Apparatus and method for delivering compounds to a living organism

• US 20040127475A1
• Filed: 09/12/2003
• Published: 07/01/2004
• Est. Priority Date: 12/29/1999
• Status: Abandoned Application

• Current Assignee: X-Cell Medical Incorporated
• Original Assignee: E-2 Vascular Technology, LLC
• Inventors: Moses, Jeffrey W., Roubin, Gary S., New, Gishel, Leon, Martin B., Kipshidze, Nicholas
• Application Number:
  US10/661,820
• Publication Number:
  US 20040127475A1
• Time in Patent Office: Days
• US Class Current: 514/171
• 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 2300/43 : Hormones, e.g. dexamethasone
• 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

Abstract

A method of treating or preventing high-risk plaque is provided. The method may include applying to a medical device an effective amount of a composition comprising a sex hormone, anti-hormone, sex-hormone agonist, steroid-hormone inhibitor/antagonist (partial or full), selective estrogen receptor modulator (SERM), or a combination thereof. The medical device may be inserted into an area of a living organism that is or has a propensity to be affected by high-risk plaque.

Claims

1. A method of treating or preventing high-risk plaque, the method comprising:

applying to a medical device an effective amount of a composition comprising a sex hormone, anti-hormone, sex-hormone agonist, steroid-hormone inhibitor/antagonist (partial or full), selective estrogen receptor modulator (SERM), or a combination thereof; and

inserting the medical device into an area of a living organism that is or has a propensity to be affected by high-risk plaque.

2. The method of claim 1, further comprising allowing at least a portion of the sex hormone, anti-hormone, sex-hormone agonist, steroid-hormone inhibitor/antagonist (partial or full), selective estrogen receptor modulator (SERM), or combination thereof, to gradually release from the medical device into the area of the living organism that is or has a propersity to be affected by the high-risk plaque, thereby treating or preventing the high-risk plaque.

3. The method of claim 1, wherein the composition comprises a sex hormone and the sex hormone comprises estrogen, progesterone, testosterone, dehydroepiandrostrone (DHEA), dehydroepiandrosteronesulfate (DHEA) or a combination thereof.

4. The method of claim 1, wherein the medical device comprises a stent.

5. The method of claim 1, wherein the medical device comprises a catheter, a balloon catheter or a balloon.

6. The method of claim 1, wherein the composition comprises a sex hormone and the sex hormone comprises estrogen.

7. The method of claim 6, wherein the medical device comprises a stent.

8. The method of claim 6, wherein the medical device comprises a catheter.

9. The method of claim 1, wherein the composition comprises a sex-hormone agonist and the sex-hormone agonist comprises estradiol, estrone, ethinyl estradiol, conjugated equine estrogen, or a combination thereof.

10. The method of claim 1, wherein the composition comprises an anti-hormone and the anti-hormone comprises an anti-estrogen, Faslodex, an anti-androgen, cyproterone acetate, an anti-testosterone, or a combination thereof.

11. The method of claim 1, wherein the composition comprises a steroid-hormone inhibitor/antagonist (partial or full) and the steroid-hormone inhibitor/antagonist (partial or full) comprises aminogluthemide, anastrazole, letrozole, or a combination thereof.

12. The method of claim 1, wherein the composition comprises a SERM and the SERM comprises a raloxifene, tamoxifen, tibolone, idoxifene, or a combination thereof.

13. The method of claim 1, wherein the affected area of the living organism comprises tissue, tubular organs, blood vessels, coronary or peripheral of organs, myocardium, skeletal, smooth muscles or a combination thereof.

14. The method of claim 1, wherein the effective dose of the composition comprises about 50 μ

g to about 1000 μ

g.

15. The method of claim 1, wherein the effective dose of the composition comprises about 50 μ

g to about 276 μ

g.

16. The method of claim 1, wherein the composition further comprises an antibody, oligonucleotide, antiproliferative, anticancer agent, growth factor, gene, antithrombotic agent thrombin inhibitor, antithrombogenic agent, thrombolytic agent, fibrinolytic agent, vasospasm inhibitor, calcium channel blocker, vasodilator, antihypertensive agent, antimicrobial agent, antibiotic, anti-lipid agent, inhibitor of surface glycoprotein receptors, antiplatelet agent, antimitotic, microtubule inhibitor, anti-secretory agent, actin inhibitor, remodeling inhibitor, antisense nucleotide, anti-metabolite, anticancer chemotherapeutic agent, anti-inflammatory steroid or non-steroidal anti-inflammatory agent, immunosuppressive agent, growth hormone antagonist, dopamine agonist, radiotherapeutic agent, peptide, protein, enzyme, extracellular matrix component, angiotensin-converting enzyme (ACE) inhibitor, free radical scavenger, chelator, antioxidant, anti-polymerase, antiviral agent, photodynamic therapy agent, gene therapy agent or combination thereof.

