Fluid management flow implants of improved occlusion resistance

• US 20060074388A1
• Filed: 09/30/2004
• Published: 04/06/2006
• Est. Priority Date: 09/30/2004
• Status: Active Grant

• Current Assignee: Integra LifeSciences Switzerland Sàrl
• Original Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Inventors: Dextradeur, Alan, Mauge, Christophe
• Granted Patent: US 7,976,517 B2
• Time in Patent Office: Days
• US Class Current: 604/265
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• 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 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• 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 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

This invention relates to achieving or improving uniform distribution of fluid flow in medical devices such as when combined with antibiotics impregnated in a catheter and/or with a drug-eluting catheter to further inhibit the catheter from becoming occluded by debris in the CSF or by bacterial biofilm formation or tissue proliferation in the catheter.

Claims

1. A method of minimizing formation of bacterial biofilm or tissue proliferation in implantable fluid management systems comprising:

f) providing an implant comprising an antimicrobial or drug-eluting catheter having a proximal and distal end;

g) providing a flow distribution enhancing tip at the distal end of the catheter;

h) inserting the distal end of the catheter into an area to be drained;

i) placing the proximal end of the catheter in a selected area inside or outside of the human body; and

j) draining fluid from the area to be drained to the selected area through the catheter.

2. The method of claim 1, wherein the flow distribution enhancing tip comprises a distal end which is sealed and a plurality of inlet apertures located between the distal and proximal ends of the tip.

3. The method of claim 2, wherein the flow distribution enhancing tip comprises an inlet aperture geometry wherein the inlet apertures progressively increase in cross-sectional area from the most proximal inlet aperture to the most distal inlet aperture.

4. The method of claim 1 wherein the antimicrobial catheter comprises an antimicrobial agent selected from the group consisting of tetracyclines, rifamycins, macrolides, penicillins, cephalosporins, other beta-lactam antibiotics, aminoglycosides, chloramphenicol, sufonamides, glycopeptides, quinolones, fusidic acid, trimethoprim, metronidazole, clindamycins, mupirocin, polyenes, azoles, beta-lactam inhibitors and mixtures thereof.

5. The method of claim 4 wherein the antimicrobial agent is selected from the group consisting of isminocycline, rifampin, erythromycin, nafcillin, cefazolin, imipenem, aztreonam, gentamicin, sulfamethoxazole, vancomycin, ciprofloxacin, trimethoprim, metronidazole, clindamycin, teicoplanin, mupirocin, azithromycin, clarithromycin, ofloxacin, lomefloxacin, norfloxacin, nalidixic acid, sparfloxacin, pefloxacin, amifloxacin, enoxacin, fleroxacin, temafloxacin, tosufloxacin, clinafloxacin, sulbactam, clavulanic acid, amphotericin B, fluconazole, itraconazole, ketoconazole, nystatin and mixtures thereof.

6. The method of claim 4 wherein the antimicrobial agent is selected from the group consisting of rifampin, clindamycin hydrochloride and mixtures thereof.

7. The method of claim 4, 5 or 6 wherein the wherein the flow distribution enhancing tip comprises a distal end which is sealed and a plurality of inlet apertures located between the distal and proximal ends of the tip.

8. The method of claim 4, 5 or 6 wherein the wherein the flow distribution enhancing tip comprises an inlet aperture geometry wherein the inlet apertures progressively increase in cross-sectional area from the most proximal inlet aperture to the most distal inlet aperture.

9. The method of claim 1 wherein the drug-eluting catheter comprises a drug selected from the group consisting of vinca alkaloids, paclitaxel, epidipodophyllotoxins, anthracyclines, mitoxantrone, bleomycins, plicamycin (mithramycin) and mitomycin, enzymes;

antiplatelet agents;

anti-proliferative/antimitotic alkylating agents;

anti-proliferative/antimitotic antimetabolites;

platinum coordination complexes;

hormones;

anti-coagulants;

fibrinolytic agents;

anti-inflammatory steriods, non-steroidal agents;

para-aminophenol derivatives;

indole and indene acetic acids, heteroaryl acetic acids, mycophenolic acids, enolic acids, nabumetone, gold compounds;

immunosuppressives;

sirolimus (rapamycin), azathioprine, mycophenolate mofetil);

angiogenic agents;

s vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF);

angiotensin receptor blockers;

nitric oxide donors;

antisense oligionucleotides and combinations thereof;

cell cycle inhibitors, mTOR inhibitors, and growth factor receptor signal transduction kinase inhibitors;

retenoids;

cyclin/CDK inhibitors;

HMG co-enzyme reductase inhibitors (statins);

protease inhibitors and mixtures thereof.

