Enhanced stability implantable medical device

• US 8,209,015 B2
• Filed: 10/08/2008
• Issued: 06/26/2012
• Est. Priority Date: 10/09/2007
• Status: Expired due to Fees

• Current Assignee: Stealth Therapeutics, Inc.
• Original Assignee: Stealth Therapeutics, Inc.
• Inventors: Glenn, Bradley J.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US12/287,398
• Publication Number:
  US 20090093765A1
• Time in Patent Office: 1,357 Days
• Field of Search: None
• US Class Current: 607/36
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation

Abstract

An implantable medical device is provided which has a housing of an elongate form to minimize a size of an incision required for implantation. A stabilizing element is associated with the elongated form housing for the medical device. The stabilizing element transitions from a low profile initial form to a higher width final form to provide the medical device with a stabilized footprint after implantation. The stabilizing element is in the form of a rotating wing in one embodiment. In another embodiment, the stabilizing element is in the form of an expanding loop that can bend to extend out of side openings of a cavity within the housing, to provide such stabilization at the implantation site. The medical device can be in the form of a pacemaker, infusion pump, vascular access port or other subcutaneously implanted medical device.

Claims

1. A shape variable medical device for implantation subcutaneously, the medical device comprising in combination:

a housing;

said housing having an elongate form between a front end and a rear end;

said housing having a long dimension extending from said front end to said rear end along a long axis;

said housing having a lateral dimension extending along a lateral axis non-parallel with said long axis;

said lateral dimension having a length less than a length of said long dimension;

at least one stabilizing element;

said stabilizing element pivotably attached to said housing;

said stabilizing element having an elongate form extending between ends thereof;

said ends of said stabilizing element joined together by sides extending between said ends and on opposite portions of said stabilizing element;

said sides of said stabilizing element longer than said ends of said stabilizing element;

said sides of said stabilizing element having a length longer than a length of said lateral dimension, such that when said stabilizing element is rotated from a first position more aligned with said long axis to a second position more aligned with said lateral axis, said stabilizing element extends laterally from said housing to stabilize said housing; and

wherein an axle is provided extending non-parallel with said long dimension of said housing, said stabilizing element pivotably attached to said housing through said axle.

2. A shape variable medical device for implantation subcutaneously, the medical device comprising in combination:

a housing;

said housing having an elongate form between a front end and a rear end;

said housing having a long dimension extending from said front end to said rear end along a long axis;

said housing having a lateral dimension extending along a lateral axis non-parallel with said long axis;

said lateral dimension having a length less than a length of said long dimension;

at least one stabilizing element;

said stabilizing element pivotably attached to said housing;

said stabilizing element having an elongate form extending between ends thereof;

said ends of said stabilizing element joined together by sides extending between said ends and on opposite portions of said stabilizing element;

said sides of said stabilizing element longer than said ends of said stabilizing element;

said sides of said stabilizing element having a length longer than a length of said lateral dimension, such that when said stabilizing element is rotated from a first position more aligned with said long axis to a second position more aligned with said lateral axis, said stabilizing element extends laterally from said housing to stabilize said housing; and

wherein an axle extends non-parallel with said long axis from a bottom of said housing, said stabilizing element pivotably attached to said axle.

3. The medical device of claim 2 wherein said stabilizing element has a shape similar to that of a perimeter of said housing, such that said stabilizing element remains substantially within a perimeter of said housing when said stabilizing element has said ends of said stabilizing element aligned with said long axis of said housing.

4. The medical device of claim 2 wherein said stabilizing element is adapted to rotate at least about 45°

relative to said housing.

5. The medical device of claim 2 wherein a detent snap assembly is formed into said stabilizing element and said housing to cause said stabilizing element to tend to remain in a deployed position after rotation to said deployed position to maintain stability for said medical device.

6. The medical device of claim 2 wherein said housing and said stabilizing element include holes therein, said holes adapted to receive sutures passing therethrough to secure said stabilizing element in a deployed orientation rotated away from alignment with said perimeter of said housing to maintain stability of said medical device after implantation.

7. The medical device of claim 2 wherein electric leads extend from said housing and said housing contains at least portions of a cardiac rhythm manager therein, such that said medical device is in the form of a cardiac rhythm manager.

8. A medical device adapted to be implanted subcutaneously and to morph between a lower profile dynamic form and a higher profile static form, the medical device comprising in combination:

a housing;

said housing adapted to contain at least a portion of a medical device therein for treatment of a patient into which the medical device is implanted;

said housing having an elongate form with a lateral width lesser than a long axis length thereof;

said long axis length non-parallel with said lateral width;

a stabilizing element interfacing with said housing;

wherein an axle is provided extending non-parallel with said long axis length of said housing, said stabilizing element pivotably attached to said housing through said axle; and

said stabilizing element adapted to be affixed to said housing and adjusted to exhibit a width greater than said lateral width of said housing when said stabilizing element is transitioned from a lower profile dynamic form for the medical device to a higher profile static form for the medical device.

9. The medical device of claim 8 wherein said stabilizing element has a length between ends thereof at least as great as said long axis length of said housing.

10. The medical device of claim 8 wherein said stabilizing element is adapted to rotate relative to said housing to transition said stabilizing element from the lower profile dynamic position to the higher profile static position.

11. The medical device of claim 10 wherein said stabilizing element is in the form of a wing having an elongate form extending between ends thereof.

12. The medical device of claim 11 wherein said wing has a contour similar to the contour of said housing with said wing adapted to rotate at least about 45°

from the lower profile dynamic position to the higher profile static position for said wing.

13. The medical device of claim 11 wherein a pair of wings are provided, each of said wings adapted to rotate in opposite directions relative to said housing, said pair of wings having similar lengths extending between ends thereof, with rear most ends of said pair of wings having beveled surfaces thereon at least partially facing each other, such that a spreader rod can be inserted between said beveled surfaces and cause rotation of said wings in opposite directions away from said spreader rod upon impacting each of said beveled surfaces.

14. The medical device of claim 8 wherein said housing includes electrical leads extending therefrom and said housing includes at least portions of a cardiac rhythm manager therein, such that the medical device is in the form of a cardiac rhythm manager.