Implantable medical device with pharmacologically active layer

• US 20060025726A1
• Filed: 09/27/2005
• Published: 02/02/2006
• Est. Priority Date: 06/04/1996
• Status: Abandoned Application

• Current Assignee: Vance Products Incorporated (Cook Group Incorporated)
• Original Assignee: Vance Products Incorporated (Cook Group Incorporated)
• Inventors: Andrews, Marvin O., Fischer, Frank J. Jr., Miller, Jessica Watts
• Application Number:
  US11/236,390
• Publication Number:
  US 20060025726A1
• Time in Patent Office: Days
• US Class Current: 604/265
• 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 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• 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: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

An implantable medical device 10 such as a catheter with a controlled-release pharmacologically active ingredient for minimizing the risk of infection or other physiological afflictions associated with the implantation thereof. The device includes a base material and a controlled-release outer layer containing a bioactive material, for example, paclitaxel.

Claims

1. An implantable medical device, comprising:

a medical device for insertion into a patient;

an attachment layer on at least a portion of the medical device; and

a controlled-release outer layer on at least a portion of the attachment layer, wherein the outer layer further comprises at least one pharmacologically active compound effective to inhibit the growth of organisms relative to an uncoated device.

2. The device of claim 1, wherein the pharmacologically compound is selected from the group consisting of a non-steroidal anti-inflammatory agent, a penicillin, acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium, Norvir®

, Crixivan®

, a cephalosporin, a carbepenem, a beta-lactam, an antibiotic, an aminoglycoside, a macrolide, a lincosamide, a glycopeptide, a tetracyline, a chloramphenicol, a quinolone, a fucidin, a sulfonamide, a trimethoprim, a rifamycin, an oxaline, a streptogramin, a lipopeptide, a ketolide, a polyene, an azole, and an echinocandin.

3. The device of claim 1, wherein the pharmacologically active compound is selected from the group consisting of alpha-terpineol, methylisothiazolone, cetylpyridinium chloride, chloroxyleneol, hexachlorophene, chlorhexidine and other cationic biguanides, methylene chloride, iodine and iodophores, triclosan, taurinamides, nitrofurantoin, methenamine, aldehydes, azylic acid, rifampycin, silver, benzyl peroxide, alcohols, and carboxylic acids and salts, and silver sulfadiazine.

4. The device of claim 1, wherein the medical device is selected from the group consisting of a ureteral stent, a urethral catheter, a biliary stent, a pancreatic stent, a catheter for suprapubic drainage, a catheter for nephrostomy drainage, a catheter for nasal pancreatic drainage, and a nasal biliary drainage catheter.

5. The device of claim 1, wherein a cross-section of a majority portion of the medical device is not changed after insertion into the patient.

6. The device of claim 1, wherein the compound is released over a period of up to six months.

7. The device of claim 1, wherein the pharmacologically active compound comprises an antiviral or antimicrobial agent.

8. The device of claim 1, wherein the pharmacologically active compound comprises an anti-encrustation compound, an antispasmodic compound, or an antiseptic compound.

9. The device of claim 1, further comprising an antiencrustation compound selected from the group consisting of heparin, covalent heparin, dexamethazone, dexamethasone sodium phosphate, dexamethasone acetate and another dexamethasone derivative.

10. The device of claim 1, further comprising an antiencrustation compound selected from the group consisting of triclosan, silver nitrate, ofloxacin, ciproflaxin, phosphorylcholine, and trimethoprim.

11. The device of claim 1, wherein the pharmacologically active compound is aspirin.

12. The device of claim 1 wherein the pharmacologically compound is an anthracycline, a fluoropyrimidine, a podophylotoxin, or an etoposide.

13. An implantable medical device, comprising:

a medical device for implanting into a patient;

an attachment layer on at least a portion of the medical device; and

a controlled-release outer layer on at least a portion of the attachment layer, wherein the outer layer further comprises a pharmacologically active compound and an additional compound.

14. The implantable device of claim 13, wherein the additional compound is heparin, covalent heparin, dexamethazone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative.

15. The implantable device of claim 13, wherein the additional compound is Gentian Violet.

16. The implantable device of claim 13, wherein the pharmacologically active compound is chlorhexidine and the additional compound is Gentian Violet.

17. The implantable device of claim 13, wherein the additional compound is paclitaxel.

18. The implantable device of claim 13, wherein one of the pharmacologically active compound and the additional compound is aspirin.

19. A method of treating a patient, the method comprising:

furnishing an implantable medical device with at least one pharmacologically active controlled-release outer layer; and

placing the device into the patient, wherein the pharmacologically active compound is selected from the group consisting of a non-steroidal anti-inflammatory agent, a penicillin, acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium, Norvir®

, Crixivan®

, a cephalosporin, a carbepenem, a beta-lactam, an antibiotic, an anti-viral compound, an aminoglycoside, a macrolide, a lincosamide, a glycopeptide, a tetracyline, a chloramphenicol, a quinolone, a fucidin, a sulfonamide, a trimethoprim, a rifamycin, an oxaline, a streptogramin, a lipopeptide, a ketolide, a polyene, an azole, and an echinocandin; and

implanting said device in said patient.

20. The device of claim 19, further comprising an additional pharmacologically active compound selected from the group consisting of alpha-terpineol, methylisothiazolone, cetylpyridinium chloride, chloroxyleneol, hexachlorophene, chlorhexidine and other cationic biguanides, methylene chloride, iodine and iodophores, triclosan, taurinamides, nitrofurantoin, methenamine, aldehydes, azylic acid, rifampycin, silver, benzyl peroxide, alcohols, and carboxylic acids and salts, and silver sulfadiazine.