Prosthesis with multiple drugs applied separately by fluid jet application in discrete unmixed droplets

• US 20040185081A1
• Filed: 11/07/2003
• Published: 09/23/2004
• Est. Priority Date: 11/07/2002
• Status: Abandoned Application

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Cromack, Keith, Tarcha, Peter, Hui, Ho-Wah, Verlee, Donald, Toner, John
• Application Number:
  US10/703,891
• Publication Number:
  US 20040185081A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: B05C 13/025 : relatively small cylindrical objects, e.g. cans, bottles
• CPC Class Codes: B05C 5/0216 : by relative movement of article and outlet according to a predetermined path
• CPC Class Codes: G11B 7/00 : Recording or reproducing by optical means, e.g. recording using a thermal beam of optical radiation by modifying optical properties or the physical structure, reproducing using an optical beam at lower power by sensing optical properties; Record carriers therefor G11B11/00, G11B13/00 take precedence

Abstract

An interventional device for delivery of multiple beneficial agents. The device includes a prosthesis having a surface loaded with a plurality of discrete droplets of first and second beneficial agents. The discrete droplets of beneficial agent are loaded along a first controlled trajectory and the second beneficial agent is loaded along a second controlled trajectory. The first controlled trajectory and the second controlled trajectory can be aligned to allow mixing of the first and second beneficial agents prior to being loaded onto the surface of the prosthesis.

Claims

1. An interventional device for the delivery of multiple beneficial agents, the device comprising:

a prosthesis to be deployed in a lumen, the prosthesis having a surface;

a plurality of discrete droplets of a first beneficial agent loaded on the surface of the prosthesis; and

a plurality of discrete droplets of a second beneficial agent loaded on the surface of the prosthesis.

2. The interventional device of claim 1, wherein the first beneficial agent and the second beneficial agent are incompatible.

3. The interventional device of claim 1, wherein the first beneficial agent is dissolved in a first solvent and the second beneficial agent is dissolved in a second solvent, and further wherein the first solvent and the second solvent are immiscible.

4. The interventional device of claim 1, wherein the discrete droplets of the first beneficial agent are loaded along a first controlled trajectory and the discrete droplets of the second beneficial agent are loaded along a second controlled trajectory;

the first controlled trajectory and the second controlled trajectory being aligned to allow the first beneficial agent and the second beneficial agent to mix prior to being loaded onto the surface of the prosthesis.

5. The interventional device of claim 1, wherein the discrete droplets of the first beneficial agent and the discrete droplets of the second beneficial agent mix on the surface of the prosthesis.

6. The interventional device of claim 1, wherein the first beneficial agent is dissolved in a solvent and the second beneficial agent causes the first beneficial agent to precipitate out of the solvent.

7. The interventional device of claim 1, wherein the first beneficial agent and the second beneficial agent are loaded on the prosthesis in unmixed droplets to provide a selected pattern.

8. The interventional device of claim 1, wherein at least one of the first beneficial agent and the second beneficial agent is mixed with a binder prior to being loaded on the prosthesis.

9. The interventional device of claim 8, wherein the binder is a phosphorylcholine-linked polymer.

10. The interventional device of claim 8, wherein the second beneficial agent cures the binder on the prosthesis with the first beneficial agent mixed therein.

11. The interventional device of claim 8, wherein the first beneficial agent is mixed with a binder having a first release rate for delivery of the first beneficial agent.

12. The interventional device of claim 11, wherein the second beneficial agent is mixed with a binder having a second release rate for delivery of the second beneficial agent;

the first release rate being different than the second release rate.

13. The interventional device of claim 1, wherein the prosthesis includes at least one cavity defined therein, the at least one cavity being at least partially loaded with a base material;

and further wherein the first beneficial agent and the second beneficial agent are loaded to the base material.

14. The interventional device of claim 1, wherein the prosthesis includes at least one cavity, the at least one cavity defining a mouth having a first cross-dimension and a reservoir having a second cross-dimension, the second cross-dimension being greater than the first cross-dimension.

15. The interventional device of claim 1, further including a plurality of discrete droplets of a third beneficial agent loaded on the surface of the prosthesis.

