Patent foramen ovale closure device with steerable delivery system

• US 8,834,562 B2
• Filed: 07/07/2006
• Issued: 09/16/2014
• Est. Priority Date: 07/07/2005
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Chin-Chen, Chao, Grishaber, Randy David Burce, Kammerer, Gene W., Khan, Issac John, Park, Jin, Olsen, Daniel, Cedro, Rudolph
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US11/483,240
• Publication Number:
  US 20070032796A1
• Time in Patent Office: 2,993 Days
• Field of Search: 606/213, 606/219, 606/216, 606/151, 606/224, 606/225, 623/2.11, 227/67, 227/68
• US Class Current: 623/2.11
• 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 2017/003 Steerable
• 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 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle

Abstract

The present invention relates to a delivery system for delivering a device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The delivery system has an elongate member having a proximal and distal end. A deflectable needle assembly having luminal and abluminal surfaces is slideably engaged within the elongate member. An actuator is slideabley engaged within the elongate member and attached to the needle tip assembly such that translational movement of the actuator causes deflection of the deflectable needle assembly.

Claims

1. A delivery system for deploying a medical device used to close a passageway in a body comprising:

a catheter shaft having a proximal and distal end;

a deflectable tissue piercing structure slideably engaged within the catheter shaft, the deflectable tissue piercing structure having a tubular shape defining a longitudinal axis, with luminal and abluminal surfaces and an open distal tip, at least a portion of the tissue piercing structure being deflectable relative to the longitudinal axis, the deflectable tissue piercing structure further comprising;

a tubular needle body along the proximal end of the tissue piercing structure;

a tubular needle tip along the distal end of the tissue piercing structure, the needle tip terminating with a chamfered end;

a first longitudinal member forming a needle tang that attaches to the distal end of the catheter shaft to form a tab such that the catheter shaft and the needle tang cannot move relative to on another;

a second longitudinal member forming a needle spine being directly attached between the proximal end of tubular needle tip and the distal end of the tubular needle body but not to the catheter shaft, such that the needle spine is free to move within the catheter shaft; and

a needle support tube covering at least a portion of the tissue piercing structure to constrain at least a portion of the first longitudinal member and the second longitudinal member during deflection of the tissue piercing structure;

and

an actuator slideably engaged within the catheter shaft and attached to the needle spine such that translational movement of the actuator relative to the catheter shaft causes deflection of the tissue piercing structure about the tab.

2. The delivery system of claim 1 further comprising a delivery mechanism for deploying the medical device, the delivery mechanism being slideably engaged within the tissue piercing structure.

3. The delivery system of claim 2 wherein the delivery mechanism is a plunger.

4. The delivery system of claim 1 further comprising a mechanism for imparting linear translational movement to the actuator.

5. The delivery system of claim 4 wherein the mechanism for imparting movement to the actuator is a handle attached to the proximal end of the actuator.

6. The delivery system of claim 1 further comprising a sheath coaxially disposed over the catheter shaft diametrically sized such that the catheter shaft is slideably engaged within the sheath.

7. The delivery system of claim 1 wherein the tissue piercing structure is 10 French or smaller in diameter.

8. The delivery system of claim 1 wherein the tissue piercing structure comprises nitinol.

9. The delivery system of claim 1 wherein the tissue piercing structure is between 3 and 7 millimeters long.

10. The delivery system of claim 1 further comprising a sheath coaxial with the catheter shaft and diametrically sized so the catheter shaft is slideably engaged within the sheath.

11. A delivery system for deploying a medical device used to close a passageway in a body comprising:

a catheter shaft having a proximal and distal end;

a deflectable tissue piercing structure slideably engaged within the catheter shaft, the deflectable tissue piercing structure having a tubular shape defining a longitudinal axis, with luminal and abluminal surfaces and a distal tip, at least a portion of the tissue piercing structure being deflectable relative to the longitudinal axis, the tissue piercing structure further comprising;

a tubular needle body along the proximal end of the tissue piercing structure;

a tubular needle tip along the distal end of the tissue piercing structure, the needle tip terminating with a chamfered end;

a first longitudinal member forming a needle tang that attaches to the distal end of the catheter shaft to form a tab such that the catheter shaft and the needle tang cannot move relative to one another;

a second longitudinal member forming a needle spine directly attached between the proximal end of tubular needle tip and the distal end of the tubular needle body but not to the catheter shaft, such that the needle spine is free to move within the catheter shaft; and

a needle support tube covering a least a portion of the tissue piercing structure to constrain at least a portion of the first longitudinal member and the second longitudinal member during deflection of the tissue piercing structure;

and

an actuator slideably engaged within the catheter shaft and attached to the needle spine such that translational movement of the actuator relative to the catheter shaft causes deflection of the tissue piercing structure about the tab.