Device and method for suturing intracardiac defects

• US 8,361,088 B2
• Filed: 10/23/2008
• Issued: 01/29/2013
• Est. Priority Date: 09/26/2003
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: McIntosh, Scott A.
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US12/257,127
• Publication Number:
  US 20090048615A1
• Time in Patent Office: 1,559 Days
• Field of Search: 606/139, 606144-150, 606213-217, 606/232, 128/898
• US Class Current: 606/144
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0491 Sewing machines for surgery
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A method for suturing a patent foramen ovale (PFO) includes providing a suturing device, advancing the suturing device through the inferior vena cava, right atrium, and PFO such that a first foot of the device is positioned in the left atrium, deploying the first foot to a deployed position, orienting the suturing device such that a distal portion of tissue of the PFO is received in a pre-formed curve portion of a foot housing of the device, advancing the first needle through tissue and further into a first needle receptacle disposed on the first foot, and advancing at least one end of the length of suture through the tissue to suture the PFO.

Claims

1. A method for suturing a patent foramen ovale (PFO), the method comprising:

providing a suturing device comprising;

a housing having a foot actuation handle and a needle actuation handle, the housing having a proximal end and a distal end;

a flexible shaft extending from the distal end of the housing, the flexible shaft having a proximal end and a distal end and a longitudinal axis;

a foot housing extending from the distal end of the shaft and having a foot housing proximal end and foot housing distal end, both of which are aligned with the longitudinal axis of the flexible shaft, the foot housing defining a pre-formed curve portion between the foot housing proximal end and foot housing distal end, the pre-formed curve portion being in the curved configuration in a pre-deployed and deployed configuration of the suturing device, the foot housing carrying a pivotable first foot pivotal about a pivotal axis orientated in the pre-formed curve portion, the first foot being operatively connected to a first foot actuation wire and a second foot actuation wire, the first foot actuation wire being connected to the foot actuation handle and being routed over a bearing disposed proximal to and radially offset from a pivot point of the first foot, the first foot actuation wire and the second foot actuation wire being connected to the first foot on opposite sides of the pivot point and extending from the foot toward the bearing at angular orientations transverse to one another;

a first needle extending from the needle actuation handle and through the shaft;

a length of suture having a first end and a second end; and

a distal sheath coupled to the foot housing distal end and extending distally from the foot housing distal end of the foot housing, the distal sheath defining a guidewire lumen distally the foot housing, a proximal end of the distal sheath having a longitudinal axis aligned with the longitudinal axis of the foot housing and the flexible shaft;

advancing the suturing device through an inferior vena cava, right atrium, and PFO such that the first foot is positioned in the left atrium;

deploying the first foot to a deployed position;

orienting the suturing device such that a distal portion of tissue of the PFO is received in the pre-formed curve portion of the foot housing;

advancing the first needle through tissue and further into a first needle receptacle disposed on the first foot; and

advancing the first end of the length of suture through the tissue.

2. The method according to claim 1, wherein advancing the first end of the length of suture comprises engaging a locking device to lockably suture the PFO.

3. The method according to claim 2, wherein the locking device comprises a locking element, the first end of the length of suture, and a plurality of beads along a length of the suture, and

advancing the first end of the length of suture comprises passing one or more of the plurality of beads through the locking element for locking engagement therewith.

4. The method according to claim 1, wherein deploying the first foot comprises deploying the first foot about the pivotal axis oriented proximate to and distal from a nadir of the pre-formed curved portion of the foot housing.

5. The method according to claim 1, further comprising advancing a second needle through tissue and further into a second needle receptacle disposed on the first foot.

6. The method according to claim 5, wherein the suturing device further comprises a flexible filament disposed along a length of the first foot, and wherein:

advancing the first needle through tissue causes a first end of the flexible filament to couple to one end of the length of suture, and

advancing the second needle through tissue causes a second end of the flexible filament to releasably couple to the second needle.

7. The method according to claim 6, further comprising retracting the second needle from the second needle receptacle and through the tissue, and thereby causing the second end of the flexible filament, coupled to the second needle, to be drawn through the tissue.

