DISPLACEMENT BASED LOCK AND RELEASE MECHANISM

• US 20160206423A1
• Filed: 01/14/2016
• Published: 07/21/2016
• Est. Priority Date: 01/16/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: O'Sullivan, Richard, Flannery, Art, McAfee, Patricia, Feeley, Marc, Darst, John, O'Connor, Tim, Ino, Takashi H., Foster, Daniel J., Rohl, James P., Agrawal, Sumit, Boyhan, Noel
• Granted Patent: US 10,449,043 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit

Abstract

A medical device system may include a valve replacement implant including an anchor member reversibly actuatable between a delivery configuration and a deployed configuration, wherein the implant includes at least one locking element configured to lock the anchor member in the deployed configuration, and at least one actuator element configured to engage the at least one locking element and actuate the anchor member between the delivery configuration and the deployed configuration. The at least one actuator element may include a self-biased cam mechanism configured to extend into and engage a first locking portion of the at least one locking element.

Claims

1. A medical device system, comprising:

a valve replacement implant including an anchor member reversibly actuatable between a delivery configuration and a deployed configuration;

wherein the implant includes at least one locking element configured to lock the anchor member in the deployed configuration; and

at least one actuator element configured to engage the at least one locking element and actuate the anchor member between the delivery configuration and the deployed configuration;

wherein the at least one actuator element includes a self-biased cam mechanism configured to extend into and engage a first locking portion of the at least one locking element.

2. The medical device system of claim 1, wherein the first locking portion includes a longitudinally-oriented passageway extending therethrough, and at least one side aperture extending transversely through a side wall of the first locking portion to the passageway, the at least one side aperture being configured to receive the cam mechanism therein such that the cam mechanism extends through the at least one side aperture.

3. The medical device system of claim 2, wherein the first locking portion of the at least one locking element is fixedly attached to the anchor member and a second locking portion of the at least one locking element is fixedly attached to the anchor member, the first locking portion and the second locking portion being longitudinally movable relative to each other in the delivery configuration.

4. The medical device system of claim 3, wherein the first locking portion is fixedly attached to a distal portion of the anchor member and the second locking portion is fixedly attached to a proximal portion of the anchor member.

5. The medical device system of claim 3, wherein the second locking portion includes:

a base portion having a longitudinal axis extending between a proximal end and a distal end, the base portion defining a top surface and a bottom surface;

a body portion defining a longitudinal channel extending therethrough, at least a part of the body portion extending upwardly from the base portion; and

a flap portion extending toward the proximal end from the body portion;

wherein the base portion includes a plurality of protrusions extending upwardly from the top surface proximal of the flap portion;

wherein the second locking portion is configured to slidably receive the first locking portion within the longitudinal channel.

6. The medical device system of claim 5, wherein the body portion includes at least one ramp tapering into the longitudinal channel at the distal end thereof;

wherein the at least one ramp is configured to engage the cam mechanism and urge the cam mechanism extending through the at least one side aperture inwardly, thereby releasing the at least one actuator element from the first locking portion.

7. The medical device system of claim 5, wherein the flap portion includes a second transversely-oriented ridge extending downwardly toward the base portion and laterally across the base portion, such that when the second locking portion is viewed along the longitudinal axis, the second transversely-oriented ridge obstructs at least a portion of the longitudinal channel.

8. The medical device system of claim 5, wherein the plurality of protrusions extends upwardly to a height above the top surface greater than a proximalmost edge of the flap portion.

9. The medical device system of claim 5, wherein the plurality of protrusions extends laterally to a distance from the longitudinal axis equal to or greater than the flap portion.

10. The medical device system of claim 5, wherein the flap portion is self-biased toward an equilibrium position relative to the base portion.

11. The medical device system of claim 5, wherein the first locking portion includes an engagement portion having a first transversely-oriented ridge adjacent a proximal end thereof.

12. The medical device system of claim 11, wherein the flap portion engages the first transversely-oriented ridge in the deployed configuration.

13. The medical device system of claim 1, wherein the cam mechanism includes a first leg having a transversely extending first projection configured to engage the first locking portion.

14. The medical device system of claim 13, wherein the cam mechanism further includes a second leg having a transversely extending second projection, the second projection extending in a direction opposite the first projection.

15. The medical device system of claim 13, wherein the at least one actuator element includes a retractable release pin disposed alongside the first leg, thereby preventing the cam mechanism from disengaging the first locking portion.

16. The medical device system of claim 15, wherein the retractable release pin is slidably disposed within a bore of the at least one actuator element.

17. The medical device system of claim 5, wherein a profile of the second locking portion includes a generally rectangular pocket between the flap portion and the top surface;

and a passage extending proximally from the pocket in a curve extending toward the bottom surface around a proximalmost tip of the flap portion and then back away from the bottom surface between the proximalmost tip of the flap portion and the plurality of protrusions to an upwardly-facing opening;

wherein the plurality of protrusions defines an upwardmost edge disposed at a greater distance from the bottom surface than a bottommost edge of the flap portion.

18. A method of releasing a heart valve replacement implant from a delivery device, wherein the implant includes an anchor member reversibly actuatable between a delivery configuration and a deployed configuration and at least one locking element configured to lock the anchor member in the deployed configuration, and the delivery device includes at least one actuator element configured to engage the at least one locking element and actuate the anchor member between the delivery configuration and the deployed configuration, wherein the at least one actuator element includes a self-biased cam mechanism configured to extend into and engage a first locking portion of the at least one locking element, the method comprising:

guiding the implant to a target location in the delivery configuration with the delivery device;

retracting the at least one actuator element such that a first transverse ridge on the first locking portion engages a second transverse ridge on a second locking portion, thereby locking the anchor member in the deployed configuration;

receiving tactile feedback that the anchor member has achieved the deployed configuration;

further retracting the at least one actuator element to disengage the at least one actuator element from the first locking portion; and

withdrawing the at least one actuator element from the at least one locking element, thereby leaving the implant at the target location.

19. The method of claim 18, wherein the tactile feedback includes an increase in force required to retract the at least one actuator element.

20. The method of claim 18, further including the steps of:

after receiving tactile feedback, verifying positioning of the implant within the target location;

advancing the at least one actuator element distally to unlock the anchor member from the deployed configuration;

repositioning the implant at the target location; and

retracting the at least one actuator element to re-lock the anchor member in the deployed configuration.