US 20120271275A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0271275 A1 Biggs et al. (43) Pub. Date: Oct. 25, 2012 (54) MEDICAL DEVICES AND METHODS Publication Classification COMPRISING AN ANABOLICAGENT FOR (51) Int. Cl WOUND HEALING A6II 3/58 (2006.01) A6M 5/42 (2006.01) (75) Inventors: Danielle L. Biggs, Collierville, TN A6IP 7/02 (2006.01) 5147 (US); Jared T. Wilsey, Memphis, (52) U.S. Cl. ......................................... 604/506; 514/176 TN (US) (57) ABSTRACT Improved medical devices and methods are provided com (73) Assignee: WARSAW ORTHOPEDIC, INC., prising an anabolic agent for wound healing. These improved Warsaw, IN (US) medical devices and methods can enhance wound healing in wounds from cuts, abrasions, lesions, burns including Sun burn, Surgical incisions, pressure ulcers, diabetic ulcers, trau (21) Appl. No.: 13/093,479 matic wounds, or other injuries or maladies, which can be chronic or non-chronic in origin. In some embodiments, the medical device comprises a drug depot that releases the ana (22) Filed: Apr. 25, 2011 bolic agent over at least 3 days to enhance wound healing. Patent Application Publication Oct. 25, 2012 US 2012/0271275 A1 o?uaegsås?on,ang?eoongoasoonaoºn6unee?-,punoanseneuerreoov?orozouens 2%3%%*{{{3% (siti) are e assad US 2012/0271275 A1 Oct. 25, 2012 MEDICAL DEVICES AND METHODS tions in the A, B, C and/or D rings have been made to increase COMPRISING AN ANABOLICAGENT FOR binding activity to the Steroid receptor and to increase lipid WOUND HEALING solubility of the anabolic steroids and prolong its activity. For example, alkylation at 17-alpha position with methyl or ethyl BACKGROUND groups create orally active compounds because it slows the 0001 Wounds can occur from various types of cuts, abra degradation of the drug by the liver. Esterification at the 3 sions, burns including Sunburn, Surgical incisions, pressure and/or 17 positions allow the anabolic steroid compound to be ulcers, diabetic ulcers, lesions and other injuries or maladies, activated in the blood stream when parenterally administered both chronic and non-chronic. The healing rate of a wound and also increases the duration of effectiveness by increasing can be improved by controlling the environment around the the lipid solubility. Alterations of the ring structure also allow wound during the healing process. Many wound treatments different anabolic steroid compounds to have different ana involve cleaning the wound and debriding it, and often, cov bolic to androgenic effects. ering it with a wound dressing to help it heal faster. 0007 Although anabolic agents are conventionally used 0002 Commonly used wound dressings include gauzes, to increase muscles mass and body weight, to date, they have foams, sponges, cotton wads or other fibrous materials. not been widely appreciated for local administration for Gauzes and other fibrous materials are used to absorb fluids wound healing. Therefore, there is a need for improved medi by capillary action to remove exudates from the wound and cal devices and methods comprising an anabolic agent for prevent influx of bacteria and other pathogens while the wound healing. wound heals. Often, wound dressings are normally draped over the treatment site and held in place by sutures or adhe SUMMARY sives. However, the Suturing of these wound dressings in 0008 Improved medical devices and methods are pro place is often tedious and time-consuming and not desirable vided comprising an anabolic agent for wound healing. These in many body sites. Adhesives used in wound healing are improved medical devices and methods can enhance wound normally used external to the body and not applied directly to healing in wounds from cuts, abrasions, lesions, burns includ the damaged tissue but to adjacent healthy tissue because they ing Sunburn, Surgical incisions, pressure ulcers, diabetic must be removed. Sometimes tissue can grow into the wound ulcers, traumatic wounds, or other injuries or maladies, which dressing as the wound heals, but this tissue is torn when the can be chronic or non-chronic in origin. wound dressing is removed causing injury to the wound, 0009. In one embodiment, there is an implantable medical which causes further delays in healing. device for treating a wound in a patient in need of such 0003. Other materials have been used alone or in conjunc treatment, the implantable medical device comprisinganana tion with wound dressings, such as gels hydrogels, granules bolic agent, and at least one biodegradable polymer, the medi and pastes to promote wound healing by keeping the wound cal device having a surface that releases (i) about 5% to about bed moist, cleaning the wound, and also removing necrotic 45% of the anabolic agent relative to a total amount of the matter from it by fluid