17. The method of claim 1, wherein the high-risk plaque comprises vulnerable plaque.

18. A local-delivery device for treating or preventing high-risk plaque in a living organism, the device comprising:

a medical device at least partially coated with an effective dose of a composition comprising a sex hormone, anti-hormone, sex-hormone agonist, steroid-hormone inhibitor/antagonist (partial or full), selective estrogen receptor modulator (SERM), or a combination thereof, the local-delivery device being suitable for treating or preventing high-risk plaque.

19. The device of claim 18, wherein the medical device comprises a stent.

20. The device of claim 19, wherein the composition comprises a sex hormone, and the sex hormone comprises estrogen.

21. The device of claim 18, wherein the medical device comprises a catheter, a balloon catheter or a balloon.

22. The device of claim 18, further comprising a platform, natural carrier, pharmaceutical agent, polymer or combination thereof at least partially encompassing the composition, thereby allowing for gradual release of the composition therefrom when the medical device is inserted into a living organism.

23. The device of claim 18, wherein the medical device is at least partially coated with a polymer and the polymer comprises a biostable polymer, a bioabsorbable polymer, biodegradable, bioerodable or a combination thereof.

24. The device of claim 18, wherein the effective dose of the composition comprises about 50 μ

g to about 1000 μ

g.

25. The device of claim 18, wherein the effective dose of the composition comprises about 50 μ

g to about 276 μ

g.

26. The device of claim 18, wherein the effective dose of the composition comprises about 2.4 μ

g to about 3.2 μ

g per 1 mm² of medical device.

27. The device of claim 18, 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 a combination thereof.

28. The device of claim 18, wherein the composition further comprises an antibody, oligonucleotide, antiproliferative, anticancer agent, growth factor, gene, antithrombotic agent thrombin inhibitor, antithrombogenic agent, thrombolytic agent, fibrinolytic agent, vasospasm inhibitor, calcium channel blocker, vasodilator, antihypertensive agent, antimicrobial agent, antibiotic, anti-lipid agent, inhibitor of surface glycoprotein receptors, antiplatelet agent, antimitotic, microtubule inhibitor, anti-secretory agent, actin inhibitor, remodeling inhibitor, antisense nucleotide, anti metabolite, anticancer chemotherapeutic agent, anti-inflammatory steroid or non-steroidal anti-inflammatory agent, immunosuppressive agent, growth hormone antagonist, dopamine agonist, radiotherapeutic agent, peptide, protein, enzyme, extracellular matrix component, angiotensin-converting enzyme (ACE) inhibitor, free radical scavenger, chelator, antioxidant, anti polymerase, antiviral agent, photodynamic therapy agent, gene therapy agent or combination thereof.

29. A method of treating high-risk plaque in a living organism, the method comprising:

applying an effective dose of a composition comprising estrogen, estradiol or a derivative thereof to a stent by chemical or physical bonding;

placing the stent at or near high-risk plaque; and

releasing the estrogen, estradiol or derivative thereof.

30. The method of claim 29, wherein applying an effective dose of the composition to the stent comprises immersing the stent in a solution comprising estrogen, estradiol or a combination thereof and allowing the stent to dry.

31. The method of claim 29, wherein the effective dose of the composition comprises about 50 μ

g to about 1000 μ

g.

32. The method of claim 29, wherein the effective dose of the composition comprises about 50 μ

g to about 276 μ

g.

33. The method of claim 29, wherein the effective dose comprises about 2.4 μ

g to about 3.2 μ

g of the composition per 1 mM² of stent.

34. The method of claim 29, wherein the chemical bonding comprises at least partially encompassing the composition with a platform, natural carrier, pharmaceutical agent, polymer or combination to allow for gradual elution of the composition therefrom.

35. The method of claim 34, wherein the platform at least partially encompasses the composition and the platform comprises silicon carbide, carbon, diamond, diamond-like coating, polytetrafluoroethylene, hylauronic acid, polyactone or a combination thereof.

36. The method of claim 34, wherein the natural carrier at least partially encompasses the composition and the natural carrier comprises collagen, laminen, heparin, fibrin, a naturally occurring substance that absorbs to cellulose or a combination thereof.

37. The method of claim 34, wherein the pharmaceutical agent at least partially encompasses the composition and the pharmaceutical agent comprises polyurethane, segmented polyurethane, poly-L-lactic acid, cellulose ester, polyethylene glycol, polyphosphate esters or a combination thereof.

38. The method of claim 34, wherein the polymer at least partially encompasses the composition and the polymer comprises a biostable polymer, a bioabsorbable polymer or a combination thereof.

39. The method of claim 29, wherein the high-risk plaque comprises vulnerable plaque.