Apparatus and method for delivering compounds to a living organism

• US 6,471,979 B2
• Filed: 08/30/2001
• Issued: 10/29/2002
• Est. Priority Date: 12/29/1999
• Status: Expired due to Fees

• Current Assignee: X-Cell Medical Incorporated
• Original Assignee: E-2 Vascular Technology, LLC
• Inventors: Leon, Martin B., Kipshidze, Nicholas, Moses, Jeffrey W., New, Gishel, Roubin, Gary S.
• Primary Examiner(s): Webman, Edward J.
• Assistant Examiner(s): Nguyen, Helen
• Application Number:
  US09/943,648
• Publication Number:
  US 20020072511A1
• Time in Patent Office: 425 Days
• Field of Search: 424/422, 424/423, 514/182, 514/824, 623/1.42, 623/1.43, 604/264, 604/93, 604/915
• US Class Current: 424/422
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: A61K 31/404 Indoles, e.g. pindolol
• CPC Class Codes: A61K 31/4196 1,2,4-Triazoles
• CPC Class Codes: A61K 31/451 having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
• CPC Class Codes: A61K 31/4535 containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/566 having an oxo group in position 17, e.g. estrone
• CPC Class Codes: A61K 31/567 substituted in position 17 alpha, e.g. mestranol, norethandrolone
• CPC Class Codes: A61K 31/5685 having an oxo group in position 17, e.g. androsterone
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/685 one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
• CPC Class Codes: A61L 2300/416 : Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/43 : Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 2300/602 : Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 29/16 : Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/0057 : Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1072 : having balloons with two or more compartments
• CPC Class Codes: A61M 25/00 : Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

A method of treating or preventing vascular disease in a living organism. The method includes delivering an effective amount of a composition including a sex hormone, anti-hormone, sex-hormone agonist, steroid-hormone inhibitor/antagonist (partial or full), selective estrogen receptor modulator (SERM), or a combination thereof, to an affected area of a living organism.

Claims

1. A local-delivery device for treating and preventing restenosis in a living organism, the device comprising:

a stent coated with a platform, natural carrier of pharmaceutical agent; and

an effective dose of a composition comprising estrogen, stradiol or a derivative thereof, wherein the platform, natural carrier of pharmaceutical agent at least partially encompasses the composition, thereby allowing for gradual release of the composition therefrom when the stent is inserted into an area of a living organism affected by restenosis.

2. The device of claim 1, wherein the pharmaceutical agent is phosphorylcholine.

3. The device of claim 2, wherein the effective dose of the composition is about 50 μ

g to about 1000 μ

g.

4. The device of claim 2, wherein the effective dose of the composition is about 50 μ

g to about 276 μ

g.

5. The device of claim 2, wherein the effective dose of the composition is about 2.4 μ

g to about 3.2 μ

g per 1 mm² of stent.

6. The device of claim 1, wherein the composition further comprises a sex hormone, anti-hormone, sex-hormone agonist, steroid-hormone inhibitor/antagonist (partial or full), selective estrogen receptor modulator (SERM) or combination thereof.

7. The device of claim 1, wherein the composition further comprises an antibody, oligonucleotide, antiproliferative, anticancer agent, growth factor, gene, antithrombotic agent or combination thereof.