10. The method of claim 1 wherein the drug comprises paclitaxel.

11. The method of claim 1 wherein the drug comprises sirolimus and mycophenolic acid.

12. The method of claim 1 wherein the drug comprises sirolimus.

13. A fluid management system comprising:

a) an antimicrobial or drug-eluting device comprising a proximal and distal end; and

b) a flow distribution enhancing tip at the distal end of the device.

14. The system of claim 13, wherein the device is selected from the group consisting of catheters, shunts, hydrocephalus shunts, central nervous catheters, dialysis grafts, and drainage tubes.

15. The system of claim 14, wherein the device is a catheter.

16. The system of claim 14, wherein the device is a hydrocephalus shunt.

17. The system of claim 13, wherein the device comprises antimicrobial agents selected from the group consisting of tetracyclines, rifamycins, macrolides, penicillins, cephalosporins, other beta-lactam antibiotics, aminoglycosides, chloramphenicol, sufonamides, glycopeptides, quinolones, fusidic acid, trimethoprim, metronidazole, clindamycins, mupirocin, polyenes, azoles, beta-lactam inhibitors and mixtures thereof.

18. The system of claim 17, wherein the antimicrobial agent is selected from the group consisting of isminocycline, rifampin, erythromycin, nafcillin, cefazolin, imipenem, aztreonam, gentamicin, sulfamethoxazole, vancomycin, ciprofloxacin, trimethoprim, metronidazole, clindamycin, teicoplanin, mupirocin, azithromycin, clarithromycin, ofloxacin, lomefloxacin, norfloxacin, nalidixic acid, sparfloxacin, pefloxacin, amifloxacin, enoxacin, fleroxacin, temafloxacin, tosufloxacin, clinafloxacin, sulbactam, clavulanic acid, amphotericin B, fluconazole, itraconazole, ketoconazole, nystatin and mixtures thereof.

19. The system of claim 17, wherein the antimicrobial agent is selected from the group consisting of rifampin, clindamycin hydrochloride and mixtures thereof.

20. The system of claim 13, wherein the flow distribution enhancing tip comprises a distal end which is sealed and a plurality of inlet apertures located between the distal and proximal ends of the tip.

21. The system of claim 20, wherein the flow distribution enhancing tip comprises an inlet aperture geometry wherein the inlet apertures progressively decrease in cross-sectional area from the most proximal inlet aperture to the most distal inlet aperture.

22. The system of claim 13, wherein the drug in the drug-eluting device comprises a drug selected from the group consisting of vinca alkaloids, paclitaxel, epidipodophyllotoxins, anthracyclines, mitoxantrone, bleomycins, plicamycin (mithramycin) and mitomycin, enzymes;

antiplatelet agents;

anti-proliferative/antimitotic alkylating agents;

anti-proliferative/antimitotic antimetabolites;

platinum coordination complexes;

hormones;

anti-coagulants;

fibrinolytic agents;

anti-inflammatory steriods, non-steroidal agents;

para-aminophenol derivatives;

indole and indene acetic acids, heteroaryl acetic acids, mycophenolic acids, enolic acids, nabumetone, gold compounds;

immunosuppressives;

sirolimus (rapamycin), azathioprine, mycophenolate mofetil);

angiogenic agents;

vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF);

angiotensin receptor blockers;

nitric oxide donors;

antisense oligionucleotides and combinations thereof;

cell cycle inhibitors, mTOR inhibitors, and growth factor receptor signal transduction kinase inhibitors;

retenoids;

cyclin/CDK inhibitors;

HMG co-enzyme reductase inhibitors (statins);

protease inhibitors and mixtures thereof.

23. The system of claim 22, wherein the drug comprises paclitaxel.

24. The system of claim 22, wherein the drug comprises a combination of sirolimus and mycophenolic acid.

25. The system of claim 22, wherein the drug comprises sirolimus.