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WO 2010/024870 Al (12) INTERNATIONALAPPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 4 March 2010 (04.03.2010) WO 2010/024870 Al (51) International Patent Classification: CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, A61F 13/00 (2006.01) DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (21) International Application Number: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, PCT/US2009/004808 ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (22) International Filing Date: NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, 24 August 2009 (24.08.2009) SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of regional protection available): ARIPO (BW, GH, (30) Priority Data: GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, 12/23 1,104 29 August 2008 (29.08.2008) US ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, (72) Inventor; and ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, (71) Applicant : JENNINGS-SPRING, Barbara, Brooke MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, SM, [US/US]; 10844 North Dogwood Trail, Jupiter, FL 33478 TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, (US). ML, MR, NE, SN, TD, TG). (74) Agent: FISHMAN, Irving, M.; C/o Cohen Tauber Declarations under Rule 4.17: Spievack and Wagner, 420 Lexington Avenue, Suite — as to the identity of the inventor (Rule 4.17(ϊ)) 2400, New York, NY 101 70 (US). — as to applicant's entitlement to apply for and be granted (81) Designated States (unless otherwise indicated, for every a patent (Rule 4.1 7(H)) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, [Continued on next page] (54) Title: SKIN-CONTACTING-ADHESIVE FREE DRESSING (57) Abstract: A dressing having a flexible sleeve shaped to accommo date a substantially cylindrical body portion, the sleeve having a lining which is substantially non-adherent to the body part being bandaged and having a peripheral securement means which attaches two peripheral portions to each other without those portions being circumferentially ad hered to the sleeve portion. FIG. 10 as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(Ui)) — with international search report (Art. 21(3)) of inventors hip (Rule 4.17 (iv)) Attorney Docket No. 147.003 SKIN-CONTACTING-ADHESIVE FREE DRESSING CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation -in-part of copending US 11/434,689, filed May 16, 2006, which is incorporated herein by reference in its entirety. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not Applicable FIELD OF THE INVENTION [0003] The invention relates to transdermal drug delivery for injured body parts and organs in need of pharmaceutical interventions without the need for an adhesive in contact with the skin. The administration areas where the compounds can be delivered are body parts that are primarily cylindrical in shape. For example, the arm, leg, torso, finger, toes, will be most advantageous to place the adhesiveless unit/dressing for therapeutic interventions. [0004] The invention further relates to various transdermal and topical drug applications in a variety of contexts without the need for skin-contacting adhesives. These include such bandages Attorney Docket No. 147.003 with or without energy sources for supplementally driving the drug into or through the skin and includes, without limitation such systems as iontophoretic, sonophoretic, pulsed electronic, photophoretic, etc. In these topical and/or transdermal application, the body part being treated need not be injured or wounded, but the application of the therapeutic agent or other material can be for the expression of an effect at other parts of the person, animal being treated. Drug formulations from which active agents are delivered vary over a wide range and include, without limitation, solutions, dispersions, emulsions, liposomal encapsulations, dispersions in solids such as monolithic polymers, etc. They include formulations in currently marketed transdermal products, inotophoretic products, sonophoretic products, and photophoretic products to name a few. Where the active agent can be made into a readily soluble form (such as formulations of the "orally disintegrating type"), they can also be used as dry materials embedded or absorbed in one or more layers which will be wetted, either directly from the skin contact site or by briefly wetting or hydrating either the skin contact site or the dressing at about the time of application. Dispersions of active agents in adhesives are also suitable formulations for the represent invention provided that the adhesive used does not come in contact with the skin or wound being dressed. BACKGROUND OF THE INVENTION [0005] Bandage application for applying medications to compromised skin, whether merely slightly broken (scrapes or small cuts) or severely compromised such as in severe large scale burns require bandages to be very gingerly applied and removed so as to avoid disturbing the Attorney Docket No. 147.003 healing process. Transdermal and topical bandages usually have adhesives associated therewith that adhere to skin very well and make it difficult to remove and change bandages without significant pulling on skin or causing substantial stresses and torques on the injured area. These situations result in re-injury to the healing site or further opening and sometimes expanding would area, even when the adhesive is on the periphery of the wound site. Further, where the skin or wound area being dressed has scabs, friability, or hairs, the removal of adhesives from the skin can be painful. In addition, in older patients, or those with arthritic conditions, the removal of adhesive dressings can be quite difficult. [0006] In many transdermal contexts, whether with or without the foregoing issue, a significant difficulty involves skin irritation, frequently due to the skin-contacting adhesives being utilized to secure the transdermal to the body. Because of such irritation, transdermal patches have traditionally been made as small as possible so that as small a region as possible is affected (and leaving alternate application sites for rotation of application of subsequent dosages while the prior application site recovers). The size limitation of the transdermal patch means that for many drugs, the formulations must have a flux enhancer in order to achieve a sufficient delivery rate (inherent delivery rate/unit area X area of application) for an efficacious product. Unfortunately, flux enhancers frequently are themselves irritating to the skin and thus, more times than not, just exacerbate the problem. Still other drugs, even with the flux enhancers, have insufficient delivery rates from trandermals of the conventional sizes. Attorney Docket No. 147.003 [0007] In further contexts, certain drugs have been incompatible with various adhesives (chemical or physical instability of the drug) or plasticize (or "soften") the adhesive through which it must pass or in which it is embedded), meaning that the number and kind of adhesives that can be used are limited, often leaving only the more irritating adhesives as the only suitable ones, or resulting in devices in which the drug containing layer partially pulls away from the device when its "release liner" is removed or the device tends to fall off the patient prematurely, either way resulting in underdosing of the patient. [0008] Some attempts have been made to increase drug flux through the skin, with and without permeation enhancers by using various energy sources to help drive the material through the skin. These include iontophoretic systems (utilizing charged moieties and applied current), sonophoretic systems (utilizing ultrasonication), photophoretic systems (utilizing (generally non- ablative) laser energy), etc. Other attempts have been made using liposomal encapsulation to take advantage of liposomal transport and fairly recently nanoenapsulation (delivery of proteins such as insulin and other large molecules across skin). [0009] The present invention addresses these issues in the transdermal context by removing the need for the skin-contacting adhesive, allowing the size of the transdermal to be increased, which then permits efficacious delivery of materials with lower inherent flux rates as the total delivery per unit time is increased ((inherent flux) X (area of device)). This allows for reduction or elimination of the flux enhancers, so as to further avoid skin irritation, and allows for the application of transdermal technology to a range of molecules to which it could not be applied Attorney Docket No. 147.003 previously. The coupling of the present dressing devices with or the incorporation within the present dressing devices of various driving energy structures (iontophoretic, sonophoretic, pulsed electronic, and/or photophoretic) further expands the range of molecules that can be delivered, as does the use of liposomal and nano-encapsulations. OBJECTS OF THE INVENTION [0010] It is therefore an object of the invention to provide a dressing for a substantially cylindrically shaped body part with a securement means allowing the dressing to be applied and removed with the proper amount of pressure in order to promote hemostasis. [0011] It is yet another object of the invention to provide a dressing for an animal or human substantially cylindrical body part that permits easy removal of the dressing without involving the bandaged part in the removal process. [0012] Yet another object of the invention is to provide a surgical dressing which preserves hygienic conditions by providing an improved securement means.
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