Systems and methods for treating a vessel using focused force

• US 9,050,441 B2
• Filed: 06/13/2013
• Issued: 06/09/2015
• Est. Priority Date: 05/11/2006
• Status: Active Grant

• Current Assignee: Y-Med, Inc. (Becton, Dickinson & Co)
• Original Assignee: Y-Med, Inc. (Becton, Dickinson & Co)
• Inventors: Solar, Ronald J., Shaked, Yoav
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US13/917,352
• Publication Number:
  US 20140163602A1
• Time in Patent Office: 726 Days
• Field of Search: 604/164.13
• US Class Current: 1/1
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• 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 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/09016 with mandrils
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A device for introduction into a body vessel includes a main elongated element, a balloon positioned at the main elongated element distal end, a distal connecting element positioned at the distal end of the balloon to receive a guidewire during use, and a longitudinally movable sheath positioned external to the main elongated element, a position of the sheath distal end with respect to the balloon defining an exposed portion of the balloon that expands when fluid is delivered to the balloon through the inflation lumen.

Claims

1. A device for introduction into a vessel, comprising:

a main elongated element having a main elongated element proximal end and a main elongated element distal end;

a balloon positioned at the main elongated element distal end, the balloon having a balloon proximal end, a balloon distal end, and an inflation lumen therethrough;

a distal connecting element positioned at the distal end of the balloon to receive a guidewire during use;

a longitudinally movable sheath positioned external to the main elongated element, the longitudinally movable sheath having a distal end and a proximal end; and

a core wire unslidingly attached to the main elongated element at a core wire attachment point, the core wire including an internal core wire portion positioned within the main elongated element and an external core wire portion positioned distally with respect to the internal core wire portion, the external core wire portion external to and running alongside the balloon,

wherein a position of the sheath distal end with respect to the balloon defines an exposed portion of the balloon that expands when fluid is delivered to the balloon through the inflation lumen.

2. The device according to claim 1, further comprising a tracking guidewire for advancement of the device into the vessel, the tracking guidewire positioned through the distal connecting element, wherein the distal connecting element is a generally cylindrical rail attached to the balloon distal end.

3. The device according to claim 1, wherein the distal connecting element is at a rotational distance from the external core wire portion of the core wire.

4. The device according to claim 1, the device further comprising a first radiopaque marker and a second radiopaque marker on the core wire along a first longitudinal axis, and a third radiopaque marker on a second longitudinal axis different from the first longitudinal axis.

5. The device according to claim 1, wherein the external core wire portion further comprises a coil wrapped around at least a portion thereof, the coil-wrapped portion positioned adjacent to the balloon, and at least one radiopaque marker on the external core wire portion.

6. The device according to claim 1, wherein a distal end of the sheath includes a tapered end with a soft edge that expands upon retraction of the sheath over the balloon.

7. The device according to claim 1, wherein the sheath comprises a braided material to prevent an unexposed portion of the balloon from expanding when the sheath is positioned external to the unexposed portion of the balloon.

8. The device according to claim 1, wherein the sheath comprises a helical coil to prevent an unexposed portion of the balloon from expanding when the sheath is positioned external to the unexposed portion of the balloon.

9. The device according to claim 1, further comprising an auxiliary elongate element proximal to the balloon within a portion of the main elongate element and aligned with the distal connecting element, and a core wire attached to the auxiliary elongate element.

10. The device according to claim 1, further comprising a handle at a proximal end of the sheath for longitudinally positioning the sheath with respect to the balloon.

11. The device according to claim 10, wherein the handle includes markings to indicate the sheath retraction and provide a length of the exposed portion of the balloon.

12. A method for treating a lesion in a vessel, comprising:

providing a device having a main elongated element, a balloon positioned at a distal end of the main elongated element, a distal connecting element positioned at a distal end of the balloon, and a longitudinally movable sheath positioned external to the main elongated element and a portion of the balloon;

inserting a tracking guidewire into the vessel;

backloading the tracking guidewire into the distal connecting element;

advancing the device over the tracking guidewire until the distal end of the device is adjacent to the lesion;

retracting the sheath to expose an exposed portion of the balloon having a length suitable for treating the lesion; and

inflating the exposed portion of the balloon to push at least the tracking guidewire against a first portion of the lesion in the vessel,

wherein the sheath prevents expansion of an unexposed portion of the balloon.

13. The method according to claim 12, wherein the device further comprises a core wire with an external core wire portion external to and running alongside the balloon, wherein inflating the exposed portion of the balloon pushes the external core wire portion against a second portion of the lesion rotationally displaced from the first portion.