donation. These materials may also anabolic agent loaded in the medical device over a first period absorb exudate from the wound. However, there is a need to of up to 48 hours and (ii) about 55% to about 95% of the develop improved wound healing therapies that enhance anabolic agent relative to a total amount of the anabolic agent wound healing. loaded in the medical device over a subsequent period of at 0004 Anabolic agents are a class of pharmaceutical com least 3 days. In some embodiments, the medical device is a pounds known to the medical profession for their properties biodegradable polymer drug depot. of increasing muscles mass and body weight. These proper 0010. In another embodiment, there is an implantable drug ties of building up muscle mass and weight are beneficial for depot for treating a wound in a patient in need of Such treat patients with decreased muscle mass and weight loss experi ment, the implantable drug depot comprising an anabolic enced in patients with conditions such as cancer, HIV or other agent, and at least one biodegradable polymer, the implant muscle wasting syndromes. Anabolic Steroids also have been able drug depot having a surface that releases (i) about 5% to used by the medical profession to stimulate puberty and about 25% of the anabolic agent relative to a total amount of growth in children and for hormone replacement therapy. the anabolic agent loaded in the drug depot over a first period 0005 Anabolic steroids can be represented by the follow of up to 24 hours and (ii) about 75% to about 95% of the ing general structure: anabolic agent relative to a total amount of the anabolic agent loaded in the drug depot over a Subsequent period of at least 3 days. In some embodiments, the anabolic agent is an ana bolic steroid that is in a non-esterified form. 0011. In yet another embodiment, there is a method for treating a wound in a patient in need of Such treatment, the method comprising administeringananabolic agent locally at or near the wound, the anabolic agent being administered by a topical formulation, an infusion pump or local injection over a period of at least 3 days so as to enhance healing of the wound. 0012. The medical device may: (i) consist of only the 0006 Testosterone is an example of a naturally occurring anabolic agent (or one or more of its pharmaceutically accept anabolic steroid that exhibits the above general structure able salts, esterified forms or non-esterified forms thereof) except it has a double bonded oxygen at position 3 of the A and the biodegradable polymer(s); or (ii) consist essentially ring and a hydroxyl group at position 17 on the D ring. Many of the anabolic agent (and/or one or more of its pharmaceu modifications of the above general structure to various posi tically acceptable salts, esterified forms or non-esterified US 2012/0271275 A1 Oct. 25, 2012 forms thereof) and the biodegradable polymer(s); or (iii) testing measurements. Moreover, all ranges disclosed herein comprise the anabolic agent (and/or one or more of its phar are to be understood to encompass any and all Subranges maceutically acceptable salts, esterified forms or non-esteri subsumed therein. For example, a range of “1 to 10” includes fied forms thereof), and the biodegradable polymer(s) and any and all Subranges between (and including) the minimum one or more other active ingredients, Surfactants, excipients value of 1 and the maximum value of 10, that is, any and all or other ingredients or combinations thereof. When there are Subranges having a minimum value of equal to or greater than other active ingredients, Surfactants, pore forming agents, 1 and a maximum value of equal to or less than 10, e.g., 5.5 to plasticizers, excipients or other ingredients or combinations 10. thereof in the formulation, in some embodiments these other compounds or combinations thereofcomprise less than 50 wt. DEFINITIONS %. less than 40 wt.%, less than 30 wt.%, less than 20 wt.%, 0018. It is noted that, as used in this specification and the less than 19 wt.%, less than 18 wt.%, less than 17 wt.%, less appended claims, the singular forms “a,” “an and “the than 16 wt.%, less than 15 wt.%, less than 14 wt.%, less than include plural referents unless expressly and unequivocally 13 wt.%, less than 12 wt.%, less than 11 wt.%, less than 10 limited to one referent. Thus, for example, reference to “a wt.%, less than 9 wt.%, less than 8 wt.%, less than 7 wt.%, drug depot includes one, two, three or more drug depots. less than 6 wt.%, less than 5 wt.%, less than 4 wt.%, less than (0019. The term “implantable” as utilized herein refers to a 3 wt.%, less than 2 wt.%, less than 1 wt.% or less than 0.5 wt. biocompatible medical device (e.g., drug depot) retaining %. potential for Successful placement within a mammal.