LEAD ASSEMBLY FOR IMPLANTABLE MICROSTIMULATOR

• US 20090005823A1
• Filed: 09/09/2008
• Published: 01/01/2009
• Est. Priority Date: 01/29/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Whitehurst, Todd K., McGivern, James P., Pianca, Anne M.
• Granted Patent: US 8,204,595 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: H01R 13/5224 for medical use
• CPC Class Codes: H01R 43/16 for manufacturing contact members, e.g. by punching and by bending
• CPC Class Codes: Y10T 29/49204 Contact or terminal manufacturing

Abstract

A lead assembly for a small implantable medical device (a.k.a, microdevice 10) provides means to attach a remote electrode to microdevice, which means inhibit fluid ingress when microdevice is not attached to lead assembly. Microdevices may provide either or both tissue stimulation and sensing. Known microdevices include spaced apart electrodes on the outer surface of the microdevice. Lead assembly includes an insulated lead including a proximal end and a distal end, with at least one conductor therebetween; at least one electrode at the distal end of the lead and electrically connected to the at least one conductor, and a connector attached to the proximal end of the lead and adapted to be removably connectable to microdevice. Connector includes at least one contact to electrically connect at least one device electrode on microdevice to at least one conductor, thereby electrically connecting at least electrode and the at least one electrode at the distal end of lead. Lead assembly is configured to inhibit fluid ingress into the connector. A number of embodiments of the invention, capable of inhibiting fluid ingress into connector, are taught.

Claims

1. An implantable medical device, comprising:

an implantable leadless microstimulator comprising a microstimulator body and a first electrode and a second electrode disposed on opposing ends of the microstimulator body; and

a first lead assembly comprising

at least one remote electrode disposed at a distal end of the first lead assembly,

an insulated conductor electrically connected to the at least one remote electrode, and

a connector disposed at a proximal end of the insulated conductor, wherein the connector is configured and arranged to receive, and substantially entirely cover, the first electrode of the microstimulator, the connector comprising a contact to electrically connect the first electrode to the insulated conductor, wherein the connector is configured and arranged to inhibit fluid ingress into the connector.

2. The implantable medical device of claim 1, wherein the microstimulator, if implanted in the absence of the first lead assembly, is capable of providing stimulating electrical energy to surrounding tissue using the first and second electrodes.

3. The implantable medical device of claim 1, wherein the connector comprises a pouch of elastic biocompatible material configured and arranged to cover at least a portion of the first electrode of the microstimulator when the first electrode is received and inhibit fluid ingress into the connector when the first electrode is received.

4. The implantable medical device of claim 3, wherein the elastic biocompatible material is configured and arranged to seal the connector when the first electrode is not present in the connector.

5. The implantable medical device of claim 4 further comprising suture material configured and arranged to seal the connector when the first electrode is not present in the connector by wrapping around at least a portion of the pouch.

6. The implantable medical device of claim 4 further comprising at least one circumferential spring coupled to the biocompatible elastic material to aid in sealing the connector when the first electrode is not present in the connector.

7. The implantable medical device of claim 6, wherein the at least one circumferential spring is distinguishable from the biocompatible elastic material.

8. The implantable medical device of claim 6, wherein the at least one circumferential spring is configured and arranged to collapse a portion of the connector to seal the connector when the first electrode is not present in the connector.

9. The implantable medical device of claim 4 further comprising at least one leaf spring coupled to the biocompatible elastic material to aid in sealing the connector when the first electrode is not present in the connector.

10. The implantable medical device of claim 9, wherein the at least one leaf spring is distinguishable from the biocompatible elastic material.

11. The implantable medical device of claim 9, wherein the at least one leaf spring is configured and arranged to collapse a portion of the connector to seal the connector when the first electrode is not present in the connector.

12. The implantable medical device of claim 9, wherein the at least one leaf spring is disposed on an exterior of the pouch.

13. The implantable medical device of claim 9, wherein the at least one leaf spring is incorporated longitudinally in walls of the pouch.

14. The implantable medical device of claim 1, wherein the contact is configured with at least one edge that extends at least partly around the first electrode when the microstimulator is inserted into the connector and which aides the connector in inhibiting fluid ingress into the connector when the first electrode is not present in the connector.

15. The implantable medical device of claim 1 further comprising a plug adapted for insertion into the connector when the first electrode is not present in the connector.

16. The implantable medical device of claim 1, wherein the second electrode of the microstimulator and the at least one remote electrode of the first lead assembly are configured to form an electrode pair to allow, when the implantable medical device is implanted, flow of electrical energy through tissue disposed therebetween.

17. The implantable medical device of claim 1 further comprising a second lead assembly comprising

at least one remote electrode disposed at a distal end of the second lead assembly,

an insulated conductor electrically connected to the at least one remote electrode of the second lead assembly, and

a connector disposed at a proximal end of the second lead assembly, wherein the connector is configured to receive, and substantially entirely cover, the second electrode of the microstimulator, the connector comprising a contact to electrically connect the second electrode to the insulated conductor, wherein the connector is configured and arranged to inhibit fluid ingress into the connector.

18. The implantable medical device of claim 17, wherein the at least one remote electrode of the first lead assembly and the at least one remote electrode of the second lead assembly are configured and arranged to form an electrode pair to allow, when the implantable medical device is implanted, flow of electrical energy through tissue disposed therebetween.

19. An implantable medical device, comprising:

an implantable leadless microstimulator comprising a microstimulator body and a first electrode and a second electrode disposed on opposing ends of the microstimulator body; and

a lead assembly comprising

at least one remote electrode disposed at a distal end of the lead assembly,

an insulated conductor electrically coupled to the at least one remote electrode,

a connector attached to the proximal end of the insulated conductor, the connector adapted to be removably connectable to, and substantially entirely cover, the first electrode of the microstimulator, wherein the connector comprises at least one contact to electrically couple the first electrode to the insulated conductor, and

a closure defined in the connector, the closure configured and arranged to inhibit fluid ingress into a portion of the connector that receives the first electrode, wherein the closure collapses and seals when the first electrode of the microstimulator is not present in the connector.

20. A method for using an implantable medical device, the method comprising:

electrically coupling a connector of a lead assembly to a first electrode of a microstimulator, the lead assembly comprising an insulated conductor having a remote electrode at a distal end that electrically couples to the connector at a proximal end, the microstimulator comprising a second electrode electrically coupled to the first electrode; and

stimulating tissue adjacent the remote electrode of the lead assembly by generating electrical pulses in the microstimulator.