medical-grade acrylic adhesives for skin contact.” Journal of applied polymer science 45.2 (1992): 355-361). Other PSAs may be based on silicones. The selection of an appropriate PSA having the desired peel strength may be left to the skill of the person of ordinary skill in this art. Peel strength is a measure of how firmly the PSA adheres to the user’s body and may be measured in various ways, measuring the force required to separate two reference surfaces adhered with the PSA. In some embodiments, the PSA is modified by adding one or more active agents, such as a corticosteroid directly to the PSA composition.
As shown in the figures, embodiments of the invention can include a variety of elements such as a continuous glucose monitoring (CGM) device 100, a subcutaneous glucose sensor 102, a double sided pressure sensitive adhesive 104, a skin adhesive layer 106, a skin adhesive layer comprising a therapeutic agent 108, a therapeutic agent 110, a backing layer 112, a substrate 114 and a microfluidic path 11. In embodiments of the invention, a pressure sensitive adhesive layer covers substantially the entire extent of the adhesive surface. Alternatively, regions of the adhesive surface are covered with a pressure sensitive adhesive and adjacent regions are covered with active agents such as a therapeutic agent (see, e.g.,
While a wide variety of therapeutic agents can be used in such patches, typically in these embodiments, the therapeutic compound comprises an anti-inflammatory agent such as a corticosteroid. Examples of anti-inflammatory drugs include both steroidal and non-steroidal (NSAID) anti-inflammatories such as, without limitation, clobetasol, alclofenac, alclometasone dipropionate, algestone acetonide, alpha amylase, amcinafal, amcinafide, amfenac sodium, amiprilose hydrochloride, anakinra, anirolac, anitrazafen, apazone, balsalazide disodium, bendazac, benoxaprofen, benzydamine hydrochloride, bromelains, broperamole, budesonide, carprofen, cicloprofen, cintazone, cliprofen, clobetasol propionate, clobetasone butyrate, clopirac, cloticasone propionate, cortodoxone, deflazacort, desonide, desoximetasone,momentasone, cortisone, cortisone acetate, hydrocortisone, prednisone, prednisone acetate, diclofenac potassium, diclofenac sodium, diflorasone diacetate, diflumidone sodium, diflunisal, difluprednate, diftalone, dimethyl sulfoxide, drocinonide, endrysone, enlimomab, enolicam sodium, epirizole, etodolac, etofenamate, felbinac, fenamole, fenbufen, fenclofenac, fenclorac, fendosal, fenpipalone, fentiazac, flazalone, fluazacort, flufenamic acid, flumizole, flunisolide acetate, flunixin, flunixin meglumine, fluocortin butyl, fluorometholone acetate, fluquazone, flurbiprofen, fluretofen, fluticasone propionate, furaprofen, furobufen, halcinonide, halobetasol propionate, halopredone acetate, ibufenac, ibuprofen, ibuprofen aluminum, ibuprofen piconol, ilonidap, indomethacin, indomethacin sodium, indoprofen, indoxole, intrazole, isoflupredone acetate, isoxepac, isoxicam, ketoprofen, lofemizole hydrochloride, lomoxicam, loteprednol etabonate, meclofenamate sodium, meclofenamic acid, meclorisone dibutyrate, mefenamic acid, mesalamine, meseclazone, methylprednisolone suleptanate, momiflumate, nabumetone, naproxen, naproxen sodium, naproxol, nimazone, olsalazine sodium, orgotein, orpanoxin, oxaprozin, oxyphenbutazone, paranyline hydrochloride, pentosan polysulfate sodium, phenbutazone sodium glycerate, pirfenidone, piroxicam, piroxicam cinnamate, piroxicam olamine, pirprofen, prednazate, prifelone, prodolic acid, proquazone, proxazole, proxazole citrate, rimexolone, romazarit, salcolex, salnacedin, salsalate, sanguinarium chloride, seclazone, sermetacin, sudoxicam, sulindac, suprofen, talmetacin, talniflumate, talosalate, tebufelone, tenidap, tenidap sodium, tenoxicam, tesicam, tesimide, tetrydamine, tiopinac, tixocortol pivalate, tolmetin, tolmetin sodium, triclonide, triflumidate, zidometacin, zomepirac sodium, tacrolimus and pimecrolimus.
Additionally, examples of steroidal anti-inflammatory drugs include, without limitation, 21-acetoxypregnenolone, alclometasone, algestone, amcinonide, budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, deflazacort, desonide, desoximetasone, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, fluprednidene acetate, fluprednisolone, flurandrenolide, fluticasone propionate, formocortal, halcinonide, halobetasol propionate, halometasone, halopredone acetate, hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone, medrysone, meprednisone, methylprednisolone, mometasone furoate, prednicarbate, prednisolone, prednisolone 25-diethylamino-acetate, prednisolone sodium phosphate, prednisone, prednival, prednylidene, rimexolone, tixocortol, triamcinolone, triamcinolone acetonide, triamcinolone benetonide, triamcinolone hexacetonide, any of their derivatives, and combinations thereof.
Furthermore, examples of nonsteroidal anti-inflammatory drugs include, without limitation, COX-1 and COX nonspecific inhibitors (e.g., salicylic acid derivatives, aspirin, sodium salicylate, choline magnesium trisalicylate, salsalate, diflunisal, sulfasalazine and olsalazine; para-aminophenol derivatives such as acetaminophen; indole and indene acetic acids such as indomethacin and sulindac; heteroaryl acetic acids such as tolmetin, dicofenac and ketorolac; arylpropionic acids such as ibuprofen, naproxen, flurbiprofen, ketoprofen, fenoprofen and oxaprozin), and selective COX-2 inhibitors (e.g., diaryl-substituted furanones such as rofecoxib; diaryl-substituted pyrazoles such as celecoxib; indole acetic acids such as etodolac and sulfonanilides such as nimesulide), and combinations thereof.
Additionally, other naturally occurring or synthetic drugs, agents, molecules (e.g., hyaluronidase), and proteins may be included with the response-inhibiting agent to mitigate foreign-body responses and/or help facilitate the body in absorbing the medication.
It is to be understood that this invention is not limited to the particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims. In the description of the preferred embodiment, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration a specific embodiment in which the invention may be practiced. It is to be understood that other embodiments may be utilized, and structural changes may be made without departing from the scope of the present invention.
This application claims the benefit under 35 U.S.C. Section 119(e) of co-pending and U.S. Provisional Patent Application Serial No 63/325,257, filed on Mar. 30, 2022 and entitled “MINIMIZING SKIN IRRITATION DUE TO SKIN ADHESION PATCHES” which application is incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 63325257 | Mar 2022 | US |
