Sealing device and delivery system

• US 8,956,389 B2
• Filed: 07/07/2009
• Issued: 02/17/2015
• Est. Priority Date: 06/22/2009
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Van Orden, Brad W.
• Primary Examiner(s): Fishback, Ashley
• Assistant Examiner(s): OU, JING RUI
• Application Number:
  US12/498,606
• Publication Number:
  US 20100324538A1
• Time in Patent Office: 2,051 Days
• Field of Search: 606/213, 606/215, 606/221, 606/151, 606/157, 606/158, 606/103.04, 606/200, 606/191, 604/528
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: B29C 65/02 by heating, with or without pressure
• CPC Class Codes: B29C 65/48 using adhesives , i.e. using supplementary joining material; solvent bonding
• CPC Class Codes: B29C 65/4805 characterised by the type of adhesives
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses

Abstract

The invention relates to a sealing device for repair of cardiac and vascular defects or tissue opening such as a patent foramen ovale (PFO) or shunt in the heart, the vascular system, etc. and particularly provides an occluder device and trans-catheter occluder delivery system. The sealing device would have improved conformity to heart anatomy and be easily deployed, repositioned, and retrieved at the opening site.

Claims

1. A system for delivering a sealing device into a heart, the system comprising:

a sealing device;

a housing having a slot, the slot comprising a first portion and a second portion;

a first tube configured to be releasably coupled to a proximal end portion of the sealing device;

a second tube configured to be releasably coupled to a distal end portion of the sealing device; and

a first linear actuator located within the slot of the housing, the first linear actuator being configured to advance the first tube, the second tube, and the sealing device when the first linear actuator is advanced along the slot of the housing and the sealing device is coupled to the proximal and distal end portions of the first and second tubes, respectively, and the first linear actuator being configured to retract the first tube, the second tube, and the sealing device when the first linear actuator is retracted along the slot of the housing and the sealing device is coupled to the proximal and distal end portions of the first and second tubes, respectively,

wherein advancing or retracting the first linear actuator along the first portion of the slot advances or retracts the first tube without advancing or retracting the second tube, and wherein advancing or retracting the first linear actuator along the second portion of the slot advances or retracts the first tube and the second tube.

2. The delivery system of claim 1, wherein at least a portion of the second tube is disposed within the first tube, wherein at least a portion of the first tube and at least a portion of the second tube is disposed within a third tube, and wherein the first, second, and third tubes each extend into the housing through an aperture at the distal end of the housing.

3. The system of claim 1, further comprising a second linear actuator.

4. The system of claim 3, wherein a lock release actuator is coupled to the second linear actuator.

5. The system of claim 3, further comprising a third tube, and wherein the second linear actuator actuates the third tube and the second tube.

6. The system of claim 1, wherein the first tube and the second tube extend into the housing through an aperture at a distal end of the housing.

7. The system of claim 6, wherein the second tube is at least partially disposed within the first tube.

8. A system for delivering a sealing device into a heart, the system comprising:

a sealing device;

a housing including a slot;

a first tube configured to be releasably coupled to a proximal end portion of the sealing device;

a second tube configured to be releasably coupled to a distal end portion of the sealing device;

a third tube, wherein at least a portion of the first tube is disposed within the third tube and at least a portion of the second tube is disposed within the third tube, and wherein the first tube, the second tube, and the third tube each extend into the housing through an aperture at the distal end of the housing; and

a first linear actuator located within the slot, the first linear actuator advancing the first tube and the second tube when the first linear actuator is advanced along the slot, and the first linear actuator retracting the first tube and the second tube when the first linear actuator is retracted along the slot,

wherein the slot comprises a first portion and a second portion, and wherein advancing or retracting the first linear actuator along the first portion of the slot advances or retracts the first tube without advancing or retracting the second tube, and advancing or retracting the first linear actuator along the second portion of the slot advances or retracts the first tube and the second tube.

9. The system of claim 8, further comprising a second linear actuator.

10. The system of claim 9, wherein a lock release actuator is coupled to the second linear actuator.

11. The system of claim 9, wherein the second linear actuator actuates the third tube and the second tube.

12. A system for delivering a sealing device into a heart, the system comprising:

a sealing device comprising an expandable frame and a sealing member at least partially encapsulating the expandable frame;

wherein the sealing device comprises a proximal end portion and a distal end portion; and

a delivery device comprising;

a housing having a slot;

a first tube releasably coupled to a proximal end portion of the sealing device;

a second tube releasably coupled to a distal end portion of the sealing device; and

a first linear actuator located within the slot, the first linear actuator advancing the first tube, the second tube, and the sealing device when the first linear actuator is advanced along the slot, and the first linear actuator retracting the first tube, the second tube, and the sealing device when the first linear actuator is retracted along the slot,

wherein the slot comprises a first portion and a second portion, wherein advancing or retracting the first linear actuator along the first portion of the slot advances or retracts the first tube and the proximal end portion of the sealing device without advancing or retracting the second tube and the distal end portion of the sealing device, and wherein advancing or retracting the first linear actuator along the second portion of the slot advances or retracts the first tube, the second tube, and the proximal and distal end portions of the sealing device.

13. The system of claim 12, wherein advancing the first linear actuator along the first portion of the slot decreases a distance by which the proximal and distal end portions of the sealing device are separated, and retracting the first linear actuator along the first portion of the slot increases the distance by which the proximal and distal end portions of the sealing device are separated.

14. The system of claim 12, wherein the delivery device further comprises a second linear actuator.

15. The system of claim 14, wherein, an actuation of the second linear actuator separates the sealing device from the delivery device.

16. The system of claim 14, wherein a lock release actuator is coupled to the second linear actuator.

17. The system of claim 12, further comprising a third tube.

18. The system of claim 17, wherein at least a portion of the first tube is disposed within the third tube and at least a portion of the second tube is disposed within the third tube, and wherein the first tube, the second tube, and the third tube each extend into the housing through an aperture at the distal end of the housing.