Drug – bio-affecting and body treating compositions – Designated organic nonactive ingredient containing other... – Solid synthetic organic polymer
Reexamination Certificate
2000-06-09
2003-07-08
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Designated organic nonactive ingredient containing other...
Solid synthetic organic polymer
C514S944000, C424S078020, C424S422000, C424S484000, C424S486000
Reexamination Certificate
active
06589998
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The field of this invention is gel compositions for delivery to a breast milk duct for mapping a duct or ducts before surgical excision of any part of the breast or ductal system.
2. Description of the Background Art
Breast cancer is the most common cancer in women, with well over 100,000 new cases being diagnosed each year (see e.g. Goodson W H & King E B, Chapter 4: Discharges and Secretions of the Nipple, The Breast: Comprehensive Management of Benign and Malignant Diseases 2nd Ed. vol 2, Bland & Kirby eds. W. B. Saunders Co, Philadelphia, Pa. pp. 51-74, (1998)). Breast cancer usually arises from a single ductal system and exists in a precancerous state for a number of years. Surgical procedures can include removal of part or all of a duct containing a cancerous lesion (a ductectomy), removal of a lump in a breast duct (a lumpectomy), or performing a partial or total mastectomy. These procedures would be well served with surgical adjuvants to aid the practitioner to identify the duct or ducts or part of the duct to be removed. For a complete description of such procedures on the breast, and definitions of the various types of breast tissue removal procedures, see Love, S. THE BREAST BOOK, 2
nd
Ed. Lindsey Ed. Perseus Books, Reading Mass. 1995.
Lumpectomies, ductectomies (partial or complete) and mastectomies (partial or complete) are successful only to the extent that all cancerous tissue is removed during the surgical procedure. Since breast cancer originates in a breast duct or ducts, identifying the duct or ducts affected for surgery can provide a surgeon with a well needed, previously unavailable tool with which to generate clean margins at the excision, increase the likelihood of getting all the cancer with the excision, and increase long term likelihood of success from the procedure. The present invention provides such benefits to breast cancer patients and practitioners in the field.
3. Relevant Literature
Preoperative galactography (the injection of liquid dye into breast ducts) has been used to target a lesion in a breast duct before surgical excision of the breast duct, as described in Van Zee et al.,
Cancer
1998 82:1874-80, Hou et al.,
Clin Imaging
1998 22:89-94, Vega et al.,
Acta Radiologica
1997 38:240-2, Hou et al.,
Radiology
1995 195:568-9, Baker et al.,
AJR Am J Reontgenol
1994 162:821-4, and Grillo et al.,
AnnChir Bynaecol
1990 79:6-9.
A process for forming an ablative or protective corneal shield or mask using an in situ forming gel applied to the eye are described and claimed in U.S. Pat. No. 5,587,175 to MDV Technologies for use in ophthalmic laser surgery and drug delivery to the eye.
Biodegradable in situ forming implants and methods of producing them are described in U.S. Pat. No. 5,733,950 to Atrix Pharmaceuticals using a water insoluble biodegradable polymer dissolved in a water soluble organic solvent for the purpose of drug delivery to a site in the body including the mouth, periodontal pocket, the eye or the vagina where there is considerable fluid flow.
SUMMARY OF THE INVENTION
The invention provides a biocompatable composition comprising a polymer that has a solubility greater than 0.5 grams per 100 ml of solvent, a molecular weight in a range of between about 1 and 500 kilodaltons and a weight/weight ratio of polymer to solvent in a range between about 0.5:100 to 100:0.5; the composition is liquid in a solvent and undergoes a gel transition inside a target breast milk duct within about 30 minutes of delivery of the composition to the target duct. The gel transition time can be in a range from about 0 to 2 minutes, from about 2 to 5 minutes, from about 6 to 10 minutes, from about 11 to 15 minutes, from about 16 to 20 minutes, from about 21 to 25 minutes, or from about 26 to 30 minutes. The solvent can be water.
The polymer can be alkyl celluloses, hydroxyalky methylcelluloses, hyaluronic acid, sodium chondroitin sulfate, polyacrylic acid, polyacrylamide, polycyanolacrylates, methyl methacrylate polymers, 2-hydroxyethyl methacrylate polymers, cyclodextrin, polydextrose, dextran, gelatin, polygalacturonic acid, polyvinyl alcohol, polyvinyl pyrrolidone, polyalkylene glycols, or polyethylene oxide. The solvent can be an organic solvent. The polymer can be water-soluble and comprise a polyethylenepolypropylene glycol block copolymer.
The gel transition can occur as a result of in situ cross-linking of the gel composition. The gel composition can comprise cross cationic/anionic cross linkable moieties. The cross linking reaction can be activated by a chemical reaction, a change in temperature, or application of energy. The cross linking can be activated by an application of an energy source selected from the group consisting of radiation, magnetic, ultrasonic, ultra-violet, radio frequency, visible light, and heat.
The composition can undergo a gel transition between about 28° and 41° C. The composition can undergo a gel transition at the physiological pH of a breast milk duct. The pH can be in a range of from about pH 7.5 to about pH 9.0, or in a range of from about pH 7.8 to about pH 8.2. The composition can undergo a gel transition under isotonic conditions.
The gel in the target duct can be distinguishable from tissue. The gel in the target duct can be colored. The gel in the target duct can be harder than tissue. The gel can further comprise an additive to provide detection of the gel inside the target duct. Additionally, an additive may be placed in the gel in order to provide detection of the gel before incision through the breast tissue and skin. The additive can be a dye.
The additive to distinguish the target duct from tissue can be a dye capable of staining ductile tissue with a color visible to the naked eye, a fluorescent dye, a radiographic contrast agent, a radionuclide, a ferromagnetic material, a sonographically reflective material, a thermographically reflective material, an impedance altering molecule, a radioactive agent, a vital dye or an agent detectable by infrared sensor. The additive can be a food coloring dye. The dye can be isosulfan blue, methylene blue, Chicago sky blue, marina blue, tetramethylrhodamine, Texas red-X, or Oregon green. The dye can be a fluorescent dye including, e.g. fluorescein, rhodamine, or indocyanine green. The composition can comprise a therapeutic additive or a diagnostic additive.
The invention further provides a method for forming a in vivo gel map of a breast duct comprising administering to a target breast milk duct a biocompatable composition comprising a polymer in a solvent capable of a gel transition inside the target duct, wherein the composition is liquid at room temperature and undergoes a gel transition inside the target duct within about 30 minutes of delivery of the composition. The method can further comprise cooling any one or more of the target breast, a breast duct access tool, the composition, and the polymer before administering the composition to the target duct. The gel transition time can be in a range from about 0 to 2 minutes, from about 2 to 5 minutes, from about 6 to 10 minutes, from about 11 to 15 minutes, from about 16 to 20 minutes, from about 21 to 25 minutes, or from about 26 to 30 minutes. The composition can be administered using a catheter with a lumen small enough to access a breast milk duct. The lumen of the portion of the catheter that accesses the breast duct comprises a diameter less than 0.10 inches. The composition can further comprise diagnostic or therapeutic additives or additives that aid in detecting the duct.
The invention is a method for identifying one or more breast ducts in a breast or for identifying part of a breast duct for providing a surgeon guidance in a procedure to remove some or all breast tissue from the patient comprising administering to one or more breast ducts in the target breast a biocompatable composition capable of a gel transition inside a breast duct, wherein the presence of the gel inside the duct provides identification of the duct during surgery. The procedu
Bianchi Annette
Gont Linda
Hung David
Love Susan
Nikolchev Julian
Cytyc Health Corporation
Fubara Blessing
Page Thurman K.
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