Sealing device and delivery system

• US 10,806,437 B2
• Filed: 09/20/2016
• Issued: 10/20/2020
• 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: Aurilia, Brad D., Masters, Steven J.
• Primary Examiner(s): Ou, Jing Rui
• Application Number:
  US15/270,968
• Publication Number:
  US 20170007221A1
• Time in Patent Office: 1,491 Days
• 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 method of delivering a medical device to a delivery site within a patient, the method comprising:

releasably coupling a medical device with a deployment handle, the medical device including an expandable frame having a plurality of struts extending from a proximal end to a distal end of the frame;

arranging the medical device into an elongated configuration with the deployment handle by actuating a linear actuator within a slot to a proximal stopping position;

arranging the medical device into a deployed configuration by actuating the linear actuator within the slot to a distal stopping position subsequent to actuating the linear actuator to the proximal stopping position; and

moving the linear actuator laterally from a distal notch of the slot prior to withdrawing the linear actuator proximally within the slot.

2. The method of claim 1, further comprising actuating a release actuator to release the medical device from the deployment handle.

3. The method of claim 1, wherein arranging the medical device into the elongated configuration includes withdrawing the medical device within a catheter lumen of the deployment handle.

4. The method of claim 1, wherein the expandable frame comprises a proximal frame portion, and releasably coupling the medical device to the deployment handle includes coupling the proximal frame portion to the deployment handle.

5. The method of claim 1, wherein the proximal stopping position is indicative of the medical device being arranged in the elongated configuration.

6. The method of claim 1, further comprising moving the linear actuator laterally within the slot at the proximal stopping position into a proximal notch of the slot.

7. The method of claim 1, further comprising allowing the medical device to self-expand upon release from the deployment handle at the delivery site within the patient.

8. The method of claim 7, wherein the expandable frame comprises a shape memory alloy configured to self-expand upon release from the deployment handle.

9. The method of claim 1, wherein the deployment handle comprises a first tube extending from an end of the deployment handle;

a second tube configured to retract within the first tube; and

a third tube configured to retract within the second tube.

10. The method of claim 9, wherein actuating the linear actuator within the slot comprising retracting the third tube within the second tube, and retracting the second tube within the first tube.

11. The method of claim 1, wherein the medical device comprises a substantially bell shape.

12. A method for operating a deployment handle, the method comprising:

actuating at least one linear actuator within a channel arranged within a housing of the deployment handle, the deployment handle comprising a first tube extending from an end of the housing, a second tube configured to retract within the first tube, a third tube configured to retract within the second tube, and the channel having a length portion arranged along at least a partial length of the housing, and the at least one linear actuator being configured to move within the channel along the length thereof;

actuating the at least one linear actuator within the channel in the deployment handle to retract the third tube within the second tube, and retract the second tube within the first tube based on a position of the at least one linear actuator within the channel; and

releasably coupling a medical device to the deployment handle for delivery thereof, wherein the medical device comprises an elongated configuration and a deployed configuration and transitioning the third tube within the second tube and the second tube within the first tube elongates the medical device to the elongated configuration in response to withdrawing the at least one linear actuator proximally within the channel.

13. A method of delivering a medical device to a delivery site within a patient, the method comprising:

releasably coupling a medical device with a deployment handle, the medical device including an expandable frame having a plurality of struts extending from a proximal end to a distal end of the frame;

arranging the medical device into an elongated configuration with the deployment handle by actuating a linear actuator within a slot to a proximal stopping position;

arranging the medical device into a deployed configuration by actuating the linear actuator within the slot to a distal stopping position subsequent to actuating the linear actuator to the proximal stopping position; and

moving the linear actuator laterally within the slot at the proximal stopping position into a proximal notch of the slot.