8. The method according to claim 7, wherein advancing the first end of the length of suture through the tissue comprises drawing the flexible filament, coupled to the first end of the length of suture, through the tissue until the first end of the length of suture, coupled to the first end of the flexible filament, is also drawn therethrough.

9. The method according to claim 1, wherein when the first foot is in the deployed position, the distance from one end thereof to the foot housing is longer than the distance from the other end thereof to the foot housing.

10. A method for suturing a Patent Foramen Ovale (PFO) having a Primum tissue and a Secundum tissue, the method comprising:

providing a suturing device comprising;

a housing having a first foot actuation handle and a first needle actuation handle, the housing having a proximal end and a distal end;

a flexible shaft extending from the distal end of the housing, the flexible shaft having a proximal end and a distal end and supports a distal foot housing carrying a pivotal first foot, the first foot being selectively deployable from a low profile configuration to a deployed configuration having a proximal side and a distal side, the distal foot housing having a foot housing proximal end, a foot housing distal end and a pre-formed curve portion between the foot housing proximal end and the foot housing distal end, the foot housing proximal end and the foot housing distal end being axially aligned with a longitudinal axis of the flexible shaft and the pre-formed curve portion being in a curved configuration in a pre-deployed and deployed configuration of the suturing device, the first foot being operatively connected to a first foot actuation wire and a second foot actuation wire, the first foot actuation wire being connected to the foot actuation handle and being routed over a bearing disposed proximal to and radially offset from a pivot point of the first foot, the first foot actuation wire and the second foot actuation wire being connected to the first foot on opposite sides of the pivot point and extending from the foot toward the bearing at angular orientations transverse to one another; and

a distal sheath extending distally from the foot housing distal end of the foot housing, the distal sheath defining a guidewire lumen distal the foot housing distal end of the foot housing;

advancing a distal portion of a suturing device through a right atrium, the PFO and into a left atrium;

deploying the first foot to a deployed position such that the first foot is oriented at a selectable acute angle from the longitudinal axis to provide optimal apposition of the first foot to one of the Primum tissue and the Secundum tissue;

positioning the deployed first foot adjacent to one of the Primum tissue and the Secundum tissue;

orienting the suturing device such that a distal portion of one of the Primum tissue and the Secundum tissue of the PFO is received in the pre-formed curve portion of the foot housing;

advancing a first needle of the suturing device through the one of the Primum tissue and Secundum tissue, and into receptive association with the deployed first foot, the first needle supporting one end of a length of suture; and

drawing the one end of the length of suture through one of the Primum tissue and Secundum tissue.

11. The method according to claim 10, wherein

advancing the one end of the length of suture comprises engaging a locking device to lockably suture the PFO.

12. The method according to claim 11, wherein the locking device comprises a locking element, the first end of the length of suture, and a plurality of beads along a length of the suture, and

advancing the first one of the length of suture comprises passing one or more of the plurality of beads through the locking element for locking engagement therewith.

13. The method according to claim 10, wherein deploying the first foot comprises deploying the first foot about the pivotal axis oriented proximate to and distal from a nadir of the pre-formed curved portion of the foot housing.

14. The method according to claim 10, wherein the selectable acute angle is less than about 80 degrees.

15. The method according to claim 10, wherein the selectable acute angle is less than about 51 degrees.

16. The method according to claim 10, further comprising:

positioning the deployed first foot adjacent to one of the other of the Secundum tissue and the Primum tissue; and

advancing a second needle of the suturing device through the other of the Secundum tissue and Primum tissue, and into receptive association with the deployed first foot.

17. The method according to claim 16, wherein the suturing device includes a flexible filament disposed along the length of the first foot, and wherein

advancing the first needle of the suturing device through the one of the Primum tissue and Secundum tissue causes a first end of the flexible filament to couple to a first end of the length of suture, and

advancing the second needle of the suturing device through the other of the Secundum tissue and Primum tissue causes the second end of the flexible filament to releasably couple to the second needle.

18. The method according to claim 17, further comprising:

retracting the second needle from said receptive association with the deployed first foot, and through the other of the Secundum tissue and Primum tissue, and thereby causing a second end of the flexible filament, coupled to the second needle, to be drawn therethrough.