Therapeutic sleeve for implantable medical device

• US 8,430,852 B2
• Filed: 03/31/2009
• Issued: 04/30/2013
• Est. Priority Date: 04/17/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bischoff, Thomas C., Jagler, Robyn L.
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US12/415,311
• Publication Number:
  US 20090198197A1
• Time in Patent Office: 1,491 Days
• Field of Search: 604/523, 604/524, 604/530, 604/265
• US Class Current: 604/265
• CPC Class Codes: A61K 31/65 Tetracyclines
• CPC Class Codes: A61L 2300/402 Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• 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 25/02 Holding devices, e.g. on the body

Abstract

A therapeutic sleeve is disposable about a therapy delivery element. The sleeve has a first opening, a second opening, and a radially elastic body member disposed between the first and second opening. The body member forms a lumen extending from the first opening to the second opening and is configured to be disposed about the therapy delivery element. The sleeve further includes a therapeutic agent releasable from the body member when implanted in a patient.

Claims

1. A therapeutic sleeve disposable about a therapy delivery element, the therapy delivery element having an outer diameter and an outer surface about which the sleeve is disposable, the sleeve comprising:

a first opening;

a second opening;

a body member disposed between the first and second opening, the body member being formed from elastic material;

a lumen extending though the body member from the first opening to the second opening, the lumen being configured to be disposed about at least a portion of the outer surface of the therapy delivery element; and

a therapeutic agent releasable from the body member when implanted in a patient,

wherein at least a portion of the body member has a first inner diameter defined by the lumen in a relaxed state and a second inner diameter defined by the lumen in a radially stretched state,

wherein the first inner diameter is smaller than the second inner diameter, and

wherein the first inner diameter is smaller than the outer diameter of the therapy delivery element, and the second inner diameter is larger than the outer diameter of the therapy delivery element,

wherein the therapeutic agent is an antimicrobial agent and wherein the sleeve is configured to elute substantially all of the antimicrobial agent within one week of being implanted in a patient.

2. The sleeve of claim 1, wherein the body member is configured to grippingly engage the least a portion of the outer surface of the therapy delivery element such that a pull force of 0.25 pound-force or more is required to move the sleeve along the outer surface of the therapy delivery element.

3. The sleeve of claim 1, wherein the body member is formed of silicone.

4. The sleeve of claim 1, wherein the body member is free of slits.

5. The sleeve of claim 1, wherein the therapeutic agent is minocycline.

6. The sleeve of claim 5, wherein the sleeve further comprises rifampin, wherein the rifampin is releasable from the body member when implanted in the patient.

7. The sleeve of claim 6, wherein the therapy delivery element is operably couplable to an active implantable medical device having an exterior surface area.

8. The sleeve of claim 7, wherein the minocycline is included in the sleeve in an amount of between 3 and 50 micrograms per square inch of the exterior surface area of the active device, and wherein the rifampin is included in the sleeve in an amount between 3 and 50 micrograms per square inch of the exterior surface area of the active device.

9. The sleeve of claim 8, wherein the minocycline is present in an amount between 5 and 25 micrograms per square inch of the exterior surface area of the active device, and wherein the rifampin is present in an amount between 5 and 25 micrograms per square inch of the exterior surface area of the active device.

10. The sleeve of claim 6, wherein the sleeve includes an effective amount of minocycline and rifampin, and wherein the sleeve is configured to elute 40% or more of the minocycline and rifampin within 48 hours of being implanted in a patient.

11. The sleeve of claim 10, wherein the sleeve is configured to elute 60% or more of the minocycline and rifampin within 24 hours of being implanted in a patient.

12. The sleeve of claim 10, wherein the sleeve is configured to release substantially all the minocycline within 24 hours of being implanted.

13. The sleeve of claim 12, wherein the sleeve is configured to release substantially all the rifampin within 72 hours of being implanted.

14. A system comprising a therapeutic sleeve according to claim 1 and the therapy delivery element about which the sleeve is configured to be disposed.

19. The sleeve of claim 1, wherein the body member comprises a biodegradable polymer.

15. A kit comprising:

a sleeve having a first opening, a second opening, a body member disposed between the first and second opening, and a lumen extending though the body member from the first opening to the second opening, wherein the body member is formed from an elastic material and wherein at least a portion of the body member has a first inner diameter defined by the lumen in a relaxed state and a second inner diameter defined by the lumen in a radially stretched state, wherein the first inner diameter is smaller than the second inner diameter, wherein the sleeve further includes a therapeutic agent releasable from the body member when implanted in a patient wherein the therapeutic agent is an antimicrobial agent and wherein the sleeve is configured to elute substantially all of the antimicrobial agent within one week of being implanted in a patient;

a therapy delivery element having an outer diameter and an outer surface about which the sleeve is disposable, the outer diameter being larger than the first inner diameter of the at least a portion of the body member of the sleeve and smaller than the second inner diameter of the at least a portion of the body member of the sleeve; and

a deployment apparatus including a sleeve receiving element,

the sleeve receiving element comprising an elongate member having a distal opening and a lumen extending proximally in the elongate member from the distal opening,

wherein the lumen of the elongate member is configured to slidably receive at least a portion of the therapy delivery element,

wherein the elongate member has an outer diameter larger than the first inner diameter of the at least a portion of the body member of the sleeve and smaller than the second inner diameter of the at least a portion of the body member of the sleeve such that the sleeve is disposable about the elongate member and, when the sleeve is disposed about the elongate member, the at least a portion of the body member of the sleeve engages at least a portion of the elongate member, and wherein the sleeve is moveable about the elongate member.

17. The kit of claim 15, wherein the sleeve comprises a biodegradable polymer.

16. A kit for disposing a sleeve about a therapy delivery element, the therapy delivery element having an outer diameter and an outer surface about which the sleeve is disposable, the kit comprising:

the sleeve having a first opening, a second opening, a body member disposed between the first and second opening, and a lumen extending though the body member from the first opening to the second opening, wherein the body member is formed from an elastic material and wherein at least a portion of the body member has a first inner diameter defined by the lumen in a relaxed state and a second inner diameter defined by the lumen in a radially stretched state, wherein the first inner diameter is smaller than the second inner diameter, wherein the sleeve further includes a therapeutic agent releasable from the body member when implanted in a patient and wherein the outer diameter of the therapy delivery element is larger than the first inner diameter of the at least a portion of the body member of the sleeve and is smaller than the second inner diameter of the at least a portion of the body member of the sleeve wherein the therapeutic agent is an antimicrobial agent and wherein the sleeve is configured to elute substantially all of the antimicrobial agent within one week of being implanted in a patient;

a deployment apparatus including an sleeve receiving element,

the sleeve receiving element comprising an elongate member having a distal opening and a lumen extending proximally in the elongate member from the distal opening,

wherein the lumen of the elongate member is configured to slidably receive at least a portion of the therapy delivery element,

wherein the elongate member has an outer diameter larger than the first inner diameter of the at least a portion of the body member defined by the lumen of the sleeve and smaller than the second inner diameter of the at least a portion of the body member defined by lumen of the sleeve such that the sleeve is disposable about the elongate member and, when the sleeve is disposed about the elongate member, the at least a portion of the body member of the sleeve engages at least a portion of the elongate member, and wherein the sleeve is moveable about the elongate member.

18. The kit of claim 16, wherein the sleeve comprises a biodegradable polymer.