Low profile delivery system for transcatheter heart valve

• US 10,478,296 B2
• Filed: 11/20/2018
• Issued: 11/19/2019
• Est. Priority Date: 05/09/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Le, Thanh Huy, Tran, Tri D., Cayabyab, Ronaldo C., Taylor, David M., Vidal, Antonio O., Bowes, Robert
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US16/197,244
• Publication Number:
  US 20190083259A1
• Time in Patent Office: 364 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• 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 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• 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 25/1011 Multiple balloon catheters

Abstract

An apparatus for delivering a prosthetic heart valve includes a steerable guide catheter, a balloon catheter, and a flex indicator. The guide catheter has a handle and a guide tube extending from the handle. The guide tube has a distal end portion comprising a steerable section. The guide catheter further includes an adjustment mechanism on the handle and a pull wire connecting the adjustment mechanism to the steerable section for changing flexion of the steerable section. The balloon catheter includes a shaft extending coaxially through the guide tube. The shaft includes a proximal end portion and a distal end portion. The balloon catheter further includes a balloon mounted on the distal end portion of the shaft. The flex indicator moves relative to the handle upon adjustment of the adjustment mechanism. The handle includes visual indicia adjacent the flex indicator to provide visual indication of the flexion of the steerable section.

Claims

1. An apparatus for delivering a prosthetic heart valve to a patient'"'"'s native aortic valve, the apparatus comprising:

a steerable guide catheter having a handle portion and an elongated guide tube extending from the handle portion, the elongated guide tube having a distal end portion comprising a steerable section, the guide catheter further comprising an adjustment mechanism on the handle portion and a pull wire operatively connecting the adjustment mechanism to the steerable section for changing flexion of the steerable section via manual adjustment of the adjustment mechanism;

a balloon catheter comprising an elongated shaft extending coaxially through the guide tube, the shaft comprising a proximal end portion and a distal end portion, the balloon catheter further comprising an inflatable balloon mounted on the distal end portion of the shaft; and

a flex indicator that moves longitudinally relative to the adjustment mechanism and the guide tube upon manual adjustment of the adjustment mechanism relative to the handle portion,

wherein the handle portion comprises visual indicia adjacent the flex indicator to provide visual indication of the flexion of the steerable section.

2. The apparatus of claim 1, wherein the visual indicia include a first indicator and a second indicator, wherein the first indicator represents a minimal flexion of the steerable section, and wherein the second indicator represents a maximum flexion of the steerable section.

3. The apparatus of claim 1, wherein the handle portion comprises a proximal end portion and a distal end portion, wherein the flex indicator moves toward the proximal end portion of the handle portion when the flexion of the steerable section is increased, and wherein the flex indicator moves toward the distal end portion of the handle portion when the flexion of the steerable section is decreased.

4. The apparatus of claim 1, wherein the handle portion comprises an elongated slot and the visual indicia are located adjacent the slot, and wherein the flex indicator moves parallel to a length of the slot upon manual adjustment of the adjustment mechanism.

5. The apparatus of claim 1, wherein the adjustment mechanism comprises a rotatable knob, wherein rotating the knob in a first direction relative to the handle portion increases the flexion of the steerable section, and wherein rotating the knob in a second direction relative to the handle portion decreases the flexion of the steerable section.

6. The apparatus of claim 5, wherein the knob is coupled to the handle portion at a location distal to the flex indicator.

7. The apparatus of claim 5, wherein the first direction is clockwise, and wherein the second direction is counterclockwise.

8. The apparatus of claim 5, wherein the adjustment mechanism further comprises a threaded shaft coupled to the knob, and wherein the flex indicator engages threads of the threaded shaft such that rotation of the knob rotates the threaded shaft, which causes the flex indicator to move axially relative to the handle portion.

9. An apparatus for delivering a prosthetic heart valve to a patient'"'"'s native aortic valve, the apparatus comprising:

a steerable guide catheter having a handle portion and an elongated guide tube extending from the handle portion, the elongated guide tube having a distal end portion comprising a steerable section, the guide catheter further comprising an adjustment device on the handle portion and a pull wire operatively connecting the adjustment device to the steerable section, wherein the adjustment device comprises a rotatable knob, and wherein rotating the knob relative to the handle portion changes a curvature of the steerable section;

a balloon catheter comprising an elongated shaft extending coaxially through the guide tube, the shaft comprising a proximal end portion and a distal end portion, the balloon catheter further comprising an inflatable balloon mounted on the distal end portion of the shaft; and

a flex indicator that moves axially relative to the knob and the guide tube upon rotation of the knob relative to the handle portion, wherein the handle portion restricts rotational movement of the flex indicator relative to the handle portion, and

wherein the handle portion comprises one or more visual indicators adjacent the flex indicator to provide visual indication of the curvature of the steerable section.

10. The apparatus of claim 9, wherein the one or more visual indicators include a first indicator and a second indicator, wherein the first indicator represents a non-curved configuration of the steerable section, and wherein the second indicator represents a maximum curved configuration of the steerable section.

