Micro-catheter device and method of using same

• US 20060144408A1
• Filed: 07/21/2005
• Published: 07/06/2006
• Est. Priority Date: 07/23/2004
• Status: Abandoned Application

• Current Assignee: Stereotaxis, Inc.
• Original Assignee: Stereotaxis, Inc.
• Inventors: Ferry, Steven J.
• Application Number:
  US11/186,407
• Publication Number:
  US 20060144408A1
• Time in Patent Office: Days
• US Class Current: 128/899
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers

Abstract

The micro-catheter has regions of different flexibility along its length, and has a magnetic element responsive to an applied magnetic field disposed in the distal end. The magnetic field may be applied with at least one stationary or at least one moveable magnet external to the subject body. The distal end of the micro-catheter is sufficiently flexible and the tip is sized such that the tip can bend or deflect at least 50 degrees when subjected to a magnetic field of as low as 0.1 Tesla and more preferably as low as 0.08 Tesla having a reference angle 90 degrees relative to the orientation of the distal end of the catheter.

Claims

1. A catheter having a proximal and a distal end, the catheter comprising:

a tubular inner member;

a support structure layer that surrounds at least a portion of the tubular inner member;

a magnetically responsive member on the distal end of the inner member;

at least two sleeves axially disposed over the inner member the support structure layer, the at least two sleeves having at least two different flexibilities; and

an encapsulating layer that surrounds the magnetically responsive member on the distal end, enclosing the magnetic member on the inner member.

2. The catheter according to claim 1 wherein at least a portion of the magnet member overlies the support structure layer.

3. The catheter according to claim 1 wherein there are sleeves disposed on the proximal and distal sides of the magnetically responsive element.

4. The catheter according to claim 1 wherein there are a plurality of sleeves proximal to the magnetically responsive element, and wherein the flexibility of the sleeves increases from the proximal end of the catheter toward the magnetically responsive member

5. The catheter of claim 1, wherein the support structure comprises a reinforcing wire disposed around the tubular liner.

6. The catheter of claim 1, wherein the magnetic member comprises a sleeve of magnetic material that is axially disposed over at least a portion of the support structure layer.

7. The catheter of claim 1, wherein at least one of the at least two sleeves is comprised of a material having a radiopacity level effective for enabling the catheter to be viewed by fluoroscopic imaging.

8. The catheter of claim 1, wherein the at least two sleeves comprise a decreasing hardness as the distance to the distal end decreases.

9. The catheter of claim 8, wherein the decreasing hardness of the sleeves provides an increasing degree of flexibility toward the distal end of the catheter.

10. The catheter of claim 9, wherein the distal end of the catheter deflects at least 50 degrees relative to the longitudinal axis in response to an applied magnetic field of at least 0.1 Tesla in a direction 90 degrees from the original orientation of the distal end of the catheter.

11. The catheter of claim 1, wherein the catheter is capable of bending at a minimum radius of about 0.15 inches without kinking or permanently bending.

12. A micro-catheter having a proximal and distal end;

the micro-catheter comprising;

a tubular inner member extending from the proximal end to the distal end and having a lumen therebetween;

a layer of reinforcing wire disposed around the outside of at least a portion of the inner member;

a magnetically responsive sleeve axially disposed on the inner member and disposed over at least a portion of the reinforcing wire adjacent the distal end of the micro-catheter;

a plurality of sleeves of varying lengths and stiffnesses, which are axially disposed over the inner member proximal to the magnetically responsive sleeve, the sleeves arranged in decreasing order of stiffness toward the distal end;

an encapsulating layer disposed on the distal end and surrounding at least the magnetic sleeve.

13. The micro-catheter of claim 12, wherein at least one of the plurality of sleeves are comprised of a material having a radiopacity effective for enabling the micro-catheter to be viewed by radio imaging devices.

14. The micro-catheter of claim 12, wherein the decreasing stiffness of the one or more sleeves provides an increasing degree of flexibility to the length of the micro-catheter toward the distal end of the micro-catheter.

15. The catheter of claim 13, wherein the distal end of the catheter deflects at least 50 degrees relative to the longitudinal axis in response to an applied magnetic field of at least 0.1 Tesla in a direction 90 degrees from the original orientation of the distal end of the catheter.

16. The micro-catheter of claim 15, wherein the micro-catheter is capable of bending at a minimum radius of about 0.15 inches without kinking or permanently bending.

17. The catheter of claim 12 wherein a sleeve is disposed on the proximal and distal sides of the magnetically responsive member, and wherein the encapsulation layer is bonded to the sleeves on the proximal and distal sides of the magnetically responsive member

18. The catheter of claim 16, further comprising a hydrophilic layer over at least a portion of the outer surface of the catheter.

19. The catheter device of claim 18, wherein the outside diameter of the catheter adjacent the distal end is less than about 0.146 inches, such that the catheter may be inserted within a typical guiding catheter.

20. An improved micro-catheter device having a proximal and distal end and a lumen therebetween;

the improvement comprising;

a tubular inner member;

a layer of reinforcing wire disposed around the outside of the inner liner;

a magnetically responsive sleeve axially disposed over the reinforcing wire on the distal end of the inner member;

a plurality of sleeves of varying lengths and stiffnesses, which are axially disposed over the reinforcing wire layer proximal to the magnetic sleeve, wherein the plurality of sleeves are sequentially arranged in a manner such that the stiffness of the sleeves generally decreases toward the distal end; and

an encapsulating layer disposed on the distal end and surrounding the magnetic sleeve.

21. The improved micro-catheter device of claim 20, wherein the distal end of the catheter is capable of bending at a minimum radius of about 0.15 inches without kinking or permanently bending, and is capable of being deflected at least 50 degrees relative to the longitudinal axis in response to an applied magnetic field of at least 0.1 Tesla in a direction 90 degrees from the original orientation of the distal end of the catheter.

22. The improved micro-catheter device of claim 21, wherein the plurality of sleeves comprise at least 7 sleeves having a hardnesses ranging from 25 to 72 durometer.

23. The improved micro-catheter device of claim 22, wherein a first sleeve abuts the magnetic sleeve on the distal end of the micro-catheter and has a length in the range of 1 to 2 centimeters and a durometer in the range of 30 to 40 durometer.

24. The improved micro-catheter device of claim 23, wherein a second sleeve from the distal end has a length in the range of 9.66 to 10.66 centimeters and a durometer in the range of 20 to 30 durometer.

25. The improved micro-catheter device of claim 24, wherein a third sleeve from the distal end has a length in the range of 9.66 to 10.66 centimeters and a durometer in the range of 30 to 40 durometer.

26. The improved micro-catheter device of claim 25, wherein a fourth sleeve from the distal end has a length in the range of 9.66 to 10.66 centimeters and a durometer in the range of 35 to 45 durometer.

27. The improved micro-catheter device of claim 26, wherein a fifth sleeve from the distal end has a length in the range of 9.66 to 10.66 centimeters and a durometer in the range of 50 to 60 durometer.

28. The improved micro-catheter device of claim 27, wherein a sixth sleeve from the distal end has a length in the range of 9.66 to 10.66 centimeters and a durometer in the range of 58 to 68 durometer.

29. The improved micro-catheter device of claim 28, wherein a seventh sleeve from the distal end has a length in the range of 15 to 17 centimeters and a durometer in the range of 67 to 77 durometer.