16. The interventional device of claim 15, wherein the first beneficial agent is dexamethasone, the second beneficial agent is estradiol, and the third beneficial agent is the rapamycin analog 3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-3-methoxy-4-tetrazol-1-yl)cyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido [2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone;

23,27-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone.

17. The interventional device of claim 15, wherein the first beneficial agent, the second beneficial agent and the third beneficial agent are each dissolved in a first solvent.

18. The interventional device of claim 1, wherein at least one of the first beneficial agent and the second beneficial agent is selected from a group consisting of antithrombotics, anticoagulants, antiplatelet agents, anti-lipid agents, thrombolytics, antiproliferatives, anti-inflammatories, agents that inhibit hyperplasia, smooth muscle cell inhibitors, antibiotics, growth factor inhibitors, cell adhesion inhibitors, cell adhesion promoters, antimitotics, antifibrins, antioxidants, antineoplastics, agents that promote endothelial cell recovery, antiallergic substances, radiopaque agents, viral vectors, antisense compounds, oligionucleotides, cell permeation enhancers, angiogenesis agents, paclitaxel, rapamycin, Everolimus, heparin, estradiol, dexamethasone, analogs thereof, rapamycin analog is 3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-3-methoxy-4-tetrazol-1-yl)cyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone;

23,27-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone, and combinations thereof.

19. The interventional device of claim 1, further including an overcoat applied over at least a portion of the surface.

20. The interventional device of claim 1, wherein beneficial agent is applied to the prosthesis using a fluid jet dispenser having a dispensing element capable of dispensing beneficial agent in discrete droplets, each droplet having a controlled trajectory.

21. An interventional device for delivery of beneficial agent, the device comprising:

a prosthesis to be deployed in a lumen, the prosthesis having a first surface and a second surface;

the first surface of the prosthesis at least partially loaded with a first beneficial agent; and

the second surface at least partially loaded with a second beneficial agent;

at least one of the first beneficial agent and the second beneficial agent being loaded by a fluid-dispenser having a dispensing element capable of dispensing beneficial agent in discrete droplets, each droplet having a controlled trajectory.

22. The interventional device of claim 21, wherein the prosthesis has a tubular body when deployed, the tubular body defining a longitudinal axis;

and further wherein the first surface of the prosthesis is defined as an inner surface of the tubular body and the second surface of the prosthesis is defined as an outer surface of the tubular body.

23. The interventional device of claim 21, wherein at least one of the first beneficial and second beneficial agent is selected from a group consisting of antiplatelet agents, aspirin, cell adhesion promoters, agents that promote endothelial healing, agents that promote migration, angiogenesis promoters, cytokines, anti migrative agents, antifibrins, estradiol, anti-inflammatories, anti-proliferatives, smooth muscle inhibitors, cell adhesion promoters, and 3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-3-methoxy-4-tetrazol-1-yl)cyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone;

23,27-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone, and combinations thereof.

24. The interventional device of claim 21, wherein the prosthesis is defined by a plurality of interconnecting structural members;

the first surface of the prosthesis including a first selected set of the structural members and the second surface of the prosthesis including a second selected set of the structural members.

25. The interventional device of claim 24, wherein at least one of the first selected set of structural members and the second selected set of structural members defines at least one ring-shaped element extending around a circumference of the tubular body.

26. The interventional device of claim 21, wherein the first beneficial agent has a first local areal density and the second beneficial agent has a second local areal density.

27. The interventional device of claim 26, wherein at least one of the first local areal density and the second local areal density is uniform across a selected portion of the prosthesis.

28. The interventional device of claim 21, wherein at least one of the first local areal density of beneficial agent and the second local areal density is varied across a selected portion of the prosthesis.

29. The interventional device of claim 21, further including a third beneficial agent loaded on at least one of the first surface and second surface of the prosthesis.

30. The interventional device of claim 21, the prosthesis further includes a base material layer, the base material layer defining a pattern on the prosthesis for loading the beneficial agent.

31. The interventional device of claim 21, further including an overcoat applied to at least one of the inner surface or the outer surface of the prosthesis.