Pharmacological delivery implement for use with cardiac repair devices

• US 20050228496A1
• Filed: 04/07/2004
• Published: 10/13/2005
• Est. Priority Date: 04/07/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Shu, Mark C.S., Coppin, Chris M., Mensah, Eugene A.
• Granted Patent: US 8,349,001 B2
• Time in Patent Office: Days
• US Class Current: 623/2.410
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0024 made from both porous and non-porous parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A pharmacological delivery implement for use with cardiac repair devices. The pharmacological delivery implement comprises a porous member defining an outer surface, an internal channel configured to selectively house a pharmacological agent, and a plurality of release holes each extending from the outer surface to the internal channel. Following implantation of the pharmacological delivery implement, at least a portion of the pharmacological agent exits the internal channel through the plurality of release holes.

Claims

1. A pharmacological delivery implement for use with cardiac repair devices comprising:

a porous member defining;

an outer surface,

an internal channel configured to selectively maintain a pharmacological agent, and

a plurality of release holes each extending from the outer surface to the internal channel;

wherein following implantation of the pharmacological delivery implement within the cardiac system, at least a portion of the pharmacological agent exits the internal channel through the plurality of release holes.

2. The pharmacological delivery implement of claim 1, wherein the porous member further defines at least one injection site providing access to the internal channel from the outer surface for injecting the pharmacological agent into the internal channel.

3. The pharmacological delivery implement of claim 1, wherein the plurality of release holes are inherently formed by the pores of the porous member.

4. The pharmacological delivery implement of claim 1, wherein the plurality of release holes are formed separately from the pores of the porous member.

5. The pharmacological delivery implement of claim 1, wherein the porous member is formed of silicone.

6. The pharmacological delivery implement of claim 1, wherein the porous member is formed of an elastomeric polymer.

7. The pharmacological delivery implement of claim 1, further including a pharmacological agent selectively maintained within the internal channel, wherein the porous member has a porosity relative to a viscosity of the pharmacological agent to maintain at least a portion of the pharmacological agent within the internal channel for a desired time period.

8. The pharmacological delivery implement of claim 1, further including a pharmacological agent selectively maintained within the internal channel, wherein the porous member has a porosity relative to an elution profile of the pharmacological agent to maintain at least a portion of the pharmacological agent within the internal channel for a desired time period.

9. The pharmacological delivery implement of claim 1, wherein the porous member is annular.

10. The pharmacological delivery implement of claim 1, wherein the porous member is arcuate.

11. The pharmacological delivery implement of claim 1, wherein the outer surface defines an outflow side and an inflow side opposite the outflow side, and at least a portion of the plurality of release holes extend from the outflow side of the outer surface to the internal channel, and further wherein following implantation, fluid flow from the inflow side to the outflow side of the outer surface facilitates the exit of at least a portion of the pharmacological agent from the internal channel.

12. A cardiac repair device comprising:

a porous member defining;

an outer surface,

an internal channel configured to selectively maintain a pharmacological agent, and

a plurality of release holes each extending from the outer surface to the internal channel; and

a fabric sheath encompassing the porous member;

wherein following implantation of the cardiac repair device within the cardiac system, at least a portion of the pharmacological agent exits the internal channel through the plurality of release holes.

13. The cardiac repair device of claim 12, wherein the porous member further defines at least one injection site providing access to the internal channel from he outer surface for injecting the pharmacological agent into the internal channel.

14. The cardiac repair device of claim 12, wherein the plurality of release holes are formed by the pores of the porous member.

15. The cardiac repair device of claim 12, further including a pharmacological agent selectively maintained within the internal channel of the porous member, wherein the porous member has a porosity relative to the viscosity of the pharmacological agent to maintain at least a portion of the pharmacological agent within the internal channel for a desired time period.

16. The cardiac repair device of claim 12, further including a pharmacological agent selectively maintained within the internal channel of the porous member, wherein the porous member has a porosity relative to an elution profile of the pharmacological agent to maintain at least a portion of the pharmacological agent within the internal channel for a desired time period.

17. The cardiac repair device of claim 12, further comprising:

a prosthetic heart valve, wherein the fabric sheath is coupled to and serves as a sewing ring of the prosthetic heart valve.

18. The cardiac repair device of claim 17, wherein the prosthetic heart valve has flexible leaflets.

19. The cardiac repair device of claim 17, wherein the prosthetic heart valve is a mechanical heart valve.

20. The cardiac repair device of claim 12, wherein the cardiac repair device is an annuloplasty prosthesis.

21. The cardiac repair device of claim 20, wherein the cardiac repair device is an annuloplasty band.

22. The cardiac repair device of claim 20, wherein the cardiac repair device is an annuloplasty ring.

23. The cardiac repair device of claim 12, wherein the outer surface defines an outflow side and an inflow side opposite the outflow side, and at least a portion of the plurality of release holes extend from the outflow side of the outer surface to the internal channel, and further wherein following implantation, fluid flow from the inflow side to the outflow side of the outer surface facilitates the exit of at least a portion of the pharmacological agent from the internal channel.

24. A method of delivering a pharmacological agent to cardiac tissue, the method comprising:

providing a porous member defining;

an outer surface,

an internal channel configured to selectively maintain a pharmacological agent, and

a plurality of release holes each extending from the outer surface to the internal channel;

filling the internal channel with a pharmacological agent;

implanting the porous member filled with the pharmacological agent within a cardiac system;

wherein upon functioning of the cardiac system, at least a portion of the pharmacological agent exits the internal channel via the plurality of release holes.

25. The method of claim 24, wherein the porous member further defines at least one injection site extending from the outer surface of the porous member to the internal channel, and the step of filling the internal channel with a pharmacological agent is performed via the injection site.

26. The method of claim 24, further including:

storing the porous member prior to use, wherein the filling the internal channel with a pharmacological agent occurs after the step of storing the porous member and prior to the step of implanting the porous member.

27. The method of claim 24, further including:

storing the porous member prior to use, wherein filling the internal channel with the pharmacological agent occurs prior to the step of storing the porous member.

28. The method of claim 24, wherein implanting the porous member includes implanting a heart valve prosthesis including the porous member.

29. The method of claim 24, wherein implanting the porous member includes implanting an annuloplasty prosthesis including the porous member.

30. The method of claim 24, wherein the outer surface defines an outflow side and an inflow side opposite the outflow side, and at least a portion of the plurality of release holes extend from the outflow side of the outer surface to the internal channel, and further upon functioning of the cardiac system, fluid flow from the inflow side to the outflow side of the outer surface facilitates the exit of at least a portion of the pharmacological agent from the internal channel.