Abstract: The disclosure is directed to medroxyprogesterone compositions suitable for subcutaneous injection comprising about 360 mg/ml to 440 mg/ml medroxyprogesterone acetate, 1.35 mg/ml to 1.65 mg/ml docusate sodium, polyethylene glycol, and water. Methods of using these compositions are also described.

Abstract: Biodegradable contraceptive implants and methods of making and using thereof, are preferably formed of poly(?-pentadecalactone-co-p-dioxanone) [poly(PDL-co-DO)], a family of polyester copolymers that degrade slowly in the presence of water. The material is suitable as the basis of a biodegradable contraceptive implant that provides sustained release of a progestin at a rate similar to a commercially available nondegradable implant. In a preferred embodiment, the progestin is levonorgestrel (LNG), a hormone that prevents pregnancy by preventing the release of an egg from the ovary or by preventing fertilization of the egg by sperm. The implant may be inserted subcutaneously, allowing degradation over a period of up to about 18 or 24 months, eliminating the need for removal by a trained practitioner.

Abstract: The disclosure is directed to medroxyprogesterone compositions suitable for subcutaneous injection comprising about 260 mg/ml to 440 mg/ml medroxyprogesterone acetate, about 0.6 mg/ml to 1.5 mg/ml docusate sodium and, polyethylene glycol. Methods of using these compositions are also described.

Abstract: An intra-cavity ultrasound imaging and therapy system is provided. The system includes an intra-cavity ultrasound probe including a housing configure to be inserted into a cavity proximate to a region of interest (ROI). The housing includes a transducer array located proximate to a distal end of the housing. The system also includes a diagnostic control circuit configured to direct the transducer array to collect diagnostic ultrasound signals from the ROI. The diagnostic control circuit is configured to generate an ultrasound image based on the diagnostic ultrasound signals. The diagnostic control circuit is further configured to direct the transducer array to deliver a high intensity focused ultrasound (HIFU) therapy at a treatment location based on target information derived from the ultrasound image.

Abstract: A device for delivering an agent into breast milk while breastfeeding. In one embodiment, the device includes a breast shield modified to engage a non-woven material which has been impregnated with a milk soluble active agent such as sodium dodecyl sulphate (SDS). A lactating animal, e.g. a woman, uses this agent-delivering breast shield during breastfeeding to administer prophylactic or therapeutic agents to a suckling infant. The inventions are particularly well suited to preventing transmission of HIV virus from mother to child. Alternatively, the agent-laden material could be used with a baby bottle nipple or pacifier.

Abstract: A vaginal drug delivery system includes a device formed of porous material that holds a flowable therapeutic formulation. The device, preferably in a soft, prewetted state, is inserted into the vagina to reside typically at or near the cervix where it continuously releases the flowable therapeutic formulation through its outer surface which is in contact with the vaginal surfaces. In operation, the flowable therapeutic formulation migrates via capillary forces from a reservoir that is centrally located in the device and through a covering that envelopes the reservoir.

Abstract: A medical device is provided which forms a physical barrier between the two ends of a cut vas during a vasectomy procedure, comprising a biodegradable, polymeric cap that is applied over at least one prostatic end of the vas, the cap including a fastener for preventing premature dislodgement.

Abstract: A vaginal drug delivery system includes a device formed of porous material that holds a flowable therapeutic formulation. The device, preferably in a soft, prewetted state, is inserted into the vagina to reside typically at or near the cervix where it continuously releases the flowable therapeutic formulation through its outer surface which is in contact with the vaginal surfaces. In operation, the flowable therapeutic formulation migrates via capillary forces from a reservoir that is centrally located in the device and through a covering that envelopes the reservoir.

Abstract: A vaginal drug delivery system includes a device formed of porous material that holds a flowable therapeutic formulation. The device, preferably in a soft, prewetted state, is inserted into the vagina to reside typically at or near the cervix where it continuously releases the flowable therapeutic formulation through its outer surface which is in contact with the vaginal surfaces. In operation, the flowable therapeutic formulation migrates via capillary forces from a reservoir that is centrally located in the device and through a covering that envelopes the reservoir.

Abstract: A vaginal device provides physical and chemical barriers to contraception or protection against sexually transmitted diseases, or both. The device includes a towelette having approximately 1 to 10 ml of preventive formulation incorporated therein by absorption. During intercourse, the towelette rests in the upper vagina and effectively functions as both a physical and chemical barrier to contraception. In some embodiments, the towelette may become compressed into a crumpled, disc-like shape, which may enhance its properties as a physical barrier. In other embodiments, the vaginal device includes a flexible ring that is affixed to the towelette to define a dome-shaped towelette portion on one side of the ring and a depending skirt on the other side, with the dome portion being designed to cover the cervix. Means to facilitate insertion and removal of the device are described.