14. The method according to claim 12, wherein the sheath is initially positioned in a most distal position fully covering the balloon for insertion and comprises a tapered tip that expands during retraction of the sheath to expose the exposed portion of the balloon.

15. The method according to claim 12, wherein retracting the sheath is controlled at a proximal end of the device, the proximal end of the device including markings to indicate the length of the exposed portion of the balloon.

16. The method according to claim 12, further comprising removing the device proximally along the tracking guidewire and exchanging for a second device using a rapid exchange method.

17. A device for introduction into a vessel, comprising:

a main elongated element having a main elongated element proximal end and a main elongated element distal end;

a balloon positioned at the main elongated element distal end, the balloon having a balloon proximal end, a balloon distal end, and an inflation lumen therethrough;

a distal connecting element positioned at the distal end of the balloon to receive a guidewire during use; and

a longitudinally movable sheath positioned external to the main elongated element, the longitudinally movable sheath having a distal end and a proximal end,

wherein a position of the sheath distal end with respect to the balloon defines an exposed portion of the balloon that expands when fluid is delivered to the balloon through the inflation lumen and

wherein a sheath distal end includes a tapered end with a soft edge that expands upon retraction of the sheath over the balloon.

18. The device according to claim 17, further comprising a tracking guidewire for advancement of the device into the vessel, the tracking guidewire positioned through the distal connecting element, wherein the distal connecting element is a generally cylindrical rail attached to the balloon distal end.

19. The device according to claim 17, further comprising a core wire unslidingly attached to the main elongated element at a core wire attachment point, the core wire including an internal core wire portion positioned within the main elongated element and an external core wire portion positioned distally with respect to the internal core wire portion, the external core wire portion external to and running alongside the balloon.

20. The device according to claim 17, wherein the sheath comprises a braided material to prevent an unexposed portion of the balloon from expanding when the sheath is positioned external to the unexposed portion of the balloon.

21. The device according to claim 17, wherein the sheath comprises a helical coil to prevent an unexposed portion of the balloon from expanding when the sheath is positioned external to the unexposed portion of the balloon.

22. The device according to claim 17, further comprising an auxiliary elongate element proximal to the balloon within a portion of the main elongate element and aligned with the distal connecting element, and a core wire attached to the auxiliary elongate element.

23. The device according to claim 17, wherein the handle includes markings to indicate the sheath retraction and provide a length of the exposed portion of the balloon.

24. A device for introduction into a vessel, comprising:

a main elongated element having a main elongated element proximal end and a main elongated element distal end;

a balloon positioned at the main elongated element distal end, the balloon having a balloon proximal end, a balloon distal end, and an inflation lumen therethrough;

a distal connecting element positioned at the distal end of the balloon to receive a guidewire during use;

a longitudinally movable sheath positioned external to the main elongated element, the longitudinally movable sheath having a distal end and a proximal end,

an auxiliary elongate element proximal to the balloon within a portion of the main elongate element and aligned with the distal connecting element; and

a core wire attached to the auxiliary elongate element

wherein a position of the sheath distal end with respect to the balloon defines an exposed portion of the balloon that expands when fluid is delivered to the balloon through the inflation lumen.

25. The device according to claim 24, further comprising an auxiliary elongate element proximal to the balloon within a portion of the main elongate element and aligned with the distal connecting element, and a core wire attached to the auxiliary elongate element.

26. The device according to claim 24, further comprising a tracking guidewire for advancement of the device into the vessel, the tracking guidewire positioned through the distal connecting element, wherein the distal connecting element is a generally cylindrical rail attached to the balloon distal end.

27. The device according to claim 24, further comprising a core wire unslidingly attached to the main elongated element at a core wire attachment point, the core wire including an internal core wire portion positioned within the main elongated element and an external core wire portion positioned distally with respect to the internal core wire portion, the external core wire portion external to and running alongside the balloon.

28. The device according to claim 24, wherein a distal end of the sheath includes a tapered end with a soft edge that expands upon retraction of the sheath over the balloon.

29. The device according to claim 24, wherein the sheath comprises a braided material to prevent an unexposed portion of the balloon from expanding when the sheath is positioned external to the unexposed portion of the balloon.

30. The device according to claim 24, wherein the sheath comprises a helical coil to prevent an unexposed portion of the balloon from expanding when the sheath is positioned external to the unexposed portion of the balloon.

31. The device according to claim 24, wherein the handle includes markings to indicate the sheath retraction and provide a length of the exposed portion of the balloon.