11. The apparatus of claim 9, wherein the handle portion comprises a proximal end portion and a distal end portion, wherein the flex indicator moves toward the proximal end portion of the handle portion when the curvature of the steerable section is increased, and wherein the flex indicator moves toward the distal end portion of the handle portion when the curvature of the steerable section is decreased.

12. The apparatus of claim 9, wherein the handle portion comprises an elongated slot, and wherein the flex indicator moves axially within the slot upon rotation of the knob of the adjustment device.

13. The apparatus of claim 9, wherein rotating the knob of the adjustment device in a first direction relative to the handle portion increases the curvature of the steerable section, and wherein rotating the knob of the adjustment device in a second direction relative to the handle portion decreases the curvature of the steerable section.

14. The apparatus of claim 13, wherein the first direction is clockwise, and wherein the second direction is counterclockwise.

15. The apparatus of claim 9, wherein the adjustment device further comprises a threaded shaft coupled to the knob, and wherein the flex indicator moves axially relative to the knob and the guide tube when the threaded shaft is rotated relative to the handle portion.

16. The apparatus of claim 9, wherein the knob of the adjustment device is coupled to the handle portion at a location distal to the flex indicator.

17. An apparatus for indicating flex of a distal end of a catheter, the apparatus comprising:

a guide catheter having an elongated first shaft with a distal end portion, a proximal end portion, and a lumen extending from the distal end portion to the proximal end portion, wherein the lumen of the guide catheter is configured for receiving an elongated second shaft of a balloon catheter;

at least one wire connected to the distal end portion of the first shaft;

a handle portion comprising a flex activating member, the flex activating member being coupled to the at least one wire such that adjustment of the flex activating member causes the distal end portion of the first shaft to flex; and

a flex indicating member,

wherein adjustment of the flex activating member causes the flex indicating member to move longitudinally relative to the flex activating member and the first shaft to indicate an amount of flex of the distal end portion of the first shaft.

18. The apparatus of claim 17, wherein the handle portion comprises a slot for receiving at least a portion of the flex indicating member, and wherein the flex activating member comprises a rotatable member.

19. The apparatus of claim 18, wherein the rotatable member includes an internally threaded surface portion and an externally threaded surface portion, wherein the internally threaded surface portion is configured to receiving a slide member connected to the at least one wire, and wherein the externally threaded surface portion is configured to receive an extending portion of the flex indicating member.

20. The apparatus of claim 19, wherein rotating the rotatable member causes the slide member to move along the internally threaded surface portion, wherein the movement of the slide member along the internally threaded surface portion changes the amount of flex of the distal end portion of the first shaft, wherein the rotation of the rotatable member causes the flex indicating member to move longitudinally and change its position within the slot of the handle portion, and wherein the position of the flex indicating member within the slot indicates the amount of flex of the distal end portion of the first shaft.

21. An apparatus for delivering a prosthetic heart valve to a patient'"'"'s native aortic valve, the apparatus comprising:

a steerable guide catheter having a handle portion and an elongated guide tube extending from the handle portion, the elongated guide tube having a distal end portion comprising a steerable section, the guide catheter further comprising an adjustment mechanism on the handle portion and a pull wire operatively connecting the adjustment mechanism to the steerable section for changing flexion of the steerable section via manual adjustment of the adjustment mechanism;

a balloon catheter comprising an elongated shaft extending coaxially through the guide tube, the shaft comprising a proximal end portion and a distal end portion, the balloon catheter further comprising an inflatable balloon mounted on the distal end portion of the shaft; and

a flex indicator that moves relative to the handle portion upon manual adjustment of the adjustment mechanism,

wherein the handle portion comprises a proximal end portion, a distal end portion, and visual indicia adjacent the flex indicator to provide visual indication of the flexion of the steerable section, wherein the flex indicator moves toward the proximal end portion of the handle portion when the flexion of the steerable section is increased, and wherein the flex indicator moves toward the distal end portion of the handle portion when the flexion of the steerable section is decreased.

22. An apparatus for delivering a prosthetic heart valve to a patient'"'"'s native aortic valve, the apparatus comprising:

a steerable guide catheter having a handle portion and an elongated guide tube extending from the handle portion, the elongated guide tube having a distal end portion comprising a steerable section, the guide catheter further comprising an adjustment mechanism on the handle portion and a pull wire operatively connecting the adjustment mechanism to the steerable section for changing flexion of the steerable section via manual adjustment of the adjustment mechanism;

a balloon catheter comprising an elongated shaft extending coaxially through the guide tube, the shaft comprising a proximal end portion and a distal end portion, the balloon catheter further comprising an inflatable balloon mounted on the distal end portion of the shaft; and

a flex indicator that moves relative to the handle portion upon manual adjustment of the adjustment mechanism,

wherein the handle portion comprises an elongated slot and visual indicia adjacent the flex indicator, wherein the flex indicator moves parallel to a length of the slot upon manual adjustment of the adjustment mechanism, and wherein the visual indicia provide visual indication of the flexion of the steerable section.