Method and apparatus for patching a tissue opening

• US 6,419,669 B1
• Filed: 11/22/1999
• Issued: 07/16/2002
• Est. Priority Date: 09/20/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Appriva Medical, Inc. (Medtronic Plc)
• Inventors: Lesh, Michael D., Frazier, Andrew G. C., Roue, Chad C., van der Burg, Erik J.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/447,390
• Time in Patent Office: 967 Days
• Field of Search: 606/108, 606/198, 606/107, 606/500, 606/115, 606/117, 606/507, 606/511, 606/139
• US Class Current: 604/500
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0477 : with pre-tied sutures
• CPC Class Codes: A61B 2017/048 : for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0645 : being elastically deformed for insertion
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/24 : Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2427 : Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: Y10S 606/907 : Composed of particular material or coated

Abstract

Disclosed is a closure catheter, for patching a tissue opening such as an atrial septal defect, patent foreman ovale, or the left atrial appendage of the heart. The closure catheter carries a deployable patch and a plurality of tissue anchors, which may be deployed to secure the patch to surrounding tissue. Methods are also disclosed.

Claims

1. A method of patching an atrial septal defect, comprising the steps of:

providing a catheter having an elongate, flexible body with a proximal end and a distal end, a patch and at least two anchors removably carried by the distal end;

advancing the distal end to a position near the atrial septal defect;

positioning the patch across the defect; and

deploying the anchors from the catheter to secure the patch across the defect.

2. A method of patching an atrial septal defect as in claim 1, wherein the positioning step comprises enlarging the cross section of the patch from a reduced profile for advancing the catheter to an enlarged profile for patching the defect.

3. A method of patching an atrial septal defect as in claim 1, wherein the positioning step comprises inclining at least one patch support from an axial orientation to an inclined orientation to position the patch across the defect.

4. A method of patching an atrial septal defect as in claim 3, wherein the positioning step comprises inclining at least three patch supports from an axial orientation to an inclined orientation to position the patch across the defect.

5. A method of patching an atrial septal defect as in claim 3, wherein the deploying the anchors step comprises advancing the anchors distally through the patch and into tissue adjacent the defect to secure the patch across the defect.

6. A method of closing an opening in a subcutaneous tissue plane, comprising the steps of:

providing a catheter having a longitudinal axis, a patch and at least one anchor thereon;

advancing the catheter to the opening;

positioning the patch across the opening such that the patch is approximately parallel to the tissue plane and transverse to the longitudinal axis; and

advancing the anchor into tissue to secure the patch across the opening.

7. A method of closing an opening in a subcutaneous tissue plane as in claim 6, wherein the advancing the anchor step comprises advancing the anchor through the patch and into the tissue.

8. A method of closing an opening in a subcutaneous tissue plane as in claim 6, wherein the advancing the anchor step comprises advancing at least three anchors into the tissue to secure the patch across the opening.

9. A method of closing an opening in a subcutaneous tissue plane as in claim 6, wherein the opening is a naturally occurring opening.

10. A method of closing an opening in a subcutaneous tissue plane as in claim 9, wherein the opening is an atrial septal defect.

11. A method of closing an opening in a subcutaneous tissue plane as in claim 6, wherein the opening is a surgically created opening.

12. A method of closing an opening in a subcutaneous tissue plane as in claim 6, further comprising the step of unfolding the patch from a reduced configuration to an enlarged configuration prior to the advancing the anchor step.

13. A deployment catheter for deploying a patch across a tissue aperture, comprising:

an elongate body, having a proximal end and a distal end;

at least one patch support for removably carrying a patch; and

at least one anchor support hingeably connected to the patch support for removably carrying at least one anchor.

14. A deployment catheter as in claim 13, wherein the anchor support is movable between an axial orientation and an inclined orientation with respect to a longitudinal axis of the body.

15. A deployment catheter as in claim 14, wherein the anchor support is hingably connected to the patch support.

16. A deployment catheter as in claim 15, comprising at least four anchor supports and at least four patch supports.

17. A deployment catheter as in claim 14, further comprising a control on the proximal end of the body, wherein the anchor support is movable from the axial orientation to the inclined orientation in response to manipulation of the control.

18. A patch deployment catheter for deploying a patch across an opening, comprising:

an elongate body, having a proximal end and a distal end;

at least two supports on the catheter, movable between an axial orientation and an inclined orientation, each support comprising a proximal section, a distal section, and a hinge in between; and

a control on the catheter for moving the hinge radially outwardly from a first position for introducing the catheter to a site in the body to a second position for deploying the patch at the site;

wherein the supports are in the axial orientation when the hinge is in the first position.

19. A patch deployment catheter as in claim 18, wherein the body is flexible.

20. A patch deployment catheter as in claim 18, further comprising at least one tissue anchor carried by the proximal section of each support.

21. A patch deployment catheter as in claim 18, further comprising at least one patch carried by the distal section of each support.

22. A patch deployment catheter as in claim 21, comprising a tissue ingrowth surface on the patch.

23. A patch deployment catheter as in claim 20, wherein the proximal section comprises a tube and the tissue anchor is removably carried inside of the tube.

24. A patch deployment catheter as in claim 23, further comprising a deployment actuator extending throughout the length of the catheter, and the tissue anchor is advanced distally out of tube in response to axial movement of the actuator.