Devices and methods for controlling and indicating the length of an interventional element

• US 8,585,747 B2
• Filed: 12/10/2007
• Issued: 11/19/2013
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: JW Medical Systems Ltd
• Inventors: Andreas, Bernard, Karratt, Joseph, Flom, James R., Blackwood, Bradley
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US11/953,242
• Publication Number:
  US 20080091257A1
• Time in Patent Office: 2,171 Days
• Field of Search: 604/96.01, 604/97.01, 604/103.07, 604/103.08, 604/103.11, 604/916, 606190-195, 606/198, 606/108, 623/1.11, 623/1.12, 623/1.23, 623/2.11
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 25/0136 Handles therefor

Abstract

Devices and methods are provided for controlling and indicating the deployed length of an interventional element on an interventional catheter. The interventional element may be a stent or series of stents, a balloon, or any other interventional element for which length control is necessary or desirable. Devices for controlling the length of the interventional element include gear driven actuators, motors, and other mechanisms. Devices for indicating length of an interventional element to the user include sensors, detents, visual displays and other mechanisms providing visual, audible, and tangible indications of length to the user. The control and indication devices preferably work in tandem to enable highly precise adjustment of interventional element length.

Claims

1. A catheter comprising:

an elongated flexible shaft having a distal end and a proximal end;

an interventional element at the distal end, the interventional element having an adjustable length, wherein the interventional element comprises a stent comprising a plurality of discrete unconnected stent segments releasably coupled to the shaft adjacent the distal end thereof;

an actuator at the proximal end for adjusting the length of the interventional element, wherein an actuation of the actuator adjusts the number of discrete stent segments in a deployable portion of the stent, and wherein the actuator controls the length of the deployable portion of the stent, the deployable portion being released from the shaft while an undeployed portion of the stent remains coupled to the shaft; and

a post slidably coupled with the actuator at a distal end of the actuator such that the post is retractable within the actuator;

wherein a distal end of the post is disposed externally of the actuator, and wherein a distal portion of the post comprises an indication device for providing a tactile indication of the length of the deployable portion of the stent before deployment of the deployable portion.

2. The catheter of claim 1, wherein the interventional element further comprises a balloon.

3. The catheter of claim 2, further comprising a sheath slidably disposed over the balloon, the actuator being coupled to the sheath to axially reposition the sheath relative to the balloon.

4. The catheter of claim 1, wherein the actuator is movable through a distance correlated with the length.

5. The catheter of claim 1, wherein the actuator is movable through a stroke, each stroke of the actuator adjusting the length a predetermined amount.

6. The catheter of claim 1, wherein the indication device comprises a stop that limits the movement of the actuator.

7. The catheter of claim 1, further comprising a sensor for detecting the number of discrete stent segments of the deployable portion of the interventional element.

8. The catheter of claim 7, wherein the sensor is disposed near a distal end of the shaft.

9. The catheter of claim 7, wherein the sensor is optical.

10. The catheter of claim 7, wherein the sensor is magnetic.

11. The catheter of claim 7, further comprising a display associated with the sensor for displaying an indication of the length.

12. The catheter of claim 1, wherein the actuator provides a visual indication of the length.

13. The catheter of claim 1, wherein the indication device emits an audible indication of the length.

14. The catheter of claim 1, wherein the indication device comprises a plurality of holes and a movable detent, each hole being configured to receive the detent, whereby adjusting the length moves the detent from one hole to another hole.

15. The catheter of claim 14, wherein the reception of the detent in one of the holes provides the tactile indication of the length of the interventional element.

16. The catheter of claim 1, wherein the actuator comprises a ratchet mechanism that allows adjustment of the length in a first direction and prevents adjustment of the length in a second direction.

17. A catheter comprising:

an elongated flexible shaft having a distal end a proximal end;

an expandable member mounted at the distal end of the shaft, the expandable member being expandable to an expanded configuration having an expanded length;

a sheath axially movable relative to the shaft and being positionable around at least a portion of the expandable member to restrain the expansion thereof;

a stent comprising a plurality of discrete unconnected stent segments, the stent segments of the stent releasably positioned over the expandable member;

an actuator at the proximal end for controlling the position of the sheath relative to the expandable member to adjust the expanded length of the expandable member, wherein actuation of the actuator adjusts the number of discrete stent segments in a deployable portion of the stent, and wherein the actuator controls the length of the deployable portion of the stent, the deployable portion being released from the shaft while an undeployed portion of the stent remains coupled to the shaft; and

a post slidably coupled with the actuator such that the post is retractable within the actuator;

wherein a distal end of the post is disposed externally of the actuator, and wherein a distal portion of the post comprises an indication device for providing a tactile indication of the expanded length of the deployable portion before deployment thereof.

