Expandable fixation mechanism

• US 8,489,189 B2
• Filed: 10/29/2004
• Issued: 07/16/2013
• Est. Priority Date: 10/29/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tronnes, Carole A.
• Primary Examiner(s): Getzow, Scott
• Assistant Examiner(s): PATTON, AMANDA K
• Application Number:
  US10/977,500
• Publication Number:
  US 20060095078A1
• Time in Patent Office: 3,182 Days
• Field of Search: 607/36, 607/119, 607/126, 607/127, 607/128
• US Class Current: 607/36
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation

Abstract

In general, the invention is directed to a medical device implantable in a body of a patient. The device includes a housing with a plurality of collapsible fixation structures coupled to the housing, and can be in a collapsed configuration or an expanded configuration. The device assumes a collapsed configuration when in the bore of an insertion device, and assumes the expanded configuration when expelled from the insertion device into the body of the patient. The extended fixation structures engage the tissues in the body and restrict migration. One exemplary application of the invention is in the context of a microstimulator, with a pulse generator housed in the housing and one or more electrodes coupled to the housing. The fixation structures help keep the electrodes proximate to the tissues that are to receive the stimulation.

Claims

1. An implantable medical device comprising:

a housing comprising a first end and a second end substantially opposite the first end;

an electrode coupled to the housing;

a pulse generator coupled to the electrode; and

a plurality of collapsible fixation structures coupled to the housing, wherein the collapsible fixation structures are configured to collapse in a first direction toward the first end of the housing and in a second direction toward the second end, wherein the fixation structures include flanges, and the flanges each comprise a plurality of ribs and webbing deployed between at least two of the ribs.

2. The device of claim 1, wherein the housing is constructed of at least one of silicone, polyurethane, titanium, stainless steel, fluoropolymer and hydrogel.

3. The device of claim 1, wherein at least one fixation structure is constructed of at least one of silicone, polyurethane, titanium, stainless steel, fluoropolymer and hydrogel.

4. The device of claim 1, wherein the housing is substantially cylindrical and has a diameter from one millimeter to seven millimeters.

5. The device of claim 1, wherein a length of the housing is from ten millimeters to twenty millimeters.

6. The device of claim 1, further comprising a power supply coupled to the pulse generator.

7. The device of claim 1, wherein the fixation structures include tines.

8. The device of claim 1, wherein the collapsible fixation structures are configured to assume a fully expanded state, wherein the housing defines an axis, and wherein the fixation structures are oriented substantially orthogonally from the axis when in the fully expanded state.

9. The device of claim 1, wherein the collapsible fixation structures are configured to assume a collapsed state, and wherein the device is sized to fit inside a bore of an insertion device.

10. The device of claim 9, wherein the insertion device comprises one of a needle, a hollow trocar, an endoscope, a catheter or a cannula.

11. The device of claim 1, wherein the collapsible fixation structures are configured to assume a fully expanded configuration, and wherein at least a portion of at least one fixation structure projects from one to seven millimeters from the housing when the fixation structure is in the fully expanded configuration.

12. The device of claim 1, wherein the device comprises an implantable neurostimulator.

13. The device of claim 1, wherein the device comprises an implantable physiological sensor.

14. The device of claim 1, wherein the electrode is deployed on a surface of at least one of the plurality of fixation structures.

15. The device of claim 1, wherein at least one of the plurality of collapsible fixation structures comprises a hydrogel fixation structure that expands in size upon contact with a fluid.

16. The device of claim 1, wherein at least one of the plurality of collapsible fixation structures is formed integrally with the housing.

17. The device of claim 1, wherein the housing defines an axis extending from the first end to the second end and the collapsible fixation structures are configured to assume a fully expanded state, and wherein, in the fully expanded state, at least one rib of the plurality of ribs extends further from the axis than the webbing extends from the axis.

18. An implantable medical device comprising:

a pulse generator means for generating an electrical stimulation;

a housing means for housing the pulse generator means, the housing means comprising a first end and a second end substantially opposite the first end;

an electrode means for delivering the electrical stimulation from the pulse generator means to a target tissue; and

a plurality of collapsible fixation means coupled to the housing means for restricting migration of the housing means when the housing means is implanted proximate to the target tissue, wherein the collapsible fixation means are configured to collapse in a first direction toward the first end of the housing means and in a second direction toward the second end, wherein the collapsible fixation means each comprise a flange, wherein the flange comprises a plurality of ribs and webbing deployed between at least two of the ribs.

19. The implantable medical device of claim 18, further comprising a power supply means coupled to the pulse generator means for supplying power to the pulse generator means.

20. The implantable medical device of claim 18, wherein the housing means defines an axis extending from the first end to the second end, wherein the collapsible fixation means are configured to assume a fully expanded state, and wherein, in the fully expanded state, at least one rib of the plurality of ribs extends further from, the axis than the webbing extends from the axis.