Abstract: The present invention relates to a method of female sterilization including delivery of a macrolide antibiotic or a pharmacologically acceptable salt of a macrolide antibiotic to the uterine cavity or fallopian tube of the female. The present invention also relates to a method of endometrial ablation including delivery of a macrolide antibiotic or a pharmacologically acceptable salt of a macrolide antibiotic to the uterine cavity of a female. The endometrial ablation effected in this manner may be used to treat the conditions of excessive menstrual bleeding or menstrual pain in women. A preferred macrolide antibiotic is erythromycin, or its pharmacologically acceptable salts.

Abstract: A vaginal device provides physical and chemical barriers to contraception or protection against sexually transmitted diseases, or both. The device includes a towelette having approximately 5 ml of preventive formulation incorporated therein by absorption. During intercourse, the towelette rests in the upper vagina and effectively functions as both a physical and chemical barrier to contraception. In some embodiments, the towelette may become compressed into a crumpled, disc-like shape, which may enhance its properties as a physical barrier. Means to facilitate insertion and removal of the device are described.

Abstract: A prophylactic device is described which is constructed primarily from portions of plastic film material alternatingly sealed at their periphery and at an aperture contained in the film to yield an accordion-like section. The prophylactic device, as manufactured, is relatively flat, but it can expand to cover a body part to provide protection from transmission of bodily fluids between individuals. The prophylactic device can be used as a glove-like device, a finger cot, a condom, or a wound covering, depending on the size and configuration of the device.

Abstract: A prophylactic device is described which is constructed primarily from portions of plastic film material alternatingly sealed at their periphery and at an aperture contained in the film to yield an accordion-like section. The prophylactic device, as manufactured, is relatively flat, but it can expand to cover a body part to provide protection from transmission of bodily fluids between individuals. The prophylactic device can be used as a glove-like device, a finger cot, a condom, or a wound covering, depending on the size and configuration of the device.

Abstract: A stress-softened thermoplastic elastomeric (TPE) film which has been subjected to tensional deformation comprising at least uniaxial strain, and having improved textural and thermal transmissivity characteristics, as compared to a native, unstretched material. Such stress-softened thermoplastic elastomeric film may be employed in a wide variety of articles, including condoms, finger cots, tubular bandages, and the like. Condoms comprising such stress-softened TPE film are described, including condoms having a main sheath comprising stress-softened and non-stress-softened areas in a pattern or other predetermined arrangement. A variety of methods and apparatus for forming stress-softened tubular articles of thermoplastic elastomeric film is disclosed.

Abstract: A generally loose-fitting tubular sheath article, such as a condom, which has a closed distal end and an open proximal end which is bounded by a knitted material that bears compressively on the sheathed member to provide retention. The knitted material may be in the form of a band which is affixed to the sheath by everting a portion of the sheath material at the proximal end over the knitted material and attaching the sheath material to itself, thereby creating a toroidal enclosure in which the knitted material is disposed. Constriction of the sheathed member is minimized by the knitted material which provides a large surface area for retentive contact.

Abstract: A method of making a condom from a precursor tubular element formed of elastic film material, having a closed distal end and an open proximal end. The precursor tubular element is placed over a tubular mandril and expanded outwardly from the mandril against a surrounding cylindrical chamber, following which the expanded precursor tubular element is deflated for subsequent condom usage.

Abstract: An article having a main sheath portion formed of a flexible and/or elastic material closed at a distal end thereof and open at a proximal end thereof, with a first flange element formed of a flexible and elastic material, and having an aperture formed or pressure-formable therein, secured to the open proximal end of the sheath. In a single flange embodiment, the main sheath portion may be provided in a center-compacted configuration, for bidirectional application of the sheath. In a multi-flange embodiment, a second flange element is secured at an outer portion thereof to the first flange element and has an aperture formed or pressure-formable therein, in substantial alignment with the aperture of the first flange element, whereby the sheath is extended or extensible from a compacted state through the aperture in either the first or the second flange element. In a specific embodiment, the article comprises a condom which may be donned in either of two directions.

Abstract: A stress-softened thermoplastic elastomeric (TPE) film which has been subjected to tensional deformation comprising at least uniaxial strain, and having improved textural and thermal transmissivity characteristics, as compared to a native, unstretched material. Such stress-softened thermoplastic elastomeric film may be employed in a wide variety of articles, including condoms, finger cots, tubular bandages, and the like. Condoms comprising such stress-softened TPE film are described, including condoms having a main sheath comprising stress-softened and non-stress-softened areas in a pattern or other predetermined arrangement. A variety of methods and apparatus for forming stress-softened tubular articles of thermoplastic elastomeric film is disclosed.