Rapid exchange pre-dilator

• US 8,419,680 B2
• Filed: 06/24/2005
• Issued: 04/16/2013
• Est. Priority Date: 06/24/2005
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Stenzel, Eric B.
• Primary Examiner(s): SHUMATE, VICTORIA PEARL
• Application Number:
  US11/166,539
• Publication Number:
  US 20070010863A1
• Time in Patent Office: 2,853 Days
• Field of Search: 604/103.04, 604/104, 604/264, 623/1.1, 606/191
• US Class Current: 604/103.04
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A predilation device may comprise a shaft portion and a distal tip having helical threadings. The predilation device may further include a rapid exchange element rotatably coupled to the shaft portion. A guidewire may slidably engage the rapid exchange element and may guide the predilation device to a lesion site. The predilation device may be positioned with the distal tip abutting the lesion. The shaft portion may be rotated, thereby rotating the tip and causing the tip to pass through the lesion and predilate the lesion. In some embodiments, the tip may remove lesion material.

Claims

1. A predilator comprising:

a catheter, the catheter comprising a catheter shaft defining a central axis, the shaft having a distal tip, the distal tip having helical threadings; and

a rapid exchange element having a first internal passageway and a second internal passageway, a portion of the catheter shaft passing through the first internal passageway;

wherein the rapid exchange element is rotatably coupled to the shaft allowing rotation of the shaft about its central axis when the rapid exchange element and at least a portion of the shaft are oriented within a body vessel.

2. The predilator of claim 1, further comprising a guidewire adjacent to said catheter shaft;

a portion of the guidewire passing through the second internal passageway of the rapid exchange element.

3. The predilator of claim 1, wherein the rapid exchange element is fixed against moving along the axis of the shaft.

4. The predilator of claim 3, wherein the first internal passageway includes a raised flange which engages an annular groove in the catheter shaft.

5. The predilator of claim 3, wherein the catheter shaft includes a raised flange which engages an annular groove in the first internal passageway.

6. The predilator of claim 3, where in the first internal passageway includes a shaped wall portion constructed and arranged to rotatably engage the catheter shaft.

7. The predilator of claim 1, wherein the rapid exchange element comprises a removable clip.

8. The predilator of claim 1, wherein the rapid exchange element further comprises a bearing groove, and ball bearings within the bearing groove are arranged to roll between the bearing groove and the shaft.

9. The predilator of claim 1, wherein the shaft further comprises a bearing groove, and ball bearings within the bearing groove are arranged to roll between the bearing groove and the rapid exchange element.

10. The predilator of claim 1, wherein the shaft and distal tip further comprise an internal lumen, and the tip further includes an aperture in fluid communication with the internal lumen, the predilator configured to draw removed lesion material through said aperture and said internal lumen.

11. The predilator of claim 10, wherein the aperture is offset from the central axis of the shaft.

12. The predilator of claim 1, wherein the tip includes a distal grinding portion.

13. The predilator of claim 1, further comprising a stent oriented about the shaft between the tip and the rapid exchange element.

14. The predilator of claim 13, wherein an outer diameter of the tip is equal to or greater than an outer diameter of the stent when the stent is unexpanded.

15. The predilator of claim 1, further comprising an inflation balloon located between the tip and the rapid exchange element.

16. The predilator of claim 15, further comprising a stent oriented about the inflation balloon.

17. The predilator of claim 1, wherein the tip tapers to a point.

18. A predilator comprising:

a shaft having a distal tip and an inner lumen, the distal tip tapering to and forming a point, the distal tip having helical threadings; and

a rapid exchange element, the rapid exchange element being rotatably coupled to the shaft such that the shaft is rotatable with respect to the rapid exchange element and fixed from movement along a length of the shaft.

19. The predilator of claim 18, further comprising an aperture in the distal tip, the aperture offset from a central axis of the shaft.

20. The predilator of claim 19 wherein the distal tip comprises threadings located distal to the aperture.

21. The predilator of claim 18, further comprising a plurality of apertures in the distal tip in fluid communication with said inner lumen, the predilator configured to draw removed lesion material through said apertures and said inner lumen.

22. The predilator of claim 18, wherein a rotatable coupling between the rapid exchange element and the shaft comprises a raised flange and a recess, either the rapid exchange element or the shaft comprising the flange, the other comprising the recess, at least a portion of the raised flange oriented in the recess.

23. A device comprising:

a catheter shaft defining a central axis, the shaft having a distal tip, the distal tip comprising a taper having helical threadings; and

a rapid exchange element having a first internal passageway and a second internal passageway, a portion of the catheter shaft oriented in the first internal passageway, the rapid exchange element attached to the shaft by a rotatable coupling, said rotatable coupling comprising a raised flange and a recess, either the rapid exchange element or the shaft comprising the flange, the other comprising the recess, at least a portion of the raised flange oriented in the recess.