Implantable microstimulator with plastic housing and methods of manufacture and use

• US 7,706,892 B2
• Filed: 01/20/2005
• Issued: 04/27/2010
• Est. Priority Date: 01/20/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Colvin, Michael Steven, Haller, Matt Isaac, He, Tom Xiaohai
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Heller; Tammie K
• Application Number:
  US11/040,209
• Publication Number:
  US 20060161204A1
• Time in Patent Office: 1,923 Days
• Field of Search: 600373-381, 607/116, 607/118
• US Class Current: 607/116
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

An implantable microstimulator includes a plastic housing having a first end and a second end; an electronic subassembly disposed within the housing; a first electrode disposed at the first end of the plastic housing and in electrical communication with the electronic subassembly; and a second electrode disposed at the second end of the plastic housing and in electrical communication with the electronic subassembly. The plastic housing, first electrode, and second electrode form a hermetically sealed structure around the electronic subassembly.

Claims

1. An implantable microstimulator comprising:

an elongate plastic housing having a first end and a second end, wherein the first end includes a first plastic threaded region and an access to an interior of the housing;

an electronic subassembly disposed within the interior of the housing;

a first end cap comprising a plastic body, a second plastic threaded region, and a conductive coating coated over at least a portion of the plastic body to form a first electrode, wherein the first electrode is in electrical communication with the electronic subassembly and the first and second plastic threaded regions are dimensioned to mate to form a seal between the first end and the first end cap and block the access to the interior of the housing, and wherein the first and second plastic threaded regions are solvent welded or melted directly to each other to facilitate a hermetic, plastic seal; and

a second electrode disposed at the second end of the plastic housing and in electrical communication with the electronic subassembly;

wherein the access is dimensioned to allow insertion of the electronic subassembly therethrough.

2. The implantable microstimulator of claim 1, further comprising a power source disposed within the plastic housing.

3. The implantable microstimulator of claim 1, further comprising a second end cap comprising the second electrode and a third threaded region.

4. The implantable microstimulator of claim 3, wherein the second end cap comprises:

a plastic body, wherein the third threaded region is a third threaded plastic region; and

a conductive coating coated over at least a portion of the plastic body, the conductive coating forming the second electrode.

5. The implantable micro stimulator of claim 1, wherein the plastic housing comprises a hydrophobic plastic.

6. The implantable microstimulator of claim 1, wherein plastic housing comprises polyolefins, polypropylene homopolymer or copolymer, TEFLON™

, or polyetheretherketone.

7. The implantable microstimulator of claim 1, further comprising a coating disposed over the plastic housing.

8. The implantable microstimulator of claim 7, wherein the coating increases moisture resistance of the plastic housing.

9. The implantable microstimulator of claim 1, further comprising a solvent weld of a plastic material of the plastic body of the first end cap directly to a plastic material of the plastic housing.

10. The implantable microstimulator of claim 1, further comprising a melt seal of a plastic material of the plastic housing directly to a plastic material of the plastic body of the first end cap.

11. The implantable microstimulator of claim 1, wherein:

the first electrode defines a hole through which a lead is disposed; and

the lead is coupled to the electronic subassembly and the first electrode.

12. The implantable microstimulator of claim 1, wherein:

the plastic housing is a cylinder; and

the first and second electrodes are disposed at opposite ends of the cylinder.

13. The implantable microstimulator of claim 1, wherein the first and second ends are opposing ends of the plastic housing.

14. The implantable microstimulator of claim 1, further comprising an antenna disposed within the plastic housing and coupled to the electronic subassembly.

15. The implantable microstimulator of claim 1, wherein the first end cap comprises a laterally-directed surface oriented to facilitate screwing of the first end cap into the plastic housing.

16. An apparatus comprising:

an implantable microstimulator comprising

an elongate plastic housing having a first plastic threaded region at a first open end and a second plastic threaded region at a second open end,

an electronic subassembly disposed within the interior of the plastic housing, wherein the electronic subassembly is dimensioned to be insertable through at least one of the first open end and the second open end,

a first end cap comprising a third plastic threaded region and a first electrode, wherein the first electrode is in electrical communication with the electronic subassembly and the first and third plastic threaded regions are dimensioned to mate to cap the first open end and block fluid access to the interior of the housing when the implantable microstimulator is implanted in a patient, and

a second end cap comprising a fourth plastic threaded region and a second electrode, wherein the second electrode is in electrical communication with the electronic subassembly and the second and fourth plastic threaded regions are dimensioned to mate to cap the second open end and block fluid access to the interior of the housing when the implantable microstimulator is implanted in a patient.

17. The apparatus of claim 16, further comprising an external control unit configured and arranged to communicate with the electronic subassembly to provide signals to the implantable microstimulator, wherein the external control unit comprises a programming unit comprising an interface for entering information to be provided to the microstimulator.

18. The apparatus of claim 16, further comprising an external control unit configured and arranged to communicate with the electronic subassembly to provide signals to the implantable microstimulator, wherein the external control unit comprises a telemetry unit with a transmitter to transmit the signals to the implantable microstimulator.

19. An implantable microstimulator comprising:

an elongate plastic housing having a first end and a second end, wherein the first end includes a first plastic threaded region and an access to an interior of the housing;

an electronic subassembly disposed within the interior of the housing;

a first end cap comprising a second plastic threaded region and a first electrode, wherein the first electrode is in electrical communication with the electronic subassembly and the first and second plastic threaded regions are dimensioned to mate to form a seal between the first end and the first end cap and block fluid access to the interior of the housing when the microstimulator is implanted in a body of a patient; and

a second electrode disposed at the second end of the plastic housing and in electrical communication with the electronic subassembly;

wherein the access is dimensioned to allow insertion of the electronic subassembly therethrough.