Flexible hermetic enclosure for implantable medical devices

• US 20060217779A1
• Filed: 03/24/2005
• Published: 09/28/2006
• Est. Priority Date: 03/24/2005
• Status: Active Grant

• Current Assignee: Interventional Autonomics Corporation
• Original Assignee: Synecor LLC
• Inventors: Ransbury, Terrance, Athas, William L., Gwerder, Arthur
• Granted Patent: US 7,363,082 B2
• Time in Patent Office: Days
• US Class Current: 607/36
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37516 Intravascular implants
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence

Abstract

A flexible, hermetically sealed enclosure device allows for the controlled insertion of an implantable device into the body of a patient. A series of bellows can be used to interconnect a number of rigid containers, each containing electronic or other components necessary for the implantable device. The bellows provide flexibility, columnar strength, and torqueability (for steering), while protecting the internal components. The bellows also can be welded to the containers to form a hermetic seal that can be electrically continous, whereby standard wiring and components can be used without fear of corrosion or contamination. Such an enclosure can be used with systems such as an intravascular implantable pacing, drug delivery, or defibrillation system.

Claims

1. A flexible enclosure for implantation in a body, comprising:

a plurality of rigid containers, each container operable to contain at least one component to be implanted into the body; and

a plurality of mechanical bellows, each bellows connecting two of the rigid containers to form an elongated chain of containers and bellows, each bellows further having an internal passage allowing for interconnection of the components in the rigid containers.

2. A flexible enclosure according to claim 1, wherein:

the flexible enclosure is operable to be implanted in the vasculature of the body.

3. A flexible enclosure according to claim 1, wherein:

the components form a device selected from the group consisting of pacemakers, defibrillators, and drug delivery devices.

4. A flexible enclosure according to claim 1, wherein:

each connection between a bellows and a container forms a hermetic seal.

5. A flexible enclosure according to claim 1, wherein:

each bellows allows for flexing over a range of about 360°

.

6. A flexible enclosure according to claim 1, wherein:

each of the containers is formed of a biocompatible material.

7. A flexible enclosure according to claim 1, wherein:

each of the containers is formed of a material selected from the group consisting of titanium, nitinol, stainless steel, nickel, and biocompatible polymers polymers.

8. A flexible enclosure according to claim 1, wherein:

each of the bellows is formed of a biocompatible material.

9. A flexible enclosure according to claim 1, wherein:

each of the bellows is formed of a material selected from the group consisting of titanium, nitinol, stainless steel, nickel, and biocompatible polymers.

10. A flexible enclosure according to claim 1, wherein:

each of the containers is cylindrical in shape.

11. A flexible enclosure according to claim 1, wherein:

each of the containers and bellows has a diameter in the range of about 3 mm to about 15 mm.

12. A flexible enclosure according to claim 1, wherein:

each of the containers and bellows has a diameter in the range of about 3 mm to about 8 mm.

13. A flexible enclosure according to claim 1, wherein:

each of the containers and bellows is covered by an electrically insulative coating.

14. A flexible enclosure according to claim 1, wherein:

at least one of the bellows is pre-shaped to have a particular curvature.

15. A flexible enclosure according to claim 1, further comprising:

a retractable introducer sheath shaped to fit around the connected containers and bellows.

16. A flexible enclosure according to claim 15, further comprising:

an anchor connected to one of the containers and operable to be compressed when covered by the sheath, the anchor further operable to expand upon retraction of the sheath in order to hold the position of the enclosure in the body.

17. A flexible enclosure according to claim 1, wherein:

each bellows provides for three-dimensional flexing.

18. A flexible enclosure according to claim 1, wherein:

each bellows provides shock absorption.

19. A flexible enclosure according to claim 1, further comprising:

a sleeving over each bellows.

21. A flexible enclosure according to claim 1, wherein:

the connected plurality of rigid containers and plurality of mechanical bellows provides 1;

1 torque transmission over an entire length of the flexible enclosure.

22. A flexible enclosure according to claim 21, wherein:

the torque transmission provides steerability when navigating the flexible enclosure into place within the body.

20. A flexible enclosure according to claim 20, wherein:

the sleeving is formed of one of silicone and polyurethane.

23. A flexible enclosure for implantation in a body, comprising:

a plurality of cylindrical containers, each container operable to contain at least one component to be implanted into the body; and

a plurality of cylindrical bellows, each bellows connecting two of the rigid containers to form an elongated array of containers and bellows, each bellows being welded to the corresponding two containers to form a hermetic seal such that an internal passage in the bellows allows for interconnection of the components using non-biocompatible materials.

24. A flexible enclosure according to claim 23, wherein:

the plurality of cylindrical bellows and rigid containers form an electrically continuous structure.

25. A flexible enclosure according to claim 23, wherein:

the plurality of cylindrical bellows and rigid containers form a continuous structure that shields components inside the continuous structure.

26. A flexible enclosure according to claim 23, wherein:

the enclosure is operable to be implanted in the vasculature of the body.

27. A flexible enclosure according to claim 23, wherein:

the components form a device selected from the group consisting of pacemakers, defibrillators, and drug delivery devices.

28. A flexible enclosure according to claim 23, wherein:

each of the containers and bellows is formed of a biocompatible material.

29. A flexible enclosure according to claim 23, wherein:

each of the containers is formed of a material selected from the group consisting of titanium, nitinol, stainless steel, nickel, gold plating, propylene, and biocompatible polymers.

30. A flexible enclosure according to claim 23, wherein:

each of the bellows is formed of a material selected from the group consisting of titanium, nitinol, stainless steel, nickel, and biocompatible polymers polymers.

31. A flexible enclosure according to claim 23, wherein:

each of the containers and bellows has a diameter in the range of about 3 mm to about 15 mm.

32. A flexible enclosure according to claim 23, wherein:

each of the containers and bellows has a diameter in the range of about 3 mm to about 8 mm.

33. A flexible enclosure according to claim 23, wherein:

each of the containers and bellows is covered by an electrically insulative coating.

34. A flexible enclosure according to claim 23, wherein:

at least one of the bellows is pre-shaped to have a particular curvature.

35. A flexible enclosure according to claim 23, further comprising:

a retractable introducer sheath shaped to fit around the connected containers and bellows.

36. A flexible enclosure according to claim 35, further comprising:

an anchor connected to one of the containers and operable to be compressed when covered by the sheath, the anchor further operable to expand upon retraction of the sheath in order to hold the position of the enclosure in the body.

37. A method of implanting an intravascular device, comprising the steps of:

introducing an intravascular device into the vasculature of a patient, the intravascular device including a flexible enclosure consisting of a plurality of rigid containers, each container containing at least one component of the intravascular device, and a plurality of mechanical bellows, each bellows connecting two of the rigid containers to form an elongated chain of containers and bellows, each bellows further having an internal passage allowing for interconnection of the components in the rigid containers;

advancing the intravascular device to a target location within the vasculature; and

anchoring the intravascular device within the target location.

38. A method according to claim 37, further comprising:

positioning at least one electrode within the cardiovascular system, the electrode coupled to the intravascular device.

39. A method according to claim 37, wherein:

the flexible enclosure includes an electrode positioned on the outside of the flexible enclosure, the electrode coupled to the intravascular device.

40. A method according to claim 37, wherein:

the anchoring step includes placing an anchor in contact with the flexible enclosure and expanding an anchor into contact with a wall of the target location.