BALLOON RELEASE MECHANISM FOR TAVI IMPLANT

• US 20140257457A1
• Filed: 03/06/2014
• Published: 09/11/2014
• Est. Priority Date: 03/07/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Glazier, Valerie J., Wang, Huisun, Grafov, Alex
• Granted Patent: US 9,339,385 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A delivery system for an implantable medical device having at least one retention member at an end thereof includes a shaft extending in a longitudinal direction. An elongated sheath surrounds the shaft. The sheath is slidable relative to the shaft in the longitudinal direction. A space is defined inside of the sheath and is adapted to receive the medical device in an assembled or collapsed condition. A retainer is positioned at a first end of the space. At least one recess is provided in the retainer and is adapted to receive the retention member of the medical device in the assembled condition. A selectively activable member is disposed in the compartment between the longitudinal shaft and the medical device. When in an activated state, the member expands radially relative to the shaft, thereby urging the retention member to disengage from the recess.

Claims

1. A delivery system for an implantable medical device having at least one retention member, the delivery system comprising:

a shaft extending in a longitudinal direction;

an elongated sheath surrounding the shaft, the sheath being slidable relative to the shaft in the longitudinal direction;

a space defined inside of the sheath and adapted to receive the medical device in an assembled condition;

a retainer positioned at a first end of the space, the retainer having at least one recess adapted to receive the retention member of the medical device in the assembled condition; and

a selectively activable inflatable member adapted to be disposed in the space between the longitudinal shaft and the medical device,

wherein in an activated state, the inflatable member expands radially relative to the shaft, thereby urging the at least one retention member to disengage from the at least one recess.

2. The delivery system of claim 1, wherein the activable inflatable member is an inflatable balloon.

3. The delivery system of claim 1, further comprising:

a lumen along the shaft for delivering a fluid to the activable inflatable member.

4. The delivery system of claim 1, wherein the retainer further comprises a plurality of recesses configured to receive a plurality of strut junctions of a stent of the medical device.

5. The delivery system of claim 1, wherein the inflatable element comprises a woven or braided polymer.

6. The delivery system of claim 1, further comprising:

an inflation medium to selectively activate the inflatable member.

7. The delivery system of claim 6, wherein the inflation medium comprises saline, air or helium.

8. The delivery system of claim 1, further comprising:

a sensor for detecting an engagement of the retention member with the corresponding recess.

9. The delivery system of claim 8, wherein the delivery system is configured to automatically activate the inflatable member responsive to a signal from the sensor indicative of engagement of the retention member with the corresponding recess.

10. The delivery system of claim 1, wherein the recess comprises:

a neck; and

a disc-like end.

11. The delivery system of claim 10, wherein the retention member comprises:

a strut; and

a disc-like end,

wherein the disc-like end of the recess is configured to accommodate the disc-like end of the retention member, and

wherein the neck is configured to accommodate the strut.

12. The delivery system of claim 10, wherein the neck is substantially smaller than the disc-like end of the retention member.

13. A delivery system for an implantable medical device, the delivery system comprising:

an implantable device having at least one retention member;

a delivery device for releasably securing the implantable device thereto, the delivery device comprising;

an elongated shaft;

an elongated sheath surrounding a portion of the shaft and slidable relative thereto in a longitudinal direction;

a retainer coupled to the shaft and configured to be received within the sheath, the retainer having a portion thereof configured to releasably receive the at least one retention member of the implantable device; and

a selectively inflatable member adapted to be disposed in a space between the shaft and the implantable device,

wherein the at least one retention member is configured to be released upon inflation of the inflatable member.

14. The delivery system of claim 13, wherein the activable inflatable member is a balloon.

15. The delivery system of claim 13, further comprising:

a sensor for detecting an engagement of the retention member with the corresponding recess.

16. The delivery system of claim 15, wherein the delivery system is configured to automatically activate the inflatable member responsive to a signal from the sensor indicative of engagement of the retention member with the corresponding recess.

17. The delivery system of claim 13, wherein the inflatable element comprises a woven or braided polymer.

18. A method for delivering an implantable medical device having at least one retention member coupled to a stent thereof, the method comprising:

positioning a delivery device comprising a retainer, the implantable medical device, a balloon element disposed underneath at least the stent at a predetermined location in a heart, the implantable medical device being in a collapsed state thereof with the retention member engaged with corresponding at least one recess in the retainer;

unsheathing the receiving space to expose at least the stent portion of the implantable medical device; and

causing the balloon element to expand to disengage the at least one retention member from the corresponding at least one recess in the retainer, if the at least one retention member remains engaged with the at least one corresponding recess after an expansion of the medical device from its collapsed state.

19. The method of claim 18, wherein the device further comprises a sensor for detecting engagement of at least one retention member with the corresponding recess;

and

wherein the step of causing the balloon to expand is automatic, responsive to a signal from the sensor, the signal indicative of the engagement of at least one retention member with the corresponding recess.

20. The method of claim 18, further comprising introducing an inflation medium into the balloon element to cause the balloon element to expand.