18. The catheter of claim 17, wherein the actuator is movable through a distance correlated with the expandable length.

19. The catheter of claim 17, wherein the actuator is movable through a stroke, each stroke of the actuator adjusting the expandable length a predetermined amount.

20. The catheter of claim 17, wherein the indication device comprises a stop that limits the movement of the actuator.

21. The catheter of claim 17, further comprising a sensor for detecting the number of discrete stent segments of the deployable portion.

22. The catheter of claim 21, wherein the sensor is disposed near a distal end of the shaft.

23. The catheter of claim 21, wherein the sensor is optical.

24. The catheter of claim 21, wherein the sensor is magnetic.

25. The catheter of claim 21, further comprising a display associated with the sensor for displaying an indication of the length.

26. The catheter of claim 17, wherein the actuator provides a visual indication of the length.

27. The catheter of claim 17, wherein the indication device emits an audible indication of the length.

28. The catheter of claim 17, wherein the indication device comprises a plurality of holes and a movable detent, each hole being configured to receive the detent, whereby adjusting the length moves the detent from one hole to another hole.

29. The catheter of claim 28, wherein the reception of the detent in one of the holes provides the tactile indication of the length of the interventional element.

30. The catheter of claim 17, wherein the actuator comprises a ratchet mechanism that allows adjustment of the length in a first direction and prevents adjustment of the length in a second direction.

31. A stent delivery catheter comprising:

an elongated flexible shaft having distal and proximal ends;

a stent comprising a plurality of discrete unconnected stent segments releasably mounted at the distal end, a deployable portion of the stent being releasable from the catheter to assume an expanded configuration, the deployable portion having a length and comprising one or more stent segments;

an actuator at the proximal end for controlling the length of the deployable portion, wherein actuation of the actuator adjusts the number of discrete stent segments in the deployable portion, and wherein the actuator controls the length of the deployable portion of the stent, the deployable portion being released from the shaft while an undeployed portion of the stent remains coupled to the shaft; and

a post slidably coupled with the actuator such that the post is retractable within the actuator;

wherein a distal end of the post is disposed externally of the actuator, and wherein a distal portion of the post comprises an indication device for tactilely indicating the length of the deployable portion before deployment of the deployable portion.

32. The catheter of claim 31, wherein the actuator is movable through a distance correlated with the length.

33. The catheter of claim 31, wherein the actuator is movable through a stroke, each stroke of the actuator adjusting the length a predetermined amount.

34. The catheter of claim 33, wherein the stent comprises a plurality of stent segments, and the stroke corresponds to a segment length of one of the stent segments.

35. The catheter of claim 31, wherein the indication device comprises a stop that limits the movement of the actuator.

36. The catheter of claim 31, further comprising a sensor for detecting the number of discrete stent segments of the deployable portion.

37. The catheter of claim 36, wherein the sensor is disposed near a distal end of the shaft.

38. The catheter of claim 36, wherein the sensor is optical.

39. The catheter of claim 36, wherein the sensor is magnetic.

40. The catheter of claim 36, further comprising a display associated with the sensor for displaying an indication of the length.

41. The catheter of claim 31, wherein the actuator provides a visual indication of the length.

42. The catheter of claim 31, wherein the indication device emits an audible indication of the length.

43. The catheter of claim 31, wherein the indication device comprises a plurality of holes and a movable detent, each hole being configured to receive the detent, whereby adjusting the length moves the detent from one hole to another hole.

44. The catheter of claim 43, wherein the reception of the detent in one of the holes provides the tactile indication of the length of the interventional element.

45. The catheter of claim 31, wherein the actuator comprises a ratchet mechanism that allows adjustment of the length in a first direction and prevents adjustment of the length in a second direction.

46. The catheter of claim 31, wherein the catheter further comprises a sheath slidable relative to the stent segments for selectively covering a first portion of the stent segment and exposing a second portion of the stent segments.

47. The catheter of claim 46, wherein the actuator moves the sheath relative to the stent segments.

48. The catheter of claim 31, wherein the actuator is further adapted to axially separate a first stent segment from a second stent segment prior to expansion thereof.

49. The catheter of claim 48, wherein the actuator is adapted to separate the first and second stent segments by a predetermined distance.

50. The catheter of claim 48, wherein the actuator has a first position for controlling the number of stent segments in the deployable portion and a second position for controlling the separation between the first and second stent segments.

51. The catheter of claim 31, wherein the indication device indicates a number of stent segments in the deployable portion.

52. The catheter of claim 31, wherein the indication device indicates the length of the undeployed portion.