Systems and devices for reducing the size of an internal tissue opening

• US 8,864,809 B2
• Filed: 08/08/2007
• Issued: 10/21/2014
• Est. Priority Date: 08/09/2006
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Miles, Scott D., Davis, Clark C., Fox, DeWayne C., Edmiston, Daryl R., Linder, Richard J.
• Primary Examiner(s): MASHACK, MARK F
• Application Number:
  US11/836,013
• Publication Number:
  US 20080039922A1
• Time in Patent Office: 2,631 Days
• Field of Search: 606/213, 606/139, 606/144, 606/148, 606/151, 606/108, 606191-200, 623 111- 125, 623/2.11
• US Class Current: 623/1.11
• 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 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• 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 2017/0061 Implements located only on one side of the opening
• 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 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00858 high friction, non-slip on handles A61B2017/00429
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00884 : enhancing wound closure
• CPC Class Codes: A61B 2017/12054 : Details concerning the detachment of the occluding device from the introduction device

Abstract

A medical system for treating an internal tissue opening can include a closure device and associated delivery device. The closure device can include a multi-cellular body portion operatively associated with a first anchor and a second anchor. The closure device can be configured to apply lateral force to tissue of the internal tissue opening for tissue approximation. The closure device can also include an ingrowth material. The delivery device can include an actuating assembly configured to partially deploy the closure device by a first movement, and deploy a second portion of the closure device by a second movement. The delivery device can also include a release assembly to selectively release or disconnect the closure device from the delivery device.

Claims

1. A delivery device for delivering a medical device from a catheter, the delivery device comprising:

a handle body defining a longitudinal axis extending therethrough; and

an actuating assembly operatively associated with said handle body and configured to unsheathe the medical device from the catheter, said actuating assembly including a linear guide defining a linear slot extending parallel to the longitudinal axis and a helical guide defining a helical slot, said actuating assembly being adapted to move linearly with respect to said handle body to an end of the linear slot to unsheathe at least a first portion of the medical device from the catheter, and, once fully moved linearly along the linear guide, to then rotate with respect to said handle body along the helical slot of the helical guide to unsheathe at least a second portion of the medical device from the catheter;

wherein said actuating assembly comprises a first member adapted to move linearly with respect to said handle body to unsheathe said at least a first portion of the medical device;

wherein said actuating assembly comprises a second tubular member adapted to rotate with respect to said handle body to unsheathe said at least a second portion of the medical device, the first member slidably positioned relative to and movable within said second tubular member such that the second tubular member is rotatable relative to the first member; and

wherein the linear slot is contiguous with the helical slot.

2. A delivery device as recited in claim 1, further comprising a release assembly adapted to facilitate detachment of the medical device from the delivery device.

3. A delivery device as recited in claim 1, further comprising a delivery assembly adapted to facilitate delivery of the medical device.

4. A delivery device as recited in claim 1, further comprising a catheter linked to said actuating assembly, wherein said catheter comprises a first lumen and second lumen in a non-coaxial arrangement.

5. A delivery device for delivering a Patent Foramen Ovale closure device, the delivery device comprising:

a handle body defining a longitudinal axis extending therethrough;

a catheter having a proximal end and a distal end, the proximal end coupled to said handle body and the distal end configured to contain the closure device;

a first member operatively associated with said handle body, said first member including a linear guide defining a linear slot therein extending linearly parallel to the longitudinal axis and being adapted to move linearly along the linear slot with respect to said handle body to partially unsheathe the closure device from the distal end of the catheter; and

a second tubular member including a helical guide defining a helical slot therein, said second tubular member being linked to said handle body and said first member, said second tubular member, upon the first member being fully moved to partially unsheathe the closure device, being adapted to move linearly with respect to said handle body and adapted to rotate along said helical slot with respect to said handle body and said first member to fully unsheathe the closure device from the distal end of the catheter, said first member slidably positioned relative to and moveable within said second tubular member such that the second tubular member is rotatable relative to the first member.

6. A delivery device as recited in claim 5, wherein said first member is linked to said handle body by a pin.

7. A delivery device as recited in claim 5, wherein linear movement of said first member with respect to said handle body causes at least a first portion of the closure device to be unsheathed.

8. A delivery device as recited in claim 5, wherein said first member is configured to linearly move with respect to said handle body and is configured to unsheathe a first anchor of the closure device.

9. A delivery device as recited in claim 5, wherein said second tubular member is configured to rotationally move with respect to said handle body and is configured to unsheathe a second anchor of the closure device.

10. A delivery device as recited in claim 5, wherein said catheter comprises tether lines extending through a catheter lumen such that said tether lines are sized and configured to extend between and are coupled to said handle body and the closure device.

11. A medical system for treating an internal tissue opening, the system comprising:

a medical device; and

a delivery device comprising;

a handle body defining a longitudinal axis extending therethrough;

a catheter having a proximal end and a distal end, the proximal end coupled to said handle body and the distal end configured to contain the medical device; and

an actuating assembly operatively associated with said handle body, said actuating assembly being adapted to selectively unsheathe a first portion of said medical device from the distal end of the catheter by a first mechanism, the first mechanism including a linear guide defining a linear slot and extending parallel with the longitudinal axis and configured to actuate by linear movement of a knob along the linear slot, and said actuating assembly being adapted to selectively unsheathe a second portion of said medical device from the distal end of the catheter by a second mechanism, the second mechanism including a helical guide defining a helical slot and, upon full linear movement of the knob, configured to actuate by rotational movement of the knob along the helical slot, the first mechanism and the second mechanism configured to be sequentially actuated to distinguish which of the first portion and the second portion of the medical device is being unsheathed from the catheter;

wherein said first mechanism comprises a first member adapted to move linearly with respect to said handle body to unsheathe the first portion of the medical device; and

wherein said second mechanism comprises a second tubular member adapted to rotate with respect to said handle body to unsheathe the second portion of the medical device, the first member slidably positioned relative to and moveable within said second tubular member such that the second tubular member is rotatable relative to the first member.

12. A medical system as recited in claim 11, wherein said medical device comprises a multi-cellular structure and at least one anchor operatively associated with said multi-cellular structure.

13. A medical system as recited in claim 11, wherein said first mechanism comprises a linear movement of the knob.

14. A medical system as recited in claim 11, wherein said second mechanism comprises a rotational movement of the knob.

15. A medical system as recited in claim 11, wherein said medical device comprises a substantially flat frame.