Magnetic navigation maneuvering sheath

• US 20080006280A1
• Filed: 07/20/2005
• Published: 01/10/2008
• Est. Priority Date: 07/20/2004
• Status: Abandoned Application

• Current Assignee: Stereotaxis, Inc.
• Original Assignee: Stereotaxis, Inc.
• Inventors: DiMonda, Richard, Aliberto, Anthony, Sell, Janothan, Diaz, Michael
• Application Number:
  US11/185,437
• Publication Number:
  US 20080006280A1
• Time in Patent Office: Days
• US Class Current: 128/899
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 34/73 Manipulators for magnetic surgery
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

The inventive apparatus may be slid onto a guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing and advanced to the distal end of the guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing to assist in holding the distal end of the guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing at a target location within a patient, by utilizing an externally applied magnetic field to hold a plurality of magnetic elements on the apparatus in alignment with the target location. A medical device may then be advanced through the guiding catheter, for example, to the target location in the patient, without the guiding catheter backing out. The apparatus in combination with magnetic navigation thus provides support to hold the guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing in place to prevent back out of the catheter.

Claims

1. An apparatus for positioning a guide catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing at a target location in the body, the apparatus comprising:

a flexible sheath having a proximal end and a distal end, and a lumen therebetween; and

one or more magnetic elements disposed on the distal end of the flexible sheath, wherein the distal end of the sheath is held in alignment with the target location through the interaction of an externally applied magnetic field associated with the one or more magnetic elements and at least one external magnetic field source outside the patient'"'"'s body.

2. The apparatus of claim 1, wherein the lumen of the sheath has a minimum inside diameter sufficient for accepting a typical guide catheter, or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing

3. The apparatus of claim 1, wherein the one or more magnetic elements are made of such material and are of such dimensions that under the influence of an applied magnetic field, the distal end portion of the apparatus substantially aligns with the local applied magnetic field.

4. The apparatus of claim 1, wherein the magnetic elements are made of a neodymium-iron boron.

5. The apparatus of claim 1, wherein the magnetic elements are made of a magnetic stainless steel.

6. The apparatus of claim 3, wherein the tip of the sheath is capable of being reoriented a minimum of 10 degrees relative to the axis of the distal end of the guide catheter, or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing when subjected to a magnetic field having a reference angle 10 or more degrees relative to the axis of the distal end of the guide catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing.

7. The apparatus of claim 6, wherein the magnetically responsive elements respond to a field strength of as low as 0.1 Tesla.

8. The apparatus of claim 7 wherein the magnetically responsive elements respond to a field strength as low as 0.06 Tesla.

9. The apparatus of claim 7, wherein the one or more magnetic elements are secured to the sheath with an adhesive or other suitable bonding methods.

10. The apparatus of claim 2, wherein the inside diameter of the lumen is at least 2 millimeters.

11. An apparatus for positioning a guide catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing at a target location in the body, the apparatus comprising:

a flexible sheath having a proximal end and a distal end, a lumen therebetween, and a hole near the distal end providing an exit from the lumen through the side of the sheath; and

a magnetic element disposed in the distal end of the flexible sheath.

12. The apparatus of claim 11, wherein the magnetically responsive element in the distal end of the sheath is capable of orienting the distal end in a desired position at the target location through the interaction of an externally applied magnetic field associated with the magnetic element and at least one external magnetic field source outside the patient'"'"'s body.

13. The apparatus of claim 12, wherein the lumen of the sheath has a minimum inside diameter sufficient for accepting a typical guide catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing

14. The apparatus of claim 13, wherein the magnetic element is made of such material and is of such dimensions that under the influence of an applied magnetic field, the distal end portion of the apparatus substantially aligns with the local applied magnetic field.

15. The apparatus of claim 14, wherein the magnetic element is made of a neodymium-iron boron.

16. The apparatus of claim 14, wherein the magnetic element is made of a magnetic stainless steel.

17. The apparatus of claim 14, wherein the tip of the sheath is capable of being reoriented a minimum of 10 degrees relative to the axis of the distal end of the guide catheter, when subjected to a magnetic field having a reference angle 10 or more degrees relative to the axis of the distal end of the guide catheter.

18. The apparatus of claim 15, wherein the magnetically responsive elements respond to a field strength of as low as 0.1 Tesla.

19. The apparatus of claim 18 wherein the magnetically responsive elements respond to a field strength as low as 0.06 Tesla.

20. The apparatus of claim 18, wherein the magnetic element is secured to the sheath with an adhesive or other suitable bonding methods.

21. The apparatus of claim 11, wherein the inside diameter of the sheath is at least about 2 millimeters.

22. The apparatus of claim 11, wherein the magnetic element has a length in the range of about 2 to about 30 millimeters.

23. An apparatus for positioning a guide catheter at a target location in the body, the apparatus comprising:

a flexible sheath having a proximal end and a distal end, a lumen therebetween, and a hole near the distal end exiting the lumen through the side of the sheath; and

a magnetic element disposed in the distal end of the flexible sheath, wherein the magnetic element in the distal end of the sheath is capable of orienting the distal end in a desired position at the target location through the interaction of an externally applied magnetic field associated with the magnetic element and at least one external magnetic field source outside the patient'"'"'s body.

24. The apparatus of claim 23, wherein the lumen of the sheath has a minimum inside diameter sufficient for accepting a typical guide catheter, or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing

25. The apparatus of claim 24, wherein the magnetic element is made of such material and is of such dimensions that under the influence of an applied magnetic field, the distal end portion of the apparatus substantially aligns with the local applied magnetic field.

26. The apparatus of claim 25, wherein the magnetic element is made of a neodymium-iron boron.

27. The apparatus of claim 25, wherein the magnetic element is made of a magnetic stainless steel.

28. The apparatus of claim 25, wherein the tip of the sheath is capable of being reoriented a minimum of 10 degrees relative to the axis of the distal end of the guide catheter, when subjected to a magnetic field having a reference angle 10 or more degrees relative to the axis of the distal end of the guide catheter, or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing

29. The apparatus of claim 28, wherein the magnetic field is of a magnitude of about 0.1 Tesla.

30. The apparatus of claim 28 wherein the magnetically responsive elements respond to a field strength as low as 0.06 Tesla.

31. The apparatus of claim 27, wherein the magnetic element is secured to the sheath with an adhesive or other suitable bonding methods.

32. The apparatus of claim 25, wherein the inside diameter of the sheath is a minimum of 2 millimeters.

33. The apparatus of claim 25, wherein the magnetic element has a length in the range of about 2 to about 30 millimeters.

34. A method of supporting a guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing using a sheath having one or more magnetically responsive elements near the distal end of the sheath, the method comprising the steps of:

inserting the distal end of the guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing into the subject body and advancing the guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing towards the target location within the subject body;

sliding the distal end of the sheath onto the proximal end of the guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing and advancing the sheath in the subject body towards the distal end of the guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing; and

subjecting the distal end of the sheath to a magnetic field applied external to the subject body so as to cause the one or more magnetically responsive elements to align with the direction of the magnetic field and hold the distal end of the guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing in a desired direction and position.

35. The method of claim 34, further comprising the steps of:

reorienting the magnetic field to align the distal end of the sheath and guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing with the desired target location; and

advancing the distal end of the guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing to the target location in the subject body.

36. The method of claim 35, further comprising the step of advancing a medical device through the guiding catheter or other thru-lumen catheters, solid catheters, such as Electrophysiology catheters and multi-lumen tubing to the desired target location.