Rotational markers

• US 8,014,849 B2
• Filed: 11/21/2003
• Issued: 09/06/2011
• Est. Priority Date: 11/21/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Corporation, Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Stryker Corporation, Stryker Nv Operations Limited (Stryker Corporation)
• Inventors: Peckham, John Eric
• Primary Examiner(s): Chen; Tse
• Assistant Examiner(s): Cheng; Jacqueline
• Application Number:
  US10/719,421
• Publication Number:
  US 20050113686A1
• Time in Patent Office: 2,846 Days
• Field of Search: 600/424, 600/414, 600/407
• US Class Current: 600/424
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2002/30617 Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

A medical device includes a rotational marker. A marker may be viewable under an imaging device, such as a fluoroscope or an MRI system. A rotational marker allows the rotational orientation of a medical device to be determined with respect to the surrounding environment. A medical device including a rotational marker may comprise an implantable medical device, a delivery system for delivery of an implantable medical device, and the like.

Claims

1. An apparatus, comprising:

a medical device and a marker wire coupled to said medical device, the medical device having a length and a longitudinal axis, the marker wire comprising four contiguous portions defining the perimeter of a closed area, wherein two portions extend in a circumferential direction about the longitudinal axis of the medical device but not entirely about the circumference of the medical device, and two portions linearly extend in a direction parallel to the longitudinal axis of the medical device, the closed area having a length that is less than the length of the medical device, wherein the rotational orientation of the marker wire may be determined using an imaging device when the medical device is positioned within a bodily lumen;

a first directional indicator coupled to said medical device and intersecting said marker wire, the first directional indicator comprising a first portion of a symbol;

a second directional indicator coupled to said medical device and intersecting said marker wire, said second directional indicator offset from said first directional indicator, the second directional indicator comprising a second portion of the symbol;

wherein images of said first and second directional indicators physically connect to form the symbol when viewed from a proper rotational orientation about the longitudinal axis when viewed orthogonally to the longitudinal axis using an imaging device.

2. The apparatus of claim 1, wherein the marker wire is continuous.

3. The apparatus of claim 1, wherein the marker wire comprises a closed circuit.

4. The apparatus of claim 1, wherein the medical device comprises a catheter.

5. The apparatus of claim 1, wherein the medical device comprises a catheter sheath.

6. The apparatus of claim 1, wherein the medical device comprises a device that may be implanted within a bodily lumen.

7. The apparatus of claim 1, wherein the medical device comprises a stent.

8. The apparatus of claim 7, wherein the stent is self expanding.

9. The apparatus of claim 7, wherein the stent further comprises a graft that covers a portion of the stent, wherein the graft is aligned with the closed area defined by the marker wire.

10. The apparatus of claim 9, wherein the graft defines an arc length, and the first portion of the marker wire defines a similar arc length.

11. The apparatus of claim 1, wherein the medical device comprises an expansion balloon.

12. The apparatus of claim 1, wherein the marker wire comprises an MRI marker.

13. The apparatus of claim 1, further comprising a lumen and a port.

14. The apparatus of claim 13, wherein the lumen is arranged to carry away bodily material.

15. The apparatus of claim 13, wherein said marker wire extends about a rim of the port.

16. The apparatus of claim 1, further comprising a rotational ablation device.

17. An apparatus, comprising:

a medical device and a marker wire coupled to said medical device, the medical device having a longitudinal axis, the marker wire comprising four contiguous portions defining the perimeter of a closed area, wherein two portions extend in a circumferential direction about the longitudinal axis of the medical device but not entirely about the circumference of the medical device, and two portions linearly extend in a direction parallel to the longitudinal axis of the medical device, wherein the rotational orientation of the marker wire may be determined using an imaging device when the medical device is positioned within a bodily lumen;

a first directional indicator coupled to said medical device and oriented in a direction non-parallel to the longitudinal axis, the first directional indicator intersecting said marker wire and comprising a first portion of a symbol;

a second directional indicator coupled to said medical device offset from said first directional indicator and oriented in a direction non-parallel to the longitudinal axis, the second directional indicator intersecting said marker wire and comprising a second portion of the symbol;

wherein images of said first and second directional indicators physically connect to form the symbol when viewed from a proper rotational orientation about the longitudinal axis when viewed orthogonally to the longitudinal axis using an imaging device.

18. The apparatus of claim 17, wherein the symbol is an arrow.

19. The apparatus of claim 17, wherein the symbol is viewable over a rotational range of 30°

or less.

20. The apparatus of claim 17, wherein the second directional indicator is offset from the first directional indicator in a circumferential direction.

21. The apparatus of claim 20, wherein the symbol is an arrow.

22. The apparatus of claim 20, further comprising a partial graft, wherein the symbol indicates the orientation of the partial graft.

23. The apparatus of claim 20, wherein the symbol is viewable over a rotational range of 5°

or less.

24. A method of positioning an implantable medical device within a bodily lumen, comprising:

a) providing a medical device having a longitudinal axis and a rotational marker coupled to the medical device, the rotational marker comprising;

a marker wire comprising four contiguous portions defining the perimeter of a closed area, wherein two portions extend in a circumferential direction about the longitudinal axis of the medical device but not entirely about the circumference of the medical device, and two portions linearly extend in a direction parallel to the longitudinal axis of the medical device the closed area having a length that is less than the length of the medical device, wherein the rotational orientation of the marker wire may be determined using an imaging device when the medical device is positioned within a bodily lumen, and

a first directional indicator coupled to said medical device, the first directional indicator intersecting said marker wire and comprising a first portion of a symbol,

a second directional indicator coupled to said medical device offset from said first directional indicator, the second directional indicator intersecting said marker wire and comprising a second portion of the symbol, wherein images of said first and second directional indicators physically connect to form the symbol when viewed from a proper rotational orientation using an imaging device;

b) inserting the medical device into a bodily lumen and maneuvering the device to a worksite;

c) viewing the worksite and the device through an imaging device, the rotational marker and the first and second directional indicators being visible upon the imaging device, wherein the rotational orientation of the marker wire may be determined using the imaging device;

d) positioning the medical device to a proper rotational orientation using the rotational marker and the first and second directional indicators as viewed orthogonally to the longitudinal axis upon the imaging system.